[Title 42 CFR ]
[Code of Federal Regulations (annual edition) - October 1, 2009 Edition]
[From the U.S. Government Printing Office]



[[Page i]]

          

          42


          Part 482 to End

          Revised as of October 1, 2009


          Public Health
          



________________________

          Containing a codification of documents of general 
          applicability and future effect

          As of October 1, 2009
          With Ancillaries
                    Published by
                    Office of the Federal Register
                    National Archives and Records
                    Administration
                    A Special Edition of the Federal Register

[[Page ii]]

          U.S. GOVERNMENT OFFICIAL EDITION NOTICE

          Legal Status and Use of Seals and Logos
          
          
          The seal of the National Archives and Records Administration 
              (NARA) authenticates the Code of Federal Regulations (CFR) as 
              the official codification of Federal regulations established 
              under the Federal Register Act. Under the provisions of 44 
              U.S.C. 1507, the contents of the CFR, a special edition of the 
              Federal Register, shall be judicially noticed. The CFR is 
              prima facie evidence of the original documents published in 
              the Federal Register (44 U.S.C. 1510).

          It is prohibited to use NARA's official seal and the stylized Code 
              of Federal Regulations logo on any republication of this 
              material without the express, written permission of the 
              Archivist of the United States or the Archivist's designee. 
              Any person using NARA's official seals and logos in a manner 
              inconsistent with the provisions of 36 CFR part 1200 is 
              subject to the penalties specified in 18 U.S.C. 506, 701, and 
              1017.

          Use of ISBN Prefix

          This is the Official U.S. Government edition of this publication 
              and is herein identified to certify its authenticity. Use of 
              the 0-16 ISBN prefix is for U.S. Government Printing Office 
              Official Editions only. The Superintendent of Documents of the 
              U.S. Government Printing Office requests that any reprinted 
              edition clearly be labeled as a copy of the authentic work 
              with a new ISBN.

              
              
          U . S . G O V E R N M E N T P R I N T I N G O F F I C E

          ------------------------------------------------------------------

          U.S. Superintendent of Documents  Washington, DC 
              20402-0001

          http://bookstore.gpo.gov

          Phone: toll-free (866) 512-1800; DC area (202) 512-1800

[[Page iii]]







As of October 1, 2009

Title 42, Part 430 to End

Revised as of October 1, 2008

Is Replaced by

Title 40, Parts 430 to 481

and

Title 42, Part 482 to End



[[Page v]]





                            Table of Contents



                                                                    Page
  Explanation.................................................     vii

  Title 42:
          Chapter IV--Centers for Medicare & Medicaid 
          Services, Department of Health and Human Services 
          (Continued)                                                3
          Chapter V--Office of Inspector General-Health Care, 
          Department of Health and Human Services                  665
  Finding Aids:
      Table of CFR Titles and Chapters........................     771
      Alphabetical List of Agencies Appearing in the CFR......     791
      Table of OMB Control Numbers............................     801
      List of CFR Sections Affected...........................     803

[[Page vi]]





                     ----------------------------

                     Cite this Code: CFR
                     To cite the regulations in 
                       this volume use title, 
                       part and section number. 
                       Thus, 42 CFR 482.1 refers 
                       to title 42, part 482, 
                       section 1.

                     ----------------------------

[[Page vii]]



                               EXPLANATION

    The Code of Federal Regulations is a codification of the general and 
permanent rules published in the Federal Register by the Executive 
departments and agencies of the Federal Government. The Code is divided 
into 50 titles which represent broad areas subject to Federal 
regulation. Each title is divided into chapters which usually bear the 
name of the issuing agency. Each chapter is further subdivided into 
parts covering specific regulatory areas.
    Each volume of the Code is revised at least once each calendar year 
and issued on a quarterly basis approximately as follows:

Title 1 through Title 16.................................as of January 1
Title 17 through Title 27..................................as of April 1
Title 28 through Title 41...................................as of July 1
Title 42 through Title 50................................as of October 1

    The appropriate revision date is printed on the cover of each 
volume.

LEGAL STATUS

    The contents of the Federal Register are required to be judicially 
noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie 
evidence of the text of the original documents (44 U.S.C. 1510).

HOW TO USE THE CODE OF FEDERAL REGULATIONS

    The Code of Federal Regulations is kept up to date by the individual 
issues of the Federal Register. These two publications must be used 
together to determine the latest version of any given rule.
    To determine whether a Code volume has been amended since its 
revision date (in this case, October 1, 2009), consult the ``List of CFR 
Sections Affected (LSA),'' which is issued monthly, and the ``Cumulative 
List of Parts Affected,'' which appears in the Reader Aids section of 
the daily Federal Register. These two lists will identify the Federal 
Register page number of the latest amendment of any given rule.

EFFECTIVE AND EXPIRATION DATES

    Each volume of the Code contains amendments published in the Federal 
Register since the last revision of that volume of the Code. Source 
citations for the regulations are referred to by volume number and page 
number of the Federal Register and date of publication. Publication 
dates and effective dates are usually not the same and care must be 
exercised by the user in determining the actual effective date. In 
instances where the effective date is beyond the cut-off date for the 
Code a note has been inserted to reflect the future effective date. In 
those instances where a regulation published in the Federal Register 
states a date certain for expiration, an appropriate note will be 
inserted following the text.

OMB CONTROL NUMBERS

    The Paperwork Reduction Act of 1980 (Pub. L. 96-511) requires 
Federal agencies to display an OMB control number with their information 
collection request.

[[Page viii]]

Many agencies have begun publishing numerous OMB control numbers as 
amendments to existing regulations in the CFR. These OMB numbers are 
placed as close as possible to the applicable recordkeeping or reporting 
requirements.

OBSOLETE PROVISIONS

    Provisions that become obsolete before the revision date stated on 
the cover of each volume are not carried. Code users may find the text 
of provisions in effect on a given date in the past by using the 
appropriate numerical list of sections affected. For the period before 
January 1, 2001, consult either the List of CFR Sections Affected, 1949-
1963, 1964-1972, 1973-1985, or 1986-2000, published in eleven separate 
volumes. For the period beginning January 1, 2001, a ``List of CFR 
Sections Affected'' is published at the end of each CFR volume.

INCORPORATION BY REFERENCE

    What is incorporation by reference? Incorporation by reference was 
established by statute and allows Federal agencies to meet the 
requirement to publish regulations in the Federal Register by referring 
to materials already published elsewhere. For an incorporation to be 
valid, the Director of the Federal Register must approve it. The legal 
effect of incorporation by reference is that the material is treated as 
if it were published in full in the Federal Register (5 U.S.C. 552(a)). 
This material, like any other properly issued regulation, has the force 
of law.
    What is a proper incorporation by reference? The Director of the 
Federal Register will approve an incorporation by reference only when 
the requirements of 1 CFR part 51 are met. Some of the elements on which 
approval is based are:
    (a) The incorporation will substantially reduce the volume of 
material published in the Federal Register.
    (b) The matter incorporated is in fact available to the extent 
necessary to afford fairness and uniformity in the administrative 
process.
    (c) The incorporating document is drafted and submitted for 
publication in accordance with 1 CFR part 51.
    What if the material incorporated by reference cannot be found? If 
you have any problem locating or obtaining a copy of material listed as 
an approved incorporation by reference, please contact the agency that 
issued the regulation containing that incorporation. If, after 
contacting the agency, you find the material is not available, please 
notify the Director of the Federal Register, National Archives and 
Records Administration, Washington DC 20408, or call 202-741-6010.

CFR INDEXES AND TABULAR GUIDES

    A subject index to the Code of Federal Regulations is contained in a 
separate volume, revised annually as of January 1, entitled CFR Index 
and Finding Aids. This volume contains the Parallel Table of Authorities 
and Rules. A list of CFR titles, chapters, subchapters, and parts and an 
alphabetical list of agencies publishing in the CFR are also included in 
this volume.
    An index to the text of ``Title 3--The President'' is carried within 
that volume.
    The Federal Register Index is issued monthly in cumulative form. 
This index is based on a consolidation of the ``Contents'' entries in 
the daily Federal Register.
    A List of CFR Sections Affected (LSA) is published monthly, keyed to 
the revision dates of the 50 CFR titles.




[[Page ix]]



REPUBLICATION OF MATERIAL

    There are no restrictions on the republication of material appearing 
in the Code of Federal Regulations.

INQUIRIES

    For a legal interpretation or explanation of any regulation in this 
volume, contact the issuing agency. The issuing agency's name appears at 
the top of odd-numbered pages.
    For inquiries concerning CFR reference assistance, call 202-741-6000 
or write to the Director, Office of the Federal Register, National 
Archives and Records Administration, Washington, DC 20408 or e-mail 
fedreg.info@nara.gov.

SALES

    The Government Printing Office (GPO) processes all sales and 
distribution of the CFR. For payment by credit card, call toll-free, 
866-512-1800, or DC area, 202-512-1800, M-F 8 a.m. to 4 p.m. e.s.t. or 
fax your order to 202-512-2250, 24 hours a day. For payment by check, 
write to: US Government Printing Office - New Orders, P.O. Box 979050, 
St. Louis, MO 63197-9000. For GPO Customer Service call 202-512-1803.

ELECTRONIC SERVICES

    The full text of the Code of Federal Regulations, the LSA (List of 
CFR Sections Affected), The United States Government Manual, the Federal 
Register, Public Laws, Public Papers, Daily Compilation of Presidential 
Documents and the Privacy Act Compilation are available in electronic 
format via Federalregister.gov. For more information, contact Electronic 
Information Dissemination Services, U.S. Government Printing Office. 
Phone 202-512-1530, or 888-293-6498 (toll-free). E-mail, 
gpoaccess@gpo.gov.
    The Office of the Federal Register also offers a free service on the 
National Archives and Records Administration's (NARA) World Wide Web 
site for public law numbers, Federal Register finding aids, and related 
information. Connect to NARA's web site at www.archives.gov/federal-
register. The NARA site also contains links to GPO Access.

    Raymond A. Mosley,
    Director,
    Office of the Federal Register.
    October 1, 2009.







[[Page xi]]



                               THIS TITLE

    Title 42--Public Health is composed of five volumes. The parts in 
these volumes are arranged in the following order: Parts 1-399, parts 
400-413, parts 414-429, parts 430 to 481, and part 482 to end. The first 
volume (parts 1-399) contains current regulations issued under chapter 
I--Public Health Service (HHS). The second, third, and fourth volumes 
(parts 400-413, parts 414-429, and parts 430 to 481) include regulations 
issued under chapter IV--Centers for Medicare & Medicaid Services (HHS) 
and the fifth volume (part 482 to end) contains the remaining 
regulations in chapter IV and the regulations issued under chapter V by 
the Office of Inspector General-Health Care (HHS). The contents of these 
volumes represent all current regulations codified under this title of 
the CFR as of October 1, 2009.

    The OMB control numbers for the Centers for Medicare & Medicaid 
Services appear in Sec.  400.310 of chapter IV. For the convenience of 
the user, subpart C consisting of Sec. Sec.  400.300-400.310 is 
reprinted in the Finding Aids section of the third, fourth and fifth 
volumes.

    For this volume, Jonn V. Lilyea was Chief Editor. The Code of 
Federal Regulations publication program is under the direction of 
Michael L. White, assisted by Ann Worley.


[[Page 1]]



                         TITLE 42--PUBLIC HEALTH




                            (Part 482 to End)

  --------------------------------------------------------------------
                                                                    Part

chapter iv--Centers for Medicare & Medicaid Services, 
  Department of Health and Human Services (Continued).......         482

chapter v--Office of Inspector General-Health Care, 
  Department of Health and Human Services...................        1000

[[Page 3]]



  CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 
                  HEALTH AND HUMAN SERVICES (CONTINUED)




  --------------------------------------------------------------------


  Editorial Note: Nomenclature changes to chapter IV appear at 66 FR 
39452, July 31, 2001; 67 FR 36540, May 24, 2002; and 69 FR 18803, Apr. 
9, 2004.

                SUBCHAPTER G--STANDARDS AND CERTIFICATION
Part                                                                Page
482             Conditions of participation for hospitals...           5
483             Requirements for States and long term care 
                    facilities..............................          40
484             Home health services........................         110
485             Conditions of participation: Specialized 
                    providers...............................         131
486             Conditions for coverage of specialized 
                    services furnished by suppliers.........         160
488             Survey, certification, and enforcement 
                    procedures..............................         179
489             Provider agreements and supplier approval...         469
491             Certification of certain health facilities..         500
493             Laboratory requirements.....................         506
494             Conditions for coverage for end-stage renal 
                    disease facilities......................         627
498             Appeals procedures for determinations that 
                    affect participation in the Medicare 
                    program and for determinations that 
                    affect the participation of ICFs/MR and 
                    certain NFs in the Medicaid program.....         643
      SUBCHAPTER H--HEALTH CARE INFRASTRUCTURE IMPROVEMENT PROGRAM
505             Establishment of the health care 
                    infrastructure improvement program......         660

[[Page 5]]



                SUBCHAPTER G_STANDARDS AND CERTIFICATION





PART 482_CONDITIONS OF PARTICIPATION FOR HOSPITALS--Table of Contents




                      Subpart A_General Provisions

Sec.
482.1 Basis and scope.
482.2 Provision of emergency services by nonparticipating hospitals.

                        Subpart B_Administration

482.11 Condition of participation: Compliance with Federal, State and 
          local laws.
482.12 Condition of participation: Governing body.
482.13 Condition of participation: Patient's rights.

                   Subpart C_Basic Hospital Functions

482.21 Condition of participation: Quality assessment and performance 
          improvement program.
482.22 Condition of participation: Medical staff.
482.23 Condition of participation: Nursing services.
482.24 Condition of participation: Medical record services.
482.25 Condition of participation: Pharmaceutical services.
482.26 Condition of participation: Radiologic services.
482.27 Condition of participation: Laboratory services.
482.28 Condition of participation: Food and dietetic services.
482.30 Condition of participation: Utilization review.
482.41 Condition of participation: Physical environment.
482.42 Condition of participation: Infection control.
482.43 Condition of participation: Discharge planning.
482.45 Condition of participation: Organ, tissue, and eye procurement.

                  Subpart D_Optional Hospital Services

482.51 Condition of participation: Surgical services.
482.52 Condition of participation: Anesthesia services.
482.53 Condition of participation: Nuclear medicine services.
482.54 Condition of participation: Outpatient services.
482.55 Condition of participation: Emergency services.
482.56 Condition of participation: Rehabilitation services.
482.57 Condition of participation: Respiratory care services.

             Subpart E_Requirements for Specialty Hospitals

482.60 Special provisions applying to psychiatric hospitals.
482.61 Condition of participation: Special medical record requirements 
          for psychiatric hospitals.
482.62 Condition of participation: Special staff requirements for 
          psychiatric hospitals.
482.66 Special requirements for hospital providers of long-term care 
          services (``swing-beds'').
482.68 Special requirements for transplant centers.
482.70 Definitions.

               General Requirements for Transplant Centers

482.72 Condition of participation: OPTN Membership.
482.74 Condition of participation: Notification to CMS.
482.76 Condition of participation: Pediatric Transplants.

  Transplant Center Data Submission, Clinical Experience, and Outcome 
                              Requirements

482.80 Condition of participation: Data submission, clinical experience, 
          and outcome requirements for initial approval of transplant 
          centers.
482.82 Condition of participation: Data submission, clinical experience, 
          and outcome requirements for re-approval of transplant 
          centers.

                 Transplant Center Process Requirements

482.90 Condition of participation: Patient and living donor selection.
482.92 Condition of participation: Organ recovery and receipt.
482.94 Condition of participation: Patient and living donor management.
482.96 Condition of participation: Quality assessment and performance 
          improvement (QAPI).
482.98 Condition of participation: Human resources.
482.100 Condition of participation: Organ procurement.
482.102 Condition of participation: Patient and living donor rights.
482.104 Condition of participation: Additional requirements for kidney 
          transplant centers.


[[Page 6]]


    Authority: Secs. 1102, 1871 and 1881 of the Social Security Act (42 
U.S.C. 1302, 1395hh, and 1395rr), unless otherwise noted.

    Source: 51 FR 22042, June 17, 1986, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  482.1  Basis and scope.

    (a) Statutory basis. (1) Section 1861(e) of the Act provides that--
    (i) Hospitals participating in Medicare must meet certain specified 
requirements; and
    (ii) The Secretary may impose additional requirements if they are 
found necessary in the interest of the health and safety of the 
individuals who are furnished services in hospitals.
    (2) Section 1861(f) of the Act provides that an institution 
participating in Medicare as a psychiatric hospital must meet certain 
specified requirements imposed on hospitals under section 1861(e), must 
be primarily engaged in providing, by or under the supervision of a 
physician, psychiatric services for the diagnosis and treatment of 
mentally ill persons, must maintain clinical records and other records 
that the Secretary finds necessary, and must meet staffing requirements 
that the Secretary finds necessary to carry out an active program of 
treatment for individuals who are furnished services in the hospital. A 
distinct part of an institution can participate as a psychiatric 
hospital if the institution meets the specified 1861(e) requirements and 
is primarily engaged in providing psychiatric services, and if the 
distinct part meets the records and staffing requirements that the 
Secretary finds necessary.
    (3) Sections 1861(k) and 1902(a)(30) of the Act provide that 
hospitals participating in Medicare and Medicaid must have a utilization 
review plan that meets specified requirements.
    (4) Section 1883 of the Act sets forth the requirements for 
hospitals that provide long term care under an agreement with the 
Secretary.
    (5) Section 1905(a) of the Act provides that ``medical assistance'' 
(Medicaid) payments may be applied to various hospital services. 
Regulations interpreting those provisions specify that hospitals 
receiving payment under Medicaid must meet the requirements for 
participation in Medicare (except in the case of medical supervision of 
nurse-midwife services. See Sec. Sec.  440.10 and 440.165 of this 
chapter.).
    (b) Scope. Except as provided in subpart A of part 488 of this 
chapter, the provisions of this part serve as the basis of survey 
activities for the purpose of determining whether a hospital qualifies 
for a provider agreement under Medicare and Medicaid.

[51 FR 22042, June 17, 1986, as amended at 60 FR 50442, Sept. 29, 1995]



Sec.  482.2  Provision of emergency services by nonparticipating hospitals.

    (a) The services of an institution that does not have an agreement 
to participate in the Medicare program may, nevertheless, be reimbursed 
under the program if--
    (1) The services are emergency services; and
    (2) The institution meets the requirements of section 1861(e) (1) 
through (5) and (7) of the Act. Rules applicable to emergency services 
furnished by nonparticipating hospitals are set forth in subpart G of 
part 424 of this chapter.
    (b) Section 440.170(e) of this chapter defines emergency hospital 
services for purposes of Medicaid reimbursement.

[51 FR 22042, June 17, 1986, as amended at 53 FR 6648, Mar. 2, 1988]



                        Subpart B_Administration



Sec.  482.11  Condition of participation: Compliance with Federal, State and local laws.

    (a) The hospital must be in compliance with applicable Federal laws 
related to the health and safety of patients.
    (b) The hospital must be--
    (1) Licensed; or
    (2) Approved as meeting standards for licensing established by the 
agency of the State or locality responsible for licensing hospitals.
    (c) The hospital must assure that personnel are licensed or meet 
other applicable standards that are required by State or local laws.

[[Page 7]]



Sec.  482.12  Condition of participation: Governing body.

    The hospital must have an effective governing body legally 
responsible for the conduct of the hospital as an institution. If a 
hospital does not have an organized governing body, the persons legally 
responsible for the conduct of the hospital must carry out the functions 
specified in this part that pertain to the governing body.
    (a) Standard: Medical staff. The governing body must:
    (1) Determine, in accordance with State law, which categories of 
practitioners are eligible candidates for appointment to the medical 
staff;
    (2) Appoint members of the medical staff after considering the 
recommendations of the existing members of the medical staff;
    (3) Assure that the medical staff has bylaws;
    (4) Approve medical staff bylaws and other medical staff rules and 
regulations;
    (5) Ensure that the medical staff is accountable to the governing 
body for the quality of care provided to patients;
    (6) Ensure the criteria for selection are individual character, 
competence, training, experience, and judgment; and
    (7) Ensure that under no circumstances is the accordance of staff 
membership or professional privileges in the hospital dependent solely 
upon certification, fellowship, or membership in a specialty body or 
society.
    (b) Standard: Chief executive officer. The governing body must 
appoint a chief executive officer who is responsible for managing the 
hospital.
    (c) Standard: Care of patients. In accordance with hospital policy, 
the governing body must ensure that the following requirements are met:
    (1) Every Medicare patient is under the care of:
    (i) A doctor of medicine or osteopathy (This provision is not to be 
construed to limit the authority of a doctor of medicine or osteopathy 
to delegate tasks to other qualified health care personnel to the extent 
recognized under State law or a State's regulatory mechanism.);
    (ii) A doctor of dental surgery or dental medicine who is legally 
authorized to practice dentistry by the State and who is acting within 
the scope of his or her license;
    (iii) A doctor of podiatric medicine, but only with respect to 
functions which he or she is legally authorized by the State to perform;
    (iv) A doctor of optometry who is legally authorized to practice 
optometry by the State in which he or she practices;
    (v) A chiropractor who is licensed by the State or legally 
authorized to perform the services of a chiropractor, but only with 
respect to treatment by means of manual manipulation of the spine to 
correct a subluxation demonstrated by x-ray to exist; and
    (vi) A clinical psychologist as defined in Sec.  410.71 of this 
chapter, but only with respect to clinical psychologist services as 
defined in Sec.  410.71 of this chapter and only to the extent permitted 
by State law.
    (2) Patients are admitted to the hospital only on the recommendation 
of a licensed practitioner permitted by the State to admit patients to a 
hospital. If a Medicare patient is admitted by a practitioner not 
specified in paragraph (c)(1) of this section, that patient is under the 
care of a doctor of medicine or osteopathy.
    (3) A doctor of medicine or osteopathy is on duty or on call at all 
times.
    (4) A doctor of medicine or osteopathy is responsible for the care 
of each Medicare patient with respect to any medical or psychiatric 
problem that--
    (i) is present on admission or develops during hospitalization; and
    (ii) Is not specifically within the scope of practice of a doctor of 
dental surgery, dental medicine, podiatric medicine, or optometry; a 
chiropractor; or clinical psychologist, as that scope is--
    (A) Defined by the medical staff;
    (B) Permitted by State law; and
    (C) Limited, under paragraph (c)(1)(v) of this section, with respect 
to chiropractors.
    (d) Standard: Institutional plan and budget. The institution must 
have an overall institutional plan that meets the following conditions:

[[Page 8]]

    (1) The plan must include an annual operating budget that is 
prepared according to generally accepted accounting principles.
    (2) The budget must include all anticipated income and expenses. 
This provision does not require that the budget identify item by item 
the components of each anticipated income or expense.
    (3) The plan must provide for capital expenditures for at least a 3-
year period, including the year in which the operating budget specified 
in paragraph (d)(2) of this section is applicable.
    (4) The plan must include and identify in detail the objective of, 
and the anticipated sources of financing for, each anticipated capital 
expenditure in excess of $600,000 (or a lesser amount that is 
established, in accordance with section 1122(g)(1) of the Act, by the 
State in which the hospital is located) that relates to any of the 
following:
    (i) Acquisition of land;
    (ii) Improvement of land, buildings, and equipment; or
    (iii) The replacement, modernization, and expansion of buildings and 
equipment.
    (5) The plan must be submitted for review to the planning agency 
designated in accordance with section 1122(b) of the Act, or if an 
agency is not designated, to the appropriate health planning agency in 
the State. (See part 100 of this title.) A capital expenditure is not 
subject to section 1122 review if 75 percent of the health care 
facility's patients who are expected to use the service for which the 
capital expenditure is made are individuals enrolled in a health 
maintenance organization (HMO) or competitive medical plan (CMP) that 
meets the requirements of section 1876(b) of the Act, and if the 
Department determines that the capital expenditure is for services and 
facilities that are needed by the HMO or CMP in order to operate 
efficiently and economically and that are not otherwise readily 
accessible to the HMO or CMP because--
    (i) The facilities do not provide common services at the same site;
    (ii) The facilities are not available under a contract of reasonable 
duration;
    (iii) Full and equal medical staff privileges in the facilities are 
not available;
    (iv) Arrangements with these facilities are not administratively 
feasible; or
    (v) The purchase of these services is more costly than if the HMO or 
CMP provided the services directly.
    (6) The plan must be reviewed and updated annually.
    (7) The plan must be prepared--
    (i) Under the direction of the governing body; and
    (ii) By a committee consisting of representatives of the governing 
body, the administrative staff, and the medical staff of the 
institution.
    (e) Standard: Contracted services. The governing body must be 
responsible for services furnished in the hospital whether or not they 
are furnished under contracts. The governing body must ensure that a 
contractor of services (including one for shared services and joint 
ventures) furnishes services that permit the hospital to comply with all 
applicable conditions of participation and standards for the contracted 
services.
    (1) The governing body must ensure that the services performed under 
a contract are provided in a safe and effective manner.
    (2) The hospital must maintain a list of all contracted services, 
including the scope and nature of the services provided.
    (f) Standard: Emergency services. (1) If emergency services are 
provided at the hospital, the hospital must comply with the requirements 
of Sec.  482.55.
    (2) If emergency services are not provided at the hospital, the 
governing body must assure that the medical staff has written policies 
and procedures for appraisal of emergencies, initial treatment, and 
referral when appropriate.
    (3) If emergency services are provided at the hospital but are not 
provided at one or more off-campus departments of the hospital, the 
governing body of the hospital must assure that the medical staff has 
written policies and procedures in effect with respect to the off-campus 
department(s) for appraisal of

[[Page 9]]

emergencies and referral when appropriate.

[51 FR 22042, June 17, 1986; 51 FR 27847, Aug. 4, 1986, as amended at 53 
FR 6549, Mar. 1, 1988; 53 FR 18987, May 26, 1988; 56 FR 8852, Mar. 1, 
1991; 56 FR 23022, May 20, 1991; 59 FR 46514, Sept. 8, 1994; 63 FR 
20130, Apr. 23, 1998; 63 FR 33874, June 22, 1998; 68 FR 53262, Sept. 9, 
2003]



Sec.  482.13  Condition of participation: Patient's rights.

    A hospital must protect and promote each patient's rights.
    (a) Standard: Notice of rights--(1) A hospital must inform each 
patient, or when appropriate, the patient's representative (as allowed 
under State law), of the patient's rights, in advance of furnishing or 
discontinuing patient care whenever possible.
    (2) The hospital must establish a process for prompt resolution of 
patient grievances and must inform each patient whom to contact to file 
a grievance. The hospital's governing body must approve and be 
responsible for the effective operation of the grievance process and 
must review and resolve grievances, unless it delegates the 
responsibility in writing to a grievance committee. The grievance 
process must include a mechanism for timely referral of patient concerns 
regarding quality of care or premature discharge to the appropriate 
Utilization and Quality Control Quality Improvement Organization. At a 
minimum:
    (i) The hospital must establish a clearly explained procedure for 
the submission of a patient's written or verbal grievance to the 
hospital.
    (ii) The grievance process must specify time frames for review of 
the grievance and the provision of a response.
    (iii) In its resolution of the grievance, the hospital must provide 
the patient with written notice of its decision that contains the name 
of the hospital contact person, the steps taken on behalf of the patient 
to investigate the grievance, the results of the grievance process, and 
the date of completion.
    (b) Standard: Exercise of rights. (1) The patient has the right to 
participate in the development and implementation of his or her plan of 
care.
    (2) The patient or his or her representative (as allowed under State 
law) has the right to make informed decisions regarding his or her care. 
The patient's rights include being informed of his or her health status, 
being involved in care planning and treatment, and being able to request 
or refuse treatment. This right must not be construed as a mechanism to 
demand the provision of treatment or services deemed medically 
unnecessary or inappropriate.
    (3) The patient has the right to formulate advance directives and to 
have hospital staff and practitioners who provide care in the hospital 
comply with these directives, in accordance with Sec.  489.100 of this 
part (Definition), Sec.  489.102 of this part (Requirements for 
providers), and Sec.  489.104 of this part (Effective dates).
    (4) The patient has the right to have a family member or 
representative of his or her choice and his or her own physician 
notified promptly of his or her admission to the hospital.
    (c) Standard: Privacy and safety. (1) The patient has the right to 
personal privacy.
    (2) The patient has the right to receive care in a safe setting.
    (3) The patient has the right to be free from all forms of abuse or 
harassment.
    (d) Standard: Confidentiality of patient records. (1) The patient 
has the right to the confidentiality of his or her clinical records.
    (2) The patient has the right to access information contained in his 
or her clinical records within a reasonable time frame. The hospital 
must not frustrate the legitimate efforts of individuals to gain access 
to their own medical records and must actively seek to meet these 
requests as quickly as its record keeping system permits.
    (e) Standard: Restraint or seclusion. All patients have the right to 
be free from physical or mental abuse, and corporal punishment. All 
patients have the right to be free from restraint or seclusion, of any 
form, imposed as a means of coercion, discipline, convenience, or 
retaliation by staff. Restraint or seclusion may only be imposed to 
ensure the immediate physical safety of the patient, a staff member, or 
others and must be discontinued at the earliest possible time.
    (1) Definitions. (i) A restraint is--

[[Page 10]]

    (A) Any manual method, physical or mechanical device, material, or 
equipment that immobilizes or reduces the ability of a patient to move 
his or her arms, legs, body, or head freely; or
    (B) A drug or medication when it is used as a restriction to manage 
the patient's behavior or restrict the patient's freedom of movement and 
is not a standard treatment or dosage for the patient's condition.
    (C) A restraint does not include devices, such as orthopedically 
prescribed devices, surgical dressings or bandages, protective helmets, 
or other methods that involve the physical holding of a patient for the 
purpose of conducting routine physical examinations or tests, or to 
protect the patient from falling out of bed, or to permit the patient to 
participate in activities without the risk of physical harm (this does 
not include a physical escort).
    (ii) Seclusion is the involuntary confinement of a patient alone in 
a room or area from which the patient is physically prevented from 
leaving. Seclusion may only be used for the management of violent or 
self-destructive behavior.
    (2) Restraint or seclusion may only be used when less restrictive 
interventions have been determined to be ineffective to protect the 
patient a staff member or others from harm.
    (3) The type or technique of restraint or seclusion used must be the 
least restrictive intervention that will be effective to protect the 
patient, a staff member, or others from harm.
    (4) The use of restraint or seclusion must be--
    (i) In accordance with a written modification to the patient's plan 
of care; and
    (ii) Implemented in accordance with safe and appropriate restraint 
and seclusion techniques as determined by hospital policy in accordance 
with State law.
    (5) The use of restraint or seclusion must be in accordance with the 
order of a physician or other licensed independent practitioner who is 
responsible for the care of the patient as specified under Sec.  
482.12(c) and authorized to order restraint or seclusion by hospital 
policy in accordance with State law.
    (6) Orders for the use of restraint or seclusion must never be 
written as a standing order or on an as needed basis (PRN).
    (7) The attending physician must be consulted as soon as possible if 
the attending physician did not order the restraint or seclusion.
    (8) Unless superseded by State law that is more restrictive--
    (i) Each order for restraint or seclusion used for the management of 
violent or self-destructive behavior that jeopardizes the immediate 
physical safety of the patient, a staff member, or others may only be 
renewed in accordance with the following limits for up to a total of 24 
hours:
    (A) 4 hours for adults 18 years of age or older;
    (B) 2 hours for children and adolescents 9 to 17 years of age; or
    (C) 1 hour for children under 9 years of age; and
    (ii) After 24 hours, before writing a new order for the use of 
restraint or seclusion for the management of violent or self-destructive 
behavior, a physician or other licensed independent practitioner who is 
responsible for the care of the patient as specified under Sec.  
482.12(c) of this part and authorized to order restraint or seclusion by 
hospital policy in accordance with State law must see and assess the 
patient.
    (iii) Each order for restraint used to ensure the physical safety of 
the non-violent or non-self-destructive patient may be renewed as 
authorized by hospital policy.
    (9) Restraint or seclusion must be discontinued at the earliest 
possible time, regardless of the length of time identified in the order.
    (10) The condition of the patient who is restrained or secluded must 
be monitored by a physician, other licensed independent practitioner or 
trained staff that have completed the training criteria specified in 
paragraph (f) of this section at an interval determined by hospital 
policy.
    (11) Physician and other licensed independent practitioner training 
requirements must be specified in hospital policy. At a minimum, 
physicians and other licensed independent practitioners authorized to 
order restraint or

[[Page 11]]

seclusion by hospital policy in accordance with State law must have a 
working knowledge of hospital policy regarding the use of restraint or 
seclusion.
    (12) When restraint or seclusion is used for the management of 
violent or self-destructive behavior that jeopardizes the immediate 
physical safety of the patient, a staff member, or others, the patient 
must be seen face-to-face within 1 hour after the initiation of the 
intervention--
    (i) By a--
    (A) Physician or other licensed independent practitioner; or
    (B) Registered nurse or physician assistant who has been trained in 
accordance with the requirements specified in paragraph (f) of this 
section.
    (ii) To evaluate--
    (A) The patient's immediate situation;
    (B) The patient's reaction to the intervention;
    (C) The patient's medical and behavioral condition; and
    (D) The need to continue or terminate the restraint or seclusion.
    (13) States are free to have requirements by statute or regulation 
that are more restrictive than those contained in paragraph (e)(12)(i) 
of this section.
    (14) If the face-to-face evaluation specified in paragraph (e)(12) 
of this section is conducted by a trained registered nurse or physician 
assistant, the trained registered nurse or physician assistant must 
consult the attending physician or other licensed independent 
practitioner who is responsible for the care of the patient as specified 
under Sec.  482.12(c) as soon as possible after the completion of the 1-
hour face-to-face evaluation.
    (15) All requirements specified under this paragraph are applicable 
to the simultaneous use of restraint and seclusion. Simultaneous 
restraint and seclusion use is only permitted if the patient is 
continually monitored--
    (i) Face-to-face by an assigned, trained staff member; or
    (ii) By trained staff using both video and audio equipment. This 
monitoring must be in close proximity to the patient.
    (16) When restraint or seclusion is used, there must be 
documentation in the patient's medical record of the following:
    (i) The 1-hour face-to-face medical and behavioral evaluation if 
restraint or seclusion is used to manage violent or self-destructive 
behavior;
    (ii) A description of the patient's behavior and the intervention 
used;
    (iii) Alternatives or other less restrictive interventions attempted 
(as applicable);
    (iv) The patient's condition or symptom(s) that warranted the use of 
the restraint or seclusion; and
    (v) The patient's response to the intervention(s) used, including 
the rationale for continued use of the intervention.
    (f) Standard: Restraint or seclusion: Staff training requirements. 
The patient has the right to safe implementation of restraint or 
seclusion by trained staff.
    (1) Training intervals. Staff must be trained and able to 
demonstrate competency in the application of restraints, implementation 
of seclusion, monitoring, assessment, and providing care for a patient 
in restraint or seclusion--
    (i) Before performing any of the actions specified in this 
paragraph;
    (ii) As part of orientation; and
    (iii) Subsequently on a periodic basis consistent with hospital 
policy.
    (2) Training content. The hospital must require appropriate staff to 
have education, training, and demonstrated knowledge based on the 
specific needs of the patient population in at least the following:
    (i) Techniques to identify staff and patient behaviors, events, and 
environmental factors that may trigger circumstances that require the 
use of a restraint or seclusion.
    (ii) The use of nonphysical intervention skills.
    (iii) Choosing the least restrictive intervention based on an 
individualized assessment of the patient's medical, or behavioral status 
or condition.
    (iv) The safe application and use of all types of restraint or 
seclusion used in the hospital, including training in how to recognize 
and respond to signs of physical and psychological distress (for 
example, positional asphyxia);
    (v) Clinical identification of specific behavioral changes that 
indicate that

[[Page 12]]

restraint or seclusion is no longer necessary.
    (vi) Monitoring the physical and psychological well-being of the 
patient who is restrained or secluded, including but not limited to, 
respiratory and circulatory status, skin integrity, vital signs, and any 
special requirements specified by hospital policy associated with the 1-
hour face-to-face evaluation.
    (vii) The use of first aid techniques and certification in the use 
of cardiopulmonary resuscitation, including required periodic 
recertification.
    (3) Trainer requirements. Individuals providing staff training must 
be qualified as evidenced by education, training, and experience in 
techniques used to address patients' behaviors.
    (4) Training documentation. The hospital must document in the staff 
personnel records that the training and demonstration of competency were 
successfully completed.
    (g) Standard: Death reporting requirements: Hospitals must report 
deaths associated with the use of seclusion or restraint.
    (1) The hospital must report the following information to CMS:
    (i) Each death that occurs while a patient is in restraint or 
seclusion.
    (ii) Each death that occurs within 24 hours after the patient has 
been removed from restraint or seclusion.
    (iii) Each death known to the hospital that occurs within 1 week 
after restraint or seclusion where it is reasonable to assume that use 
of restraint or placement in seclusion contributed directly or 
indirectly to a patient's death. ``Reasonable to assume'' in this 
context includes, but is not limited to, deaths related to restrictions 
of movement for prolonged periods of time, or death related to chest 
compression, restriction of breathing or asphyxiation.
    (2) Each death referenced in this paragraph must be reported to CMS 
by telephone no later than the close of business the next business day 
following knowledge of the patient's death.
    (3) Staff must document in the patient's medical record the date and 
time the death was reported to CMS.

[71 FR 71426, Dec. 8, 2006]



                   Subpart C_Basic Hospital Functions



Sec.  482.21  Condition of participation: Quality assessment and performance improvement program.

    The hospital must develop, implement, and maintain an effective, 
ongoing, hospital-wide, data-driven quality assessment and performance 
improvement program. The hospital's governing body must ensure that the 
program reflects the complexity of the hospital's organization and 
services; involves all hospital departments and services (including 
those services furnished under contract or arrangement); and focuses on 
indicators related to improved health outcomes and the prevention and 
reduction of medical errors. The hospital must maintain and demonstrate 
evidence of its QAPI program for review by CMS.
    (a) Standard: Program scope. (1) The program must include, but not 
be limited to, an ongoing program that shows measurable improvement in 
indicators for which there is evidence that it will improve health 
outcomes and identify and reduce medical errors.
    (2) The hospital must measure, analyze, and track quality 
indicators, including adverse patient events, and other aspects of 
performance that assess processes of care, hospital service and 
operations.
    (b) Standard: Program data. (1) The program must incorporate quality 
indicator data including patient care data, and other relevant data, for 
example, information submitted to, or received from, the hospital's 
Quality Improvement Organization.
    (2) The hospital must use the data collected to--
    (i) Monitor the effectiveness and safety of services and quality of 
care; and
    (ii) Identify opportunities for improvement and changes that will 
lead to improvement.
    (3) The frequency and detail of data collection must be specified by 
the hospital's governing body.
    (c) Standard: Program activities. (1) The hospital must set 
priorities for its performance improvement activities that--

[[Page 13]]

    (i) Focus on high-risk, high-volume, or problem-prone areas;
    (ii) Consider the incidence, prevalence, and severity of problems in 
those areas; and
    (iii) Affect health outcomes, patient safety, and quality of care.
    (2) Performance improvement activities must track medical errors and 
adverse patient events, analyze their causes, and implement preventive 
actions and mechanisms that include feedback and learning throughout the 
hospital.
    (3) The hospital must take actions aimed at performance improvement 
and, after implementing those actions, the hospital must measure its 
success, and track performance to ensure that improvements are 
sustained.
    (d) Standard: Performance improvement projects. As part of its 
quality assessment and performance improvement program, the hospital 
must conduct performance improvement projects.
    (1) The number and scope of distinct improvement projects conducted 
annually must be proportional to the scope and complexity of the 
hospital's services and operations.
    (2) A hospital may, as one of its projects, develop and implement an 
information technology system explicitly designed to improve patient 
safety and quality of care. This project, in its initial stage of 
development, does not need to demonstrate measurable improvement in 
indicators related to health outcomes.
    (3) The hospital must document what quality improvement projects are 
being conducted, the reasons for conducting these projects, and the 
measurable progress achieved on these projects.
    (4) A hospital is not required to participate in a QIO cooperative 
project, but its own projects are required to be of comparable effort.
    (e) Standard: Executive responsibilities. The hospital's governing 
body (or organized group or individual who assumes full legal authority 
and responsibility for operations of the hospital), medical staff, and 
administrative officials are responsible and accountable for ensuring 
the following:
    (1) That an ongoing program for quality improvement and patient 
safety, including the reduction of medical errors, is defined, 
implemented, and maintained.
    (2) That the hospital-wide quality assessment and performance 
improvement efforts address priorities for improved quality of care and 
patient safety; and that all improvement actions are evaluated.
    (3) That clear expectations for safety are established.
    (4) That adequate resources are allocated for measuring, assessing, 
improving, and sustaining the hospital's performance and reducing risk 
to patients.
    (5) That the determination of the number of distinct improvement 
projects is conducted annually.

[68 FR 3454, Jan. 24, 2003]



Sec.  482.22  Condition of participation: Medical staff.

    The hospital must have an organized medical staff that operates 
under bylaws approved by the governing body and is responsible for the 
quality of medical care provided to patients by the hospital.
    (a) Standard: Composition of the medical staff. The medical staff 
must be composed of doctors of medicine or osteopathy and, in accordance 
with State law, may also be composed of other practitioners appointed by 
the governing body.
    (1) The medical staff must periodically conduct appraisals of its 
members.
    (2) The medical staff must examine credentials of candidates for 
medical staff membership and make recommendations to the governing body 
on the appointment of the candidates.
    (b) Standard: Medical staff organization and accountability. The 
medical staff must be well organized and accountable to the governing 
body for the quality of the medical care provided to patients.
    (1) The medical staff must be organized in a manner approved by the 
governing body.
    (2) If the medical staff has an executive committee, a majority of 
the members of the committee must be doctors of medicine or osteopathy.
    (3) The responsibility for organization and conduct of the medical 
staff must be assigned only to an individual

[[Page 14]]

doctor of medicine or osteopathy or, when permitted by State law of the 
State in which the hospital is located, a doctor of dental surgery or 
dental medicine.
    (c) Standard: Medical staff bylaws. The medical staff must adopt and 
enforce bylaws to carry out its responsibilities. The bylaws must:
    (1) Be approved by the governing body.
    (2) Include a statement of the duties and privileges of each 
category of medical staff (e.g., active, courtesy, etc.)
    (3) Describe the organization of the medical staff.
    (4) Describe the qualifications to be met by a candidate in order 
for the medical staff to recommend that the candidate be appointed by 
the governing body.
    (5) Include a requirement that--
    (i) A medical history and physical examination be completed and 
documented for each patient no more than 30 days before or 24 hours 
after admission or registration, but prior to surgery or a procedure 
requiring anesthesia services. The medical history and physical 
examination must be completed and documented by a physician (as defined 
in section 1861(r) of the Act), an oromaxillofacial surgeon, or other 
qualified licensed individual in accordance with State law and hospital 
policy.
    (ii) An updated examination of the patient, including any changes in 
the patient's condition, be completed and documented within 24 hours 
after admission or registration, but prior to surgery or a procedure 
requiring anesthesia services, when the medical history and physical 
examination are completed within 30 days before admission or 
registration. The updated examination of the patient, including any 
changes in the patient's condition, must be completed and documented by 
a physician (as defined in section 1861(r) of the Act), an 
oromaxillofacial surgeon, or other qualified licensed individual in 
accordance with State law and hospital policy.
    (6) Include criteria for determining the privileges to be granted to 
individual practitioners and a procedure for applying the criteria to 
individuals requesting privileges.
    (d) Standard: Autopsies. The medical staff should attempt to secure 
autopsies in all cases of unusual deaths and of medical-legal and 
educational interest. The mechanism for documenting permission to 
perform an autopsy must be defined. There must be a system for notifying 
the medical staff, and specifically the attending practitioner, when an 
autopsy is being performed.

[51 FR 22042, June 17, 1986, as amended at 59 FR 64152, Dec. 13, 1994; 
71 FR 68694, Nov. 27, 2006; 72 FR 66933, Nov. 27, 2007]



Sec.  482.23  Condition of participation: Nursing services.

    The hospital must have an organized nursing service that provides 
24-hour nursing services. The nursing services must be furnished or 
supervised by a registered nurse.
    (a) Standard: Organization. The hospital must have a well-organized 
service with a plan of administrative authority and delineation of 
responsibilities for patient care. The director of the nursing service 
must be a licensed registered nurse. He or she is responsible for the 
operation of the service, including determining the types and numbers of 
nursing personnel and staff necessary to provide nursing care for all 
areas of the hospital.
    (b) Standard: Staffing and delivery of care. The nursing service 
must have adequate numbers of licensed registered nurses, licensed 
practical (vocational) nurses, and other personnel to provide nursing 
care to all patients as needed. There must be supervisory and staff 
personnel for each department or nursing unit to ensure, when needed, 
the immediate availability of a registered nurse for bedside care of any 
patient.
    (1) The hospital must provide 24-hour nursing services furnished or 
supervised by a registered nurse, and have a licensed practical nurse or 
registered nurse on duty at all times, except for rural hospitals that 
have in effect a 24-hour nursing waiver granted under Sec.  488.54(c) of 
this chapter.
    (2) The nursing service must have a procedure to ensure that 
hospital nursing personnel for whom licensure is required have valid and 
current licensure.

[[Page 15]]

    (3) A registered nurse must supervise and evaluate the nursing care 
for each patient.
    (4) The hospital must ensure that the nursing staff develops, and 
keeps current, a nursing care plan for each patient.
    (5) A registered nurse must assign the nursing care of each patient 
to other nursing personnel in accordance with the patient's needs and 
the specialized qualifications and competence of the nursing staff 
available.
    (6) Non-employee licensed nurses who are working in the hospital 
must adhere to the policies and procedures of the hospital. The director 
of nursing service must provide for the adequate supervision and 
evaluation of the clinical activities of non-employee nursing personnel 
which occur within the responsibility of the nursing service.
    (c) Standard: Preparation and administration of drugs. Drugs and 
biologicals must be prepared and administered in accordance with Federal 
and State laws, the orders of the practitioner or practitioners 
responsible for the patient's care as specified under Sec.  482.12(c), 
and accepted standards of practice.
    (1) All drugs and biologicals must be administered by, or under 
supervision of, nursing or other personnel in accordance with Federal 
and State laws and regulations, including applicable licensing 
requirements, and in accordance with the approved medical staff policies 
and procedures.
    (2) With the exception of influenza and pneumococcal polysaccharide 
vaccines, which may be administered per physician-approved hospital 
policy after an assessment of contraindications, orders for drugs and 
biologicals must be documented and signed by a practitioner who is 
authorized to write orders by hospital policy and in accordance with 
State law, and who is responsible for the care of the patient as 
specified under Sec.  482.12(c).
    (i) If verbal orders are used, they are to be used infrequently.
    (ii) When verbal orders are used, they must only be accepted by 
persons who are authorized to do so by hospital policy and procedures 
consistent with Federal and State law.
    (3) Blood transfusions and intravenous medications must be 
administered in accordance with State law and approved medical staff 
policies and procedures. If blood transfusions and intravenous 
medications are administered by personnel other than doctors of medicine 
or osteopathy, the personnel must have special training for this duty.
    (4) There must be a hospital procedure for reporting transfusion 
reactions, adverse drug reactions, and errors in administration of 
drugs.

[51 FR 22042, June 17, 1986, as amended at 67 FR 61814, Oct. 2, 2002; 71 
FR 68694, Nov. 27, 2006; 72 FR 66933, Nov. 27, 2007]



Sec.  482.24  Condition of participation: Medical record services.

    The hospital must have a medical record service that has 
administrative responsibility for medical records. A medical record must 
be maintained for every individual evaluated or treated in the hospital.
    (a) Standard: Organization and staffing. The organization of the 
medical record service must be appropriate to the scope and complexity 
of the services performed. The hospital must employ adequate personnel 
to ensure prompt completion, filing, and retrieval of records.
    (b) Standard: Form and retention of record. The hospital must 
maintain a medical record for each inpatient and outpatient. Medical 
records must be accurately written, promptly completed, properly filed 
and retained, and accessible. The hospital must use a system of author 
identification and record maintenance that ensures the integrity of the 
authentification and protects the security of all record entries.
    (1) Medical records must be retained in their original or legally 
reproduced form for a period of at least 5 years.
    (2) The hospital must have a system of coding and indexing medical 
records. The system must allow for timely retrieval by diagnosis and 
procedure, in order to support medical care evaluation studies.
    (3) The hospital must have a procedure for ensuring the 
confidentiality of patient records. In-formation from or copies of 
records may be released only

[[Page 16]]

to authorized individuals, and the hospital must ensure that 
unauthorized individuals cannot gain access to or alter patient records. 
Original medical records must be released by the hospital only in 
accordance with Federal or State laws, court orders, or subpoenas.
    (c) Standard: Content of record. The medical record must contain 
information to justify admission and continued hospitalization, support 
the diagnosis, and describe the patient's progress and response to 
medications and services.
    (1) All patient medical record entries must be legible, complete, 
dated, timed, and authenticated in written or electronic form by the 
person responsible for providing or evaluating the service provided, 
consistent with hospital policies and procedures.
    (i) All orders, including verbal orders, must be dated, timed, and 
authenticated promptly by the ordering practitioner, except as noted in 
paragraph (c)(1)(ii) of this section.
    (ii) For the 5 year period following January 26, 2007, all orders, 
including verbal orders, must be dated, timed, and authenticated by the 
ordering practitioner or another practitioner who is responsible for the 
care of the patient as specified under Sec.  482.12(c) and authorized to 
write orders by hospital policy in accordance with State law.
    (iii) All verbal orders must be authenticated based upon Federal and 
State law. If there is no State law that designates a specific timeframe 
for the authentication of verbal orders, verbal orders must be 
authenticated within 48 hours.
    (2) All records must document the following, as appropriate:
    (i) Evidence of--
    (A) A medical history and physical examination completed and 
documented no more than 30 days before or 24 hours after admission or 
registration, but prior to surgery or a procedure requiring anesthesia 
services. The medical history and physical examination must be placed in 
the patient's medical record within 24 hours after admission or 
registration, but prior to surgery or a procedure requiring anesthesia 
services.
    (B) An updated examination of the patient, including any changes in 
the patient's condition, when the medical history and physical 
examination are completed within 30 days before admission or 
registration. Documentation of the updated examination must be placed in 
the patient's medical record within 24 hours after admission or 
registration, but prior to surgery or a procedure requiring anesthesia 
services.
    (ii) Admitting diagnosis.
    (iii) Results of all consultative evaluations of the patient and 
appropriate findings by clinical and other staff involved in the care of 
the patient.
    (iv) Documentation of complications, hospital acquired infections, 
and unfavorable reactions to drugs and anesthesia.
    (v) Properly executed informed consent forms for procedures and 
treatments specified by the medical staff, or by Federal or State law if 
applicable, to require written patient consent.
    (vi) All practitioners' orders, nursing notes, reports of treatment, 
medication records, radiology, and laboratory reports, and vital signs 
and other information necessary to monitor the patient's condition.
    (vii) Discharge summary with outcome of hospitalization, disposition 
of case, and provisions for follow-up care.
    (viii) Final diagnosis with completion of medical records within 30 
days following discharge.

[51 FR 22042, June 17, 1986, as amended at 71 FR 68694, Nov. 27, 2006; 
72 FR 66933, Nov. 27, 2007]



Sec.  482.25  Condition of participation: Pharmaceutical services.

    The hospital must have pharmaceutical services that meet the needs 
of the patients. The institution must have a pharmacy directed by a 
registered pharmacist or a drug storage area under competent 
supervision. The medical staff is responsible for developing policies 
and procedures that minimize drug errors. This function may be delegated 
to the hospital's organized pharmaceutical service.
    (a) Standard: Pharmacy management and administration. The pharmacy 
or drug storage area must be administered in accordance with accepted 
professional principles.
    (1) A full-time, part-time, or consulting pharmacist must be 
responsible

[[Page 17]]

for developing, supervising, and coordinating all the activities of the 
pharmacy services.
    (2) The pharmaceutical service must have an adequate number of 
personnel to ensure quality pharmaceutical services, including emergency 
services.
    (3) Current and accurate records must be kept of the receipt and 
disposition of all scheduled drugs.
    (b) Standard: Delivery of services. In order to provide patient 
safety, drugs and biologicals must be controlled and distributed in 
accordance with applicable standards of practice, consistent with 
Federal and State law.
    (1) All compounding, packaging, and dispensing of drugs and 
biologicals must be under the supervision of a pharmacist and performed 
consistent with State and Federal laws.
    (2)(i) All drugs and biologicals must be kept in a secure area, and 
locked when appropriate.
    (ii) Drugs listed in Schedules II, III, IV, and V of the 
Comprehensive Drug Abuse Prevention and Control Act of 1970 must be kept 
locked within a secure area.
    (iii) Only authorized personnel may have access to locked areas.
    (3) Outdated, mislabeled, or otherwise unusable drugs and 
biologicals must not be available for patient use.
    (4) When a pharmacist is not available, drugs and biologicals must 
be removed from the pharmacy or storage area only by personnel 
designated in the policies of the medical staff and pharmaceutical 
service, in accordance with Federal and State law.
    (5) Drugs and biologicals not specifically prescribed as to time or 
number of doses must automatically be stopped after a reasonable time 
that is predetermined by the medical staff.
    (6) Drug administration errors, adverse drug reactions, and 
incompatibilities must be immediately reported to the attending 
physician and, if appropriate, to the hospital-wide quality assurance 
program.
    (7) Abuses and losses of controlled substances must be reported, in 
accordance with applicable Federal and State laws, to the individual 
responsible for the pharmaceutical service, and to the chief executive 
officer, as appropriate.
    (8) Information relating to drug interactions and information of 
drug therapy, side effects, toxicology, dosage, indications for use, and 
routes of administration must be available to the professional staff.
    (9) A formulary system must be established by the medical staff to 
assure quality pharmaceuticals at reasonable costs.

[51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986; 71 FR 68694, 
Nov. 27, 2006]



Sec.  482.26  Condition of participation: Radiologic services.

    The hospital must maintain, or have available, diagnostic radiologic 
services. If therapeutic services are also provided, they, as well as 
the diagnostic services, must meet professionally approved standards for 
safety and personnel qualifications.
    (a) Standard: Radiologic services. The hospital must maintain, or 
have available, radiologic services according to needs of the patients.
    (b) Standard: Safety for patients and personnel. The radiologic 
services, particularly ionizing radiology procedures, must be free from 
hazards for patients and personnel.
    (1) Proper safety precutions must be maintained against radiation 
hazards. This includes adequate shielding for patients, personnel, and 
facilities, as well as appropriate storage, use, and disposal of 
radioactive materials.
    (2) Periodic inspection of equipment must be made and hazards 
identified must be promptly corrected.
    (3) Radiation workers must be checked periodically, by the use of 
exposure meters or badge tests, for amount of radiation exposure.
    (4) Radiologic services must be provided only on the order of 
practitioners with clinical privileges or, consistent with State law, of 
other practitioners authorized by the medical staff and the governing 
body to order the services.
    (c) Standard: Personnel. (1) A qualified full-time, part-time, or 
consulting radiologist must supervise the ionizing radiology services 
and must interpret

[[Page 18]]

only those radiologic tests that are determined by the medical staff to 
require a radiologist's specialized knowledge. For purposes of this 
section, a radiologist is a doctor of medicine or osteopathy who is 
qualified by education and experience in radiology.
    (2) Only personnel designated as qualified by the medical staff may 
use the radiologic equipment and administer procedures.
    (d) Standard: Records. Records of radiologic services must be 
maintained.
    (1) The radiologist or other practitioner who performs radiology 
services must sign reports of his or her interpretations.
    (2) The hospital must maintain the following for at least 5 years:
    (i) Copies of reports and printouts.
    (ii) Films, scans, and other image records, as appropriate.

[51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986]



Sec.  482.27  Condition of participation: Laboratory services.

    The hospital must maintain, or have available, adequate laboratory 
services to meet the needs of its patients. The hospital must ensure 
that all laboratory services provided to its patients are performed in a 
facility certified in accordance with part 493 of this chapter.
    (a) Standard: Adequacy of laboratory services. The hospital must 
have laboratory services available, either directly or through a 
contractual agreement with a certified laboratory that meets 
requirements of part 493 of this chapter.
    (1) Emergency laboratory services must be available 24 hours a day.
    (2) A written description of services provided must be available to 
the medical staff.
    (3) The laboratory must make provision for proper receipt and 
reporting of tissue specimens.
    (4) The medical staff and a pathologist must determine which tissue 
specimens require a macroscopic (gross) examination and which require 
both macroscopic and microscopic examinations.
    (b) Standard: Potentially infectious blood and blood components--(1) 
Potentially human immunodeficiency virus (HIV) infectious blood and 
blood components. Potentially HIV infectious blood and blood components 
are prior collections from a donor--
    (i) Who tested negative at the time of donation but tests reactive 
for evidence of HIV infection on a later donation;
    (ii) Who tests positive on the supplemental (additional, more 
specific) test or other follow-up testing required by FDA; and
    (iii) For whom the timing of seroconversion cannot be precisely 
estimated.
    (2) Potentially hepatitis C virus (HCV) infectious blood and blood 
components. Potentially HCV infectious blood and blood components are 
the blood and blood components identified in 21 CFR 610.47.
    (3) Services furnished by an outside blood collecting establishment. 
If a hospital regularly uses the services of an outside blood collecting 
establishment, it must have an agreement with the blood collecting 
establishment that governs the procurement, transfer, and availability 
of blood and blood components. The agreement must require that the blood 
collecting establishment notify the hospital--
    (i) Within 3 calendar days if the blood collecting establishment 
supplied blood and blood components collected from a donor who tested 
negative at the time of donation but tests reactive for evidence of HIV 
or HCV infection on a later donation or who is determined to be at 
increased risk for transmitting HIV or HCV infection;
    (ii) Within 45 days of the test, of the results of the supplemental 
(additional, more specific) test for HIV or HCV, as relevant, or other 
follow-up testing required by FDA; and
    (iii) Within 3 calendar days after the blood collecting 
establishment supplied blood and blood components collected from an 
infectious donor, whenever records are available, as set forth at 21 CFR 
610.48(b)(3).
    (4) Quarantine and disposition of blood and blood components pending 
completion of testing. If the blood collecting establishment (either 
internal or under an agreement) notifies the hospital of the

[[Page 19]]

reactive HIV or HCV screening test results, the hospital must determine 
the disposition of the blood or blood product and quarantine all blood 
and blood components from previous donations in inventory.
    (i) If the blood collecting establishment notifies the hospital that 
the result of the supplemental (additional, more specific) test or other 
follow-up testing required by FDA is negative, absent other informative 
test results, the hospital may release the blood and blood components 
from quarantine.
    (ii) If the blood collecting establishment notifies the hospital 
that the result of the supplemental, (additional, more specific) test or 
other follow-up testing required by FDA is positive, the hospital must--
    (A) Dispose of the blood and blood components; and
    (B) Notify the transfusion recipients as set forth in paragraph 
(b)(6) of this section.
    (iii) If the blood collecting establishment notifies the hospital 
that the result of the supplemental, (additional, more specific) test or 
other follow-up testing required by FDA is indeterminate, the hospital 
must destroy or label prior collections of blood or blood components 
held in quarantine as set forth at 21 CFR 610.46(b)(2), 610.47(b)(2), 
and 610.48(c)(2).
    (5) Recordkeeping by the hospital. The hospital must maintain--
    (i) Records of the source and disposition of all units of blood and 
blood components for at least 10 years from the date of disposition in a 
manner that permits prompt retrieval; and
    (ii) A fully funded plan to transfer these records to another 
hospital or other entity if such hospital ceases operation for any 
reason.
    (6) Patient notification. If the hospital has administered 
potentially HIV or HCV infectious blood or blood components (either 
directly through its own blood collecting establishment or under an 
agreement) or released such blood or blood components to another entity 
or individual, the hospital must take the following actions:
    (i) Make reasonable attempts to notify the patient, or to notify the 
attending physician or the physician who ordered the blood or blood 
component and ask the physician to notify the patient, or other 
individual as permitted under paragraph (b)(10) of this section, that 
potentially HIV or HCV infectious blood or blood components were 
transfused to the patient and that there may be a need for HIV or HCV 
testing and counseling.
    (ii) If the physician is unavailable or declines to make the 
notification, make reasonable attempts to give this notification to the 
patient, legal guardian, or relative.
    (iii) Document in the patient's medical record the notification or 
attempts to give the required notification.
    (7) Timeframe for notification--(i) For donors tested on or after 
February 20, 2008. For notifications resulting from donors tested on or 
after February 20, 2008 as set forth at 21 CFR 610.46 and 21 CFR 610.47 
the notification effort begins when the blood collecting establishment 
notifies the hospital that it received potentially HIV or HCV infectious 
blood and blood components. The hospital must make reasonable attempts 
to give notification over a period of 12 weeks unless--
    (A) The patient is located and notified; or
    (B) The hospital is unable to locate the patient and documents in 
the patient's medical record the extenuating circumstances beyond the 
hospital's control that caused the notification timeframe to exceed 12 
weeks.
    (ii) For donors tested before February 20, 2008. For notifications 
resulting from donors tested before February 20, 2008 as set forth at 21 
CFR 610.48(b) and (c), the notification effort begins when the blood 
collecting establishment notifies the hospital that it received 
potentially HCV infectious blood and blood components. The hospital must 
make reasonable attempts to give notification and must complete the 
actions within 1 year of the date on which the hospital received 
notification from the outside blood collecting establishment.
    (8) Content of notification. The notification must include the 
following information:
    (i) A basic explanation of the need for HIV or HCV testing and 
counseling;
    (ii) Enough oral or written information so that an informed decision 
can

[[Page 20]]

be made about whether to obtain HIV or HCV testing and counseling; and
    (iii) A list of programs or places where the person can obtain HIV 
or HCV testing and counseling, including any requirements or 
restrictions the program may impose.
    (9) Policies and procedures. The hospital must establish policies 
and procedures for notification and documentation that conform to 
Federal, State, and local laws, including requirements for the 
confidentiality of medical records and other patient information.
    (10) Notification to legal representative or relative. If the 
patient has been adjudged incompetent by a State court, the physician or 
hospital must notify a legal representative designated in accordance 
with State law. If the patient is competent, but State law permits a 
legal representative or relative to receive the information on the 
patient's behalf, the physician or hospital must notify the patient or 
his or her legal representative or relative. For possible HIV infectious 
transfusion recipients that are deceased, the physician or hospital must 
inform the deceased patient's legal representative or relative. If the 
patient is a minor, the parents or legal guardian must be notified.
    (11) Applicability. HCV notification requirements resulting from 
donors tested before February 20, 2008 as set forth at 21 CFR 610.48 
will expire on August 24, 2015.
    (c) General blood safety issues. For lookback activities only 
related to new blood safety issues that are identified after August 24, 
2007, hospitals must comply with FDA regulations as they pertain to 
blood safety issues in the following areas:
    (1) Appropriate testing and quarantining of infectious blood and 
blood components.
    (2) Notification and counseling of recipients that may have received 
infectious blood and blood components.

[57 FR 7136, Feb. 28, 1992, as amended at 61 FR 47433, Sept. 9, 1996; 72 
FR 48573, Aug. 24, 2007]



Sec.  482.28  Condition of participation: Food and dietetic services.

    The hospital must have organized dietary services that are directed 
and staffed by adequate qualified personnel. However, a hospital that 
has a contract with an outside food management company may be found to 
meet this Condition of participation if the company has a dietitian who 
serves the hospital on a full-time, part-time, or consultant basis, and 
if the company maintains at least the minimum standards specified in 
this section and provides for constant liaison with the hospital medical 
staff for recommendations on dietetic policies affecting patient 
treatment.
    (a) Standard: Organization. (1) The hospital must have a full-time 
employee who--
    (i) Serves as director of the food and dietetic service;
    (ii) Is responsible for the daily management of the dietary 
services; and
    (iii) Is qualified by experience or training.
    (2) There must be a qualified dietitian, full-time, part-time, or on 
a consultant basis.
    (3) There must be administrative and technical personnel competent 
in their respective duties.
    (b) Standard: Diets. Menus must meet the needs of the patients.
    (1) Therapeutic diets must be prescribed by the practitioner or 
practitioners responsible for the care of the patients.
    (2) Nutritional needs must be met in accordance with recognized 
dietary practices and in accordance with orders of the practitioner or 
practitioners responsible for the care of the patients.
    (3) A current therapeutic diet manual approved by the dietitian and 
medical staff must be readily available to all medical, nursing, and 
food service personnel.



Sec.  482.30  Condition of participation: Utilization review.

    The hospital must have in effect a utilization review (UR) plan that 
provides for review of services furnished by the institution and by 
members of the medical staff to patients entitled to benefits under the 
Medicare and Medicaid programs.
    (a) Applicability. The provisions of this section apply except in 
either of the following circumstances:
    (1) A Utilization and Quality Control Quality Improvement 
Organization

[[Page 21]]

(QIO) has assumed binding review for the hospital.
    (2) CMS has determined that the UR procedures established by the 
State under title XIX of the Act are superior to the procedures required 
in this section, and has required hospitals in that State to meet the UR 
plan requirements under Sec. Sec.  456.50 through 456.245 of this 
chapter.
    (b) Standard: Composition of utilization review committee. A UR 
committee consisting of two or more practitioners must carry out the UR 
function. At least two of the members of the committee must be doctors 
of medicine or osteopathy. The other members may be any of the other 
types of practitioners specified in Sec.  482.12(c)(1).
    (1) Except as specified in paragraphs (b) (2) and (3) of this 
section, the UR committee must be one of the following:
    (i) A staff committee of the institution;
    (ii) A group outside the institution--
    (A) Established by the local medical society and some or all of the 
hospitals in the locality; or
    (B) Established in a manner approved by CMS.
    (2) If, because of the small size of the institution, it is 
impracticable to have a properly functioning staff committee, the UR 
committee must be established as specified in paragraph (b)(1)(ii) of 
this section.
    (3) The committee's or group's reviews may not be conducted by any 
individual who--
    (i) Has a direct financial interest (for example, an ownership 
interest) in that hospital; or
    (ii) Was professionally involved in the care of the patient whose 
case is being reviewed.
    (c) Standard: Scope and frequency of review. (1) The UR plan must 
provide for review for Medicare and Medicaid patients with respect to 
the medical necessity of--
    (i) Admissions to the institution;
    (ii) The duration of stays; and
    (iii) Professional services furnished, including drugs and 
biologicals.
    (2) Review of admissions may be performed before, at, or after 
hospital admission.
    (3) Except as specified in paragraph (e) of this section, reviews 
may be conducted on a sample basis.
    (4) Hospitals that are paid for inpatient hospital services under 
the prospective payment system set forth in Part 412 of this chapter 
must conduct review of duration of stays and review of professional 
services as follows:
    (i) For duration of stays, these hospitals need review only cases 
that they reasonably assume to be outlier cases based on extended length 
of stay, as described in Sec.  412.80(a)(1)(i) of this chapter; and
    (ii) For professional services, these hospitals need review only 
cases that they reasonably assume to be outlier cases based on 
extraordinarily high costs, as described in Sec.  412.80(a)(1)(ii) of 
this chapter.
    (d) Standard: Determination regarding admissions or continued stays. 
(1) The determination that an admission or continued stay is not 
medically necessary--
    (i) May be made by one member of the UR committee if the 
practitioner or practitioners responsible for the care of the patient, 
as specified of Sec.  482.12(c), concur with the determination or fail 
to present their views when afforded the opportunity; and
    (ii) Must be made by at least two members of the UR committee in all 
other cases.
    (2) Before making a determination that an admission or continued 
stay is not medically necessary, the UR committee must consult the 
practitioner or practitioners responsible for the care of the patient, 
as specified in Sec.  482.12(c), and afford the practitioner or 
practitioners the opportunity to present their views.
    (3) If the committee decides that admission to or continued stay in 
the hospital is not medically necessary, written notification must be 
given, no later than 2 days after the determination, to the hospital, 
the patient, and the practitioner or practitioners responsible for the 
care of the patient, as specified in Sec.  482.12(c);
    (e) Standard: Extended stay review. (1) In hospitals that are not 
paid under the prospective payment system, the UR committee must make a 
periodic review, as specified in the UR plan, of

[[Page 22]]

each current inpatient receiving hospital services during a continuous 
period of extended duration. The scheduling of the periodic reviews 
may--
    (i) Be the same for all cases; or
    (ii) Differ for different classes of cases.
    (2) In hospitals paid under the prospective payment system, the UR 
committee must review all cases reasonably assumed by the hospital to be 
outlier cases because the extended length of stay exceeds the threshold 
criteria for the diagnosis, as described in Sec.  412.80(a)(1)(i). The 
hospital is not required to review an extended stay that does not exceed 
the outlier threshold for the diagnosis.
    (3) The UR committee must make the periodic review no later than 7 
days after the day required in the UR plan.
    (f) Standard: Review of professional services. The committee must 
review professional services provided, to determine medical necessity 
and to promote the most efficient use of available health facilities and 
services.



Sec.  482.41  Condition of participation: Physical environment.

    The hospital must be constructed, arranged, and maintained to ensure 
the safety of the patient, and to provide facilities for diagnosis and 
treatment and for special hospital services appropriate to the needs of 
the community.
    (a) Standard: Buildings. The condition of the physical plant and the 
overall hospital environment must be developed and maintained in such a 
manner that the safety and well-being of patients are assured.
    (1) There must be emergency power and lighting in at least the 
operating, recovery, intensive care, and emergency rooms, and 
stairwells. In all other areas not serviced by the emergency supply 
source, battery lamps and flashlights must be available.
    (2) There must be facilities for emergency gas and water supply.
    (b) Standard: Life safety from fire. (1) Except as otherwise 
provided in this section--
    (i) The hospital must meet the applicable provisions of the 2000 
edition of the Life Safety Code of the National Fire Protection 
Association. The Director of the Office of the Federal Register has 
approved the NFPA 101 [reg] 2000 edition of the Life Safety 
Code, issued January 14, 2000, for incorporation by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy of the Code is 
available for inspection at the CMS Information Resource Center, 7500 
Security Boulevard, Baltimore, MD or at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal--register/code--of--federal--regulations/ibr--
locations.html. Copies may be obtained from the National Fire Protection 
Association, 1 Batterymarch Park, Quincy, MA 02269. If any changes in 
this edition of the Code are incorporated by reference, CMS will publish 
notice in the Federal Register to announce the changes.
    (ii) Chapter 19.3.6.3.2, exception number 2 of the adopted edition 
of the LSC does not apply to hospitals.
    (2) After consideration of State survey agency findings, CMS may 
waive specific provisions of the Life Safety Code which, if rigidly 
applied, would result in unreasonable hardship upon the facility, but 
only if the waiver does not adversely affect the health and safety of 
the patients.
    (3) The provisions of the Life Safety Code do not apply in a State 
where CMS finds that a fire and safety code imposed by State law 
adequately protects patients in hospitals.
    (4) Beginning March 13, 2006, a hospital must be in compliance with 
Chapter 19.2.9, Emergency Lighting.
    (5) Beginning March 13, 2006, Chapter 19.3.6.3.2, exception number 2 
does not apply to hospitals.
    (6) The hospital must have procedures for the proper routine storage 
and prompt disposal of trash.
    (7) The hospital must have written fire control plans that contain 
provisions for prompt reporting of fires; extinguishing fires; 
protection of patients, personnel and guests; evacuation; and 
cooperation with fire fighting authorities.
    (8) The hospital must maintain written evidence of regular 
inspection and approval by State or local fire control agencies.

[[Page 23]]

    (9) Notwithstanding any provisions of the 2000 edition of the Life 
Safety Code to the contrary, a hospital may install alcohol-based hand 
rub dispensers in its facility if--
    (i) Use of alcohol-based hand rub dispensers does not conflict with 
any State or local codes that prohibit or otherwise restrict the 
placement of alcohol-based hand rub dispensers in health care 
facilities;
    (ii) The dispensers are installed in a manner that minimizes leaks 
and spills that could lead to falls;
    (iii) The dispensers are installed in a manner that adequately 
protects against inappropriate access;
    (iv) The dispensers are installed in accordance with chapter 
18.3.2.7 or chapter 19.3.2.7 of the 2000 edition of the Life Safety 
Code, as amended by NFPA Temporary Interim Amendment 00-1(101), issued 
by the Standards Council of the National Fire Protection Association on 
April 15, 2004. The Director of the Office of the Federal Register has 
approved NFPA Temporary Interim Amendment 00-1(101) for incorporation by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy 
of the amendment is available for inspection at the CMS Information 
Resource Center, 7500 Security Boulevard, Baltimore, MD and at the 
Office of the Federal Register, 800 North Capitol Street NW., Suite 700, 
Washington, DC. Copies may be obtained from the National Fire Protection 
Association, 1 Batterymarch Park, Quincy, MA 02269; and
    (v) The dispensers are maintained in accordance with dispenser 
manufacturer guidelines.
    (c) Standard: Facilities. The hospital must maintain adequate 
facilities for its services.
    (1) Diagnostic and therapeutic facilities must be located for the 
safety of patients.
    (2) Facilities, supplies, and equipment must be maintained to ensure 
an acceptable level of safety and quality.
    (3) The extent and complexity of facilities must be determined by 
the services offered.
    (4) There must be proper ventilation, light, and temperature 
controls in pharmaceutical, food preparation, and other appropriate 
areas.

[51 FR 22042, June 17, 1986, as amended at 53 FR 11509, Apr. 7, 1988; 68 
FR 1386, Jan. 10, 2003; 69 FR 49267, Aug. 11, 2004; 70 FR 15238, Mar. 
25, 2005; 71 FR 55340, Sept. 22, 2006]



Sec.  482.42  Condition of participation: Infection control.

    The hospital must provide a sanitary environment to avoid sources 
and transmission of infections and communicable diseases. There must be 
an active program for the prevention, control, and investigation of 
infections and communicable diseases.
    (a) Standard: Organization and policies. A person or persons must be 
designated as infection control officer or officers to develop and 
implement policies governing control of infections and communicable 
diseases.
    (1) The infection control officer or officers must develop a system 
for identifying, reporting, investigating, and controlling infections 
and communicable diseases of patients and personnel.
    (2) The infection control officer or officers must maintain a log of 
incidents related to infections and communicable diseases.
    (b) Standard: Responsibilities of chief executive officer, medical 
staff, and director of nursing services. The chief executive officer, 
the medical staff, and the director of nursing services must--
    (1) Ensure that the hospital-wide quality assurance program and 
training programs address problems identified by the infection control 
officer or officers; and
    (2) Be responsible for the implementation of successful corrective 
action plans in affected problem areas.



Sec.  482.43  Condition of participation: Discharge planning.

    The hospital must have in effect a discharge planning process that 
applies to all patients. The hospital's policies and procedures must be 
specified in writing.
    (a) Standard: Identification of patients in need of discharge 
planning. The hospital must identify at an early stage of 
hospitalization all patients who are

[[Page 24]]

likely to suffer adverse health consequences upon discharge if there is 
no adequate discharge planning.
    (b) Standard: Discharge planning evaluation. (1) The hospital must 
provide a discharge planning evaluation to the patients identified in 
paragraph (a) of this section, and to other patients upon the patient's 
request, the request of a person acting on the patient's behalf, or the 
request of the physician.
    (2) A registered nurse, social worker, or other appropriately 
qualified personnel must develop, or supervise the development of, the 
evaluation.
    (3) The discharge planning evaluation must include an evaluation of 
the likelihood of a patient needing post- hospital services and of the 
availability of the services.
    (4) The discharge planning evaluation must include an evaluation of 
the likelihood of a patient's capacity for self-care or of the 
possibility of the patient being cared for in the environment from which 
he or she entered the hospital.
    (5) The hospital personnel must complete the evaluation on a timely 
basis so that appropriate arrangements for post-hospital care are made 
before discharge, and to avoid unnecessary delays in discharge.
    (6) The hospital must include the discharge planning evaluation in 
the patient's medical record for use in establishing an appropriate 
discharge plan and must discuss the results of the evaluation with the 
patient or individual acting on his or her behalf.
    (c) Standard: Discharge plan. (1) A registered nurse, social worker, 
or other appropriately qualified personnel must develop, or supervise 
the development of, a discharge plan if the discharge planning 
evaluation indicates a need for a discharge plan.
    (2) In the absence of a finding by the hospital that a patient needs 
a discharge plan, the patient's physician may request a discharge plan. 
In such a case, the hospital must develop a discharge plan for the 
patient.
    (3) The hospital must arrange for the initial implementation of the 
patient's discharge plan.
    (4) The hospital must reassess the patient's discharge plan if there 
are factors that may affect continuing care needs or the appropriateness 
of the discharge plan.
    (5) As needed, the patient and family members or interested persons 
must be counseled to prepare them for post-hospital care.
    (6) The hospital must include in the discharge plan a list of HHAs 
or SNFs that are available to the patient, that are participating in the 
Medicare program, and that serve the geographic area (as defined by the 
HHA) in which the patient resides, or in the case of a SNF, in the 
geographic area requested by the patient. HHAs must request to be listed 
by the hospital as available.
    (i) This list must only be presented to patients for whom home 
health care or post-hospital extended care services are indicated and 
appropriate as determined by the discharge planning evaluation.
    (ii) For patients enrolled in managed care organizations, the 
hospital must indicate the availability of home health and posthospital 
extended care services through individuals and entities that have a 
contract with the managed care organizations.
    (iii) The hospital must document in the patient's medical record 
that the list was presented to the patient or to the individual acting 
on the patient's behalf.
    (7) The hospital, as part of the discharge planning process, must 
inform the patient or the patient's family of their freedom to choose 
among participating Medicare providers of posthospital care services and 
must, when possible, respect patient and family preferences when they 
are expressed. The hospital must not specify or otherwise limit the 
qualified providers that are available to the patient.
    (8) The discharge plan must identify any HHA or SNF to which the 
patient is referred in which the hospital has a disclosable financial 
interest, as specified by the Secretary, and any HHA or SNF that has a 
disclosable financial interest in a hospital under Medicare. Financial 
interests that are disclosable under Medicare are determined in 
accordance with the provisions of Part 420, Subpart C, of this chapter.
    (d) Standard: Transfer or referral. The hospital must transfer or 
refer patients, along with necessary medical

[[Page 25]]

information, to appropriate facilities, agencies, or outpatient 
services, as needed, for followup or ancillary care.
    (e) Standard: Reassessment. The hospital must reassess its discharge 
planning process on an on-going basis. The reassessment must include a 
review of discharge plans to ensure that they are responsive to 
discharge needs.

[59 FR 64152, Dec. 13, 1994, as amended at 69 FR 49268, Aug. 11, 2004]



Sec.  482.45  Condition of participation: Organ, tissue, and eye procurement.

    (a) Standard: Organ procurement responsibilities. The hospital must 
have and implement written protocols that:
    (1) Incorporate an agreement with an OPO designated under part 486 
of this chapter, under which it must notify, in a timely manner, the OPO 
or a third party designated by the OPO of individuals whose death is 
imminent or who have died in the hospital. The OPO determines medical 
suitability for organ donation and, in the absence of alternative 
arrangements by the hospital, the OPO determines medical suitability for 
tissue and eye donation, using the definition of potential tissue and 
eye donor and the notification protocol developed in consultation with 
the tissue and eye banks identified by the hospital for this purpose;
    (2) Incorporate an agreement with at least one tissue bank and at 
least one eye bank to cooperate in the retrieval, processing, 
preservation, storage and distribution of tissues and eyes, as may be 
appropriate to assure that all usable tissues and eyes are obtained from 
potential donors, insofar as such an agreement does not interfere with 
organ procurement;
    (3) Ensure, in collaboration with the designated OPO, that the 
family of each potential donor is informed of its options to donate 
organs, tissues, or eyes or to decline to donate. The individual 
designated by the hospital to initiate the request to the family must be 
an organ procurement representative or a designated requestor. A 
designated requestor is an individual who has completed a course offered 
or approved by the OPO and designed in conjunction with the tissue and 
eye bank community in the methodology for approaching potential donor 
families and requesting organ or tissue donation;
    (4) Encourage discretion and sensitivity with respect to the 
circumstances, views, and beliefs of the families of potential donors;
    (5) Ensure that the hospital works cooperatively with the designated 
OPO, tissue bank and eye bank in educating staff on donation issues, 
reviewing death records to improve identification of potential donors, 
and maintaining potential donors while necessary testing and placement 
of potential donated organs, tissues, and eyes take place.
    (b) Standard: Organ transplantation responsibilities. (1) A hospital 
in which organ transplants are performed must be a member of the Organ 
Procurement and Transplantation Network (OPTN) established and operated 
in accordance with section 372 of the Public Health Service (PHS) Act 
(42 U.S.C. 274) and abide by its rules. The term ``rules of the OPTN'' 
means those rules provided for in regulations issued by the Secretary in 
accordance with section 372 of the PHS Act which are enforceable under 
42 CFR 121.10. No hospital is considered to be out of compliance with 
section 1138(a)(1)(B) of the Act, or with the requirements of this 
paragraph, unless the Secretary has given the OPTN formal notice that he 
or she approves the decision to exclude the hospital from the OPTN and 
has notified the hospital in writing.
    (2) For purposes of these standards, the term ``organ'' means a 
human kidney, liver, heart, lung, or pancreas.
    (3) If a hospital performs any type of transplants, it must provide 
organ-transplant-related data, as requested by the OPTN, the Scientific 
Registry, and the OPOs. The hospital must also provide such data 
directly to the Department when requested by the Secretary.

[63 FR 33875, June 22, 1998]



                  Subpart D_Optional Hospital Services



Sec.  482.51  Condition of participation: Surgical services.

    If the hospital provides surgical services, the services must be 
well organized and provided in accordance with

[[Page 26]]

acceptable standards of practice. If outpatient surgical services are 
offered the services must be consistent in quality with inpatient care 
in accordance with the complexity of services offered.
    (a) Standard: Organization and staffing. The organization of the 
surgical services must be appropriate to the scope of the services 
offered.
    (1) The operating rooms must be supervised by an experienced 
registered nurse or a doctor of medicine or osteopathy.
    (2) Licensed practical nurses (LPNs) and surgical technologists 
(operating room technicians) may serve as ``scrub nurses'' under the 
supervision of a registered nurse.
    (3) Qualified registered nurses may perform circulating duties in 
the operating room. In accordance with applicable State laws and 
approved medical staff policies and procedures, LPNs and surgical 
technologists may assist in circulatory duties under the surpervision of 
a qualified registered nurse who is immediately available to respond to 
emergencies.
    (4) Surgical privileges must be delineated for all practitioners 
performing surgery in accordance with the competencies of each 
practitioner. The surgical service must maintain a roster of 
practitioners specifying the surgical privileges of each practitioner.
    (b) Standard: Delivery of service. Surgical services must be 
consistent with needs and resources. Policies governing surgical care 
must be designed to assure the achievement and maintenance of high 
standards of medical practice and patient care.
    (1) Prior to surgery or a procedure requiring anesthesia services 
and except in the case of emergencies:
    (i) A medical history and physical examination must be completed and 
documented no more than 30 days before or 24 hours after admission or 
registration.
    (ii) An updated examination of the patient, including any changes in 
the patient's condition, must be completed and documented within 24 
hours after admission or registration when the medical history and 
physical examination are completed within 30 days before admission or 
registration.
    (2) A properly executed informed consent form for the operation must 
be in the patient's chart before surgery, except in emergencies.
    (3) The following equipment must be available to the operating room 
suites: call-in-system, cardiac monitor, resuscitator, defibrillator, 
aspirator, and tracheotomy set.
    (4) There must be adequate provisions for immediate post-operative 
care.
    (5) The operating room register must be complete and up-to-date.
    (6) An operative report describing techniques, findings, and tissues 
removed or altered must be written or dictated immediately following 
surgery and signed by the surgeon.

[51 FR 22042, June 17, 1986, as amended at 72 FR 66933, Nov. 27, 2007]



Sec.  482.52  Condition of participation: Anesthesia services.

    If the hospital furnishes anesthesia services, they must be provided 
in a well-organized manner under the direction of a qualified doctor of 
medicine or osteopathy. The service is responsible for all anesthesia 
administered in the hospital.
    (a) Standard: Organization and staffing. The organization of 
anesthesia services must be appropriate to the scope of the services 
offered. Anesthesia must be administered only by--
    (1) A qualified anesthesiologist;
    (2) A doctor of medicine or osteopathy (other than an 
anesthesiologist);
    (3) A dentist, oral surgeon, or podiatrist who is qualified to 
administer anesthesia under State law;
    (4) A certified registered nurse anesthetist (CRNA), as defined in 
Sec.  410.69(b) of this chapter, who, unless exempted in accordance with 
paragraph (c)of this section, is under the supervision of the operating 
practitioner or of an anesthesiologist who is immediately available if 
needed; or
    (5) An anesthesiologist's assistant, as defined in Sec.  410.69(b) 
of this chapter, who is under the supervision of an anesthesiologist who 
is immediately available if needed.
    (b) Standard: Delivery of services. Anesthesia services must be 
consistent with needs and resources. Policies on anesthesia procedures 
must include the

[[Page 27]]

delineation of preanesthesia and post anesthesia responsibilities. The 
policies must ensure that the following are provided for each patient:
    (1) A preanesthesia evaluation completed and documented by an 
individual qualified to administer anesthesia, as specified in paragraph 
(a) of this section, performed within 48 hours prior to surgery or a 
procedure requiring anesthesia services.
    (2) An intraoperative anesthesia record.
    (3) A postanesthesia evaluation completed and documented by an 
individual qualified to administer anesthesia, as specified in paragraph 
(a) of this section, no later than 48 hours after surgery or a procedure 
requiring anesthesia services. The postanesthesia evaluation for 
anesthesia recovery must be completed in accordance with State law and 
with hospital policies and procedures that have been approved by the 
medical staff and that reflect current standards of anesthesia care.
    (c) Standard: State exemption. (1) A hospital may be exempted from 
the requirement for physician supervision of CRNAs as described in 
paragraph (a)(4) of this section, if the State in which the hospital is 
located submits a letter to CMS signed by the Governor, following 
consultation with the State's Boards of Medicine and Nursing, requesting 
exemption from physician supervision of CRNAs. The letter from the 
Governor must attest that he or she has consulted with State Boards of 
Medicine and Nursing about issues related to access to and the quality 
of anesthesia services in the State and has concluded that it is in the 
best interests of the State's citizens to opt-out of the current 
physician supervision requirement, and that the opt-out is consistent 
with State law.
    (2) The request for exemption and recognition of State laws, and the 
withdrawal of the request may be submitted at any time, and are 
effective upon submission.

[51 FR 22042, June 17, 1986 as amended at 57 FR 33900, July 31, 1992; 66 
FR 56769, Nov. 13, 2001; 71 FR 68694, Nov. 27, 2006; 72 FR 66934, Nov. 
27, 2007]



Sec.  482.53  Condition of participation: Nuclear medicine services.

    If the hospital provides nuclear medicine services, those services 
must meet the needs of the patients in accordance with acceptable 
standards of practice.
    (a) Standard: Organization and staffing. The organization of the 
nuclear medicine service must be appropriate to the scope and complexity 
of the services offered.
    (1) There must be a director who is a doctor of medicine or 
osteopathy qualified in nuclear medicine.
    (2) The qualifications, training, functions, and responsibilities of 
nuclear medicine personnel must be specified by the service director and 
approved by the medical staff.
    (b) Standard: Delivery of service. Radioactive materials must be 
prepared, labeled, used, transported, stored, and disposed of in 
accordance with acceptable standards of practice.
    (1) In-house preparation of radiopharmaceuticals is by, or under, 
the direct supervision of an appropriately trained registered pharmacist 
or a doctor of medicine or osteopathy.
    (2) There is proper storage and disposal of radioactive material.
    (3) If laboratory tests are performed in the nuclear medicine 
service, the service must meet the applicable requirement for laboratory 
services specified in Sec.  482.27.
    (c) Standard: Facilities. Equipment and supplies must be appropriate 
for the types of nuclear medicine services offered and must be 
maintained for safe and efficient performance. The equipment must be--
    (1) Maintained in safe operating condition; and
    (2) Inspected, tested, and calibrated at least annually by qualified 
personnel.
    (d) Standard: Records. The hospital must maintain signed and dated 
reports of nuclear medicine interpretations, consultations, and 
procedures.
    (1) The hospital must maintain copies of nuclear medicine reports 
for at least 5 years.
    (2) The practitioner approved by the medical staff to interpret 
diagnostic procedures must sign and date the interpretation of these 
tests.

[[Page 28]]

    (3) The hospital must maintain records of the receipt and 
disposition of radiopharmaceuticals.
    (4) Nuclear medicine services must be ordered only by practitioner 
whose scope of Federal or State licensure and whose defined staff 
privileges allow such referrals.

[51 FR 22042, June 17, 1986, as amended at 57 FR 7136, Feb. 28, 1992]



Sec.  482.54  Condition of participation: Outpatient services.

    If the hospital provides outpatient services, the services must meet 
the needs of the patients in accordance with acceptable standards of 
practice.
    (a) Standard: Organization. Outpatient services must be 
appropriately organized and integrated with inpatient services.
    (b) Standard: Personnel. The hospitals must--
    (1) Assign an individual to be responsible for outpatient services; 
and
    (2) Have appropriate professional and nonprofessional personnel 
available.



Sec.  482.55  Condition of participation: Emergency services.

    The hospital must meet the emergency needs of patients in accordance 
with acceptable standards of practice.
    (a) Standard: Organization and direction. If emergency services are 
provided at the hospital--
    (1) The services must be organized under the direction of a 
qualified member of the medical staff;
    (2) The services must be integrated with other departments of the 
hospital;
    (3) The policies and procedures governing medical care provided in 
the emergency service or department are established by and are a 
continuing responsibility of the medical staff.
    (b) Standard: Personnel. (1) The emergency services must be 
supervised by a qualified member of the medical staff.
    (2) There must be adequate medical and nursing personnel qualified 
in emergency care to meet the written emergency procedures and needs 
anticipated by the facility.



Sec.  482.56  Condition of participation: Rehabilitation services.

    If the hospital provides rehabilitation, physical therapy, 
occupational therapy, audiology, or speech pathology services, the 
services must be organized and staffed to ensure the health and safety 
of patients.
    (a) Standard: Organization and staffing. The organization of the 
service must be appropriate to the scope of the services offered.
    (1) The director of the services must have the necessary knowledge, 
experience, and capabilities to properly supervise and administer the 
services.
    (2) Physical therapy, occupational therapy, speech-language 
pathology or audiology services, if provided, must be provided by 
qualified physical therapists, physical therapist assistants, 
occupational therapists, occupational therapy assistants, speech-
language pathologists, or audiologists as defined in part 484 of this 
chapter.
    (b) Standard: Delivery of services. Services must be given in 
accordance with orders of practitioners who are authorized by the 
medical staff to order the services, and the orders must be incorporated 
in the patient's record. The provision of care and the personnel 
qualifications must be in accordance with national acceptable standards 
of practice and must also meet the requirements of Sec.  409.17.

[51 FR 22042, June 17, 1986, as amended at 72 FR 66406, Nov. 27, 2007]



Sec.  482.57  Condition of participation: Respiratory care services.

    The hospital must meet the needs of the patients in accordance with 
acceptable standards of practice. The following requirements apply if 
the hospital provides respiratory care service.
    (a) Standard: Organization and Staffing. The organization of the 
respiratory care services must be appropriate to the scope and 
complexity of the services offered.
    (1) There must be a director of respiratory care services who is a 
doctor of medicine or osteopathy with the knowledge experience, and 
capabilities to supervise and administer the service properly. The 
director may serve on either a full-time or part-time basis.
    (2) There must be adequate numbers of respiratory therapists, 
respiratory therapy technicians, and other personnel who meet the 
qualifications

[[Page 29]]

specified by the medical staff, consistent with State law.
    (b) Standard: Delivery of Services. Services must be delivered in 
accordance with medical staff directives.
    (1) Personnel qualified to perform specific procedures and the 
amount of supervision required for personnel to carry out specific 
procedures must be designated in writing.
    (2) If blood gases or other laboratory tests are performed in the 
respiratory care unit, the unit must meet the applicable requirements 
for laboratory services specified in Sec.  482.27.
    (3) Services must be provided only on, and in accordance with, the 
orders of a doctor of medicine or osteopathy.

[51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986, as amended at 57 
FR 7136, Feb. 28, 1992]



             Subpart E_Requirements for Specialty Hospitals

    Source: 72 FR 15273, Mar. 30, 2007, unless otherwise noted.



Sec.  482.60  Special provisions applying to psychiatric hospitals.

    Psychiatric hospital must--
    (a) Be primarily engaged in providing, by or under the supervision 
of a doctor of medicine or osteopathy, psychiatric services for the 
diagnosis and treatment of mentally ill persons;
    (b) Meet the conditions of participation specified in Sec. Sec.  
482.1 through 482.23 and Sec. Sec.  482.25 through 482.57;
    (c) Maintain clinical records on all patients, including records 
sufficient to permit CMS to determine the degree and intensity of 
treatment furnished to Medicare beneficiaries, as specified in Sec.  
482.61; and
    (d) Meet the staffing requirements specified in Sec.  482.62.

[72 FR 60788, Oct. 26, 2007]



Sec.  482.61  Condition of participation: Special medical record requirements for psychiatric hospitals.

    The medical records maintained by a psychiatric hospital must permit 
determination of the degree and intensity of the treatment provided to 
individuals who are furnished services in the institution.
    (a) Standard: Development of assessment/diagnostic data. Medical 
records must stress the psychiatric components of the record, including 
history of findings and treatment provided for the psychiatric condition 
for which the patient is hospitalized.
    (1) The identification data must include the patient's legal status.
    (2) A provisional or admitting diagnosis must be made on every 
patient at the time of admission, and must include the diagnoses of 
intercurrent diseases as well as the psychiatric diagnoses.
    (3) The reasons for admission must be clearly documented as stated 
by the patient and/or others significantly involved.
    (4) The social service records, including reports of interviews with 
patients, family members, and others, must provide an assessment of home 
plans and family attitudes, and community resource contacts as well as a 
social history.
    (5) When indicated, a complete neurological examination must be 
recorded at the time of the admission physical examination.
    (b) Standard: Psychiatric evaluation. Each patient must receive a 
psychiatric evaluation that must--
    (1) Be completed within 60 hours of admission;
    (2) Include a medical history;
    (3) Contain a record of mental status;
    (4) Note the onset of illness and the circumstances leading to 
admission;
    (5) Describe attitudes and behavior;
    (6) Estimate intellectual functioning, memory functioning, and 
orientation; and
    (7) Include an inventory of the patient's assets in descriptive, not 
interpretative, fashion.
    (c) Standard: Treatment plan. (1) Each patient must have an 
individual comprehensive treatment plan that must be based on an 
inventory of the patient's strengths and disabilities. The written plan 
must include--
    (i) A substantiated diagnosis;
    (ii) Short-term and long-range goals;
    (iii) The specific treatment modalities utilized;
    (iv) The responsibilities of each member of the treatment team; and

[[Page 30]]

    (v) Adequate documentation to justify the diagnosis and the 
treatment and rehabilitation activities carried out.
    (2) The treatment received by the patient must be documented in such 
a way to assure that all active therapeutic efforts are included.
    (d) Standard: Recording progress. Progress notes must be recorded by 
the doctor of medicine or osteopathy responsible for the care of the 
patient as specified in Sec.  482.12(c), nurse, social worker and, when 
appropriate, others significantly involved in active treatment 
modalities. The frequency of progress notes is determined by the 
condition of the patient but must be recorded at least weekly for the 
first 2 months and at least once a month thereafter and must contain 
recommendations for revisions in the treatment plan as indicated as well 
as precise assessment of the patient's progress in accordance with the 
original or revised treatment plan.
    (e) Standard: Discharge planning and discharge summary. The record 
of each patient who has been discharged must have a discharge summary 
that includes a recapitulation of the patient's hospitalization and 
recommendations from appropriate services concerning follow-up or 
aftercare as well as a brief summary of the patient's condition on 
discharge.

[72 FR 60788, Oct. 26, 2007]



Sec.  482.62  Condition of participation: Special staff requirements for psychiatric hospitals.

    The hospital must have adequate numbers of qualified professional 
and supportive staff to evaluate patients, formulate written, 
individualized comprehensive treatment plans, provide active treatment 
measures, and engage in discharge planning.
    (a) Standard: Personnel. The hospital must employ or undertake to 
provide adequate numbers of qualified professional, technical, and 
consultative personnel to:
    (1) Evaluate patients;
    (2) Formulate written individualized, comprehensive treatment plans;
    (3) Provide active treatment measures; and
    (4) Engage in discharge planning.
    (b) Standard: Director of inpatient psychiatric services; medical 
staff. Inpatient psychiatric services must be under the supervision of a 
clinical director, service chief, or equivalent who is qualified to 
provide the leadership required for an intensive treatment program. The 
number and qualifications of doctors of medicine and osteopathy must be 
adequate to provide essential psychiatric services.
    (1) The clinical director, service chief, or equivalent must meet 
the training and experience requirements for examination by the American 
Board of Psychiatry and Neurology or the American Osteopathic Board of 
Neurology and Psychiatry.
    (2) The director must monitor and evaluate the quality and 
appropriateness of services and treatment provided by the medical staff.
    (c) Standard: Availability of medical personnel. Doctors of medicine 
or osteopathy and other appropriate professional personnel must be 
available to provide necessary medical and surgical diagnostic and 
treatment services. If medical and surgical diagnostic and treatment 
services are not available within the institution, the institution must 
have an agreement with an outside source of these services to ensure 
that they are immediately available or a satisfactory agreement must be 
established for transferring patients to a general hospital that 
participates in the Medicare program.
    (d) Standard: Nursing services. The hospital must have a qualified 
director of psychiatric nursing services. In addition to the director of 
nursing, there must be adequate numbers of registered nurses, licensed 
practical nurses, and mental health workers to provide nursing care 
necessary under each patient's active treatment program and to maintain 
progress notes on each patient.
    (1) The director of psychiatric nursing services must be a 
registered nurse who has a master's degree in psychiatric or mental 
health nursing, or its equivalent from a school of nursing accredited by 
the National League for Nursing, or be qualified by education and 
experience in the care of the mentally ill. The director must 
demonstrate competence to participate in

[[Page 31]]

interdisciplinary formulation of individual treatment plans; to give 
skilled nursing care and therapy; and to direct, monitor, and evaluate 
the nursing care furnished.
    (2) The staffing pattern must insure the availability of a 
registered professional nurse 24 hours each day. There must be adequate 
numbers of registered nurses, licensed practical nurses, and mental 
health workers to provide the nursing care necessary under each 
patient's active treatment program.
    (e) Standard: Psychological services. The hospital must provide or 
have available psychological services to meet the needs of the patients.
    (f) Standard: Social services. There must be a director of social 
services who monitors and evaluates the quality and appropriateness of 
social services furnished. The services must be furnished in accordance 
with accepted standards of practice and established policies and 
procedures.
    (1) The director of the social work department or service must have 
a master's degree from an accredited school of social work or must be 
qualified by education and experience in the social services needs of 
the mentally ill. If the director does not hold a masters degree in 
social work, at least one staff member must have this qualification.
    (2) Social service staff responsibilities must include, but are not 
limited to, participating in discharge planning, arranging for follow-up 
care, and developing mechanisms for exchange of appropriate, information 
with sources outside the hospital.
    (g) Standard: Therapeutic activities. The hospital must provide a 
therapeutic activities program.
    (1) The program must be appropriate to the needs and interests of 
patients and be directed toward restoring and maintaining optimal levels 
of physical and psychosocial functioning.
    (2) The number of qualified therapists, support personnel, and 
consultants must be adequate to provide comprehensive therapeutic 
activities consistent with each patient's active treatment program.

[72 FR 60788, Oct. 26, 2007]



Sec.  482.66  Special requirements for hospital providers of long-term care services (``swing-beds'').

    A hospital that has a Medicare provider agreement must meet the 
following requirements in order to be granted an approval from CMS to 
provide post-hospital extended care services, as specified in Sec.  
409.30 of this chapter, and be reimbursed as a swing-bed hospital, as 
specified in Sec.  413.114 of this chapter:
    (a) Eligibility. A hospital must meet the following eligibility 
requirements:
    (1) The facility has fewer than 100 hospital beds, excluding beds 
for newborns and beds in intensive care type inpatient units (for 
eligibility of hospitals with distinct parts electing the optional 
reimbursement method, see Sec.  413.24(d)(5) of this chapter).
    (2) The hospital is located in a rural area. This includes all areas 
not delineated as ``urbanized'' areas by the Census Bureau, based on the 
most recent census.
    (3) The hospital does not have in effect a 24-hour nursing waiver 
granted under Sec.  488.54(c) of this chapter.
    (4) The hospital has not had a swing-bed approval terminated within 
the two years previous to application.
    (b) Skilled nursing facility services. The facility is substantially 
in compliance with the following skilled nursing facility requirements 
contained in subpart B of part 483 of this chapter.
    (1) Resident rights (Sec.  483.10 (b)(3), (b)(4), (b)(5), (b)(6), 
(d), (e), (h), (i), (j)(1)(vii), (j)(1)(viii), (l), and (m)).
    (2) Admission, transfer, and discharge rights (Sec.  483.12 (a)(1), 
(a)(2), (a)(3), (a)(4), (a)(5), (a)(6), and (a)(7)).
    (3) Resident behavior and facility practices (Sec.  483.13).
    (4) Patient activities (Sec.  483.15(f)).
    (5) Social services (Sec.  483.15(g)).
    (6) Discharge planning (Sec.  483.20(e)).
    (7) Specialized rehabilitative services (Sec.  483.45).
    (8) Dental services (Sec.  483.55).

[72 FR 60788, Oct. 26, 2007]



Sec.  482.68  Special requirements for transplant centers.

    A transplant center located within a hospital that has a Medicare 
provider agreement must meet the conditions of participation specified 
in Sec. Sec.  482.72

[[Page 32]]

through 482.104 in order to be granted approval from CMS to provide 
transplant services.
    (a) Unless specified otherwise, the conditions of participation at 
Sec. Sec.  482.72 through 482.104 apply to heart, heart-lung, intestine, 
kidney, liver, lung, and pancreas centers.
    (b) In addition to meeting the conditions of participation specified 
in Sec. Sec.  482.72 through 482.104, a transplant center must also meet 
the conditions of participation specified in Sec. Sec.  482.1 through 
482.57.



Sec.  482.70  Definitions.

    As used in this subpart, the following definitions apply:
    Adverse event means an untoward, undesirable, and usually 
unanticipated event that causes death or serious injury, or the risk 
thereof. As applied to transplant centers, examples of adverse events 
include (but are not limited to) serious medical complications or death 
caused by living donation; unintentional transplantation of organs of 
mismatched blood types; transplantation of organs to unintended 
recipients; and unintended transmission of infectious disease to a 
recipient.
    End-Stage Renal Disease (ESRD) means that stage of renal impairment 
that appears irreversible and permanent, and requires a regular course 
of dialysis or kidney transplantation to maintain life.
    ESRD Network means all Medicare-approved ESRD facilities in a 
designated geographic area specified by CMS.
    Heart-Lung transplant center means a transplant center that is 
located in a hospital with an existing Medicare-approved heart 
transplant center and an existing Medicare-approved lung center that 
performs combined heart-lung transplants.
    Intestine transplant center means a Medicare-approved liver 
transplant center that performs intestine transplants, combined liver-
intestine transplants, or multivisceral transplants.
    Network organization means the administrative governing body to the 
network and liaison to the Federal government.
    Pancreas transplant center means a Medicare-approved kidney 
transplant center that performs pancreas transplants alone or subsequent 
to a kidney transplant as well as kidney-pancreas transplants.
    Transplant center means an organ-specific transplant program (as 
defined in this rule) within a transplant hospital (for example, a 
hospital's lung transplant program may also be referred to as the 
hospital's lung transplant center).
    Transplant hospital means a hospital that furnishes organ 
transplants and other medical and surgical specialty services required 
for the care of transplant patients.
    Transplant program means a component within a transplant hospital 
(as defined in this rule) that provides transplantation of a particular 
type of organ.

               General Requirements for Transplant Centers



Sec.  482.72  Condition of participation: OPTN membership.

    A transplant center must be located in a transplant hospital that is 
a member of and abides by the rules and requirements of the Organ 
Procurement and Transplantation Network (OPTN) established and operated 
in accordance with section 372 of the Public Health Service (PHS) Act 
(42 U.S.C. 274). The term ``rules and requirements of the OPTN'' means 
those rules and requirements approved by the Secretary pursuant to Sec.  
121.4 of this title. No hospital that provides transplantation services 
shall be deemed to be out of compliance with section 1138(a)(1)(B) of 
the Act or this section unless the Secretary has given the OPTN formal 
notice that he or she approves the decision to exclude the transplant 
hospital from the OPTN and also has notified the transplant hospital in 
writing.



Sec.  482.74  Condition of participation: Notification to CMS.

