[Title 42 CFR ]
[Code of Federal Regulations (annual edition) - October 1, 2010 Edition]
[From the U.S. Government Printing Office]
[[Page i]]
42
Part 482 to End
Revised as of October 1, 2010
Public Health
________________________
Containing a codification of documents of general
applicability and future effect
As of October 1, 2010
With Ancillaries
Published by
Office of the Federal Register
National Archives and Records
Administration
A Special Edition of the Federal Register
[[Page ii]]
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[[Page iii]]
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 707
Finding Aids:
Table of CFR Titles and Chapters........................ 813
Alphabetical List of Agencies Appearing in the CFR...... 833
Table of OMB Control Numbers............................ 843
List of CFR Sections Affected........................... 845
[[Page iv]]
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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.
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[[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
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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
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LEGAL STATUS
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HOW TO USE THE CODE OF FEDERAL REGULATIONS
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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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Office of the Federal Register.
October 1, 2010.
[[Page ix]]
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, 2010.
The OMB control numbers for the Centers for Medicare & Medicaid
Services appear in Sec. 400.310 of chapter IV. For the convenience of
the user, subpart C consisting of Sec. Sec. 400.300-400.310 is
reprinted in the Finding Aids section of the third, fourth and fifth
volumes.
For this volume, Jonn V. Lilyea was Chief Editor. The Code of
Federal Regulations publication program is under the direction of
Michael L. White, assisted by Ann Worley.
[[Page 1]]
TITLE 42--PUBLIC HEALTH
(This book contains parts 482 to End)
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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)
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Editorial Note: Nomenclature changes to chapter IV appear at 66 FR
39452, July 31, 2001; 67 FR 36540, May 24, 2002; and 69 FR 18803, Apr.
9, 2004.
SUBCHAPTER G--STANDARDS AND CERTIFICATION
Part Page
482 Conditions of participation for hospitals... 5
483 Requirements for States and long term care
facilities.............................. 40
484 Home health services........................ 111
485 Conditions of participation: Specialized
providers............................... 132
486 Conditions for coverage of specialized
services furnished by suppliers......... 161
488 Survey, certification, and enforcement
procedures.............................. 179
489 Provider agreements and supplier approval... 469
491 Certification of certain health facilities.. 501
493 Laboratory requirements..................... 506
494 Conditions for coverage for end-stage renal
disease facilities...................... 627
495 Standards for the Electronic Health Record
Technology Incentive Program............ 643
498 Appeals procedures for determinations that
affect participation in the Medicare
program and for determinations that
affect the participation of ICFs/MR and
certain NFs in the Medicaid program..... 684
SUBCHAPTER H--HEALTH CARE INFRASTRUCTURE IMPROVEMENT PROGRAM
505 Establishment of the health care
infrastructure improvement program...... 702
[[Page 5]]
SUBCHAPTER G_STANDARDS AND CERTIFICATION
PART 482_CONDITIONS OF PARTICIPATION FOR HOSPITALS--Table of Contents
Subpart A_General Provisions
Sec.
482.1 Basis and scope.
482.2 Provision of emergency services by nonparticipating hospitals.
Subpart B_Administration
482.11 Condition of participation: Compliance with Federal, State and
local laws.
482.12 Condition of participation: Governing body.
482.13 Condition of participation: Patient's rights.
Subpart C_Basic Hospital Functions
482.21 Condition of participation: Quality assessment and performance
improvement program.
482.22 Condition of participation: Medical staff.
482.23 Condition of participation: Nursing services.
482.24 Condition of participation: Medical record services.
482.25 Condition of participation: Pharmaceutical services.
482.26 Condition of participation: Radiologic services.
482.27 Condition of participation: Laboratory services.
482.28 Condition of participation: Food and dietetic services.
482.30 Condition of participation: Utilization review.
482.41 Condition of participation: Physical environment.
482.42 Condition of participation: Infection control.
482.43 Condition of participation: Discharge planning.
482.45 Condition of participation: Organ, tissue, and eye procurement.
Subpart D_Optional Hospital Services
482.51 Condition of participation: Surgical services.
482.52 Condition of participation: Anesthesia services.
482.53 Condition of participation: Nuclear medicine services.
482.54 Condition of participation: Outpatient services.
482.55 Condition of participation: Emergency services.
482.56 Condition of participation: Rehabilitation services.
482.57 Condition of participation: Respiratory care services.
Subpart E_Requirements for Specialty Hospitals
482.60 Special provisions applying to psychiatric hospitals.
482.61 Condition of participation: Special medical record requirements
for psychiatric hospitals.
