[Title 42 CFR ]
[Code of Federal Regulations (annual edition) - October 1, 2017 Edition]
[From the U.S. Government Publishing Office]



[[Page i]]

          

          Title 42

Public Health


________________________

Part 482 to End

                         Revised as of October 1, 2017

          Containing a codification of documents of general 
          applicability and future effect

          As of October 1, 2017
                    Published by the Office of the Federal Register 
                    National Archives and Records Administration as a 
                    Special Edition of the Federal Register

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                            Table of Contents



                                                                    Page
  Explanation.................................................       v

  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                  981
  Finding Aids:
      Table of CFR Titles and Chapters........................    1095
      Alphabetical List of Agencies Appearing in the CFR......    1115
      List of CFR Sections Affected...........................    1125

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

                     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 v]]



                               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 
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    To determine whether a Code volume has been amended since its 
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OMB CONTROL NUMBERS

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collection request.

[[Page vi]]

Many agencies have begun publishing numerous OMB control numbers as 
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[[Page vii]]

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    Oliver A. Potts,
    Director,
    Office of the Federal Register.
    October 1, 2017.

                                
                                      
                            

  

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                               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, 2017.

    For this volume, Gabrielle E. Burns was Chief Editor. The Code of 
Federal Regulations publication program is under the direction of John 
Hyrum Martinez, assisted by Stephen J. Frattini.

[[Page 1]]



                         TITLE 42--PUBLIC HEALTH




                  (This book contains 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, 69 FR 18803, Apr. 9, 
2004, and 77 FR 29028, May 16, 2012.

                SUBCHAPTER G--STANDARDS AND CERTIFICATION
Part                                                                Page
482             Conditions of participation for hospitals...           5
483             Requirements for States and long term care 
                    facilities..............................          48
484             Home health services........................         149
485             Conditions of participation: Specialized 
                    providers...............................         192
486             Conditions for coverage of specialized 
                    services furnished by suppliers.........         242
488             Survey, certification, and enforcement 
                    procedures..............................         264
489             Provider agreements and supplier approval...         572
491             Certification of certain health facilities..         606
493             Laboratory requirements.....................         613
494             Conditions for coverage for end-stage renal 
                    disease facilities......................         735
495             Standards for the Electronic Health Record 
                    Technology Incentive Program............         754
498             Appeals procedures for determinations that 
                    affect participation in the Medicare 
                    program and for determinations that 
                    affect the participation of ICFs/IID and 
                    certain NFs in the Medicaid program.....         848
       SUBCHAPTER H--HEALTH CARE INFRASTRUCTURE AND MODEL PROGRAMS
505             Establishment of the health care 
                    infrastructure improvement program......         867
510             Comprehensive care for joint replacement 
                    model...................................         870

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512             Episode payment model.......................         910
                   SUBCHAPTER I--BASIC HEALTH PROGRAM
600             Administration, eligibility, essential 
                    health benefits, performance standards, 
                    service delivery requirements, premium 
                    and cost sharing, allotments, and 
                    reconciliation..........................         961
601-699         [Reserved]

[[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.
482.15  Condition of participation: Emergency preparedness.

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

             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.
482.68  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.
482.78  Condition of participation: Emergency preparedness for 
          transplant centers.

  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.

[[Page 6]]

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

    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 Secs. 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.

    There must be an effective governing body that is legally 
responsible for the conduct of the hospital. 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.
    (8) Ensure that, when telemedicine services are furnished to the 
hospital's patients through an agreement with a distant-site hospital, 
the agreement is written and that it specifies that it is the 
responsibility of the governing body of the distant-site hospital to 
meet the requirements in paragraphs (a)(1) through (a)(7) of this 
section with regard to the distant-site hospital's physicians and 
practitioners providing telemedicine services. The governing body of the 
hospital whose patients are receiving the telemedicine services may, in 
accordance with Sec. 482.22(a)(3) of this part, grant privileges based 
on its medical staff recommendations that rely on information provided 
by the distant-site hospital.
    (9) Ensure that when telemedicine services are furnished to the 
hospital's patients through an agreement with a distant-site 
telemedicine entity, the written agreement specifies that the distant-
site telemedicine entity is a contractor of services to the hospital and 
as such, in accordance with Sec. 482.12(e), furnishes the contracted 
services in a manner that permits the hospital to comply with all 
applicable conditions of participation for the contracted services, 
including, but not limited to, the requirements in paragraphs (a)(1) 
through (a)(7) of this section with regard to the distant-site 
telemedicine entity's physicians and practitioners providing 
telemedicine services. The governing body of the hospital whose patients 
are receiving the telemedicine services may, in accordance with 
Sec. 482.22(a)(4) of this part, grant privileges to physicians and 
practitioners employed by the distant-site telemedicine entity based on 
such hospital's medical staff recommendations; such staff 
recommendations may rely on information provided by the distant-site 
telemedicine entity.
    (10) Consult directly with the individual assigned the 
responsibility for the organization and conduct of the hospital's 
medical staff, or his or her designee. At a minimum, this direct 
consultation must occur periodically throughout the fiscal or calendar 
year and include discussion of matters related to the quality of medical 
care provided to patients of the hospital. For a multi-hospital system 
using a single governing body, the single multi-hospital system 
governing body must consult directly with the individual responsible for 
the organized medical staff (or his or her designee) of each hospital 
within its system in addition to the other requirements of this 
paragraph (a).
    (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:

[[Page 8]]

    (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:
    (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

[[Page 9]]

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 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; 76 FR 25562, May 5, 2011; 77 FR 29074, May 16, 2012; 79 FR 27154, 
May 12, 2014]



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.

[[Page 10]]

    (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--
    (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

[[Page 11]]

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 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

[[Page 12]]

    (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 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) With the exception of deaths described under paragraph (g)(2) of 
this section, the hospital must report the following information to CMS 
by telephone, facsimile, or electronically, as determined by CMS, no 
later than the close of business on the next business day following 
knowledge of the patient's death:
    (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, regardless of the type(s) of restraint 
used on the patient during this time. ``Reasonable to assume'' in this 
context includes, but is not limited to,

[[Page 13]]

deaths related to restrictions of movement for prolonged periods of 
time, or death related to chest compression, restriction of breathing, 
or asphyxiation.
    (2) When no seclusion has been used and when the only restraints 
used on the patient are those applied exclusively to the patient's 
wrist(s), and which are composed solely of soft, non-rigid, cloth-like 
materials, the hospital staff must record in an internal log or other 
system, the following information:
    (i) Any death that occurs while a patient is in such restraints.
    (ii) Any death that occurs within 24 hours after a patient has been 
removed from such restraints.
    (3) The staff must document in the patient's medical record the date 
and time the death was:
    (i) Reported to CMS for deaths described in paragraph (g)(1) of this 
section; or
    (ii) Recorded in the internal log or other system for deaths 
described in paragraph (g)(2) of this section.
    (4) For deaths described in paragraph (g)(2) of this section, 
entries into the internal log or other system must be documented as 
follows:
    (i) Each entry must be made not later than seven days after the date 
of death of the patient.
    (ii) Each entry must document the patient's name, date of birth, 
date of death, name of attending physician or other licensed independent 
practitioner who is responsible for the care of the patient as specified 
under Sec. 482.12(c), medical record number, and primary diagnosis(es).
    (iii) The information must be made available in either written or 
electronic form to CMS immediately upon request.
    (h) Standard: Patient visitation rights. A hospital must have 
written policies and procedures regarding the visitation rights of 
patients, including those setting forth any clinically necessary or 
reasonable restriction or limitation that the hospital may need to place 
on such rights and the reasons for the clinical restriction or 
limitation. A hospital must meet the following requirements:
    (1) Inform each patient (or support person, where appropriate) of 
his or her visitation rights, including any clinical restriction or 
limitation on such rights, when he or she is informed of his or her 
other rights under this section.
    (2) Inform each patient (or support person, where appropriate) of 
the right, subject to his or her consent, to receive the visitors whom 
he or she designates, including, but not limited to, a spouse, a 
domestic partner (including a same-sex domestic partner), another family 
member, or a friend, and his or her right to withdraw or deny such 
consent at any time.
    (3) Not restrict, limit, or otherwise deny visitation privileges on 
the basis of race, color, national origin, religion, sex, gender 
identity, sexual orientation, or disability.
    (4) Ensure that all visitors enjoy full and equal visitation 
privileges consistent with patient preferences.

[71 FR 71426, Dec. 8, 2006, as amended at 75 FR 70844, Nov. 19, 2010; 77 
FR 29074, May 16, 2012]



Sec. 482.15  Condition of participation: Emergency preparedness.

    The hospital must comply with all applicable Federal, State, and 
local emergency preparedness requirements. The hospital must develop and 
maintain a comprehensive emergency preparedness program that meets the 
requirements of this section, utilizing an all-hazards approach. The 
emergency preparedness program must include, but not be limited to, the 
following elements:
    (a) Emergency plan. The hospital must develop and maintain an 
emergency preparedness plan that must be reviewed, and updated at least 
annually. The plan must do the following:
    (1) Be based on and include a documented, facility-based and 
community-based risk assessment, utilizing an all-hazards approach.
    (2) Include strategies for addressing emergency events identified by 
the risk assessment.
    (3) Address patient population, including, but not limited to, 
persons at-risk; the type of services the hospital has the ability to 
provide in an emergency; and continuity of operations, including 
delegations of authority and succession plans.

[[Page 14]]

    (4) Include a process for cooperation and collaboration with local, 
tribal, regional, State, and Federal emergency preparedness officials' 
efforts to maintain an integrated response during a disaster or 
emergency situation, including documentation of the hospital's efforts 
to contact such officials and, when applicable, its participation in 
collaborative and cooperative planning efforts.
    (b) Policies and procedures. The hospital must develop and implement 
emergency preparedness policies and procedures, based on the emergency 
plan set forth in paragraph (a) of this section, risk assessment at 
paragraph (a)(1) of this section, and the communication plan at 
paragraph (c) of this section. The policies and procedures must be 
reviewed and updated at least annually. At a minimum, the policies and 
procedures must address the following:
    (1) The provision of subsistence needs for staff and patients, 
whether they evacuate or shelter in place, include, but are not limited 
to the following:
    (i) Food, water, medical, and pharmaceutical supplies.
    (ii) Alternate sources of energy to maintain the following:
    (A) Temperatures to protect patient health and safety and for the 
safe and sanitary storage of provisions.
    (B) Emergency lighting.
    (C) Fire detection, extinguishing, and alarm systems.
    (D) Sewage and waste disposal.
    (2) A system to track the location of on-duty staff and sheltered 
patients in the hospital's care during an emergency. If on-duty staff 
and sheltered patients are relocated during the emergency, the hospital 
must document the specific name and location of the receiving facility 
or other location.
    (3) Safe evacuation from the hospital, which includes consideration 
of care and treatment needs of evacuees; staff responsibilities; 
transportation; identification of evacuation location(s); and primary 
and alternate means of communication with external sources of 
assistance.
    (4) A means to shelter in place for patients, staff, and volunteers 
who remain in the facility.
    (5) A system of medical documentation that preserves patient 
information, protects confidentiality of patient information, and 
secures and maintains the availability of records.
    (6) The use of volunteers in an emergency and other emergency 
staffing strategies, including the process and role for integration of 
State and Federally designated health care professionals to address 
surge needs during an emergency.
    (7) The development of arrangements with other hospitals and other 
providers to receive patients in the event of limitations or cessation 
of operations to maintain the continuity of services to hospital 
patients.
    (8) The role of the hospital under a waiver declared by the 
Secretary, in accordance with section 1135 of the Act, in the provision 
of care and treatment at an alternate care site identified by emergency 
management officials.
    (c) Communication plan. The hospital must develop and maintain an 
emergency preparedness communication plan that complies with Federal, 
State, and local laws and must be reviewed and updated at least 
annually. The communication plan must include all of the following:
    (1) Names and contact information for the following:
    (i) Staff.
    (ii) Entities providing services under arrangement.
    (iii) Patients' physicians.
    (iv) Other hospitals and CAHs
    (v) Volunteers.
    (2) Contact information for the following:
    (i) Federal, State, tribal, regional, and local emergency 
preparedness staff.
    (ii) Other sources of assistance.
    (3) Primary and alternate means for communicating with the 
following:
    (i) Hospital's staff.
    (ii) Federal, State, tribal, regional, and local emergency 
management agencies.
    (4) A method for sharing information and medical documentation for 
patients under the hospital's care, as necessary, with other health care 
providers to maintain the continuity of care.

[[Page 15]]

    (5) A means, in the event of an evacuation, to release patient 
information as permitted under 45 CFR 164.510(b)(1)(ii).
    (6) A means of providing information about the general condition and 
location of patients under the facility's care as permitted under 45 CFR 
164.510(b)(4).
    (7) A means of providing information about the hospital's occupancy, 
needs, and its ability to provide assistance, to the authority having 
jurisdiction, the Incident Command Center, or designee.
    (d) Training and testing. The hospital must develop and maintain an 
emergency preparedness training and testing program that is based on the 
emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program must be 
reviewed and updated at least annually.
    (1) Training program. The hospital must do all of the following:
    (i) Initial training in emergency preparedness policies and 
procedures to all new and existing staff, individuals providing services 
under arrangement, and volunteers, consistent with their expected role.
    (ii) Provide emergency preparedness training at least annually.
    (iii) Maintain documentation of the training.
    (iv) Demonstrate staff knowledge of emergency procedures.
    (2) Testing. The hospital must conduct exercises to test the 
emergency plan at least annually. The hospital must do all of the 
following:
    (i) Participate in a full-scale exercise that is community-based or 
when a community-based exercise is not accessible, an individual, 
facility-based. If the hospital experiences an actual natural or man-
made emergency that requires activation of the emergency plan, the 
hospital is exempt from engaging in a community-based or individual, 
facility-based full-scale exercise for 1 year following the onset of the 
actual event.
    (ii) Conduct an additional exercise that may include, but is not 
limited to the following:
    (A) A second full-scale exercise that is community-based or 
individual, facility-based.
    (B) A tabletop exercise that includes a group discussion led by a 
facilitator, using a narrated, clinically-relevant emergency scenario, 
and a set of problem statements, directed messages, or prepared 
questions designed to challenge an emergency plan.
    (iii) Analyze the hospital's response to and maintain documentation 
of all drills, tabletop exercises, and emergency events, and revise the 
hospital's emergency plan, as needed.
    (e) Emergency and standby power systems. The hospital must implement 
emergency and standby power systems based on the emergency plan set 
forth in paragraph (a) of this section and in the policies and 
procedures plan set forth in paragraphs (b)(1)(i) and (ii) of this 
section.
    (1) Emergency generator location. The generator must be located in 
accordance with the location requirements found in the Health Care 
Facilities Code (NFPA 99 and Tentative Interim Amendments TIA 12-2, TIA 
12-3, TIA 12-4, TIA 12-5, and TIA 12-6), Life Safety Code (NFPA 101 and 
Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-
4), and NFPA 110, when a new structure is built or when an existing 
structure or building is renovated.
    (2) Emergency generator inspection and testing. The hospital must 
implement the emergency power system inspection, testing, and 
maintenance requirements found in the Health Care Facilities Code, NFPA 
110, and Life Safety Code.
    (3) Emergency generator fuel. Hospitals that maintain an onsite fuel 
source to power emergency generators must have a plan for how it will 
keep emergency power systems operational during the emergency, unless it 
evacuates.
    (f) Integrated healthcare systems. If a hospital is part of a 
healthcare system consisting of multiple separately certified healthcare 
facilities that elects to have a unified and integrated emergency 
preparedness program, the hospital may choose to participate in the 
healthcare system's coordinated emergency preparedness program. If 
elected,

[[Page 16]]

the unified and integrated emergency preparedness program must--
    (1) Demonstrate that each separately certified facility within the 
system actively participated in the development of the unified and 
integrated emergency preparedness program.
    (2) Be developed and maintained in a manner that takes into account 
each separately certified facility's unique circumstances, patient 
populations, and services offered.
    (3) Demonstrate that each separately certified facility is capable 
of actively using the unified and integrated emergency preparedness 
program and is in compliance with the program.
    (4) Include a unified and integrated emergency plan that meets the 
requirements of paragraphs (a)(2), (3), and (4) of this section. The 
unified and integrated emergency plan must also be based on and include 
the following:
    (i) A documented community-based risk assessment, utilizing an all-
hazards approach.
    (ii) A documented individual facility-based risk assessment for each 
separately certified facility within the health system, utilizing an 
all-hazards approach.
    (5) Include integrated policies and procedures that meet the 
requirements set forth in paragraph (b) of this section, a coordinated 
communication plan and training and testing programs that meet the 
requirements of paragraphs (c) and (d) of this section, respectively.
    (g) Transplant hospitals. If a hospital has one or more transplant 
centers (as defined in Sec. 482.70)--
    (1) A representative from each transplant center must be included in 
the development and maintenance of the hospital's emergency preparedness 
program; and
    (2) The hospital must develop and maintain mutually agreed upon 
protocols that address the duties and responsibilities of the hospital, 
each transplant center, and the OPO for the DSA where the hospital is 
situated, unless the hospital has been granted a waiver to work with 
another OPO, during an emergency.
    (h) The standards incorporated by reference in this section are 
approved for incorporation by reference by the Director of the Office of 
the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 
51. You may obtain the material from the sources listed below. You may 
inspect a copy 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. If any 
changes in this edition of the Code are incorporated by reference, CMS 
will publish a document in the Federal Register to announce the changes.
    (1) National Fire Protection Association, 1 Batterymarch Park, 
Quincy, MA 02169, www.nfpa.org, 1.617.770.3000.
    (i) NFPA 99, Health Care Facilities Code, 2012 edition, issued 
August 11, 2011.
    (ii) Technical interim amendment (TIA) 12-2 to NFPA 99, issued 
August 11, 2011.
    (iii) TIA 12-3 to NFPA 99, issued August 9, 2012.
    (iv) TIA 12-4 to NFPA 99, issued March 7, 2013.
    (v) TIA 12-5 to NFPA 99, issued August 1, 2013.
    (vi) TIA 12-6 to NFPA 99, issued March 3, 2014.
    (vii) NFPA 101, Life Safety Code, 2012 edition, issued August 11, 
2011.
    (viii) TIA 12-1 to NFPA 101, issued August 11, 2011.
    (ix) TIA 12-2 to NFPA 101, issued October 30, 2012.
    (x) TIA 12-3 to NFPA 101, issued October 22, 2013.
    (xi) TIA 12-4 to NFPA 101, issued October 22, 2013.
    (xii) NFPA 110, Standard for Emergency and Standby Power Systems, 
2010 edition, including TIAs to chapter 7, issued August 6, 2009.
    (2) [Reserved]

[81 FR 64028, Sept. 16, 2016; 81 FR 80594, Nov. 16, 2016]

[[Page 17]]



                   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--
    (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,

[[Page 18]]

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 which is responsible 
for the quality of medical care provided to patients by the hospital.
    (a) Standard: Eligibility and process for appointment to medical 
staff. The medical staff must be composed of doctors of medicine or 
osteopathy. In accordance with State law, including scope-of-practice 
laws, the medical staff may also include other categories of physicians 
(as listed at Sec. 482.12(c)(1)) and non-physician practitioners who are 
determined to be eligible for appointment by the governing body.
    (1) The medical staff must periodically conduct appraisals of its 
members.
    (2) The medical staff must examine the credentials of all eligible 
candidates for medical staff membership and make recommendations to the 
governing body on the appointment of these candidates in accordance with 
State law, including scope-of-practice laws, and the medical staff 
bylaws, rules, and regulations. A candidate who has been recommended by 
the medical staff and who has been appointed by the governing body is 
subject to all medical staff bylaws, rules, and regulations, in addition 
to the requirements contained in this section.
    (3) When telemedicine services are furnished to the hospital's 
patients through an agreement with a distant-site hospital, the 
governing body of the hospital whose patients are receiving the 
telemedicine services may choose, in lieu of the requirements in 
paragraphs (a)(1) and (a)(2) of this section, to have its medical staff 
rely upon the credentialing and privileging decisions made by the 
distant-site hospital when making recommendations on privileges for the 
individual distant-site physicians and practitioners providing such 
services, if the hospital's governing body ensures, through its written 
agreement with the distant-site hospital, that all of the following 
provisions are met:
    (i) The distant-site hospital providing the telemedicine services is 
a Medicare-participating hospital.
    (ii) The individual distant-site physician or practitioner is 
privileged at the distant-site hospital providing the telemedicine 
services, which provides a current list of the distant-site physician's 
or practitioner's privileges at the distant-site hospital.
    (iii) The individual distant-site physician or practitioner holds a 
license issued or recognized by the State in which the hospital whose 
patients are receiving the telemedicine services is located.
    (iv) With respect to a distant-site physician or practitioner, who 
holds current privileges at the hospital whose patients are receiving 
the telemedicine services, the hospital has evidence of an internal 
review of the distant-site physician's or practitioner's performance of 
these privileges and sends the distant-site hospital such performance 
information for use in the periodic appraisal of the distant-site 
physician or practitioner. At a minimum, this information must include 
all adverse events that result from the telemedicine services provided 
by the distant-site physician or practitioner to the hospital's patients 
and all complaints the hospital has received about the distant-site 
physician or practitioner.
    (4) When telemedicine services are furnished to the hospital's 
patients through an agreement with a distant-site telemedicine entity, 
the governing body of the hospital whose patients are receiving the 
telemedicine services

[[Page 19]]

may choose, in lieu of the requirements in paragraphs (a)(1) and (a)(2) 
of this section, to have its medical staff rely upon the credentialing 
and privileging decisions made by the distant-site telemedicine entity 
when making recommendations on privileges for the individual distant-
site physicians and practitioners providing such services, if the 
hospital's governing body ensures, through its written agreement with 
the distant-site telemedicine entity, that the distant-site telemedicine 
entity furnishes services that, in accordance with Sec. 482.12(e), 
permit the hospital to comply with all applicable conditions of 
participation for the contracted services. The hospital's governing body 
must also ensure, through its written agreement with the distant-site 
telemedicine entity, that all of the following provisions are met:
    (i) The distant-site telemedicine entity's medical staff 
credentialing and privileging process and standards at least meet the 
standards at Sec. 482.12(a)(1) through (a)(7) and Sec. 482.22(a)(1) 
through (a)(2).
    (ii) The individual distant-site physician or practitioner is 
privileged at the distant-site telemedicine entity providing the 
telemedicine services, which provides the hospital with a current list 
of the distant-site physician's or practitioner's privileges at the 
distant-site telemedicine entity.
    (iii) The individual distant-site physician or practitioner holds a 
license issued or recognized by the State in which the hospital whose 
patients are receiving such telemedicine services is located.
    (iv) With respect to a distant-site physician or practitioner, who 
holds current privileges at the hospital whose patients are receiving 
the telemedicine services, the hospital has evidence of an internal 
review of the distant-site physician's or practitioner's performance of 
these privileges and sends the distant-site telemedicine entity such 
performance information for use in the periodic appraisal of the 
distant-site physician or practitioner. At a minimum, this information 
must include all adverse events that result from the telemedicine 
services provided by the distant-site physician or practitioner to the 
hospital's patients, and all complaints the hospital has received about 
the distant-site physician or practitioner.
    (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 one of the following:
    (i) An individual doctor of medicine or osteopathy.
    (ii) A doctor of dental surgery or dental medicine, when permitted 
by State law of the State in which the hospital is located.
    (iii) A doctor of podiatric medicine, when permitted by State law of 
the State in which the hospital is located.
    (4) If a hospital is part of a hospital system consisting of 
multiple separately certified hospitals and the system elects to have a 
unified and integrated medical staff for its member hospitals, after 
determining that such a decision is in accordance with all applicable 
State and local laws, each separately certified hospital must 
demonstrate that:
    (i) The medical staff members of each separately certified hospital 
in the system (that is, all medical staff members who hold specific 
privileges to practice at that hospital) have voted by majority, in 
accordance with medical staff bylaws, either to accept a unified and 
integrated medical staff structure or to opt out of such a structure and 
to maintain a separate and distinct medical staff for their respective 
hospital;
    (ii) The unified and integrated medical staff has bylaws, rules, and 
requirements that describe its processes for self-governance, 
appointment, credentialing, privileging, and oversight, as well as its 
peer review policies and due process rights guarantees, and

[[Page 20]]

which include a process for the members of the medical staff of each 
separately certified hospital (that is, all medical staff members who 
hold specific privileges to practice at that hospital) to be advised of 
their rights to opt out of the unified and integrated medical staff 
structure after a majority vote by the members to maintain a separate 
and distinct medical staff for their hospital;
    (iii) The unified and integrated medical staff is established in a 
manner that takes into account each member hospital's unique 
circumstances and any significant differences in patient populations and 
services offered in each hospital; and
    (iv) The unified and integrated medical staff establishes and 
implements policies and procedures to ensure that the needs and concerns 
expressed by members of the medical staff, at each of its separately 
certified hospitals, regardless of practice or location, are given due 
consideration, and that the unified and integrated medical staff has 
mechanisms in place to ensure that issues localized to particular 
hospitals are duly considered and addressed.
    (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. For distant-site physicians and 
practitioners requesting privileges to furnish telemedicine services 
under an agreement with the hospital, the criteria for determining 
privileges and the procedure for applying the criteria are also subject 
to the requirements in Sec. 482.12(a)(8) and (a)(9), and 
Sec. 482.22(a)(3) and (a)(4).
    (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; 76 FR 25563, May 
5, 2011; 77 FR 29074, May 16, 2012; 79 FR 27154, May 12, 2014]



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.

[[Page 21]]

    (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.
    (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. The nursing care 
plan may be part of an interdisciplinary care plan.
    (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. (1) 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.
    (i) Drugs and biologicals may be prepared and administered on the 
orders of other practitioners not specified under Sec. 482.12(c) only if 
such practitioners are acting in accordance with State law, including 
scope-of-practice laws, hospital policies, and medical staff bylaws, 
rules, and regulations.
    (ii) Drugs and biologicals may be prepared and administered on the 
orders contained within pre-printed and electronic standing orders, 
order sets, and protocols for patient orders only if such orders meet 
the requirements of Sec. 482.24(c)(3).
    (2) 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.
    (3) With the exception of influenza and pneumococcal 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 in accordance with State law and hospital policy, 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.
    (iii) Orders for drugs and biologicals may be documented and signed 
by other practitioners not specified under Sec. 482.12(c) only if such 
practitioners are acting in accordance with State law,

[[Page 22]]

including scope-of-practice laws, hospital policies, and medical staff 
bylaws, rules, and regulations.
    (4) Blood transfusions and intravenous medications must be 
administered in accordance with State law and approved medical staff 
policies and procedures.
    (5) There must be a hospital procedure for reporting transfusion 
reactions, adverse drug reactions, and errors in administration of 
drugs.
    (6) The hospital may allow a patient (or his or her caregiver/
support person where appropriate) to self-administer both hospital-
issued medications and the patient's own medications brought into the 
hospital, as defined and specified in the hospital's policies and 
procedures.
    (i) If the hospital allows a patient to self-administer specific 
hospital-issued medications, then the hospital must have policies and 
procedures in place to:
    (A) Ensure that a practitioner responsible for the care of the 
patient has issued an order, consistent with hospital policy, permitting 
self-administration.
    (B) Assess the capacity of the patient (or the patient's caregiver/
support person where appropriate) to self-administer the specified 
medication(s).
    (C) Instruct the patient (or the patient's caregiver/support person 
where appropriate) in the safe and accurate administration of the 
specified medication(s).
    (D) Address the security of the medication(s) for each patient.
    (E) Document the administration of each medication, as reported by 
the patient (or the patient's caregiver/support person where 
appropriate), in the patient's medical record.
    (ii) If the hospital allows a patient to self-administer his or her 
own specific medications brought into the hospital, then the hospital 
must have policies and procedures in place to:
    (A) Ensure that a practitioner responsible for the care of the 
patient has issued an order, consistent with hospital policy, permitting 
self-administration of medications the patient brought into the 
hospital.
    (B) Assess the capacity of the patient (or the patient's caregiver/
support person where appropriate) to self-administer the specified 
medication(s), and also determine if the patient (or the patient's 
caregiver/support person where appropriate) needs instruction in the 
safe and accurate administration of the specified medication(s).
    (C) Identify the specified medication(s) and visually evaluate the 
medication(s) for integrity.
    (D) Address the security of the medication(s) for each patient.
    (E) Document the administration of each medication, as reported by 
the patient (or the patient's caregiver/support person where 
appropriate), in the patient's medical record.

[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; 77 FR 29074, May 
16, 2012; 78 FR 50970, Aug. 19, 2013; 79 FR 44129, July 30, 2014]



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.

[[Page 23]]

    (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 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.
    (2) All orders, including verbal orders, must be dated, timed, and 
authenticated promptly by the ordering practitioner or by another 
practitioner who is responsible for the care of the patient only if such 
a practitioner is acting in accordance with State law, including scope-
of-practice laws, hospital policies, and medical staff bylaws, rules, 
and regulations.
    (3) Hospitals may use pre-printed and electronic standing orders, 
order sets, and protocols for patient orders only if the hospital:
    (i) Establishes that such orders and protocols have been reviewed 
and approved by the medical staff and the hospital's nursing and 
pharmacy leadership;
    (ii) Demonstrates that such orders and protocols are consistent with 
nationally recognized and evidence-based guidelines;
    (iii) Ensures that the periodic and regular review of such orders 
and protocols is conducted by the medical staff and the hospital's 
nursing and pharmacy leadership to determine the continuing usefulness 
and safety of the orders and protocols; and
    (iv) Ensures that such orders and protocols are dated, timed, and 
authenticated promptly in the patient's medical record by the ordering 
practitioner or by another practitioner responsible for the care of the 
patient only if such a practitioner is acting in accordance with State 
law, including scope-of-practice laws, hospital policies, and medical 
staff bylaws, rules, and regulations.
    (4) 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.

[[Page 24]]

    (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; 77 FR 29074, May 16, 2012]



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 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's quality assessment and 
performance improvement 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; 77 FR 29075, May 16, 2012]



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.

[[Page 25]]

    (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 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

[[Page 26]]

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 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 beneficiaries 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

[[Page 27]]

    (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 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 beneficiaries 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 beneficiaries 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.

[[Page 28]]

    (1) Individual patient nutritional needs must be met in accordance 
with recognized dietary practices.
    (2) All patient diets, including therapeutic diets, must be ordered 
by a practitioner responsible for the care of the patient, or by a 
qualified dietitian or qualified nutrition professional as authorized by 
the medical staff and in accordance with State law governing dietitians 
and nutrition professionals.
    (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.

[51 FR 22042, June 17, 1986, as amended at 79 FR 27154, May 12, 2014]



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 (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 Secs. 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--

[[Page 29]]

    (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 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 and must 
proceed in accordance with the Life Safety Code (NFPA 101 and Tentative 
Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4.) 
Outpatient surgical departments must meet the provisions applicable to 
Ambulatory Health Care Occupancies, regardless of the number of patients 
served.
    (ii) Notwithstanding paragraph (b)(1)(i) of this section, corridor 
doors and doors to rooms containing flammable or combustible materials 
must be provided with positive latching hardware. Roller latches are 
prohibited on such doors.
    (2) In consideration of a recommendation by the State survey agency 
or Accrediting Organization or at the discretion of the Secretary, may 
waive, for periods deemed appropriate, specific provisions of the Life 
Safety Code, which would result in unreasonable hardship upon a 
hospital, but only if the waiver will 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

[[Page 30]]

imposed by State law adequately protects patients in hospitals.
    (4) The hospital must have procedures for the proper routine storage 
and prompt disposal of trash.
    (5) 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.
    (6) The hospital must maintain written evidence of regular 
inspection and approval by State or local fire control agencies.
    (7) A hospital may install alcohol-based hand rub dispensers in its 
facility if the dispensers are installed in a manner that adequately 
protects against inappropriate access;
    (8) When a sprinkler system is shut down for more than 10 hours, the 
hospital must:
    (i) Evacuate the building or portion of the building affected by the 
system outage until the system is back in service, or
    (ii) Establish a fire watch until the system is back in service.
    (9) Buildings must have an outside window or outside door in every 
sleeping room, and for any building constructed after July 5, 2016 the 
sill height must not exceed 36 inches above the floor. Windows in atrium 
walls are considered outside windows for the purposes of this 
requirement.
    (i) The sill height requirement does not apply to newborn nurseries 
and rooms intended for occupancy for less than 24 hours.
    (ii) The sill height in special nursing care areas of new 
occupancies must not exceed 60 inches.
    (c) Standard: Building safety. Except as otherwise provided in this 
section, the hospital must meet the applicable provisions and must 
proceed in accordance with the Health Care Facilities Code (NFPA 99 and 
Tentative Interim Amendments TIA 12-2, TIA 12-3, TIA 12-4, TIA 12-5 and 
TIA 12-6).
    (1) Chapters 7, 8, 12, and 13 of the adopted Health Care Facilities 
Code do not apply to a hospital.
    (2) If application of the Health Care Facilities Code required under 
paragraph (c) of this section would result in unreasonable hardship for 
the hospital, CMS may waive specific provisions of the Health Care 
Facilities Code, but only if the waiver does not adversely affect the 
health and safety of patients.
    (d) 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.
    (e) The standards incorporated by reference in this section are 
approved for incorporation by reference by the Director of the Office of 
the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 
51. You may inspect a copy 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. If any changes in this edition of the Code are 
incorporated by reference, CMS will publish a document in the Federal 
Register to announce the changes.
    (1) National Fire Protection Association, 1 Batterymarch Park, 
Quincy, MA 02169, www.nfpa.org, 1.617.770.3000.
    (i) NFPA 99, Standards for Health Care Facilities Code of the 
National Fire Protection Association 99, 2012 edition, issued August 11, 
2011.
    (ii) TIA 12-2 to NFPA 99, issued August 11, 2011.
    (iii) TIA 12-3 to NFPA 99, issued August 9, 2012.
    (iv) TIA 12-4 to NFPA 99, issued March 7, 2013.
    (v) TIA 12-5 to NFPA 99, issued August 1, 2013.
    (vi) TIA 12-6 to NFPA 99, issued March 3, 2014.

[[Page 31]]

    (vii) NFPA 101, Life Safety Code, 2012 edition, issued August 11, 
2011;
    (viii) TIA 12-1 to NFPA 101, issued August 11, 2011.
    (ix) TIA 12-2 to NFPA 101, issued October 30, 2012.
    (x) TIA 12-3 to NFPA 101, issued October 22, 2013.
    (xi) TIA 12-4 to NFPA 101, issued October 22, 2013.
    (2) [Reserved]

[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; 81 FR 26899, May 4, 2016; 81 FR 
42548, June 30, 2016]



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. The infection control officer or officers must develop a 
system for identifying, reporting, investigating, and controlling 
infections and communicable diseases of patients and personnel.
    (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 assessment and performance 
improvement (QAPI) 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.

[51 FR 22042, June 17, 1986, as amended at 77 FR 29075, May 16, 2012; 79 
FR 10396, Feb. 25, 2014]



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 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

[[Page 32]]

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 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

[[Page 33]]

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 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.

[[Page 34]]

    (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 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

[[Page 35]]

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 
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.
    (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; 79 
FR 27154, May 12, 2014]



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 hospital must--
    (1) Assign one or more individuals to be responsible for outpatient 
services.
    (2) Have appropriate professional and nonprofessional personnel 
available at each location where outpatient services are offered, based 
on the scope and complexity of outpatient services.
    (c) Standard: Orders for outpatient services. Outpatient services 
must be ordered by a practitioner who meets the following conditions:
    (1) Is responsible for the care of the patient.
    (2) Is licensed in the State where he or she provides care to the 
patient.
    (3) Is acting within his or her scope of practice under State law.
    (4) Is authorized in accordance with State law and policies adopted 
by the medical staff, and approved by the governing body, to order the 
applicable outpatient services. This applies to the following:
    (i) All practitioners who are appointed to the hospital's medical 
staff and who have been granted privileges to order the applicable 
outpatient services.

[[Page 36]]

    (ii) All practitioners not appointed to the medical staff, but who 
satisfy the above criteria for authorization by the medical staff and 
the hospital for ordering the applicable outpatient services for their 
patients.

[51 FR 22042, June 17, 1986, as amended at 77 FR 29075, May 16, 2012; 79 
FR 27154, May 12, 2014]



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 only be provided 
under the orders of a qualified and licensed practitioner who is 
responsible for the care of the patient, acting within his or her scope 
of practice under State law, and who is authorized by the hospital's 
medical staff to order the services in accordance with hospital policies 
and procedures and State laws.
    (1) All rehabilitation services orders must be documented in the 
patient's medical record in accordance with the requirements at 
Sec. 482.24.
    (2) 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 of this chapter.

[51 FR 22042, June 17, 1986, as amended at 72 FR 66406, Nov. 27, 2007; 
75 FR 50418, Aug. 16, 2010]



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 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

[[Page 37]]

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 only be provided under the orders of a qualified 
and licensed practitioner who is responsible for the care of the 
patient, acting within his or her scope of practice under State law, and 
who is authorized by the hospital's medical staff to order the services 
in accordance with hospital policies and procedures and State laws.
    (4) All respiratory care services orders must be documented in the 
patient's medical record in accordance with the requirements at 
Sec. 482.24.

[51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986, as amended at 57 
FR 7136, Feb. 28, 1992; 75 FR 50418, Aug. 16, 2010]



Sec. 482.58  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)(7), (c)(1), (c)(2)(iii), (c)(6), 
(d), (e)(2), (e)(4), (f)(4)(ii), (f)(4)(iii), (f)(9), (h), (g)(8), 
(g)(17), and (g)(18) introductory text.
    (2) Admission, transfer, and discharge rights (Sec. 483.5 definition 
of transfer and discharge, Sec. 483.15(c)(1), (c)(2)(i), (c)(2)(ii), 
(c)(3), (c)(4), (c)(5), and (c)(7)).
    (3) Freedom from abuse, neglect, and exploitation 
(Sec. 483.12(a)(1), (a)(2), (a)(3)(i), (a)(3)(ii), (a)(4), (b)(1), 
(b)(2), (c)).
    (4) Patient activities (Sec. 483.24(c)).
    (5) Social services (Sec. 483.40(d) and 483.70(p)).
    (6) Discharge planning (Sec. 483.20(e)).
    (7) Specialized rehabilitative services (Sec. 483.65).
    (8) Dental services (Sec. 483.55).

[72 FR 60788, Oct. 26, 2007. Redesignated at 79 FR 27155, May 12, 2014, 
as amended at 81 FR 68847, Oct. 4, 2016; 82 FR 32258, July 13, 2017]



             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 Secs. 482.1 
through 482.23 and Secs. 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

[[Page 38]]

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
    (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;

[[Page 39]]

    (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 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.

[[Page 40]]

    (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. 482.68  Special requirement for transplant centers.

    A transplant center located within a hospital that has a Medicare 
provider agreement must meet the conditions of participation specified 
in Secs. 482.72 through 482.104 in order to be granted approval from CMS 
to provide transplant services.
    (a) Unless specified otherwise, the conditions of participation at 
Secs. 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 Secs. 482.72 through 482.104, a transplant center must also meet the 
conditions of participation in Secs. 482.1 through 482.57, except for 
Sec. 482.15.

[81 FR 64030, Sept. 16, 2016]



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 
beneficiaries; and unintended transmission of infectious disease to a 
beneficiary.
    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

[[Page 41]]

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 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) 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
    (3) 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.

[72 FR 15273, Mar. 30, 2007, as amended at 79 FR 27155, May 12, 2014]



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 Secs. 482.72 through 482.74 and 
Secs. 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 
Secs. 482.72 through 482.74 and Secs. 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

[[Page 42]]

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.



Sec. 482.78  Condition of participation: Emergency preparedness
for transplant centers.

    A transplant center must be included in the emergency preparedness 
planning and the emergency preparedness program as set forth in 
Sec. 482.15 for the hospital in which it is located. However, a 
transplant center is not individually responsible for the emergency 
preparedness requirements set forth in Sec. 482.15.
    (a) Standard: Policies and procedures. A transplant center must have 
policies and procedures that address emergency preparedness. These 
policies and procedures must be included in the hospital's emergency 
preparedness program.
    (b) Standard: Protocols with hospital and OPO. A transplant center 
must develop and maintain mutually agreed upon protocols that address 
the duties and responsibilities of the transplant center, the hospital 
in which the transplant center is operated, and the OPO designated by 
the Secretary, unless the hospital has an approved waiver to work with 
another OPO, during an emergency.

[81 FR 64030, Sept. 16, 2016]

  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 beneficiary 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. 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 Beneficiaries (SRTR) center-specific report.
    (2) 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 1.85.
    (d) Exceptions. (1) A heart-lung transplant center is not required 
to comply with the clinical experience requirements in paragraph (b) of 
this section

[[Page 43]]

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.

[72 FR 15273, Mar. 30, 2007, as amended at 79 FR 27155, May 12, 2014; 81 
FR 79880, Nov. 14, 2016]



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, 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 donors) performed during the prior 3 
years. 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 prior 3 years.
    (c) Standard: Outcome requirements. CMS will review outcomes for all 
transplants performed at a center, including outcomes for living donor 
transplants, if applicable. 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) 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 1.85.
    (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

[[Page 44]]

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.

[72 FR 15273, Mar. 30, 2007, as amended at 79 FR 27155, May 12, 2014; 81 
FR 79880, Nov. 14, 2016]

                 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 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-beneficiary 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 beneficiary.
    (a) 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 beneficiary.
    (b) 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 beneficiary immediately before the 
removal of the donor organ(s) and, if applicable, prior to the removal 
of the beneficiary 's organ(s).

[51 FR 22042, June 17, 1986, as amended at 77 FR 29076, May 16, 2012]



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

[[Page 45]]

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 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

[[Page 46]]

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 beneficiary 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 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

[[Page 47]]

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.
    (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 
beneficiary '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:

[[Page 48]]

    (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 
beneficiary;
    (5) The potential medical or psychosocial risks to the donor;
    (6) The national and transplant center-specific outcomes for 
beneficiaries, 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
    (9) The fact that if a transplant is not provided in a Medicare-
approved transplant center it could affect the transplant beneficiary'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  Freedom from abuse, neglect, and exploitation.

[[Page 49]]

483.15  Admission, transfer, and discharge rights.
483.20  Resident assessment.
483.21  Comprehensive person-centered care planning.
483.24  Quality of life.
483.25  Quality of care.
483.30  Physician services.
483.35  Nursing services.
483.40  Behavioral health services.
483.45  Pharmacy services.
483.50  Laboratory, radiology, and other diagnostic services.
483.55  Dental services.
483.60  Food and nutrition services.
483.65  Specialized rehabilitative services.
483.70  Administration.
483.73  Emergency preparedness.
483.75  Quality assurance and performance improvement.
483.80  Infection control.
483.85  Compliance and ethics program.
483.90  Physical environment.
483.95  Training requirements.

 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.
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 intellectual disability 
          requires specialized services (PASARR/IID).
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.
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.

[[Page 50]]

Subpart H [Reserved]

 Subpart I_Conditions of Participation for Intermediate Care Facilities 
             for Individuals with Intellectual Disabilities

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.
483.475  Condition of participation: Emergency preparedness.
483.480  Condition of participation: Dietetic services.

    Authority: Secs. 1102, 1128I, 1819, 1871 and 1919 of the Social 
Security Act (42 U.S.C. 1302, 1320a-7, 1395i, 1395hh and 1396r).

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), (d), and (f) of 
the Act provide that--
    (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), (d), and (f) of the Act provide that 
nursing facilities participating in Medicaid must meet certain specific 
requirements.
    (4) Sections 1128I(b) and (c) require that--
    (i) Skilled nursing facilities or nursing facility have in operation 
a compliance and ethics program that is effective in preventing and 
detecting criminal, civil, and administrative violations.
    (ii) The Secretary establish and implement a quality assurance and 
performance improvement program for facilities, including multi-unit 
chains of facilities.
    (5) Section 1150B establishes requirements for reporting to law 
enforcement crimes occurring in federally funded LTC facilities.
    (b) Scope. The provisions of this part contain the requirements that 
an institution must meet in order to qualify to participate as a Skilled 
Nursing Facility 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; 81 FR 68848, Oct. 4, 2016]



Sec. 483.5  Definitions.

    As used in this subpart, the following definitions apply:
    Abuse. Abuse is the willful infliction of injury, unreasonable 
confinement, intimidation, or punishment with resulting physical harm, 
pain or mental anguish. Abuse also includes the deprivation by an 
individual, including a caretaker, of goods or services that are 
necessary to attain or maintain physical, mental, and psychosocial well-
being. Instances of abuse of all residents, irrespective of any mental 
or physical condition, cause physical harm, pain or mental anguish. It 
includes verbal abuse, sexual abuse, physical abuse, and mental abuse 
including abuse facilitated or enabled through the use of technology. 
Willful, as used in this definition of abuse, means the individual must 
have acted deliberately, not that the individual must have intended to 
inflict injury or harm.
    Adverse event. An adverse event is an untoward, undesirable, and 
usually unanticipated event that causes death or serious injury, or the 
risk thereof.