    (a) A transplant center must notify CMS immediately of any 
significant changes related to the center's transplant program or 
changes that could affect its compliance with the conditions of 
participation. Instances in which CMS should receive information

[[Page 33]]

for follow up, as appropriate, include, but are not limited to:
    (1) Change in key staff members of the transplant team, such as a 
change in the individual the transplant center designated to the OPTN as 
the center's ``primary transplant surgeon'' or ``primary transplant 
physician;'
    (2) A decrease in the center's number of transplants or survival 
rates that could result in the center being out of compliance with Sec.  
482.82;
    (3) Termination of an agreement between the hospital in which the 
transplant center is located and an OPO for the recovery and receipt of 
organs as required by section 482.100; and
    (4) Inactivation of the transplant center.
    (b) Upon receiving notification of significant changes, CMS will 
follow up with the transplant center as appropriate, including (but not 
limited to):
    (1) Requesting additional information;
    (2) Analyzing the information; or
    (3) Conducting an on-site review.



Sec.  482.76  Condition of participation: Pediatric Transplants.

    A transplant center that seeks Medicare approval to provide 
transplantation services to pediatric patients must submit to CMS a 
request specifically for Medicare approval to perform pediatric 
transplants using the procedures described at Sec.  488.61 of this 
chapter.
    (a) Except as specified in paragraph (d) of this section, a center 
requesting Medicare approval to perform pediatric transplants must meet 
all the conditions of participation at Sec. Sec.  482.72 through 482.74 
and Sec. Sec.  482.80 through 482.104 with respect to its pediatric 
patients.
    (b) A center that performs 50 percent or more of its transplants in 
a 12-month period on adult patients must be approved to perform adult 
transplants in order to be approved to perform pediatric transplants.
    (1) Loss of Medicare approval to perform adult transplants, whether 
voluntary or involuntary, will result in loss of the center's approval 
to perform pediatric transplants.
    (2) Loss of Medicare approval to perform pediatric transplants, 
whether voluntary or involuntary, may trigger a review of the center's 
Medicare approval to perform adult transplants.
    (c) A center that performs 50 percent or more of its transplants in 
a 12-month period on pediatric patients must be approved to perform 
pediatric transplants in order to be approved to perform adult 
transplants.
    (1) Loss of Medicare approval to perform pediatric transplants, 
whether voluntary or involuntary, will result in loss of the center's 
approval to perform adult transplants.
    (2) Loss of Medicare approval to perform adult transplants, whether 
voluntary or involuntary, may trigger a review of the center's Medicare 
approval to perform pediatric transplants.
    (3) A center that performs 50 percent or more of its transplants on 
pediatric patients in a 12-month period is not required to meet the 
clinical experience requirements prior to its request for approval as a 
pediatric transplant center.
    (d) Instead of meeting all conditions of participation at Sec. Sec.  
482.72 through 482.74 and Sec. Sec.  482.80 through 482.104, a heart 
transplant center that wishes to provide transplantation services to 
pediatric heart patients may be approved to perform pediatric heart 
transplants by meeting the Omnibus Budget Reconciliation Act of 1987 
criteria in section 4009(b) (Pub. L. 100-203), as follows:
    (1) The center's pediatric transplant program must be operated 
jointly by the hospital and another facility that is Medicare-approved;
    (2) The unified program shares the same transplant surgeons and 
quality improvement program (including oversight committee, patient 
protocol, and patient selection criteria); and
    (3) The center demonstrates to the satisfaction of the Secretary 
that it is able to provide the specialized facilities, services, and 
personnel that are required by pediatric heart transplant patients.

[[Page 34]]

  Transplant Center Data Submission, Clinical Experience, and Outcome 
                              Requirements



Sec.  482.80  Condition of participation: Data submission, clinical experience, and outcome requirements for initial approval of transplant centers.

    Except as specified in paragraph (d) of this section, and Sec.  
488.61 of this chapter, transplant centers must meet all data 
submission, clinical experience, and outcome requirements to be granted 
initial approval by CMS.
    (a) Standard: Data submission. No later than 90 days after the due 
date established by the OPTN, a transplant center must submit to the 
OPTN at least 95 percent of required data on all transplants (deceased 
and living donor) it has performed. Required data submissions include, 
but are not limited to, submission of the appropriate OPTN forms for 
transplant candidate registration, transplant recipient registration and 
follow-up, and living donor registration and follow-up.
    (b) Standard: Clinical experience. To be considered for initial 
approval, an organ-specific transplant center must generally perform 10 
transplants over a 12-month period.
    (c) Standard: Outcome requirements. CMS will review outcomes for all 
transplants performed at a center, including outcomes for living donor 
transplants, if applicable. Except for lung transplants, CMS will review 
adult and pediatric outcomes separately when a center requests Medicare 
approval to perform both adult and pediatric transplants.
    (1) CMS will compare each transplant center's observed number of 
patient deaths and graft failures 1-year post-transplant to the center's 
expected number of patient deaths and graft failures 1-year post-
transplant using the data contained in the most recent Scientific 
Registry of Transplant Recipients (SRTR) center-specific report.
    (2) The required number of transplants must have been performed 
during the time frame reported in the most recent SRTR center-specific 
report.
    (3) CMS will not consider a center's patient and graft survival 
rates to be acceptable if:
    (i) A center's observed patient survival rate or observed graft 
survival rate is lower than its expected patient survival rate or 
expected graft survival rate; and
    (ii) All three of the following thresholds are crossed over:
    (A) The one-sided p-value is less than 0.05,
    (B) The number of observed events (patient deaths or graft failures) 
minus the number of expected events is greater than 3, and
    (C) The number of observed events divided by the number of expected 
events is greater than 1.5.
    (d) Exceptions. (1) A heart-lung transplant center is not required 
to comply with the clinical experience requirements in paragraph (b) of 
this section or the outcome requirements in paragraph (c) of this 
section for heart-lung transplants performed at the center.
    (2) An intestine transplant center is not required to comply with 
the outcome performance requirements in paragraph (c) of this section 
for intestine, combined liver-intestine or multivisceral transplants 
performed at the center.
    (3) A pancreas transplant center is not required to comply with the 
clinical experience requirements in paragraph (b) of this section or the 
outcome requirements in paragraph (c) of this section for pancreas 
transplants performed at the center.
    (4) A center that is requesting initial Medicare approval to perform 
pediatric transplants is not required to comply with the clinical 
experience requirements in paragraph (b) of this section prior to its 
request for approval as a pediatric transplant center.
    (5) A kidney transplant center that is not Medicare-approved on the 
effective date of this rule is required to perform at least 3 
transplants over a 12-month period prior to its request for initial 
approval.



Sec.  482.82  Condition of participation: Data submission, clinical experience, and outcome requirements for re-approval of transplant centers.

    Except as specified in paragraph (d) of this section, and Sec.  
488.61 of this chapter, transplant centers must meet all data 
submission, clinical experience,

[[Page 35]]

and outcome requirements in order to be re-approved.
    (a) Standard: Data submission. No later than 90 days after the due 
date established by the OPTN, a transplant center must submit to the 
OPTN at least 95 percent of the required data submissions on all 
transplants (deceased and living donor) it has performed over the 3-year 
approval period. Required data submissions include, but are not limited 
to, submission of the appropriate OPTN forms for transplant candidate 
registration, transplant recipient registration and follow-up, and 
living donor registration and follow-up.
    (b) Standard: Clinical experience. To be considered for re-approval, 
an organ-specific transplant center must generally perform an average of 
10 transplants per year during the re-approval period.
    (c) Standard: Outcome requirements. CMS will review outcomes for all 
transplants performed at a center, including outcomes for living donor 
transplants if applicable. Except for lung transplants, CMS will review 
adult and pediatric outcomes separately when a center requests Medicare 
approval to perform both adult and pediatric transplants.
    (1) CMS will compare each transplant center's observed number of 
patient deaths and graft failures 1-year post-transplant to the center's 
expected number of patient deaths and graft failures 1-year post-
transplant using data contained in the most recent SRTR center-specific 
report.
    (2) The required number of transplants must have been performed 
during the time frame reported in the most recent SRTR center-specific 
report.
    (3) CMS will not consider a center's patient and graft survival 
rates to be acceptable if:
    (i) A center's observed patient survival rate or observed graft 
survival rate is lower than its expected patient survival rate and graft 
survival rate; and
    (ii) All three of the following thresholds are crossed over:
    (A) The one-sided p-value is less than 0.05,
    (B) The number of observed events (patient deaths or graft failures) 
minus the number of expected events is greater than 3, and
    (C) The number of observed events divided by the number of expected 
events is greater than 1.5.
    (d) Exceptions. (1) A heart-lung transplant center is not required 
to comply with the clinical experience requirements in paragraph (b) of 
this section or the outcome requirements in paragraph (c) of this 
section for heart-lung transplants performed at the center.
    (2) An intestine transplant center is not required to comply with 
the outcome requirements in paragraph (c) of this section for intestine, 
combined liver-intestine, and multivisceral transplants performed at the 
center.
    (3) A pancreas transplant center is not required to comply with the 
clinical experience requirements in paragraph (b) of this section or the 
outcome requirements in paragraph (c) of this section for pancreas 
transplants performed at the center.
    (4) A center that is approved to perform pediatric transplants is 
not required to comply with the clinical experience requirements in 
paragraph (b) of this section to be re-approved.

                 Transplant Center Process Requirements



Sec.  482.90  Condition of participation: Patient and living donor selection.

    The transplant center must use written patient selection criteria in 
determining a patient's suitability for placement on the waiting list or 
a patient's suitability for transplantation. If a center performs living 
donor transplants, the center also must use written donor selection 
criteria in determining the suitability of candidates for donation.
    (a) Standard: Patient selection. Patient selection criteria must 
ensure fair and non-discriminatory distribution of organs.
    (1) Prior to placement on the center's waiting list, a prospective 
transplant candidate must receive a psychosocial evaluation, if 
possible.
    (2) Before a transplant center places a transplant candidate on its 
waiting list, the candidate's medical record must contain documentation 
that the

[[Page 36]]

candidate's blood type has been determined.
    (3) When a patient is placed on a center's waiting list or is 
selected to receive a transplant, the center must document in the 
patient's medical record the patient selection criteria used.
    (4) A transplant center must provide a copy of its patient selection 
criteria to a transplant patient, or a dialysis facility, as requested 
by a patient or a dialysis facility.
    (b) Standard: Living donor selection. The living donor selection 
criteria must be consistent with the general principles of medical 
ethics. Transplant centers must:
    (1) Ensure that a prospective living donor receives a medical and 
psychosocial evaluation prior to donation,
    (2) Document in the living donor's medical records the living 
donor's suitability for donation, and
    (3) Document that the living donor has given informed consent, as 
required under Sec.  482.102.



Sec.  482.92  Condition of participation: Organ recovery and receipt.

    Transplant centers must have written protocols for validation of 
donor-recipient blood type and other vital data for the deceased organ 
recovery, organ receipt, and living donor organ transplantation 
processes. The transplanting surgeon at the transplant center is 
responsible for ensuring the medical suitability of donor organs for 
transplantation into the intended recipient.
    (a) Standard: Organ recovery. When the identity of an intended 
transplant recipient is known and the transplant center sends a team to 
recover the organ(s), the transplant center's recovery team must review 
and compare the donor data with the recipient blood type and other vital 
data before organ recovery takes place.
    (b) Standard: Organ receipt. After an organ arrives at a transplant 
center, prior to transplantation, the transplanting surgeon and another 
licensed health care professional must verify that the donor's blood 
type and other vital data are compatible with transplantation of the 
intended recipient
    (c) Standard: Living donor transplantation. If a center performs 
living donor transplants, the transplanting surgeon and another licensed 
health care professional at the center must verify that the living 
donor's blood type and other vital data are compatible with 
transplantation of the intended recipient immediately before the removal 
of the donor organ(s) and, if applicable, prior to the removal of the 
recipient's organ(s).



Sec.  482.94  Condition of participation: Patient and living donor management.

    Transplant centers must have written patient management policies for 
the transplant and discharge phases of transplantation. If a transplant 
center performs living donor transplants, the center also must have 
written donor management policies for the donor evaluation, donation, 
and discharge phases of living organ donation.
    (a) Standard: Patient and living donor care. The transplant center's 
patient and donor management policies must ensure that:
    (1) Each transplant patient is under the care of a multidisciplinary 
patient care team coordinated by a physician throughout the transplant 
and discharge phases of transplantation; and
    (2) If a center performs living donor transplants, each living donor 
is under the care of a multidisciplinary patient care team coordinated 
by a physician throughout the donor evaluation, donation, and discharge 
phases of donation.
    (b) Standard: Waiting list management. Transplant centers must keep 
their waiting lists up to date on an ongoing basis, including:
    (1) Updating of waiting list patients' clinical information;
    (2) Removing patients from the center's waiting list if a patient 
receives a transplant or dies, or if there is any other reason the 
patient should no longer be on a center's waiting list; and
    (3) Notifying the OPTN no later than 24 hours after a patient's 
removal from the center's waiting list.
    (c) Standard: Patient records. Transplant centers must maintain up-
to-date and accurate patient management records for each patient who 
receives

[[Page 37]]

an evaluation for placement on a center's waiting list and who is 
admitted for organ transplantation.
    (1) For each patient who receives an evaluation for placement on a 
center's waiting list, the center must document in the patient's record 
that the patient (and in the case of a kidney patient, the patient's 
usual dialysis facility) has been informed of his or her transplant 
status, including notification of:
    (i) The patient's placement on the center's waiting list;
    (ii) The center's decision not to place the patient on its waiting 
list; or
    (iii) The center's inability to make a determination regarding the 
patient's placement on its waiting list because further clinical testing 
or documentation is needed.
    (2) If a patient on the waiting list is removed from the waiting 
list for any reason other than death or transplantation, the transplant 
center must document in the patient's record that the patient (and in 
the case of a kidney patient, the patient's usual dialysis facility) was 
notified no later than 10 days after the date the patient was removed 
from the waiting list.
    (3) In the case of patients admitted for organ transplants, 
transplant centers must maintain written records of:
    (i) Multidisciplinary patient care planning during the transplant 
period; and
    (ii) Multidisciplinary discharge planning for post-transplant care.
    (d) Standard: Social services. The transplant center must make 
social services available, furnished by qualified social workers, to 
transplant patients, living donors, and their families. A qualified 
social worker is an individual who meets licensing requirements in the 
State in which he or she practices; and
    (1) Completed a course of study with specialization in clinical 
practice and holds a master's degree from a graduate school of social 
work accredited by the Council on Social Work Education; or
    (2) Is working as a social worker in a transplant center as of the 
effective date of this final rule and has served for at least 2 years as 
a social worker, 1 year of which was in a transplantation program, and 
has established a consultative relationship with a social worker who is 
qualified under (d)(1) of this paragraph.
    (e) Standard: Nutritional services. Transplant centers must make 
nutritional assessments and diet counseling services, furnished by a 
qualified dietitian, available to all transplant patients and living 
donors. A qualified dietitian is an individual who meets practice 
requirements in the State in which he or she practices and is a 
registered dietitian with the Commission on Dietetic Registration.



Sec.  482.96  Condition of participation: Quality assessment and performance improvement (QAPI).

    Transplant centers must develop, implement, and maintain a written, 
comprehensive, data-driven QAPI program designed to monitor and evaluate 
performance of all transplantation services, including services provided 
under contract or arrangement.
    (a) Standard: Components of a QAPI program. The transplant center's 
QAPI program must use objective measures to evaluate the center's 
performance with regard to transplantation activities and outcomes. 
Outcome measures may include, but are not limited to, patient and donor 
selection criteria, accuracy of the waiting list in accordance with the 
OPTN waiting list requirements, accuracy of donor and recipient 
matching, patient and donor management, techniques for organ recovery, 
consent practices, patient education, patient satisfaction, and patient 
rights. The transplant center must take actions that result in 
performance improvements and track performance to ensure that 
improvements are sustained.
    (b) Standard: Adverse events. A transplant center must establish and 
implement written policies to address and document adverse events that 
occur during any phase of an organ transplantation case.
    (1) The policies must address, at a minimum, the process for the 
identification, reporting, analysis, and prevention of adverse events.
    (2) The transplant center must conduct a thorough analysis of and 
document any adverse event and must utilize the analysis to effect 
changes in

[[Page 38]]

the transplant center's policies and practices to prevent repeat 
incidents.



Sec.  482.98  Condition of participation: Human resources.

    The transplant center must ensure that all individuals who provide 
services and/or supervise services at the center, including individuals 
furnishing services under contract or arrangement, are qualified to 
provide or supervise such services.
    (a) Standard: Director of a transplant center. The transplant center 
must be under the general supervision of a qualified transplant surgeon 
or a qualified physician-director. The director of a transplant center 
need not serve full-time and may also serve as a center's primary 
transplant surgeon or transplant physician in accordance with Sec.  
482.98(b). The director is responsible for planning, organizing, 
conducting, and directing the transplant center and must devote 
sufficient time to carry out these responsibilities, which include but 
are not limited to the following:
    (1) Coordinating with the hospital in which the transplant center is 
located to ensure adequate training of nursing staff and clinical 
transplant coordinators in the care of transplant patients and living 
donors.
    (2) Ensuring that tissue typing and organ procurement services are 
available.
    (3) Ensuring that transplantation surgery is performed by, or under 
the direct supervision of, a qualified transplant surgeon in accordance 
with Sec.  482.98(b).
    (b) Standard: Transplant surgeon and physician. The transplant 
center must identify to the OPTN a primary transplant surgeon and a 
transplant physician with the appropriate training and experience to 
provide transplantation services, who are immediately available to 
provide transplantation services when an organ is offered for 
transplantation.
    (1) The transplant surgeon is responsible for providing surgical 
services related to transplantation.
    (2) The transplant physician is responsible for providing and 
coordinating transplantation care.
    (c) Standard: Clinical transplant coordinator. The transplant center 
must have a clinical transplant coordinator to ensure the continuity of 
care of patients and living donors during the pre-transplant, 
transplant, and discharge phases of transplantation and the donor 
evaluation, donation, and discharge phases of donation. The clinical 
transplant coordinator must be a registered nurse or clinician licensed 
by the State in which the clinical transplant coordinator practices, who 
has experience and knowledge of transplantation and living donation 
issues. The clinical transplant coordinator's responsibilities must 
include, but are not limited to, the following:
    (1) Ensuring the coordination of the clinical aspects of transplant 
patient and living donor care; and
    (2) Acting as a liaison between a kidney transplant center and 
dialysis facilities, as applicable.
    (d) Standard: Independent living donor advocate or living donor 
advocate team. The transplant center that performs living donor 
transplantation must identify either an independent living donor 
advocate or an independent living donor advocate team to ensure 
protection of the rights of living donors and prospective living donors.
    (1) The living donor advocate or living donor advocate team must not 
be involved in transplantation activities on a routine basis.
    (2) The independent living donor advocate or living donor advocate 
team must demonstrate:
    (i) Knowledge of living organ donation, transplantation, medical 
ethics, and informed consent; and
    (ii) Understanding of the potential impact of family and other 
external pressures on the prospective living donor's decision whether to 
donate and the ability to discuss these issues with the donor.
    (3) The independent living donor advocate or living donor advocate 
team is responsible for:
    (i) Representing and advising the donor;
    (ii) Protecting and promoting the interests of the donor; and
    (iii) Respecting the donor's decision and ensuring that the donor's 
decision is informed and free from coercion.

[[Page 39]]

    (e) Standard: Transplant team. The transplant center must identify a 
multidisciplinary transplant team and describe the responsibilities of 
each member of the team. The team must be composed of individuals with 
the appropriate qualifications, training, and experience in the relevant 
areas of medicine, nursing, nutrition, social services, transplant 
coordination, and pharmacology.
    (f) Standard: Resource commitment. The transplant center must 
demonstrate availability of expertise in internal medicine, surgery, 
anesthesiology, immunology, infectious disease control, pathology, 
radiology, blood banking, and patient education as related to the 
provision of transplantation services.



Sec.  482.100  Condition of participation: Organ procurement.

    The transplant center must ensure that the hospital in which it 
operates has a written agreement for the receipt of organs with an OPO 
designated by the Secretary that identifies specific responsibilities 
for the hospital and for the OPO with respect to organ recovery and 
organ allocation.



Sec.  482.102  Condition of participation: Patient and living donor rights.

    In addition to meeting the condition of participation ``Patients 
rights'' requirements at Sec.  482.13, the transplant center must 
protect and promote each transplant patient's and living donor's rights.
    (a) Standard: Informed consent for transplant patients. Transplant 
centers must implement written transplant patient informed consent 
policies that inform each patient of:
    (1) The evaluation process;
    (2) The surgical procedure;
    (3) Alternative treatments;
    (4) Potential medical or psychosocial risks;
    (5) National and transplant center-specific outcomes, from the most 
recent SRTR center-specific report, including (but not limited to) the 
transplant center's observed and expected 1-year patient and graft 
survival, national 1-year patient and graft survival, and notification 
about all Medicare outcome requirements not being met by the transplant 
center;
    (6) Organ donor risk factors that could affect the success of the 
graft or the health of the patient, including, but not limited to, the 
donor's history, condition or age of the organs used, or the patient's 
potential risk of contracting the human immunodeficiency virus and other 
infectious diseases if the disease cannot be detected in an infected 
donor;
    (7) His or her right to refuse transplantation; and
    (8) The fact that if his or her transplant is not provided in a 
Medicare-approved transplant center it could affect the transplant 
recipient's ability to have his or her immunosuppressive drugs paid for 
under Medicare Part B.
    (b) Standard: Informed consent for living donors. Transplant centers 
must implement written living donor informed consent policies that 
inform the prospective living donor of all aspects of, and potential 
outcomes from, living donation. Transplant centers must ensure that the 
prospective living donor is fully informed about the following:
    (1) The fact that communication between the donor and the transplant 
center will remain confidential, in accordance with the requirements at 
45 CFR parts 160 and 164.
    (2) The evaluation process;
    (3) The surgical procedure, including post-operative treatment;
    (4) The availability of alternative treatments for the transplant 
recipient;
    (5) The potential medical or psychosocial risks to the donor;
    (6) The national and transplant center-specific outcomes for 
recipients, and the national and center-specific outcomes for living 
donors, as data are available;
    (7) The possibility that future health problems related to the 
donation may not be covered by the donor's insurance and that the 
donor's ability to obtain health, disability, or life insurance may be 
affected;
    (8) The donor's right to opt out of donation at any time during the 
donation process; and

[[Page 40]]

    (9) The fact that if a transplant is not provided in a Medicare-
approved transplant center it could affect the transplant recipient's 
ability to have his or her immunosuppressive drugs paid for under 
Medicare Part B.
    (c) Standard: Notification to patients. Transplant centers must 
notify patients placed on the center's waiting list of information about 
the center that could impact the patient's ability to receive a 
transplant should an organ become available, and what procedures are in 
place to ensure the availability of a transplant team.
    (1) A transplant center served by a single transplant surgeon or 
physician must inform patients placed on the center's waiting list of:
    (i) The potential unavailability of the transplant surgeon or 
physician; and
    (ii) Whether the center has a mechanism to provide an alternate 
transplant surgeon or transplant physician.
    (2) At least 30 days before a center's Medicare approval is 
terminated, whether voluntarily or involuntarily, the center must:
    (i) Inform patients on the center's waiting list and provide 
assistance to waiting list patients who choose to transfer to the 
waiting list of another Medicare-approved transplant center without loss 
of time accrued on the waiting list; and
    (ii) Inform Medicare beneficiaries on the center's waiting list that 
Medicare will no longer pay for transplants performed at the center 
after the effective date of the center's termination of approval.
    (3) As soon as possible prior to a transplant center's voluntary 
inactivation, the center must inform patients on the center's waiting 
list and, as directed by the Secretary, provide assistance to waiting 
list patients who choose to transfer to the waiting list of another 
Medicare-approved transplant center without loss of time accrued on the 
waiting list.



Sec.  482.104  Condition of participation: Additional requirements for kidney transplant centers.

    (a) Standard: End stage renal disease (ESRD) services. Kidney 
transplant centers must directly furnish transplantation and other 
medical and surgical specialty services required for the care of ESRD 
patients. A kidney transplant center must have written policies and 
procedures for ongoing communications with dialysis patients' local 
dialysis facilities.
    (b) Standard: Dialysis services. Kidney transplant centers must 
furnish inpatient dialysis services directly or under arrangement.
    (c) Standard: Participation in network activities. Kidney transplant 
centers must cooperate with the ESRD Network designated for their 
geographic area, in fulfilling the terms of the Network's current 
statement of work.



PART 483_REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES--Table of Contents




Subpart A [Reserved]

          Subpart B_Requirements for Long Term Care Facilities

Sec.
483.1 Basis and scope.
483.5 Definitions.
483.10 Resident rights.
483.12 Admission, transfer and discharge rights.
483.13 Resident behavior and facility practices.
483.15 Quality of life.
483.20 Resident assessment.
483.25 Quality of care.
483.30 Nursing services.
483.35 Dietary services.
483.40 Physician services.
483.45 Specialized rehabilitative services.
483.55 Dental services.
483.60 Pharmacy services.
483.65 Infection control.
483.70 Physical environment.
483.75 Administration.

 Subpart C_Preadmission Screening and Annual Review of Mentally Ill and 
                      Mentally Retarded Individuals

483.100 Basis.
483.102 Applicability and definitions.
483.104 State plan requirement.
483.106 Basic rule.
483.108 Relationship of PASARR to other Medicaid processes.
483.110 Out-of-State arrangements.
483.112 Preadmission screening of applicants for admission to NFs.
483.114 Annual review of NF residents.
483.116 Residents and applicants determined to require NF level of 
          services.

[[Page 41]]

483.118 Residents and applicants determined not to require NF level of 
          services.
483.120 Specialized services.
483.122 FFP for NF services.
483.124 FFP for specialized services.
483.126 Appropriate placement.
483.128 PASARR evaluation criteria.
483.130 PASARR determination criteria.
483.132 Evaluating the need for NF services and NF level of care 
          (PASARR/NF).
483.134 Evaluating whether an individual with mental illness requires 
          specialized services (PASARR/MI).
483.136 Evaluating whether an individual with mental retardation 
          requires specialized services (PASARR/MR).
483.138 Maintenance of services and availability of FFP.

 Subpart D_Requirements That Must Be Met by States and State Agencies: 
    Nurse Aide Training and Competency Evaluation; and Paid Feeding 
                               Assistants

483.150 Statutory basis; Deemed meeting or waiver of requirements.
483.151 State review and approval of nurse aide training and competency 
          evaluation programs and competency evaluation programs.
483.152 Requirements for approval of a nurse aide training and 
          competency evaluation program.
483.154 Nurse aide competency evaluation.
483.156 Registry of nurse aides.
483.158 FFP for nurse aide training and competency evaluation.
483.160 Requirements for training of paid feeding assistants.

 Subpart E_Appeals of Discharges, Transfers, and Preadmission Screening 
           and Annual Resident Review (PASARR) Determinations

483.200 Statutory basis.
483.202 Definitions.
483.204 Provision of a hearing and appeal system.
483.206 Transfers, discharges and relocations subject to appeal.

 Subpart F_Requirements That Must Be Met by States and State Agencies, 
                           Resident Assessment

483.315 Specification of resident assessment instrument.

    Subpart G_Condition of Participation for the Use of Restraint or 
  Seclusion in Psychiatric Residential Treatment Facilities Providing 
       Inpatient Psychiatric Services for Individuals Under Age 21

483.350 Basis and scope.
483.352 Definitions.
483.354 General requirements for psychiatric residential treatment 
          facilities.
483.356 Protection of residents.
483.358 Orders for the use of restraint or seclusion.
483.360 Consultation with treatment team physician.
483.362 Monitoring of the resident in and immediately after restraint.
483.364 Monitoring of the resident in and immediately after seclusion.
483.366 Notification of parent(s) or legal guardian(s).
483.368 Application of time out.
483.370 Postintervention debriefings.
483.372 Medical treatment for injuries resulting from an emergency 
          safety intervention.
483.374 Facility reporting.
483.376 Education and training.

Subpart H [Reserved]

 Subpart I_Conditions of Participation for Intermediate Care Facilities 
                        for the Mentally Retarded

483.400 Basis and purpose.
483.405 Relationship to other HHS regulations.
483.410 Condition of participation: Governing body and management.
483.420 Condition of participation: Client protections.
483.430 Condition of participation: Facility staffing.
483.440 Condition of participation: Active treatment services.
483.450 Condition of participation: Client behavior and facility 
          practices.
483.460 Condition of participation: Health care services.
483.470 Condition of participation: Physical environment.
483.480 Condition of participation: Dietetic services.

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 
1302 and 1395hh).

Subpart A [Reserved]



          Subpart B_Requirements for Long Term Care Facilities

    Source: 54 FR 5359, Feb. 2, 1989, unless otherwise noted.



Sec.  483.1  Basis and scope.

    (a) Statutory basis. (1) Sections 1819 (a), (b), (c), and (d) of the 
Act provide that--

[[Page 42]]

    (i) Skilled nursing facilities participating in Medicare must meet 
certain specified requirements; and
    (ii) The Secretary may impose additional requirements (see section 
1819(d)(4)(B)) if they are necessary for the health and safety of 
individuals to whom services are furnished in the facilities.
    (2) Section 1861(l) of the Act requires the facility to have in 
effect a transfer agreement with a hospital.
    (3) Sections 1919 (a), (b), (c), and (d) of the Act provide that 
nursing facilities participating in Medicaid must meet certain specific 
requirements.
    (b) Scope. The provisions of this part contain the requirements that 
an institution must meet in order to qualify to participate as a SNF in 
the Medicare program, and as a nursing facility in the Medicaid program. 
They serve as the basis for survey activities for the purpose of 
determining whether a facility meets the requirements for participation 
in Medicare and Medicaid.

[56 FR 48867, Sept. 26, 1991, as amended at 57 FR 43924, Sept. 23, 1992; 
60 FR 50443, Sept. 29, 1995]



Sec.  483.5  Definitions.

    (a) Facility defined. For purposes of this subpart, facility means a 
skilled nursing facility (SNF) that meets the requirements of sections 
1819(a), (b), (c), and (d) of the Act, or a nursing facility (NF) that 
meets the requirements of sections 1919(a), (b), (c), and (d) of the 
Act. ``Facility'' may include a distinct part of an institution (as 
defined in paragraph (b) of this section and specified in Sec.  440.40 
and Sec.  440.155 of this chapter), but does not include an institution 
for the mentally retarded or persons with related conditions described 
in Sec.  440.150 of this chapter. For Medicare and Medicaid purposes 
(including eligibility, coverage, certification, and payment), the 
``facility'' is always the entity that participates in the program, 
whether that entity is comprised of all of, or a distinct part of, a 
larger institution. For Medicare, an SNF (see section 1819(a)(1) of the 
Act), and for Medicaid, an NF (see section 1919(a)(1) of the Act) may 
not be an institution for mental diseases as defined in Sec.  435.1010 
of this chapter.
    (b) Distinct part--(1) Definition. A distinct part SNF or NF is 
physically distinguishable from the larger institution or institutional 
complex that houses it, meets the requirements of this paragraph and of 
paragraph (b)(2) of this section, and meets the applicable statutory 
requirements for SNFs or NFs in sections 1819 or 1919 of the Act, 
respectively. A distinct part SNF or NF may be comprised of one or more 
buildings or designated parts of buildings (that is, wings, wards, or 
floors) that are: In the same physical area immediately adjacent to the 
institution's main buildings; other areas and structures that are not 
strictly contiguous to the main buildings but are located within close 
proximity of the main buildings; and any other areas that CMS determines 
on an individual basis, to be part of the institution's campus. A 
distinct part must include all of the beds within the designated area, 
and cannot consist of a random collection of individual rooms or beds 
that are scattered throughout the physical plant. The term ``distinct 
part'' also includes a composite distinct part that meets the additional 
requirements of paragraph (c) of this section.
    (2) Requirements. In addition to meeting the participation 
requirements for long-term care facilities set forth elsewhere in this 
subpart, a distinct part SNF or NF must meet all of the following 
requirements:
    (i) The SNF or NF must be operated under common ownership and 
control (that is, common governance) by the institution of which it is a 
distinct part, as evidenced by the following:
    (A) The SNF or NF is wholly owned by the institution of which it is 
a distinct part.
    (B) The SNF or NF is subject to the by-laws and operating decisions 
of a common governing body.
    (C) The institution of which the SNF or NF is a distinct part has 
final responsibility for the distinct part's administrative decisions 
and personnel policies, and final approval for the distinct part's 
personnel actions.
    (D) The SNF or NF functions as an integral and subordinate part of 
the institution of which it is a distinct part, with significant common 
resource

[[Page 43]]

usage of buildings, equipment, personnel, and services.
    (ii) The administrator of the SNF or NF reports to and is directly 
accountable to the management of the institution of which the SNF or NF 
is a distinct part.
    (iii) The SNF or NF must have a designated medical director who is 
responsible for implementing care policies and coordinating medical 
care, and who is directly accountable to the management of the 
institution of which it is a distinct part.
    (iv) The SNF or NF is financially integrated with the institution of 
which it is a distinct part, as evidenced by the sharing of income and 
expenses with that institution, and the reporting of its costs on that 
institution's cost report.
    (v) A single institution can have a maximum of only one distinct 
part SNF and one distinct part NF.
    (vi) (A) An institution cannot designate a distinct part SNF or NF, 
but instead must submit a written request with documentation that 
demonstrates it meets the criteria set forth above to CMS to determine 
if it may be considered a distinct part.
    (B) The effective date of approval of a distinct part is the date 
that CMS determines all requirements (including enrollment with the 
fiscal intermediary (FI)) are met for approval, and cannot be made 
retroactive.
    (C) The institution must request approval from CMS for all proposed 
changes in the number of beds in the approved distinct part.
    (c) Composite distinct part--(1) Definition. A composite distinct 
part is a distinct part consisting of two or more noncontiguous 
components that are not located within the same campus, as defined in 
Sec.  413.65(a)(2) of this chapter.
    (2) Requirements. In addition to meeting the requirements of 
paragraph (b) of this section, a composite distinct part must meet all 
of the following requirements:
    (i) A SNF or NF that is a composite of more than one location will 
be treated as a single distinct part of the institution of which it is a 
distinct part. As such, the composite distinct part will have only one 
provider agreement and only one provider number.
    (ii) If two or more institutions (each with a distinct part SNF or 
NF) undergo a change of ownership, CMS must approve the existing SNFs or 
NFs as meeting the requirements before they are considered a composite 
distinct part of a single institution. In making such a determination, 
CMS considers whether its approval or disapproval of a composite 
distinct part promotes the effective and efficient use of public monies 
without sacrificing the quality of care.
    (iii) If there is a change of ownership of a composite distinct part 
SNF or NF, the assignment of the provider agreement to the new owner 
will apply to all of the approved locations that comprise the composite 
distinct part SNF or NF.
    (iv) To ensure quality of care and quality of life for all 
residents, the various components of a composite distinct part must meet 
all of the requirements for participation independently in each 
location.
    (d) Common area. Common areas are dining rooms, activity rooms, 
meeting rooms where residents are located on a regular basis, and other 
areas in the facility where residents may gather together with other 
residents, visitors, and staff.
    (e) Fully sprinklered. A fully sprinklered long term care facility 
is one that has all areas sprinklered in accordance with National Fire 
Protection Association 13 ``Standard for the Installation of Sprinkler 
Systems'' without the use of waivers or the Fire Safety Evaluation 
System.

[68 FR 46071, Aug. 4, 2003, as amended at 71 FR 39229, July 12, 2006; 71 
FR 55340, Sept. 22, 2006]



Sec.  483.10  Resident rights.

    The resident has a right to a dignified existence, self-
determination, and communication with and access to persons and services 
inside and outside the facility. A facility must protect and promote the 
rights of each resident, including each of the following rights:
    (a) Exercise of rights. (1) The resident has the right to exercise 
his or her rights as a resident of the facility and as a citizen or 
resident of the United States.

[[Page 44]]

    (2) The resident has the right to be free of interference, coercion, 
discrimination, and reprisal from the facility in exercising his or her 
rights.
    (3) In the case of a resident adjudged incompetent under the laws of 
a State by a court of competent jurisdiction, the rights of the resident 
are exercised by the person appointed under State law to act on the 
resident's behalf.
    (4) In the case of a resident who has not been adjudged incompetent 
by the State court, any legal-surrogate designated in accordance with 
State law may exercise the resident's rights to the extent provided by 
State law.
    (b) Notice of rights and services. (1) The facility must inform the 
resident both orally and in writing in a language that the resident 
understands of his or her rights and all rules and regulations governing 
resident conduct and responsibilities during the stay in the facility. 
The facility must also provide the resident with the notice (if any) of 
the State developed under section 1919(e)(6) of the Act. Such 
notification must be made prior to or upon admission and during the 
resident's stay. Receipt of such information, and any amendments to it, 
must be acknowledged in writing;
    (2) The resident or his or her legal representative has the right--
    (i) Upon an oral or written request, to access all records 
pertaining to himself or herself including current clinical records 
within 24 hours (excluding weekends and holidays); and
    (ii) After receipt of his or her records for inspection, to purchase 
at a cost not to exceed the community standard photocopies of the 
records or any portions of them upon request and 2 working days advance 
notice to the facility.
    (3) The resident has the right to be fully informed in language that 
he or she can understand of his or her total health status, including 
but not limited to, his or her medical condition;
    (4) The resident has the right to refuse treatment, to refuse to 
participate in experimental research, and to formulate an advance 
directive as specified in paragraph (8) of this section; and
    (5) The facility must--
    (i) Inform each resident who is entitled to Medicaid benefits, in 
writing, at the time of admission to the nursing facility or, when the 
resident becomes eligible for Medicaid of--
    (A) The items and services that are included in nursing facility 
services under the State plan and for which the resident may not be 
charged;
    (B) Those other items and services that the facility offers and for 
which the resident may be charged, and the amount of charges for those 
services; and
    (ii) Inform each resident when changes are made to the items and 
services specified in paragraphs (5)(i) (A) and (B) of this section.
    (6) The facility must inform each resident before, or at the time of 
admission, and periodically during the resident's stay, of services 
available in the facility and of charges for those services, including 
any charges for services not covered under Medicare or by the facility's 
per diem rate.
    (7) The facility must furnish a written description of legal rights 
which includes--
    (i) A description of the manner of protecting personal funds, under 
paragraph (c) of this section;
    (ii) A description of the requirements and procedures for 
establishing eligibility for Medicaid, including the right to request an 
assessment under section 1924(c) which determines the extent of a 
couple's non-exempt resources at the time of institutionalization and 
attributes to the community spouse an equitable share of resources which 
cannot be considered available for payment toward the cost of the 
institutionalized spouse's medical care in his or her process of 
spending down to Medicaid eligibility levels;
    (iii) A posting of names, addresses, and telephone numbers of all 
pertinent State client advocacy groups such as the State survey and 
certification agency, the State licensure office, the State ombudsman 
program, the protection and advocacy network, and the Medicaid fraud 
control unit; and
    (iv) A statement that the resident may file a complaint with the 
State survey and certification agency concerning resident abuse, 
neglect, misappropriation of resident property in the facility, and non-
compliance with the advance directives requirements.

[[Page 45]]

    (8) The facility must comply with the requirements specified in 
subpart I of part 489 of this chapter relating to maintaining written 
policies and procedures regarding advance directives. These requirements 
include provisions to inform and provide written information to all 
adult residents concerning the right to accept or refuse medical or 
surgical treatment and, at the individual's option, formulate an advance 
directive. This includes a written description of the facility's 
policies to implement advance directives and applicable State law. 
Facilities are permitted to contract with other entities to furnish this 
information but are still legally responsible for ensuring that the 
requirements of this section are met. If an adult individual is 
incapacitated at the time of admission and is unable to receive 
information (due to the incapacitating condition or a mental disorder) 
or articulate whether or not he or she has executed an advance 
directive, the facility may give advance directive information to the 
individual's family or surrogate in the same manner that it issues other 
materials about policies and procedures to the family of the 
incapacitated individual or to a surrogate or other concerned persons in 
accordance with State law. The facility is not relieved of its 
obligation to provide this information to the individual once he or she 
is no longer incapacitated or unable to receive such information. 
Follow-up procedures must be in place to provide the information to the 
individual directly at the appropriate time.
    (9) The facility must inform each resident of the name, specialty, 
and way of contacting the physician responsible for his or her care.
    (10) The facility must prominently display in the facility written 
information, and provide to residents and applicants for admission oral 
and written information about how to apply for and use Medicare and 
Medicaid benefits, and how to receive refunds for previous payments 
covered by such benefits.
    (11) Notification of changes. (i) A facility must immediately inform 
the resident; consult with the resident's physician; and if known, 
notify the resident's legal respresentative or an interested family 
member when there is--
    (A) An accident involving the resident which results in injury and 
has the potential for requiring physician intervention;
    (B) A significant change in the resident's physical, mental, or 
psychosocial status (i.e., a deterioration in health, mental, or 
psychosocial status in either life-threatening conditions or clinical 
complications);
    (C) A need to alter treatment significantly (i.e., a need to 
discontinue an existing form of treatment due to adverse consequences, 
or to commence a new form of treatment); or
    (D) A decision to transfer or discharge the resident from the 
facility as specified in Sec.  483.12(a).
    (ii) The facility must also promptly notify the resident and, if 
known, the resident's legal representative or interested family member 
when there is--
    (A) A change in room or roommate assignment as specified in Sec.  
483.15(e)(2); or
    (B) A change in resident rights under Federal or State law or 
regulations as specified in paragraph (b)(1) of this section.
    (iii) The facility must record and periodically update the address 
and phone number of the resident's legal representative or interested 
family member.
    (12) Admission to a composite distinct part. A facility that is a 
composite distinct part (as defined in Sec.  483.5(c) of this subpart) 
must disclose in its admission agreement its physical configuration, 
including the various locations that comprise the composite distinct 
part, and must specify the policies that apply to room changes between 
its different locations under Sec.  483.12(a)(8).
    (c) Protection of resident funds. (1) The resident has the right to 
manage his or her financial affairs, and the facility may not require 
residents to deposit their personal funds with the facility.
    (2) Management of personal funds. Upon written authorization of a 
resident, the facility must hold, safeguard, manage, and account for the 
personal funds of the resident deposited with the facility, as specified 
in paragraphs (c)(3)-(8) of this section.
    (3) Deposit of funds. (i) Funds in excess of $50. The facility must 
deposit any residents' personal funds in excess of

[[Page 46]]

$50 in an interest bearing account (or accounts) that is separate from 
any of the facility's operating accounts, and that credits all interest 
earned on resident's funds to that account. (In pooled accounts, there 
must be a separate accounting for each resident's share.)
    (ii) Funds less than $50. The facility must maintain a resident's 
personal funds that do not exceed $50 in a non-interest bearing account, 
interest-bearing account, or petty cash fund.
    (4) Accounting and records. The facility must establish and maintain 
a system that assures a full and complete and separate accounting, 
according to generally accepted accounting principles, of each 
resident's personal funds entrusted to the facility on the resident's 
behalf.
    (i) The system must preclude any commingling of resident funds with 
facility funds or with the funds of any person other than another 
resident.
    (ii) The individual financial record must be available through 
quarterly statements and on request to the resident or his or her legal 
representative.
    (5) Notice of certain balances. The facility must notify each 
resident that receives Medicaid benefits--
    (i) When the amount in the resident's account reaches $200 less than 
the SSI resource limit for one person, specified in section 
1611(a)(3)(B) of the Act; and
    (ii) That, if the amount in the account, in addition to the value of 
the resident's other nonexempt resources, reaches the SSI resource limit 
for one person, the resident may lose eligibility for Medicaid or SSI.
    (6) Conveyance upon death. Upon the death of a resident with a 
personal fund deposited with the facility, the facility must convey 
within 30 days the resident's funds, and a final accounting of those 
funds, to the individual or probate jurisdiction administering the 
resident's estate.
    (7) Assurance of financial security. The facility must purchase a 
surety bond, or otherwise provide assurance satisfactory to the 
Secretary, to assure the security of all personal funds of residents 
deposited with the facility.
    (8) Limitation on charges to personal funds. The facility may not 
impose a charge against the personal funds of a resident for any item or 
service for which payment is made under Medicaid or Medicare (except for 
applicable deductible and coinsurance amounts). The facility may charge 
the resident for requested services that are more expensive than or in 
excess of covered services in accordance with Sec.  489.32 of this 
chapter. (This does not affect the prohibition on facility charges for 
items and services for which Medicaid has paid. See Sec.  447.15, which 
limits participation in the Medicaid program to providers who accept, as 
payment in full, Medicaid payment plus any deductible, coinsurance, or 
copayment required by the plan to be paid by the individual.)
    (i) Services included in Medicare or Medicaid payment. During the 
course of a covered Medicare or Medicaid stay, facilities may not charge 
a resident for the following categories of items and services:
    (A) Nursing services as required at Sec.  483.30 of this subpart.
    (B) Dietary services as required at Sec.  483.35 of this subpart.
    (C) An activities program as required at Sec.  483.15(f) of this 
subpart.
    (D) Room/bed maintenance services.
    (E) Routine personal hygiene items and services as required to meet 
the needs of residents, including, but not limited to, hair hygiene 
supplies, comb, brush, bath soap, disinfecting soaps or specialized 
cleansing agents when indicated to treat special skin problems or to 
fight infection, razor, shaving cream, toothbrush, toothpaste, denture 
adhesive, denture cleaner, dental floss, moisturizing lotion, tissues, 
cotton balls, cotton swabs, deodorant, incontinence care and supplies, 
sanitary napkins and related supplies, towels, washcloths, hospital 
gowns, over the counter drugs, hair and nail hygiene services, bathing, 
and basic personal laundry.
    (F) Medically-related social services as required at Sec.  483.15(g) 
of this subpart.
    (ii) Items and services that may be charged to residents' funds. 
Listed below are general categories and examples of items and services 
that the facility may charge to residents' funds if they are requested 
by a resident, if the facility informs the resident that there will be a 
charge, and if payment is not made by Medicare or Medicaid:

[[Page 47]]

    (A) Telephone.
    (B) Television/radio for personal use.
    (C) Personal comfort items, including smoking materials, notions and 
novelties, and confections.
    (D) Cosmetic and grooming items and services in excess of those for 
which payment is made under Medicaid or Medicare.
    (E) Personal clothing.
    (F) Personal reading matter.
    (G) Gifts purchased on behalf of a resident.
    (H) Flowers and plants.
    (I) Social events and entertainment offered outside the scope of the 
activities program, provided under Sec.  483.15(f) of this subpart.
    (J) Noncovered special care services such as privately hired nurses 
or aides.
    (K) Private room, except when therapeutically required (for example, 
isolation for infection control).
    (L) Specially prepared or alternative food requested instead of the 
food generally prepared by the facility, as required by Sec.  483.35 of 
this subpart.
    (iii) Requests for items and services. (A) The facility must not 
charge a resident (or his or her representative) for any item or service 
not requested by the resident.
    (B) The facility must not require a resident (or his or her 
representative) to request any item or service as a condition of 
admission or continued stay.
    (C) The facility must inform the resident (or his or her 
representative) requesting an item or service for which a charge will be 
made that there will be a charge for the item or service and what the 
charge will be.
    (d) Free choice. The resident has the right to--
    (1) Choose a personal attending physician;
    (2) Be fully informed in advance about care and treatment and of any 
changes in that care or treatment that may affect the resident's well-
being; and
    (3) Unless adjudged incompetent or otherwise found to be 
incapacitated under the laws of the State, participate in planning care 
and treatment or changes in care and treatment.
    (e) Privacy and confidentiality. The resident has the right to 
personal privacy and confidentiality of his or her personal and clinical 
records.
    (1) Personal privacy includes accommodations, medical treatment, 
written and telephone communications, personal care, visits, and 
meetings of family and resident groups, but this does not require the 
facility to provide a private room for each resident;
    (2) Except as provided in paragraph (e)(3) of this section, the 
resident may approve or refuse the release of personal and clinical 
records to any individual outside the facility;
    (3) The resident's right to refuse release of personal and clinical 
records does not apply when--
    (i) The resident is transferred to another health care institution; 
or
    (ii) Record release is required by law.
    (f) Grievances. A resident has the right to--
    (1) Voice grievances without discrimination or reprisal. Such 
grievances include those with respect to treatment which has been 
furnished as well as that which has not been furnished; and
    (2) Prompt efforts by the facility to resolve grievances the 
resident may have, including those with respect to the behavior of other 
residents.
    (g) Examination of survey results. A resident has the right to--
    (1) Examine the results of the most recent survey of the facility 
conducted by Federal or State surveyors and any plan of correction in 
effect with respect to the facility. The facility must make the results 
available for examination in a place readily accessible to residents, 
and must post a notice of their availability; and
    (2) Receive information from agencies acting as client advocates, 
and be afforded the opportunity to contact these agencies.
    (h) Work. The resident has the right to--
    (1) Refuse to perform services for the facility;
    (2) Perform services for the facility, if he or she chooses, when--
    (i) The facility has documented the need or desire for work in the 
plan of care;
    (ii) The plan specifies the nature of the services performed and 
whether the services are voluntary or paid;

[[Page 48]]

    (iii) Compensation for paid services is at or above prevailing 
rates; and
    (iv) The resident agrees to the work arrangement described in the 
plan of care.
    (i) Mail. The resident has the right to privacy in written 
communications, including the right to--
    (1) Send and promptly receive mail that is unopened; and
    (2) Have access to stationery, postage, and writing implements at 
the resident's own expense.
    (j) Access and visitation rights. (1) The resident has the right and 
the facility must provide immediate access to any resident by the 
following:
    (i) Any representative of the Secretary;
    (ii) Any representative of the State:
    (iii) The resident's individual physician;
    (iv) The State long term care ombudsman (established under section 
307(a)(12) of the Older Americans Act of 1965);
    (v) The agency responsible for the protection and advocacy system 
for developmentally disabled individuals (established under part C of 
the Developmental Disabilities Assistance and Bill of Rights Act);
    (vi) The agency responsible for the protection and advocacy system 
for mentally ill individuals (established under the Protection and 
Advocacy for Mentally Ill Individuals Act);
    (vii) Subject to the resident's right to deny or withdraw consent at 
any time, immediate family or other relatives of the resident; and
    (viii) Subject to reasonable restrictions and the resident's right 
to deny or withdraw consent at any time, others who are visiting with 
the consent of the resident.
    (2) The facility must provide reasonable access to any resident by 
any entity or individual that provides health, social, legal, or other 
services to the resident, subject to the resident's right to deny or 
withdraw consent at any time.
    (3) The facility must allow representatives of the State Ombudsman, 
described in paragraph (j)(1)(iv) of this section, to examine a 
resident's clinical records with the permission of the resident or the 
resident's legal representative, and consistent with State law.
    (k) Telephone. The resident has the right to have reasonable access 
to the use of a telephone where calls can be made without being 
overheard.
    (l) Personal property. The resident has the right to retain and use 
personal possessions, including some furnishings, and appropriate 
clothing, as space permits, unless to do so would infringe upon the 
rights or health and safety of other residents.
    (m) Married couples. The resident has the right to share a room with 
his or her spouse when married residents live in the same facility and 
both spouses consent to the arrangement.
    (n) Self-Administration of Drugs. An individual resident may self-
administer drugs if the interdisciplinary team, as defined by Sec.  
483.20(d)(2)(ii), has determined that this practice is safe.
    (o) Refusal of certain transfers. (1) An individual has the right to 
refuse a transfer to another room within the institution, if the purpose 
of the transfer is to relocate--
    (i) A resident of a SNF from the distinct part of the institution 
that is a SNF to a part of the institution that is not a SNF, or
    (ii) A resident of a NF from the distinct part of the institution 
that is a NF to a distinct part of the institution that is a SNF.
    (2) A resident's exercise of the right to refuse transfer under 
paragraph (o)(1) of this section does not affect the individual's 
eligibility or entitlement to Medicare or Medicaid benefits.

[56 FR 48867, Sept. 26, 1991, as amended at 57 FR 8202, Mar. 6, 1992; 57 
FR 43924, Sept. 23, 1992; 57 FR 53587, Nov. 12, 1992; 60 FR 33293, June 
27, 1995; 68 FR 46072, Aug. 4, 2003]



Sec.  483.12  Admission, transfer and discharge rights.

    (a) Transfer and discharge--
    (1) Definition: Transfer and discharge includes movement of a 
resident to a bed outside of the certified facility whether that bed is 
in the same physical plant or not. Transfer and discharge does not refer 
to movement of a resident to a bed within the same certified facility.
    (2) Transfer and discharge requirements. The facility must permit 
each

[[Page 49]]

resident to remain in the facility, and not transfer or discharge the 
resident from the facility unless--
    (i) The transfer or discharge is necessary for the resident's 
welfare and the resident's needs cannot be met in the facility;
    (ii) The transfer or discharge is appropriate because the resident's 
health has improved sufficiently so the resident no longer needs the 
services provided by the facility;
    (iii) The safety of individuals in the facility is endangered;
    (iv) The health of individuals in the facility would otherwise be 
endangered;
    (v) The resident has failed, after reasonable and appropriate 
notice, to pay for (or to have paid under Medicare or Medicaid) a stay 
at the facility. For a resident who becomes eligible for Medicaid after 
admission to a facility, the facility may charge a resident only 
allowable charges under Medicaid; or
    (vi) The facility ceases to operate.
    (3) Documentation. When the facility transfers or discharges a 
resident under any of the circumstances specified in paragraphs 
(a)(2)(i) through (v) of this section, the resident's clinical record 
must be documented. The documentation must be made by--
    (i) The resident's physician when transfer or discharge is necessary 
under paragraph (a)(2)(i) or paragraph (a)(2)(ii) of this section; and
    (ii) A physician when transfer or discharge is necessary under 
paragraph (a)(2)(iv) of this section.
    (4) Notice before transfer. Before a facility transfers or 
discharges a resident, the facility must--
    (i) Notify the resident and, if known, a family member or legal 
representative of the resident of the transfer or discharge and the 
reasons for the move in writing and in a language and manner they 
understand.
    (ii) Record the reasons in the resident's clinical record; and
    (iii) Include in the notice the items described in paragraph (a)(6) 
of this section.
    (5) Timing of the notice. (i) Except when specified in paragraph 
(a)(5)(ii) of this section, the notice of transfer or discharge required 
under paragraph (a)(4) of this section must be made by the facility at 
least 30 days before the resident is transferred or discharged.
    (ii) Notice may be made as soon as practicable before transfer or 
discharge when--
    (A) the safety of individuals in the facility would be endangered 
under paragraph (a)(2)(iii) of this section;
    (B) The health of individuals in the facility would be endangered, 
under paragraph (a)(2)(iv) of this section;
    (C) The resident's health improves sufficiently to allow a more 
immediate transfer or discharge, under paragraph (a)(2)(ii) of this 
section;
    (D) An immediate transfer or discharge is required by the resident's 
urgent medical needs, under paragraph (a)(2)(i) of this section; or
    (E) A resident has not resided in the facility for 30 days.
    (6) Contents of the notice. The written notice specified in 
paragraph (a)(4) of this section must include the following:
    (i) The reason for transfer or discharge;
    (ii) The effective date of transfer or discharge;
    (iii) The location to which the resident is transferred or 
discharged;
    (iv) A statement that the resident has the right to appeal the 
action to the State;
    (v) The name, address and telephone number of the State long term 
care ombudsman;
    (vi) For nursing facility residents with developmental disabilities, 
the mailing address and telephone number of the agency responsible for 
the protection and advocacy of developmentally disabled individuals 
established under Part C of the Developmental Disabilities Assistance 
and Bill of Rights Act; and
    (vii) For nursing facility residents who are mentally ill, the 
mailing address and telephone number of the agency responsible for the 
protection and advocacy of mentally ill individuals established under 
the Protection and Advocacy for Mentally Ill Individuals Act.
    (7) Orientation for transfer or discharge. A facility must provide 
sufficient preparation and orientation to residents to ensure safe and 
orderly transfer or discharge from the facility.

[[Page 50]]

    (8) Room changes in a composite distinct part. Room changes in a 
facility that is a composite distinct part (as defined in Sec.  
483.5(c)) must be limited to moves within the particular building in 
which the resident resides, unless the resident voluntarily agrees to 
move to another of the composite distinct part's locations.
    (b) Notice of bed-hold policy and readmission--(1) Notice before 
transfer. Before a nursing facility transfers a resident to a hospital 
or allows a resident to go on therapeutic leave, the nursing facility 
must provide written information to the resident and a family member or 
legal representative that specifies--
    (i) The duration of the bed-hold policy under the State plan, if 
any, during which the resident is permitted to return and resume 
residence in the nursing facility; and
    (ii) The nursing facility's policies regarding bed-hold periods, 
which must be consistent with paragraph (b)(3) of this section, 
permitting a resident to return.
    (2) Bed-hold notice upon transfer. At the time of transfer of a 
resident for hospitalization or therapeutic leave, a nursing facility 
must provide to the resident and a family member or legal representative 
written notice which specifies the duration of the bed-hold policy 
described in paragraph (b)(1) of this section.
    (3) Permitting resident to return to facility. A nursing facility 
must establish and follow a written policy under which a resident, whose 
hospitalization or therapeutic leave exceeds the bed-hold period under 
the State plan, is readmitted to the facility immediately upon the first 
availability of a bed in a semi-private room if the resident--
    (i) Requires the services provided by the facility; and
    (ii) Is eligible for Medicaid nursing facility services.
    (4) Readmission to a composite distinct part. When the nursing 
facility to which a resident is readmitted is a composite distinct part 
(as defined in Sec.  483.5(c) of this subpart), the resident must be 
permitted to return to an available bed in the particular location of 
the composite distinct part in which he or she resided previously. If a 
bed is not available in that location at the time of readmission, the 
resident must be given the option to return to that location upon the 
first availability of a bed there.
    (c) Equal access to quality care. (1) A facility must establish and 
maintain identical policies and practices regarding transfer, discharge, 
and the provision of services under the State plan for all individuals 
regardless of source of payment;
    (2) The facility may charge any amount for services furnished to 
non-Medicaid residents consistent with the notice requirement in Sec.  
483.10(b)(5)(i) and (b)(6) describing the charges; and
    (3) The State is not required to offer additional services on behalf 
of a resident other than services provided in the State plan.
    (d) Admissions policy. (1) The facility must--
    (i) Not require residents or potential residents to waive their 
rights to Medicare or Medicaid; and
    (ii) Not require oral or written assurance that residents or 
potential residents are not eligible for, or will not apply for, 
Medicare or Medicaid benefits.
    (2) The facility must not require a third party guarantee of payment 
to the facility as a condition of admission or expedited admission, or 
continued stay in the facility. However, the facility may require an 
individual who has legal access to a resident's income or resources 
available to pay for facility care to sign a contract, without incurring 
personal financial liability, to provide facility payment from the 
resident's income or resources.
    (3) In the case of a person eligible for Medicaid, a nursing 
facility must not charge, solicit, accept, or receive, in addition to 
any amount otherwise required to be paid under the State plan, any gift, 
money, donation, or other consideration as a precondition of admission, 
expedited admission or continued stay in the facility. However,--
    (i) A nursing facility may charge a resident who is eligible for 
Medicaid for items and services the resident has requested and received, 
and that are not specified in the State plan as included in the term 
``nursing facility services'' so long as the facility gives proper 
notice of the availability and

[[Page 51]]

cost of these services to residents and does not condition the 
resident's admission or continued stay on the request for and receipt of 
such additional services; and
    (ii) A nursing facility may solicit, accept, or receive a 
charitable, religious, or philanthropic contribution from an 
organization or from a person unrelated to a Medicaid eligible resident 
or potential resident, but only to the extent that the contribution is 
not a condition of admission, expedited admission, or continued stay in 
the facility for a Medicaid eligible resident.
    (4) States or political subdivisions may apply stricter admissions 
standards under State or local laws than are specified in this section, 
to prohibit discrimination against individuals entitled to Medicaid.

[56 FR 48869, Sept. 26, 1991, as amended at 57 FR 43924, Sept. 23, 1992; 
68 FR 46072, Aug. 4, 2003]



Sec.  483.13  Resident behavior and facility practices.

    (a) Restraints. The resident has the right to be free from any 
physical or chemical restraints imposed for purposes of discipline or 
convenience, and not required to treat the resident's medical symptoms.
    (b) Abuse. The resident has the right to be free from verbal, 
sexual, physical, and mental abuse, corporal punishment, and involuntary 
seclusion.
    (c) Staff treatment of residents. The facility must develop and 
implement written policies and procedures that prohibit mistreatment, 
neglect, and abuse of residents and misappropriation of resident 
property.
    (1) The facility must--
    (i) Not use verbal, mental, sexual, or physical abuse, corporal 
punishment, or involuntary seclusion;
    (ii) Not employ individuals who have been--
    (A) Found guilty of abusing, neglecting, or mistreating residents by 
a court of law; or
    (B) Have had a finding entered into the State nurse aide registry 
concerning abuse, neglect, mistreatment of residents or misappropriation 
of their property; and
    (iii) Report any knowledge it has of actions by a court of law 
against an employee, which would indicate unfitness for service as a 
nurse aide or other facility staff to the State nurse aide registry or 
licensing authorities.
    (2) The facility must ensure that all alleged violations involving 
mistreatment, neglect, or abuse, including injuries of unknown source, 
and misappropriation of resident property are reported immediately to 
the administrator of the facility and to other officials in accordance 
with State law through established procedures (including to the State 
survey and certification agency).
    (3) The facility must have evidence that all alleged violations are 
thoroughly investigated, and must prevent further potential abuse while 
the investigation is in progress.
    (4) The results of all investigations must be reported to the 
administrator or his designated representative and to other officials in 
accordance with State law (including to the State survey and 
certification agency) within 5 working days of the incident, and if the 
alleged violation is verified appropriate corrective action must be 
taken.

[56 FR 48870, Sept. 26, 1991, as amended at 57 FR 43924, Sept. 23, 1992]



Sec.  483.15  Quality of life.

    A facility must care for its residents in a manner and in an 
environment that promotes maintenance or enhancement of each resident's 
quality of life.
    (a) Dignity. The facility must promote care for residents in a 
manner and in an environment that maintains or enhances each resident's 
dignity and respect in full recognition of his or her individuality.
    (b) Self-determination and participation. The resident has the right 
to--
    (1) Choose activities, schedules, and health care consistent with 
his or her interests, assessments, and plans of care;
    (2) Interact with members of the community both inside and outside 
the facility; and
    (3) Make choices about aspects of his or her life in the facility 
that are significant to the resident.
    (c) Participation in resident and family groups. (1) A resident has 
the right to

[[Page 52]]

organize and participate in resident groups in the facility;
    (2) A resident's family has the right to meet in the facility with 
the families of other residents in the facility;
    (3) The facility must provide a resident or family group, if one 
exists, with private space;
    (4) Staff or visitors may attend meetings at the group's invitation;
    (5) The facility must provide a designated staff person responsible 
for providing assistance and responding to written requests that result 
from group meetings;
    (6) When a resident or family group exists, the facility must listen 
to the views and act upon the grievances and recommendations of 
residents and families concerning proposed policy and operational 
decisions affecting resident care and life in the facility.
    (d) Participation in other activities. A resident has the right to 
participate in social, religious, and community activities that do not 
interfere with the rights of other residents in the facility.
    (e) Accommodation of needs. A resident has the right to--
    (1) Reside and receive services in the facility with reasonable 
accommodation of individual needs and preferences, except when the 
health or safety of the individual or other residents would be 
endangered; and
    (2) Receive notice before the resident's room or roommate in the 
facility is changed.
    (f) Activities. (1) The facility must provide for an ongoing program 
of activities designed to meet, in accordance with the comprehensive 
assessment, the interests and the physical, mental, and psychosocial 
well-being of each resident.
    (2) The activities program must be directed by a qualified 
professional who--
    (i) Is a qualified therapeutic recreation specialist or an 
activities professional who--
    (A) Is licensed or registered, if applicable, by the State in which 
practicing; and
    (B) Is eligible for certification as a therapeutic recreation 
specialist or as an activities professional by a recognized accrediting 
body on or after October 1, 1990; or
    (ii) Has 2 years of experience in a social or recreational program 
within the last 5 years, 1 of which was full-time in a patient 
activities program in a health care setting; or
    (iii) Is a qualified occupational therapist or occupational therapy 
assistant; or
    (iv) Has completed a training course approved by the State.
    (g) Social Services. (1) The facility must provide medically-related 
social services to attain or maintain the highest practicable physical, 
mental, and psychosocial well-being of each resident.
    (2) A facility with more than 120 beds must employ a qualified 
social worker on a full-time basis.
    (3) Qualifications of social worker. A qualified social worker is an 
individual with--
    (i) A bachelor's degree in social work or a bachelor's degree in a 
human services field including but not limited to sociology, special 
education, rehabilitation counseling, and psychology; and
    (ii) One year of supervised social work experience in a health care 
setting working directly with individuals.
    (h) Environment. The facility must provide--
    (1) A safe, clean, comfortable, and homelike environment, allowing 
the resident to use his or her personal belongings to the extent 
possible;
    (2) Housekeeping and maintenance services necessary to maintain a 
sanitary, orderly, and comfortable interior;
    (3) Clean bed and bath linens that are in good condition;
    (4) Private closet space in each resident room, as specified in 
Sec.  483.70(d)(2)(iv) of this part;
    (5) Adequate and comfortable lighting levels in all areas;
    (6) Comfortable and safe temperature levels. Facilities initially 
certified after October 1, 1990 must maintain a temperature range of 71-
81[deg]F; and
    (7) For the maintenance of comfortable sound levels.

[56 FR 48871, Sept. 26, 1991, as amended at 57 FR 43924, Sept. 23, 1992]

[[Page 53]]



Sec.  483.20  Resident assessment.

    The facility must conduct initially and periodically a 
comprehensive, accurate, standardized, reproducible assessment of each 
resident's functional capacity.
    (a) Admission orders. At the time each resident is admitted, the 
facility must have physician orders for the resident's immediate care.
    (b) Comprehensive assessments--(1) Resident assessment instrument. A 
facility must make a comprehensive assessment of a resident's needs, 
using the resident assessment instrument (RAI) specified by the State. 
The assessment must include at least the following:
    (i) Identification and demographic information.
    (ii) Customary routine.
    (iii) Cognitive patterns.
    (iv) Communication.
    (v) Vision.
    (vi) Mood and behavior patterns.
    (vii) Psychosocial well-being.
    (viii) Physical functioning and structural problems.
    (ix) Continence.
    (x) Disease diagnoses and health conditions.
    (xi) Dental and nutritional status.
    (xii) Skin condition.
    (xiii) Activity pursuit.
    (xiv) Medications.
    (xv) Special treatments and procedures.
    (xvi) Discharge potential.
    (xvii) Documentation of summary information regarding the additional 
assessment performed on the care areas triggered by the completion of 
the Minimum Data Set (MDS).
    (xviii) Documentation of participation in assessment.
    The assessment process must include direct observation and 
communication with the resident, as well as communication with licensed 
and nonlicensed direct care staff members on all shifts.
    (2) When required. Subject to the timeframes prescribed in Sec.  
413.343(b) of this chapter, a facility must conduct a comprehensive 
assessment of a resident in accordance with the timeframes specified in 
paragraphs (b)(2) (i) through (iii) of this section. The timeframes 
prescribed in Sec.  413.343(b) of this chapter do not apply to CAHs.
    (i) Within 14 calendar days after admission, excluding readmissions 
in which there is no significant change in the resident's physical or 
mental condition. (For purposes of this section, ``readmission'' means a 
return to the facility following a temporary absence for hospitalization 
or for therapeutic leave.)
    (ii) Within 14 calendar days after the facility determines, or 
should have determined, that there has been a significant change in the 
resident's physical or mental condition. (For purposes of this section, 
a ``significant change'' means a major decline or improvement in the 
resident's status that will not normally resolve itself without further 
intervention by staff or by implementing standard disease-related 
clinical interventions, that has an impact on more than one area of the 
resident's health status, and requires interdisciplinary review or 
revision of the care plan, or both.)
    (iii) Not less often than once every 12 months.
    (c) Quarterly review assessment. A facility must assess a resident 
using the quarterly review instrument specified by the State and 
approved by CMS not less frequently than once every 3 months.
    (d) Use. A facility must maintain all resident assessments completed 
within the previous 15 months in the resident's active record and use 
the results of the assessments to develop, review, and revise the 
resident's comprehensive plan f care.
    (e) Coordination. A facility must coordinate assessments with the 
preadmission screening and resident review program under Medicaid in 
part 483, subpart C to the maximum extent practicable to avoid 
duplicative testing and effort.
    (f) Automated data processing requirement--(1) Encoding data. Within 
7 days after a facility completes a resident's assessment, a facility 
must encode the following information for each resident in the facility:
    (i) Admission assessment.
    (ii) Annual assessment updates.
    (iii) Significant change in status assessments.
    (iv) Quarterly review assessments.

[[Page 54]]

    (v) A subset of items upon a resident's transfer, reentry, 
discharge, and death.
    (vi) Background (face-sheet) information, if there is no admission 
assessment.
    (2) Transmitting data. Within 7 days after a facility completes a 
resident's assessment, a facility must be capable of transmitting to the 
CMS System information for each resident contained in the MDS in a 
format that conforms to standard record layouts and data dictionaries, 
and that passes standardized edits defined by CMS and the State.
    (3) Transmittal requirements. Within 14 days after a facility 
completes a resident's assessment, a facility must electronically 
transmit encoded, accurate, and complete MDS data to the CMS System, 
including the following:
    (i) Admission assessment.
    (ii) Annual assessment.
    (iii) Significant change in status assessment.
    (iv) Significant correction of prior full assessment.
    (v) Significant correction of prior quarterly assessment.
    (vi) Quarterly review.
    (vii) A subset of items upon a resident's transfer, reentry, 
discharge, and death.
    (viii) Background (face-sheet) information, for an initial 
transmission of MDS data on a resident that does not have an admission 
assessment.
    (4) Data format. The facility must transmit data in the format 
specified by CMS or, for a State which has an alternate RAI approved by 
CMS, in the format specified by the State and approved by CMS.
    (5) Resident-identifiable information. (i) A facility may not 
release information that is resident-identifiable to the public.
    (ii) The facility may release information that is resident-
identifiable to an agent only in accordance with a contract under which 
the agent agrees not to use or disclose the information except to the 
extent the facility itself is permitted to do so.
    (g) Accuracy of assessments. The assessment must accurately reflect 
the resident's status.
    (h) Coordination. A registered nurse must conduct or coordinate each 
assessment with the appropriate participation of health professionals.
    (i) Certification. (1) A registered nurse must sign and certify that 
the assessment is completed.
    (2) Each individual who completes a portion of the assessment must 
sign and certify the accuracy of that portion of the assessment.
    (j) Penalty for falsification. (1) Under Medicare and Medicaid, an 
individual who willfully and knowingly--
    (i) Certifies a material and false statement in a resident 
assessment is subject to a civil money penalty of not more than $1,000 
for each assessment; or
    (ii) Causes another individual to certify a material and false 
statement in a resident assessment is subject to a civil money penalty 
of not more than $5,000 for each assessment.
    (2) Clinical disagreement does not constitute a material and false 
statement.
    (k) Comprehensive care plans. (1) The facility must develop a 
comprehensive care plan for each resident that includes measurable 
objectives and timetables to meet a resident's medical, nursing, and 
mental and psychosocial needs that are identified in the comprehensive 
assessment. The care plan must describe the following--
    (i) The services that are to be furnished to attain or maintain the 
resident's highest practicable physical, mental, and psychosocial well-
being as required under Sec.  483.25; and
    (ii) Any services that would otherwise be required under Sec.  
483.25 but are not provided due to the resident's exercise of rights 
under Sec.  483.10, including the right to refuse treatment under Sec.  
483.10(b)(4).
    (2) A comprehensive care plan must be--
    (i) Developed within 7 days after completion of the comprehensive 
assessment;
    (ii) Prepared by an interdisciplinary team, that includes the 
attending physician, a registered nurse with responsibility for the 
resident, and other appropriate staff in disciplines as determined by 
the resident's needs, and, to

[[Page 55]]

the extent practicable, the participation of the resident, the 
resident's family or the resident's legal representative; and
    (iii) Periodically reviewed and revised by a team of qualified 
persons after each assessment.
    (3) The services provided or arranged by the facility must--
    (i) Meet professional standards of quality; and
    (ii) Be provided by qualified persons in accordance with each 
resident's written plan of care.
    (l) Discharge summary. When the facility anticipates discharge a 
resident must have a discharge summary that includes--
    (1) A recapitulation of the resident's stay;
    (2) A final summary of the resident's status to include items in 
paragraph (b)(2) of this section, at the time of the discharge that is 
available for release to authorized persons and agencies, with the 
consent of the resident or legal representative; and
    (3) A post-discharge plan of care that is developed with the 
participation of the resident and his or her family, which will assist 
the resident to adjust to his or her new living environment.
    (m) Preadmission screening for mentally ill individuals and 
individuals with mental retardation. (1) A nursing facility must not 
admit, on or after January 1, 1989, any new resident with--
    (i) Mental illness as defined in paragraph (f)(2)(i) of this 
section, unless the State mental health authority has determined, based 
on an independent physical and mental evaluation performed by a person 
or entity other than the State mental health authority, prior to 
admission,
    (A) That, because of the physical and mental condition of the 
individual, the individual requires the level of services provided by a 
nursing facility; and
    (B) If the individual requires such level of services, whether the 
individual requires specialized services; or
    (ii) Mental retardation, as defined in paragraph (f)(2)(ii) of this 
section, unless the State mental retardation or developmental disability 
authority has determined prior to admission--
    (A) That, because of the physical and mental condition of the 
individual, the individual requires the level of services provided by a 
nursing facility; and
    (B) If the individual requires such level of services, whether the 
individual requires specialized services for mental retardation.
    (2) Definition. For purposes of this section--
    (i) An individual is considered to have mental illness if the 
individual has a serious mental illness as defined in Sec.  
483.102(b)(1).
    (ii) An individual is considered to be mentally retarded if the 
individual is mentally retarded as defined in Sec.  483.102(b)(3) or is 
a person with a related condition as described in 42 CFR 435.1010 of 
this chapter.

[56 FR 48871, Sept. 26, 1991, as amended at 57 FR 43924, Sept. 23, 1992; 
62 FR 67211, Dec. 23, 1997; 63 FR 53307, Oct. 5, 1998; 64 FR 41543, July 
30, 1999; 68 FR 46072, Aug. 4, 2003; 71 FR 39229, July 12, 2006; 74 FR 
40363, Aug.11, 2009]



Sec.  483.25  Quality of care.

    Each resident must receive and the facility must provide the 
necessary care and services to attain or maintain the highest 
practicable physical, mental, and psychosocial well-being, in accordance 
with the comprehensive assessment and plan of care.
    (a) Activities of daily living. Based on the comprehensive 
assessment of a resident, the facility must ensure that--
    (1) A resident's abilities in activities of daily living do not 
diminish unless circumstances of the individual's clinical condition 
demonstrate that diminution was unavoidable. This includes the 
resident's ability to--
    (i) Bathe, dress, and groom;
    (ii) Transfer and ambulate;
    (iii) Toilet;
    (iv) Eat; and
    (v) Use speech, language, or other functional communication systems.
    (2) A resident is given the appropriate treatment and services to 
maintain or improve his or her abilities specified in paragraph (a)(1) 
of this section; and
    (3) A resident who is unable to carry out activities of daily living 
receives the necessary services to maintain good nutrition, grooming, 
and personal and oral hygiene.

[[Page 56]]

    (b) Vision and hearing. To ensure that residents receive proper 
treatment and assistive devices to maintain vision and hearing 
abilities, the facility must, if necessary, assist the resident--
    (1) In making appointments, and
    (2) By arranging for transportation to and from the office of a 
practitioner specializing in the treatment of vision or hearing 
impairment or the office of a professional specializing in the provision 
of vision or hearing assistive devices.
    (c) Pressure sores. Based on the comprehensive assessment of a 
resident, the facility must ensure that--
    (1) A resident who enters the facility without pressure sores does 
not develop pressure sores unless the individual's clinical condition 
demonstrates that they were unavoidable; and
    (2) A resident having pressure sores receives necessary treatment 
and services to promote healing, prevent infection and prevent new sores 
from developing.
    (d) Urinary Incontinence. Based on the resident's comprehensive 
assessment, the facility must ensure that--
    (1) A resident who enters the facility without an indwelling 
catheter is not catheterized unless the resident's clinical condition 
demonstrates that catheterization was necessary; and
    (2) A resident who is incontinent of bladder receives appropriate 
treatment and services to prevent urinary tract infections and to 
restore as much normal bladder function as possible.
    (e) Range of motion. Based on the comprehensive assessment of a 
resident, the facility must ensure that--
    (1) A resident who enters the facility without a limited range of 
motion does not experience reduction in range of motion unless the 
resident's clinical condition demonstrates that a reduction in range of 
motion is unavoidable; and
    (2) A resident with a limited range of motion receives appropriate 
treatment and services to increase range of motion and/or to prevent 
further decrease in range of motion.
    (f) Mental and Psychosocial functioning. Based on the comprehensive 
assessment of a resident, the facility must ensure that--
    (1) A resident who displays mental or psychosocial adjustment 
difficulty, receives appropriate treatment and services to correct the 
assessed problem, and
    (2) A resident whose assessment did not reveal a mental or 
psychosocial adjustment difficulty does not display a pattern of 
decreased social interaction and/or increased withdrawn, angry, or 
depressive behaviors, unless the resident's clinical condition 
demonstrates that such a pattern was unavoidable.
    (g) Naso-gastric tubes. Based on the comprehensive assessment of a 
resident, the facility must ensure that--
    (1) A resident who has been able to eat enough alone or with 
assistance is not fed by naso-gastric tube unless the resident's 
clinical condition demonstrates that use of a naso-gastric tube was 
unavoidable; and
    (2) A resident who is fed by a naso-gastric or gastrostomy tube 
receives the appropriate treatment and services to prevent aspiration 
pneumonia, diarrhea, vomiting, dehydration, metabolic abnormalities, and 
nasal-pharyngeal ulcers and to restore, if possible, normal eating 
skills.
    (h) Accidents. The facility must ensure that--
    (1) The resident environment remains as free of accident hazards as 
is possible; and
    (2) Each resident receives adequate supervision and assistance 
devices to prevent accidents.
    (i) Nutrition. Based on a resident's comprehensive assessment, the 
facility must ensure that a resident--
    (1) Maintains acceptable parameters of nutritional status, such as 
body weight and protein levels, unless the resident's clinical condition 
demonstrates that this is not possible; and
    (2) Receives a therapeutic diet when there is a nutritional problem.
    (j) Hydration. The facility must provide each resident with 
sufficient fluid intake to maintain proper hydration and health.
    (k) Special needs. The facility must ensure that residents receive 
proper treatment and care for the following special services:
    (1) Injections;
    (2) Parenteral and enteral fluids;

[[Page 57]]

    (3) Colostomy, ureterostomy, or ileostomy care;
    (4) Tracheostomy care;
    (5) Tracheal suctioning;
    (6) Respiratory care;
    (7) Foot care; and
    (8) Prostheses.
    (l) Unnecessary drugs--(1) General. Each resident's drug regimen 
must be free from unnecessary drugs. An unnecessary drug is any drug 
when used:
    (i) In excessive dose (including duplicate drug therapy); or
    (ii) For excessive duration; or
    (iii) Without adequate monitoring; or
    (iv) Without adequate indications for its use; or
    (v) In the presence of adverse consequences which indicate the dose 
should be reduced or discontinued; or
    (vi) Any combinations of the reasons above.
    (2) Antipsychotic Drugs. Based on a comprehensive assessment of a 
resident, the facility must ensure that--
    (i) Residents who have not used antipsychotic drugs are not given 
these drugs unless antipsychotic drug therapy is necessary to treat a 
specific condition as diagnosed and documented in the clinical record; 
and
    (ii) Residents who use antipsychotic drugs receive gradual dose 
reductions, and behavioral interventions, unless clinically 
contraindicated, in an effort to discontinue these drugs.
    (m) Medication Errors. The facility must ensure that--
    (1) It is free of medication error rates of five percent or greater; 
and
    (2) Residents are free of any significant medication errors.
    (n) Influenza and pneumococcal immunizations--(1) Influenza. The 
facility must develop policies and procedures that ensure that--
    (i) Before offering the influenza immunization, each resident or the 
resident's legal representative receives education regarding the 
benefits and potential side effects of the immunization;
    (ii) Each resident is offered an influenza immunization October 1 
through March 31 annually, unless the immunization is medically 
contraindicated or the resident has already been immunized during this 
time period;
    (iii) The resident or the resident's legal representative has the 
opportunity to refuse immunization; and
    (iv) The resident's medical record includes documentation that 
indicates, at a minimum, the following:
    (A) That the resident or resident's legal representative was 
provided education regarding the benefits and potential side effects of 
influenza immunization; and
    (B) That the resident either received the influenza immunization or 
did not receive the influenza immunization due to medical 
contraindications or refusal.
    (2) Pneumococcal disease. The facility must develop policies and 
procedures that ensure that--
    (i) Before offering the pneumococcal immunization, each resident or 
the resident's legal representative receives education regarding the 
benefits and potential side effects of the immunization;
    (ii) Each resident is offered a pneumococcal immunization, unless 
the immunization is medically contraindicated or the resident has 
already been immunized;
    (iii) The resident or the resident's legal representative has the 
opportunity to refuse immunization; and
    (iv) The resident's medical record includes documentation that 
indicates, at a minimum, the following:
    (A) That the resident or resident's legal representative was 
provided education regarding the benefits and potential side effects of 
pneumococcal immunization; and
    (B) That the resident either received the pneumococcal immunization 
or did not receive the pneumococcal immunization due to medical 
contraindication or refusal.
    (v) Exception. As an alternative, based on an assessment and 
practitioner recommendation, a second pneumococcal immunization may be 
given after 5 years following the first pneumococcal immunization, 
unless medically contraindicated or the resident or the resident's legal 
representative refuses the second immunization.

[56 FR 48873, Sept. 26, 1991, as amended at 57 FR 43925, Sept. 23, 1992; 
70 FR 58851, Oct. 7, 2005]

[[Page 58]]



Sec.  483.30  Nursing services.

    The facility must have sufficient nursing staff to provide nursing 
and related services to attain or maintain the highest practicable 
physical, mental, and psychosocial well-being of each resident, as 
determined by resident assessments and individual plans of care.
    (a) Sufficient staff. (1) The facility must provide services by 
sufficient numbers of each of the following types of personnel on a 24-
hour basis to provide nursing care to all residents in accordance with 
resident care plans:
    (i) Except when waived under paragraph (c) of this section, licensed 
nurses; and
    (ii) Other nursing personnel.
    (2) Except when waived under paragraph (c) of this section, the 
facility must designate a licensed nurse to serve as a charge nurse on 
each tour of duty.
    (b) Registered nurse. (1) Except when waived under paragraph (c) or 
(d) of this section, the facility must use the services of a registered 
nurse for at least 8 consecutive hours a day, 7 days a week.
    (2) Except when waived under paragraph (c) or (d) of this section, 
the facility must designate a registered nurse to serve as the director 
of nursing on a full time basis.
    (3) The director of nursing may serve as a charge nurse only when 
the facility has an average daily occupancy of 60 or fewer residents.
    (c) Nursing facilities: Waiver of requirement to provide licensed 
nurses on a 24-hour basis. To the extent that a facility is unable to 
meet the requirements of paragraphs (a)(2) and (b)(1) of this section, a 
State may waive such requirements with respect to the facility if--
    (1) The facility demonstrates to the satisfaction of the State that 
the facility has been unable, despite diligent efforts (including 
offering wages at the community prevailing rate for nursing facilities), 
to recruit appropriate personnel;
    (2) The State determines that a waiver of the requirement will not 
endanger the health or safety of individuals staying in the facility;
    (3) The State finds that, for any periods in which licensed nursing 
services are not available, a registered nurse or a physician is 
obligated to respond immediately to telephone calls from the facility;
    (4) A waiver granted under the conditions listed in paragraph (c) of 
this section is subject to annual State review;
    (5) In granting or renewing a waiver, a facility may be required by 
the State to use other qualified, licensed personnel;
    (6) The State agency granting a waiver of such requirements provides 
notice of the waiver to the State long term care ombudsman (established 
under section 307(a)(12) of the Older Americans Act of 1965) and the 
protection and advocacy system in the State for the mentally ill and 
mentally retarded; and
    (7) The nursing facility that is granted such a waiver by a State 
notifies residents of the facility (or, where appropriate, the guardians 
or legal representatives of such residents) and members of their 
immediate families of the waiver.
    (d) SNFs: Waiver of the requirement to provide services of a 
registered nurse for more than 40 hours a week. (1) The Secretary may 
waive the requirement that a SNF provide the services of a registered 
nurse for more than 40 hours a week, including a director of nursing 
specified in paragraph (b) of this section, if the Secretary finds 
that--
    (i) The facility is located in a rural area and the supply of 
skilled nursing facility services in the area is not sufficient to meet 
the needs of individuals residing in the area;
    (ii) The facility has one full-time registered nurse who is 
regularly on duty at the facility 40 hours a week; and
    (iii) The facility either--
    (A) Has only patients whose physicians have indicated (through 
physicians' orders or admission notes) that they do not require the 
services of a registered nurse or a physician for a 48-hours period, or
    (B) Has made arrangements for a registered nurse or a physician to 
spend time at the facility, as determined necessary by the physician, to 
provide necessary skilled nursing services on days when the regular 
full-time registered nurse is not on duty;
    (iv) The Secretary provides notice of the waiver to the State long 
term care

[[Page 59]]

ombudsman (established under section 307(a)(12) of the Older Americans 
Act of 1965) and the protection and advocacy system in the State for the 
mentally ill and mentally retarded; and
    (v) The facility that is granted such a waiver notifies residents of 
the facility (or, where appropriate, the guardians or legal 
representatives of such residents) and members of their immediate 
families of the waiver.
    (2) A waiver of the registered nurse requirement under paragraph 
(d)(1) of this section is subject to annual renewal by the Secretary.
    (e) Nurse staffing information--(1) Data requirements. The facility 
must post the following information on a daily basis:
    (i) Facility name.
    (ii) The current date.
    (iii) The total number and the actual hours worked by the following 
categories of licensed and unlicensed nursing staff directly responsible 
for resident care per shift:
    (A) Registered nurses.
    (B) Licensed practical nurses or licensed vocational nurses (as 
defined under State law).
    (C) Certified nurse aides.
    (iv) Resident census.
    (2) Posting requirements. (i) The facility must post the nurse 
staffing data specified in paragraph (e)(1) of this section on a daily 
basis at the beginning of each shift.
    (ii) Data must be posted as follows:
    (A) Clear and readable format.
    (B) In a prominent place readily accessible to residents and 
visitors.
    (3) Public access to posted nurse staffing data. The facility must, 
upon oral or written request, make nurse staffing data available to the 
public for review at a cost not to exceed the community standard.
    (4) Facility data retention requirements. The facility must maintain 
the posted daily nurse staffing data for a minimum of 18 months, or as 
required by State law, whichever is greater.

[56 FR 48873, Sept. 26, 1991, as amended at 57 FR 43925, Sept. 23, 1992; 
70 FR 62073, Oct. 28, 2005]



Sec.  483.35  Dietary services.

    The facility must provide each resident with a nourishing, 
palatable, well-balanced diet that meets the daily nutritional and 
special dietary needs of each resident.
    (a) Staffing. The facility must employ a qualified dietitian either 
full-time, part-time, or on a consultant basis.
    (1) If a qualified dietitian is not employed full-time, the facility 
must designate a person to serve as the director of food service who 
receives frequently scheduled consultation from a qualified dietitian.
    (2) A qualified dietitian is one who is qualified based upon either 
registration by the Commission on Dietetic Registration of the American 
Dietetic Association, or on the basis of education, training, or 
experience in identification of dietary needs, planning, and 
implementation of dietary programs.
    (b) Sufficient staff. The facility must employ sufficient support 
personnel competent to carry out the functions of the dietary service.
    (c) Menus and nutritional adequacy. Menus must--
    (1) Meet the nutritional needs of residents in accordance with the 
recommended dietary allowances of the Food and Nutrition Board of the 
National Research Council, National Academy of Sciences;
    (2) Be prepared in advance; and
    (3) Be followed.
    (d) Food. Each resident receives and the facility provides--
    (1) Food prepared by methods that conserve nutritive value, flavor, 
and appearance;
    (2) Food that is palatable, attractive, and at the proper 
temperature;
    (3) Food prepared in a form designed to meet individual needs; and
    (4) Substitutes offered of similar nutritive value to residents who 
refuse food served.
    (e) Therapeutic diets. Therapeutic diets must be prescribed by the 
attending physician.
    (f) Frequency of meals. (1) Each resident receives and the facility 
provides at least three meals daily, at regular times comparable to 
normal mealtimes in the community.
    (2) There must be no more than 14 hours between a substantial 
evening meal and breakfast the following day, except as provided in (4) 
below.
    (3) The facility must offer snacks at bedtime daily.

[[Page 60]]

    (4) When a nourishing snack is provided at bedtime, up to 16 hours 
may elapse between a substantial evening meal and breakfast the 
following day if a resident group agrees to this meal span, and a 
nourishing snack is served.
    (g) Assistive devices. The facility must provide special eating 
equipment and utensils for residents who need them.
    (h) Paid feeding assistants--(1) State-approved training course. A 
facility may use a paid feeding assistant, as defined in Sec.  488.301 
of this chapter, if--
    (i) The feeding assistant has successfully completed a State-
approved training course that meets the requirements of Sec.  483.160 
before feeding residents; and
    (ii) The use of feeding assistants is consistent with State law.
    (2) Supervision. (i) A feeding assistant must work under the 
supervision of a registered nurse (RN) or licensed practical nurse 
(LPN).
    (ii) In an emergency, a feeding assistant must call a supervisory 
nurse for help on the resident call system.
    (3) Resident selection criteria. (i) A facility must ensure that a 
feeding assistant feeds only residents who have no complicated feeding 
problems.
    (ii) Complicated feeding problems include, but are not limited to, 
difficulty swallowing, recurrent lung aspirations, and tube or 
parenteral/IV feedings.
    (iii) The facility must base resident selection on the charge 
nurse's assessment and the resident's latest assessment and plan of 
care.
    (i) Sanitary conditions. The facility must--
    (1) Procure food from sources approved or considered satisfactory by 
Federal, State, or local authorities;
    (2) Store, prepare, distribute, and serve food under sanitary 
conditions; and
    (3) Dispose of garbage and refuse properly.

[56 FR 48874, Sept. 26, 1991, as amended at 68 FR 55539, Sept. 26, 2003]



Sec.  483.40  Physician services.

    A physician must personally approve in writing a recommendation that 
an individual be admitted to a facility. Each resident must remain under 
the care of a physician.
    (a) Physician supervision. The facility must ensure that--
    (1) The medical care of each resident is supervised by a physician; 
and
    (2) Another physician supervises the medical care of residents when 
their attending physician is unavailable.
    (b) Physician visits. The physician must--
    (1) Review the resident's total program of care, including 
medications and treatments, at each visit required by paragraph (c) of 
this section;
    (2) Write, sign, and date progress notes at each visit; and
    (3) Sign and date all orders with the exception of influenza and 
pneumococcal polysaccharide vaccines, which may be administered per 
physician-approved facility policy after an assessment for 
contraindications.
    (c) Frequency of physician visits. (1) The resident must be seen by 
a physician at least once every 30 days for the first 90 days after 
admission, and at least once every 60 days thereafter.
    (2) A physician visit is considered timely if it occurs not later 
than 10 days after the date the visit was required.
    (3) Except as provided in paragraphs (c)(4) and (f) of this section, 
all required physician visits must be made by the physician personally.
    (4) At the option of the physician, required visits in SNFs after 
the initial visit may alternate between personal visits by the physician 
and visits by a physician assistant, nurse practitioner, or clinical 
nurse specialist in accordance with paragraph (e) of this section.
    (d) Availability of physicians for emergency care. The facility must 
provide or arrange for the provision of physician services 24 hours a 
day, in case of an emergency.
    (e) Physician delegation of tasks in SNFs. (1) Except as specified 
in paragraph (e)(2) of this section, a physician may delegate tasks to a 
physician assistant, nurse practitioner, or clinical nurse specialist 
who--
    (i) Meets the applicable definition in Sec.  491.2 of this chapter 
or, in the case of a clinical nurse specialist, is licensed as such by 
the State;
    (ii) Is acting within the scope of practice as defined by State law; 
and

[[Page 61]]

    (iii) Is under the supervision of the physician.
    (2) A physician may not delegate a task when the regulations specify 
that the physician must perform it personally, or when the delegation is 
prohibited under State law or by the facility's own policies.
    (f) Performance of physician tasks in NFs. At the option of the 
State, any required physician task in a NF (including tasks which the 
regulations specify must be performed personally by the physician) may 
also be satisfied when performed by a nurse practitioner, clinical nurse 
specialist, or physician assistant who is not an employee of the 
facility but who is working in collaboration with a physician.

[56 FR 48875, Sept. 26, 1991, as amended at 67 FR 61814, Oct. 2, 2002]



Sec.  483.45  Specialized rehabilitative services.

    (a) Provision of services. If specialized rehabilitative services 
such as but not limited to physical therapy, speech-language pathology, 
occupational therapy, and mental health rehabilitative services for 
mental illness and mental retardation, are required in the resident's 
comprehensive plan of care, the facility must--
    (1) Provide the required services; or
    (2) Obtain the required services from an outside resource (in 
accordance with Sec.  483.75(h) of this part) from a provider of 
specialized rehabilitative services.
    (b) Qualifications. Specialized rehabilitative services must be 
provided under the written order of a physician by qualified personnel.

[56 FR 48875, Sept. 26, 1991, as amended at 57 FR 43925, Sept. 23, 1992]



Sec.  483.55  Dental services.

    The facility must assist residents in obtaining routine and 24-hour 
emergency dental care.
    (a) Skilled nursing facilities. A facility (1) Must provide or 
obtain from an outside resource, in accordance with Sec.  483.75(h) of 
this part, routine and emergency dental services to meet the needs of 
each resident;
    (2) May charge a Medicare resident an additional amount for routine 
and emergency dental services;
    (3) Must if necessary, assist the resident--
    (i) In making appointments; and
    (ii) By arranging for transportation to and from the dentist's 
office; and
    (4) Promptly refer residents with lost or damaged dentures to a 
dentist.
    (b) Nursing facilities. The facility (1) Must provide or obtain from 
an outside resource, in accordance with Sec.  483.75(h) of this part, 
the following dental services to meet the needs of each resident:
    (i) Routine dental services (to the extent covered under the State 
plan); and
    (ii) Emergency dental services;
    (2) Must, if necessary, assist the resident--
    (i) In making appointments; and
    (ii) By arranging for transportation to and from the dentist's 
office; and
    (3) Must promptly refer residents with lost or damaged dentures to a 
dentist.

[56 FR 48875, Sept. 26, 1991]



Sec.  483.60  Pharmacy services.

    The facility must provide routine and emergency drugs and 
biologicals to its residents, or obtain them under an agreement 
described in Sec.  483.75(h) of this part. The facility may permit 
unlicensed personnel to administer drugs if State law permits, but only 
under the general supervision of a licensed nurse.
    (a) Procedures. A facility must provide pharmaceutical services 
(including procedures that assure the accurate acquiring, receiving, 
dispensing, and administering of all drugs and biologicals) to meet the 
needs of each resident.
    (b) Service consultation. The facility must employ or obtain the 
services of a licensed pharmacist who--
    (1) Provides consultation on all aspects of the provision of 
pharmacy services in the facility;
    (2) Establishes a system of records of receipt and disposition of 
all controlled drugs in sufficient detail to enable an accurate 
reconciliation; and
    (3) Determines that drug records are in order and that an account of 
all controlled drugs is maintained and periodically reconciled.
    (c) Drug regimen review. (1) The drug regimen of each resident must 
be reviewed at least once a month by a licensed pharmacist.

[[Page 62]]

    (2) The pharmacist must report any irregularities to the attending 
physician and the director of nursing, and these reports must be acted 
upon.
    (d) Labeling of drugs and biologicals. Drugs and biologicals used in 
the facility must be labeled in accordance with currently accepted 
professional principles, and include the appropriate accessory and 
cautionary instructions, and the expiration date when applicable.
    (e) Storage of drugs and biologicals. (1) In accordance with State 
and Federal laws, the facility must store all drugs and biologicals in 
locked compartments under proper temperature controls, and permit only 
authorized personnel to have access to the keys.
    (2) The facility must provide separately locked, permanently affixed 
compartments for storage of controlled drugs listed in Schedule II of 
the Comprehensive Drug Abuse Prevention and Control Act of 1976 and 
other drugs subject to abuse, except when the facility uses single unit 
package drug distribution systems in which the quantity stored is 
minimal and a missing dose can be readily detected.

[56 FR 48875, Sept. 26, 1991, as amended at 57 FR 43925, Sept. 23, 1992]



Sec.  483.65  Infection control.

    The facility must establish and maintain an infection control 
program designed to provide a safe, sanitary, and comfortable 
environment and to help prevent the development and transmission of 
disease and infection.
    (a) Infection control program. The facility must establish an 
infection control program under which it--
    (1) Investigates, controls, and prevents infections in the facility;
    (2) Decides what procedures, such as isolation, should be applied to 
an individual resident; and
    (3) Maintains a record of incidents and corrective actions related 
to infections.
    (b) Preventing spread of infection. (1) When the infection control 
program determines that a resident needs isolation to prevent the spread 
of infection, the facility must isolate the resident.
    (2) The facility must prohibit employees with a communicable disease 
or infected skin lesions from direct contact with residents or their 
food, if direct contact will transmit the disease.
    (3) The facility must require staff to wash their hands after each 
direct resident contact for which handwashing is indicated by accepted 
professional practice.
    (c) Linens. Personnel must handle, store, process, and transport 
linens so as to prevent the spread of infection.

[56 FR 48876, Sept. 26, 1991, as amended at 57 FR 43925, Sept. 23, 1992]



Sec.  483.70  Physical environment.

    The facility must be designed, constructed, equipped, and maintained 
to protect the health and safety of residents, personnel and the public.
    (a) Life safety from fire. (1) Except as otherwise provided in this 
section--
    (i) The facility must meet the applicable provisions of the 2000 
edition of the Life Safety Code of the National Fire Protection 
Association. The Director of the Office of the Federal Register has 
approved the NFPA 101 [reg] 2000 edition of the Life Safety 
Code, issued January 14, 2000, for incorporation by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy of the Code is 
available for inspection at the CMS Information Resource Center, 7500 
Security Boulevard, Baltimore, MD or at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal--register/code--of--federal--regulations/ibr--
locations.html. Copies may be obtained from the National Fire Protection 
Association, 1 Batterymarch Park, Quincy, MA 02269. If any changes in 
this edition of the Code are incorporated by reference, CMS will publish 
notice in the Federal Register to announce the changes.
    (ii) Chapter 19.3.6.3.2, exception number 2 of the adopted edition 
of the LSC does not apply to long-term care facilities.
    (2) After consideration of State survey agency findings, CMS may 
waive specific provisions of the Life Safety ode which, if rigidly 
applied, would result in unreasonable hardship upon the facility, but 
only if the waiver does not

[[Page 63]]

adversely affect the health and safety of the patients.
    (3) The provisions of the Life safety Code do not apply in a State 
where CMS finds, in accordance with applicable provisions of sections 
1819(d)(2)(B)(ii) and 1919(d)(2)(B)(ii) of the Act, that a fire and 
safety code imposed by State law adequately protects patients, residents 
and personnel in long term care facilities.
    (4) Beginning March 13, 2006, a long-term care facility must be in 
compliance with Chapter 19.2.9, Emergency Lighting.
    (5) Beginning March 13, 2006, Chapter 19.3.6.3.2, exception number 2 
does not apply to long-term care facilities.
    (6) Notwithstanding any provisions of the 2000 edition of the Life 
Safety Code to the contrary, a long-term care facility may install 
alcohol-based hand rub dispensers in its facility if--
    (i) Use of alcohol-based hand rub dispensers does not conflict with 
any State or local codes that prohibit or otherwise restrict the 
placement of alcohol-based hand rub dispensers in health care 
facilities;
    (ii) The dispensers are installed in a manner that minimizes leaks 
and spills that could lead to falls;
    (iii) The dispensers are installed in a manner that adequately 
protects against inappropriate access;
    (iv) The dispensers are installed in accordance with chapter 
18.3.2.7 or chapter 19.3.2.7 of the 2000 edition of the Life Safety 
Code, as amended by NFPA Temporary Interim Amendment 00-1(101), issued 
by the Standards Council of the National Fire Protection Association on 
April 15, 2004. The Director of the Office of the Federal Register has 
approved NFPA Temporary Interim Amendment 00-1(101) for incorporation by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy 
of the amendment is available for inspection at the CMS Information 
Resource Center, 7500 Security Boulevard, Baltimore, MD and at the 
Office of the Federal Register, 800 North Capitol Street NW., Suite 700, 
Washington, DC. Copies may be obtained from the National Fire Protection 
Association, 1 Batterymarch Park, Quincy, MA 02269; and
    (v) The dispensers are maintained in accordance with dispenser 
manufacturer guidelines.
    (7) A long term care facility must:
    (i) Install, at least, battery-operated single station smoke alarms 
in accordance with the manufacturer's recommendations in resident 
sleeping rooms and common areas.
    (ii) Have a program for inspection, testing, maintenance, and 
battery replacement that conforms to the manufacturer's recommendations 
and that verifies correct operation of the smoke alarms.
    (iii) Exception:
    (A) The facility has system-based smoke detectors in patient rooms 
and common areas that are installed, tested, and maintained in 
accordance with NFPA 72, National Fire Alarm Code, for system-based 
smoke detectors; or
    (B) The facility is fully sprinklered in accordance with NFPA 13, 
Standard for the Installation of Sprinkler Systems.
    (8) A long term care facility must:
    (i) Install an approved, supervised automatic sprinkler system in 
accordance with the 1999 edition of NFPA 13, Standard for the 
Installation of Sprinkler Systems, as incorporated by reference, 
throughout the building by August 13, 2013. The Director of the Office 
of the Federal Register has approved the NFPA 13 1999 edition of the 
Standard for the Installation of Sprinkler Systems, issued July 22, 1999 
for incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51. A copy of the Code is available for inspection at the CMS 
Information Resource Center, 7500 Security Boulevard, Baltimore, MD or 
at the National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal--register/code--of--
federal--regulations/ibr--locations.html. Copies may be obtained from 
the National Fire Protection Association, 1 Batterymarch Park, Quincy, 
MA 02269.
    (ii) Test, inspect, and maintain an approved, supervised automatic 
sprinkler system in accordance with the 1998 edition of NFPA 25, 
Standard for the Inspection, Testing, and Maintenance of Water-Based 
Fire Protection Systems, as

[[Page 64]]

incorporated by reference. The Director of the Office of the Federal 
Register has approved the NFPA 25, Standard for the Inspection, Testing, 
and Maintenance of Water-Based Fire Protection Systems, 1998 edition, 
issued January 16, 1998 for incorporation by reference in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51. A copy of the Code is available 
for inspection at the CMS Information Resource Center, 7500 Security 
Boulevard, Baltimore, MD or at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html. 
Copies may be obtained from the National Fire Protection Association, 1 
Batterymarch Park, Quincy, MA 02269.
    (b) Emergency power. (1) An emergency electrical power system must 
supply power adequate at least for lighting all entrances and exits; 
equipment to maintain the fire detection, alarm, and extinguishing 
systems; and life support systems in the event the normal electrical 
supply is interrupted.
    (2) When life support systems are used, the facility must provide 
emergency electrical power with an emergency generator (as defined in 
NFPA 99, Health Care Facilities) that is located on the premises.
    (c) Space and equipment. The facility must--
    (1) Provide sufficient space and equipment in dining, health 
services, recreation, and program areas to enable staff to provide 
residents with needed services as required by these standards and as 
identified in each resident's plan of care; and
    (2) Maintain all essential mechanical, electrical, and patient care 
equipment in safe operating condition.
    (d) Resident rooms. Resident rooms must be designed and equipped for 
adequate nursing care, comfort, and privacy of residents.
    (1) Bedrooms must--
    (i) Accommodate no more than four residents;
    (ii) Measure at least 80 square feet per resident in multiple 
resident bedrooms, and at least 100 square feet in single resident 
rooms;
    (iii) Have direct access to an exit corridor;
    (iv) Be designed or equipped to assure full visual privacy for each 
resident;
    (v) In facilities initially certified after March 31, 1992, except 
in private rooms, each bed must have ceiling suspended curtains, which 
extend around the bed to provide total visual privacy in combination 
with adjacent walls and curtains;
    (vi) Have at least one window to the outside; and
    (vii) Have a floor at or above grade level.
    (2) The facility must provide each resident with--
    (i) A separate bed of proper size and height for the convenience of 
the resident;
    (ii) A clean, comfortable mattress;
    (iii) Bedding appropriate to the weather and climate; and
    (iv) Functional furniture appropriate to the resident's needs, and 
individual closet space in the resident's bedroom with clothes racks and 
shelves accessible to the resident.
    (3) CMS, or in the case of a nursing facility the survey agency, may 
permit variations in requirements specified in paragraphs (d)(1) (i) and 
(ii) of this section relating to rooms in individual cases when the 
facility demonstrates in writing that the variations--
    (i) Are in accordance with the special needs of the residents; and
    (ii) Will not adversely affect residents' health and safety.
    (e) Toilet facilities. Each resident room must be equipped with or 
located near toilet and bathing facilities.
    (f) Resident call system. The nurse's station must be equipped to 
receive resident calls through a communication system from--
    (1) Resident rooms; and
    (2) Toilet and bathing facilities.
    (g) Dining and resident activities. The facility must provide one or 
more rooms designated for resident dining and activities. These rooms 
must--
    (1) Be well lighted;
    (2) Be well ventilated, with nonsmoking areas identified;
    (3) Be adequately furnished; and
    (4) Have sufficient space to accommodate all activities.