482.62 Condition of participation: Special staff requirements for
psychiatric hospitals.
482.66 Special requirements for hospital providers of long-term care
services (``swing-beds'').
482.68 Special requirements for transplant centers.
482.70 Definitions.
General Requirements for Transplant Centers
482.72 Condition of participation: OPTN Membership.
482.74 Condition of participation: Notification to CMS.
482.76 Condition of participation: Pediatric Transplants.
Transplant Center Data Submission, Clinical Experience, and Outcome
Requirements
482.80 Condition of participation: Data submission, clinical experience,
and outcome requirements for initial approval of transplant
centers.
482.82 Condition of participation: Data submission, clinical experience,
and outcome requirements for re-approval of transplant
centers.
Transplant Center Process Requirements
482.90 Condition of participation: Patient and living donor selection.
482.92 Condition of participation: Organ recovery and receipt.
482.94 Condition of participation: Patient and living donor management.
482.96 Condition of participation: Quality assessment and performance
improvement (QAPI).
482.98 Condition of participation: Human resources.
482.100 Condition of participation: Organ procurement.
482.102 Condition of participation: Patient and living donor rights.
482.104 Condition of participation: Additional requirements for kidney
transplant centers.
[[Page 6]]
Authority: Secs. 1102, 1871 and 1881 of the Social Security Act (42
U.S.C. 1302, 1395hh, and 1395rr), unless otherwise noted.
Source: 51 FR 22042, June 17, 1986, unless otherwise noted.
Subpart A_General Provisions
Sec. 482.1 Basis and scope.
(a) Statutory basis. (1) Section 1861(e) of the Act provides that--
(i) Hospitals participating in Medicare must meet certain specified
requirements; and
(ii) The Secretary may impose additional requirements if they are
found necessary in the interest of the health and safety of the
individuals who are furnished services in hospitals.
(2) Section 1861(f) of the Act provides that an institution
participating in Medicare as a psychiatric hospital must meet certain
specified requirements imposed on hospitals under section 1861(e), must
be primarily engaged in providing, by or under the supervision of a
physician, psychiatric services for the diagnosis and treatment of
mentally ill persons, must maintain clinical records and other records
that the Secretary finds necessary, and must meet staffing requirements
that the Secretary finds necessary to carry out an active program of
treatment for individuals who are furnished services in the hospital. A
distinct part of an institution can participate as a psychiatric
hospital if the institution meets the specified 1861(e) requirements and
is primarily engaged in providing psychiatric services, and if the
distinct part meets the records and staffing requirements that the
Secretary finds necessary.
(3) Sections 1861(k) and 1902(a)(30) of the Act provide that
hospitals participating in Medicare and Medicaid must have a utilization
review plan that meets specified requirements.
(4) Section 1883 of the Act sets forth the requirements for
hospitals that provide long term care under an agreement with the
Secretary.
(5) Section 1905(a) of the Act provides that ``medical assistance''
(Medicaid) payments may be applied to various hospital services.
Regulations interpreting those provisions specify that hospitals
receiving payment under Medicaid must meet the requirements for
participation in Medicare (except in the case of medical supervision of
nurse-midwife services. See Sec. Sec. 440.10 and 440.165 of this
chapter.).
(b) Scope. Except as provided in subpart A of part 488 of this
chapter, the provisions of this part serve as the basis of survey
activities for the purpose of determining whether a hospital qualifies
for a provider agreement under Medicare and Medicaid.
[51 FR 22042, June 17, 1986, as amended at 60 FR 50442, Sept. 29, 1995]
Sec. 482.2 Provision of emergency services by nonparticipating hospitals.
(a) The services of an institution that does not have an agreement
to participate in the Medicare program may, nevertheless, be reimbursed
under the program if--
(1) The services are emergency services; and
(2) The institution meets the requirements of section 1861(e) (1)
through (5) and (7) of the Act. Rules applicable to emergency services
furnished by nonparticipating hospitals are set forth in subpart G of
part 424 of this chapter.
(b) Section 440.170(e) of this chapter defines emergency hospital
services for purposes of Medicaid reimbursement.
[51 FR 22042, June 17, 1986, as amended at 53 FR 6648, Mar. 2, 1988]
Subpart B_Administration
Sec. 482.11 Condition of participation: Compliance with Federal, State and
local laws.
(a) The hospital must be in compliance with applicable Federal laws
related to the health and safety of patients.
(b) The hospital must be--
(1) Licensed; or
(2) Approved as meeting standards for licensing established by the
agency of the State or locality responsible for licensing hospitals.
(c) The hospital must assure that personnel are licensed or meet
other applicable standards that are required by State or local laws.