[[Page 51]]

    Common area. Common areas are areas in the facility where residents 
may gather together with other residents, visitors, and staff or engage 
in individual pursuits, apart from their residential rooms. This 
includes but is not limited to living rooms, dining rooms, activity 
rooms, outdoor areas, and meeting rooms where residents are located on a 
regular basis.
    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 
specified in the definition of ``distinct part'' 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.
    (v) Use of composite distinct parts to segregate residents by 
payment source or on a basis other than care needs is prohibited.
    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 (2) of this definition, 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 comprise 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 with the main buildings but are located within close 
proximity to 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 specified in the definition of ``composite distinct part'' 
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 52]]

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.
    Exploitation. Exploitation means taking advantage of a resident for 
personal gain through the use of manipulation, intimidation, threats, or 
coercion.
    Facility. 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 
individuals with intellectual disabilities 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.
    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.
    Licensed health professional. A licensed health professional is 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; or registered respiratory therapist or 
certified respiratory therapy technician.
    Major modification means the modification of more than 50 percent, 
or more than 4,500 square feet, of the smoke compartment.
    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.
    Mistreatment means inappropriate treatment or exploitation of a 
resident.
    Neglect is the failure of the facility, its employees or service 
providers to provide goods and services to a resident that are necessary 
to avoid physical harm, pain, mental anguish, or emotional distress.
    Nurse aide. A nurse aide is any individual providing nursing or 
nursing-related services to residents in a facility. This term may also 
include an individual who provides these services through an agency or 
under a contract with the facility, but is not a licensed health 
professional, a registered dietitian, or someone who volunteers to

[[Page 53]]

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.
    Person-centered care. For purposes of this subpart, person-centered 
care means to focus on the resident as the locus of control and support 
the resident in making their own choices and having control over their 
daily lives.
    Resident representative. For purposes of this subpart, the term 
resident representative means any of the following:
    (1) An individual chosen by the resident to act on behalf of the 
resident in order to support the resident in decision-making; access 
medical, social or other personal information of the resident; manage 
financial matters; or receive notifications;
    (2) A person authorized by State or Federal law (including but not 
limited to agents under power of attorney, representative payees, and 
other fiduciaries) to act on behalf of the resident in order to support 
the resident in decision-making; access medical, social or other 
personal information of the resident; manage financial matters; or 
receive notifications;
    (3) Legal representative, as used in section 712 of the Older 
Americans Act; or.
    (4) The court-appointed guardian or conservator of a resident.
    (5) Nothing in this rule is intended to expand the scope of 
authority of any resident representative beyond that authority 
specifically authorized by the resident, State or Federal law, or a 
court of competent jurisdiction.
    Sexual abuse is non-consensual sexual contact of any type with a 
resident.
    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.

[68 FR 46071, Aug. 4, 2003, as amended at 71 FR 39229, July 12, 2006; 71 
FR 55340, Sept. 22, 2006; 79 FR 27155, May 12, 2014; 81 FR 68848, Oct. 
4, 2016; 82 FR 32259, July 13, 2017]



Sec. 483.10  Resident rights.

    (a) Residents 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, including those 
specified in this section.
    (1) A facility must treat each resident with respect and dignity and 
care for each resident in a manner and in an environment that promotes 
maintenance or enhancement of his or her quality of life, recognizing 
each resident's individuality. The facility must protect and promote the 
rights of the resident.
    (2) The facility must provide equal access to quality care 
regardless of diagnosis, severity of condition, or payment source. A 
facility must establish and maintain identical policies and practices 
regarding transfer, discharge, and the provision of services under the 
State plan for all residents regardless of payment source.
    (b) Exercise of rights. 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.
    (1) The facility must ensure that the resident can exercise his or 
her rights without interference, coercion, discrimination, or reprisal 
from the facility
    (2) The resident has the right to be free of interference, coercion, 
discrimination, and reprisal from the facility in exercising his or her 
rights and to be supported by the facility in the exercise of his or her 
rights as required under this subpart.
    (3) In the case of a resident who has not been adjudged incompetent 
by the state court, the resident has the right to designate a 
representative, in accordance with State law and any legal surrogate so 
designated may exercise the resident's rights to the extent provided by 
state law. The same-sex spouse of a resident must be afforded treatment 
equal to that afforded to an opposite-sex spouse if the marriage was 
valid in the jurisdiction in which it was celebrated.
    (i) The resident representative has the right to exercise the 
resident's rights to the extent those rights are delegated to the 
resident representative.
    (ii) The resident retains the right to exercise those rights not 
delegated to a

[[Page 54]]

resident representative, including the right to revoke a delegation of 
rights, except as limited by State law.
    (4) The facility must treat the decisions of a resident 
representative as the decisions of the resident to the extent required 
by the court or delegated by the resident, in accordance with applicable 
law.
    (5) The facility shall not extend the resident representative the 
right to make decisions on behalf of the resident beyond the extent 
required by the court or delegated by the resident, in accordance with 
applicable law.
    (6) If the facility has reason to believe that a resident 
representative is making decisions or taking actions that are not in the 
best interests of a resident, the facility shall report such concerns in 
the manner required under State law.
    (7) 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 
devolve to and are exercised by the resident representative appointed 
under State law to act on the resident's behalf. The court-appointed 
resident representative exercises the resident's rights to the extent 
judged necessary by a court of competent jurisdiction, in accordance 
with State law
    (i) In the case of a resident representative whose decision-making 
authority is limited by State law or court appointment, the resident 
retains the right to make those decision outside the representative's 
authority.
    (ii) The resident's wishes and preferences must be considered in the 
exercise of rights by the representative.
    (iii) To the extent practicable, the resident must be provided with 
opportunities to participate in the care planning process.
    (c) Planning and implementing care. The resident has the right to be 
informed of, and participate in, his or her treatment, including:
    (1) 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.
    (2) The right to participate in the development and implementation 
of his or her person-centered plan of care, including but not limited 
to:
    (i) The right to participate in the planning process, including the 
right to identify individuals or roles to be included in the planning 
process, the right to request meetings and the right to request 
revisions to the person-centered plan of care.
    (ii) The right to participate in establishing the expected goals and 
outcomes of care, the type, amount, frequency, and duration of care, and 
any other factors related to the effectiveness of the plan of care.
    (iii) The right to be informed, in advance, of changes to the plan 
of care.
    (iv) The right to receive the services and/or items included in the 
plan of care.
    (v) The right to see the care plan, including the right to sign 
after significant changes to the plan of care.
    (3) The facility shall inform the resident of the right to 
participate in his or her treatment and shall support the resident in 
this right. The planning process must--
    (i) Facilitate the inclusion of the resident and/or resident 
representative.
    (ii) Include an assessment of the resident's strengths and needs.
    (iii) Incorporate the resident's personal and cultural preferences 
in developing goals of care.
    (4) The right to be informed, in advance, of the care to be 
furnished and the type of care giver or professional that will furnish 
care.
    (5) The right to be informed in advance, by the physician or other 
practitioner or professional, of the risks and benefits of proposed 
care, of treatment and treatment alternatives or treatment options and 
to choose the alternative or option he or she prefers.
    (6) The right to request, refuse, and/or discontinue treatment, to 
participate in or refuse to participate in experimental research, and to 
formulate an advance directive.
    (7) The right to self-administer medications if the 
interdisciplinary team, as defined by Sec. 483.21(b)(2)(ii), has 
determined that this practice is clinically appropriate.

[[Page 55]]

    (8) Nothing in this paragraph should be construed as the right of 
the resident to receive the provision of medical treatment or medical 
services deemed medically unnecessary or inappropriate.
    (d) Choice of attending physician. The resident has the right to 
choose his or her attending physician.
    (1) The physician must be licensed to practice, and
    (2) If the physician chosen by the resident refuses to or does not 
meet requirements specified in this part, the facility may seek 
alternate physician participation as specified in paragraphs (d)(4) and 
(5) of this section to assure provision of appropriate and adequate care 
and treatment.
    (3) The facility must ensure that each resident remains informed of 
the name, specialty, and way of contacting the physician and other 
primary care professionals responsible for his or her care.
    (4) The facility must inform the resident if the facility determines 
that the physician chosen by the resident is unable or unwilling to meet 
requirements specified in this part and the facility seeks alternate 
physician participation to assure provision of appropriate and adequate 
care and treatment. The facility must discuss the alternative physician 
participation with the resident and honor the resident's preferences, if 
any, among options.
    (5) If the resident subsequently selects another attending physician 
who meets the requirements specified in this part, the facility must 
honor that choice.
    (e) Respect and dignity. The resident has a right to be treated with 
respect and dignity, including:
    (1) 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, consistent with 
Sec. 483.12(a)(2).
    (2) The right to retain and use personal possessions, including 
furnishings, and clothing, as space permits, unless to do so would 
infringe upon the rights or health and safety of other residents.
    (3) The right to reside and receive services in the facility with 
reasonable accommodation of resident needs and preferences except when 
to do so would endanger the health or safety of the resident or other 
residents.
    (4) 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.
    (5) The right to share a room with his or her roommate of choice 
when practicable, when both residents live in the same facility and both 
residents consent to the arrangement.
    (6) The right to receive written notice, including the reason for 
the change, before the resident's room or roommate in the facility is 
changed.
    (7) The right to refuse to transfer to another room in the facility, 
if the purpose of the transfer is:
    (i) To relocate 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) to relocate 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.
    (iii) solely for the convenience of staff.
    (8) A resident's exercise of the right to refuse transfer does not 
affect the resident's eligibility or entitlement to Medicare or Medicaid 
benefits.
    (f) Self-determination. The resident has the right to and the 
facility must promote and facilitate resident self-determination through 
support of resident choice, including but not limited to the rights 
specified in paragraphs (f)(1) through (11) of this section.
    (1) The resident has a right to choose activities, schedules 
(including sleeping and waking times), health care and providers of 
health care services consistent with his or her interests, assessments, 
plan of care and other applicable provisions of this part.
    (2) The resident has the right to make choices about aspects of his 
or her life in the facility that are significant to the resident.
    (3) The resident has a right to interact with members of the 
community and participate in community activities both inside and 
outside the facility.
    (4) The resident has a right to receive visitors of his or her 
choosing at the

[[Page 56]]

time of his or her choosing, subject to the resident's right to deny 
visitation when applicable, and in a manner that does not impose on the 
rights of another resident.
    (i) The facility must provide immediate access to any resident by--
    (A) Any representative of the Secretary,
    (B) Any representative of the State,
    (C) Any representative of the Office of the State long term care 
ombudsman, (established under section 712 of the Older Americans Act of 
1965, as amended 2016 (42 U.S.C. 3001 et seq.),
    (D) The resident's individual physician,
    (E) Any representative of the protection and advocacy systems, as 
designated by the state, and as established under the Developmental 
Disabilities Assistance and Bill of Rights Act of 2000 (42 U.S.C. 15001 
et seq.),
    (F) Any representative of the agency responsible for the protection 
and advocacy system for individuals with a mental disorder (established 
under the Protection and Advocacy for Mentally Ill Individuals Act of 
2000 (42 U.S.C. 10801 et seq.), and
    (G) The resident representative.
    (ii) The facility must provide immediate access to a resident by 
immediate family and other relatives of the resident, subject to the 
resident's right to deny or withdraw consent at any time;
    (iii) The facility must provide immediate access to a resident by 
others who are visiting with the consent of the resident, subject to 
reasonable clinical and safety restrictions and the resident's right to 
deny or withdraw consent at any time;
    (iv) The facility must provide reasonable access to a 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; and
    (v) The facility must have written policies and procedures regarding 
the visitation rights of residents, including those setting forth any 
clinically necessary or reasonable restriction or limitation or safety 
restriction or limitation, when such limitations may apply consistent 
with the requirements of this subpart, that the facility may need to 
place on such rights and the reasons for the clinical or safety 
restriction or limitation.
    (vi) A facility must meet the following requirements:
    (A) Inform each resident (or resident representative, where 
appropriate) of his or her visitation rights and related facility policy 
and procedures, including any clinical or safety restriction or 
limitation on such rights, consistent with the requirements of this 
subpart, the reasons for the restriction or limitation, and to whom the 
restrictions apply, when he or she is informed of his or her other 
rights under this section.
    (B) Inform each resident of the right, subject to his or her 
consent, to receive the visitors whom he or she designates, including, 
but not limited to, a spouse (including a same-sex spouse), a domestic 
partner (including a same-sex domestic partner), another family member, 
or a friend, and his or her right to withdraw or deny such consent at 
any time.
    (C) Not restrict, limit, or otherwise deny visitation privileges on 
the basis of race, color, national origin, religion, sex, gender 
identity, sexual orientation, or disability.
    (D) Ensure that all visitors enjoy full and equal visitation 
privileges consistent with resident preferences.
    (5) The resident has a right to organize and participate in resident 
groups in the facility.
    (i) The facility must provide a resident or family group, if one 
exists, with private space; and take reasonable steps, with the approval 
of the group, to make residents and family members aware of upcoming 
meetings in a timely manner.
    (ii) Staff, visitors, or other guests may attend resident group or 
family group meetings only at the respective group's invitation.
    (iii) The facility must provide a designated staff person who is 
approved by the resident or family group and the facility and who is 
responsible for providing assistance and responding to written requests 
that result from group meetings.
    (iv) The facility must consider the views of a resident or family 
group and act promptly upon the grievances and

[[Page 57]]

recommendations of such groups concerning issues of resident care and 
life in the facility.
    (A) The facility must be able to demonstrate their response and 
rationale for such response.
    (B) This should not be construed to mean that the facility must 
implement as recommended every request of the resident or family group.
    (6) The resident has a right to participate in family groups.
    (7) The resident has a right to have family member(s) or other 
resident representative(s) meet in the facility with the families or 
resident representative(s) of other residents in the facility.
    (8) The resident has a right to participate in other activities, 
including social, religious, and community activities that do not 
interfere with the rights of other residents in the facility.
    (9) The resident has a right to choose to or refuse to perform 
services for the facility and the facility must not require a resident 
to perform services for the facility. The resident may perform services 
for the facility, if he or she chooses, when--
    (i) The facility has documented the resident's 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;
    (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.
    (10) The resident has a right to manage his or her financial 
affairs. This includes the right to know, in advance, what charges a 
facility may impose against a resident's personal funds.
    (i) The facility must not require residents to deposit their 
personal funds with the facility. If a resident chooses to deposit 
personal funds with the facility, upon written authorization of a 
resident, the facility must act as a fiduciary of the resident's funds 
and hold, safeguard, manage, and account for the personal funds of the 
resident deposited with the facility, as specified in this section.
    (ii) Deposit of funds. (A) In general: Except as set out in 
paragraph (f)(10)(ii)(B) of this section, the facility must deposit any 
residents' personal funds in excess of $100 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.) The facility must maintain a 
resident's personal funds that do not exceed $100 in a non-interest 
bearing account, interest-bearing account, or petty cash fund.
    (B) Residents whose care is funded by Medicaid: The facility must 
deposit the residents' personal funds in excess of $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.) The facility must 
maintain personal funds that do not exceed $50 in a non-interest bearing 
account, interest-bearing account, or petty cash fund.
    (iii) Accounting and records. (A) 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.
    (B) The system must preclude any commingling of resident funds with 
facility funds or with the funds of any person other than another 
resident.
    (C) The individual financial record must be available to the 
resident through quarterly statements and upon request.
    (iv) Notice of certain balances. The facility must notify each 
resident that receives Medicaid benefits--
    (A) 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
    (B) 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.

[[Page 58]]

    (v) Conveyance upon discharge, eviction, or death. Upon the 
discharge, eviction, or 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 
resident, or in the case of death, the individual or probate 
jurisdiction administering the resident's estate, in accordance with 
State law.
    (vi) 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.
    (11) The facility must 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 of this chapter, 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 must not 
charge a resident for the following categories of items and services:
    (A) Nursing services as required at Sec. 483.35.
    (B) Food and Nutrition services as required at Sec. 483.60.
    (C) An activities program as required at Sec. 483.24(c).
    (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 
assistance, and basic personal laundry.
    (F) Medically-related social services as required at Sec. 483.40(d).
    (G) Hospice services elected by the resident and paid for under the 
Medicare Hospice Benefit or paid for by Medicaid under a state plan.
    (ii) Items and services that may be charged to residents' funds. 
Paragraphs (f)(11)(ii)(A) through (L) of this section 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 they 
are not required to achieve the goals stated in the resident's care 
plan, if the facility informs the resident that there will be a charge, 
and if payment is not made by Medicare or Medicaid:
    (A) Telephone, including a cellular phone.
    (B) Television/radio, personal computer or other electronic device 
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) Cost to participate in social events and entertainment outside 
the scope of the activities program, provided under Sec. 483.24(c).
    (J) Non-covered special care services such as privately hired nurses 
or aides.
    (K) Private room, except when therapeutically required (for example, 
isolation for infection control).
    (L) Except as provided in (e)(11)(ii)(L)(1) and (2) of this section, 
specially prepared or alternative food requested instead of the food and 
meals generally prepared by the facility, as required by Sec. 483.60.

[[Page 59]]

    (1) The facility may not charge for special foods and meals, 
including medically prescribed dietary supplements, ordered by the 
resident's physician, physician assistant, nurse practitioner, or 
clinical nurse specialist, as these are included in accordance with 
Sec. 483.60.
    (2) In accordance with Sec. 483.60(c) through (f), when preparing 
foods and meals, a facility must take into consideration residents' 
needs and preferences and the overall cultural and religious make-up of 
the facility's population.
    (iii) Requests for items and services. (A) The facility can only 
charge a resident for any non-covered item or service if such item or 
service is specifically requested by the resident.
    (B) The facility must not require a resident to request any item or 
service as a condition of admission or continued stay.
    (C) The facility must inform, orally and in writing, the resident 
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.
    (g) Information and communication. (1) The resident has the right to 
be informed of his or her rights and of all rules and regulations 
governing resident conduct and responsibilities during his or her stay 
in the facility.
    (2) The resident has the right to access personal and medical 
records pertaining to him or herself.
    (i) The facility must provide the resident with access to personal 
and medical records pertaining to him or herself, upon an oral or 
written request, in the form and format requested by the individual, if 
it is readily producible in such form and format (including in an 
electronic form or format when such records are maintained 
electronically); or, if not, in a readable hard copy form or such other 
form and format as agreed to by the facility and the individual, within 
24 hours (excluding weekends and holidays); and
    (ii) The facility must allow the resident to obtain a copy of the 
records or any portions thereof (including in an electronic form or 
format when such records are maintained electronically) upon request and 
2 working days advance notice to the facility. The facility may impose a 
reasonable, cost-based fee on the provision of copies, provided that the 
fee includes only the cost of:
    (A) Labor for copying the records requested by the individual, 
whether in paper or electronic form;
    (B) Supplies for creating the paper copy or electronic media if the 
individual requests that the electronic copy be provided on portable 
media; and
    (C) Postage, when the individual has requested the copy be mailed.
    (3) With the exception of information described in paragraphs (g)(2) 
and (g)(11) of this section, the facility must ensure that information 
is provided to each resident in a form and manner the resident can 
access and understand, including in an alternative format or in a 
language that the resident can understand. Summaries that translate 
information described in paragraph (g)(2) of this section may be made 
available to the patient at their request and expense in accordance with 
applicable law.
    (4) The resident has the right to receive notices orally (meaning 
spoken) and in writing (including Braille) in a format and a language he 
or she understands, including;
    (i) Required notices as specified in this section. The facility must 
furnish to each resident a written description of legal rights which 
includes--
    (A) A description of the manner of protecting personal funds, under 
paragraph (f)(10) of this section;
    (B) A description of the requirements and procedures for 
establishing eligibility for Medicaid, including the right to request an 
assessment of resources under section 1924(c) of the Social Security 
Act.
    (C) A list of names, addresses (mailing and email), and telephone 
numbers of all pertinent State regulatory and informational agencies, 
resident advocacy groups such as the State Survey Agency, the State 
licensure office, the State Long-Term Care Ombudsman program, the 
protection and advocacy agency, adult protective services where state 
law provides for jurisdiction in

[[Page 60]]

long-term care facilities, the local contact agency for information 
about returning to the community and the Medicaid Fraud Control Unit; 
and
    (D) A statement that the resident may file a complaint with the 
State Survey Agency concerning any suspected violation of state or 
federal nursing facility regulations, including but not limited to 
resident abuse, neglect, exploitation, misappropriation of resident 
property in the facility, non-compliance with the advance directives 
requirements and requests for information regarding returning to the 
community.
    (ii) Information and contact information for State and local 
advocacy organizations, including but not limited to the State Survey 
Agency, the State Long-Term Care Ombudsman program (established under 
section 712 of the Older Americans Act of 1965, as amended 2016 (42 
U.S.C. 3001 et seq.) and the protection and advocacy system (as 
designated by the state, and as established under the Developmental 
Disabilities Assistance and Bill of Rights Act of 2000 (42 U.S.C. 15001 
et seq.);
    (iii) Information regarding Medicare and Medicaid eligibility and 
coverage;
    (iv) Contact information for the Aging and Disability Resource 
Center (established under Section 202(a)(20)(B)(iii) of the Older 
Americans Act); or other No Wrong Door Program
    (v) Contact information for the Medicaid Fraud Control Unit; and
    (vi) Information and contact information for filing grievances or 
complaints concerning any suspected violation of state or federal 
nursing facility regulations, including but not limited to resident 
abuse, neglect, exploitation, misappropriation of resident property in 
the facility, non-compliance with the advance directives requirements 
and requests for information regarding returning to the community.
    (5) The facility must post, in a form and manner accessible and 
understandable to residents, and resident representatives:
    (i) A list of names, addresses (mailing and email), and telephone 
numbers of all pertinent State agencies and advocacy groups, such as the 
State Survey Agency, the State licensure office, adult protective 
services where state law provides for jurisdiction in long-term care 
facilities, the Office of the State Long-Term Care Ombudsman program, 
the protection and advocacy network, home and community based service 
programs, and the Medicaid Fraud Control Unit; and
    (ii) A statement that the resident may file a complaint with the 
State Survey Agency concerning any suspected violation of state or 
federal nursing facility regulations, including but not limited to 
resident abuse, neglect, exploitation, misappropriation of resident 
property in the facility, non-compliance with the advance directives 
requirements (42 CFR part 489 subpart I) and requests for information 
regarding returning to the community.
    (6) The resident has the right to have reasonable access to the use 
of a telephone, including TTY and TDD services, and a place in the 
facility where calls can be made without being overheard. This includes 
the right to retain and use a cellular phone at the resident's own 
expense.
    (7) The facility must protect and facilitate that resident's right 
to communicate with individuals and entities within and external to the 
facility, including reasonable access to:
    (i) A telephone, including TTY and TDD services;
    (ii) The internet, to the extent available to the facility; and
    (iii) Stationery, postage, writing implements and the ability to 
send mail.
    (8) The resident has the right to send and receive mail, and to 
receive letters, packages and other materials delivered to the facility 
for the resident through a means other than a postal service, including 
the right to:
    (i) Privacy of such communications consistent with this section; and
    (ii) Access to stationery, postage, and writing implements at the 
resident's own expense.
    (9) The resident has the right to have reasonable access to and 
privacy in their use of electronic communications such as email and 
video communications and for Internet research.
    (i) If the access is available to the facility
    (ii) At the resident's expense, if any additional expense is 
incurred by the

[[Page 61]]

facility to provide such access to the resident.
    (iii) Such use must comply with state and federal law.
    (10) The resident has the right to--
    (i) 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; and
    (ii) Receive information from agencies acting as client advocates, 
and be afforded the opportunity to contact these agencies.
    (11) The facility must--
    (i) Post in a place readily accessible to residents, and family 
members and legal representatives of residents, the results of the most 
recent survey of the facility.
    (ii) Have reports with respect to any surveys, certifications, and 
complaint investigations made respecting the facility during the 3 
preceding years, and any plan of correction in effect with respect to 
the facility, available for any individual to review upon request; and
    (iii) Post notice of the availability of such reports in areas of 
the facility that are prominent and accessible to the public.
    (iv) The facility shall not make available identifying information 
about complainants or residents.
    (12) The facility must comply with the requirements specified in 42 
CFR part 489, subpart I (Advance Directives).
    (i) 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 resident's 
option, formulate an advance directive.
    (ii) This includes a written description of the facility's policies 
to implement advance directives and applicable State law.
    (iii) 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.
    (iv) If an adult individual is incapacitated at the time of 
admission and is unable to receive information or articulate whether or 
not he or she has executed an advance directive, the facility may give 
advance directive information to the individual's resident 
representative in accordance with State law.
    (v) The facility is not relieved of its obligation to provide this 
information to the individual once he or she is able to receive such 
information. Follow-up procedures must be in place to provide the 
information to the individual directly at the appropriate time.
    (13) The facility must 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.
    (14) Notification of changes. (i) A facility must immediately inform 
the resident; consult with the resident's physician; and notify, 
consistent with his or her authority, the resident representative(s), 
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 (that is, a deterioration in health, mental, or 
psychosocial status in either life-threatening conditions or clinical 
complications);
    (C) A need to alter treatment significantly (that is, a need to 
discontinue or change 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. 483.15(c)(1)(ii).
    (ii) When making notification under paragraph (g)(14)(i) of this 
section, the facility must ensure that all pertinent information 
specified in Sec. 483.15(c)(2) is available and provided upon request to 
the physician.
    (iii) The facility must also promptly notify the resident and the 
resident representative, if any, when there is--
    (A) A change in room or roommate assignment as specified in 
Sec. 483.10(e)(6); or
    (B) A change in resident rights under Federal or State law or 
regulations as

[[Page 62]]

specified in paragraph (e)(10) of this section.
    (iv) The facility must record and periodically update the address 
(mailing and email) and phone number of the resident representative(s).
    (15) Admission to a composite distinct part. A facility that is a 
composite distinct part (as defined in Sec. 483.5 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. 483.15(c)(9).
    (16) The facility must provide a notice of rights and services to 
the resident prior to or upon admission and during the resident's stay.
    (i) 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.
    (ii) The facility must also provide the resident with the State-
developed notice of Medicaid rights and obligations, if any.
    (iii) Receipt of such information, and any amendments to it, must be 
acknowledged in writing;
    (17) The facility must--
    (i) Inform each Medicaid-eligible resident, in writing, at the time 
of admission to the nursing facility and 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 Medicaid-eligible resident when changes are made to 
the items and services specified in Sec. 483.10(g)(17)(i)(A) and (B) of 
this section.
    (18) 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/Medicaid or by the 
facility's per diem rate.
    (i) Where changes in coverage are made to items and services covered 
by Medicare and/or by the Medicaid State plan, the facility must provide 
notice to residents of the change as soon as is reasonably possible.
    (ii) Where changes are made to charges for other items and services 
that the facility offers, the facility must inform the resident in 
writing at least 60 days prior to implementation of the change.
    (iii) If a resident dies or is hospitalized or is transferred and 
does not return to the facility, the facility must refund to the 
resident, resident representative, or estate, as applicable, any deposit 
or charges already paid, less the facility's per diem rate, for the days 
the resident actually resided or reserved or retained a bed in the 
facility, regardless of any minimum stay or discharge notice 
requirements.
    (iv) The facility must refund to the resident or resident 
representative any and all refunds due the resident within 30 days from 
the resident's date of discharge from the facility.
    (v) The terms of an admission contract by or on behalf of an 
individual seeking admission to the facility must not conflict with the 
requirements of these regulations.
    (h) Privacy and confidentiality. The resident has a right to 
personal privacy and confidentiality of his or her personal and medical 
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) The facility must respect the residents right to personal 
privacy, including the right to privacy in his or her oral (that is, 
spoken), written, and electronic communications, including the right to 
send and promptly receive unopened mail and other letters, packages and 
other materials delivered to the facility for the resident, including 
those delivered through a means other than a postal service.

[[Page 63]]

    (3) The resident has a right to secure and confidential personal and 
medical records.
    (i) The resident has the right to refuse the release of personal and 
medical records except as provided at Sec. 483.70(i)(2) or other 
applicable federal or state laws.
    (ii) The facility must allow representatives of the Office of the 
State Long-Term Care Ombudsman to examine a resident's medical, social, 
and administrative records in accordance with State law.
    (i) Safe environment. The resident has a right to a safe, clean, 
comfortable and homelike environment, including but not limited to 
receiving treatment and supports for daily living safely. 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.
    (i) This includes ensuring that the resident can receive care and 
services safely and that the physical layout of the facility maximizes 
resident independence and does not pose a safety risk.
    (ii) The facility shall exercise reasonable care for the protection 
of the resident's property from loss or theft.
    (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. 483.90(e)(2)(iv);
    (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 
to 81 [deg]F; and
    (7) For the maintenance of comfortable sound levels.
    (j) Grievances. (1) The resident has the right to voice grievances 
to the facility or other agency or entity that hears grievances without 
discrimination or reprisal and without fear of discrimination or 
reprisal. Such grievances include those with respect to care and 
treatment which has been furnished as well as that which has not been 
furnished, the behavior of staff and of other residents; and other 
concerns regarding their LTC facility stay.
    (2) The resident has the right to and the facility must make prompt 
efforts by the facility to resolve grievances the resident may have, in 
accordance with this paragraph.
    (3) The facility must make information on how to file a grievance or 
complaint available to the resident.
    (4) The facility must establish a grievance policy to ensure the 
prompt resolution of all grievances regarding the residents' rights 
contained in this paragraph. Upon request, the provider must give a copy 
of the grievance policy to the resident. The grievance policy must 
include:
    (i) Notifying resident individually or through postings in prominent 
locations throughout the facility of the right to file grievances orally 
(meaning spoken) or in writing; the right to file grievances 
anonymously; the contact information of the grievance official with whom 
a grievance can be filed, that is, his or her name, business address 
(mailing and email) and business phone number; a reasonable expected 
time frame for completing the review of the grievance; the right to 
obtain a written decision regarding his or her grievance; and the 
contact information of independent entities with whom grievances may be 
filed, that is, the pertinent State agency, Quality Improvement 
Organization, State Survey Agency and State Long-Term Care Ombudsman 
program or protection and advocacy system;
    (ii) Identifying a Grievance Official who is responsible for 
overseeing the grievance process, receiving and tracking grievances 
through to their conclusion; leading any necessary investigations by the 
facility; maintaining the confidentiality of all information associated 
with grievances, for example, the identity of the resident for those 
grievances submitted anonymously; issuing written grievance decisions to 
the resident; and coordinating with state and federal agencies as 
necessary in light of specific allegations;
    (iii) As necessary, taking immediate action to prevent further 
potential violations of any resident right while the alleged violation 
is being investigated;

[[Page 64]]

    (iv) Consistent with Sec. 483.12(c)(1), immediately reporting all 
alleged violations involving neglect, abuse, including injuries of 
unknown source, and/or misappropriation of resident property, by anyone 
furnishing services on behalf of the provider, to the administrator of 
the provider; and as required by State law;
    (v) Ensuring that all written grievance decisions include the date 
the grievance was received, a summary statement of the resident's 
grievance, the steps taken to investigate the grievance, a summary of 
the pertinent findings or conclusions regarding the resident's 
concern(s), a statement as to whether the grievance was confirmed or not 
confirmed, any corrective action taken or to be taken by the facility as 
a result of the grievance, and the date the written decision was issued;
    (vi) Taking appropriate corrective action in accordance with State 
law if the alleged violation of the residents' rights is confirmed by 
the facility or if an outside entity having jurisdiction, such as the 
State Survey Agency, Quality Improvement Organization, or local law 
enforcement agency confirms a violation of any of these residents' 
rights within its area of responsibility; and
    (vii) Maintaining evidence demonstrating the results of all 
grievances for a period of no less than 3 years from the issuance of the 
grievance decision.
    (k) Contact with external entities. A facility must not prohibit or 
in any way discourage a resident from communicating with federal, state, 
or local officials, including, but not limited to, federal and state 
surveyors, other federal or state health department employees, including 
representatives of the Office of the State Long-Term Care Ombudsman, and 
any representative of the agency responsible for the protection and 
advocacy system for individuals with mental disorder (established under 
the Protection and Advocacy for Mentally Ill Individuals Act of 2000 (42 
U.S.C. 10801 et seq.), regarding any matter, whether or not subject to 
arbitration or any other type of judicial or regulatory action.

[81 FR 68849, Oct. 4, 2016, as amended at 82 FR 32259, July 13, 2017]



Sec. 483.12  Freedom from abuse, neglect, and exploitation.

    The resident has the right to be free from abuse, neglect, 
misappropriation of resident property, and exploitation as defined in 
this subpart. This includes but is not limited to freedom from corporal 
punishment, involuntary seclusion and any physical or chemical restraint 
not required to treat the resident's medical symptoms.
    (a) The facility must--
    (1) Not use verbal, mental, sexual, or physical abuse, corporal 
punishment, or involuntary seclusion;
    (2) Ensure that the resident is free from physical or chemical 
restraints imposed for purposes of discipline or convenience and that 
are not required to treat the resident's medical symptoms. When the use 
of restraints is indicated, the facility must use the least restrictive 
alternative for the least amount of time and document ongoing re-
evaluation of the need for restraints.
    (3) Not employ or otherwise engage individuals who--
    (i) Have been found guilty of abuse, neglect, exploitation, 
misappropriation of property, or mistreatment by a court of law;
    (ii) Have had a finding entered into the State nurse aide registry 
concerning abuse, neglect, exploitation, mistreatment of residents or 
misappropriation of their property; or
    (iii) Have a disciplinary action in effect against his or her 
professional license by a state licensure body as a result of a finding 
of abuse, neglect, exploitation, mistreatment of residents or 
misappropriation of resident property.
    (4) Report to the State nurse aide registry or licensing authorities 
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.
    (b) The facility must develop and implement written policies and 
procedures that:
    (1) Prohibit and prevent abuse, neglect, and exploitation of 
residents and misappropriation of resident property,
    (2) Establish policies and procedures to investigate any such 
allegations, and

[[Page 65]]

    (3) Include training as required at paragraph Sec. 483.95.
    (4) Establish coordination with the QAPI program required under 
Sec. 483.75.
    (5) Ensure reporting of crimes occurring in federally-funded long-
term care facilities in accordance with section 1150B of the Act. The 
policies and procedures must include but are not limited to the 
following elements.
    (i) Annually notifying covered individuals, as defined at section 
1150B(a)(3) of the Act, of that individual's obligation to comply with 
the following reporting requirements.
    (A) Each covered individual shall report to the State Agency and one 
or more law enforcement entities for the political subdivision in which 
the facility is located any reasonable suspicion of a crime against any 
individual who is a resident of, or is receiving care from, the 
facility.
    (B) Each covered individual shall report immediately, but not later 
than 2 hours after forming the suspicion, if the events that cause the 
suspicion result in serious bodily injury, or not later than 24 hours if 
the events that cause the suspicion do not result in serious bodily 
injury.
    (ii) Posting a conspicuous notice of employee rights, as defined at 
section 1150B(d)(3) of the Act.
    (iii) Prohibiting and preventing retaliation, as defined at section 
1150B(d)(1) and (2) of the Act.
    (c) In response to allegations of abuse, neglect, exploitation, or 
mistreatment, the facility must:
    (1) Ensure that all alleged violations involving abuse, neglect, 
exploitation or mistreatment, including injuries of unknown source and 
misappropriation of resident property, are reported immediately, but not 
later than 2 hours after the allegation is made, if the events that 
cause the allegation involve abuse or result in serious bodily injury, 
or not later than 24 hours if the events that cause the allegation do 
not involve abuse and do not result in serious bodily injury, to the 
administrator of the facility and to other officials (including to the 
State Survey Agency and adult protective services where state law 
provides for jurisdiction in long-term care facilities) in accordance 
with State law through established procedures.
    (2) Have evidence that all alleged violations are thoroughly 
investigated.
    (3) Prevent further potential abuse, neglect, exploitation, or 
mistreatment while the investigation is in progress.
    (4) Report the results of all investigations to the administrator or 
his or her designated representative and to other officials in 
accordance with State law, including to the State Survey Agency, within 
5 working days of the incident, and if the alleged violation is verified 
appropriate corrective action must be taken.

[81 FR 68855, Oct. 4, 2016]



Sec. 483.15  Admission, transfer, and discharge rights.

    (a) Admissions policy. (1) The facility must establish and implement 
an admissions policy.
    (2) The facility must--
    (i) Not request or require residents or potential residents to waive 
their rights as set forth in this subpart and in applicable state, 
federal or local licensing or certification laws, including but not 
limited to their rights to Medicare or Medicaid; and
    (ii) Not request or require oral or written assurance that residents 
or potential residents are not eligible for, or will not apply for, 
Medicare or Medicaid benefits.
    (iii) Not request or require residents or potential residents to 
waive potential facility liability for losses of personal property
    (3) The facility must not request or 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 
request and require a resident representative 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.
    (4) 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

[[Page 66]]

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 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.
    (5) 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.
    (6) A nursing facility must disclose and provide to a resident or 
potential resident prior to time of admission, notice of special 
characteristics or service limitations of the facility.
    (7) A nursing facility that is a composite distinct part as defined 
in Sec. 483.5 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 paragraph (c)(9) of 
this section.
    (b) Equal access to quality care. (1) A facility must establish, 
maintain and implement identical policies and practices regarding 
transfer and discharge, as defined in Sec. 483.5 and the provision of 
services for all individuals regardless of source of payment, consistent 
with Sec. 483.10(a)(2);
    (2) The facility may charge any amount for services furnished to 
non-Medicaid residents unless otherwise limited by state law and 
consistent with the notice requirement in Sec. 483.10(g)(18)(i) and 
(g)(4)(i) 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.
    (c) Transfer and discharge--(1) Facility requirements--(i) The 
facility must permit each resident to remain in the facility, and not 
transfer or discharge the resident from the facility unless--
    (A) The transfer or discharge is necessary for the resident's 
welfare and the resident's needs cannot be met in the facility;
    (B) 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;
    (C) The safety of individuals in the facility is endangered due to 
the clinical or behavioral status of the resident;
    (D) The health of individuals in the facility would otherwise be 
endangered;
    (E) 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. Non-payment applies if the resident does not submit the 
necessary paperwork for third party payment or after the third party, 
including Medicare or Medicaid, denies the claim and the resident 
refuses to pay for his or her stay. 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
    (F) The facility ceases to operate.
    (ii) The facility may not transfer or discharge the resident while 
the appeal is pending, pursuant to Sec. 431.230 of this chapter, when a 
resident exercises his or her right to appeal a transfer or discharge 
notice from the facility pursuant to Sec. 431.220(a)(3) of this chapter, 
unless the failure to discharge or transfer would endanger the health or 
safety of the resident or other individuals in the facility. The 
facility must document the danger that failure to transfer or discharge 
would pose.
    (2) Documentation. When the facility transfers or discharges a 
resident under any of the circumstances specified in

[[Page 67]]

paragraphs (c)(1)(i)(A) through (F) of this section, the facility must 
ensure that the transfer or discharge is documented in the resident's 
medical record and appropriate information is communicated to the 
receiving health care institution or provider.
    (i) Documentation in the resident's medical record must include:
    (A) The basis for the transfer per paragraph (c)(1)(i) of this 
section.
    (B) In the case of paragraph (c)(1)(i)(A) of this section, the 
specific resident need(s) that cannot be met, facility attempts to meet 
the resident needs, and the service available at the receiving facility 
to meet the need(s).
    (ii) The documentation required by paragraph (c)(2)(i) of this 
section must be made by--
    (A) The resident's physician when transfer or discharge is necessary 
under paragraph (c)(1)(A) or (B) of this section; and
    (B) A physician when transfer or discharge is necessary under 
paragraph (c)(1)(i)(C) or (D) of this section.
    (iii) Information provided to the receiving provider must include a 
minimum of the following:
    (A) Contact information of the practitioner responsible for the care 
of the resident
    (B) Resident representative information including contact 
information.
    (C) Advance Directive information.
    (D) All special instructions or precautions for ongoing care, as 
appropriate.
    (E) Comprehensive care plan goals,
    (F) All other necessary information, including a copy of the 
resident's discharge summary, consistent with Sec. 483.21(c)(2), as 
applicable, and any other documentation, as applicable, to ensure a safe 
and effective transition of care.
    (3) Notice before transfer. Before a facility transfers or 
discharges a resident, the facility must--
    (i) Notify the resident and the resident's representative(s) of the 
transfer or discharge and the reasons for the move in writing and in a 
language and manner they understand. The facility must send a copy of 
the notice to a representative of the Office of the State Long-Term Care 
Ombudsman.
    (ii) Record the reasons for the transfer or discharge in the 
resident's medical record in accordance with paragraph (c)(2) of this 
section; and
    (iii) Include in the notice the items described in paragraph (c)(5) 
of this section.
    (4) Timing of the notice. (i) Except as specified in paragraphs 
(c)(4)(ii) and (8) of this section, the notice of transfer or discharge 
required under this section must be made by the facility at least 30 
days before the resident is transferred or discharged.
    (ii) Notice must be made as soon as practicable before transfer or 
discharge when--
    (A) The safety of individuals in the facility would be endangered 
under paragraph (c)(1)(i)(C) of this section;
    (B) The health of individuals in the facility would be endangered, 
under paragraph (c)(1)(i)(D) of this section;
    (C) The resident's health improves sufficiently to allow a more 
immediate transfer or discharge, under paragraph (c)(1)(i)(B) of this 
section;
    (D) An immediate transfer or discharge is required by the resident's 
urgent medical needs, under paragraph (c)(1)(i)(A) of this section; or
    (E) A resident has not resided in the facility for 30 days.
    (5) Contents of the notice. The written notice specified in 
paragraph (c)(3) 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 of the resident's appeal rights, including the 
name, address (mailing and email), and telephone number of the entity 
which receives such requests; and information on how to obtain an appeal 
form and assistance in completing the form and submitting the appeal 
hearing request;
    (v) The name, address (mailing and email) and telephone number of 
the Office of the State Long-Term Care Ombudsman;
    (vi) For nursing facility residents with intellectual and 
developmental disabilities or related disabilities, the

[[Page 68]]

mailing and email address and telephone number of the agency responsible 
for the protection and advocacy of individuals with developmental 
disabilities established under Part C of the Developmental Disabilities 
Assistance and Bill of Rights Act of 2000 (Pub. L. 106-402, codified at 
42 U.S.C. 15001 et seq.); and
    (vii) For nursing facility residents with a mental disorder or 
related disabilities, the mailing and email address and telephone number 
of the agency responsible for the protection and advocacy of individuals 
with a mental disorder established under the Protection and Advocacy for 
Mentally Ill Individuals Act.
    (6) Changes to the notice. If the information in the notice changes 
prior to effecting the transfer or discharge, the facility must update 
the recipients of the notice as soon as practicable once the updated 
information becomes available.
    (7) Orientation for transfer or discharge. A facility must provide 
and document sufficient preparation and orientation to residents to 
ensure safe and orderly transfer or discharge from the facility. This 
orientation must be provided in a form and manner that the resident can 
understand.
    (8) Notice in advance of facility closure. In the case of facility 
closure, the individual who is the administrator of the facility must 
provide written notification prior to the impending closure to the State 
Survey Agency, the Office of the State Long-Term Care Ombudsman, 
residents of the facility, and the resident representatives, as well as 
the plan for the transfer and adequate relocation of the residents, as 
required at Sec. 483.70(l).
    (9) Room changes in a composite distinct part. Room changes in a 
facility that is a composite distinct part (as defined in Sec. 483.5) 
are subject to the requirements of Sec. 483.10(e)(7) and 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.
    (d) Notice of bed-hold policy and return--(1) Notice before 
transfer. Before a nursing facility transfers a resident to a hospital 
or the resident goes on therapeutic leave, the nursing facility must 
provide written information to the resident or resident representative 
that specifies--
    (i) The duration of the state bed-hold policy, if any, during which 
the resident is permitted to return and resume residence in the nursing 
facility;
    (ii) The reserve bed payment policy in the state plan, under 
Sec. 447.40 of this chapter, if any;
    (iii) The nursing facility's policies regarding bed-hold periods, 
which must be consistent with paragraph (e)(1) of this section, 
permitting a resident to return; and
    (iv) The information specified in paragraph (e)(1) of this section.
    (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 the resident representative written 
notice which specifies the duration of the bed-hold policy described in 
paragraph (d)(1) of this section.
    (e)(1) Permitting residents to return to facility. A facility must 
establish and follow a written policy on permitting residents to return 
to the facility after they are hospitalized or placed on therapeutic 
leave. The policy must provide for the following.
    (i) A resident, whose hospitalization or therapeutic leave exceeds 
the bed-hold period under the State plan, returns to the facility to 
their previous room if available or immediately upon the first 
availability of a bed in a semi-private room if the resident
    (A) Requires the services provided by the facility; and
    (B) Is eligible for Medicare skilled nursing facility services or 
Medicaid nursing facility services.
    (ii) If the facility that determines that a resident who was 
transferred with an expectation of returning to the facility cannot 
return to the facility, the facility must comply with the requirements 
of paragraph (c) as they apply to discharges.
    (2) Readmission to a composite distinct part. When the facility to 
which a resident returns is a composite distinct part (as defined in 
Sec. 483.5), the resident must be permitted to return to an available 
bed in the particular location

[[Page 69]]

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 return, the 
resident must be given the option to return to that location upon the 
first availability of a bed there.