[[Page 65]]

    (h) Other environmental conditions. The facility must provide a 
safe, functional, sanitary, and comfortable environment for the 
residents, staff and the public. The facility must--
    (1) Establish procedures to ensure that water is available to 
essential areas when there is a loss of normal water supply;
    (2) Have adequate outside ventilation by means of windows, or 
mechanical ventilation, or a combination of the two;
    (3) Equip corridors with firmly secured handrails on each side; and
    (4) Maintain an effective pest control program so that the facility 
is free of pests and rodents.

[56 FR 48876, Sept. 26, 1991, as amended at 57 FR 43925, Sept. 23, 1992; 
68 FR 1386, Jan. 10, 2003; 69 FR 49268, Aug. 11, 2004; 70 FR 15238, Mar. 
25, 2005; 71 FR 55340, Sept. 22, 2006; 73 FR 47091, Aug. 13, 2008]



Sec.  483.75  Administration.

    A facility must be administered in a manner that enables it to use 
its resources effectively and efficiently to attain or maintain the 
highest practicable physical, mental, and psychosocial well-being of 
each resident.
    (a) Licensure. A facility must be licensed under applicable State 
and local law.
    (b) Compliance with Federal, State, and local laws and professional 
standards. The facility must operate and provide services in compliance 
with all applicable Federal, State, and local laws, regulations, and 
codes, and with accepted professional standards and principles that 
apply to professionals providing services in such a facility.
    (c) Relationship to other HHS regulations. In addition to compliance 
with the regulations set forth in this subpart, facilities are obliged 
to meet the applicable provisions of other HHS regulations, including 
but not limited to those pertaining to nondiscrimination on the basis of 
race, color, or national origin (45 CFR part 80); nondiscrimination on 
the basis of handicap (45 CFR part 84); nondiscrimination on the basis 
of age (45 CFR part 91); protection of human subjects of research (45 
CFR part 46); and fraud and abuse (42 CFR part 455). Although these 
regulations are not in themselves considered requirements under this 
part, their violation may result in the termination or suspension of, or 
the refusal to grant or continue payment with Federal funds.
    (d) Governing body. (1) The facility must have a governing body, or 
designated persons functioning as a governing body, that is legally 
responsible for establishing and implementing policies regarding the 
management and operation of the facility; and
    (2) The governing body appoints the administrator who is--
    (i) Licensed by the State where licensing is required; and
    (ii) Responsible for management of the facility.
    (e) Required training of nursing aides--(1) Definitions.
    Licensed health professional means a physician; physician assistant; 
nurse practitioner; physical, speech, or occupational therapist; 
physical or occupational therapy assistant; registered professional 
nurse; licensed practical nurse; or licensed or certified social worker.
    Nurse aide means any individual providing nursing or nursing-related 
services to residents in a facility who is not a licensed health 
professional, a registered dietitian, or someone who volunteers to 
provide such services without pay. Nurse aides do not include those 
individuals who furnish services to residents only as paid feeding 
assistants as defined in Sec.  488.301 of this chapter.
    (2) General rule. A facility must not use any individual working in 
the facility as a nurse aide for more than 4 months, on a full-time 
basis, unless:
    (i) That individual is competent to provide nursing and nursing 
related services; and
    (ii)(A) That individual has completed a training and competency 
evaluation program, or a competency evaluation program approved by the 
State as meeting the requirements of Sec. Sec.  483.151-483.154 of this 
part; or
    (B) That individual has been deemed or determined competent as 
provided in Sec.  483.150 (a) and (b).
    (3) Non-permanent employees. A facility must not use on a temporary, 
per diem, leased, or any basis other than a permanent employee any 
individual who does not meet the requirements in

[[Page 66]]

paragraphs (e)(2) (i) and (ii) of this section.
    (4) Competency. A facility must not use any individual who has 
worked less than 4 months as a nurse aide in that facility unless the 
individual--
    (i) Is a full-time employee in a State-approved training and 
competency evaluation program;
    (ii) Has demonstrated competence through satisfactory participation 
in a State-approved nurse aide training and competency evaluation 
program or competency evaluation program; or
    (iii) Has been deemed or determined competent as provided in Sec.  
483.150 (a) and (b).
    (5) Registry verification. Before allowing an individual to serve as 
a nurse aide, a facility must receive registry verification that the 
individual has met competency evaluation requirements unless--
    (i) The individual is a full-time employee in a training and 
competency evaluation program approved by the State; or
    (ii) The individual can prove that he or she has recently 
successfully completed a training and competency evaluation program or 
competency evaluation program approved by the State and has not yet been 
included in the registry. Facilities must follow up to ensure that such 
an individual actually becomes registered.
    (6) Multi-State registry verification. Before allowing an individual 
to serve as a nurse aide, a facility must seek information from every 
State registry established under sections 1819(e)(2)(A) or 1919(e)(2)(A) 
of the Act the facility believes will include information on the 
individual.
    (7) Required retraining. If, since an individual's most recent 
completion of a training and competency evaluation program, there has 
been a continuous period of 24 consecutive months during none of which 
the individual provided nursing or nursing-related services for monetary 
compensation, the individual must complete a new training and competency 
evaluation program or a new competency evaluation program.
    (8) Regular in-service education. The facility must complete a 
performance review of every nurse aide at least once every 12 months, 
and must provide regular in-service education based on the outcome of 
these reviews. The in-service training must--
    (i) Be sufficient to ensure the continuing competence of nurse 
aides, but must be no less than 12 hours per year;
    (ii) Address areas of weakness as determined in nurse aides' 
performance reviews and may address the special needs of residents as 
determined by the facility staff; and
    (iii) For nurse aides providing services to individuals with 
cognitive impairments, also address the care of the cognitively 
impaired.
    (f) Proficiency of Nurse aides. The facility must ensure that nurse 
aides are able to demonstrate competency in skills and techniques 
necessary to care for residents' needs, as identified through resident 
assessments, and described in the plan of care.
    (g) Staff qualifications. (1) The facility must employ on a full-
time, part-time or consultant basis those professionals necessary to 
carry out the provisions of these requirements.
    (2) Professional staff must be licensed, certified, or registered in 
accordance with applicable State laws.
    (h) Use of outside resources. (1) If the facility does not employ a 
qualified professional person to furnish a specific service to be 
provided by the facility, the facility must have that service furnished 
to residents by a person or agency outside the facility under an 
arrangement described in section 1861(w) of the Act or (with respect to 
services furnished to NF residents and dental services furnished to SNF 
residents) an agreement described in paragraph (h)(2) of this section.
    (2) Arrangements as described in section 1861(w) of the Act or 
agreements pertaining to services furnished by outside resources must 
specify in writing that the facility assumes responsibility for--
    (i) Obtaining services that meet professional standards and 
principles that apply to professionals providing services in such a 
facility; and
    (ii) The timeliness of the services.
    (i) Medical director. (1) The facility must designate a physician to 
serve as medical director.
    (2) The medical director is responsible for--

[[Page 67]]

    (i) Implementation of resident care policies; and
    (ii) The coordination of medical care in the facility.
    (j) Laboratory services. (1) The facility must provide or obtain 
laboratory services to meet the needs of its residents. The facility is 
responsible for the quality and timeliness of the services.
    (i) If the facility provides its own laboratory services, the 
services must meet the applicable requirements for laboratories 
specified in part 493 of this chapter.
    (ii) If the facility provides blood bank and transfusion services, 
it must meet the applicable requirements for laboratories specified in 
part 493 of this chapter.
    (iii) If the laboratory chooses to refer specimens for testing to 
another laboratory, the referral laboratory must be certified in the 
appropriate specialties and subspecialties of services in accordance 
with the requirements of part 493 of this chapter.
    (iv) If the facility does not provide laboratory services on site, 
it must have an agreement to obtain these services from a laboratory 
that meets the applicable requirements of part 493 of this chapter.
    (2) The facility must--
    (i) Provide or obtain laboratory services only when ordered by the 
attending physician;
    (ii) Promptly notify the attending physican of the findings;
    (iii) Assist the resident in making transportation arrangements to 
and from the source of service, if the resident needs asistance; and
    (iv) File in the resident's clinical record laboratory reports that 
are dated and contain the name and address of the testing laboratory.
    (k) Radiology and other diagnostic services. (1) The facility must 
provide or obtain radiology and other diagnostic services to meet the 
needs of its residents. The facility is responsible for the quality and 
timeliness of the services.
    (i) If the facility provides its own diagnostic services, the 
services must meet the applicable conditions of participation for 
hospitals contained in Sec.  482.26 of this subchapter.
    (ii) If the facility does not provide its own diagnostic services, 
it must have an agreement to obtain these services from a provider or 
supplier that is approved to provide these services under Medicare.
    (2) The facility must--
    (i) Provide or obtain radiology and other diagnostic services only 
when ordered by the attending physician;
    (ii) Promptly notify the attending physician of the findings;
    (iii) Assist the resident in making transportation arrangements to 
and from the source of service, if the resident needs assistance; and
    (iv) File in the resident's clinical record signed and dated reports 
of x-ray and other diagnostic services.
    (l) Clinical records. (1) The facility must maintain clinical 
records on each resident in accordance with accepted professional 
standards and practices that are--
    (i) Complete;
    (ii) Accurately documented;
    (iii) Readily accessible; and
    (iv) Systematically organized.
    (2) Clinical records must be retained for--
    (i) The period of time required by State law; or
    (ii) Five years from the date of discharge when there is no 
requirement in State law; or
    (iii) For a minor, three years after a resident reaches legal age 
under State law.
    (3) The facility must safeguard clinical record information against 
loss, destruction, or unauthorized use;
    (4) The facility must keep confidential all information contained in 
the resident's records, regardless of the form or storage method of the 
records, except when release is required by--
    (i) Transfer to another health care institution;
    (ii) Law;
    (iii) Third party payment contract; or
    (iv) The resident.
    (5) The clinical record must contain--
    (i) Sufficient information to identify the resident;
    (ii) A record of the resident's assessments;
    (iii) The plan of care and services provided;

[[Page 68]]

    (iv) The results of any preadmission screening conducted by the 
State; and
    (v) Progress notes.
    (m) Disaster and emergency preparedness. (1) The facility must have 
detailed written plans and procedures to meet all potential emergencies 
and disasters, such as fire, severe weather, and missing residents.
    (2) The facility must train all employees in emergency procedures 
when they begin to work in the facility, periodically review the 
procedures with existing staff, and carry out unannounced staff drills 
using those procedures.
    (n) Transfer agreement. (1) In accordance with section 1861(l) of 
the Act, the facility (other than a nursing facility which is located in 
a State on an Indian reservation) must have in effect a written transfer 
agreement with one or more hospitals approved for participation under 
the Medicare and Medicaid programs that reasonably assures that--
    (i) Residents will be transferred from the facility to the hospital, 
and ensured of timely admission to the hospital when transfer is 
medically appropriate as determined by the attending physician; and
    (ii) Medical and other information needed for care and treatment of 
residents, and, when the transferring facility deems it appropriate, for 
determining whether such residents can be adequately cared for in a less 
expensive setting than either the facility or the hospital, will be 
exchanged between the institutions.
    (2) The facility is considered to have a transfer agreement in 
effect if the facility has attempted in good faith to enter into an 
agreement with a hospital sufficiently close to the facility to make 
transfer feasible.
    (o) Quality assessment and assurance. (1) A facility must maintain a 
quality assessment and assurance committee consisting of--
    (i) The director of nursing services;
    (ii) A physician designated by the facility; and
    (iii) At least 3 other members of the facility's staff.
    (2) The quality assessment and assurance committee--
    (i) Meets at least quarterly to identify issues with respect to 
which quality assessment and assurance activities are necessary; and
    (ii) Develops and implements appropriate plans of action to correct 
identified quality deficiencies.
    (3) A State or the Secretary may not require disclosure of the 
records of such committee except in so far as such disclosure is related 
to the compliance of such committee with the requirements of this 
section.
    (4) Good faith attempts by the committee to identify and correct 
quality deficiencies will not be used as a basis for sanctions.
    (p) Disclosure of ownership. (1) The facility must comply with the 
disclosure requirements of Sec. Sec.  420.206 and 455.104 of this 
chapter.
    (2) The facility must provide written notice to the State agency 
responsible for licensing the facility at the time of change, if a 
change occurs in--
    (i) Persons with an ownership or control interest, as defined in 
Sec. Sec.  420.201 and 455.101 of this chapter;
    (ii) The officers, directors, agents, or managing employees;
    (iii) The corporation, association, or other company responsible for 
the management of the facility; or
    (iv) The facility's administrator or director of nursing.
    (3) The notice specified in paragraph (p)(2) of this section must 
include the identity of each new individual or company.
    (q) Required training of feeding assistants. A facility must not use 
any individual working in the facility as a paid feeding assistant 
unless that individual has successfully completed a State-approved 
training program for feeding assistants, as specified in Sec.  483.160 
of this part.

[56 FR 48877, Sept. 26, 1991, as amended at 56 FR 48918, Sept. 26, 1991; 
57 FR 7136, Feb. 28, 1992; 57 FR 43925, Sept. 23, 1992; 59 FR 56237, 
Nov. 10, 1994; 63 FR 26311, May 12, 1998; 68 FR 55539, Sept. 26, 2003; 
74 FR 40363, Aug. 11, 2009]



 Subpart C_Preadmission Screening and Annual Review of Mentally Ill and 
                      Mentally Retarded Individuals

    Source: 57 FR 56506, Nov. 30, 1992, unless otherwise noted.

[[Page 69]]



Sec.  483.100  Basis.

    The requirements of Sec. Sec.  483.100 through 483.138 governing the 
State's responsibility for preadmission screening and annual resident 
review (PASARR) of individuals with mental illness and mental 
retardation are based on section 1919(e)(7) of the Act.



Sec.  483.102  Applicability and definitions.

    (a) This subpart applies to the screening or reviewing of all 
individuals with mental illness or mental retardation who apply to or 
reside in Medicaid certified NFs regardless of the source of payment for 
the NF services, and regardless of the individual's or resident's known 
diagnoses.
    (b) Definitions. As used in this subpart--
    (1) An individual is considered to have a serious mental illness 
(MI) if the individual meets the following requirements on diagnosis, 
level of impairment and duration of illness:
    (i) Diagnosis. The individual has a major mental disorder 
diagnosable under the Diagnostic and Statistical Manual of Mental 
Disorders, 3rd edition, revised in 1987.
    Incorporation of the 1987 edition of the Diagnostic and Statistical 
Manual of Mental Disorders, 3rd edition, was approved by the Director of 
the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 
51 that govern the use of incorporation by reference. \1\
---------------------------------------------------------------------------

    \1\ The Diagnostic and Statistical Manual of Mental Disorders is 
available for inspection at the Centers for Medicare & Medicaid 
Services, room 132, East High Rise Building, 6325 Security Boulevard, 
Baltimore, Maryland, or at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html. 
Copies may be obtained from the American Psychiatric Association, 
Division of Publications and Marketing, 1400 K Street, NW., Washington, 
DC 20005.
---------------------------------------------------------------------------

    This mental disorder is--
    (A) A schizophrenic, mood, paranoid, panic or other severe anxiety 
disorder; somatoform disorder; personality disorder; other psychotic 
disorder; or another mental disorder that may lead to a chronic 
disability; but
    (B) Not a primary diagnosis of dementia, including Alzheimer's 
disease or a related disorder, or a non-primary diagnosis of dementia 
unless the primary diagnosis is a major mental disorder as defined in 
paragraph (b)(1)(i)(A) of this section.
    (ii) Level of impairment. The disorder results in functional 
limitations in major life activities within the past 3 to 6 months that 
would be appropriate for the individual's developmental stage. An 
individual typically has at least one of the following characteristics 
on a continuing or intermittent basis:
    (A) Interpersonal functioning. The individual has serious difficulty 
interacting appropriately and communicating effectively with other 
persons, has a possible history of altercations, evictions, firing, fear 
of strangers, avoidance of interpersonal relationships and social 
isolation;
    (B) Concentration, persistence, and pace. The individual has serious 
difficulty in sustaining focused attention for a long enough period to 
permit the completion of tasks commonly found in work settings or in 
work-like structured activities occurring in school or home settings, 
manifests difficulties in concentration, inability to complete simple 
tasks within an established time period, makes frequent errors, or 
requires assistance in the completion of these tasks; and
    (C) Adaptation to change. The individual has serious difficulty in 
adapting to typical changes in circumstances associated with work, 
school, family, or social interaction, manifests agitation, exacerbated 
signs and symptoms associated with the illness, or withdrawal from the 
situation, or requires intervention by the mental health or judicial 
system.
    (iii) Recent treatment. The treatment history indicates that the 
individual has experienced at least one of the following:
    (A) Psychiatric treatment more intensive than outpatient care more 
than once in the past 2 years (e.g., partial hospitalization or 
inpatient hospitalization); or
    (B) Within the last 2 years, due to the mental disorder, experienced 
an episode of significant disruption to the

[[Page 70]]

normal living situation, for which supportive services were required to 
maintain functioning at home, or in a residential treatment environment, 
or which resulted in intervention by housing or law enforcement 
officials.
    (2) An individual is considered to have dementia if he or she has a 
primary diagnosis of dementia, as described in the Diagnostic and 
Statistical Manual of Mental Disorders, 3rd edition, revised in 1987, or 
a non-primary diagnosis of dementia unless the primary diagnosis is a 
major mental disorder as defined in paragraph (b)(1)(i)(A) of this 
section.
    (3) An individual is considered to have mental retardation (MR) if 
he or she has--
    (i) A level of retardation (mild, moderate, severe or profound) 
described in the American Association on Mental Retardation's Manual on 
Classification in Mental Retardation (1983). Incorporation by reference 
of the 1983 edition of the American Association on Mental Retardation's 
Manual on Classification in Mental Retardation was approved by the 
Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 
1 CFR part 51 that govern the use of incorporations by reference;\2\ or
---------------------------------------------------------------------------

    \2\ The American Association on Mental Retardation's Manual on 
Classification in Mental Retardation is available for inspection at the 
Centers for Medicare & Medicaid Services, Room 132, East High Rise 
Building, 6325 Security Boulevard, Baltimore, Maryland, or at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal--register/code--of--federal--
regulations/ibr--locations.html. Copies may be obtained from the 
American Association on Mental Retardation, 1719 Kalorama Rd., NW., 
Washington, DC 20009.
---------------------------------------------------------------------------

    (ii) A related condition as defined by Sec.  435.1010 of this 
chapter.

[57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr. 28, 1993; 71 FR 39229, 
July 12, 2006]



Sec.  483.104  State plan requirement.

    As a condition of approval of the State plan, the State must operate 
a preadmission screening and annual resident review program that meets 
the requirements of Sec. Sec.  483.100 through 438.138.



Sec.  483.106  Basic rule.

    (a) Requirement. The State PASARR program must require--(1) 
Preadmission screening of all individuals with mental illness or mental 
retardation who apply as new admissions to Medicaid NFs on or after 
January 1, 1989;
    (2) Initial review, by April 1, 1990, of all current residents with 
mental retardation or mental illness who entered Medicaid NFs prior to 
January 1, 1989; and
    (3) At least annual review, as of April 1, 1990, of all residents 
with mental illness or mental retardation, regardless of whether they 
were first screened under the preadmission screening or annual resident 
review requirements.
    (b) Admissions, readmissions and interfacility transfers--(1) New 
admission. An individual is a new admission if he or she is admitted to 
any NF for the first time or does not qualify as a readmission. With the 
exception of certain hospital discharges described in paragraph (b)(2) 
of this section, new admissions are subject to preadmission screening.
    (2) Exempted hospital discharge. (i) An exempted hospital discharge 
means an individual--
    (A) Who is admitted to any NF directly from a hospital after 
receiving acute inpatient care at the hospital;
    (B) Who requires NF services for the condition for which he or she 
received care in the hospital; and
    (C) Whose attending physician has certified before admission to the 
facility that the individual is likely to require less than 30 days 
nursing facility services.
    (ii) If an individual who enters a NF as an exempted hospital 
discharge is later found to require more than 30 days of NF care, the 
State mental health or mental retardation authority must conduct an 
annual resident review within 40 calendar days of admission.
    (3) Readmissions. An individual is a readmission if he or she was 
readmitted to a facility from a hospital to which he or she was 
transferred for

[[Page 71]]

the purpose of receiving care. Readmissions are subject to annual 
resident review rather than preadmission screening.
    (4) Interfacility transfers--(i) An interfacility transfer occurs 
when an individual is transferred from one NF to another NF, with or 
without an intervening hospital stay. Interfacility transfers are 
subject to annual resident review rather than preadmission screening.
    (ii) In cases of transfer of a resident with MI or MR from a NF to a 
hospital or to another NF, the transferring NF is responsible for 
ensuring that copies of the resident's most recent PASARR and resident 
assessment reports accompany the transferring resident.
    (c) Purpose. The preadmission screening and annual resident review 
process must result in determinations based on a physical and mental 
evaluation of each individual with mental illness or mental retardation, 
that are described in Sec. Sec.  483.112 and 483.114.
    (d) Responsibility for evaluations and determinations. The PASARR 
determinations of whether an individual requires the level of services 
provided by a NF and whether specialized services are needed--
    (1) For individuals with mental illness, must be made by the State 
mental health authority and be based on an independent physical and 
mental evaluation performed by a person or entity other than the State 
mental health authority; and
    (2) For individuals with mental retardation, must be made by the 
State mental retardation or developmental disabilities authority.
    (e) Delegation of responsibility--(1) The State mental health and 
mental retardation authorities may delegate by subcontract or otherwise 
the evaluation and determination functions for which they are 
responsible to another entity only if--
    (i) The State mental health and mental retardation authorities 
retain ultimate control and responsibility for the performance of their 
statutory obligations;
    (ii) The two determinations as to the need for NF services and for 
specialized services are made, based on a consistent analysis of the 
data; and
    (iii) The entity to which the delegation is made is not a NF or an 
entity that has a direct or indirect affiliation or relationship with a 
NF.
    (2) The State mental retardation authority has responsibility for 
both the evaluation and determination functions for individuals with MR 
whereas the State mental health authority has responsibility only for 
the determination function.
    (3) The evaluation of individuals with MI cannot be delegated by the 
State mental health authority because it does not have responsibility 
for this function. The evaluation function must be performed by a person 
or entity other than the State mental health authority. In designating 
an independent person or entity to perform MI evaluations, the State 
must not use a NF or an entity that has a direct or indirect affiliation 
or relationship with a NF.

[57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr. 28, 1993]



Sec.  483.108  Relationship of PASARR to other Medicaid processes.

    (a) PASARR determinations made by the State mental health or mental 
retardation authorities cannot be countermanded by the State Medicaid 
agency, either in the claims process or through other utilization 
control/review processes or by the State survey and certification 
agency. Only appeals determinations made through the system specified in 
subpart E of this part may overturn a PASARR determination made by the 
State mental health or mental retardation authorities.
    (b) In making their determinations, however, the State mental health 
and mental retardation authorities must not use criteria relating to the 
need for NF care or specialized services that are inconsistent with this 
regulation and any supplementary criteria adopted by the State Medicaid 
agency under its approved State plan.
    (c) To the maximum extent practicable, in order to avoid duplicative 
testing and effort, the PASARR must be coordinated with the routine 
resident assessments required by Sec.  483.20(b).



Sec.  483.110  Out-of-State arrangements.

    (a) Basic rule. The State in which the individual is a State 
resident (or would

[[Page 72]]

be a State resident at the time he or she becomes eligible for 
Medicaid), as defined in Sec.  435.403 of this chapter, must pay for the 
PASARR and make the required determinations, in accordance with Sec.  
431.52(b).
    (b) Agreements. A State may include arrangements for PASARR in its 
provider agreements with out-of-State facilities or reciprocal 
interstate agreements.

[57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr. 28, 1993]



Sec.  483.112  Preadmission screening of applicants for admission to NFs.

    (a) Determination of need for NF services. For each NF applicant 
with MI or MR, the State mental health or mental retardation authority 
(as appropriate) must determine, in accordance with Sec.  483.130, 
whether, because of the resident's physical and mental condition, the 
individual requires the level of services provided by a NF.
    (b) Determination of need for specialized services. If the 
individual with mental illness or mental retardation is determined to 
require a NF level of care, the State mental health or mental 
retardation authority (as appropriate) must also determine, in 
accordance with Sec.  483.130, whether the individual requires 
specialized services for the mental illness or mental retardation, as 
defined in Sec.  483.120.
    (c) Timeliness--(1) Except as specified in paragraph (c)(4) of this 
section, a preadmission screening determination must be made in writing 
within an annual average of 7 to 9 working days of referral of the 
individual with MI or MR by whatever agent performs the Level I 
identification, under Sec.  483.128(a) of this part, to the State mental 
health or mental retardation authority for screening. (See Sec.  
483.128(a) for discussion of Level I evaluation.)
    (2) The State may convey determinations verbally to nursing 
facilities and the individual and confirm them in writing.
    (3) The State may compute separate annual averages for the mentally 
ill and the mentally retarded/developmentally disabled populations.
    (4) The Secretary may grant an exception to the timeliness standard 
in paragraph (c)(1) of this section when the State--
    (i) Exceeds the annual average; and
    (ii) Provides justification satisfactory to the Secretary that a 
longer time period was necessary.



Sec.  483.114  Annual review of NF residents.

    (a) Individuals with mental illness. For each resident of a NF who 
has mental illness, the State mental health authority must determine in 
accordance with Sec.  483.130 whether, because of the resident's 
physical and mental condition, the resident requires--
    (1) The level of services provided by--
    (i) A NF;
    (ii) An inpatient psychiatric hospital for individuals under age 21, 
as described in section 1905(h) of the Act; or
    (iii) An institution for mental diseases providing medical 
assistance to individuals age 65 or older; and
    (2) Specialized services for mental illness, as defined in Sec.  
483.120.
    (b) Individuals with mental retardation. For each resident of a NF 
who has mental retardation, the State mental retardation or 
developmental disability authority must determine in accordance with 
Sec.  483.130 whether, because of his or her physical or mental 
condition, the resident requires--
    (1) The level of services provided by a NF or an intermediate care 
facility for the mentally retarded; and
    (2) Specialized services for mental retardation as defined in Sec.  
483.120.
    (c) Frequency of review--(1) A review and determination must be 
conducted for each resident of a Medicaid NF who has mental illness or 
mental retardation not less often than annually.
    (2) ``Annually'' is defined as occurring within every fourth quarter 
after the previous preadmission screen or annual resident review.
    (d) April 1, 1990 deadline for initial reviews. The first set of 
annual reviews on residents who entered the NF prior to January 1, 1989, 
must be completed by April 1, 1990.

[[Page 73]]



Sec.  483.116  Residents and applicants determined to require NF level of services.

    (a) Individuals needing NF services. If the State mental health or 
mental retardation authority determines that a resident or applicant for 
admission to a NF requires a NF level of services, the NF may admit or 
retain the individual.
    (b) Individuals needing NF services and specialized services. If the 
State mental health or mental retardation authority determines that a 
resident or applicant for admission requires both a NF level of services 
and specialized services for the mental illness or mental retardation--
    (1) The NF may admit or retain the individual; and
    (2) The State must provide or arrange for the provision of the 
specialized services needed by the individual while he or she resides in 
the NF.



Sec.  483.118  Residents and applicants determined not to require NF level of services.

    (a) Applicants who do not require NF services. If the State mental 
health or mental retardation authority determines that an applicant for 
admission to a NF does not require NF services, the applicant cannot be 
admitted. NF services are not a covered Medicaid service for that 
individual, and further screening is not required.
    (b) Residents who require neither NF services nor specialized 
services for MI or MR. If the State mental health or mental retardation 
authority determines that a resident requires neither the level of 
services provided by a NF nor specialized services for MI or MR, 
regardless of the length of stay in the facility, the State must--
    (1) Arrange for the safe and orderly discharge of the resident from 
the facility in accordance with Sec.  483.12(a); and
    (2) Prepare and orient the resident for discharge.
    (c) Residents who do not require NF services but require specialized 
services for MI or MR--(1) Long term residents. Except as otherwise may 
be provided in an alternative disposition plan adopted under section 
1919(e)(7)(E) of the Act, for any resident who has continuously resided 
in a NF for at least 30 months before the date of the determination, and 
who requires only specialized services as defined in Sec.  483.120, the 
State must, in consultation with the resident's family or legal 
representative and caregivers--
    (i) Offer the resident the choice of remaining in the facility or of 
receiving services in an alternative appropriate setting;
    (ii) Inform the resident of the institutional and noninstitutional 
alternatives covered under the State Medicaid plan for the resident;
    (iii) Clarify the effect on eligibility for Medicaid services under 
the State plan if the resident chooses to leave the facility, including 
its effect on readmission to the facility; and
    (iv) Regardless of the resident's choice, provide for, or arrange 
for the provision of specialized services for the mental illness or 
mental retardation.
    (2) Short term residents. Except as otherwise may be provided in an 
alternative disposition plan adopted under section 1919(e)(7)(E) of the 
Act, for any resident who requires only specialized services, as defined 
in Sec.  483.120, and who has not continuously resided in a NF for at 
least 30 months before the date of the determination, the State must, in 
consultation with the resident's family or legal representative and 
caregivers--
    (i) Arrange for the safe and orderly discharge of the resident from 
the facility in accordance with Sec.  483.12(a);
    (ii) Prepare and orient the resident for discharge; and
    (iii) Provide for, or arrange for the provision of, specialized 
services for the mental illness or mental retardation.
    (3) For the purpose of establishing length of stay in a NF, the 30 
months of continuous residence in a NF or longer--
    (i) Is calculated back from the date of the first annual resident 
review determination which finds that the individual is not in need of 
NF level of services;
    (ii) May include temporary absences for hospitalization or 
therapeutic leave; and
    (iii) May consist of consecutive residences in more than one NF.

[[Page 74]]



Sec.  483.120  Specialized services.

    (a) Definition--(1) For mental illness, specialized services means 
the services specified by the State which, combined with services 
provided by the NF, results in the continuous and aggressive 
implementation of an individualized plan of care that--
    (i) Is developed and supervised by an interdisciplinary team, which 
includes a physician, qualified mental health professionals and, as 
appropriate, other professionals.
    (ii) Prescribes specific therapies and activities for the treatment 
of persons experiencing an acute episode of serious mental illness, 
which necessitates supervision by trained mental health personnel; and
    (iii) Is directed toward diagnosing and reducing the resident's 
behavioral symptoms that necessitated institutionalization, improving 
his or her level of independent functioning, and achieving a functioning 
level that permits reduction in the intensity of mental health services 
to below the level of specialized services at the earliest possible 
time.
    (2) For mental retardation, specialized services means the services 
specified by the State which, combined with services provided by the NF 
or other service providers, results in treatment which meets the 
requirements of Sec.  483.440(a)(1).
    (b) Who must receive specialized services. The State must provide or 
arrange for the provision of specialized services, in accordance with 
this subpart, to all NF residents with MI or MR whose needs are such 
that continuous supervision, treatment and training by qualified mental 
health or mental retardation personnel is necessary, as identified by 
the screening provided in Sec.  483.130 or Sec. Sec.  483.134 and 
483.136.
    (c) Services of lesser intensity than specialized services. The NF 
must provide mental health or mental retardation services which are of a 
lesser intensity than specialized services to all residents who need 
such services.



Sec.  483.122  FFP for NF services.

    (a) Basic rule. Except as otherwise may be provided in an 
alternative disposition plan adopted under section 1919(e)(7)(E) of the 
Act, FFP is available in State expenditures for NF services provided to 
a Medicaid eligible individual subject to the requirements of this part 
only if the individual has been determined--
    (1) To need NF care under Sec.  483.116(a) or
    (2) Not to need NF services but to need specialized services, meets 
the requirements of Sec.  483.118(c)(1), and elects to stay in the NF.
    (b) FFP for late reviews. When a preadmission screening has not been 
performed prior to admission or an annual review is not performed 
timely, in accordance with Sec.  483.114(c), but either is performed at 
a later date, FFP is available only for services furnished after the 
screening or review has been performed, subject to the provisions of 
paragraph (a) of this section.



Sec.  483.124  FFP for specialized services.

    FFP is not available for specialized services furnished to NF 
residents as NF services.



Sec.  483.126  Appropriate placement.

    Placement of an individual with MI or MR in a NF may be considered 
appropriate only when the individual's needs are such that he or she 
meets the minimum standards for admission and the individual's needs for 
treatment do not exceed the level of services which can be delivered in 
the NF to which the individual is admitted either through NF services 
alone or, where necessary, through NF services supplemented by 
specialized services provided by or arranged for by the State.



Sec.  483.128  PASARR evaluation criteria.

    (a) Level I: Identification of individuals with MI or MR. The 
State's PASARR program must identify all individuals who are suspected 
of having MI or MR as defined in Sec.  483.102. This identification 
function is termed Level I. Level II is the function of evaluating and 
determining whether NF services and specialized services are needed. The 
State's performance of the Level I identification function must provide 
at least, in the case of first time identifications, for the issuance of 
written notice to the individual or resident and his or her legal 
representative that the individual or resident is suspected of

[[Page 75]]

having MI or MR and is being referred to the State mental health or 
mental retardation authority for Level II screening.
    (b) Adaptation to culture, language, ethnic origin. Evaluations 
performed under PASARR and PASARR notices must be adapted to the 
cultural background, language, ethnic origin and means of communication 
used by the individual being evaluated.
    (c) Participation by individual and family. PASARR evaluations must 
involve--
    (1) The individual being evaluated;
    (2) The individual's legal representative, if one has been 
designated under State law; and
    (3) The individual's family if--
    (i) Available; and
    (ii) The individual or the legal representative agrees to family 
participation.
    (d) Interdisciplinary coordination. When parts of a PASARR 
evaluation are performed by more than one evaluator, the State must 
ensure that there is interdisciplinary coordination among the 
evaluators.
    (e) The State's PASARR program must use at least the evaluative 
criteria of Sec.  483.130 (if one or both determinations can easily be 
made categorically as described in Sec.  483.130) or of Sec. Sec.  
483.132 and 483.134 or Sec.  483.136 (or, in the case of individuals 
with both MI and MR, Sec. Sec.  483.132, 483.134 and 483.136 if a more 
extensive individualized evaluation is required).
    (f) Data. In the case of individualized evaluations, information 
that is necessary for determining whether it is appropriate for the 
individual with MI or MR to be placed in an NF or in another appropriate 
setting should be gathered throughout all applicable portions of the 
PASARR evaluation (Sec. Sec.  483.132 and 483.134 and/or Sec.  483.136). 
The two determinations relating to the need for NF level of care and 
specialized services are interrelated and must be based upon a 
comprehensive analysis of all data concerning the individual.
    (g) Preexisting data. Evaluators may use relevant evaluative data, 
obtained prior to initiation of preadmission screening or annual 
resident review, if the data are considered valid and accurate and 
reflect the current functional status of the individual. However, in the 
case of individualized evaluations, to supplement and verify the 
currency and accuracy of existing data, the State's PASARR program may 
need to gather additional information necessary to assess proper 
placement and treatment.
    (h) Findings. For both categorical and individualized 
determinations, findings of the evaluation must correspond to the 
person's current functional status as documented in medical and social 
history records.
    (i) Evaluation report: Individualized determinations. For 
individualized PASARR determinations, findings must be issued in the 
form of a written evaluative report which--
    (1) Identifies the name and professional title of person(s) who 
performed the evaluation(s) and the date on which each portion of the 
evaluation was administered;
    (2) Provides a summary of the medical and social history, including 
the positive traits or developmental strengths and weaknesses or 
developmental needs of the evaluated individual;
    (3) If NF services are recommended, identifies the specific services 
which are required to meet the evaluated individual's needs, including 
services required in paragraph (i)(5) of this section;
    (4) If specialized services are not recommended, identifies any 
specific mental retardation or mental health services which are of a 
lesser intensity than specialized services that are required to meet the 
evaluated individual's needs;
    (5) If specialized services are recommended, identifies the specific 
mental retardation or mental health services required to meet the 
evaluated individual's needs; and
    (6) Includes the bases for the report's conclusions.
    (j) Evaluation report: Categorical determinations. For categorical 
PASARR determinations, findings must be issued in the form of an 
abbreviated written evaluative report which--
    (1) Identifies the name and professional title of the person 
applying the

[[Page 76]]

categorical determination and the data on which the application was 
made;
    (2) Explains the categorical determination(s) that has (have) been 
made and, if only one of the two required determinations can be made 
categorically, describes the nature of any further screening which is 
required;
    (3) Identifies, to the extent possible, based on the available data, 
NF services, including any mental health or specialized psychiatric 
rehabilitative services, that may be needed; and
    (4) Includes the bases for the report's conclusions.
    (k) Interpretation of findings to individual. For both categorical 
and individualized determinations, findings of the evaluation must be 
interpreted and explained to the individual and, where applicable, to a 
legal representative designated under State law.
    (l) Evaluation report. The evaluator must send a copy of the 
evaluation report to the--
    (1) Individual or resident and his or her legal representative;
    (2) Appropriate State authority in sufficient time for the State 
authorities to meet the times identified in Sec.  483.112(c) for PASs 
and Sec.  483.114(c) for ARRs;
    (3) Admitting or retaining NF;
    (4) Individual's attending physician; and
    (5) The discharging hospital if the individual is seeking NF 
admission from a hospital.
    (m) The evaluation may be terminated if the evaluator finds at any 
time during the evaluation that the individual being evaluated--
    (1) Does not have MI or MR; or
    (2) Has--
    (i) A primary diagnosis of dementia (including Alzheimer's Disease 
or a related disorder); or
    (ii) A non-primary diagnosis of dementia without a primary diagnosis 
that is a serious mental illness, and does not have a diagnosis of MR or 
a related condition.

[57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr. 28, 1993]



Sec.  483.130  PASARR determination criteria.

    (a) Basis for determinations. Determinations made by the State 
mental health or mental retardation authority as to whether NF level of 
services and specialized services are needed must be based on an 
evaluation of data concerning the individual, as specified in paragraph 
(b) of this section.
    (b) Types of determinations. Determinations may be--
    (1) Advance group determinations, in accordance with this section, 
by category that take into account that certain diagnoses, levels of 
severity of illness, or need for a particular service clearly indicate 
that admission to or residence in a NF is normally needed, or that the 
provision of specialized services is not normally needed; or
    (2) Individualized determinations based on more extensive 
individualized evaluations as required in Sec.  483.132, Sec.  483.134, 
or Sec.  483.136 (or, in the case of an individual having both MR and 
MI, Sec. Sec.  483.134 and 483.136).
    (c) Group determinations by category. Advance group determinations 
by category developed by the State mental health or mental retardation 
authorities may be made applicable to individuals by the NF or other 
evaluator following Level I review only if existing data on the 
individual appear to be current and accurate and are sufficient to allow 
the evaluator readily to determine that the individual fits into the 
category established by the State authorities (see Sec.  483.132(c)). 
Sources of existing data on the individual that could form the basis for 
applying a categorical determination by the State authorities would be 
hospital records, physician's evaluations, election of hospice status, 
records of community mental health centers or community mental 
retardation or developmental disability providers.
    (d) Examples of categories. Examples of categories for which the 
State mental health or mental retardation authority may make an advance 
group determination that NF services are needed are--
    (1) Convalescent care from an acute physical illness which--
    (i) Required hospitalization; and
    (ii) Does not meet all the criteria for an exempt hospital 
discharge, which is not subject to preadmission screening, as specified 
in Sec.  483.106(b)(2).

[[Page 77]]

    (2) Terminal illness, as defined for hospice purposes in Sec.  418.3 
of this chapter;
    (3) Severe physical illnesses such as coma, ventilator dependence, 
functioning at a brain stem level, or diagnoses such as chronic 
obstructive pulmonary disease, Parkinson's disease, Huntington's 
disease, amyotrophic lateral sclerosis, and congestive heart failure 
which result in a level of impairment so severe that the individual 
could not be expected to benefit from specialized services;
    (4) Provisional admissions pending further assessment in cases of 
delirium where an accurate diagnosis cannot be made until the delirium 
clears;
    (5) Provisional admissions pending further assessment in emergency 
situations requiring protective services, with placement in a nursing 
facility not to exceed 7 days; and
    (6) Very brief and finite stays of up to a fixed number of days to 
provide respite to in-home caregivers to whom the individual with MI or 
MR is expected to return following the brief NF stay.
    (e) Time limits. The State may specify time limits for categorical 
determinations that NF services are needed and in the case of paragraphs 
(d)(4), (5) and (6) of this section, must specify a time limit which is 
appropriate for provisional admissions pending further assessment and 
for emergency situations and respite care. If an individual is later 
determined to need a longer stay than the State's limit allows, the 
individual must be subjected to an annual resident review before 
continuation of the stay may be permitted and payment made for days of 
NF care beyond the State's time limit.
    (f) The State mental health and mental retardation authorities may 
make categorical determinations that specialized services are not needed 
in the provisional, emergency and respite admission situations 
identified in Sec.  483.130(d)(4)-(6). In all other cases, except for 
Sec.  483.130(h), a determination that specialized services are not 
needed must be based on a more extensive individualized evaluation under 
Sec.  483.134 or Sec.  483.136.
    (g) Categorical determinations: No positive specialized treatment 
determinations. The State mental health and mental retardation 
authorities must not make categorical determinations that specialized 
services are needed. Such a determination must be based on a more 
extensive individualized evaluation under Sec.  483.134 or Sec.  483.136 
to determine the exact nature of the specialized services that are 
needed.
    (h) Categorical determinations: Dementia and MR. The State mental 
retardation authority may make categorical determinations that 
individuals with dementia, which exists in combination with mental 
retardation or a related condition, do not need specialized services.
    (i) If a State mental health or mental retardation authority 
determines NF needs by category, it may not waive the specialized 
services determination. The appropriate State authority must also 
determine whether specialized services are needed either by category (if 
permitted) or by individualized evaluations, as specified in Sec.  
483.134 or Sec.  483.136.
    (j) Recording determinations. All determinations made by the State 
mental health and mental retardation authority, regardless of how they 
are arrived at, must be recorded in the individual's record.
    (k) Notice of determination. The State mental health or mental 
retardation authority must notify in writing the following entities of a 
determination made under this subpart:
    (1) The evaluated individual and his or her legal representative;
    (2) The admitting or retaining NF;
    (3) The individual or resident's attending physician; and
    (4) The discharging hospital, unless the individual is exempt from 
preadmission screening as provided for at Sec.  483.106(b)(2).
    (l) Contents of notice. Each notice of the determination made by the 
State mental health or mental retardation authority must include--
    (1) Whether a NF level of services is needed;
    (2) Whether specialized services are needed;
    (3) The placement options that are available to the individual 
consistent with these determinations; and

[[Page 78]]

    (4) The rights of the individual to appeal the determination under 
subpart E of this part.
    (m) Placement options. Except as otherwise may be provided in an 
alternative disposition plan adopted under section 1919(e)(7)(E) of the 
Act, the placement options and the required State actions are as 
follows:
    (1) Can be admitted to a NF. Any applicant for admission to a NF who 
has MI or MR and who requires the level of services provided by a NF, 
regardless of whether specialized services are also needed, may be 
admitted to a NF, if the placement is appropriate, as determined in 
Sec.  483.126. If specialized services are also needed, the State is 
responsible for providing or arranging for the provision of the 
specialized services.
    (2) Cannot be admitted to a NF. Any applicant for admission to a NF 
who has MI or MR and who does not require the level of services provided 
by a NF, regardless of whether specialized services are also needed, is 
inappropriate for NF placement and must not be admitted.
    (3) Can be considered appropriate for continued placement in a NF. 
Any NF resident with MI or MR who requires the level of services 
provided by a NF, regardless of the length of his or her stay or the 
need for specialized services, can continue to reside in the NF, if the 
placement is appropriate, as determined in Sec.  483.126.
    (4) May choose to remain in the NF even though the placement would 
otherwise be inappropriate. Any NF resident with MI or MR who does not 
require the level of services provided by a NF but does require 
specialized services and who has continuously resided in a NF for at 
least 30 consecutive months before the date of determination may choose 
to continue to reside in the facility or to receive covered services in 
an alternative appropriate institutional or noninstitutional setting. 
Wherever the resident chooses to reside, the State must meet his or her 
specialized services needs. The determination notice must provide 
information concerning how, when, and by whom the various placement 
options available to the resident will be fully explained to the 
resident.
    (5) Cannot be considered appropriate for continued placement in a NF 
and must be discharged (short-term residents). Any NF resident with MI 
or MR who does not require the level of services provided by a NF but 
does require specialized services and who has resided in a NF for less 
than 30 consecutive months must be discharged in accordance with Sec.  
483.12(a) to an appropriate setting where the State must provide 
specialized services. The determination notice must provide information 
on how, when, and by whom the resident will be advised of discharge 
arrangements and of his/her appeal rights under both PASARR and 
discharge provisions.
    (6) Cannot be considered appropriate for continued placement in a NF 
and must be discharged (short or long-term residents). Any NF resident 
with MI or MR who does not require the level of services provided by a 
NF and does not require specialized services regardless of his or her 
length of stay, must be discharged in accordance with Sec.  483.12(a). 
The determination notice must provide information on how, when, and by 
whom the resident will be advised of discharge arrangements and of his 
or her appeal rights under both PASARR and discharge provisions.
    (n) Specialized services needed in a NF. If a determination is made 
to admit or allow to remain in a NF any individual who requires 
specialized services, the determination must be supported by assurances 
that the specialized services that are needed can and will be provided 
or arranged for by the State while the individual resides in the NF.
    (o) Record retention. The State PASARR system must maintain records 
of evaluations and determinations, regardless of whether they are 
performed categorically or individually, in order to support its 
determinations and actions and to protect the appeal rights of 
individuals subjected to PASARR; and
    (p) Tracking system. The State PASARR system must establish and 
maintain a tracking system for all individuals with MI or MR in NFs to 
ensure that appeals and future reviews are performed in accordance with 
this subpart and subpart E.

[57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr. 28, 1993]

[[Page 79]]



Sec.  483.132  Evaluating the need for NF services and NF level of care (PASARR/NF).

    (a) Basic rule. For each applicant for admission to a NF and each NF 
resident who has MI or MR, the evaluator must assess whether--
    (1) The individual's total needs are such that his or her needs can 
be met in an appropriate community setting;
    (2) The individual's total needs are such that they can be met only 
on an inpatient basis, which may include the option of placement in a 
home and community-based services waiver program, but for which the 
inpatient care would be required;
    (3) If inpatient care is appropriate and desired, the NF is an 
appropriate institutional setting for meeting those needs in accordance 
with Sec.  483.126; or
    (4) If the inpatient care is appropriate and desired but the NF is 
not the appropriate setting for meeting the individual's needs in 
accordance with Sec.  483.126, another setting such as an ICF/MR 
(including small, community-based facilities), an IMD providing services 
to individuals aged 65 or older, or a psychiatric hospital is an 
appropriate institutional setting for meeting those needs.
    (b) Determining appropriate placement. In determining appropriate 
placement, the evaluator must prioritize the physical and mental needs 
of the individual being evaluated, taking into account the severity of 
each condition.
    (c) Data. At a minimum, the data relied on to make a determination 
must include:
    (1) Evaluation of physical status (for example, diagnoses, date of 
onset, medical history, and prognosis);
    (2) Evaluation of mental status (for example, diagnoses, date of 
onset, medical history, likelihood that the individual may be a danger 
to himself/herself or others); and
    (3) Functional assessment (activities of daily living).
    (d) Based on the data compiled in Sec.  483.132 and, as appropriate, 
in Sec. Sec.  483.134 and 483.136, the State mental health or mental 
retardation authority must determine whether an NF level of services is 
needed.



Sec.  483.134  Evaluating whether an individual with mental illness requires specialized services (PASARR/MI).

    (a) Purpose. The purpose of this section is to identify the minimum 
data needs and process requirements for the State mental health 
authority, which is responsible for determining whether or not the 
applicant or resident with MI, as defined in Sec.  483.102(b)(1) of this 
part, needs a specialized services program for mental illness as defined 
in Sec.  483.120.
    (b) Data. Minimum data collected must include--(1) A comprehensive 
history and physical examination of the person. The following areas must 
be included (if not previously addressed):
    (i) Complete medical history;
    (ii) Review of all body systems;
    (iii) Specific evaluation of the person's neurological system in the 
areas of motor functioning, sensory functioning, gait, deep tendon 
reflexes, cranial nerves, and abnormal reflexes; and
    (iv) In case of abnormal findings which are the basis for an NF 
placement, additional evaluations conducted by appropriate specialists.
    (2) A comprehensive drug history including current or immediate past 
use of medications that could mask symptoms or mimic mental illness.
    (3) A psychosocial evaluation of the person, including current 
living arrangements and medical and support systems.
    (4) A comprehensive psychiatric evaluation including a complete 
psychiatric history, evaluation of intellectual functioning, memory 
functioning, and orientation, description of current attitudes and overt 
behaviors, affect, suicidal or homicidal ideation, paranoia, and degree 
of reality testing (presence and content of delusions) and 
hallucinations.
    (5) A functional assessment of the individual's ability to engage in 
activities of daily living and the level of support that would be needed 
to assist the individual to perform these activities while living in the 
community. The assessment must determine whether this level of support 
can be provided to the individual in an alternative community setting or 
whether the level of support needed is such that NF placement is 
required.

[[Page 80]]

    (6) The functional assessment must address the following areas: 
Self-monitoring of health status, self-administering and scheduling of 
medical treatment, including medication compliance, or both, self-
monitoring of nutritional status, handling money, dressing 
appropriately, and grooming.
    (c) Personnel requirements. (1) If the history and physical 
examination are not performed by a physician, then a physician must 
review and concur with the conclusions.
    (2) The State may designate the mental health professionals who are 
qualified--
    (i) To perform the evaluations required under paragraph (b) (2)-(6) 
of this section including the--
    (A) Comprehensive drug history;
    (B) Psychosocial evaluation;
    (C) Comprehensive psychiatric evaluation;
    (D) Functional assessment; and
    (ii) To make the determination required in paragraph (d) of this 
section.
    (d) Data interpretation. Based on the data compiled, a qualified 
mental health professional, as designated by the State, must validate 
the diagnosis of mental illness and determine whether a program of 
psychiatric specialized services is needed.



Sec.  483.136  Evaluating whether an individual with mental retardation requires specialized services (PASARR/MR).

    (a) Purpose. The purpose of this section is to identify the minimum 
data needs and process requirements for the State mental retardation 
authority to determine whether or not the applicant or resident with 
mental retardation, as defined in Sec.  483.102(b)(3) of this part, 
needs a continuous specialized services program, which is analogous to 
active treatment, as defined in Sec.  435.1010 of this chapter and Sec.  
483.440.
    (b) Data. Minimum data collected must include the individual's 
comprehensive history and physical examination results to identify the 
following information or, in the absence of data, must include 
information that permits a reviewer specifically to assess:
    (1) The individual's medical problems;
    (2) The level of impact these problems have on the individual's 
independent functioning;
    (3) All current medications used by the individual and the current 
response of the individual to any prescribed medications in the 
following drug groups:
    (i) Hypnotics,
    (ii) Antipsychotics (neuroleptics),
    (iii) Mood stabilizers and antidepressants,
    (iv) Antianxiety-sedative agents, and
    (v) Anti-Parkinson agents.
    (4) Self-monitoring of health status;
    (5) Self-administering and scheduling of medical treatments;
    (6) Self-monitoring of nutritional status;
    (7) Self-help development such as toileting, dressing, grooming, and 
eating;
    (8) Sensorimotor development, such as ambulation, positioning, 
transfer skills, gross motor dexterity, visual motor perception, fine 
motor dexterity, eye-hand coordination, and extent to which prosthetic, 
orthotic, corrective or mechanical supportive devices can improve the 
individual's functional capacity;
    (9) Speech and language (communication) development, such as 
expressive language (verbal and nonverbal), receptive language (verbal 
and nonverbal), extent to which non-oral communication systems can 
improve the individual's function capacity, auditory functioning, and 
extent to which amplification devices (for example, hearing aid) or a 
program of amplification can improve the individual's functional 
capacity;
    (10) Social development, such as interpersonal skills, recreation-
leisure skills, and relationships with others;
    (11) Academic/educational development, including functional learning 
skills;
    (12) Independent living development such as meal preparation, 
budgeting and personal finances, survival skills, mobility skills 
(orientation to the neighborhood, town, city), laundry, housekeeping, 
shopping, bedmaking, care of clothing, and orientation skills (for 
individuals with visual impairments);

[[Page 81]]

    (13) Vocational development, including present vocational skills;
    (14) Affective development such as interests, and skills involved 
with expressing emotions, making judgments, and making independent 
decisions; and
    (15) The presence of identifiable maladaptive or inappropriate 
behaviors of the individual based on systematic observation (including, 
but not limited to, the frequency and intensity of identified 
maladaptive or inappropriate behaviors).
    (c) Data interpretation--(1) The State must ensure that a licensed 
psychologist identifies the intellectual functioning measurement of 
individuals with MR or a related condition.
    (2) Based on the data compiled in paragraph (b) of this section, the 
State mental retardation authority, using appropriate personnel, as 
designated by the State, must validate that the individual has MR or is 
a person with a related condition and must determine whether specialized 
services for mental retardation are needed. In making this 
determination, the State mental retardation authority must make a 
qualitative judgment on the extent to which the person's status 
reflects, singly and collectively, the characteristics commonly 
associated with the need for specialized services, including--
    (i) Inability to--
    (A) Take care of the most personal care needs;
    (B) Understand simple commands;
    (C) Communicate basic needs and wants;
    (D) Be employed at a productive wage level without systematic long 
term supervision or support;
    (E) Learn new skills without aggressive and consistent training;
    (F) Apply skills learned in a training situation to other 
environments or settings without aggressive and consistent training;
    (G) Demonstrate behavior appropriate to the time, situation or place 
without direct supervision; and
    (H) Make decisions requiring informed consent without extreme 
difficulty;
    (ii) Demonstration of severe maladaptive behavior(s) that place the 
person or others in jeopardy to health and safety; and
    (iii) Presence of other skill deficits or specialized training needs 
that necessitate the availability of trained MR personnel, 24 hours per 
day, to teach the person functional skills.

[57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr. 28, 1993, as amended at 
71 FR 39229, July 12, 2006]



Sec.  483.138  Maintenance of services and availability of FFP.

    (a) Maintenance of services. If a NF mails a 30 day notice of its 
intent to transfer or discharge a resident, under Sec.  483.12(a) of 
this chapter, the agency may not terminate or reduce services until--
    (1) The expiration of the notice period; or
    (2) A subpart E appeal, if one has been filed, has been resolved.
    (b) Availability of FFP. FFP is available for expenditures for 
services provided to Medicaid recipients during--
    (1) The 30 day notice period specified in Sec.  483.12(a) of this 
chapter; or
    (2) During the period an appeal is in progress.



 Subpart D_Requirements That Must Be Met by States and State Agencies: 
    Nurse Aide Training and Competency Evaluation, and Paid Feeding 
                               Assistants

    Source: 56 FR 48919, Sept. 26, 1991, unless otherwise noted.



Sec.  483.150  Statutory basis; Deemed meeting or waiver of requirements.

    (a) Statutory basis. This subpart is based on sections 1819(b)(5) 
and 1919(b)(5) of the Act, which establish standards for training nurse-
aides and for evaluating their competency.
    (b) Deemed meeting of requirements. A nurse aide is deemed to 
satisfy the requirement of completing a training and competency 
evaluation approved by the State if he or she successfully completed a 
training and competency evaluation program before July 1, 1989 if--
    (1) The aide would have satisfied this requirement if--
    (i) At least 60 hours were substituted for 75 hours in sections 
1819(f)(2) and 1919(f)(2) of the Act, and

[[Page 82]]

    (ii) The individual has made up at least the difference in the 
number of hours in the program he or she completed and 75 hours in 
supervised practical nurse aide training or in regular in-service nurse 
aide education;

or
    (2) The individual was found to be competent (whether or not by the 
State) after the completion of nurse aide training of at least 100 hours 
duration.
    (c) Waiver of requirements. A State may--
    (1) Waive the requirement for an individual to complete a competency 
evaluation program approved by the State for any individual who can 
demonstrate to the satisfaction of the State that he or she has served 
as a nurse aide at one or more facilities of the same employer in the 
state for at least 24 consecutive months before December 19, 1989; or
    (2) Deem an individual to have completed a nurse aide training and 
competency evaluation program approved by the State if the individual 
completed, before July 1, 1989, such a program that the State determines 
would have met the requirements for approval at the time it was offered.

[56 FR 48919, Sept. 26, 1991; 56 FR 59331, Nov. 25, 1991, as amended at 
60 FR 50443, Sept. 29, 1995]



Sec.  483.151  State review and approval of nurse aide training and competency evaluation programs and competency evaluation programs.

    (a) State review and administration. (1) The State--
    (i) Must specify any nurse aide training and competency evaluation 
programs that the State approves as meeting the requirements of Sec.  
483.152 and/or competency evaluations programs that the State approves 
as meeting the requirements of Sec.  483.154; and
    (ii) May choose to offer a nurse aide training and competency 
evaluation program that meets the requirements of Sec.  483.152 and/or a 
competency evaluation program that meets the requirements of Sec.  
483.154.
    (2) If the State does not choose to offer a nurse aide training and 
competency evaluation program or competency evaluation program, the 
State must review and approve or disapprove nurse aide training and 
competency evaluation programs and nurse aide competency evaluation 
programs upon request.
    (3) The State survey agency must in the course of all surveys, 
determine whether the nurse aide training and competency evaluation 
requirements of Sec.  483.75(e) are met.
    (b) Requirements for approval of programs. (1) Before the State 
approves a nurse aide training and competency evaluation program or 
competency evaluation program, the State must--
    (i) Determine whether the nurse aide training and competency 
evaluation program meets the course requirements of Sec. Sec.  483.152:
    (ii) Determine whether the nurse aide competency evaluation program 
meets the requirements of Sec.  483.154; and
    (iii) In all reviews other than the initial review, visit the entity 
providing the program.
    (2) The State may not approve a nurse aide training and competency 
evaluation program or competency evaluation program offered by or in a 
facility which, in the previous two years--
    (i) In the case of a skilled nursing facility, has operated under a 
waiver under section 1819(b)(4)(C)(ii)(II) of the Act;
    (ii) In the case of a nursing facility, has operated under a waiver 
under section 1919(b)(4)(C)(ii) of the Act that was granted on the basis 
of a demonstration that the facility is unable to provide nursing care 
required under section 1919(b)(4)(C)(i) of the Act for a period in 
excess of 48 hours per week;
    (iii) Has been subject to an extended (or partial extended) survey 
under sections 1819(g)(2)(B)(i) or 1919(g)(2)(B)(i) of the Act;
    (iv) Has been assessed a civil money penalty described in section 
1819(h)(2)(B)(ii) of 1919(h)(2)(A)(ii) of the Act of not less than 
$5,000; or
    (v) Has been subject to a remedy described in sections 1819(h)(2)(B) 
(i) or (iii), 1819(h)(4), 1919(h)(1)(B)(i), or 1919(h)(2)(A) (i), (iii) 
or (iv) of the Act.
    (3) A State may not, until two years since the assessment of the 
penalty (or penalties) has elapsed, approve a nurse

[[Page 83]]

aide training and competency evaluation program or competency evaluation 
program offered by or in a facility that, within the two-year period 
beginning October 1, 1988--
    (i) Had its participation terminated under title XVIII of the Act or 
under the State plan under title XIX of the Act;
    (ii) Was subject to a denial of payment under title XVIII or title 
XIX;
    (iii) Was assessed a civil money penalty of not less than $5,000 for 
deficiencies in nursing facility standards;
    (iv) Operated under temporary management appointed to oversee the 
operation of the facility and to ensure the health and safety of its 
residents; or
    (v) Pursuant to State action, was closed or had its residents 
transferred.
    (c) Time frame for acting on a request for approval. The State must, 
within 90 days of the date of a request under paragraph (a)(3) of this 
section or receipt of additional information from the requester--
    (1) Advise the requester whether or not the program has been 
approved; or
    (2) Request additional information form the requesting entity.
    (d) Duration of approval. The State may not grant approval of a 
nurse aide training and competency evaluation program for a period 
longer than 2 years. A program must notify the State and the State must 
review that program when there are substantive changes made to that 
program within the 2-year period.
    (e) Withdrawal of approval. (1) The State must withdraw approval of 
a nurse aide training and competency evaluation program or nurse aide 
competency evaluation program offered by or in a facility described in 
paragraph (b)(2) of this section.
    (2) The State may withdraw approval of a nurse aide training and 
competency evaluation program or nurse aide competency evaluation 
program if the State determines that any of the applicable requirements 
of Sec. Sec.  483.152 or 483.154 are not met by the program.
    (3) The State must withdraw approval of a nurse aide training and 
competency evaluation program or a nurse aide competency evaluation 
program if the entity providing the program refuses to permit 
unannounced visits by the State.
    (4) If a State withdraws approval of a nurse aide training and 
competency evaluation program or competency evaluation program--
    (i) The State must notify the program in writing, indicating the 
reason(s) for withdrawal of approval of the program.
    (ii) Students who have started a training and competency evaluation 
program from which approval has been withdrawn must be allowed to 
complete the course.



Sec.  483.152  Requirements for approval of a nurse aide training and competency evaluation program.

    (a) For a nurse aide training and competency evaluation program to 
be approved by the State, it must, at a minimum--
    (1) Consist of no less than 75 clock hours of training;
    (2) Include at least the subjects specified in paragraph (b) of this 
section;
    (3) Include at least 16 hours of supervised practical training. 
Supervised practical training means training in a laboratory or other 
setting in which the trainee demonstrates knowledge while performing 
tasks on an individual under the direct supervision of a registered 
nurse or a licensed practical nurse;
    (4) Ensure that--
    (i) Students do not perform any services for which they have not 
trained and been found proficient by the instructor; and
    (ii) Students who are providing services to residents are under the 
general supervision of a licensed nurse or a registered nurse;
    (5) Meet the following requirements for instructors who train nurse 
aides;
    (i) The training of nurse aides must be performed by or under the 
general supervision of a registered nurse who possesses a minimum of 2 
years of nursing experience, at least 1 year of which must be in the 
provision of long term care facility services;
    (ii) Instructors must have completed a course in teaching adults or 
have experience in teaching adults or supervising nurse aides;

[[Page 84]]

    (iii) In a facility-based program, the training of nurse aides may 
be performed under the general supervision of the director of nursing 
for the facility who is prohibited from performing the actual training; 
and
    (iv) Other personnel from the health professions may supplement the 
instructor, including, but not limited to, registered nurses, licensed 
practical/vocational nurses, pharmacists, dietitians, social workers, 
sanitarians, fire safety experts, nursing home administrators, 
gerontologists, psychologists, physical and occupational therapists, 
activities specialists, speech/language/hearing therapists, and resident 
rights experts. Supplemental personnel must have at least 1 year of 
experience in their fields;
    (6) Contain competency evaluation procedures specified in Sec.  
483.154.
    (b) The curriculum of the nurse aide training program must include--
    (1) At least a total of 16 hours of training in the following areas 
prior to any direct contact with a resident:
    (i) Communication and interpersonal skills;
    (ii) Infection control;
    (iii) Safety/emergency procedures, including the Heimlich maneuver;
    (iv) Promoting residents' independence; and
    (v) Respecting residents' rights.
    (2) Basic nursing skills;
    (i) Taking and recording vital signs;
    (ii) Measuring and recording height and weight;
    (iii) Caring for the residents' environment;
    (iv) Recognizing abnormal changes in body functioning and the 
importance of reporting such changes to a supervisor; and
    (v) Caring for residents when death is imminent.
    (3) Personal care skills, including, but not limited to--
    (i) Bathing;
    (ii) Grooming, including mouth care;
    (iii) Dressing;
    (iv) Toileting;
    (v) Assisting with eating and hydration;
    (vi) Proper feeding techniques;
    (vii) Skin care; and
    (viii) Transfers, positioning, and turning.
    (4) Mental health and social service needs:
    (i) Modifying aide's behavior in response to residents' behavior;
    (ii) Awareness of developmental tasks associated with the aging 
process;
    (iii) How to respond to resident behavior;
    (iv) Allowing the resident to make personal choices, providing and 
reinforcing other behavior consistent with the resident's dignity; and
    (v) Using the resident's family as a source of emotional support.
    (5) Care of cognitively impaired residents:
    (i) Techniques for addressing the unique needs and behaviors of 
individual with dementia (Alzheimer's and others);
    (ii) Communicating with cognitively impaired residents;
    (iii) Understanding the behavior of cognitively impaired residents;
    (iv) Appropriate responses to the behavior of cognitively impaired 
residents; and
    (v) Methods of reducing the effects of cognitive impairments.
    (6) Basic restorative services:
    (i) Training the resident in self care according to the resident's 
abilities;
    (ii) Use of assistive devices in transferring, ambulation, eating, 
and dressing;
    (iii) Maintenance of range of motion;
    (iv) Proper turning and positioning in bed and chair;
    (v) Bowel and bladder training; and
    (vi) Care and use of prosthetic and orthotic devices.
    (7) Residents' Rights.
    (i) Providing privacy and maintenance of confidentiality;
    (ii) Promoting the residents' right to make personal choices to 
accommodate their needs;
    (iii) Giving assistance in resolving grievances and disputes;
    (iv) Providing needed assistance in getting to and participating in 
resident and family groups and other activities;
    (v) Maintaining care and security of residents' personal 
possessions;
    (vi) Promoting the resident's right to be free from abuse, 
mistreatment, and

[[Page 85]]

neglect and the need to report any instances of such treatment to 
appropriate facility staff;
    (vii) Avoiding the need for restraints in accordance with current 
professional standards.
    (c) Prohibition of charges. (1) No nurse aide who is employed by, or 
who has received an offer of employment from, a facility on the date on 
which the aide begins a nurse aide training and competency evaluation 
program may be charged for any portion of the program (including any 
fees for textbooks or other required course materials).
    (2) If an individual who is not employed, or does not have an offer 
to be employed, as a nurse aide becomes employed by, or receives an 
offer of employment from, a facility not later than 12 months after 
completing a nurse aide training and competency evaluation program, the 
State must provide for the reimbursement of costs incurred in completing 
the program on a pro rata basis during the period in which the 
individual is employed as a nurse aide.



Sec.  483.154  Nurse aide competency evaluation.

    (a) Notification to Individual. The State must advise in advance any 
individual who takes the competency evaluation that a record of the 
successful completion of the evaluation will be included in the State's 
nurse aid registry.
    (b) Content of the competency evaluation program--(1) Written or 
oral examinations. The competency evaluation must--
    (i) Allow an aide to choose between a written and an oral 
examination;
    (ii) Address each course requirement specified in Sec.  483.152(b);
    (iii) Be developed from a pool of test questions, only a portion of 
which is used in any one examination;
    (iv) Use a system that prevents disclosure of both the pool of 
questions and the individual competency evaluations; and
    (v) If oral, must be read from a prepared text in a neutral manner.
    (2) Demonstration of skills. The skills demonstration must consist 
of a demonstration of randomly selected items drawn from a pool 
consisting of the tasks generally performed by nurse aides. This pool of 
skills must include all of the personal care skills listed in Sec.  
483.152(b)(3).
    (c) Administration of the competency evaluation. (1) The competency 
examination must be administered and evaluated only by--
    (i) The State directly; or
    (ii) A State approved entity which is neither a skilled nursing 
facility that participates in Medicare nor a nursing facility that 
participates in Medicaid.
    (2) No nurse aide who is employed by, or who has received an offer 
of employment from, a facility on the date on which the aide begins a 
nurse aide competency evaluation program may be charged for any portion 
of the program.
    (3) If an individual who is not employed, or does not have an offer 
to be employed, as a nurse aide becomes employed by, or receives an 
offer of employment from, a facility not later than 12 months after 
completing a nurse aide competency evaluation program, the State must 
provide for the reimbursement of costs incurred in completing the 
program on a pro rata basis during the period in which the individual is 
employed as a nurse aide.
    (4) The skills demonstration part of the evaluation must be--
    (i) Performed in a facility or laboratory setting comparable to the 
setting in which the individual will function as a nurse aide; and
    (ii) Administered and evaluated by a registered nurse with at least 
one year's experience in providing care for the elderly or the 
chronically ill of any age.
    (d) Facility proctoring of the competency evaluation. (1) The 
competency evaluation may, at the nurse aide's option, be conducted at 
the facility in which the nurse aide is or will be employed unless the 
facility is described in Sec.  483.151(b)(2).
    (2) The State may permit the competency evaluation to be proctored 
by facility personnel if the State finds that the procedure adopted by 
the facility assures that the competency evaluation program--
    (i) Is secure from tampering;

[[Page 86]]

    (ii) Is standardized and scored by a testing, educational, or other 
organization approved by the State; and
    (iii) Requires no scoring by facility personnel.
    (3) The State must retract the right to proctor nurse aide 
competency evaluations from facilities in which the State finds any 
evidence of impropriety, including evidence of tampering by facility 
staff.
    (e) Successful completion of the competency evaluation program. (1) 
The State must establish a standard for satisfactory completion of the 
competency evaluation. To complete the competency evaluation 
successfully an individual must pass both the written or oral 
examination and the skills demonstration.
    (2) A record of successful completion of the competency evaluation 
must be included in the nurse aide registry provided in Sec.  483.156 
within 30 days of the date if the individual is found to be competent.
    (f) Unsuccessful completion of the competency evaluation program. 
(1) If the individual does not complete the evaluation satisfactorily, 
the individual must be advised--
    (i) Of the areas which he or she; did not pass; and
    (ii) That he or she has at least three opportunities to take the 
evaluation.
    (2) The State may impose a maximum upon the number of times an 
individual upon the number of times an individual may attempt to 
complete the competency evaluation successfully, but the maximum may be 
no less than three.



Sec.  483.156  Registry of nurse aides.

    (a) Establishment of registry. The State must establish and maintain 
a registry of nurse aides that meets the requirement of this section. 
The registry--
    (1) Must include as a minimum the information contained in paragraph 
(c) of this section:
    (2) Must be sufficiently accessible to meet the needs of the public 
and health care providers promptly;
    (3) May include home health aides who have successfully completed a 
home health aide competency evaluation program approved by the State if 
home health aides are differentiated from nurse aides; and
    (4) Must provide that any response to an inquiry that includes a 
finding of abuse, neglect, or misappropriation of property also include 
any statement disputing the finding made by the nurse aide, as provided 
under paragraph (c)(1)(ix) of this section.
    (b) Registry operation. (1) The State may contract the daily 
operation and maintenance of the registry to a non-State entity. 
However, the State must maintain accountability for overall operation of 
the registry and compliance with these regulations.
    (2) Only the State survey and certification agency may place on the 
registry findings of abuse, neglect, or misappropriation of property.
    (3) The State must determine which individuals who (i) have 
successfully completed a nurse aide training and competency evaluation 
program or nurse aide competency evaluation program; (ii) have been 
deemed as meeting these requirements; or (iii) have had these 
requirements waived by the State do not qualify to remain on the 
registry because they have performed no nursing or nursing-related 
services for a period of 24 consecutive months.
    (4) The State may not impose any charges related to registration on 
individuals listed in the registry.
    (5) The State must provide information on the registry promptly.
    (c) Registry Content. (1) The registry must contain at least the 
following information on each individual who has successfully completed 
a nurse aide training and competency evaluation program which meets the 
requirements of Sec.  483.152 or a competency evaluation which meets the 
requirements of Sec.  483.154 and has been found by the State to be 
competent to function as a nurse aide or who may function as a nurse 
aide because of meeting criteria in Sec.  483.150:
    (i) The individual's full name.
    (ii) Information necessary to identify each individual;
    (iii) The date the individual became eligible for placement in the 
registry through successfully completing a nurse aide training and 
competency evaluation program or competency

[[Page 87]]

evaluation program or by meeting the requirements of Sec.  483.150; and
    (iv) The following information on any finding by the State survey 
agency of abuse, neglect, or misappropriation of property by the 
individual:
    (A) Documentation of the State's investigation, including the nature 
of the allegation and the evidence that led the State to conclude that 
the allegation was valid;
    (B) The date of the hearing, if the individual chose to have one, 
and its outcome; and
    (C) A statement by the individual disputing the allegation, if he or 
she chooses to make one; and
    (D) This information must be included in the registry within 10 
working days of the finding and must remain in the registry permanently, 
unless the finding was made in error, the individual was found not 
guilty in a court of law, or the State is notified of the individual's 
death.
    (2) The registry must remove entries for individuals who have 
performed no nursing or nursing-related services for a period of 24 
consecutive months, unless the individual's registry entry includes 
documented findings of abuse, neglect, or misappropriation of property.
    (d) Disclosure of information. The State must--
    (1) Disclose all of the information in Sec.  483.156(c)(1) (iii) and 
(iv) to all requesters and may disclose additional information it deems 
necessary; and
    (2) Promptly provide individuals with all information contained in 
the registry on them when adverse findings are placed on the registry 
and upon request. Individuals on the registry must have sufficient 
opportunity to correct any misstatements or inaccuracies contained in 
the registry.

[56 FR 48919, Sept. 26, 1991; 56 FR 59331, Nov. 25, 1991]



Sec.  483.158  FFP for nurse aide training and competency evaluation.

    (a) State expenditures for nurse aide training and competency 
evaluation programs and competency evaluation programs are 
administrative costs. They are matched as indicated in Sec.  
433.15(b)(8) of this chapter.
    (b) FFP is available for State expenditures associated with nurse 
aide training and competency evaluation programs and competency 
evaluation programs only for--
    (1) Nurse aides employed by a facility;
    (2) Nurse aides who have an offer of employment from a facility;
    (3) Nurse aides who become employed by a facility not later than 12 
months after completing a nurse aide training and competency evaluation 
program or competency evaluation program; or
    (4) Nurse aides who receive an offer of employment from a facility 
not later than 12 months after completing a nurse aide training and 
competency evaluation program or competency evaluation program.



Sec.  483.160  Requirements for training of paid feeding assistants.

    (a) Minimum training course contents. A State-approved training 
course for paid feeding assistants must include, at a minimum, 8 hours 
of training in the following:
    (1) Feeding techniques.
    (2) Assistance with feeding and hydration.
    (3) Communication and interpersonal skills.
    (4) Appropriate responses to resident behavior.
    (5) Safety and emergency procedures, including the Heimlich 
maneuver.
    (6) Infection control.
    (7) Resident rights.
    (8) Recognizing changes in residents that are inconsistent with 
their normal behavior and the importance of reporting those changes to 
the supervisory nurse.
    (b) Maintenance of records. A facility must maintain a record of all 
individuals, used by the facility as feeding assistants, who have 
successfully completed the training course for paid feeding assistants.

[68 FR 55539, Sept. 26, 2003]

[[Page 88]]



 Subpart E_Appeals of Discharges, Transfers, and Preadmission Screening 
           and Annual Resident Review (PASARR) Determinations

    Source: 57 FR 56514, Nov. 30, 1992, unless otherwise noted.



Sec.  483.200  Statutory basis.

    This subpart is based on sections 1819(e)(3) and (f)(3) and 
1919(e)(3) and (f)(3) of the Act, which require States to make 
available, to individuals who are discharged or transferred from SNFs or 
NFs, an appeals process that complies with guidelines issued by the 
Secretary.

[60 FR 50443, Sept. 29, 1995]



Sec.  483.202  Definitions.

    For purposes of this subpart and subparts B and C--
    Discharge means movement from an entity that participates in 
Medicare as a skilled nursing facility, a Medicare certified distinct 
part, an entity that participates in Medicaid as a nursing facility, or 
a Medicaid certified distinct part to a noninstitutional setting when 
the discharging facility ceases to be legally responsible for the care 
of the resident.
    Individual means an individual or any legal representative of the 
individual.
    Resident means a resident of a SNF or NF or any legal representative 
of the resident.
    Transfer means movement from an entity that participates in Medicare 
as a skilled nursing facility, a Medicare certified distinct part, an 
entity that participates in Medicaid as a nursing facility or a Medicaid 
certified distinct part to another institutional setting when the legal 
responsibility for the care of the resident changes from the 
transferring facility to the receiving facility.



Sec.  483.204  Provision of a hearing and appeal system.

    (a) Each State must provide a system for:
    (1) A resident of a SNF or a NF to appeal a notice from the SNF or 
NF of intent to discharge or transfer the resident; and
    (2) An individual who has been adversely affected by any PASARR 
determination made by the State in the context of either a preadmission 
screening or an annual resident review under subpart C of part 483 to 
appeal that determination.
    (b) The State must provide an appeals system that meets the 
requirements of this subpart, Sec.  483.12 of this part, and part 431 
subpart E of this chapter.

[57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr. 28, 1993]



Sec.  483.206  Transfers, discharges and relocations subject to appeal.

    (a) ``Facility'' means a certified entity, either a Medicare SNF or 
a Medicaid NF (see Sec. Sec.  483.5 and 483.12(a)(1)).
    (b) A resident has appeal rights when he or she is transferred 
from--
    (1) A certified bed into a noncertified bed; and
    (2) A bed in a certified entity to a bed in an entity which is 
certified as a different provider.
    (c) A resident has no appeal rights when he or she is moved from one 
bed in the certified entity to another bed in the same certified entity.



 Subpart F_Requirements That Must be Met by States and State Agencies, 
                           Resident Assessment



Sec.  483.315  Specification of resident assessment instrument.

    (a) Statutory basis. Sections 1819(e)(5) and 1919(e)(5) of the Act 
require that a State specify the resident assessment instrument (RAI) to 
be used by long term care facilities in the State when conducting 
initial and periodic assessments of each resident's functional capacity, 
in accordance with Sec.  483.20.
    (b) State options in specifying an RAI. The RAI that the State 
specifies must be one of the following:
    (1) The instrument designated by CMS.
    (2) An alternate instrument specified by the State and approved by 
CMS, using the criteria specified in the State Operations Manual issued 
by CMS (CMS Pub. 7) which is available for purchase through the National 
Technical

[[Page 89]]

Information Service, 5285 Port Royal Rd., Springfield, VA 22151.
    (c) State requirements in specifying an RAI. (1) Within 30 days 
after CMS notifies the State of the CMS-designated RAI or changes to it, 
the State must do one of the following:
    (i) Specify the CMS-designated RAI.
    (ii) Notify CMS of its intent to specify an alternate instrument.
    (2) Within 60 days after receiving CMS approval of an alternate RAI, 
the State must specify the RAI for use by all long term care facilities 
participating in the Medicare and Medicaid programs.
    (3) After specifying an instrument, the State must provide periodic 
educational programs for facility staff to assist with implementation of 
the RAI.
    (4) A State must audit implementation of the RAI through the survey 
process.
    (5) A State must obtain approval from CMS before making any 
modifications to its RAI.
    (6) A State must adopt revisions to the RAI that are specified by 
CMS.
    (d) CMS-designated RAI. The CMS-designated RAI is published in the 
State Operations Manual issued by CMS (CMS Pub. 7), as updated 
periodically, and consists of the following:
    (1) The minimum data set (MDS) and common definitions.
    (2) Care area assessment (CAA) guidelines and care area triggers 
(CATs) that are necessary to accurately assess residents, established by 
CMS.
    (3) The quarterly review, based on a subset of the MDS specified by 
CMS.
    (4) The requirements for use of the RAI that appear at Sec.  483.20.
    (e) Minimum data set (MDS). The MDS includes assessment in the areas 
specified in Sec.  483.20(b)(i) through (xviii) of this chapter, and as 
defined in the RAI manual published in the State Operations Manual 
issued by CMS (CMS Pub. 100-07).
    (f) [Reserved]
    (g) Criteria for CMS approval of alternate instrument. To receive 
CMS approval, a State's alternate instrument must use the standardized 
format, organization, item labels and definitions, and instructions 
specified by CMS in the latest issuance of the State Operations Manual 
issued by CMS (CMS Pub. 7).
    (h) State MDS system and database requirements. As part of facility 
agency responsibilities, the State Survey Agency must:
    (1) Support and maintain the CMS State system and database.
    (2) Specify to a facility the method of transmission of data, and 
instruct the facility on this method.
    (3) Upon receipt of facility data from CMS, ensure that a facility 
resolves errors.
    (4) Analyze data and generate reports, as specified by CMS.
    (i) State identification of agency that receives RAI data. The State 
must identify the component agency that receives RAI data, and ensure 
that this agency restricts access to the data except for the following:
    (1) Reports that contain no resident-identifiable data.
    (2) Transmission of reports to CMS.
    (3) Transmission of data and reports to the State agency that 
conducts surveys to ensure compliance with Medicare and Medicaid 
participation requirements, for purposes related to this function.
    (4) Transmission of data and reports to the State Medicaid agency 
for purposes directly related to the administration of the State 
Medicaid plan.
    (5) Transmission of data and reports to other entities only when 
authorized as a routine use by CMS.
    (j) Resident-identifiable data. (1) The State may not release 
information that is resident-identifiable to the public.
    (2) The State may not release RAI data that is resident-identifiable 
except in accordance with a written agreement under which the recipient 
agrees to be bound by the restrictions described in paragraph (i) of 
this section.

[62 FR 67212, Dec. 23, 1997, as amended at 74 FR 40363, Aug. 11, 2009]

[[Page 90]]



    Subpart G_Condition of Participation for the Use of Restraint or 
  Seclusion in Psychiatric Residential Treatment Facilities Providing 
       Inpatient Psychiatric Services for Individuals Under Age 21

    Source: 66 FR 7161, Jan. 22, 2001, unless otherwise noted.



Sec.  483.350  Basis and scope.

    (a) Statutory basis. Sections 1905(a)(16) and (h) of the Act provide 
that inpatient psychiatric services for individuals under age 21 include 
only inpatient services that are provided in an institution (or distinct 
part thereof) that is a psychiatric hospital as defined in section 
1861(f) of the Act or in another inpatient setting that the Secretary 
has specified in regulations. Additionally, the Children's Health Act of 
2000 (Pub. L. 106-310) imposes procedural reporting and training 
requirements regarding the use of restraints and involuntary seclusion 
in facilities, specifically including facilities that provide inpatient 
psychiatric services for children under the age of 21 as defined by 
sections 1905(a)(16) and (h) of the Act.
    (b) Scope. This subpart imposes requirements regarding the use of 
restraint or seclusion in psychiatric residential treatment facilities, 
that are not hospitals, providing inpatient psychiatric services to 
individuals under age 21.



Sec.  483.352  Definitions.

    For purposes of this subpart, the following definitions apply:
    Drug used as a restraint means any drug that--
    (1) Is administered to manage a resident's behavior in a way that 
reduces the safety risk to the resident or others;
    (2) Has the temporary effect of restricting the resident's freedom 
of movement; and
    (3) Is not a standard treatment for the resident's medical or 
psychiatric condition.
    Emergency safety intervention means the use of restraint or 
seclusion as an immediate response to an emergency safety situation.
    Emergency safety situation means unanticipated resident behavior 
that places the resident or others at serious threat of violence or 
injury if no intervention occurs and that calls for an emergency safety 
intervention as defined in this section.
    Mechanical restraint means any device attached or adjacent to the 
resident's body that he or she cannot easily remove that restricts 
freedom of movement or normal access to his or her body.
    Minor means a minor as defined under State law and, for the purpose 
of this subpart, includes a resident who has been declared legally 
incompetent by the applicable State court.
    Personal restraint means the application of physical force without 
the use of any device, for the purposes of restraining the free movement 
of a resident's body. The term personal restraint does not include 
briefly holding without undue force a resident in order to calm or 
comfort him or her, or holding a resident's hand to safely escort a 
resident from one area to another.
    Psychiatric Residential Treatment Facility means a facility other 
than a hospital, that provides psychiatric services, as described in 
subpart D of part 441 of this chapter, to individuals under age 21, in 
an inpatient setting.
    Restraint means a ``personal restraint,'' ``mechanical restraint,'' 
or ``drug used as a restraint'' as defined in this section.
    Seclusion means the involuntary confinement of a resident alone in a 
room or an area from which the resident is physically prevented from 
leaving.
    Serious injury means any significant impairment of the physical 
condition of the resident as determined by qualified medical personnel. 
This includes, but is not limited to, burns, lacerations, bone 
fractures, substantial hematoma, and injuries to internal organs, 
whether self-inflicted or inflicted by someone else.
    Staff means those individuals with responsibility for managing a 
resident's health or participating in an emergency safety intervention 
and who are employed by the facility on a full-time, part-time, or 
contract basis.

[[Page 91]]

    Time out means the restriction of a resident for a period of time to 
a designated area from which the resident is not physically prevented 
from leaving, for the purpose of providing the resident an opportunity 
to regain self-control.

[66 FR 7161, Jan. 22, 2001, as amended at 66 FR 28116, May 22, 2001]



Sec.  483.354  General requirements for psychiatric residential treatment facilities.

    A psychiatric residential treatment facility must meet the 
requirements in Sec.  441.151 through Sec.  441.182 of this chapter.



Sec.  483.356  Protection of residents.

    (a) Restraint and seclusion policy for the protection of residents. 
(1) Each resident has the right to be free from restraint or seclusion, 
of any form, used as a means of coercion, discipline, convenience, or 
retaliation.
    (2) An order for restraint or seclusion must not be written as a 
standing order or on an as-needed basis.
    (3) Restraint or seclusion must not result in harm or injury to the 
resident and must be used only--
    (i) To ensure the safety of the resident or others during an 
emergency safety situation; and
    (ii) Until the emergency safety situation has ceased and the 
resident's safety and the safety of others can be ensured, even if the 
restraint or seclusion order has not expired.
    (4) Restraint and seclusion must not be used simultaneously.
    (b) Emergency safety intervention. An emergency safety intervention 
must be performed in a manner that is safe, proportionate, and 
appropriate to the severity of the behavior, and the resident's 
chronological and developmental age; size; gender; physical, medical, 
and psychiatric condition; and personal history (including any history 
of physical or sexual abuse).
    (c) Notification of facility policy. At admission, the facility 
must--
    (1) Inform both the incoming resident and, in the case of a minor, 
the resident's parent(s) or legal guardian(s) of the facility's policy 
regarding the use of restraint or seclusion during an emergency safety 
situation that may occur while the resident is in the program;
    (2) Communicate its restraint and seclusion policy in a language 
that the resident, or his or her parent(s) or legal guardian(s) 
understands (including American Sign Language, if appropriate) and when 
necessary, the facility must provide interpreters or translators;
    (3) Obtain an acknowledgment, in writing, from the resident, or in 
the case of a minor, from the parent(s) or legal guardian(s) that he or 
she has been informed of the facility's policy on the use of restraint 
or seclusion during an emergency safety situation. Staff must file this 
acknowledgment in the resident's record; and
    (4) Provide a copy of the facility policy to the resident and in the 
case of a minor, to the resident's parent(s) or legal guardian(s).
    (d) Contact information. The facility's policy must provide contact 
information, including the phone number and mailing address, for the 
appropriate State Protection and Advocacy organization.



Sec.  483.358  Orders for the use of restraint or seclusion.

    (a) Orders for restraint or seclusion must be by a physician, or 
other licensed practitioner permitted by the State and the facility to 
order restraint or seclusion and trained in the use of emergency safety 
interventions. Federal regulations at 42 CFR 441.151 require that 
inpatient psychiatric services for recipients under age 21 be provided 
under the direction of a physician.
    (b) If the resident's treatment team physician is available, only he 
or she can order restraint or seclusion.
    (c) A physician or other licensed practitioner permitted by the 
state and the facility to order restraint or seclusion must order the 
least restrictive emergency safety intervention that is most likely to 
be effective in resolving the emergency safety situation based on 
consultation with staff.
    (d) If the order for restraint or seclusion is verbal, the verbal 
order must be received by a registered nurse or other licensed staff 
such as a licensed practical nurse, while the emergency safety

[[Page 92]]

intervention is being initiated by staff or immediately after the 
emergency safety situation ends. The physician or other licensed 
practitioner permitted by the state and the facility to order restraint 
or seclusion must verify the verbal order in a signed written form in 
the resident's record. The physician or other licensed practitioner 
permitted by the state and the facility to order restraint or seclusion 
must be available to staff for consultation, at least by telephone, 
throughout the period of the emergency safety intervention.
    (e) Each order for restraint or seclusion must:
    (1) Be limited to no longer than the duration of the emergency 
safety situation; and
    (2) Under no circumstances exceed 4 hours for residents ages 18 to 
21; 2 hours for residents ages 9 to 17; or 1 hour for residents under 
age 9.
    (f) Within 1 hour of the initiation of the emergency safety 
intervention a physician, or other licensed practitioner trained in the 
use of emergency safety interventions and permitted by the state and the 
facility to assess the physical and psychological well being of 
residents, must conduct a face-to-face assessment of the physical and 
psychological well being of the resident, including but not limited to--
    (1) The resident's physical and psychological status;
    (2) The resident's behavior;
    (3) The appropriateness of the intervention measures; and
    (4) Any complications resulting from the intervention.
    (g) Each order for restraint or seclusion must include--
    (1) The name of the ordering physician or other licensed 
practitioner permitted by the state and the facility to order restraint 
or seclusion;
    (2) The date and time the order was obtained; and
    (3) The emergency safety intervention ordered, including the length 
of time for which the physician or other licensed practitioner permitted 
by the state and the facility to order restraint or seclusion authorized 
its use.
    (h) Staff must document the intervention in the resident's record. 
That documentation must be completed by the end of the shift in which 
the intervention occurs. If the intervention does not end during the 
shift in which it began, documentation must be completed during the 
shift in which it ends. Documentation must include all of the following:
    (1) Each order for restraint or seclusion as required in paragraph 
(g) of this section.
    (2) The time the emergency safety intervention actually began and 
ended.
    (3) The time and results of the 1-hour assessment required in 
paragraph (f) of this section.
    (4) The emergency safety situation that required the resident to be 
restrained or put in seclusion.
    (5) The name of staff involved in the emergency safety intervention.
    (i) The facility must maintain a record of each emergency safety 
situation, the interventions used, and their outcomes.
    (j) The physician or other licensed practitioner permitted by the 
state and the facility to order restraint or seclusion must sign the 
restraint or seclusion order in the resident's record as soon as 
possible.

[66 FR 7161, Jan. 22, 2001, as amended at 66 FR 28116, May 22, 2001]



Sec.  483.360  Consultation with treatment team physician.

    If a physician or other licensed practitioner permitted by the state 
and the facility to order restraint or seclusion orders the use of 
restraint or seclusion, that person must contact the resident's 
treatment team physician, unless the ordering physician is in fact the 
resident's treatment team physician. The person ordering the use of 
restraint or seclusion must--
    (a) Consult with the resident's treatment team physician as soon as 
possible and inform the team physician of the emergency safety situation 
that required the resident to be restrained or placed in seclusion; and
    (b) Document in the resident's record the date and time the team 
physician was consulted.

[66 FR 7161, Jan. 22, 2001, as amended at 66 FR 28117, May 22, 2001]

[[Page 93]]



Sec.  483.362  Monitoring of the resident in and immediately after restraint.

    (a) Clinical staff trained in the use of emergency safety 
interventions must be physically present, continually assessing and 
monitoring the physical and psychological well-being of the resident and 
the safe use of restraint throughout the duration of the emergency 
safety intervention.
    (b) If the emergency safety situation continues beyond the time 
limit of the order for the use of restraint, a registered nurse or other 
licensed staff, such as a licensed practical nurse, must immediately 
contact the ordering physician or other licensed practitioner permitted 
by the state and the facility to order restraint or seclusion to receive 
further instructions.
    (c) A physician, or other licensed practitioner permitted by the 
state and the facility to evaluate the resident's well-being and trained 
in the use of emergency safety interventions, must evaluate the 
resident's well-being immediately after the restraint is removed.

[66 FR 7161, Jan. 22, 2001, as amended at 66 FR 28117, May 22, 2001]



Sec.  483.364  Monitoring of the resident in and immediately after seclusion.

    (a) Clinical staff, trained in the use of emergency safety 
interventions, must be physically present in or immediately outside the 
seclusion room, continually assessing, monitoring, and evaluating the 
physical and psychological well-being of the resident in seclusion. 
Video monitoring does not meet this requirement.
    (b) A room used for seclusion must--
    (1) Allow staff full view of the resident in all areas of the room; 
and
    (2) Be free of potentially hazardous conditions such as unprotected 
light fixtures and electrical outlets.
    (c) If the emergency safety situation continues beyond the time 
limit of the order for the use of seclusion, a registered nurse or other 
licensed staff, such as a licensed practical nurse, must immediately 
contact the ordering physician or other licensed practitioner permitted 
by the state and the facility to order restraint or seclusion to receive 
further instructions.
    (d) A physician, or other licensed practitioner permitted by the 
state and the facility to evaluate the resident's well-being and trained 
in the use of emergency safety interventions, must evaluate the 
resident's well-being immediately after the resident is removed from 
seclusion.

[66 FR 7161, Jan. 22, 2001, as amended at 66 FR 28117, May 22, 2001]



Sec.  483.366  Notification of parent(s) or legal guardian(s).

    If the resident is a minor as defined in this subpart:
    (a) The facility must notify the parent(s) or legal guardian(s) of 
the resident who has been restrained or placed in seclusion as soon as 
possible after the initiation of each emergency safety intervention.
    (b) The facility must document in the resident's record that the 
parent(s) or legal guardian(s) has been notified of the emergency safety 
intervention, including the date and time of notification and the name 
of the staff person providing the notification.



Sec.  483.368  Application of time out.

    (a) A resident in time out must never be physically prevented from 
leaving the time out area.
    (b) Time out may take place away from the area of activity or from 
other residents, such as in the resident's room (exclusionary), or in 
the area of activity or other residents (inclusionary).
    (c) Staff must monitor the resident while he or she is in time out.



Sec.  483.370  Postintervention debriefings.

    (a) Within 24 hours after the use of restraint or seclusion, staff 
involved in an emergency safety intervention and the resident must have 
a face-to-face discussion. This discussion must include all staff 
involved in the intervention except when the presence of a particular 
staff person may jeopardize the well-being of the resident. Other staff 
and the resident's parent(s) or legal guardian(s) may participate in the 
disussion when it is deemed appropriate by the facility. The facility 
must conduct such discussion in a language that is understood by the 
resident's parent(s) or legal guardian(s).

[[Page 94]]

The discussion must provide both the resident and staff the opportunity 
to discuss the circumstances resulting in the use of restraint or 
seclusion and strategies to be used by the staff, the resident, or 
others that could prevent the future use of restraint or seclusion.
    (b) Within 24 hours after the use of restraint or seclusion, all 
staff involved in the emergency safety intervention, and appropriate 
supervisory and administrative staff, must conduct a debriefing session 
that includes, at a minimum, a review and discussion of--
    (1) The emergency safety situation that required the intervention, 
including a discussion of the precipitating factors that led up to the 
intervention;
    (2) Alternative techniques that might have prevented the use of the 
restraint or seclusion;
    (3) The procedures, if any, that staff are to implement to prevent 
any recurrence of the use of restraint or seclusion; and
    (4) The outcome of the intervention, including any injuries that may 
have resulted from the use of restraint or seclusion.
    (c) Staff must document in the resident's record that both 
debriefing sessions took place and must include in that documentation 
the names of staff who were present for the debriefing, names of staff 
that were excused from the debriefing, and any changes to the resident's 
treatment plan that result from the debriefings.



Sec.  483.372  Medical treatment for injuries resulting from an emergency safety intervention.

    (a) Staff must immediately obtain medical treatment from qualified 
medical personnel for a resident injured as a result of an emergency 
safety intervention.
    (b) The psychiatric residential treatment facility must have 
affiliations or written transfer agreements in effect with one or more 
hospitals approved for participation under the Medicaid program that 
reasonably ensure that--
    (1) A resident will be transferred from the facility to a hospital 
and admitted in a timely manner when a transfer is medically necessary 
for medical care or acute psychiatric care;
    (2) Medical and other information needed for care of the resident in 
light of such a transfer, will be exchanged between the institutions in 
accordance with State medical privacy law, including any information 
needed to determine whether the appropriate care can be provided in a 
less restrictive setting; and
    (3) Services are available to each resident 24 hours a day, 7 days a 
week.
    (c) Staff must document in the resident's record, all injuries that 
occur as a result of an emergency safety intervention, including 
injuries to staff resulting from that intervention.
    (d) Staff involved in an emergency safety intervention that results 
in an injury to a resident or staff must meet with supervisory staff and 
evaluate the circumstances that caused the injury and develop a plan to 
prevent future injuries.



Sec.  483.374  Facility reporting.

    (a) Attestation of facility compliance. Each psychiatric residential 
treatment facility that provides inpatient psychiatric services to 
individuals under age 21 must attest, in writing, that the facility is 
in compliance with CMS's standards governing the use of restraint and 
seclusion. This attestation must be signed by the facility director.
    (1) A facility with a current provider agreement with the Medicaid 
agency must provide its attestation to the State Medicaid agency by July 
21, 2001.
    (2) A facility enrolling as a Medicaid provider must meet this 
requirement at the time it executes a provider agreement with the 
Medicaid agency.
    (b) Reporting of serious occurrences. The facility must report each 
serious occurrence to both the State Medicaid agency and, unless 
prohibited by State law, the State-designated Protection and Advocacy 
system. Serious occurrences that must be reported include a resident's 
death, a serious injury to a resident as defined in Sec.  483.352 of 
this part, and a resident's suicide attempt.
    (1) Staff must report any serious occurrence involving a resident to 
both the State Medicaid agency and the State-designated Protection and 
Advocacy system by no later than close of business the next business day 
after a

[[Page 95]]

serious occurrence. The report must include the name of the resident 
involved in the serious occurrence, a description of the occurrence, and 
the name, street address, and telephone number of the facility.
    (2) In the case of a minor, the facility must notify the resident's 
parent(s) or legal guardian(s) as soon as possible, and in no case later 
than 24 hours after the serious occurrence.
    (3) Staff must document in the resident's record that the serious 
occurrence was reported to both the State Medicaid agency and the State-
designated Protection and Advocacy system, including the name of the 
person to whom the incident was reported. A copy of the report must be 
maintained in the resident's record, as well as in the incident and 
accident report logs kept by the facility.
    (c) Reporting of deaths. In addition to the reporting requirements 
contained in paragraph (b) of this section, facilities must report the 
death of any resident to the Centers for Medicare & Medicaid Services 
(CMS) regional office.
    (1) Staff must report the death of any resident to the CMS regional 
office by no later than close of business the next business day after 
the resident's death.
    (2) Staff must document in the resident's record that the death was 
reported to the CMS regional office.

[66 FR 7161, Jan. 22, 2001, as amended at 66 FR 28117, May 22, 2001]



Sec.  483.376  Education and training.

    (a) The facility must require staff to have ongoing education, 
training, and demonstrated knowledge of--
    (1) Techniques to identify staff and resident behaviors, events, and 
environmental factors that may trigger emergency safety situations;
    (2) The use of nonphysical intervention skills, such as de-
escalation, mediation conflict resolution, active listening, and verbal 
and observational methods, to prevent emergency safety situations; and
    (3) The safe use of restraint and the safe use of seclusion, 
including the ability to recognize and respond to signs of physical 
distress in residents who are restrained or in seclusion.
    (b) Certification in the use of cardiopulmonary resuscitation, 
including periodic recertification, is required.
    (c) Individuals who are qualified by education, training, and 
experience must provide staff training.
    (d) Staff training must include training exercises in which staff 
members successfully demonstrate in practice the techniques they have 
learned for managing emergency safety situations.
    (e) Staff must be trained and demonstrate competency before 
participating in an emergency safety intervention.
    (f) Staff must demonstrate their competencies as specified in 
paragraph (a) of this section on a semiannual basis and their 
competencies as specified in paragraph (b) of this section on an annual 
basis.
    (g) The facility must document in the staff personnel records that 
the training and demonstration of competency were successfully 
completed. Documentation must include the date training was completed 
and the name of persons certifying the completion of training.
    (h) All training programs and materials used by the facility must be 
available for review by CMS, the State Medicaid agency, and the State 
survey agency.

Subpart H [Reserved]



 Subpart I_Conditions of Participation for Intermediate Care Facilities 
                        for the Mentally Retarded

    Source: 53 FR 20496, June 3, 1988, unless otherwise noted. 
Redesignated at 56 FR 48918, Sept. 26, 1991.



Sec.  483.400  Basis and purpose.

    This subpart implements section 1905 (c) and (d) of the Act which 
gives the Secretary authority to prescribe regulations for intermediate 
care facility services in facilities for the mentally retarded or 
persons with related conditions.

[[Page 96]]



Sec.  483.405  Relationship to other HHS regulations.

    In addition to compliance with the regulations set forth in this 
subpart, facilities are obliged to meet the applicable provisions of 
other HHS regulations, including but not limited to those pertaining to 
nondiscrimination on the basis of race, color, or national origin (45 
CFR Part 80), nondiscrimination on the basis of handicap (45 CFR Part 
84), nondiscrimination on the basis of age (45 CFR Part 91), protection 
of human subjects of research (45 CFR Part 46), and fraud and abuse (42 
CFR Part 455). Although those regulations are not in themselves 
considered conditions of participation under this Part, their violation 
may result in the termination or suspension of, or the refusal to grant 
or continue, Federal financial assistance.



Sec.  483.410  Condition of participation: Governing body and management.

    (a) Standard: Governing body. The facility must identify an 
individual or individuals to constitute the governing body of the 
facility. The governing body must--
    (1) Exercise general policy, budget, and operating direction over 
the facility;
    (2) Set the qualifications (in addition to those already set by 
State law, if any) for the administrator of the facility; and
    (3) Appoint the administrator of the facility.
    (b) Standard: Compliance with Federal, State, and local laws. The 
facility must be in compliance with all applicable provisions of 
Federal, State and local laws, regulations and codes pertaining to 
health, safety, and sanitation.
    (c) Standard: Client records. (1) The facility must develop and 
maintain a recordkeeping system that includes a separate record for each 
client and that documents the client's health care, active treatment, 
social information, and protection of the client's rights.
    (2) The facility must keep confidential all information contained in 
the clients' records, regardless of the form or storage method of the 
records.
    (3) The facility must develop and implement policies and procedures 
governing the release of any client information, including consents 
necessary from the client, or parents (if the client is a minor) or 
legal guardian.
    (4) Any individual who makes an entry in a client's record must make 
it legibly, date it, and sign it.
    (5) The facility must provide a legend to explain any symbol or 
abbreviation used in a client's record.
    (6) The facility must provide each identified residential living 
unit with appropriate aspects of each client's record.
    (d) Standard: Services provided under agreements with outside 
sources. (1) If a service required under this subpart is not provided 
directly, the facility must have a written agreement with an outside 
program, resource, or service to furnish the necessary service, 
including emergency and other health care.
    (2) The agreement must--
    (i) Contain the responsibilities, functions, objectives, and other 
terms agreed to by both parties; and
    (ii) Provide that the facility is responsible for assuring that the 
outside services meet the standards for quality of services contained in 
this subpart.
    (3) The facility must assure that outside services meet the needs of 
each client.
    (4) If living quarters are not provided in a facility owned by the 
ICF/MR, the ICF/MR remains directly responsible for the standards 
relating to physical environment that are specified in Sec.  483.470 (a) 
through (g), (j) and (k).
    (e) Standard: Licensure. The facility must be licensed under 
applicable State and local law.

[53 FR 20496, June 3, 1988. Redesignated at 56 FR 48918, Sept. 26, 1991, 
and amended at 57 FR 43925, Sept. 23, 1992]



Sec.  483.420  Condition of participation: Client protections.