[[Page 7]]
Sec. 482.12 Condition of participation: Governing body.
The hospital must have an effective governing body legally
responsible for the conduct of the hospital as an institution. If a
hospital does not have an organized governing body, the persons legally
responsible for the conduct of the hospital must carry out the functions
specified in this part that pertain to the governing body.
(a) Standard: Medical staff. The governing body must:
(1) Determine, in accordance with State law, which categories of
practitioners are eligible candidates for appointment to the medical
staff;
(2) Appoint members of the medical staff after considering the
recommendations of the existing members of the medical staff;
(3) Assure that the medical staff has bylaws;
(4) Approve medical staff bylaws and other medical staff rules and
regulations;
(5) Ensure that the medical staff is accountable to the governing
body for the quality of care provided to patients;
(6) Ensure the criteria for selection are individual character,
competence, training, experience, and judgment; and
(7) Ensure that under no circumstances is the accordance of staff
membership or professional privileges in the hospital dependent solely
upon certification, fellowship, or membership in a specialty body or
society.
(b) Standard: Chief executive officer. The governing body must
appoint a chief executive officer who is responsible for managing the
hospital.
(c) Standard: Care of patients. In accordance with hospital policy,
the governing body must ensure that the following requirements are met:
(1) Every Medicare patient is under the care of:
(i) A doctor of medicine or osteopathy (This provision is not to be
construed to limit the authority of a doctor of medicine or osteopathy
to delegate tasks to other qualified health care personnel to the extent
recognized under State law or a State's regulatory mechanism.);
(ii) A doctor of dental surgery or dental medicine who is legally
authorized to practice dentistry by the State and who is acting within
the scope of his or her license;
(iii) A doctor of podiatric medicine, but only with respect to
functions which he or she is legally authorized by the State to perform;
(iv) A doctor of optometry who is legally authorized to practice
optometry by the State in which he or she practices;
(v) A chiropractor who is licensed by the State or legally
authorized to perform the services of a chiropractor, but only with
respect to treatment by means of manual manipulation of the spine to
correct a subluxation demonstrated by x-ray to exist; and
(vi) A clinical psychologist as defined in Sec. 410.71 of this
chapter, but only with respect to clinical psychologist services as
defined in Sec. 410.71 of this chapter and only to the extent permitted
by State law.
(2) Patients are admitted to the hospital only on the recommendation
of a licensed practitioner permitted by the State to admit patients to a
hospital. If a Medicare patient is admitted by a practitioner not
specified in paragraph (c)(1) of this section, that patient is under the
care of a doctor of medicine or osteopathy.
(3) A doctor of medicine or osteopathy is on duty or on call at all
times.
(4) A doctor of medicine or osteopathy is responsible for the care
of each Medicare patient with respect to any medical or psychiatric
problem that--
(i) is present on admission or develops during hospitalization; and
(ii) Is not specifically within the scope of practice of a doctor of
dental surgery, dental medicine, podiatric medicine, or optometry; a
chiropractor; or clinical psychologist, as that scope is--
(A) Defined by the medical staff;
(B) Permitted by State law; and
(C) Limited, under paragraph (c)(1)(v) of this section, with respect
to chiropractors.
(d) Standard: Institutional plan and budget. The institution must
have an overall institutional plan that meets the following conditions:
[[Page 8]]
(1) The plan must include an annual operating budget that is
prepared according to generally accepted accounting principles.
(2) The budget must include all anticipated income and expenses.
This provision does not require that the budget identify item by item
the components of each anticipated income or expense.
(3) The plan must provide for capital expenditures for at least a 3-
year period, including the year in which the operating budget specified
in paragraph (d)(2) of this section is applicable.
(4) The plan must include and identify in detail the objective of,
and the anticipated sources of financing for, each anticipated capital
expenditure in excess of $600,000 (or a lesser amount that is
established, in accordance with section 1122(g)(1) of the Act, by the
State in which the hospital is located) that relates to any of the
following:
(i) Acquisition of land;
(ii) Improvement of land, buildings, and equipment; or
(iii) The replacement, modernization, and expansion of buildings and
equipment.