[81 FR 68855, Oct. 4, 2016, as amended at 82 FR 32259, July 13, 2017]



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, 
strengths, goals, life history and preferences, using the resident 
assessment instrument (RAI) specified by CMS. 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 planning.
    (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 of care.
    (e) Coordination. A facility must coordinate assessments with the 
preadmission screening and resident review (PASARR) program under 
Medicaid in subpart C of this part to the maximum extent practicable to 
avoid duplicative testing and effort. Coordination includes--

[[Page 70]]

    (1) Incorporating the recommendations from the PASARR level II 
determination and the PASARR evaluation report into a resident's 
assessment, care planning, and transitions of care.
    (2) Referring all level II residents and all residents with newly 
evident or possible serious mental disorder, intellectual disability, or 
a related condition for level II resident review upon a significant 
change in status assessment.
    (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.
    (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 
as adjusted annually under 45 CFR part 102 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 as adjusted annually under 45 CFR part 102 for 
each assessment.
    (2) Clinical disagreement does not constitute a material and false 
statement.
    (k) Preadmission screening for individuals with a mental disorder 
and individuals with intellectual disability. (1) A nursing facility 
must not admit, on or after January 1, 1989, any new resident with--
    (i) Mental disorder as defined in paragraph (k)(3)(i) of this 
section, unless

[[Page 71]]

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) Intellectual disability, as defined in paragraph (k)(3)(ii) of 
this section, unless the State intellectual disability 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 intellectual disability.
    (2) Exceptions. For purposes of this section--
    (i) The preadmission screening program under paragraph (k)(1) of 
this section need not provide for determinations in the case of the 
readmission to a nursing facility of an individual who, after being 
admitted to the nursing facility, was transferred for care in a 
hospital.
    (ii) The State may choose not to apply the preadmission screening 
program under paragraph (k)(1) of this section to the admission to a 
nursing facility of an individual--
    (A) Who is admitted to the facility directly from a hospital after 
receiving acute inpatient care at the hospital,
    (B) Who requires nursing facility services for the condition for 
which the individual 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 of 
nursing facility services.
    (3) Definition. For purposes of this section--
    (i) An individual is considered to have a mental disorder if the 
individual has a serious mental disorder as defined in 
Sec. 483.102(b)(1).
    (ii) An individual is considered to have an intellectual disability 
if the individual has an intellectual disability as defined in 
Sec. 483.102(b)(3) or is a person with a related condition as described 
in Sec. 435.1010 of this chapter.
    (4) A nursing facility must notify the state mental health authority 
or state intellectual disability authority, as applicable, promptly 
after a significant change in the mental or physical condition of a 
resident who has a mental disorder or intellectual disability for 
resident review.

[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; 81 FR 61563, Sept. 6, 2016; 81 FR 68857, Oct. 4, 
2016]



Sec. 483.21  Comprehensive person-centered care planning.

    (a) Baseline care plans. (1) The facility must develop and implement 
a baseline care plan for each resident that includes the instructions 
needed to provide effective and person-centered care of the resident 
that meet professional standards of quality care. The baseline care plan 
must--
    (i) Be developed within 48 hours of a resident's admission.
    (ii) Include the minimum healthcare information necessary to 
properly care for a resident including, but not limited to:
    (A) Initial goals based on admission orders.
    (B) Physician orders.
    (C) Dietary orders.
    (D) Therapy services.
    (E) Social services.
    (F) PASARR recommendation, if applicable.
    (2) The facility may develop a comprehensive care plan in place of 
the baseline care plan if the comprehensive care plan--
    (i) Is developed within 48 hours of the resident's admission.
    (ii) Meets the requirements set forth in paragraph (b) of this 
section (excepting paragraph (b)(2)(i) of this section).
    (3) The facility must provide the resident and their representative 
with a summary of the baseline care plan that includes but is not 
limited to:
    (i) The initial goals of the resident.

[[Page 72]]

    (ii) A summary of the resident's medications and dietary 
instructions.
    (iii) Any services and treatments to be administered by the facility 
and personnel acting on behalf of the facility.
    (iv) Any updated information based on the details of the 
comprehensive care plan, as necessary.
    (b) Comprehensive care plans. (1) The facility must develop and 
implement a comprehensive person-centered care plan for each resident, 
consistent with the resident rights set forth at Sec. 483.10(c)(2) and 
Sec. 483.10(c)(3), that includes measurable objectives and timeframes to 
meet a resident's medical, nursing, and mental and psychosocial needs 
that are identified in the comprehensive assessment. The comprehensive 
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. 483.24, Sec. 483.25, or Sec. 483.40; and
    (ii) Any services that would otherwise be required under 
Sec. 483.24, Sec. 483.25, or Sec. 483.40 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(c)(6).
    (iii) Any specialized services or specialized rehabilitative 
services the nursing facility will provide as a result of PASARR 
recommendations. If a facility disagrees with the findings of the 
PASARR, it must indicate its rationale in the resident's medical record.
    (iv) In consultation with the resident and the resident's 
representative(s)--
    (A) The resident's goals for admission and desired outcomes.
    (B) The resident's preference and potential for future discharge. 
Facilities must document whether the resident's desire to return to the 
community was assessed and any referrals to local contact agencies and/
or other appropriate entities, for this purpose.
    (C) Discharge plans in the comprehensive care plan, as appropriate, 
in accordance with the requirements set forth in paragraph (c) of this 
section.
    (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 but is not 
limited to--
    (A) The attending physician.
    (B) A registered nurse with responsibility for the resident.
    (C) A nurse aide with responsibility for the resident.
    (D) A member of food and nutrition services staff.
    (E) To the extent practicable, the participation of the resident and 
the resident's representative(s). An explanation must be included in a 
resident's medical record if the participation of the resident and their 
resident representative is determined not practicable for the 
development of the resident's care plan.
    (F) Other appropriate staff or professionals in disciplines as 
determined by the resident's needs or as requested by the resident.
    (iii) Reviewed and revised by the interdisciplinary team after each 
assessment, including both the comprehensive and quarterly review 
assessments.
    (3) The services provided or arranged by the facility, as outlined 
by the comprehensive care plan, must--
    (i) Meet professional standards of quality.
    (ii) Be provided by qualified persons in accordance with each 
resident's written plan of care.
    (iii) Be culturally-competent and trauma-informed.
    (c) Discharge planning--(1) Discharge planning process. The facility 
must develop and implement an effective discharge planning process that 
focuses on the resident's discharge goals, the preparation of residents 
to be active partners and effectively transition them to post-discharge 
care, and the reduction of factors leading to preventable readmissions. 
The facility's discharge planning process must be consistent with the 
discharge rights set forth at Sec. 483.15(b) as applicable and--
    (i) Ensure that the discharge needs of each resident are identified 
and result in the development of a discharge plan for each resident.

[[Page 73]]

    (ii) Include regular re-evaluation of residents to identify changes 
that require modification of the discharge plan. The discharge plan must 
be updated, as needed, to reflect these changes.
    (iii) Involve the interdisciplinary team, as defined by 
Sec. 483.21(b)(2)(ii), in the ongoing process of developing the 
discharge plan.
    (iv) Consider caregiver/support person availability and the 
resident's or caregiver's/support person(s) capacity and capability to 
perform required care, as part of the identification of discharge needs.
    (v) Involve the resident and resident representative in the 
development of the discharge plan and inform the resident and resident 
representative of the final plan.
    (vi) Address the resident's goals of care and treatment preferences.
    (vii) Document that a resident has been asked about their interest 
in receiving information regarding returning to the community.
    (A) If the resident indicates an interest in returning to the 
community, the facility must document any referrals to local contact 
agencies or other appropriate entities made for this purpose.
    (B) Facilities must update a resident's comprehensive care plan and 
discharge plan, as appropriate, in response to information received from 
referrals to local contact agencies or other appropriate entities.
    (C) If discharge to the community is determined to not be feasible, 
the facility must document who made the determination and why.
    (viii) For residents who are transferred to another SNF or who are 
discharged to a HHA, IRF, or LTCH, assist residents and their resident 
representatives in selecting a post-acute care provider by using data 
that includes, but is not limited to SNF, HHA, IRF, or LTCH standardized 
patient assessment data, data on quality measures, and data on resource 
use to the extent the data is available. The facility must ensure that 
the post-acute care standardized patient assessment data, data on 
quality measures, and data on resource use is relevant and applicable to 
the resident's goals of care and treatment preferences.
    (ix) Document, complete on a timely basis based on the resident's 
needs, and include in the clinical record, the evaluation of the 
resident's discharge needs and discharge plan. The results of the 
evaluation must be discussed with the resident or resident's 
representative. All relevant resident information must be incorporated 
into the discharge plan to facilitate its implementation and to avoid 
unnecessary delays in the resident's discharge or transfer.
    (2) Discharge summary. When the facility anticipates discharge a 
resident must have a discharge summary that includes, but is not limited 
to, the following:
    (i) A recapitulation of the resident's stay that includes, but is 
not limited to, diagnoses, course of illness/treatment or therapy, and 
pertinent lab, radiology, and consultation results.
    (ii) A final summary of the resident's status to include items in 
paragraph (b)(1) of Sec. 483.20, at the time of the discharge that is 
available for release to authorized persons and agencies, with the 
consent of the resident or resident's representative.
    (iii) Reconciliation of all pre-discharge medications with the 
resident's post-discharge medications (both prescribed and over-the-
counter).
    (iv) A post-discharge plan of care that is developed with the 
participation of the resident and, with the resident's consent, the 
resident representative(s), which will assist the resident to adjust to 
his or her new living environment. The post-discharge plan of care must 
indicate where the individual plans to reside, any arrangements that 
have been made for the resident's follow up care and any post-discharge 
medical and non-medical services.

[81 FR 68858, Oct. 4, 2016]



Sec. 483.24  Quality of life.

    Quality of life is a fundamental principle that applies to all care 
and services provided to facility residents. 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, consistent

[[Page 74]]

with the resident's comprehensive assessment and plan of care.
    (a) Based on the comprehensive assessment of a resident and 
consistent with the resident's needs and choices, the facility must 
provide the necessary care and services to ensure that a resident's 
abilities in activities of daily living do not diminish unless 
circumstances of the individual's clinical condition demonstrate that 
such diminution was unavoidable. This includes the facility ensuring 
that:
    (1) A resident is given the appropriate treatment and services to 
maintain or improve his or her ability to carry out the activities of 
daily living, including those specified in paragraph (b) of this 
section,
    (2) 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, and
    (3) Personnel provide basic life support, including CPR, to a 
resident requiring such emergency care prior to the arrival of emergency 
medical personnel and subject to related physician orders and the 
resident's advance directives.
    (b) Activities of daily living. The facility must provide care and 
services in accordance with paragraph (a) of this section for the 
following activities of daily living:
    (1) Hygiene--bathing, dressing, grooming, and oral care,
    (2) Mobility--transfer and ambulation, including walking,
    (3) Elimination--toileting,
    (4) Dining--eating, including meals and snacks,
    (5) Communication, including
    (i) Speech,
    (ii) Language,
    (iii) Other functional communication systems.
    (c) Activities. (1) The facility must provide, based on the 
comprehensive assessment and care plan and the preferences of each 
resident, an ongoing program to support residents in their choice of 
activities, both facility-sponsored group and individual activities and 
independent activities, designed to meet the interests of and support 
the physical, mental, and psychosocial well-being of each resident, 
encouraging both independence and interaction in the community.
    (2) The activities program must be directed by a qualified 
professional who is a qualified therapeutic recreation specialist or an 
activities professional who--
    (i) Is licensed or registered, if applicable, by the State in which 
practicing; and
    (ii) Is:
    (A) 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
    (B) Has 2 years of experience in a social or recreational program 
within the last 5 years, one of which was full-time in a therapeutic 
activities program; or
    (C) Is a qualified occupational therapist or occupational therapy 
assistant; or
    (D) Has completed a training course approved by the State.

[81 FR 68859, Oct. 4, 2016]



Sec. 483.25  Quality of care.

    Quality of care is a fundamental principle that applies to all 
treatment and care provided to facility residents. Based on the 
comprehensive assessment of a resident, the facility must ensure that 
residents receive treatment and care in accordance with professional 
standards of practice, the comprehensive person-centered care plan, and 
the resident's choices, including but not limited to the following:
    (a) 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.
    (b) Skin integrity--(1) Pressure ulcers. Based on the comprehensive 
assessment of a resident, the facility must ensure that--
    (i) A resident receives care, consistent with professional standards 
of practice, to prevent pressure ulcers and

[[Page 75]]

does not develop pressure ulcers unless the individual's clinical 
condition demonstrates that they were unavoidable; and
    (ii) A resident with pressure ulcers receives necessary treatment 
and services, consistent with professional standards of practice, to 
promote healing, prevent infection and prevent new ulcers from 
developing.
    (2) Foot care. To ensure that residents receive proper treatment and 
care to maintain mobility and good foot health, the facility must--
    (i) Provide foot care and treatment, in accordance with professional 
standards of practice, including to prevent complications from the 
resident's medical condition(s) and
    (ii) If necessary, assist the resident in making appointments with a 
qualified person, and arranging for transportation to and from such 
appointments.
    (c) Mobility. (1) The facility must ensure that a resident who 
enters the facility without 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 limited range of motion receives appropriate 
treatment and services to increase range of motion and/or to prevent 
further decrease in range of motion.
    (3) A resident with limited mobility receives appropriate services, 
equipment, and assistance to maintain or improve mobility with the 
maximum practicable independence unless a reduction in mobility is 
demonstrably unavoidable.
    (d) 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.
    (e) Incontinence. (1) The facility must ensure that a resident who 
is continent of bladder and bowel on admission receives services and 
assistance to maintain continence unless his or her clinical condition 
is or becomes such that continence is not possible to maintain.
    (2) For a resident with urinary incontinence, based on the 
resident's comprehensive assessment, the facility must ensure that--
    (i) A resident who enters the facility without an indwelling 
catheter is not catheterized unless the resident's clinical condition 
demonstrates that catheterization was necessary;
    (ii) A resident who enters the facility with an indwelling catheter 
or subsequently receives one is assessed for removal of the catheter as 
soon as possible unless the resident's clinical condition demonstrates 
that catheterization is necessary, and
    (iii) A resident who is incontinent of bladder receives appropriate 
treatment and services to prevent urinary tract infections and to 
restore continence to the extent possible.
    (3) For a resident with fecal incontinence, based on the resident's 
comprehensive assessment, the facility must ensure that a resident who 
is incontinent of bowel receives appropriate treatment and services to 
restore as much normal bowel function as possible.
    (f) Colostomy, urostomy, or ileostomy care. The facility must ensure 
that residents who require colostomy, urostomy, or ileostomy services, 
receive such care consistent with professional standards of practice, 
the comprehensive person-centered care plan, and the residents' goals 
and preferences.
    (g) Assisted nutrition and hydration. (Includes naso-gastric and 
gastrostomy tubes, both percutaneous endoscopic gastrostomy and 
percutaneous endoscopic jejunostomy, and enteral fluids). Based on a 
resident's comprehensive assessment, the facility must ensure that a 
resident--
    (1) Maintains acceptable parameters of nutritional status, such as 
usual body weight or desirable body weight range and electrolyte 
balance, unless the resident's clinical condition demonstrates that this 
is not possible or resident preferences indicate otherwise;
    (2) Is offered sufficient fluid intake to maintain proper hydration 
and health; and
    (3) Is offered a therapeutic diet when there is a nutritional 
problem and the

[[Page 76]]

health care provider orders a therapeutic diet.
    (4) A resident who has been able to eat enough alone or with 
assistance is not fed by enteral methods unless the resident's clinical 
condition demonstrates that enteral feeding was clinically indicated and 
consented to by the resident; and
    (5) A resident who is fed by enteral means receives the appropriate 
treatment and services to restore, if possible, oral eating skills and 
to prevent complications of enteral feeding including but not limited to 
aspiration pneumonia, diarrhea, vomiting, dehydration, metabolic 
abnormalities, and nasal-pharyngeal ulcers.
    (h) Parenteral fluids. Parenteral fluids must be administered 
consistent with professional standards of practice and in accordance 
with physician orders, the comprehensive person-centered care plan, and 
the resident's goals and preferences.
    (i) Respiratory care, including tracheostomy care and tracheal 
suctioning. The facility must ensure that a resident who needs 
respiratory care, including tracheostomy care and tracheal suctioning, 
is provided such care, consistent with professional standards of 
practice, the comprehensive person-centered care plan, the residents' 
goals and preferences, and Sec. 483.65 of this subpart.
    (j) Prostheses. The facility must ensure that a resident who has a 
prosthesis is provided care and assistance, consistent with professional 
standards of practice, the comprehensive person-centered care plan, and 
the residents' goals and preferences, to wear and be able to use the 
prosthetic device.
    (k) Pain management. The facility must ensure that pain management 
is provided to residents who require such services, consistent with 
professional standards of practice, the comprehensive person-centered 
care plan, and the residents' goals and preferences.
    (l) Dialysis. The facility must ensure that residents who require 
dialysis receive such services, consistent with professional standards 
of practice, the comprehensive person-centered care plan, and the 
residents' goals and preferences.
    (m) Trauma-informed care. The facility must ensure that residents 
who are trauma survivors receive culturally-competent, trauma-informed 
care in accordance with professional standards of practice and 
accounting for residents' experiences and preferences in order to 
eliminate or mitigate triggers that may cause re-traumatization of the 
resident.
    (n) Bed rails. The facility must attempt to use appropriate 
alternatives prior to installing a side or bed rail. If a bed or side 
rail is used, the facility must ensure correct installation, use, and 
maintenance of bed rails, including but not limited to the following 
elements.
    (1) Assess the resident for risk of entrapment from bed rails prior 
to installation.
    (2) Review the risks and benefits of bed rails with the resident or 
resident representative and obtain informed consent prior to 
installation.
    (3) Ensure that the bed's dimensions are appropriate for the 
resident's size and weight.
    (4) Follow the manufacturers' recommendations and specifications for 
installing and maintaining bed rails.

[81 FR 68860, Oct. 4, 2016]



Sec. 483.30  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, physician assistant, nurse 
practitioner, or clinical nurse specialist must provide orders for the 
resident's immediate care and needs.
    (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

[[Page 77]]

    (3) Sign and date all orders with the exception of influenza and 
pneumococcal 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)(4) 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
    (iii) Is under the supervision of the physician.
    (2) A resident's attending physician may delegate the task of 
writing dietary orders, consistent with Sec. 483.60, to a qualified 
dietitian or other clinically qualified nutrition professional who--
    (i) Is acting within the scope of practice as defined by State law; 
and
    (ii) Is under the supervision of the physician.
    (3) A resident's attending physician may delegate the task of 
writing therapy orders, consistent with Sec. 483.65, to a qualified 
therapist who--
    (i) Is acting within the scope of practice as defined by State law; 
and
    (ii) Is under the supervision of the physician.
    (4) 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. 
Redesignated and amended at 81 FR 68861, Oct. 4, 2016]



Sec. 483.35  Nursing services.

    The facility must have sufficient nursing staff with the appropriate 
competencies and skills sets to provide nursing and related services to 
assure resident safety and 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 and 
considering the number, acuity and diagnoses of the facility's resident 
population in accordance with the facility assessment required at 
Sec. 483.70(e).
    (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 (e) of this section, licensed 
nurses; and
    (ii) Other nursing personnel, including but not limited to nurse 
aides.
    (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.
    (3) The facility must ensure that licensed nurses have the specific 
competencies and skill sets necessary to care for residents' needs, as 
identified

[[Page 78]]

through resident assessments, and described in the plan of care.
    (4) Providing care includes but is not limited to assessing, 
evaluating, planning and implementing resident care plans and responding 
to resident's needs.
    (b) Registered nurse. (1) Except when waived under paragraph (e) or 
(f) 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 (e) or (f) 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) 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.
    (d) Requirements for facility hiring and use of nursing aides--(1) 
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 Secs. 483.151 through 483.154; or
    (B) That individual has been deemed or determined competent as 
provided in Sec. 483.150(a) and (b).
    (2) 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 paragraphs (d)(1) (i) 
and (ii) of this section.
    (3) Minimum 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).
    (4) 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.
    (5) 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 that the facility believes will include information on the 
individual.
    (6) 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.
    (7) 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. In-service training must comply with the requirements of 
Sec. 483.95(g).
    (e) Nursing facilities: Waiver of requirement to provide licensed 
nurses on a 24-

[[Page 79]]

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 Office of the State Long-Term Care Ombudsman 
(established under section 712 of the Older Americans Act of 1965) and 
the protection and advocacy system in the State for individuals with a 
mental disorder who are eligible for such services as provided by the 
protection and advocacy agency; and
    (7) The nursing facility that is granted such a waiver by a State 
notifies residents of the facility and their resident representatives of 
the waiver.
    (f) 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 Office of 
the State Long-Term Care Ombudsman (established under section 712 of the 
Older Americans Act of 1965) and the protection and advocacy system in 
the State for individuals with developmental disabilities or mental 
disorders; and
    (v) The facility that is granted such a waiver notifies residents of 
the facility and their resident representatives 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.
    (g) 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.

[[Page 80]]

    (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. Redesignated and amended at 81 FR 68861, 
Oct. 4, 2016]



Sec. 483.40  Behavioral health services.

    Each resident must receive and the facility must provide the 
necessary behavioral health 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. 
Behavioral health encompasses a resident's whole emotional and mental 
well-being, which includes, but is not limited to, the prevention and 
treatment of mental and substance use disorders.
    (a) The facility must have sufficient staff who provide direct 
services to residents with the appropriate competencies and skills sets 
to provide nursing and related services to assure resident safety and 
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 and considering the number, 
acuity and diagnoses of the facility's resident population in accordance 
with Sec. 483.70(e). These competencies and skills sets include, but are 
not limited to, knowledge of and appropriate training and supervision 
for:
    (1) Caring for residents with mental and psychosocial disorders, as 
well as residents with a history of trauma and/or post-traumatic stress 
disorder, that have been identified in the facility assessment conducted 
pursuant to Sec. 483.70(e), and
    (2) Implementing non-pharmacological interventions.
    (b) Based on the comprehensive assessment of a resident, the 
facility must ensure that--
    (1) A resident who displays or is diagnosed with mental disorder or 
psychosocial adjustment difficulty, or who has a history of trauma and/
or post-traumatic stress disorder, receives appropriate treatment and 
services to correct the assessed problem or to attain the highest 
practicable mental and psychosocial well-being;
    (2) A resident whose assessment did not reveal or who does not have 
a diagnosis of a mental or psychosocial adjustment difficulty or a 
documented history of trauma and/or post-traumatic stress disorder 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 development of such a pattern was 
unavoidable; and
    (3) A resident who displays or is diagnosed with dementia, receives 
the appropriate treatment and services to attain or maintain his or her 
highest practicable physical, mental, and psychosocial well-being.
    (c) If rehabilitative services such as but not limited to physical 
therapy, speech-language pathology, occupational therapy, and 
rehabilitative services for mental disorders and intellectual 
disability, are required in the resident's comprehensive plan of care, 
the facility must--
    (1) Provide the required services, including specialized 
rehabilitation services as required in Sec. 483.65; or
    (2) Obtain the required services from an outside resource (in 
accordance with Sec. 483.70(g) of this part) from a Medicare and/or 
Medicaid provider of specialized rehabilitative services.
    (d) The facility must provide medically-related social services to 
attain or maintain the highest practicable physical, mental and 
psychosocial well-being of each resident.

[81 FR 68862, Oct. 4, 2016]



Sec. 483.45  Pharmacy services.

    The facility must provide routine and emergency drugs and 
biologicals to its residents, or obtain them under an agreement 
described in Sec. 483.70(g). The facility may permit unlicensed 
personnel to administer drugs if State law permits, but only under the 
general supervision of a licensed nurse.

[[Page 81]]

    (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.
    (2) This review must include a review of the resident's medical 
chart.
    (3) A psychotropic drug is any drug that affects brain activities 
associated with mental processes and behavior. These drugs include, but 
are not limited to, drugs in the following categories:
    (i) Anti-psychotic;
    (ii) Anti-depressant;
    (iii) Anti-anxiety; and
    (iv) Hypnotic.
    (4) The pharmacist must report any irregularities to the attending 
physician and the facility's medical director and director of nursing, 
and these reports must be acted upon.
    (i) Irregularities include, but are not limited to, any drug that 
meets the criteria set forth in paragraph (d) of this section for an 
unnecessary drug.
    (ii) Any irregularities noted by the pharmacist during this review 
must be documented on a separate, written report that is sent to the 
attending physician and the facility's medical director and director of 
nursing and lists, at a minimum, the resident's name, the relevant drug, 
and the irregularity the pharmacist identified.
    (iii) The attending physician must document in the resident's 
medical record that the identified irregularity has been reviewed and 
what, if any, action has been taken to address it. If there is to be no 
change in the medication, the attending physician should document his or 
her rationale in the resident's medical record.
    (5) The facility must develop and maintain policies and procedures 
for the monthly drug regimen review that include, but are not limited 
to, time frames for the different steps in the process and steps the 
pharmacist must take when he or she identifies an irregularity that 
requires urgent action to protect the resident.
    (d) Unnecessary drugs--General. Each resident's drug regimen must be 
free from unnecessary drugs. An unnecessary drug is any drug when used--
    (1) In excessive dose (including duplicate drug therapy); or
    (2) For excessive duration; or
    (3) Without adequate monitoring; or
    (4) Without adequate indications for its use; or
    (5) In the presence of adverse consequences which indicate the dose 
should be reduced or discontinued; or
    (6) Any combinations of the reasons stated in paragraphs (d)(1) 
through (5) of this section.
    (e) Psychotropic drugs. Based on a comprehensive assessment of a 
resident, the facility must ensure that--
    (1) Residents who have not used psychotropic drugs are not given 
these drugs unless the medication is necessary to treat a specific 
condition as diagnosed and documented in the clinical record;
    (2) Residents who use psychotropic drugs receive gradual dose 
reductions, and behavioral interventions, unless clinically 
contraindicated, in an effort to discontinue these drugs;
    (3) Residents do not receive psychotropic drugs pursuant to a PRN 
order unless that medication is necessary to treat a diagnosed specific 
condition that is documented in the clinical record; and
    (4) PRN orders for psychotropic drugs are limited to 14 days. Except 
as provided in Sec. 483.45(e)(5), if the attending physician or 
prescribing practitioner believes that it is appropriate for the PRN 
order to be extended beyond 14 days, he or she should document their 
rationale in the resident's medical

[[Page 82]]

record and indicate the duration for the PRN order.
    (5) PRN orders for anti-psychotic drugs are limited to 14 days and 
cannot be renewed unless the attending physician or prescribing 
practitioner evaluates the resident for the appropriateness of that 
medication.
    (f) Medication errors. The facility must ensure that its--
    (1) Medication error rates are not 5 percent or greater; and
    (2) Residents are free of any significant medication errors.
    (g) 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.
    (h) 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. 
Redesignated and amended at 81 FR 68861, 68863, Oct. 4, 2016; 82 FR 
32259, July 13, 2017]



Sec. 483.50  Laboratory, radiology, and other diagnostic services.

    (a) 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 a 
physician; physician assistant; nurse practitioner or clinical nurse 
specialist in accordance with State law, including scope of practice 
laws.
    (ii) Promptly notify the ordering physician, physician assistant, 
nurse practitioner, or clinical nurse specialist of laboratory results 
that fall outside of clinical reference ranges in accordance with 
facility policies and procedures for notification of a practitioner or 
per the ordering physician's orders.
    (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 laboratory reports that 
are dated and contain the name and address of the testing laboratory.
    (b) 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:

[[Page 83]]

    (i) Provide or obtain radiology and other diagnostic services only 
when ordered by a physician; physician assistant; nurse practitioner or 
clinical nurse specialist in accordance with State law, including scope 
of practice laws.
    (ii) Promptly notify the ordering physician, physician assistant, 
nurse practitioner, or clinical nurse specialist of results that fall 
outside of clinical reference ranges in accordance with facility 
policies and procedures for notification of a practitioner or per the 
ordering physician's orders.
    (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.

[81 FR 68863, Oct. 4, 2016, as amended at 82 FR 32259, July 13, 2017]



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. 483.70(g), 
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 have a policy identifying those circumstances when the loss 
or damage of dentures is the facility's responsibility and may not 
charge a resident for the loss or damage of dentures determined in 
accordance with facility policy to be the facility's responsibility;
    (4) Must if necessary or if requested, assist the resident--
    (i) In making appointments; and
    (ii) By arranging for transportation to and from the dental services 
location; and
    (5) Must promptly, within 3 days, refer residents with lost or 
damaged dentures for dental services. If a referral does not occur 
within 3 days, the facility must provide documentation of what they did 
to ensure the resident could still eat and drink adequately while 
awaiting dental services and the extenuating circumstances that led to 
the delay.
    (b) Nursing facilities. The facility (1) Must provide or obtain from 
an outside resource, in accordance with Sec. 483.70(g), 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 or if requested, assist the resident--
    (i) In making appointments; and
    (ii) By arranging for transportation to and from the dental services 
locations;
    (3) Must promptly, within 3 days, refer residents with lost or 
damaged dentures for dental services. If a referral does not occur 
within 3 days, the facility must provide documentation of what they did 
to ensure the resident could still eat and drink adequately while 
awaiting dental services and the extenuating circumstances that led to 
the delay;
    (4) Must have a policy identifying those circumstances when the loss 
or damage of dentures is the facility's responsibility and may not 
charge a resident for the loss or damage of dentures determined in 
accordance with facility policy to be the facility's responsibility; and
    (5) Must assist residents who are eligible and wish to participate 
to apply for reimbursement of dental services as an incurred medical 
expense under the State plan.

[56 FR 48875, Sept. 26, 1991, as amended at 81 FR 68864, Oct. 4, 2016]



Sec. 483.60  Food and nutrition services.

    The facility must provide each resident with a nourishing, 
palatable, well-balanced diet that meets his or her daily nutritional 
and special dietary needs, taking into consideration the preferences of 
each resident.
    (a) Staffing. The facility must employ sufficient staff with the 
appropriate competencies and skills sets to carry out the functions of 
the food and nutrition service, taking into consideration resident 
assessments, individual plans of care and the number, acuity and 
diagnoses of the facility's resident population in accordance with the 
facility

[[Page 84]]

assessment required at Sec. 483.70(e). This includes:
    (1) A qualified dietitian or other clinically qualified nutrition 
professional either full-time, part-time, or on a consultant basis. A 
qualified dietitian or other clinically qualified nutrition professional 
is one who--
    (i) Holds a bachelor's or higher degree granted by a regionally 
accredited college or university in the United States (or an equivalent 
foreign degree) with completion of the academic requirements of a 
program in nutrition or dietetics accredited by an appropriate national 
accreditation organization recognized for this purpose.
    (ii) Has completed at least 900 hours of supervised dietetics 
practice under the supervision of a registered dietitian or nutrition 
professional.
    (iii) Is licensed or certified as a dietitian or nutrition 
professional by the State in which the services are performed. In a 
state that does not provide for licensure or certification, the 
individual will be deemed to have met this requirement if he or she is 
recognized as a ``registered dietitian'' by the Commission on Dietetic 
Registration or its successor organization, or meets the requirements of 
paragraphs (a)(1)(i) and (ii) of this section.
    (iv) For dietitians hired or contracted with prior to November 28, 
2016, meets these requirements no later than 5 years after November 28, 
2016 or as required by state law.
    (2) If a qualified dietitian or other clinically qualified nutrition 
professional is not employed full-time, the facility must designate a 
person to serve as the director of food and nutrition services who--
    (i) For designations prior to November 28, 2016, meets the following 
requirements no later than 5 years after November 28, 2016, or no later 
than 1 year after November 28, 2016 for designations after November 28, 
2016, is:
    (A) A certified dietary manager; or
    (B) A certified food service manager, or
    (C) Has similar national certification for food service management 
and safety from a national certifying body; or
    (D) Has an associate's or higher degree in food service management 
or in hospitality, if the course study includes food service or 
restaurant management, from an accredited institution of higher 
learning; and
    (ii) In States that have established standards for food service 
managers or dietary managers, meets State requirements for food service 
managers or dietary managers, and
    (iii) Receives frequently scheduled consultations from a qualified 
dietitian or other clinically qualified nutrition professional.
    (3) Support staff. The facility must provide sufficient support 
personnel to safely and effectively carry out the functions of the food 
and nutrition service.
    (b) A member of the Food and Nutrition Services staff must 
participate on the interdisciplinary team as required in 
Sec. 483.21(b)(2)(ii).
    (c) Menus and nutritional adequacy. Menus must--
    (1) Meet the nutritional needs of residents in accordance with 
established national guidelines.;
    (2) Be prepared in advance;
    (3) Be followed;
    (4) Reflect, based on a facility's reasonable efforts, the 
religious, cultural, and ethnic needs of the resident population, as 
well as input received from residents and resident groups;
    (5) Be updated periodically;
    (6) Be reviewed by the facility's dietitian or other clinically 
qualified nutrition professional for nutritional adequacy; and
    (7) Nothing in this paragraph should be construed to limit the 
resident's right to make personal dietary choices.
    (d) Food and drink. Each resident receives and the facility 
provides--
    (1) Food prepared by methods that conserve nutritive value, flavor, 
and appearance;
    (2) Food and drink that is palatable, attractive, and at a safe and 
appetizing temperature;
    (3) Food prepared in a form designed to meet individual needs;
    (4) Food that accommodates resident allergies, intolerances, and 
preferences;
    (5) Appealing options of similar nutritive value to residents who 
choose not to eat food that is initially served or who request a 
different meal choice; and

[[Page 85]]

    (6) Drinks, including water and other liquids consistent with 
resident needs and preferences and sufficient to maintain resident 
hydration.
    (e) Therapeutic diets. (1) Therapeutic diets must be prescribed by 
the attending physician.
    (2) The attending physician may delegate to a registered or licensed 
dietitian the task of prescribing a resident's diet, including a 
therapeutic diet, to the extent allowed by State law.
    (f) Frequency of meals. (1) Each resident must receive and the 
facility must provide at least three meals daily, at regular times 
comparable to normal mealtimes in the community or in accordance with 
resident needs, preferences, requests, and plan of care.
    (2) There must be no more than 14 hours between a substantial 
evening meal and breakfast the following day, except when a nourishing 
snack is served 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.
    (3) Suitable, nourishing alternative meals and snacks must be 
provided to residents who want to eat at non-traditional times or 
outside of scheduled meal service times, consistent with the resident 
plan of care.
    (g) Assistive devices. The facility must provide special eating 
equipment and utensils for residents who need them and appropriate 
assistance to ensure that the resident can use the assistive devices 
when consuming meals and snacks.
    (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.
    (3) Resident selection criteria. (i) A facility must ensure that a 
feeding assistant provides dining assistance only for 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 
interdisciplinary team's assessment and the resident's latest assessment 
and plan of care. Appropriateness for this program should be reflected 
in the comprehensive care plan.
    (i) Food safety requirements. The facility must--
    (1) Procure food from sources approved or considered satisfactory by 
federal, state, or local authorities;
    (i) This may include food items obtained directly from local 
producers, subject to applicable State and local laws or regulations.
    (ii) This provision does not prohibit or prevent facilities from 
using produce grown in facility gardens, subject to compliance with 
applicable safe growing and food-handling practices.
    (iii) This provision does not preclude residents from consuming 
foods not procured by the facility.
    (2) Store, prepare, distribute, and serve food in accordance with 
professional standards for food service safety.
    (3) Have a policy regarding use and storage of foods brought to 
residents by family and other visitors to ensure safe and sanitary 
storage, handling, and consumption, and
    (4) Dispose of garbage and refuse properly.

[81 FR 68864, Oct. 4, 2016]



Sec. 483.65  Specialized rehabilitative services.

    (a) Provision of services. If specialized rehabilitative services 
such as but not limited to physical therapy, speech-language pathology, 
occupational therapy, respiratory therapy, and rehabilitative services 
for a mental disorder and intellectual disability or services of a 
lesser intensity as set forth at Sec. 483.120(c), are required in the 
resident's comprehensive plan of care, the facility must--
    (1) Provide the required services; or

[[Page 86]]

    (2) In accordance with Sec. 483.70(g), obtain the required services 
from an outside resource that is a provider of specialized 
rehabilitative services and is not excluded from participating in any 
federal or state health care programs pursuant to section 1128 and 1156 
of the Act.
    (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. 
Redesignated and amended at 81 FR 68861, 68865, Oct. 4, 2016]



Sec. 483.70  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 disability (45 CFR part 84); nondiscrimination on the basis 
of age (45 CFR part 91); nondiscrimination on the basis of race, color, 
national origin, sex, age, or disability (45 CFR part 92); protection of 
human subjects of research (45 CFR part 46); and fraud and abuse (42 CFR 
part 455) and protection of individually identifiable health information 
(45 CFR parts 160 and 164). Violations of such other provisions may 
result in a finding of non-compliance with this paragraph.
    (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;
    (ii) Responsible for management of the facility; and
    (iii) Reports to and is accountable to the governing body.
    (3) The governing body is responsible and accountable for the QAPI 
program, in accordance with Sec. 483.75(f).
    (e) Facility assessment. The facility must conduct and document a 
facility-wide assessment to determine what resources are necessary to 
care for its residents competently during both day-to-day operations and 
emergencies. The facility must review and update that assessment, as 
necessary, and at least annually. The facility must also review and 
update this assessment whenever there is, or the facility plans for, any 
change that would require a substantial modification to any part of this 
assessment. The facility assessment must address or include:
    (1) The facility's resident population, including, but not limited 
to,
    (i) Both the number of residents and the facility's resident 
capacity;
    (ii) The care required by the resident population considering the 
types of diseases, conditions, physical and cognitive disabilities, 
overall acuity, and other pertinent facts that are present within that 
population;
    (iii) The staff competencies that are necessary to provide the level 
and types of care needed for the resident population;
    (iv) The physical environment, equipment, services, and other 
physical plant considerations that are necessary to care for this 
population; and
    (v) Any ethnic, cultural, or religious factors that may potentially 
affect the care provided by the facility, including, but not limited to, 
activities and food and nutrition services.
    (2) The facility's resources, including but not limited to,

[[Page 87]]

    (i) All buildings and/or other physical structures and vehicles;
    (ii) Equipment (medical and non-medical);
    (iii) Services provided, such as physical therapy, pharmacy, and 
specific rehabilitation therapies;
    (iv) All personnel, including managers, staff (both employees and 
those who provide services under contract), and volunteers, as well as 
their education and/or training and any competencies related to resident 
care;
    (v) Contracts, memorandums of understanding, or other agreements 
with third parties to provide services or equipment to the facility 
during both normal operations and emergencies; and
    (vi) Health information technology resources, such as systems for 
electronically managing patient records and electronically sharing 
information with other organizations.
    (3) A facility-based and community-based risk assessment, utilizing 
an all-hazards approach.
    (f) 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.
    (g) 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 (g)(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.
    (h) Medical director. (1) The facility must designate a physician to 
serve as medical director.
    (2) The medical director is responsible for--
    (i) Implementation of resident care policies; and
    (ii) The coordination of medical care in the facility.
    (i) Medical records. (1) In accordance with accepted professional 
standards and practices, the facility must maintain medical records on 
each resident that are--
    (i) Complete;
    (ii) Accurately documented;
    (iii) Readily accessible; and
    (iv) Systematically organized.
    (2) 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--
    (i) To the individual, or their resident representative where 
permitted by applicable law;
    (ii) Required by law;
    (iii) For treatment, payment, or health care operations, as 
permitted by and in compliance with 45 CFR 164.506;
    (iv) For public health activities, reporting of abuse, neglect, or 
domestic violence, health oversight activities, judicial and 
administrative proceedings, law enforcement purposes, organ donation 
purposes, research purposes, or to coroners, medical examiners, funeral 
directors, and to avert a serious threat to health or safety as 
permitted by and in compliance with 45 CFR 164.512.
    (3) The facility must safeguard medical record information against 
loss, destruction, or unauthorized use;
    (4) Medical 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, 3 years after a resident reaches legal age under 
State law.
    (5) The medical record must contain--
    (i) Sufficient information to identify the resident;
    (ii) A record of the resident's assessments;

[[Page 88]]

    (iii) The comprehensive plan of care and services provided;
    (iv) The results of any preadmission screening and resident review 
evaluations and determinations conducted by the State;
    (v) Physician's, nurse's, and other licensed professional's progress 
notes; and
    (vi) Laboratory, radiology and other diagnostic services reports as 
required under Sec. 483.50.
    (j) 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 or, in an 
emergency situation, by another practitioner in accordance with facility 
policy and consistent with state law; 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 receive appropriate services or 
receive services in a less restrictive setting than either the facility 
or the hospital, or reintegrated into the community, will be exchanged 
between the providers, including but not limited to the information 
required under Sec. 483.15(c)(2)(iii).
    (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.
    (k) Disclosure of ownership. (1) The facility must comply with the 
disclosure requirements of Secs. 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 
Secs. 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 (k)(2) of this section must 
include the identity of each new individual or company.
    (l) Facility closure-Administrator. Any individual who is the 
administrator of the facility must:
    (1) Submit to the State Survey Agency, the State LTC ombudsman, 
residents of the facility, and the legal representatives of such 
residents or other responsible parties, written notification of an 
impending closure:
    (i) At least 60 days prior to the date of closure; or
    (ii) In the case of a facility where the Secretary or a State 
terminates the facility's participation in the Medicare and/or Medicaid 
programs, not later than the date that the Secretary determines 
appropriate;
    (2) Ensure that the facility does not admit any new residents on or 
after the date on which such written notification is submitted; and
    (3) Include in the notice the plan, that has been approved by the 
State, for the transfer and adequate relocation of the residents of the 
facility by a date that would be specified by the State prior to 
closure, including assurances that the residents would be transferred to 
the most appropriate facility or other setting in terms of quality, 
services, and location, taking into consideration the needs, choice, and 
best interests of each resident.
    (m) Facility closure. The facility must have in place policies and 
procedures to ensure that the administrator's duties and 
responsibilities involve providing the appropriate notices in the event 
of a facility closure, as required at paragraph (l) of this section.
    (n) Binding arbitration agreements. (1) A facility must not enter 
into a pre-dispute agreement for binding arbitration with any resident 
or resident's

[[Page 89]]

representative nor require that a resident sign an arbitration agreement 
as a condition of admission to the LTC facility.
    (2) If, after a dispute between the facility and a resident arises, 
and a facility chooses to ask a resident or his or her representative to 
enter into an agreement for binding arbitration, the facility must 
comply with all of the requirements in this section.
    (i) The facility must ensure that:
    (A) The agreement is explained to the resident and their 
representative in a form and manner that he or she understands, 
including in a language the resident and their representative 
understands, and
    (B) The resident acknowledges that he or she understands the 
agreement.
    (ii) The agreement must:
    (A) Be entered into by the resident voluntarily.
    (B) Provide for the selection of a neutral arbitrator agreed upon by 
both parties.
    (C) Provide for selection of a venue convenient to both parties.
    (iii) A resident's continuing right to remain in the facility must 
not be contingent upon the resident or the resident's representative 
signing a binding arbitration agreement.
    (iv) The agreement must not contain any language that prohibits or 
discourages the resident or anyone else from communicating with federal, 
state, or local officials, including but not limited to, federal and 
state surveyors, other federal or state health department employees, and 
representatives of the Office of the State Long-Term Care Ombudsman, in 
accordance with Sec. 483.10(k).
    (v) The agreement may be signed by another individual if:
    (A) Allowed by state law;
    (B) All of the requirements in this section are met; and
    (C) That individual has no interest in the facility.
    (vi) When the facility and a resident resolve a dispute with 
arbitration, a copy of the signed agreement for binding arbitration and 
the arbitrator's final decision must be retained by the facility for 5 
years and be available for inspection upon request by CMS or its 
designee.
    (o) Hospice services. (1) A long-term care (LTC) facility may do 
either of the following:
    (i) Arrange for the provision of hospice services through an 
agreement with one or more Medicare-certified hospices.
    (ii) Not arrange for the provision of hospice services at the 
facility through an agreement with a Medicare-certified hospice and 
assist the resident in transferring to a facility that will arrange for 
the provision of hospice services when a resident requests a transfer.
    (2) If hospice care is furnished in an LTC facility through an 
agreement as specified in paragraph (o)(1)(i) of this section with a 
hospice, the LTC facility must meet the following requirements:
    (i) Ensure that the hospice services meet professional standards and 
principles that apply to individuals providing services in the facility, 
and to the timeliness of the services.
    (ii) Have a written agreement with the hospice that is signed by an 
authorized representative of the hospice and an authorized 
representative of the LTC facility before hospice care is furnished to 
any resident. The written agreement must set out at least the following:
    (A) The services the hospice will provide.
    (B) The hospice's responsibilities for determining the appropriate 
hospice plan of care as specified in Sec. 418.112 (d) of this chapter.
    (C) The services the LTC facility will continue to provide, based on 
each resident's plan of care.
    (D) A communication process, including how the communication will be 
documented between the LTC facility and the hospice provider, to ensure 
that the needs of the resident are addressed and met 24 hours per day.
    (E) A provision that the LTC facility immediately notifies the 
hospice about the following:
    (1) A significant change in the resident's physical, mental, social, 
or emotional status.
    (2) Clinical complications that suggest a need to alter the plan of 
care.
    (3) A need to transfer the resident from the facility for any 
condition.
    (4) The resident's death.