    (a) Standard: Protection of clients' rights. The facility must 
ensure the rights of all clients. Therefore, the facility must--
    (1) Inform each client, parent (if the client is a minor), or legal 
guardian, of the client's rights and the rules of the facility;
    (2) Inform each client, parent (if the client is a minor), or legal 
guardian, of

[[Page 97]]

the client's medical condition, developmental and behavioral status, 
attendant risks of treatment, and of the right to refuse treatment;
    (3) Allow and encourage individual clients to exercise their rights 
as clients of the facility, and as citizens of the United States, 
including the right to file complaints, and the right to due process;
    (4) Allow individual clients to manage their financial affairs and 
teach them to do so to the extent of their capabilities;
    (5) Ensure that clients are not subjected to physical, verbal, 
sexual or psychological abuse or punishment;
    (6) Ensure that clients are free from unnecessary drugs and physical 
restraints and are provided active treatment to reduce dependency on 
drugs and physical restraints;
    (7) Provide each client with the opportunity for personal privacy 
and ensure privacy during treatment and care of personal needs;
    (8) Ensure that clients are not compelled to perform services for 
the facility and ensure that clients who do work for the facility are 
compensated for their efforts at prevailing wages and commensurate with 
their abilities;
    (9) Ensure clients the opportunity to communicate, associate and 
meet privately with individuals of their choice, and to send and receive 
unopened mail;
    (10) Ensure that clients have access to telephones with privacy for 
incoming and outgoing local and long distance calls except as 
contraindicated by factors identified within their individual program 
plans;
    (11) Ensure clients the opportunity to participate in social, 
religious, and community group activities;
    (12) Ensure that clients have the right to retain and use 
appropriate personal possessions and clothing, and ensure that each 
client is dressed in his or her own clothing each day; and
    (13) Permit a husband and wife who both reside in the facility to 
share a room.
    (b) Standard: Client finances. (1) The facility must establish and 
maintain a system that--
    (i) Assures a full and complete accounting of clients' personal 
funds entrusted to the facility on behalf of clients; and
    (ii) Precludes any commingling of client funds with facility funds 
or with the funds of any person other than another client.
    (2) The client's financial record must be available on request to 
the client, parents (if the client is a minor) or legal guardian.
    (c) Standard: Communication with clients, parents, and guardians. 
The facility must--
    (1) Promote participation of parents (if the client is a minor) and 
legal guardians in the process of providing active treatment to a client 
unless their participation is unobtainable or inappropriate;
    (2) Answer communications from clients' families and friends 
promptly and appropriately;
    (3) Promote visits by individuals with a relationship to the client 
(such as family, close friends, legal guardians and advocates) at any 
reasonable hour, without prior notice, consistent with the right of that 
client's and other clients' privacy, unless the interdisciplinary team 
determines that the visit would not be appropriate;
    (4) Promote visits by parents or guardians to any area of the 
facility that provides direct client care services to the client, 
consistent with the right of that client's and other clients' privacy;
    (5) Promote frequent and informal leaves from the facility for 
visits, trips, or vacations; and
    (6) Notify promptly the client's parents or guardian of any 
significant incidents, or changes in the client's condition including, 
but not limited to, serious illness, accident, death, abuse, or 
unauthorized absence.
    (d) Standard: Staff treatment of clients. (1) The facility must 
develop and implement written policies and procedures that prohibit 
mistreatment, neglect or abuse of the client.
    (i) Staff of the facility must not use physical, verbal, sexual or 
psychological abuse or punishment.
    (ii) Staff must not punish a client by withholding food or hydration 
that contributes to a nutritionally adequate diet.

[[Page 98]]

    (iii) The facility must prohibit the employment of individuals with 
a conviction or prior employment history of child or client abuse, 
neglect or mistreatment.
    (2) The facility must ensure that all allegations of mistreatment, 
neglect or abuse, as well as injuries of unknown source, are reported 
immediately to the administrator or to other officials in accordance 
with State law through established procedures.
    (3) The facility must have evidence that all alleged violations are 
thoroughly investigated and must prevent further potential abuse while 
the investigation is in progress.
    (4) The results of all investigations must be reported to the 
administrator or designated representative or to other officials in 
accordance with State law within five working days of the incident and, 
if the alleged violation is verified, appropriate corrective action must 
be taken.



Sec.  483.430  Condition of participation: Facility staffing.

    (a) Standard: Qualified mental retardation professional. Each 
client's active treatment program must be integrated, coordinated and 
monitored by a qualified mental retardation professional who--
    (1) Has at least one year of experience working directly with 
persons with mental retardation or other developmental disabilities; and
    (2) Is one of the following:
    (i) A doctor of medicine or osteopathy.
    (ii) A registered nurse.
    (iii) An individual who holds at least a bachelor's degree in a 
professional category specified in paragraph (b)(5) of this section.
    (b) Standard: Professional program services. (1) Each client must 
receive the professional program services needed to implement the active 
treatment program defined by each client's individual program plan. 
Professional program staff must work directly with clients and with 
paraprofessional, nonprofessional and other professional program staff 
who work with clients.
    (2) The facility must have available enough qualified professional 
staff to carry out and monitor the various professional interventions in 
accordance with the stated goals and objectives of every individual 
program plan.
    (3) Professional program staff must participate as members of the 
interdisciplinary team in relevant aspects of the active treatment 
process.
    (4) Professional program staff must participate in on-going staff 
development and training in both formal and informal settings with other 
professional, paraprofessional, and nonprofessional staff members.
    (5) Professional program staff must be licensed, certified, or 
registered, as applicable, to provide professional services by the State 
in which he or she practices. Those professional program staff who do 
not fall under the jurisdiction of State licensure, certification, or 
registration requirements, specified in Sec.  483.410(b), must meet the 
following qualifications:
    (i) To be designated as an occupational therapist, an individual 
must be eligible for certification as an occupational therapist by the 
American Occupational Therapy Association or another comparable body.
    (ii) To be designated as an occupational therapy assistant, an 
individual must be eligible for certification as a certified 
occupational therapy assistant by the American Occupational Therapy 
Association or another comparable body.
    (iii) To be designated as a physical therapist, an individual must 
be eligible for certification as a physical therapist by the American 
Physical Therapy Association or another comparable body.
    (iv) To be designated as a physical therapy assistant, an individual 
must be eligible for registration by the American Physical Therapy 
Association or be a graduate of a two year college-level program 
approved by the American Physical Therapy Association or another 
comparable body.
    (v) To be designated as a psychologist, an individual must have at 
least a master's degree in psychology from an accredited school.
    (vi) To be designated as a social worker, an individual must--
    (A) Hold a graduate degree from a school of social work accredited 
or approved by the Council on Social Work

[[Page 99]]

Education or another comparable body; or
    (B) Hold a Bachelor of Social Work degree from a college or 
university accredited or approved by the Council on Social Work 
Education or another comparable body.
    (vii) To be designated as a speech-language pathologist or 
audiologist, an individual must--
    (A) Be eligible for a Certificate of Clinical Competence in Speech-
Language Pathology or Audiology granted by the American Speech-Language-
Hearing Association or another comparable body; or
    (B) Meet the educational requirements for certification and be in 
the process of accumulating the supervised experience required for 
certification.
    (viii) To be designated as a professional recreation staff member, 
an individual must have a bachelor's degree in recreation or in a 
specialty area such as art, dance, music or physical education.
    (ix) To be designated as a professional dietitian, an individual 
must be eligible for registration by the American Dietetics Association.
    (x) To be designated as a human services professional an individual 
must have at least a bachelor's degree in a human services field 
(including, but not limited to: sociology, special education, 
rehabilitation counseling, and psychology).
    (xi) If the client's individual program plan is being successfully 
implemented by facility staff, professional program staff meeting the 
qualifications of paragraph (b)(5) (i) through (x) of this section are 
not required--
    (A) Except for qualified mental retardation professionals;
    (B) Except for the requirements of paragraph (b)(2) of this section 
concerning the facility's provision of enough qualified professional 
program staff; and
    (C) Unless otherwise specified by State licensure and certification 
requirements.
    (c) Standard: Facility staffing. (1) The facility must not depend 
upon clients or volunteers to perform direct care services for the 
facility.
    (2) There must be responsible direct care staff on duty and awake on 
a 24-hour basis, when clients are present, to take prompt, appropriate 
action in case of injury, illness, fire or other emergency, in each 
defined residential living unit housing--
    (i) Clients for whom a physician has ordered a medical care plan;
    (ii) Clients who are aggressive, assaultive or security risks;
    (iii) More than 16 clients; or
    (iv) Fewer than 16 clients within a multi-unit building.
    (3) There must be a responsible direct care staff person on duty on 
a 24 hour basis (when clients are present) to respond to injuries and 
symptoms of illness, and to handle emergencies, in each defined 
residential living unit housing--
    (i) Clients for whom a physician has not ordered a medical care 
plan;
    (ii) Clients who are not aggressive, assaultive or security risks; 
and
    (iii) Sixteen or fewer clients,
    (4) The facility must provide sufficient support staff so that 
direct care staff are not required to perform support services to the 
extent that these duties interfere with the exercise of their primary 
direct client care duties.
    (d) Standard: Direct care (residential living unit) staff. (1) The 
facility must provide sufficient direct care staff to manage and 
supervise clients in accordance with their individual program plans.
    (2) Direct care staff are defined as the present on-duty staff 
calculated over all shifts in a 24-hour period for each defined 
residential living unit.
    (3) Direct care staff must be provided by the facility in the 
following minimum ratios of direct care staff to clients:
    (i) For each defined residential living unit serving children under 
the age of 12, severely and profoundly retarded clients, clients with 
severe physical disabilities, or clients who are aggressive, assaultive, 
or security risks, or who manifest severely hyperactive or psychotic-
like behavior, the staff to client ratio is 1 to 3.2.
    (ii) For each defined residential living unit serving moderately 
retarded clients, the staff to client ratio is 1 to 4.
    (iii) For each defined residential living unit serving clients who 
function

[[Page 100]]

within the range of mild retardation, the staff to client ratio is 1 to 
6.4.
    (4) When there are no clients present in the living unit, a 
responsible staff member must be available by telephone.
    (e) Standard: Staff training program. (1) The facility must provide 
each employee with initial and continuing training that enables the 
employee to perform his or her duties effectively, efficiently, and 
competently.
    (2) For employees who work with clients, training must focus on 
skills and competencies directed toward clients' developmental, 
behavioral, and health needs.
    (3) Staff must be able to demonstrate the skills and techniques 
necessary to administer interventions to manage the inappropriate 
behavior of clients.
    (4) Staff must be able to demonstrate the skills and techniques 
necessary to implement the individual program plans for each client for 
whom they are responsible.



Sec.  483.440  Condition of participation: Active treatment services.

    (a) Standard: Active treatment. (1) Each client must receive a 
continuous active treatment program, which includes aggressive, 
consistent implementation of a program of specialized and generic 
training, treatment, health services and related services described in 
this subpart, that is directed toward--
    (i) The acquisition of the behaviors necessary for the client to 
function with as much self determination and independence as possible; 
and
    (ii) The prevention or deceleration of regression or loss of current 
optimal functional status.
    (2) Active treatment does not include services to maintain generally 
independent clients who are able to function with little supervision or 
in the absence of a continuous active treatment program.
    (b) Standard: Admissions, transfers, and discharge. (1) Clients who 
are admitted by the facility must be in need of and receiving active 
treatment services.
    (2) Admission decisions must be based on a preliminary evaluation of 
the client that is conducted or updated by the facility or by outside 
sources.
    (3) A preliminary evaluation must contain background information as 
well as currently valid assessments of functional developmental, 
behavioral, social, health and nutritional status to determine if the 
facility can provide for the client's needs and if the client is likely 
to benefit from placement in the facility.
    (4) If a client is to be either transferred or discharged, the 
facility must--
    (i) Have documentation in the client's record that the client was 
transferred or discharged for good cause; and
    (ii) Provide a reasonable time to prepare the client and his or her 
parents or guardian for the transfer or discharge (except in 
emergencies).
    (5) At the time of the discharge, the facility must--
    (i) Develop a final summary of the client's developmental, 
behavioral, social, health and nutritional status and, with the consent 
of the client, parents (if the client is a minor) or legal guardian, 
provide a copy to authorized persons and agencies; and
    (ii) Provide a post-discharge plan of care that will assist the 
client to adjust to the new living environment.
    (c) Standard: Individual program plan. (1) Each client must have an 
individual program plan developed by an interdisciplinary team that 
represents the professions, disciplines or service areas that are 
relevant to--
    (i) Identifying the client's needs, as described by the 
comprehensive functional assessments required in paragraph (c)(3) of 
this section; and
    (ii) Designing programs that meet the client's needs.
    (2) Appropriate facility staff must participate in interdisciplinary 
team meetings. Participation by other agencies serving the client is 
encouraged. Participation by the client, his or her parent (if the 
client is a minor), or the client's legal guardian is required unless 
that participation is unobtainable or inappropriate.
    (3) Within 30 days after admission, the interdisciplinary team must 
perform accurate assessments or reassessments as needed to supplement 
the preliminary evaluation conducted prior to

[[Page 101]]

admission. The comprehensive functional assessment must take into 
consideration the client's age (for example, child, young adult, elderly 
person) and the implications for active treatment at each stage, as 
applicable, and must--
    (i) Identify the presenting problems and disabilities and where 
possible, their causes;
    (ii) Identify the client's specific developmental strengths;
    (iii) Identify the client's specific developmental and behavioral 
management needs;
    (iv) Identify the client's need for services without regard to the 
actual availability of the services needed; and
    (v) Include physical development and health, nutritional status, 
sensorimotor development, affective development, speech and language 
development and auditory functioning, cognitive development, social 
development, adaptive behaviors or independent living skills necessary 
for the client to be able to function in the community, and as 
applicable, vocational skills.
    (4) Within 30 days after admission, the interdisciplinary team must 
prepare for each client an individual program plan that states the 
specific objectives necessary to meet the client's needs, as identified 
by the comprehensive assessment required by paragraph (c)(3) of this 
section, and the planned sequence for dealing with those objectives. 
These objectives must--
    (i) Be stated separately, in terms of a single behavioral outcome;
    (ii) Be assigned projected completion dates;
    (iii) Be expressed in behavioral terms that provide measurable 
indices of performance;
    (iv) Be organized to reflect a developmental progression appropriate 
to the individual; and
    (v) Be assigned priorities.
    (5) Each written training program designed to implement the 
objectives in the individual program plan must specify:
    (i) The methods to be used;
    (ii) The schedule for use of the method;
    (iii) The person responsible for the program;
    (iv) The type of data and frequency of data collection necessary to 
be able to assess progress toward the desired objectives;
    (v) The inappropriate client behavior(s), if applicable; and
    (vi) Provision for the appropriate expression of behavior and the 
replacement of inappropriate behavior, if applicable, with behavior that 
is adaptive or appropriate.
    (6) The individual program plan must also:
    (i) Describe relevant interventions to support the individual toward 
independence.
    (ii) Identify the location where program strategy information (which 
must be accessible to any person responsible for implementation) can be 
found.
    (iii) Include, for those clients who lack them, training in personal 
skills essential for privacy and independence (including, but not 
limited to, toilet training, personal hygiene, dental hygiene, self-
feeding, bathing, dressing, grooming, and communication of basic needs), 
until it has been demonstrated that the client is developmentally 
incapable of acquiring them.
    (iv) Identify mechanical supports, if needed, to achieve proper body 
position, balance, or alignment. The plan must specify the reason for 
each support, the situations in which each is to be applied, and a 
schedule for the use of each support.
    (v) Provide that clients who have multiple disabling conditions 
spend a major portion of each waking day out of bed and outside the 
bedroom area, moving about by various methods and devices whenever 
possible.
    (vi) Include opportunities for client choice and self-management.
    (7) A copy of each client's individual program plan must be made 
available to all relevant staff, including staff of other agencies who 
work with the client, and to the client, parents (if the client is a 
minor) or legal guardian.
    (d) Standard: Program implementation. (1) As soon as the 
interdisciplinary team has formulated a client's individual program 
plan, each client must receive a continuous active treatment program 
consisting of needed interventions and services in sufficient number

[[Page 102]]

and frequency to support the achievement of the objectives identified in 
the individual program plan.
    (2) The facility must develop an active treatment schedule that 
outlines the current active treatment program and that is readily 
available for review by relevant staff.
    (3) Except for those facets of the individual program plan that must 
be implemented only by licensed personnel, each client's individual 
program plan must be implemented by all staff who work with the client, 
including professional, paraprofessional and nonprofessional staff.
    (e) Standard: Program documentation. (1) Data relative to 
accomplishment of the criteria specified in client individual program 
plan objectives must be documented in measureable terms.
    (2) The facility must document significant events that are related 
to the client's individual program plan and assessments and that 
contribute to an overall understanding of the client's ongoing level and 
quality of functioning.
    (f) Standard: Program monitoring and change. (1) The individual 
program plan must be reviewed at least by the qualified mental 
retardation professional and revised as necessary, including, but not 
limited to situations in which the client--
    (i) Has successfully completed an objective or objectives identified 
in the individual program plan;
    (ii) Is regressing or losing skills already gained;
    (iii) Is failing to progress toward identified objectives after 
reasonable efforts have been made; or
    (iv) Is being considered for training towards new objectives.
    (2) At least annually, the comprehensive functional assessment of 
each client must be reviewed by the interdisciplinary team for relevancy 
and updated as needed, and the individual program plan must be revised, 
as appropriate, repeating the process set forth in paragraph (c) of this 
section.
    (3) The facility must designate and use a specially constituted 
committee or committees consisting of members of facility staff, 
parents, legal guardians, clients (as appropriate), qualified persons 
who have either experience or training in contemporary practices to 
change inappropriate client behavior, and persons with no ownership or 
controlling interest in the facility to--
    (i) Review, approve, and monitor individual programs designed to 
manage inappropriate behavior and other programs that, in the opinion of 
the committee, involve risks to client protection and rights;
    (ii) Insure that these programs are conducted only with the written 
informed consent of the client, parent (if the client is a minor), or 
legal guardian; and
    (iii) Review, monitor and make suggestions to the facility about its 
practices and programs as they relate to drug usage, physical 
restraints, time-out rooms, application of painful or noxious stimuli, 
control of inappropriate behavior, protection of client rights and 
funds, and any other area that the committee believes need to be 
addressed.
    (4) The provisions of paragraph (f)(3) of this section may be 
modified only if, in the judgment of the State survey agency, Court 
decrees, State law or regulations provide for equivalent client 
protection and consultation.



Sec.  483.450  Condition of participation: Client behavior and facility practices.

    (a) Standard: Facility practices--Conduct toward clients. (1) The 
facility must develop and implement written policies and procedures for 
the management of conduct between staff and clients. These policies and 
procedures must--
    (i) Promote the growth, development and independence of the client;
    (ii) Address the extent to which client choice will be accommodated 
in daily decision-making, emphasizing self-determination and self-
management, to the extent possible;
    (iii) Specify client conduct to be allowed or not allowed; and
    (iv) Be available to all staff, clients, parents of minor children, 
and legal guardians.
    (2) To the extent possible, clients must participate in the 
formulation of these policies and procedures.
    (3) Clients must not discipline other clients, except as part of an 
organized

[[Page 103]]

system of self-government, as set forth in facility policy.
    (b) Standard: Management of inappropriate client behavior. (1) The 
facility must develop and implement written policies and procedures that 
govern the management of inappropriate client behavior. These policies 
and procedures must be consistent with the provisions of paragraph (a) 
of this section. These procedures must--
    (i) Specify all facility approved interventions to manage 
inappropriate client behavior;
    (ii) Designate these interventions on a hierarchy to be implemented, 
ranging from most positive or least intrusive, to least positive or most 
intrusive;
    (iii) Insure, prior to the use of more restrictive techniques, that 
the client's record documents that programs incorporating the use of 
less intrusive or more positive techniques have been tried 
systematically and demonstrated to be ineffective; and
    (iv) Address the following:
    (A) The use of time-out rooms.
    (B) The use of physical restraints.
    (C) The use of drugs to manage inappropriate behavior.
    (D) The application of painful or noxious stimuli.
    (E) The staff members who may authorize the use of specified 
interventions.
    (F) A mechanism for monitoring and controlling the use of such 
interventions.
    (2) Interventions to manage inappropriate client behavior must be 
employed with sufficient safeguards and supervision to ensure that the 
safety, welfare and civil and human rights of clients are adequately 
protected.
    (3) Techniques to manage inappropriate client behavior must never be 
used for disciplinary purposes, for the convenience of staff or as a 
substitute for an active treatment program.
    (4) The use of systematic interventions to manage inappropriate 
client behavior must be incorporated into the client's individual 
program plan, in accordance with Sec.  483.440(c) (4) and (5) of this 
subpart.
    (5) Standing or as needed programs to control inappropriate behavior 
are not permitted.
    (c) Standard: Time-out rooms. (1) A client may be placed in a room 
from which egress is prevented only if the following conditions are met:
    (i) The placement is a part of an approved systematic time-out 
program as required by paragraph (b) of this section. (Thus, emergency 
placement of a client into a time-out room is not allowed.)
    (ii) The client is under the direct constant visual supervision of 
designated staff.
    (iii) The door to the room is held shut by staff or by a mechanism 
requiring constant physical pressure from a staff member to keep the 
mechanism engaged.
    (2) Placement of a client in a time-out room must not exceed one 
hour.
    (3) Clients placed in time-out rooms must be protected from 
hazardous conditions including, but not limited to, presence of sharp 
corners and objects, uncovered light fixtures, unprotected electrical 
outlets.
    (4) A record of time-out activities must be kept.
    (d) Standard: Physical restraints. (1) The facility may employ 
physical restraint only--
    (i) As an integral part of an individual program plan that is 
intended to lead to less restrictive means of managing and eliminating 
the behavior for which the restraint is applied;
    (ii) As an emergency measure, but only if absolutely necessary to 
protect the client or others from injury; or
    (iii) As a health-related protection prescribed by a physician, but 
only if absolutely necessary during the conduct of a specific medical or 
surgical procedure, or only if absolutely necessary for client 
protection during the time that a medical condition exists.
    (2) Authorizations to use or extend restraints as an emergency must 
be:
    (i) In effect no longer than 12 consecutive hours; and
    (ii) Obtained as soon as the client is restrained or stable.
    (3) The facility must not issue orders for restraint on a standing 
or as needed basis.
    (4) A client placed in restraint must be checked at least every 30 
minutes by staff trained in the use of restraints, released from the 
restraint as quickly

[[Page 104]]

as possible, and a record of these checks and usage must be kept.
    (5) Restraints must be designed and used so as not to cause physical 
injury to the client and so as to cause the least possible discomfort.
    (6) Opportunity for motion and exercise must be provided for a 
period of not less than 10 minutes during each two hour period in which 
restraint is employed, and a record of such activity must be kept.
    (7) Barred enclosures must not be more than three feet in height and 
must not have tops.
    (e) Standard: Drug usage. (1) The facility must not use drugs in 
doses that interfere with the individual client's daily living 
activities.
    (2) Drugs used for control of inappropriate behavior must be 
approved by the interdisciplinary team and be used only as an integral 
part of the client's individual program plan that is directed 
specifically towards the reduction of and eventual elimination of the 
behaviors for which the drugs are employed.
    (3) Drugs used for control of inappropriate behavior must not be 
used until it can be justified that the harmful effects of the behavior 
clearly outweigh the potentially harmful effects of the drugs.
    (4) Drugs used for control of inappropriate behavior must be--
    (i) Monitored closely, in conjunction with the physician and the 
drug regimen review requirement at Sec.  483.460(j), for desired 
responses and adverse consequences by facility staff; and
    (ii) Gradually withdrawn at least annually in a carefully monitored 
program conducted in conjunction with the interdisciplinary team, unless 
clinical evidence justifies that this is contraindicated.



Sec.  483.460  Condition of participation: Health care services.

    (a) Standard: Physician services. (1) The facility must ensure the 
availability of physician services 24 hours a day.
    (2) The physician must develop, in coordination with licensed 
nursing personnel, a medical care plan of treatment for a client if the 
physician determines that an individual client requires 24-hour licensed 
nursing care. This plan must be integrated in the individual program 
plan.
    (3) The facility must provide or obtain preventive and general 
medical care as well as annual physical examinations of each client that 
at a minimum include the following:
    (i) Evaluation of vision and hearing.
    (ii) Immunizations, using as a guide the recommendations of the 
Public Health Service Advisory Commitee on Immunization Practices or of 
the Committee on the Control of Infectious Diseases of the American 
Academy of Pediatrics.
    (iii) Routine screening laboratory examinations as determined 
necessary by the physician, and special studies when needed.
    (iv) Tuberculosis control, appropriate to the facility's population, 
and in accordance with the recommendations of the American College of 
Chest Physicians or the section of diseases of the chest of the American 
Academy of Pediatrics, or both.
    (4) To the extent permitted by State law, the facility may utilize 
physician assistants and nurse practitioners to provide physician 
services as described in this section.
    (b) Standard: Physician participation in the individual program 
plan. A physician must participate in--
    (1) The establishment of each newly admitted client's initial 
individual program plan as required by Sec.  456.380 of this chapter 
that specified plan of care requirements for ICFs; and
    (2) If appropriate, physicians must participate in the review and 
update of an individual program plan as part of the interdisciplinary 
team process either in person or through written report to the 
interdisciplinary team.
    (c) Standard: Nursing services. The facility must provide clients 
with nursing services in accordance with their needs. These services 
must include--
    (1) Participation as appropriate in the development, review, and 
update of an individual program plan as part of the interdisciplinary 
team process;
    (2) The development, with a physician, of a medical care plan of 
treatment for a client when the physician has determined that an 
individual client requires such a plan;

[[Page 105]]

    (3) For those clients certified as not needing a medical care plan, 
a review of their health status which must--
    (i) Be by a direct physical examination;
    (ii) Be by a licensed nurse;
    (iii) Be on a quarterly or more frequent basis depending on client 
need;
    (iv) Be recorded in the client's record; and
    (v) Result in any necessary action (including referral to a 
physician to address client health problems).
    (4) Other nursing care as prescribed by the physician or as 
identified by client needs; and
    (5) Implementing, with other members of the interdisciplinary team, 
appropriate protective and preventive health measures that include, but 
are not limited to--
    (i) Training clients and staff as needed in appropriate health and 
hygiene methods;
    (ii) Control of communicable diseases and infections, including the 
instruction of other personnel in methods of infection control; and
    (iii) Training direct care staff in detecting signs and symptoms of 
illness or dysfunction, first aid for accidents or illness, and basic 
skills required to meet the health needs of the clients.
    (d) Standard: Nursing staff. (1) Nurses providing services in the 
facility must have a current license to practice in the State.
    (2) The facility must employ or arrange for licensed nursing 
services sufficient to care for clients health needs including those 
clients with medical care plans.
    (3) The facility must utilize registered nurses as appropriate and 
required by State law to perform the health services specified in this 
section.
    (4) If the facility utilizes only licensed practical or vocational 
nurses to provide health services, it must have a formal arrangement 
with a registered nurse to be available for verbal or onsite 
consultation to the licensed practical or vocational nurse.
    (5) Non-licensed nursing personnel who work with clients under a 
medical care plan must do so under the supervision of licensed persons.
    (e) Standard: Dental services. (1) The facility must provide or make 
arrangements for comprehensive diagnostic and treatment services for 
each client from qualified personnel, including licensed dentists and 
dental hygienists either through organized dental services in-house or 
through arrangement.
    (2) If appropriate, dental professionals must participate, in the 
development, review and update of an individual program plan as part of 
the interdisciplinary process either in person or through written report 
to the interdisciplinary team.
    (3) The facility must provide education and training in the 
maintenance of oral health.
    (f) Standard: Comprehensive dental diagnostic services. 
Comprehensive dental diagnostic services include--
    (1) A complete extraoral and intraoral examination, using all 
diagnostic aids necessary to properly evaluate the client's oral 
condition, not later than one month after admission to the facility 
(unless the examination was completed within twelve months before 
admission);
    (2) Periodic examination and diagnosis performed at least annually, 
including radiographs when indicated and detection of manifestations of 
systemic disease; and
    (3) A review of the results of examination and entry of the results 
in the client's dental record.
    (g) Standard: Comprehensive dental treatment. The facility must 
ensure comprehensive dental treatment services that include--
    (1) The availability for emergency dental treatment on a 24-hour-a-
day basis by a licensed dentist; and
    (2) Dental care needed for relief of pain and infections, 
restoration of teeth, and maintenance of dental health.
    (h) Standard: Documentation of dental services. (1) If the facility 
maintains an in-house dental service, the facility must keep a permanent 
dental record for each client, with a dental summary maintained in the 
client's living unit.
    (2) If the facility does not maintain an in-house dental service, 
the facility must obtain a dental summary of the results of dental 
visits and maintain

[[Page 106]]

the summary in the client's living unit.
    (i) Standard: Pharmacy services. The facility must provide or make 
arrangements for the provision of routine and emergency drugs and 
biologicals to its clients. Drugs and biologicals may be obtained from 
community or contract pharmacists or the facility may maintain a 
licensed pharmacy.
    (j) Standard: Drug regimen review. (1) A pharmacist with input from 
the interdisciplinary team must review the drug regimen of each client 
at least quarterly.
    (2) The pharmacist must report any irregularities in clients' drug 
regimens to the prescribing physician and interdisciplinary team.
    (3) The pharmacist must prepare a record of each client's drug 
regimen reviews and the facility must maintain that record.
    (4) An individual medication administration record must be 
maintained for each client.
    (5) As appropriate the pharmacist must participate in the 
development, implementation, and review of each client's individual 
program plan either in person or through written report to the 
interdisciplinary team.
    (k) Standard: Drug administration. The facility must have an 
organized system for drug administration that identifies each drug up to 
the point of administration. The system must assure that--
    (1) All drugs are administered in compliance with the physician's 
orders;
    (2) All drugs, including those that are self-administered, are 
administered without error;
    (3) Unlicensed personnel are allowed to administer drugs only if 
State law permits;
    (4) Clients are taught how to administer their own medications if 
the interdisciplinary team determines that self administration of 
medications is an appropriate objective, and if the physician does not 
specify otherwise;
    (5) The client's physician is informed of the interdisciplinary 
team's decision that self-administration of medications is an objective 
for the client;
    (6) No client self-administers medications until he or she 
demonstrates the competency to do so;
    (7) Drugs used by clients while not under the direct care of the 
facility are packaged and labeled in accordance with State law; and
    (8) Drug administration errors and adverse drug reactions are 
recorded and reported immediately to a physician.
    (l) Standard: Drug storage and recordkeeping. (1) The facility must 
store drugs under proper conditions of sanitation, temperature, light, 
humidity, and security.
    (2) The facility must keep all drugs and biologicals locked except 
when being prepared for administration. Only authorized persons may have 
access to the keys to the drug storage area. Clients who have been 
trained to self administer drugs in accordance with Sec.  483.460(k)(4) 
may have access to keys to their individual drug supply.
    (3) The facility must maintain records of the receipt and 
disposition of all controlled drugs.
    (4) The facility must, on a sample basis, periodically reconcile the 
receipt and disposition of all controlled drugs in schedules II through 
IV (drugs subject to the Comprehensive Drug Abuse Prevention and Control 
Act of 1970, 21 U.S.C. 801 et seq., as implemented by 21 CFR part 308).
    (5) If the facility maintains a licensed pharmacy, the facility must 
comply with the regulations for controlled drugs.
    (m) Standard: Drug labeling. (1) Labeling of drugs and biologicals 
must--
    (i) Be based on currently accepted professional principles and 
practices; and
    (ii) Include the appropriate accessory and cautionary instructions, 
as well as the expiration date, if applicable.
    (2) The facility must remove from use--
    (i) Outdated drugs; and
    (ii) Drug containers with worn, illegible, or missing labels.
    (3) Drugs and biologicals packaged in containers designated for a 
particular client must be immediately removed from the client's current 
medication supply if discontinued by the physician.
    (n) Standard: Laboratory services. (1) If a facility chooses to 
provide laboratory services, the laboratory must meet the

[[Page 107]]

requirements specified in part 493 of this chapter.
    (2) If the laboratory chooses to refer specimens for testing to 
another laboratory, the referral laboratory must be certified in the 
appropriate specialties and subspecialities of service in accordance 
with the requirements of part 493 of this chapter.

[53 FR 20496, June 3, 1988, as amended at 57 FR 7136, Feb. 28, 1992]



Sec.  483.470  Condition of participation: Physical environment.

    (a) Standard: Client living environment. (1) The facility must not 
house clients of grossly different ages, developmental levels, and 
social needs in close physical or social proximity unless the housing is 
planned to promote the growth and development of all those housed 
together.
    (2) The facility must not segregate clients solely on the basis of 
their physical disabilities. It must integrate clients who have 
ambulation deficits or who are deaf, blind, or have seizure disorders, 
etc., with others of comparable social and intellectual development.
    (b) Standard: Client bedrooms. (1) Bedrooms must--
    (i) Be rooms that have at least one outside wall;
    (ii) Be equipped with or located near toilet and bathing facilities;
    (iii) Accommodate no more than four clients unless granted a 
variance under paragraph (b)(3) of this section;
    (iv) Measure at least 60 square feet per client in multiple client 
bedrooms and at least 80 square feet in single client bedrooms; and
    (v) In all facilities initially certified, or in buildings 
constructed or with major renovations or conversions on or after October 
3, 1988, have walls that extend from floor to ceiling.
    (2) If a bedroom is below grade level, it must have a window that--
    (i) Is usable as a second means of escape by the client(s) occupying 
the room; and
    (ii) Is no more than 44 inches (measured to the window sill) above 
the floor unless the facility is surveyed under the Health Care 
Occupancy Chapter of the Life Safety Code, in which case the window must 
be no more than 36 inches (measured to the window sill) above the floor.
    (3) The survey agency may grant a variance from the limit of four 
clients per room only if a physician who is a member of the 
interdisciplinary team and who is a qualified mental retardation 
professional--
    (i) Certifies that each client to be placed in a bedroom housing 
more than four persons is so severely medically impaired as to require 
direct and continuous monitoring during sleeping hours; and
    (ii) Documents the reasons why housing in a room of only four or 
fewer persons would not be medically feasible.
    (4) The facility must provide each client with--
    (i) A separate bed of proper size and height for the convenience of 
the client;
    (ii) A clean, comfortable, mattress;
    (iii) Bedding appropriate to the weather and climate; and
    (iv) Functional furniture appropriate to the client's needs, and 
individual closet space in the client's bedroom with clothes racks and 
shelves accessible to the client.
    (c) Standard: Storage space in bedroom. The facility must provide--
    (1) Space and equipment for daily out-of-bed activity for all 
clients who are not yet mobile, except those who have a short-term 
illness or those few clients for whom out-of-bed activity is a threat to 
health and safety; and
    (2) Suitable storage space, accessible to clients, for personal 
possessions, such as TVs, radios, prosthetic equipment and clothing.
    (d) Standard: Client bathrooms. The facility must--
    (1) Provide toilet and bathing facilities appropriate in number, 
size, and design to meet the needs of the clients;
    (2) Provide for individual privacy in toilets, bathtubs, and 
showers; and
    (3) In areas of the facility where clients who have not been trained 
to regulate water temperature are exposed to hot water, ensure that the 
temperature of the water does not exceed 110[deg] Fahrenheit.
    (e) Standard: Heating and ventilation. (1) Each client bedroom in 
the facility must have--

[[Page 108]]

    (i) At least one window to the outside; and
    (ii) Direct outside ventilation by means of windows, air 
conditioning, or mechanical ventilation.
    (2) The facility must--
    (i) Maintain the temperature and humidity within a normal comfort 
range by heating, air conditioning or other means; and
    (ii) Ensure that the heating apparatus does not constitute a burn or 
smoke hazard to clients.
    (f) Standard: Floors. The facility must have--
    (1) Floors that have a resilient, nonabrasive, and slip-resistant 
surface;
    (2) Nonabrasive carpeting, if the area used by clients is carpeted 
and serves clients who lie on the floor or ambulate with parts of their 
bodies, other than feet, touching the floor; and
    (3) Exposed floor surfaces and floor coverings that promote mobility 
in areas used by clients, and promote maintenance of sanitary 
conditions.
    (g) Standard: Space and equipment. The facility must--
    (1) Provide sufficient space and equipment in dining, living, health 
services, recreation, and program areas (including adequately equipped 
and sound treated areas for hearing and other evaluations if they are 
conducted in the facility) to enable staff to provide clients with 
needed services as required by this subpart and as identified in each 
client's individual program plan.
    (2) Furnish, maintain in good repair, and teach clients to use and 
to make informed choices about the use of dentures, eyeglasses, hearing 
and other communications aids, braces, and other devices identified by 
the interdisciplinary team as needed by the client.
    (3) Provide adequate clean linen and dirty linen storage areas.
    (h) Standard: Emergency plan and procedures. (1) The facility must 
develop and implement detailed written plans and procedures to meet all 
potential emergencies and disasters such as fire, severe weather, and 
missing clients.
    (2) The facility must communicate, periodically review, make the 
plan available, and provide training to the staff.
    (i) Standard: Evacuation drills. (1) The facility must hold 
evacuation drills at least quarterly for each shift of personnel and 
under varied conditions to--
    (i) Ensure that all personnel on all shifts are trained to perform 
assigned tasks;
    (ii) Ensure that all personnel on all shifts are familiar with the 
use of the facility's fire protection features; and
    (iii) Evaluate the effectiveness of emergency and disaster plans and 
procedures.
    (2) The facility must--
    (i) Actually evacuate clients during at least one drill each year on 
each shift;
    (ii) Make special provisions for the evacuation of clients with 
physical disabilities;
    (iii) File a report and evaluation on each evacuation drill;
    (iv) Investigate all problems with evacuation drills, including 
accidents, and take corrective action; and
    (v) During fire drills, clients may be evacuated to a safe area in 
facilities certified under the Health Care Occupancies Chapter of the 
Life Safety Code.
    (3) Facilities must meet the requirements of paragraphs (i)(1) and 
(2) of this section for any live-in and relief staff they utilize.
    (j) Standard: Fire protection--(1) General. Except as otherwise 
provided in this section--
    (i) The facility must meet the applicable provisions of either the 
Health Care Occupancies Chapters or the Residential Board and Care 
Occupancies Chapter of the 2000 edition of the Life Safety Code of the 
National Fire Protection Association. The Director of the Office of the 
Federal Register has approved the NFPA 101 [reg] 2000 edition 
of the Life Safety Code, issued January 14, 2000, for incorporation by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy 
of the Code is available for inspection at the CMS Information Resource 
Center, 7500 Security Boulevard, Baltimore, MD or at the National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal--register/code--of--federal--
regulations/

[[Page 109]]

ibr--locations.html. Copies may be obtained from the National Fire 
Protection Association, 1 Batterymarch Park, Quincy, MA 02269. If any 
changes in this edition of the Code are incorporated by reference, CMS 
will publish notice in the Federal Register to announce the changes.
    (ii) Chapter 19.3.6.3.2, exception number 2 of the adopted LSC does 
not apply to a facility.
    (2) The State survey agency may apply a single chapter of the LSC to 
the entire facility or may apply different chapters to different 
buildings or parts of buildings as permitted by the LSC.
    (3) A facility that meets the LSC definition of a residential board 
and care occupancy must have its evacuation capability evaluated in 
accordance with the Evacuation Difficulty Index of the Fire Safety 
Evaluation System for Board and Care facilities (FSES/BC).
    (4) If CMS finds that the State has a fire and safety code imposed 
by State law that adequately protects a facility's clients, CMS may 
allow the State survey agency to apply the State's fire and safety code 
instead of the LSC.
    (5) Beginning March 13, 2006, a facility must be in compliance with 
Chapter 19.2.9, Emergency Lighting.
    (6) Beginning March 13, 2006, Chapter 19.3.6.3.2, exception number 2 
does not apply to a facility.
    (7) Facilities that meet the LSC definition of a health care 
occupancy. (i) After consideration of State survey agency 
recommendations, CMS may waive, for appropriate periods, specific 
provisions of the Life Safety Code if the following requirements are 
met:
    (A) The waiver would not adversely affect the health and safety of 
the clients.
    (B) Rigid application of specific provisions would result in an 
unreasonable hardship for the facility.
    (ii) Notwithstanding any provisions of the 2000 edition of the Life 
Safety Code to the contrary, a facility may install alcohol-based hand 
rub dispensers if--
    (A) Use of alcohol-based hand rub dispensers does not conflict with 
any State or local codes that prohibit or otherwise restrict the 
placement of alcohol-based hand rub dispensers in health care 
facilities;
    (B) The dispensers are installed in a manner that minimizes leaks 
and spills that could lead to falls;
    (C) The dispensers are installed in a manner that adequately 
protects against inappropriate access;
    (D) The dispensers are installed in accordance with chapter 18.3.2.7 
or chapter 19.3.2.7 of the 2000 edition of the Life Safety Code, as 
amended by NFPA Temporary Interim Amendment 00-1(101), issued by the 
Standards Council of the National Fire Protection Association on April 
15, 2004. The Director of the Office of the Federal Register has 
approved NFPA Temporary Interim Amendment 00-1(101) for incorporation by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy 
of the amendment is available for inspection at the CMS Information 
Resource Center, 7500 Security Boulevard, Baltimore, MD and at the 
Office of the Federal Register, 800 North Capitol Street NW., Suite 700, 
Washington, DC. Copies may be obtained from the National Fire Protection 
Association, 1 Batterymarch Park, Quincy, MA 02269; and
    (E) The dispensers are maintained in accordance with dispenser 
manufacturer guidelines.
    (k) Standard: Paint. The facility must--
    (1) Use lead-free paint inside the facility; and
    (2) Remove or cover interior paint or plaster containing lead so 
that it is not accessible to clients.
    (l) Standard: Infection control. (1) The facility must provide a 
sanitary environment to avoid sources and transmission of infections. 
There must be an active program for the prevention, control, and 
investigation of infection and communicable diseases.
    (2) The facility must implement successful corrective action in 
affected problem areas.
    (3) The facility must maintain a record of incidents and corrective 
actions related to infections.
    (4) The facility must prohibit employees with symptoms or signs of a

[[Page 110]]

communicable disease from direct contact with clients and their food.

[53 FR 20496, June 3, 1988. Redesignated at 56 FR 48918, Sept. 26, 1991, 
as amended at 68 FR 1387, Jan. 10, 2003; 69 FR 49271, Aug. 11, 2004; 70 
FR 15239, Mar. 25, 2005; 71 FR 55340, Sept. 22, 2006]



Sec.  483.480  Condition of participation: Dietetic services.

    (a) Standard: Food and nutrition services. (1) Each client must 
receive a nourishing, well-balanced diet including modified and 
specially-prescribed diets.
    (2) A qualified dietitian must be employed either full-time, part-
time, or on a consultant basis at the facility's discretion.
    (3) If a qualified dietitian is not employed full-time, the facility 
must designate a person to serve as the director of food services.
    (4) The client's interdisciplinary team, including a qualified 
dietitian and physician, must prescribe all modified and special diets 
including those used as a part of a program to manage inappropriate 
client behavior.
    (5) Foods proposed for use as a primary reinforcement of adaptive 
behavior are evaluated in light of the client's nutritional status and 
needs.
    (6) Unless otherwise specified by medical needs, the diet must be 
prepared at least in accordance with the latest edition of the 
recommended dietary allowances of the Food and Nutrition Board of the 
National Research Council, National Academy of Sciences, adjusted for 
age, sex, disability and activity.
    (b) Standard: Meal services. (1) Each client must receive at least 
three meals daily, at regular times comparable to normal mealtimes in 
the community with--
    (i) Not more than 14 hours between a substantial evening meal and 
breakfast of the following day, except on weekends and holidays when a 
nourishing snack is provided at bedtime, 16 hours may elapse between a 
substantial evening meal and breakfast; and
    (ii) Not less than 10 hours between breakfast and the evening meal 
of the same day, except as provided under paragraph (b)(1)(i) of this 
section.
    (2) Food must be served--
    (i) In appropriate quantity;
    (ii) At appropriate temperature;
    (iii) In a form consistent with the developmental level of the 
client; and
    (iv) With appropriate utensils.
    (3) Food served to clients individually and uneaten must be 
discarded.
    (c) Standard: Menus. (1) Menus must--
    (i) Be prepared in advance;
    (ii) Provide a variety of foods at each meal;
    (iii) Be different for the same days of each week and adjusted for 
seasonal changes; and
    (iv) Include the average portion sizes for menu items.
    (2) Menus for food actually served must be kept on file for 30 days.
    (d) Standard: Dining areas and service. The facility must--
    (1) Serve meals for all clients, including persons with ambulation 
deficits, in dining areas, unless otherwise specified by the 
interdisciplinary team or a physician;
    (2) Provide table service for all clients who can and will eat at a 
table, including clients in wheelchairs;
    (3) Equip areas with tables, chairs, eating utensils, and dishes 
designed to meet the developmental needs of each client;
    (4) Supervise and staff dining rooms adequately to direct self-help 
dining procedure, to assure that each client receives enough food and to 
assure that each client eats in a manner consistent with his or her 
developmental level: and
    (5) Ensure that each client eats in an upright position, unless 
otherwise specified by the interdisciplinary team or a physician.



PART 484_HOME HEALTH SERVICES--Table of Contents




                      Subpart A_General Provisions

Sec.
484.1 Basis and scope.
484.2 Definitions.
484.4 Personnel qualifications.

                        Subpart B_Administration

484.10 Condition of participation: Patient rights.
484.11 Condition of participation: Release of patient identifiable OASIS 
          information.
484.12 Condition of participation: Compliance with Federal, State, and 
          local laws,

[[Page 111]]

          disclosure and ownership information, and accepted 
          professional standards and principles.
484.14 Condition of participation: Organization, services, and 
          administration.
484.16 Condition of participation: Group of professional personnel.
484.18 Condition of participation: Acceptance of patients, plan of care, 
          and medical supervision.
484.20 Condition of participation: Reporting OASIS information.

                    Subpart C_Furnishing of Services

484.30 Condition of participation: Skilled nursing services.
484.32 Condition of participation: Therapy services.
484.34 Condition of participation: Medical social services.
484.36 Condition of participation: Home health aide services.
484.38 Condition of participation: Qualifying to furnish outpatient 
          physical therapy or speech pathology services.
484.48 Condition of participation: Clinical records.
484.52 Condition of participation: Evaluation of the agency's program.
484.55 Condition of participation: Comprehensive assessment of patients.

Subpart D [Reserved]

      Subpart E_Prospective Payment System for Home Health Agencies

484.200 Basis and scope.
484.202 Definitions.
484.205 Basis of payment.
484.210 Data used for the calculation of the national prospective 60-day 
          episode payment.
484.215 Initial establishment of the calculation of the national 60-day 
          episode payment.
484.220 Calculation of the national adjusted prospective 60-day episode 
          payment rate for case-mix and area wage levels.
484.225 Annual update of the national adjusted prospective 60-day 
          episode payment rate.
484.230 Methodology used for the calculation of the low-utilization 
          payment adjustment.
484.235 Methodology used for the calculation of the partial episode 
          payment adjustment.
484.240 Methodology used for the calculation of the outlier payment.
484.245 Accelerated payments for home health agencies.
484.250 Patient assessment data.
484.260 Limitation on review.
484.265 Additional payment.

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 
1302 and 1395(hh)) unless otherwise indicated.

    Source: 54 FR 33367, Aug. 14, 1989, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  484.1  Basis and scope.

    (a) Basis and scope. This part is based on the indicated provisions 
of the following sections of the Act:
    (1) Sections 1861(o) and 1891 establish the conditions that an HHA 
must meet in order to participate in Medicare.
    (2) Section 1861(z) specifies the Institutional planning standards 
that HHAs must meet.
    (3) Section 1895 provides for the establishment of a prospective 
payment system for home health services covered under Medicare.
    (b) This part also sets forth additional requirements that are 
considered necessary to ensure the health and safety of patients.

[60 FR 50443, Sept. 29, 1995, as amended at 65 FR 41211, July 3, 2000]



Sec.  484.2  Definitions.

    As used in this part, unless the context indicates otherwise--Bylaws 
or equivalent means a set of rules adopted by an HHA for governing the 
agency's operation.
    Branch office means a location or site from which a home health 
agency provides services within a portion of the total geographic area 
served by the parent agency. The branch office is part of the home 
health agency and is located sufficiently close to share administration, 
supervision, and services in a manner that renders it unnecessary for 
the branch independently to meet the conditions of participation as a 
home health agency.
    Clinical note means a notation of a contact with a patient that is 
written and dated by a member of the health team, and that describes 
signs and symptoms, treatment and drugs administered and the patient's 
reaction, and any changes in physical or emotional condition.
    HHA stands for home health agency.
    Nonprofit agency means an agency exempt from Federal income taxation

[[Page 112]]

under section 501 of the Internal Revenue Code of 1954.
    Parent home health agency means the agency that develops and 
maintains administrative controls of subunits and/or branch offices.
    Primary home health agency means the agency that is responsible for 
the services furnished to patients and for implementation of the plan of 
care.
    Progress note means a written notation, dated and signed by a member 
of the health team, that summarizes facts about care furnished and the 
patient's response during a given period of time.
    Proprietary agency means a private profit-making agency licensed by 
the State.
    Public agency means an agency operated by a State or local 
government.
    Subdivision means a component of a multi-function health agency, 
such as the home care department of a hospital or the nursing division 
of a health department, which independently meets the conditions of 
participation for HHAs. A subdivision that has subunits or branch 
offices is considered a parent agency.
    Subunit means a semi-autonomous organization that--
    (1) Serves patients in a geographic area different from that of the 
parent agency; and
    (2) Must independently meet the conditions of participation for HHAs 
because it is too far from the parent agency to share administration, 
supervision, and services on a daily basis.
    Summary report means the compilation of the pertinent factors of a 
patient's clinical notes and progress notes that is submitted to the 
patient's physician.
    Supervision means authoritative procedural guidance by a qualified 
person for the accomplishment of a function or activity. Unless 
otherwise specified in this part, the supervisor must be on the premises 
to supervise an individual who does not meet the qualifications 
specified in Sec.  484.4.



Sec.  484.4  Personnel qualifications.

    Staff required to meet the conditions set forth in this part are 
staff who meet the qualifications specified in this section.
    Administrator, home health agency. A person who:
    (a) Is a licensed physician; or
    (b) Is a registered nurse; or
    (c) Has training and experience in health service administration and 
at least 1 year of supervisory or administrative experience in home 
health care or related health programs.
    Audiologist. A person who:
    (a) Meets the education and experience requirements for a 
Certificate of Clinical Competence in audiology granted by the American 
Speech-Language-Hearing Association; or
    (b) Meets the educational requirements for certification and is in 
the process of accumulating the supervised experience required for 
certification.
    Home health aide. Effective for services furnished after August 14, 
1990, a person who has successfully completed a State-established or 
other training program that meets the requirements of Sec.  484.36(a) 
and a competency evaluation program or State licensure program that 
meets the requirements of Sec.  484.36 (b) or (e), or a competency 
evaluation program or State licensure program that meets the 
requirements of Sec.  484.36 (b) or (e). An individual is not considered 
to have completed a training and competency evaluation program, or a 
competency evaluation program if, since the individual's most recent 
completion of this program(s), there has been a continuous period of 24 
consecutive months during none of which the individual furnished 
services described in Sec.  409.40 of this chapter for compensation.
    Occupational therapist. A person who--
    (a)(1) Is licensed or otherwise regulated, if applicable, as an 
occupational therapist by the State in which practicing, unless 
licensure does not apply;
    (2) Graduated after successful completion of an occupational 
therapist education program accredited by the Accreditation Council for 
Occupational Therapy Education (ACOTE) of the American Occupational 
Therapy Association, Inc. (AOTA), or successor organizations of ACOTE; 
and
    (3) Is eligible to take, or has successfully completed the entry-
level certification examination for occupational therapists developed 
and administered

[[Page 113]]

by the National Board for Certification in Occupational Therapy, Inc. 
(NBCOT).
    (b) On or before December 31, 2009--
    (1) Is licensed or otherwise regulated, if applicable, as an 
occupational therapist by the State in which practicing; or
    (2) When licensure or other regulation does not apply--
    (i) Graduated after successful completion of an occupational 
therapist education program accredited by the Accreditation Council for 
Occupational Therapy Education (ACOTE) of the American Occupational 
Therapy Association, Inc. (AOTA) or successor organizations of ACOTE; 
and
    (ii) Is eligible to take, or has successfully completed the entry-
level certification examination for occupational therapists developed 
and administered by the National Board for Certification in Occupational 
Therapy, Inc., (NBCOT).
    (c) On or before January 1, 2008--
    (1) Graduated after successful completion of an occupational therapy 
program accredited jointly by the committee on Allied Health Education 
and Accreditation of the American Medical Association and the American 
Occupational Therapy Association; or
    (2) Is eligible for the National Registration Examination of the 
American Occupational Therapy Association or the National Board for 
Certification in Occupational Therapy.
    (d) On or before December 31, 1977--
    (1) Had 2 years of appropriate experience as an occupational 
therapist; and
    (2) Had achieved a satisfactory grade on an occupational therapist 
proficiency examination conducted, approved, or sponsored by the U.S. 
Public Health Service.
    (e) If educated outside the United States, must meet all of the 
following:
    (1) Graduated after successful completion of an occupational 
therapist education program accredited as substantially equivalent to 
occupational therapist entry level education in the United States by one 
of the following:
    (i) The Accreditation Council for Occupational Therapy Education 
(ACOTE).
    (ii) Successor organizations of ACOTE.
    (iii) The World Federation of Occupational Therapists.
    (iv) A credentialing body approved by the American Occupational 
Therapy Association.
    (2) Successfully completed the entry-level certification examination 
for occupational therapists developed and administered by the National 
Board for Certification in Occupational Therapy, Inc. (NBCOT).
    (3) On or before December 31, 2009, is licensed or otherwise 
regulated, if applicable, as an occupational therapist by the State in 
which practicing.
    Occupational therapy assistant. A person who--
    (a) Meets all of the following:
    (1) Is licensed, unless licensure does not apply, or otherwise 
regulated, if applicable, as an occupational therapy assistant by the 
State in which practicing.
    (2) Graduated after successful completion of an occupational therapy 
assistant education program accredited by the Accreditation Council for 
Occupational Therapy Education, (ACOTE) of the American Occupational 
Therapy Association, Inc. (AOTA) or its successor organizations.
    (3) Is eligible to take or successfully completed the entry-level 
certification examination for occupational therapy assistants developed 
and administered by the National Board for Certification in Occupational 
Therapy, Inc. (NBCOT).
    (b) On or before December 31, 2009--
    (1) Is licensed or otherwise regulated as an occupational therapy 
assistant, if applicable, by the State in which practicing; or any 
qualifications defined by the State in which practicing, unless 
licensure does not apply; or
    (2) Must meet both of the following:
    (i) Completed certification requirements to practice as an 
occupational therapy assistant established by a credentialing 
organization approved by the American Occupational Therapy Association.
    (ii) After January 1, 2010, meets the requirements in paragraph (a) 
of this section.
    (c) After December 31, 1977 and on or before December 31, 2007--
    (1) Completed certification requirements to practice as an 
occupational

[[Page 114]]

therapy assistant established by a credentialing organization approved 
by the American Occupational Therapy Association; or
    (2) Completed the requirements to practice as an occupational 
therapy assistant applicable in the State in which practicing.
    (d) On or before December 31, 1977--
    (1) Had 2 years of appropriate experience as an occupational therapy 
assistant; and
    (2) Had achieved a satisfactory grade on an occupational therapy 
assistant proficiency examination conducted, approved, or sponsored by 
the U.S. Public Health Service.
    (e) If educated outside the United States, on or after January 1, 
2008--
    (1) Graduated after successful completion of an occupational therapy 
assistant education program that is accredited as substantially 
equivalent to occupational therapist assistant entry level education in 
the United States by--
    (i) The Accreditation Council for Occupational Therapy Education 
(ACOTE).
    (ii) Its successor organizations.
    (iii) The World Federation of Occupational Therapists.
    (iv) By a credentialing body approved by the American Occupational 
Therapy Association; and
    (2) Successfully completed the entry-level certification examination 
for occupational therapy assistants developed and administered by the 
National Board for Certification in Occupational Therapy, Inc. (NBCOT).
    Physical therapist. A person who is licensed, if applicable, by the 
State in which practicing, unless licensure does not apply and meets one 
of the following requirements:
    (a)(1) Graduated after successful completion of a physical therapist 
education program approved by one of the following:
    (i) The Commission on Accreditation in Physical Therapy Education 
(CAPTE).
    (ii) Successor organizations of CAPTE.
    (iii) An education program outside the United States determined to 
be substantially equivalent to physical therapist entry-level education 
in the United States by a credentials evaluation organization approved 
by the American Physical Therapy Association or an organization 
identified in 8 CFR 212.15(e) as it relates to physical therapists; and
    (2) Passed an examination for physical therapists approved by the 
State in which physical therapy services are provided.
    (b) On or before December 31, 2009--
    (1) Graduated after successful completion of a physical therapy 
curriculum approved by the Commission on Accreditation in Physical 
Therapy Education (CAPTE); or
    (2) Meets both of the following:
    (i) Graduated after successful completion of an education program 
determined to be substantially equivalent to physical therapist entry 
level education in the United States by a credentials evaluation 
organization approved by the American Physical Therapy Association or 
identified in 8 CFR 212.15(e) as it relates to physical therapists.
    (ii) Passed an examination for physical therapists approved by the 
State in which physical therapy services are provided.
    (c) Before January 1, 2008--
    (1) Graduated from a physical therapy curriculum approved by one of 
the following:
    (i) The American Physical Therapy Association.
    (ii) The Committee on Allied Health Education and Accreditation of 
the American Medical Association.
    (iii) The Council on Medical Education of the American Medical 
Association and the American Physical Therapy Association.
    (d) On or before December 31, 1977 was licensed or qualified as a 
physical therapist and meets both of the following:
    (1) Has 2 years of appropriate experience as a physical therapist.
    (2) Has achieved a satisfactory grade on a proficiency examination 
conducted, approved, or sponsored by the U.S. Public Health Service.
    (e) Before January 1, 1966--
    (1) Was admitted to membership by the American Physical Therapy 
Association; or

[[Page 115]]

    (2) Was admitted to registration by the American Registry of 
Physical Therapists; or
    (3) Has graduated from a physical therapy curriculum in a 4-year 
college or university approved by a State department of education.
    (f) Before January 1, 1966 was licensed or registered, and before 
January 1, 1970, had 15 years of full-time experience in the treatment 
of illness or injury through the practice of physical therapy in which 
services were rendered under the order and direction of attending and 
referring doctors of medicine or osteopathy.
    (g) If trained outside the United States before January 1, 2008, 
meets the following requirements:
    (1) Was graduated since 1928 from a physical therapy curriculum 
approved in the country in which the curriculum was located and in which 
there is a member organization of the World Confederation for Physical 
Therapy.
    (2) Meets the requirements for membership in a member organization 
of the World Confederation for Physical Therapy.
    Physical therapist assistant. A person who is licensed, unless 
licensure does not apply, registered, or certified as a physical 
therapist assistant, if applicable, by the State in which practicing, 
and meets one of the following requirements:
    (a)(1) Graduated from a physical therapist assistant curriculum 
approved by the Commission on Accreditation in Physical Therapy 
Education of the American Physical Therapy Association; or if educated 
outside the United States or trained in the United States military, 
graduated from an education program determined to be substantially 
equivalent to physical therapist assistant entry level education in the 
United States by a credentials evaluation organization approved by the 
American Physical Therapy Association or identified at 8 CFR 212.15(e); 
and
    (2) Passed a national examination for physical therapist assistants.
    (b) On or before December 31, 2009, meets one of the following:
    (1) Is licensed, or otherwise regulated in the State in which 
practicing.
    (2) In States where licensure or other regulations do not apply, 
graduated on or before December 31, 2009, from a 2-year college-level 
program approved by the American Physical Therapy Association and, 
effective January 1, 2010 meets the requirements of paragraph (a) of 
this definition.
    (c) Before January 1, 2008, where licensure or other regulation does 
not apply, graduated from a 2-year college-level program approved by the 
American Physical Therapy Association.
    (d) On or before December 31, 1977, was licensed or qualified as a 
physical therapist assistant and has achieved a satisfactory grade on a 
proficiency examination conducted, approved, or sponsored by the U.S. 
Public Health Service.
    Physician. A doctor of medicine, osteophathy or podiatry legally 
authorized to practice medicine and surgery by the State in which such 
function or action is performed.
    Practical (vocational) nurse. A person who is licensed as a 
practical (vocational) nurse by the State in which practicing.
    Public health nurse. A registered nurse who has completed a 
baccalaureate degree program approved by the National League for Nursing 
for public health nursing preparation or postregistered nurse study that 
includes content aproved by the National League for Nursing for public 
health nursing preparation.
    Registered nurse (RN). A graduate of an approved school of 
professional nursing, who is licensed as a registered nurse by the State 
in which practicing.
    Social work assistant. A person who:
    (1) Has a baccalaureate degree in social work, psychology, 
sociology, or other field related to social work, and has had at least 1 
year of social work experience in a health care setting; or
    (2) Has 2 years of appropriate experience as a social work 
assistant, and has achieved a satisfactory grade on a proficiency 
examination conducted, approved, or sponsored by the U.S. Public Health 
Service, except that these determinations of proficiency do not apply 
with respect to persons initially licensed by a State or seeking initial 
qualification as a social work assistant after December 31, 1977.

[[Page 116]]

    Social worker. A person who has a master's degree from a school of 
social work accredited by the Council on Social Work Education, and has 
1 year of social work experience in a health care setting.
    Speech-language pathologist. A person who meets either of the 
following requirements:
    (a) The education and experience requirements for a Certificate of 
Clinical Competence in speech-language pathology granted by the American 
Speech-Language-Hearing Association.
    (b) The educational requirements for certification and is in the 
process of accumulating the supervised experience required for 
certification.

[54 FR 33367, August 14, 1989, as amended at 56 FR 32973, July 18, 1991; 
69 FR 66426, Nov. 15, 2004; 72 FR 66406, Nov. 27, 2007; 73 FR 2433, Jan. 
15, 2008]



                        Subpart B_Administration



Sec.  484.10  Condition of participation: Patient rights.

    The patient has the right to be informed of his or her rights. The 
HHA must protect and promote the exercise of these rights.
    (a) Standard: Notice of rights. (1) The HHA must provide the patient 
with a written notice of the patient's rights in advance of furnishing 
care to the patient or during the initial evaluation visit before the 
initiation of treatment.
    (2) The HHA must maintain documentation showing that it has complied 
with the requirements of this section.
    (b) Standard: Exercise of rights and respect for property and 
person. (1) The patient has the right to exercise his or her rights as a 
patient of the HHA.
    (2) The patient's family or guardian may exercise the patient's 
rights when the patient has been judged incompetent.
    (3) The patient has the right to have his or her property treated 
with respect.
    (4) The patient has the right to voice grievances regarding 
treatment or care that is (or fails to be) furnished, or regarding the 
lack of respect for property by anyone who is furnishing services on 
behalf of the HHA and must not be subjected to discrimination or 
reprisal for doing so.
    (5) The HHA must investigate complaints made by a patient or the 
patient's family or guardian regarding treatment or care that is (or 
fails to be) furnished, or regarding the lack of respect for the 
patient's property by anyone furnishing services on behalf of the HHA, 
and must document both the existence of the complaint and the resolution 
of the complaint.
    (c) Standard: Right to be informed and to participate in planning 
care and treatment. (1) The patient has the right to be informed, in 
advance about the care to be furnished, and of any changes in the care 
to be furnished.
    (i) The HHA must advise the patient in advance of the disciplines 
that will furnish care, and the frequency of visits proposed to be 
furnished.
    (ii) The HHA must advise the patient in advance of any change in the 
plan of care before the change is made.
    (2) The patient has the right to participate in the planning of the 
care.
    (i) The HHA must advise the patient in advance of the right to 
participate in planning the care or treatment and in planning changes in 
the care or treatment.
    (ii) The HHA complies with the requirements of subpart I of part 489 
of this chapter relating to maintaining written policies and procedures 
regarding advance directives. The HHA must inform and distribute written 
information to the patient, in advance, concerning its policies on 
advance directives, including a description of applicable State law. The 
HHA may furnish advance directives information to a patient at the time 
of the first home visit, as long as the information is furnished before 
care is provided.
    (d) Standard: Confidentiality of medical records. The patient has 
the right to confidentiality of the clinical records maintained by the 
HHA. The HHA must advise the patient of the agency's policies and 
procedures regarding disclosure of clinical records.
    (e) Standard: Patient liability for payment. (1) The patient has the 
right to be advised, before care is initiated, of the extent to which 
payment for the HHA services may be expected from

[[Page 117]]

Medicare or other sources, and the extent to which payment may be 
required from the patient. Before the care is initiated, the HHA must 
inform the patient, orally and in writing, of--
    (i) The extent to which payment may be expected from Medicare, 
Medicaid, or any other Federally funded or aided program known to the 
HHA;
    (ii) The charges for services that will not be covered by Medicare; 
and
    (iii) The charges that the individual may have to pay.
    (2) The patient has the right to be advised orally and in writing of 
any changes in the information provided in accordance with paragraph 
(e)(1) of this section when they occur. The HHA must advise the patient 
of these changes orally and in writing as soon as possible, but no later 
than 30 calendar days from the date that the HHA becomes aware of a 
change.
    (f) Standard: Home health hotline. The patient has the right to be 
advised of the availability of the toll-free HHA hotline in the State. 
When the agency accepts the patient for treatment or care, the HHA must 
advise the patient in writing of the telephone number of the home health 
hotline established by the State, the hours of its operation, and that 
the purpose of the hotline is to receive complaints or questions about 
local HHAs. The patient also has the right to use this hotline to lodge 
complaints concerning the implementation of the advance directives 
requirements.

[54 FR 33367, August 14, 1989, as amended at 56 FR 32973, July 18, 1991; 
57 FR 8203, Mar. 6, 1992; 60 FR 33293, June 27, 1995]



Sec.  484.11  Condition of participation: Release of patient identifiable OASIS information.

    The HHA and agent acting on behalf of the HHA in accordance with a 
written contract must ensure the confidentiality of all patient 
identifiable information contained in the clinical record, including 
OASIS data, and may not release patient identifiable OASIS information 
to the public.

[64 FR 3763, Jan. 25, 1999]



Sec.  484.12  Condition of participation: Compliance with Federal, State, and local laws, disclosure and ownership information, and accepted professional 
          standards and principles.

    (a) Standard: Compliance with Federal, State, and local laws and 
regulations. The HHA and its staff must operate and furnish services in 
compliance with all applicable Federal, State, and local laws and 
regulations. If State or applicable local law provides for the licensure 
of HHAs, an agency not subject to licensure is approved by the licensing 
authority as meeting the standards established for licensure.
    (b) Standard: Disclosure of ownership and management information. 
The HHA must comply with the requirements of Part 420, Subpart C of this 
chapter. The HHA also must disclose the following information to the 
State survey agency at the time of the HHA's initial request for 
certification, for each survey, and at the time of any change in 
ownership or management:
    (1) The name and address of all persons with an ownership or control 
interest in the HHA as defined in Sec. Sec.  420.201, 420.202, and 
420.206 of this chapter.
    (2) The name and address of each person who is an officer, a 
director, an agent or a managing employee of the HHA as defined in 
Sec. Sec.  420.201, 420.202, and 420.206 of this chapter.
    (3) The name and address of the corporation, association, or other 
company that is responsible for the management of the HHA, and the name 
and address of the chief executive officer and the chairman of the board 
of directors of that corporation, association, or other company 
responsible for the management of the HHA.
    (c) Standard: Compliance with accepted professional standards and 
principles. The HHA and its staff must comply with accepted professional 
standards and principles that apply to professionals furnishing services 
in an HHA.

[[Page 118]]



Sec.  484.14  Condition of participation: Organization, services, and administration.

    Organization, services furnished, administrative control, and lines 
of authority for the delegation of responsibility down to the patient 
care level are clearly set forth in writing and are readily 
identifiable. Administrative and supervisory functions are not delegated 
to another agency or organization and all services not furnished 
directly, including services provided through subunits are monitored and 
controlled by the parent agency. If an agency has subunits, appropriate 
administrative records are maintained for each subunit.
    (a) Standard: Services furnished. Part-time or intermittent skilled 
nursing services and at least one other therapeutic service (physical, 
speech, or occupational therapy; medical social services; or home health 
aide services) are made available on a visiting basis, in a place of 
residence used as a patient's home. An HHA must provide at least one of 
the qualifying services directly through agency employees, but may 
provide the second qualifying service and additional services under 
arrangements with another agency or organization.
    (b) Standard: Governing body. A governing body (or designated 
persons so functioning) assumes full legal authority and responsibility 
for the operation of the agency. The governing body appoints a qualified 
administrator, arranges for professional advice as required under Sec.  
484.16, adopts and periodically reviews written bylaws or an acceptable 
equivalent, and oversees the management and fiscal affairs of the 
agency.
    (c) Standard: Administrator. The administrator, who may also be the 
supervising physician or registered nurse required under paragraph (d) 
of this section, organizes and directs the agency's ongoing functions; 
maintains ongoing liaison among the governing body, the group of 
professional personnel, and the staff; employs qualified personnel and 
ensures adequate staff education and evaluations; ensures the accuracy 
of public information materials and activities; and implements an 
effective budgeting and accounting system. A qualified person is 
authorized in writing to act in the absence of the administrator.
    (d) Standard: Supervising physician or registered nurse. The skilled 
nursing and other therapeutic services furnished are under the 
supervision and direction of a physician or a registered nurse (who 
preferably has at least 1 year of nursing experience and is a public 
health nurse). This person, or similarly qualified alternate, is 
available at all times during operating hours and participates in all 
activities relevant to the professional services furnished, including 
the development of qualifications and the assignment of personnel.
    (e) Standard: Personnel policies. Personnel practices and patient 
care are supported by appropriate, written personnel policies. Personnel 
records include qualifications and licensure that are kept current.
    (f) Standard: Personnel under hourly or per visit contracts. If 
personnel under hourly or per visit contracts are used by the HHA, there 
is a written contract between those personnel and the agency that 
specifies the following:
    (1) Patients are accepted for care only by the primary HHA.
    (2) The services to be furnished.
    (3) The necessity to conform to all applicable agency policies, 
including personnel qualifications.
    (4) The responsibility for participating in developing plans of 
care.
    (5) The manner in which services will be controlled, coordinated, 
and evaluated by the primary HHA.
    (6) The procedures for submitting clinical and progress notes, 
scheduling of visits, periodic patient evaluation.
    (7) The procedures for payment for services furnished under the 
contract.
    (g) Standard: Coordination of patient services. All personnel 
furnishing services maintain liaison to ensure that their efforts are 
coordinated effectively and support the objectives outlined in the plan 
of care. The clinical record or minutes of case conferences establish 
that effective interchange, reporting, and coordination of patient care 
does occur. A written summary report for each patient is sent to the 
attending physician at least every 60 days.

[[Page 119]]

    (h) Standard: Services under arrangements. Services furnished under 
arrangements are subject to a written contract conforming with the 
requirements specified in paragraph (f) of this section and with the 
requirements of section 1861(w) of the Act (42 U.S.C. 1495x(w)).
    (i) Standard: Institutional planning. The HHA, under the direction 
of the governing body, prepares an overall plan and a budget that 
includes an annual operating budget and capital expenditure plan.
    (1) Annual operating budget. There is an annual operating budget 
that includes all anticipated income and expenses related to items that 
would, under generally accepted accounting principles, be considered 
income and expense items. However, it is not required that there be 
prepared, in connection with any budget, an item by item identification 
of the components of each type of anticipated income or expense.
    (2) Capital expenditure plan. (i) There is a capital expenditure 
plan for at least a 3-year period, including the operating budget year. 
The plan includes and identifies in detail the anticipated sources of 
financing for, and the objectives of, each anticipated expenditure of 
more than $600,000 for items that would under generally accepted 
accounting principles, be considered capital items. In determining if a 
single capital expenditure exceeds $600,000, the cost of studies, 
surveys, designs, plans, working drawings, specifications, and other 
activities essential to the acquisition, improvement, modernization, 
expansion, or replacement of land, plant, building, and equipment are 
included. Expenditures directly or indirectly related to capital 
expenditures, such as grading, paving, broker commissions, taxes 
assessed during the construction period, and costs involved in 
demolishing or razing structures on land are also included. Transactions 
that are separated in time, but are components of an overall plan or 
patient care objective, are viewed in their entirety without regard to 
their timing. Other costs related to capital expenditures include title 
fees, permit and license fees, broker commissions, architect, legal, 
accounting, and appraisal fees; interest, finance, or carrying charges 
on bonds, notes and other costs incurred for borrowing funds.
    (ii) If the anticipated source of financing is, in any part, the 
anticipated payment from title V (Maternal and Child Health and Crippled 
Children's Services) or title XVIII (Medicare) or title XIX (Medicaid) 
of the Social Security Act, the plan specifies the following:
    (A) Whether the proposed capital expenditure is required to comform, 
or is likely to be required to conform, to current standards, criteria, 
or plans developed in accordance with the Public Health Service Act or 
the Mental Retardation Facilities and Community Mental Health Centers 
Construction Act of 1963.
    (B) Whether a capital expenditure proposal has been submitted to the 
designated planning agency for approval in accordance with section 1122 
of the Act (42 U.S.C. 1320a-1) and implementing regulations.
    (C) Whether the designated planning agency has approved or 
disapproved the proposed capital expenditure if it was presented to that 
agency.
    (3) Preparation of plan and budget. The overall plan and budget is 
prepared under the direction of the governing body of the HHA by a 
committee consisting of representatives of the governing body, the 
administrative staff, and the medical staff (if any) of the HHA.
    (4) Annual review of plan and budget. The overall plan and budget is 
reviewed and updated at least annually by the committee referred to in 
paragraph (i)(3) of this section under the direction of the governing 
body of the HHA.
    (j) Standard: Laboratory services. (1) If the HHA engages in 
laboratory testing outside of the context of assisting an individual in 
self-administering a test with an appliance that has been cleared for 
that purpose by the FDA, such testing must be in compliance with all 
applicable requirements of part 493 of this chapter.
    (2) If the HHA chooses to refer specimens for laboratory testing to 
another laboratory, the referral laboratory must be certified in the 
appropriate

[[Page 120]]

specialties and subspecialties of services in accordance with the 
applicable requirements of part 493 of this chapter.

[54 FR 33367, August 14, 1989, as amended at 56 FR 32973, July 18, 1991; 
56 FR 51334, Oct. 11, 1991; 57 FR 7136, Feb. 28, 1992; 66 FR 32778, June 
18, 2001]



Sec.  484.16  Condition of participation: Group of professional personnel.

    A group of professional personnel, which includes at least one 
physician and one registered nurse (preferably a public health nurse), 
and with appropriate representation from other professional disciplines, 
establishes and annually reviews the agency's policies governing scope 
of services offered, admission and discharge policies, medical 
supervision and plans of care, emergency care, clinical records, 
personnel qualifications, and program evaluation. At least one member of 
the group is neither an owner nor an employee of the agency.
    (a) Standard: Advisory and evaluation function. The group of 
professional personnel meets frequently to advise the agency on 
professional issues, to participate in the evaluation of the agency's 
program, and to assist the agency in maintaining liaison with other 
health care providers in the community and in the agency's community 
information program. The meetings are documented by dated minutes.

[54 FR 33367, August 14, 1989, as amended at 56 FR 32974, July 18, 1991]



Sec.  484.18  Condition of participation: Acceptance of patients, plan of care, and medical supervision.

    Patients are accepted for treatment on the basis of a reasonable 
expectation that the patient's medical, nursing, and social needs can be 
met adequately by the agency in the patient's place of residence. Care 
follows a written plan of care established and periodically reviewed by 
a doctor of medicine, osteopathy, or podiatric medicine.
    (a) Standard: Plan of care. The plan of care developed in 
consultation with the agency staff covers all pertinent diagnoses, 
including mental status, types of services and equipment required, 
frequency of visits, prognosis, rehabilitation potential, functional 
limitations, activities permitted, nutritional requirements, medications 
and treatments, any safety measures to protect against injury, 
instructions for timely discharge or referral, and any other appropriate 
items. If a physician refers a patient under a plan of care that cannot 
be completed until after an evaluation visit, the physician is consulted 
to approve additions or modifications to the original plan. Orders for 
therapy services include the specific procedures and modalities to be 
used and the amount, frequency, and duration. The therapist and other 
agency personnel participate in developing the plan of care.
    (b) Standard: Periodic review of plan of care. The total plan of 
care is reviewed by the attending physician and HHA personnel as often 
as the severity of the patient's condition requires, but at least once 
every 60 days or more frequently when there is a beneficiary elected 
transfer; a significant change in condition resulting in a change in the 
case-mix assignment; or a discharge and return to the same HHA during 
the 60-day episode. Agency professional staff promptly alert the 
physician to any changes that suggest a need to alter the plan of care.
    (c) Standard: Conformance with physician orders. Drugs and 
treatments are administered by agency staff only as ordered by the 
physician with the exception of influenza and pneumococcal 
polysaccharide vaccines, which may be administered per agency policy 
developed in consultation with a physician, and after an assessment for 
contraindications. Verbal orders are put in writing and signed and dated 
with the date of receipt by the registered nurse or qualified therapist 
(as defined in Sec.  484.4 of this chapter) responsible for furnishing 
or supervising the ordered services. Verbal orders are only accepted by 
personnel authorized to do so by applicable State and Federal laws and 
regulations as well as by the HHA's internal policies.

[54 FR 33367, August 14, 1989, as amended at 56 FR 32974, July 18, 1991; 
64 FR 3784, Jan. 25, 1999; 65 FR 41211, July 3, 2000; 67 FR 61814, Oct. 
2, 2002]

[[Page 121]]



Sec.  484.20  Condition of participation: Reporting OASIS information.

    HHAs must electronically report all OASIS data collected in 
accordance with Sec.  484.55.
    (a) Standard: Encoding and transmitting OASIS data. An HHA must 
encode and electronically transmit each completed OASIS assessment to 
the State agency or the CMS OASIS contractor, regarding each beneficiary 
with respect to which such information is required to be transmitted (as 
determined by the Secretary), within 30 days of completing the 
assessment of the beneficiary.
    (b) Standard: Accuracy of encoded OASIS data. The encoded OASIS data 
must accurately reflect the patient's status at the time of assessment.
    (c) Standard: Transmittal of OASIS data. An HHA must--
    (1) For all completed assessments, transmit OASIS data in a format 
that meets the requirements of paragraph (d) of this section.
    (2) Successfully transmit test data to the State agency or CMS OASIS 
contractor.
    (3) Transmit data using electronics communications software that 
provides a direct telephone connection from the HHA to the State agency 
or CMS OASIS contractor.
    (4) Transmit data that includes the CMS-assigned branch 
identification number, as applicable.
    (d) Standard: Data Format. The HHA must encode and transmit data 
using the software available from CMS or software that conforms to CMS 
standard electronic record layout, edit specifications, and data 
dictionary, and that includes the required OASIS data set.

[64 FR 3763, Jan. 25, 1999, as amended at 70 FR 76208, Dec. 23, 2005]



                    Subpart C_Furnishing of Services



Sec.  484.30  Condition of participation: Skilled nursing services.

    The HHA furnishes skilled nursing services by or under the 
supervision of a registered nurse and in accordance with the plan of 
care.
    (a) Standard: Duties of the registered nurse. The registered nurse 
makes the initial evaluation visit, regularly reevaluates the patient's 
nursing needs, initiates the plan of care and necessary revisions, 
furnishes those services requiring substantial and specialized nursing 
skill, initiates appropriate preventive and rehabilitative nursing 
procedures, prepares clinical and progress notes, coordinates services, 
informs the physician and other personnel of changes in the patient's 
condition and needs, counsels the patient and family in meeting nursing 
and related needs, participates in in-service programs, and supervises 
and teaches other nursing personnel.
    (b) Standard: Duties of the licensed practical nurse. The licensed 
practical nurse furnishes services in accordance with agency policies, 
prepares clinical and progress notes, assists the physician and 
registered nurse in performing specialized procedures, prepares 
equipment and materials for treatments observing aseptic technique as 
required, and assists the patient in learning appropriate self-care 
techniques.

[54 FR 33367, August 14, 1989, as amended at 56 FR 32974, July 18, 1991]



Sec.  484.32  Condition of participation: Therapy services.

    Any therapy services offered by the HHA directly or under 
arrangement are given by a qualified therapist or by a qualified therapy 
assistant under the supervision of a qualified therapist and in 
accordance with the plan of care. The qualified therapist assists the 
physician in evaluating level of function, helps develop the plan of 
care (revising it as necessary), prepares clinical and progress notes, 
advises and consults with the family and other agency personnel, and 
participates in in-service programs.
    (a) Standard: Supervision of physical therapy assistant and 
occupational therapy assistant. Services furnished by a qualified 
physical therapy assistant or qualified occupational therapy assistant 
may be furnished under the supervision of a qualified physical or 
occupational therapist. A physical therapy assistant or occupational 
therapy assistant performs services planned, delegated, and supervised 
by the therapist, assists in preparing clinical notes and progress 
reports, and participates in

[[Page 122]]

educating the patient and family, and in in-service programs.
    (b) Standard: Supervision of speech therapy services. Speech therapy 
services are furnished only by or under supervision of a qualified 
speech pathologist or audiologist.

[54 FR 33367, August 14, 1989, as amended at 56 FR 32974, July 18, 1991]



Sec.  484.34  Condition of participation: Medical social services.

    If the agency furnishes medical social services, those services are 
given by a qualified social worker or by a qualified social work 
assistant under the supervision of a qualified social worker, and in 
accordance with the plan of care. The social worker assists the 
physician and other team members in understanding the significant social 
and emotional factors related to the health problems, participates in 
the development of the plan of care, prepares clinical and progress 
notes, works with the family, uses appropriate community resources, 
participates in discharge planning and in-service programs, and acts as 
a consultant to other agency personnel.



Sec.  484.36  Condition of participation: Home health aide services.

    Home health aides are selected on the basis of such factors as a 
sympathetic attitude toward the care of the sick, ability to read, 
write, and carry out directions, and maturity and ability to deal 
effectively with the demands of the job. They are closely supervised to 
ensure their competence in providing care. For home health services 
furnished (either directly or through arrangements with other 
organizations) after August 14, 1990, the HHA must use individuals who 
meet the personnel qualifications specified in Sec.  484.4 for ``home 
health aide''.
    (a) Standard: Home health aide training--(1) Content and duration of 
training. The aide training program must address each of the following 
subject areas through classroom and supervised practical training 
totalling at least 75 hours, with at least 16 hours devoted to 
supervised practical training. The individual being trained must 
complete at least 16 hours of classroom training before beginning the 
supervisied practical training.
    (i) Communications skills.
    (ii) Observation, reporting and documentation of patient status and 
the care or service furnished.
    (iii) Reading and recording temperature, pulse, and respiration.
    (iv) Basic infection control procedures.
    (v) Basic elements of body functioning and changes in body function 
that must be reported to an aide's supervisor.
    (vi) Maintenance of a clean, safe, and healthy environment.
    (vii) Recognizing emergencies and knowledge of emergency procedures.
    (viii) The physical, emotional, and developmental needs of and ways 
to work with the populations served by the HHA, including the need for 
respect for the patient, his or her privacy and his or her property.
    (ix) Appropriate and safe techniques in personal hygiene and 
grooming that include--
    (A) Bed bath.
    (B) Sponge, tub, or shower bath.
    (C) Shampoo, sink, tub, or bed.
    (D) Nail and skin care.
    (E) Oral hygiene.
    (F) Toileting and elimination.
    (x) Safe transfer techniques and ambulation.
    (xi) Normal range of motion and positioning.
    (xii) Adequate nutrition and fluid intake.
    (xiii) Any other task that the HHA may choose to have the home 
health aide perform.
    ``Supervised practical training'' means training in a laboratory or 
other setting in which the trainee demonstrates knowledge while 
performing tasks on an individual under the direct supervision of a 
registered nurse or licensed practical nurse.
    (2) Conduct of training--(i) Organizations. A home health aide 
training program may be offered by any organization except an HHA that, 
within the previous 2 years has been found--
    (A) Out of compliance with requirements of this paragraph (a) or 
paragraph (b) of this section;
    (B) To permit an individual that does not meet the definition of 
``home

[[Page 123]]

health aide'' as specified in Sec.  484.4 to furnish home health aide 
services (with the exception of licensed health professionals and 
volunteers);
    (C) Has been subject to an extended (or partial extended) survey as 
a result of having been found to have furnished substandard care (or for 
other reasons at the discretion of the CMS or the State);
    (D) Has been assessed a civil monetary penalty of not less than 
$5,000 as an intermediate sanction;
    (E) Has been found to have compliance deficiencies that endanger the 
health and safety of the HHA's patients and has had a temporary 
management appointed to oversee the management of the HHA;
    (F) Has had all or part of its Medicare payments suspended; or
    (G) Under any Federal or State law within the 2-year period 
beginning on October 1, 1988--
    (1) Has had its participation in the Medicare program terminated;
    (2) Has been assessed a penalty of not less than $5,000 for 
deficiencies in Federal or State standards for HHAs;
    (3) Was subject to a suspension of Medicare payments to which it 
otherwise would have been entitled;
    (4) Had operated under a temporary management that was appointed to 
oversee the operation of the HHA and to ensure the health and safety of 
the HHA's patients; or
    (5) Was closed or had it's residents transferred by the State.
    (ii) Qualifications for instructors. The training of home health 
aides and the supervision of home health aides during the supervised 
practical portion of the training must be performed by or under the 
general supervision of a registered nurse who possesses a minimum of 2 
years of nursing experience, at least 1 year of which must be in the 
provision of home health care. Other individuals may be used to provide 
instruction under the supervision of a qualified registered nurse.
    (3) Documentation of training. The HHA must maintain sufficient 
documentation to demonstrate that the requirements of this standard are 
met.
    (b) Standard: Competency evaluation and in-service training--(1) 
Applicability. An individual may furnish home health aide services on 
behalf of an HHA only after that individual has successfully completed a 
competency evaluation program as described in this paragraph. The HHA is 
responsible for ensuring that the individuals who furnish home health 
aide services on its behalf meet the competency evaluation requirements 
of this section.
    (2) Content and frequency of evaluations and amount of in-service 
training. (i) The competency evaluation must address each of the 
subjects listed in paragraph (a)(1) (ii) through (xiii) of this section.
    (ii) The HHA must complete a performance review of each home health 
aide no less frequently than every 12 months.
    (iii) The home health aide must receive at least 12 hours of in-
service training during each 12-month period. The in-service training 
may be furnished while the aide is furnishing care to the patient.
    (3) Conduct of evaluation and training--(i) Organizations. A home 
health aide competency evaluation program may be offered by any 
organization except as specified in paragraph (a)(2)(i) of this section.
    The in-service training may be offered by any organization.
    (ii) Evaluators and instructors. The competency evaluation must be 
performed by a registered nurse. The in-service training generally must 
be supervised by a registered nurse who possesses a minimum of 2 years 
of nursing experience at least 1 year of which must be in the provision 
of home health care.
    (iii) Subject areas. The subject areas listed at paragraphs (a)(1) 
(iii), (ix), (x), and (xi) of this section must be evaluated after 
observation of the aide's performance of the tasks with a patient. The 
other subject areas in paragraph (a)(1) of this section may be evaluated 
through written examination, oral examination, or after observation of a 
home health aide with a patient.
    (4) Competency determination. (i) A home health aide is not 
considered competent in any task for which he or she is evaluated as 
``unsatisfactory''. The aide must not perform that task

[[Page 124]]

without direct supervision by a licensed nurse until after he or she 
receives training in the task for which he or she was evaluated as 
``unsatisfactory'' and passes a subsequent evaluation with 
``satisfactory''.
    (ii) A home health aide is not considered to have successfully 
passed a competency evaluation if the aide has an ``unsatisfactory'' 
rating in more than one of the required areas.
    (5) Documentation of competency evaluation. The HHA must maintain 
documentation which demonstrates that the requirements of this standard 
are met.
    (6) Effective date. The HHA must implement a competency evaluation 
program that meets the requirements of this paragraph before February 
14, 1990. The HHA must provide the preparation necessary for the 
individual to successfully complete the competency evaluation program. 
After August 14, 1990, the HHA may use only those aides that have been 
found to be competent in accordance with Sec.  484.36(b).
    (c) Standard: Assignment and duties of the home health aide--(1) 
Assignment. The home health aide is assigned to a specific patient by 
the registered nurse. Written patient care instructions for the home 
health aide must be prepared by the registered nurse or other 
appropriate professional who is responsible for the supervision of the 
home health aide under paragraph (d) of this section.
    (2) Duties. The home health aide provides services that are ordered 
by the physician in the plan of care and that the aide is permitted to 
perform under State law. The duties of a home health aide include the 
provision of hands-on personal care, performance of simple procedures as 
an extension of therapy or nursing services, assistance in ambulation or 
exercises, and assistance in administering medications that are 
ordinarily self-administered. Any home health aide services offered by 
an HHA must be provided by a qualified home health aide.
    (d) Standard: Supervision. (1) If the patient receives skilled 
nursing care, the registered nurse must perform the supervisory visit 
required by paragraph (d)(2) of this section. If the patient is not 
receiving skilled nursing care, but is receiving another skilled service 
(that is, physical therapy, occupational therapy, or speech-language 
pathology services), supervision may be provided by the appropriate 
therapist.
    (2) The registered nurse (or another professional described in 
paragraph (d)(1) of this section) must make an on-site visit to the 
patient's home no less frequently than every 2 weeks.
    (3) If home health aide services are provided to a patient who is 
not receiving skilled nursing care, physical or occupational therapy or 
speech-language pathology services, the registered nurse must make a 
supervisory visit to the patient's home no less frequently than every 60 
days. In these cases, to ensure that the aide is properly caring for the 
patient, each supervisory visit must occur while the home health aide is 
providing patient care.
    (4) If home health aide services are provided by an individual who 
is not employed directly by the HHA (or hospice), the services of the 
home health aide must be provided under arrangements, as defined in 
section 1861(w)(1) of the Act. If the HHA (or hospice) chooses to 
provide home health aide services under arrangements with another 
organization, the HHA's (or hospice's) responsibilities include, but are 
not limited to--
    (i) Ensuring the overall quality of the care provided by the aide;
    (ii) Supervision of the aide's services as described in paragraphs 
(d)(1) and (d)(2) of this section; and
    (iii) Ensuring that home health aides providing services under 
arrangements have met the training requirements of paragraphs (a) and 
(b) of this section.
    (e) Personal care attendant: Evaluation requirements--(1) 
Applicability. This paragraph applies to individuals who are employed by 
HHAs exclusively to furnish personal care attendant services under a 
Medicaid personal care benefit.
    (2) Rule. An individual may furnish personal care services, as 
defined in Sec.  440.170 of this chapter, on behalf of an HHA after the 
individual has been found competent by the State to furnish those 
services for which a competency evaluation is required by paragraph (b) 
of this section and which the individual is required to perform. The

[[Page 125]]

individual need not be determined competent in those services listed in 
paragraph (a) of this section that the individual is not required to 
furnish.

[54 FR 33367, August 14, 1989, as amended at 56 FR 32974, July 18, 1991; 
56 FR 51334, Oct. 11, 1991; 59 FR 65498, Dec. 20, 1994; 60 FR 39123, 
Aug. 1, 1995; 66 FR 32778, June 18, 2001]



Sec.  484.38  Condition of participation: Qualifying to furnish outpatient physical therapy or speech pathology services.

    An HHA that wishes to furnish outpatient physical therapy or speech 
pathology services must meet all the pertinent conditions of this part 
and also meet the additional health and safety requirements set forth in 
Sec. Sec.  485.711, 485.713, 485.715, 485.719, 485.723, and 485.727 of 
this chapter to implement section 1861(p) of the Act.

[54 FR 33367, Aug. 14, 1989, as amended at 60 FR 2329, Jan. 9, 1995; 60 
FR 11632, Mar. 2, 1995]



Sec.  484.48  Condition of participation: Clinical records.

    A clinical record containing pertinent past and current findings in 
accordance with accepted professional standards is maintained for every 
patient receiving home health services. In addition to the plan of care, 
the record contains appropriate identifying information; name of 
physician; drug, dietary, treatment, and activity orders; signed and 
dated clinical and progress notes; copies of summary reports sent to the 
attending physician; and a discharge summary. The HHA must inform the 
attending physician of the availability of a discharge summary. The 
discharge summary must be sent to the attending physician upon request 
and must include the patient's medical and health status at discharge.
    (a) Standards: Retention of records. Clinical records are retained 
for 5 years after the month the cost report to which the records apply 
is filed with the intermediary, unless State law stipulates a longer 
period of time. Policies provide for retention even if the HHA 
discontinues operations. If a patient is transferred to another health 
facility, a copy of the record or abstract is sent with the patient.
    (b) Standards: Protection of records. Clinical record information is 
safe-guarded against loss or unauthorized use. Written procedures govern 
use and removal of records and the conditions for release of 
information. Patient's written consent is required for release of 
information not authorized by law.

[54 FR 33367, Aug. 14, 1989, as amended at 60 FR 65498, Dec. 20, 1994]



Sec.  484.52  Condition of participation: Evaluation of the agency's program.

    The HHA has written policies requiring an overall evaluation of the 
agency's total program at least once a year by the group of professional 
personnel (or a committee of this group), HHA staff, and consumers, or 
by professional people outside the agency working in conjunction with 
consumers. The evaluation consists of an overall policy and 
administrative review and a clinical record review. The evaluation 
assesses the extent to which the agency's program is appropriate, 
adequate, effective, and efficient. Results of the evaluation are 
reported to and acted upon by those responsible for the operation of the 
agency and are maintained separately as administrative records.
    (a) Standard: Policy and administrative review. As a part of the 
evaluation process the policies and administrative practices of the 
agency are reviewed to determine the extent to which they promote 
patient care that is appropriate, adequate, effective, and efficient. 
Mechanisms are established in writing for the collection of pertinent 
data to assist in evaluation.
    (b) Standard: Clinical record review. At least quarterly, 
appropriate health professionals, representing at least the scope of the 
program, review a sample of both active and closed clinical records to 
determine whether established policies are followed in furnishing 
services directly or under arrangement. There is a continuing review of 
clinical records for each 60-day period that a patient receives home 
health services to determine adequacy of the plan of care and 
appropriateness of continuation of care.

[54 FR 33367, Aug. 14, 1989; 66 FR 32778, June 18, 2001]

[[Page 126]]



Sec.  484.55  Condition of participation: Comprehensive assessment of patients.

    Each patient must receive, and an HHA must provide, a patient-
specific, comprehensive assessment that accurately reflects the 
patient's current health status and includes information that may be 
used to demonstrate the patient's progress toward achievement of desired 
outcomes. The comprehensive assessment must identify the patient's 
continuing need for home care and meet the patient's medical, nursing, 
rehabilitative, social, and discharge planning needs. For Medicare 
beneficiaries, the HHA must verify the patient's eligibility for the 
Medicare home health benefit including homebound status, both at the 
time of the initial assessment visit and at the time of the 
comprehensive assessment. The comprehensive assessment must also 
incorporate the use of the current version of the Outcome and Assessment 
Information Set (OASIS) items, using the language and groupings of the 
OASIS items, as specified by the Secretary.
    (a) Standard: Initial assessment visit. (1) A registered nurse must 
conduct an initial assessment visit to determine the immediate care and 
support needs of the patient; and, for Medicare patients, to determine 
eligibility for the Medicare home health benefit, including homebound 
status. The initial assessment visit must be held either within 48 hours 
of referral, or within 48 hours of the patient's return home, or on the 
physician-ordered start of care date.
    (2) When rehabilitation therapy service (speech language pathology, 
physical therapy, or occupational therapy) is the only service ordered 
by the physician, and if the need for that service establishes program 
eligibility, the initial assessment visit may be made by the appropriate 
rehabilitation skilled professional.
    (b) Standard: Completion of the comprehensive assessment. (1) The 
comprehensive assessment must be completed in a timely manner, 
consistent with the patient's immediate needs, but no later than 5 
calendar days after the start of care.
    (2) Except as provided in paragraph (b)(3) of this section, a 
registered nurse must complete the comprehensive assessment and for 
Medicare patients, determine eligibility for the Medicare home health 
benefit, including homebound status.
    (3) When physical therapy, speech-language pathology, or 
occupational therapy is the only service ordered by the physician, a 
physical therapist, speech-language pathologist or occupational 
therapist may complete the comprehensive assessment, and for Medicare 
patients, determine eligibility for the Medicare home health benefit, 
including homebound status. The occupational therapist may complete the 
comprehensive assessment if the need for occupational therapy 
establishes program eligibility.
    (c) Standard: Drug regimen review. The comprehensive assessment must 
include a review of all medications the patient is currently using in 
order to identify any potential adverse effects and drug reactions, 
including ineffective drug therapy, significant side effects, 
significant drug interactions, duplicate drug therapy, and noncompliance 
with drug therapy.
    (d) Standard: Update of the comprehensive assessment. The 
comprehensive assessment must be updated and revised (including the 
administration of the OASIS) as frequently as the patient's condition 
warrants due to a major decline or improvement in the patient's health 
status, but not less frequently than--
    (1) The last five days of every 60 days beginning with the start-of-
care date, unless there is a--
    (i) Beneficiary elected transfer;
    (ii) Significant change in condition resulting in a new case-mix 
assignment; or
    (iii) Discharge and return to the same HHA during the 60-day 
episode.
    (2) Within 48 hours of the patient's return to the home from a 
hospital admission of 24 hours or more for any reason other than 
diagnostic tests;
    (3) At discharge.
    (e) Standard: Incorporation of OASIS data items. The OASIS data 
items determined by the Secretary must be incorporated into the HHA's 
own assessment and must include: clinical record

[[Page 127]]

items, demographics and patient history, living arrangements, supportive 
assistance, sensory status, integumentary status, respiratory status, 
elimination status, neuro/emotional/behavioral status, activities of 
daily living, medications, equipment management, emergent care, and data 
items collected at inpatient facility admission or discharge only.

[64 FR 3784, Jan. 25, 1999, as amended at 65 FR 41211, July 3, 2000]

Subpart D [Reserved]



      Subpart E_Prospective Payment System for Home Health Agencies

    Source: 65 FR 41212, July 3, 2000, unless otherwise noted.



Sec.  484.200  Basis and scope.

    (a) Basis. This subpart implements section 1895 of the Act, which 
provides for the implementation of a prospective payment system (PPS) 
for HHAs for portions of cost reporting periods occurring on or after 
October 1, 2000.
    (b) Scope. This subpart sets forth the framework for the HHA PPS, 
including the methodology used for the development of the payment rates, 
associated adjustments, and related rules.



Sec.  484.202  Definitions.

    As used in this subpart--
    Case-mix index means a scale that measures the relative difference 
in resource intensity among different groups in the clinical model.
    Discipline means one of the six home health disciplines covered 
under the Medicare home health benefit (skilled nursing services, home 
health aide services, physical therapy services, occupational therapy 
services, speech- language pathology services, and medical social 
services).
    Home health market basket index means an index that reflects changes 
over time in the prices of an appropriate mix of goods and services 
included in home health services.
    Rural area means, with respect to home health episodes ending on or 
after January 1, 2006, an area defined in Sec.  412.64(b)(1)(ii)(C) of 
this chapter.
    Urban area means, with respect to home health episodes ending on or 
after January 1, 2006, an area defined in Sec.  412.64(b)(1)(ii)(A) and 
(B) of this chapter.

[70 FR 68142, Nov. 9, 2005]



Sec.  484.205  Basis of payment.

    (a) Method of payment. An HHA receives a national prospective 60-day 
episode payment of a predetermined rate for a home health service 
previously paid on a reasonable cost basis (except the osteoporosis drug 
defined in section 1861(kk) of the Act) as of August 5, 1997. The 
national 60-day episode payment is determined in accordance with Sec.  
484.215. The national prospective 60-day episode payment is subject to 
the following adjustments and additional payments:
    (1) A low-utilization payment adjustment (LUPA) of a predetermined 
per-visit rate as specified in Sec.  484.230.
    (2) A partial episode payment (PEP) adjustment due to an intervening 
event defined as a beneficiary elected transfer or a discharge and 
return to the same HHA during the 60-day episode, that warrants a new 
60-day episode payment during an existing 60-day episode, that initiates 
the start of a new 60-day episode payment and a new physician 
certification of the new plan of care. The PEP adjustment is determined 
in accordance with Sec.  484.235.
    (3) An outlier payment is determined in accordance with Sec.  
484.240.
    (b) Episode payment. The national prospective 60-day episode payment 
represents payment in full for all costs associated with furnishing home 
health services previously paid on a reasonable cost basis (except the 
osteoporosis drug listed in section 1861(m) of the Act as defined in 
section 1861(kk) of the Act) as of August 5, 1997 unless the national 
60-day episode payment is subject to a low-utilization payment 
adjustment set forth in Sec.  484.230, a partial episode payment 
adjustment set forth at Sec.  484.235, or an additional outlier payment 
set forth in Sec.  484.240. All payments under this system may be 
subject to a medical review adjustment reflecting beneficiary 
eligibility, medical necessity determinations, and HHRG assignment. DME 
provided as a home health service as defined in section

[[Page 128]]

1861(m) of the Act continues to be paid the fee schedule amount.
    (1) Split percentage payment for initial episodes. The initial 
percentage payment for initial episodes is paid to an HHA at 60 percent 
of the case-mix and wage adjusted 60-day episode rate. The residual 
final payment for initial episodes is paid at 40 percent of the case-mix 
and wage adjusted 60-day episode rate. Split percentage payments are 
made in accordance with requirements at Sec.  409.43(c) of this chapter.
    (2) Split percentage payment for subsequent episodes. The initial 
percentage payment for subsequent episodes is paid to an HHA at 50 
percent of the case-mix and wage adjusted 60-day episode rate. The 
residual final payment for subsequent episodes is paid at 50 percent of 
the case-mix and wage adjusted 60-day episode rate. Split percentage 
payments are made in accordance with requirements at Sec.  409.43(c) of 
this chapter.
    (c) Low-utilization payment. An HHA receives a national 60-day 
episode payment of a predetermined rate for home health services 
previously paid on a reasonable cost basis as of August 5, 1997, unless 
CMS determines at the end of the 60-day episode that the HHA furnished 
minimal services to a patient during the 60-day episode. A low- 
utilization payment adjustment is determined in accordance with Sec.  
484.230.
    (d) Partial episode payment adjustment. An HHA receives a national 
60-day episode payment of a predetermined rate for home health services 
previously paid on a reasonable cost basis as of August 5, 1997, unless 
CMS determines an intervening event, defined as a beneficiary elected 
transfer, or discharge and return to the same HHA during a 60-day 
episode, warrants a new 60-day episode payment. The PEP adjustment would 
not apply in situations of transfers among HHAs of common ownership as 
defined in Sec.  424.22 of this chapter. Those situations would be 
considered services provided under arrangement on behalf of the 
originating HHA by the receiving HHA with the common ownership interest 
for the balance of the 60-day episode. The common ownership exception to 
the transfer PEP adjustment does not apply if the beneficiary moves to a 
different MSA or Non-MSA during the 60-day episode before the transfer 
to the receiving HHA. The transferring HHA in situations of common 
ownership not only serves as a billing agent, but must also exercise 
professional responsibility over the arranged-for services in order for 
services provided under arrangements to be paid. The discharge and 
return to the same HHA during the 60-day episode is only recognized in 
those circumstances when a beneficiary reached the goals in the original 
plan of care. The original plan of care must have been terminated with 
no anticipated need for additional home health services for the balance 
of the 60-day episode. If the intervening event warrants a new 60-day 
episode payment and the new physician certification of a new plan of 
care, the initial HHA receives a partial episode payment adjustment 
reflecting the length of time the patient remained under its care. A 
partial episode payment adjustment is determined in accordance with 
Sec.  484.235.
    (e) Outlier payment. An HHA receives a national 60-day episode 
payment of a predetermined rate for a home health service paid on a 
reasonable cost basis as of August 5, 1997, unless the imputed cost of 
the 60-day episode exceeds a threshold amount. The outlier payment is 
defined to be a proportion of the imputed costs beyond the threshold. An 
outlier payment is a payment in addition to the national 60-day episode 
payment. The total of all outlier payments is limited to 5 percent of 
total outlays under the HHA PPS. An outlier payment is determined in 
accordance with Sec.  484.240.

[65 FR 41212, July 3, 2000, as amended at 72 FR 49878]



Sec.  484.210  Data used for the calculation of the national prospective 60-day episode payment.

    To calculate the national prospective 60-day episode payment, CMS 
uses the following:
    (a) Medicare cost data on the most recent audited cost report data 
available.
    (b) Utilization data based on Medicare claims.
    (c) An appropriate wage index to adjust for area wage differences.

[[Page 129]]

    (d) The most recent projections of increases in costs from the HHA 
market basket index.
    (e) OASIS assessment data and other data that account for the 
relative resource utilization for different HHA Medicare patient case-
mix.



Sec.  484.215  Initial establishment of the calculation of the national 60-day episode payment.