(5) The plan must be submitted for review to the planning agency
designated in accordance with section 1122(b) of the Act, or if an
agency is not designated, to the appropriate health planning agency in
the State. (See part 100 of this title.) A capital expenditure is not
subject to section 1122 review if 75 percent of the health care
facility's patients who are expected to use the service for which the
capital expenditure is made are individuals enrolled in a health
maintenance organization (HMO) or competitive medical plan (CMP) that
meets the requirements of section 1876(b) of the Act, and if the
Department determines that the capital expenditure is for services and
facilities that are needed by the HMO or CMP in order to operate
efficiently and economically and that are not otherwise readily
accessible to the HMO or CMP because--
(i) The facilities do not provide common services at the same site;
(ii) The facilities are not available under a contract of reasonable
duration;
(iii) Full and equal medical staff privileges in the facilities are
not available;
(iv) Arrangements with these facilities are not administratively
feasible; or
(v) The purchase of these services is more costly than if the HMO or
CMP provided the services directly.
(6) The plan must be reviewed and updated annually.
(7) The plan must be prepared--
(i) Under the direction of the governing body; and
(ii) By a committee consisting of representatives of the governing
body, the administrative staff, and the medical staff of the
institution.
(e) Standard: Contracted services. The governing body must be
responsible for services furnished in the hospital whether or not they
are furnished under contracts. The governing body must ensure that a
contractor of services (including one for shared services and joint
ventures) furnishes services that permit the hospital to comply with all
applicable conditions of participation and standards for the contracted
services.
(1) The governing body must ensure that the services performed under
a contract are provided in a safe and effective manner.
(2) The hospital must maintain a list of all contracted services,
including the scope and nature of the services provided.
(f) Standard: Emergency services. (1) If emergency services are
provided at the hospital, the hospital must comply with the requirements
of Sec. 482.55.
(2) If emergency services are not provided at the hospital, the
governing body must assure that the medical staff has written policies
and procedures for appraisal of emergencies, initial treatment, and
referral when appropriate.
(3) If emergency services are provided at the hospital but are not
provided at one or more off-campus departments of the hospital, the
governing body of the hospital must assure that the medical staff has
written policies and procedures in effect with respect to the off-campus
department(s) for appraisal of
[[Page 9]]
emergencies and referral when appropriate.
[51 FR 22042, June 17, 1986; 51 FR 27847, Aug. 4, 1986, as amended at 53
FR 6549, Mar. 1, 1988; 53 FR 18987, May 26, 1988; 56 FR 8852, Mar. 1,
1991; 56 FR 23022, May 20, 1991; 59 FR 46514, Sept. 8, 1994; 63 FR
20130, Apr. 23, 1998; 63 FR 33874, June 22, 1998; 68 FR 53262, Sept. 9,
2003]
Sec. 482.13 Condition of participation: Patient's rights.
A hospital must protect and promote each patient's rights.
(a) Standard: Notice of rights--(1) A hospital must inform each
patient, or when appropriate, the patient's representative (as allowed
under State law), of the patient's rights, in advance of furnishing or
discontinuing patient care whenever possible.
(2) The hospital must establish a process for prompt resolution of
patient grievances and must inform each patient whom to contact to file
a grievance. The hospital's governing body must approve and be
responsible for the effective operation of the grievance process and
must review and resolve grievances, unless it delegates the
responsibility in writing to a grievance committee. The grievance
process must include a mechanism for timely referral of patient concerns
regarding quality of care or premature discharge to the appropriate
Utilization and Quality Control Quality Improvement Organization. At a
minimum:
(i) The hospital must establish a clearly explained procedure for
the submission of a patient's written or verbal grievance to the
hospital.
(ii) The grievance process must specify time frames for review of
the grievance and the provision of a response.
(iii) In its resolution of the grievance, the hospital must provide
the patient with written notice of its decision that contains the name
of the hospital contact person, the steps taken on behalf of the patient
to investigate the grievance, the results of the grievance process, and
the date of completion.
(b) Standard: Exercise of rights. (1) The patient has the right to
participate in the development and implementation of his or her plan of
care.
(2) The patient or his or her representative (as allowed under State
law) has the right to make informed decisions regarding his or her care.
The patient's rights include being informed of his or her health status,
being involved in care planning and treatment, and being able to request
or refuse treatment. This right must not be construed as a mechanism to
demand the provision of treatment or services deemed medically
unnecessary or inappropriate.
(3) The patient has the right to formulate advance directives and to
have hospital staff and practitioners who provide care in the hospital
comply with these directives, in accordance with Sec. 489.100 of this
part (Definition), Sec. 489.102 of this part (Requirements for
providers), and Sec. 489.104 of this part (Effective dates).
(4) The patient has the right to have a family member or
representative of his or her choice and his or her own physician
notified promptly of his or her admission to the hospital.
(c) Standard: Privacy and safety. (1) The patient has the right to
personal privacy.
(2) The patient has the right to receive care in a safe setting.
(3) The patient has the right to be free from all forms of abuse or
harassment.