[[Page 90]]

    (F) A provision stating that the hospice assumes responsibility for 
determining the appropriate course of hospice care, including the 
determination to change the level of services provided.
    (G) An agreement that it is the LTC facility's responsibility to 
furnish 24-hour room and board care, meet the resident's personal care 
and nursing needs in coordination with the hospice representative, and 
ensure that the level of care provided is appropriately based on the 
individual resident's needs.
    (H) A delineation of the hospice's responsibilities, including but 
not limited to, providing medical direction and management of the 
patient; nursing; counseling (including spiritual, dietary, and 
bereavement); social work; providing medical supplies, durable medical 
equipment, and drugs necessary for the palliation of pain and symptoms 
associated with the terminal illness and related conditions; and all 
other hospice services that are necessary for the care of the resident's 
terminal illness and related conditions.
    (I) A provision that when the LTC facility personnel are responsible 
for the administration of prescribed therapies, including those 
therapies determined appropriate by the hospice and delineated in the 
hospice plan of care, the LTC facility personnel may administer the 
therapies where permitted by State law and as specified by the LTC 
facility.
    (J) A provision stating that the LTC facility must report all 
alleged violations involving mistreatment, neglect, or verbal, mental, 
sexual, and physical abuse, including injuries of unknown source, and 
misappropriation of patient property by hospice personnel, to the 
hospice administrator immediately when the LTC facility becomes aware of 
the alleged violation.
    (K) A delineation of the responsibilities of the hospice and the LTC 
facility to provide bereavement services to LTC facility staff.
    (3) Each LTC facility arranging for the provision of hospice care 
under a written agreement must designate a member of the facility's 
interdisciplinary team who is responsible for working with hospice 
representatives to coordinate care to the resident provided by the LTC 
facility staff and hospice staff. The interdisciplinary team member must 
have a clinical background, function within their State scope of 
practice act, and have the ability to assess the resident or have access 
to someone that has the skills and capabilities to assess the resident. 
The designated interdisciplinary team member is responsible for the 
following:
    (i) Collaborating with hospice representatives and coordinating LTC 
facility staff participation in the hospice care planning process for 
those residents receiving these services.
    (ii) Communicating with hospice representatives and other healthcare 
providers participating in the provision of care for the terminal 
illness, related conditions, and other conditions, to ensure quality of 
care for the patient and family.
    (iii) Ensuring that the LTC facility communicates with the hospice 
medical director, the patient's attending physician, and other 
practitioners participating in the provision of care to the patient as 
needed to coordinate the hospice care with the medical care provided by 
other physicians.
    (iv) Obtaining the following information from the hospice:
    (A) The most recent hospice plan of care specific to each patient.
    (B) Hospice election form.
    (C) Physician certification and recertification of the terminal 
illness specific to each patient.
    (D) Names and contact information for hospice personnel involved in 
hospice care of each patient.
    (E) Instructions on how to access the hospice's 24-hour on-call 
system.
    (F) Hospice medication information specific to each patient.
    (G) Hospice physician and attending physician (if any) orders 
specific to each patient.
    (v) Ensuring that the LTC facility staff provides orientation in the 
policies and procedures of the facility, including patient rights, 
appropriate forms, and record keeping requirements, to hospice staff 
furnishing care to LTC residents.
    (4) Each LTC facility providing hospice care under a written 
agreement

[[Page 91]]

must ensure that each resident's written plan of care includes both the 
most recent hospice plan of care and a description of the services 
furnished by the LTC facility to attain or maintain the resident's 
highest practicable physical, mental, and psychosocial well-being, as 
required at Sec. 483.25.
    (p) Social worker. Any facility with more than 120 beds must employ 
a qualified social worker on a full-time basis. A qualified social 
worker is:
    (1) An individual with a minimum of a bachelor's degree in social 
work or a bachelor's degree in a human services field including, but not 
limited to, sociology, gerontology, special education, rehabilitation 
counseling, and psychology; and
    (2) One year of supervised social work experience in a health care 
setting working directly with individuals.
    (q) Mandatory submission of staffing information based on payroll 
data in a uniform format. Long-term care facilities must electronically 
submit to CMS complete and accurate direct care staffing information, 
including information for agency and contract staff, based on payroll 
and other verifiable and auditable data in a uniform format according to 
specifications established by CMS.
    (1) Direct Care Staff. Direct Care Staff are those individuals who, 
through interpersonal contact with residents or resident care 
management, provide care and services to allow residents to attain or 
maintain the highest practicable physical, mental, and psychosocial 
well-being. Direct care staff does not include individuals whose primary 
duty is maintaining the physical environment of the long term care 
facility (for example, housekeeping).
    (2) Submission requirements. The facility must electronically submit 
to CMS complete and accurate direct care staffing information, including 
the following:
    (i) The category of work for each person on direct care staff 
(including, but not limited to, whether the individual is a registered 
nurse, licensed practical nurse, licensed vocational nurse, certified 
nursing assistant, therapist, or other type of medical personnel as 
specified by CMS);
    (ii) Resident census data; and
    (iii) Information on direct care staff turnover and tenure, and on 
the hours of care provided by each category of staff per resident per 
day (including, but not limited to, start date, end date (as 
applicable), and hours worked for each individual).
    (3) Distinguishing employee from agency and contract staff. When 
reporting information about direct care staff, the facility must specify 
whether the individual is an employee of the facility, or is engaged by 
the facility under contract or through an agency.
    (4) Data format. The facility must submit direct care staffing 
information in the uniform format specified by CMS.
    (5) Submission schedule. The facility must submit direct care 
staffing information on the schedule specified by CMS, but no less 
frequently than quarterly.

[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; 76 FR 9511, Feb. 18, 2011; 78 FR 16805, Mar. 
19, 2013; 78 FR 38605, June 27, 2013; 80 FR 46477, Aug. 4, 2015; 81 FR 
64032, Sept. 16, 2016. Redesignated and amended at 81 FR 68861, 68865, 
Oct. 4, 2016; 82 FR 32259, July 13, 2017]



Sec. 483.73  Emergency preparedness.

    The LTC facility must comply with all applicable Federal, State and 
local emergency preparedness requirements. The LTC facility must 
establish and maintain an emergency preparedness program that meets the 
requirements of this section. The emergency preparedness program must 
include, but not be limited to, the following elements:
    (a) Emergency plan. The LTC facility must develop and maintain an 
emergency preparedness plan that must be reviewed, and updated at least 
annually. The plan must do all of the following:
    (1) Be based on and include a documented, facility-based and 
community-based risk assessment, utilizing an all-hazards approach, 
including missing residents.
    (2) Include strategies for addressing emergency events identified by 
the risk assessment.

[[Page 92]]

    (3) Address resident population, including, but not limited to, 
persons at-risk; the type of services the LTC facility has the ability 
to provide in an emergency; and continuity of operations, including 
delegations of authority and succession plans.
    (4) Include a process for cooperation and collaboration with local, 
tribal, regional, State, or Federal emergency preparedness officials' 
efforts to maintain an integrated response during a disaster or 
emergency situation, including documentation of the LTC facility's 
efforts to contact such officials and, when applicable, of its 
participation in collaborative and cooperative planning efforts.
    (b) Policies and procedures. The LTC facility must develop and 
implement emergency preparedness policies and procedures, based on the 
emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, and the communication 
plan at paragraph (c) of this section. The policies and procedures must 
be reviewed and updated at least annually. At a minimum, the policies 
and procedures must address the following:
    (1) The provision of subsistence needs for staff and residents, 
whether they evacuate or shelter in place, include, but are not limited 
to the following:
    (i) Food, water, medical, and pharmaceutical supplies.
    (ii) Alternate sources of energy to maintain--
    (A) Temperatures to protect resident health and safety and for the 
safe and sanitary storage of provisions;
    (B) Emergency lighting;
    (C) Fire detection, extinguishing, and alarm systems; and
    (D) Sewage and waste disposal.
    (2) A system to track the location of on-duty staff and sheltered 
residents in the LTC facility's care during and after an emergency. If 
on-duty staff and sheltered residents are relocated during the 
emergency, the LTC facility must document the specific name and location 
of the receiving facility or other location.
    (3) Safe evacuation from the LTC facility, which includes 
consideration of care and treatment needs of evacuees; staff 
responsibilities; transportation; identification of evacuation 
location(s); and primary and alternate means of communication with 
external sources of assistance.
    (4) A means to shelter in place for residents, staff, and volunteers 
who remain in the LTC facility.
    (5) A system of medical documentation that preserves resident 
information, protects confidentiality of resident information, and 
secures and maintains the availability of records.
    (6) The use of volunteers in an emergency or other emergency 
staffing strategies, including the process and role for integration of 
State or Federally designated health care professionals to address surge 
needs during an emergency.
    (7) The development of arrangements with other LTC facilities and 
other providers to receive residents in the event of limitations or 
cessation of operations to maintain the continuity of services to LTC 
residents.
    (8) The role of the LTC facility under a waiver declared by the 
Secretary, in accordance with section 1135 of the Act, in the provision 
of care and treatment at an alternate care site identified by emergency 
management officials.
    (c) Communication plan. The LTC facility must develop and maintain 
an emergency preparedness communication plan that complies with Federal, 
State, and local laws and must be reviewed and updated at least 
annually. The communication plan must include all of the following:
    (1) Names and contact information for the following:
    (i) Staff.
    (ii) Entities providing services under arrangement.
    (iii) Residents' physicians.
    (iv) Other LTC facilities.
    (v) Volunteers.
    (2) Contact information for the following:
    (i) Federal, State, tribal, regional, or local emergency 
preparedness staff.
    (ii) The State Licensing and Certification Agency.
    (iii) The Office of the State Long-Term Care Ombudsman.
    (iv) Other sources of assistance.
    (3) Primary and alternate means for communicating with the 
following:

[[Page 93]]

    (i) LTC facility's staff.
    (ii) Federal, State, tribal, regional, or local emergency management 
agencies.
    (4) A method for sharing information and medical documentation for 
residents under the LTC facility's care, as necessary, with other health 
care providers to maintain the continuity of care.
    (5) A means, in the event of an evacuation, to release resident 
information as permitted under 45 CFR 164.510(b)(1)(ii).
    (6) A means of providing information about the general condition and 
location of residents under the facility's care as permitted under 45 
CFR 164.510(b)(4).
    (7) A means of providing information about the LTC facility's 
occupancy, needs, and its ability to provide assistance, to the 
authority having jurisdiction or the Incident Command Center, or 
designee.
    (8) A method for sharing information from the emergency plan that 
the facility has determined is appropriate with residents and their 
families or representatives.
    (d) Training and testing. The LTC facility must develop and maintain 
an emergency preparedness training and testing program that is based on 
the emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program must be 
reviewed and updated at least annually.
    (1) Training program. The LTC facility must do all of the following:
    (i) Initial training in emergency preparedness policies and 
procedures to all new and existing staff, individuals providing services 
under arrangement, and volunteers, consistent with their expected roles.
    (ii) Provide emergency preparedness training at least annually.
    (iii) Maintain documentation of the training.
    (iv) Demonstrate staff knowledge of emergency procedures.
    (2) Testing. The LTC facility must conduct exercises to test the 
emergency plan at least annually, including unannounced staff drills 
using the emergency procedures. The LTC facility must do the following:
    (i) Participate in a full-scale exercise that is community-based or 
when a community-based exercise is not accessible, an individual, 
facility-based. If the LTC facility experiences an actual natural or 
man-made emergency that requires activation of the emergency plan, the 
LTC facility is exempt from engaging in a community-based or individual, 
facility-based full-scale exercise for 1 year following the onset of the 
actual event.
    (ii) Conduct an additional exercise that may include, but is not 
limited to the following:
    (A) A second full-scale exercise that is community-based or 
individual, facility-based.
    (B) A tabletop exercise that includes a group discussion led by a 
facilitator, using a narrated, clinically-relevant emergency scenario, 
and a set of problem statements, directed messages, or prepared 
questions designed to challenge an emergency plan.
    (iii) Analyze the LTC facility's response to and maintain 
documentation of all drills, tabletop exercises, and emergency events, 
and revise the LTC facility's emergency plan, as needed.
    (e) Emergency and standby power systems. The LTC facility must 
implement emergency and standby power systems based on the emergency 
plan set forth in paragraph (a) of this section.
    (1) Emergency generator location. The generator must be located in 
accordance with the location requirements found in the Health Care 
Facilities Code (NFPA 99 and Tentative Interim Amendments TIA 12-2, TIA 
12-3, TIA 12-4, TIA 12-5, and TIA 12-6), Life Safety Code (NFPA 101 and 
Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-
4), and NFPA 110, when a new structure is built or when an existing 
structure or building is renovated.
    (2) Emergency generator inspection and testing. The LTC facility 
must implement the emergency power system inspection, testing, and 
maintenance requirements found in the Health Care Facilities Code, NFPA 
110, and Life Safety Code.

[[Page 94]]

    (3) Emergency generator fuel. LTC facilities that maintain an onsite 
fuel source to power emergency generators must have a plan for how it 
will keep emergency power systems operational during the emergency, 
unless it evacuates.
    (f) Integrated healthcare systems. If a LTC facility is part of a 
healthcare system consisting of multiple separately certified healthcare 
facilities that elects to have a unified and integrated emergency 
preparedness program, the LTC facility may choose to participate in the 
healthcare system's coordinated emergency preparedness program. If 
elected, the unified and integrated emergency preparedness program must 
do all of the following:
    (1) Demonstrate that each separately certified facility within the 
system actively participated in the development of the unified and 
integrated emergency preparedness program.
    (2) Be developed and maintained in a manner that takes into account 
each separately certified facility's unique circumstances, patient 
populations, and services offered.
    (3) Demonstrate that each separately certified facility is capable 
of actively using the unified and integrated emergency preparedness 
program and is in compliance with the program.
    (4) Include a unified and integrated emergency plan that meets the 
requirements of paragraphs (a)(2), (3), and (4) of this section. The 
unified and integrated emergency plan must also be based on and 
include--
    (i) A documented community-based risk assessment, utilizing an all-
hazards approach.
    (ii) A documented individual facility-based risk assessment for each 
separately certified facility within the health system, utilizing an 
all-hazards approach.
    (5) Include integrated policies and procedures that meet the 
requirements set forth in paragraph (b) of this section, a coordinated 
communication plan and training and testing programs that meet the 
requirements of paragraphs (c) and (d) of this section, respectively.
    (g) The standards incorporated by reference in this section are 
approved for incorporation by reference by the Director of the Office of 
the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 
51. You may obtain the material from the sources listed below. You may 
inspect a copy 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. If any 
changes in this edition of the Code are incorporated by reference, CMS 
will publish a document in the Federal Register to announce the changes.
    (1) National Fire Protection Association, 1 Batterymarch Park, 
Quincy, MA 02169, www.nfpa.org, 1.617.770.3000.
    (i) NFPA 99, Health Care Facilities Code 2012 edition, issued August 
11, 2011.
    (ii) Technical interim amendment (TIA) 12-2 to NFPA 99, issued 
August 11, 2011.
    (iii) TIA 12-3 to NFPA 99, issued August 9, 2012.
    (iv) TIA 12-4 to NFPA 99, issued March 7, 2013.
    (v) TIA 12-5 to NFPA 99, issued August 1, 2013.
    (vi) TIA 12-6 to NFPA 99, issued March 3, 2014.
    (vii) NFPA 101, Life Safety Code, 2012 edition, issued August 11, 
2011.
    (viii) TIA 12-1 to NFPA 101, issued August 11, 2011.
    (ix) TIA 12-2 to NFPA 101, issued October 30, 2012.
    (x) TIA 12-3 to NFPA 101, issued October 22, 2013.
    (xi) TIA 12-4 to NFPA 101, issued October 22, 2013.
    (xii) NFPA 110, Standard for Emergency and Standby Power Systems, 
2010 edition, including TIAs to chapter 7, issued August 6, 2009.
    (2) [Reserved]

[81 FR 64030, Sept. 16, 2016; 81 FR 80594, Nov. 16, 2016]



Sec. 483.75  Quality assurance and performance improvement.

    (a) Quality assurance and performance improvement (QAPI) program. 
Each LTC facility, including a facility that is

[[Page 95]]

part of a multiunit chain, must develop, implement, and maintain an 
effective, comprehensive, data-driven QAPI program that focuses on 
indicators of the outcomes of care and quality of life. The facility 
must--
    (1) Maintain documentation and demonstrate evidence of its ongoing 
QAPI program that meets the requirements of this section. This may 
include but is not limited to systems and reports demonstrating 
systematic identification, reporting, investigation, analysis, and 
prevention of adverse events; and documentation demonstrating the 
development, implementation, and evaluation of corrective actions or 
performance improvement activities;
    (2) Present its QAPI plan to the State Survey Agency no later than 1 
year after the promulgation of this regulation;
    (3) Present its QAPI plan to a State Survey Agency or Federal 
surveyor at each annual recertification survey and upon request during 
any other survey and to CMS upon request; and
    (4) Present documentation and evidence of its ongoing QAPI program's 
implementation and the facility's compliance with requirements to a 
State Survey Agency, Federal surveyor or CMS upon request.
    (b) Program design and scope. A facility must design its QAPI 
program to be ongoing, comprehensive, and to address the full range of 
care and services provided by the facility. It must:
    (1) Address all systems of care and management practices;
    (2) Include clinical care, quality of life, and resident choice;
    (3) Utilize the best available evidence to define and measure 
indicators of quality and facility goals that reflect processes of care 
and facility operations that have been shown to be predictive of desired 
outcomes for residents of a SNF or NF.
    (4) Reflect the complexities, unique care, and services that the 
facility provides.
    (c) Program feedback, data systems and monitoring. A facility must 
establish and implement written policies and procedures for feedback, 
data collections systems, and monitoring, including adverse event 
monitoring. The policies and procedures must include, at a minimum, the 
following:
    (1) Facility maintenance of effective systems to obtain and use of 
feedback and input from direct care staff, other staff, residents, and 
resident representatives, including how such information will be used to 
identify problems that are high risk, high volume, or problem-prone, and 
opportunities for improvement.
    (2) Facility maintenance of effective systems to identify, collect, 
and use data and information from all departments, including but not 
limited to the facility assessment required at Sec. 483.70(e) and 
including how such information will be used to develop and monitor 
performance indicators.
    (3) Facility development, monitoring, and evaluation of performance 
indicators, including the methodology and frequency for such 
development, monitoring, and evaluation.
    (4) Facility adverse event monitoring, including the methods by 
which the facility will systematically identify, report, track, 
investigate, analyze and use data and information relating to adverse 
events in the facility, including how the facility will use the data to 
develop activities to prevent adverse events.
    (d) Program systematic analysis and systemic action. (1) The 
facility must take actions aimed at performance improvement and, after 
implementing those actions, measure its success, and track performance 
to ensure that improvements are realized and sustained.
    (2) The facility will develop and implement policies addressing:
    (i) How they will use a systematic approach to determine underlying 
causes of problems impacting larger systems;
    (ii) How they will develop corrective actions that will be designed 
to effect change at the systems level to prevent quality of care, 
quality of life, or safety problems ; and
    (iii) How the facility will monitor the effectiveness of its 
performance improvement activities to ensure that improvements are 
sustained.
    (e) Program activities. (1) The facility must set priorities for its 
performance improvement activities that focus on high-risk, high-volume, 
or problem-prone areas; consider the incidence,

[[Page 96]]

prevalence, and severity of problems in those areas; and affect health 
outcomes, resident safety, resident autonomy, resident choice, and 
quality of care.
    (2) Performance improvement activities must track medical errors and 
adverse resident events, analyze their causes, and implement preventive 
actions and mechanisms that include feedback and learning throughout the 
facility.
    (3) As a part of their performance improvement activities, the 
facility must conduct distinct performance improvement projects. The 
number and frequency of improvement projects conducted by the facility 
must reflect the scope and complexity of the facility's services and 
available resources, as reflected in the facility assessment required at 
Sec. 483.70(e). Improvement projects must include at least annually a 
project that focuses on high risk or problem-prone areas identified 
through the data collection and analysis described in paragraphs (c) and 
(d) of this section.
    (f) Governance and leadership. The governing body and/or executive 
leadership (or organized group or individual who assumes full legal 
authority and responsibility for operation of the facility) is 
responsible and accountable for ensuring that--
    (1) An ongoing QAPI program is defined, implemented, and maintained 
and addresses identified priorities.
    (2) The QAPI program is sustained during transitions in leadership 
and staffing;
    (3) The QAPI program is adequately resourced, including ensuring 
staff time, equipment, and technical training as needed;
    (4) The QAPI program identifies and prioritizes problems and 
opportunities that reflect organizational process, functions, and 
services provided to resident based on performance indicator data, and 
resident and staff input, and other information.
    (5) Corrective actions address gaps in systems, and are evaluated 
for effectiveness; and
    (6) Clear expectations are set around safety, quality, rights, 
choice, and respect.
    (g) Quality assessment and assurance. (1) A facility must maintain a 
quality assessment and assurance committee consisting at a minimum of:
    (i) The director of nursing services;
    (ii) The Medical Director or his or her designee;
    (iii) At least three other members of the facility's staff, at least 
one of who must be the administrator, owner, a board member or other 
individual in a leadership role; and
    (iv) The infection preventionist.
    (2) The quality assessment and assurance committee reports to the 
facility's governing body, or designated person(s) functioning as a 
governing body regarding its activities, including implementation of the 
QAPI program required under paragraphs (a) through (e) of this section. 
The committee must:
    (i) Meet at least quarterly and as needed to coordinate and evaluate 
activities under the QAPI program, such as identifying issues with 
respect to which quality assessment and assurance activities, including 
performance improvement projects required under the QAPI program, are 
necessary; and
    (ii) Develop and implement appropriate plans of action to correct 
identified quality deficiencies; and
    (iii) Regularly review and analyze data, including data collected 
under the QAPI program and data resulting from drug regimen reviews, and 
act on available data to make improvements.
    (h) Disclosure of information. 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.
    (i) Sanctions. Good faith attempts by the committee to identify and 
correct quality deficiencies will not be used as a basis for sanctions.

[81 FR 68867, Oct. 4, 2016, as amended at 82 FR 32259, July 13, 2017]



Sec. 483.80  Infection control.

    The facility must establish and maintain an infection prevention and 
control program designed to provide a safe, sanitary, and comfortable 
environment and to help prevent the development and transmission of 
communicable diseases and infections.

[[Page 97]]

    (a) Infection prevention and control program. The facility must 
establish an infection prevention and control program (IPCP) that must 
include, at a minimum, the following elements:
    (1) A system for preventing, identifying, reporting, investigating, 
and controlling infections and communicable diseases for all residents, 
staff, volunteers, visitors, and other individuals providing services 
under a contractual arrangement based upon the facility assessment 
conducted according to Sec. 483.70(e) and following accepted national 
standards;
    (2) Written standards, policies, and procedures for the program, 
which must include, but are not limited to:
    (i) A system of surveillance designed to identify possible 
communicable diseases or infections before they can spread to other 
persons in the facility;
    (ii) When and to whom possible incidents of communicable disease or 
infections should be reported;
    (iii) Standard and transmission-based precautions to be followed to 
prevent spread of infections;
    (iv) When and how isolation should be used for a resident; including 
but not limited to:
    (A) The type and duration of the isolation, depending upon the 
infectious agent or organism involved, and
    (B) A requirement that the isolation should be the least restrictive 
possible for the resident under the circumstances.
    (v) The circumstances under which 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; and
    (vi) The hand hygiene procedures to be followed by staff involved in 
direct resident contact.
    (3) An antibiotic stewardship program that includes antibiotic use 
protocols and a system to monitor antibiotic use.
    (4) A system for recording incidents identified under the facility's 
IPCP and the corrective actions taken by the facility.
    (b) Infection preventionist. The facility must designate one or more 
individual(s) as the infection preventionist(s) (IPs) who are 
responsible for the facility's IPCP. The IP must:
    (1) Have primary professional training in nursing, medical 
technology, microbiology, epidemiology, or other related field;
    (2) Be qualified by education, training, experience or 
certification;
    (3) Work at least part-time at the facility; and
    (4) Have completed specialized training in infection prevention and 
control.
    (c) IP participation on quality assessment and assurance committee. 
The individual designated as the IP, or at least one of the individuals 
if there is more than one IP, must be a member of the facility's quality 
assessment and assurance committee and report to the committee on the 
IPCP on a regular basis.
    (d) Influenza and pneumococcal immunizations--(1) Influenza. The 
facility must develop policies and procedures to ensure that--
    (i) Before offering the influenza immunization, each resident or the 
resident's 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 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 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 to ensure that--
    (i) Before offering the pneumococcal immunization, each resident or 
the

[[Page 98]]

resident's 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 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 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.
    (e) Linens. Personnel must handle, store, process, and transport 
linens so as to prevent the spread of infection.
    (f) Annual review. The facility will conduct an annual review of its 
IPCP and update their program, as necessary.

[81 FR 68868, Oct. 4, 2016]



Sec. 483.85  Compliance and ethics program.

    (a) Definitions. For purposes of this section, the following 
definitions apply:
    Compliance and ethics program means, with respect to a facility, a 
program of the operating organization that--
    (1) Has been reasonably designed, implemented, and enforced so that 
it is likely to be effective in preventing and detecting criminal, 
civil, and administrative violations under the Act and in promoting 
quality of care; and
    (2) Includes, at a minimum, the required components specified in 
paragraph (c) of this section.
    High-level personnel means individual(s) who have substantial 
control over the operating organization or who have a substantial role 
in the making of policy within the operating organization.
    Operating organization means the individual(s) or entity that 
operates a facility.
    (b) General rule. Beginning November 28, 2019, the operating 
organization for each facility must have in operation a compliance and 
ethics program (as defined in paragraph (a) of this section) that meets 
the requirements of this section.
    (c) Required components for all facilities. The operating 
organization for each facility must develop, implement, and maintain an 
effective compliance and ethics program that contains, at a minimum, the 
following components:
    (1) Established written compliance and ethics standards, policies, 
and procedures to follow that are reasonably capable of reducing the 
prospect of criminal, civil, and administrative violations under the Act 
and promote quality of care, which include, but are not limited to, the 
designation of an appropriate compliance and ethics program contact to 
which individuals may report suspected violations, as well as an 
alternate method of reporting suspected violations anonymously without 
fear of retribution; and disciplinary standards that set out the 
consequences for committing violations for the operating organization's 
entire staff; individuals providing services under a contractual 
arrangement; and volunteers, consistent with the volunteers' expected 
roles.
    (2) Assignment of specific individuals within the high-level 
personnel of the operating organization with the overall responsibility 
to oversee compliance with the operating organization's compliance and 
ethics program's standards, policies, and procedures, such as, but not 
limited to, the chief executive officer (CEO), members of the board of 
directors, or directors of major divisions in the operating 
organization.
    (3) Sufficient resources and authority to the specific individuals 
designated in paragraph (c)(2) of this section to reasonably assure 
compliance with such standards, policies, and procedures.
    (4) Due care not to delegate substantial discretionary authority to 
individuals who the operating organization knew, or should have known 
through

[[Page 99]]

the exercise of due diligence, had a propensity to engage in criminal, 
civil, and administrative violations under the Social Security Act.
    (5) The facility takes steps to effectively communicate the 
standards, policies, and procedures in the operating organization's 
compliance and ethics program to the operating organization's entire 
staff; individuals providing services under a contractual arrangement; 
and volunteers, consistent with the volunteers' expected roles. 
Requirements include, but are not limited to, mandatory participation in 
training as set forth at Sec. 483.95(f) or orientation programs, or 
disseminating information that explains in a practical manner what is 
required under the program.
    (6) The facility takes reasonable steps to achieve compliance with 
the program's standards, policies, and procedures. Such steps include, 
but are not limited to, utilizing monitoring and auditing systems 
reasonably designed to detect criminal, civil, and administrative 
violations under the Act by any of the operating organization's staff, 
individuals providing services under a contractual arrangement, or 
volunteers, having in place and publicizing a reporting system whereby 
any of these individuals could report violations by others anonymously 
within the operating organization without fear of retribution, and 
having a process for ensuring the integrity of any reported data.
    (7) Consistent enforcement of the operating organization's 
standards, policies, and procedures through appropriate disciplinary 
mechanisms, including, as appropriate, discipline of individuals 
responsible for the failure to detect and report a violation to the 
compliance and ethics program contact identified in the operating 
organization's compliance and ethics program.
    (8) After a violation is detected, the operating organization must 
ensure that all reasonable steps identified in its program are taken to 
respond appropriately to the violation and to prevent further similar 
violations, including any necessary modification to the operating 
organization's program to prevent and detect criminal, civil, and 
administrative violations under the Act.
    (d) Additional required components for operating organizations with 
five or more facilities. In addition to all of the other requirements in 
paragraphs (a), (b), (c), and (e) of this section, operating 
organizations that operate five or more facilities must also include, at 
a minimum, the following components in their compliance and ethics 
program:
    (1) A mandatory annual training program on the operating 
organization's compliance and ethics program that meets the requirements 
set forth in Sec. 483.95(f).
    (2) A designated compliance officer for whom the operating 
organization's compliance and ethics program is a major responsibility. 
This individual must report directly to the operating organization's 
governing body and not be subordinate to the general counsel, chief 
financial officer or chief operating officer.
    (3) Designated compliance liaisons located at each of the operating 
organization's facilities.
    (e) Annual review. The operating organization for each facility must 
review its compliance and ethics program annually and revise its program 
as needed to reflect changes in all applicable laws or regulations and 
within the operating organization and its facilities to improve its 
performance in deterring, reducing, and detecting violations under the 
Act and in promoting quality of care.

[81 FR 68869, Oct. 4, 2016, as amended at 82 FR 32259, July 13, 2017]



Sec. 483.90  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 LTC facility must meet the applicable provisions and must 
proceed in accordance with the Life Safety Code (NFPA 101 and Tentative 
Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4.)
    (ii) Notwithstanding paragraph (a)(1)(i) of this section, corridor 
doors and doors to rooms containing flammable or combustible materials 
must

[[Page 100]]

be provided with positive latching hardware. Roller latches are 
prohibited on such doors.
    (2) In consideration of a recommendation by the State survey agency 
or Accrediting Organization or at the discretion of the Secretary, may 
waive, for periods deemed appropriate, specific provisions of the Life 
Safety Code, which would result in unreasonable hardship upon a long-
term care facility, but only if the waiver will 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, 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) A long-term care facility may install alcohol-based hand rub 
dispensers in its facility if the dispensers are installed in a manner 
that adequately protects against inappropriate access.
    (5) 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.
    (6) 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 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.
    (iii) Subject to approval by CMS, a long term care facility may be 
granted an extension of the sprinkler installation deadline for a time 
period not to exceed 2 years from August 13, 2013, if the facility meets 
all of the following conditions:
    (A) It is in the process of replacing its current building, or 
undergoing major modifications to improve the living conditions for 
residents in all

[[Page 101]]

unsprinklered living areas that requires the movement of corridor, room, 
partition, or structural walls or supports, in addition to the 
installation of a sprinkler system; or, has had its planned sprinkler 
installation so impaired by a disaster or emergency, as indicated by a 
declaration under section 319 of the Public Health Service Act, that CMS 
finds it would be impractical to meet the sprinkler installation due 
date.
    (B) It demonstrates that it has made the necessary financial 
commitments to complete the building replacement or modification; or 
pursuant to a declared disaster or emergency, CMS finds it impractical 
to make reasonable and necessary financial commitments.
    (C) Before applying for the deadline extension, it has submitted 
plans to State and local authorities that are necessary for approval of 
the replacement building or major modification that includes the 
required sprinkler installation, and has received approval of the plans 
from State and local authorities.
    (D) It agrees to complete interim steps to improve fire safety, as 
determined by CMS.
    (iv) An extension granted under paragraph (a)(8)(iii) of this 
section may be renewed once, for an additional period not to exceed 1 
year, if the following conditions are met:
    (A) CMS finds that extenuating circumstances beyond the control of 
the facility will prevent full compliance with the provisions in 
paragraph (a)(8)(i) of this section by the end of the first waiver 
period.
    (B) All other conditions of paragraph (a)(8)(iii) of this section 
are met.
    (7) Buildings must have an outside window or outside door in every 
sleeping room, and for any building constructed after July 5, 2016 the 
sill height must not exceed 36 inches above the floor. Windows in atrium 
walls are considered outside windows for the purposes of this 
requirement.
    (8) When a sprinkler system is shut down for more than 10 hours, the 
LTC facility must:
    (i) Evacuate the building or portion of the building affected by the 
system outage until the system is back in service, or
    (ii) Establish a fire watch until the system is back in service.
    (b) Standard: Building safety. Except as otherwise provided in this 
section, the LTC facility must meet the applicable provisions and must 
proceed in accordance with the Health Care Facilities Code (NFPA 99 and 
Tentative Interim Amendments TIA 12-2, TIA 12-3, TIA 12-4, TIA 12-5 and 
TIA 12-6).
    (1) Chapters 7, 8, 12, and 13 of the adopted Health Care Facilities 
Code do not apply to a LTC facility.
    (2) If application of the Health Care Facilities Code required under 
paragraph (b) of this section would result in unreasonable hardship for 
the LTC facility, CMS may waive specific provisions of the Health Care 
Facilities Code, but only if the waiver does not adversely affect the 
health and safety of residents.
    (c) 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.
    (d) 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.
    (e) 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. For facilities that 
receive

[[Page 102]]

approval of construction or reconstruction plans by State and local 
authorities or are newly certified after November 28, 2016, bedrooms 
must accommodate no more than two 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 safety and 
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.
    (f) Bathroom facilities. Each resident room must be equipped with or 
located near toilet and bathing facilities. For facilities that receive 
approval of construction from State and local authorities or are newly 
certified after November 28, 2016, each resident room must have its own 
bathroom equipped with at least a commode and sink.
    (g) Resident call system. The facility must be adequately equipped 
to allow residents to call for staff assistance through a communication 
system which relays the call directly to a staff member or to a 
centralized staff work area from--
    (1) Each resident's bedside; and
    (2) Toilet and bathing facilities.
    (h) 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;
    (3) Be adequately furnished; and
    (4) Have sufficient space to accommodate all activities.
    (i) 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.
    (5) Establish policies, in accordance with applicable Federal, 
State, and local laws and regulations, regarding smoking, smoking areas, 
and smoking safety that also take into account non-smoking residents.
    (j) The standards incorporated by reference in this section are 
approved for incorporation by reference by the Director of the Office of 
the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 
51. You may inspect a copy 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. If any changes in this edition of the Code are 
incorporated by reference, CMS will publish

[[Page 103]]

a document in the Federal Register to announce the changes.
    (1) National Fire Protection Association, 1 Batterymarch Park, 
Quincy, MA 02169, www.nfpa.org, 1.617.770.3000.
    (i) NFPA 99, Standards for Health Care Facilities Code of the 
National Fire Protection Association 99, 2012 edition, issued August 11, 
2011.
    (ii) TIA 12-2 to NFPA 99, issued August 11, 2011.
    (iii) TIA 12-3 to NFPA 99, issued August 9, 2012.
    (iv) TIA 12-4 to NFPA 99, issued March 7, 2013.
    (v) TIA 12-5 to NFPA 99, issued August 1, 2013.
    (vi) TIA 12-6 to NFPA 99, issued March 3, 2014.
    (vii) NFPA 101, Life Safety Code, 2012 edition, issued August 11, 
2011;
    (viii) TIA 12-1 to NFPA 101, issued August 11, 2011.
    (ix) TIA 12-2 to NFPA 101, issued October 30, 2012.
    (x) TIA 12-3 to NFPA 101, issued October 22, 2013.
    (xi) TIA 12-4 to NFPA 101, issued October 22, 2013.
    (2) [Reserved]

[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; 79 FR 
27155, May 12, 2014; 81 FR 26899, May 4, 2016; 81 FR 42548, June 30, 
2016. Redesignated and amended at 81 FR 68861, 68870, Oct. 4, 2016; 82 
FR 32259, July 13, 2017]



Sec. 483.95  Training requirements.

    A facility must develop, implement, and maintain an effective 
training program for all new and existing staff; individuals providing 
services under a contractual arrangement; and volunteers, consistent 
with their expected roles. A facility must determine the amount and 
types of training necessary based on a facility assessment as specified 
at Sec. 483.70(e). Training topics must include but are not limited to--
    (a) Communication. A facility must include effective communications 
as mandatory training for direct care staff.
    (b) Resident's rights and facility responsibilities. A facility must 
ensure that staff members are educated on the rights of the resident and 
the responsibilities of a facility to properly care for its residents as 
set forth at Sec. 483.10, respectively.
    (c) Abuse, neglect, and exploitation. In addition to the freedom 
from abuse, neglect, and exploitation requirements in Sec. 483.12, 
facilities must also provide training to their staff that at a minimum 
educates staff on--
    (1) Activities that constitute abuse, neglect, exploitation, and 
misappropriation of resident property as set forth at Sec. 483.12.
    (2) Procedures for reporting incidents of abuse, neglect, 
exploitation, or the misappropriation of resident property.
    (3) Dementia management and resident abuse prevention.
    (d) Quality assurance and performance improvement. A facility must 
include as part of its QAPI program mandatory training that outlines and 
informs staff of the elements and goals of the facility's QAPI program 
as set forth at Sec. 483.75.
    (e) Infection control. A facility must include as part of its 
infection prevention and control program mandatory training that 
includes the written standards, policies, and procedures for the program 
as described at Sec. 483.80(a)(2).
    (f) Compliance and ethics. The operating organization for each 
facility must include as part of its compliance and ethics program, as 
set forth at Sec. 483.85--
    (1) An effective way to communicate that program's standards, 
policies, and procedures through a training program or in another 
practical manner which explains the requirements under the program.
    (2) Annual training if the operating organization operates five or 
more facilities.
    (g) Required in-service training for nurse aides. In-service 
training must--
    (1) Be sufficient to ensure the continuing competence of nurse 
aides, but must be no less than 12 hours per year.
    (2) Include dementia management training and resident abuse 
prevention training.
    (3) Address areas of weakness as determined in nurse aides' 
performance reviews and facility assessment at Sec. 483.70(e) and may 
address the special

[[Page 104]]

needs of residents as determined by the facility staff.
    (4) For nurse aides providing services to individuals with cognitive 
impairments, also address the care of the cognitively impaired.
    (h) 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.
    (i) Behavioral health. A facility must provide behavioral health 
training consistent with the requirements at Sec. 483.40 and as 
determined by the facility assessment at Sec. 483.70(e).

[81 FR 68870, Oct. 4, 2016]



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

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



Sec. 483.100  Basis.

    The requirements of Secs. 483.100 through 483.138 governing the 
State's responsibility for preadmission screening and annual resident 
review (PASARR) of individuals with mental illness and intellectual 
disability 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 intellectual disability 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

[[Page 105]]

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 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 intellectual disability 
(IID) if he or she has--
    (i) A level of retardation (mild, moderate, severe or profound) 
described in the American Association on Intellectual Disability's 
Manual on Classification in Intellectual Disability (1983). 
Incorporation by reference of the 1983 edition of the American 
Association on Intellectual Disability's Manual on Classification in 
Intellectual Disability 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 Intellectual Disability's Manual on 
Classification in Intellectual Disability 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 Intellectual Disability, 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 Secs. 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 
intellectual disability 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 
intellectual disability 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 intellectual disability, 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.

[[Page 106]]

    (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 intellectual disability 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 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 IID 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 intellectual 
disability, that are described in Secs. 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 intellectual disability, must be made by 
the State intellectual disability or developmental disabilities 
authority.
    (e) Delegation of responsibility--(1) The State mental health and 
intellectual disability 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 intellectual disability 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 intellectual disability authority has responsibility 
for both the evaluation and determination functions for individuals with 
IID 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 
intellectual

[[Page 107]]

disability 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 intellectual disability authorities.
    (b) In making their determinations, however, the State mental health 
and intellectual disability 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 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 IID, the State mental health or intellectual disability 
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 intellectual disability is determined 
to require a NF level of care, the State mental health or intellectual 
disability authority (as appropriate) must also determine, in accordance 
with Sec. 483.130, whether the individual requires specialized services 
for the mental illness or intellectual disability, 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 IID by whatever agent performs the Level I 
identification, under Sec. 483.128(a) of this part, to the State mental 
health or intellectual disability 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 individuals with intellectual disabilities/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 intellectual disability. For each resident of a 
NF who has intellectual disability, the State

[[Page 108]]

intellectual disability 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 individuals with intellectual disabilities; and
    (2) Specialized services for intellectual disability 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 
intellectual disability 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.



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

    (a) Individuals needing NF services. If the State mental health or 
intellectual disability 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 intellectual disability authority determines that 
a resident or applicant for admission requires both a NF level of 
services and specialized services for the mental illness or intellectual 
disability--
    (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 intellectual disability 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 IID. If the State mental health or intellectual 
disability authority determines that a resident requires neither the 
level of services provided by a NF nor specialized services for MI or 
IID, 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. 483.15(b); and
    (2) Prepare and orient the resident for discharge.
    (c) Residents who do not require NF services but require specialized 
services for MI or IID--(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 
intellectual disability.
    (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,

[[Page 109]]

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. 483.15(b);
    (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 intellectual disability.
    (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.

[57 FR 56506, Nov. 30, 1992, as amended at 81 FR 68871, Oct. 4, 2016]



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 intellectual disability, 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 IID whose needs are such 
that continuous supervision, treatment and training by qualified mental 
health or intellectual disability personnel is necessary, as identified 
by the screening provided in Sec. 483.130 or Secs. 483.134 and 483.136.
    (c) Services of lesser intensity than specialized services. The NF 
must provide mental health or intellectual disability 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.

[[Page 110]]



Sec. 483.126  Appropriate placement.

    Placement of an individual with MI or IID 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 IID. The 
State's PASARR program must identify all individuals who are suspected 
of having MI or IID 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 having MI 
or IID and is being referred to the State mental health or intellectual 
disability 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 Secs. 483.132 and 
483.134 or Sec. 483.136 (or, in the case of individuals with both MI and 
IID, Secs. 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 IID to be placed in an NF or in another 
appropriate setting should be gathered throughout all applicable 
portions of the PASARR evaluation (Secs. 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

[[Page 111]]

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 intellectual disability 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 
intellectual disability 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 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 IID; 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 IID 
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 intellectual disability 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 IID and MI, 
Secs. 483.134 and 483.136).
    (c) Group determinations by category. Advance group determinations 
by category developed by the State mental

[[Page 112]]

health or intellectual disability 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 intellectual disability or developmental disability 
providers.
    (d) Examples of categories. Examples of categories for which the 
State mental health or intellectual disability 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).
    (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 
IID 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 intellectual disability 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 intellectual disability 
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 IID. The State 
intellectual disability authority may make categorical determinations 
that individuals with dementia, which exists in combination with 
intellectual disability or a related condition, do not need specialized 
services.
    (i) If a State mental health or intellectual disability 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.

[[Page 113]]

    (j) Recording determinations. All determinations made by the State 
mental health and intellectual disability 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 intellectual 
disability 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 intellectual disability 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
    (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 IID 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 IID 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 IID 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 IID 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 IID 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. 483.15(b) 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 IID 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

[[Page 114]]

in accordance with Sec. 483.15(b). 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 IID 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, as amended at 
81 FR 68871, Oct. 4, 2016]



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 IID, 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/IID 
(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 Secs. 483.134 and 483.136, the State mental health or intellectual 
disability 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

[[Page 115]]

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.
    (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 intellectual 
disability requires specialized services (PASARR/IID).

    (a) Purpose. The purpose of this section is to identify the minimum 
data needs and process requirements for the State intellectual 
disability authority to determine whether or not the applicant or 
resident with intellectual disability, 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;

[[Page 116]]

    (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);
    (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 IID or a related condition.
    (2) Based on the data compiled in paragraph (b) of this section, the 
State intellectual disability authority, using appropriate personnel, as 
designated by the State, must validate that the individual has IID or is 
a person with a related condition and must determine whether specialized 
services for intellectual disability are needed. In making this 
determination, the State intellectual disability 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 IID 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. 483.15(b) 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.

[[Page 117]]

    (b) Availability of FFP. FFP is available for expenditures for 
services provided to Medicaid beneficiaries during--
    (1) The 30 day notice period specified in Sec. 483.15(b) of this 
chapter; or
    (2) During the period an appeal is in progress.

[57 FR 56506, Nov. 30, 1992, as amended at 81 FR 68871, Oct. 4, 2016]



 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), 
1819(f)(2), 1919(b)(5), and 1919(f)(2) 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
    (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; 75 FR 21179, Apr. 23, 2010]



Sec. 483.151  State review and approval of nurse aide training
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 Secs. 483.35(c) and (d) and 483.95(g) 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

[[Page 118]]

program meets the course requirements of 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 as adjusted annually under 45 CFR part 102; 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 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 as 
adjusted annually under 45 CFR part 102 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) Waiver of disapproval of nurse aide training programs. (1) A 
facility may request that CMS waive the disapproval of its nurse aide 
training program when the facility has been assessed a civil money 
penalty of not less than $5,000 as adjusted annually under 45 CFR part 
102 if the civil money penalty was not related to the quality of care 
furnished to residents in the facility.
    (2) For purposes of this provision, ``quality of care furnished to 
residents'' means the direct hands-on care and treatment that a health 
care professional or direct care staff furnished to a resident.
    (3) Any waiver of disapproval of a nurse aide training program does 
not waive any requirement upon the facility to pay any civil money 
penalty.
    (d) 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.
    (e) 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.
    (f) 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. 483.152 or Sec. 483.154 are not met by the program.
    (3) The State must withdraw approval of a nurse aide training and

[[Page 119]]

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.