    (a) Determining an HHA's costs. In calculating the initial 
unadjusted national 60-day episode payment applicable for a service 
furnished by an HHA using data on the most recent available audited cost 
reports, CMS determines each HHA's costs by summing its allowable costs 
for the period. CMS determines the national mean cost per visit.
    (b) Determining HHA utilization. In calculating the initial 
unadjusted national 60-day episode payment, CMS determines the national 
mean utilization for each of the six disciplines using home health 
claims data.
    (c) Use of the market basket index. CMS uses the HHA market basket 
index to adjust the HHA cost data to reflect cost increases occurring 
between October 1, 1996 through September 30, 2001.
    (d) Calculation of the unadjusted national average prospective 
payment amount for the 60-day episode. CMS calculates the unadjusted 
national 60-day episode payment in the following manner:
    (1) By computing the mean national cost per visit.
    (2) By computing the national mean utilization for each discipline.
    (3) By multiplying the mean national cost per visit by the national 
mean utilization summed in the aggregate for the six disciplines.
    (4) By adding to the amount derived in paragraph (d)(3) of this 
section, amounts for nonroutine medical supplies, an OASIS adjustment 
for estimated ongoing reporting costs, an OASIS adjustment for the one 
time implementation costs associated with assessment scheduling form 
changes and amounts for Part B therapies that could have been unbundled 
to Part B prior to October 1, 2000. The resulting amount is the 
unadjusted national 60-day episode rate.
    (e) Standardization of the data for variation in area wage levels 
and case-mix. CMS standardizes--
    (1) The cost data described in paragraph (a) of this section to 
remove the effects of geographic variation in wage levels and variation 
in case-mix;
    (2) The cost data for geographic variation in wage levels using the 
hospital wage index; and
    (3) The cost data for HHA variation in case-mix using the case-mix 
indices and other data that indicate HHA case-mix.



Sec.  484.220  Calculation of the adjusted national prospective 60-day episode payment rate for case-mix and area wage levels.

    CMS adjusts the national prospective 60-day episode payment rate to 
account for the following:
    (a) HHA case-mix using a case-mix index to explain the relative 
resource utilization of different patients. To address changes to the 
case-mix that are a result of changes in the coding or classification of 
different units of service that do not reflect real changes in case-mix, 
the national prospective 60-day episode payment rate will be adjusted 
downward as follows:
    (1) For CY 2008, the adjustment is 2.75 percent.
    (2) For CY 2009 and CY 2010, the adjustment is 2.75 percent in each 
year.
    (3) For CY 2011, the adjustment is 2.71 percent.
    (b) Geographic differences in wage levels using an appropriate wage 
index based on the site of service of the beneficiary.

[72 FR 49879, Aug. 29, 2007]



Sec.  484.225  Annual update of the unadjusted national prospective 60-day episode payment rate.

    (a) CMS updates the unadjusted national 60-day episode payment rate 
on a fiscal year basis.
    (b) For fiscal year 2001, the unadjusted national 60-day episode 
payment rate is adjusted using the latest available home health market 
basket index factors.
    (c) For fiscal years 2002 and 2003, the unadjusted national 
prospective 60-day episode payment rate is updated by a factor equal to 
the applicable home

[[Page 130]]

health market basket minus 1.1 percentage points.
    (d) For the last calendar quarter of 2003 and the first calendar 
quarter of 2004, the unadjusted national prospective 60-day episode 
payment rate is equal to the rate from the previous fiscal year (FY 
2003) increased by the applicable home health market basket index 
amount.
    (e) For the last the 3 calendar quarters of 2004, the unadjusted 
national prospective 60-day episode payment rate is equal to the rate 
from the previous fiscal year (FY 2003) increased by the applicable home 
health market basket minus 0.8 percentage points.
    (f) For calendar year 2005, the unadjusted national prospective 60-
day episode payment rate is equal to the rate from the previous calendar 
year, increased by the applicable home health market basket minus 0.8 
percentage points.
    (g) For calendar year 2006, the unadjusted national prospective 60-
day episode payment rate is equal to the rate from calendar year 2005.
    (h) For 2007 and subsequent calendar years, in the case of a home 
health agency that submits home health quality data, as specified by the 
Secretary, the unadjusted national prospective 60-day episode rate is 
equal to the rate for the previous calendar year increased by the 
applicable home health market basket index amount.
    (i) For 2007 and subsequent calendar years, in the case of a home 
health agency that does not submit home health quality data, as 
specified by the Secretary, the unadjusted national prospective 60-day 
episode rate is equal to the rate for the previous calendar year 
increased by the applicable home health market basket index amount minus 
2 percentage points. Any reduction of the percentage change will apply 
only to the calendar year involved and will not be taken into account in 
computing the prospective payment amount for a subsequent calendar year.

[65 FR 41212, July 3, 2000, as amended at 69 FR 62138, Oct. 22, 2004; 71 
FR 65935, Nov. 9, 2006]



Sec.  484.230  Methodology used for the calculation of the low-utilization payment adjustment.

    An episode with four or fewer visits is paid the national per-visit 
amount by discipline updated annually by the applicable market basket 
for each visit type. The national per-visit amount is determined by 
using cost data set forth in Sec.  484.210(a) and adjusting by the 
appropriate wage index based on the site of service for the beneficiary. 
For 2008 and subsequent calendar years, an amount will be added to low-
utilization payment adjustments for low-utilization episodes that occur 
as the beneficiary's only episode or initial episode in a sequence of 
adjacent episodes. For purposes of the home health PPS, a sequence of 
adjacent episodes for a beneficiary is a series of claims with no more 
than 60 days without home care between the end of one episode, which is 
the 60th day (except for episodes that have been PEP-adjusted), and the 
beginning of the next episode. This additional amount will be updated 
annually after 2008 by a factor equal to the applicable home health 
market basket percentage.

[65 FR 41212, July 3, 2000, as amended at 72 FR 69879, Aug. 29, 2007]



Sec.  484.235  Methodology used for the calculation of the partial episode payment adjustment.

    (a) CMS makes a PEP adjustment to the original 60-day episode 
payment that is interrupted by an intervening event described in Sec.  
484.205(d).
    (b) The original 60-day episode payment is adjusted to reflect the 
length of time the beneficiary remained under the care of the original 
HHA based on the first billable visit date through and including the 
last billable visit date.
    (c) The partial episode payment is calculated by determining the 
actual days served by the original HHA as a proportion of 60 multiplied 
by the initial 60-day episode payment.



Sec.  484.240  Methodology used for the calculation of the outlier payment.

    (a) CMS makes an outlier payment for an episode whose estimated cost 
exceeds a threshold amount for each case-mix group.

[[Page 131]]

    (b) The outlier threshold for each case-mix group is the episode 
payment amount for that group, the PEP adjustment amount for the episode 
plus a fixed dollar loss amount that is the same for all case-mix 
groups.
    (c) The outlier payment is a proportion of the amount of estimated 
cost beyond the threshold.
    (d) CMS imputes the cost for each episode by multiplying the 
national per-visit amount of each discipline by the number of visits in 
the discipline and computing the total imputed cost for all disciplines.
    (e) The fixed dollar loss amount and the loss sharing proportion are 
chosen so that the estimated total outlier payment is no more than 5 
percent of total payment under home health PPS.

[65 FR 41212, July 3, 2000, as amended at 72 FR 69879, Aug. 29, 2007]



Sec.  484.245  Accelerated payments for home health agencies.

    (a) General rule. Upon request, an accelerated payment may be made 
to an HHA that is receiving payment under the home health prospective 
payment system if the HHA is experiencing financial difficulties because 
there is a delay by the intermediary in making payment to the HHA.
    (b) Approval of payment. An HHA's request for an accelerated payment 
must be approved by the intermediary and CMS.
    (c) Amount of payment. The amount of the accelerated payment is 
computed as a percentage of the net payment for unbilled or unpaid 
covered services.
    (d) Recovery of payment. Recovery of the accelerated payment is made 
by recoupment as HHA bills are processed or by direct payment by the 
HHA.



Sec.  484.250  Patient assessment data.

    An HHA must submit to CMS the OASIS data described at Sec.  
484.55(b)(1) and (d)(1) in order for CMS to administer the payment rate 
methodologies described in Sec. Sec.  484.215, 484.230, 484.235, and 
484.237.



Sec.  484.260  Limitation on review.

    An HHA is not entitled to judicial or administrative review under 
sections 1869 or 1878 of the Act, or otherwise, with regard to the 
establishment of the payment unit, including the national 60-day 
prospective episode payment rate, adjustments and outlier payments. An 
HHA is not entitled to the review regarding the establishment of the 
transition period, definition and application of the unit of payments, 
the computation of initial standard prospective payment amounts, the 
establishment of the adjustment for outliers, and the establishment of 
case-mix and area wage adjustment factors.



Sec.  484.265  Additional payment.

    QIO photocopy and mailing costs. An additional payment is made to a 
home health agency in accordance with Sec.  476.78 of this chapter for 
the costs of photocopying and mailing medical records requested by a 
QIO.

[68 FR 67960, Dec. 5, 2003]



PART 485_CONDITIONS OF PARTICIPATION: SPECIALIZED PROVIDERS--Table of Contents




Subpart A [Reserved]

    Subpart B_Conditions of Participation: Comprehensive Outpatient 
                        Rehabilitation Facilities

Sec.
485.50 Basis and scope.
485.51 Definition.
485.54 Condition of participation: Compliance with State and local laws.
485.56 Condition of participation: Governing body and administration.
485.58 Condition of participation: Comprehensive rehabilitation program.
485.60 Condition of participation: Clinical records.
485.62 Condition of participation: Physical environment.
485.64 Condition of participation: Disaster procedures.
485.66 Condition of participation: Utilization review plan.
485.70 Personnel qualifications.
485.74 Appeal rights.

Subparts C-E [Reserved]

 Subpart F_Conditions of Participation: Critical Access Hospitals (CAHs)

485.601 Basis and scope.
485.602 Definitions.
485.603 Rural health network.
485.604 Personnel qualifications.

[[Page 132]]

485.606 Designation and certification of CAHs.
485.608 Condition of participation: Compliance with Federal, State, and 
          local laws and regulations.
485.610 Condition of participation: Status and location.
485.612 Condition of participation: Compliance with hospital 
          requirements at the time of application.
485.616 Condition of participation: Agreements.
485.618 Condition of participation: Emergency services.
485.620 Condition of participation: Number of beds and length of stay.
485.623 Condition of participation: Physical plant and environment.
485.627 Condition of participation: Organizational structure.
485.631 Condition of participation: Staffing and staff responsibilities.
485.635 Condition of participation: Provision of services.
485.638 Condition of participation: Clinical records.
485.639 Condition of participation: Surgical services.
485.641 Condition of participation: Periodic evaluation and quality 
          assurance review.
485.643 Condition of participation: Organ, tissue, and eye procurement.
485.645 Special requirements for CAH providers of long-term care 
          services (``swing-beds'').
485.647 Condition of participation: psychiatric and rehabilitation 
          distinct part units.

Subpart G [Reserved]

   Subpart H_Conditions of Participation for Clinics, Rehabilitation 
Agencies, and Public Health Agencies as Providers of Outpatient Physical 
             Therapy and Speech-Language Pathology Services

485.701 Basis and scope.
485.703 Definitions.
485.705 Personnel qualifications.
485.707 Condition of participation: Compliance with Federal, State, and 
          local laws.
485.709 Condition of participation: Administrative management.
485.711 Condition of participation: Plan of care and physician 
          involvement.
485.713 Condition of participation: Physical therapy services.
485.715 Condition of participation: Speech pathology services.
485.717 Condition of participation: Rehabilitation program.
485.719 Condition of participation: Arrangements for physical therapy 
          and speech pathology services to be performed by other than 
          salaried organization personnel.
485.721 Condition of participation: Clinical records.
485.723 Condition of participation: Physical environment.
485.725 Condition of participation: Infection control.
485.727 Condition of participation: Disaster preparedness.
485.729 Condition of participation: Program evaluation.

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 
1302 and 1395(hh)).

    Source: 48 FR 56293, Dec. 15, 1982, unless otherwise noted. 
Redesignated at 50 FR 33034, Aug. 16, 1985.

Subpart A [Reserved]



    Subpart B_Conditions of Participation: Comprehensive Outpatient 
                        Rehabilitation Facilities



Sec.  485.50  Basis and scope.

    This subpart sets forth the conditions that facilities must meet to 
be certified as comprehensive outpatient rehabilitation facilities 
(CORFs) under section 1861(cc)(2) of the Social Security Act and be 
accepted for participation in Medicare in accordance with part 489 of 
this chapter.



Sec.  485.51  Definition.

    As used in this subpart, unless the context indicates otherwise, 
``comprehensive outpatient rehabilitation facility'', ``CORF'', or 
``facility'' means a nonresidential facility that--
    (a) Is established and operated exclusively for the purpose of 
providing diagnostic, therapeutic, and restorative services to 
outpatients for the rehabilitation of injured, disabled, or sick 
persons, at a single fixed location, by or under the supervision of a 
physician except as provided in paragraph (c) of this section;
    (b) Meets all the requirements of this subpart.
    (c) Exception. May provide influenza, pneumococcal and Hepatitis B 
vaccines provided the applicable conditions of coverage under Sec.  
410.58 and Sec.  410.63 of this chapter are met.

[48 FR 56293, Dec. 15, 1982, as amended at 72 FR 66408, Nov. 27, 2007]

[[Page 133]]



Sec.  485.54  Condition of participation: Compliance with State and local laws.

    The facility and all personnel who provide services must be in 
compliance with applicable State and local laws and regulations.
    (a) Standard: Licensure of facility. If State or local law provides 
for licensing, the facility must be currently licensed or approved as 
meeting the standards established for licensure.
    (b) Standard: Licensure of personnel. Personnel that provide service 
must be licensed, certified, or registered in accordance with applicable 
State and local laws.



Sec.  485.56  Condition of participation: Governing body and administration.

    The facility must have a governing body that assumes full legal 
responsibility for establishing and implementing policies regarding the 
management and operation of the facility.
    (a) Standard: Disclosure of ownership. The facility must comply with 
the provisions of part 420, subpart C of this chapter that require 
health care providers and fiscal agents to disclose certain information 
about ownership and control.
    (b) Standard: Administrator. The governing body must appoint an 
administrator who--
    (1) Is responsible for the overall management of the facility under 
the authority delegated by the governing body;
    (2) Implements and enforces the facility's policies and procedures;
    (3) Designates, in writing, an individual who, in the absence of the 
administrator, acts on behalf of the administrator; and
    (4) Retains professional and administrative responsibility for all 
personnel providing facility services.
    (c) Standard: Group of professional personnel. The facility must 
have a group of professional personnel associated with the facility 
that--
    (1) Develops and periodically reviews policies to govern the 
services provided by the facility; and
    (2) Consists of at least one physician and one professional 
representing each of the services provided by the facility.
    (d) Standard: Institutional budget plan. The facility must have an 
institutional budget plan that meets the following conditions:
    (1) It is prepared, under the direction of the governing body, by a 
committee consisting of representatives of the governing body and the 
administrative staff.
    (2) It provides for--
    (i) An annual operating budget prepared according to generally 
accepted accounting principles;
    (ii) A 3-year capital expenditure plan if expenditures in excess of 
$100,000 are anticipated, for that period, for the acquisition of land; 
the improvement of land, buildings, and equipment; and the replacement, 
modernization, and expansion of buildings and equipment; and
    (iii) Annual review and updating by the governing body.
    (e) Standard: Patient care policies. The facility must have written 
patient care policies that govern the services it furnishes. The patient 
care policies must include the following:
    (1) A description of the services the facility furnishes through 
employees and those furnished under arrangements.
    (2) Rules for and personnel responsibilities in handling medical 
emergencies.
    (3) Rules for the storage, handling, and administration of drugs and 
biologicals.
    (4) Criteria for patient admission, continuing care, and discharge.
    (5) Procedures for preparing and maintaining clinical records on all 
patients.
    (6) A procedure for explaining to the patient and the patient's 
family the extent and purpose of the services to be provided.
    (7) A procedure to assist the referring physician in locating 
another level of care for--patients whose treatment has terminated and 
who are discharged.
    (8) A requirement that patients accepted by the facility must be 
under the care of a physician.
    (9) A requirement that there be a plan of treatment established by a 
physician for each patient.
    (10) A procedure to ensure that the group of professional personnel 
reviews

[[Page 134]]

and takes appropriate action on recommendations from the utilization 
review committee regarding patient care policies.
    (f) Standard: Delegation of authority. The responsibility for 
overall administration, management, and operation must be retained by 
the facility itself and not delegated to others.
    (1) The facility may enter into a contract for purposes of 
assistance in financial management and may delegate to others the 
following and similar services:
    (i) Bookkeeping.
    (ii) Assistance in the development of procedures for billing and 
accounting systems.
    (iii) Assistance in the development of an operating budget.
    (iv) Purchase of supplies in bulk form.
    (v) The preparation of financial statements.
    (2) When the services listed in paragraph (f)(1) of this section are 
delegated, a contract must be in effect and:
    (i) May not be for a term of more than 5 years;
    (ii) Must be subject to termination within 60 days of written notice 
by either party;
    (iii) Must contain a clause requiring renegotiation of any provision 
that CMS finds to be in contravention to any new, revised or amended 
Federal regulation or law;
    (iv) Must state that only the facility may bill the Medicare 
program; and
    (v) May not include clauses that state or imply that the contractor 
has power and authority to act on behalf of the facility, or clauses 
that give the contractor rights, duties, discretions, or 
responsibilities that enable it to dictate the administration, 
mangement, or operations of the facility.



Sec.  485.58  Condition of participation: Comprehensive rehabilitation program.

    The facility must provide a coordinated rehabilitation program that 
includes, at a minimum, physicians' services, physical therapy services, 
and social or psychological services. These services must be furnished 
by personnel that meet the qualifications set forth in Sec. Sec.  485.70 
and 484.4 of this chapter and must be consistent with the plan of 
treatment and the results of comprehensive patient assessments.
    (a) Standard: Physician services. (1) A facility physician must be 
present in the facility for a sufficient time to--
    (i) Provide, in accordance with accepted principles of medical 
practice, medical direction, medical care services, consultation, and 
medical supervision of nonphysician staff;
    (ii) Establish the plan of treatment in cases where a plan has not 
been established by the referring physician;
    (iii) Assist in establishing and implementing the facility's patient 
care policies; and
    (iv) Participate in plan of treatment reviews, patient case review 
conferences, comprehensive patient assessment and reassessments, and 
utilization review.
    (2) The facility must provide for emergency physician services 
during the facility operating hours.
    (b) Standard: Plan of treatment. For each patient, a physician must 
establish a plan of treatment before the facility initiates treatment. 
The plan of treatment must meet the following requirements:
    (1) It must delineate anticipated goals and specify the type, 
amount, frequency and duration of services to be provided.
    (2) It must be promptly evaluated after changes in the patient's 
condition and revised when necessary.
    (3) It must, if appropriate, be developed in consultation with the 
facility physician and the appropriate facility professional personnel.
    (4) It must be reviewed at least every 60 days by a facility 
physician who, when appropriate, consults with the professional 
personnel providing services. The results of this review must be 
communicated to the patient's referring physician for concurrence before 
treatment is continued or discontinued.
    (5) It must be revised if the comprehensive reassessment of the 
patient's status or the results of the patient case review conference 
indicate the need for revision.
    (c) Standard: Coordination of services. The facility must designate, 
in writing, a qualified professional to ensure that

[[Page 135]]

professional personnel coordinate their related activities and exchange 
information about each patient under their care. Mechanisms to assist in 
the coordination of services must include--
    (1) Providing to all personnel associated with the facility, a 
schedule indicating the frequency and type of services provided at the 
facility;
    (2) A procedure for communicating to all patient care personnel 
pertinent information concerning significant changes in the patient's 
status;
    (3) Periodic clinical record entries, noting at least the patient's 
status in relationship to goal attainment; and
    (4) Scheduling patient case review conferences for purposes of 
determining appropriateness of treatment, when indicated by the results 
of the initial comprehensive patient assessment, reassessment(s), the 
recommendation of the facility physician (or other physician who 
established the plan of treatment), or upon the recommendation of one of 
the professionals providing services.
    (d) Standard: Provision of services. (1) All patients must be 
referred to the facility by a physician who provides the following 
information to the facility before treatment is initiated:
    (i) The patient's significant medical history.
    (ii) Current medical findings.
    (iii) Diagnosis(es) and contraindications to any treatment modality.
    (iv) Rehabilitation goals, if determined.
    (2) Services may be provided by facility employees or by others 
under arrangements made by the facility.
    (3) The facility must have on its premises the necessary equipment 
to implement the plan of treatment and sufficient space to allow 
adequate care.
    (4) The services must be furnished by personnel that meet the 
qualifications of Sec.  485.70 and the number of qualified personnel 
must be adequate for the volume and diversity of services offered. 
Personnel that do not meet the qualifications specified in Sec.  485.70 
may be used by the facility in assisting qualified staff. When a 
qualified individual is assisted by these personnel, the qualified 
individual must be on the premises, and must instruct these personnel in 
appropriate patient care service techniques and retain responsibility 
for their activities.
    (5) A qualified professional must initiate and coordinate the 
appropriate portions of the plan of treatment, monitor the patient's 
progress, and recommend changes, in the plan, if necessary.
    (6) A qualified professional representing each service made 
available at the facility must be either on the premises of the facility 
or must be available through direct telecommunication for consultation 
and assistance during the facility's operating hours. At least one 
qualified professional must be on the premises during the facility's 
operating hours.
    (7) All services must be provided consistent with accepted 
professional standards and practice.
    (e) Standard: Scope and site of services--(1) Basic requirements. 
The facility must provide all the CORF services required in the plan of 
treatment and, except as provided in paragraph (e)(2) of this section, 
must provide the services on its premises.
    (2) Exceptions. Physical therapy, occupational therapy, and speech-
language pathology services may be furnished away from the premises of 
the CORF including the individual's home when payment is not otherwise 
made under Title XVIII of the Act. In addition, a single home 
environment evaluation is covered if there is a need to evaluate the 
potential impact of the home environment on the rehabilitation goals. 
The single home environment evaluation requires the presence of the 
patient and the physical therapist, occupational therapist, or speech-
language pathologist, as appropriate.
    (f) Standard: Patient assessment. Each qualified professional 
involved in the patient's care, as specified in the plan of treatment, 
must--
    (1) Carry out an initial patient assessment; and
    (2) In order to identify whether or not the current plan of 
treatment is appropriate, perform a patient reassessment after 
significant changes in the patient's status.
    (g) Standard: Laboratory services. (1) If the facility provides its 
own laboratory services, the services must meet the

[[Page 136]]

applicable requirements for laboratories specified in part 493 of this 
chapter.
    (2) If the facility chooses to refer specimens for laboratory 
testing, the referral laboratory must be certified in the appropriate 
specialties and subspecialties of services in accordance with the 
requirements of part 493 of this chapter.

[48 FR 56293, Dec. 15, 1982, as amended at 56 FR 8852, Mar. 1, 1991; 57 
FR 7137, Feb. 28, 1992; 73 FR 69941, Nov. 19, 2008]



Sec.  485.60  Condition of participation: Clinical records.

    The facility must maintain clinical records on all patients in 
accordance with accepted professional standards and practice. The 
clinical records must be completely, promptly, and accurately 
documented, readily accessible, and systematically organized to 
facilitate retrieval and compilation of information.
    (a) Standard: Content. Each clinical record must contain sufficient 
information to identify the patient clearly and to justify the diagnosis 
and treatment. Entries in the clinical record must be made as frequently 
as is necessary to insure effective treatment and must be signed by 
personnel providing services. All entries made by assistant level 
personnel must be countersigned by the corresponding professional. 
Documentation on each patient must be consolidated into one clinical 
record that must contain--
    (1) The initial assessment and subsequent reassessments of the 
patient's needs;
    (2) Current plan of treatment;
    (3) Identification data and consent or authorization forms;
    (4) Pertinent medical history, past and present;
    (5) A report of pertinent physical examinations if any;
    (6) Progress notes or other documentation that reflect patient 
reaction to treatment, tests, or injury, or the need to change the 
established plan of treatment; and
    (7) Upon discharge, a discharge summary including patient status 
relative to goal achievement, prognosis, and future treatment 
considerations.
    (b) Standard: Protection of clinical record information. The 
facility must safeguard clinical record information against loss, 
destruction, or unauthorized use. The facility must have procedures that 
govern the use and removal of records and the conditions for release of 
information. The facility must obtain the patient's written consent 
before releasing information not required to be released by law.
    (c) Standard: Retention and preservation. The facility must retain 
clinical record information for 5 years after patient discharge and must 
make provision for the maintenance of such records in the event that it 
is no longer able to treat patients.



Sec.  485.62  Condition of participation: Physical environment.

    The facility must provide a physical environment that protects the 
health and safety or patients, personnel, and the public.
    (a) Standard: Safety and comfort of patients. The physical premises 
of the facility and those areas of its surrounding physical structure 
that are used by the patients (including at least all stairwells, 
corridors and passageways) must meet the following requirements:
    (1) Applicable Federal, State, and local building, fire, and safety 
codes must be met.
    (2) Fire extinguishers must be easily accessible and fire 
regulations must be prominently posted.
    (3) A fire alarm system with local (in-house) capability must be 
functional, and where power is generated by electricity, an alternate 
power source with automatic triggering must be present.
    (4) Lights, supported by an emergency power source, must be placed 
at exits.
    (5) A sufficient number of staff to evacuate patients during a 
disaster must be on the premises of the facility whenever patients are 
being treated.
    (6) Lighting must be sufficient to carry out services safely; room 
temperature must be maintained at comfortable levels; and ventilation 
through windows, mechanical means, or a combination of both must be 
provided.

[[Page 137]]

    (7) Safe and sufficient space must be available for the scope of 
services offered.
    (b) Standard: Sanitary environment. The facility must maintain a 
sanitary environment and establish a program to identify, investigate, 
prevent, and control the cause of patient infections.
    (1) The facility must establish written policies and procedures 
designed to control and prevent infection in the facility and to 
investigate and identify possible causes of infection.
    (2) The facility must monitor the infection control program to 
ensure that the staff implement the policies and procedures and that the 
policies and procedures are consistent with current practices in the 
field.
    (3) The facility must make available at all times a quantity of 
laundered linen adequate for proper care and comfort of patients. Linens 
must be handled, stored, and processed in a mannner that prevents the 
spread of infection.
    (4) Provisions must be in effect to ensure that the facility's 
premises are maintained free of rodent and insect infestation.
    (c) Standard: Maintenance of equipment, physical location, and 
grounds. The facility must establish a written preventive maintenance 
program to ensure that--
    (1) All equipment is properly maintained and equipment needing 
periodic calibration is calibrated consistent with the manufacturer's 
recommendations; and
    (2) The interior of the facility, the exterior of the physical 
structure housing the facility, and the exterior walkways and parking 
areas are clean and orderly and maintained free of any defects that are 
a hazard to patients, personnel, and the public.
    (d) Standard: Access for the physically impaired. The facility must 
ensure the following:
    (1) Doorways, stairwells, corridors, and passageways used by 
patients are--
    (i) Of adequate width to allow for easy movement of all patients 
(including those on stretchers or in wheelchairs); and
    (ii) In the case of stairwells, equipped with firmly attached 
handrails on at least one side.
    (2) At least one toilet facility is accessible and constructed to 
allow utilization by ambulatory and nonambulatory individuals.
    (3) At least one entrance is usable by individuals in wheelchairs.
    (4) In multi-story buildings, elevators are accessible to and usable 
by the physically impaired on the level that they use to enter the 
building and all levels normally used by the patients of the facility.
    (5) Parking spaces are large enough and close enough to the facility 
to allow safe access by the physically impaired.



Sec.  485.64  Condition of participation: Disaster procedures.

    The facility must have written policies and procedures that 
specifically define the handling of patients, personnel, records, and 
the public during disasters. All personnel associated with the facility 
must be knowledgeable with respect to these procedures, be trained in 
their application, and be assigned specific responsibilities.
    (a) Standard: Disaster plan. The facility's written disaster plan 
must be developed and maintained with assistance of qualified fire, 
safety, and other appropriate experts. The plan must include--
    (1) Procedures for prompt transfer of casualties and records;
    (2) Procedures for notifying community emergency personnel (for 
example, fire department, ambulance, etc.);
    (3) Instructions regarding the location and use of alarm systems and 
signals and fire fighting equipment; and
    (4) Specification of evacuation routes and procedures for leaving 
the facility.
    (b) Standard: Drills and staff training. (1) The facility must 
provide ongoing training and drills for all personnel associated with 
the facility in all aspects of disaster preparedness.
    (2) All new personnel must be oriented and assigned specific 
responsibilities regarding the facility's disaster plan within two weeks 
of their first workday.



Sec.  485.66  Condition of participation: Utilization review plan.

    The facility must have in effect a written utilization review plan 
that is

[[Page 138]]

implemented at least each quarter, to assess the necessity of services 
and promotes the most efficient use of services provided by the 
facility.
    (a) Standard: Utilization review committee. The utilization review 
committee, consisting of the group of professional personnel specified 
in Sec.  485.56(c), a committee of this group, or a group of similar 
composition, comprised by professional personnel not associated with the 
facility, must carry out the utilization review plan.
    (b) Standard: Utilization review plan. The utilization review plan 
must contain written procedures for evaluating--
    (1) Admissions, continued care, and discharges using, at a minimum, 
the criteria established in the patient care policies;
    (2) The applicability of the plan of treatment to established goals; 
and
    (3) The adequacy of clinical records with regard to--
    (i) Assessing the quality of services provided; and
    (ii) Determining whether the facility's policies and clinical 
practices are compatible and promote appropriate and efficient 
utilization of services.



Sec.  485.70  Personnel qualifications.

    This section sets forth the qualifications that must be met, as a 
condition of participation, under Sec.  485.58, and as a condition of 
coverage of services under Sec.  410.100 of this chapter.
    (a) A facility physician must be a doctor of medicine or osteopathy 
who--
    (1) Is licensed under State law to practice medicine or surgery; and
    (2) Has had, subsequent to completing a 1-year hospital internship, 
at least 1 year of training in the medical management of patients 
requiring rehabilitation services; or
    (3) Has had at least 1 year of full-time or part-time experience in 
a rehabilitation setting providing physicians' services similar to those 
required in this subpart.
    (b) A licensed practical nurse must be licensed as a practical or 
vocational nurse by the State in which practicing, if applicable.
    (c) An occupational therapist and an occupational therapy assistant 
must meet the qualifications in Sec.  484.4 of this chapter.
    (d) An orthotist must--
    (1) Be licensed by the State in which practicing, if applicable;
    (2) Have successfully completed a training program in orthotics that 
is jointly recognized by the American Council on Education and the 
American Board for Certification in Orthotics and Prosthetics; and
    (3) Be eligible to take that Board's certification examination in 
orthotics.
    (e) A physical therapist and a physical therapist assistant must 
meet the qualifications in Sec.  484.4 of this chapter.
    (f) A prosthetist must--
    (1) Be licensed by the State in which practicing, if applicable;
    (2) Have successfully completed a training program in prosthetics 
that is jointly recognized by the American Council on Education and the 
American Board for Certification in Orthotics and Prosthetics; and
    (3) Be eligible to take that Board's certification examination in 
prosthetics.
    (g) A psychologist must be certified or licensed by the State in 
which he or she is practicing, if that State requires certification or 
licensing, and must hold a masters degree in psychology from and 
educational institution approved by the State in which the institution 
is located.
    (h) A registered nurse must be a graduate of an approved school of 
nursing and be licensed as a registered nurse by the State in which 
practicing, if applicable.
    (i) A rehabilitation counselor must--
    (1) Be licensed by the State in which practicing, if applicable;
    (2) Hold at least a bachelor's degree; and
    (3) Be eligible to take the certification examination administered 
by the Commission on Rehabilitation Counselor Certification.
    (j) A respiratory therapist must--
    (1) Be licensed by the State in which practicing, if applicable;
    (2) Have successfully completed a nationally--accredited educational 
program that confers eligibility for the National Board for Respiratory 
Care (NBRC) registry exams, and have

[[Page 139]]

passed the registry examination administered by the NBRC, or
    (3) Have equivalent training and experience as determined by the 
National Board for Respiratory Care (NBRC) and passed the registry 
examination administered by the NBRC.
    (k) A respiratory therapy technician must--
    (1) Be licensed by the State in which practicing, if applicable;
    (2) Have successfully completed a training program accredited by the 
Committees on Allied Health Education and Accreditation (CAHEA) in 
collaboration with the Joint Review Committee for Respiratory Therapy 
Education; and
    (3) Either--
    (i) Be eligible to take the certification examination for 
respiratory therapy technicians administered by the National Board for 
Respiratory Therapy, Inc,; or
    (ii) Have equivalent training and experience as determined by the 
National Board for Respiratory Therapy, Inc.
    (l) A social worker must--
    (1) Be licensed by the State in which practicing, if applicable;
    (2) Hold at least a bachelor's degree from a school accredited or 
approved by the Council on Social Work Education; and
    (3) Have 1 year of social work experience in a health care setting.
    (m) A speech-language pathologist must meet the qualifications set 
forth in part 484 of this chapter.

[48 FR 56293, Dec. 15, 1982. Redesignated and amended at 50 FR 33034, 
Aug. 16, 1985; 51 FR 41352, Nov. 14, 1986; 60 FR 2327, Jan. 9, 1995; 72 
FR 66408, Nov. 27, 2007; 73 FR 69941, Nov. 19, 2008]



Sec.  485.74  Appeal rights.

    The appeal provisions set forth in part 498 of this chapter, for 
providers, are applicable to any entity that is participating or seeks 
to participate in the Medicare program as a CORF.

[48 FR 56293, Dec. 15, 1982, as amended at 52 FR 22454, June 12, 1987]

Subparts C-E [Reserved]



 Subpart F_Conditions of Participation: Critical Access Hospitals (CAHs)

    Source: 58 FR 30671, May 26, 1993, unless otherwise noted.



Sec.  485.601  Basis and scope.

    (a) Statutory basis. This subpart is based on section 1820 of the 
Act which sets forth the conditions for designating certain hospitals as 
CAHs.
    (b) Scope. This subpart sets forth the conditions that a hospital 
must meet to be designated as a CAH.

[58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997]



Sec.  485.602  Definitions.

    As used in this subpart, unless the context indicates otherwise:
    Direct services means services provided by employed staff of the 
CAH, not services provided through arrangements or agreements.

[59 FR 45403, Sept. 1, 1994, as amended at 62 FR 46037, Aug. 29, 1997]



Sec.  485.603  Rural health network.

    A rural health network is an organization that meets the following 
specifications:
    (a) It includes--
    (1) At least one hospital that the State has designated or plans to 
designate as a CAH; and
    (2) At least one hospital that furnishes acute care services.
    (b) The members of the organization have entered into agreements 
regarding--
    (1) Patient referral and transfer;
    (2) The development and use of communications systems, including, 
where feasible, telemetry systems and systems for electronic sharing of 
patient data; and
    (3) The provision of emergency and nonemergency transportation among 
members.
    (c) Each CAH has an agreement with respect to credentialing and 
quality assurance with at least--
    (1) One hospital that is a member of the network when applicable;
    (2) One QIO or equivalent entity; or

[[Page 140]]

    (3) One other appropriate and qualified entity identified in the 
State rural health care plan.

[58 FR 30671, May 26, 1993, as amended at 62 FR 46035, Aug. 29, 1997; 63 
FR 26359, May 12, 1998]



Sec.  485.604  Personnel qualifications.

    Staff that furnish services in a CAH must meet the applicable 
requirements of this section.
    (a) Clinical nurse specialist. A clinical nurse specialist must be a 
person who performs the services of a clinical nurse specialist as 
authorized by the State, in accordance with State law or the State 
regulatory mechanism provided by State law.
    (b) Nurse practitioner. A nurse practitioner must be a registered 
professional nurse who is currently licensed to practice in the State, 
who meets the State's requirements governing the qualification of nurse 
practitioners, and who meets one of the following conditions:
    (1) Is currently certified as a primary care nurse practitioner by 
the American Nurses' Association or by the National Board of Pediatric 
Nurse Practitioners and Associates.
    (2) Has successfully completed a 1 academic year program that--
    (i) Prepares registered nurses to perform an expanded role in the 
delivery of primary care;
    (ii) Includes at least 4 months (in the aggregate) of classroom 
instruction and a component of supervised clinical practice; and
    (iii) Awards a degree, diploma, or certificate to persons who 
successfully complete the program.
    (3) Has successfully completed a formal educational program (for 
preparing registered nurses to perform an expanded role in the delivery 
of primary care) that does not meet the requirements of paragraph (a)(2) 
of this section, and has been performing an expanded role in the 
delivery of primary care for a total of 12 months during the 18-month 
period immediately preceding June 25, 1993.
    (c) Physician assistant. A physician assistant must be a person who 
meets the applicable State requirements governing the qualifications for 
assistants to primary care physicians, and who meets at least one of the 
following conditions:
    (1) Is currently certified by the National Commission on 
Certification of Physician Assistants to assist primary care physicians.
    (2) Has satisfactorily completed a program for preparing physician 
assistants that--
    (i) Was at least one academic year in length;
    (ii) Consisted of supervised clinical practice and at least 4 months 
(in the aggregate) of classroom instruction directed toward preparing 
students to deliver health care; and
    (iii) Was accredited by the American Medical Association's Committee 
on Allied Health Education and Accreditation.
    (3) Has satisfactorily completed a formal educational program (for 
preparing physician assistants) that does not meet the requirements of 
paragraph (c)(2) of this section and has been assisting primary care 
physicians for a total of 12 months during the 18-month period 
immediately preceding June 25, 1993.

[58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997]



Sec.  485.606  Designation and certification of CAHs.

    (a) Criteria for State designation. (1) A State that has established 
a Medicare rural hospital flexibility program described in section 
1820(c) of the Act may designate one or more facilities as CAHs if each 
facility meets the CAH conditions of participation in this subpart F.
    (2) The State must not deny any hospital that is otherwise eligible 
for designation as a CAH under this paragraph (a) solely because the 
hospital has entered into an agreement under which the hospital may 
provide posthospital SNF care as described in Sec.  482.66 of this 
chapter.
    (b) Criteria for CMS certification. CMS certifies a facility as a 
CAH if--
    (1) The facility is designated as a CAH by the State in which it is 
located and has been surveyed by the State survey agency or by CMS and 
found to meet all conditions of participation in

[[Page 141]]

this Part and all other applicable requirements for participation in 
Part 489 of this chapter.
    (2) The facility is a medical assistance facility operating in 
Montana or a rural primary care hospital designated by CMS before August 
5, 1997, and is otherwise eligible to be designated as a CAH by the 
State under the rules in this subpart.

[62 FR 46036, Aug. 29, 1997, as amended at 63 FR 26359, May 12, 1998]



Sec.  485.608  Condition of participation: Compliance with Federal, State, and local laws and regulations.

    The CAH and its staff are in compliance with applicable Federal, 
State and local laws and regulations.
    (a) Standard: Compliance with Federal laws and regulations. The CAH 
is in compliance with applicable Federal laws and regulations related to 
the health and safety of patients.
    (b) Standard: Compliance with State and local laws and regulations. 
All patient care services are furnished in accordance with applicable 
State and local laws and regulations.
    (c) Standard: Licensure of CAH. The CAH is licensed in accordance 
with applicable Federal, State and local laws and regulations.
    (d) Standard: Licensure, certification or registration of personnel. 
Staff of the CAH are licensed, certified, or registered in accordance 
with applicable Federal, State, and local laws and regulations.

[58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997]



Sec.  485.610  Condition of participation: Status and location.

    (a) Standard: Status. The facility is--
    (1) A currently participating hospital that meets all conditions of 
participation set forth in this subpart;
    (2) A recently closed facility, provided that the facility--
    (i) Was a hospital that ceased operations on or after the date that 
is 10 years before November 29, 1999; and
    (ii) Meets the criteria for designation under this subpart as of the 
effective date of its designation; or
    (3) A health clinic or a health center (as defined by the State) 
that--
    (i) Is licensed by the State as a health clinic or a health center;
    (ii) Was a hospital that was downsized to a health clinic or a 
health center; and
    (iii) As of the effective date of its designation, meets the 
criteria for designation set forth in this subpart.
    (b) Standard: Location in a rural area or treatment as rural. The 
CAH meets the requirements of either paragraph (b)(1) or (b)(2) or 
(b)(3) of this section.
    (1) The CAH meets the following requirements:
    (i) The CAH is located outside any area that is a Metropolitan 
Statistical Area, as defined by the Office of Management and Budget, or 
that has been recognized as urban under Sec.  412.64(b), excluding 
paragraph (b)(3) of this chapter;
    (ii) The CAH has not been classified as an urban hospital for 
purposes of the standardized payment amount by CMS or the Medicare 
Geographic Classification Review Board under Sec.  412.230(e) of this 
chapter, and is not among a group of hospitals that have been 
redesignated to an adjacent urban area under Sec.  412.232 of this 
chapter.
    (2) The CAH is located within a Metropolitan Statistical Area, as 
defined by the Office of Management and Budget, but is being treated as 
being located in a rural area in accordance with Sec.  412.103 of this 
chapter.
    (3) Effective for October 1, 2004 through September 30, 2006, the 
CAH does not meet the location requirements in either paragraph (b)(1) 
or (b)(2) of this section and is located in a county that, in FY 2004, 
was not part of a Metropolitan Statistical Area as defined by the Office 
of Management and Budget, but as of FY 2005 was included as part of such 
a Metropolitan Statistical Area as a result of the most recent census 
data and implementation of the new Metropolitan Statistical Area 
definitions announced by the Office of Management and Budget on June 3, 
2003.
    (4) Effective for October 1, 2009 through September 30, 2011, the 
CAH does not meet the location requirements in either paragraph (b)(1) 
or (b)(2) of this section and is located in a county that, in FY 2009, 
was not part of

[[Page 142]]

a Metropolitan Statistical Area as defined by the Office of Management 
and Budget, but, as of FY 2010, was included as part of such a 
Metropolitan Statistical Area as a result of the most recent census data 
and implementation of the new Metropolitan Statistical Area definitions 
announced by the Office of Management and Budget on November 20, 2008.
    (c) Standard: Location relative to other facilities or necessary 
provider certification. The CAH is located more than a 35-mile drive 
(or, in the case of mountainous terrain or in areas with only secondary 
roads available, a 15-mile drive) from a hospital or another CAH, or 
before January 1, 2006, the CAH is certified by the State as being a 
necessary provider of health care services to residents in the area. A 
CAH that is designated as a necessary provider on or before December 31, 
2005, will maintain its necessary provider designation after January 1, 
2006.
    (d) Standard: Relocation of CAHs with a necessary provider 
designation. A CAH that has a necessary provider designation from the 
State that was in effect prior to January 1, 2006, and relocates its 
facility after January 1, 2006, can continue to meet the location 
requirement of paragraph (c) of this section based on the necessary 
provider designation only if the relocated facility meets the 
requirements as specified in paragraph (d)(1) of this section.
    (1) If a necessary provider CAH relocates its facility and begins 
providing services in a new location, the CAH can continue to meet the 
location requirement of paragraph (c) of this section based on the 
necessary provider designation only if the CAH in its new location--
    (i) Serves at least 75 percent of the same service area that it 
served prior to its relocation;
    (ii) Provides at least 75 percent of the same services that it 
provided prior to the relocation; and
    (iii) Is staffed by 75 percent of the same staff (including medical 
staff, contracted staff, and employees) that were on staff at the 
original location.
    (2) If a CAH that has been designated as a necessary provider by the 
State begins providing services at another location after January 1, 
2006, and does not meet the requirements in paragraph (d)(1) of this 
section, the action will be considered a cessation of business as 
described in Sec.  489.52(b)(3).
    (e) Standard: Off-campus and co-location requirements for CAHs. A 
CAH may continue to meet the location requirements of paragraph (c) of 
this section only if the CAH meets the following:
    (1) If a CAH with a necessary provider designation is co-located 
(that is, it shares a campus, as defined in Sec.  413.65(a)(2) of this 
chapter, with another hospital or CAH), the necessary provider CAH can 
continue to meet the location requirement of paragraph (c) of this 
section only if the co-location arrangement was in effect before January 
1, 2008, and the type and scope of services offered by the facility co-
located with the necessary provider CAH do not change. A change of 
ownership of any of the facilities with a co-location arrangement that 
was in effect before January 1, 2008, will not be considered to be a new 
co-location arrangement.
    (2) If a CAH or a necessary provider CAH operates an off-campus 
provider-based location, excluding an RHC as defined in Sec.  
405.2401(b) of this chapter, but including a department or remote 
location, as defined in Sec.  413.65(a)(2) of this chapter, or an off-
campus distinct part psychiatric or rehabilitation unit, as defined in 
Sec.  485.647, that was created or acquired by the CAH on or after 
January 1, 2008, the CAH can continue to meet the location requirement 
of paragraph (c) of this section only if the off-campus provider-based 
location or off-campus distinct part unit is located more than a 35-mile 
drive (or, in the case of mountainous terrain or in areas with only 
secondary roads available, a 15-mile drive) from a hospital or another 
CAH.
    (3) If either a CAH or a CAH that has been designated as a necessary 
provider by the State does not meet the requirements in paragraph (e)(1) 
of this section, by co-locating with another hospital or CAH on or after 
January 1, 2008, or creates or acquires an off-campus provider-based 
location or off-campus distinct part unit on or after January 1, 2008, 
that does not meet the requirements in paragraph (e)(2) of this section, 
the CAH's provider agreement

[[Page 143]]

will be subject to termination in accordance with the provisions of 
Sec.  489.53(a)(3) of this subchapter, unless the CAH terminates the 
off-campus arrangement or the co-location arrangement, or both.

[62 FR 46036, Aug. 29, 1997, as amended at 65 FR 47052, Aug. 1, 2000; 66 
FR 39938, Aug. 1, 2001; 69 FR 49271, Aug. 11, 2004; 69 FR 60252, Oct. 7, 
2004; 70 FR 47490, Aug. 12, 2005; 71 FR 48143, Aug. 18, 2006; 72 FR 
66934, Nov. 27, 2007; 73 FR 9862, Feb. 22, 2008; 74 FR 44001, Aug. 27, 
2009]



Sec.  485.612  Condition of participation: Compliance with hospital requirements at the time of application.

    Except for recently closed facilities as described in Sec.  
485.610(a)(2), or health clinics or health centers as described in Sec.  
485.610(a)(3), the facility is a hospital that has a provider agreement 
to participate in the Medicare program as a hospital at the time the 
hospital applies for designation as a CAH.

[66 FR 32196, June 13, 2001]



Sec.  485.616  Condition of participation: Agreements.

    (a) Standard: Agreements with network hospitals. In the case of a 
CAH that is a member of a rural health network as defined in Sec.  
485.603 of this chapter, the CAH has in effect an agreement with at 
least one hospital that is a member of the network for--
    (1) Patient referral and transfer;
    (2) The development and use of communications systems of the 
network, including the network's system for the electronic sharing of 
patient data, and telemetry and medical records, if the network has in 
operation such a system; and
    (3) The provision of emergency and nonemergency transportation 
between the facility and the hospital.
    (b) Standard: Agreements for credentialing and quality assurance. 
Each CAH that is a member of a rural health network shall have an 
agreement with respect to credentialing and quality assurance with at 
least--
    (1) One hospital that is a member of the network;
    (2) One QIO or equivalent entity; or
    (3) One other appropriate and qualified entity identified in the 
State rural health care plan.

[62 FR 46036, Aug. 29, 1997]



Sec.  485.618  Condition of participation: Emergency services.

    The CAH provides emergency care necessary to meet the needs of its 
inpatients and outpatients.
    (a) Standard: Availability. Emergency services are available on a 
24-hours a day basis.
    (b) Standard: Equipment, supplies, and medication. Equipment, 
supplies, and medication used in treating emergency cases are kept at 
the CAH and are readily available for treating emergency cases. The 
items available must include the following:
    (1) Drugs and biologicals commonly used in life-saving procedures, 
including analgesics, local anesthetics, antibiotics, anticonvulsants, 
antidotes and emetics, serums and toxoids, antiarrythmics, cardiac 
glycosides, antihypertensives, diuretics, and electrolytes and 
replacement solutions.
    (2) Equipment and supplies commonly used in life-saving procedures, 
including airways, endotracheal tubes, ambu bag/valve/mask, oxygen, 
tourniquets, immobilization devices, nasogastric tubes, splints, IV 
therapy supplies, suction machine, defibrillator, cardiac monitor, chest 
tubes, and indwelling urinary catheters.
    (c) Standard: Blood and blood products. The facility provides, 
either directly or under arrangements, the following:
    (1) Services for the procurement, safekeeping, and transfusion of 
blood, including the availability of blood products needed for 
emergencies on a 24-hours a day basis.
    (2) Blood storage facilities that meet the requirements of 42 CFR 
part 493, subpart K, and are under the control and supervision of a 
pathologist or other qualified doctor of medicine or osteopathy. If 
blood banking services are provided under an arrangement, the 
arrangement is approved by the facility's medical staff and by the 
persons directly responsible for the operation of the facility.

[[Page 144]]

    (d) Standard: Personnel. (1) Except as specified in paragraph (d)(3) 
of this section, there must be a doctor of medicine or osteopathy, a 
physician assistant, a nurse practitioner, or a clinical nurse 
specialist, with training or experience in emergency care, on call and 
immediately available by telephone or radio contact, and available on 
site within the following timeframes:
    (i) Within 30 minutes, on a 24-hour a day basis, if the CAH is 
located in an area other than an area described in paragraph (d)(1)(ii) 
of this section; or
    (ii) Within 60 minutes, on a 24-hour a day basis, if all of the 
following requirements are met:
    (A) The CAH is located in an area designated as a frontier area 
(that is, an area with fewer than six residents per square mile based on 
the latest population data published by the Bureau of the Census) or in 
an area that meets the criteria for a remote location adopted by the 
State in its rural health care plan, and approved by CMS, under section 
1820(b) of the Act.
    (B) The State has determined, under criteria in its rural health 
care plan, that allowing an emergency response time longer than 30 
minutes is the only feasible method of providing emergency care to 
residents of the area served by the CAH.
    (C) The State maintains documentation showing that the response time 
of up to 60 minutes at a particular CAH it designates is justified 
because other available alternatives would increase the time needed to 
stabilize a patient in an emergency.
    (2) A registered nurse with training and experience in emergency 
care can be utilized to conduct specific medical screening examinations 
only if--
    (i) The registered nurse is on site and immediately available at the 
CAH when a patient requests medical care; and
    (ii) The nature of the patient's request for medical care is within 
the scope of practice of a registered nurse and consistent with 
applicable State laws and the CAH's bylaws or rules and regulations.
    (3) A registered nurse satisfies the personnel requirement specified 
in paragraph (d)(1) of this section for a temporary period if--
    (i) The CAH has no greater than 10 beds;
    (ii) The CAH is located in an area designated as a frontier area or 
remote location as described in paragraph (d)(1)(ii)(A) of this section;
    (iii) The State in which the CAH is located submits a letter to CMS 
signed by the Governor, following consultation on the issue of using RNs 
on a temporary basis as part of their State rural healthcare plan with 
the State Boards of Medicine and Nursing, and in accordance with State 
law, requesting that a registered nurse with training and experience in 
emergency care be included in the list of personnel specified in 
paragraph (d)(1) of this section. The letter from the Governor must 
attest that he or she has consulted with State Boards of Medicine and 
Nursing about issues related to access to and the quality of emergency 
services in the States. The letter from the Governor must also describe 
the circumstances and duration of the temporary request to include the 
registered nurses on the list of personnel specified in paragraph (d)(1) 
of this section;
    (iv) Once a Governor submits a letter, as specified in paragraph 
(d)(3)(iii) of this section, a CAH must submit documentation to the 
State survey agency demonstrating that it has been unable, due to the 
shortage of such personnel in the area, to provide adequate coverage as 
specified in this paragraph (d).
    (4) The request, as specified in paragraph (d)(3)(iii) of this 
section, and the withdrawal of the request, may be submitted to us at 
any time, and are effective upon submission.
    (e) Standard: Coordination with emergency response systems. The CAH 
must, in coordination with emergency response systems in the area, 
establish procedures under which a doctor of medicine or osteopathy is 
immediately available by telephone or radio contact on a 24-hours a day 
basis to receive emergency calls, provide information on treatment of 
emergency patients,

[[Page 145]]

and refer patients to the CAH or other appropriate locations for 
treatment.

[58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997; 64 
FR 41544, July 30, 1999; 67 FR 80041, Dec. 31, 2002; 69 FR 49271, Aug. 
11, 2004; 71 FR 68230, Nov. 24, 2006]



Sec.  485.620  Condition of participation: Number of beds and length of stay.

    (a) Standard: Number of beds. Except as permitted for CAHs having 
distinct part units under Sec.  485.647, the CAH maintains no more than 
25 inpatient beds after January 1, 2004, that can be used for either 
inpatient or swing-bed services.
    (b) Standard: Length of stay. The CAH provides acute inpatient care 
for a period that does not exceed, on an annual average basis, 96 hours 
per patient.

[62 FR 46036, Aug. 29, 1997, as amended at 65 FR 47052, Aug. 1, 2000; 69 
FR 49271, Aug. 11, 2004; 69 FR 60252, Oct. 7, 2004]



Sec.  485.623  Condition of participation: Physical plant and environment.

    (a) Standard: Construction. The CAH is constructed, arranged, and 
maintained to ensure access to and safety of patients, and provides 
adequate space for the provision of direct services.
    (b) Standard: Maintenance. The CAH has housekeeping and preventive 
maintenance programs to ensure that--
    (1) All essential mechanical, electrical, and patient-care equipment 
is maintained in safe operating condition;
    (2) There is proper routine storage and prompt disposal of trash;
    (3) Drugs and biologicals are appropriately stored;
    (4) The premises are clean and orderly; and
    (5) There is proper ventilation, lighting, and temperature control 
in all pharmaceutical, patient care, and food preparation areas.
    (c) Standard: Emergency procedures. The CAH assures the safety of 
patients in non-medical emergencies by--
    (1) Training staff in handling emergencies, including prompt 
reporting of fires, extinguishing of fires, protection and, where 
necessary, evacuation of patients, personnel, and guests, and 
cooperation with fire fighting and disaster authorities;
    (2) Providing for emergency power and lighting in the emergency room 
and for battery lamps and flashlights in other areas;
    (3) Providing for an emergency fuel and water supply; and
    (4) Taking other appropriate measures that are consistent with the 
particular conditions of the area in which the CAH is located.
    (d) Standard: Life safety from fire. (1) Except as otherwise 
provided in this section--
    (i) The CAH must meet the applicable provisions of the 2000 edition 
of the Life Safety Code of the National Fire Protection Association. The 
Director of the Office of the Federal Register has approved the NFPA 101 
[reg] 2000 edition of the Life Safety Code, issued January 
14, 2000, for incorporation by reference in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51. A copy of the Code is available for inspection 
at the CMS Information Resource Center, 7500 Security Boulevard, 
Baltimore, MD or at the National Archives and Records Administration 
(NARA). For information on the availability of this material at NARA, 
call 202-741-6030, or go to: http://www.archives.gov/federal--register/
code--of--federal--regulations/ibr--locations.html. Copies may be 
obtained from the National Fire Protection Association, 1 Batterymarch 
Park, Quincy, MA 02269. If any changes in this edition of the Code are 
incorporated by reference, CMS will publish notice in the Federal 
Register to announce the changes.
    (ii) Chapter 19.3.6.3.2, exception number 2 of the adopted edition 
of the Life Safety Code does not apply to a CAH.
    (2) If CMS finds that the State has a fire and safety code imposed 
by State law that adequately protects patients, CMS may allow the State 
survey agency to apply the State's fire and safety code instead of the 
LSC.
    (3) After consideration of State survey agency findings, CMS may 
waive specific provisions of the Life Safety Code that, if rigidly 
applied, would result in unreasonable hardship on the CAH, but only if 
the waiver does not adversely affect the health and safety of patients.

[[Page 146]]

    (4) The CAH maintains written evidence of regular inspection and 
approval by State or local fire control agencies.
    (5) Beginning March 13, 2006, a critical access hospital must be in 
compliance with Chapter 9.2.9, Emergency Lighting.
    (6) Beginning March 13, 2006, Chapter 19.3.6.3.2, exception number 2 
does not apply to critical access hospitals.
    (7) Notwithstanding any provisions of the 2000 edition of the Life 
Safety Code to the contrary, a critical access hospital may install 
alcohol-based hand rub dispensers in its facility if--
    (i) Use of alcohol-based hand rub dispensers does not conflict with 
any State or local codes that prohibit or otherwise restrict the 
placement of alcohol-based hand rub dispensers in health care 
facilities;
    (ii) The dispensers are installed in a manner that minimizes leaks 
and spills that could lead to falls;
    (iii) The dispensers are installed in a manner that adequately 
protects against inappropriate access;
    (iv) The dispensers are installed in accordance with chapter 
18.3.2.7 or chapter 19.3.2.7 of the 2000 edition of the Life Safety 
Code, as amended by NFPA Temporary Interim Amendment 00-1(101), issued 
by the Standards Council of the National Fire Protection Association on 
April 15, 2004. The Director of the Office of the Federal Register has 
approved NFPA Temporary Interim Amendment 00-1(101) for incorporation by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy 
of the amendment is available for inspection at the CMS Information 
Resource Center, 7500 Security Boulevard, Baltimore, MD and at the 
Office of the Federal Register, 800 North Capitol Street NW., Suite 700, 
Washington, DC. Copies may be obtained from the National Fire Protection 
Association, 1 Batterymarch Park, Quincy, MA 02269; and
    (v) The dispensers are maintained in accordance with dispenser 
manufacturer guidelines.

[58 FR 30671, May 26, 1993, as amended at 62 FR 46036, 46037, Aug. 29, 
1997; 68 FR 1387, Jan. 10, 2003; 69 FR 49271, Aug. 11, 2004; 70 FR 
15239, Mar. 25, 2005; 71 FR 55341, Sept. 22, 2006]



Sec.  485.627  Condition of participation: Organizational structure.

    (a) Standard: Governing body or responsible individual. The CAH has 
a governing body or an individual that assumes full legal responsibility 
for determining, implementing and monitoring policies governing the 
CAH's total operation and for ensuring that those policies are 
administered so as to provide quality health care in a safe environment.
    (b) Standard: Disclosure. The CAH discloses the names and addresses 
of--
    (1) Its owners, or those with a controlling interest in the CAH or 
in any subcontractor in which the CAH directly or indirectly has a 5 
percent or more ownership interest, in accordance with subpart C of part 
420 of this chapter;
    (2) The person principally responsible for the operation of the CAH; 
and
    (3) The person responsible for medical direction.

[58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997]



Sec.  485.631  Condition of participation: Staffing and staff responsibilities.

    (a) Standard: Staffing--(1) The CAH has a professional health care 
staff that includes one or more doctors of medicine or osteopathy, and 
may include one or more physician assistants, nurse practitioners, or 
clinical nurse specialists.
    (2) Any ancillary personnel are supervised by the professional 
staff.
    (3) The staff is sufficient to provide the services essential to the 
operation of the CAH.
    (4) A doctor of medicine or osteopathy, nurse practitioner, clinical 
nurse specialist, or physician assistant is available to furnish patient 
care services at all times the CAH operates.
    (5) A registered nurse, clinical nurse specialist, or licensed 
practical nurse is on duty whenever the CAH has one or more inpatients.
    (b) Standard: Responsibilities of the doctor of medicine or 
osteopathy. (1) The doctor of medicine or osteopathy--
    (i) Provides medical direction for the CAH's health care activities 
and consultation for, and medical supervision of, the health care staff;

[[Page 147]]

    (ii) In conjunction with the physician assistant and/or nurse 
practitioner member(s), participates in developing, executing, and 
periodically reviewing the CAH's written policies governing the services 
it furnishes.
    (iii) In conjunction with the physician assistant and/or nurse 
practitioner members, periodically reviews the CAH's patient records, 
provides medical orders, and provides medical care services to the 
patients of the CAH; and
    (iv) Periodically reviews and signs the records of all inpatients 
cared for by nurse practitioners, clinical nurse specialists, certified 
nurse midwives, or physician assistants.
    (v) Periodically, but not less than every 2 weeks, reviews and signs 
a sample of outpatient records of patients cared for by nurse 
practitioners, clinical nurse specialists, certified nurse midwives, or 
physician assistants according to the policies of the CAH and according 
to current standards of practice where State law requires record reviews 
or co-signatures, or both, by a collaborating physician.
    (vi) Is not required to review and sign outpatient records of 
patients cared for by nurse practitioners, clinical nurse specialists, 
certified nurse midwives, or physician assistants where State law does 
not require record reviews or co-signatures, or both, by a collaborating 
physician.
    (2) A doctor of medicine or osteopathy is present for sufficient 
periods of time, at least once in every 2 week period (except in 
extraordinary circumstances) to provide the medical direction, medical 
care services, consultation, and supervision described in this 
paragraph, and is available through direct radio or telephone 
communication for consultation, assistance with medical emergencies, or 
patient referral. The extraordinary circumstances are documented in the 
records of the CAH. A site visit is not required if no patients have 
been treated since the latest site visit.
    (c) Standard: Physician assistant, nurse practitioner, and clinical 
nurse specialist responsibilities. (1) The physician assistant, the 
nurse practitioner, or clinical nurse specialist members of the CAH's 
staff--
    (i) Participate in the development, execution and periodic review of 
the written policies governing the services the CAH furnishes; and
    (ii) Participate with a doctor of medicine or osteopathy in a 
periodic review of the patients' health records.
    (2) The physician assistant, nurse practitioner, or clinical nurse 
specialist performs the following functions to the extent they are not 
being performed by a doctor of medicine or osteopathy:
    (i) Provides services in accordance with the CAH's policies.
    (ii) Arranges for, or refers patients to, needed services that 
cannot be furnished at the CAH, and assures that adequate patient health 
records are maintained and transferred as required when patients are 
referred.
    (3) Whenever a patient is admitted to the CAH by a nurse 
practitioner, physician assistant, or clinical nurse specialist, a 
doctor of medicine or osteopathy on the staff of the CAH is notified of 
the admission.

[58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997; 70 
FR 68728, Nov. 10, 2005]



Sec.  485.635  Condition of participation: Provision of services.

    (a) Standard: Patient care policies. (1) The CAH's health care 
services are furnished in accordance with appropriate written policies 
that are consistent with applicable State law.
    (2) The policies are developed with the advice of a group of 
professional personnel that includes one or more doctors of medicine or 
osteopathy and one or more physician assistants, nurse practitioners, or 
clinical nurse specialists, if they are on staff under the provisions of 
Sec.  485.631(a)(1); at least one member is not a member of the CAH 
staff.
    (3) The policies include the following: (i) A description of the 
services the CAH furnishes directly and those furnished through 
agreement or arrangement.
    (ii) Policies and procedures for emergency medical services.
    (iii) Guidelines for the medical management of health problems that 
include the conditions requiring medical consultation and/or patient 
referral,

[[Page 148]]

the maintenance of health care records, and procedures for the periodic 
review and evaluation of the services furnished by the CAH.
    (iv) Rules for the storage, handling, dispensation, and 
administration of drugs and biologicals. These rules must provide that 
there is a drug storage area that is administered in accordance with 
accepted professional principles, that current and accurate records are 
kept of the receipt and disposition of all scheduled drugs, and that 
outdated, mislabeled, or otherwise unusable drugs are not available for 
patient use.
    (v) Procedures for reporting adverse drug reactions and errors in 
the administration of drugs.
    (vi) A system for identifying, reporting, investigating and 
controlling infections and communicable diseases of patients and 
personnel.
    (vii) If the CAH furnishes inpatient services, procedures that 
ensure that the nutritional needs of inpatients are met in accordance 
with recognized dietary practices and the orders of the practitioner 
responsible for the care of the patients, and that the requirement of 
Sec.  483.25(i) is met with respect to inpatients receiving posthospital 
SNF care.
    (4) These policies are reviewed at least annually by the group of 
professional personnel required under paragraph (a)(2) of this section, 
and reviewed as necessary by the CAH.
    (b) Standard: Direct services--(1) General. The CAH staff furnishes, 
as direct services, those diagnostic and therapeutic services and 
supplies that are commonly furnished in a physician's office or at 
another entry point into the health care delivery system, such as a low 
intensity hospital outpatient department or emergency department. These 
direct services include medical history, physical examination, specimen 
collection, assessment of health status, and treatment for a variety of 
medical conditions.
    (2) Laboratory services. The CAH provides, as direct services, basic 
laboratory services essential to the immediate diagnosis and treatment 
of the patient that meet the standards imposed under section 353 of the 
Public Health Service Act (42 U.S.C. 236a). (See the laboratory 
requirements specified in part 493 of this chapter.) The services 
provided include:
    (i) Chemical examination of urine by stick or tablet method or both 
(including urine ketones);
    (ii) Hemoglobin or hematocrit;
    (iii) Blood glucose:
    (iv) Examination of stool specimens for occult blood;
    (v) Pregnancy tests; and
    (vi) Primary culturing for transmittal to a certified laboratory.
    (3) Radiology services. Radiology services furnished at the CAH are 
provided as direct services by staff qualified under State law, and do 
not expose CAH patients or staff to radiation hazards.
    (4) Emergency procedures. In accordance with the requirements of 
Sec.  485.618, the CAH provides as direct services medical emergency 
procedures as a first response to common life-threatening injuries and 
acute illness.
    (c) Standard: Services provided through agreements or arrangements. 
(1) The CAH has agreements or arrangements (as appropriate) with one or 
more providers or suppliers participating under Medicare to furnish 
other services to its patients, including--
    (i) Inpatient hospital care;
    (ii) Services of doctors of medicine or osteopathy; and
    (iii) Additional or specialized diagnostic and clinical laboratory 
services that are not available at the CAH.
    (iv) Food and other services to meet inpatients' nutritional needs 
to the extent these services are not provided directly by the CAH.
    (2) If the agreements or arrangements are not in writing, the CAH is 
able to present evidence that patients referred by the CAH are being 
accepted and treated.
    (3) The CAH maintains a list of all services furnished under 
arrangements or agreements. The list describes the nature and scope of 
the services provided.
    (4) The person principally responsible for the operation of the CAH 
under Sec.  485.627(b)(2) of this chapter is also responsible for the 
following:
    (i) Services furnished in the CAH whether or not they are furnished 
under arrangements or agreements.

[[Page 149]]

    (ii) Ensuring that a contractor of services (including one for 
shared services and joint ventures) furnishes services that enable the 
CAH to comply with all applicable conditions of participation and 
standards for the contracted services.
    (d) Standard: Nursing services. Nursing services must meet the needs 
of patients.
    (1) A registered nurse must provide (or assign to other personnel) 
the nursing care of each patient, including patients at a SNF level of 
care in a swing-bed CAH. The care must be provided in accordance with 
the patient's needs and the specialized qualifications and competence of 
the staff available.
    (2) A registered nurse or, where permitted by State law, a physician 
assistant, must supervise and evaluate the nursing care for each 
patient, including patients at a SNF level of care in a swing-bed CAH.
    (3) All drugs, biologicals, and intravenous medications must be 
administered by or under the supervision of a registered nurse, a doctor 
of medicine or osteopathy, or, where permitted by State law, a physician 
assistant, in accordance with written and signed orders, accepted 
standards of practice, and Federal and State laws.
    (4) A nursing care plan must be developed and kept current for each 
inpatient.
    (e) Standard: Rehabilitation Therapy Services. Physical therapy, 
occupational therapy, and speech-language pathology services furnished 
at the CAH, if provided, are provided by staff qualified under State 
law, and consistent with the requirements for therapy services in Sec.  
409.17 of this subpart.

[58 FR 30671, May 26, 1993; 58 FR 49935, Sept. 24, 1993, as amended at 
59 FR 45403, Sept. 1, 1994; 62 FR 46037, Aug. 29, 1997; 72 FR 66408, 
Nov. 27, 2007; 73 FR 69941, Nov. 19, 2008]



Sec.  485.638  Conditions of participation: Clinical records.

    (a) Standard: Records system--(1) The CAH maintains a clinical 
records system in accordance with written policies and procedures.
    (2) The records are legible, complete, accurately documented, 
readily accessible, and systematically organized.
    (3) A designated member of the professional staff is responsible for 
maintaining the records and for ensuring that they are completely and 
accurately documented, readily accessible, and systematically organized.
    (4) For each patient receiving health care services, the CAH 
maintains a record that includes, as applicable--
    (i) Identification and social data, evidence of properly executed 
informed consent forms, pertinent medical history, assessment of the 
health status and health care needs of the patient, and a brief summary 
of the episode, disposition, and instructions to the patient;
    (ii) Reports of physical examinations, diagnostic and laboratory 
test results, including clinical laboratory services, and consultative 
findings;
    (iii) All orders of doctors of medicine or osteopathy or other 
practitioners, reports of treatments and medications, nursing notes and 
documentation of complications, and other pertinent information 
necessary to monitor the patient's progress, such as temperature 
graphics, progress notes describing the patient's response to treatment; 
and
    (iv) Dated signatures of the doctor of medicine or osteopathy or 
other health care professional.
    (b) Standard: Protection of record information--(1) The CAH 
maintains the confidentiality of record information and provides 
safeguards against loss, destruction, or unauthorized use.
    (2) Written policies and procedures govern the use and removal of 
records from the CAH and the conditions for the release of information.
    (3) The patient's written consent is required for release of 
information not required by law.
    (c) Standard: Retention of records. The records are retained for at 
least 6 years from date of last entry, and longer if required by State 
statute, or if the records may be needed in any pending proceeding.

[58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997]



Sec.  485.639  Condition of participation: Surgical services.

    Surgical procedures must be performed in a safe manner by qualified 
practitioners who have been granted

[[Page 150]]

clinical privileges by the governing body of the CAH in accordance with 
the designation requirements under paragraph (a) of this section.
    (a) Designation of qualified practitioners. The CAH designates the 
practitioners who are allowed to perform surgery for CAH patients, in 
accordance with its approved policies and procedures, and with State 
scope of practice laws. Surgery is performed only by--
    (1) A doctor of medicine or osteopathy, including an osteopathic 
practitioner recognized under section 1101(a)(7) of the Act;
    (2) A doctor of dental surgery or dental medicine; or
    (3) A doctor of podiatric medicine.
    (b) Anesthetic risk and evaluation. (1) A qualified practitioner, as 
specified in paragraph (a) of this section, must examine the patient 
immediately before surgery to evaluate the risk of the procedure to be 
performed.
    (2) A qualified practitioner, as specified in paragraph (c) of this 
section, must examine each patient before surgery to evaluate the risk 
of anesthesia.
    (3) Before discharge from the CAH, each patient must be evaluated 
for proper anesthesia recovery by a qualified practitioner, as specified 
in paragraph (c) of this section.
    (c) Administration of anesthesia. The CAH designates the person who 
is allowed to administer anesthesia to CAH patients in accordance with 
its approved policies and procedures and with State scope-of-practice 
laws.
    (1) Anesthesia must be administered by only--
    (i) A qualified anesthesiologist;
    (ii) A doctor of medicine or osteopathy other than an 
anesthesiologist; including an osteopathic practitioner recognized under 
section 1101(a)(7) of the Act;
    (iii) A doctor of dental surgery or dental medicine;
    (iv) A doctor of podiatric medicine;
    (v) A certified registered nurse anesthetist (CRNA), as defined in 
Sec.  410.69(b) of this chapter;
    (vi) An anesthesiologist's assistant, as defined in Sec.  410.69(b) 
of this chapter; or
    (vii) A supervised trainee in an approved educational program, as 
described in Sec. Sec.  413.85 or 413.86 of this chapter.
    (2) In those cases in which a CRNA administers the anesthesia, the 
anesthetist must be under the supervision of the operating practitioner 
except as provided in paragraph (e) of this section. An 
anesthesiologist's assistant who administers anesthesia must be under 
the supervision of an anesthesiologist.
    (d) Discharge. All patients are discharged in the company of a 
responsible adult, except those exempted by the practitioner who 
performed the surgical procedure.
    (e) Standard: State exemption. (1) A CAH may be exempted from the 
requirement for physician supervision of CRNAs as described in paragraph 
(c)(2) of this section, if the State in which the CAH is located submits 
a letter to CMS signed by the Governor, following consultation with the 
State's Boards of Medicine and Nursing, requesting exemption from 
physician supervision for CRNAs. The letter from the Governor must 
attest that he or she has consulted with the State Boards of Medicine 
and Nursing about issues related to access to and the quality of 
anesthesia services in the State and has concluded that it is in the 
best interests of the State's citizens to opt-out of the current 
physician supervision requirement, and that the opt-out is consistent 
with State law.
    (2) The request for exemption and recognition of State laws and the 
withdrawal of the request may be submitted at any time, and are 
effective upon submission.

[60 FR 45851, Sept. 1, 1995, as amended at 62 FR 46037, Aug. 29, 1997; 
66 FR 39938, Aug. 1, 2001; 66 FR 56769, Nov. 13, 2001]



Sec.  485.641  Condition of participation: Periodic evaluation and quality assurance review.

    (a) Standard: Periodic evaluation--(1) The CAH carries out or 
arranges for a periodic evaluation of its total program. The evaluation 
is done at least once a year and includes review of--
    (i) The utilization of CAH services, including at least the number 
of patients served and the volume of services;

[[Page 151]]

    (ii) A representative sample of both active and closed clinical 
records; and
    (iii) The CAH's health care policies.
    (2) The purpose of the evaluation is to determine whether the 
utilization of services was appropriate, the established policies were 
followed, and any changes are needed.
    (b) Standard: Quality assurance. The CAH has an effective quality 
assurance program to evaluate the quality and appropriateness of the 
diagnosis and treatment furnished in the CAH and of the treatment 
outcomes. The program requires that--
    (1) All patient care services and other services affecting patient 
health and safety, are evaluated;
    (2) Nosocomial infections and medication therapy are evaluated;
    (3) The quality and appropriateness of the diagnosis and treatment 
furnished by nurse practitioners, clinical nurse specialists, and 
physician assistants at the CAH are evaluated by a member of the CAH 
staff who is a doctor of medicine or osteopathy or by another doctor of 
medicine or osteopathy under contract with the CAH;
    (4) The quality and appropriateness of the diagnosis and treatment 
furnished by doctors of medicine or osteopathy at the CAH are evaluated 
by--
    (i) One hospital that is a member of the network, when applicable;
    (ii) One QIO or equivalent entity; or
    (iii) One other appropriate and qualified entity identified in the 
State rural health care plan; and
    (5)(i) The CAH staff considers the findings of the evaluations, 
including any findings or recommendations of the QIO, and takes 
corrective action if necessary.
    (ii) The CAH also takes appropriate remedial action to address 
deficiencies found through the quality assurance program.
    (iii) The CAH documents the outcome of all remedial action.

[58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997; 63 
FR 26359, May 12, 1998]



Sec.  485.643  Condition of participation: Organ, tissue, and eye procurement.

    The CAH must have and implement written protocols that:
    (a) Incorporate an agreement with an OPO designated under part 486 
of this chapter, under which it must notify, in a timely manner, the OPO 
or a third party designated by the OPO of individuals whose death is 
imminent or who have died in the CAH. The OPO determines medical 
suitability for organ donation and, in the absence of alternative 
arrangements by the CAH, the OPO determines medical suitability for 
tissue and eye donation, using the definition of potential tissue and 
eye donor and the notification protocol developed in consultation with 
the tissue and eye banks identified by the CAH for this purpose;
    (b) Incorporate an agreement with at least one tissue bank and at 
least one eye bank to cooperate in the retrieval, processing, 
preservation, storage and distribution of tissues and eyes, as may be 
appropriate to assure that all usable tissues and eyes are obtained from 
potential donors, insofar as such an agreement does not interfere with 
organ procurement;
    (c) Ensure, in collaboration with the designated OPO, that the 
family of each potential donor is informed of its option to either 
donate or not donate organs, tissues, or eyes. The individual designated 
by the CAH to initiate the request to the family must be a designated 
requestor. A designated requestor is an individual who has completed a 
course offered or approved by the OPO and designed in conjunction with 
the tissue and eye bank community in the methodology for approaching 
potential donor families and requesting organ or tissue donation;
    (d) Encourage discretion and sensitivity with respect to the 
circumstances, views, and beliefs of the families of potential donors;
    (e) Ensure that the CAH works cooperatively with the designated OPO, 
tissue bank and eye bank in educating staff on donation issues, 
reviewing death records to improve identification of potential donors, 
and maintaining potential donors while necessary testing and placement 
of potential donated organs, tissues, and eyes take place.

[[Page 152]]

    (f) For purposes of these standards, the term ``organ'' means a 
human kidney, liver, heart, lung, pancreas, or intestines (or 
multivisceral organs).

[65 FR 47110, Aug. 1, 2000, as amended at 66 FR 39938, Aug. 1, 2001]



Sec.  485.645  Special requirements for CAH providers of long-term care services (``swing-beds'')

    A CAH must meet the following requirements in order to be granted an 
approval from CMS to provided post-hospital SNF care, as specified in 
Sec.  409.30 of this chapter, and to be paid for SNF-level services, in 
accordance with paragraph (c) of this section.
    (a) Eligibility. A CAH must meet the following eligibility 
requirements:
    (1) The facility has been certified as a CAH by CMS under Sec.  
485.606(b) of this subpart; and
    (2) The facility provides not more than 25 inpatient beds. Any bed 
of a unit of the facility that is licensed as a distinct-part SNF at the 
time the facility applies to the State for designation as a CAH is not 
counted under paragraph (a) of this section.
    (b) Facilities participating as rural primary care hospitals (RPCHs) 
on September 30, 1997. These facilities must meet the following 
requirements:
    (1) Notwithstanding paragraph (a) of this section, a CAH that 
participated in Medicare as a RPCH on September 30, 1997, and on that 
date had in effect an approval from CMS to use its inpatient facilities 
to provide post-hospital SNF care may continue in that status under the 
same terms, conditions and limitations that were applicable at the time 
those approvals were granted.
    (2) A CAH that was granted swing-bed approval under paragraph (b)(1) 
of this section may request that its application to be a CAH and swing-
bed provider be reevaluated under paragraph (a) of this section. If this 
request is approved, the approval is effective not earlier than October 
1, 1997. As of the date of approval, the CAH no longer has any status 
under paragraph (b)(1) of this section and may not request reinstatement 
under paragraph (b)(1) of this section.
    (c) Payment. Payment for inpatient RPCH services to a CAH that has 
qualified as a CAH under the provisions in paragraph (a) of this section 
is made in accordance with Sec.  413.70 of this chapter. Payment for 
post-hospital SNF-level of care services is made in accordance with the 
payment provisions in Sec.  413.114 of this chapter.
    (d) SNF services. The CAH is substantially in compliance with the 
following SNF requirements contained in subpart B of part 483 of this 
chapter:
    (1) Residents rights (Sec.  483.10(b)(3) through (b)(6), (d) (e), 
(h), (i), (j)(1)(vii) and (viii), (l), and (m) of this chapter).
    (2) Admission, transfer, and discharge rights (Sec.  483.12(a) of 
this chapter).
    (3) Resident behavior and facility practices (Sec.  483.13 of this 
chapter).
    (4) Patient activities (Sec.  483.15(f) of this chapter), except 
that the services may be directed either by a qualified professional 
meeting the requirements of Sec.  485.15(f)(2), or by an individual on 
the facility staff who is designated as the activities director and who 
serves in consultation with a therapeutic recreation specialist, 
occupational therapist, or other professional with experience or 
education in recreational therapy.
    (5) Social services (Sec.  483.15(g) of this chapter).
    (6) Comprehensive assessment, comprehensive care plan, and discharge 
planning (Sec.  483.20(b), (k), and (l) of this chapter, except that the 
CAH is not required to use the resident assessment instrument (RAI) 
specified by the State that is required under Sec.  483.20(b), or to 
comply with the requirements for frequency, scope, and number of 
assessments prescribed in Sec.  413.343(b) of this chapter).
    (7) Specialized rehabilitative services (Sec.  483.45 of this 
chapter).
    (8) Dental services (Sec.  483.55 of this chapter).
    (9) Nutrition (Sec.  483.25(i) of this chapter).

[63 FR 26359, May 12, 1998 as amended at 64 FR 41544, July 30, 1999; 67 
FR 50120, Aug. 1, 2002; 69 FR 49272, Aug. 11, 2004]



Sec.  485.647  Condition of participation: psychiatric and rehabilitation distinct part units.

    (a) Conditions. (1) If a CAH provides inpatient psychiatric services 
in a distinct part unit, the services furnished by the distinct part 
unit must comply

[[Page 153]]

with the hospital requirements specified in Subparts A, B, C, and D of 
Part 482 of this subchapter, the common requirements of Sec.  
412.25(a)(2) through (f) of Part 412 of this chapter for hospital units 
excluded from the prospective payment systems, and the additional 
requirements of Sec.  412.27 of Part 412 of this chapter for excluded 
psychiatric units.
    (2) If a CAH provides inpatient rehabilitation services in a 
distinct part unit, the services furnished by the distinct part unit 
must comply with the hospital requirements specified in Subparts A, B, 
C, and D of Part 482 of this subchapter, the common requirements of 
Sec.  412.25(a)(2) through (f) of Part 412 of this chapter for hospital 
units excluded from the prospective payments systems, and the additional 
requirements of Sec. Sec.  412.29 and Sec.  412.30 of Part 412 of this 
chapter related specifically to rehabilitation units.
    (b) Eligibility requirements. (1) To be eligible to receive Medicare 
payments for psychiatric or rehabilitation services as a distinct part 
unit, the facility provides no more than 10 beds in the distinct part 
unit.
    (2) The beds in the distinct part are excluded from the 25 
inpatient-bed count limit specified in Sec.  485.620(a).
    (3) The average annual 96-hour length of stay requirement specified 
under Sec.  485.620(b) does not apply to the 10 beds in the distinct 
part units specified in paragraph (b)(1) of this section, and admissions 
and days of inpatient care in the distinct part units are not taken into 
account in determining the CAH's compliance with the limits on the 
number of beds and length of stay in Sec.  485.620.

[69 FR 49272, Aug. 11, 2004]

Subpart G [Reserved]



   Subpart H_Conditions of Participation for Clinics, Rehabilitation 
Agencies, and Public Health Agencies as Providers of Outpatient Physical 
             Therapy and Speech-Language Pathology Services



Sec.  485.701  Basis and scope.

    This subpart implements section 1861(p)(4) of the Act, which--
    (a) Defines outpatient physical therapy and speech pathology 
services;
    (b) Imposes requirements with respect to adequate program, 
facilities, policies, staffing, and clinical records; and
    (c) Authorizes the Secretary to establish by regulation other health 
and safety requirements.

[60 FR 2327, Jan. 9, 1995]



Sec.  485.703  Definitions.

    Clinic. A facility that is established primarily to furnish 
outpatient physician services and that meets the following tests of 
physician involvement:
    (1) The medical services are furnished by a group of three or more 
physicians practicing medicine together.
    (2) A physician is present during all hours of operation of the 
clinic to furnish medical services, as distinguished from purely 
administrative services.
    Extension location. A location or site from which a rehabilitation 
agency provides services within a portion of the total geographic area 
served by the primary site. The extension location is part of the 
rehabilitation agency. The extension location should be located 
sufficiently close to share administration, supervision, and services in 
a manner that renders it unnecessary for the extension location to 
independently meet the conditions of participation as a rehabilitation 
agency.
    Organization. A clinic, rehabilitation agency, or public health 
agency.
    Public health agency. An official agency established by a State or 
local government, the primary function of which is to maintain the 
health of the population served by performing environmental health 
services, preventive medical services, and in certain cases, therapeutic 
services.

[[Page 154]]

    Rehabilitation agency. An agency that--
    (1) Provides an integrated interdisciplinary rehabilitation program 
designed to upgrade the physical functioning of handicapped disabled 
individuals by bringing specialized rehabilitation staff together to 
perform as a team; and
    (2) Provides at least physical therapy or speech-language pathology 
services.
    Supervision. Authoritative procedural guidance that is for the 
accomplishment of a function or activity and that--
    (1) Includes initial direction and periodic observation of the 
actual performance of the function or activity; and
    (2) Is furnished by a qualified person--
    (i) Whose sphere of competence encompasses the particular function 
or activity; and
    (ii) Who (unless otherwise provided in this subpart) is on the 
premises if the person performing the function or activity does not meet 
the assistant-level practitioner qualifications specified in Sec.  
485.705.

[41 FR 20865, May 21, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977, 
and amended at 53 FR 12015, Apr. 12, 1988; 54 FR 38679, Sept. 20, 1989. 
Redesignated and amended at 60 FR 2326, 2327, Jan. 9, 1995; 60 FR 50447, 
Sept. 29, 1995; 73 FR 69941, Nov. 19, 2008]



Sec.  485.705  Personnel qualifications.

    (a) General qualification requirements. Except as specified in 
paragraphs (b) and (c) of this section, all personnel who are involved 
in the furnishing of outpatient physical therapy, occupational therapy, 
and speech-language pathology services directly by or under arrangements 
with an organization must be legally authorized (licensed or, if 
applicable, certified or registered) to practice by the State in which 
they perform the functions or actions, and must act only within the 
scope of their State license or State certification or registration.
    (b) Exception for Federally defined qualifications. The following 
Federally defined qualifications must be met:
    (1) For a physician, the qualifications and conditions as defined in 
section 1861(r) of the Act and the requirements in part 484 of this 
chapter.
    (2) For a speech-language pathologist, the qualifications specified 
in section 1861(11)(1) of the Act and the requirements in part 484 of 
this chapter.
    (c) Exceptions when no State Licensing laws or State certification 
or registration requirements exist. If no State licensing laws or State 
certification or registration requirements exist for the profession, the 
following requirements must be met--
    (1) An administrator is a person who has a bachelor's degree and:
    (i) Has experience or specialized training in the administration of 
health institutions or agencies; or
    (ii) Is qualified and has experience in one of the professional 
health disciplines.
    (2) An occupational therapist must meet the requirements in part 484 
of this chapter.
    (3) An occupational therapy assistant must meet the requirements in 
part 484 of this chapter.
    (4) A physical therapist must meet the requirements in part 484 of 
this chapter.
    (5) A physical therapist assistant must meet the requirements in 
part 484 of this chapter.
    (6) A social worker must meet the requirements in part 484 of this 
chapter.
    (7) A vocational specialist is a person who has a baccalaureate 
degree and--
    (i) Two years experience in vocational counseling in a 
rehabilitation setting such as a sheltered workshop, State employment 
service agency, etc.; or
    (ii) At least 18 semester hours in vocational rehabilitation, 
educational or vocational guidance, psychology, social work, special 
education or personnel administration, and 1 year of experience in 
vocational counseling in a rehabilitation setting; or
    (iii) A master's degree in vocational counseling.
    (8) A nurse practitioner is a person who must:
    (i) Be a registered professional nurse who is authorized by the 
State in which the services are furnished to practice as a nurse 
practitioner in accordance with State law; and

[[Page 155]]

    (ii) Be certified as a nurse practitioner by a recognized national 
certifying body that has established standards for nurse practitioners; 
or
    (iii) Be a registered professional nurse who is authorized by the 
State in which the services are furnished to practice as a nurse 
practitioner in accordance with State law and have been granted a 
Medicare billing number as a nurse practitioner by December 31, 2000; or
    (iv) Be a nurse practitioner who on or after January 1, 2001, 
applies for a Medicare billing number for the first time and meets the 
standards for nurse practitioners in paragraphs (c)(8)(i) and (c)(8)(ii) 
of this section; or
    (v) Be a nurse practitioner who on or after January 1, 2003, applies 
for a Medicare billing number for the first time and possesses a 
master's degree in nursing and meets the standards for nurse 
practitioners in paragraphs (b)(1)(i) and (b)(1)(ii) of this section.
    (9) A clinical nurse specialist is a person who must:
    (i) Be a registered nurse who is currently licensed to practice in 
the State where he or she practices and be authorized to perform the 
services of a clinical nurse specialist in accordance with State law;
    (ii) Have a master's degree in a defined clinical area of nursing 
from an accredited educational institution; and,
    (iii) Be certified as a clinical nurse specialist by the American 
Nurses Credentialing Center.
    (10) A physician assistant is a person who:
    (i) Has graduated from a physician assistant educational program 
that is accredited by the Commission on Accreditation of Allied Health 
Education Programs; or
    (ii) Has passed the national certification examination that is 
administered by the National Commission on Certification of Physician 
Assistants; and
    (iii) Is licensed by the State to practice as a physician assistant.

[63 FR 58912, Nov. 2, 1998; 64 FR 25457, May 12, 1999; 64 FR 59442, Nov. 
2, 1999]



Sec.  485.707  Condition of participation: Compliance with Federal, State, and local laws.

    The organization and its staff are in compliance with all applicable 
Federal, State, and local laws and regulations.
    (a) Standard: Licensure of organization. In any State in which State 
or applicable local law provides for the licensing of organizations, a 
clinic, rehabilitation agency, or public health agency is licensed in 
accordance with applicable laws.
    (b) Standard: Licensure or registration of personnel. Staff of the 
organization are licensed or registered in accordance with applicable 
laws.

[41 FR 20865, May 21, 1976, unless otherwise noted. Redesignated at 42 
FR 52826, Sept. 30, 1977. Further redesignated and amended at 60 FR 
2326, 2327, Jan. 9, 1995]



Sec.  485.709  Condition of participation: Administrative management.

    The clinic or rehabilitation agency has an effective governing body 
that is legally responsible for the conduct of the clinic or 
rehabilitation agency. The governing body designates an administrator, 
and establishes administrative policies.
    (a) Standard: Governing body. There is a governing body (or 
designated person(s) so functioning) which assumes full legal 
responsibility for the overall conduct of the clinic or rehabilitation 
agency and for compliance with applicable laws and regulations. The name 
of the owner(s) of the clinic or rehabilitation agency is fully 
disclosed to the State agency. In the case of corporations, the names of 
the corporate officers are made known.
    (b) Standard: Administrator. The governing body--
    (1) Appoints a qualified full-time administrator;
    (2) Delegates to the administrator the internal operation of the 
clinic or rehabilitation agency in accordance with written policies;
    (3) Defines clearly the administrator's responsibilities for 
procurement and direction of personnel; and
    (4) Designates a competent individual to act during temporary 
absence of the administrator.

[[Page 156]]

    (c) Standard: Personnel policies. Personnel practices are supported 
by appropriate written personnel policies that are kept current. 
Personnel records include the qualifications of all professional and 
assistant level personnel, as well as evidence of State licensure if 
applicable.
    (d) Standard: Patient care policies. Patient care practices and 
procedures are supported by written policies established by a group of 
professional personnel including one or more physicians associated with 
the clinic or rehabilitation agency, one or more qualified physical 
therapists (if physical therapy services are provided), and one or more 
qualified speech pathologists (if speech pathology services are 
provided). The policies govern the outpatient physical therapy and/or 
speech pathology services and related services that are provided. These 
policies are evaluated at least annually by the group of professional 
personnel, and revised as necessary based upon this evaluation.

[41 FR 20865, May 21, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977, 
and amended at 53 FR 12015, Apr. 12, 1988. Redesignated and amended at 
60 FR 2326, 2327, Jan. 9, 1995; 60 FR 50447, Sept. 29, 1995]



Sec.  485.711  Condition of participation: Plan of care and physician involvement.

    For each patient in need of outpatient physical therapy or speech 
pathology services, there is a written plan of care established and 
periodically reviewed by a physician, or by a physical therapist or 
speech pathologist respectively.
    (a) Standard: Medical history and prior treatment. The following are 
obtained by the organization before or at the time of initiation of 
treatment:
    (1) The patient's significant past history.
    (2) Current medical findings, if any.
    (3) Diagnosis(es), if established.
    (4) Physician's orders, if any.
    (5) Rehabilitation goals, if determined.
    (6) Contraindications, if any.
    (7) The extent to which the patient is aware of the diagnosis(es) 
and prognosis.
    (8) If appropriate, the summary of treatment furnished and results 
achieved during previous periods of rehabilitation services or 
institutionalization.
    (b) Standard: Plan of care. (1) For each patient there is a written 
plan of care established by the physician or by the physical therapist 
or speech-language pathologist who furnishes the services.
    (2) The plan of care for physical therapy or speech pathology 
services indicates anticipated goals and specifies for those services 
the--
    (i) Type;
    (ii) Amount;
    (iii) Frequency; and
    (iv) Duration.
    (3) The plan of care and results of treatment are reviewed by the 
physician or by the individual who established the plan at least as 
often as the patient's condition requires, and the indicated action is 
taken.
    (4) Changes in the plan of care are noted in the clinical record. If 
the patient has an attending physician, the therapist or speech-language 
pathologist who furnishes the services promptly notifies him or her of 
any change in the patient's condition or in the plan of care.
    (c) Standard: Emergency care. The rehabilitation agency must 
establish procedures to be followed by personnel in an emergency, which 
cover immediate care of the patient, persons to be notified, and reports 
to be prepared.

[54 FR 38679, Sept. 20, 1989. Redesignated and amended at 60 FR 2326, 
2327, Jan. 9, 1995; 63 FR 58913, Nov. 2, 1998; 73 FR 69941, Nov. 19, 
2008]



Sec.  485.713  Condition of participation: Physical therapy services.

    If the organization offers physical therapy services, it provides an 
adequate program of physical therapy and has an adequate number of 
qualified personnel and the equipment necessary to carry out its program 
and to fulfill its objectives.
    (a) Standard: Adequate program. (1) The organization is considered 
to have an adequate outpatient physical therapy program if it can:
    (i) Provide services using therapeutic exercise and the modalities 
of heat, cold, water, and electricity;

[[Page 157]]

    (ii) Conduct patient evaluations; and
    (iii) Administer tests and measurements of strength, balance, 
endurance, range of motion, and activities of daily living.
    (2) A qualified physical therapist is present or readily available 
to offer supervision when a physical therapist assistant furnishes 
services.
    (i) If a qualified physical therapist is not on the premises during 
all hours of operation, patients are scheduled so as to ensure that the 
therapist is present when special skills are needed, for example, for 
evaluation and reevaluation.
    (ii) When a physical therapist assistant furnishes services off the 
organization's premises, those services are supervised by a qualified 
physical therapist who makes an onsite supervisory visit at least once 
every 30 days.
    (b) Standard: Facilities and equipment. The organization has the 
equipment and facilities required to provide the range of services 
necessary in the treatment of the types of disabilities it accepts for 
service.
    (c) Standard: Personnel qualified to provide physical therapy 
services. Physical therapy services are provided by, or under the 
supervision of, a qualified physical therapist. The number of qualified 
physical therapists and qualified physical therapist assistants is 
adequate for the volume and diversity of physical therapy services 
offered. A qualified physical therapist is on the premises or readily 
available during the operating hours of the organization.
    (d) Standard: Supportive personnel. If personnel are available to 
assist qualified physical therapists by performing services incident to 
physical therapy that do not require professional knowledge and skill, 
these personnel are instructed in appropriate patient care services by 
qualified physical therapists who retain responsibility for the 
treatment prescribed by the attending physician.

[41 FR 20865, May 21, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977. 
Further redesignated and amended at 60 FR 2326, 2327, Jan. 9, 1995; 60 
FR 50447, Sept. 29, 1995]



Sec.  485.715  Condition of participation: Speech pathology services.

    If speech pathology services are offered, the organization provides 
an adequate program of speech pathology and has an adequate number of 
qualified personnel and the equipment necessary to carry out its program 
and to fulfill its objectives.
    (a) Standard: Adequate program. The organization is considered to 
have an adequate outpatient speech pathology program if it can provide 
the diagnostic and treatment services to effectively treat speech 
disorders.
    (b) Standard: Facilities and equipment. The organization has the 
equipment and facilities required to provide the range of services 
necessary in the treatment of the types of speech disorders it accepts 
for service.
    (c) Standard: Personnel qualified to provide speech pathology 
services. Speech pathology services are given or supervised by a 
qualified speech pathologist and the number of qualified speech 
pathologists is adequate for the volume and diversity of speech 
pathology services offered. At least one qualified speech pathologist is 
present at all times when speech pathology services are furnished.

[41 FR 20865, May 21, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977. 
Further redesignated and amended at 60 FR 2326-2328, Jan. 9, 1995]



Sec.  485.717  Condition of participation: Rehabilitation program.

    This condition and standards apply only to a rehabilitation agency's 
own patients, not to patients of hospitals, skilled nursing facilities 
(SNFs), or Medicaid nursing facilities (NFs) to which the agency 
furnishes services. The hospital, SNF, or NF is responsible for ensuring 
that qualified staff furnish services for which they arrange or contract 
for their patients. The rehabilitation agency provides physical therapy 
and speech-language pathology services to all of its patients who need 
them.
    (a) Standard: Qualification of staff. The agency's therapy services 
are furnished by qualified individuals as direct services and/or 
services provided under contract.
    (b) Standard: Arrangements for services. If services are provided 
under contract,

[[Page 158]]

the contract must specify the term of the contract, the manner of 
termination or renewal and provide that the agency retains 
responsibility for the control and supervision of the services.

[73 FR 69942, Nov. 19, 2008]



Sec.  485.719  Condition of participation: Arrangements for physical therapy and speech pathology services to be performed by other than salaried organization 
          personnel.

    (a) Conditions. If an organization provides outpatient physical 
therapy or speech pathology services under an arrangement with others, 
the services are to be furnished in accordance with the terms of a 
written contract, which provides that the organization retains of 
professional and administrative responsibility for, and control and 
supervision of, the services.
    (b) Standard: Contract provisions. The contract--
    (1) Specifies the term of the contract and the manner of termination 
or renewal;
    (2) Requires that personnel who furnish the services meet the 
requirements that are set forth in this subpart for salaried personnel; 
and
    (3) Provides that the contracting outside resource may not bill the 
patient or Medicare for the services. This limitation is based on 
section 1861(w)(1) of the Act, which provides that--
    (i) Only the provider may bill the beneficiary for covered services 
furnished under arrangements; and
    (ii) Receipt of Medicare payment by the provider, on behalf of an 
entitled individual, discharges the liability of the individual or any 
other person to pay for those services.

[56 FR 46562, Sept. 13, 1991. Redesignated and amended at 60 FR 2326, 
2328, Jan. 9, 1995; 60 FR 50447, Sept. 29, 1995]



Sec.  485.721  Condition of participation: Clinical records.

    The organization maintains clinical records on all patients in 
accordance with accepted professional standards, and practices. The 
clinical records are completely and accurately documented, readily 
accessible, and systematically organized to facilitate retrieving and 
compiling information.
    (a) Standard: Protection of clinical record information. The 
organization recognizes the confidentiality of clinical record 
information and provides safeguards against loss, destruction, or 
unauthorized use. Written procedures govern the use and removal of 
records and the conditions for release of information. The patient's 
written consent is required for release of information not authorized by 
law.
    (b) Standard: Content. The clinical record contains sufficient 
information to identify the patient clearly, to justify the 
diagnosis(es) and treatment, and to document the results accurately. All 
clinical records contain the following general categories of data:
    (1) Documented evidence of the assessment of the needs of the 
patient, of an appropriate plan of care, and of the care and services 
furnished.
    (2) Identification data and consent forms.
    (3) Medical history.
    (4) Report of physical examinations, if any.
    (5) Observations and progress notes.
    (6) Reports of treatments and clinical findings.
    (7) Discharge summary including final diagnosis(es) and prognosis.
    (c) Standard: Completion of records and centralization of reports. 
Current clinical records and those of discharged patients are completed 
promptly. All clinical information pertaining to a patient is 
centralized in the patient's clinical record. Each physician signs the 
entries that he or she makes in the clinical record.
    (d) Standard: Retention and preservation. Clinical records are 
retained for at least:
    (1) The period determined by the respective State statute, or the 
statute of limitations in the State; or
    (2) In the absence of a State statute--
    (i) Five years after the date of discharge; or
    (ii) In the case of a minor, 3 years after the patient becomes of 
age under State law or 5 years after the date of discharge, whichever is 
longer.
    (e) Standard: Indexes. Clinical records are indexed at least 
according to name of patient to facilitate acquisition of

[[Page 159]]

statistical medical information and retrieval of records for research or 
administrative action.
    (f) Standard: Location and facilities. The organization maintains 
adequate facilities and equipment, conveniently located, to provide 
efficient processing of clinical records (reviewing, indexing, filing, 
and prompt retrieval).

[41 FR 20865, May 21, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977. 
Further redesignated and amended at 60 FR 2326-2328, Jan. 9, 1995]



Sec.  485.723  Condition of participation: Physical environment.

    The building housing the organization is constructed, equipped, and 
maintained to protect the health and safety of patients, personnel, and 
the public and provides a functional, sanitary, and comfortable 
environment.
    (a) Standard: Safety of patients. The organization satisfies the 
following requirements:
    (1) It complies with all applicable State and local building, fire, 
and safety codes.
    (2) Permanently attached automatic fire-extinguishing systems of 
adequate capacity are installed in all areas of the premises considered 
to have special fire hazards. Fire extinguishers are conveniently 
located on each floor of the premises. Fire regulations are prominently 
posted.
    (3) Doorways, passageways and stairwells negotiated by patients are:
    (i) Of adequate width to allow for easy movement of all patients 
(including those on stretchers or in wheelchairs), (ii) free from 
obstruction at all times, and (iii) in the case of stairwells, equipped 
with firmly attached handrails on at least one side.
    (4) Lights are placed at exits and in corridors used by patients and 
are supported by an emergency power source.
    (5) A fire alarm system with local alarm capability and, where 
applicable, an emergency power source, is functional.
    (6) At least two persons are on duty on the premises of the 
organization whenever a patient is being treated.
    (7) No occupancies or activities undesirable or injurious to the 
health and safety of patients are located in the building.
    (b) Standard: Maintenance of equipment, building, and grounds. The 
organization establishes a written preventive-maintenance program to 
ensure that--
    (1) The equipment is operative, and is properly calibrated; and
    (2) The interior and exterior of the building are clean and orderly 
and maintained free of any defects that are a potential hazard to 
patients, personnel, and the public.
    (c) Standard: Other environmental considerations. The organization 
provides a functional, sanitary, and comfortable environment for 
patients, personnel, and the public.
    (1) Provision is made for adequate and comfortable lighting levels 
in all areas; limitation of sounds at comfort levels; a comfortable room 
temperature; and adequate ventilation through windows, mechanical means, 
or a combination of both.
    (2) Toilet rooms, toilet stalls, and lavatories are accessible and 
constructed so as to allow use by nonambulatory and semiambulatory 
individuals.
    (3) Whatever the size of the building, there is an adequate amount 
of space for the services provided and disabilities treated, including 
reception area, staff space, examining room, treatment areas, and 
storage.

[41 FR 20865, May 21, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977. 
Further redesignated and amended at 60 FR 2326-2328, Jan. 9, 1995]



Sec.  485.725  Condition of participation: Infection control.

    The organization that provides outpatient physical therapy services 
establishes an infection-control committee of representative 
professional staff with responsibility for overall infection control. 
All necessary housekeeping and maintenance services are provided to 
maintain a sanitary and comfortable environment and to help prevent the 
development and transmission of infection.
    (a) Standard: Infection-control committee. The infection-control 
committee establishes policies and procedures for investigating, 
controlling, and preventing infections in the organization and monitors 
staff performance to ensure that the policies and procedures are 
executed.

[[Page 160]]

    (b) All personnel follow written procedures for effective aseptic 
techniques. The procedures are reviewed annually and revised if 
necessary to improve them.
    (c) Standard: Housekeeping. (1) The organization employs sufficient 
housekeeping personnel and provides all necessary equipment to maintain 
a safe, clean, and orderly interior. A full-time employee is designated 
as the one responsible for the housekeeping services and for supervision 
and training of housekeeping personnel.
    (2) An organization that has a contract with an outside resource for 
housekeeping services may be found to be in compliance with this 
standard provided the organization or outside resource or both meet the 
requirements of the standard.
    (d) Standard: Linen. The organization has available at all times a 
quantity of linen essential for proper care and comfort of patients. 
Linens are handled, stored, processed, and transported in such a manner 
as to prevent the spread of infection.
    (e) Standard: Pest control. The organization's premises are 
maintained free from insects and rodents through operation of a pest-
control program.

[41 FR 20865, May 21, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977. 
Further redesignated and amended at 60 FR 2326, 2328, Jan. 9, 1995; 60 
FR 50447, Sept. 29, 1995]



Sec.  485.727  Condition of participation: Disaster preparedness.

    The organization has a written plan, periodically rehearsed, with 
procedures to be followed in the event of an internal or external 
disaster and for the care of casualties (patients and personnel) arising 
from a disaster.
    (a) Standard: Disaster plan. The organization has a written plan in 
operation, with procedures to be followed in the event of fire, 
explosion, or other disaster. The plan is developed and maintained with 
the assistance of qualified fire, safety, and other appropriate experts, 
and includes:
    (1) Transfer of casualties and records;
    (2) The location and use of alarm systems and signals;
    (3) Methods of containing fire;
    (4) Notification of appropriate persons; and
    (5) Evacuation routes and procedures.
    (b) Standard: Staff training and drills. All employees are trained, 
as part of their employment orientation, in all aspects of preparedness 
for any disaster. The disaster program includes orientation and ongoing 
training and drills for all personnel in all procedures so that each 
employee promptly and correctly carries out his assigned role in case of 
a disaster.

[41 FR 20865, May 21, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977, 
and amended at 53 FR 12015, Apr. 12, 1988. Redesignated and amended at 
60 FR 2326-2327, 2329, Jan. 9, 1995]



Sec.  485.729  Condition of participation: Program evaluation.