(d) Standard: Confidentiality of patient records. (1) The patient
has the right to the confidentiality of his or her clinical records.
(2) The patient has the right to access information contained in his
or her clinical records within a reasonable time frame. The hospital
must not frustrate the legitimate efforts of individuals to gain access
to their own medical records and must actively seek to meet these
requests as quickly as its record keeping system permits.
(e) Standard: Restraint or seclusion. All patients have the right to
be free from physical or mental abuse, and corporal punishment. All
patients have the right to be free from restraint or seclusion, of any
form, imposed as a means of coercion, discipline, convenience, or
retaliation by staff. Restraint or seclusion may only be imposed to
ensure the immediate physical safety of the patient, a staff member, or
others and must be discontinued at the earliest possible time.
(1) Definitions. (i) A restraint is--
[[Page 10]]
(A) Any manual method, physical or mechanical device, material, or
equipment that immobilizes or reduces the ability of a patient to move
his or her arms, legs, body, or head freely; or
(B) A drug or medication when it is used as a restriction to manage
the patient's behavior or restrict the patient's freedom of movement and
is not a standard treatment or dosage for the patient's condition.
(C) A restraint does not include devices, such as orthopedically
prescribed devices, surgical dressings or bandages, protective helmets,
or other methods that involve the physical holding of a patient for the
purpose of conducting routine physical examinations or tests, or to
protect the patient from falling out of bed, or to permit the patient to
participate in activities without the risk of physical harm (this does
not include a physical escort).
(ii) Seclusion is the involuntary confinement of a patient alone in
a room or area from which the patient is physically prevented from
leaving. Seclusion may only be used for the management of violent or
self-destructive behavior.
(2) Restraint or seclusion may only be used when less restrictive
interventions have been determined to be ineffective to protect the
patient a staff member or others from harm.
(3) The type or technique of restraint or seclusion used must be the
least restrictive intervention that will be effective to protect the
patient, a staff member, or others from harm.
(4) The use of restraint or seclusion must be--
(i) In accordance with a written modification to the patient's plan
of care; and
(ii) Implemented in accordance with safe and appropriate restraint
and seclusion techniques as determined by hospital policy in accordance
with State law.
(5) The use of restraint or seclusion must be in accordance with the
order of a physician or other licensed independent practitioner who is
responsible for the care of the patient as specified under Sec.
482.12(c) and authorized to order restraint or seclusion by hospital
policy in accordance with State law.
(6) Orders for the use of restraint or seclusion must never be
written as a standing order or on an as needed basis (PRN).
(7) The attending physician must be consulted as soon as possible if
the attending physician did not order the restraint or seclusion.
(8) Unless superseded by State law that is more restrictive--
(i) Each order for restraint or seclusion used for the management of
violent or self-destructive behavior that jeopardizes the immediate
physical safety of the patient, a staff member, or others may only be
renewed in accordance with the following limits for up to a total of 24
hours:
(A) 4 hours for adults 18 years of age or older;
(B) 2 hours for children and adolescents 9 to 17 years of age; or
(C) 1 hour for children under 9 years of age; and
(ii) After 24 hours, before writing a new order for the use of
restraint or seclusion for the management of violent or self-destructive
behavior, a physician or other licensed independent practitioner who is
responsible for the care of the patient as specified under Sec.
482.12(c) of this part and authorized to order restraint or seclusion by
hospital policy in accordance with State law must see and assess the
patient.
(iii) Each order for restraint used to ensure the physical safety of
the non-violent or non-self-destructive patient may be renewed as
authorized by hospital policy.
(9) Restraint or seclusion must be discontinued at the earliest
possible time, regardless of the length of time identified in the order.
(10) The condition of the patient who is restrained or secluded must
be monitored by a physician, other licensed independent practitioner or
trained staff that have completed the training criteria specified in
paragraph (f) of this section at an interval determined by hospital
policy.
(11) Physician and other licensed independent practitioner training
requirements must be specified in hospital policy. At a minimum,
physicians and other licensed independent practitioners authorized to
order restraint or
[[Page 11]]
seclusion by hospital policy in accordance with State law must have a
working knowledge of hospital policy regarding the use of restraint or
seclusion.
(12) When restraint or seclusion is used for the management of
violent or self-destructive behavior that jeopardizes the immediate
physical safety of the patient, a staff member, or others, the patient
must be seen face-to-face within 1 hour after the initiation of the
intervention--
(i) By a--
(A) Physician or other licensed independent practitioner; or
(B) Registered nurse or physician assistant who has been trained in
accordance with the requirements specified in paragraph (f) of this
section.