[56 FR 48919, Sept. 26, 1991, as amended at 75 FR 21179, Apr. 23, 2010; 
81 FR 61563, Sept. 6, 2016; 81 FR 68871, Oct. 4, 2016]



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;
    (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;

[[Page 120]]

    (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 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

[[Page 121]]

    (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;
    (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;

[[Page 122]]

    (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 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.

[[Page 123]]

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]



 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

[[Page 124]]

    (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. 483.15(h), and part 431 subpart E of 
this chapter.

[57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr. 28, 1993, as amended at 
81 FR 68871, Oct. 4, 2016]



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. 483.5).
    (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.

[57 FR 56514, Nov. 30, 1992, as amended at 81 FR 68871, Oct. 4, 2016]



 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 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

[[Page 125]]

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 
beneficiary 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]



    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

[[Page 126]]

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.
    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

[[Page 127]]

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 beneficiaries 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 
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

[[Page 128]]

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]



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.

[[Page 129]]

    (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). 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;

[[Page 130]]

    (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 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.

[[Page 131]]

    (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 Individuals with Intellectual Disabilities

    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 individuals with intellectual 
disabilities or persons with related conditions.



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.

[[Page 132]]

    (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/IID, the ICF/IID 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 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--

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    (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.
    (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 intellectual disability professional. Each 
client's active treatment program must be integrated, coordinated and 
monitored by a qualified intellectual disability professional who--
    (1) Has at least one year of experience working directly with 
persons with intellectual disability 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.

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    (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 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 intellectual disability 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

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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 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

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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 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:

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    (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 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 intellectual 
disability 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.

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    (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 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

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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 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.

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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 Committee 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;
    (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.

[[Page 141]]

    (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 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

[[Page 142]]

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 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--

[[Page 143]]

    (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 intellectual disability 
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--
    (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) [Reserved]

[[Page 144]]

    (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 and must proceed in accordance with the Life Safety 
Code (NFPA 101 and Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 
12-3, and TIA 12-4.)
    (ii) Notwithstanding paragraph (j)(1)(i) of this section, corridor 
doors and doors to rooms containing flammable or combustible materials 
must be provided with positive latching hardware. Roller latches are 
prohibited on such doors.
    (iii) Chapters 32.3.2.11.2 and 33.3.2.11.2 of the adopted 2012 Life 
Safety Code do not apply to a facility.
    (iv) Beginning July 5, 2019, an ICF-IID must be in compliance with 
Chapter 33.2.3.5.7.1, Sprinklers in attics, or Chapter 33.2.3.5.7.2, 
Heat detection systems in attics of the Life Safety Code.
    (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) Facilities that meet the Life Safety Code definition of a health 
care occupancy. (i) In consideration of a recommendation by the State 
survey agency or Accrediting Organization or at the discretion of the 
Secretary, may waive, for periods deemed appropriate, specific 
provisions of the Life Safety Code, which would result in unreasonable 
hardship upon a residential board and care facility, but only if the 
waiver will not adversely affect the health and safety of the patients.
    (ii) A facility may install alcohol-based hand rub dispensers if the 
dispensers are installed in a manner that adequately protects against 
inappropriate access.
    (iii) When a sprinkler system is shut down for more than 10 hours, 
the ICF-IID must:
    (A) Evacuate the building or portion of the building affected by the 
system outage until the system is back in service, or
    (B) Establish a fire watch until the system is back in service.
    (iv) Beginning July 5, 2019, an ICF-IID must be in compliance with 
Chapter 33.2.3.5.7.1, sprinklers in attics, or Chapter 33.2.3.5.7.2, 
heat detection systems in attics of the Life Safety Code.
    (v) Except as otherwise provided in this section, ICF-IIDs must meet 
the applicable provisions and must proceed in accordance with the Health 
Care Facilities Code (NFPA 99 and Tentative

[[Page 145]]

Interim Amendments TIA 12-2, TIA 12-3, TIA 12-4, TIA 12-5 and TIA 12-6).
    (A) Chapter 7,8,12 and 13 of the adopted Health Care Facilities Code 
does not apply to an ICF-IID.
    (B) If application of the Health Care Facilities Code required under 
paragraph (j)(5)(iv) of this section would result in unreasonable 
hardship for the ICF-IID, CMS may waive specific provisions of the 
Health Care Facilities Code, but only if the waiver does not adversely 
affect the health and safety of clients.
    (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 
communicable disease from direct contact with clients and their food.
    (m) The standards incorporated by reference in this section are 
approved for incorporation by reference by the Director of the Office of 
the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 
51. You may inspect a copy 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. If any changes in this edition of the Code are 
incorporated by reference, CMS will publish a document in the Federal 
Register to announce the changes.
    (1) National Fire Protection Association, 1 Batterymarch Park, 
Quincy, MA 02169, www.nfpa.org, 1.617.770.3000.
    (i) NFPA 99, Standards for Health Care Facilities Code of the 
National Fire Protection Association 99, 2012 edition, issued August 11, 
2011.
    (ii) TIA 12-2 to NFPA 99, issued August 11, 2011.
    (iii) TIA 12-3 to NFPA 99, issued August 9, 2012.
    (iv) TIA 12-4 to NFPA 99, issued March 7, 2013.
    (v) TIA 12-5 to NFPA 99, issued August 1, 2013.
    (vi) TIA 12-6 to NFPA 99, issued March 3, 2014.
    (vii) NFPA 101, Life Safety Code, 2012 edition, issued August 11, 
2011;
    (viii) TIA 12-1 to NFPA 101, issued August 11, 2011.
    (ix) TIA 12-2 to NFPA 101, issued October 30, 2012.
    (x) TIA 12-3 to NFPA 101, issued October 22, 2013.
    (xi) TIA 12-4 to NFPA 101, issued October 22, 2013.
    (2) [Reserved]

[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; 81 FR 26900, May 
4, 2016; 81 FR 64032, Sept. 16, 2016]



Sec. 483.475  Condition of participation: Emergency preparedness.

    The Intermediate Care Facility for Individuals with Intellectual 
Disabilities (ICF/IID) must comply with all applicable Federal, State, 
and local emergency preparedness requirements. The ICF/IID must 
establish and maintain an emergency preparedness program that meets the 
requirements of this section. The emergency preparedness program must 
include, but not be limited to, the following elements:
    (a) Emergency plan. The ICF/IID must develop and maintain an 
emergency preparedness plan that must be reviewed, and updated at least 
annually. The plan must do all of the following:
    (1) Be based on and include a documented, facility-based and 
community-based risk assessment, utilizing an all-hazards approach, 
including missing clients.

[[Page 146]]

    (2) Include strategies for addressing emergency events identified by 
the risk assessment.
    (3) Address the special needs of its client population, including, 
but not limited to, persons at-risk; the type of services the ICF/IID 
has the ability to provide in an emergency; and continuity of 
operations, including delegations of authority and succession plans.
    (4) Include a process for cooperation and collaboration with local, 
tribal, regional, State, and Federal emergency preparedness officials' 
efforts to maintain an integrated response during a disaster or 
emergency situation, including documentation of the ICF/IID efforts to 
contact such officials and, when applicable, of its participation in 
collaborative and cooperative planning efforts.
    (b) Policies and procedures. The ICF/IID must develop and implement 
emergency preparedness policies and procedures, based on the emergency 
plan set forth in paragraph (a) of this section, risk assessment at 
paragraph (a)(1) of this section, and the communication plan at 
paragraph (c) of this section. The policies and procedures must be 
reviewed and updated at least annually. At a minimum, the policies and 
procedures must address the following:
    (1) The provision of subsistence needs for staff and clients, 
whether they evacuate or shelter in place, include, but are not limited 
to the following:
    (i) Food, water, medical, and pharmaceutical supplies.
    (ii) Alternate sources of energy to maintain the following:
    (A) Temperatures to protect client health and safety and for the 
safe and sanitary storage of provisions.
    (B) Emergency lighting.
    (C) Fire detection, extinguishing, and alarm systems.
    (D) Sewage and waste disposal.
    (2) A system to track the location of on-duty staff and sheltered 
clients in the ICF/IID's care during and after an emergency. If on-duty 
staff and sheltered clients are relocated during the emergency, the ICF/
IID must document the specific name and location of the receiving 
facility or other location.
    (3) Safe evacuation from the ICF/IID, which includes consideration 
of care and treatment needs of evacuees; staff responsibilities; 
transportation; identification of evacuation location(s); and primary 
and alternate means of communication with external sources of 
assistance.
    (4) A means to shelter in place for clients, staff, and volunteers 
who remain in the facility.
    (5) A system of medical documentation that preserves client 
information, protects confidentiality of client information, and secures 
and maintains the availability of records.
    (6) The use of volunteers in an emergency or other emergency 
staffing strategies, including the process and role for integration of 
State or Federally designated health care professionals to address surge 
needs during an emergency.
    (7) The development of arrangements with other ICF/IIDs or other 
providers to receive clients in the event of limitations or cessation of 
operations to maintain the continuity of services to ICF/IID clients.
    (8) The role of the ICF/IID under a waiver declared by the 
Secretary, in accordance with section 1135 of the Act, in the provision 
of care and treatment at an alternate care site identified by emergency 
management officials.
    (c) Communication plan. The ICF/IID must develop and maintain an 
emergency preparedness communication plan that complies with Federal, 
State, and local laws and must be reviewed and updated at least 
annually. The communication plan must include the following:
    (1) Names and contact information for the following:
    (i) Staff.
    (ii) Entities providing services under arrangement.
    (iii) Clients' physicians.
    (iv) Other ICF/IIDs.
    (v) Volunteers.
    (2) Contact information for the following:
    (i) Federal, State, tribal, regional, and local emergency 
preparedness staff.
    (ii) Other sources of assistance.
    (iii) The State Licensing and Certification Agency.

[[Page 147]]

    (iv) The State Protection and Advocacy Agency.
    (3) Primary and alternate means for communicating with the ICF/IID's 
staff, Federal, State, tribal, regional, and local emergency management 
agencies.
    (4) A method for sharing information and medical documentation for 
clients under the ICF/IID's care, as necessary, with other health care 
providers to maintain the continuity of care.
    (5) A means, in the event of an evacuation, to release client 
information as permitted under 45 CFR 164.510(b)(1)(ii).
    (6) A means of providing information about the general condition and 
location of clients under the facility's care as permitted under 45 CFR 
164.510(b)(4).
    (7) A means of providing information about the ICF/IID's occupancy, 
needs, and its ability to provide assistance, to the authority having 
jurisdiction, the Incident Command Center, or designee.
    (8) A method for sharing information from the emergency plan that 
the facility has determined is appropriate with clients and their 
families or representatives.
    (d) Training and testing. The ICF/IID must develop and maintain an 
emergency preparedness training and testing program that is based on the 
emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program must be 
reviewed and updated at least annually. The ICF/IID must meet the 
requirements for evacuation drills and training at Sec. 483.470(h).
    (1) Training program. The ICF/IID must do all the following:
    (i) Initial training in emergency preparedness policies and 
procedures to all new and existing staff, individuals providing services 
under arrangement, and volunteers, consistent with their expected roles.
    (ii) Provide emergency preparedness training at least annually.
    (iii) Maintain documentation of the training.
    (iv) Demonstrate staff knowledge of emergency procedures.
    (2) Testing. The ICF/IID must conduct exercises to test the 
emergency plan at least annually. The ICF/IID must do the following:
    (i) Participate in a full-scale exercise that is community-based or 
when a community-based exercise is not accessible, an individual, 
facility-based. If the ICF/IID experiences an actual natural or man-made 
emergency that requires activation of the emergency plan, the ICF/IID is 
exempt from engaging in a community-based or individual, facility-based 
full-scale exercise for 1 year following the onset of the actual event.
    (ii) Conduct an additional exercise that may include, but is not 
limited to the following:
    (A) A second full-scale exercise that is community-based or 
individual, facility-based.
    (B) A tabletop exercise that includes a group discussion led by a 
facilitator, using a narrated, clinically-relevant emergency scenario, 
and a set of problem statements, directed messages, or prepared 
questions designed to challenge an emergency plan.
    (iii) Analyze the ICF/IID's response to and maintain documentation 
of all drills, tabletop exercises, and emergency events, and revise the 
ICF/IID's emergency plan, as needed.
    (e) Integrated healthcare systems. If an ICF/IID is part of a 
healthcare system consisting of multiple separately certified healthcare 
facilities that elects to have a unified and integrated emergency 
preparedness program, the ICF/IID may choose to participate in the 
healthcare system's coordinated emergency preparedness program. If 
elected, the unified and integrated emergency preparedness program must 
do all of the following:
    (1) Demonstrate that each separately certified facility within the 
system actively participated in the development of the unified and 
integrated emergency preparedness program.
    (2) Be developed and maintained in a manner that takes into account 
each separately certified facility's unique circumstances, patient 
populations, and services offered.
    (3) Demonstrate that each separately certified facility is capable 
of actively

[[Page 148]]

using the unified and integrated emergency preparedness program and is 
in compliance with the program.
    (4) Include a unified and integrated emergency plan that meets the 
requirements of paragraphs (a)(2), (3), and (4) of this section. The 
unified and integrated emergency plan must also be based on and include 
all of the following:
    (i) A documented community-based risk assessment, utilizing an all-
hazards approach.
    (ii) A documented individual facility-based risk assessment for each 
separately certified facility within the health system, utilizing an 
all-hazards approach.
    (5) Include integrated policies and procedures that meet the 
requirements set forth in paragraph (b) of this section, a coordinated 
communication plan and training and testing programs that meet the 
requirements of paragraphs (c) and (d) of this section, respectively.

[81 FR 64032, Sept. 16, 2016]



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

[[Page 149]]

    (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, 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.
484.22  Condition of participation: Emergency preparedness.

                    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 unadjusted national 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  [Reserved]
484.250  Patient assessment data.
484.260  Limitation on review.
484.265  Additional payment.

 Subpart F_Home Health Value-Based Purchasing (HHVBP) Model Components 
       for Competing Home Health Agencies Within State Boundaries

484.300  Basis and scope of subpart.
484.305  Definitions.
484.310  Applicability of the Home Health Value-Based Purchasing (HHVBP) 
          Model.
484.315  Data reporting for measures and evaluation under the Home 
          Health Value-Based Purchasing (HHVBP) Model.
484.320  Calculation of the Total Performance Score.
484.325  Payments for home health services under Home Health Value-Based 
          Purchasing (HHVBP) Model.
484.330  Process for determining and applying the value-based payment 
          adjustment under the Home Health Value-Based Purchasing 
          (HHVBP) Model.
484.335  Appeals process for the Home Health Value-Based Purchasing 
          (HHVBP) Model.

    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.

[[Page 150]]

    (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 
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

[[Page 151]]

    (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 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.

[[Page 152]]

    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 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

[[Page 153]]

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
    (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

[[Page 154]]

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.
    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 has a master's or doctoral 
degree in speech-language pathology, and who meets either of the 
following requirements:
    (a) Is licensed as a speech-language pathologist by the State in 
which the individual furnishes such services; or
    (b) In the case of an individual who furnishes services in a State 
which does not license speech-language pathologists:
    (1) Has successfully completed 350 clock hours of supervised 
clinical practicum (or is in the process of accumulating such supervised 
clinical experience);
    (2) Performed not less than 9 months of supervised full-time speech-
language pathology services after obtaining a master's or doctoral 
degree in speech-language pathology or a related field; and
    (3) Successfully completed a national examination in speech-language 
pathology approved by the Secretary.

[54 FR 33367, Aug. 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; 79 FR 66118, Nov. 6, 2014]

    Effective Date Note: At 82 FR 4578, Jan. 13, 2017, subpart A was 
revised, effective July 13, 2017. At 82 FR 31729, July 10, 2017, this 
amendment was delayed until Jan. 13, 2018. For the convenience of the 
user, the revised text is set forth as follows:



                      Subpart A_General Provisions



Sec. 484.1  Basis and scope.

    (a) Basis. This part is based on:
    (1) Sections 1861(o) and 1891 of the Act, which establish the 
conditions that an HHA must meet in order to participate in the Medicare 
program and which, along with the additional requirements set forth in 
this part, are considered necessary to ensure the health and safety of 
patients; and
    (2) Section 1861(z) of the Act, which specifies the institutional 
planning standards that HHAs must meet.
    (b) Scope. The provisions of this part serve as the basis for survey 
activities for the purpose of determining whether an agency meets the 
requirements for participation in the Medicare program.



Sec. 484.2  Definitions.

    As used in subparts A, B, and C, of this part--
    Branch office means an approved 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 parent home health agency must 
provide supervision and administrative control of any branch office. It 
is unnecessary for the branch office to independently meet the 
conditions of participation as a home health agency.

[[Page 155]]

    Clinical note means a notation of a contact with a patient that is 
written, timed, and dated, and which describes signs and symptoms, 
treatment, drugs administered and the patient's reaction or response, 
and any changes in physical or emotional condition during a given period 
of time.
    In advance means that HHA staff must complete the task prior to 
performing any hands-on care or any patient education.
    Parent home health agency means the agency that provides direct 
support and administrative control of a branch.
    Primary home health agency means the HHA which accepts the initial 
referral of a patient, and which provides services directly to the 
patient or via another health care provider under arrangements (as 
applicable).
    Proprietary agency means a private, for-profit agency.
    Public agency means an agency operated by a state or local 
government.
    Quality indicator means a specific, valid, and reliable measure of 
access, care outcomes, or satisfaction, or a measure of a process of 
care.
    Representative means the patient's legal representative, such as a 
guardian, who makes health-care decisions on the patient's behalf, or a 
patient-selected representative who participates in making decisions 
related to the patient's care or well-being, including but not limited 
to, a family member or an advocate for the patient. The patient 
determines the role of the representative, to the extent possible.
    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 branch offices is 
considered a parent agency.
    Summary report means the compilation of the pertinent factors of a 
patient's clinical notes that is submitted to the patient's physician.
    Supervised practical training means training in a practicum 
laboratory or other setting in which the trainee demonstrates knowledge 
while providing covered services to an individual under the direct 
supervision of either a registered nurse or a licensed practical nurse 
who is under the supervision of a registered nurse.
    Verbal order means a physician order that is spoken to appropriate 
personnel and later put in writing for the purposes of documenting as 
well as establishing or revising the patient's plan of care.



                        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.

[[Page 156]]

    (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 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, Aug. 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

[[Page 157]]

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 Secs. 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 
Secs. 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.



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.

[[Page 158]]

    (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.
    (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 Intellectual Disability 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

[[Page 159]]

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

[54 FR 33367, Aug. 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, Aug. 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.

[[Page 160]]

    (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, Aug. 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]



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]



Sec. 484.22  Condition of participation: Emergency preparedness.

    The Home Health Agency (HHA) must comply with all applicable 
Federal, State, and local emergency preparedness requirements. The HHA 
must establish and maintain an emergency preparedness program that meets 
the requirements of this section. The emergency preparedness program 
must include, but not be limited to, the following elements:
    (a) Emergency plan. The HHA must develop and maintain an emergency 
preparedness plan that must be reviewed, and updated at least annually. 
The plan must do all of the following:
    (1) Be based on and include a documented, facility-based and 
community-based risk assessment, utilizing an all-hazards approach.
    (2) Include strategies for addressing emergency events identified by 
the risk assessment.
    (3) Address patient population, including, but not limited to, the 
type of services the HHA has the ability to provide in an emergency; and 
continuity of operations, including delegations of authority and 
succession plans.
    (4) Include a process for cooperation and collaboration with local, 
tribal, regional, State, and Federal emergency preparedness officials' 
efforts to maintain an integrated response during a disaster or 
emergency situation, including documentation of the HHA's efforts to 
contact such officials and, when applicable, of its participation in 
collaborative and cooperative planning efforts.
    (b) Policies and procedures. The HHA must develop and implement 
emergency preparedness policies and procedures, based on the emergency 
plan set

[[Page 161]]

forth in paragraph (a) of this section, risk assessment at paragraph 
(a)(1) of this section, and the communication plan at paragraph (c) of 
this section. The policies and procedures must be reviewed and updated 
at least annually. At a minimum, the policies and procedures must 
address the following:
    (1) The plans for the HHA's patients during a natural or man-made 
disaster. Individual plans for each patient must be included as part of 
the comprehensive patient assessment, which must be conducted according 
to the provisions at Sec. 484.55.
    (2) The procedures to inform State and local emergency preparedness 
officials about HHA patients in need of evacuation from their residences 
at any time due to an emergency situation based on the patient's medical 
and psychiatric condition and home environment.
    (3) The procedures to follow up with on-duty staff and patients to 
determine services that are needed, in the event that there is an 
interruption in services during or due to an emergency. The HHA must 
inform State and local officials of any on-duty staff or patients that 
they are unable to contact.
    (4) A system of medical documentation that preserves patient 
information, protects confidentiality of patient information, and 
secures and maintains the availability of records.
    (5) The use of volunteers in an emergency or other emergency 
staffing strategies, including the process and role for integration of 
State or Federally designated health care professionals to address surge 
needs during an emergency.
    (c) Communication plan. The HHA must develop and maintain an 
emergency preparedness communication plan that complies with Federal, 
State, and local laws and must be reviewed and updated at least 
annually. The communication plan must include all of the following:
    (1) Names and contact information for the following:
    (i) Staff.
    (ii) Entities providing services under arrangement.
    (iii) Patients' physicians.
    (iv) Volunteers.
    (2) Contact information for the following:
    (i) Federal, State, tribal, regional, or local emergency 
preparedness staff.
    (ii) Other sources of assistance.
    (3) Primary and alternate means for communicating with the HHA's 
staff, Federal, State, tribal, regional, and local emergency management 
agencies.
    (4) A method for sharing information and medical documentation for 
patients under the HHA's care, as necessary, with other health care 
providers to maintain the continuity of care.
    (5) A means of providing information about the general condition and 
location of patients under the facility's care as permitted under 45 CFR 
164.510(b)(4).
    (6) A means of providing information about the HHA's needs, and its 
ability to provide assistance, to the authority having jurisdiction, the 
Incident Command Center, or designee.
    (d) Training and testing. The HHA must develop and maintain an 
emergency preparedness training and testing program that is based on the 
emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program must be 
reviewed and updated at least annually.
    (1) Training program. The HHA must do all of the following:
    (i) Initial training in emergency preparedness policies and 
procedures to all new and existing staff, individuals providing services 
under arrangement, and volunteers, consistent with their expected roles.
    (ii) Provide emergency preparedness training at least annually.
    (iii) Maintain documentation of the training.
    (iv) Demonstrate staff knowledge of emergency procedures.
    (2) Testing. The HHA must conduct exercises to test the emergency 
plan at least annually. The HHA must do the following:
    (i) Participate in a full-scale exercise that is community-based or 
when a community-based exercise is not accessible, an individual, 
facility-based. If

[[Page 162]]

the HHA experiences an actual natural or man-made emergency that 
requires activation of the emergency plan, the HHA is exempt from 
engaging in a community-based or individual, facility-based full-scale 
exercise for 1 year following the onset of the actual event.
    (ii) Conduct an additional exercise that may include, but is not 
limited to the following:
    (A) A second full-scale exercise that is community-based or 
individual, facility-based.
    (B) A tabletop exercise that includes a group discussion led by a 
facilitator, using a narrated, clinically-relevant emergency scenario, 
and a set of problem statements, directed messages, or prepared 
questions designed to challenge an emergency plan.
    (iii) Analyze the HHA's response to and maintain documentation of 
all drills, tabletop exercises, and emergency events, and revise the 
HHA's emergency plan, as needed.
    (e) Integrated healthcare systems. If a HHA is part of a healthcare 
system consisting of multiple separately certified healthcare facilities 
that elects to have a unified and integrated emergency preparedness 
program, the HHA may choose to participate in the healthcare system's 
coordinated emergency preparedness program. If elected, the unified and 
integrated emergency preparedness program must do all of the following:
    (1) Demonstrate that each separately certified facility within the 
system actively participated in the development of the unified and 
integrated emergency preparedness program.
    (2) Be developed and maintained in a manner that takes into account 
each separately certified facility's unique circumstances, patient 
populations, and services offered.
    (3) Demonstrate that each separately certified facility is capable 
of actively using the unified and integrated emergency preparedness 
program and is in compliance with the program.
    (4) Include a unified and integrated emergency plan that meets the 
requirements of paragraphs (a)(2), (3), and (4) of this section. The 
unified and integrated emergency plan must also be based on and include 
all of the following:
    (i) A documented community-based risk assessment, utilizing an all-
hazards approach.
    (ii) A documented individual facility-based risk assessment for each 
separately certified facility within the health system, utilizing an 
all-hazards approach.
    (5) Include integrated policies and procedures that meet the 
requirements set forth in paragraph (b) of this section, a coordinated 
communication plan and training and testing programs that meet the 
requirements of paragraphs (c) and (d) of this section, respectively.

[81 FR 64033, Sept. 16, 2016; 81 FR 80594, Nov. 16, 2016]

    Effective Date Note: At 82 FR 4578, Jan. 13, 2017, subpart B was 
revised, effective July 13, 2017. At 82 FR 31732, July 10, 2017, this 
amendment was corrected. At 82 FR 31729, July 10, 2010, this amendment 
was delayed until Jan. 13, 2018. For the convenience of the user, the 
revised text is set forth as follows:



                         Subpart B_Patient Care



Sec. 484.40  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.



Sec. 484.45  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 CMS system, regarding each beneficiary with respect to which 
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 QIES ASAP System or CMS 
OASIS contractor.

[[Page 163]]

    (3) Transmit data using electronic communications software that 
complies with the Federal Information Processing Standard (FIPS 140-2, 
issued May 25, 2001) from the HHA or the HHA contractor to the CMS 
collection site.
    (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.



Sec. 484.50  Condition of participation: Patient rights.

    The patient and representative (if any), have the right to be 
informed of the patient's rights in a language and manner the individual 
understands. The HHA must protect and promote the exercise of these 
rights.
    (a) Standard: Notice of rights. The HHA must--
    (1) Provide the patient and the patient's legal representative (if 
any), the following information during the initial evaluation visit, in 
advance of furnishing care to the patient:
    (i) Written notice of the patient's rights and responsibilities 
under this rule, and the HHA's transfer and discharge policies as set 
forth in paragraph (d) of this section. Written notice must be 
understandable to persons who have limited English proficiency and 
accessible to individuals with disabilities;
    (ii) Contact information for the HHA administrator, including the 
administrator's name, business address, and business phone number in 
order to receive complaints.
    (iii) An OASIS privacy notice to all patients for whom the OASIS 
data is collected.
    (2) Obtain the patient's or legal representative's signature 
confirming that he or she has received a copy of the notice of rights 
and responsibilities.
    (3) Provide verbal notice of the patient's rights and 
responsibilities in the individual's primary or preferred language and 
in a manner the individual understands, free of charge, with the use of 
a competent interpreter if necessary, no later than the completion of 
the second visit from a skilled professional as described in 
Sec. 484.75.
    (4) Provide written notice of the patient's rights and 
responsibilities under this rule and the HHA's transfer and discharge 
policies as set forth in paragraph (d) of this section to a patient-
selected representative within 4 business days of the initial evaluation 
visit.
    (b) Standard: Exercise of rights. (1) If a patient has been adjudged 
to lack legal capacity to make health care decisions as established by 
state law by a court of proper jurisdiction, the rights of the patient 
may be exercised by the person appointed by the state court to act on 
the patient's behalf.
    (2) If a state court has not adjudged a patient to lack legal 
capacity to make health care decisions as defined by state law, the 
patient's representative may exercise the patient's rights.
    (3) If a patient has been adjudged to lack legal capacity to make 
health care decisions under state law by a court of proper jurisdiction, 
the patient may exercise his or her rights to the extent allowed by 
court order.
    (c) Standard: Rights of the patient. The patient has the right to--
    (1) Have his or her property and person treated with respect;
    (2) Be free from verbal, mental, sexual, and physical abuse, 
including injuries of unknown source, neglect and misappropriation of 
property;
    (3) Make complaints to the HHA regarding treatment or care that is 
(or fails to be) furnished, and the lack of respect for property and/or 
person by anyone who is furnishing services on behalf of the HHA;
    (4) Participate in, be informed about, and consent or refuse care in 
advance of and during treatment, where appropriate, with respect to--
    (i) Completion of all assessments;
    (ii) The care to be furnished, based on the comprehensive 
assessment;
    (iii) Establishing and revising the plan of care;
    (iv) The disciplines that will furnish the care;
    (v) The frequency of visits;
    (vi) Expected outcomes of care, including patient-identified goals, 
and anticipated risks and benefits;
    (vii) Any factors that could impact treatment effectiveness; and
    (viii) Any changes in the care to be furnished.
    (5) Receive all services outlined in the plan of care.
    (6) Have a confidential clinical record. Access to or release of 
patient information and clinical records is permitted in accordance with 
45 CFR parts 160 and 164.
    (7) Be advised of--
    (i) The extent to which payment for HHA services may be expected 
from Medicare, Medicaid, or any other federally-funded or federal aid 
program known to the HHA,
    (ii) The charges for services that may not be covered by Medicare, 
Medicaid, or any other federally-funded or federal aid program known to 
the HHA,
    (iii) The charges the individual may have to pay before care is 
initiated; and
    (iv) Any changes in the information provided in accordance with 
paragraph (c)(7) of this section when they occur. The HHA must advise 
the patient and representative (if

[[Page 164]]

any), of these changes as soon as possible, in advance of the next home 
health visit. The HHA must comply with the patient notice requirements 
at 42 CFR 411.408(d)(2) and 42 CFR 411.408(f).
    (8) Receive proper written notice, in advance of a specific service 
being furnished, if the HHA believes that the service may be non-covered 
care; or in advance of the HHA reducing or terminating on-going care. 
The HHA must also comply with the requirements of 42 CFR 405.1200 
through 405.1204.
    (9) Be advised of the state toll free home health telephone hot 
line, its contact information, its hours of operation, and that its 
purpose is to receive complaints or questions about local HHAs.
    (10) Be advised of the names, addresses, and telephone numbers of 
the following Federally-funded and state-funded entities that serve the 
area where the patient resides:
    (i) Agency on Aging,
    (ii) Center for Independent Living,
    (iii) Protection and Advocacy Agency,
    (iv) Aging and Disability Resource Center; and
    (v) Quality Improvement Organization.
    (11) Be free from any discrimination or reprisal for exercising his 
or her rights or for voicing grievances to the HHA or an outside entity.
    (12) Be informed of the right to access auxiliary aids and language 
services as described in paragraph (f) of this section, and how to 
access these services.
    (d) Standard: Transfer and discharge. The patient and representative 
(if any), have a right to be informed of the HHA's policies for transfer 
and discharge. The HHA may only transfer or discharge the patient from 
the HHA if:
    (1) The transfer or discharge is necessary for the patient's welfare 
because the HHA and the physician who is responsible for the home health 
plan of care agree that the HHA can no longer meet the patient's needs, 
based on the patient's acuity. The HHA must arrange a safe and 
appropriate transfer to other care entities when the needs of the 
patient exceed the HHA's capabilities;
    (2) The patient or payer will no longer pay for the services 
provided by the HHA;
    (3) The transfer or discharge is appropriate because the physician 
who is responsible for the home health plan of care and the HHA agree 
that the measurable outcomes and goals set forth in the plan of care in 
accordance with Sec. 484.60(a)(2)(xiv) have been achieved, and the HHA 
and the physician who is responsible for the home health plan of care 
agree that the patient no longer needs the HHA's services;
    (4) The patient refuses services, or elects to be transferred or 
discharged;
    (5) The HHA determines, under a policy set by the HHA for the 
purpose of addressing discharge for cause that meets the requirements of 
paragraphs (d)(5)(i) through (d)(5)(iii) of this section, that the 
patient's (or other persons in the patient's home) behavior is 
disruptive, abusive, or uncooperative to the extent that delivery of 
care to the patient or the ability of the HHA to operate effectively is 
seriously impaired. The HHA must do the following before it discharges a 
patient for cause:
    (i) Advise the patient, representative (if any), the physician(s) 
issuing orders for the home health plan of care, and the patient's 
primary care practitioner or other health care professional who will be 
responsible for providing care and services to the patient after 
discharge from the HHA (if any) that a discharge for cause is being 
considered;
    (ii) Make efforts to resolve the problem(s) presented by the 
patient's behavior, the behavior of other persons in the patient's home, 
or situation;
    (iii) Provide the patient and representative (if any), with contact 
information for other agencies or providers who may be able to provide 
care; and
    (iv) Document the problem(s) and efforts made to resolve the 
problem(s), and enter this documentation into its clinical records;
    (6) The patient dies; or
    (7) The HHA ceases to operate.
    (e) Standard: Investigation of complaints. (1) The HHA must--
    (i) Investigate complaints made by a patient, the patient's 
representative (if any), and the patient's caregivers and family, 
including, but not limited to, the following topics:
    (A) Treatment or care that is (or fails to be) furnished, is 
furnished inconsistently, or is furnished inappropriately; and
    (B) Mistreatment, neglect, or verbal, mental, sexual, and physical 
abuse, including injuries of unknown source, and/or misappropriation of 
patient property by anyone furnishing services on behalf of the HHA.
    (ii) Document both the existence of the complaint and the resolution 
of the complaint; and
    (iii) Take action to prevent further potential violations, including 
retaliation, while the complaint is being investigated.
    (2) Any HHA staff (whether employed directly or under arrangements) 
in the normal course of providing services to patients, who identifies, 
notices, or recognizes incidences or circumstances of mistreatment, 
neglect, verbal, mental, sexual, and/or physical abuse, including 
injuries of unknown source, or misappropriation of patient property, 
must report these findings immediately to the HHA and other appropriate 
authorities in accordance with state law.
    (f) Standard: Accessibility. Information must be provided to 
patients in plain language and in a manner that is accessible and timely 
to--

[[Page 165]]

    (1) Persons with disabilities, including accessible Web sites and 
the provision of auxiliary aids and services at no cost to the 
individual in accordance with the Americans with Disabilities Act and 
Section 504 of the Rehabilitation Act.
    (2) Persons with limited English proficiency through the provision 
of language services at no cost to the individual, including oral 
interpretation and written translations.



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

    Each patient must receive, and an HHA must provide, a patient-
specific, comprehensive assessment. 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.
    (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 who is responsible for the home health plan of care, 
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: Content of the comprehensive assessment. The 
comprehensive assessment must accurately reflect the patient's status, 
and must include, at a minimum, the following information:
    (1) The patient's current health, psychosocial, functional, and 
cognitive status;
    (2) The patient's strengths, goals, and care preferences, including 
information that may be used to demonstrate the patient's progress 
toward achievement of the goals identified by the patient and the 
measurable outcomes identified by the HHA;
    (3) The patient's continuing need for home care;
    (4) The patient's medical, nursing, rehabilitative, social, and 
discharge planning needs;
    (5) 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.
    (6) The patient's primary caregiver(s), if any, and other available 
supports, including their:
    (i) Willingness and ability to provide care, and
    (ii) Availability and schedules;
    (7) The patient's representative (if any);
    (8) Incorporation 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. The OASIS 
data items determined by the Secretary must include: clinical record 
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.
    (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 5 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; 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, or on physician-ordered resumption date;

[[Page 166]]

    (3) At discharge.



Sec. 484.60  Condition of participation: Care planning, coordination of 
          services, and quality of care.

    Patients are accepted for treatment on the reasonable expectation 
that an HHA can meet the patient's medical, nursing, rehabilitative, and 
social needs in his or her place of residence. Each patient must receive 
an individualized written plan of care, including any revisions or 
additions. The individualized plan of care must specify the care and 
services necessary to meet the patient-specific needs as identified in 
the comprehensive assessment, including identification of the 
responsible discipline(s), and the measurable outcomes that the HHA 
anticipates will occur as a result of implementing and coordinating the 
plan of care. The individualized plan of care must also specify the 
patient and caregiver education and training. Services must be furnished 
in accordance with accepted standards of practice.
    (a) Standard: Plan of care. (1) Each patient must receive the home 
health services that are written in an individualized plan of care that 
identifies patient-specific measurable outcomes and goals, and which is 
established, periodically reviewed, and signed by a doctor of medicine, 
osteopathy, or podiatry acting within the scope of his or her state 
license, certification, or registration. 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.
    (2) The individualized plan of care must include the following:
    (i) All pertinent diagnoses;
    (ii) The patient's mental, psychosocial, and cognitive status;
    (iii) The types of services, supplies, and equipment required;
    (iv) The frequency and duration of visits to be made;
    (v) Prognosis;
    (vi) Rehabilitation potential;
    (vii) Functional limitations;
    (viii) Activities permitted;
    (ix) Nutritional requirements;
    (x) All medications and treatments;
    (xi) Safety measures to protect against injury;
    (xii) A description of the patient's risk for emergency department 
visits and hospital re-admission, and all necessary interventions to 
address the underlying risk factors.
    (xiii) Patient and caregiver education and training to facilitate 
timely discharge;
    (xiv) Patient-specific interventions and education; measurable 
outcomes and goals identified by the HHA and the patient;
    (xv) Information related to any advanced directives; and
    (xvi) Any additional items the HHA or physician may choose to 
include.
    (3) All patient care orders, including verbal orders, must be 
recorded in the plan of care.
    (b) Standard: Conformance with physician orders. (1) Drugs, 
services, and treatments are administered only as ordered by a 
physician.
    (2) Influenza and pneumococcal vaccines may be administered per 
agency policy developed in consultation with a physician, and after an 
assessment of the patient to determine for contraindications.
    (3) Verbal orders must be accepted only by personnel authorized to 
do so by applicable state laws and regulations and by the HHA's internal 
policies.
    (4) When services are provided on the basis of a physician's verbal 
orders, a nurse acting in accordance with state licensure requirements, 
or other qualified practitioner responsible for furnishing or 
supervising the ordered services, in accordance with state law and the 
HHA's policies, must document the orders in the patient's clinical 
record, and sign, date, and time the orders. Verbal orders must be 
authenticated and dated by the physician in accordance with applicable 
state laws and regulations, as well as the HHA's internal policies.
    (c) Standard: Review and revision of the plan of care. (1) The 
individualized plan of care must be reviewed and revised by the 
physician who is responsible for the home health plan of care and the 
HHA as frequently as the patient's condition or needs require, but no 
less frequently than once every 60 days, beginning with the start of 
care date. The HHA must promptly alert the relevant physician(s) to any 
changes in the patient's condition or needs that suggest that outcomes 
are not being achieved and/or that the plan of care should be altered.
    (2) A revised plan of care must reflect current information from the 
patient's updated comprehensive assessment, and contain information 
concerning the patient's progress toward the measurable outcomes and 
goals identified by the HHA and patient in the plan of care.
    (3) Revisions to the plan of care must be communicated as follows:
    (i) Any revision to the plan of care due to a change in patient 
health status must be communicated to the patient, representative (if 
any), caregiver, and all physicians issuing orders for the HHA plan of 
care.
    (ii) Any revisions related to plans for the patient's discharge must 
be communicated to the patient, representative, caregiver, all 
physicians issuing orders for the HHA plan of care, and the patient's 
primary care practitioner or other health care professional who will be 
responsible for providing care and services to the patient after 
discharge from the HHA (if any).
    (d) Standard: Coordination of care. The HHA must:

[[Page 167]]

    (1) Assure communication with all physicians involved in the plan of 
care.
    (2) Integrate orders from all physicians involved in the plan of 
care to assure the coordination of all services and interventions 
provided to the patient.
    (3) Integrate services, whether services are provided directly or 
under arrangement, to assure the identification of patient needs and 
factors that could affect patient safety and treatment effectiveness and 
the coordination of care provided by all disciplines.
    (4) Coordinate care delivery to meet the patient's needs, and 
involve the patient, representative (if any), and caregiver(s), as 
appropriate, in the coordination of care activities.
    (5) Ensure that each patient, and his or her caregiver(s) where 
applicable, receive ongoing education and training provided by the HHA, 
as appropriate, regarding the care and services identified in the plan 
of care. The HHA must provide training, as necessary, to ensure a timely 
discharge.
    (e) Standard: Written information to the patient. The HHA must 
provide the patient and caregiver with a copy of written instructions 
outlining:
    (1) Visit schedule, including frequency of visits by HHA personnel 
and personnel acting on behalf of the HHA.
    (2) Patient medication schedule/instructions, including: medication 
name, dosage and frequency and which medications will be administered by 
HHA personnel and personnel acting on behalf of the HHA.
    (3) Any treatments to be administered by HHA personnel and personnel 
acting on behalf of the HHA, including therapy services.
    (4) Any other pertinent instruction related to the patient's care 
and treatments that the HHA will provide, specific to the patient's care 
needs.
    (5) Name and contact information of the HHA clinical manager.



Sec. 484.65  Condition of participation: Quality assessment and 
          performance improvement (QAPI).

    The HHA must develop, implement, evaluate, and maintain an 
effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's 
governing body must ensure that the program reflects the complexity of 
its organization and services; involves all HHA services (including 
those services provided under contract or arrangement); focuses on 
indicators related to improved outcomes, including the use of emergent 
care services, hospital admissions and re-admissions; and takes actions 
that address the HHA's performance across the spectrum of care, 
including the prevention and reduction of medical errors. The HHA must 
maintain documentary evidence of its QAPI program and be able to 
demonstrate its operation to CMS.
    (a) Standard: Program scope. (1) The program must at least be 
capable of showing measurable improvement in indicators for which there 
is evidence that improvement in those indicators will improve health 
outcomes, patient safety, and quality of care.
    (2) The HHA must measure, analyze, and track quality indicators, 
including adverse patient events, and other aspects of performance that 
enable the HHA to assess processes of care, HHA services, and 
operations.
    (b) Standard: Program data. (1) The program must utilize quality 
indicator data, including measures derived from OASIS, where applicable, 
and other relevant data, in the design of its program.
    (2) The HHA must use the data collected to--
    (i) Monitor the effectiveness and safety of services and quality of 
care; and
    (ii) Identify opportunities for improvement.
    (3) The frequency and detail of the data collection must be approved 
by the HHA's governing body.
    (c) Standard: Program activities. (1) The HHA's performance 
improvement activities must--
    (i) Focus on high risk, high volume, or problem-prone areas;
    (ii) Consider incidence, prevalence, and severity of problems in 
those areas; and
    (iii) Lead to an immediate correction of any identified problem that 
directly or potentially threaten the health and safety of patients.
    (2) Performance improvement activities must track adverse patient 
events, analyze their causes, and implement preventive actions.
    (3) The HHA must take actions aimed at performance improvement, and, 
after implementing those actions, the HHA must measure its success and 
track performance to ensure that improvements are sustained.
    (d) Standard: Performance improvement projects. Beginning July 13, 
2018 HHAs must conduct performance improvement projects.
    (1) The number and scope of distinct improvement projects conducted 
annually must reflect the scope, complexity, and past performance of the 
HHA's services and operations.
    (2) The HHA must document the quality improvement projects 
undertaken, the reasons for conducting these projects, and the 
measurable progress achieved on these projects.
    (e) Standard: Executive responsibilities. The HHA's governing body 
is responsible for ensuring the following:
    (1) That an ongoing program for quality improvement and patient 
safety is defined, implemented, and maintained;
    (2) That the HHA-wide quality assessment and performance improvement 
efforts address priorities for improved quality of care

[[Page 168]]

and patient safety, and that all improvement actions are evaluated for 
effectiveness;
    (3) That clear expectations for patient safety are established, 
implemented, and maintained; and
    (4) That any findings of fraud or waste are appropriately addressed.



Sec. 484.70  Condition of participation: Infection prevention and 
          control.

    The HHA must maintain and document an infection control program 
which has as its goal the prevention and control of infections and 
communicable diseases.
    (a) Standard: Prevention. The HHA must follow accepted standards of 
practice, including the use of standard precautions, to prevent the 
transmission of infections and communicable diseases.
    (b) Standard: Control. The HHA must maintain a coordinated agency-
wide program for the surveillance, identification, prevention, control, 
and investigation of infectious and communicable diseases that is an 
integral part of the HHA's quality assessment and performance 
improvement (QAPI) program. The infection control program must include:
    (1) A method for identifying infectious and communicable disease 
problems; and
    (2) A plan for the appropriate actions that are expected to result 
in improvement and disease prevention.
    (c) Standard: Education. The HHA must provide infection control 
education to staff, patients, and caregiver(s).



Sec. 484.75  Condition of participation: Skilled professional services.

    Skilled professional services include skilled nursing services, 
physical therapy, speech-language pathology services, and occupational 
therapy, as specified in Sec. 409.44 of this chapter, and physician and 
medical social work services as specified in Sec. 409.45 of this 
chapter. Skilled professionals who provide services to HHA patients 
directly or under arrangement must participate in the coordination of 
care.
    (a) Standard: Provision of services by skilled professionals. 
Skilled professional services are authorized, delivered, and supervised 
only by health care professionals who meet the appropriate 
qualifications specified under Sec. 484.115 and who practice according 
to the HHA's policies and procedures.
    (b) Standard: Responsibilities of skilled professionals. Skilled 
professionals must assume responsibility for, but not be restricted to, 
the following:
    (1) Ongoing interdisciplinary assessment of the patient;
    (2) Development and evaluation of the plan of care in partnership 
with the patient, representative (if any), and caregiver(s);
    (3) Providing services that are ordered by the physician as 
indicated in the plan of care;
    (4) Patient, caregiver, and family counseling;
    (5) Patient and caregiver education;
    (6) Preparing clinical notes;
    (7) Communication with all physicians involved in the plan of care 
and other health care practitioners (as appropriate) related to the 
current plan of care;
    (8) Participation in the HHA's QAPI program; and
    (9) Participation in HHA-sponsored in-service training.
    (c) Supervision of skilled professional assistants. (1) Nursing 
services are provided under the supervision of a registered nurse that 
meets the requirements of Sec. 484.115(k).
    (2) Rehabilitative therapy services are provided under the 
supervision of an occupational therapist or physical therapist that 
meets the requirements of Sec. 484.115(f) or (h), respectively.
    (3) Medical social services are provided under the supervision of a 
social worker that meets the requirements of Sec. 484.115(m).