    The organization has procedures that provide for a systematic 
evaluation of its total program to ensure appropriate utilization of 
services and to determine whether the organization's policies are 
followed in providing services to patients through employees or under 
arrangements with others.
    (a) Standard: Clinical-record review. A sample of active and closed 
clinical records is reviewed quarterly by the appropriate health 
professionals to ensure that established policies are followed in 
providing services.
    (b) Standard: Annual statistical evaluation. An evaluation is 
conducted annually of statistical data such as number of different 
patients treated, number of patient visits, condition on admission and 
discharge, number of new patients, number of patients by diagnosis(es), 
sources of referral, number and cost of units of service by treatment 
given, and total staff days or work hours by discipline.

[41 FR 20865, May 21, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977. 
Further redesignated and amended at 60 FR 2326-2327, 2329, Jan. 9, 1995]



PART 486_CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES FURNISHED BY SUPPLIERS--Table of Contents




                      Subpart A_General Provisions

Sec.
486.1 Basis and scope.

Subpart B [Reserved]

[[Page 161]]

       Subpart C_Conditions for Coverage: Portable X-Ray Services

486.100 Condition for coverage: Compliance with Federal, State, and 
          local laws and regulations.
486.102 Condition for coverage: Supervision by a qualified physician.
486.104 Condition for coverage: Qualifications, orientation, and health 
          of technical personnel.
486.106 Condition for coverage: Referral for service and preservation of 
          records.
486.108 Condition for coverage: Safety standards.
486.110 Condition for coverage: Inspection of equipment.

Subparts D-F [Reserved]

Subpart G_Requirements for Certification and Designation and Conditions 
              for Coverage: Organ Procurement Organizations

486.301 Basis and scope.
486.302 Definitions.

             Requirements for Certification and Designation

486.303 Requirements for certification.
486.304 Requirements for designation.
486.306 OPO service area size designation and documentation 
          requirements.
486.308 Designation of one OPO for each service area.
486.309 Re-certification from August 1, 2006 through July 31, 2010.
486.310 Changes in control or ownership or service area.

                  Re-certification and De-certification

486.312 De-certification.
486.314 Appeals.
486.316 Re-certification and competition processes.

           Organ Procurement Organization Outcome Requirements

486.318 Condition: Outcome measures.

       Organ Procurement Organization Process Performance Measures

486.320 Condition: Participation in Organ Procurement and 
          Transplantation Network.
486.322 Condition: Relationships with hospitals, critical access 
          hospitals, and tissue banks.
486.324 Condition: Administration and governing body.
486.326 Condition: Human resources.
486.328 Condition: Reporting of data.
486.330 Condition: Information management.
486.342 Condition: Requesting consent.
486.344 Condition: Evaluation and management of potential donors and 
          organ placement and recovery.
486.346 Condition: Organ preparation and transport.
486.348 Condition: Quality assessment and performance improvement 
          (QAPI).

    Authority: Secs. 1102, 1138, and 1871 of the Social Security Act (42 
U.S.C. 1302, 1320b-8, and 1395hh) and section 371 of the Public Health 
Service Act (42 U.S.C 273).



                      Subpart A_General Provisions



Sec.  486.1  Basis and scope.

    (a) Statutory basis. This part is based on the following sections of 
the Act:

    1102 and 1138(b), 1871 of the Social Security Act, section 371(b) of 
the Public Health Service Act--for coverage of organ procurement 
services.
    1861(p)--for coverage of outpatient physical therapy services 
furnished by physical therapists in independent practice.
    1861(s) (3), (15), and (17)--for coverage of portable X-ray 
services.

    (b) Scope. (1) This part sets forth the conditions for coverage of 
certain specialized services that are furnished by suppliers and that 
are not specified in other portions of this chapter.
    (2) The conditions for coverage of other specialized services 
furnished by suppliers are set forth in the following regulations which, 
unless otherwise indicated, are part of this chapter:
    (i) Ambulatory surgical center (ASC) services--Part 416.
    (ii) Ambulance services--Part 410, subpart B.
    (iii) ESRD services--Part 405, subpart U.
    (iv) Laboratory services--Part 493.
    (v) Mammography services--Part 410, subpart B (Sec.  410.34) and 21 
CFR Part 900, subpart B, of the Food and Drug Administration 
regulations.
    (vi) Rural health clinic and Federally qualified health center 
services--Part 491, subpart A.

[60 FR 50447, Sept. 29, 1995, as amended at 71 FR 31046, May 31, 2006]

Subpart B [Reserved]

[[Page 162]]



       Subpart C_Conditions for Coverage: Portable X-Ray Services

    Authority: Secs. 1102, 1861(s) (3), (11) and (12), 1864, and 1871 of 
the Social Security Act (42 U.S.C. 1302, 1395x(s) (3), (11), and (12), 
1395aa and 1395hh).

    Source: 34 FR 388, Jan. 10, 1969, unless otherwise noted. 
Redesignated at 42 FR 52826, Sept. 30, 1977, and further redesignated 
and amended at 60 FR 2326, Jan. 9, 1995.



Sec.  486.100  Condition for coverage: Compliance with Federal, State, and local laws and regulations.

    The supplier of portable X-ray services is in conformity with all 
applicable Federal, State, and local laws and regulations.
    (a) Standard--licensure or registration of supplier. In any State in 
which State or applicable local law provides for the licensure or 
registration of suppliers of X-ray services, the supplier is (1) 
licensed or registered pursuant to such law, or (2) approved by the 
agency of the State or locality responsible for licensure or 
registration as meeting the standards established for such licensure or 
registration.
    (b) Standard--licensure or registration of personnel. All personnel 
engaged in operating portable X-ray equipment are currently licensed or 
registered in accordance with all applicable State and local laws.
    (c) Standard--licensure or registration of equipment. All portable 
X-ray equipment used in providing portable X-ray services is licensed or 
registered in accordance with all applicable State and local laws.
    (d) Standard--conformity with other Federal, State, and local laws 
and regulations. The supplier of portable X-ray services agrees to 
render such services in conformity with Federal, State, and local laws 
relating to safety standards.

[34 FR 388, Jan. 10, 1969. Redesignated at 42 FR 52826, Sept. 30, 1977. 
Further redesignated and amended at 60 FR 2326, Jan. 9, 1995; 60 FR 
45086, Aug. 30, 1995]



Sec.  486.102  Condition for coverage: Supervision by a qualified physician.

    Portable X-ray services are provided under the supervision of a 
qualified physician.
    (a) Standard--physician supervision. The performance of the 
roentgenologic procedures is subject to the supervision of a physician 
who meets the requirements of paragraph (b) of this section and one of 
the following requirements is met:
    (1) The supervising physician owns the equipment and it is operated 
only by his employees, or
    (2) The supervising physician certifies annually that he 
periodically checks the procedural manuals and observes the operators' 
performance, that he has verified that equipment and personnel meet 
applicable Federal, State, and local licensure and registration 
requirements and that safe operating procedures are used.
    (b) Standard--qualifications of the physician supervisor. Portable 
X-ray services are provided under the supervision of a licensed doctor 
of medicine or licensed doctor of osteopathy who is qualified by 
advanced training and experience in the use of X-rays for diagnostic 
purposes, i.e., he (1) is certified in radiology by the American Board 
of Radiology or by the American Osteopathic Board of Radiology or 
possesses qualifications which are equivalent to those required for such 
certification, or (2) is certified or meets the requirements for 
certification in a medical specialty in which he has become qualified by 
experience and training in the use of X-rays for diagnostic purposes, or 
(3) specializes in radiology and is recognized by the medical community 
as a specialist in radiology.

[34 FR 388, Jan. 10, 1969. Redesignated at 42 FR 52826, Sept. 30, 1977. 
Further redesignated and amended at 60 FR 2326, Jan. 9, 1995; 60 FR 
45086, Aug. 30, 1995]



Sec.  486.104  Condition for coverage: Qualifications, orientation and health of technical personnel.

    Portable X-ray services are provided by qualified technologists.
    (a) Standard-qualifications of technologists. All operators of the 
portable X-ray equipment meet the requirements of paragraphs (a)(1), 
(2), (3), or (4) of this section:
    (1) Successful completion of a program of formal training in X-ray 
technology in a school approved by the Joint Review Committee on 
Education

[[Page 163]]

in Radiologic Technology (JRCERT), or have earned a bachelor's or 
associate degree in radiologic technology from an accredited college or 
university.
    (2) For those whose training was completed prior to July 1, 1966, 
but on or after July 1, 1960: Successful completion of 24 full months of 
training and/or experience under the direct supervision of a physician 
who is certified in radiology by the American College of Radiology or 
who possesses qualifications which are equivalent to those required for 
such certification, and at least 12 full months of pertinent portable X-
ray equipment operation experience in the 5 years prior to January 1, 
1968.
    (3) For those whose training was completed prior to July 1, 1960: 
Successful completion of 24 full months of training and/or experience of 
which at least 12 full months were under the direct supervision of a 
physician who is certified in radiology by the American College of 
Radiology or who possesses qualifications which are equivalent to those 
required for such certification, and at least 12 full months of 
pertinent portable X-ray equipment operation experience in the 5 years 
prior to January 1, 1968.
    (4) For those whose training was completed prior to January 1, 1993, 
successful completion of a program of formal training in X-ray 
technology in a school approved by the Council on Education of the 
American Medical Association, or by the American Osteopathic Association 
is acceptable.
    (b) Standard--personnel orientation. The supplier of portable X-ray 
services has an orientation program for personnel, based on a procedural 
manual which is: Available to all members of the staff, incorporates 
relevant portions of professionally recognized documents, and includes 
instruction in all of the following:
    (1) Precautions to be followed to protect the patient from 
unnecessary exposure to radiation;
    (2) Precautions to be followed to protect an individual supporting 
the patient during X-ray procedures from unnecessary exposure to 
radiation;
    (3) Precautions to be followed to protect other individuals in the 
surrounding environment from exposure to radiation;
    (4) Precautions to be followed to protect the operator of portable 
X-ray equipment from unnecessary exposure to radiation;
    (5) Considerations in determining the area which will receive the 
primary beam;
    (6) Determination of the time interval at which to check personnel 
radiation monitors;
    (7) Use of the personnel radiation monitor in providing an 
additional check on safety of equipment;
    (8) Proper use and maintenance of equipment;
    (9) Proper maintenance of records;
    (10) Technical problems which may arise and methods of solution;
    (11) Protection against electrical hazards;
    (12) Hazards of excessive exposure to radiation.
    (c) Standard: Employee records. Records are maintained and include 
evidence that--
    (1) Each employee is qualified for his or her position by means of 
training and experience; and
    (2) Employees receive adequate health supervision.

[34 FR 388, Jan. 10, 1969. Redesignated at 42 FR 52826, Sept. 30, 1977, 
and amended at 53 FR 12015, Apr. 12, 1988; 60 FR 45086, Aug. 30, 1995; 
73 FR 69942, Nov. 19, 2008]



Sec.  486.106  Condition for coverage: Referral for service and preservation of records.

    All portable X-ray services performed for Medicare beneficiaries are 
ordered by a doctor of medicine or doctor of osteopathy and records are 
properly preserved.
    (a) Standard--referral by a physician. Portable X-ray examinations 
are performed only on the order of a doctor of medicine or doctor of 
osteopathy licensed to practice in the State. The supplier's records 
show that:
    (1) The X-ray test was ordered by a licensed doctor of medicine or 
doctor of osteopathy, and
    (2) Such physician's written, signed order specifies the reason an 
X-ray test is required, the area of the body to be exposed, the number 
of radiographs to be obtained, and the views needed; it

[[Page 164]]

also includes a statement concerning the condition of the patient which 
indicates why portable X-ray services are necessary.
    (b) Standard--records of examinations performed. The supplier makes 
for each patient a record of the date of the X-ray examination, the name 
of the patient, a description of the procedures ordered and performed, 
the referring physician, the operator(s) of the portable X-ray equipment 
who performed the examination, the physician to whom the radiograph was 
sent, and the date it was sent.
    (c) Standard--preservation of records. Such reports are maintained 
for a period of at least 2 years, or for the period of time required by 
State law for such records (as distinguished from requirements as to the 
radiograph itself), whichever is longer.

[34 FR 388, Jan. 10, 1969. Redesignated at 42 FR 52826, Sept. 30, 1977. 
Further redesignated and amended at 60 FR 2326, Jan. 9, 1995; 60 FR 
45086, Aug. 30, 1995]



Sec.  486.108  Condition for coverage: Safety standards.

    X-ray examinations are conducted through the use of equipment which 
is free of unnecessary hazards for patients, personnel, and other 
persons in the immediate environment, and through operating procedures 
which provide minimum radiation exposure to patients, personnel, and 
other persons in the immediate environment.
    (a) Standard--tube housing and devices to restrict the useful beam. 
The tube housing is of diagnostic type. Diaphragms, cones, or adjustable 
collimators capable of restricting the useful beam to the area of 
clinical interest are used and provide the same degree of protection as 
is required of the housing.
    (b) Standard--total filtration. (1) The aluminum equivalent of the 
total filtration in the primary beam is not less than that shown in the 
following table except when contraindicated for a particular diagnostic 
procedure.

------------------------------------------------------------------------
                                             Total filtration (inherent
              Operating kVp                         plus added)
------------------------------------------------------------------------
Below 50 kVp.............................  0.5 millimeters aluminum.
50-70 kVp................................  1.5 millimeters aluminum.
Above 70 kVp.............................  2.5 millimeters aluminum.
------------------------------------------------------------------------

    (2) If the filter in the machine is not accessible for examination 
or the total filtration is unknown, it can be assumed that the 
requirements are met if the half-value layer is not less than that shown 
in the following table:

------------------------------------------------------------------------
              Operating kVp                       Half-value layer
------------------------------------------------------------------------
50 kVp...................................  0.6 millimeters aluminum.
70 kVp...................................  1.6 millimeters aluminum.
90 kVp...................................  2.6 millimeters aluminum.
100 kVp..................................  2.8 millimeters aluminum.
110 kVp..................................  3.0 millimeters aluminum.
120 kVp..................................  3.3 millimeters aluminum.
------------------------------------------------------------------------

    (c) Standard--termination of exposure. A device is provided to 
terminate the exposure after a preset time or exposure.
    (d) Standard--control panel. The control panel provides a device 
(usually a milliammeter or a means for an audible signal to give 
positive indication of the production of X-rays whenever the X-ray tube 
is energized. The control panel includes appropriate indicators 
(labelled control settings and/or meters) which show the physical 
factors (such as kVp, mA, exposure time or whether timing is automatic) 
used for the exposure.
    (e) Standard--exposure control switch. The exposure control switch 
is of the dead-man type and is so arranged that the operator can stand 
at least 6 feet from the patient and well away from the useful beam.
    (f) Standard--protection against electrical hazards. Only shockproof 
equipment is used. All electrical equipment is grounded.
    (g) Standard--mechanical supporting or restraining devices. 
Mechanical supporting or restraining devices are provided so that such 
devices can be used when a patient must be held in position for 
radiography.
    (h) Standard--protective gloves and aprons. Protective gloves and 
aprons are provided so that when the patient must be held by an 
individual, that individual is protected with these shielding devices.
    (i) Standard--restriction of the useful beam. Diaphragms, cones, or 
adjustable collimators are used to restrict the useful beam to the area 
of clinical interest.
    (j) Standard--personnel monitoring. A device which can be worn to 
monitor

[[Page 165]]

radiation exposure (e.g., a film badge) is provided to each individual 
who operates portable X-ray equipment. The device is evaluated for 
radiation exposure to the operator at least monthly and appropriate 
records are maintained by the supplier of portable X-ray services of 
radiation exposure measured by such a device for each individual.
    (k) Standard--personnel and public protection. No individual 
occupationally exposed to radiation is permitted to hold patients during 
exposures except during emergencies, nor is any other individual 
regularly used for this service. Care is taken to assure that pregnant 
women do not assist in portable X-ray examinations.

[34 FR 388, Jan. 10, 1969. Redesignated at 42 FR 52826, Sept. 30, 1977. 
Further redesignated and amended at 60 FR 2326, Jan. 9, 1995; 60 FR 
45086, Aug. 30, 1995]



Sec.  486.110  Condition for coverage: Inspection of equipment.

    Inspections of all X-ray equipment and shielding are made by 
qualified individuals at intervals not greater than every 24 months.
    (a) Standard--qualified inspectors. Inspections are made at least 
every 24 months by a radiation health specialist who is on the staff of 
or approved by an appropriate State or local government agency.
    (b) Standard--records of inspection and scope of inspection. The 
supplier maintains records of current inspections which include the 
extent to which equipment and shielding are in compliance with the 
safety standards outlined in Sec.  486.108.

[34 FR 388, Jan. 10, 1969. Redesignated at 42 FR 52826, Sept. 30, 1977. 
Further redesignated and amended at 60 FR 2326, Jan. 9, 1995; 60 FR 
45086, Aug. 30, 1995; 60 FR 50447, Sept. 29, 1995]

Subparts D-F [Reserved]



Subpart G_Requirements for Certification and Designation and Conditions 
              for Coverage: Organ Procurement Organizations

    Source: 71 FR 31046, May 31, 2006, unless otherwise noted.



Sec.  486.301  Basis and scope.

    (a) Statutory basis. (1) Section 1138(b) of the Act sets forth the 
requirements that an organ procurement organization (OPO) must meet to 
have its organ procurement services to hospitals covered under Medicare 
and Medicaid. These include certification as a ``qualified'' OPO and 
designation as the OPO for a particular service area.
    (2) Section 371(b) of the Public Health Service Act sets forth the 
requirements for certification and the functions that a qualified OPO is 
expected to perform.
    (3) Section 1102 of the Act authorizes the Secretary of Health and 
Human Services to make and publish rules and regulations necessary to 
the efficient administration of the functions that are assigned to the 
Secretary under the Act.
    (4) Section 1871 of the Act authorizes the Secretary to prescribe 
regulations as may be necessary to carry out the administration of the 
Medicare program under title XVIII.
    (b) Scope. This subpart sets forth--
    (1) The conditions and requirements that an OPO must meet;
    (2) The procedures for certification and designation of OPOs; and
    (3) The terms of the agreement with CMS and the basis for and the 
effect of de-certification.
    (4) The requirements for an OPO to be re-certified.



Sec.  486.302  Definitions.

    As used in this subpart, the following definitions apply:
    Adverse event means an untoward, undesirable, and usually 
unanticipated event that causes death or serious injury or the risk 
thereof. As applied to OPOs, adverse events include but are not limited 
to transmission of disease from a donor to a recipient, avoidable loss 
of a medically suitable potential donor for whom consent for donation 
has been obtained, or delivery to a transplant center of the wrong organ 
or an organ whose blood type does not match the blood type of the 
intended recipient.
    Agreement cycle refers to the time period of at least 4 years when 
an agreement is in effect between CMS and an OPO.

[[Page 166]]

    Certification means a CMS determination that an OPO meets the 
requirements for certification at Sec.  486.303.
    Death record review means an assessment of the medical chart of a 
deceased patient to evaluate potential for organ donation.
    Decertification means a CMS determination that an OPO no longer 
meets the requirements for certification at Sec.  486.303.
    Designated requestor or effective requestor is an individual 
(generally employed by a hospital), who is trained to handle or 
participate in the donation consent process. The designated requestor 
may request consent for donation from the family of a potential donor or 
from the individual(s) responsible for making the donation decision in 
circumstances permitted under State law, provide information about 
donation to the family or decision-maker(s), or provide support to or 
collaborate with the OPO in the donation consent process.
    Designation means CMS assignment of a geographic service area to an 
OPO. Once an OPO is certified and assigned a geographic service area, 
organ procurement costs of the OPO are eligible for Medicare and 
Medicaid payment under section 1138(b)(1)(F) of the Act.
    Donation service area (DSA) means a geographical area of sufficient 
size to ensure maximum effectiveness in the procurement and equitable 
distribution of organs and that either includes an entire metropolitan 
statistical area or does not include any part of such an area and that 
meets the standards of this subpart.
    Donor means a deceased individual from whom at least one 
vascularized organ (heart, liver, lung, kidney, pancreas, or intestine) 
is recovered for the purpose of transplantation.
    Donor after cardiac death (DCD) means an individual who donates 
after his or her heart has irreversibly stopped beating. A donor after 
cardiac death may be termed a non-heartbeating or asystolic donor.
    Donor document is any documented indication of an individual's 
choice in regard to donation that meets the requirements of the 
governing state law.
    Eligible death for organ donation means the death of a patient 70 
years old or younger, who ultimately is legally declared brain dead 
according to hospital policy independent of family decision regarding 
donation or availability of next-of-kin, independent of medical examiner 
or coroner involvement in the case, and independent of local acceptance 
criteria or transplant center practice, who exhibits none of the 
following:
    (1) Active infections (specific diagnoses).
    (i) Bacterial:
    (A) Tuberculosis.
    (B) Gangrenous bowel or perforated bowel and/or intra-abdominal 
sepsis.
    (ii) Viral:
    (A) HIV infection by serologic or molecular detection.
    (B) Rabies.
    (C) Reactive Hepatitis B Surface Antigen.
    (D) Retroviral infections including HTLV I/II.
    (E) Viral Encephalitis or Meningitis.
    (F) Active Herpes simplex, varicella zoster, or cytomegalovirus 
viremia or pneumonia.
    (G) Acute Epstein Barr Virus (mononucleosis).
    (H) West Nile Virus infection.
    (I) Severe acute respiratory syndrome (SARS).
    (iii) Fungal:
    (A) Active infection with Cryptococcus, Aspergillus, Histoplasma, 
Coccidioides.
    (B) Active candidemia or invasive yeast infection.
    (iv) Parasites: active infection with Trypanosoma cruzi (Chagas'), 
Leishmania, Strongyloides, or Malaria (Plasmodium sp.).
    (v) Prion: Creutzfeldt-Jacob Disease.
    (2) General:
    (i) Aplastic Anemia.
    (ii) Agranulocytosis.
    (iii) Extreme Immaturity (<500 grams or gestational age of <32 
weeks).
    (iv) Current malignant neoplasms except non-melanoma skin cancers 
such as basal cell and squamous cell cancer and primary CNS tumors 
without evident metastatic disease.
    (v) Previous malignant neoplasms with current evident metastatic 
disease.
    (vi) A history of melanoma.

[[Page 167]]

    (vii) Hematologic malignancies: Leukemia, Hodgkin's Disease, 
Lymphoma, Multiple Myeloma.
    (viii) Multi-system organ failure (MSOF) due to overwhelming sepsis 
or MSOF without sepsis defined as 3 or more systems in simultaneous 
failure for a period of 24 hours or more without response to treatment 
or resuscitation.
    (ix) Active Fungal, Parasitic, viral, or Bacterial Meningitis or 
encephalitis.
    (3) The number of eligible deaths is the denominator for the 
donation rate outcome performance measure as described at Sec.  
486.318(a)(1).
    Eligible donor means any donor that meets the eligible death 
criteria. The number of eligible donors is the numerator of the donation 
rate outcome performance measure.
    Entire metropolitan statistical area means a metropolitan 
statistical area (MSA), a consolidated metropolitan statistical area 
(CMSA), or a primary metropolitan statistical area (PMSA) listed in the 
State and Metropolitan Area Data Book published by the U.S. Bureau of 
the Census. CMS does not recognize a CMSA as a metropolitan area for the 
purposes of establishing a geographical area for an OPO.
    Expected donation rate means the donation rate expected for an OPO 
based on the national experience for OPOs serving similar hospitals and 
donation service areas. This rate is adjusted for the following hospital 
characteristics: Level I or Level II trauma center, Metropolitan 
Statistical Area size, MS Case Mix Index, total bed size, number of 
intensive care unit (ICU) beds, primary service, presence of a 
neurosurgery unit, and hospital control/ownership.
    Observed donation rate is the number of donors meeting the 
eligibility criteria per 100 deaths.
    Open area means an OPO service area for which CMS has notified the 
public that it is accepting applications for designation.
    Organ means a human kidney, liver, heart, lung, pancreas, or 
intestine (or multivisceral organs when transplanted at the same time as 
an intestine).
    Organ procurement organization (OPO) means an organization that 
performs or coordinates the procurement, preservation, and transport of 
organs and maintains a system for locating prospective recipients for 
available organs.
    Re-certification cycle means the 4-year cycle during which an OPO is 
certified.
    Standard criteria donor (SCD) means a donor that meets the 
eligibility criteria for an eligible donor and does not meet the 
criteria to be a donor after cardiac death or expanded criteria donor.
    Transplant hospital means a hospital that provides organ transplants 
and other medical and surgical specialty services required for the care 
of transplant patients. There may be one or more types of organ 
transplant centers operating within the same transplant hospital.
    Urgent need occurs when an OPO's noncompliance with one or more 
conditions for coverage has caused, or is likely to cause, serious 
injury, harm, impairment, or death to a potential or actual donor or an 
organ recipient.

             Requirements for Certification and Designation



Sec.  486.303  Requirements for certification.

    In order to be certified as a qualified organ procurement 
organization, an organ procurement organization must:
    (a) Have received a grant under 42 U.S.C. 273(a) or have been 
certified or re-certified by the Secretary within the previous 4 years 
as being a qualified OPO.
    (b) Be a non-profit entity that is exempt from Federal income 
taxation under section 501 of the Internal Revenue Code of 1986.
    (c) Have accounting and other fiscal procedures necessary to assure 
the fiscal stability of the organization, including procedures to obtain 
payment for kidneys and non-renal organs provided to transplant 
hospitals.
    (d) Have an agreement with CMS, as the Secretary's designated 
representative, to be reimbursed under title XVIII for the procurement 
of kidneys.
    (e) Have been re-certified as an OPO under the Medicare program from 
January 1, 2002 through December 31, 2005.

[[Page 168]]

    (f) Have procedures to obtain payment for non-renal organs provided 
to transplant centers.
    (g) Agree to enter into an agreement with any hospital or critical 
access hospital in the OPO's service area, including a transplant 
hospital that requests an agreement.
    (h) Meet the conditions for coverage for organ procurement 
organizations, which include both outcome and process performance 
measures.
    (i) Meet the provisions of titles XI, XVIII, and XIX of the Act, 
section 371(b) of the Public Health Services Act, and any other 
applicable Federal regulations.



Sec.  486.304  Requirements for designation.

    (a) Designation is a condition for payment. Payment may be made 
under the Medicare and Medicaid programs for organ procurement costs 
attributable to payments made to an OPO by a hospital only if the OPO 
has been designated by CMS as an OPO.
    (b) An OPO must be certified as a qualified OPO by CMS under 42 
U.S.C. 273(b) and Sec.  486.303 to be eligible for designation.
    (c) An OPO must enter into an agreement with CMS in order for the 
organ procurement costs attributable to the OPO to be reimbursed under 
Medicare and Medicaid.



Sec.  486.306  OPO service area size designation and documentation requirements.

    (a) General documentation requirement. An OPO must make available to 
CMS documentation verifying that the OPO meets the requirements of 
paragraphs (b) through (d) of this section at the time of application 
and throughout the period of its designation.
    (b) Service area designation. The defined service area either 
includes an entire metropolitan statistical area or a New England county 
metropolitan statistical area as specified by the Director of the Office 
of Management and Budget or does not include any part of such an area.
    (c) Service area location and characteristics. An OPO must define 
and document a proposed service area's location through the following 
information:
    (1) The names of counties (or parishes in Louisiana) served or, if 
the service area includes an entire State, the name of the State.
    (2) Geographic boundaries of the service area.
    (3) The number and the names of all hospitals and critical access 
hospitals in the service area that have both a ventilator and an 
operating room.



Sec.  486.308  Designation of one OPO for each service area.

    (a) CMS designates only one OPO per service area. A service area is 
open for competition when the OPO for the service area is de-certified 
and all administrative appeals under Sec.  486.314 are exhausted.
    (b) Designation periods--
    (1) General. An OPO is normally designated for a 4-year agreement 
cycle. The period may be shorter, for example, if an OPO has voluntarily 
terminated its agreement with CMS and CMS selects a successor OPO for 
the balance of the 4-year agreement cycle. In rare situations, a 
designation period may be longer, for example, a designation may be 
extended if additional time is needed to select a successor OPO to an 
OPO that has been de-certified.
    (2) Re-Certification. Re-certification must occur not more 
frequently than once every 4 years.
    (c) Unless CMS has granted a hospital a waiver under paragraphs
    (d) through (f) of this section, the hospital must enter into an 
agreement only with the OPO designated to serve the area in which the 
hospital is located.
    (d) If CMS changes the OPO designated for an area, hospitals located 
in that area must enter into agreements with the newly designated OPO or 
submit a request for a waiver in accordance with paragraph (e) of this 
section within 30 days of notice of the change in designation.
    (e) A hospital may request and CMS may grant a waiver permitting the 
hospital to have an agreement with a designated OPO other than the OPO 
designated for the service area in which the hospital is located. To 
qualify for a waiver, the hospital must submit data to CMS establishing 
that--

[[Page 169]]

    (1) The waiver is expected to increase organ donations; and
    (2) The waiver will ensure equitable treatment of patients listed 
for transplants within the service area served by the hospital's 
designated OPO and within the service area served by the OPO with which 
the hospital seeks to enter into an agreement.
    (f) In making a determination on waiver requests, CMS considers--
    (1) Cost effectiveness;
    (2) Improvements in quality;
    (3) Changes in a hospital's designated OPO due to changes in the 
definitions of metropolitan statistical areas, if applicable; and
    (4) The length and continuity of a hospital's relationship with an 
OPO other than the hospital's designated OPO.
    (g) A hospital may continue to operate under its existing agreement 
with an out-of-area OPO while CMS is processing the waiver request. If a 
waiver request is denied, a hospital must enter into an agreement with 
the designated OPO within 30 days of notification of the final 
determination.



Sec.  486.309  Re-certification from August 1, 2006 through July 31, 2010.

    An OPO will be considered to be re-certified for the period of 
August 1, 2006 through July 31, 2010 if an OPO met the standards to be a 
qualified OPO within a 4-year period ending December 31, 2001 and has an 
agreement with the Secretary that is scheduled to terminate on July 31, 
2006. Agreements based on the August 1, 2006 through July 31, 2010 re-
certification cycle will end on January 31, 2011.



Sec.  486.310  Changes in control or ownership or service area.

    (a) OPO requirements. (1) A designated OPO considering a change in 
control (see Sec.  413.17(b)(3)) or ownership or in its service area 
must notify CMS before putting it into effect. This notification is 
required to ensure that the OPO, if changed, will continue to satisfy 
Medicare and Medicaid requirements. The merger of one OPO into another 
or the consolidation of one OPO with another is considered a change in 
control or ownership.
    (2) A designated OPO considering a change in its service area must 
obtain prior CMS approval. In the case of a service area change that 
results from a change of control or ownership due to merger or 
consolidation, the OPOs must resubmit the information required in an 
application for designation. The OPO must provide information specific 
to the board structure of the new organization, as well as operating 
budgets, financial information, and other written documentation CMS 
determines to be necessary for designation.
    (b) CMS requirements. (1) If CMS finds that the OPO has changed to 
such an extent that it no longer satisfies the requirements for OPO 
designation, CMS may de-certify the OPO and declare the OPO's service 
area to be an open area. An OPO may appeal such a de-certification as 
set forth in Sec.  486.314. The OPO's service area is not opened for 
competition until the conclusion of the administrative appeals process.
    (2) If CMS finds that the changed OPO continues to satisfy the 
requirements for OPO designation, the period of designation of the 
changed OPO is the remaining portion of the 4-year term of the OPO that 
was reorganized. If more than one designated OPO is involved in the 
reorganization, the remaining designation term is the longest of the 
remaining periods unless CMS determines that a shorter period is in the 
best interest of the Medicare and Medicaid programs. The changed OPO 
must continue to meet the requirements for certification at Sec.  
486.303 throughout the remaining period.

                  Re-Certification and De-Certification



Sec.  486.312  De-certification.

    (a) Voluntary termination of agreement. If an OPO wishes to 
terminate its agreement, the OPO must send CMS written notice of its 
intention to terminate its agreement and the proposed effective date. 
CMS may approve the proposed date, set a different date no later than 6 
months after the proposed effective date, or set a date less than 6 
months after the proposed effective date if it determines that a 
different date would not disrupt services to the

[[Page 170]]

service area. If CMS determines that a designated OPO has ceased to 
furnish organ procurement services to its service area, the cessation of 
services is deemed to constitute a voluntary termination by the OPO, 
effective on a date determined by CMS. CMS will de-certify the OPO as of 
the effective date of the voluntary termination.
    (b) Involuntary termination of agreement. During the term of the 
agreement, CMS may terminate an agreement with an OPO if the OPO no 
longer meets the requirements for certification at Sec.  486.303. CMS 
may also terminate an agreement immediately in cases of urgent need, 
such as the discovery of unsound medical practices. CMS will de-certify 
the OPO as of the effective date of the involuntary termination.
    (c) Non-renewal of agreement. CMS will not voluntarily renew its 
agreement with an OPO if the OPO fails to meet the requirements for 
certification at Sec.  486.318, based on findings from the most recent 
re-certification cycle, or the other requirements for certification at 
Sec.  486.303. CMS will de-certify the OPO as of the ending date of the 
agreement.
    (d) Notice to OPO. Except in cases of urgent need, CMS gives written 
notice of de-certification to an OPO at least 90 days before the 
effective date of the de-certification. In cases of urgent need, CMS 
gives written notice of de-certification to an OPO at least 3 calendar 
days prior to the effective date of the de-certification. The notice of 
de-certification states the reasons for de-certification and the 
effective date.
    (e) Public notice. Once CMS approves the date for a voluntary 
termination, the OPO must provide prompt public notice of the date of 
de-certification and such other information as CMS may require through 
publication in local newspapers in the service area. In the case of 
involuntary termination or non-renewal of an agreement, CMS provides 
public notice of the date of de-certification through publication in 
local newspapers in the service area. No payment under titles XVIII or 
XIX of the Act will be made with respect to organ procurement costs 
attributable to the OPO on or after the effective date of de-
certification.



Sec.  486.314  Appeals.

    If an OPO's de-certification is due to involuntary termination or 
non-renewal of its agreement with CMS, the OPO may appeal the de-
certification on substantive and procedural grounds.
    (a) Notice of initial determination. CMS mails notice to the OPO of 
an initial de-certification determination. The notice contains the 
reasons for the determination, the effect of the determination, and the 
OPO's right to seek reconsideration.
    (b) Reconsideration. (1) Filing request. If the OPO is dissatisfied 
with the de-certification determination, it has 15 business days from 
receipt of the notice of de-certification to seek reconsideration from 
CMS. The request for reconsideration must state the issues or findings 
of fact with which the OPO disagrees and the reasons for disagreement.
    (2) An OPO must seek reconsideration before it is entitled to seek a 
hearing before a hearing officer. If an OPO does not request 
reconsideration or its request is not made timely, the OPO has no right 
to further administrative review.
    (3) Reconsideration determination. CMS makes a written reconsidered 
determination within 10 business days of receipt of the request for 
reconsideration, affirming, reversing, or modifying the initial 
determination and the findings on which it was based. CMS augments the 
administrative record to include any additional materials submitted by 
the OPO, and a copy of the reconsideration decision and sends the 
supplemented administrative record to the CMS hearing officer.
    (c) Request for hearing. An OPO dissatisfied with the CMS 
reconsideration decision, must file a request for a hearing before a CMS 
hearing officer within 40 business days of receipt of the notice of the 
reconsideration determination. If an OPO does not request a hearing or 
its request is not received timely, the OPO has no right to further 
administrative review.
    (d) Administrative record. The hearing officer sends the 
administrative record to both parties within 10 business days of receipt 
of the request for a hearing.

[[Page 171]]

    (1) The administrative record consists of, but is not limited to, 
the following:
    (i) Factual findings from the survey(s) on the OPO conditions for 
coverage.
    (ii) Data from the outcome measures.
    (iii) Rankings of OPOs based on the outcome data.
    (iv) Correspondence between CMS and the affected OPO.
    (2) The administrative record will not include any privileged 
information.
    (e) Pre-Hearing conference. At any time before the hearing, the CMS 
hearing officer may call a pre-hearing conference if he or she believes 
that a conference would more clearly define the issues. At the pre-
hearing conference, the hearing officer may establish the briefing 
schedule, sets the hearing date, and addresses other administrative 
matters. The hearing officer will issue an order reflecting the results 
of the pre-hearing conference.
    (f) Date of hearing. The hearing officer sets a date for the hearing 
that is no more than 60 calendar days following the receipt of the 
request for a hearing.
    (g) Conduct of hearing. (1) The hearing is open to both parties, CMS 
and the OPO.
    (2) The hearing officer inquires fully into all the matters at issue 
and receives in evidence the testimony of witnesses and any documents 
that are relevant and material.
    (3) The hearing officer provides the parties with an opportunity to 
enter an objection to the inclusion of any document. The hearing officer 
will consider the objection and will rule on the document's 
admissibility.
    (4) The hearing officer decides the order in which the evidence and 
the arguments of the parties are presented and the conduct of the 
hearing.
    (5) The hearing officer rules on the admissibility of evidence and 
may admit evidence that would be inadmissible under rules applicable to 
court procedures.
    (6) The hearing officer rules on motions and other procedural items.
    (7) The hearing officer regulates the course of the hearing and 
conduct of counsel.
    (8) The hearing officer may examine witnesses.
    (9) The hearing officer takes any action authorized by the rules in 
this subpart.
    (h) Parties' rights. CMS and the OPO may:
    (1) Appear by counsel or other authorized representative, in all 
hearing proceedings.
    (2) Participate in any pre-hearing conference held by the hearing 
officer.
    (3) Agree to stipulations as to facts which will be made a part of 
the record.
    (4) Make opening statements at the hearing.
    (5) Present relevant evidence on the issues at the hearing.
    (6) Present witnesses, who then must be available for cross-
examination, and cross-examine witnesses presented by the other party.
    (7) Present oral arguments at the hearing.
    (i) Hearing officer's decision. The hearing officer renders a 
decision on the appeal of the notice of de-certification within 20 
business days of the hearing.
    (1) Reversal of de-certification. If the hearing officer reverses 
CMS' determination to de-certify an OPO in a case involving the 
involuntary termination of the OPO's agreement, CMS will not terminate 
the OPO's agreement and will not de-certify the OPO.
    (2) De-certification is upheld. If the de-certification 
determination is upheld by the hearing officer, the OPO is de-certified 
and it has no further administrative appeal rights.
    (j) Extension of agreement. If there is insufficient time prior to 
expiration of an agreement with CMS to allow for competition of the 
service area and, if necessary, transition of the service area to a 
successor OPO, CMS may choose to extend the OPO's agreement with CMS.
    (k) Effects of de-certification. Medicare and Medicaid payments may 
not be made for organ procurement services the OPO furnishes on or after 
the effective date of de-certification. CMS will then open the de-
certified OPO's service area for competition as set forth in Sec.  
486.316(c).

[[Page 172]]



Sec.  486.316  Re-certification and competition processes.

    (a) Re-Certification of OPOs. An OPO is re-certified for an 
additional 4 years and its service area is not opened for competition 
when the OPO:
    (1) Meets all 3 outcome measure requirements at Sec.  486.318; and
    (2) Has been shown by survey to be in compliance with the 
requirements for certification at Sec.  486.303, including the 
conditions for coverage at Sec.  486.320 through Sec.  486.348.
    (b) De-certification and competition. If an OPO does not meet all 3 
outcome measures as described in paragraph (a)(1) of this section or the 
requirements described in paragraph (a)(2) of this section, the OPO is 
de-certified. If the OPO does not appeal or the OPO appeals and the 
reconsideration official and CMS hearing officer uphold the de-
certification, the OPO's service area is opened for competition from 
other OPOs. The de-certified OPO is not permitted to compete for its 
open area or any other open area. An OPO competing for an open service 
area must submit information and data that describe the barriers in its 
service area, how they affected organ donation, what steps the OPO took 
to overcome them, and the results.
    (c) Criteria to compete. To compete for an open service area, an OPO 
must meet the criteria in paragraph (a) of this section and the 
following additional criteria:
    (1) The OPO's performance on the donation rate outcome measure and 
yield outcome measure is at or above 100 percent of the mean national 
rate averaged over the 4 years of the re-certification cycle; and
    (2) The OPO's donation rate is at least 15 percentage points higher 
than the donation rate of the OPO currently designated for the service 
area.
    (3) The OPO must compete for the entire service area.
    (d) Criteria for selection. CMS will designate an OPO for an open 
service area based on the following criteria:
    (1) Performance on the outcome measures at Sec.  486.318;
    (2) Relative success in meeting the process performance measures and 
other conditions at Sec. Sec.  486.320 through 486.348;
    (3) Contiguity to the open service area.
    (4) Success in identifying and overcoming barriers to donation 
within its own service area and the relevance of those barriers to 
barriers in the open area. An OPO competing for an open service area 
must submit information and data that describe the barriers in its 
service area, how they affected organ donation, what steps the OPO took 
to overcome them, and the results.
    (e) No OPO applies. If no OPO applies to compete for a de-certified 
OPO's open area, CMS may select a single OPO to take over the entire 
open area or may adjust the service area boundaries of two or more 
contiguous OPOs to incorporate the open area. CMS will make its decision 
based on the criteria in paragraph (d) of this section.

           Organ Procurement Organization Outcome Requirements



Sec.  486.318  Condition: Outcome measures.

    (a) With the exception of OPOs operating exclusively in non-
contiguous U.S. states, commonwealths, territories, or possessions, an 
OPO must meet all 3 of the following outcome measures:
    (1) The OPO's donation rate of eligible donors as a percentage of 
eligible deaths is no more than 1.5 standard deviations below the mean 
national donation rate of eligible donors as a percentage of eligible 
deaths, averaged over the 4 years of the re-certification cycle. Both 
the numerator and denominator of an individual OPO's donation rate ratio 
are adjusted by adding a 1 for each donation after cardiac death donor 
and each donor over the age of 70;
    (2) The observed donation rate is not significantly lower than the 
expected donation rate for 18 or more months of the 36 months of data 
used for re-certification, as calculated by the SRTR;
    (3) At least 2 out of the 3 following yield measures are no more 
than 1 standard deviation below the national mean, averaged over the 4 
years of the re-certification cycle:

[[Page 173]]

    (i) The number of organs transplanted per standard criteria donor, 
including pancreata used for islet cell transplantation;
    (ii) The number of organs transplanted per expanded criteria donor, 
including pancreata used for islet cell transplantation; and
    (iii) The number of organs used for research per donor, including 
pancreata used for islet cell research.
    (b) For OPOs operating exclusively in non-contiguous U.S. states, 
commonwealths, territories, and possessions, the OPO outcome measures 
are as follows:
    (1) The OPO's donation rate of eligible donors as a percentage of 
eligible deaths is no more than 1.5 standard deviations below the mean 
national donation rate of eligible donors as a percentage of eligible 
deaths, averaged over the 4 years of the re-certification cycle. Both 
the numerator and denominator of an individual OPO's donation rate ratio 
are adjusted by adding a 1 for each donation after cardiac death donor 
and each donor over the age of 70;
    (2) The observed donation rate is not significantly lower than the 
expected donation rate for 18 or more months of the 36 months of data 
used for re-certification, as calculated by the SRTR;
    (3) At least 2 out of the 3 following are no more than 1 standard 
deviation below the national mean:
    (i) The number of kidneys transplanted per standard criteria donor;
    (ii) The number of kidneys transplanted per expanded criteria donor; 
and
    (iii) The number of organs used for research per donor, including 
pancreata recovered for islet cell transplantation.
    (c) Data for the outcome measures.
    (1) An OPO's performance on the outcome measures is based on 36 
months of data, beginning with January 1 of the first full year of the 
re-certification cycle and ending 36 months later on December 31, 7 
months prior to the end of the re-certification cycle.
    (2) If an OPO takes over another OPO's service area on a date later 
than January 1 of the first full year of the re-certification cycle so 
that 36 months of data are not available to evaluate the OPO's 
performance in its new service area, we will not hold the OPO 
accountable for its performance in the new area until the end of the 
following re-certification cycle when 36 months of data are available.

       Organ Procurement Organization Process Performance Measures



Sec.  486.320  Condition: Participation in Organ Procurement and Transplantation Network.

    After being designated, an OPO must become a member of, participate 
in, and abide by the rules and requirements of the OPTN established and 
operated in accordance with section 372 of the Public Health Service Act 
(42 U.S.C. 274). The term ``rules and requirements of the OPTN'' means 
those rules and requirements approved by the Secretary. No OPO is 
considered out of compliance with section 1138(b)(1)(D) of the Act or 
this section until the Secretary approves a determination that the OPO 
failed to comply with the rules and requirements of the OPTN. The 
Secretary may impose sanctions under section 1138 only after such non-
compliance has been determined in this manner.



Sec.  486.322  Condition: Relationships with hospitals, critical access hospitals, and tissue banks.

    (a) Standard: Hospital agreements. An OPO must have a written 
agreement with 95 percent of the Medicare and Medicaid participating 
hospitals and critical access hospitals in its service area that have 
both a ventilator and an operating room and have not been granted a 
waiver by CMS to work with another OPO. The agreement must describe the 
responsibilities of both the OPO and hospital or critical access 
hospital in regard to donation after cardiac death (if the OPO has a 
protocol for donation after cardiac death) and the requirements for 
hospitals at Sec.  482.45 or Sec.  485.643. The agreement must specify 
the meaning of the terms ``timely referral'' and ``imminent death.''
    (b) Standard: Designated requestor training for hospital staff. The 
OPO must offer to provide designated requestor training on at least an 
annual

[[Page 174]]

basis for hospital and critical access hospital staff.
    (c) Standard: Cooperation with tissue banks.
    (1) The OPO must have arrangements to cooperate with tissue banks 
that have agreements with hospitals and critical access hospitals with 
which the OPO has agreements. The OPO must cooperate in the following 
activities, as may be appropriate, to ensure that all usable tissues are 
obtained from potential donors:
    (i) Screening and referral of potential tissue donors.
    (ii) Obtaining informed consent from families of potential tissue 
donors.
    (iii) Retrieval, processing, preservation, storage, and distribution 
of tissues.
    (iv) Providing designated requestor training.
    (2) An OPO is not required to have an arrangement with a tissue bank 
that is unwilling to have an arrangement with the OPO.



Sec.  486.324  Condition: Administration and governing body.

    (a) While an OPO may have more than one board, the OPO must have an 
advisory board that has both the authority described in paragraph (b) of 
this section and the following membership:
    (1) Members who represent hospital administrators, either intensive 
care or emergency room personnel, tissue banks, and voluntary health 
associations in the OPO's service area.
    (2) Individuals who represent the public residing in the OPO's 
service area.
    (3) A physician with knowledge, experience, or skill in the field of 
human histocompatibility, or an individual with a doctorate degree in a 
biological science and with knowledge, experience, or skills in the 
field of human histocompatibility.
    (4) A neurosurgeon or other physician with knowledge or skills in 
the neurosciences.
    (5) A transplant surgeon representing each transplant hospital in 
the service area with which the OPO has arrangements to coordinate its 
activities. The transplant surgeon must have practicing privileges and 
perform transplants in the transplant hospital represented.
    (6) An organ donor family member.
    (b) The OPO board described in paragraph (a) of this section has the 
authority to recommend policies for the following:
    (1) Procurement of organs.
    (2) Effective agreements to identify potential organ donors with a 
substantial majority of hospitals in its service area that have 
facilities for organ donation.
    (3) Systematic efforts, including professional education, to acquire 
all useable organs from potential donors.
    (4) Arrangements for the acquisition and preservation of donated 
organs and provision of quality standards for the acquisition of organs 
that are consistent with the standards adopted by the OPTN, including 
arranging for testing with respect to preventing the acquisition of 
organs that are infected with the etiologic agent for acquired 
immunodeficiency syndrome (AIDS).
    (5) Appropriate tissue typing of organs.
    (6) A system for allocation of organs among transplant patients that 
is consistent with the rules and requirements of the OPTN, as defined in 
Sec.  486.320 of this part.
    (7) Transportation of organs to transplant hospitals.
    (8) Coordination of activities with transplant hospitals in the 
OPO's service area.
    (9) Participation in the OPTN.
    (10) Arrangements to cooperate with tissue banks for the retrieval, 
processing, preservation, storage, and distribution of tissues as may be 
appropriate to assure that all useable tissues are obtained from 
potential donors.
    (11) Annual evaluation of the effectiveness of the OPO in acquiring 
organs.
    (12) Assistance to hospitals in establishing and implementing 
protocols for making routine inquiries about organ donations by 
potential donors.
    (c) The advisory board described in paragraph (a) of this section 
has no authority over any other activity of the OPO and may not serve as 
the OPO's governing body or board of directors. Members of the advisory 
board described in paragraph (a) of this section

[[Page 175]]

are prohibited from serving on any other OPO board.
    (d) The OPO must have bylaws for each of its board(s) that address 
potential conflicts of interest, length of terms, and criteria for 
selecting and removing members. (e) A governing body must have full 
legal authority and responsibility for the management and provision of 
all OPO services and must develop and oversee implementation of policies 
and procedures considered necessary for the effective administration of 
the OPO, including fiscal operations, the OPO's quality assessment and 
performance improvement (QAPI) program, and services furnished under 
contract or arrangement, including agreements for these services. The 
governing body must appoint an individual to be responsible for the day-
to-day operation of the OPO.
    (e) A governing body must have full legal authority and 
responsibility for the management and provision of all OPO services and 
must develop and oversee implementation of policies and procedures 
considered necessary for the effective administration of the OPO, 
including fiscal operations, the OPO's quality assessment and 
performance improvement (QAPI) program, and services furnished under 
contract or arrangement, including agreements for these services. The 
governing body must appoint an individual to be responsible for the day-
to-day operation of the OPO.
    (f) The OPO must have procedures to address potential conflicts of 
interest for the governing body described in paragraph (d) of this 
section.
    (g) The OPO's policies must state whether the OPO recovers organs 
from donors after cardiac death.



Sec.  486.326  Condition: Human resources.

    All OPOs must have a sufficient number of qualified staff, including 
a director, a medical director, organ procurement coordinators, and 
hospital development staff to obtain all usable organs from potential 
donors, and to ensure that required services are provided to families of 
potential donors, hospitals, tissue banks, and individuals and 
facilities that use organs for research.
    (a) Standard: Qualifications. (1) The OPO must ensure that all 
individuals who provide services and/or supervise services, including 
services furnished under contract or arrangement, are qualified to 
provide or supervise the services.
    (2) The OPO must develop and implement a written policy that 
addresses potential conflicts of interest for the OPO's director, 
medical director, senior management, and procurement coordinators.
    (3) The OPO must have credentialing records for physicians and other 
practitioners who routinely recover organs in hospitals under contract 
or arrangement with the OPO and ensure that all physicians and other 
practitioners who recover organs in hospitals with which the OPO has 
agreements are qualified and trained.
    (b) Standard: Staffing. (1) The OPO must provide sufficient 
coverage, either by its own staff or under contract or arrangement, to 
assure both that hospital referral calls are screened for donor 
potential and that potential donors are evaluated for medical 
suitability for organ and/or tissue donation in a timely manner.
    (2) The OPO must have a sufficient number of qualified staff to 
provide information and support to potential organ donor families; 
request consent for donation; ensure optimal maintenance of the donor, 
efficient placement of organs, and adequate oversight of organ recovery; 
and conduct QAPI activities, such as death record reviews and hospital 
development.
    (3) The OPO must provide a sufficient number of recovery personnel, 
either from its own staff or under contract or arrangement, to ensure 
that all usable organs are recovered in a manner that, to the extent 
possible, preserves them for transplantation.
    (c) Standard: Education, training, and performance evaluation. The 
OPO must provide its staff with the education, training, and supervision 
necessary to furnish required services. Training must include but is not 
limited to performance expectations for staff, applicable organizational 
policies and procedures, and QAPI activities. OPOs must evaluate the 
performance of their staffs and provide training, as needed,

[[Page 176]]

to improve individual and overall staff performance and effectiveness.
    (d) Standard: Medical director. The OPO's medical director is a 
physician licensed in at least one of the States or territories within 
the OPO's service area or as required by State or territory law or by 
the jurisdiction in which the OPO is located. The medical director is 
responsible for implementation of the OPO's protocols for donor 
evaluation and management and organ recovery and placement. The medical 
director is responsible for oversight of the clinical management of 
potential donors, including providing assistance in managing a donor 
case when the surgeon on call is unavailable.



Sec.  486.328  Condition: Reporting of data.

    (a) An OPO must provide individually-identifiable, hospital-specific 
organ donation and transplantation data and other information to the 
Organ Procurement and Transplantation Network, the Scientific Registry 
of Transplant Recipients, and DHHS, as requested by the Secretary. The 
data may include, but are not limited to:
    (1) Number of hospital deaths;
    (2) Results of death record reviews;
    (3) Number and timeliness of referral calls from hospitals;
    (4) Number of eligible deaths;
    (5) Data related to non-recovery of organs;
    (6) Data about consents for donation;
    (7) Number of eligible donors;
    (8) Number of organs recovered, by type of organ; and
    (9) Number of organs transplanted, by type of organ.
    (b) An OPO must provide hospital-specific organ donation data 
annually to the transplant hospitals with which it has agreements.
    (c) Data to be used for OPO re-certification purposes must be 
reported to the OPTN and must include data for all deaths in all 
hospitals and critical access hospitals in the OPO's donation service 
area, unless a hospital or critical access hospital has been granted a 
waiver to work with a different OPO.
    (d) Data reported by the OPO to the OPTN must be reported within 30 
days after the end of the month in which a death occurred. If an OPO 
determines through death record review or other means that the data it 
reported to the OPTN was incorrect, it must report the corrected data to 
the OPTN within 30 days of the end of the month in which the error is 
identified.
    (e) For the purpose of determining the information to be collected 
under paragraph (a) of this section, the following definitions apply:
    (1) Kidneys procured. Each kidney recovered will be counted 
individually. En bloc kidneys recovered will count as two kidneys 
procured.
    (2) Kidneys transplanted. Each kidney transplanted will be counted 
individually. En bloc kidney transplants will be counted as two kidneys 
transplanted.
    (3) Extra-renal organs procured. Each organ recovered is counted 
individually.
    (4) Extra-renal organs transplanted. Each organ or part thereof 
transplanted will be counted individually. For example, a single liver 
is counted as one organ procured and each portion that is transplanted 
will count as one transplant. Further, a heart and double lung 
transplant will be counted as three organs transplanted. A kidney/
pancreas transplant will count as one kidney transplanted and one extra-
renal organ transplanted.



Sec.  486.330  Condition: Information management.

    An OPO must establish and use an electronic information management 
system to maintain the required medical, social and identifying 
information for every donor and transplant recipient and develop and 
follow procedures to ensure the confidentiality and security of the 
information.
    (a) Donor information. The OPO must maintain a record for every 
donor. The record must include, at a minimum, information identifying 
the donor (for example, name, address, date of birth, social security 
number or other unique identifier, such as Medicare health insurance 
claim number), organs and (when applicable) tissues recovered, date of 
the organ recovery, donor management data, all test results, current 
hospital history, past medical and social history, the pronouncement of

[[Page 177]]

death, and consent and next-of-kin information.
    (b) Disposition of organs. The OPO must maintain records showing the 
disposition of each organ recovered for the purpose of transplantation, 
including information identifying transplant recipients.
    (c) Data retention. Donor and transplant recipient records must be 
maintained in a human readable and reproducible paper or electronic 
format for 7 years.
    (d) Format of records. The OPO must maintain data in a format that 
can readily be transferred to a successor OPO and in the event of a 
transfer must provide to CMS copies of all records, data, and software 
necessary to ensure uninterrupted service by a successor OPO. Records 
and data subject to this requirement include donor and transplant 
recipient records and procedural manuals and other materials used in 
conducting OPO operations.



Sec.  486.342  Condition: Requesting consent.

    An OPO must encourage discretion and sensitivity with respect to the 
circumstances, views, and beliefs of potential donor families.
    (a) An OPO must have a written protocol to ensure that, in the 
absence of a donor document, the individual(s) responsible for making 
the donation decision are informed of their options to donate organs or 
tissues (when the OPO is making a request for tissues) or to decline to 
donate. The OPO must provide to the individual(s) responsible for making 
the donation decision, at a minimum, the following:
    (1) A list of the organs and/or tissues that may be recovered.
    (2) The most likely uses for the donated organs or tissues.
    (3) A description of the screening and recovery processes.
    (4) Information about the organizations that will recover, process, 
and distribute the tissue.
    (5) Information regarding access to and release of the donor's 
medical records.
    (6) An explanation of the impact the donation process will have on 
burial arrangements and the appearance of the donor's body.
    (7) Contact information for individual(s) with questions or 
concerns.
    (8) A copy of the signed consent form if a donation is made.
    (b) If an OPO does not request consent to donation because a 
potential donor consented to donation before his or her death in a 
manner that satisfied applicable State law requirements in the potential 
donor's State of residence, the OPO must provide information about the 
donation to the family of the potential donor, as requested.



Sec.  486.344  Condition: Evaluation and management of potential donors and organ placement and recovery.

    The OPO must have written protocols for donor evaluation and 
management and organ placement and recovery that meet current standards 
of practice and are designed to maximize organ quality and optimize the 
number of donors and the number of organs recovered and transplanted per 
donor.
    (a) Potential donor protocol management. (1) The medical director is 
responsible for ensuring that potential donor evaluation and management 
protocols are implemented correctly and appropriately to ensure that 
potential donors are thoroughly assessed for medical suitability for 
organ donation and clinically managed to optimize organ viability and 
function.
    (2) The OPO must implement a system that ensures that a qualified 
physician or other qualified individual is available to assist in the 
medical management of a potential donor when the surgeon on call is 
unavailable.
    (b) Potential donor evaluation. The OPO must do the following:
    (1) Verify that death has been pronounced according to applicable 
local, State, and Federal laws.
    (2) Determine whether there are conditions that may influence donor 
acceptance.
    (3) If possible, obtain the potential donor's medical and social 
history.
    (4) Review the potential donor's medical chart and perform a 
physical examination of the donor.
    (5) Obtain the potential donor's vital signs and perform all 
pertinent tests.

[[Page 178]]

    (c) Testing. The OPO must do the following:
    (1) Arrange for screening and testing of the potential donor for 
infectious disease according to current standards of practice, including 
testing for the human immunodeficiency virus.
    (2) Ensure that screening and testing of the potential donor 
(including point-of-care testing and blood typing) are conducted by a 
laboratory that is certified in the appropriate specialty or 
subspecialty of service in accordance with part 493 of this chapter.
    (3) Ensure that the potential donor's blood is typed using two 
separate blood samples.
    (4) Document potential donor's record with all test results, 
including blood type, before organ recovery.
    (d) Standard: Collaboration with transplant programs. (1) The OPO 
must establish protocols in collaboration with transplant programs that 
define the roles and responsibilities of the OPO and the transplant 
program for all activities associated with the evaluation and management 
of potential donors, organ recovery, and organ placement, including 
donation after cardiac death, if the OPO has implemented a protocol for 
donation after cardiac death.
    (2) The protocol must ensure that:
    (i) The OPO is responsible for two separate determinations of the 
donor's blood type;
    (ii) If the identify of the intended recipient is known, the OPO has 
a procedure to ensure that prior to organ recovery, an individual from 
the OPO's staff compares the blood type of the donor with the blood type 
of the intended recipient, and the accuracy of the comparison is 
verified by a different individual;
    (iii) Documentation of the donor's blood type accompanies the organ 
to the hospital where the transplant will take place.
    (3) The established protocols must be reviewed regularly with the 
transplant programs to incorporate practices that have been shown to 
maximize organ donation and transplantation.
    (e) Documentation of recipient information. If the intended 
recipient has been identified prior to recovery of an organ for 
transplantation, the OPO must have written documentation from the OPTN 
showing, at a minimum, the intended organ recipient's ranking in 
relation to other suitable candidates and the recipient's OPTN 
identification number and blood type.
    (f) Donation after cardiac death. If an OPO recovers organs from 
donors after cardiac death, the OPO must have protocols that address the 
following:
    (1) Criteria for evaluating patients for donation after cardiac 
death;
    (2) Withdrawal of support, including the relationship between the 
time of consent to donation and the withdrawal of support;
    (3) Use of medications and interventions not related to withdrawal 
of support;
    (4) Involvement of family members prior to organ recovery;
    (5) Criteria for declaration of death and the time period that must 
elapse prior to organ recovery.
    (g) Organ allocation. The OPO must have a system to allocate donated 
organs among transplant patients that is consistent with the rules and 
requirements of the OPTN, as defined in Sec.  486.320 of this part.
    (h) Organ placement. The OPO must develop and implement a protocol 
to maximize placement of organs for transplantation.



Sec.  486.346  Condition: Organ preparation and transport.

    (a) The OPO must arrange for testing of organs for infectious 
disease and tissue typing of organs according to current standards of 
practice. The OPO must ensure that testing and tissue typing of organs 
are conducted by a laboratory that is certified in the appropriate 
specialty or subspecialty of service in accordance with part 493 of this 
chapter.
    (b) The OPO must send complete documentation of donor information to 
the transplant center with the organ, including donor evaluation, the 
complete record of the donor's management, documentation of consent, 
documentation of the pronouncement of death, and documentation for 
determining organ quality. Two individuals, one of whom must be an OPO 
employee, must verify that the documentation that accompanies an organ 
to a transplant center is correct.

[[Page 179]]

    (c) The OPO must develop and follow a written protocol for 
packaging, labeling, handling, and shipping organs in a manner that 
ensures their arrival without compromise to the quality of the organ. 
The protocol must include procedures to check the accuracy and integrity 
of labels, packaging, and contents prior to transport, including 
verification by two individuals, one of whom must be an OPO employee, 
that information listed on the labels is correct.
    (d) All packaging in which an organ is transported must be marked 
with the identification number, specific contents, and donor's blood 
type.



Sec.  486.348  Condition: Quality assessment and performance improvement (QAPI).

    The OPO must develop, implement, and maintain a comprehensive, data-
driven QAPI program designed to monitor and evaluate performance of all 
donation services, including services provided under contract or 
arrangement.
    (a) Standard: Components of a QAPI program. The OPO's QAPI program 
must include objective measures to evaluate and demonstrate improved 
performance with regard to OPO activities, such as hospital development, 
designated requestor training, donor management, timeliness of on-site 
response to hospital referrals, consent practices, organ recovery and 
placement, and organ packaging and transport. The OPO must take actions 
that result in performance improvements and track performance to ensure 
that improvements are sustained.
    (b) Standard: Death record reviews. As part of its ongoing QAPI 
efforts, an OPO must conduct at least monthly death record reviews in 
every Medicare and Medicaid participating hospital in its service area 
that has a Level I or Level II trauma center or 150 or more beds, a 
ventilator, and an intensive care unit (unless the hospital has a waiver 
to work with another OPO), with the exception of psychiatric and 
rehabilitation hospitals. When missed opportunities for donation are 
identified, the OPO must implement actions to improve performance.
    (c) Standard: Adverse events. (1) An OPO must establish written 
policies to address, at a minimum, the process for identification, 
reporting, analysis, and prevention of adverse events that occur during 
the organ donation process.
    (2) The OPO must conduct a thorough analysis of any adverse event 
and must use the analysis to affect changes in the OPO's policies and 
practices to prevent repeat incidents.



PART 488_SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES--Table of Contents




                      Subpart A_General Provisions

Sec.
488.1 Definitions.
488.2 Statutory basis.
488.3 Conditions of participation; conditions for coverage; and long-
          term care requirements.
488.4 Application and reapplication procedures for accreditation 
          organizations.
488.5 Effect of JCAHO or AOA accreditation of hospitals.
488.6 Other national accreditation programs for hospitals and other 
          providers and suppliers.
488.7 Validation survey.
488.8 Federal review of accreditation organizations.
488.9 Onsite observation of accreditation organization operations.
488.10 State survey agency review: Statutory provisions.
488.11 State survey agency functions.
488.12 Effect of survey agency certification.
488.14 Effect of QIO review.
488.18 Documentation of findings.
488.20 Periodic review of compliance and approval.
488.24 Certification of noncompliance.
488.26 Determining compliance.
488.28 Providers or suppliers, other than SNFs and NFs, with 
          deficiencies.
488.30 Revisit user fee for revisit surveys.

                     Subpart B_Special Requirements

488.52 [Reserved]
488.54 Temporary waivers applicable to hospitals.
488.56 Temporary waivers applicable to skilled nursing facilities.
488.60 Special procedures for approving end stage renal disease 
          facilities.
488.61 Special procedures for approval and re-approval of organ 
          transplant centers.
488.64 Remote facility variances for utilization review requirements.

[[Page 180]]

488.68 State Agency responsibilities for OASIS collection and data base 
          requirements.

                  Subpart C_Survey Forms and Procedures

488.100 Long term care survey forms, Part A.
488.105 Long term care survey forms, Part B.
488.110 Procedural guidelines.
488.115 Care guidelines.

 Subpart D_Reconsideration of Adverse Determinations_Deeming Authority 
for Accreditation Organizations and CLIA Exemption of Laboratories Under 
                             State Programs

488.201 Reconsideration.
488.203 Withdrawal of request for reconsideration.
488.205 Right to informal hearing.
488.207 Informal hearing procedures.
488.209 Hearing officer's findings.
488.211 Final reconsideration determination.

     Subpart E_Survey and Certification of Long-Term Care Facilities

488.300 Statutory basis.
488.301 Definitions.
488.303 State plan requirement.
488.305 Standard surveys.
488.307 Unannounced surveys.
488.308 Survey frequency.
488.310 Extended survey.
488.312 Consistency of survey results.
488.314 Survey teams.
488.318 Inadequate survey performance.
488.320 Sanctions for inadequate survey performance.
488.325 Disclosure of results of surveys and activities.
488.330 Certification of compliance or noncompliance.
488.331 Informal dispute resolution.
488.332 Investigation of complaints of violations and monitoring of 
          compliance.
488.334 Educational programs.
488.335 Action on complaints of resident neglect and abuse, and 
          misappropriation of resident property.

 Subpart F_Enforcement of Compliance For Long-Term Care Facilities with 
                              Deficiencies

488.400 Statutory basis.
488.401 Definitions.
488.402 General provisions.
488.404 Factors to be considered in selecting remedies.
488.406 Available remedies.
488.408 Selection of remedies.
488.410 Action when there is immediate jeopardy.
488.412 Action when there is no immediate jeopardy.
488.414 Action when there is repeated substandard quality of care.
488.415 Temporary management.
488.417 Denial of payment for all new admissions.
488.418 Secretarial authority to deny all payments.
488.422 State monitoring.
488.424 Directed plan of correction.
488.425 Directed inservice training.
488.426 Transfer of residents, or closure of the facility and transfer 
          of residents.
488.430 Civil money penalties: Basis for imposing penalty.
488.432 Civil money penalties: When a penalty is collected.
488.434 Civil money penalties: Notice of penalty.
488.436 Civil money penalties: Waiver of hearing, reduction of penalty 
          amount.
488.438 Civil money penalties: Amount of penalty.
488.440 Civil money penalties: Effective date and duration of penalty.
488.442 Civil money penalties: Due date for payment of penalty.
488.444 Civil money penalties: Settlement of penalties.
488.450 Continuation of payments to a facility with deficiencies.
488.452 State and Federal disagreements involving findings not in 
          agreement in non-State operated NFs and dually participating 
          facilities when there is no immediate jeopardy.
488.454 Duration of remedies.
488.456 Termination of provider agreement.

Subpart G [Reserved]

Subpart H_Termination of Medicare Coverage and Alternative Sanctions for 
                End-Stage Renal Disease (ESRD) Facilities

488.604 Termination of Medicare coverage.
488.606 Alternative sanctions.
488.608 Notice of alternative sanction and appeal rights: Termination of 
          coverage.
488.610 Notice of appeal rights: Alternative sanctions.

    Authority: Secs. 1102 and 1871 of the Social Security Act, unless 
otherwise noted (42 U.S.C. 1302 and 1395(hh)); Continuing Resolution 
Pub. L. 110-149 H.J. Res. 72.

    Source: 53 FR 22859, June 17, 1988, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  488.1  Definitions.

    As used in this part--

[[Page 181]]

    Accredited provider or supplier means a provider or supplier that 
has voluntarily applied for and has been accredited by a national 
accreditation program meeting the requirements of and approved by CMS in 
accordance with Sec.  488.5 or Sec.  488.6.
    Act means the Social Security Act.
    AOA stands for the American Osteopathic Association.
    Certification is a recommendation made by the State survey agency on 
the compliance of providers and suppliers with the conditions of 
participation, requirements (for SNFs and NFs), and conditions of 
coverage.
    Conditions for coverage means the requirements suppliers must meet 
to participate in the Medicare program.
    Conditions of participation means the requirements providers other 
than skilled nursing facilities must meet to participate in the Medicare 
program and includes conditions of certification for rural health 
clinics.
    Full review means a survey of a hospital for compliance with all 
conditions of participation for hospitals.
    JCAHO stands for the Joint Commission on Accreditation of Healthcare 
Organizations.
    Medicare condition means any condition of participation or for 
coverage, including any long term care requirements.
    Provider of services or provider means a hospital, critical access 
hospital, skilled nursing facility, nursing facility, home health 
agency, hospice, comprehensive outpatient rehabilitation facility, or 
provider of outpatient physical therapy or speech pathology services.
    Rate of disparity means the percentage of all sample validation 
surveys for which a State survey agency finds noncompliance with one or 
more Medicare conditions and no comparable condition level deficiency 
was cited by the accreditation organization, where it is reasonable to 
conclude that the deficiencies were present at the time of the 
accreditation organization's most recent surveys of providers or 
suppliers of the same type.

    Example:  Assume that during a validation review period State survey 
agencies perform validation surveys at 200 facilities of the same type 
(for example, ambulatory surgical centers, home health agencies) 
accredited by the same accreditation organization. The State survey 
agencies find 60 of the facilities out of compliance with one or more 
Medicare conditions, and it is reasonable to conclude that these 
deficiencies were present at the time of the most recent survey by an 
accreditation organization. The accreditation organization, however, has 
found deficiencies comparable to the condition level deficiencies at 
only 22 of the 60 facilities. These validation results would yield ((60-
22)/200) a rate of disparity of 19 percent.

    Reasonable assurance means that an accreditation organization has 
demonstrated to CMS's satisfaction that its requirements, taken as a 
whole, are at least as stringent as those established by CMS, taken as a 
whole.
    State includes the District of Columbia, the Commonwealth of Puerto 
Rico, the Virgin Islands, Guam, and American Samoa.
    State survey agency means the State health agency or other 
appropriate State or local agency used by HFCA to perform survey and 
review functions for Medicare.
    Substantial allegation of noncompliance means a complaint from any 
of a variety of sources (including complaints submitted in person, by 
telephone, through written correspondence, or in newspaper or magazine 
articles) that, if substantiated, would affect the health and safety of 
patients and raises doubts as to a provider's or supplier's 
noncompliance with any Medicare condition.
    Supplier means any of the following: Independent laboratory; 
portable X-ray services; physical therapist in independent practice; 
ESRD facility; rural health clinic; Federally qualified health center; 
chiropractor; or ambulatory surgical center.
    Validation review period means the one year period during which CMS 
conducts a review of the validation surveys and evaluates the results of 
the most recent surveys performed by the accreditation organization.

[53 FR 22859, June 17, 1988, as amended at 54 FR 5373, Feb. 2, 1989; 56 
FR 48879, Sept. 26, 1991; 57 FR 24982, June 12, 1992; 58 FR 30676, May 
26, 1993; 58 FR 61838, Nov. 23, 1993; 62 FR 46037, Aug. 29, 1997; 71 FR 
68230, Nov. 24, 2006]

[[Page 182]]



Sec.  488.2  Statutory basis.

    This part is based on the indicated provisions of the following 
sections of the Act:

1128--Exclusion of entities from participation in Medicare.
1128A--Civil money penalties.
1814--Conditions for, and limitations on, payment for Part A services.
1819--Requirements for SNFs.
1861(f)--Requirements for psychiatric hospitals.
1861(z)--Institutional planning standards that hospitals and SNFs must 
meet.
1861(ee)--Discharge planning guidelines for hospitals.
1861(ss)(2)--Accreditation of religious nonmedical health care 
institutions.
1864--Use of State survey agencies.
1865--Effect of accreditation.
1880--Requirements for hospitals and SNFs of the Indian Health Service.
1883--Requirements for hospitals that provide SNF care.
1902--Requirements for participation in the Medicaid program.
1913--Medicaid requirements for hospitals that provide NF care.
1919--Medicaid requirements for NFs.

[60 FR 50443, Sept. 29, 1995, as amended at 64 FR 67052, Nov. 30, 1999]



Sec.  488.3  Conditions of participation; conditions for coverage; and long-term care requirements.

    (a) Basic rules. In order to be approved for participation in or 
coverage under the Medicare program, a prospective provider or supplier 
must:
    (1) Meet the applicable statutory definition in section 1138(b), 
1819, 1832(a)(2)(F), 1861, 1881, or 1919 of the Act; and
    (2) Be in compliance with the applicable conditions or long-term 
care requirements prescribed in subpart N, Q or U of part 405, part 416, 
subpart C of part 418, part 482, part 483, part 484, part 485, subpart A 
of part 491, or part 494 of this chapter.
    (b) Special Conditions. (1) The Secretary, after consultation with 
the JCAHO or AOA, may issue conditions of participation for hospitals 
higher or more precise than those of either those accrediting bodies.
    (2) The Secretary may, at a State's request, approve health and 
safety requirements for providers and suppliers in that State, which are 
higher than those otherwise applied in the Medicare program.
    (3) If a State or political subdivision imposes higher requirements 
on institutions as a condition for the purchase of health services under 
a State Medicaid Plan approved under Title XIX of the Act, (or if Guam, 
Puerto Rico, or the Virgin Islands does so under a State plan for Old 
Age Assistance under Title I of the Act, or for Aid to the Aged, Blind, 
and Disabled under the original Title XVI of the Act), the Secretary is 
required to impose similar requirements as a condition for payment under 
Medicare in that State or political subdivision.

[53 FR 22859, June 17, 1988, as amended at 58 FR 61838, Nov. 23, 1993]



Sec.  488.4  Application and reapplication procedures for accreditation organizations.

    (a) A national accreditation organization applying for approval of 
deeming authority for Medicare requirements under Sec.  488.5 or 488.6 
of this subpart must furnish to CMS the information and materials 
specified in paragraphs (a)(1) through (10) of this section. A national 
accreditation organization reapplying for approval must furnish to CMS 
whatever information and materials from paragraphs (a)(1) through (10) 
of this section that CMS requests. The materials and information are--
    (1) The types of providers and suppliers for which the organization 
is requesting approval;
    (2) A detailed comparison of the organization's accreditation 
requirements and standards with the applicable Medicare requirements 
(for example, a crosswalk);
    (3) A detailed description of the organization's survey process, 
including--
    (i) Frequency of the surveys performed;
    (ii) Copies of the organization's survey forms, guidelines and 
instructions to surveyors;
    (iii) Accreditation survey review process and the accreditation 
status decision-making process;
    (iv) Procedures used to notify accredited facilities of deficiencies 
and the

[[Page 183]]

procedures used to monitor the correction of deficiencies in accredited 
facilities; and
    (v) Whether surveys are announced or unannounced;
    (4) Detailed information about the individuals who perform surveys 
for the accreditation organization, including--
    (i) The size and composition of accreditation survey teams for each 
type of provider and supplier accredited;
    (ii) The education and experience requirements surveyors must meet;
    (iii) The content and frequency of the in-service training provided 
to survey personnel;
    (iv) The evaluation systems used to monitor the performance of 
individual surveyors and survey teams; and
    (v) Policies and procedures with respect to an individual's 
participation in the survey or accreditation decision process of any 
facility with which the individual is professionally or financially 
affiliated;
    (5) A description of the organization's data management and analysis 
system with respect to its surveys and accreditation decisions, 
including the kinds of reports, tables, and other displays generated by 
that system;
    (6) The organization's procedures for responding to and for the 
investigation of complaints against accredited facilities, including 
policies and procedures regarding coordination of these activities with 
appropriate licensing bodies and ombudsmen programs;
    (7) The organization's policies and procedures with respect to the 
withholding or removal of accreditation status for facilities that fail 
to meet the accreditation organization's standards or requirements, and 
other actions taken by the organization in response to noncompliance 
with its standards and requirements;
    (8) A description of all types (for example, full, partial, type of 
facility, etc.) and categories (provisional, conditional, temporary, 
etc.) of accreditation offered by the organization, the duration of each 
type and category of accreditation and a statement specifying the types 
and categories of accreditation for which approval of deeming authority 
is sought;
    (9) A list of all currently accredited facilities, the type and 
category of accreditation currently held by each facility, and the 
expiration date of each facility's current accreditation; and
    (10) A list of all full and partial accreditation surveys scheduled 
to be performed by the organization.
    (b) The accreditation organization must also submit the following 
supporting documentation--
    (1) A written presentation that demonstrates the organization's 
ability to furnish CMS with electronic data in ASCII comparable code;
    (2) A resource analysis that demonstrates that the organization's 
staffing, funding and other resources are adequate to perform the 
required surveys and related activities; and
    (3) A statement acknowledging that as a condition for approval of 
deeming authority, the organization will agree to--
    (i) Notify CMS in writing of any facility that has had its 
accreditation revoked, withdrawn, or revised, or that has had any other 
remedial or adverse action taken against it by the accreditation 
organization within 30 days of any such action taken;
    (ii) Notify all accredited facilities within 10 days of CMS's 
withdrawal of the organization's approval of deeming authority;
    (iii) Notify CMS in writing at least 30 days in advance of the 
effective date of any proposed changes in accreditation requirements;
    (iv) Within 30 days of a change in CMS requirements, submit to CMS 
an acknowledgement of CMS's notification of the change as well as a 
revised crosswalk reflecting the new requirements and inform CMS about 
how the organization plans to alter its requirements to conform to CMS's 
new requirements;
    (v) Permit its surveyors to serve as witnesses if CMS takes an 
adverse action based on accreditation findings;
    (vi) [Reserved]
    (vii) Notify CMS in writing within ten days of a deficiency 
identified in any accreditation entity where the deficiency poses an 
immediate jeopardy to the entity's patients or residents or a hazard to 
the general public; and
    (viii) Conform accreditation requirements to changes in Medicare 
requirements.

[[Page 184]]

    (c) If CMS determines that additional information is necessary to 
make a determination for approval or denial of the accreditation 
organization's application for deeming authority, the organization will 
be notified and afforded an opportunity to provide the additional 
information.
    (d) CMS may visit the organization's offices to verify 
representations made by the organization in its application, including, 
but not limited to, review of documents and interviews with the 
organization's staff.
    (e) The accreditation organization will receive a formal notice from 
CMS stating whether the request for deeming authority has been approved 
or denied, the rationale for any denial, and reconsideration and 
reapplication procedures.
    (f) An accreditation organization may withdraw its application for 
approval of deeming authority at any time before the formal notice 
provided for in paragraph (e) of this section is received.
    (g) Except as provided in paragraph (i) of this section, an 
accreditation organization that has been notified that its request for 
deeming authority has been denied may request a reconsideration of that 
determination in accordance with subpart D of this part.
    (h) Except as provided in paragraph (i) of this section, any 
accreditation organization whose request for approval of deeming 
authority has been denied may resubmit its application if the 
organization--
    (1) Has revised its accreditation program to address the rationale 
for denial of its previous request;
    (2) Can demonstrate that it can provide reasonable assurance that 
its accredited facilities meet applicable Medicare requirements; and
    (3) Resubmits the application in its entirety.
    (i) If an accreditation organization has requested, in accordance 
with part 488, subpart D of this chapter, a reconsideration of CMS's 
determination that its request for deeming approval is denied, it may 
not submit a new application for deeming authority for the type of 
provider or supplier that is at issue in the reconsideration until the 
reconsideration is administratively final.

[58 FR 61838, Nov. 23, 1993]



Sec.  488.5  Effect of JCAHO or AOA accreditation of hospitals.

    (a) Deemed to meet. Institutions accredited as hospitals by the 
JCAHO or AOA are deemed to meet all of the Medicare conditions of 
participation for hospitals, except--
    (1) The requirement for utilization review as specified in section 
1861(e)(6) of the Act and in Sec.  482.30 of this chapter;
    (2) The additional special staffing and medical records requirements 
that are considered necessary for the provision of active treatment in 
psychiatric hospitals (section 1861(f) of the Act) and implementing 
regulations; and
    (3) Any requirements under section 1861(e) of the Act and 
implementing regulations that CMS, after consulting with JCAHO or AOA, 
identifies as being higher or more precise than the requirements for 
accreditation (section 1865(a)(4) of the Act).
    (b) Deemed status for providers and suppliers that participate in 
the Medicaid program. Eligibility for Medicaid participation can be 
established through Medicare deemed status for providers and suppliers 
that are not required under Medicaid regulations to comply with any 
requirements other than Medicare participation requirements for that 
provider r supplier type.
    (c) Release and use of hospital accreditation surveys. (1) A 
hospital deemed to meet program requirements must authorize its 
accreditation organization to release to CMS and the State survey agency 
a copy of its most current accreditation survey together with any other 
information related to the survey that CMS may require (including 
corrective action plans).
    (2) CMS may use a validation survey, an accreditation survey or 
other information related to the survey to determine that a hospital 
does not meet the Medicare conditions of participation.
    (3) CMS may disclose the survey and information related to the 
survey to the extent that the accreditation survey and related survey 
information are

[[Page 185]]

related to an enforcement action taken by CMS.

[58 FR 61840, Nov. 23, 1993]



Sec.  488.6  Other national accreditation programs for hospitals and other providers and suppliers.

    (a) In accordance with the requirements of this subpart, a national 
accreditation program for hospitals; psychiatric hospitals; transplant 
centers, except for kidney transplant centers; SNFs; HHAs; ASCs; RHCs; 
CORFs; hospices; religious nonmedical health care institutions; 
screening mammography services; critical access hospitals; or clinic, 
rehabilitation agency, or public health agency providers of outpatient 
physical therapy, occupational therapy or speech pathology services may 
provide reasonable assurance to CMS that it requires the providers or 
suppliers it accredits to meet requirements that are at least as 
stringent as the Medicare conditions when taken as a whole. In such a 
case, CMS may deem the providers or suppliers the program accredits to 
be in compliance with the appropriate Medicare conditions. These 
providers and suppliers are subject to validation surveys under Sec.  
488.7 of this subpart. CMS will publish notices in the Federal Register 
in accordance with Sec.  488.8(b) identifying the programs and deeming 
authority of any national accreditation program and the providers or 
suppliers it accredits. The notice will describe how the accreditation 
organization's accreditation program provides reasonable assurance that 
entities accredited by the organization meet Medicare requirements. (See 
Sec.  488.5 for requirements concerning hospitals accredited by JCAHO or 
AOA.)
    (b) Eligibility for Medicaid participation can be established 
through Medicare deemed status for providers and suppliers that are not 
required under Medicaid regulations to comply with any requirements 
other than Medicare participation requirements for that provider or 
supplier type.
    (c)(1) A provider or supplier deemed to meet program requirements 
under paragraph (a) of this section must authorize its accreditation 
organization to release to CMS and the State survey agency a copy of its 
most current accreditation survey, together with any information related 
to the survey that CMS may require (including corrective action plans).
    (2) CMS may determine that a provider or supplier does not meet the 
Medicare conditions on the basis of its own investigation of the 
accreditation survey or any other information related to the survey.
    (3) Upon written request, CMS may disclose the survey and 
information related to the survey--
    (i) Of any HHA; or
    (ii) Of any other provider or supplier specified at paragraph (a) of 
this section if the accreditation survey and related survey information 
relate to an enforcement action taken by CMS.

[58 FR 61840, Nov. 23, 1993, as amended at 62 FR 46037, Aug. 29, 1997; 
64 FR 67052, Nov. 30, 1999; 72 FR 15278, Mar. 30, 2007]



Sec.  488.7  Validation survey.

    (a) Basis for survey. CMS may require a survey of an accredited 
provider or supplier to validate its organization's accreditation 
process. These surveys will be conducted on a representative sample 
basis, or in response to substantial allegations of noncompliance.
    (1) When conducted on a representative sample basis, the survey is 
comprehensive and addresses all Medicare conditions or is focused on a 
specific condition or conditions.
    (2) When conducted in response to a substantial allegation, the 
State survey agency surveys for any condition that CMS determines is 
related to the allegations.
    (3) If the State survey agency substantiates a deficiency and CMS 
determines that the provider or supplier is out of compliance with any 
Medicare condition, the State survey agency conducts a full Medicare 
survey.
    (b) Effect of selection for survey. A provider or supplier selected 
for a validation survey must--
    (1) Authorize the validation survey to take place; and
    (2) Authorize the State survey agency to monitor the correction of 
any deficiencies found through the validation survey.
    (c) Refusal to cooperate with survey. If a provider or supplier 
selected for a validation survey fails to comply with

[[Page 186]]

the requirements specified in paragraph (b) of this section, it will no 
longer be deemed to meet the Medicare conditions but will be subject to 
full review by the State survey agency in accordance with Sec.  488.11 
and may be subject to termination of its provider agreement under Sec.  
489.53 of this chapter.
    (d) Consequences of finding of noncompliance. If a validation survey 
results in a finding that the provider or supplier is out of compliance 
with one or more Medicare conditions, the provider or supplier will no 
longer be deemed to meet any Medicare conditions. Specifically, the 
provider or supplier will be subject to the participation and 
enforcement requirements applied to all providers or suppliers that are 
found out of compliance following a State agency survey under Sec.  
488.24 and to full review by a State agency survey in accordance with 
Sec.  488.11 and may be subject to termination of the provider agreement 
under Sec.  439.53 of this chapter and any other applicable intermediate 
sanctions and remedies.
    (e) Reinstating effect of accreditation. An accredited provider or 
supplier will again be deemed to meet the Medicare conditions in 
accordance with this section if--
    (1) It withdraws any prior refusal to authorize its accreditation 
organization to release a copy of the provider's or supplier's current 
accreditation survey;
    (2) It withdraws any prior refusal to allow a validation survey; and
    (3) CMS finds that the provider or supplier meets all the applicable 
Medicare conditions. If CMS finds that an accredited facility meets the 
Life Safety Code Standard by virtue of a plan of correction, the State 
survey agency will continue to monitor the facility until it is in 
compliance with the Life Safety Code Standard.

[58 FR 61840, Nov. 23, 1993]



Sec.  488.8  Federal review of accreditation organizations.

    (a) Review and approval of national accreditation organization. 
CMS's review and evaluation of a national accreditation organization 
will be conducted in accordance with, but will not necessarily be 
limited to, the following general criteria--
    (1) The equivalency of an accreditation organization's accreditation 
requirements of an entity to the comparable CMS requirements for the 
entity;
    (2) The organization's survey process to determine--
    (i) The composition of the survey team, surveyor qualifications, and 
the ability of the organization to provide continuing surveyor training;
    (ii) The comparability of survey procedures to those of State survey 
agencies, including survey frequency, and the ability to investigate and 
respond appropriately to complaints against accredited facilities;
    (iii) The organization's procedures for monitoring providers or 
suppliers found by the organization to be out of compliance with program 
requirements. These monitoring procedures are to be used only when the 
organization identifies noncompliance. If noncompliance is identified 
through validation surveys, the State survey agency monitors corrections 
as specified at Sec.  488.7(b)(3);
    (iv) The ability of the organization to report deficiencies to the 
surveyed facilities and respond to the facility's plan of correction in 
a timely manner;
    (v) The ability of the organization to provide CMS with electronic 
data in ASCII comparable code and reports necessary for effective 
validation and assessment of the organization survey process;
    (vi) The adequacy of staff and other resources;
    (vii) The organization's ability to provide adequate funding for 
performing required surveys; and
    (viii) The organization's policies with respect to whether surveys 
are announced or unannounced; and
    (3) The accreditation organization's agreement to provide CMS with a 
copy of the most current accreditation survey together with any other 
information related to the survey as CMS may require (including 
corrective action plans).
    (b) Notice and comment. (1) CMS will publish a proposed notice in 
the Federal Register whenever it contemplates approving an accreditation

[[Page 187]]

organization's application for deeming authority. The proposed notice 
will specify the basis for granting approval of deeming authority and 
the types of providers and suppliers accredited by the organization for 
which deeming authority would be approved. The proposed notice will also 
describe how the accreditation organization's accreditation program 
provides reasonable assurance that entities accredited by the 
organization meet Medicare requirements. The proposed notice will also 
provide opportunity for public comment.
    (2) CMS will publish a final notice in the Federal Register whenever 
it grants deeming authority to a national accreditation organization. 
Publication of the final notice will follow publication of the proposed 
notice by at least six months. The final notice will specify the 
effective date of the approval of deeming authority and the term of 
approval (which will not exceed six years).
    (c) Effects of approval of an accreditation organization. CMS will 
deem providers and suppliers accredited by an approved accreditation 
organization to meet the Medicare conditions for which the approval of 
deeming authority has specifically been granted. The deeming authority 
will take effect 90 days following the publication of the final notice.
    (d) Continuing Federal oversight of equivalency of an accreditation 
organization and removal of deeming authority. This paragraph 
establishes specific criteria and procedures for continuing oversight 
and for removing the approval of deeming authority of a national 
accreditation organization.
    (1) Comparability review. CMS will compare the equivalency of an 
accreditation organization's accreditation requirements to the 
comparable CMS requirements if--
    (i) CMS imposes new requirements or changes its survey process;
    (ii) An accreditation organization proposes to adopt new 
requirements or change its survey process. An accreditation organization 
must provide written notification to CMS at least 30 days in advance of 
the effective date of any proposed changes in its accreditation 
requirements or survey process; and
    (iii) An accreditation organization's approval has been in effect 
for the maximum term specified by CMS in the final notice.
    (2) Validation review. Following the end of a validation review 
period, CMS will identify any accreditation programs for which--
    (i) Validation survey results indicate a rate of disparity between 
certifications of the accreditation organization and certification of 
the State agency of 20 percent or more; or
    (ii) Validation survey results, irrespective of the rate of 
disparity, indicate widespread or systematic problems in an 
organization's accreditation process that provide evidence that there is 
no longer reasonable assurance that accredited entities meet Medicare 
requirements.
    (3) Reapplication procedures. (i) Every six years, or sooner as 
determined by CMS, an approved accreditation organization must reapply 
for continued approval of deeming authority. CMS will notify the 
organization of the materials the organization must submit as part of 
the reapplication procedure.
    (ii) An accreditation organization that is not meeting the 
requirements of this subpart, as determined through a comparability 
review, must furnish CMS, upon request and at any time, with the 
reapplication materials CMS requests. CMS will establish a deadline by 
which the materials are to be submitted.
    (e) Notice. If a comparability or validation review reveals 
documentation that an accreditation organization is not meeting the 
requirements of this subpart, CMS will provide written notice to the 
organization indicating that its deeming authority approval may be in 
jeopardy and that a deeming authority review is being initiated. The 
notice provides the following information--
    (1) A statement of the requirements, instances, rates or patterns of 
discrepancies that were found as well as other related documentation;
    (2) An explanation of CMS's deeming authority review on which the 
final determination is based;

[[Page 188]]

    (3) A description of the process available if the accreditation 
organization wishes an opportunity to explain or justify the findings 
made during the comparability or validation review;
    (4) A description of the possible actions that may be imposed by CMS 
based on the findings from the validation review; and
    (5) The reapplication materials the organization must submit and the 
deadline for their submission.
    (f) Deeming authority review. (1) CMS will conduct a review of an 
accreditation organization's accreditation program if the comparability 
or validation review produces findings as described at paragraph (d)(1) 
or (2), respectively, of this section. CMS will review as appropriate 
either or both--
    (i) The requirements of the accreditation organization; or
    (ii) The criteria described in paragraph (a)(1) of this section to 
reevaluate whether the accreditation organization continues to meet all 
these criteria.
    (2) If CMS determines, following the deeming authority review, that 
the accreditation organization has failed to adopt requirements 
comparable to CMS's or submit new requirements timely, the accreditation 
organization may be given a conditional approval of its deeming 
authority for a probationary period of up to 180 days to adopt 
comparable requirements.
    (3) If CMS determines, following the deeming authority review, that 
the rate of disparity identified during the validation review meets 
either of the criteria set forth in paragraph (d)(2) of this section 
CMS--
    (i) May give the accreditation organization conditional approval of 
its deeming authority during a probationary period of up to one year 
(whether or not there are also noncomparable requirements) that will be 
effective 30 days following the date of this determination;
    (ii) Will require the accreditation organization to release to CMS 
upon its request any facility-specific data that is required by CMS for 
continued monitoring:
    (iii) Will require the accreditation organization to provide CMS 
with a survey schedule for the purpose of intermittent onsite monitoring 
by CMS staff, State surveyors, or both; and
    (iv) Will publish in the Medicare Annual Report to Congress the name 
of any accreditation organization given a probationary period by CMS.
    (4) Within 60 days after the end of any probationary period, CMS 
will make a final determination as to whether or not an accreditation 
program continues to meet the criteria described at paragraph (a)(1) of 
this section and will issue an appropriate notice (including reasons for 
the determination) to the accreditation organization and affected 
providers or suppliers. This determination will be based on any of the 
following--
    (i) The evaluation of the most current validation survey and review 
findings. The evaluation must indicate an acceptable rate of disparity 
of less than 20 percent between the certifications of the accreditation 
organization and the certifications of the State agency as described at 
paragraph (d)(2)(i) of this section in order for the accreditation 
organization to retain its approval;
    (ii) The evaluation of facility-specific data, as necessary, as well 
as other related information;
    (iii) The evaluation of an accreditation organization's surveyors in 
terms of qualifications, ongoing training composition of survey team, 
etc.;
    (iv) The evaluation of survey procedures; or
    (v) The accreditation requirements.
    (5) If the accreditation program has not made improvements 
acceptable to CMS during the probationary period, CMS may remove 
recognition of deemed authority effective 30 days from the date that it 
provides written notice to the organization that its deeming authority 
will be removed.
    (6) The existence of any validation review, deeming authority 
review, probationary period, or any other action by CMS, does not affect 
or limit the conducting of any validation survey.
    (7) CMS will publish a notice in the Federal Register containing a 
justification of the basis for removing the deeming authority from an 
accreditation organization. The notice will provide the reasons the 
accreditation organization's accreditation program no longer meets 
Medicare requirements.

[[Page 189]]

    (8) After CMS removes approval of an accreditation organization's 
deeming authority, an affected provider's or supplier's deemed status 
continues in effect 60 days after the removal of approval. CMS may 
extend the period for an additional 60 days for a provider or supplier 
if it determines that the provider or supplier submitted an application 
within the initial 60 day timeframe to another approved accreditation 
organization or to CMS so that a certification of compliance with 
Medicare conditions can be determined.
    (9) Failure to comply with the timeframe requirements specified in 
paragraph (f)(8) of this section will jeopardize a provider's or 
supplier's participation in the Medicare program and where applicable in 
the Medicaid program.
    (g) If at any time CMS determines that the continued approval of 
deeming authority of any accreditation organization poses an immediate 
jeopardy to the patients of the entities accredited by that 
organization, or such continued approval otherwise constitutes a 
significant hazard to the public health, CMS may immediately withdraw 
the approval of deeming authority of that accreditation organization.
    (h) Any accreditation organization dissatisfied with a determination 
to remove its deeming authority may request a reconsideration of that 
determination in accordance with subpart D of this part.

[58 FR 61841, Nov. 23, 1993]



Sec.  488.9  Onsite observation of accreditation organization operations.

    As part of the application review process, the validation review 
process, or the continuing oversight of an accreditation organization's 
performance, CMS may conduct an onsite inspection of the accreditation 
organization's operations and offices to verify the organization's 
representations and to assess the organization's compliance with its own 
policies and procedures. The onsite inspection may include, but is not 
limited to, the review of documents, auditing meetings concerning the 
accreditation process, the evaluation of survey results or the 
accreditation decision-making process, and interviews with the 
organization's staff.

[58 FR 61842, Nov. 23, 1993]



Sec.  488.10  State survey agency review: Statutory provisions.

    (a) Section 1864(a) of the Act requires the Secretary to enter into 
an agreement with any State that is able and willing to do so, under 
which appropriate State or local survey agencies will determine whether:
    (1) Providers or prospective providers meet the Medicare conditions 
of participation or requirements (for SNFs and NFs);
    (2) Suppliers meet the conditions for coverage; and
    (3) Rural health clinics meet the conditions of certification.
    (b) Section 1865(a) of the Act provides that if an institution is 
accredited as a hospital by the JCAHO, it will be deemed to meet the 
conditions of participation:
    (1) Except those specified in Sec.  488.5;
    (2) Provided that such hospital, if it is included within a 
validation survey, authorizes the JCAHO to release to CMS (on a 
confidential basis) upon request a copy of the most current JCAHO 
accreditation survey.
    (c) Section 1864(c) of the Act authorizes the Secretary to enter 
into agreements with State survey agencies for the purpose of conducting 
validation surveys in hospitals accredited by the JCAHO. Section 1865(b) 
provides that an accredited hospital which is found after a validation 
survey to have significant deficiencies related to the health and safety 
of patients will no longer be deemed to meet the conditions of 
participation.
    (d) Section 1865(a) of the Act also provides that if CMS finds that 
accreditation of a hospital; psychiatric hospital; SNF; HHA; hospice; 
ASC; RHC; CORF; laboratory; screening mammography service; critical 
access hospital; or clinic, rehabilitation agency, or public health 
agency provider of outpatient physical therapy, occupational therapy, or 
speech pathology services by any national accreditation organization 
provides reasonable assurance that any or all Medicare conditions are

[[Page 190]]

met, CMS may treat the provider or supplier as meeting the conditions.

[53 FR 22859, June 17, 1988, as amended at 56 FR 48879, Sept. 26, 1991; 
58 FR 61842, Nov. 23, 1993; 62 FR 46037, Aug. 29, 1997]



Sec.  488.11  State survey agency functions.

    State and local agencies that have agreements under section 1864(a) 
of the Act perform the following functions:
    (a) Survey and make recommendations regarding the issues listed in 
Sec.  488.10.
    (b) Conduct validation surveys of accredited facilities as provided 
in Sec.  488.7.
    (c) Perform other surveys and carry out other appropriate activities 
and certify their findings to CMS.
    (d) Make recommendations regarding the effective dates of provider 
agreements and supplier approvals in accordance with Sec.  489.13 of 
this chapter.

[62 FR 43936, Aug. 18, 1997]



Sec.  488.12  Effect of survey agency certification.

    Certifications by the State survey agency represent recommendations 
to CMS.
    (a) On the basis of these recommendations, CMS will determine 
whether:
    (1) A provider or supplier is eligible to participate in or be 
covered under the Medicare program; or
    (2) An accredited hospital is deemed to meet the Medicare conditions 
of participation or is subject to full review by the State survey 
agency.
    (b) Notice of CMS's determination will be sent to the provider or 
supplier.



Sec.  488.14  Effect of QIO review.

    When a QIO is conducting review activities under section 1154 of the 
Act and part 466 of this chapter, its activities are in lieu of the 
utilization review and evaluation activities required of health care 
institutions under sections 1861(e)(6), and 1861(k) of the Act.

[59 FR 56237, Nov. 10, 1994]



Sec.  488.18  Documentation of findings.

    (a) The findings of the State agency with respect to each of the 
conditions of participation, requirements (for SNFs and NFs), or 
conditions for coverage must be adequately documented. When the State 
agency certifies to the Secretary that a provider or supplier is not in 
compliance with the conditions or requirements (for SNFs and NFs), and 
therefore not eligible to participate in the program, such documentation 
includes, in addition to the description of the specific deficiencies 
which resulted in the agency's recommendation, any provider or supplier 
response.
    (b) If a provider or supplier is certified by the State agency as in 
compliance with the conditions or participation requirements (for SNFs 
and NFs) or as meeting the requirements for special certification (see 
Sec.  488.54), with deficiencies not adversely affecting the health and 
safety of patients, the following information will be incorporated into 
the finding:
    (1) A statement of the deficiencies that were found.
    (2) A description of further action that is required to remove the 
deficiencies.
    (3) A time-phased plan of correction developed by the provider and 
supplier and concurred with by the State agency.
    (4) A scheduled time for a resurvey of the institution or agency to 
be conducted by the State agency within 90 days following the completion 
of the survey.
    (c) If, on the basis of the State certification, the Secretary 
determines that the provider or supplier is eligible to participate, the 
information described in paragraph (b) of this section will be 
incorporated into a notice of eligibility to the provider or supplier.
    (d) If the State agency receives information to the effect that a 
hospital or a critical access hospital (as defined in section 
1861(mm)(1) of the Act) has violated Sec.  489.24 of this chapter, the 
State agency is to report the information to CMS promptly.

[39 FR 2251, Jan. 17, 1974. Redesignated at 39 FR 11419, Mar. 28, 1974, 
and further redesignated at 42 FR 52826, Sept. 30, 1977. Redesignated at 
53 FR 23100, June 17, 1988; 59 FR 32120, June 22, 1994; 59 FR 56237, 
Nov. 10, 1994; 62 FR 46037, Aug. 29, 1997]

    Effective Date Note: At 59 FR 32120, June 22, 1994, in Sec.  488.18, 
paragraph (d) was added. The amendment contains information collection 
and recordkeeping requirements and

[[Page 191]]

will not become effective until approval has been given by the Office of 
Management and Budget.



Sec.  488.20  Periodic review of compliance and approval.

    (a) Determinations by CMS to the effect that a provider or supplier 
is in compliance with the conditions of participation, or requirements 
(for SNFs and NFs), or the conditions for coverage are made as often as 
CMS deems necessary and may be more or less than a 12-month period, 
except for SNFs, NFs and HHAs. (See Sec.  488.308 for special rules for 
SNFs and NFs.)
    (b) The responsibilities of State survey agencies in the review and 
certification of compliance are as follows:
    (1) Resurvey providers or suppliers as frequently as necessary to 
ascertain compliance and confirm the correction of deficiencies;
    (2) Review reports prepared by a Professional Standards Review 
Organization (authorized under Part B Title XI of the Act) or a State 
inspection of care team (authorized under Title XIX of the Act) 
regarding the quality of a facility's care;
    (3) Evaluate reports that may pertain to the health and safety of 
patients; and
    (4) Take appropriate actions that may be necessary to achieve 
compliance or certify noncompliance to CMS.
    (c) A State survey agency certification to CMS that a provider or 
supplier is no longer in compliance with the conditions of participation 
or requirements (for SNFs and NFs) or conditions for coverage will 
supersede the State survey agency's previous certification.

(Secs. 1102, 1814, 1861, 1863 through 1866, 1871, and 1881; 42 U.S.C. 
1302, 1395f, 1395x, 1395z through 1395cc, 1395hh, and 1395rr)

[45 FR 74833, Nov. 12, 1981. Redesignated and amended at 53 FR 23100, 
June 17, 1988, and further amended at 54 FR 5373, Feb. 2, 1989; 56 FR 
48879, Sept. 26, 1991; 59 FR 56237, Nov. 10, 1994]



Sec.  488.24  Certification of noncompliance.

    (a) Special rules for certification of noncompliance for SNFs and 
NFs are set forth in Sec.  488.330.
    (b) The State agency will certify that a provider or supplier is not 
or is no longer in compliance with the conditions of participation or 
conditions for coverage where the deficiencies are of such character as 
to substantially limit the provider's or supplier's capacity to furnish 
adequate care or which adversely affect the health and safety of 
patients; or
    (c) If CMS determines that an institution or agency does not qualify 
for participation or coverage because it is not in compliance with the 
conditions of participation or conditions for coverage, or if a 
provider's agreement is terminated for that reason, the institution or 
agency has the right to request that the determination be reviewed. 
(Appeals procedures are set forth in Part 498 of this chapter.)

[59 FR 56237, Nov. 10, 1994]



Sec.  488.26  Determining compliance.

    (a) Additional rules for certification of compliance for SNFs and 
NFs are set forth in Sec.  488.330.
    (b) The decision as to whether there is compliance with a particular 
requirement, condition of participation, or condition for coverage 
depends upon the manner and degree to which the provider or supplier 
satisfies the various standards within each condition. Evaluation of a 
provider's or supplier's performance against these standards enables the 
State survey agency to document the nature and extent of deficiencies, 
if any, with respect to a particular function, and to assess the need 
for improvement in relation to the prescribed conditions.
    (c) The State survey agency must adhere to the following principles 
in determining compliance with participation requirements:
    (1) The survey process is the means to assess compliance with 
Federal health, safety and quality standards;
    (2) The survey process uses resident outcomes as the primary means 
to establish the compliance status of facilities. Specifically surveyors 
will directly observe the actual provision of care and services to 
residents, and the effects of that care, to assess whether the care 
provided meets the needs of individual residents;
    (3) Surveyors are professionals who use their judgment, in concert 
with

[[Page 192]]

Federal forms and procedures, to determine compliance;
    (4) Federal procedures are used by all surveyors to ensure uniform 
and consistent application and interpretation of Federal requirements;
    (5) Federal forms are used by all surveyors to ensure proper 
recording of findings and to document the basis for the findings.
    (d) The State survey agency must use the survey methods, procedures, 
and forms that are prescribed by CMS.
    (e) The State survey agency must ensure that a facility's actual 
provision of care and services to residents and the effects of that care 
on residents are assessed in a systematic manner.