(ii) To evaluate--
(A) The patient's immediate situation;
(B) The patient's reaction to the intervention;
(C) The patient's medical and behavioral condition; and
(D) The need to continue or terminate the restraint or seclusion.
(13) States are free to have requirements by statute or regulation
that are more restrictive than those contained in paragraph (e)(12)(i)
of this section.
(14) If the face-to-face evaluation specified in paragraph (e)(12)
of this section is conducted by a trained registered nurse or physician
assistant, the trained registered nurse or physician assistant must
consult the attending physician or other licensed independent
practitioner who is responsible for the care of the patient as specified
under Sec. 482.12(c) as soon as possible after the completion of the 1-
hour face-to-face evaluation.
(15) All requirements specified under this paragraph are applicable
to the simultaneous use of restraint and seclusion. Simultaneous
restraint and seclusion use is only permitted if the patient is
continually monitored--
(i) Face-to-face by an assigned, trained staff member; or
(ii) By trained staff using both video and audio equipment. This
monitoring must be in close proximity to the patient.
(16) When restraint or seclusion is used, there must be
documentation in the patient's medical record of the following:
(i) The 1-hour face-to-face medical and behavioral evaluation if
restraint or seclusion is used to manage violent or self-destructive
behavior;
(ii) A description of the patient's behavior and the intervention
used;
(iii) Alternatives or other less restrictive interventions attempted
(as applicable);
(iv) The patient's condition or symptom(s) that warranted the use of
the restraint or seclusion; and
(v) The patient's response to the intervention(s) used, including
the rationale for continued use of the intervention.
(f) Standard: Restraint or seclusion: Staff training requirements.
The patient has the right to safe implementation of restraint or
seclusion by trained staff.
(1) Training intervals. Staff must be trained and able to
demonstrate competency in the application of restraints, implementation
of seclusion, monitoring, assessment, and providing care for a patient
in restraint or seclusion--
(i) Before performing any of the actions specified in this
paragraph;
(ii) As part of orientation; and
(iii) Subsequently on a periodic basis consistent with hospital
policy.
(2) Training content. The hospital must require appropriate staff to
have education, training, and demonstrated knowledge based on the
specific needs of the patient population in at least the following:
(i) Techniques to identify staff and patient behaviors, events, and
environmental factors that may trigger circumstances that require the
use of a restraint or seclusion.
(ii) The use of nonphysical intervention skills.
(iii) Choosing the least restrictive intervention based on an
individualized assessment of the patient's medical, or behavioral status
or condition.
(iv) The safe application and use of all types of restraint or
seclusion used in the hospital, including training in how to recognize
and respond to signs of physical and psychological distress (for
example, positional asphyxia);
(v) Clinical identification of specific behavioral changes that
indicate that
[[Page 12]]
restraint or seclusion is no longer necessary.
(vi) Monitoring the physical and psychological well-being of the
patient who is restrained or secluded, including but not limited to,
respiratory and circulatory status, skin integrity, vital signs, and any
special requirements specified by hospital policy associated with the 1-
hour face-to-face evaluation.
(vii) The use of first aid techniques and certification in the use
of cardiopulmonary resuscitation, including required periodic
recertification.
(3) Trainer requirements. Individuals providing staff training must
be qualified as evidenced by education, training, and experience in
techniques used to address patients' behaviors.
(4) Training documentation. The hospital must document in the staff
personnel records that the training and demonstration of competency were
successfully completed.
(g) Standard: Death reporting requirements: Hospitals must report
deaths associated with the use of seclusion or restraint.
(1) The hospital must report the following information to CMS:
(i) Each death that occurs while a patient is in restraint or
seclusion.
(ii) Each death that occurs within 24 hours after the patient has
been removed from restraint or seclusion.
(iii) Each death known to the hospital that occurs within 1 week
after restraint or seclusion where it is reasonable to assume that use
of restraint or placement in seclusion contributed directly or
indirectly to a patient's death. ``Reasonable to assume'' in this
context includes, but is not limited to, deaths related to restrictions
of movement for prolonged periods of time, or death related to chest
compression, restriction of breathing or asphyxiation.
(2) Each death referenced in this paragraph must be reported to CMS
by telephone no later than the close of business the next business day
following knowledge of the patient's death.
(3) Staff must document in the patient's medical record the date and
time the death was reported to CMS.
[71 FR 71426, Dec. 8, 2006]
Subpart C_Basic Hospital Functions
Sec. 482.21 Condition of participation: Quality assessment and performance
improvement program.