Sec. 484.80  Condition of participation: Home health aide services.

    All home health aide services must be provided by individuals who 
meet the personnel requirements specified in paragraph (a) of this 
section.
    (a) Standard: Home health aide qualifications. (1) A qualified home 
health aide is a person who has successfully completed:
    (i) A training and competency evaluation program as specified in 
paragraphs (b) and (c) respectively of this section; or
    (ii) A competency evaluation program that meets the requirements of 
paragraph (c) of this section; or
    (iii) A nurse aide training and competency evaluation program 
approved by the state as meeting the requirements of Sec. 483.151 
through Sec. 483.154 of this chapter, and is currently listed in good 
standing on the state nurse aide registry; or
    (iv) The requirements of a state licensure program that meets the 
provisions of paragraphs (b) and (c) of this section.
    (2) A home health aide or nurse aide is not considered to have 
completed a program, as specified in paragraph (a)(1) of this section, 
if, since the individual's most recent completion of the program(s), 
there has been a continuous period of 24 consecutive months during which 
none of the services furnished by the individual as described in 
Sec. 409.40 of this chapter were for compensation. If there has been a 
24-month lapse in furnishing services for compensation, the individual 
must complete another program, as specified in paragraph (a)(1) of this 
section, before providing services.
    (b) Standard: Content and duration of home health aide classroom and 
supervised practical training. (1) Home health aide training must 
include classroom and supervised practical

[[Page 169]]

training in a practicum laboratory or other setting in which the trainee 
demonstrates knowledge while providing services to an individual under 
the direct supervision of a registered nurse, or a licensed practical 
nurse who is under the supervision of a registered nurse. Classroom and 
supervised practical training must total at least 75 hours.
    (2) A minimum of 16 hours of classroom training must precede a 
minimum of 16 hours of supervised practical training as part of the 75 
hours.
    (3) A home health aide training program must address each of the 
following subject areas:
    (i) Communication skills, including the ability to read, write, and 
verbally report clinical information to patients, representatives, and 
caregivers, as well as to other HHA staff.
    (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 prevention and 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 the knowledge of instituting 
emergency procedures and their application.
    (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 performing personal hygiene 
and grooming tasks that include--
    (A) Bed bath;
    (B) Sponge, tub, and shower bath;
    (C) Hair shampooing in sink, tub, and 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) Recognizing and reporting changes in skin condition; and
    (xiv) Any other task that the HHA may choose to have an aide perform 
as permitted under state law.
    (xv) The HHA is responsible for training home health aides, as 
needed, for skills not covered in the basic checklist, as described in 
paragraph (b)(3)(ix) of this section.
    (4) The HHA must maintain documentation that demonstrates that the 
requirements of this standard have been met.
    (c) Standard: Competency evaluation. An individual may furnish home 
health services on behalf of an HHA only after that individual has 
successfully completed a competency evaluation program as described in 
this section.
    (1) The competency evaluation must address each of the subjects 
listed in paragraph (b)(3) of this section. Subject areas specified 
under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section 
must be evaluated by observing an aide's performance of the task with a 
patient. The remaining subject areas may be evaluated through written 
examination, oral examination, or after observation of a home health 
aide with a patient.
    (2) A home health aide competency evaluation program may be offered 
by any organization, except as specified in paragraph (f) of this 
section.
    (3) The competency evaluation must be performed by a registered 
nurse in consultation with other skilled professionals, as appropriate.
    (4) A home health aide is not considered competent in any task for 
which he or she is evaluated as unsatisfactory. An aide must not perform 
that task without direct supervision by a registered nurse until after 
he or she has received training in the task for which he or she was 
evaluated as ``unsatisfactory,'' and has successfully completed a 
subsequent evaluation. 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) The HHA must maintain documentation which demonstrates that the 
requirements of this standard have been met.
    (d) Standard: In-service training. A home health aide must receive 
at least 12 hours of in-service training during each 12-month period. 
In-service training may occur while an aide is furnishing care to a 
patient.
    (1) In-service training may be offered by any organization and must 
be supervised by a registered nurse.
    (2) The HHA must maintain documentation that demonstrates the 
requirements of this standard have been met.
    (e) Standard: Qualifications for instructors conducting classroom 
and supervised practical training. Classroom and supervised practical 
training must be performed by a registered nurse who possesses a minimum 
of 2 years nursing experience, at least 1 year of which must be in home 
health care, or by other individuals under the general supervision of 
the registered nurse.
    (f) Standard: Eligible training and competency evaluation 
organizations. A home health aide training program and competency 
evaluation program may be offered by any organization except by an HHA 
that, within the previous 2 years:

[[Page 170]]

    (1) Was out of compliance with the requirements of paragraphs (b), 
(c), (d), or (e) of this section; or
    (2) Permitted an individual who does not meet the definition of a 
``qualified home health aide'' as specified in paragraph (a) of this 
section to furnish home health aide services (with the exception of 
licensed health professionals and volunteers); or
    (3) Was subjected to an extended (or partially extended) survey as a 
result of having been found to have furnished substandard care (or for 
other reasons as determined by CMS or the state); or
    (4) Was assessed a civil monetary penalty of $5,000 or more as an 
intermediate sanction; or
    (5) Was found to have compliance deficiencies that endangered the 
health and safety of the HHA's patients, and had temporary management 
appointed to oversee the management of the HHA; or
    (6) Had all or part of its Medicare payments suspended; or
    (7) Was found under any federal or state law to have:
    (i) Had its participation in the Medicare program terminated; or
    (ii) Been assessed a penalty of $5,000 or more for deficiencies in 
federal or state standards for HHAs; or
    (iii) Been subjected to a suspension of Medicare payments to which 
it otherwise would have been entitled; or
    (iv) Operated under 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
    (v) Been closed, or had its patients transferred by the state; or
    (vi) Been excluded from participating in federal health care 
programs or debarred from participating in any government program.
    (g) Standard: Home health aide assignments and duties. (1) Home 
health aides are assigned to a specific patient by a registered nurse or 
other appropriate skilled professional, with written patient care 
instructions for a home health aide prepared by that registered nurse or 
other appropriate skilled professional (that is, physical therapist, 
speech-language pathologist, or occupational therapist).
    (2) A home health aide provides services that are:
    (i) Ordered by the physician;
    (ii) Included in the plan of care;
    (iii) Permitted to be performed under state law; and
    (iv) Consistent with the home health aide training.
    (3) The duties of a home health aide include:
    (i) The provision of hands-on personal care;
    (ii) The performance of simple procedures as an extension of therapy 
or nursing services;
    (iii) Assistance in ambulation or exercises; and
    (iv) Assistance in administering medications ordinarily self-
administered.
    (4) Home health aides must be members of the interdisciplinary team, 
must report changes in the patient's condition to a registered nurse or 
other appropriate skilled professional, and must complete appropriate 
records in compliance with the HHA's policies and procedures.
    (h) Standard: Supervision of home health aides. (1)(i) If home 
health aide services are provided to a patient who is receiving skilled 
nursing, physical or occupational therapy, or speech-language pathology 
services, a registered nurse or other appropriate skilled professional 
who is familiar with the patient, the patient's plan of care, and the 
written patient care instructions described in Sec. 484.80(g), must make 
an onsite visit to the patient's home no less frequently than every 14 
days. The home health aide does not have to be present during this 
visit.
    (ii) If an area of concern in aide services is noted by the 
supervising registered nurse or other appropriate skilled professional, 
then the supervising individual must make an on-site visit to the 
location where the patient is receiving care in order to observe and 
assess the aide while he or she is performing care.
    (iii) A registered nurse or other appropriate skilled professional 
must make an annual on-site visit to the location where a patient is 
receiving care in order to observe and assess each aide while he or she 
is performing care.
    (2) 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 an 
on-site visit to the location where the patient is receiving care no 
less frequently than every 60 days in order to observe and assess each 
aide while he or she is performing care.
    (3) If a deficiency in aide services is verified by the registered 
nurse or other appropriate skilled professional during an on-site visit, 
then the agency must conduct, and the home health aide must complete a 
competency evaluation in accordance with paragraph (c) of this section.
    (4) Home health aide supervision must ensure that aides furnish care 
in a safe and effective manner, including, but not limited to, the 
following elements:
    (i) Following the patient's plan of care for completion of tasks 
assigned to a home health aide by the registered nurse or other 
appropriate skilled professional;

[[Page 171]]

    (ii) Maintaining an open communication process with the patient, 
representative (if any), caregivers, and family;
    (iii) Demonstrating competency with assigned tasks;
    (iv) Complying with infection prevention and control policies and 
procedures;
    (v) Reporting changes in the patient's condition; and
    (vi) Honoring patient rights.
    (5) If the home health agency chooses to provide home health aide 
services under arrangements, as defined in section 1861(w)(1) of the 
Act, the HHA's responsibilities also include, but are not limited to:
    (i) Ensuring the overall quality of care provided by an aide;
    (ii) Supervising aide services as described in paragraphs (h)(1) and 
(2) of this section; and
    (iii) Ensuring that home health aides who provide services under 
arrangement have met the training or competency evaluation requirements, 
or both, of this part.
    (i) Standard: Individuals furnishing Medicaid personal care aide-
only services under a Medicaid personal care benefit. An individual may 
furnish personal care services, as defined in Sec. 440.167 of this 
chapter, on behalf of an HHA. Before the individual may furnish personal 
care services, the individual must meet all qualification standards 
established by the state. The individual only needs to demonstrate 
competency in the services the individual is required to furnish.



                    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, Aug. 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 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, Aug. 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

[[Page 172]]

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 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

[[Page 173]]

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 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.

[[Page 174]]

    (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 
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, Aug. 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]

[[Page 175]]



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 
Secs. 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]



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

[[Page 176]]

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; 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 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

[[Page 177]]

items collected at inpatient facility admission or discharge only.

[64 FR 3784, Jan. 25, 1999, as amended at 65 FR 41211, July 3, 2000; 74 
FR 58134, Nov. 10, 2009]

    Effective Date Note: At 82 FR 4578, Jan. 13, 2017, subpart C was 
revised, effective July 13, 2017. At 82 FR 31732, July 10, 2017, this 
amendment was corrected. At 82 FR 31729, July 10, 2017, this amendment 
was delayed until Jan. 13, 2018. For the convenience of the user, the 
revised text is set forth as follows:



                  Subpart C_Organizational Environment



Sec. 484.100  Condition of participation: Compliance with Federal, 
          State, and local laws and regulations related to the health 
          and safety of patients.

    The HHA and its staff must operate and furnish services in 
compliance with all applicable federal, state, and local laws and 
regulations related to the health and safety of patients. If state or 
local law provides licensing of HHAs, the HHA must be licensed.
    (a) 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 names and addresses of all persons with an ownership or 
controlling interest in the HHA as defined in Sec. 420.201, 
Sec. 420.202, and Sec. 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. 420.201, Sec. 420.202, and Sec. 420.206 of this chapter.
    (3) The name and business address of the corporation, association, 
or other company that is responsible for the management of the HHA, and 
the names and addresses of the chief executive officer and the 
chairperson of the board of directors of that corporation, association, 
or other company responsible for the management of the HHA.
    (b) Standard: Licensing. The HHA, its branches, and all persons 
furnishing services to patients must be licensed, certified, or 
registered, as applicable, in accordance with the state licensing 
authority as meeting those requirements.
    (c) 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 Food and Drug Administration, the testing must be in 
compliance with all applicable requirements of part 493 of this chapter. 
The HHA may not substitute its equipment for a patient's equipment when 
assisting with self-administered tests.
    (2) If the HHA refers specimens for laboratory testing, the referral 
laboratory must be certified in the appropriate specialties and 
subspecialties of services in accordance with the applicable 
requirements of part 493 of this chapter.



Sec. 484.102  Condition of participation: Emergency preparedness.

    The Home Health Agency (HHA) must comply with all applicable 
Federal, State, and local emergency preparedness requirements. The HHA 
must establish and maintain an emergency preparedness program that meets 
the requirements of this section. The emergency preparedness program 
must include, but not be limited to, the following elements:
    (a) Emergency plan. The HHA must develop and maintain an emergency 
preparedness plan that must be reviewed, and updated at least annually. 
The plan must do all of the following:
    (1) Be based on and include a documented, facility-based and 
community-based risk assessment, utilizing an all-hazards approach.
    (2) Include strategies for addressing emergency events identified by 
the risk assessment.
    (3) Address patient population, including, but not limited to, the 
type of services the HHA has the ability to provide in an emergency; and 
continuity of operations, including delegations of authority and 
succession plans.
    (4) Include a process for cooperation and collaboration with local, 
tribal, regional, State, and Federal emergency preparedness officials' 
efforts to maintain an integrated response during a disaster or 
emergency situation, including documentation of the HHA's efforts to 
contact such officials and, when applicable, of its participation in 
collaborative and cooperative planning efforts.
    (b) Policies and procedures. The HHA must develop and implement 
emergency preparedness policies and procedures, based on the emergency 
plan set forth in paragraph (a) of this section, risk assessment at 
paragraph (a)(1) of this section, and the communication plan at 
paragraph (c) of this section. The policies and procedures must be 
reviewed and updated at least annually. At a minimum, the policies and 
procedures must address the following:
    (1) The plans for the HHA's patients during a natural or man-made 
disaster. Individual plans for each patient must be included as part of 
the comprehensive patient assessment, which must be conducted according 
to the provisions at Sec. 484.55.
    (2) The procedures to inform State and local emergency preparedness 
officials about HHA patients in need of evacuation from

[[Page 178]]

their residences at any time due to an emergency situation based on the 
patient's medical and psychiatric condition and home environment.
    (3) The procedures to follow up with on-duty staff and patients to 
determine services that are needed, in the event that there is an 
interruption in services during or due to an emergency. The HHA must 
inform State and local officials of any on-duty staff or patients that 
they are unable to contact.
    (4) A system of medical documentation that preserves patient 
information, protects confidentiality of patient information, and 
secures and maintains the availability of records.
    (5) The use of volunteers in an emergency or other emergency 
staffing strategies, including the process and role for integration of 
State or Federally designated health care professionals to address surge 
needs during an emergency.
    (c) Communication plan. The HHA must develop and maintain an 
emergency preparedness communication plan that complies with Federal, 
State, and local laws and must be reviewed and updated at least 
annually. The communication plan must include all of the following:
    (1) Names and contact information for the following:
    (i) Staff.
    (ii) Entities providing services under arrangement.
    (iii) Patients' physicians.
    (iv) Volunteers.
    (2) Contact information for the following:
    (i) Federal, State, tribal, regional, or local emergency 
preparedness staff.
    (ii) Other sources of assistance.
    (3) Primary and alternate means for communicating with the HHA's 
staff, Federal, State, tribal, regional, and local emergency management 
agencies.
    (4) A method for sharing information and medical documentation for 
patients under the HHA's care, as necessary, with other health care 
providers to maintain the continuity of care.
    (5) A means of providing information about the general condition and 
location of patients under the facility's care as permitted under 45 CFR 
164.510(b)(4).
    (6) A means of providing information about the HHA's needs, and its 
ability to provide assistance, to the authority having jurisdiction, the 
Incident Command Center, or designee.
    (d) Training and testing. The HHA must develop and maintain an 
emergency preparedness training and testing program that is based on the 
emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program must be 
reviewed and updated at least annually.
    (1) Training program. The HHA must do all of the following:
    (i) Initial training in emergency preparedness policies and 
procedures to all new and existing staff, individuals providing services 
under arrangement, and volunteers, consistent with their expected roles.
    (ii) Provide emergency preparedness training at least annually.
    (iii) Maintain documentation of the training.
    (ii) Demonstrate staff knowledge of emergency procedures.
    (2) Testing. The HHA must conduct exercises to test the emergency 
plan at least annually. The HHA must do the following:
    (i) Participate in a full-scale exercise that is community-based or 
when a community-based exercise is not accessible, an individual, 
facility-based. If the HHA experiences an actual natural or man-made 
emergency that requires activation of the emergency plan, the HHA is 
exempt from engaging in a community-based or individual, facility-based 
full-scale exercise for 1 year following the onset of the actual event.
    (ii) Conduct an additional exercise that may include, but is not 
limited to the following:
    (A) A second full-scale exercise that is community-based or 
individual, facility-based.
    (B) A tabletop exercise that includes a group discussion led by a 
facilitator, using a narrated, clinically-relevant emergency scenario, 
and a set of problem statements, directed messages, or prepared 
questions designed to challenge an emergency plan.
    (iii) Analyze the HHA's response to and maintain documentation of 
all drills, tabletop exercises, and emergency events, and revise the 
HHA's emergency plan, as needed.
    (e) Integrated healthcare systems. If a HHA is part of a healthcare 
system consisting of multiple separately certified healthcare facilities 
that elects to have a unified and integrated emergency preparedness 
program, the HHA may choose to participate in the healthcare system's 
coordinated emergency preparedness program. If elected, the unified and 
integrated emergency preparedness program must do all of the following:
    (1) Demonstrate that each separately certified facility within the 
system actively participated in the development of the unified and 
integrated emergency preparedness program.
    (2) Be developed and maintained in a manner that takes into account 
each separately certified facility's unique circumstances, patient 
populations, and services offered.
    (3) Demonstrate that each separately certified facility is capable 
of actively using the

[[Page 179]]

unified and integrated emergency preparedness program and is in 
compliance with the program.
    (4) Include a unified and integrated emergency plan that meets the 
requirements of paragraphs (a)(2), (3), and (4) of this section. The 
unified and integrated emergency plan must also be based on and include 
all of the following:
    (i) A documented community-based risk assessment, utilizing an all-
hazards approach.
    (ii) A documented individual facility-based risk assessment for each 
separately certified facility within the health system, utilizing an 
all-hazards approach.
    (5) Include integrated policies and procedures that meet the 
requirements set forth in paragraph (b) of this section, a coordinated 
communication plan and training and testing programs that meet the 
requirements of paragraphs (c) and (d) of this section, respectively.



Sec. 484.105  Condition of participation: Organization and 
          administration of services.

    The HHA must organize, manage, and administer its resources to 
attain and maintain the highest practicable functional capacity, 
including providing optimal care to achieve the goals and outcomes 
identified in the patient's plan of care, for each patient's medical, 
nursing, and rehabilitative needs. The HHA must assure that 
administrative and supervisory functions are not delegated to another 
agency or organization, and all services not furnished directly are 
monitored and controlled. The HHA must set forth, in writing, its 
organizational structure, including lines of authority, and services 
furnished.
    (a) Standard: Governing body. A governing body (or designated 
persons so functioning) must assume full legal authority and 
responsibility for the agency's overall management and operation, the 
provision of all home health services, fiscal operations, review of the 
agency's budget and its operational plans, and its quality assessment 
and performance improvement program.
    (b) Standard: Administrator. (1) The administrator must:
    (i) Be appointed by and report to the governing body;
    (ii) Be responsible for all day-to-day operations of the HHA;
    (iii) Ensure that a clinical manager as described in paragraph (c) 
of this section is available during all operating hours;
    (iv) Ensure that the HHA employs qualified personnel, including 
assuring the development of personnel qualifications and policies.
    (2) When the administrator is not available, a qualified, pre-
designated person, who is authorized in writing by the administrator and 
the governing body, assumes the same responsibilities and obligations as 
the administrator. The pre-designated person may be the clinical manager 
as described in paragraph (c) of this section.
    (3) The administrator or a pre-designated person is available during 
all operating hours.
    (c) Clinical manager. One or more qualified individuals must provide 
oversight of all patient care services and personnel. Oversight must 
include the following--
    (1) Making patient and personnel assignments,
    (2) Coordinating patient care,
    (3) Coordinating referrals,
    (4) Assuring that patient needs are continually assessed, and
    (5) Assuring the development, implementation, and updates of the 
individualized plan of care.
    (d) Standard: Parent-branch relationship. (1) The parent HHA is 
responsible for reporting all branch locations of the HHA to the state 
survey agency at the time of the HHA's request for initial 
certification, at each survey, and at the time the parent proposes to 
add or delete a branch.
    (2) The parent HHA provides direct support and administrative 
control of its branches.
    (e) Standard: Services under arrangement. (1) The HHA must ensure 
that all services furnished under arrangement provided by other entities 
or individuals meet the requirements of this part and the requirements 
of section 1861(w) of the Act (42 U.S.C. 1395x (w)).
    (2) An HHA must have a written agreement with another agency, with 
an organization, or with an individual when that entity or individual 
furnishes services under arrangement to the HHA's patients. The HHA must 
maintain overall responsibility for the services provided under 
arrangement, as well as the manner in which they are furnished. The 
agency, organization, or individual providing services under arrangement 
may not have been:
    (i) Denied Medicare or Medicaid enrollment;
    (ii) Been excluded or terminated from any federal health care 
program or Medicaid;
    (iii) Had its Medicare or Medicaid billing privileges revoked; or
    (iv) Been debarred from participating in any government program.
    (3) The primary HHA is responsible for patient care, and must 
conduct and provide, either directly or under arrangements, all services 
rendered to patients.
    (f) Standard: Services furnished. (1) Skilled nursing services and 
at least one other therapeutic service (physical therapy, speech-
language pathology, 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

[[Page 180]]

least one of the services described in this subsection directly, but may 
provide the second service and additional services under arrangement 
with another agency or organization.
    (2) All HHA services must be provided in accordance with current 
clinical practice guidelines and accepted professional standards of 
practice.
    (g) Standard: Outpatient physical therapy or speech-language 
pathology services. An HHA that furnishes outpatient physical therapy or 
speech-language pathology services must meet all of the applicable 
conditions of this part and the additional health and safety 
requirements set forth in Sec. 485.711, Sec. 485.713, Sec. 485.715, 
Sec. 485.719, Sec. 485.723, and Sec. 485.727 of this chapter to 
implement section 1861(p) of the Act.
    (h) 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 Services 
Block Grant) 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 conform, 
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.



Sec. 484.110  Condition of participation: Clinical records.

    The HHA must maintain a clinical record containing past and current 
information for every patient accepted by the HHA and receiving home 
health services. Information contained in the clinical record must be 
accurate, adhere to current clinical record documentation standards of 
practice, and be available to the physician(s) issuing orders for the 
home health plan of care, and appropriate HHA staff. This information 
may be maintained electronically.
    (a) Standard: Contents of clinical record. The record must include:
    (1) The patient's current comprehensive assessment, including all of 
the assessments from the most recent home health admission, clinical 
notes, plans of care, and physician orders;
    (2) All interventions, including medication administration, 
treatments, and services, and responses to those interventions;
    (3) Goals in the patient's plans of care and the patient's progress 
toward achieving them;
    (4) Contact information for the patient, the patient's 
representative (if any), and the patient's primary caregiver(s);

[[Page 181]]

    (5) Contact information for the primary care practitioner or other 
health care professional who will be responsible for providing care and 
services to the patient after discharge from the HHA; and
    (6)(i) A completed discharge summary that is sent to the primary 
care practitioner or other health care professional who will be 
responsible for providing care and services to the patient after 
discharge from the HHA (if any) within 5 business days of the patient's 
discharge; or
    (ii) A completed transfer summary that is sent within 2 business 
days of a planned transfer, if the patient's care will be immediately 
continued in a health care facility; or
    (iii) A completed transfer summary that is sent within 2 business 
days of becoming aware of an unplanned transfer, if the patient is still 
receiving care in a health care facility at the time when the HHA 
becomes aware of the transfer.
    (b) Standard: Authentication. All entries must be legible, clear, 
complete, and appropriately authenticated, dated, and timed. 
Authentication must include a signature and a title (occupation), or a 
secured computer entry by a unique identifier, of a primary author who 
has reviewed and approved the entry.
    (c) Standard: Retention of records. (1) Clinical records must be 
retained for 5 years after the discharge of the patient, unless state 
law stipulates a longer period of time.
    (2) The HHA's policies must provide for retention of clinical 
records even if it discontinues operation. When an HHA discontinues 
operation, it must inform the state agency where clinical records will 
be maintained.
    (d) Standard: Protection of records. The clinical record, its 
contents, and the information contained therein must be safeguarded 
against loss or unauthorized use. The HHA must be in compliance with the 
rules regarding protected health information set out at 45 CFR parts 160 
and 164.
    (e) Standard: Retrieval of clinical records. A patient's clinical 
record (whether hard copy or electronic form) must be made available to 
a patient, free of charge, upon request at the next home visit, or 
within 4 business days (whichever comes first).



Sec. 484.115  Condition of participation: Personnel qualifications.

    HHA staff are required to meet the following standards:
    (a) Standard: Administrator, home health agency. (1) For individuals 
that began employment with the HHA prior to January 13, 2018, a person 
who:
    (i) Is a licensed physician;
    (ii) Is a registered nurse; or
    (iii) Has training and experience in health service administration 
and at least 1 year of supervisory administrative experience in home 
health care or a related health care program.
    (2) For individuals that begin employment with an HHA on or after 
July 13, 2017, a person who:
    (i) Is a licensed physician, a registered nurse, or holds an 
undergraduate degree; and
    (ii) Has experience in health service administration, with at least 
1 year of supervisory or administrative experience in home health care 
or a related health care program.
    (b) Standard: Audiologist. A person who:
    (1) Meets the education and experience requirements for a 
Certificate of Clinical Competence in audiology granted by the American 
Speech-Language-Hearing Association; or
    (2) Meets the educational requirements for certification and is in 
the process of accumulating the supervised experience required for 
certification.
    (c) Standard: Clinical manager. A person who is a licensed 
physician, physical therapist, speech-language pathologist, occupational 
therapist, audiologist, social worker, or a registered nurse.
    (d) Standard: Home health aide. A person who meets the 
qualifications for home health aides specified in section 1891(a)(3) of 
the Act and implemented at Sec. 484.80.
    (e) Standard: Licensed practical (vocational) nurse. A person who 
has completed a practical (vocational) nursing program, is licensed in 
the state where practicing, and who furnishes services under the 
supervision of a qualified registered nurse.
    (f) Standard: Occupational therapist. A person who--
    (1)(i) Is licensed or otherwise regulated, if applicable, as an 
occupational therapist by the state in which practicing, unless 
licensure does not apply;
    (ii) 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
    (iii) 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).
    (2) On or before December 31, 2009--
    (i) Is licensed or otherwise regulated, if applicable, as an 
occupational therapist by the state in which practicing; or
    (ii) When licensure or other regulation does not apply--
    (A) Graduated after successful completion of an occupational 
therapist education program accredited by the accreditation Council for 
Occupational Therapy Education (ACOTE) of the American Occupational

[[Page 182]]

Therapy Association, Inc. (AOTA) or successor organizations of ACOTE; 
and
    (B) 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).
    (3) On or before January 1, 2008--
    (i) 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
    (ii) Is eligible for the National Registration Examination of the 
American Occupational Therapy Association or the National Board for 
Certification in Occupational Therapy.
    (4) On or before December 31, 1977--
    (i) Had 2 years of appropriate experience as an occupational 
therapist; and
    (ii) Had achieved a satisfactory grade on an occupational therapist 
proficiency examination conducted, approved, or sponsored by the U.S. 
Public Health Service.
    (5) If educated outside the United States, must meet both of the 
following:
    (i) 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:
    (A) The Accreditation Council for Occupational Therapy Education 
(ACOTE).
    (B) Successor organizations of ACOTE.
    (C) The World Federation of Occupational Therapists.
    (D) A credentialing body approved by the American Occupational 
Therapy Association.
    (E) Successfully completed the entry level certification examination 
for occupational therapists developed and administered by the National 
Board for Certification in Occupational Therapy, Inc. (NBCOT).
    (ii) On or before December 31, 2009, is licensed or otherwise 
regulated, if applicable, as an occupational therapist by the state in 
which practicing.
    (g) Standard: Occupational therapy assistant. A person who--
    (1) Meets all of the following:
    (i) Is licensed or otherwise regulated, if applicable, as an 
occupational therapy assistant by the state in which practicing, unless 
licensure does apply.
    (ii) 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.
    (iii) 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).
    (2) On or before December 31, 2009--
    (i) 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
    (ii) Must meet both of the following:
    (A) Completed certification requirements to practice as an 
occupational therapy assistant established by a credentialing 
organization approved by the American Occupational Therapy Association.
    (B) After January 1, 2010, meets the requirements in paragraph 
(f)(1) of this section.
    (3) After December 31, 1977 and on or before December 31, 2007--
    (i) Completed certification requirements to practice as an 
occupational therapy assistant established by a credentialing 
organization approved by the American Occupational Therapy Association; 
or
    (ii) Completed the requirements to practice as an occupational 
therapy assistant applicable in the state in which practicing.
    (4) On or before December 31, 1977--
    (i) Had 2 years of appropriate experience as an occupational therapy 
assistant; and
    (ii) Had achieved a satisfactory grade on an occupational therapy 
assistant proficiency examination conducted, approved, or sponsored by 
the U.S. Public Health Service.
    (5) If educated outside the United States, on or after January 1, 
2008--
    (i) 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--
    (A) The Accreditation Council for Occupational Therapy Education 
(ACOTE).
    (B) Its successor organizations.
    (C) The World Federation of Occupational Therapists.
    (D) By a credentialing body approved by the American Occupational 
Therapy Association; and
    (E) 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).
    (ii) [Reserved]
    (h) Standard: 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:

[[Page 183]]

    (1)(i) Graduated after successful completion of a physical therapist 
education program approved by one of the following:
    (A) The Commission on Accreditation in Physical Therapy Education 
(CAPTE).
    (B) Successor organizations of CAPTE.
    (C) 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.
    (ii) Passed an examination for physical therapists approved by the 
state in which physical therapy services are provided.
    (2) On or before December 31, 2009--
    (i) Graduated after successful completion of a physical therapy 
curriculum approved by the Commission on Accreditation in Physical 
Therapy Education (CAPTE); or
    (ii) Meets both of the following:
    (A) 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.
    (B) Passed an examination for physical therapists approved by the 
state in which physical therapy services are provided.
    (3) Before January 1, 2008 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.
    (4) On or before December 31, 1977 was licensed or qualified as a 
physical therapist and meets both of the following:
    (i) Has 2 years of appropriate experience as a physical therapist.
    (ii) Has achieved a satisfactory grade on a proficiency examination 
conducted, approved, or sponsored by the U.S. Public Health Service.
    (5) Before January 1, 1966--
    (i) Was admitted to membership by the American Physical Therapy 
Association;
    (ii) Was admitted to registration by the American Registry of 
Physical Therapists; or
    (iii) Graduated from a physical therapy curriculum in a 4-year 
college or university approved by a state department of education.
    (6) Before January 1, 1966 was licensed or registered, and before 
January 1, 1970, had 15 years of fulltime 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.
    (7) If trained outside the United States before January 1, 2008, 
meets the following requirements:
    (i) 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.
    (ii) Meets the requirements for membership in a member organization 
of the World Confederation for Physical Therapy.
    (i) Standard: Physical therapist assistant. A person who is 
licensed, registered or certified as a physical therapist assistant, if 
applicable, by the state in which practicing, unless licensure does not 
apply and meets one of the following requirements:
    (1)(i) 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
    (ii) Passed a national examination for physical therapist 
assistants.
    (2) On or before December 31, 2009, meets one of the following:
    (i) Is licensed, or otherwise regulated in the state in which 
practicing.
    (ii) In states where licensure or other regulations do not apply, 
graduated before December 31, 2009, from a 2-year college-level program 
approved by the American Physical Therapy Association and after January 
1, 2010, meets the requirements of paragraph (h)(1) of this section.
    (3) 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.
    (4) 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.
    (j) Standard: Physician. A person who meets the qualifications and 
conditions specified in section 1861(r) of the Act and implemented at 
Sec. 410.20(b) of this chapter.
    (k) Standard: Registered nurse. A graduate of an approved school of 
professional nursing who is licensed in the state where practicing.

[[Page 184]]

    (l) Standard: Social Work Assistant. A person who provides services 
under the supervision of a qualified social worker and:
    (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 the 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.
    (m) Standard: Social worker. A person who has a master's or doctoral 
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.
    (n) Standard: Speech-language pathologist. A person who has a 
master's or doctoral degree in speech-language pathology, and who meets 
either of the following requirements:
    (1) Is licensed as a speech-language pathologist by the state in 
which the individual furnishes such services; or
    (2) In the case of an individual who furnishes services in a state 
which does not license speech-language pathologists:
    (i) Has successfully completed 350 clock hours of supervised 
clinical practicum (or is in the process of accumulating supervised 
clinical experience);
    (ii) Performed not less than 9 months of supervised full-time 
speech-language pathology services after obtaining a master's or 
doctoral degree in speech-language pathology or a related field; and
    (iii) Successfully completed a national examination in speech-
language pathology approved by the Secretary.

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).
    Furnishing Negative Pressure Wound Therapy (NPWT) using a disposable 
device means the application of a new applicable disposable device, as 
that term is defined in section 1834(s)(2) of the Act, which includes 
the professional services (specified by the assigned CPT[supreg] code) 
that are provided.
    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, as amended at 81 FR 76796, Nov. 3, 2016]



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:

[[Page 185]]

    (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, standardized 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 1861(m) of the Act continues 
to be paid the fee schedule amount. Separate payment is made for 
``furnishing NPWT using a disposable device,'' as that term is defined 
in Sec. 484.202, which is not included in the episode payment.
    (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. (1) An HHA receives a 
national 60-day episode payment of a predetermined rate for home health 
services unless CMS determines an intervening event, defined as a 
beneficiary elected transfer or discharge with goals met or no 
expectation of return to home health and the beneficiary returned to 
home health during the 60-day episode, warrants a new 60-day episode for 
purposes of payment. A start of care OASIS assessment and physician 
certification of the new plan of care are required.
    (2) The PEP adjustment will not apply in situations of transfers 
among HHAs of common ownership. Those situations will 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.
    (3) If the intervening event warrants a new 60-day episode payment 
and a new physician certification and a new plan of care, the initial 
HHA receives a

[[Page 186]]

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, 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 no more than 2.5 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, Aug. 29, 2007; 80 
FR 68717, Nov. 5, 2015; 81 FR 76796, Nov. 3, 2016]



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.
    (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. 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 Secs. 484.215, 484.230 and 484.235.

[65 FR 41212, July 3, 2000, as amended at 74 FR 58134, Nov. 10, 2009]



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.

[[Page 187]]



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 3.79 percent.
    (4) For CY 2012, the adjustment is 3.79 percent.
    (5) For CY 2013, the adjustment is 1.32 percent.
    (6) For CY 2016, CY 2017, and CY 2018, the adjustment is 0.97 
percent in each year.
    (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, as amended at 80 FR 68717, Nov. 5, 2015]



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 (as defined in section 1895(b)(1)(B) of the Act).
    (b) For 2007 and subsequent calendar years, in accordance with 
section 1895(b)(3)(B)(v) of the Act, 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.
    (c) For 2007 and subsequent calendar years, in accordance with 
section 1895(b)(3)(B)(v) of the Act, 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.

[80 FR 68717, Nov. 5, 2015]



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.

[65 FR 41212, July 3, 2000, as amended at 72 FR 69879, Aug. 29, 2007; 80 
FR 68717, Nov. 5, 2015]



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.

[[Page 188]]

    (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.
    (b) The outlier threshold for each case-mix group is the episode 
payment amount for that group, or 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-15 minute unit amount of each discipline by the number of 
15 minute units 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 2.5 
percent of total payment under home health PPS.
    (f) The total amount of outlier payments to a specific home health 
agency for a year may not exceed an amount equal to 10 percent of the 
total payments to the specific agency under home health PPS for the 
year.

[65 FR 41212, July 3, 2000, as amended at 72 FR 69879, Aug. 29, 2007; 80 
FR 68717, Nov. 5, 2015; 81 FR 76796, Nov. 3, 2016]



Sec. 484.245  [Reserved]



Sec. 484.250  Patient assessment data.

    (a) Data submission. An HHA must submit the following data to CMS:
    (1) The OASIS data described at Sec. 484.55(b)(1) and (d)(1) for CMS 
to administer the payment rate methodologies described in Secs. 484.215, 
484.230, and 484.235, and to meet the quality reporting requirements of 
section 1895(b)(3)(B)(v) of the Act.
    (2) The Home Health Care CAHPS survey data for CMS to administer the 
payment rate methodologies described in Sec. 484.225(c), and to meet the 
quality reporting requirements of section 1895(b)(3)(B)(v) of the Act.
    (b) Patient count. An HHA that has less than 60 eligible unique 
HHCAHPS patients annually must annually submit to CMS their total 
HHCAHPS patient count to CMS to be exempt from the HHCAHPS reporting 
requirements for a calendar year period.
    (c) Survey requirements. An HHA must contract with an approved, 
independent HHCAHPS survey vendor to administer the HHCAHPS Survey on 
its behalf.
    (1) CMS approves an HHCAHPS survey vendor if such applicant has been 
in business for a minimum of 3 years and has conducted surveys of 
individuals and samples for at least 2 years.
    (i) For HHCAHPS, a ``survey of individuals'' is defined as the 
collection of data from at least 600 individuals selected by statistical 
sampling methods and the data collected are used for statistical 
purposes.
    (ii) All applicants that meet these requirements will be approved by 
CMS.
    (2) No organization, firm, or business that owns, operates, or 
provides staffing for a HHA is permitted to administer its own Home 
Health Care CAHPS (HHCAHPS) Survey or administer the survey on behalf of 
any other HHA in the capacity as an HHCAHPS survey vendor. Such 
organizations will not be approved by CMS as HHCAHPS survey vendors.
    (3) Approved HHCAHPS survey vendors must fully comply with all 
HHCAHPS oversight activities, including allowing CMS and its HHCAHPS 
program team to perform site visits at the vendors' company locations.

[76 FR 68606, Nov. 4, 2011, as amended at 77 FR 67164, Nov. 8, 2012; 79 
FR 66118, Nov. 6, 2014; 80 FR 68718, Nov. 5, 2015]



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,

[[Page 189]]

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]



 Subpart F_Home Health Value-Based Purchasing (HHVBP) Model Components 
       for Competing Home Health Agencies Within State Boundaries

    Source: 80 FR 68718, Nov. 5, 2015, unless otherwise noted.



Sec. 484.300  Basis and scope of subpart.

    This subpart is established under sections 1102, 1115A, and 1871 of 
the Act (42 U.S.C. 1315a), which authorizes the Secretary to issue 
regulations to operate the Medicare program and test innovative payment 
and service delivery models to improve coordination, quality, and 
efficiency of health care services furnished under Title XVIII.



Sec. 484.305  Definitions.

    As used in this subpart--
    Applicable measure means a measure for which the competing HHA has 
provided 20 home health episodes of care per year.
    Applicable percent means a maximum upward or downward adjustment for 
a given performance year, not to exceed the following:
    (1) For CY 2018, 3-percent.
    (2) For CY 2019, 5-percent.
    (3) For CY 2020, 6-percent.
    (4) For CY 2021, 7-percent.
    (5) For CY 2022, 8-percent.
    Benchmark refers to the mean of the top decile of Medicare-certified 
HHA performance on the specified quality measure during the baseline 
period, calculated for each state.
    Competing home health agency or agencies means an agency or 
agencies:
    (1) That has or have a current Medicare certification; and,
    (2) Is or are being paid by CMS for home health care delivered 
within any of the states specified in Sec. 484.310.
    Home health prospective payment system (HH PPS) refers to the basis 
of payment for home health agencies as set forth in Secs. 484.200 
through 484.245.
    Larger-volume cohort means the group of competing home health 
agencies within the boundaries of selected states that are participating 
in HHCAHPs in accordance with Sec. 484.250.
    Linear exchange function is the means to translate a competing HHA's 
Total Performance Score into a value-based payment adjustment 
percentage.
    New measures means those measures to be reported by competing HHAs 
under the HHVBP Model that are not otherwise reported by Medicare-
certified HHAs to CMS and were identified to fill gaps to cover National 
Quality Strategy Domains not completely covered by existing measures in 
the home health setting.
    Payment adjustment means the amount by which a competing HHA's final 
claim payment amount under the HH PPS is changed in accordance with the 
methodology described in Sec. 484.325.
    Performance period means the time period during which data are 
collected for the purpose of calculating a competing HHA's performance 
on measures.
    Selected state(s) means those nine states that were randomly 
selected to compete/participate in the HHVBP Model via a computer 
algorithm designed for random selection and identified at 
Sec. 484.310(b).
    Smaller-volume cohort means the group of competing home health 
agencies within the boundaries of selected states that are exempt from 
participation in HHCAHPs in accordance with Sec. 484.250.
    Total Performance Score means the numeric score ranging from 0 to 
100 awarded to each competing HHA based on its performance under the 
HHVBP Model.
    Value-based purchasing means measuring, reporting, and rewarding 
excellence in health care delivery that takes into consideration 
quality, efficiency, and alignment of incentives. Effective

[[Page 190]]

health care services and high performing health care providers may be 
rewarded with improved reputations through public reporting, enhanced 
payments through differential reimbursements, and increased market share 
through purchaser, payer, and/or consumer selection.

[80 FR 68718, Nov. 5, 2015, as amended at 81 FR 76796, Nov. 3, 2016]



Sec. 484.310  Applicability of the Home Health Value-Based Purchasing
(HHVBP) Model.

    (a) General rule. The HHVBP Model applies to all Medicare-certified 
home health agencies (HHAs) in selected states.
    (b) Selected states. Nine states have been selected in accordance 
with CMS's selection methodology. All Medicare-certified HHAs that 
provide services in Massachusetts, Maryland, North Carolina, Florida, 
Washington, Arizona, Iowa, Nebraska, and Tennessee will be required to 
compete in this model.



Sec. 484.315  Data reporting for measures and evaluation under the
Home Health Value-Based Purchasing (HHVBP) Model.

    (a) Competing home health agencies will be evaluated using a set of 
quality measures.
    (b) Competing home health agencies in selected states will be 
required to report information on New Measures, as determined 
appropriate by the Secretary, to CMS in the form, manner, and at a time 
specified by the Secretary.
    (c) Competing home health agencies in selected states will be 
required to collect and report such information as the Secretary 
determines is necessary for purposes of monitoring and evaluating the 
HHVBP Model under section 1115A(b)(4) of the Act (42 U.S.C. 1315a).

[80 FR 68718, Nov. 5, 2015, as amended at 81 FR 76796, Nov. 3, 2016]



Sec. 484.320  Calculation of the Total Performance Score.

    A competing home health agency's Total Performance Score for a model 
year is calculated as follows:
    (a) CMS will award points to the competing home health agency for 
performance on each of the applicable measures excluding the New 
Measures.
    (b) CMS will award points to the competing home health agency for 
reporting on each of the New Measures worth up to ten percent of the 
Total Performance Score.
    (c) CMS will sum all points awarded for each applicable measure 
excluding the New Measures weighted equally at the individual measure 
level, to calculate a value worth 90-percent of the Total Performance 
Score.
    (d) The sum of the points awarded to a competing HHA for each 
applicable measure and the points awarded to a competing HHA for 
reporting data on each New Measure is the competing HHA's Total 
Performance Score for the calendar year.

[80 FR 68718, Nov. 5, 2015, as amended at 81 FR 76796, Nov. 3, 2016]



Sec. 484.325  Payments for home health services under Home Health
Value-Based Purchasing (HHVBP) Model.

    CMS will determine a payment adjustment up to the maximum applicable 
percentage, upward or downward, under the HHVBP Model for each competing 
home health agency based on the agency's Total Performance Score using a 
linear exchange function. Payment adjustments made under the HHVBP Model 
will be calculated as a percentage of otherwise-applicable payments for 
home health services provided under section 1895 of the Act (42 U.S.C. 
1395fff).



Sec. 484.330  Process for determining and applying the value-based 
payment adjustment under the Home Health Value-Based Purchasing 
(HHVBP) Model.

    (a) General. Competing home health agencies will be ranked within 
the larger-volume and smaller-volume cohorts in selected states based on 
the performance standards that apply to the HHVBP Model for the baseline 
year, and CMS will make value-based payment adjustments to the competing 
HHAs as specified in this section.
    (b) Calculation of the value-based payment adjustment amount. The 
value-based payment adjustment amount is calculated by multiplying the 
Home Health Prospective Payment final

[[Page 191]]

claim payment amount as calculated in accordance with Sec. 484.205 by 
the payment adjustment percentage.
    (c) Calculation of the payment adjustment percentage. The payment 
adjustment percentage is calculated as the product of: The applicable 
percent as defined in Sec. 484.320, the competing HHA's Total 
Performance Score divided by 100, and the linear exchange function 
slope.



Sec. 484.335  Appeals process for the Home Health Value-Based
Purchasing (HHVBP) Model.