[59 FR 56237, Nov. 10, 1994]



Sec.  488.28  Providers or suppliers, other than SNFs and NFs, with deficiencies.

    (a) If a provider or supplier is found to be deficient with respect 
to one or more of the standards in the conditions of participation or 
conditions for coverage, it may participate in or be covered under the 
Health Insurance for the Aged and Disabled Program only if the facility 
has submitted an acceptable plan of correction for achieving compliance 
within a reasonable period of time acceptable to the Secretary.
    (b) The existing deficiencies noted either individually or in 
combination neither jeopardize the health and safety of patients nor are 
of such character as to seriously limit the provider's capacity to 
render adequate care.
    (c)(1) If it is determined during a survey that a provider or 
supplier is not in compliance with one or more of the standards, it is 
granted a reasonable time to achieve compliance.
    (2) The amount of time depends upon the--
    (i) Nature of the deficiency; and
    (ii) State survey agency's judgment as to the capabilities of the 
facility to provide adequate and safe care.
    (d) Ordinarily a provider or supplier is expected to take the steps 
needed to achieve compliance within 60 days of being notified of the 
deficiencies but the State survey agency may recommend that additional 
time be granted by the Secretary in individual situations, if in its 
judgment, it is not reasonable to expect compliance within 60 days, for 
example, a facility must obtain the approval of its governing body, or 
engage in competitive bidding.

[59 FR 56237, Nov. 10, 1994]



Sec.  488.30  Revisit user fee for revisit surveys.

    (a) Definitions. As used in this section, the following definitions 
apply:
    Certification (both initial and recertification) means those 
activities as defined in Sec.  488.1.
    Complaint surveys means those surveys conducted on the basis of a 
substantial allegation of noncompliance, as defined in Sec.  488.1.
    Provider of services, provider, or supplier has the meaning defined 
in Sec.  488.1, and ambulatory surgical centers, transplant centers, and 
religious nonmedical health care institutions subject to Sec.  416.2, 
Sec.  482.70, and Sec.  403.702 [C8] of this chapter, respectively, will 
be subject to user fees unless otherwise exempted.
    Revisit survey means a survey performed with respect to a provider 
or supplier cited for deficiencies during an initial certification, 
recertification, or substantiated complaint survey and that is designed 
to evaluate the extent to which previously-cited deficiencies have been 
corrected and the provider or supplier is in substantial compliance with 
applicable conditions of participation, requirements, or conditions for 
coverage. Revisit surveys include both offsite and onsite review.
    Substantiated complaint survey means a complaint survey that results 
in the proof or finding of noncompliance at the time of the survey, a 
finding that noncompliance was proven to exist, but was corrected prior 
to the survey, and includes any deficiency that is cited during a 
complaint survey, whether or not the cited deficiency was the original 
subject of the complaint.
    (b) Criteria for determining the fee. (1) The provider or supplier 
will be assessed a revisit user fee based upon one or more of the 
following:
    (i) The average cost per provider or supplier type.
    (ii) The type of revisit survey conducted (onsite or offsite).
    (iii) The size of the provider or supplier.

[[Page 193]]

    (iv) The number of follow-up revisits resulting from uncorrected 
deficiencies.
    (v) The seriousness and number of deficiencies.
    (2) CMS may adjust the fees to account for any regional differences 
in cost.
    (c) Fee schedule. CMS must publish in the Federal Register the 
proposed and final notices of a uniform fee schedule before it assesses 
revised revisit user fees. The notices must set forth which criteria 
will be used and how, as well as the amounts of the assessed fees based 
on the criteria as identified in paragraph (b) of this subpart.
    (d) Collection of fees. (1) Fees for revisit surveys under this 
section may be deducted from amounts otherwise payable to the provider 
or supplier. As they are collected, fees will be deposited as an offset 
collection to be used exclusively for survey and certification 
activities conducted by State survey agencies pursuant to section 1864 
of the Act or by CMS, and will be available for CMS until expended. CMS 
may devise other collection methods as it deems appropriate. In 
determining these methods, CMS will consider efficiency, effectiveness, 
and convenience for the providers, suppliers, and CMS. CMS may consider 
any method allowed by law, including: Credit card; electronic fund 
transfer; check; money order; and offset collections from claims 
submitted.
    (2) Fees for revisit surveys under this section are not allowable 
items on a cost report, as identified in part 413, subpart B of this 
chapter, under title XVIII of the Act.
    (3) Fees for revisit surveys will be due for any revisit surveys 
conducted during the time period for which authority to levy a revisit 
user fee exists.
    (e) Reconsideration process for revisit user fees. (1) CMS will 
review a request for reconsideration of an assessed revisit user fee--
    (i) If a provider or supplier believes an error of fact has been 
made in the application of the revisit user fee, such as clerical 
errors, billing for a fee already paid, or assessment of a fee when 
there was no revisit conducted, and
    (ii) If the request for reconsideration is received by CMS within 14 
calendar days from the date identified on the revisit user fee 
assessment notice.
    (2) CMS will issue a credit toward any future revisit surveys 
conducted, if the provider or supplier has remitted an assessed revisit 
user fee and for which a reconsideration request is found in favor of 
the provider or supplier. If in the event that CMS judges that a 
significant amount of time has elapsed before such a credit is used, CMS 
will refund the assessed revisit user fee amount paid to the provider or 
supplier.
    (3) CMS will not reconsider the assessment of revisit user fees that 
request reconsideration of the survey findings or deficiency citations 
that may have given rise to the revisit, the revisit findings, the need 
for the revisit itself, or other similarly identified basis for the 
assessment of the revisit user fee.
    (f) Enforcement. If the full revisit user fee payment is not 
received within 30 calendar days from the date identified on the revisit 
user fee assessment notice, CMS may terminate the facility's provider 
agreement (pursuant to Sec.  489.53(a)(16) of this chapter) and 
enrollment in the Medicare program or the supplier's enrollment and 
participation in the Medicare program (pursuant to Sec.  424.535(a)(1) 
of this chapter).

[72 FR 53648, Sept. 19, 2007]



                     Subpart B_Special Requirements



Sec.  488.52  [Reserved]



Sec.  488.54  Temporary waivers applicable to hospitals.

    (a) General provisions. If a hospital is found to be out of 
compliance with one or more conditions of participation for hospitals, 
as specified in part 482 of this chapter, a temporary waiver may be 
granted by CMS. CMS may extend a temporary waiver only if such a waiver 
would not jeopardize or adversely affect the health and safety of 
patients. The waiver may be issued for any one year period or less under 
certain circumstances. The waiver may be withdrawn earlier if CMS 
determines this action is necessary to protect the

[[Page 194]]

health and safety of patients. A waiver may be granted only if:
    (1) The hospital is located in a rural area. This includes all areas 
not delineated as ``urban'' by the Bureau of the Census, based on the 
most recent census;
    (2) The hospital has 50 or fewer inpatient hospital beds;
    (3) The character and seriousness of the deficiencies do not 
adversely affect the health and safety of patients; and
    (4) The hospital has made and continues to make a good faith effort 
to comply with personnel requirements consistent with any waiver.
    (b) Minimum compliance requirements. Each case will have to be 
decided on its individual merits, and while the degree and extent of 
compliance will vary, the institution must, as a minimum, meet all of 
the statutory conditions in section 1861(e)(1)-(8), in addition to 
meeting such other requirements as the Secretary finds necessary under 
section 1861(e)(9). (For further information relating to the exception 
in section 1861(e)(5) of the Act, see paragraph (c) of this section.)
    (c) Temporary waiver of 24-hour nursing requirement of 24-hour 
registered nurse requirement. CMS may waive the requirement contained in 
section 1861(e)(5) that a hospital must provide 24-hour nursing service 
furnished or supervised by a registered nurse. Such a waiver may be 
granted when the following criteria are met:
    (1) The hospital's failure to comply fully with the 24-hour nursing 
requirement is attributable to a temporary shortage of qualified nursing 
personnel in the area in which the hospital is located.
    (2) A registered nurse is present on the premises to furnish or 
supervise the nursing services during at least the daytime shift, 7 days 
a week.
    (3) The hospital has in charge, on all tours of duty not covered by 
a registered nurse, a licensed practical (vocational) nurse.
    (4) The hospital complies with all requirements specified in 
paragraph (a) of this section.
    (d) Temporary waiver for technical personnel. CMS may waive 
technical personnel requirements, issued under section 1861(e)(9) of the 
Act, contained in the Conditions of Participation; Hospitals (part 482 
of this chapter). Such a waiver must take into account the availability 
of technical personnel and the educational opportunities for technical 
personnel in the area in which the hospital is located. CMS may also 
limit the scope of services furnished by a hospital in conjunction with 
the waiver in order not to adversely affect the health and safety of the 
patients. In addition, the hospital must also comply with all 
requirements specified in paragraph (a) of this section.

[39 FR 2251, Jan. 17, 1974. Redesignated at 39 FR 11419, Mar. 28, 1974, 
and amended at 41 FR 27962, July 8, 1976. Further redesignated at 42 FR 
52826, Sept. 30, 1977, and amended at 47 FR 31531, July 20, 1982; 51 FR 
22041, June 17, 1986. Redesignated at 53 FR 23100, June 17, 1988]



Sec.  488.56  Temporary waivers applicable to skilled nursing facilities.

    (a) Waiver of 7-day registered nurse requirement. To the extent that 
Sec.  483.30 of this chapter requires any skilled nursing facility to 
engage the services of a registered nurse more than 40 hours a week, the 
Secretary may waive such requirement for such periods as he deems 
appropriate if, based upon documented findings of the State agency, he 
determines that:
    (1) Such facility is located in a rural area and the supply of 
skilled nursing facility services in such area is not sufficient to meet 
the needs of individual patients therein,
    (2) Such facility has at least one fulltime registered nurse who is 
regularly on duty at such facility 40 hours a week, and
    (3) Such facility (i) has only patients whose attending physicians 
have indicated (through physicians' orders or admission notes) that each 
such patient does not require the services of a registered nurse for a 
48-hour period, or (ii) has made arrangements for a registered nurse or 
a physician to spend such time at the facility as is determined 
necessary by the patient's attending physician to provide necessary 
services on days when the regular fulltime registered nurse is not on 
duty.
    (4) Such facility has made and continues to make a good faith effort 
to

[[Page 195]]

comply with the more than 40-hour registered nurse requirement, but such 
compliance is impeded by the unavailability of registered nurses in the 
area.
    (b) Waiver of medical director requirement. To the extent that Sec.  
488.75(i) of this chapter requires any skilled nursing facility to 
engage the services of a medical director either part-time or full-time, 
the Secretary may waive such requirement for such periods as he deems 
appropriate if, based upon documented findings of the State agency, he 
determines that:
    (1) Such facility is located in an area where the supply of 
physicians is not sufficient to permit compliance with this requirement 
without seriously reducing the availability of physician services within 
the area, and
    (2) Such facility has made and continues to make a good faith effort 
to comply with Sec.  488.75(i) of this chapter, but such compliance is 
impeded by the unavailability of physicians in the area.

[39 FR 35777, Oct. 3, 1974. Redesignated and amended at 42 FR 52826, 
Sept. 30, 1977. Further redesignated and amended at 53 FR 23100, June 
17, 1988, and further amended at 56 FR 48879, Sept. 26, 1991; 57 FR 
43925, Sept. 23, 1992]



Sec.  488.60  Special procedures for approving end stage renal disease facilities.

    (a) Consideration for approval. An ESRD facility that wishes to be 
approved or that wishes an expansion of dialysis services to be approved 
for coverage, in accordance with part 494 of this chapter, must secure a 
determination by the Secretary. To secure a determination, the facility 
must submit the following documents and data for consideration by the 
Secretary:
    (1) Certification by the State agency referred to in Sec.  488.12 of 
this part.
    (2) Data furnished by ESRD network organizations and recommendations 
of the Public Health Service concerning the facility's contribution to 
the ESRD services of the network.
    (3) Data concerning the facility's compliance with professional 
norms and standards.
    (4) Data pertaining to the facility's qualifications for approval or 
for any expansion of services.
    (b) Determining compliance with minimal utilization rates: Time 
limitations--(1) Unconditional status. A facility which meets minimal 
utilization requirements will be assigned this status as long as it 
continues to meet these requirements.
    (2) Conditional status. A conditional status may be granted to a 
facility for not more than four consecutive calendar years and will not 
be renewable (see Sec.  405.2122(b) of this chapter). Its status may be 
examined each calendar year to ascertain its compliance with Subpart U.
    (3) Exception status. Under unusual circumstances (see Sec.  
405.2122 (b) of this chapter) the Secretary may grant a time-limited 
exception to a facility which is not in compliance with the minimal 
utilization rate(s) for either unconditional status or conditional 
status. This exception status may be granted, and may be renewed on an 
annual basis, under circumstances where rigid application of minimal 
utilization rate requirements would adversely affect the achievement of 
ESRD program objectives.
    (c) New applicant. A facility which has not previously participated 
in the ESRD program must submit a plan detailing how it expects to meet 
the conditional minimal utilization rate status by the end of the second 
calendar year of its operation under the program and meet the 
unconditional minimal utilization rate status by the end of the fourth 
calendar year of its operation under the program.
    (d) Notification. The Secretary will notify each facility and its 
network coordinating council of its initial and its subsequent minimal 
utilization rate classification.
    (e) Failure to meet minimal utilization rate. A facility failing to 
meet standards for unconditional status or conditional status, or if 
applicable, for exception status, will be so notified at the time of 
such classification.
    (f) Interim regulations participant. A facility previously 
participating under the interim regulations will not be approved under 
the program established by subpart U until it has demonstrated that it 
meets all the applicable requirements of this subpart, including the 
appropriate minimal utilization

[[Page 196]]

rate. It may continue under the interim program only for a period not to 
exceed 1 year from the effective date of these amendments (see Sec.  
405.2100(c) of this chapter). During this period it may demonstrate its 
ability to meet the appropriate minimal utilization rate. Failure to 
qualify under this subpart will automatically terminate coverage of such 
facility's services under the ESRD program at the end of such year.

[41 FR 22510, June 3, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977, 
and further amended at 45 FR 58124, Sept. 2, 1980. Redesignated and 
amended at 53 FR 23100, June 17, 1988; 73 FR 20474, Apr. 15, 2008]



Sec.  488.61  Special procedures for approval and re-approval of organ transplant centers.

    For the purposes of this subpart, the survey, certification, and 
enforcement procedures described at 42 CFR part 488, subpart A apply to 
transplant centers, including the periodic review of compliance and 
approval described at Sec.  488.20.
    (a) Initial approval procedures for transplant centers that are not 
Medicare-approved as of June 28, 2007. A transplant center, including a 
kidney transplant center, may submit a request to CMS for Medicare 
approval at any time.
    (1) The request, signed by a person authorized to represent the 
center (for example, a chief executive officer), must include:
    (i) The hospital's Medicare provider I.D. number;
    (ii) Name(s) of the designated primary transplant surgeon and 
primary transplant physician; and,
    (iii) A statement from the OPTN that the center has complied with 
all data submission requirements.
    (2) To determine compliance with the clinical experience and outcome 
requirements at Sec. Sec.  482.80(b) and 482.80(c), CMS will review the 
data contained in the most recent OPTN Data Report and 1-year patient 
and graft survival data contained in the most recent Scientific Registry 
of Transplant Recipient (SRTR) center-specific report.
    (3) If CMS determines that a transplant center has not met the data 
submission, clinical experience, or outcome requirements, CMS may deny 
the request for approval or may review the center's compliance with the 
conditions of participation at Sec. Sec.  482.72 through 482.76 and 
Sec. Sec.  482.90 through 482.104 of this chapter, using the procedures 
described at 42 CFR part 488, subpart A, to determine whether the 
center's request will be approved. CMS will notify the transplant center 
in writing whether it is approved and, if approved, of the effective 
date of its approval.
    (4) CMS will consider mitigating factors, including (but not limited 
to) the following in considering initial approval of a transplant center 
that does not meet the data submission, clinical experience, outcome 
requirements and other conditions of participation:
    (i) The extent to which outcome measures are met or exceeded;
    (ii) Availability of Medicare-approved transplant centers in the 
area; and
    (iii) Extenuating circumstances (e.g., natural disaster) that may 
have a temporary effect on meeting the conditions of participation.
    (iv) CMS will not approve any program with a condition-level 
deficiency. However, CMS may approve a program with a standard-level 
deficiency upon receipt of an acceptable plan of correction.
    (5) If CMS determines that a transplant center has met the data 
submission, clinical experience, and outcome requirements, CMS will 
review the center's compliance with the conditions of participation 
contained at Sec. Sec.  482.72 through 482.76 and Sec. Sec.  482.90 
through 482.104 of this chapter using the procedures described at 42 CFR 
part 488, subpart A. If the transplant center is found to be in 
compliance with all the conditions of participation at Sec. Sec.  482.72 
through 482.104, except for Sec.  482.82 of this chapter (Re-approval 
Requirements), CMS will notify the transplant center in writing of the 
effective date of its Medicare-approval. CMS will notify the transplant 
center in writing if it is not Medicare-approved.
    (6) A kidney transplant center may submit a request for initial 
approval after performing at least 3 transplants over a 12-month period.
    (7) Transplant centers will be approved for 3 years.

[[Page 197]]

    (b) Initial approval procedures for transplant centers, including 
kidney transplant centers, that are Medicare approved as of June 28, 
2007. (1) A transplant center that wants to continue to be Medicare 
approved must be in compliance with the conditions of participation at 
Sec. Sec.  482.72 through 482.104 as of June 28, 2007 and submit a 
request to CMS for Medicare approval under the conditions of 
participation no later than December 26, 2007, using the process 
described in paragraph (a)(1) of the section.
    (2) CMS will determine whether to approve the transplant center, 
using the procedures described in paragraphs (a)(2) through (a)(5) of 
this section. Until CMS makes a determination whether to approve the 
transplant center under the conditions of participation at Sec. Sec.  
482.72 through 482.104, the transplant center will continue to be 
Medicare approved under the end stage renal disease (ESRD) conditions 
for coverage (CfCs) in part 405, subpart U of this chapter for kidney 
transplant centers or the pertinent national coverage decisions (NCDs) 
for extra-renal organ transplant centers, as applicable, and the 
transplant center will continue to be reimbursed for services provided 
to Medicare beneficiaries.
    (3) Once CMS approves a kidney transplant center under the 
conditions of participation, the ESRD CfCs no longer apply to the center 
as of the date of its approval. Once CMS approves an extra-renal organ 
transplant center under the conditions of participation, the NCDs no 
longer apply to the center as of the date of its approval.
    (4) If a transplant center that is Medicare approved as of June 28, 
2007 submits a request for approval under the CoPs at Sec. Sec.  482.72 
through 482.104 of this chapter but CMS does not approve the transplant 
center, or if the transplant center does not submit its request to CMS 
for Medicare approval under the CoPs by December 26, 2007, CMS will 
revoke the transplant center's approval under the conditions for 
coverage for kidney transplant centers or the national coverage 
decisions for extra-renal transplant centers, as applicable, and the 
transplant center will no longer be reimbursed for services provided to 
Medicare beneficiaries. CMS will notify the transplant center in writing 
of the effective date of its loss of Medicare approval.
    (c) Re-approval procedures. Once Medicare-approved, transplant 
centers, including kidney transplant centers, must be in compliance with 
all the conditions of participation for transplant centers at Sec. Sec.  
482.72 through 482.104 of this chapter, except for Sec.  482.80 (initial 
approval requirements) throughout the 3-year approval period.
    (1) Prior to the end of the 3-year approval period, CMS will review 
the transplant center's data in making re-approval determinations.
    (i) To determine compliance with the data submission requirements at 
Sec.  482.82(a) of this chapter, CMS will request data submission data 
from the OPTN for the previous 3 calendar years.
    (ii) To determine compliance with the clinical experience and 
outcome requirements at Sec.  482.82(b) and Sec.  482.82(c) of this 
chapter, CMS will review the data contained in the most recent OPTN Data 
Report and 1-year patient and graft survival data contained in the most 
recent SRTR center-specific reports.
    (2) If CMS determines that a transplant center has not met the data 
submission, clinical experience, or outcome requirements at Sec.  
482.82, the transplant center will be reviewed for compliance with 
Sec. Sec.  482.72 through 482.76 and Sec. Sec.  482.90 through 482.104 
of this chapter, using the procedures described at 42 CFR part 488, 
subpart A.
    (3) If CMS determines that a transplant center has met the data 
submission, clinical experience, and outcome requirements at Sec.  
482.82, CMS may choose to review the transplant center for compliance 
with Sec. Sec.  482.72 through 482.76 and Sec. Sec.  482.90 through 
482.104 of this chapter, using the procedures described at 42 CFR part 
488, subpart A.
    (4) CMS will consider mitigating factors, including (but not limited 
to) the following in considering re-approval of a transplant center that 
does not meet the data submission, clinical experience, outcome 
requirements and other conditions of participation:
    (i) The extent to which outcome measures are met or exceeded;

[[Page 198]]

    (ii) Availability of Medicare-approved transplant centers in the 
area; and
    (iii) Extenuating circumstances (e.g., natural disaster) that may 
have a temporary effect on meeting the conditions of participation.
    (iv) CMS will not approve any program with a condition-level 
deficiency. However, CMS may re-approve a program with a standard-level 
deficiency upon receipt of an acceptable plan of correction.
    (5) CMS will notify the transplant center in writing if its approval 
is being revoked and of the effective date of the revocation.
    (d) Loss of Medicare Approval. Centers that have lost their Medicare 
approval may seek re-entry into the Medicare program at any time. A 
center that has lost its Medicare approval must:
    (1) Request initial approval using the procedures described in Sec.  
488.61(a);
    (2) Be in compliance with Sec. Sec.  482.72 through 482.104 of this 
chapter, except for Sec.  482.82 (Re-approval Requirements), at the time 
of the request for Medicare approval; and
    (3) Submit a report to CMS documenting any changes or corrective 
actions taken by the center as a result of the loss of its Medicare 
approval status.
    (e) Transplant Center Inactivity. A transplant center may remain 
inactive and retain its Medicare approval for a period not to exceed 12 
months during the 3-year approval cycle. A transplant center must notify 
CMS upon its voluntary inactivation as required by Sec.  482.74(d) of 
this chapter.

[72 FR 15278, Mar. 30, 2007]



Sec.  488.64  Remote facility variances for utilization review requirements.

    (a) As used in this section:
    (1) An ``available'' individual is one who:
    (i) Possesses the necessary professional qualifications;
    (ii) Is not precluded from participating by reason of financial 
interest in any such facility or direct responsibility for the care of 
the patients being reviewed or, in the case of a skilled nursing 
facility, employment by the facility; and
    (iii) Is not precluded from effective participation by the distance 
between the facility and his residence, office, or other place of work. 
An individual whose residence, office, or other place of work is more 
than approximately one hour's travel time from the facility shall be 
considered precluded from effective participation.
    (2) ``Adjacent facility'' means a health care facility located 
within a 50-mile radius of the facility which requests a variance.
    (b) The Secretary may grant a requesting facility a variance from 
the time frames set forth in Sec. Sec.  405.1137(d) of this chapter and 
482.30 as applicable, within which reviews all of cases must be 
commenced and completed, upon a showing satisfactory to the Secretary 
that the requesting facility has been unable to meet one or more of the 
requirements of Sec.  405.1137 of this chapter or Sec.  482.30 of this 
chapter, as applicable, by reason of insufficient medical and other 
professional personnel available to conduct the utilization review 
required by Sec.  405.1137 of this chapter or Sec.  482.30 of this 
chapter, as applicable.
    (c) The request for variance shall document the requesting 
facility's inability to meet the requirements for which a variance is 
requested and the facility's good faith efforts to comply with the 
requirements contained in Sec.  405.1137 of this chapter or Sec.  482.30 
of this chapter, as applicable.
    (d) The request shall include an assurance by the requesting 
facility that it will continue its good faith efforts to meet the 
requirements contained in Sec.  405.1137 of this chapter or Sec.  482.30 
of this chapter, as applicable.
    (e) A revised utilization review plan for the requesting facility 
shall be submitted concurrently with the request for a variance. The 
revised plan shall specify the methods and procedures which the 
requesting facility will use, if a variance is granted, to assure:
    (1) That effective and timely control will be maintained over the 
utilization of services; and
    (2) That reviews will be conducted so as to improve the quality of 
care provided to patients.
    (f) The request for a variance shall include:
    (1) The name, location, and type (e.g., hospital, skilled nursing 
facility) of the

[[Page 199]]

facility for which the variance is requested;
    (2) The total number of patient admissions and average daily patient 
census at the facility within the previous six months;
    (3) The total number of title XVIII and title XIX patient admissions 
and the average daily patient census of title XVIII and title XIX 
patients in the facility within the previous six months;
    (4) As relevant to the request, the names of all physicians on the 
active staff of the facility and the names of all other professional 
personnel on the staff of the facility, or both;
    (5) The name, location, and type of each adjacent facility (e.g., 
hospital, skilled nursing facility);
    (6) The distance and average travel time between the facility and 
each adjacent facility;
    (7) As relevant to the request, the location of practice of 
available physicians and the estimated number of other available 
professional personnel, or both (see paragraph (a)(1)(iii) of this 
section);
    (8) Documentation by the facility of its attempt to obtain the 
services of available physicians or other professional personnel, or 
both; and
    (9) A statement of whether a QIO exists in the area where the 
facility is located.
    (g) The Secretary shall promptly notify the facility of the action 
taken on the request. Where a variance is in effect, the validation of 
utilization review pursuant to Sec.  405.1137 of this chapter or Sec.  
482.30 shall be made with reference to the revised utilization review 
plan submitted with the request for variance.
    (h) The Secretary, in granting a variance, will specify the period 
for which the variance has been granted; such period will not exceed one 
year. A request for a renewal shall be submitted not later than 30 days 
prior to the expiration of the variance and shall contain all 
information required by paragraphs (c), (d), and (f) of this section. 
Renewal of the variance will be contingent upon the facility's 
continuing to meet the provisions of this section.

[40 FR 30818, July 23, 1975. Redesignated at 42 FR 52826, Sept. 30, 
1977; 51 FR 22041, June 17, 1986; 51 FR 27847, Aug. 4, 1986; 51 FR 
43197, Dec. 1, 1986. Redesignated and amended at 53 FR 23100, June 17, 
1988]



Sec.  488.68  State Agency responsibilities for OASIS collection and data base requirements.

    As part of State agency survey responsibilities, the State agency or 
other entity designated by CMS has overall responsibility for fulfilling 
the following requirements for operating the OASIS system:
    (a) Establish and maintain an OASIS database. The State agency or 
other entity designated by CMS must--
    (1) Use a standard system developed or approved by CMS to collect, 
store, and analyze data;
    (2) Conduct basic system management activities including hardware 
and software maintenance, system back-up, and monitoring the status of 
the database; and
    (3) Obtain CMS approval before modifying any parts of the CMS 
standard system including, but not limited to, standard CMS-approved--
    (i) OASIS data items;
    (ii) Record formats and validation edits; and
    (iii) Agency encoding and transmission methods.
    (b) Analyze and edit OASIS data. The State agency or other entity 
designated by CMS must--
    (1) Upon receipt of data from an HHA, edit the data as specified by 
CMS and ensure that the HHA resolves errors within the limits specified 
by CMS;
    (2) At least monthly, make available for retrieval by CMS all edited 
OASIS records received during that period, according to formats 
specified by CMS, and correct and retransmit previously rejected data as 
needed; and
    (3) Analyze data and generate reports as specified by CMS.
    (c) Ensure accuracy of OASIS data. The State agency must audit the 
accuracy of the OASIS data through the survey process.

[[Page 200]]

    (d) Restrict access to OASIS data. The State agency or other entity 
designated by CMS must do the following:
    (1) Ensure that access to data is restricted except for the 
transmission of data and reports to--
    (i) CMS;
    (ii) The State agency component that conducts surveys for purposes 
related to this function; and
    (iii) Other entities if authorized by CMS.
    (2) Ensure that patient identifiable OASIS data is released only to 
the extent that it is permitted under the Privacy Act of 1974.
    (e) Provide training and technical support for HHAs. The State 
agency or other entity designated by CMS must--
    (1) Instruct each HHA on the administration of the data set, 
privacy/confidentiality of the data set, and integration of the OASIS 
data set into the facility's own record keeping system;
    (2) Instruct each HHA on the use of software to encode and transmit 
OASIS data to the State;
    (3) Specify to a facility the method of transmission of data to the 
State, and instruct the facility on this method.
    (4) Monitor each HHA's ability to transmit OASIS data.
    (5) Provide ongoing technical assistance and general support to HHAs 
in implementing the OASIS reporting requirements specified in the 
conditions of participation for home health agencies; and
    (6) Carry out any other functions as designated by CMS necessary to 
maintain OASIS data on the standard State system.

[64 FR 3763, Jan. 25, 1999]



                  SUBPART C_SURVEY FORMS AND PROCEDURES

[[Page 201]]



Sec.  488.100  Long term care survey forms, Part A.
[GRAPHIC] [TIFF OMITTED] TC01JA91.016


[[Page 202]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.017


[[Page 203]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.018


[[Page 204]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.019


[[Page 205]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.020


[[Page 206]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.021


[[Page 207]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.022


[[Page 208]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.023


[[Page 209]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.024


[[Page 210]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.025


[[Page 211]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.026


[[Page 212]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.027


[[Page 213]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.028


[[Page 214]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.029


[[Page 215]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.030


[[Page 216]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.031


[[Page 217]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.032


[[Page 218]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.033


[[Page 219]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.034


[[Page 220]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.035


[[Page 221]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.036


[[Page 222]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.037


[[Page 223]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.038


[[Page 224]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.039


[[Page 225]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.040


[[Page 226]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.041


[[Page 227]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.042


[[Page 228]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.043


[[Page 229]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.044


[[Page 230]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.045


[[Page 231]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.046


[[Page 232]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.047


[[Page 233]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.048


[[Page 234]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.049


[[Page 235]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.050


[[Page 236]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.051


[[Page 237]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.052


[[Page 238]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.053


[[Page 239]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.054


[[Page 240]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.055


[[Page 241]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.056


[[Page 242]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.057


[[Page 243]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.058


[[Page 244]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.059


[[Page 245]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.060


[[Page 246]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.061


[[Page 247]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.062


[[Page 248]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.063


[[Page 249]]





Sec.  488.105  Long term care survey forms, Part B.
[GRAPHIC] [TIFF OMITTED] TC01JA91.064


[[Page 250]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.065


[[Page 251]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.066


[[Page 252]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.067


[[Page 253]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.068


[[Page 254]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.069


[[Page 255]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.070


[[Page 256]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.071


[[Page 257]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.072


[[Page 258]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.073


[[Page 259]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.074


[[Page 260]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.075


[[Page 261]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.076


[[Page 262]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.077


[[Page 263]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.078


[[Page 264]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.079


[[Page 265]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.080


[[Page 266]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.081


[[Page 267]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.082


[[Page 268]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.083


[[Page 269]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.084


[[Page 270]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.085


[[Page 271]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.086


[[Page 272]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.087


[[Page 273]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.088


[[Page 274]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.089


[[Page 275]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.090


[[Page 276]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.091


[[Page 277]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.092


[[Page 278]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.093


[[Page 279]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.094


[[Page 280]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.095


[[Page 281]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.096


[[Page 282]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.097


[[Page 283]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.098


[[Page 284]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.099


[[Page 285]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.100


[[Page 286]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.101


[[Page 287]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.102


[[Page 288]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.103


[[Page 289]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.104


[[Page 290]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.105


[[Page 291]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.106


[[Page 292]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.107


[[Page 293]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.108


[[Page 294]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.109



Sec.  488.110  Procedural guidelines.

    SNF/ICF Survey Process. The purpose for implementing a new SNF/ICF 
survey process is to assess whether the quality of care, as intended by 
the law and regulations, and as needed by the resident, is actually 
being provided in nursing homes. Although the onsite review procedures 
have been changed, facilities must continue to meet all applicable 
Conditions/Standards, in order to participate in Medicare/Medicaid 
programs. That is, the methods used to

[[Page 295]]

compile information about compliance with law and regulations are 
changed; the law and regulations themselves are not changed. The new 
process differs from the traditional process, principally in terms of 
its emphasis on resident outcomes. In ascertaining whether residents 
grooming and personal hygiene needs are met, for example, surveyors will 
no longer routinely evaluate a facility's written policies and 
procedures. Instead, surveyors will observe residents in order to make 
that determination. In addition, surveyors will confirm, through 
interviews with residents and staff, that such needs are indeed met on a 
regular basis. In most reviews, then, surveyors will ascertain whether 
the facility is actually providing the required and needed care and 
services, rather than whether the facility is capable of providing the 
care and services.

 The Outcome-Oriented Survey Process--Skilled Nursing Facilities (SNFs) 
                 and Intermediate Care Facilities (ICFs)

    (a) General.
    (b) The Survey Tasks.
    (c) Task 1--Entrance Conference.
    (d) Task 2--Resident Sample--Selection Methodology.
    (e) Task 3--Tour of the Facility.
    (f) Task 4--Observation/Interview/Medical Record Review (including 
drug regimen review).
    (g) Task 5--Drug Pass Observation.
    (h) Task 6--Dining Area and Eating Assistance Observation.
    (i) Task 7--Forming the Deficiency Statement.
    (j) Task 8--Exit Conference.
    (k) Plan of Correction.
    (l) Followup Surveys.
    (m) Role of Surveyor.
    (n) Confidentiality and Respect for Resident Privacy.
    (o) Team Composition.
    (p) Type of Facility-Application of SNF or ICF Regulations.
    (q) Use of Part A and Part B of the Survey Report.

    (a) General. A complete SNF/ICF facility survey consists of three 
components:
     Life Safety Code requirements;
     Administrative and structural requirements (Part 
A of the Survey Report, Form CMS-525); and
     Direct resident care requirements (Part B of the 
Survey Report, Form CMS-519), along with the related worksheets (CMS-520 
through 524).
    Use this survey process for all surveys of SNFs and ICFs--whether 
freestanding, distinct parts, or dually certified. Do not use this 
process for surveys of Intermediate Care Facilities for Mentally 
Retarded (ICFs/MR), swing-bed hospitals or skilled nursing sections of 
hospitals that are not separately certified as SNF distinct parts. Do 
not announce SNF/ICF surveys ahead of time.
    (b) The Survey Tasks. Listed below are the survey tasks for easy 
reference:
     Task 1. Entrance Conference.
     Task 2. Resident Sample--Selection Methodology.
     Task 3. Tour of the Facility. Resident Needs. 
Physical Environment. Meeting with Resident Council Representatives. 
Tour Summation and Focus of Remaining Survey Activity.
     Task 4. Observation/Interview/Medical Record. 
Review of Each Individual in the Resident Sample (including drug regimen 
review).
     Task 5. Drug Pass Observation.
     Task 6. Dining Area and Eating Assistance 
Observation.
     Task 7. Forming the Deficiency Statement (if 
necessary).
     Task 8. Exit Conference.
    (c) Task 1--Entrance Conference. Perform these activities during the 
entrance conference in every certification and recertification survey:
     Introduce all members of the team to the facility 
staff, if possible, even though the whole team may not be present for 
the entire entrance conference. (All surveyors wear identification 
tags.)
     Explain the SNF/ICF survey process as resident 
centered in focus, and outline the basic steps.
     Ask the facility for a list showing names of 
residents by room number with each of the following care needs/
treatments identified for each resident to whom they apply:

--Decubitus care
--Restraints
--Catheters
--Injections
--Parenteral fluids
--Rehabilitation service
--Colostomy/ileostomy care
--Respiratory care

[[Page 296]]

--Tracheostomy care
--Suctioning
--Tube feeding

    Use this list for selecting the resident sample.
     Ask the facility to complete page 2 of Form CMS-
519 (Resident Census) as soon as possible, so that the information can 
further orient you to the facility's population. In a survey of a SNF 
with a distinct part ICF, you may collect two sets of census data. 
However, consolidate the information when submitting it to the regional 
office. You may modify the Resident Census Form to include the numbers 
of licensed and certified beds, if necessary.
     Ask the facility to post signs on readily viewed 
areas (at least one on each floor) announcing that State surveyors are 
in the facility performing an ``inspection,'' and are available to meet 
with residents in private. Also indicate the name and telephone number 
of the State agency. Hand-printed signs with legible, large letters are 
acceptable.
     If the facility has a Resident Council, make 
mutually agreeable arrangements to meet privately with the president and 
officers and other individuals they might invite.
     Inform the facility that interviews with 
residents and Resident Councils are conducted privately, unless they 
independently request otherwise, in order to enhance the development of 
rapport as well as to allay any resident anxiety. Tell the facility that 
information is gathered from interviews, the tour, observations, 
discussions, record review, and facility officials. Point out that the 
facility will be given an opportunity to respond to all findings.
    (d) Task 2--Resident Sample--Selection Methodology. This methodology 
is aimed at formulating a sample that reflects the actual distribution 
of care needs/treatments in the facility population.
    Primarily performed on a random basis, it also ensures 
representation in the sample of certain care needs and treatments that 
are assessed during the survey.
    (1) Sample Size. Calculate the size of the sample according to the 
following guide:

------------------------------------------------------------------------
                                          Number of residents in sample
    Number of residents in facility                    \1\
------------------------------------------------------------------------
0-60 residents.........................  25% of residents (minimum--10).
61-120 residents.......................  20% of residents (minimum--15).
121-200 residents......................  15% of residents (minimum--24).
201+ residents.........................  10% of residents (minimum--30).
 
------------------------------------------------------------------------
\1\ Maximum--50.

    Note that the calculation is based on the resident census, not beds. 
After determining the appropriate sample size, select residents for the 
sample in a random manner. You may, for example, select every fifth 
resident from the resident census, beginning at a random position on the 
list. For surveys of dually certified facilities or distinct part SNFs/
ICFs, first use the combined SNF/ICF population to calculate the size of 
the sample, and then select a sample that reflects the proportions of 
SNF and ICF residents in the facility's overall population.
    (2) Special Care Needs/Treatments. The survey form specifies several 
care needs/treatments that must always be reviewed when they apply to 
any facility residents. These include:

 Decubitus Care
 Restraints
 Catheters
 Injections, Parenteral Fluids, Colostomy/Ileostomy, 
    Respiratory Care, Tracheostomy Care, Suctioning, Tube Feeding
 Rehabilitative Services (physical therapy, speech 
    pathology and audiology services, occupational therapy)

    Due to the relatively low prevalence of these care needs/treatments, 
appropriate residents may be either under-

represented or entirely omitted from the sample. Therefore, determine 
during the tour how many residents in the random selection fall into 
each of these care categories. Then, compare the number of such 
residents in the random selection with the total number of residents in 
the facility with each specified care need/treatment (based on either 
the resident census or other information provided by the facility).
    Review no less than 25 percent of the residents in each of these 
special care needs/treatments categories. For example, if the facility 
has 10 residents with

[[Page 297]]

decubitus ulcers, but only one of these residents is selected randomly, 
review two more residents with decubitis ulcers (25% of 10 equals 2.5, 
so review a total of 3). Or, if the facility has two residents who 
require tube feeding, neither of whom is in the random selection, review 
the care of at least one of the these residents. This can be 
accomplished in the following manner:
    Conduct in-depth reviews of the randomly selected residents and then 
perform limited reviews of additional residents as needed to cover the 
specified care categories. Such reviews are limited to the care and 
services related to the pertinent care areas only, e.g., catheters, 
restraints, or colostomy. Utilize those worksheets or portions of 
worksheets which are appropriate to the limited review. Refer to the 
Care Guidelines, as a resource document, when appropriate.
    Always keep in mind that neither the random selection approach nor 
the review of residents within the specified care categories precludes 
investigation of other resident care situations that you believe might 
pose a serious threat to a resident's health or safety. Add to the 
sample, as appropriate.
    (e) Task 3--Tour of the Facility--(1) Purpose. Conduct the tour in 
order to:
     Develop an overall picture of the types and 
patterns of care delivery present within the facility;
     View the physical environment; and
     Ascertain whether randomly selected residents are 
communicative and willing to be interviewed.
    (2) Protocol. You may tour the entire facility as a team or 
separately, as long as all areas of the facility are examined by at 
least one team member. Success of the latter approach, however, is 
largely dependent on open intra-team communication and the ability of 
each team member to identify situations for further review by the team 
member of the appropriate discipline. You may conduct the tour with or 
without facility staff accompanying you, as you prefer. Facilities, 
however, vary in staff member availability. Record your notes on the 
Tour Notes Worksheet, Form CMS-521.
    Allow approximately three hours for the tour. Converse with 
residents, family members/significant others (if present), and staff, 
asking open-ended questions in order to confirm observations, obtain 
additional information, or corroborate information, (e.g., accidents, 
odors, apparent inappropriate dress, adequacy and appropriateness of 
activities). Converse sufficiently with residents selected for in-depth 
review to ascertain whether they are willing to be interviewed and are 
communicative. Observe staff interactions with other staff members as 
well as with residents for insight into matters such as resident rights 
and assignments of staff responsibilities.
    Always knock and/or get permission before entering a room or 
interrupting privacy. If you wish to inspect a resident's skin, observe 
a treatment procedure, or observe a resident who is exposed, courteously 
ask permission from the resident if she/he comprehends, or ask 
permission from the staff nurse if the resident cannot communicate. Do 
not do ``hands-on'' monitoring such as removal of dressings; ask staff 
to remove a dressing or handle a resident.
    (3) Resident Needs. While touring, focus on the residents' needs--
physical, emotional, psychosocial, or spiritual--and whether those needs 
are being met. Refer to the following list as needed:

--Personal hygiene, grooming, and appropriate dress
--Position
--Assistive and other restorative devices
--Rehabilitation issues
--Functional limitations in ADL
--Functional limitations in gait, balance and coordination
--Hydration and nutritional status
--Resident rights
--Activity for time of day (appropriate or inappropriate)
--Emotional status
--Level of orientation
--Awareness of surroundings
--Behaviors
--Cleanliness of immediate environment (wheelchair, bed, bedside table, 
    etc.)
--Odors
--Adequate clothing and care supplies as well as maintenance and 
    cleanliness of same

    (4) Review of the Physical Environment. As you tour each resident's 
room and

[[Page 298]]

auxiliary rooms, also examine them in connection with the physical 
environment requirements. You need not document physical environment on 
the Tour Notes Worksheet. Instead, you may note any negative findings 
directly on the Survey Report Form in the remarks section.
    (5) Meeting With Resident Council Representatives. If a facility has 
a Resident Council, one or more surveyors meet with the respresentatives 
in a private area. Facility staff members do not attend unless 
specifically requested by the Council. Explain the purpose of the survey 
and briefly outline the steps in the survey process, i.e., entrance 
conference * * * exit conference. Indicate your interest in learning 
about the strengths of the facility in addition to any complaints or 
shortcomings. State that this meeting is one part of the information 
gathering; the findings have not yet been completed nor the conclusions 
formulated. Explain further, however, that the official survey findings 
are usually available within three months after the completion of the 
survey, and give the telephone number of the State agency office.
    Use this meeting to ascertain strengths and/or problems, if any, 
from the consumer's perspective, as well as to develop additional 
information about aspects of care and services gleaned during the tour 
that were possibly substandard.
    Conduct the meeting in a manner that allows for comments about any 
aspect of the facility. (See the section on Interview Procedures.) Use 
open-ended questions such as:

     ``What is best about this home?''
     ``What is worst?''
     ``What would you like to change?''

    In order to get more detail, use questions such as:

     ``Can you be more specific?''
     ``Can you give me an example?''
     ``What can anyone else tell me about this?''

    If you wish to obtain information about a topic not raised by the 
residents, use an approach like the following:

     ``Tell me what you think about the food/staff/
cleanliness here.''
     ``What would make it better?''
     ``What don't you like? What do you like?''

    (6) Tour Summation and Focus of Remaining Survey Activity. When the 
tour is completed, review the resident census data provided by the 
facility. Determine if the care categories specified in the section on 
Resident Sample are sufficiently represented in the random selection, 
make adjustments as needed, and complete the listing of residents on the 
worksheet labeled ``Residents Selected for In-depth Review'', Form CMS-
520.
    Transcribe notes of a negative nature onto the SRF in the 
``Remarks'' column under the appropriate rule. Findings from a later 
segment in the survey or gathered by another surveyor may combine to 
substantiate a deficiency. You need not check ``met'' or ``not met'' at 
this point in the survey. Discuss significant impressions/conclusions at 
the completion of each subsequent survey task, and transfer any negative 
findings onto the Survey Report Form in the Remarks section.
    (f) Task 4--Observation/Interview/Medical Record Review (including 
drug regimen review). Perform the in-depth review of each individual in 
the resident sample in order to ascertain whether the facility is 
meeting resident needs. Evaluate specific indicators for each resident, 
utilizing the front and back of the ``Observation/Interview/Record 
Review (OIRR)'' worksheet, Form CMS-524. You may prefer to perform the 
record review first, complete resident/staff/family observations and 
interviews, and finally, return to the record for any final unresolved 
issues. On the other hand, you may prefer to do the interviews first. 
Either method is acceptable. Whenever possible, however, complete one 
resident's observation/interview/medical record review and document the 
OIRR before moving onto another resident. If because of the facility 
layout, it is more efficient to do more than one record review at a 
time, limit such record review to two or three residents so your 
familiarity with the particular resident and continuity of the OIRR are 
not compromised.
    (1) Observation. Conduct observations concurrently with interviews 
of residents, family/significant others, and

[[Page 299]]

discussions with direct care staff [of the various disciplines involved. 
In multi-facility operations, whenever possible, observe staff that is 
regularly assigned to the facility in order to gain an understanding of 
the care and services usually provided.] Maintain respect for resident 
privacy. Minimize disruption of the operations of the facility or 
impositions upon any resident as much as possible. Based upon your 
observations of the residents' needs, gather information about any of 
the following areas, as appropriate:

Bowel and bladder training
Catheter care
Restraints
Injections
Parenteral fluids
Tube feeding/gastrostomy
Colostomy/ileostomy
Respiratory therapy
Tracheostomy care
Suctioning

    (2) Interviews. Interview each resident in private unless he/she 
independently requests that a facility staff member or other individual 
be present. Conduct the in-depth interview in a nonthreatening and 
noninvasive fashion so as to decrease anxiety and defensiveness. The 
open-ended approach described in the section on the Resident Council is 
also appropriate for the in-depth interview. While prolonged time 
expenditure is not usually a worthwhile use of resources or the 
resident's time, do allow time initially to establish rapport.
    At each interview:

     Introduce yourself.
     Address the resident by name.
     Explain in simple terms the reason for your visit 
(e.g., to assure that the care and services are adequate and appropriate 
for each resident).
     Briefly outline the process--entrance conference, 
tour, interviews, observations, review of medical records, resident 
interviews, and exit conference.
     Mention that the selection of a particular 
resident for an interview is not meant to imply that his/her care is 
substandard or that the facility provides substandard care. Also mention 
that most of those interviewed are selected randomly.
     Assure that you will strive for anonymity for the 
resident and that the interview is used in addition to medical records, 
observations, discussions, etc., to capture an accurate picture of the 
treatment and care provided by the facility. Explain that the official 
findings of the survey are usually available to the public about three 
months after completion of the survey, but resident names are not given 
to the public.
     When residents experience difficulty expressing 
themselves:

--Avoid pressuring residents to verbalize
--Accept and respond to all communication
--Ignore mistakes in word choice
--Allow time for recollection of words
--Encourage self-expression through any means available

     When interviewing residents with decreased 
receptive capacity:

--Speak slowly and distinctly
--Speak at conversational voice level
--Sit within the resident's line of vision
 Listen to all resident information/allegations 
    without judgment. Information gathered subsequently may substantiate 
    or repudiate an allegation.

    The length of the interview varies, depending on the condition and 
wishes of the resident and the amount of information supplied. Expect 
the average interview, however, to last approximately 15 minutes. 
Courteously terminate an interview whenever the resident is unable or 
unwilling to continue, or is too confused or disoriented to continue. 
Do, however, perform the other activities of this task (observation and 
record review). If, in spite of your conversing during the tour, you 
find that less than 40 percent of the residents in your sample are 
sufficiently alert and willing to be interviewed, try to select 
replacements so that a complete OIRR is performed for a group this size, 
if possible. There may be situations, however, where the resident 
population has a high percentage of confused individuals and this 
percentage is not achievable. Expect that the information from confused 
individuals can be, but is not necessarily, less

[[Page 300]]

reliable than that from more alert individuals.
    Include the following areas in the interview of each resident in the 
sample:

Activities of daily living
Grooming/hygiene
Nutrition/dietary
Restorative/rehabilitation care and services
Activities
Social services
Resident rights

    Refer to the Care Guidelines ``evaluation factors'' as a resource 
for possible elements to consider when focusing on particular aspects of 
care and resident needs.
    Document information obtained from the interviews/observations on 
the OIRR Worksheet. Record in the ``Notes'' section any additional 
information you may need in connection with substandard care or 
services. Unless the resident specifically requests that he/she be 
identified, do not reveal the source of the information gleaned from the 
interview.
    (3) Medical Record Review. The medical record review is a three-part 
process, which involves first reconciling the observation/interview 
findings with the record, then reconciling the record against itself, 
and lastly performing the drug regimen review.
    Document your findings on the OIRR Worksheet, as appropriate, and 
summarize on the Survey Report Form the findings that are indicative of 
problematic or substandard care. Be alert for repeated similar instances 
of substandard care developing as the number of completed OIRR 
Worksheets increases.

    Note: The problems related to a particular standard or condition 
could range from identical (e.g., meals not in accordance with dietary 
plan) to different but related (e.g., nursing services--lapse in care 
provided to residents with catheters, to residents with contractures, to 
residents needing assistance for personal hygiene and residents with 
improperly applied restraints).

    (i) Reconciling the observation/interview findings with the record. 
Determine if:

     An assessment has been performed.
     A plan with goals has been developed.
     The interventions have been carried out.
     The resident has been evaluated to determine the 
effectiveness of the interventions.

    For example, if a resident has developed a decubitus ulcer while in 
the facility, record review can validate staff and resident interviews 
regarding the facility's attempts at prevention. Use your own judgment; 
review as much of the record(s) as necessary to evaluate the care 
planning. Note that facilities need not establish specific areas in the 
record stating ``Assessment,'' ``Plan,'' ``Intervention,'' or 
``Evaluation'' in order for the documentation to be considered adequate.
    (ii) Reconciling the record with itself. Determine:

     If the resident has been properly assessed for 
all his/her needs.
     That normal and routine nursing practices such as 
periodic weights, temperatures, blood pressures, etc., are performed as 
required by the resident's conditions.

    (iii) Performing the drug regimen review. The purpose of the drug 
regimen review is to determine if the pharmacist has reviewed the drug 
regimen on a monthly basis. Follow the procedures in Part One of 
Appendix N, Surveyor Procedures for Pharmaceutical Service Requirements 
in Long-Term Care Facilities. Fill in the appropriate boxes on the top 
left hand corner of the reverse side of the OIRR Worksheet, Form CMS-
524. Appendix N lists many irregularities that can occur. Review at 
least six different indicators on each survey. However, the same six 
indicators need not be reviewed on every survey.

    Note: If you detect irregularities and the documentation 
demonstrates that the pharmacist has notified the attending physician, 
do not cite a deficiency. Do, however, bring the irregularity to the 
attention of the medical director or other facility official, and note 
the official's name and date of notification on the Survey Report Form.
    (g) Task 5--Drug Pass Observation. The purpose of the drug pass 
observation is to observe the actual preparation and administration of 
medications to residents. With this approach, there is no doubt that the 
errors detected, if any, are errors in drug administration, not

[[Page 301]]

documentation. Follow the procedure in Part Two of Appendix N, Surveyor 
Procedures for Pharmaceutical Service Requirements in Long-Term Care 
Facilities, and complete the Drug Pass Worksheet, Form CMS-522. Be as 
neutral and unobtrusive as possible during the drug pass observation. 
Whenever possible, select one surveyor, who is a Registered Nurse or a 
pharmacist, to observe the drug pass of approximately 20 residents. In 
facilities where fewer than 20 residents are receiving medications, 
review as many residents receiving medications as possible. Residents 
selected for the in-depth review need not be included in the group 
chosen for the drug pass; however, their whole or partial inclusion is 
acceptable. In order to get a balanced view of a facility's practices, 
observe more than one person administering a drug pass, if feasible. 
This might involve observing the morning pass one day in Wing A, for 
example, and the morning pass the next day in Wing B.
    Transfer findings noted on the ``Drug Pass'' worksheet to the SRF 
under the appropriate rule. If your team concludes that the facility's 
medication error rate is 5 percent or more, cite the deficiency under 
Nursing Services/Administration of Drugs. Report the error rate under 
F209. If the deficiency is at the standard level, cite it in Nursing 
Services, rather than Pharmacy.
    (h) Task 6--Dining Area and Eating Assistance Observation. The 
purpose of this task is to ascertain the extent to which the facility 
meets dietary needs, particularly for those who require eating 
assistance. This task also yields information about staff interaction 
with residents, promptness and appropriateness of assistance, adaptive 
equipment usage and availability, as well as appropriateness of dress 
and hygiene for meals.
    For this task, use the worksheet entitled ``Dining Area and Eating 
Assistance Observation'' (Form CMS-523). Observe two meals; for a 
balanced view, try to observe meals at different times of the day. For 
example, try to observe a breakfast and a dinner rather than two 
breakfasts. Give particular care to performing observations as 
unobtrusively as possible. Chatting with residents and sitting down 
nearby may help alleviate resident anxiety over the observation process.
    Select a minimum of five residents for each meal observation and 
include residents who have their meals in their rooms. Residents 
selected for the in-depth review need not be included in the dining and 
eating assistance observation; however, their whole or partial inclusion 
is acceptable. Ascertain the extent to which the facility assesses, 
plans, and evaluates the nutritional care of residents and eating 
assistance needs by reviewing the sample of 10 or more residents. If you 
are unable to determine whether the facility meets the standards from 
the sample reviewed, expand the sample and focus on the specific area(s) 
in question, until you can formulate a conclusion about the extent of 
compliance. As with the other survey tasks, transfer the findings noted 
on the ``Dining & Eating Assistance Observation'' worksheet to the 
Survey Report Form.
    (i) Task 7--Forming the Deficiency Statement--(1) General. The 
Survey Report Form contains information about all of the negative 
findings of the survey. Be sure to transfer to the Survey Report Form 
data from the tour, drug pass observation, dining area and eating 
assistance observation, as well as in-depth review of the sample of 
residents. Transfer only those findings which could possibly contribute 
to a determination that the facility is deficient in a certain area.
    Meet as a group in a pre-exit conference to discuss the findings and 
make conclusions about the deficiencies, subject to information provided 
by facility officials that may further explain the situation. Review the 
summaries/conclusions from each task and decide whether any further 
information and/or documentation is necessary to substantiate a 
deficiency. As the facility for additional information for clarification 
about particular findings, if necessary. Always consider information 
provided by the facility. If the facility considers as acceptable, 
practices which you believe are not acceptable, ask the facility to 
backup its contention with suitable reference material or sources and 
submit them for your consideration.

[[Page 302]]

    (2) Analysis. Analyze the findings on the Survey Report Form for the 
degree of severity, frequency of occurrence and impact on delivery of 
care or quality of life. The threshold at which the frequency of 
occurrences amounts to a deficiency varies from situation to situation. 
One occurrence directly related to a life-threatening or fatal outcome 
can be cited as a deficiency. On the other hand, a few sporadic 
occurrences may have so slight an impact on delivery of care or quality 
of life that they do not warrant a deficiency citation. Review carefully 
all the information gathered. What may appear during observation as a 
pattern, may or may not be corroborated by records, staff, and 
residents. For example, six of the 32 residents in the sample are 
dressed in mismatched, poorly buttoned clothes. A few of the six are 
wearing slippers without socks. A few others are wearing worn clothes. 
Six occurrences might well be indicative of a pattern of susbstandard 
care. Close scrutiny of records, discussions with staff, and interviews 
reveal, however, that the six residents are participating in dressing 
retraining programs. Those residents who are without socks, chose to do 
so. The worn clothing items were also chosen--they are favorites.
    Combinations of substandard care such as poor grooming of a number 
of residents, lack of ambulation of a number of residents, lack of 
attention to positioning, poor skin care, etc., can yield a deficiency 
in nursing services just as 10 out of 10 residents receiving substandard 
care for decubiti yields a deficiency.
    (3) Deficiencies Alleged by Staff or Residents. If staff or 
residents allege deficiencies, but records, interviews, and observation 
fail to confirm the situation, it is unlikely that a deficiency exists. 
Care and services that are indeed confirmed by the survey to be in 
compliance with the regulatory requirements, but considered deficient by 
residents or staff, cannot be cited as deficient for certification 
purposes. On the other hand, if an allegation is of a very serious 
nature (e.g., resident abuse) and the tools of record review and 
observation are not effective because the problem is concealed, obtain 
as much information as possible or necessary to ascertain compliance, 
and cite accordingly. Residents, family, or former employees may be 
helpful for information gathering.
    (4) Composing the Deficiency Statement. Write the deficiency 
statement in terms specific enough to allow a reasonably knowledgeable 
person to understand the aspect(s) of the requirement(s) that is (are) 
not met. Do not delve into the facility's policies and procedures to 
determine or speculate on the root cause of a deficiency, or sift 
through various alternatives in an effort to prescribe an acceptable 
remedy. Indicate the data prefix tag and regulatory citation, followed 
by a summary of the deficiency and supporting findings using resident 
identifiers, not resident names, as in the following example.

    F102 SNF 405.1123(b).--Each resident has not had a physician's visit 
at least once every 30 days for the first 90 days after admission. 
Resident 1602 has not been seen by a physician since she was 
admitted 50 days ago. Her condition has deteriorated since that time 
(formulation of decubiti, infections).

    When the data prefix tag does not repeat the regulations, also 
include a short phrase that describes the prefix tag (e.g., F117 
decubitus ulcer care). List the data tags in numerical order, whenever 
possible.
    (j) Task 8--Exit Conference. The purpose of the exit conference is 
to inform the facility of survey findings and to arrange for a plan of 
correction, if needed. Keep the tone of the exit conference consistent 
with the character of the survey process--inspection and enforcement. 
Tactful, business-like, professional presentation of the findings is of 
paramount importance. Recognize that the facility may wish to respond to 
various findings. Although deficiency statements continue to depend, in 
part, on surveyor professional judgment, support your conclusions with 
resident-specific examples (identifiers other than names) whenever you 
can do so without compromising confidentiality. Before formally citing 
deficiencies, discuss any allegations or findings that could not be 
substantiated during earlier tasks in the process. For example, if 
information is gathered that suggests a newly hired

[[Page 303]]

R.N. is not currently licensed, ask the facility officials to present 
current licensure information for the nurse in question. Identify 
residents when the substandard care is readily observed or discerned 
through record review. Ensure that the facility improves the care 
provided to all affected residents, not only the identified residents. 
Make clear to the facility that during a follow-up visit the surveyors 
may review residents other than those with significant problems from the 
original sample, in order to see that the facility has corrected the 
problems overall. Do not disclose the source of information provided 
during interviews, unless the resident has specifically requested you to 
inform the facility of his/her comments or complaints. In accordance 
with your Agency's policy, present the Statement of Deficiencies, form 
CMS-2567, on site or after supervisory review, no later than 10 calendar 
days following the survey.
    (k) Plan of Correction. Explain to the facility that your role is to 
identify care and services which are not consistent with the regulatory 
requirements, rather than to ascertain the root causes of deficiencies. 
Each facility is expected to review its own care delivery. Subsequent to 
the exit conference, each facility is required to submit a plan of 
correction that identifies necessary changes in operation that will 
assure correction of the cited deficiencies. In reviewing and accepting 
a proposed plan of correction, apply these criteria:

     Does the facility have a reasonable approach for 
correcting the deficiencies?
     Is there a high probability that the planned 
action will result in compliance?
     Is compliance expected timely?

    Plans of correction specific to residents identified on the 
deficiency statement are acceptable only where the deficiency is 
determined to be unique to that resident and not indicative of a 
possible systemic problem. For example, as a result of an aide being 
absent, two residents are not ambulated three times that day as called 
for in their care plans. A plan of correction that says ``Ambulate John 
Jones and Mary Smith three times per day,'' is not acceptable. An 
acceptable plan of correction would explain changes made to the 
facility's staffing and scheduling in order to gurantee that staff is 
available to provide all necessary services for all residents.
    Acceptance of the plan of correction does not absolve the facility 
of the responsibility for compliance should the implementation not 
result in correction and compliance. Acceptance indicates the State 
agency's acknowledgement that the facility indicated a willingness and 
ability to make corrections adequately and timely.
    Allow the facility up to 10 days to prepare and submit the plan of 
correction to the State agency, however, follow your SA policy if the 
timeframe is shorter. Retain the various survey worksheets as well as 
the Survey Report Form at the State agency. Forward the deficiency 
statement to the CMS regional office.
    (l) Follow-up Surveys. The purpose of the follow-up survey is to re-
evaluate the specific types of care or care delivery patterns that were 
cited as deficient during the original survey. Ascertain the corrective 
status of all deficiencies cited on the CMS-2567. Because this survey 
process focuses on the actual provision of care and services, revisits 
are almost always necessary to ascertain whether the deficienicies have 
indeed been corrected. The nature of the deficiencies dictates the scope 
of the follow-up visit. Use as many tasks or portions of the Survey 
Report Form(s) as needed to ascertain compliance status. For example, 
you need not perform another drug pass if no drug related deficiencies 
were cited on the initial survey. Similarly, you need not repeat the 
dining area and eating assistance observations if no related problems 
were identified. All or some of the aspects of the observation/
interview/medical record review, however, are likely to be appropriate 
for the follow-up survey.
    When selecting the resident sample for the follow-up, determine the 
sample size using the same formula as used earlier in the survey, with 
the following exceptions:

     The maximum sample size is 30 residents, rather 
than 50.

[[Page 304]]

     The minimum sample size of 10 residents does not 
apply if only one care category was cited as deficient and the total 
number of residents in the facility in that category was less than 10 
(e.g., deficiency cited under catheter care and only five residents have 
catheters).

    Include in the sample those residents who, in your judgment, are 
appropriate for reviewing vis-a-vis the cited substandard care. If 
possible, include some residents identified as receiving substandard 
care during the initial survey. If after completing the follow-up 
activities you determine that the cited deficiencies were not corrected, 
initiate adverse action procedures, as appropriate.
    (m) Role of Surveyor. The survey and certification process is 
intended to determine whether providers and suppliers meet program 
participation requirements. The primary role of the surveyor, then, is 
to assess the quality of care and services and to relate those findings 
to statutory and regulatory requirements for program participation.
    When you find substandard care or services in the course of a 
survey, carefully document your findings. Explain the deficiency in 
sufficient detail so that the facility officials understand your 
rationale. If the cause of the deficiency is obvious, share the 
information with the provider. For example, if you cite a deficiency for 
restraints (F118), indicate that restraints were applied backwards on 
residents 1621, 1634, 1646, etc.
    In those instances where the cause is not obvious, do not delve into 
the facility's policies and procedures to determine the root cause of 
any deficiency. Do not recommend or prescribe an acceptable remedy. The 
provider is responsible for deciding on and implementing the action(s) 
necessary for achieving compliance. For the restraint situation in the 
example above, you would not ascertain whether the improper application 
was due to improper training or lack of training, nor would you attempt 
to identify the staff member who applied the restraints. It is the 
provider's responsibility to make the necessary changes or corrections 
to ensure that the restriants are applied properly.
    A secondary role for the surveyor is to provide general consultation 
to the provider/consumer community. This includes meeting with provider/
consumer associations and other groups as well as participating in 
seminars. It also includes informational activities, whereby you respond 
to oral or written inquiries about required outcomes in care and 
services.
    (n) Confidentiality and Respect for Resident Privacy. Conduct the 
survey in a manner that allows for the greatest degree of 
confidentiality for residents, particularly regarding the information 
gathered during the in-depth interviews. When recording observations 
about care and resident conditions, protect the privacy of all 
residents. Use a code such as resident identifier number rather than 
names on worksheets whenever possible. Never use a resident's name on 
the Deficiency Statement, Form CMS-2567. Block out resident names, if 
any, from any document that is disclosed to the facility, individual or 
organization.
    When communicating to the facility about substandard care, fully 
identify the resident(s) by name if the situation was identified through 
observation or record review. Improperly applied restraints, expired 
medication, cold food, gloves not worn for a sterile procedure, and diet 
inconsistent with order, are examples of problems which can be 
identified to the facility by resident name. Information about injuries 
due to broken equipment, prolonged use of restraints, and opened mail is 
less likely to be obtained through observation or record review. Do not 
reveal the source of information unless actually observed, discovered in 
the record review, or requested by the resident or family.
    (o) Team Composition. Whenever possible, use the following survey 
team model:

                        SNF/ICF Survey Team Model

    In facilities with 200 beds or less, the team size may range from 2 
to 4 members. If the team size is:

     2 members: The team has at least one RN plus 
another RN or a dietitian or a pharmacist.

[[Page 305]]

     3-4 member: In addition to the composition 
described above, the team has one or two members of any discipline such 
as a social worker, sanitarian, etc.

    If the facility has over 200 beds and the survey will last more than 
2 days, the team size may be greater than 4 members. Select additional 
disciplines as appropriate to the facility's compliance history.
    Average onsite time per survey: 60 person hours (Number of surveyors 
multiplied by the number of hours on site)
    Preferably, team members have gerontological training and 
experience. Any member may serve as the team leader, consistent with 
State agency procedures. In followup surveys, select disciplines based 
on major areas of correction. Include a social worker, for example, if 
the survey revealed major psychosocial problems. This model does not 
consider integrated survey and Inspection of Care review teams, which 
typically would be larger.
    (p) Type of Facility--Application of SNF or ICF Regulations. Apply 
the regulations to the various types of facilities in the following 
manner:

             Apply SNF regulations.
 Freestanding Skilled Nursing
 Facility (SNF)
             Apply ICF regulations.
 Freestanding Intermediate
 Care Facility (ICF)
 SNF         Apply SNF regulations.
 Distinct Part of a Hospital
 ICF         Apply ICF regulations.
 Distinct Part of a Hospital
 Dually      Apply SNF regulations and 442.346(b).
 Certified SNF/ICF
             Apply SNF regulations for SNF unit.
 Freestanding SNF with ICF     Apply ICF regulations for ICF distinct
 Distinct Part (Regardless of   part.
 the proportion of SNF and     Apply both SNF and ICF regulations for
 ICF beds, the facility type    shared services (e.g., dietary).
 is determined by the higher   If the same deficiency occurs in both the
 level of care. Therefore,      SNF and ICF components of the facility,
 LTC facilities with distinct   cite both SNF and ICF regulations.
 parts are defined as SNFs     If the deficiency occurs in the SNF part
 with ICF distinct parts.)      only, cite only the SNF regulation.
                               If the deficiency occurs in the ICF part
                                only, cite only the ICF regulation.
 

    (q) Use of Part A and Part B of the Survey Report--(1) Use of Part A 
(CMS-525). Use Part A for initial certification surveys only, except 
under the following circumstances:

     When a terminated facility requests program 
participation 60 days or more after termination. Treat this situation as 
a request for initial certification and complete Part A of the survey 
report in addition to Part B.
     If an ICF with a favorable compliance history 
requests to covert a number of beds to SNF level, complete both Part A 
and Part B for compliance with the SNF requirements. If distinct part 
status is at issue, also examine whether it meets the criteria for 
certification as a distinct part.

    (i) Addendum for Outpatient Physical Therapy (OPT) or Speech 
Pathology Services. Use the Outpatient Physical Therapy--Speech 
Pathology SRF (CMS-1893) as an addendum to Part A.
    (ii) Resurvey of Participating Facilities. Do not use Part A for 
resurveys of participating SNFs and ICFs. A determination of compliance, 
based on documented examination of the written policies and procedures 
and other pertinent documents during the initial survey, establishes the 
facility's compliance status with Part A requirements. This does not 
preclude citing deficiencies if they pertain to administrative or 
structural requirements from Part A that are uncovered incidental to a 
Part B survey. As an assurance measure, however, each facility at the 
time of recertification must complete an affidavit (on the CMS-1516) 
attesting that no substantive changes have occurred that would affect 
compliance. Each facility must also agree to notify the State agency 
immediately of any upcoming changes in its organization or management 
which may affect its compliance status. If a new administrator is unable 
to complete the affidavit, proceed with the survey using the Part B form 
and worksheets; do not use the Part A form. The survey cannot be 
considered complete, however, until the affidavit is signed. If the 
facility fails to complete the affidavit, it cannot participate in the 
program.
    (iii) Substantial Changes in a Facility's Organization and 
Management. If you receive such information, review the changes to 
ensure compliance with the regulations. Request copies of the 
appropriate documents (e.g., written policies and procedures, personnel 
qualifications, or agreements) if they were

[[Page 306]]

not submitted. If the changes have made continued compliance seem 
doubtful, determine through a Part B survey whether deficiencies have 
resulted. Cite any deficiencies on the CMS-2567 and follow the usual 
procedures.
    (2) Use of Part B (CMS-519). Use Part B and the worksheets for all 
types of SNF and ICF surveys--initials, recertifications, followup, 
complaints, etc.
    The worksheets are:

 CMS-520--Residents Selected for Indepth Review
 CMS-521--Tour Notes Worksheet
 CMS-522--Drug Pass Worksheet
 CMS-523--Dining Area and Eating Assistance Worksheet
 CMS-5245--Observation/Interview/Record Review 
    Worksheet

    For complaint investigations, perform a full or partial Part B 
survey based on the extent of the allegations. If the complaint alleges 
substandard care in a general fashion or in a variety of services and 
care areas, perform several tasks or a full Part B survey, as needed. If 
the complaint is of a more specific nature, such as an allegation of 
improper medications, perform an appropriate partial Part B survey, such 
as a drug pass review and a review of selected medical records.

[[Page 307]]



Sec.  488.115  Care guidelines.
[GRAPHIC] [TIFF OMITTED] TC01JA91.110


[[Page 308]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.111


[[Page 309]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.112


[[Page 310]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.113


[[Page 311]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.114


[[Page 312]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.115


[[Page 313]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.116


[[Page 314]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.117


[[Page 315]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.118


[[Page 316]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.119


[[Page 317]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.120


[[Page 318]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.121


[[Page 319]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.122


[[Page 320]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.123


[[Page 321]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.124


[[Page 322]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.125


[[Page 323]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.126


[[Page 324]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.127


[[Page 325]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.128


[[Page 326]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.129


[[Page 327]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.130


[[Page 328]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.131


[[Page 329]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.132


[[Page 330]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.133


[[Page 331]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.134


[[Page 332]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.135


[[Page 333]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.136


[[Page 334]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.137


[[Page 335]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.138


[[Page 336]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.139


[[Page 337]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.140


[[Page 338]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.141


[[Page 339]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.142


[[Page 340]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.143


[[Page 341]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.144


[[Page 342]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.145


[[Page 343]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.146


[[Page 344]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.147


[[Page 345]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.148


[[Page 346]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.149


[[Page 347]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.150


[[Page 348]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.151


[[Page 349]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.152


[[Page 350]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.153


[[Page 351]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.154


[[Page 352]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.155


[[Page 353]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.156


[[Page 354]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.157


[[Page 355]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.158


[[Page 356]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.159


[[Page 357]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.160


[[Page 358]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.161


[[Page 359]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.162


[[Page 360]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.163


[[Page 361]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.164


[[Page 362]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.165


[[Page 363]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.166


[[Page 364]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.167


[[Page 365]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.168


[[Page 366]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.169


[[Page 367]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.170


[[Page 368]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.171


[[Page 369]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.172


[[Page 370]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.173


[[Page 371]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.174


[[Page 372]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.175


[[Page 373]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.176


[[Page 374]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.177


[[Page 375]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.178


[[Page 376]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.179


[[Page 377]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.180


[[Page 378]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.181


[[Page 379]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.182


[[Page 380]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.183


[[Page 381]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.184


[[Page 382]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.185


[[Page 383]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.186


[[Page 384]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.187


[[Page 385]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.188


[[Page 386]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.189


[[Page 387]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.190


[[Page 388]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.191


[[Page 389]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.192


[[Page 390]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.193


[[Page 391]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.194


[[Page 392]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.195


[[Page 393]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.196


[[Page 394]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.197


[[Page 395]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.198


[[Page 396]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.199


[[Page 397]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.200


[[Page 398]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.201


[[Page 399]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.202


[[Page 400]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.203


[[Page 401]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.204


[[Page 402]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.205


[[Page 403]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.206


[[Page 404]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.207


[[Page 405]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.208


[[Page 406]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.209


[[Page 407]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.210


[[Page 408]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.211


[[Page 409]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.212


[[Page 410]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.213


[[Page 411]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.214


[[Page 412]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.215


[[Page 413]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.246


[[Page 414]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.216


[[Page 415]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.217


[[Page 416]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.218


[[Page 417]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.219


[[Page 418]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.220


[[Page 419]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.221


[[Page 420]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.222


[[Page 421]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.223


[[Page 422]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.224


[[Page 423]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.225


[[Page 424]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.226


[[Page 425]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.227


[[Page 426]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.228


[[Page 427]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.229


[[Page 428]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.230


[[Page 429]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.231


[[Page 430]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.232


[[Page 431]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.233


[[Page 432]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.234


[[Page 433]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.235


[[Page 434]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.236


[[Page 435]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.237


[[Page 436]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.238


[[Page 437]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.239


[[Page 438]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.240


[[Page 439]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.241


[[Page 440]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.242


[[Page 441]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.243


[[Page 442]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.244


[[Page 443]]


[GRAPHIC] [TIFF OMITTED] TC01JA91.245


[[Page 444]]





 Subpart D_Reconsideration of Adverse Determinations_Deeming Authority 
for Accreditation Organizations and CLIA Exemption of Laboratories Under 
                             State Programs

    Source: 57 FR 34012, July 31, 1992, unless otherwise noted.



Sec.  488.201  Reconsideration.

    (a) Right to reconsideration. (1) A national accreditation 
organization dissatisfied with a determination that its accreditation 
requirements do not provide (or do not continue to provide) reasonable 
assurance that the entities accredited by the accreditation organization 
meet the applicable long-term care requirements, conditions for 
coverage, conditions of certification, conditions of participation, or 
CLIA condition level requirements is entitled to a reconsideration as 
provided in this subpart.
    (2) A State dissatisfied with a determination that the requirements 
it imposes on laboratories in that State and under the laws of that 
State do not provide (or do not continue to provide) reasonable 
assurance that laboratories licensed or approved by the State meet 
applicable CLIA requirements is entitled to a reconsideration as 
provided in this subpart.
    (b) Eligibility for reconsideration. CMS will reconsider any 
determination to deny, remove or not renew the approval of deeming 
authority to private accreditation organizations, or any determination 
to deny, remove or not renew the approval of a State laboratory program 
for the purpose of exempting the State's laboratories from CLIA 
requirements, if the accreditation organization or State files a written 
request for a reconsideration in accordance with paragraphs (c) and (d) 
of this section.
    (c) Manner and timing of request for reconsideration. (1) A national 
accreditation organization or a State laboratory program described in 
paragraph (b), dissatisfied with a determination with respect to its 
deeming authority, or, in the case of a State, a determination with 
respect to the exemption of the laboratories in the State from CLIA 
requirements, may request a reconsideration of the determination by 
filing a request with CMS either directly by its authorized officials or 
through its legal representative. The request must be filed within 60 
days of the receipt of notice of an adverse determination or nonrenewal 
as provided in subpart A of part 488 or subpart E of part 493, as 
applicable.
    (2) Reconsideration procedures are available after the effective 
date of the decision to deny, remove, or not renew the approval of an 
accreditation organization or State laboratory program.
    (d) Content of request. The request for reconsideration must specify 
the findings or issues with which the accreditation organization or 
State disagrees and the reasons for the disagreement.

[57 FR 34012, July 31, 1992, as amended at 58 FR 61843, Nov. 23, 1993]



Sec.  488.203  Withdrawal of request for reconsideration.

    A requestor may withdraw its request for reconsideration at any time 
before the issuance of a reconsideration determination.



Sec.  488.205  Right to informal hearing.

    In response to a request for reconsideration, CMS will provide the 
accreditation organization or the State laboratory program the 
opportunity for an informal hearing as described in Sec.  488.207 that 
will--
    (a) Be conducted by a hearing officer appointed by the Administrator 
of CMS; and
    (b) Provide the accreditation organization or State laboratory 
program the opportunity to present, in writing or in person, evidence or 
documentation to refute the determination to deny approval, or to 
withdraw or not renew deeming authority or the exemption of a State's 
laboratories from CLIA requirements.



Sec.  488.207  Informal hearing procedures.

    (a) CMS will provide written notice of the time and place of the 
informal hearing at least 10 days before the scheduled date.
    (b) The informal reconsideration hearing will be conducted in 
accordance with the following procedures--

[[Page 445]]

    (1) The hearing is open to CMS and the organization requesting the 
reconsideration, including--
    (i) Authorized representatives;
    (ii) Technical advisors (individuals with knowledge of the facts of 
the case or presenting interpretation of the facts); and
    (iii) Legal counsel;
    (2) The hearing is conducted by the hearing officer who receives 
testimony and documents related to the proposed action;
    (3) Testimony and other evidence may be accepted by the hearing 
officer even though it would be inadmissable under the usual rules of 
court procedures;
    (4) Either party may call witnesses from among those individuals 
specified in paragraph (b)(1) of this section; and
    (5) The hearing officer does not have the authority to compel by 
subpoena the production of witnesses, papers, or other evidence.



Sec.  488.209  Hearing officer's findings.

    (a) Within 30 days of the close of the hearing, the hearing officer 
will present the findings and recommendations to the accreditation 
organization or State laboratory program that requested the 
reconsideration.
    (b) The written report of the hearing officer will include--
    (1) Separate numbered findings of fact; and
    (2) The legal conclusions of the hearing officer.



Sec.  488.211  Final reconsideration determination.

    (a) The hearing officer's decision is final unless the 
Administrator, within 30 days of the hearing officer's decision, chooses 
to review that decision.
    (b) The Administrator may accept, reject or modify the hearing 
officer's findings.
    (c) Should the Administrator choose to review the hearing officer's 
decision, the Administrator will issue a final reconsideration 
determination to the accreditation organization or State laboratory 
program on the basis of the hearing officer's findings and 
recommendations and other relevant information.
    (d) The reconsideration determination of the Administrator is final.
    (e) A final reconsideration determination against an accreditation 
organization or State laboratory program will be published by CMS in the 
Federal Register.



     Subpart E_Survey and Certification of Long-Term Care Facilities

    Source: 59 FR 56238, Nov. 10, 1994, unless otherwise noted.



Sec.  488.300  Statutory basis.

    Sections 1819 and 1919 of the Act establish requirements for 
surveying SNFs and NFs to determine whether they meet the requirements 
for participation in the Medicare and Medicaid programs.



Sec.  488.301  Definitions.

    As used in this subpart--
    Abbreviated standard survey means a survey other than a standard 
survey that gathers information primarily through resident-centered 
techniques on facility compliance with the requirements for 
participation. An abbreviated standard survey may be premised on 
complaints received; a change of ownership, management, or director of 
nursing; or other indicators of specific concern.
    Abuse means the willful infliction of injury, unreasonable 
confinement, intimidation, or punishment with resulting physical harm, 
pain or mental anguish.
    Deficiency means a SNF's or NF's failure to meet a participation 
requirement specified in the Act or in part 483, subpart B of this 
chapter.
    Dually participating facility means a facility that has a provider 
agreement in both the Medicare and Medicaid programs.
    Extended survey means a survey that evaluates additional 
participation requirements subsequent to finding substandard quality of 
care during a standard survey.
    Facility means a SNF or NF, or a distinct part SNF or NF, in 
accordance with Sec.  483.5 of this chapter.

[[Page 446]]

    Immediate family means husband or wife; natural or adoptive parent, 
child or sibling; stepparent, stepchild, stepbrother, or stepsister; 
father-in-law, mother-in-law, son-in-law, daughter-in-law, brother-in-
law, or sister-in-law; grandparent or grandchild.
    Immediate jeopardy means a situation in which the provider's 
noncompliance with one or more requirements of participation has caused, 
or is likely to cause, serious injury, harm, impairment, or death to a 
resident.
    Misappropriation of resident property means the deliberate 
misplacement, exploitation, or wrongful, temporary or permanent use of a 
resident's belongings or money without the resident's consent.
    Neglect means failure to provide goods and services necessary to 
avoid physical harm, mental anguish, or mental illness.
    Noncompliance means any deficiency that causes a facility to not be 
in substantial compliance.
    Nurse aide means an individual, as defined in Sec.  483.75(e)(1) of 
this chapter.
    Nursing facility (NF) means a Medicaid nursing facility.
    Paid feeding assistant means an individual who meets the 
requirements specified in Sec.  483.35(h)(2) of this chapter and who is 
paid to feed residents by a facility, or who is used under an 
arrangement with another agency or organization.
    Partial extended survey means a survey that evaluates additional 
participation requirements subsequent to finding substandard quality of 
care during an abbreviated standard survey.
    Skilled nursing facility (SNF) means a Medicare nursing facility.
    Standard survey means a periodic, resident-centered inspection which 
gathers information about the quality of service furnished in a facility 
to determine compliance with the requirements for participation.
    Substandard quality of care means one or more deficiencies related 
to participation requirements under Sec.  483.13, Resident behavior and 
facility practices, Sec.  483.15, Quality of life, or Sec.  483.25, 
Quality of care of this chapter, which constitute either immediate 
jeopardy to resident health or safety; a pattern of or widespread actual 
harm that is not immediate jeopardy; or a widespread potential for more 
than minimal harm, but less than immediate jeopardy, with no actual 
harm.
    Substantial compliance means a level of compliance with the 
requirements of participation such that any identified deficiencies pose 
no greater risk to resident health or safety than the potential for 
causing minimal harm.
    Validation survey means a survey conducted by the Secretary within 2 
months following a standard survey, abbreviated standard survey, partial 
extended survey, or extended survey for the purpose of monitoring State 
survey agency performance.

[59 FR 56238, Nov. 10, 1994, as amended at 68 FR 55539, Sept. 26, 2003]



Sec.  488.303  State plan requirement.

    (a) A State plan must provide that the requirements of this subpart 
and subpart F of this part are met, to the extent that those 
requirements apply to the Medicaid program.
    (b) A State may establish a program to reward, through public 
recognition, incentive payments, or both, nursing facilities that 
provide the highest quality care to Medicaid residents. For purposes of 
section 1903(a)(7) of the Social Security Act, proper expenses incurred 
by a State in carrying out such a program are considered to be expenses 
necessary for the proper and efficient administration of the State plan.
    (c) A State must conduct periodic educational programs for the staff 
and residents (and their representatives) of NFs in order to present 
current regulations, procedures, and policies under this subpart and 
subpart F of this part.
    (d) Required remedies for a non-State operated NF. A State must 
establish, in addition to termination of the provider agreement, the 
following remedies or an approved alternative to the following remedies 
for imposition against a non-State operated NF:
    (1) Temporary management.
    (2) Denial of payment for new admissions.
    (3) Civil money penalties.
    (4) Transfer of residents.
    (5) Closure of the facility and transfer of residents.
    (6) State monitoring.

[[Page 447]]

    (e) Optional remedies for a non-State operated NF. A State may 
establish the following remedies for imposition against a non-State 
operated NF:
    (1) Directed plan of correction.
    (2) Directed in-service training.
    (3) Alternative or additional State remedies.
    (f) Alternative or additional State remedies. If a State uses 
remedies that are in addition to those specified in paragraph (d) or (e) 
of this section, or alternative to those specified in paragraph (d) of 
this section (other than termination of participation), it must--
    (1) Specify those remedies in the State plan; and
    (2) Demonstrate to CMS's satisfaction that those alternative 
remedies are as effective in deterring noncompliance and correcting 
deficiencies as the remedies listed in paragraphs (d) and (e) of this 
section.

[59 FR 56238, Nov. 10, 1994; 60 FR 50118, Sept. 28, 1995]



Sec.  488.305  Standard surveys.

    (a) For each SNF and NF, the State survey agency must conduct 
standard surveys that include all of the following:
    (1) A case-mix stratified sample of residents;
    (2) A survey of the quality of care furnished, as measured by 
indicators of medical, nursing, and rehabilitative care, dietary and 
nutrition services, activities and social participation, and sanitation, 
infection control, and the physical environment;
    (3) An audit of written plans of care and residents' assessments to 
determine the accuracy of such assessments and the adequacy of such 
plans of care; and
    (4) A review of compliance with residents' rights requirements set 
forth in sections 1819(c) and 1919(c) of the Act.
    (b) The State survey agency's failure to follow the procedures set 
forth in this section will not invalidate otherwise legitimate 
determinations that a facility's deficiencies exist.



Sec.  488.307  Unannounced surveys.

    (a) Basic rule. All standard surveys must be unannounced.
    (b) Review of survey agency's scheduling and surveying procedures. 
(1) CMS reviews on an annual basis each State survey agency's scheduling 
and surveying procedures and practices to ensure that survey agencies 
avoid giving notice of a survey through the scheduling procedures and 
the conduct of the surveys.
    (2) CMS takes corrective action in accordance with the nature and 
complexity of the problem when survey agencies are found to have 
notified a SNF or NF through their scheduling or procedural policies. 
Sanctions for inadequate survey performance are in accordance with Sec.  
488.320.
    (c) Civil money penalties. An individual who notifies a SNF or NF, 
or causes a SNF or NF to be notified, of the time or date on which a 
standard survey is scheduled to be conducted is subject to a Federal 
civil money penalty not to exceed $2,000.



Sec.  488.308  Survey frequency.

    (a) Basic period. The survey agency must conduct a standard survey 
of each SNF and NF not later than 15 months after the last day of the 
previous standard survey.
    (b) Statewide average interval. (1) The statewide average interval 
between standard surveys must be 12 months or less, computed in 
accordance with paragraph (d) of this section.
    (2) CMS takes corrective action in accordance with the nature of the 
State survey agency's failure to ensure that the 12-month statewide 
average interval requirement is met. CMS's corrective action is in 
accordance with Sec.  488.320.
    (c) Other surveys. The survey agency may conduct a survey as 
frequently as necessary to--
    (1) Determine whether a facility complies with the participation 
requirements; and
    (2) Confirm that the facility has corrected deficiencies previously 
cited.
    (d) Computation of statewide average interval. The statewide average 
interval is computed at the end of each Federal fiscal year by comparing 
the last day of the most recent standard survey for each participating 
facility to the last day of each facility's previous standard survey.

[[Page 448]]

    (e) Special surveys. (1) The survey agency may conduct a standard or 
an abbreviated standard survey to determine whether certain changes have 
caused a decline in the quality of care furnished by a SNF or a NF, 
within 60 days of a change in the following:
    (i) Ownership;
    (ii) Entity responsible for management of a facility (management 
firm);
    (iii) Nursing home administrator; or
    (iv) Director of nursing.
    (2) The survey agency must review all complaint allegations and 
conduct a standard or an abbreviated standard survey to investigate 
complaints of violations of requirements by SNFs and NFs if its review 
of the allegation concludes that--
    (i) A deficiency in one or more of the requirements may have 
occurred; and
    (ii) Only a survey can determine whether a deficiency or 
deficiencies exist.
    (3) The survey agency does not conduct a survey if the complaint 
raises issues that are outside the purview of Federal participation 
requirements.



Sec.  488.310  Extended survey.

    (a) Purpose of survey. The purpose of an extended survey is to 
identify the policies and procedures that caused the facility to furnish 
substandard quality of care.
    (b) Scope of extended survey. An extended survey includes all of the 
following:
    (1) Review of a larger sample of resident assessments than the 
sample used in a standard survey.
    (2) Review of the staffing and in-service training.
    (3) If appropriate, examination of the contracts with consultants.
    (4) A review of the policies and procedures related to the 
requirements for which deficiencies exist.
    (5) Investigation of any participation requirement at the discretion 
of the survey agency.
    (c) Timing and basis for survey. The survey agency must conduct an 
extended survey not later than 14 calendar days after completion of a 
standard survey which found that the facility had furnished substandard 
quality of care.



Sec.  488.312  Consistency of survey results.

    CMS does and the survey agency must implement programs to measure 
accuracy and improve consistency in the application of survey results 
and enforcement remedies.



Sec.  488.314  Survey teams.

    (a) Team composition. (1) Surveys must be conducted by an 
interdisciplinary team of professionals, which must include a registered 
nurse.
    (2) Examples of professionals include, but are not limited to, 
physicians, physician assistants, nurse practitioners, physical, speech, 
or occupational therapists, registered professional nurses, dieticians, 
sanitarians, engineers, licensed practical nurses, or social workers.
    (3) The State determines what constitutes a professional, subject to 
CMS approval.
    (4) Any of the following circumstances disqualifies a surveyor for 
surveying a particular facility:
    (i) The surveyor currently works, or, within the past two years, has 
worked as an employee, as employment agency staff at the facility, or as 
an officer, consultant, or agent for the facility to be surveyed.
    (ii) The surveyor has any financial interest or any ownership 
interest in the facility.
    (iii) The surveyor has an immediate family member who has a 
relationship with a facility described in paragraphs (a)(4)(i) or 
paragraph (a)(4)(ii) of this section.
    (iv) The surveyor has an immediate family member who is a resident 
in the facility to be surveyed. For purposes of this section, an 
immediate family member is defined at Sec.  488.301 of this part.
    (b) CMS training. CMS provides comprehensive training to surveyors, 
including at least the following:
    (1) Application and interpretation of regulations for SNFs and NFs.
    (2) Techniques and survey procedures for conducting standard and 
extended surveys.
    (3) Techniques for auditing resident assessments and plans of care.
    (c) Required surveyor training. (1) Except as specified in paragraph 
(c)(3) of

[[Page 449]]

this section, the survey agency may not permit an individual to serve as 
a member of a survey team unless the individual has successfully 
completed a training and testing program prescribed by the Secretary.
    (2) The survey agency must have a mechanism to identify and respond 
to in-service training needs of the surveyors.
    (3) The survey agency may permit an individual who has not completed 
a training program to participate in a survey as a trainee if 
accompanied on-site by a surveyor who has successfully completed the 
required training and testing program.

[59 FR 56238, Nov. 10, 1994; 60 FR 50118, Sept. 28, 1995]



Sec.  488.318  Inadequate survey performance.

    (a) CMS considers survey performance to be inadequate if the State 
survey agency--
    (1) Indicates a pattern of failure to--
    (i) Identify deficiencies and the failure cannot be explained by 
changed conditions in the facility or other case specific factors;
    (ii) Cite only valid deficiencies;
    (iii) Conduct surveys in accordance with the requirements of this 
subpart; or
    (iv) Use Federal standards, protocols, and the forms, methods and 
procedures specified by CMS in manual instructions; or
    (2) Fails to identify an immediate jeopardy situation.
    (b) Inadequate survey performance does not--
    (1) Relieve a SNF or NF of its obligation to meet all requirements 
for program participation; or
    (2) Invalidate adequately documented deficiencies.



Sec.  488.320  Sanctions for inadequate survey performance.

    (a) Annual assessment of survey performance. CMS assesses the 
performance of the State's survey and certification program annually.
    (b) Sanctions for inadequate survey performance. When a State 
demonstrates inadequate survey performance, as specified in Sec.  
488.318, CMS notifies the survey agency of the inadequacy and takes 
action in accordance with paragraphs (c) and (d) of this section.
    (c) Medicaid facilities. (1) For a pattern of failure to identify 
deficiencies in Medicaid facilities, CMS--
    (i) Reduces FFP, as specified in paragraph (e) of this section, and 
if appropriate;
    (ii) Provides for training of survey teams.
    (2) For other survey inadequacies in Medicaid facilities, CMS 
provides for training of survey teams.
    (d) Medicare facilities. For all survey inadequacies in Medicare 
facilities, CMS--
    (1) Requires that the State survey agency submit a plan of 
correction;
    (2) Provides for training of survey teams;
    (3) Provides technical assistance on scheduling and procedural 
policies;
    (4) Provides CMS-directed scheduling; or
    (5) Initiates action to terminate the agreement between the 
Secretary and the State under section 1864 of the Act, either in whole 
or in part.
    (e) Reduction of FFP. In reducing FFP for inadequate survey 
performance, CMS uses the formula specified in section 1919(g)(3)(C) of 
the Act, that is 33 percent multiplied by a fraction--
    (1) The numerator of which is equal to the total number of residents 
in the NFs that CMS found to be noncompliant during validation surveys 
for that quarter; and
    (2) The denominator of which is equal to the total number of 
residents in the NFs in which CMS conducted validation surveys during 
that quarter.
    (f) Appeal of FFP reduction. When a State is dissatisfied with CMS's 
determination to reduce FFP, the State may appeal the determination to 
the Departmental Appeals Board, using the procedures specified in 45 CFR 
part 16.



Sec.  488.325  Disclosure of results of surveys and activities.

    (a) Information which must be provided to public. As provided in 
sections 1819(g)(5) and 1919(g)(5) of the Act, the following information 
must be made available to the public, upon the public's request, by the 
State or CMS for all surveys and certifications of SNFs and NFs:

[[Page 450]]

    (1) Statements of deficiencies and providers' comments.
    (2) A list of isolated deficiencies that constitute no actual harm, 
with the potential for minimal harm.
    (3) Approved plans of correction.
    (4) Statements that the facility did not submit an acceptable plan 
of correction or failed to comply with the conditions of imposed 
remedies.
    (5) Final appeal results.
    (6) Notice of termination of a facility.
    (7) Medicare and Medicaid cost reports.
    (8) Names of individuals with direct or indirect ownership interest 
in a SNF or NF, as defined in Sec.  420.201 of this chapter.
    (9) Names of individuals with direct or indirect ownership interest 
in a SNF or NF, as defined in Sec.  420.201 of this chapter, who have 
been found guilty by a court of law of a criminal offense in violation 
of Medicare or Medicaid law.
    (b) Charge to public for information. CMS and the State may charge 
the public for specified services with respect to requests for 
information in accordance with--
    (1) Section 401.140 of this chapter, for Medicare; or
    (2) State procedures, for Medicaid.
    (c) How public can request information. The public may request 
information in accordance with disclosure procedures specified in 45 CFR 
part 5.
    (d) When information must be disclosed. The disclosing agency must 
make available to the public, upon the public's request, information 
concerning all surveys and certifications of SNFs and NFs, including 
statements of deficiencies, separate listings of any isolated 
deficiencies that constitute no actual harm, with the potential for 
minimal harm, and plans of correction (which contain any provider 
response to the deficiency statement) within 14 calendar days after each 
item is made available to the facility.
    (e) Procedures for responding to requests. The procedures and time 
periods for responding to requests are in accordance with--
    (1) Section 401.136 of this chapter for documents maintained by CMS; 
and
    (2) State procedures for documents maintained by the State.
    (f) Information that must be provided to the State's long-term care 
ombudsman. The State must provide the State's long-term care ombudsman 
with the following:
    (1) A statement of deficiencies reflecting facility noncompliance, 
including a separate list of isolated deficiencies that constitute no 
harm with the potential for minimal harm.
    (2) Reports of adverse actions specified at Sec.  488.406 imposed on 
a facility.
    (3) Written response by the provider.
    (4) A provider's request for an appeal and the results of any 
appeal.
    (g) Information which must be provided to State by a facility with 
substandard quality of care. (1) To provide for the notice to physicians 
required under sections 1819(g)(5)(C) and 1919(g)(5)(C) of the Act, not 
later than 10 working days after receiving a notice of substandard 
quality of care, a SNF or NF must provide the State with a list of--
    (i) Each resident in the facility with respect to which such finding 
was made; and
    (ii) The name and address of his or her attending physician.
    (2) Failure to disclose the information timely will result in 
termination of participation or imposition of alternative remedies.
    (h) Information the State must provide to attending physician and 
State board. Not later than 20 calendar days after a SNF or NF complies 
with paragraph (g) of this section, the State must provide written 
notice of the noncompliance to--
    (1) The attending physician of each resident in the facility with 
respect to which a finding of substandard quality of care was made; and
    (2) The State board responsible for licensing the facility's 
administrator.
    (i) Access to information by State Medicaid fraud control unit. The 
State must provide access to any survey and certification information 
incidental to a SNF's or NF's participation in Medicare or Medicaid upon 
written request by the State Medicaid fraud control unit established 
under part 1007, of this title, consistent with current State laws.

[59 FR 56238, Nov. 10, 1994; 60 FR 50118, Sept. 28, 1995]

[[Page 451]]



Sec.  488.330  Certification of compliance or noncompliance.

    (a) General rules--(1) Responsibility for certification. (i) The 
State survey agency surveys all facilities for compliance or 
noncompliance with requirements for long term care facilities. The 
survey by the State survey agency may be followed by a Federal 
validation survey.
    (A) The State certifies the compliance or noncompliance of non-State 
operated NFs. Regardless of the State entity doing the certification, it 
is final, except in the case of a complaint or validation survey 
conducted by CMS, or CMS review of the State's findings.
    (B) CMS certifies the compliance or noncompliance of all State-
operated facilities.
    (C) The State survey agency certifies the compliance or 
noncompliance of a non-State operated SNF, subject to the approval of 
CMS.
    (D) The State survey agency certifies compliance or noncompliance 
for a dually participating SNF/NF. In the case of a disagreement between 
CMS and the State survey agency, a finding of noncompliance takes 
precedence over that of compliance.
    (ii) In the case of a validation survey, the Secretary's 
determination as to the facility's noncompliance is binding, and takes 
precedence over a certification of compliance resulting from the State 
survey.
    (2) Basis for certification. (i) Certification by the State is based 
on the survey agency findings.
    (ii) Certification by CMS is based on either the survey agency 
findings (in the case of State-operated facilities), or, in the case of 
a validation survey, on CMS's own survey findings.
    (b) Effect of certification--(1) Certification of compliance. A 
certification of compliance constitutes a determination that the 
facility is in substantial compliance and is eligible to participate in 
Medicaid as a NF, or in Medicare as a SNF, or in Medicare and Medicaid 
as a dually participating facility.
    (2) Certification of noncompliance. A certification of noncompliance 
requires denial of participation for prospective providers and 
enforcement action for current providers in accordance with subpart F of 
this part. Enforcement action must include one of the following:
    (i) Termination of any Medicare or Medicaid provider agreements that 
are in effect.
    (ii) Application of alternative remedies instead of, or in addition 
to, termination procedures.
    (c) Notice of certification of noncompliance and resulting action. 
The notice of certification of noncompliance is sent in accordance with 
the timeframes specified in Sec.  488.402(f), and resulting action is 
issued by CMS, except when the State is taking the action for a non-
State operated NF.
    (d) Content of notice of certification of noncompliance. The notice 
of certification of noncompliance is sent in accordance with the 
timeframes specified in Sec.  488.402(f) and includes information on all 
of the following:
    (1) Nature of noncompliance.
    (2) Any alternative remedies to be imposed under subpart F of this 
part.
    (3) Any termination or denial of participation action to be taken 
under this part.
    (4) The appeal rights available to the facility under this part.
    (5) Timeframes to be met by the provider and certifying agency with 
regard to each of the enforcement actions or appeal procedures addressed 
in the notice.
    (e) Appeals. (1) Notwithstanding any provision of State law, the 
State must impose remedies promptly on any provider of services 
participating in the Medicaid program--
    (i) After promptly notifying the facility of the deficiencies and 
impending remedy or remedies; and
    (ii) Except for civil money penalties, during any pending hearing 
that may be requested by the provider of services.
    (2) CMS imposes remedies promptly on any provider of services 
participating in the Medicare or Medicaid program or any provider of 
services participating in both the Medicare and Medicaid programs--
    (i) After promptly notifying the facility of the deficiencies and 
impending remedy or remedies; and
    (ii) Except for civil money penalties, during any pending hearing 
that may

[[Page 452]]

be requested by the provider of services.
    (3) The provisions of part 498 of this chapter apply when the 
following providers request a hearing on a denial of participation, or 
certification of noncompliance leading to an enforcement remedy 
(including termination of the provider agreement), except State 
monitoring:
    (i) All State-operated facilities;
    (ii) SNFs and dually participating SNF/NFs; and
    (iii) Any other facilities subject to a CMS validation survey or CMS 
review of the State's findings.
    (4) The provisions of part 431 of this chapter apply when a non-
State operated Medicaid NF, which has not received a CMS validation 
survey or CMS review of the State's findings, requests a hearing on the 
State's denial of participation, termination of provider agreement, or 
certification of noncompliance leading to an alternative remedy, except 
State monitoring.
    (f) Provider agreements. CMS or the Medicaid agency may execute a 
provider agreement when a prospective provider is in substantial 
compliance with all the requirements for participation for a SNF or NF, 
respectively.
    (g) Special rules for Federal validation surveys. (1) CMS may make 
independent certifications of a NF's, SNF's, or dually participating 
facility's noncompliance based on a CMS validation survey.
    (2) CMS issues the notice of actions affecting facilities for which 
CMS did validation surveys.
    (3) For non-State-operated NFs and non-State-operated dually 
participating facilities, any disagreement between CMS and the State 
regarding the timing and choice of remedies is resolved in accordance 
with Sec.  488.452.
    (4) Either CMS or the survey agency, at CMS's option, may revisit 
the facility to ensure that corrections are made.

[59 FR 56238, Nov. 10, 1994; 60 FR 50118, Sept. 28, 1995]



Sec.  488.331  Informal dispute resolution.

    (a) Opportunity to refute survey findings. (1) For non-Federal 
surveys, the State must offer a facility an informal opportunity, at the 
facility's request, to dispute survey findings upon the facility's 
receipt of the official statement of deficiencies.
    (2) For Federal surveys, CMS offers a facility an informal 
opportunity, at the facility's request, to dispute survey findings upon 
the facility's receipt of the official statement of deficiencies.
    (b)(1) Failure of the State or CMS, as appropriate, to complete 
informal dispute resolution timely cannot delay the effective date of 
any enforcement action against the facility.
    (2) A facility may not seek a delay of any enforcement action 
against it on the grounds that informal dispute resolution has not been 
completed before the effective date of the enforcement action.
    (c) If a provider is subsequently successful, during the informal 
dispute resolution process, at demonstrating that deficiencies should 
not have been cited, the deficiencies are removed from the statement of 
deficiencies and any enforcement actions imposed solely as a result of 
those cited deficiencies are rescinded.
    (d) Notification. Upon request, CMS does and the State must provide 
the facility with written notification of the informal dispute 
resolution process.



Sec.  488.332  Investigation of complaints of violations and monitoring of compliance.

    (a) Investigation of complaints. (1) The State survey agency must 
establish procedures and maintain adequate staff to investigate 
complaints of violations of participation requirements.
    (2) The State survey agency takes appropriate precautions to protect 
a complainant's anonymity and privacy, if possible.
    (3) If arrangements have been made with other State components for 
investigation of complaints, the State must have a means of 
communicating information among appropriate entities, and the State 
survey agency retains responsibility for the investigation process.
    (4) If, after investigating a complaint, the State has reason to 
believe that an identifiable individual neglected or abused a resident, 
or misappropriated a resident's property, the

[[Page 453]]

State survey agency must act on the complaint in accordance with Sec.  
488.335.
    (b) On-site monitoring. The State survey agency conducts on-site 
monitoring on an as necessary basis when--
    (1) A facility is not in substantial compliance with the 
requirements and is in the process of correcting deficiencies;
    (2) A facility has corrected deficiencies and verification of 
continued substantial compliance is needed; or
    (3) The survey agency has reason to question the substantial 
compliance of the facility with a requirement of participation.
    (c) Composition of the investigative team. A State may use a 
specialized team, which may include an attorney, auditor and appropriate 
health professionals, to identify, survey, gather and preserve evidence, 
and administer remedies to noncompliant facilities.



Sec.  488.334  Educational programs.

    A State must conduct periodic educational programs for the staff and 
residents (and their representatives) of SNFs and NFs in order to 
present current regulations, procedures, and policies on the survey, 
certification and enforcement process under this subpart and subpart F 
of this part.



Sec.  488.335  Action on complaints of resident neglect and abuse, and misappropriation of resident property.