The hospital must develop, implement, and maintain an effective,
ongoing, hospital-wide, data-driven quality assessment and performance
improvement program. The hospital's governing body must ensure that the
program reflects the complexity of the hospital's organization and
services; involves all hospital departments and services (including
those services furnished under contract or arrangement); and focuses on
indicators related to improved health outcomes and the prevention and
reduction of medical errors. The hospital must maintain and demonstrate
evidence of its QAPI program for review by CMS.
(a) Standard: Program scope. (1) The program must include, but not
be limited to, an ongoing program that shows measurable improvement in
indicators for which there is evidence that it will improve health
outcomes and identify and reduce medical errors.
(2) The hospital must measure, analyze, and track quality
indicators, including adverse patient events, and other aspects of
performance that assess processes of care, hospital service and
operations.
(b) Standard: Program data. (1) The program must incorporate quality
indicator data including patient care data, and other relevant data, for
example, information submitted to, or received from, the hospital's
Quality Improvement Organization.
(2) The hospital must use the data collected to--
(i) Monitor the effectiveness and safety of services and quality of
care; and
(ii) Identify opportunities for improvement and changes that will
lead to improvement.
(3) The frequency and detail of data collection must be specified by
the hospital's governing body.
(c) Standard: Program activities. (1) The hospital must set
priorities for its performance improvement activities that--
[[Page 13]]
(i) Focus on high-risk, high-volume, or problem-prone areas;
(ii) Consider the incidence, prevalence, and severity of problems in
those areas; and
(iii) Affect health outcomes, patient safety, and quality of care.
(2) Performance improvement activities must track medical errors and
adverse patient events, analyze their causes, and implement preventive
actions and mechanisms that include feedback and learning throughout the
hospital.
(3) The hospital must take actions aimed at performance improvement
and, after implementing those actions, the hospital must measure its
success, and track performance to ensure that improvements are
sustained.
(d) Standard: Performance improvement projects. As part of its
quality assessment and performance improvement program, the hospital
must conduct performance improvement projects.
(1) The number and scope of distinct improvement projects conducted
annually must be proportional to the scope and complexity of the
hospital's services and operations.
(2) A hospital may, as one of its projects, develop and implement an
information technology system explicitly designed to improve patient
safety and quality of care. This project, in its initial stage of
development, does not need to demonstrate measurable improvement in
indicators related to health outcomes.
(3) The hospital must document what quality improvement projects are
being conducted, the reasons for conducting these projects, and the
measurable progress achieved on these projects.
(4) A hospital is not required to participate in a QIO cooperative
project, but its own projects are required to be of comparable effort.
(e) Standard: Executive responsibilities. The hospital's governing
body (or organized group or individual who assumes full legal authority
and responsibility for operations of the hospital), medical staff, and
administrative officials are responsible and accountable for ensuring
the following:
(1) That an ongoing program for quality improvement and patient
safety, including the reduction of medical errors, is defined,
implemented, and maintained.
(2) That the hospital-wide quality assessment and performance
improvement efforts address priorities for improved quality of care and
patient safety; and that all improvement actions are evaluated.
(3) That clear expectations for safety are established.
(4) That adequate resources are allocated for measuring, assessing,
improving, and sustaining the hospital's performance and reducing risk
to patients.
(5) That the determination of the number of distinct improvement
projects is conducted annually.
[68 FR 3454, Jan. 24, 2003]
Sec. 482.22 Condition of participation: Medical staff.
The hospital must have an organized medical staff that operates
under bylaws approved by the governing body and is responsible for the
quality of medical care provided to patients by the hospital.
(a) Standard: Composition of the medical staff. The medical staff
must be composed of doctors of medicine or osteopathy and, in accordance
with State law, may also be composed of other practitioners appointed by
the governing body.
(1) The medical staff must periodically conduct appraisals of its
members.
(2) The medical staff must examine credentials of candidates for
medical staff membership and make recommendations to the governing body
on the appointment of the candidates.
(b) Standard: Medical staff organization and accountability. The
medical staff must be well organized and accountable to the governing
body for the quality of the medical care provided to patients.
(1) The medical staff must be organized in a manner approved by the
governing body.
(2) If the medical staff has an executive committee, a majority of
the members of the committee must be doctors of medicine or osteopathy.
(3) The responsibility for organization and conduct of the medical
staff must be assigned only to an individual
[[Page 14]]
doctor of medicine or osteopathy or, when permitted by State law of the
State in which the hospital is located, a doctor of dental surgery or
dental medicine.
(c) Standard: Medical staff bylaws. The medical staff must adopt and
enforce bylaws to carry out its responsibilities. The bylaws must:
(1) Be approved by the governing body.