    (a) Requests for recalculation--(1) Matters for recalculation. 
Subject to the limitations on review under section 1115A of the Act, a 
HHA may submit a request for recalculation under this section if it 
wishes to dispute the calculation of the following:
    (i) Interim performance scores.
    (ii) Annual total performance scores.
    (iii) Application of the formula to calculate annual payment 
adjustment percentages.
    (2) Time for filing a request for recalculation. A recalculation 
request must be submitted in writing within 15 calendar days after CMS 
posts the HHA-specific information on the HHVBP Secure Portal, in a time 
and manner specified by CMS.
    (3) Content of request. (i) The provider's name, address associated 
with the services delivered, and CMS Certification Number (CCN).
    (ii) The basis for requesting recalculation to include the specific 
quality measure data that the HHA believes is inaccurate or the 
calculation the HHA believes is incorrect.
    (iii) Contact information for a person at the HHA with whom CMS or 
its agent can communicate about this request, including name, email 
address, telephone number, and mailing address (must include physical 
address, not just a post office box).
    (iv) The HHA may include in the request for recalculation additional 
documentary evidence that CMS should consider. Such documents may not 
include data that was to have been filed by the applicable data 
submission deadline, but may include evidence of timely submission.
    (4) Scope of review for recalculation. In conducting the 
recalculation, CMS will review the applicable measures and performance 
scores, the evidence and findings upon which the determination was 
based, and any additional documentary evidence submitted by the home 
health agency. CMS may also review any other evidence it believes to be 
relevant to the recalculation.
    (5) Recalculation decision. CMS will issue a written notification of 
findings. A recalculation decision is subject to the request for 
reconsideration process in accordance with paragraph (b) of this 
section.
    (b) Requests for reconsideration--(1) Matters for reconsideration. A 
home health agency may request reconsideration of the recalculation of 
its annual total performance score and payment adjustment percentage 
following a decision on the home health agency's recalculation request 
submitted under paragraph (a) of this section, or the decision to deny 
the recalculation request submitted under paragraph (a) of this section.
    (2) Time for filing a request for reconsideration. The request for 
reconsideration must be submitted via the HHVBP Secure Portal within 15 
calendar days from CMS' notification to the HHA contact of the outcome 
of the recalculation process.
    (3) Content of request. (i) The name of the HHA, address associated 
with the services delivered, and CMS Certification Number (CCN).
    (ii) The basis for requesting reconsideration to include the 
specific quality measure data that the HHA believes is inaccurate or the 
calculation the HHA believes is incorrect.
    (iii) Contact information for a person at the HHA with whom CMS or 
its agent can communicate about this request, including name, email 
address, telephone number, and mailing address (must include physical 
address, not just a post office box).
    (iv) The HHA may include in the request for reconsideration 
additional documentary evidence that CMS should consider. Such documents 
may not include data that was to have been filed by the applicable data 
submission deadline, but may include evidence of timely submission.

[[Page 192]]

    (4) Scope of review for reconsideration. In conducting the 
reconsideration review, CMS will review the applicable measures and 
performance scores, the evidence and findings upon which the 
determination was based, and any additional documentary evidence 
submitted by the HHA. CMS may also review any other evidence it believes 
to be relevant to the reconsideration. The HHA must prove its case by a 
preponderance of the evidence with respect to issues of fact.
    (5) Reconsideration decision. CMS reconsideration officials will 
issue a written determination.

[81 FR 76796, Nov. 3, 2016]



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  [Reserved]
485.66  Condition of participation: Utilization review plan.
485.68  Condition of participation: Emergency preparedness.
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.
485.603  Rural health network.
485.604  Personnel qualifications.
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.
485.625  Condition of participation: Emergency preparedness.
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.

[[Page 193]]

485.723  Condition of participation: Physical environment.
485.725  Condition of participation: Infection control.
485.727  Condition of participation: Emergency preparedness.
485.729  Condition of participation: Program evaluation.

Subpart I [Reserved]

 Subpart J_Conditions of Participation: Community Mental Health Centers 
                                 (CMHCs)

485.900  Basis and scope.
485.902  Definitions.
485.904  Condition of participation: Personnel qualifications.
485.910  Condition of participation: Client rights.
485.914  Condition of participation: Admission, initial evaluation, 
          comprehensive assessment, and discharge or transfer of the 
          client.
485.916  Condition of participation: Treatment team, person-centered 
          active treatment plan, and coordination of services.
485.917  Condition of participation: Quality assessment and performance 
          improvement.
485.918  Condition of participation: Organization, governance, 
          administration of services, and partial hospitalization 
          services.
485.920  Condition of participation: Emergency preparedness.

    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]



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--

[[Page 194]]

    (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 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

[[Page 195]]

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 Secs. 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 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.

[[Page 196]]

    (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 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]

    Effective Date Note: At 82 FR 4591, Jan. 13, 2017, Sec. 485.58 
introductory text was amended by removing ``and 484.4'' and adding in 
its place ``and 484.115'', effective July 13, 2017. At 82 FR 31729, July 
10, 2017, this amendment was delayed until Jan. 13, 2018.



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

[[Page 197]]

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.
    (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 manner 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

[[Page 198]]

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  [Reserved]



Sec. 485.66  Condition of participation: Utilization review plan.

    The facility must have in effect a written utilization review plan 
that is 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. 485.68  Condition of participation: Emergency preparedness.

    The Comprehensive Outpatient Rehabilitation Facility (CORF) must 
comply with all applicable Federal, State, and local emergency 
preparedness requirements. The CORF must establish and maintain an 
emergency preparedness program that meets the requirements of this 
section. The emergency preparedness program must include, but not be 
limited to, the following elements:
    (a) Emergency plan. The CORF must develop and maintain an emergency 
preparedness plan that must be reviewed and updated at least annually. 
The plan must do all of the following:
    (1) Be based on and include a documented, facility-based and 
community-based risk assessment, utilizing an all-hazards approach.
    (2) Include strategies for addressing emergency events identified by 
the risk assessment.
    (3) Address patient population, including, but not limited to, the 
type of services the CORF has the ability to provide in an emergency; 
and continuity of operations, including delegations of authority and 
succession plans.
    (4) Include a process for cooperation and collaboration with local, 
tribal, regional, State, and Federal emergency preparedness officials' 
efforts to maintain an integrated response during a

[[Page 199]]

disaster or emergency situation, including documentation of the CORF's 
efforts to contact such officials and, when applicable, of its 
participation in collaborative and cooperative planning efforts;
    (5) Be developed and maintained with assistance from fire, safety, 
and other appropriate experts.
    (b) Policies and procedures. The CORF must develop and implement 
emergency preparedness policies and procedures, based on the emergency 
plan set forth in paragraph (a) of this section, risk assessment at 
paragraph (a)(1) of this section, and the communication plan at 
paragraph (c) of this section. The policies and procedures must be 
reviewed and updated at least annually. At a minimum, the policies and 
procedures must address the following:
    (1) Safe evacuation from the CORF, which includes staff 
responsibilities, and needs of the patients.
    (2) A means to shelter in place for patients, staff, and volunteers 
who remain in the facility.
    (3) A system of medical documentation that preserves patient 
information, protects confidentiality of patient information, and 
secures and maintains the availability of records.
    (4) The use of volunteers in an emergency and other emergency 
staffing strategies, including the process and role for integration of 
State or Federally designated health care professionals to address surge 
needs during an emergency.
    (c) Communication plan. The CORF must develop and maintain an 
emergency preparedness communication plan that complies with Federal, 
State, and local laws and must be reviewed and updated at least 
annually. The communication plan must include all of the following:
    (1) Names and contact information for the following:
    (i) Staff.
    (ii) Entities providing services under arrangement.
    (iii) Patients' physicians.
    (iv) Other CORFs.
    (v) Volunteers.
    (2) Contact information for the following:
    (i) Federal, State, tribal, regional and local emergency 
preparedness staff.
    (ii) Other sources of assistance.
    (3) Primary and alternate means for communicating with the CORF's 
staff, Federal, State, tribal, regional, and local emergency management 
agencies.
    (4) A method for sharing information and medical documentation for 
patients under the CORF's care, as necessary, with other health care 
providers to maintain the continuity of care.
    (5) A means of providing information about the CORF's needs, and its 
ability to provide assistance, to the authority having jurisdiction or 
the Incident Command Center, or designee.
    (d) Training and testing. The CORF must develop and maintain an 
emergency preparedness training and testing program that is based on the 
emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program must be 
reviewed and updated at least annually.
    (1) Training program. The CORF must do all of the following:
    (i) Provide initial training in emergency preparedness policies and 
procedures to all new and existing staff, individuals providing services 
under arrangement, and volunteers, consistent with their expected roles.
    (ii) Provide emergency preparedness training at least annually.
    (iii) Maintain documentation of the training.
    (iv) Demonstrate staff knowledge of emergency procedures. All new 
personnel must be oriented and assigned specific responsibilities 
regarding the CORF's emergency plan within 2 weeks of their first 
workday. The training program must include instruction in the location 
and use of alarm systems and signals and firefighting equipment.
    (2) Testing. The CORF must conduct exercises to test the emergency 
plan at least annually. The CORF must do the following:
    (i) Participate in a full-scale exercise that is community-based or 
when a

[[Page 200]]

community-based exercise is not accessible, an individual, facility-
based. If the CORF experiences an actual natural or man-made emergency 
that requires activation of the emergency plan, the CORF is exempt from 
engaging in a community-based or individual, facility-based full-scale 
exercise for 1 year following the onset of the actual event.
    (ii) Conduct an additional exercise that may include, but is not 
limited to the following:
    (A) A second full-scale exercise that is community-based or 
individual, facility-based.
    (B) A tabletop exercise that includes a group discussion led by a 
facilitator, using a narrated, clinically-relevant emergency scenario, 
and a set of problem statements, directed messages, or prepared 
questions designed to challenge an emergency plan.
    (iii) Analyze the CORF's response to and maintain documentation of 
all drills, tabletop exercises, and emergency events, and revise the 
CORF's emergency plan, as needed.
    (e) Integrated healthcare systems. If a CORF is part of a healthcare 
system consisting of multiple separately certified healthcare facilities 
that elects to have a unified and integrated emergency preparedness 
program, the CORF may choose to participate in the healthcare system's 
coordinated emergency preparedness program. If elected, the unified and 
integrated emergency preparedness program must do all of the following:
    (1) Demonstrate that each separately certified facility within the 
system actively participated in the development of the unified and 
integrated emergency preparedness program.
    (2) Be developed and maintained in a manner that takes into account 
each separately certified facility's unique circumstances, patient 
populations, and services offered.
    (3) Demonstrate that each separately certified facility is capable 
of actively using the unified and integrated emergency preparedness 
program and is in compliance with the program.
    (4) Include a unified and integrated emergency plan that meets the 
requirements of paragraphs (a)(2), (3), and (4) of this section. The 
unified and integrated emergency plan must also be based on and include 
the following:
    (i) A documented community-based risk assessment, utilizing an all-
hazards approach.
    (ii) A documented individual facility-based risk assessment for each 
separately certified facility within the health system, utilizing an 
all-hazards approach.
    (5) Include integrated policies and procedures that meet the 
requirements set forth in paragraph (b) of this section, a coordinated 
communication plan and training and testing programs that meet the 
requirements of paragraphs (c) and (d) of this section, respectively.

[81 FR 64035, Sept. 16, 2016]



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.

[[Page 201]]

    (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 complete one the following 
criteria:
    (1) Criterion 1. All of the following must be completed:
    (i) Be licensed by the State in which practicing, if applicable.
    (ii) Have successfully completed a nationally-accredited educational 
program for respiratory therapists.
    (iii)(A) Be eligible to take the registry examination administered 
by the National Board for Respiratory Care for respiratory therapists; 
or
    (B) Have passed the registry examination administered by the 
National Board for Respiratory Care for respiratory therapists.
    (2) Criterion 2: All of the following must be completed:
    (i) Be licensed by the State in which practicing, if applicable.
    (ii) Have equivalent training and experience as determined by the 
National Board for Respiratory Care.
    (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; 74 FR 62014, Nov. 
25, 2009]

    Effective Date Note: At 82 FR 4591, Jan. 13, 2017, Sec. 485.70(c) 
and (e) was amended by removing ``Sec. 484.4'' and adding in its place 
``Sec. 484.115'', effective July 13, 2017. At 82 FR 31729, July 10, 
2017, this amendment was delayed until Jan. 13, 2018.



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]

[[Page 202]]



 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. 485.603  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
    (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--
    (1) Is a registered nurse and is licensed to practice nursing in the 
State in which the clinical nurse specialist services are performed in 
accordance with State nurse licensing laws and regulations; and
    (2) Holds a master's or doctoral level degree in a defined clinical 
area of nursing from an accredited educational institution.
    (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.

[[Page 203]]

    (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; 77 
FR 29076, May 16, 2012]



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. 482.58 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 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; 79 
FR 27155, May 12, 2014]



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

[[Page 204]]

    (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) of this 
section or the requirements of paragraph (b)(3), (b)(4), or (b)(5) 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 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.
    (5) Effective on or after October 1, 2014, for a period of 2 years 
beginning with the effective date of the most recent Office of 
Management and Budget (OMB) standards for delineating statistical areas 
adopted by CMS, the CAH no longer meets the location requirements in 
either paragraph (b)(1) or (b)(2) of this section and is located in a 
county that, prior to the most recent OMB standards for delineating 
statistical areas adopted by CMS and the most recent Census Bureau data, 
was located in a rural area as defined by OMB, but under the most recent 
OMB standards for delineating statistical areas adopted by CMS and the 
most recent Census Bureau data, is located in an urban area.
    (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

[[Page 205]]

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 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; 75 FR 50418, Aug. 16, 2010; 79 FR 50359, Aug. 22, 2014]



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

[[Page 206]]

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.
    (c) Standard: Agreements for credentialing and privileging of 
telemedicine physicians and practitioners. (1) The governing body of the 
CAH must ensure that, when telemedicine services are furnished to the 
CAH's patients through an agreement with a distant-site hospital, the 
agreement is written and specifies that it is the responsibility of the 
governing body of the distant-site hospital to meet the following 
requirements with regard to its physicians or practitioners providing 
telemedicine services:
    (i) Determine, in accordance with State law, which categories of 
practitioners are eligible candidates for appointment to the medical 
staff.
    (ii) Appoint members of the medical staff after considering the 
recommendations of the existing members of the medical staff.
    (iii) Assure that the medical staff has bylaws.
    (iv) Approve medical staff bylaws and other medical staff rules and 
regulations.
    (v) Ensure that the medical staff is accountable to the governing 
body for the quality of care provided to patients.
    (vi) Ensure the criteria for selection are individual character, 
competence, training, experience, and judgment.
    (vii) 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.
    (2) When telemedicine services are furnished to the CAH's patients 
through an agreement with a distant-site hospital, the CAH's governing 
body or responsible individual may choose to rely upon the credentialing 
and privileging decisions made by the governing body of the distant-site 
hospital regarding individual distant-site physicians or practitioners. 
The CAH's governing body or responsible individual must ensure, through 
its written agreement with the distant-site hospital, that the following 
provisions are met:
    (i) The distant-site hospital providing telemedicine services is a 
Medicare-participating hospital.
    (ii) The individual distant-site physician or practitioner is 
privileged at the distant-site hospital providing the telemedicine 
services, which provides a current list of the distant-site physician's 
or practitioner's privileges at the distant-site hospital;
    (iii) The individual distant-site physician or practitioner holds a 
license issued or recognized by the State in which the CAH is located; 
and
    (iv) With respect to a distant-site physician or practitioner, who 
holds current privileges at the CAH whose patients are receiving the 
telemedicine services, the CAH has evidence of an internal review of the 
distant-site physician's or practitioner's performance of these 
privileges and sends the distant-site hospital such information for use 
in the periodic appraisal of the individual distant-site physician or 
practitioner. At a minimum, this information must include all adverse 
events that result from the telemedicine services provided by the 
distant-site physician or practitioner to the CAH's patients and all 
complaints the CAH has received about the distant-site physician or 
practitioner.
    (3) The governing body of the CAH must ensure that when telemedicine 
services are furnished to the CAH's patients through an agreement with a 
distant-site telemedicine entity, the agreement is written and specifies 
that the distant-site telemedicine entity is a contractor of services to 
the CAH and as such, in accordance with

[[Page 207]]

Sec. 485.635(c)(4)(ii), furnishes the contracted services in a manner 
that enables the CAH to comply with all applicable conditions of 
participation for the contracted services, including, but not limited 
to, the requirements in this section with regard to its physicians and 
practitioners providing telemedicine services.
    (4) When telemedicine services are furnished to the CAH's patients 
through an agreement with a distant-site telemedicine entity, the CAH's 
governing body or responsible individual may choose to rely upon the 
credentialing and privileging decisions made by the governing body of 
the distant-site telemedicine entity regarding individual distant-site 
physicians or practitioners. The CAH's governing body or responsible 
individual must ensure, through its written agreement with the distant-
site telemedicine entity, that the following provisions are met:
    (i) The distant-site telemedicine entity's medical staff 
credentialing and privileging process and standards at least meet the 
standards at paragraphs (c)(1)(i) through (c)(1)(vii) of this section.
    (ii) The individual distant-site physician or practitioner is 
privileged at the distant-site telemedicine entity providing the 
telemedicine services, which provides a current list to the CAH of the 
distant-site physician's or practitioner's privileges at the distant-
site telemedicine entity.
    (iii) The individual distant-site physician or practitioner holds a 
license issued or recognized by the State in which the CAH whose 
patients are receiving the telemedicine services is located.
    (iv) With respect to a distant-site physician or practitioner, who 
holds current privileges at the CAH whose patients are receiving the 
telemedicine services, the CAH has evidence of an internal review of the 
distant-site physician's or practitioner's performance of these 
privileges and sends the distant-site telemedicine entity such 
information for use in the periodic appraisal of the distant-site 
physician or practitioner. At a minimum, this information must include 
all adverse events that result from the telemedicine services provided 
by the distant-site physician or practitioner to the CAH's patients and 
all complaints the CAH has received about the distant-site physician or 
practitioner.

[62 FR 46036, Aug. 29, 1997, as amended at 76 FR 25564, May 5, 2011]



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 208]]

    (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 209]]

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. Inpatient beds may 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; 78 FR 50970, Aug. 
19, 2013]



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 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: Life safety from fire. (1) Except as otherwise 
provided in this section--
    (i) The CAH must meet the applicable provisions and must proceed in 
accordance with the Life Safety Code (NFPA 101 and Tentative Interim 
Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4.)
    (ii) Notwithstanding paragraph (d)(1)(i) of this section, corridor 
doors and doors to rooms containing flammable or combustible materials 
must be provided with positive latching hardware. Roller latches are 
prohibited on such doors.
    (2) In consideration of a recommendation by the State survey agency 
or Accrediting Organization or at the discretion of the Secretary, may 
waive, for periods deemed appropriate, specific provisions of the Life 
Safety Code, which would result in unreasonable hardship upon a CAH, but 
only if the waiver will not adversely affect the health and safety of 
the patients.
    (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.
    (4) The CAH maintains written evidence of regular inspection and 
approval by State or local fire control agencies.
    (5) A CAH may install alcohol-based hand rub dispensers in its 
facility if the dispensers are installed in a manner that adequately 
protects against inappropriate access.
    (6) When a sprinkler system is shut down for more than 10 hours, the 
CAH must:
    (i) Evacuate the building or portion of the building affected by the 
system outage until the system is back in service, or
    (ii) Establish a fire watch until the system is back in service.
    (7) Buildings must have an outside window or outside door in every 
sleeping room, and for any building constructed after July 5, 2016 the 
sill height must not exceed 36 inches above the floor. Windows in atrium 
walls are considered outside windows for the purposes of this 
requirement.
    (i) The sill height requirement does not apply to newborn nurseries 
and rooms intended for occupancy for less than 24 hours.
    (ii) Special nursing care areas of new occupancies shall not exceed 
60 inches.
    (d) Standard: Building safety. Except as otherwise provided in this 
section, the CAH must meet the applicable provisions and must proceed in 
accordance with the Health Care Facilities Code

[[Page 210]]

(NFPA 99 and Tentative Interim Amendments TIA 12-2, TIA 12-3, TIA 12-4, 
TIA 12-5 and TIA 12-6).
    (1) Chapters 7, 8, 12, and 13 of the adopted Health Care Facilities 
Code do not apply to a CAH.
    (2) If application of the Health Care Facilities Code required under 
paragraph (e) of this section would result in unreasonable hardship for 
the CAH, CMS may waive specific provisions of the Health Care Facilities 
Code, but only if the waiver does not adversely affect the health and 
safety of patients.
    (e) The standards incorporated by reference in this section are 
approved for incorporation by reference by the Director of the Office of 
the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 
51. You may inspect a copy 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. If any changes in this edition of the Code are 
incorporated by reference, CMS will publish a document in the Federal 
Register to announce the changes.
    (1) National Fire Protection Association, 1 Batterymarch Park, 
Quincy, MA 02169, www.nfpa.org, 1.617.770.3000.
    (i) NFPA 99, Standards for Health Care Facilities Code of the 
National Fire Protection Association 99, 2012 edition, issued August 11, 
2011.
    (ii) TIA 12-2 to NFPA 99, issued August 11, 2011.
    (iii) TIA 12-3 to NFPA 99, issued August 9, 2012.
    (iv) TIA 12-4 to NFPA 99, issued March 7, 2013.
    (v) TIA 12-5 to NFPA 99, issued August 1, 2013.
    (vi) TIA 12-6 to NFPA 99, issued March 3, 2014.
    (vii) NFPA 101, Life Safety Code, 2012 edition, issued August 11, 
2011;
    (viii) TIA 12-1 to NFPA 101, issued August 11, 2011.
    (ix) TIA 12-2 to NFPA 101, issued October 30, 2012.
    (x) TIA 12-3 to NFPA 101, issued October 22, 2013.
    (xi) TIA 12-4 to NFPA 101, issued October 22, 2013.
    (2) [Reserved]

[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; 77 FR 29076, May 16, 
2012; 81 FR 26901, May 4, 2016; 81 FR 64036, Sept. 16, 2016]



Sec. 485.625  Condition of participation: Emergency preparedness.

    The CAH must comply with all applicable Federal, State, and local 
emergency preparedness requirements. The CAH must develop and maintain a 
comprehensive emergency preparedness program, utilizing an all-hazards 
approach. The emergency preparedness plan must include, but not be 
limited to, the following elements:
    (a) Emergency plan. The CAH must develop and maintain an emergency 
preparedness plan that must be reviewed and updated at least annually. 
The plan must do all of the following:
    (1) Be based on and include a documented, facility-based and 
community-based risk assessment, utilizing an all-hazards approach.
    (2) Include strategies for addressing emergency events identified by 
the risk assessment.
    (3) Address patient population, including, but not limited to, 
persons at-risk; the type of services the CAH has the ability to provide 
in an emergency; and continuity of operations, including delegations of 
authority and succession plans.
    (4) Include a process for cooperation and collaboration with local, 
tribal, regional, State, and Federal emergency preparedness officials' 
efforts to maintain an integrated response during a disaster or 
emergency situation, including documentation of the CAH's efforts to 
contact such officials and, when applicable, of its participation in 
collaborative and cooperative planning efforts.
    (b) Policies and procedures. The CAH must develop and implement 
emergency preparedness policies and procedures, based on the emergency 
plan set forth in paragraph (a) of this section, risk assessment at 
paragraph (a)(1) of this section, and the communication plan at 
paragraph (c) of this section.

[[Page 211]]

The policies and procedures must be reviewed and updated at least 
annually. At a minimum, the policies and procedures must address the 
following:
    (1) The provision of subsistence needs for staff and patients, 
whether they evacuate or shelter in place, include, but are not limited 
to--
    (i) Food, water, medical, and pharmaceutical supplies;
    (ii) Alternate sources of energy to maintain:
    (A) Temperatures to protect patient health and safety and for the 
safe and sanitary storage of provisions;
    (B) Emergency lighting;
    (C) Fire detection, extinguishing, and alarm systems; and
    (D) Sewage and waste disposal.
    (2) A system to track the location of on-duty staff and sheltered 
patients in the CAH's care during an emergency. If on-duty staff and 
sheltered patients are relocated during the emergency, the CAH must 
document the specific name and location of the receiving facility or 
other location.
    (3) Safe evacuation from the CAH, which includes consideration of 
care and treatment needs of evacuees; staff responsibilities; 
transportation; identification of evacuation location(s); and primary 
and alternate means of communication with external sources of 
assistance.
    (4) A means to shelter in place for patients, staff, and volunteers 
who remain in the facility.
    (5) A system of medical documentation that preserves patient 
information, protects confidentiality of patient information, and 
secures and maintains the availability of records.
    (6) The use of volunteers in an emergency or other emergency 
staffing strategies, including the process and role for integration of 
State or Federally designated health care professionals to address surge 
needs during an emergency.
    (7) The development of arrangements with other CAHs or other 
providers to receive patients in the event of limitations or cessation 
of operations to maintain the continuity of services to CAH patients.
    (8) The role of the CAH under a waiver declared by the Secretary, in 
accordance with section 1135 of the Act, in the provision of care and 
treatment at an alternate care site identified by emergency management 
officials.
    (c) Communication plan. The CAH must develop and maintain an 
emergency preparedness communication plan that complies with Federal, 
State, and local laws and must be reviewed and updated at least 
annually. The communication plan must include all of the following:
    (1) Names and contact information for the following:
    (i) Staff.
    (ii) Entities providing services under arrangement.
    (iii) Patients' physicians.
    (iv) Other CAHs and hospitals.
    (v) Volunteers.
    (2) Contact information for the following:
    (i) Federal, State, tribal, regional, and local emergency 
preparedness staff.
    (ii) Other sources of assistance.
    (3) Primary and alternate means for communicating with the 
following:
    (i) CAH's staff.
    (ii) Federal, State, tribal, regional, and local emergency 
management agencies.
    (4) A method for sharing information and medical documentation for 
patients under the CAH's care, as necessary, with other health care 
providers to maintain the continuity of care.
    (5) A means, in the event of an evacuation, to release patient 
information as permitted under 45 CFR 164.510(b)(1)(ii).
    (6) A means of providing information about the general condition and 
location of patients under the facility's care as permitted under 45 CFR 
164.510(b)(4).
    (7) A means of providing information about the CAH's occupancy, 
needs, and its ability to provide assistance, to the authority having 
jurisdiction or the Incident Command Center, or designee.
    (d) Training and testing. The CAH must develop and maintain an 
emergency preparedness training and testing program that is based on the 
emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at

[[Page 212]]

paragraph (c) of this section. The training and testing program must be 
reviewed and updated at least annually.
    (1) Training program. The CAH must do all of the following:
    (i) Initial training in emergency preparedness policies and 
procedures, including prompt reporting and extinguishing of fires, 
protection, and where necessary, evacuation of patients, personnel, and 
guests, fire prevention, and cooperation with firefighting and disaster 
authorities, to all new and existing staff, individuals providing 
services under arrangement, and volunteers, consistent with their 
expected roles.
    (ii) Provide emergency preparedness training at least annually.
    (iii) Maintain documentation of the training.
    (iv) Demonstrate staff knowledge of emergency procedures.
    (2) Testing. The CAH must conduct exercises to test the emergency 
plan at least annually. The CAH must do the following:
    (i) Participate in a full-scale exercise that is community-based or 
when a community-based exercise is not accessible, an individual, 
facility-based exercise. If the CAH experiences an actual natural or 
man-made emergency that requires activation of the emergency plan, the 
CAH is exempt from engaging in a community-based or individual, 
facility-based full-scale exercise for 1 year following the onset of the 
actual event.
    (ii) Conduct an additional exercise that may include, but is not 
limited to the following:
    (A) A second full-scale exercise that is community-based or 
individual, facility-based.
    (B) A tabletop exercise that includes a group discussion led by a 
facilitator, using a narrated, clinically-relevant emergency scenario, 
and a set of problem statements, directed messages, or prepared 
questions designed to challenge an emergency plan.
    (iii) Analyze the CAH's response to and maintain documentation of 
all drills, tabletop exercises, and emergency events, and revise the 
CAH's emergency plan, as needed.
    (e) Emergency and standby power systems. The CAH must implement 
emergency and standby power systems based on the emergency plan set 
forth in paragraph (a) of this section.
    (1) Emergency generator location. The generator must be located in 
accordance with the location requirements found in the Health Care 
Facilities Code (NFPA 99 and Tentative Interim Amendments TIA 12-2, TIA 
12-3, TIA 12-4, TIA 12-5, and TIA 12-6), Life Safety Code (NFPA 101 and 
Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-
4), and NFPA 110, when a new structure is built or when an existing 
structure or building is renovated.
    (2) Emergency generator inspection and testing. The CAH must 
implement emergency power system inspection and testing requirements 
found in the Health Care Facilities Code, NFPA 110, and the Life Safety 
Code.
    (3) Emergency generator fuel. CAHs that maintain an onsite fuel 
source to power emergency generators must have a plan for how it will 
keep emergency power systems operational during the emergency, unless it 
evacuates.
    (f) Integrated healthcare systems. If a CAH is part of a healthcare 
system consisting of multiple separately certified healthcare facilities 
that elects to have a unified and integrated emergency preparedness 
program, the CAH may choose to participate in the healthcare system's 
coordinated emergency preparedness program. If elected, the unified and 
integrated emergency preparedness program must do all of the following:
    (1) Demonstrate that each separately certified facility within the 
system actively participated in the development of the unified and 
integrated emergency preparedness program.
    (2) Be developed and maintained in a manner that takes into account 
each separately certified facility's unique circumstances, patient 
populations, and services offered.
    (3) Demonstrate that each separately certified facility is capable 
of actively using the unified and integrated emergency preparedness 
program and is in compliance with the program.
    (4) Include a unified and integrated emergency plan that meets the 
requirements of paragraphs (a)(2), (3), and (4)

[[Page 213]]

of this section. The unified and integrated emergency plan must also be 
based on and include--
    (i) A documented community-based risk assessment, utilizing an all-
hazards approach.
    (ii) A documented individual facility-based risk assessment for each 
separately certified facility within the health system, utilizing an 
all-hazards approach.
    (5) Include integrated policies and procedures that meet the 
requirements set forth in paragraph (b) of this section, a coordinated 
communication plan and training and testing programs that meet the 
requirements of paragraphs (c) and (d) of this section, respectively.
    (g) The standards incorporated by reference in this section are 
approved for incorporation by reference by the Director of the Office of 
the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 
51. You may obtain the material from the sources listed below. You may 
inspect a copy 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. If any 
changes in this edition of the Code are incorporated by reference, CMS 
will publish a document in the Federal Register to announce the changes.
    (1) National Fire Protection Association, 1 Batterymarch Park, 
Quincy, MA 02169, www.nfpa.org, 1.617.770.3000.
    (i) NFPA 99, Health Care Facilities Code, 2012 edition, issued 
August 11, 2011.
    (ii) Technical interim amendment (TIA) 12-2 to NFPA 99, issued 
August 11, 2011.
    (iii) TIA 12-3 to NFPA 99, issued August 9, 2012.
    (iv) TIA 12-4 to NFPA 99, issued March 7, 2013.
    (v) TIA 12-5 to NFPA 99, issued August 1, 2013.
    (vi) TIA 12-6 to NFPA 99, issued March 3, 2014.
    (vii) NFPA 101, Life Safety Code, 2012 edition, issued August 11, 
2011.
    (viii) TIA 12-1 to NFPA 101, issued August 11, 2011.
    (ix) TIA 12-2 to NFPA 101, issued October 30, 2012.
    (x) TIA 12-3 to NFPA 101, issued October 22, 2013.
    (xi) TIA 12-4 to NFPA 101, issued October 22, 2013.
    (xii) NFPA 110, Standard for Emergency and Standby Power Systems, 
2010 edition, including TIAs to chapter 7, issued August 6, 2009.
    (2) [Reserved]

[81 FR 64036, Sept. 16, 2016; 81 FR 80594, Nov. 16, 2016]



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.

[[Page 214]]

    (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;
    (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 reviews and signs a sample of outpatient records of 
patients cared for by nurse practitioners, clinical nurse specialists, 
certified nurse midwives, or physician assistants only to the extent 
required under State law where State law requires 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 to provide medical direction, consultation, and 
supervision for the services provided in the CAH, and is available 
through direct radio or telephone communication or electronic 
communication for consultation, assistance with medical emergencies, or 
patient referral.
    (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; 79 FR 27155, May 12, 2014]



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 members of the 
CAH's professional healthcare staff, including 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).
    (3) The policies include the following: (i) A description of the 
services the CAH furnishes, including those furnished through agreement 
or arrangement.
    (ii) Policies and procedures for emergency medical services.

[[Page 215]]

    (iii) Guidelines for the medical management of health problems that 
include the conditions requiring medical consultation and/or patient 
referral, 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) 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(g) of this chapter 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: Patient services--(1) General: (i) The CAH provides 
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 CAH services include medical 
history, physical examination, specimen collection, assessment of health 
status, and treatment for a variety of medical conditions.
    (ii) The CAH furnishes acute care inpatient services.
    (2) Laboratory services. The CAH provides 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 the 
following:
    (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.
    (vi) Primary culturing for transmittal to a certified laboratory.
    (3) Radiology services. Radiology services furnished by the CAH are 
provided by personnel qualified under State law, and do not expose CAH 
patients or personnel to radiation hazards.
    (4) Emergency procedures. In accordance with requirements of 
Sec. 485.618, the CAH provides medical services 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) Services of doctors of medicine or osteopathy;
    (ii) Additional or specialized diagnostic and clinical laboratory 
services that are not available at the CAH; and
    (iii) 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:

[[Page 216]]

    (i) Services furnished in the CAH whether or not they are furnished 
under arrangements or agreements.
    (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.
    (5) In the case of distant-site physicians and practitioners 
providing telemedicine services to the CAH's patients under a written 
agreement between the CAH and a distant-site telemedicine entity, the 
distant-site telemedicine entity is not required to be a Medicare-
participating provider or supplier.
    (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.
    (f) Standard: Patient visitation rights. A CAH must have written 
policies and procedures regarding the visitation rights of patients, 
including those setting forth any clinically necessary or reasonable 
restriction or limitation that the CAH may need to place on such rights 
and the reasons for the clinical restriction or limitation. A CAH must 
meet the following requirements:
    (1) Inform each patient (or support person, where appropriate) of 
his or her visitation rights, including any clinical restriction or 
limitation on such rights, in advance of furnishing patient care 
whenever possible.
    (2) Inform each patient (or support person, where appropriate) of 
the right, subject to his or her consent, to receive the visitors whom 
he or she designates, including, but not limited to, a spouse, a 
domestic partner (including a same-sex domestic partner), another family 
member, or a friend, and his or her right to withdraw or deny such 
consent at any time.
    (3) Not restrict, limit, or otherwise deny visitation privileges on 
the basis of race, color, national origin, religion, sex, gender 
identity, sexual orientation, or disability.
    (4) Ensure that all visitors enjoy full and equal visitation 
privileges consistent with patient preferences.

[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; 75 FR 70844, Nov. 19, 2010; 
76 FR 25564, May 5, 2011; 77 FR 29076, May 16, 2012; 78 FR 50970, Aug. 
19, 2013; 79 FR 27156, May 12, 2014; 81 FR 68871, Oct. 4, 2016; 82 FR 
32260, July 13, 2017]



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--

[[Page 217]]

    (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.

    If a CAH provides surgical services, surgical procedures must be 
performed in a safe manner by qualified practitioners who have been 
granted clinical privileges by the governing body, or responsible 
individual, 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. 413.85 or Sec. 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

[[Page 218]]

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; 77 FR 29076, May 
16, 2012]



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;
    (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;
    (iii) One other appropriate and qualified entity identified in the 
State rural health care plan;
    (iv) In the case of distant-site physicians and practitioners 
providing telemedicine services to the CAH's patients under a written 
agreement between the CAH and a distant-site hospital, the distant-site 
hospital; or
    (v) In the case of distant-site physicians and practitioners 
providing telemedicine services to the CAH's patients under a written 
agreement between the CAH and a distant-site telemedicine entity, one of 
the entities listed in paragraphs (b)(4)(i) through (iii) of this 
section; 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; 76 FR 25564, May 5, 2011]

[[Page 219]]



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.
    (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

[[Page 220]]

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) Resident rights (Sec. 483.10(b)(7), (c)(1), (c)(2)(iii), (c)(6), 
(d), (e)(2), (e)(4), (f)(4)(ii), (f)(4)(iii), (f)(9), (g)(8), (g)(17), 
(g)(18) introductory text, (h) of this chapter).
    (2) Admission, transfer, and discharge rights (Sec. 483.5 definition 
of transfer & discharge, Sec. 483.15(c)(1), (c)(2), (c)(3), (c)(4), 
(c)(5), (c)(7), (c)(8), and (c)(9) of this chapter).
    (3) Freedom from abuse, neglect and exploitation (Sec. 483.12(a)(1), 
(a)(2), (a)(3)(i), (a)(3)(ii), (a)(4), (b)(1), (b)(2), (c)(1), (c)(2), 
(c)(3), and (c)(4) of this chapter).
    (4) Patient activities (Sec. 483.24(c) of this chapter), except that 
the services may be directed either by a qualified professional meeting 
the requirements of Sec. 483.24(c)(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. 483.40(d) and Sec. 483.70(p) of this 
chapter).
    (6) Comprehensive assessment, comprehensive care plan, and discharge 
planning (Sec. 483.20(b), and Sec. 483.21(b) and (c)(2) 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. 483.65 of this 
chapter).
    (8) Dental services (Sec. 483.55 of this chapter).
    (9) Nutrition (Sec. 483.25(g)(1) and (g)(2) 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; 81 FR 68871, Oct. 4, 
2016; 82 FR 32260, July 13, 2017]



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 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 Secs. 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]

[[Page 221]]

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.
    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

[[Page 222]]

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
    (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]

[[Page 223]]



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. 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.
    (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

[[Page 224]]

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;
    (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]

[[Page 225]]



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, 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, 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.

[[Page 226]]

    (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 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, 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.

[[Page 227]]

    (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, 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.
    (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: Emergency preparedness.

    The Clinics, Rehabilitation Agencies, and Public Health Agencies as 
Providers of Outpatient Physical Therapy and Speech-Language Pathology 
Services (``Organizations'') must comply with all applicable Federal, 
State, and local emergency preparedness requirements. The Organizations 
must establish and maintain an emergency preparedness program that meets 
the requirements of this section. The emergency preparedness program 
must include, but not be limited to, the following elements:
    (a) Emergency plan. The Organizations must develop and maintain an 
emergency preparedness plan that must be reviewed and updated at least 
annually. The plan must do all of the following:

[[Page 228]]

    (1) Be based on and include a documented, facility-based and 
community-based risk assessment, utilizing an all-hazards approach.
    (2) Include strategies for addressing emergency events identified by 
the risk assessment.
    (3) Address patient population, including, but not limited to, the 
type of services the Organizations have the ability to provide in an 
emergency; and continuity of operations, including delegations of 
authority and succession plans.
    (4) Address the location and use of alarm systems and signals; and 
methods of containing fire.
    (5) Include a process for cooperation and collaboration with local, 
tribal, regional, State, and Federal emergency preparedness officials' 
efforts to maintain an integrated response during a disaster or 
emergency situation.
    (6) Be developed and maintained with assistance from fire, safety, 
and other appropriate experts.
    (b) Policies and procedures. The Organizations must develop and 
implement emergency preparedness policies and procedures, based on the 
emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, and the communication 
plan at paragraph (c) of this section. The policies and procedures must 
be reviewed and updated at least annually. At a minimum, the policies 
and procedures must address the following:
    (1) Safe evacuation from the Organizations, which includes staff 
responsibilities, and needs of the patients.
    (2) A means to shelter in place for patients, staff, and volunteers 
who remain in the facility.
    (3) A system of medical documentation that preserves patient 
information, protects confidentiality of patient information, and 
secures and maintains the availability of records.
    (4) The use of volunteers in an emergency or other emergency 
staffing strategies, including the process and role for integration of 
State and Federally designated health care professionals to address 
surge needs during an emergency.
    (c) Communication plan. The Organizations must develop and maintain 
an emergency preparedness communication plan that complies with Federal, 
State, and local laws and must be reviewed and updated at least 
annually. The communication plan must include all of the following:
    (1) Names and contact information for the following:
    (i) Staff.
    (ii) Entities providing services under arrangement.
    (iii) Patients' physicians.
    (iv) Other Organizations.
    (v) Volunteers.
    (2) Contact information for the following:
    (i) Federal, state, tribal, regional and local emergency 
preparedness staff.
    (ii) Other sources of assistance.
    (3) Primary and alternate means for communicating with the 
following:
    (i) Organizations' staff.
    (ii) Federal, state, tribal, regional, and local emergency 
management agencies.
    (4) A method for sharing information and medical documentation for 
patients under the Organizations' care, as necessary, with other health 
care providers to maintain the continuity of care.
    (5) A means of providing information about the Organizations' needs, 
and their ability to provide assistance, to the authority having 
jurisdiction or the Incident Command Center, or designee.
    (d) Training and testing. The Organizations must develop and 
maintain an emergency preparedness training and testing program that is 
based on the emergency plan set forth in paragraph (a) of this section, 
risk assessment at paragraph (a)(1) of this section, policies and 
procedures at paragraph (b) of this section, and the communication plan 
at paragraph (c) of this section. The training and testing program must 
be reviewed and updated at least annually.
    (1) Training program. The Organizations must do all of the 
following:
    (i) Initial training in emergency preparedness policies and 
procedures to all new and existing staff, individuals providing services 
under arrangement, and volunteers, consistent with their expected roles.

[[Page 229]]

    (ii) Provide emergency preparedness training at least annually.
    (iii) Maintain documentation of the training.
    (iv) Demonstrate staff knowledge of emergency procedures.
    (2) Testing. The Organizations must conduct exercises to test the 
emergency plan at least annually. The Organizations must do the 
following:
    (i) Participate in a full-scale exercise that is community-based or 
when a community-based exercise is not accessible, an individual, 
facility-based. If the Organizations experience an actual natural or 
man-made emergency that requires activation of the emergency plan, the 
organization is exempt from engaging in a community-based or individual, 
facility-based full-scale exercise for 1 year following the onset of the 
actual event.
    (ii) Conduct an additional exercise that may include, but is not 
limited to the following:
    (A) A second full-scale exercise that is community-based or 
individual, facility-based.
    (B) A tabletop exercise that includes a group discussion led by a 
facilitator, using a narrated, clinically-relevant emergency scenario, 
and a set of problem statements, directed messages, or prepared 
questions designed to challenge an emergency plan.
    (iii) Analyze the Organization's response to and maintain 
documentation of all drills, tabletop exercises, and emergency events, 
and revise their emergency plan, as needed.
    (e) Integrated healthcare systems. If the Organizations are part of 
a healthcare system consisting of multiple separately certified 
healthcare facilities that elects to have a unified and integrated 
emergency preparedness program, the Organizations may choose to 
participate in the healthcare system's coordinated emergency 
preparedness program. If elected, the unified and integrated emergency 
preparedness program must do all of the following:
    (1) Demonstrate that each separately certified facility within the 
system actively participated in the development of the unified and 
integrated emergency preparedness program.
    (2) Be developed and maintained in a manner that takes into account 
each separately certified facility's unique circumstances, patient 
populations, and services offered.
    (3) Demonstrate that each separately certified facility is capable 
of actively using the unified and integrated emergency preparedness 
program and is in compliance.
    (4) Include a unified and integrated emergency plan that meets the 
requirements of paragraphs (a)(2), (3), and (4) of this section. The 
unified and integrated emergency plan must also be based on and include 
all of the following:
    (i) A documented community-based risk assessment, utilizing an all-
hazards approach.
    (ii) A documented individual facility-based risk assessment for each 
separately certified facility within the health system, utilizing an 
all-hazards approach.
    (5) Include integrated policies and procedures that meet the 
requirements set forth in paragraph (b) of this section, a coordinated 
communication plan and training and testing programs that meet the 
requirements of paragraphs (c) and (d) of this section, respectively.

[81 FR 64037, Sept. 16, 2016]



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,

[[Page 230]]

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, 2329, Jan. 9, 1995]

Subpart I [Reserved]



 Subpart J_Conditions of Participation: Community Mental Health Centers 
                                 (CMHCs)

    Source: 78 FR 64630, Oct. 29, 2013, unless otherwise noted.



Sec. 485.900  Basis and scope.

    (a) Basis. This subpart is based on the following sections of the 
Social Security Act:
    (1) Section 1832(a)(2)(J) of the Act specifies that payments may be 
made under Medicare Part B for partial hospitalization services 
furnished by a community mental health center (CMHC) as described in 
section 1861(ff)(3)(B) of the Act.
    (2) Section 1861(ff) of the Act describes the items and services 
that are covered under Medicare Part B as ``partial hospitalization 
services'' and the conditions under which the items and services must be 
provided. In addition, section 1861(ff) of the Act specifies that the 
entities authorized to provide partial hospitalization services under 
Medicare Part B include CMHCs and defines that term.
    (3) Section 1866(e)(2) of the Act specifies that a provider of 
services for purposes of provider agreement requirements includes a CMHC 
as defined in section 1861(ff)(3)(B) of the Act, but only with respect 
to providing partial hospitalization services.
    (b) Scope. The provisions of this subpart serve as the basis of 
survey activities for the purpose of determining whether a CMHC meets 
the specified requirements that are considered necessary to ensure the 
health and safety of clients; and for the purpose of determining whether 
a CMHC qualifies for a provider agreement under Medicare.



Sec. 485.902  Definitions.