    (a) Investigation. (1) The State must review all allegations of 
resident neglect and abuse, and misappropriation of resident property 
and follow procedures specified in Sec.  488.332.
    (2) If there is reason to believe, either through oral or written 
evidence that an individual used by a facility to provide services to 
residents could have abused or neglected a resident or misappropriated a 
resident's property, the State must investigate the allegation.
    (3) The State must have written procedures for the timely review and 
investigation of allegations of resident abuse and neglect, and 
misappropriation of resident property.
    (b) Source of complaints. The State must review all allegations 
regardless of the source.
    (c) Notification--(1) Individuals to be notified. If the State makes 
a preliminary determination, based on oral or written evidence and its 
investigation, that the abuse, neglect or misappropriation of property 
occurred, it must notify in writing--
    (i) The individuals implicated in the investigation; and
    (ii) The current administrator of the facility in which the incident 
occurred.
    (2) Timing of the notice. The State must notify the individuals 
specified in paragraph (c)(1) of this section in writing within 10 
working days of the State's investigation.
    (3) Contents of the notice. The notice must include the--
    (i) Nature of the allegation(s);
    (ii) Date and time of the occurrence;
    (iii) Right to a hearing;
    (iv) Intent to report the substantiated findings in writing, once 
the individual has had the opportunity for a hearing, to the nurse aide 
registry or appropriate licensure authority;
    (v) Fact that the individual's failure to request a hearing in 
writing within 30 days from the date of the notice will result in 
reporting the substantiated findings to the nurse aide registry or 
appropriate licensure authority.
    (vi) Consequences of waiving the right to a hearing;
    (vii) Consequences of a finding through the hearing process that the 
alleged resident abuse or neglect, or misappropriation of resident 
property did occur; and
    (viii) Fact that the individual has the right to be represented by 
an attorney at the individual's own expense.
    (d) Conduct of hearing. (1) The State must complete the hearing and 
the hearing record within 120 days from the day it receives the request 
for a hearing.
    (2) The State must hold the hearing at a reasonable place and time 
convenient for the individual.
    (e) Factors beyond the individual's control. A State must not make a 
finding that an individual has neglected a resident if the individual 
demonstrates that such neglect was caused by factors beyond the control 
of the individual.
    (f) Report of findings. If the finding is that the individual has 
neglected or abused a resident or misappropriated resident property or 
if the individual waives the right to a hearing, the State

[[Page 454]]

must report the findings in writing within 10 working days to--
    (1) The individual;
    (2) The current administrator of the facility in which the incident 
occurred; and
    (3) The administrator of the facility that currently employs the 
individual, if different than the facility in which the incident 
occurred;
    (4) The licensing authority for individuals used by the facility 
other than nurse aides, if applicable; and
    (5) The nurse aide registry for nurse aides. Only the State survey 
agency may report the findings to the nurse aide registry, and this must 
be done within 10 working days of the findings, in accordance with Sec.  
483.156(c) of this chapter. The State survey agency may not delegate 
this responsibility.
    (g) Contents and retention of report of finding to the nurse aide 
registry. (1) The report of finding must include information in 
accordance with Sec.  483.156(c) of this chapter.
    (2) The survey agency must retain the information as specified in 
paragraph (g)(1) of this section, in accordance with the procedures 
specified in Sec.  483.156(c) of this chapter.
    (h) Survey agency responsibility. (1) The survey agency must 
promptly review the results of all complaint investigations and 
determine whether or not a facility has violated any requirements in 
part 483, subpart B of this chapter.
    (2) If a facility is not in substantial compliance with the 
requirements in part 483, subpart B of this chapter, the survey agency 
initiates appropriate actions, as specified in subpart F of this part.

[59 FR 56238, Nov. 10, 1994; 60 FR 50118, Sept. 28, 1995]



 Subpart F_Enforcement of Compliance for Long-Term Care Facilities with 
                              Deficiencies

    Source: 59 FR 56243, Nov. 10, 1994, unless otherwise noted.



Sec.  488.400  Statutory basis.

    Sections 1819(h) and 1919(h) of the Act specify remedies that may be 
used by the Secretary or the State respectively when a SNF or a NF is 
not in substantial compliance with the requirements for participation in 
the Medicare and Medicaid programs. These sections also provide for 
ensuring prompt compliance and specify that these remedies are in 
addition to any others available under State or Federal law, and, except 
for civil money penalties, are imposed prior to the conduct of a 
hearing.



Sec.  488.401  Definitions.

    As used in this subpart--
    New admission means a resident who is admitted to the facility on or 
after the effective date of a denial of payment remedy and, if 
previously admitted, has been discharged before that effective date. 
Residents admitted before the effective date of the denial of payment, 
and taking temporary leave, are not considered new admissions, nor 
subject to the denial of payment.
    Plan of correction means a plan developed by the facility and 
approved by CMS or the survey agency that describes the actions the 
facility will take to correct deficiencies and specifies the date by 
which those deficiencies will be corrected.

[59 FR 56243, Nov. 10, 1994; 60 FR 50118, Sept. 28, 1995]



Sec.  488.402  General provisions.

    (a) Purpose of remedies. The purpose of remedies is to ensure prompt 
compliance with program requirements.
    (b) Basis for imposition and duration of remedies. When CMS or the 
State chooses to apply one or more remedies specified in Sec.  488.406, 
the remedies are applied on the basis of noncompliance found during 
surveys conducted by CMS or by the survey agency.
    (c) Number of remedies. CMS or the State may apply one or more 
remedies for each deficiency constituting noncompliance or for all 
deficiencies constituting noncompliance.
    (d) Plan of correction requirement. (1) Except as specified in 
paragraph (d)(2) of this section, regardless of which remedy is applied, 
each facility that has deficiencies with respect to program requirements 
must submit a plan of correction for approval by CMS or the survey 
agency.

[[Page 455]]

    (2) Isolated deficiencies. A facility is not required to submit a 
plan of correction when it has deficiencies that are isolated and have a 
potential for minimal harm, but no actual harm has occurred.
    (e) Disagreement regarding remedies. If the State and CMS disagree 
on the decision to impose a remedy, the disagreement is resolved in 
accordance with Sec.  488.452.
    (f) Notification requirements--(1) Except when the State is taking 
action against a non-State operated NF, CMS or the State (as authorized 
by CMS) gives the provider notice of the remedy, including the--
    (i) Nature of the noncompliance;
    (ii) Which remedy is imposed;
    (iii) Effective date of the remedy; and
    (iv) Right to appeal the determination leading to the remedy.
    (2) When a State is taking action against a non-State operated NF, 
the State's notice must include the same information required by CMS in 
paragraph (f)(1) of this section.
    (3) Immediate jeopardy--2 day notice. Except for civil money 
penalties and State monitoring imposed when there is immediate jeopardy, 
for all remedies specified in Sec.  488.406 imposed when there is 
immediate jeopardy, the notice must be given at least 2 calendar days 
before the effective date of the enforcement action.
    (4) No immediate jeopardy--15 day notice. Except for civil money 
penalties and State monitoring, notice must be given at least 15 
calendar days before the effective date of the enforcement action in 
situations in which there is no immediate jeopardy.
    (5) Date of enforcement action. The 2-and 15-day notice periods 
begin when the facility receives the notice.
    (6) Civil money penalties. For civil money penalties, the notices 
must be given in accordance with the provisions of Sec. Sec.  488.434 
and 488.440.
    (7) State monitoring. For State monitoring, no prior notice is 
required.

[59 FR 56243, Nov. 10, 1994; 60 FR 50118, Sept. 28, 1995, as amended at 
64 FR 13360, Mar. 18, 1999]



Sec.  488.404  Factors to be considered in selecting remedies.

    (a) Initial assessment. In order to select the appropriate remedy, 
if any, to apply to a facility with deficiencies, CMS and the State 
determine the seriousness of the deficiencies.
    (b) Determining seriousness of deficiencies. To determine the 
seriousness of the deficiency, CMS considers and the State must consider 
at least the following factors:
    (1) Whether a facility's deficiencies constitute--
    (i) No actual harm with a potential for minimal harm;
    (ii) No actual harm with a potential for more than minimal harm, but 
not immediate jeopardy;
    (iii) Actual harm that is not immediate jeopardy; or
    (iv) Immediate jeopardy to resident health or safety.
    (2) Whether the deficiencies--
    (i) Are isolated;
    (ii) Constitute a pattern; or
    (iii) Are widespread.
    (c) Other factors which may be considered in choosing a remedy 
within a remedy category. Following the initial assessment, CMS and the 
State may consider other factors, which may include, but are not limited 
to the following:
    (1) The relationship of the one deficiency to other deficiencies 
resulting in noncompliance.
    (2) The facility's prior history of noncompliance in general and 
specifically with reference to the cited deficiencies.



Sec.  488.406  Available remedies.

    (a) General. In addition to the remedy of termination of the 
provider agreement, the following remedies are available:
    (1) Temporary management.
    (2) Denial of payment including--
    (i) Denial of payment for all individuals, imposed by CMS, to a--
    (A) Skilled nursing facility, for Medicare;
    (B) State, for Medicaid; or
    (ii) Denial of payment for all new admissions.
    (3) Civil money penalties.
    (4) State monitoring.
    (5) Transfer of residents.
    (6) Closure of the facility and transfer of residents.

[[Page 456]]

    (7) Directed plan of correction.
    (8) Directed in-service training.
    (9) Alternative or additional State remedies approved by CMS.
    (b) Remedies that must be established. At a minimum, and in addition 
to termination of the provider agreement, the State must establish the 
following remedies or approved alternatives to the following remedies:
    (1) Temporary management.
    (2) Denial of payment for new admissions.
    (3) Civil money penalties.
    (4) Transfer of residents.
    (5) Closure of the facility and transfer of residents.
    (6) State monitoring.
    (c) State plan requirement. If a State wishes to use remedies for 
noncompliance that are either additional or alternative to those 
specified in paragraphs (a) or (b) of this section, it must--
    (1) Specify those remedies in the State plan; and
    (2) Demonstrate to CMS's satisfaction that those remedies are as 
effective as the remedies listed in paragraph (a) of this section, for 
deterring noncompliance and correcting deficiencies.
    (d) State remedies in dually participating facilities. If the 
State's remedy is unique to the State plan and has been approved by CMS, 
then that remedy, as imposed by the State under its Medicaid authority, 
may be imposed by CMS against the Medicare provider agreement of a 
dually participating facility.

[59 FR 56243, Nov. 10, 1994; 60 FR 50118, Sept. 28, 1995]



Sec.  488.408  Selection of remedies.

    (a) Categories of remedies. In this section, the remedies specified 
in Sec.  488.406(a) are grouped into categories and applied to 
deficiencies according to how serious the noncompliance is.
    (b) Application of remedies. After considering the factors specified 
in Sec.  488.404, as applicable, if CMS and the State choose to impose 
remedies, as provided in paragraphs (c)(1), (d)(1) and (e)(1) of this 
section, for facility noncompliance, instead of, or in addition to, 
termination of the provider agreement, CMS does and the State must 
follow the criteria set forth in paragraphs (c)(2), (d)(2), and (e)(2) 
of this section, as applicable.
    (c) Category 1. (1) Category 1 remedies include the following:
    (i) Directed plan of correction.
    (ii) State monitoring.
    (iii) Directed in-service training.
    (2) CMS does or the State must apply one or more of the remedies in 
Category 1 when there--
    (i) Are isolated deficiencies that constitute no actual harm with a 
potential for more than minimal harm but not immediate jeopardy; or
    (ii) Is a pattern of deficiencies that constitutes no actual harm 
with a potential for more than minimal harm but not immediate jeopardy.
    (3) Except when the facility is in substantial compliance, CMS or 
the State may apply one or more of the remedies in Category 1 to any 
deficiency.
    (d) Category 2. (1) Category 2 remedies include the following:
    (i) Denial of payment for new admissions.
    (ii) Denial of payment for all individuals imposed only by CMS.
    (iii) Civil money penalties of $50-3,000 per day.
    (iv) Civil money penalty of $1,000-$10,000 per instance of 
noncompliance.
    (2) CMS applies one or more of the remedies in Category 2, or, 
except for denial of payment for all individuals, the State must apply 
one or more of the remedies in Category 2 when there are--
    (i) Widespread deficiencies that constitute no actual harm with a 
potential for more than minimal harm but not immediate jeopardy; or
    (ii) One or more deficiencies that constitute actual harm that is 
not immediate jeopardy.
    (3) CMS or the State may apply one or more of the remedies in 
Category 2 to any deficiency except when--
    (i) The facility is in substantial compliance; or
    (ii) CMS or the State imposes a civil money penalty for a deficiency 
that constitutes immediate jeopardy, the penalty must be in the upper 
range of penalty amounts, as specified in Sec.  488.438(a).
    (e) Category 3. (1) Category 3 remedies include the following:
    (i) Temporary management.

[[Page 457]]

    (ii) Immediate termination.
    (iii) Civil money penalties of $3,050-$10,000 per day.
    (iv) Civil money penalty of $1,000-$10,000 per instance of 
noncompliance.
    (2) When there are one or more deficiencies that constitute 
immediate jeopardy to resident health or safety--
    (i) CMS does and the State must do one or both of the following:
    (A) Impose temporary management; or
    (B) Terminate the provider agreement;
    (ii) CMS and the State may impose a civil money penalty of $3,050-
$10,000 per day or $1,000-$10,000 per instance of noncompliance, in 
addition to imposing the remedies specified in paragraph (e)(2)(i) of 
this section.
    (3) When there are widespread deficiencies that constitute actual 
harm that is not immediate jeopardy, CMS and the State may impose 
temporary management, in addition to Category 2 remedies.
    (f) Plan of correction. (1) Except as specified in paragraph (f)(2) 
of this section, each facility that has a deficiency with regard to a 
requirement for long term care facilities must submit a plan of 
correction for approval by CMS or the State, regardless of--
    (i) Which remedies are imposed; or
    (ii) The seriousness of the deficiencies.
    (2) When there are only isolated deficiencies that CMS or the State 
determines constitute no actual harm with a potential for minimal harm, 
the facility need not submit a plan of correction.
    (g) Appeal of a certification of noncompliance. (1) A facility may 
appeal a certification of noncompliance leading to an enforcement 
remedy.
    (2) A facility may not appeal the choice of remedy, including the 
factors considered by CMS or the State in selecting the remedy, 
specified in Sec.  488.404.

[59 FR 56243, Nov. 10, 1994; 60 FR 50118, Sept. 28, 1995, as amended at 
64 FR 13360, Mar. 18, 1999]



Sec.  488.410  Action when there is immediate jeopardy.

    (a) If there is immediate jeopardy to resident health or safety, the 
State must (and CMS does) either terminate the provider agreement within 
23 calendar days of the last date of the survey or appoint a temporary 
manager to remove the immediate jeopardy. The rules for appointment of a 
temporary manager in an immediate jeopardy situation are as follows:
    (1) CMS does and the State must notify the facility that a temporary 
manager is being appointed.
    (2) If the facility fails to relinquish control to the temporary 
manager, CMS does and the State must terminate the provider agreement 
within 23 calendar days of the last day of the survey, if the immediate 
jeopardy is not removed. In these cases, State monitoring may be imposed 
pending termination.
    (3) If the facility relinquishes control to the temporary manager, 
the State must (and CMS does) notify the facility that, unless it 
removes the immediate jeopardy, its provider agreement will be 
terminated within 23 calendar days of the last day of the survey.
    (4) CMS does and the State must terminate the provider agreement 
within 23 calendar days of the last day of survey if the immediate 
jeopardy has not been removed.
    (b) CMS or the State may also impose other remedies, as appropriate.
    (c)(1) In a NF or dually participating facility, if either CMS or 
the State finds that a facility's noncompliance poses immediate jeopardy 
to resident health or safety, CMS or the State must notify the other of 
such a finding.
    (2) CMS will or the State must do one or both of the following:
    (i) Take immediate action to remove the jeopardy and correct the 
noncompliance through temporary management.
    (ii) Terminate the facility's participation under the State plan. If 
this is done, CMS will also terminate the facility's participation in 
Medicare if it is a dually participating facility.
    (d) The State must provide for the safe and orderly transfer of 
residents when the facility is terminated.
    (e) If the immediate jeopardy is also substandard quality of care, 
the State survey agency must notify attending

[[Page 458]]

physicians and the State board responsible for licensing the facility 
administrator of the finding of substandard quality of care, as 
specified in Sec.  488.325(h).

[59 FR 56243, Nov. 10, 1994; 60 FR 50118, Sept. 28, 1995]



Sec.  488.412  Action when there is no immediate jeopardy.

    (a) If a facility's deficiencies do not pose immediate jeopardy to 
residents' health or safety, and the facility is not in substantial 
compliance, CMS or the State may terminate the facility's provider 
agreement or may allow the facility to continue to participate for no 
longer than 6 months from the last day of the survey if--
    (1) The State survey agency finds that it is more appropriate to 
impose alternative remedies than to terminate the facility's provider 
agreement;
    (2) The State has submitted a plan and timetable for corrective 
action approved by CMS; and
    (3) The facility in the case of a Medicare SNF or the State in the 
case of a Medicaid NF agrees to repay to the Federal government payments 
received after the last day of the survey that first identified the 
deficiencies if corrective action is not taken in accordance with the 
approved plan of correction.
    (b) If a facility does not meet the criteria for continuation of 
payment under paragraph (a) of this section, CMS will and the State must 
terminate the facility's provider agreement.
    (c) CMS does and the State must deny payment for new admissions when 
a facility is not in substantial compliance 3 months after the last day 
of the survey.
    (d) CMS terminates the provider agreement for SNFs and NFs, and 
stops FFP to a State for a NF for which participation was continued 
under paragraph (a) of this section, if the facility is not in 
substantial compliance within 6 months of the last day of the survey.

[59 FR 56243, Nov. 10, 1994; 60 FR 50118, Sept. 28, 1995]



Sec.  488.414  Action when there is repeated substandard quality of care.

    (a) General. If a facility has been found to have provided 
substandard quality of care on the last three consecutive standard 
surveys, as defined in Sec.  488.305, regardless of other remedies 
provided--
    (1) CMS imposes denial of payment for all new admissions, as 
specified in Sec.  488.417, or denial of all payments, as specified in 
Sec.  488.418;
    (2) The State must impose denial of payment for all new admissions, 
as specified in Sec.  488.417; and
    (3) CMS does and the State survey agency must impose State 
monitoring, as specified in Sec.  488.422, until the facility has 
demonstrated to the satisfaction of CMS or the State, that it is in 
substantial compliance with all requirements and will remain in 
substantial compliance with all requirements.
    (b) Repeated noncompliance. For purposes of this section, repeated 
noncompliance is based on the repeated finding of substandard quality of 
care and not on the basis that the substance of the deficiency or the 
exact tag number for the deficiency was repeated.
    (c) Standard surveys to which this provision applies. Standard 
surveys completed by the State survey agency on or after October 1, 
1990, are used to determine whether the threshold of three consecutive 
standard surveys is met.
    (d) Program participation. (1) The determination that a certified 
facility has repeated instances of substandard quality of care is made 
without regard to any variances in the facility's program participation 
(that is, any standard survey completed for Medicare, Medicaid or both 
programs will be considered).
    (2) Termination would allow the count of repeated substandard 
quality of care surveys to start over.
    (3) Change of ownership. (i) A facility may not avoid a remedy on 
the basis that it underwent a change of ownership.
    (ii) In a facility that has undergone a change of ownership, CMS 
does not and the State may not restart the count of repeated substandard 
quality of care surveys unless the new owner can demonstrate to the 
satisfaction of CMS or the State that the poor past performance no 
longer is a factor due to the change in ownership.

[[Page 459]]

    (e) Facility alleges corrections or achieves compliance after 
repeated substandard quality of care is identified. (1) If a penalty is 
imposed for repeated substandard quality of care, it will continue until 
the facility has demonstrated to the satisfaction of CMS or the State 
that it is in substantial compliance with the requirements and that it 
will remain in substantial compliance with the requirements for a period 
of time specified by CMS or the State.
    (2) A facility will not avoid the imposition of remedies or the 
obligation to demonstrate that it will remain in compliance when it--
    (i) Alleges correction of the deficiencies cited in the most recent 
standard survey; or
    (ii) Achieves compliance before the effective date of the remedies.



Sec.  488.415  Temporary management.

    (a) Definition. Temporary management means the temporary appointment 
by CMS or the State of a substitute facility manager or administrator 
with authority to hire, terminate or reassign staff, obligate facility 
funds, alter facility procedures, and manage the facility to correct 
deficiencies identified in the facility's operation.
    (b) Qualifications. The temporary manager must--
    (1) Be qualified to oversee correction of deficiencies on the basis 
of experience and education, as determined by the State;
    (2) Not have been found guilty of misconduct by any licensing board 
or professional society in any State;
    (3) Have, or a member of his or her immediate family have, no 
financial ownership interest in the facility; and
    (4) Not currently serve or, within the past 2 years, have served as 
a member of the staff of the facility.
    (c) Payment of salary. The temporary manager's salary--
    (1) Is paid directly by the facility while the temporary manager is 
assigned to that facility; and
    (2) Must be at least equivalent to the sum of the following--
    (i) The prevailing salary paid by providers for positions of this 
type in what the State considers to be the facility's geographic area;
    (ii) Additional costs that would have reasonably been incurred by 
the provider if such person had been in an employment relationship; and
    (iii) Any other costs incurred by such a person in furnishing 
services under such an arrangement or as otherwise set by the State.
    (3) May exceed the amount specified in paragraph (c)(2) of this 
section if the State is otherwise unable to attract a qualified 
temporary manager.
    (d) Failure to relinquish authority to temporary management--(1) 
Termination of provider agreement. If a facility fails to relinquish 
authority to the temporary manager as described in this section, CMS 
will or the State must terminate the provider agreement in accordance 
with Sec.  488.456.
    (2) Failure to pay salary of temporary manager. A facility's failure 
to pay the salary of the temporary manager is considered a failure to 
relinquish authority to temporary management.
    (e) Duration of temporary management. Temporary management ends when 
the facility meets any of the conditions specified in Sec.  488.454(c).



Sec.  488.417  Denial of payment for all new admissions.

    (a) Optional denial of payment. Except as specified in paragraph (b) 
of this section, CMS or the State may deny payment for all new 
admissions when a facility is not in substantial compliance with the 
requirements, as defined in Sec.  488.401, as follows:
    (1) Medicare facilities. In the case of Medicare facilities, CMS may 
deny payment to the facility.
    (2) Medicaid facilities. In the case of Medicaid facilities--
    (i) The State may deny payment to the facility; and
    (ii) CMS may deny payment to the State for all new Medicaid 
admissions to the facility.
    (b) Required denial of payment. CMS does or the State must deny 
payment for all new admissions when--
    (1) The facility is not in substantial compliance, as defined in 
Sec.  488.401, 3 months after the last day of the survey identifying the 
noncompliance; or
    (2) The State survey agency has cited a facility with substandard 
quality of

[[Page 460]]

care on the last three consecutive standard surveys.
    (c) Resumption of payments: Repeated instances of substandard 
quality of care. When a facility has repeated instances of substandard 
quality of care, payments to the facility or, under Medicaid, CMS 
payments to the State on behalf of the facility, resume on the date 
that--
    (1) The facility achieves substantial compliance as indicated by a 
revisit or written credible evidence acceptable to CMS (for all 
facilities except non-State operated NFs against which CMS is imposing 
no remedies) or the State (for non-State operated NFs against which CMS 
is imposing no remedies); and
    (2) CMS (for all facilities except non-State operated NFs against 
which CMS is imposing no remedies) or the State (for non-State operated 
NFs against which CMS is imposing no remedies) believes that the 
facility is capable of remaining in substantial compliance.
    (d) Resumption of payments: No repeated instances of substandard 
quality of care. When a facility does not have repeated instances of 
substandard quality of care, payments to the facility or, under 
Medicaid, CMS payments to the State on behalf of the facility, resume 
prospectively on the date that the facility achieves substantial 
compliance, as indicated by a revisit or written credible evidence 
acceptable to CMS (under Medicare) or the State (under Medicaid).
    (e) Restriction. No payments to a facility or, under Medicaid, CMS 
payments to the State on behalf of the facility, are made for the period 
between the date that the--
    (1) Denial of payment remedy is imposed; and
    (2) Facility achieves substantial compliance, as determined by CMS 
or the State.

[59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept. 28, 1995]



Sec.  488.418  Secretarial authority to deny all payments.

    (a) CMS option to deny all payment. If a facility has not met a 
requirement, in addition to the authority to deny payment for all new 
admissions as specified in Sec.  488.417, CMS may deny any further 
payment for all Medicare residents in the facility and to the State for 
all Medicaid residents in the facility.
    (b) Prospective resumption of payment. Except as provided in 
paragraphs (d) and (e) of this section, if the facility achieves 
substantial compliance, CMS resumes payment prospectively from the date 
that it verifies as the date that the facility achieved substantial 
compliance.
    (c) Restriction on payment after denial of payment is imposed. If 
payment to the facility or to the State resumes after denial of payment 
for all residents, no payment is made for the period between the date 
that--
    (1) Denial of payment was imposed; and
    (2) CMS verifies as the date that the facility achieved substantial 
compliance.
    (d) Retroactive resumption of payment. Except when a facility has 
repeated instances of substandard quality of care, as specified in 
paragraph (e) of this section, when CMS or the State finds that the 
facility was in substantial compliance before the date of the revisit, 
or before CMS or the survey agency received credible evidence of such 
compliance, payment is resumed on the date that substantial compliance 
was achieved, as determined by CMS.
    (e) Resumption of payment--repeated instances of substandard care. 
When CMS denies payment for all Medicare residents for repeated 
instances of substandard quality of care, payment is resumed when--
    (1) The facility achieved substantial compliance, as indicated by a 
revisit or written credible evidence acceptable to CMS; and
    (2) CMS believes that the facility will remain in substantial 
compliance.



Sec.  488.422  State monitoring.

    (a) A State monitor--
    (1) Oversees the correction of deficiencies specified by CMS or the 
State survey agency at the facility site and protects the facility's 
residents from harm;
    (2) Is an employee or a contractor of the survey agency;
    (3) Is identified by the State as an appropriate professional to 
monitor cited deficiencies;

[[Page 461]]

    (4) Is not an employee of the facility;
    (5) Does not function as a consultant to the facility; and
    (6) Does not have an immediate family member who is a resident of 
the facility to be monitored.
    (b) A State monitor must be used when a survey agency has cited a 
facility with substandard quality of care deficiencies on the last 3 
consecutive standard surveys.
    (c) State monitoring is discontinued when--
    (1) The facility has demonstrated that it is in substantial 
compliance with the requirements, and, if imposed for repeated instances 
of substandard quality of care, will remain in compliance for a period 
of time specified by CMS or the State; or
    (2) Termination procedures are completed.

[59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept. 28, 1995]



Sec.  488.424  Directed plan of correction.

    CMS, the State survey agency, or the temporary manager (with CMS or 
State approval) may develop a plan of correction and CMS, the State, or 
the temporary manager require a facility to take action within specified 
timeframes.



Sec.  488.425  Directed inservice training.

    (a) Required training. CMS or the State agency may require the staff 
of a facility to attend an inservice training program if--
    (1) The facility has a pattern of deficiencies that indicate 
noncompliance; and
    (2) Education is likely to correct the deficiencies.
    (b) Action following training. After the staff has received 
inservice training, if the facility has not achieved substantial 
compliance, CMS or the State may impose one or more other remedies 
specified in Sec.  488.406.
    (c) Payment. The facility pays for directed inservice training.

[59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept. 28, 1995]



Sec.  488.426  Transfer of residents, or closure of the facility and transfer of residents.

    (a) Transfer of residents, or closure of the facility and transfer 
of residents in an emergency. In an emergency, the State has the 
authority to--
    (1) Transfer Medicaid and Medicare residents to another facility; or
    (2) Close the facility and transfer the Medicaid and Medicare 
residents to another facility.
    (b) Required transfer when a facility's provider agreement is 
terminated. When the State or CMS terminates a facility's provider 
agreement, the State arranges for the safe and orderly transfer of all 
Medicare and Medicaid residents to another facility.

[59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept. 28, 1995]



Sec.  488.430  Civil money penalties: Basis for imposing penalty.

    (a) CMS or the State may impose a civil money penalty for either the 
number of days a facility is not in substantial compliance with one or 
more participation requirements or for each instance that a facility is 
not in substantial compliance, regardless of whether or not the 
deficiencies constitute immediate jeopardy.
    (b) CMS or the State may impose a civil money penalty for the number 
of days of past noncompliance since the last standard survey, including 
the number of days of immediate jeopardy.

[59 FR 56243, Nov. 10, 1994, as amended at 64 FR 13360, Mar. 18, 1999]



Sec.  488.432  Civil money penalties: When a penalty is collected.

    (a) When facility requests a hearing. (1) A facility must request a 
hearing on the determination of the noncompliance that is the basis for 
imposition of the civil money penalty within the time specified in one 
of the following sections:
    (i) Section 498.40 of this chapter for a
    (A) SNF;
    (B) Dually participating facility;
    (C) State-operated NF; or
    (D) Non-State operated NF against which CMS is imposing remedies.
    (ii) Section 431.153 of this chapter for a non-State operated NF 
that is not

[[Page 462]]

subject to imposition of remedies by CMS.
    (2)(i) If a facility requests a hearing within the time specified in 
paragraph (a)(1) of this section, for a civil money penalty imposed per 
day, CMS or the State initiates collection of the penalty when there is 
a final administrative decision that upholds CMS's or the State's 
determination of noncompliance after the facility achieves substantial 
compliance or is terminated.
    (ii) If a facility requests a hearing for a civil money penalty 
imposed per instance of noncompliance within the time specified in 
paragraph (a)(1) of this section, CMS or the State initiates collection 
of the penalty when there is a final administrative decision that 
upholds CMS's or the State's determination of noncompliance.
    (b) When a facility does not request a hearing for a civil money 
penalty imposed per day. (1) If a facility does not request a hearing in 
accordance with paragraph (a) of this section, CMS or the State 
initiates collection of the penalty when the facility--
    (i) Achieves substantial compliance; or
    (ii) Is terminated.
    (2) When a facility does not request a hearing for a civil money 
penalty imposed per instance of noncompliance. If a facility does not 
request a hearing in accordance with paragraph (a) of this section, CMS 
or the State initiates collection of the penalty when the time frame for 
requesting a hearing expires.
    (c) When a facility waives a hearing. (1) If a facility waives, in 
writing, its right to a hearing as specified in Sec.  488.436, for a 
civil money penalty imposed per day, CMS or the State initiates 
collection of the penalty when the facility--
    (i) Achieves substantial compliance; or (ii) Is terminated.
    (2) If a facility waives, in writing, its right to a hearing as 
specified in Sec.  488.436, for a civil money penalty imposed per 
instance of noncompliance, CMS or the State initiates collection of the 
penalty upon receipt of the facility's notification.
    (d) Accrual and computation of penalties for a facility that--
    (1) Requests a hearing or does not request a hearing are specified 
in Sec.  488.440;
    (2) Waives its right to a hearing in writing, are specified in 
Sec. Sec.  488.436(b) and 488.440.
    (e) The collection of civil money penalties is made as provided in 
Sec.  488.442.

[59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept. 28, 1995, as amended at 
64 FR 13360, Mar. 18, 1999]



Sec.  488.434  Civil money penalties: Notice of penalty.

    (a) CMS notice of penalty. (1) CMS sends a written notice of the 
penalty to the facility for all facilities except non-State operated NFs 
when the State is imposing the penalty.
    (2) Content of notice. The notice that CMS sends includes--
    (i) The nature of the noncompliance;
    (ii) The statutory basis for the penalty;
    (iii) The amount of penalty per day of noncompliance or the amount 
of the penalty per instance of noncompliance;
    (iv) Any factors specified in Sec.  488.438(f) that were considered 
when determining the amount of the penalty;
    (v) The date of the instance of noncompliance or the date on which 
the penalty begins to accrue;
    (vi) When the penalty stops accruing, if applicable;
    (vii) When the penalty is collected; and
    (viii) Instructions for responding to the notice, including a 
statement of the facility's right to a hearing, and the implication of 
waiving a hearing, as provided in Sec.  488.436.
    (b) State notice of penalty. (1) The State must notify the facility 
in accordance with State procedures for all non-State operated NFs when 
the State takes the action.
    (2) The State's notice must--
    (i) Be in writing; and
    (ii) Include, at a minimum, the information specified in paragraph 
(a)(2) of this section.

[59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept. 28, 1995, as amended at 
64 FR 13360, Mar. 18, 1999]

[[Page 463]]



Sec.  488.436  Civil money penalties: Waiver of hearing, reduction of penalty amount.

    (a) Waiver of a hearing. The facility may waive the right to a 
hearing, in writing, within 60 days from the date of the notice imposing 
the civil money penalty.
    (b) Reduction of penalty amount. (1) If the facility waives its 
right to a hearing in accordance with the procedures specified in 
paragraph (a) of this section, CMS or the State reduces the civil money 
penalty amount by 35 percent.
    (2) If the facility does not waive its right to a hearing in 
accordance with the procedures specified in paragraph (a) of this 
section, the civil money penalty is not reduced by 35 percent.

[59 FR 56243, Nov. 10, 1994; 62 FR 44221, Aug. 20, 1997]



Sec.  488.438  Civil money penalties: Amount of penalty.

    (a) Amount of penalty. (1) The penalties are within the following 
ranges, set at $50 increments:
    (i) Upper range--$3,050-$10,000. Penalties in the range of $3,050-
$10,000 per day are imposed for deficiencies constituting immediate 
jeopardy, and as specified in paragraph (d)(2) of this section.
    (ii) Lower range--$50-$3,000. Penalties in the range of $50-$3,000 
per day are imposed for deficiencies that do not constitute immediate 
jeopardy, but either caused actual harm, or caused no actual harm, but 
have the potential for more than minimal harm.
    (2) Per instance penalty. When penalties are imposed for an instance 
of noncompliance, the penalties will be in the range of $1,000-$10,000 
per instance.
    (b) Basis for penalty amount. The amount of penalty is based on 
CMS's or the State's assessment of factors listed in paragraph (f) of 
this section.
    (c) Decreased penalty amounts. Except as specified in paragraph 
(d)(2) of this section, if immediate jeopardy is removed, but the 
noncompliance continues, CMS or the State will shift the penalty amount 
imposed per day to the lower range.
    (d) Increased penalty amounts. (1) Before a hearing requested in 
accordance with Sec.  488.432(a), CMS or the State may propose to 
increase the per day penalty amount for facility noncompliance which, 
after imposition of a lower level penalty amount, becomes sufficiently 
serious to pose immediate jeopardy.
    (2) CMS does and the State must increase the per day penalty amount 
for any repeated deficiencies for which a lower level penalty amount was 
previously imposed, regardless of whether the increased penalty amount 
would exceed the range otherwise reserved for nonimmediate jeopardy 
deficiencies.
    (3) Repeated deficiencies are deficiencies in the same regulatory 
grouping of requirements found at the last survey, subsequently 
corrected, and found again at the next survey.
    (e) Review of the penalty. When an administrative law judge or State 
hearing officer (or higher administrative review authority) finds that 
the basis for imposing a civil money penalty exists, as specified in 
Sec.  488.430, the administrative law judge or State hearing officer (or 
higher administrative review authority) may not--
    (1) Set a penalty of zero or reduce a penalty to zero;
    (2) Review the exercise of discretion by CMS or the State to impose 
a civil money penalty; and
    (3) Consider any factors in reviewing the amount of the penalty 
other than those specified in paragraph (f) of this section.
    (f) Factors affecting the amount of penalty. In determining the 
amount of penalty, CMS does or the State must take into account the 
following factors:
    (1) The facility's history of noncompliance, including repeated 
deficiencies.
    (2) The facility's financial condition.
    (3) The factors specified in Sec.  488.404.
    (4) The facility's degree of culpability. Culpability for purposes 
of this paragraph includes, but is not limited to, neglect, 
indifference, or disregard for resident care, comfort or safety. The 
absence of culpability is not a mitigating circumstance in reducing the 
amount of the penalty.

[59 FR 56243, Nov. 10, 1994, as amended at 64 FR 13360, Mar. 18, 1999; 
68 FR 46072, Aug. 4, 2003]

[[Page 464]]



Sec.  488.440  Civil money penalties: Effective date and duration of penalty.

    (a)(1) The per day civil money penalty may start accruing as early 
as the date that the facility was first out of compliance, as determined 
by CMS or the State.
    (2) A civil money penalty for each instance of noncompliance is 
imposed in a specific amount for that particular deficiency .
    (b) The per day civil money penalty is computed and collectible, as 
specified in Sec. Sec.  488.432 and 488.442, for the number of days of 
noncompliance until the date the facility achieves substantial 
compliance, or, if applicable, the date of termination when--
    (1) CMS's or the State's decision of noncompliance is upheld after a 
final administrative decision;
    (2) The facility waives its right to a hearing in accordance with 
Sec.  488.436; or
    (3) The time for requesting a hearing has expired and CMS or the 
State has not received a hearing request from the facility.
    (c) The entire penalty, whether imposed on a per day or per instance 
basis, is due and collectible as specified in the notice sent to the 
provider under paragraphs (d) and (e) of this section.
    (d)(1) When a civil money penalty is imposed on a per day basis and 
the facility achieves substantial compliance, CMS does or the State must 
send a separate notice to the facility containing the following 
information:
    (i) The amount of penalty per day.
    (ii) The number of days involved.
    (iii) The total amount due.
    (iv) The due date of the penalty.
    (v) The rate of interest assessed on the unpaid balance beginning on 
the due date, as provided in Sec.  488.442.
    (2) When a civil money penalty is imposed for an instance of 
noncompliance, CMS does or the State must send a separate notice to the 
facility containing the following information:
    (i) The amount of the penalty.
    (ii) The total amount due.
    (iii) The due date of the penalty.
    (iv) The rate of interest assessed on the unpaid balance beginning 
on the due date, as provided in Sec.  488.442.
    (e) In the case of a facility for which the provider agreement has 
been terminated and on which a civil money penalty was imposed on a per 
day basis, CMS does or the State must send this penalty information 
after the--
    (1) Final administrative decision is made;
    (2) Facility has waived its right to a hearing in accordance with 
Sec.  488.436; or
    (3) Time for requesting a hearing has expired and CMS or the state 
has not received a hearing request from the facility.
    (f) Accrual of penalties when there is no immediate jeopardy. (1) In 
the case of noncompliance that does not pose immediate jeopardy, the 
daily accrual of per day civil money penalties is imposed for the days 
of noncompliance prior to the notice specified in Sec.  488.434 and an 
additional period of no longer than 6 months following the last day of 
the survey.
    (2) After the period specified in paragraph (f)(1) of this section, 
if the facility has not achieved substantial compliance, CMS terminates 
the provider agreement and the State may terminate the provider 
agreement.
    (g)(1) In a case when per day civil money penalties are imposed, 
when a facility has deficiencies that pose immediate jeopardy, CMS does 
or the State must terminate the provider agreement within 23 calendar 
days after the last day of the survey if the immediate jeopardy remains.
    (2) The accrual of the civil money penalty imposed on a per day 
basis stops on the day the provider agreement is terminated.
    (h)(1) If an on-site revisit is necessary to confirm substantial 
compliance and the provider can supply documentation acceptable to CMS 
or the State agency that substantial compliance was achieved on a date 
preceding the revisit, penalties imposed on a per day basis only accrue 
until that date of correction for which there is written credible 
evidence.
    (2) If an on-site revisit is not necessary to confirm substantial 
compliance, penalties imposed on a per day basis only accrue until the 
date of correction for which CMS or the State receives and accepts 
written credible evidence.

[59 FR 56243, Nov. 10, 1994, as amended at 64 FR 13361, Mar. 18, 1999]

[[Page 465]]



Sec.  488.442  Civil money penalties: Due date for payment of penalty.

    (a) When payments are due for a civil money penalty imposed on a per 
day basis--(1) After a final administrative decision. A civil money 
penalty payment is due 15 days after a final administrative decision is 
made when--
    (i) The facility achieves substantial compliance before the final 
administrative decision; or
    (ii) The effective date of termination occurs before the final 
administrative decision.
    (2) When no hearing was requested. A civil money penalty payment is 
due 15 days after the time period for requesting a hearing has expired 
and a hearing request was not received when--
    (i) The facility achieved substantial compliance before the hearing 
request was due; or
    (ii) The effective date of termination occurs before the hearing 
request was due.
    (3) After a request to waive a hearing. A civil money penalty 
payment is due 15 days after receipt of the written request to waive a 
hearing when--
    (i) The facility achieved substantial compliance before CMS or the 
State received the written waiver of hearing; or
    (ii) The effective date of termination occurs before CMS or the 
State received the written waiver of hearing.
    (4) After substantial compliance is achieved. A civil money penalty 
payment is due 15 days after substantial compliance is achieved when--
    (i) The final administrative decision is made before the facility 
came into substantial compliance;
    (ii) The facility did not file a timely hearing request before it 
came into substantial compliance; or
    (iii) The facility waived its right to a hearing before it came into 
substantial compliance;
    (5) After the effective date of termination. A civil money penalty 
payment is due 15 days after the effective date of termination, if 
before the effective date of termination--
    (i) The final administrative decision was made;
    (ii) The time for requesting a hearing has expired and the facility 
did not request a hearing; or
    (iii) The facility waived its right to a hearing.
    (6) In the cases specified in paragraph (a)(4) of this section, the 
period of noncompliance may not extend beyond 6 months from the last day 
of the survey.
    (b) When payments are due for a civil money penalty imposed for an 
instance of noncompliance. Payment of a civil money penalty is due 15 
days after one of the following dates:
    (1) The final administrative decision is made;
    (2) The time for requesting a hearing has expired and the facility 
did not request a hearing; or
    (3) The facility waived its right to a hearing.
    (c) Deduction of penalty from amount owed. The amount of the 
penalty, when determined, may be deducted from any sum then or later 
owing by CMS or the State to the facility.
    (d) Interest--(1) Assessment. Interest is assessed on the unpaid 
balance of the penalty, beginning on the due date.
    (2) Medicare interest. Medicare rate of interest is the higher of--
    (i) The rate fixed by the Secretary of the Treasury after taking 
into consideration private consumer rates of interest prevailing on the 
date of the notice of the penalty amount due (published quarterly in the 
Federal Register by HHS under 45 CFR 30.13(a)); or
    (ii) The current value of funds (published annually in the Federal 
Register by the Secretary of the Treasury, subject to quarterly 
revisions).
    (3) Medicaid interest. The interest rate for Medicaid is determined 
by the State.
    (e) Penalties collected by CMS. Civil money penalties and 
corresponding interest collected by CMS from--
    (1) Medicare-participating facilities are deposited as miscellaneous 
receipts of the United States Treasury; and
    (2) Medicaid-participating facilities are returned to the State.
    (f) Collection from dually participating facilities. Civil money 
penalties collected from dually participating facilities are deposited 
as miscellaneous receipts of the United States Treasury and returned to 
the State in proportion commensurate with the relative proportions of 
Medicare and Medicaid beds

[[Page 466]]

at the facility actually in use by residents covered by the respective 
programs on the date the civil money penalty begins to accrue.
    (g) Penalties collected by the State. Civil money penalties 
collected by the State must be applied to the protection of the health 
or property of residents of facilities that the State or CMS finds 
noncompliant, such as--
    (1) Payment for the cost of relocating residents to other 
facilities;
    (2) State costs related to the operation of a facility pending 
correction of deficiencies or closure; and
    (3) Reimbursement of residents for personal funds or property lost 
at a facility as a result of actions by the facility or by individuals 
used by the facility to provide services to residents.

[59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept. 28, 1995, as amended at 
64 FR 13361, Mar. 18, 1999]



Sec.  488.444  Civil money penalties: Settlement of penalties.

    (a) CMS has authority to settle cases at any time prior to a final 
administrative decision for Medicare-only SNFs, State-operated 
facilities, or other facilities for which CMS's enforcement action 
prevails, in accordance with Sec.  488.330.
    (b) The State has the authority to settle cases at any time prior to 
the evidentiary hearing decision for all cases in which the State's 
enforcement action prevails.



Sec.  488.450  Continuation of payments to a facility with deficiencies.

    (a) Criteria. (1) CMS may continue payments to a facility not in 
substantial compliance for the periods specified in paragraph (c) of 
this section if the following criteria are met:
    (i) The State survey agency finds that it is more appropriate to 
impose alternative remedies than to terminate the facility;
    (ii) The State has submitted a plan and timetable for corrective 
action approved by CMS; and
    (iii) The facility, in the case of a Medicare SNF, or the State, in 
the case of a Medicaid NF, agrees to repay the Federal government 
payments received under this provision if corrective action is not taken 
in accordance with the approved plan and timetable for corrective 
action.
    (2) CMS or the State may terminate the SNF or NF agreement before 
the end of the correction period if the criteria in paragraph (a)(1) of 
this section are not met.
    (b) Cessation of payments. If termination is not sought, either by 
itself or along with another remedy or remedies, or any of the criteria 
set forth in paragraph (a)(1) of this section are not met or agreed to 
by either the facility or the State, the facility or State will receive 
no Medicare or Federal Medicaid payments, as applicable, from the last 
day of the survey.
    (c) Period of continued payments. If the conditions in paragraph 
(a)(1) of this section are met, CMS may continue payments to a Medicare 
facility or to the State for a Medicaid facility with noncompliance that 
does not constitute immediate jeopardy for up to 6 months from the last 
day of the survey.
    (d) Failure to achieve substantial compliance. If the facility does 
not achieve substantial compliance by the end of the period specified in 
paragraph (c) of this section,
    (1) CMS will--
    (i) Terminate the provider agreement of the Medicare SNF in 
accordance with Sec.  488.456; or
    (ii) Discontinue Federal funding to the SNF for Medicare; and
    (iii) Discontinue FFP to the State for the Medicaid NF.
    (2) The State may terminate the provider agreement for the NF.

[59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept. 28, 1995]



Sec.  488.452  State and Federal disagreements involving findings not in agreement in non-State operated NFs and dually participating facilities when there is 
          no immediate jeopardy.

    The following rules apply when CMS and the State disagree over 
findings of noncompliance or application of remedies in a non-State 
operated NF or dually participating facility:
    (a) Disagreement over whether facility has met requirements. (1) The 
State's finding of noncompliance takes precedence when--

[[Page 467]]

    (i) CMS finds that a NF or a dually participating facility is in 
substantial compliance with the participation requirements; and
    (ii) The State finds that a NF or dually participating facility has 
not achieved substantial compliance.
    (2) CMS's findings of noncompliance take precedence when--
    (i) CMS finds that a NF or a dually participating facility has not 
achieved substantial compliance; and
    (ii) The State finds that a NF or a dually participating facility is 
in substantial compliance with the participation requirements.
    (3) When CMS's survey findings take precedence, CMS may--
    (i) Impose any of the alternative remedies specified in Sec.  
488.406;
    (ii) Terminate the provider agreement subject to the applicable 
conditions of Sec.  488.450; and
    (iii) Stop FFP to the State for a NF.
    (b) Disagreement over decision to terminate. (1) CMS's decision to 
terminate the participation of a facility takes precedence when--
    (i) Both CMS and the State find that the facility has not achieved 
substantial compliance; and
    (ii) CMS, but not the State, finds that the facility's participation 
should be terminated. CMS will permit continuation of payment during the 
period prior to the effective date of termination not to exceed 6 
months, if the applicable conditions of Sec.  488.450 are met.
    (2) The State's decision to terminate a facility's participation and 
the procedures for appealing such termination, as specified in Sec.  
431.153(c) of this chapter, takes precedence when--
    (i) The State, but not CMS, finds that a NF's participation should 
be terminated; and
    (ii) The State's effective date for the termination of the NF's 
provider agreement is no later than 6 months after the last day of 
survey.
    (c) Disagreement over timing of termination of facility. The State's 
timing of termination takes precedence if it does not occur later than 6 
months after the last day of the survey when both CMS and the State find 
that--
    (1) A facility is not in substantial compliance; and
    (2) The facility's participation should be terminated.
    (d) Disagreement over remedies. (1) When CMS or the State, but not 
both, establishes one or more remedies, in addition to or as an 
alternative to termination, the additional or alternative remedies will 
also apply when--
    (i) Both CMS and the State find that a facility has not achieved 
substantial compliance; and
    (ii) Both CMS and the State find that no immediate jeopardy exists.
    (2) Overlap of remedies. When CMS and the State establish one or 
more remedies, in addition to or as an alternative to termination, only 
the CMS remedies apply when both CMS and the State find that a facility 
has not achieved substantial compliance.
    (e) Regardless of whether CMS's or the State's decision controls, 
only one noncompliance and enforcement decision is applied to the 
Medicaid agreement, and for a dually participating facility, that same 
decision will apply to the Medicare agreement.



Sec.  488.454  Duration of remedies.

    (a) Except as specified in paragraphs (b) and (d) of this section, 
alternative remedies continue until--
    (1) The facility has achieved substantial compliance, as determined 
by CMS or the State based upon a revisit or after an examination of 
credible written evidence that it can verify without an on-site visit; 
or
    (2) CMS or the State terminates the provider agreement.
    (b) In the cases of State monitoring and denial of payment imposed 
for repeated substandard quality of care, remedies continue until--
    (1) CMS or the State determines that the facility has achieved 
substantial compliance and is capable of remaining in substantial 
compliance; or
    (2) CMS or the State terminates the provider agreement.
    (c) In the case of temporary management, the remedy continues 
until--
    (1) CMS or the State determines that the facility has achieved 
substantial compliance and is capable of remaining in substantial 
compliance;
    (2) CMS or the State terminates the provider agreement; or

[[Page 468]]

    (3) The facility which has not achieved substantial compliance 
reassumes management control. In this case, CMS or the State initiates 
termination of the provider agreement and may impose additional 
remedies.
    (d) In the case of a civil money penalty imposed for an instance of 
noncompliance, the remedy is the specific amount of the civil money 
penalty imposed for the particular deficiency.
    (e) If the facility can supply documentation acceptable to CMS or 
the State survey agency that it was in substantial compliance and was 
capable of remaining in substantial compliance, if necessary, on a date 
preceding that of the revisit, the remedies terminate on the date that 
CMS or the State can verify as the date that substantial compliance was 
achieved and the facility demonstrated that it could maintain 
substantial compliance, if necessary.

[59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept. 28, 1995, as amended at 
64 FR 13361, Mar. 18, 1999]



Sec.  488.456  Termination of provider agreement.

    (a) Effect of termination. Termination of the provider agreement 
ends--
    (1) Payment to the facility; and
    (2) Any alternative remedy.
    (b) Basis for termination. (1) CMS and the State may terminate a 
facility's provider agreement if a facility--
    (i) Is not in substantial compliance with the requirements of 
participation, regardless of whether or not immediate jeopardy is 
present; or
    (ii) Fails to submit an acceptable plan of correction within the 
timeframe specified by CMS or the State.
    (2) CMS and the State terminate a facility's provider agreement if a 
facility--
    (i) Fails to relinquish control to the temporary manager, if that 
remedy is imposed by CMS or the State; or
    (ii) Does not meet the eligibility criteria for continuation of 
payment as set forth in Sec.  488.412(a)(1).
    (c) Notice of termination. Before terminating a provider agreement, 
CMS does and the State must notify the facility and the public--
    (1) At least 2 calendar days before the effective date of 
termination for a facility with immediate jeopardy deficiencies; and
    (2) At least 15 calendar days before the effective date of 
termination for a facility with non-immediate jeopardy deficiencies that 
constitute noncompliance.
    (d) Procedures for termination. (1) CMS terminates the provider 
agreement in accordance with procedures set forth in Sec.  489.53 of 
this chapter; and
    (2) The State must terminate the provider agreement of a NF in 
accordance with procedures specified in parts 431 and 442 of this 
chapter.

Subpart G [Reserved]



Subpart H_Termination of Medicare Coverage and Alternative Sanctions for 
                End-Stage Renal Disease (ESRD) Facilities

    Source: 73 FR 20475, Apr. 15, 2008, unless otherwise noted.



Sec.  488.604  Termination of Medicare coverage.

    (a) Except as otherwise provided in this subpart, failure of a 
supplier of ESRD services to meet one or more of the conditions for 
coverage set forth in part 494 of this chapter will result in 
termination of Medicare coverage of the services furnished by the 
supplier.
    (b) If termination of coverage is based solely on a supplier's 
failure to participate in network activities and pursue network goals, 
as required at Sec.  494.180(i) of this chapter, coverage may be 
reinstated when CMS determines that the supplier is making reasonable 
and appropriate efforts to meet that condition.
    (c) If termination of coverage is based on failure to meet any of 
the other conditions specified in part 494 of this chapter, coverage 
will not be reinstated until CMS finds that the reason for termination 
has been removed and there is reasonable assurance that it will not 
recur.



Sec.  488.606  Alternative sanctions.

    (a) Basis for application of alternative sanctions. CMS may, as an 
alternative to termination of Medicare coverage,

[[Page 469]]

impose one of the sanctions specified in paragraph (b) of this section 
if CMS finds that--
    (1) The supplier fails to participate in the activities and pursue 
the goals of the ESRD network that is designated to encompass the 
supplier's geographic area; and
    (2) This failure does not jeopardize patient health and safety.
    (b) Alternative sanctions. The alternative sanctions that CMS may 
apply in the circumstances specified in paragraph (a) of this section 
include the following:
    (1) Denial of payment for services furnished to patients first 
accepted for care after the effective date of the sanction as specified 
in the sanction notice.
    (2) Reduction of payments, for all ESRD services furnished by the 
supplier, by 20 percent for each 30-day period after the effective date 
of the sanction.
    (3) Withholding of all payments, without interest, for all ESRD 
services furnished by the supplier to Medicare beneficiaries.
    (c) Duration of alternative sanction. An alternative sanction 
remains in effect until CMS finds that the supplier is in substantial 
compliance with the requirement to cooperate in the network plans and 
goals, or terminates coverage of the supplier's services for lack of 
compliance.



Sec.  488.608  Notice of alternative sanction and appeal rights: Termination of coverage.

    (a) Notice of alternative sanction. CMS gives the supplier and the 
general public notice of the alternative sanction and of the effective 
date of the sanction. The effective date of the alternative sanction is 
at least 30 days after the date of the notice.
    (b) Appeal rights. Termination of Medicare coverage of a supplier's 
ESRD services because the supplier no longer meets the conditions for 
coverage of its services is an initial determination appealable under 
part 498 of this chapter.



Sec.  488.610  Notice of appeal rights: Alternative sanctions.

    If CMS proposes to apply an alternative sanction specified in Sec.  
488.606(b), the following rules apply:
    (a) CMS gives the facility notice of the proposed alternative 
sanction and 15 days in which to request a hearing.
    (b) If the facility requests a hearing, CMS provides an informal 
hearing by a CMS official who was not involved in making the appealed 
decision.
    (c) During the informal hearing, the facility--
    (1) May be represented by counsel;
    (2) Has access to the information on which the allegation was based; 
and
    (3) May present, orally or in writing, evidence and documentation to 
refute the finding of failure to participate in network activities and 
pursue network goals.
    (d) If the written decision of the informal hearing supports 
application of the alternative sanction, CMS provides the facility and 
the public, at least 30 days before the effective date of the 
alternative sanction, a written notice that specifies the effective date 
and the reasons for the alternative sanction.



PART 489_PROVIDER AGREEMENTS AND SUPPLIER APPROVAL--Table of Contents




                      Subpart A_General Provisions

Sec.
489.1 Statutory basis.
489.2 Scope of part.
489.3 Definitions.
489.10 Basic requirements.
489.11 Acceptance of a provider as a participant.
489.12 Decision to deny an agreement.
489.13 Effective date of agreement or approval.
489.18 Change of ownership or leasing: Effect on provider agreement.

               Subpart B_Essentials of Provider Agreements

489.20 Basic commitments.
489.21 Specific limitations on charges.
489.22 Special provisions applicable to prepayment requirements.
489.23 Specific limitation on charges for services provided to certain 
          enrollees of fee-for-service FEHB plans.
489.24 Special responsibilities of Medicare hospitals in emergency 
          cases.

[[Page 470]]

489.25 Special requirements concerning CHAMPUS and CHAMPVA programs.
489.26 Special requirements concerning veterans.
489.27 Beneficiary notice of discharge rights.
489.28 Special capitalization requirements for HHAs.
489.29 Special requirements concerning beneficiaries served by the 
          Indian Health Service, Tribal health programs, and urban 
          Indian organization health programs.

                       Subpart C_Allowable Charges

489.30 Allowable charges: Deductibles and coinsurance.
489.31 Allowable charges: Blood.
489.32 Allowable charges: Noncovered and partially covered services.
489.34 Allowable charges: Hospitals participating in State reimbursement 
          control systems or demonstration projects.
489.35 Notice to intermediary.

               Subpart D_Handling of Incorrect Collections

489.40 Definition of incorrect collection.
489.41 Timing and methods of handling.
489.42 Payment of offset amounts to beneficiary or other person.

 Subpart E_Termination of Agreement and Reinstatement After Termination

489.52 Termination by the provider.
489.53 Termination by CMS.
489.54 Termination by the OIG.
489.55 Exceptions to effective date of termination.
489.57 Reinstatement after termination.

               Subpart F_Surety Bond Requirements for HHAs

489.60 Definitions.
489.61 Basic requirement for surety bonds.
489.62 Requirement waived for Government-operated HHAs.
489.63 Parties to the bond.
489.64 Authorized Surety and exclusion of surety companies.
489.65 Amount of the bond.
489.66 Additional requirements of the surety bond.
489.67 Term and type of bond.
489.68 Effect of failure to obtain, maintain, and timely file a surety 
          bond.
489.69 Evidence of compliance.
489.70 Effect of payment by the Surety.
489.71 Surety's standing to appeal Medicare determinations.
489.72 Effect of review reversing CMS's determination.
489.73 Effect of conditions of payment.
489.74 Incorporation into existing provider agreements.

Subparts G-H [Reserved]

                      Subpart I_Advance Directives

489.100 Definition.
489.102 Requirements for providers.
489.104 Effective dates.

    Authority: Secs. 1102, 1819, 1820(e), 1861, 1864(m), 1866, 1869, and 
1871 of the Social Security Act (42 U.S.C. 1302, 1395i-3, 1395x, 
1395aa(m), 1395cc, 1395ff, and 1395hh).

    Source: 45 FR 22937, Apr. 4, 1980, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  489.1  Statutory basis.

    This part implements section 1866 of the Social Security Act. 
Section 1866 specifies the terms of provider agreements, the grounds for 
terminating a provider agreement, the circumstances under which payment 
for new admissions may be denied, and the circumstances under which 
payment may be withheld for failure to make timely utilization review. 
The following other sections of that Act are also pertinent.
    (a) Section 1861 defines the services covered under Medicare and the 
providers that may be reimbursed for furnishing those services.
    (b) Section 1864 provides for the use of State survey agencies to 
ascertain whether certain entities meet the conditions of participation.
    (c) Section 1871 authorizes the Secretary to prescribe regulations 
for the administration of the Medicare program.
    (d) Although section 1866 of the Act speaks only to providers and 
provider agreements, the effective date rules in this part are made 
applicable also to the approval of suppliers that meet the requirements 
specified in Sec.  489.13.
    (e) Section 1861(o)(7) of the Act requires each HHA to provide CMS 
with a surety bond.

[45 FR 22937, Apr. 4, 1980, as amended at 51 FR 24492, July 3, 1986; 62 
FR 43936, Aug. 18, 1997; 63 FR 312, Jan. 5, 1998]



Sec.  489.2  Scope of part.

    (a) Subpart A of this part sets forth the basic requirements for 
submittal

[[Page 471]]

and acceptance of a provider agreement under Medicare. Subpart B of this 
part specifies the basic commitments and limitations that the provider 
must agree to as part of an agreement to provide services. Subpart C 
specifies the limitations on allowable charges to beneficiaries for 
deductibles, coinsurance, copayments, blood, and services that must be 
part of the provider agreement. Subpart D of this part specifies how 
incorrect collections are to be handled. Subpart F sets forth the 
circumstances and procedures for denial of payments for new admissions 
and for withholding of payment as an alternative to termination of a 
provider agreement.
    (b) The following providers are subject to the provisions of this 
part:
    (1) Hospitals.
    (2) Skilled nursing facilities (SNFs).
    (3) Home health agencies (HHAs).
    (4) Clinics, rehabilitation agencies, and public health agencies.
    (5) Comprehensive outpatient rehabilitation facilities (CORFs).
    (6) Hospices.
    (7) Critical access hospital (CAHs).
    (8) Community mental health centers (CMHCs).
    (9) Religious nonmedical health care institutions (RNHCIs).
    (c)(1) Clinics, rehabilitation agencies, and public health agencies 
may enter into provider agreements only for furnishing outpatient 
physical therapy, and speech pathology services.
    (2) CMHCs may enter into provider agreements only to furnish partial 
hospitalization services.

[45 FR 22937, Apr. 4, 1980, as amended at 47 FR 56297, Dec. 15, 1982; 48 
FR 56036, Dec. 15, 1983; 51 FR 24492, July 3, 1986; 58 FR 30676, May 26, 
1993; 59 FR 6578, Feb. 11, 1994; 62 FR 46037, Aug. 29, 1997; 68 FR 
66720, Nov. 28, 2003]



Sec.  489.3  Definitions.

    For purposes of this part--
    Immediate jeopardy means a situation in which the provider's 
noncompliance with one or more requirements of participation has caused, 
or is likely to cause, serious injury, harm, impairment, or death to a 
resident.
    Physician-owned hospital means any participating hospital (as 
defined in Sec.  489.24) in which a physician, or an immediate family 
member of a physician (as defined in Sec.  411.351 of this chapter), has 
an ownership or investment interest in the hospital. The ownership or 
investment interest may be through equity, debt, or other means, and 
includes an interest in an entity that holds an ownership or investment 
interest in the hospital. This definition does not include a hospital 
with physician ownership or investment interests that satisfy the 
requirements at Sec.  411.356(a) or (b) of this chapter.
    Provider agreement means an agreement between CMS and one of the 
providers specified in Sec.  489.2(b) to provide services to Medicare 
beneficiaries and to comply with the requirements of section 1866 of the 
Act.

[48 FR 39837, Sept. 1, 1983, as amended at 51 FR 24492, July 3, 1986; 54 
FR 5373, Feb. 2, 1989; 59 FR 56250, Nov. 10, 1994; 60 FR 50119, Sept. 
28, 1995; 72 FR 47412, Aug. 22, 2007; 73 FR 48757, Aug. 19, 2008]



Sec.  489.10  Basic requirements.

    (a) Any of the providers specified in Sec.  489.2 may request 
participation in Medicare. In order to be accepted, it must meet the 
conditions of participation or requirements (for SNFs) set forth in this 
section and elsewhere in this chapter. The RNHCIs must meet the 
conditions for coverage, conditions for participation and the 
requirements set forth in this section and elsewhere in this chapter.
    (b) In order to participate in the Medicare program, the provider 
must meet the applicable civil rights requirements of:
    (1) Title VI of the Civil Rights Act of 1964, as implemented by 45 
CFR part 80, which provides that no person in the United States shall, 
on the ground of race, color, or national origin, be excluded from 
participation in, be denied the benefits of, or be subject to 
discrimination under, any program or activity receiving Federal 
financial assistance (section 601);
    (2) Section 504 of the Rehabilitation Act of 1973, as implemented by 
45 CFR part 84, which provides that no qualified handicapped person 
shall, on the basis of handicap, be excluded from participation in, be 
denied the benefits of, or otherwise be subject to discrimination under 
any program or activity receiving Federal financial assistance;

[[Page 472]]

    (3) The Age Discrimination Act of 1975, as implemented by 45 CFR 
part 90, which is designed to prohibit discrimination on the basis of 
age in programs or activities receiving Federal financial assistance. 
The Age Discrimination Act also permits federally assisted programs and 
activities, and recipients of Federal funds, to continue to use certain 
age distinctions, and factors other than age, that meet the requirements 
of the Age Discrimination Act and 45 CFR part 90; and
    (4) Other pertinent requirements of the Office of Civil Rights of 
HHS.
    (c) In order for a hospital, SNF, HHA, hospice, or RNHCI to be 
accepted, it must also meet the advance directives requirements 
specified in subpart I of this part.
    (d) The State survey agency will ascertain whether the provider 
meets the conditions of participation or requirements (for SNFs) and 
make its recommendations to CMS.
    (e) In order for a home health agency to be accepted, it must also 
meet the surety bond requirements specified in subpart F of this part.
    (f) In order for a home health agency to be accepted as a new 
provider, it must also meet the capitalization requirements specified in 
subpart B of this part.

[58 FR 61843, Nov. 23, 1993, as amended at 59 FR 6578, Feb. 11, 1994; 63 
FR 312, Jan. 5, 1998; 68 FR 66720, Nov. 28, 2003]



Sec.  489.11  Acceptance of a provider as a participant.

    (a) Action by CMS. If CMS determines that the provider meets the 
requirements, it will send the provider--
    (1) Written notice of that determination; and
    (2) Two copies of the provider agreement.
    (b) Action by provider. If the provider wishes to participate, it 
must return both copies of the agreement, duly signed by an authorized 
official, to CMS, together with a written statement indicating whether 
it has been adjudged insolvent or bankrupt in any State or Federal 
court, or whether any insolvency or bankruptcy actions are pending.
    (c) Notice of acceptance. If CMS accepts the agreement, it will 
return one copy to the provider with a written notice that--
    (1) Indicates the dates on which it was signed by the provider's 
representative and accepted by CMS; and
    (2) Specifies the effective date of the agreement.

[45 FR 22937, Apr. 4, 1980, as amended at 59 FR 56251, Nov. 10, 1994; 62 
FR 43937, Aug. 18, 1997]



Sec.  489.12  Decision to deny an agreement.

    (a) Bases for denial. CMS may refuse to enter into an agreement for 
any of the following reasons:
    (1) Principals of the prospective provider have been convicted of 
fraud (see Sec.  420.204 of this chapter);
    (2) The prospective provider has failed to disclose ownership and 
control interests in accordance with Sec.  420.206 of this chapter;
    (3) The prospective provider is a physician-owned hospital as 
defined in Sec.  489.3 and does not have procedures in place for making 
physician ownership disclosures to patients in accordance with Sec.  
489.20(u); or
    (4) The prospective provider is unable to give satisfactory 
assurance of compliance with the requirements of title XVIII of the Act.
    (b) [Reserved]
    (c) Compliance with civil rights requirements. CMS will not enter 
into a provider agreement if the provider fails to comply with civil 
rights requirements set forth in 45 CFR parts 80, 84, and 90, subject to 
the provisions of Sec.  489.10.

[45 FR 22937, Apr. 4, 1980, as amended at 51 FR 34833, Sept. 30, 1986; 
54 FR 4027, Jan. 27. 1989; 59 FR 6578, Feb. 11, 1994; 59 FR 56251, Nov. 
10, 1994; 72 FR 47413, Aug. 22, 2007]



Sec.  489.13  Effective date of agreement or approval.

    (a) Applicability--(1) General rule. Except as provided in paragraph 
(a)(2) of this section, this section applies to Medicare provider 
agreements with, and supplier approval of, entities that, as a basis for 
participation in Medicare--
    (i) Are subject to survey and certification by CMS or the State 
survey agency; or

[[Page 473]]

    (ii) Are deemed to meet Federal requirements on the basis of 
accreditation by an accrediting organization whose program has CMS 
approval at the time of accreditation survey and accreditation decision.
    (2) Exceptions. (i) For an agreement with a community mental health 
center (CMHC) or a Federally qualified health center (FQHC), the 
effective date is the date on which CMS accepts a signed agreement which 
assures that the CMHC or FQHC meets all Federal requirements.
    (ii) A Medicare supplier approval of a laboratory is effective only 
while the laboratory has in effect a valid CLIA certificate issued under 
part 493 of this chapter, and only for the specialty and subspecialty 
tests it is authorized to perform.
    (b) All Federal requirements are met on the date of survey. The 
agreement or approval is effective on the date the survey (including the 
Life Safety Code survey, if applicable) is completed, if on that date 
the provider or supplier meets all applicable Federal requirements as 
set forth in this chapter. (If the agreement or approval is time-
limited, the new agreement or approval is effective on the day following 
expiration of the current agreement or approval.)
    (c) All Federal requirements are not met on the date of survey. If 
on the date the survey is completed the provider or supplier fails to 
meet any of the requirements specified in paragraph (b) of this section, 
the following rules apply:
    (1) For an agreement with an SNF, the effective date is the date on 
which--
    (i) The SNF is in substantial compliance (as defined in Sec.  
488.301 of this chapter) with the requirements for participation; and
    (ii) CMS or the State survey agency receives from the SNF, if 
applicable, an approvable waiver request.
    (2) For an agreement with, or an approval of, any other provider or 
supplier, (except those specified in paragraph (a)(2) of this section), 
the effective date is the earlier of the following:
    (i) The date on which the provider or supplier meets all 
requirements.
    (ii) The date on which a provider or supplier is found to meet all 
conditions of participation or coverage, but has lower level 
deficiencies, and CMS or the State survey agency receives an acceptable 
plan of correction for the lower level deficiencies, or an approvable 
waiver request, or both. (The date of receipt is the effective date 
regardless of when CMS approves the plan of correction or the waiver 
request, or both.)
    (d) Accredited provider or supplier requests participation in the 
Medicare program--(1) General rule. If the provider or supplier is 
currently accredited by a national accrediting organization whose 
program had CMS approval at the time of accreditation survey and 
accreditation decision, and on the basis of accreditation, CMS has 
deemed the provider or supplier to meet Federal requirements, the 
effective date depends on whether the provider or supplier is subject to 
requirements in addition to those included in the accrediting 
organization's approved program.
    (i) Provider or supplier subject to additional requirements. If the 
provider or supplier is subject to additional requirements, the 
effective date of the agreement or approval is the date on which the 
provider or supplier meets all requirements, including the additional 
requirements.
    (ii) Provider or supplier not subject to additional requirements. 
For a provider or supplier that is not subject to additional 
requirements, the effective date is the date of the provider's or 
supplier's initial request for participation if on that date the 
provider or supplier met all Federal requirements.
    (2) Special rule: Retroactive effective date. If a provider or 
supplier meets the requirements of paragraphs (d)(1) and (d)(1)(i) or 
(d)(1)(ii) of this section, the effective date may be retroactive for up 
to one year to encompass dates on which the provider or supplier 
furnished, to a Medicare beneficiary, covered services for which it has 
not been paid.

[62 FR 43936, Aug. 18, 1997]



Sec.  489.18  Change of ownership or leasing: Effect on provider agreement.

    (a) What constitutes change of ownership--(1) Partnership. In the 
case of a

[[Page 474]]

partnership, the removal, addition, or substitution of a partner, unless 
the partners expressly agree otherwise, as permitted by applicable State 
law, constitutes change of ownership.
    (2) Unincorporated sole proprietorship. Transfer of title and 
property to another party constitutes change of ownership.
    (3) Corporation. The merger of the provider corporation into another 
corporation, or the consolidation of two or more corporations, resulting 
in the creation of a new corporation constitutes change of ownership. 
Transfer of corporate stock or the merger of another corporation into 
the provider corporation does not constitute change of ownership.
    (4) Leasing. The lease of all or part of a provider facility 
constitutes change of ownership of the leased portion.
    (b) Notice to CMS. A provider who is contemplating or negotiating a 
change of ownership must notify CMS.
    (c) Assignment of agreement. When there is a change of ownership as 
specified in paragraph (a) of this section, the existing provider 
agreement will automatically be assigned to the new owner.
    (d) Conditions that apply to assigned agreements. An assigned 
agreement is subject to all applicable statutes and regulations and to 
the terms and conditions under which it was originally issued including, 
but not limited to, the following:
    (1) Any existing plan of correction.
    (2) Compliance with applicable health and safety standards.
    (3) Compliance with the ownership and financial interest disclosure 
requirements of part 420, subpart C, of this chapter.
    (4) Compliance with civil rights requirements set forth in 45 CFR 
Parts 80, 84, and 90.
    (e) Effect of leasing. The provider agreement will be assigned to 
the lessee only to the extent of the leased portion of the facility.

[45 FR 22937, Apr. 4, 1980, as amended at 59 FR 56251, Nov. 10, 1994]



               Subpart B_Essentials of Provider Agreements



Sec.  489.20  Basic commitments.

    The provider agrees to the following:
    (a) To limit its charges to beneficiaries and to other individuals 
on their behalf, in accordance with provisions of subpart C of this 
part.
    (b) To comply with the requirements of subpart D of this part for 
the return or other disposition of any amounts incorrectly collected 
from a beneficiary or any other person in his or her behalf.
    (c) To comply with the requirements of Sec.  420.203 of this chapter 
when it hires certain former employees of intermediaries.
    (d) In the case of a hospital or a CAH that furnishes services to 
Medicare beneficiaries, either to furnish directly or to make 
arrangements (as defined in Sec.  409.3 of this chapter) for all 
Medicare-covered services to inpatients and outpatients of a hospital or 
a CAH except the following:
    (1) Physicians' services that meet the criteria of Sec.  415.102(a) 
of this chapter for payment on a reasonable charge basis.
    (2) Physician assistant services, as defined in section 
1861(s)(2)(K)(i) of the Act, that are furnished after December 31, 1990.
    (3) Nurse practitioner and clinical nurse specialist services, as 
defined in section 1861(s)(2)(K)(ii) of the Act.
    (4) Certified nurse-midwife services, as defined in section 1861(ff) 
of the Act, that are furnished after December 31, 1990.
    (5) Qualified psychologist services, as defined in section 1861(ii) 
of the Act, that are furnished after December 31, 1990.
    (6) Services of an anesthetist, as defined in Sec.  410.69 of this 
chapter.
    (e) In the case of a hospital or CAH that furnishes inpatient 
hospital services or inpatient CAH services for which payment may be 
made under Medicare, to maintain an agreement with a QIO for that 
organization to review the admissions, quality, appropriateness, and 
diagnostic information related to those inpatient services. The 
requirement of this paragraph (e) applies only if, for the area in which 
the hospital or CAH is located, there is a

[[Page 475]]

QIO that has a contract with CMS under part B of title XI of the Act.
    (f) To maintain a system that, during the admission process, 
identifies any primary payers other than Medicare, so that incorrect 
billing and Medicare overpayments can be prevented.
    (g) To bill other primary payers before Medicare.
    (h) If the provider receives payment for the same services from 
Medicare and another payer that is primary to Medicare, to reimburse 
Medicare any overpaid amount within 60 days.
    (i) If the provider receives, from a payer that is primary to 
Medicare, a payment that is reduced because the provider failed to file 
a proper claim--
    (1) To bill Medicare for an amount no greater than would have been 
payable as secondary payment if the primary insurer's payment had been 
based on a proper claim; and
    (2) To charge the beneficiary only: (i) The amount it would have 
been entitled to charge if it had filed a proper claim and received 
payment based on such a claim; and
    (ii) An amount equal to any primary payment reduction attributable 
to failure to file a proper claim, but only if the provider can show 
that--
    (A) It failed to file a proper claim solely because the beneficiary, 
for any reason other than mental or physical incapacity, failed to give 
the provider the necessary information; or
    (B) The beneficiary, who was responsible for filing a proper claim, 
failed to do so for any reason other than mental or physical incapacity.
    (j) In the State of Oregon, because of a court decision, and in the 
absence of a reversal on appeal or a statutory clarification overturning 
the decision, hospitals may bill liability insurers first. However, if 
the liability insurer does not pay ``promptly'', as defined in Sec.  
411.50 of this chapter, the hospital must withdraw its claim or lien and 
bill Medicare for covered services.
    (k) In the case of home health agencies that provide home health 
services to Medicare beneficiaries under subpart E of part 409 and 
subpart C f part 410 of this chapter, to offer to furnish catheters, 
catheter supplies, ostomy bags, and supplies related to ostomy care to 
any individual who requires them as part of their furnishing of home 
health services.
    (l) In the case of a hospital as defined in Sec.  489.24(b) to 
comply with Sec.  489.24.
    (m) In the case of a hospital as defined in Sec.  489.24(b), to 
report to CMS or the State survey agency any time it has reason to 
believe it may have received an individual who has been transferred in 
an unstable emergency medical condition from another hospital in 
violation of the requirements of Sec.  489.24(e).
    (n) In the case of inpatient hospital services, to participate in 
any health plan contracted for under 10 U.S.C. 1079 or 1086 or 38 U.S.C. 
613, in accordance with Sec.  489.25.
    (o) In the case of inpatient hospital services, to admit veterans 
whose admission has been authorized under 38 U.S.C. 603, in accordance 
with Sec.  489.26.
    (p) To comply with Sec.  489.27 of this part concerning notification 
of Medicare beneficiaries of their rights associated with the 
termination of Medicare services.
    (q) In the case of a hospital as defined in Sec.  489.24(b)--
    (1) To post conspicuously in any emergency department or in a place 
or places likely to be noticed by all individuals entering the emergency 
department, as well as those individuals waiting for examination and 
treatment in areas other than traditional emergency departments (that 
is, entrance, admitting area, waiting room, treatment area), a sign (in 
a form specified by the Secretary) specifying rights of individuals 
under Section 1867 of the Act with respect to examination and treatment 
for emergency medical conditions and women in labor; and
    (2) To post conspicuously (in a form specified by the Secretary) 
information indicating whether or not the hospital or rural primary care 
hospital participates in the Medicaid program under a State plan 
approved under title XIX.
    (r) In the case of a hospital as defined in Sec.  489.24(b) 
(including both the transferring and receiving hospitals), to maintain--
    (1) Medical and other records related to individuals transferred to 
or from the hospital for a period of 5 years from the date of the 
transfer;

[[Page 476]]

    (2) An on-call list of physicians who are on the hospital's medical 
staff or who have privileges at the hospital, or who are on the staff or 
have privileges at another hospital participating in a formal community 
call plan, in accordance with Sec.  489.24(j)(2)(iii), available to 
provide treatment necessary after the initial examination to stabilize 
individuals with emergency medical conditions who are receiving services 
required under Sec.  489.24 in accordance with the resources available 
to the hospital; and
    (3) A central log on each individual who comes to the emergency 
department, as defined in Sec.  489.24(b), seeking assistance and 
whether he or she refused treatment, was refused treatment, or whether 
he or she was transferred, admitted and treated, stabilized and 
transferred, or discharged.
    (s) In the case of an SNF, either to furnish directly or make 
arrangements (as defined in Sec.  409.3 of this chapter) for all 
Medicare-covered services furnished to a resident (as defined in Sec.  
411.15(p)(3) of this chapter) of the SNF, except the following:
    (1) Physicians' services that meet the criteria of Sec.  415.102(a) 
of this chapter for payment on a fee schedule basis.
    (2) Services performed under a physician's supervision by a 
physician assistant who meets the applicable definition in section 
1861(aa)(5) of the Act.
    (3) Services performed by a nurse practitioner or clinical nurse 
specialist who meets the applicable definition in section 1861(aa)(5) of 
the Act and is working in collaboration (as defined in section 
1861(aa)(6) of the Act) with a physician.
    (4) Services performed by a certified nurse-midwife, as defined in 
section 1861(gg) of the Act.
    (5) Services performed by a qualified psychologist, as defined in 
section 1861(ii) of the Act.
    (6) Services performed by a certified registered nurse anesthetist, 
as defined in section 1861(bb) of the Act.
    (7) Dialysis services and supplies, as defined in section 
1861(s)(2)(F) of the Act, and those ambulance services that are 
furnished in conjunction with them.
    (8) Erythropoietin (EPO) for dialysis patients, as defined in 
section 1861(s)(2)(O) of the Act.
    (9) Hospice care, as defined in section 1861(dd) of the Act.
    (10) An ambulance trip that initially conveys an individual to the 
SNF to be admitted as a resident, or that conveys an individual from the 
SNF in connection with one of the circumstances specified in Sec.  
411.15(p)(3)(i) through (p)(3)(iv) of this chapter as ending the 
individual's status as an SNF resident.
    (11) The transportation costs of electrocardiogram equipment (HCPCS 
code R0076), but only with respect to those electrocardiogram test 
services furnished during 1998.
    (12) Services described in paragraphs (s)(1) through (6) of this 
section when furnished via telehealth under section 
1834(m)(4)(C)(ii)(VII) of the Act.
    (13) Those chemotherapy items identified, as of July 1, 1999, by 
HCPCS codes J9000-J9020; J9040-J9151; J9170-J9185; J9200-J9201; J9206-
J9208; J9211; J9230-J9245; and J9265-J9600; and, as of January 1, 2004, 
by HCPCS codes A9522, A9523, A9533, and A9534.
    (14) Those chemotherapy administration services identified, as of 
July 1, 1999, by HCPCS codes 36260-36262; 36489; 36530-36535; 36640; 
36823; and 96405-96542.
    (15) Those radioisotope services identified, as of July 1, 1999, by 
HCPCS codes 79030-79440.
    (16) Those customized prosthetic devices (including artificial limbs 
and their components) identified, as of July 1, 1999, by HCPCS codes 
L5050-L5340; L5500-L5611; L5613-L5986; L5988; L6050-L6370; L6400-6880; 
L6920-L7274; and L7362-L7366, which are delivered for a resident's use 
during a stay in the SNF and intended to be used by the resident after 
discharge from the SNF.
    (t) Hospitals that are not otherwise subject to the Occupational 
Safety and Health Act of 1970 (or a State occupational safety and health 
plan that is approved under section 18(b) of the Occupational Safety and 
Health Act) must comply with the bloodborne pathogens (BBP) standards 
under 29 CFR 1910.1030. A hospital that fails to comply with the BBP 
standards may be subject to a civil money penalty in accordance with 
section 17 of the Occupational Safety and Health Act of 1970,

[[Page 477]]

including any adjustments of the civil money penalty amounts under the 
Federal Civil Penalties Inflation Adjustment Act, for a violation of the 
BBP standards. A civil money penalty will be imposed and collected in 
the same manner as civil money penalties under section 1128A(a) of the 
Social Security Act.
    (u) Except as provided in paragraph (v) of this section, in the case 
of a physician-owned hospital as defined at Sec.  489.3--
    (1) To furnish written notice to each patient at the beginning of 
the patient's hospital stay or outpatient visit that the hospital is a 
physician-owned hospital, in order to assist the patient in making an 
informed decision regarding his or her care, in accordance with Sec.  
482.13(b)(2) of this subchapter. The notice should disclose, in a manner 
reasonably designed to be understood by all patients, the fact that the 
hospital meets the Federal definition of a physician-owned hospital 
specified in Sec.  489.3 and that the list of the hospital's owners or 
investors who are physicians or immediate family members (as defined at 
Sec.  411.351 of this chapter) of physicians is available upon request 
and must be provided to the patient at the time the request for the list 
is made by or on behalf of the patient. For purposes of this paragraph 
(u)(1), the hospital stay or outpatient visit begins with the provision 
of a package of information regarding scheduled preadmission testing and 
registration for a planned hospital admission for inpatient care or an 
outpatient service.
    (2) To require each physician who is a member of the hospital's 
medical staff to agree, as a condition of continued medical staff 
membership or admitting privileges, to disclose, in writing, to all 
patients the physician refers to the hospital any ownership or 
investment interest in the hospital that is held by the physician or by 
an immediate family member (as defined at Sec.  411.351 of this chapter) 
of the physician. Disclosure must be required at the time the referral 
is made.
    (v) The requirements of paragraph (u) of this section do not apply 
to any physician-owned hospital that does not have at least one 
referring physician (as defined at Sec.  411.351 of this chapter) who 
has an ownership or investment interest in the hospital or who has an 
immediate family member who has an ownership or investment interest in 
the hospital, provided that such hospital signs an attestation statement 
to that effect and maintains such attestation in its records.
    (w) In the case of a hospital as defined in Sec.  489.24(b), to 
furnish written notice to all patients at the beginning of their 
hospital stay or outpatient visit if a doctor of medicine or a doctor of 
osteopathy is not present in the hospital 24 hours per day, 7 days per 
week, in order to assist the patients in making informed decisions 
regarding their care, in accordance with Sec.  482.13(b)(2) of this 
subchapter. The notice must indicate how the hospital will meet the 
medical needs of any patient who develops an emergency medical 
condition, as defined in Sec.  489.24(b), at a time when there is no 
physician present in the hospital. For purposes of this paragraph, the 
hospital stay or outpatient visit begins with the provision of a package 
of information regarding scheduled preadmission testing and registration 
for a planned hospital admission for inpatient care or outpatient 
service.
    (x) To comply with Sec.  488.30 of this chapter, to pay revisit user 
fees when and if assessed.

[45 FR 22937, Apr. 4, 1980, as amended at 48 FR 39837, Sept. 1, 1983; 49 
FR 323, Jan. 3, 1984; 54 FR 41747, Oct. 11, 1989; 57 FR 36018, Aug. 12, 
1992; 58 FR 30677, May 26, 1993; 59 FR 32120, June 22, 1994; 60 FR 
63189, Dec. 8, 1995; 62 FR 46037, Aug. 29, 1997; 63 FR 26312, May 12, 
1998; 65 FR 18548, Apr. 7, 2000; 65 FR 46796, July 31, 2000; 66 FR 
39601, July 31, 2001; 68 FR 16669, Apr. 4, 2003; 68 FR 43942, July 25, 
2003; 68 FR 46072, Aug. 4, 2003; 69 FR 49272, Aug. 11, 2004; 70 FR 
45055, Aug. 4, 2005; 71 FR 9471, Feb. 24, 2006; 72 FR 47413, Aug. 22, 
2007; 72 FR 53649, Sept. 19, 2007; 73 FR 48757, Aug. 19, 2008; 73 FR 
69942, Nov. 19, 2008]

    Effective Date Note: At 59 FR 32120, June 22, 1994, in Sec.  489.20, 
paragraphs (l) through (r) were added. Paragraphs (m), (r)(2) and (r)(3) 
contain information collection and recordkeeping requirements and will 
not become effective until approval has been given by the Office of 
Management and Budget.



Sec.  489.21  Specific limitations on charges.

    Except as specified in subpart C of this part, the provider agrees 
not to

[[Page 478]]

charge a beneficiary for any of the following:
    (a) Services for which the beneficiary is entitled to have payment 
made under Medicare.
    (b) Services for which the beneficiary would be entitled to have 
payment made if the provider--
    (1) Had in its files the required certification and recertification 
by a physician relating to the services furnished to the beneficiary;
    (2) Had furnished the information required by the intermediary in 
order to determine the amount due the provider on behalf of the 
individual for the period with respect to which payment is to be made or 
any prior period;
    (3) Had complied with the provisions requiring timely utilization 
review of long stay cases so that a limitation on days of service has 
not been imposed under section 1866(d) of the Act (see subpart K of part 
405 and part 482 of this chapter for utilization review requirements); 
and
    (4) Had obtained, from the beneficiary or a person acting on his or 
her behalf, a written request for payment to be made to the provider, 
and had properly filed that request. (If the beneficiary or person on 
his or her behalf refuses to execute a written request, the provider may 
charge the beneficiary for all services furnished to him or her.)
    (c) Inpatient hospital services furnished to a beneficiary who 
exhausted his or her Part A benefits, if CMS reimburses the provider for 
those services.
    (d) Custodial care and services not reasonable and necessary for the 
diagnosis or treatment of illness or injury, if--
    (1) The beneficiary was without fault in incurring the expenses; and
    (2) The determination that payment was incorrect was not made until 
after the third year following the year in which the payment notice was 
sent to the beneficiary.
    (e) Inpatient hospital services for which a beneficiary would be 
entitled to have payment made under Part A of Medicare but for a denial 
or reduction in payments under regulations at Sec.  412.48 of this 
chapter or under section 1886(f) of the Act.
    (f) Items and services furnished to a hospital inpatient (other than 
physicians' services as described in Sec.  415.102(a) of this chapter or 
the services of an anesthetist as described in Sec.  405.553(b)(4) of 
this chapter) for which Medicare payment would be made if furnished by 
the hospital or by other providers or suppliers under arrangements made 
with them by the hospital. For this purpose, a charge by another 
provider or supplier for such an item or service is treated as a charge 
by the hospital for the item or service, and is also prohibited.
    (g) [Reserved]
    (h) Items and services (other than those described in Sec. Sec.  
489.20(s)(1) through (15)) required to be furnished under Sec.  
489.20(s) to a resident of an SNF (defined in Sec.  411.15(p) of this 
chapter), for which Medicare payment would be made if furnished by the 
SNF or by other providers or suppliers under arrangements made with them 
by the SNF. For this purpose, a charge by another provider or supplier 
for such an item or service is treated as a charge by the SNF for the 
item or service, and is also prohibited.

[49 FR 324, Jan. 3, 1984, as amended at 51 FR 22052, June 17, 1986; 52 
FR 27765, July 23, 1987; 60 FR 63189, Dec. 8, 1995; 64 FR 41683, July 
30, 1999; 65 FR 46796, July 31, 2000; 65 FR 62646, Oct. 19, 2000; 66 FR 
39601, July 31, 2001]



Sec.  489.22  Special provisions applicable to prepayment requirements.

    (a) A provider may not require an individual entitled to hospital 
insurance benefits to prepay in part or in whole for inpatient services 
as a condition of admittance as an inpatient, except where it is clear 
upon admission that payment under Medicare, Part A cannot be made.
    (b) A provider may not deny covered inpatient services to an 
individual entitled to have payment made for those services on the 
ground of inability or failure to pay a requested amount at or before 
admission.
    (c) A provider may not evict, or threaten to evict, an individual 
for inability to pay a deductible or a coinsurance amount required under 
Medicare.
    (d) A provider may not charge an individual for (1) its agreement to 
admit

[[Page 479]]

or readmit the individual on some specified future date for covered 
inpatient services; or (2) for failure to remain an inpatient for any 
agreed-upon length of time or for failure to give advance notice of 
departure from the provider's facilities.

[45 FR 22937, Apr. 4, 1980, as amended at 68 FR 46072, Aug. 4, 2003]



Sec.  489.23  Specific limitation on charges for services provided to certain enrollees of fee-for-service FEHB plans.

    A provider that furnishes inpatient hospital services to a retired 
Federal worker age 65 or older who is enrolled in a fee-for-service FEHB 
plan and who is not covered under Medicare Part A, must accept, as 
payment in full, an amount that approximates as closely as possible the 
Medicare inpatient hospital prospective payment system (PPS) rate 
established under part 412. The payment to the provider is composed of a 
payment from the FEHB plan and a payment from the enrollee. This 
combined payment approximates the Medicare PPS rate. The payment from 
the FEHB plan approximates, as closely as possible, the Medicare PPS 
rate minus any applicable enrollee deductible, coinsurance, or copayment 
amount. The payment from the enrollee is equal to the applicable 
deductible, coinsurance, or copayment amount.

[62 FR 56111, Oct. 29, 1997]



Sec.  489.24  Special responsibilities of Medicare hospitals in emergency cases.

    (a) Applicability of provisions of this section. (1) In the case of 
a hospital that has an emergency department, if an individual (whether 
or not eligible for Medicare benefits and regardless of ability to pay) 
``comes to the emergency department'', as defined in paragraph (b) of 
this section, the hospital must--
    (i) Provide an appropriate medical screening examination within the 
capability of the hospital's emergency department, including ancillary 
services routinely available to the emergency department, to determine 
whether or not an emergency medical condition exists. The examination 
must be conducted by an individual(s) who is determined qualified by 
hospital bylaws or rules and regulations and who meets the requirements 
of Sec.  482.55 of this chapter concerning emergency services personnel 
and direction; and
    (ii) If an emergency medical condition is determined to exist, 
provide any necessary stabilizing treatment, as defined in paragraph (d) 
of this section, or an appropriate transfer as defined in paragraph (e) 
of this section. If the hospital admits the individual as an inpatient 
for further treatment, the hospital's obligation under this section 
ends, as specified in paragraph (d)(2) of this section.
    (2)(i) When a waiver has been issued in accordance with section 1135 
of the Act that includes a waiver under section 1135(b)(3) of the Act, 
sanctions under this section for an inappropriate transfer or for the 
direction or relocation of an individual to receive medical screening at 
an alternate location do not apply to a hospital with a dedicated 
emergency department if the following conditions are met:
    (A) The transfer is necessitated by the circumstances of the 
declared emergency in the emergency area during the emergency period.
    (B) The direction or relocation of an individual to receive medical 
screening at an alternate location is pursuant to an appropriate State 
emergency preparedness plan or, in the case of a public health emergency 
that involves a pandemic infectious disease, pursuant to a State 
pandemic preparedness plan.
    (C) The hospital does not discriminate on the basis of an 
individual's source of payment or ability to pay.
    (D) The hospital is located in an emergency area during an emergency 
period, as those terms are defined in section 1135(g)(1) of the Act.
    (E) There has been a determination that a waiver of sanctions is 
necessary.
    (ii) A waiver of these sanctions is limited to a 72-hour period 
beginning upon the implementation of a hospital disaster protocol, 
except that, if a public health emergency involves a pandemic infectious 
disease (such as pandemic influenza), the waiver will continue in effect 
until the termination of the applicable declaration of a public

[[Page 480]]

health emergency, as provided under section 1135(e)(1)(B) of the Act.
    (b) Definitions. As used in this subpart--
    Capacity means the ability of the hospital to accommodate the 
individual requesting examination or treatment of the transferred 
individual. Capacity encompasses such things as numbers and availability 
of qualified staff, beds and equipment and the hospital's past practices 
of accommodating additional patients in excess of its occupancy limits.
    Comes to the emergency department means, with respect to an 
individual who is not a patient (as defined in this section), the 
individual--
    (1) Has presented at a hospital's dedicated emergency department, as 
defined in this section, and requests examination or treatment for a 
medical condition, or has such a request made on his or her behalf. In 
the absence of such a request by or on behalf of the individual, a 
request on behalf of the individual will be considered to exist if a 
prudent layperson observer would believe, based on the individual's 
appearance or behavior, that the individual needs examination or 
treatment for a medical condition;
    (2) Has presented on hospital property, as defined in this section, 
other than the dedicated emergency department, and requests examination 
or treatment for what may be an emergency medical condition, or has such 
a request made on his or her behalf. In the absence of such a request by 
or on behalf of the individual, a request on behalf of the individual 
will be considered to exist if a prudent layperson observer would 
believe, based on the individual's appearance or behavior, that the 
individual needs emergency examination or treatment;
    (3) Is in a ground or air ambulance owned and operated by the 
hospital for purposes of examination and treatment for a medical 
condition at a hospital's dedicated emergency department, even if the 
ambulance is not on hospital grounds. However, an individual in an 
ambulance owned and operated by the hospital is not considered to have 
``come to the hospital's emergency department'' if--
    (i) The ambulance is operated under communitywide emergency medical 
service (EMS) protocols that direct it to transport the individual to a 
hospital other than the hospital that owns the ambulance; for example, 
to the closest appropriate facility. In this case, the individual is 
considered to have come to the emergency department of the hospital to 
which the individual is transported, at the time the individual is 
brought onto hospital property;
    (ii) The ambulance is operated at the direction of a physician who 
is not employed or otherwise affiliated with the hospital that owns the 
ambulance; or
    (4) Is in a ground or air nonhospital-owned ambulance on hospital 
property for presentation for examination and treatment for a medical 
condition at a hospital's dedicated emergency department. However, an 
individual in a nonhospital-owned ambulance off hospital property is not 
considered to have come to the hospital's emergency department, even if 
a member of the ambulance staff contacts the hospital by telephone or 
telemetry communications and informs the hospital that they want to 
transport the individual to the hospital for examination and treatment. 
The hospital may direct the ambulance to another facility if it is in 
``diversionary status,'' that is, it does not have the staff or 
facilities to accept any additional emergency patients. If, however, the 
ambulance staff disregards the hospital's diversion instructions and 
transports the individual onto hospital property, the individual is 
considered to have come to the emergency department.
    Dedicated emergency department means any department or facility of 
the hospital, regardless of whether it is located on or off the main 
hospital campus, that meets at least one of the following requirements:
    (1) It is licensed by the State in which it is located under 
applicable State law as an emergency room or emergency department;
    (2) It is held out to the public (by name, posted signs, 
advertising, or other means) as a place that provides care for emergency 
medical conditions on an urgent basis without requiring a previously 
scheduled appointment; or

[[Page 481]]

    (3) During the calendar year immediately preceding the calendar year 
in which a determination under this section is being made, based on a 
representative sample of patient visits that occurred during that 
calendar year, it provides at least one-third of all of its outpatient 
visits for the treatment of emergency medical conditions on an urgent 
basis without requiring a previously scheduled appointment.
    Emergency medical condition means--
    (1) A medical condition manifesting itself by acute symptoms of 
sufficient severity (including severe pain, psychiatric disturbances 
and/or symptoms of substance abuse) such that the absence of immediate 
medical attention could reasonably be expected to result in--
    (i) Placing the health of the individual (or, with respect to a 
pregnant woman, the health of the woman or her unborn child) in serious 
jeopardy;
    (ii) Serious impairment to bodily functions; or
    (iii) Serious dysfunction of any bodily organ or part; or
    (2) With respect to a pregnant woman who is having contractions--
    (i) That there is inadequate time to effect a safe transfer to 
another hospital before delivery; or
    (ii) That transfer may pose a threat to the health or safety of the 
woman or the unborn child.
    Hospital includes a critical access hospital as defined in section 
1861(mm)(1) of the Act.
    Hospital property means the entire main hospital campus as defined 
in Sec.  413.65(b) of this chapter, including the parking lot, sidewalk, 
and driveway, but excluding other areas or structures of the hospital's 
main building that are not part of the hospital, such as physician 
offices, rural health centers, skilled nursing facilities, or other 
entities that participate separately under Medicare, or restaurants, 
shops, or other nonmedical facilities.
    Hospital with an emergency department means a hospital with a 
dedicated emergency department as defined in this paragraph (b).
    Inpatient means an individual who is admitted to a hospital for bed 
occupancy for purposes of receiving inpatient hospital services as 
described in Sec.  409.10(a) of this chapter with the expectation that 
he or she will remain at least overnight and occupy a bed even though 
the situation later develops that the individual can be discharged or 
transferred to another hospital and does not actually use a hospital bed 
overnight.
    Labor means the process of childbirth beginning with the latent or 
early phase of labor and continuing through the delivery of the 
placenta. A woman experiencing contractions is in true labor unless a 
physician, certified nurse-midwife, or other qualified medical person 
acting within his or her scope of practice as defined in hospital 
medical staff bylaws and State law, certifies that, after a reasonable 
time of observation, the woman is in false labor.
    Participating hospital means (1) a hospital or (2) a critical access 
hospital as defined in section 1861(mm)(1) of the Act that has entered 
into a Medicare provider agreement under section 1866 of the Act.
    Patient means--
    (1) An individual who has begun to receive outpatient services as 
part of an encounter, as defined in Sec.  410.2 of this chapter, other 
than an encounter that the hospital is obligated by this section to 
provide;
    (2) An individual who has been admitted as an inpatient, as defined 
in this section.
    Stabilized means, with respect to an ``emergency medical condition'' 
as defined in this section under paragraph (1) of that definition, that 
no material deterioration of the condition is likely, within reasonable 
medical probability, to result from or occur during the transfer of the 
individual from a facility or, with respect to an ``emergency medical 
condition'' as defined in this section under paragraph (2) of that 
definition, that the woman has delivered the child and the placenta.
    To stabilize means, with respect to an ``emergency medical 
condition'' as defined in this section under paragraph (1) of that 
definition, to provide such medical treatment of the condition necessary 
to assure, within reasonable medical probability, that no material 
deterioration of the condition is likely to result from or occur during 
the

[[Page 482]]

transfer of the individual from a facility or that, with respect to an 
``emergency medical condition'' as defined in this section under 
paragraph (2) of that definition, the woman has delivered the child and 
the placenta.
    Transfer means the movement (including the discharge) of an 
individual outside a hospital's facilities at the direction of any 
person employed by (or affiliated or associated, directly or indirectly, 
with) the hospital, but does not include such a movement of an 
individual who (i) has been declared dead, or (ii) leaves the facility 
without the permission of any such person.
    (c) Use of dedicated emergency department for nonemergency services. 
If an individual comes to a hospital's dedicated emergency department 
and a request is made on his or her behalf for examination or treatment 
for a medical condition, but the nature of the request makes it clear 
that the medical condition is not of an emergency nature, the hospital 
is required only to perform such screening as would be appropriate for 
any individual presenting in that manner, to determine that the 
individual does not have an emergency medical condition.
    (d) Necessary stabilizing treatment for emergency medical 
conditions--(1) General. Subject to the provisions of paragraph (d)(2) 
of this section, if any individual (whether or not eligible for Medicare 
benefits) comes to a hospital and the hospital determines that the 
individual has an emergency medical condition, the hospital must provide 
either--
    (i) Within the capabilities of the staff and facilities available at 
the hospital, for further medical examination and treatment as required 
to stabilize the medical condition.
    (ii) For transfer of the individual to another medical facility in 
accordance with paragraph (e) of this section.
    (2) Exception: Application to inpatients. (i) If a hospital has 
screened an individual under paragraph (a) of this section and found the 
individual to have an emergency medical condition, and admits that 
individual as an inpatient in good faith in order to stabilize the 
emergency medical condition, the hospital has satisfied its special 
responsibilities under this section with respect to that individual.
    (ii) This section is not applicable to an inpatient who was admitted 
for elective (nonemergency) diagnosis or treatment.
    (iii) A hospital is required by the conditions of participation for 
hospitals under Part 482 of this chapter to provide care to its 
inpatients in accordance with those conditions of participation.
    (3) Refusal to consent to treatment. A hospital meets the 
requirements of paragraph (d)(1)(i) of this section with respect to an 
individual if the hospital offers the individual the further medical 
examination and treatment described in that paragraph and informs the 
individual (or a person acting on the individual's behalf) of the risks 
and benefits to the individual of the examination and treatment, but the 
individual (or a person acting on the individual's behalf) does not 
consent to the examination or treatment. The medical record must contain 
a description of the examination, treatment, or both if applicable, that 
was refused by or on behalf of the individual. The hospital must take 
all reasonable steps to secure the individual's written informed refusal 
(or that of the person acting on his or her behalf). The written 
document should indicate that the person has been informed of the risks 
and benefits of the examination or treatment, or both.
    (4) Delay in examination or treatment. (i) A participating hospital 
may not delay providing an appropriate medical screening examination 
required under paragraph (a) of this section or further medical 
examination and treatment required under paragraph (d)(1) of this 
section in order to inquire about the individual's method of payment or 
insurance status.
    (ii) A participating hospital may not seek, or direct an individual 
to seek, authorization from the individual's insurance company for 
screening or stabilization services to be furnished by a hospital, 
physician, or nonphysician practitioner to an individual until after the 
hospital has provided the appropriate medical screening examination 
required under paragraph (a) of this section, and initiated any further

[[Page 483]]

medical examination and treatment that may be required to stabilize the 
emergency medical condition under paragraph (d)(1) of this section.
    (iii) An emergency physician or nonphysician practitioner is not 
precluded from contacting the individual's physician at any time to seek 
advice regarding the individual's medical history and needs that may be 
relevant to the medical treatment and screening of the patient, as long 
as this consultation does not inappropriately delay services required 
under paragraph (a) or paragraphs (d)(1) and (d)(2) of this section.
    (iv) Hospitals may follow reasonable registration processes for 
individuals for whom examination or treatment is required by this 
section, including asking whether an individual is insured and, if so, 
what that insurance is, as long as that inquiry does not delay screening 
or treatment. Reasonable registration processes may not unduly 
discourage individuals from remaining for further evaluation.
    (5) Refusal to consent to transfer. A hospital meets the 
requirements of paragraph (d)(1)(ii) of this section with respect to an 
individual if the hospital offers to transfer the individual to another 
medical facility in accordance with paragraph (e) of this section and 
informs the individual (or a person acting on his or her behalf) of the 
risks and benefits to the individual of the transfer, but the individual 
(or a person acting on the individual's behalf) does not consent to the 
transfer. The hospital must take all reasonable steps to secure the 
individual's written informed refusal (or that of a person acting on his 
or her behalf). The written document must indicate the person has been 
informed of the risks and benefits of the transfer and state the reasons 
for the individual's refusal. The medical record must contain a 
description of the proposed transfer that was refused by or on behalf of 
the individual.
    (e) Restricting transfer until the individual is stabilized--(1) 
General. If an individual at a hospital has an emergency medical 
condition that has not been stabilized (as defined in paragraph (b) of 
this section), the hospital may not transfer the individual unless--
    (i) The transfer is an appropriate transfer (within the meaning of 
paragraph (e)(2) of this section); and
    (ii)(A) The individual (or a legally responsible person acting on 
the individual's behalf) requests the transfer, after being informed of 
the hospital's obligations under this section and of the risk of 
transfer. The request must be in writing and indicate the reasons for 
the request as well as indicate that he or she is aware of the risks and 
benefits of the transfer;
    (B) A physician (within the meaning of section 1861(r)(1) of the 
Act) has signed a certification that, based upon the information 
available at the time of transfer, the medical benefits reasonably 
expected from the provision of appropriate medical treatment at another 
medical facility outweigh the increased risks to the individual or, in 
the case of a woman in labor, to the woman or the unborn child, from 
being transferred. The certification must contain a summary of the risks 
and benefits upon which it is based; or
    (C) If a physician is not physically present in the emergency 
department at the time an individual is transferred, a qualified medical 
person (as determined by the hospital in its by-laws or rules and 
regulations) has signed a certification described in paragraph 
(e)(1)(ii)(B) of this section after a physician (as defined in section 
1861(r)(1) of the Act) in consultation with the qualified medical 
person, agrees with the certification and subsequently countersigns the 
certification. The certification must contain a summary of the risks and 
benefits upon which it is based.
    (2) A transfer to another medical facility will be appropriate only 
in those cases in which--
    (i) The transferring hospital provides medical treatment