    As used in this subpart, unless the context indicates otherwise--
    Active treatment plan means an individualized client plan that 
focuses on the provision of care and treatment services that address the 
client's physical, psychological, psychosocial, emotional, and 
therapeutic needs and goals as identified in the comprehensive 
assessment.
    Community mental health center (CMHC) means an entity as defined in 
Sec. 410.2 of this chapter.
    Comprehensive assessment means a thorough evaluation of the client's 
physical, psychological, psychosocial, emotional, and therapeutic needs 
related to the diagnosis under which care is being furnished by the 
CMHC.
    Employee of a CMHC means an individual--
    (1) Who works for the CMHC and for whom the CMHC is required to 
issue a W-2 form on his or her behalf; or
    (2) For whom an agency or organization issues a W-2 form, and who is 
assigned to such CMHC if the CMHC is a subdivision of an agency or 
organization.
    Initial evaluation means an immediate care and support assessment of 
the client's physical, psychosocial (including a screen for harm to self 
or others), and therapeutic needs related to the psychiatric illness and 
related conditions for which care is being furnished by the CMHC.
    Representative means an individual who has the authority under State 
law to authorize or terminate medical care on behalf of a client who is 
mentally or physically incapacitated. This includes a legal guardian.
    Restraint means--
    (1) Any manual method, physical or mechanical device, material, or 
equipment that immobilizes or reduces the ability of a client to move 
his or her arms, legs, body, or head freely, not including devices, such 
as orthopedically prescribed devices, surgical dressings or bandages, 
protective helmets, or other methods that involve the physical holding 
of a client for the purpose of conducting routine physical examinations 
or tests, or to protect the client from falling out of bed, or to permit 
the client to participate in activities without the risk of physical 
harm (this does not include a client being physically escorted); or

[[Page 231]]

    (2) A drug or medication when it is used as a restriction to manage 
the client's behavior or restrict the client's freedom of movement, and 
which is not a standard treatment or dosage for the client's condition.
    Seclusion means the involuntary confinement of a client alone in a 
room or an area from which the client is physically prevented from 
leaving.
    Volunteer means an individual who is an unpaid worker of the CMHC; 
or if the CMHC is a subdivision of an agency or organization, is an 
unpaid worker of the agency or organization and is assigned to the CMHC. 
All volunteers must meet the standard training requirements under 
Sec. 485.918(d).



Sec. 485.904  Condition of participation: Personnel qualifications.

    (a) Standard: General qualification requirements. All professionals 
who furnish services directly, under an individual contract, or under 
arrangements with a CMHC, must be legally authorized (licensed, 
certified or registered) in accordance with applicable Federal, State 
and local laws, and must act only within the scope of their State 
licenses, certifications, or registrations. All personnel qualifications 
must be kept current at all times.
    (b) Standard: Personnel qualifications for certain disciplines. The 
following qualifications must be met:
    (1) Administrator of a CMHC. A CMHC employee who meets the education 
and experience requirements established by the CMHC's governing body for 
that position and who is responsible for the day-to-day operation of the 
CMHC.
    (2) Clinical psychologist. An individual who meets the 
qualifications at Sec. 410.71(d) of this chapter.
    (3) Clinical Social worker. An individual who meets the 
qualifications at Sec. 410.73 of this chapter.
    (4) Social worker. An individual who--
    (i) Has a baccalaureate degree in social work from an institution 
accredited by the Council on Social Work Education, or a baccalaureate 
degree in psychology or sociology, and is supervised by a clinical 
social worker, as described in paragraph (b)(3) of this section; and
    (ii) Has 1 year of social work experience in a psychiatric 
healthcare setting.
    (5) Mental health counselor. A professional counselor who is 
certified and/or licensed by the State in which he or she practices, and 
has the skills and knowledge to provide a range of behavioral health 
services to clients. The mental health counselor conducts assessments 
and provides services in areas such as psychotherapy, substance abuse, 
crisis management, psychoeducation, and prevention programs.
    (6) Occupational therapist. A person who meets the requirements for 
the definition of ``occupational therapist'' at Sec. 484.4 of this 
chapter.
    (7) Physician. An individual who meets the qualifications and 
conditions as defined in section 1861(r) of the Act, and provides the 
services at Sec. 410.20 of this chapter, and has experience providing 
mental health services to clients.
    (8) Physician assistant. An individual who meets the qualifications 
and conditions as defined in section 1861(s)(2)(K)(i) of the Act and 
provides the services, in accordance with State law, at Sec. 410.74 of 
this chapter.
    (9) Advanced practice nurse. An individual who meets the following 
qualifications:
    (i) Is a nurse practitioner who meets the qualifications at 
Sec. 410.75 of this chapter; or
    (ii) Is a clinical nurse specialist who meets the qualifications at 
Sec. 410.76 of this chapter.
    (10) Psychiatric registered nurse. A registered nurse, who is a 
graduate of an approved school of professional nursing, is licensed as a 
registered nurse by the State in which he or she is practicing, and has 
at least 1 year of education and/or training in psychiatric nursing.
    (11) Psychiatrist. An individual who specializes in assessing and 
treating persons having psychiatric disorders; is board certified, or is 
eligible to be board certified by the American Board of Psychiatry and 
Neurology, or has documented equivalent education, training or 
experience, and is fully licensed to practice medicine in the State in 
which he or she practices.

[[Page 232]]



Sec. 485.910  Condition of participation: Client rights.

    The client has the right to be informed of his or her rights. The 
CMHC must protect and promote the exercise of these client rights.
    (a) Standard: Notice of rights and responsibilities. (1) During the 
initial evaluation, the CMHC must provide the client, the client's 
representative (if appropriate) or surrogate with verbal and written 
notice of the client's rights and responsibilities. The verbal notice 
must be in a language and manner that the client or client's 
representative or surrogate understands. Written notice must be 
understandable to persons who have limited English proficiency.
    (2) During the initial evaluation, the CMHC must inform and 
distribute written information to the client concerning its policies on 
filing a grievance.
    (3) The CMHC must obtain the client's and/or the client 
representative's signature confirming that he or she has received a copy 
of the notice of rights and responsibilities.
    (b) Standard: Exercise of rights and respect for property and 
person. (1) The client has the right to--
    (i) Exercise his or her rights as a client of the CMHC.
    (ii) Have his or her property and person treated with respect.
    (iii) Voice grievances and understand the CMHC grievance process; 
including but not limited to grievances regarding mistreatment and 
treatment or care that is (or fails to be) furnished.
    (iv) Not be subjected to discrimination or reprisal for exercising 
his or her rights.
    (2) If a client has been adjudged incompetent under State law by a 
court of proper jurisdiction, the rights of the client are exercised by 
the person appointed in accordance with State law to act on the client's 
behalf.
    (3) If a State court has not adjudged a client incompetent, any 
legal representative designated by the client in accordance with State 
law may exercise the client's rights to the extent allowed under State 
law.
    (c) Standard: Rights of the client. The client has a right to--
    (1) Be involved in developing his or her active treatment plan.
    (2) Refuse care or treatment.
    (3) Have a confidential clinical record. Access to or release of 
client information and the clinical record client information is 
permitted only in accordance with 45 CFR parts 160 and 164.
    (4) Be free from mistreatment, neglect, or verbal, mental, sexual, 
and physical abuse, including injuries of unknown source, and 
misappropriation of client property.
    (5) Receive information about specific limitations on services that 
he or she will be furnished.
    (6) Not be compelled to perform services for the CMHC, and to be 
compensated by the CMHC for any work performed for the CMHC at 
prevailing wages and commensurate with the client's abilities.
    (d) Standard: Addressing violations of client rights. The CMHC must 
adhere to the following requirements:
    (1) Ensure that all alleged violations involving mistreatment, 
neglect, or verbal, mental, sexual, and physical abuse, including 
injuries of unknown source, and misappropriation of client property by 
anyone, including those furnishing services on behalf of the CMHC, are 
reported immediately to the CMHC's administrator by CMHC employees, 
volunteers and contracted staff.
    (2) Immediately investigate all alleged violations involving anyone 
furnishing services on behalf of the CMHC and immediately take action to 
prevent further potential violations while the alleged violation is 
being verified. Investigations and documentation of all alleged 
violations must be conducted in accordance with procedures established 
by the CMHC.
    (3) Take appropriate corrective action in accordance with State law 
if the alleged violation is investigated by the CMHC's administration or 
verified by an outside entity having jurisdiction, such as the State 
survey and certification agency or the local law enforcement agency; and
    (4) Ensure that, within 5 working days of becoming aware of the 
violation, all violations are reported to the State survey and 
certification agency, and verified violations are reported to

[[Page 233]]

State and local entities having jurisdiction.
    (e) Standard: Restraint and seclusion. (1) All clients have the 
right to be free from physical or mental abuse, and corporal punishment. 
All clients 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, defined in Sec. 485.902, 
may only be imposed to ensure the immediate physical safety of the 
client, staff, or other individuals.
    (2) The use of restraint or seclusion must be in accordance with the 
written order of a physician or other licensed independent practitioner 
who is authorized to order restraint or seclusion in accordance with 
State law and must not exceed one 1-hour duration per order.
    (3) The CMHC must obtain a corresponding order for the client's 
immediate transfer to a hospital when restraint or seclusion is ordered.
    (4) Orders for the use of restraint or seclusion must never be 
written as a standing order or on an as-needed basis.
    (5) When a client becomes an immediate threat to the physical safety 
of himself or herself, staff or other individuals, the CMHC must adhere 
to the following requirements:
    (i) Restraint or seclusion may only be used when less restrictive 
interventions have been determined to be ineffective to protect the 
client or other individuals from harm.
    (ii) The type or technique of restraint or seclusion used must be 
the least restrictive intervention that will be effective to protect the 
client or other individuals from harm.
    (iii) The use of restraint or seclusion must be implemented in 
accordance with safe and appropriate restraint and seclusion techniques 
as determined by State law.
    (iv) The condition of the client who is restrained or secluded must 
be continuously monitored by a physician or by trained staff who have 
completed the training criteria specified in paragraph (f) of this 
section.
    (v) When restraint or seclusion is used, there must be documentation 
in the client's clinical record of the following:
    (A) A description of the client's behavior and the intervention 
used.
    (B) Alternatives or other less restrictive interventions attempted 
(as applicable).
    (C) The client's condition or symptom(s) that warranted the use of 
the restraint or seclusion.
    (D) The client's response to the intervention(s) used, including the 
rationale for continued use of the intervention.
    (E) The name of the hospital to which the client was transferred.
    (f) Standard: Restraint or seclusion: Staff training requirements. 
The client has the right to safe implementation of restraint or 
seclusion by trained staff. Application of restraint or seclusion in a 
CMHC must only be imposed when a client becomes an immediate physical 
threat to himself or herself, staff or other individuals and only in 
facilities where restraint and seclusion are permitted.
    (1) Training intervals. In facilities where restraint and seclusion 
are permitted, all appropriate client care staff working in the CMHC 
must be trained and able to demonstrate competency in the application of 
restraints, implementation of seclusion, monitoring, assessment, and 
providing care for a client in restraint or seclusion and use of 
alternative methods to restraint and seclusion. In facilities where 
restraint and seclusion are not permitted, appropriate client care staff 
working in CMHC must be trained in the use of alternative methods to 
restraint and seclusion. Training will occur as follows:
    (i) Before performing any of the actions specified in this paragraph 
(f).
    (ii) As part of orientation.
    (iii) Subsequently on a periodic basis, consistent with the CMHC's 
policy.
    (2) Training content. The CMHC must require all appropriate staff 
caring for clients to have appropriate education, training, and 
demonstrated knowledge based on the specific needs of the client 
population in at least the following:
    (i) Techniques to identify staff and client behaviors, events, and 
environmental factors that may trigger circumstances that could require 
the use of restraint or seclusion.

[[Page 234]]

    (ii) The use of nonphysical intervention skills.
    (iii) In facilities where restraint and seclusion are permitted, 
choosing the least restrictive intervention based on an individualized 
assessment of the client's medical and behavioral status or condition.
    (iv) The safe application and use of all types of restraint or 
seclusion that are permitted in the CMHC, including training in how to 
recognize and respond to signs of physical and psychological distress.
    (v) In facilities where restraint and seclusion are permitted, 
clinical identification of specific behavioral changes that indicate 
that restraint or seclusion is no longer necessary.
    (vi) In facilities where restraint and seclusion are permitted, 
monitoring the physical and psychological well-being of the client who 
is restrained or secluded, including, but not limited to, respiratory 
and circulatory status, skin integrity, vital signs, and any special 
requirements specified by the CMHC's policy.
    (3) Trainer requirements. Individuals providing staff training must 
be qualified as evidenced by education, training, and experience in 
techniques used to address clients' behaviors.
    (4) Training documentation. The CMHC must document in the staff 
personnel records that the training and demonstration of competency were 
successfully completed.
    (g) Standard: Death reporting requirements. The CMHC must report 
deaths associated with the use of seclusion or restraint.
    (1) The CMHC must report to CMS each death that occurs while a 
client is in restraint or seclusion awaiting transfer to a hospital.
    (2) Each death referenced in paragraph (g)(1) of this section must 
be reported to the CMS Regional Office by telephone no later than the 
close of business the next business day following knowledge of the 
client's death.
    (3) Staff must document in the client's clinical record the date and 
time the death was reported to CMS.



Sec. 485.914  Condition of participation: Admission, initial
evaluation, comprehensive assessment, and discharge or transfer 
of the client.

    The CMHC must ensure that all clients admitted into its program are 
appropriate for the services the CMHC furnishes in its facility.
    (a) Standard: Admission. (1) The CMHC must determine that each 
client is appropriate for the services it provides as specified in 
Sec. 410.2 of this chapter.
    (2) For clients assessed and admitted to receive partial 
hospitalization services, the CMHC must also meet separate requirements 
as specified in Sec. 485.918(f).
    (b) Standard: Initial evaluation. (1) A licensed mental health 
professional employed by the CMHC and acting within his or her state 
scope of practice requirements must complete the initial evaluation 
within 24 hours of the client's admission to the CMHC.
    (2) The initial evaluation, at a minimum, must include the 
following:
    (i) The admitting diagnosis as well as other diagnoses.
    (ii) The source of referral.
    (iii) The reason for admission as stated by the client or other 
individuals who are significantly involved.
    (iv) Identification of the client's immediate clinical care needs 
related to the psychiatric diagnosis.
    (v) A list of current prescriptions and over-the-counter 
medications, as well as other substances that the client may be taking.
    (vi) For partial hospitalization services only, include an 
explanation as to why the client would be at risk for hospitalization if 
the partial hospitalization services were not provided.
    (3) Based on the findings of the initial evaluation, the CMHC must 
determine the appropriate members of each client's interdisciplinary 
treatment team.
    (c) Standard: Comprehensive assessment. (1) The comprehensive 
assessment must be completed by licensed mental health professionals who 
are members of the interdisciplinary treatment team, performing within 
their State's scope of practice.
    (2) The comprehensive assessment must be completed in a timely 
manner, consistent with the client's immediate

[[Page 235]]

needs, but no later than 4 working days after admission to the CMHC.
    (3) The comprehensive assessment must identify the physical, 
psychological, psychosocial, emotional, therapeutic, and other needs 
related to the client's psychiatric illness. The CMHC's 
interdisciplinary treatment team must ensure that the active treatment 
plan is consistent with the findings of the comprehensive assessment.
    (4) The comprehensive assessment, at a minimum, must include the 
following:
    (i) The reasons for the admission.
    (ii) A psychiatric evaluation, completed by a psychiatrist, non-
physician practitioner or psychologist practicing within the scope of 
State licensure that includes the medical history and severity of 
symptoms. Information may be gathered from the client's primary health 
care provider (if any), contingent upon the client's consent.
    (iii) Information concerning previous and current mental status, 
including but not limited to, previous therapeutic interventions and 
hospitalizations.
    (iv) Information regarding the onset of symptoms of the illness and 
circumstances leading to the admission.
    (v) A description of attitudes and behaviors, including cultural and 
environmental factors that may affect the client's treatment plan.
    (vi) An assessment of intellectual functioning, memory functioning, 
and orientation.
    (vii) Complications and risk factors that may affect the care 
planning.
    (viii) Functional status, including the client's ability to 
understand and participate in his or her own care, and the client's 
strengths and goals.
    (ix) Factors affecting client safety or the safety of others, 
including behavioral and physical factors, as well as suicide risk 
factors.
    (x) A drug profile that includes a review of all of the client's 
prescription and over-the-counter medications; herbal remedies; and 
other alternative treatments or substances that could affect drug 
therapy.
    (xi) The need for referrals and further evaluation by appropriate 
health care professionals, including the client's primary health care 
provider (if any), when warranted.
    (xii) Factors to be considered in discharge planning.
    (xiii) Identification of the client's current social and health care 
support systems.
    (xiv) For pediatric clients, the CMHC must assess the social service 
needs of the client, and make referrals to social services and child 
welfare agencies as appropriate.
    (d) Standard: Update of the comprehensive assessment. (1) The CMHC 
must update the comprehensive assessment via the CMHC interdisciplinary 
treatment team, in consultation with the client's primary health care 
provider (if any), when changes in the client's status, responses to 
treatment, or goal achievement have occurred.
    (2) The assessment must be updated no less frequently than every 30 
days.
    (3) The update must include information on the client's progress 
toward desired outcomes, a reassessment of the client's response to care 
and therapies, and the client's goals.
    (e) Standard: Discharge or transfer of the client. (1) If the client 
is transferred to another entity, the CMHC must, within 2 working days, 
forward to the entity, a copy of--
    (i) The CMHC discharge summary.
    (ii) The client's clinical record, if requested.
    (2) If a client refuses the services of a CMHC, or is discharged 
from a CMHC due to noncompliance with the treatment plan, the CMHC must 
forward to the primary health care provider (if any) a copy of--
    (i) The CMHC discharge summary.
    (ii) The client's clinical record, if requested.
    (3) The CMHC discharge summary must include--
    (i) A summary of the services provided, including the client's 
symptoms, treatment and recovery goals and preferences, treatments, and 
therapies.
    (ii) The client's current active treatment plan at time of 
discharge.
    (iii) The client's most recent physician orders.
    (iv) Any other documentation that will assist in post-discharge 
continuity of care.

[[Page 236]]

    (4) The CMHC must adhere to all Federal and State-related 
requirements pertaining to the medical privacy and the release of client 
information.



Sec. 485.916  Condition of participation: Treatment team, person-
centered active treatment plan, and coordination of services.

    The CMHC must designate an interdisciplinary treatment team that is 
responsible, with the client, for directing, coordinating, and managing 
the care and services furnished for each client. The interdisciplinary 
treatment team is composed of individuals who work together to meet the 
physical, medical, psychosocial, emotional, and therapeutic needs of 
CMHC clients.
    (a) Standard: Delivery of services. (1) An interdisciplinary 
treatment team, led by a physician, NP, PA, CNS, clinical psychologist, 
or clinical social worker, must provide the care and services offered by 
the CMHC.
    (2) Based on the findings of the comprehensive assessment, the CMHC 
must determine the appropriate licensed mental health professional, who 
is a member of the client's interdisciplinary treatment team, to 
coordinate care and treatment decisions with each client, to ensure that 
each client's needs are assessed, and to ensure that the active 
treatment plan is implemented as indicated.
    (3) The interdisciplinary treatment team may include:
    (i) A doctor of medicine, osteopathy or psychiatry (who is an 
employee of or under contract with the CMHC).
    (ii) A psychiatric registered nurse.
    (iii) A clinical social worker.
    (iv) A clinical psychologist.
    (v) An occupational therapist.
    (vi) Other licensed mental health professionals, as necessary.
    (vii) Other CMHC staff or volunteers, as necessary.
    (4) If the CMHC has more than one interdisciplinary team, it must 
designate the treatment team responsible for establishing policies and 
procedures governing the coordination of services and the day-to-day 
provision of CMHC care and services.
    (b) Standard: Person-centered active treatment plan. All CMHC care 
and services furnished to clients must be consistent with an 
individualized, written, active treatment plan that is established by 
the CMHC interdisciplinary treatment team, the client, and the client's 
primary caregiver(s), in accordance with the client's recovery goals and 
preferences, within 7 working days of admission to the CMHC. The CMHC 
must ensure that each client and the client's primary caregiver(s), as 
applicable, receive education and training provided by the CMHC that are 
consistent with the client's and caregiver's responsibilities as 
identified in the active treatment plan.
    (c) Standard: Content of the person-centered active treatment plan. 
The CMHC must develop a person-centered individualized active treatment 
plan for each client. The active treatment plan must take into 
consideration client recovery goals and the issues identified in the 
comprehensive assessment. The active treatment plan must include all 
services necessary to assist the client in meeting his or her recovery 
goals, including the following:
    (1) Client diagnoses.
    (2) Treatment goals.
    (3) Interventions.
    (4) A detailed statement of the type, duration, and frequency of 
services, including social work, psychiatric nursing, counseling, and 
therapy services, necessary to meet the client's specific needs.
    (5) Drugs, treatments, and individual and/or group therapies.
    (6) Family psychotherapy with the primary focus on treatment of the 
client's conditions.
    (7) The interdisciplinary treatment team's documentation of the 
client's or representative's and primary caregiver's (if any) 
understanding, involvement, and agreement with the plan of care, in 
accordance with the CMHC's policies.
    (d) Standard: Review of the person-centered active treatment plan. 
The CMHC interdisciplinary treatment team must review, revise, and 
document the individualized active treatment plan as frequently as the 
client's condition requires, but no less frequently than every 30 
calendar days. A revised active treatment plan must include information 
from the client's initial evaluation and comprehensive assessments, the 
client's progress toward outcomes

[[Page 237]]

and goals specified in the active treatment plan, and changes in the 
client's goals. The CMHC must also meet partial hospitalization program 
requirements specified under Sec. 424.24(e) of this chapter if such 
services are included in the active treatment plan.
    (e) Standard: Coordination of services. The CMHC must develop and 
maintain a system of communication that assures the integration of 
services in accordance with its policies and procedures and, at a 
minimum, would do the following:
    (1) Ensure that the interdisciplinary treatment team maintains 
responsibility for directing, coordinating, and supervising the care and 
services provided.
    (2) Ensure that care and services are provided in accordance with 
the active treatment plan.
    (3) Ensure that the care and services provided are based on all 
assessments of the client.
    (4) Provide for and ensure the ongoing sharing of information among 
all disciplines providing care and services, whether the care and 
services are provided by employees or those under contract with the 
CMHC.
    (5) Provide for ongoing sharing of information with other health 
care and non-medical providers, including the primary health care 
provider, furnishing services to a client for conditions unrelated to 
the psychiatric condition for which the client has been admitted, and 
non-medical supports addressing environmental factors such as housing 
and employment.



Sec. 485.917  Condition of participation: Quality assessment and 
performance improvement.

    The CMHC must develop, implement, and maintain an effective, 
ongoing, CMHC-wide data-driven quality assessment and performance 
improvement program (QAPI). The CMHC's governing body must ensure that 
the program reflects the complexity of its organization and services, 
involves all CMHC services (including those services furnished under 
contract or arrangement), focuses on indicators related to improved 
behavioral health or other healthcare outcomes, and takes actions to 
demonstrate improvement in CMHC performance. The CMHC must maintain 
documentary evidence of its quality assessment and performance 
improvement program and be able to demonstrate its operation to CMS.
    (a) Standard: Program scope. (1) The CMHC program must be able to 
demonstrate measurable improvement in indicators related to improving 
behavioral health outcomes and CMHC services.
    (2) The CMHC must measure, analyze, and track quality indicators; 
adverse client events, including the use of restraint and seclusion; and 
other aspects of performance that enable the CMHC to assess processes of 
care, CMHC services, and operations.
    (b) Standard: Program data. (1) The program must use quality 
indicator data, including client care, and other relevant data, in the 
design of its program.
    (2) The CMHC must use the data collected to do the following:
    (i) Monitor the effectiveness and safety of services and quality of 
care.
    (ii) Identify opportunities and priorities for improvement.
    (3) The frequency and detail of the data collection must be approved 
by the CMHC's governing body.
    (c) Standard: Program activities. (1) The CMHC's performance 
improvement activities must:
    (i) Focus on high risk, high volume, or problem-prone areas.
    (ii) Consider incidence, prevalence, and severity of problems.
    (iii) Give priority to improvements that affect behavioral outcomes, 
client safety, and person-centered quality of care.
    (2) Performance improvement activities must track adverse client 
events, analyze their causes, and implement preventive actions and 
mechanisms that include feedback and learning throughout the CMHC.
    (3) The CMHC must take actions aimed at performance improvement and, 
after implementing those actions, the CMHC must measure its success and 
track performance to ensure that improvements are sustained.
    (d) Standard: Performance improvement projects. CMHCs must develop, 
implement and evaluate performance improvement projects.

[[Page 238]]

    (1) The number and scope of distinct performance improvement 
projects conducted annually, based on the needs of the CMHC's population 
and internal organizational needs, must reflect the scope, complexity, 
and past performance of the CMHC's services and operations.
    (2) The CMHC must document what performance improvement projects are 
being conducted, the reasons for conducting these projects, and the 
measurable progress achieved on these projects.
    (e) Standard: Executive responsibilities. The CMHC's governing body 
is responsible for ensuring the following:
    (1) That an ongoing QAPI program for quality improvement and client 
safety is defined, implemented, maintained, and evaluated annually.
    (2) That the CMHC-wide quality assessment and performance 
improvement efforts address priorities for improved quality of care and 
client safety, and that all improvement actions are evaluated for 
effectiveness.
    (3) That one or more individual(s) who are responsible for operating 
the QAPI program are designated.



Sec. 485.918  Condition of participation: Organization, governance,
administration of services, and partial hospitalization services.

    The CMHC must organize, manage, and administer its resources to 
provide CMHC services, including specialized services for children, 
elderly individuals, individuals with serious mental illness, and 
residents of its mental health service area who have been discharged 
from an inpatient mental health facility.
    (a) Standard: Governing body and administrator. (1) A CMHC must have 
a designated governing body made up of two or more designated persons, 
one of which may be the administrator, that assumes full legal authority 
and responsibility for the management of the CMHC, the services it 
furnishes, its fiscal operations, and continuous quality improvement. 
One member of the governing body must possess knowledge and experience 
as a mental health clinician.
    (2) The CMHC's governing body must appoint an administrator who 
reports to the governing body and is responsible for the day-to-day 
operation of the CMHC. The administrator must be a CMHC employee and 
meet the education and experience requirements established by the CMHC's 
governing body.
    (b) Standard: Provision of services. (1) A CMHC must be primarily 
engaged in providing the following care and services to all clients 
served by the CMHC regardless of payer type, and must do so in a manner 
that is consistent with the following accepted standards of practice:
    (i) Provides outpatient services, including specialized outpatient 
services for children, elderly individuals, individuals with serious 
mental illness, and residents of its mental health service area who have 
been discharged from inpatient mental health facilities.
    (ii) Provides 24-hour-a-day emergency care services.
    (iii) Provides day treatment, partial hospitalization services other 
than in an individual's home or in an inpatient or residential setting, 
or psychosocial rehabilitation services.
    (iv) Provides screening for clients being considered for admission 
to State mental health facilities to determine the appropriateness of 
such services, unless otherwise directed by State law.
    (v) Provides at least 40 percent of its items and services to 
individuals who are not eligible for benefits under title XVIII of the 
Act, as measured by the total number of CMHC clients treated by the CMHC 
for whom services are not paid for by Medicare, divided by the total 
number of clients treated by the CMHC for each 12-month period of 
enrollment.
    (A) A CMHC is required to submit to CMS a certification statement 
provided by an independent entity that certifies that the CMHC's client 
population meets the 40 percent requirement specified at this paragraph 
(b)(1)(v).
    (B) The certification statement described in paragraph (b)(1)(v)(A) 
of this section is required upon initial application to enroll in 
Medicare, and as a part of revalidation, including any off cycle 
revalidation, thereafter carried out pursuant to Sec. 424.530 of this 
chapter. Medicare enrollment will be denied or

[[Page 239]]

revoked in instances where the CMHC fails to provide the certification 
statement as required. Medicare enrollment will also be denied or 
revoked if the 40 percent requirement as specified in this paragraph 
(b)(1)(v) is not met.
    (vi) Provides individual and group psychotherapy utilizing a 
psychiatrist, psychologist, or other licensed mental health counselor, 
to the extent authorized under State law.
    (vii) Provides physician services.
    (viii) Provides psychiatric nursing services.
    (ix) Provides clinical social work services.
    (x) Provides family counseling services, with the primary purpose of 
treating the individual's condition.
    (xi) Provides occupational therapy services.
    (xii) Provides services of other staff trained to work with 
psychiatric clients.
    (xiii) Provides drugs and biologicals furnished for therapeutic 
purposes that cannot be self-administered.
    (xiv) Provides client training and education as related to the 
individual's care and active treatment.
    (xv) Provides individualized therapeutic activity services that are 
not primarily recreational or diversionary.
    (xvi) Provides diagnostic services.
    (2) The CMHC and individuals furnishing services on its behalf must 
meet applicable State licensing and certification requirements.
    (c) Standard: Professional management responsibility. A CMHC that 
has a written agreement with another agency, individual, or organization 
to furnish any services under arrangement must retain administrative and 
financial management and oversight of staff and services for all 
arranged services. As part of retaining financial management 
responsibility, the CMHC must retain all payment responsibility for 
services furnished under arrangement on its behalf. Arranged services 
must be supported by a written agreement which requires that all 
services be as follows:
    (1) Authorized by the CMHC.
    (2) Furnished in a safe and effective manner.
    (3) Delivered in accordance with established professional standards, 
the policies of the CMHC, and the client's active treatment plan.
    (d) Standard: Staff training. (1) A CMHC must provide education 
about CMHC care and services, and person-centered care to all employees, 
volunteers, and staff under contract who have contact with clients and 
their families.
    (2) A CMHC must provide an initial orientation for each individual 
furnishing services that addresses the specific duties of his or her 
job.
    (3) A CMHC must assess the skills and competence of all individuals 
furnishing care and, as necessary, provide in-service training and 
education programs where indicated. The CMHC must have written policies 
and procedures describing its method(s) of assessing competency and must 
maintain a written description of the in-service training provided 
during the previous 12 months.
    (e) Standard: Physical environment--(1) Environmental conditions. 
The CMHC must provide a safe, functional, sanitary, and comfortable 
environment for clients and staff that is conducive to the provision of 
services that are identified in paragraph (b) of this section.
    (2) Building. The CMHC services must be provided in a location that 
meets Federal, State, and local health and safety standards and State 
health care occupancy regulations.
    (3) Infection control. There must be policies, procedures, and 
monitoring for the prevention, control, and investigation of infection 
and communicable diseases with the goal of avoiding sources and 
transmission of infection.
    (4) Therapy sessions. The CMHC must ensure that individual or group 
therapy sessions are conducted in a manner that maintains client privacy 
and ensures client dignity.
    (f) Standard: Partial hospitalization services. A CMHC providing 
partial hospitalization services must--
    (1) Provide services as defined in Sec. 410.2 of this chapter.
    (2) Provide the services and meet the requirements specified in 
Sec. 410.43 of this chapter.
    (3) Meet the requirements for coverage as described in Sec. 410.110 
of this chapter.

[[Page 240]]

    (4) Meet the content of certification and plan of treatment 
requirements as described in Sec. 424.24(e) of this chapter.
    (g) Standard: Compliance with Federal, State, and local laws and 
regulations related to the health and safety of clients. The CMHC and 
its staff must operate and furnish services in compliance with all 
applicable Federal, State, and local laws and regulations related to the 
health and safety of clients. If State or local law provides for 
licensing of CMHCs, the CMHC must be licensed. The CMHC staff must 
follow the CMHC's policies and procedures.



Sec. 485.920  Condition of participation: Emergency preparedness.

    The Community Mental Health Center (CMHC) must comply with all 
applicable Federal, State, and local emergency preparedness 
requirements. The CMHC must establish and maintain an emergency 
preparedness program that meets the requirements of this section. The 
emergency preparedness program must include, but not be limited to, the 
following elements:
    (a) Emergency plan. The CMHC must develop and maintain an emergency 
preparedness plan that must be reviewed, and updated at least annually. 
The plan must do all of the following:
    (1) Be based on and include a documented, facility-based and 
community-based risk assessment, utilizing an all-hazards approach.
    (2) Include strategies for addressing emergency events identified by 
the risk assessment.
    (3) Address client population, including, but not limited to, the 
type of services the CMHC has the ability to provide in an emergency; 
and continuity of operations, including delegations of authority and 
succession plans.
    (4) Include a process for cooperation and collaboration with local, 
tribal, regional, State, and Federal emergency preparedness officials' 
efforts to maintain an integrated response during a disaster or 
emergency situation, including documentation of the CMHC's efforts to 
contact such officials and, when applicable, of its participation in 
collaborative and cooperative planning efforts.
    (b) Policies and procedures. The CMHC must develop and implement 
emergency preparedness policies and procedures, based on the emergency 
plan set forth in paragraph (a) of this section, risk assessment at 
paragraph (a)(1) of this section, and the communication plan at 
paragraph (c) of this section. The policies and procedures must be 
reviewed and updated at least annually. At a minimum, the policies and 
procedures must address the following:
    (1) A system to track the location of on-duty staff and sheltered 
clients in the CMHC's care during and after an emergency. If on-duty 
staff and sheltered clients are relocated during the emergency, the CMHC 
must document the specific name and location of the receiving facility 
or other location.
    (2) Safe evacuation from the CMHC, which includes consideration of 
care and treatment needs of evacuees; staff responsibilities; 
transportation; identification of evacuation location(s); and primary 
and alternate means of communication with external sources of 
assistance.
    (3) A means to shelter in place for clients, staff, and volunteers 
who remain in the facility.
    (4) A system of medical documentation that preserves client 
information, protects confidentiality of client information, and secures 
and maintains the availability of records.
    (5) The use of volunteers in an emergency or other emergency 
staffing strategies, including the process and role for integration of 
state or Federally designated health care professionals to address surge 
needs during an emergency.
    (6) The development of arrangements with other CMHCs or other 
providers to receive clients in the event of limitations or cessation of 
operations to maintain the continuity of services to CMHC clients.
    (7) The role of the CMHC under a waiver declared by the Secretary of 
Health and Human Services, in accordance with section 1135 of the Social 
Security Act, in the provision of care and treatment at an alternate 
care site identified by emergency management officials.

[[Page 241]]

    (c) Communication plan. The CMHC must develop and maintain an 
emergency preparedness communication plan that complies with Federal, 
State, and local laws and must be reviewed and updated at least 
annually. The communication plan must include all of the following:
    (1) Names and contact information for the following:
    (i) Staff.
    (ii) Entities providing services under arrangement.
    (iii) Clients' physicians.
    (iv) Other CMHCs.
    (v) Volunteers.
    (2) Contact information for the following:
    (i) Federal, State, tribal, regional, and local emergency 
preparedness staff.
    (ii) Other sources of assistance.
    (3) Primary and alternate means for communicating with the 
following:
    (i) CMHC's staff.
    (ii) Federal, State, tribal, regional, and local emergency 
management agencies.
    (4) A method for sharing information and medical documentation for 
clients under the CMHC's care, as necessary, with other health care 
providers to maintain the continuity of care.
    (5) A means, in the event of an evacuation, to release client 
information as permitted under 45 CFR 164.510(b)(1)(ii).
    (6) A means of providing information about the general condition and 
location of clients under the facility's care as permitted under 45 CFR 
164.510(b)(4).
    (7) A means of providing information about the CMHC's needs, and its 
ability to provide assistance, to the authority having jurisdiction or 
the Incident Command Center, or designee.
    (d) Training and testing. The CMHC must develop and maintain an 
emergency preparedness training and testing program that is based on the 
emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program must be 
reviewed and updated at least annually.
    (1) Training. The CMHC must provide initial training in emergency 
preparedness policies and procedures to all new and existing staff, 
individuals providing services under arrangement, and volunteers, 
consistent with their expected roles, and maintain documentation of the 
training. The CMHC must demonstrate staff knowledge of emergency 
procedures. Thereafter, the CMHC must provide emergency preparedness 
training at least annually.
    (2) Testing. The CMHC must conduct exercises to test the emergency 
plan at least annually. The CMHC must:
    (i) Participate in a full-scale exercise that is community-based or 
when a community-based exercise is not accessible, an individual, 
facility-based. If the CMHC experiences an actual natural or man-made 
emergency that requires activation of the emergency plan, the CMHC is 
exempt from engaging in a community-based or individual, facility-based 
full-scale exercise for 1 year following the onset of the actual event.
    (ii) Conduct an additional exercise that may include, but is not 
limited to the following:
    (A) A second full-scale exercise that is community-based or 
individual, facility-based.
    (B) A tabletop exercise that includes a group discussion led by a 
facilitator, using a narrated, clinically-relevant emergency scenario, 
and a set of problem statements, directed messages, or prepared 
questions designed to challenge an emergency plan.
    (iii) Analyze the CMHC's response to and maintain documentation of 
all drills, tabletop exercises, and emergency events, and revise the 
CMHC's emergency plan, as needed.
    (e) Integrated healthcare systems. If a CMHC is part of a healthcare 
system consisting of multiple separately certified healthcare facilities 
that elects to have a unified and integrated emergency preparedness 
program, the CMHC may choose to participate in the healthcare system's 
coordinated emergency preparedness program. If elected, the unified and 
integrated emergency preparedness program must do all of the following:
    (1) Demonstrate that each separately certified facility within the 
system actively participated in the development

[[Page 242]]

of the unified and integrated emergency preparedness program.
    (2) Be developed and maintained in a manner that takes into account 
each separately certified facility's unique circumstances, patient 
populations, and services offered.
    (3) Demonstrate that each separately certified facility is capable 
of actively using the unified and integrated emergency preparedness 
program and is in compliance.
    (4) Include a unified and integrated emergency plan that meets the 
requirements of paragraphs (a)(2), (3), and (4) of this section. The 
unified and integrated emergency plan must also be based on and include 
all of the following:
    (i) A documented community-based risk assessment, utilizing an all-
hazards approach.
    (ii) A documented individual facility-based risk assessment for each 
separately certified facility within the health system, utilizing an 
all-hazards approach.
    (5) Include integrated policies and procedures that meet the 
requirements set forth in paragraph (b) of this section, a coordinated 
communication plan and training and testing programs that meet the 
requirements of paragraphs (c) and (d) of this section, respectively.

[81 FR 64039, Sept. 16, 2016]



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]

       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).
486.360  Condition for Coverage: Emergency preparedness.

    Authority: Secs. 1102, 1138, and 1871 of the Social Security Act (42 
U.S.C. 1302, 1320b-8,

[[Page 243]]

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]



       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

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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 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;

[[Page 245]]

    (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 physician or a nonphysician practitioner as provided in 
Sec. 410.32(a) of this chapter or by a nonphysician practitioner as 
provided in Sec. 410.32(a)(2) and records are properly preserved.
    (a) Standard--referral by a physician or nonphysician practitioners. 
Portable X-ray examinations are performed only on the order of a 
physician licensed to practice in the State or by a nonphysician 
practitioner acting within the scope of State law. Such nonphysician 
practitioners may be treated the same as physicians treating 
beneficiaries for the purpose of this paragraph. The supplier's records 
show that:
    (1) The portable X-ray test was ordered by a licensed physician or a 
nonphysician practitioner acting within the State scope of law; and
    (2) Such physician or nonphysician practitioner's written, signed 
order specifies the reason a portable 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 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 portable X-ray examination, 
the name of the patient, a description of the procedures ordered and 
performed, the referring physician or nonphysician practitioner, 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; 77 FR 69372, Nov. 16, 2012]



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.
------------------------------------------------------------------------


[[Page 246]]

    (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 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.

[[Page 247]]



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 beneficiary, 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 beneficiary.
    Agreement cycle refers to the time period of at least 4 years when 
an agreement is in effect between CMS and an OPO.
    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 means any documented indication of an individual's 
choice regarding his or her wishes concerning organ and/or tissue 
donation that was made by that individual or

[[Page 248]]

another authorized individual in accordance with any applicable State 
law.''
    Eligible death. An eligible death for organ donation means the death 
of a person--
    (1) Who is 75 years old or younger;
    (2) Who is legally declared dead by neurologic criteria in 
accordance with State or local law;
    (3) Whose body weight is 5 kg or greater;
    (4) Whose body mass Index (BMI) is 50 kg/m2 or less;
    (5) Who had at least one kidney, liver, heart, or lung that is 
deemed to meet the eligible data definition as follows:
    (i) The kidney would be initially deemed to meet the eligible data 
definition unless the donor meets one of the following:
    (A) Is more than 70 years of age;
    (B) Is age 50-69 years with history of Type 1 diabetes for more than 
20 years;
    (C) Has polycystic kidney disease;
    (D) Has glomerulosclerosis equal to or more than 20 percent by 
kidney biopsy;
    (E) Has terminal serum creatinine greater than 4/0 mg/dl;
    (F) Has chronic renal failure; or
    (G) Has no urine output for at least or more than 24 hours;
    (ii) The liver would be initially deemed to meet the eligible data 
definition unless the donor has one of the following:
    (A) Cirrhosis;
    (B) Terminal total bilirubin equal to or more than 4 mg/dl;
    (C) Portal hypertension;
    (D) Macrosteatosis equal to or more than 50 percent or fibrosis 
equal to or more than stage II;
    (E) Fulminant hepatic failure; or
    (F) Terminal AST/ALT of more than 700 U/L.
    (iii) The heart would be initially deemed to meet the eligible data 
definition unless the donor meets one of the following:
    (A) Is more than 60 years of age;
    (B) Is at least or more than 45 years of age with a history of at 
least or more than 10 years of HTN or at least or more than 10 years of 
type 1 diabetes;
    (C) Has a history of Coronary Artery Bypass Graft (CABG);
    (D) Has a history of coronary stent/intervention;
    (E) Has a current or past medical history of myocardial infarction 
(MI);
    (F) Has a severe vessel diagnosis as supported by cardiac 
catheterization (that is more than 50 percent occlusion or 2+ vessel 
disease);
    (G) Has acute myocarditis and/or endocarditis;
    (H) Has heart failure due to cardiomyopathy;
    (I) Has an internal defibrillator or pacemaker;
    (J) Has moderate to severe single valve or 2-valve disease 
documented by echo or cardiac catheterization, or previous valve repair;
    (K) Has serial echo results showing severe global hypokinesis;
    (L) Has myxoma; or
    (M) Has congenital defects (whether surgically corrected or not).
    (iv) The lung would be initially deemed to meet the eligible data 
definition unless the donor meets one of the following:
    (A) Is more than 65 years of age;
    (B) Is diagnosed with coronary obstructive pulmonary disease (COPD) 
(for example, emphysema);
    (C) Has terminal PaO2/FiO2 less than 250 mmHg;
    (D) Has asthma (with daily prescription);
    (E) Asthma is the cause of death;
    (F) Has pulmonary fibrosis;
    (G) Has previous lobectomy;
    (H) Has multiple blebs documented on Computed Axial Tomography (CAT) 
Scan;
    (I) Has pneumonia as indicated on Computed Tomography (CT), X-ray, 
bronchoscopy, or cultures;
    (J) Has bilateral severe pulmonary contusions as per CT.
    (6) If a deceased person meets the criteria specified in paragraphs 
(1) through (5) of this definition, the death of the person would be 
classified as an eligible death, unless the donor meets any of the 
following criteria:
    (i) The donor was taken to the operating room with the intent for 
the OPO to recover organs for transplant and all organs were deemed not 
medically suitable for transplantation; or

[[Page 249]]

    (ii) The donor exhibits any of the following active infections 
(specific diagnoses) of--
    (A) Bacterial: Tuberculosis, Gangrenous bowel or perforated bowel or 
intra-abdominal sepsis;
    (B) Viral: HIV infection by serologic or molecular detection, 
Rabies, Reactive Hepatitis B Surface Antigen, Retroviral infections 
including Viral Encephalitis or Meningitis, Active Herpes simplex, 
varicella zoster, or cytomegalovirus viremia or pneumonia, Acute Epstein 
Barr Virus (mononucleosis), West Nile (c) Virus infection, SARS, except 
as provided in paragraph (8) of this definition.
    (C) Fungal: Active infection with Cryptococcus, Aspergillus, 
Histoplasma, Coccidioides, Active candidemia or invasive yeast 
infection;
    (D) Parasites: Active infection with Trypanosoma cruzi (Chagas'), 
Leishmania, Strongyloides, or Malaria (Plasmodium sp.); or
    (E) Prion: Creutzfeldt-Jacob Disease.
    (7) The following are general exclusions:
    (i) Aplastic anemia, Agranulocytosis;
    (ii) Current malignant neoplasms except non-melanoma skin cancers 
such as basal cell and squamous cell cancer and primary CNS tumors 
without evident metastatic disease;
    (iii) Previous malignant neoplasms with current evident metastatic 
disease;
    (iv) A history of melanoma;
    (v) Hematologic malignancies: Leukemia, Hodgkin's Disease, Lymphoma, 
Multiple Myeloma;
    (vi) Active Fungal, Parasitic, Viral, or Bacterial Meningitis or 
Encephalitis; and
    (vii) No discernable cause of death.
    (8) Notwithstanding paragraph (6)(ii)(B) of this definition, an HIV 
positive organ procured for the purpose of transplantation into an HIV 
positive recipient would be an exception to an active infection rule 
out, consistent with the HIV Organ Policy Equity Act (the Hope Act).
    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 beneficiaries 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 specia