(2) Include a statement of the duties and privileges of each
category of medical staff (e.g., active, courtesy, etc.)
(3) Describe the organization of the medical staff.
(4) Describe the qualifications to be met by a candidate in order
for the medical staff to recommend that the candidate be appointed by
the governing body.
(5) Include a requirement that--
(i) A medical history and physical examination be completed and
documented for each patient no more than 30 days before or 24 hours
after admission or registration, but prior to surgery or a procedure
requiring anesthesia services. The medical history and physical
examination must be completed and documented by a physician (as defined
in section 1861(r) of the Act), an oromaxillofacial surgeon, or other
qualified licensed individual in accordance with State law and hospital
policy.
(ii) An updated examination of the patient, including any changes in
the patient's condition, be completed and documented within 24 hours
after admission or registration, but prior to surgery or a procedure
requiring anesthesia services, when the medical history and physical
examination are completed within 30 days before admission or
registration. The updated examination of the patient, including any
changes in the patient's condition, must be completed and documented by
a physician (as defined in section 1861(r) of the Act), an
oromaxillofacial surgeon, or other qualified licensed individual in
accordance with State law and hospital policy.
(6) Include criteria for determining the privileges to be granted to
individual practitioners and a procedure for applying the criteria to
individuals requesting privileges.
(d) Standard: Autopsies. The medical staff should attempt to secure
autopsies in all cases of unusual deaths and of medical-legal and
educational interest. The mechanism for documenting permission to
perform an autopsy must be defined. There must be a system for notifying
the medical staff, and specifically the attending practitioner, when an
autopsy is being performed.
[51 FR 22042, June 17, 1986, as amended at 59 FR 64152, Dec. 13, 1994;
71 FR 68694, Nov. 27, 2006; 72 FR 66933, Nov. 27, 2007]
Sec. 482.23 Condition of participation: Nursing services.
The hospital must have an organized nursing service that provides
24-hour nursing services. The nursing services must be furnished or
supervised by a registered nurse.
(a) Standard: Organization. The hospital must have a well-organized
service with a plan of administrative authority and delineation of
responsibilities for patient care. The director of the nursing service
must be a licensed registered nurse. He or she is responsible for the
operation of the service, including determining the types and numbers of
nursing personnel and staff necessary to provide nursing care for all
areas of the hospital.
(b) Standard: Staffing and delivery of care. The nursing service
must have adequate numbers of licensed registered nurses, licensed
practical (vocational) nurses, and other personnel to provide nursing
care to all patients as needed. There must be supervisory and staff
personnel for each department or nursing unit to ensure, when needed,
the immediate availability of a registered nurse for bedside care of any
patient.
(1) The hospital must provide 24-hour nursing services furnished or
supervised by a registered nurse, and have a licensed practical nurse or
registered nurse on duty at all times, except for rural hospitals that
have in effect a 24-hour nursing waiver granted under Sec. 488.54(c) of
this chapter.
(2) The nursing service must have a procedure to ensure that
hospital nursing personnel for whom licensure is required have valid and
current licensure.
[[Page 15]]
(3) A registered nurse must supervise and evaluate the nursing care
for each patient.
(4) The hospital must ensure that the nursing staff develops, and
keeps current, a nursing care plan for each patient.
(5) A registered nurse must assign the nursing care of each patient
to other nursing personnel in accordance with the patient's needs and
the specialized qualifications and competence of the nursing staff
available.
(6) Non-employee licensed nurses who are working in the hospital
must adhere to the policies and procedures of the hospital. The director
of nursing service must provide for the adequate supervision and
evaluation of the clinical activities of non-employee nursing personnel
which occur within the responsibility of the nursing service.
(c) Standard: Preparation and administration of drugs. Drugs and
biologicals must be prepared and administered in accordance with Federal
and State laws, the orders of the practitioner or practitioners
responsible for the patient's care as specified under Sec. 482.12(c),
and accepted standards of practice.
(1) All drugs and biologicals must be administered by, or under
supervision of, nursing or other personnel in accordance with Federal
and State laws and regulations, including applicable licensing
requirements, and in accordance with the approved medical staff policies
and procedures.
(2) With the exception of influenza and pneumococcal polysaccharide
vaccines, which may be administered per physician-approved hospital
policy after an assessment of contraindications, orders for drugs and
biologicals must be documented and signed by a practitioner who is
authorized to write orders by hospital policy and in accordance with
State law, and who is responsible for the care of the patient as
specified under Sec. 482.12(c).
(i) If verbal orders are used, they are to be used infrequently.
(ii) When verbal orders are used, they must only be accepted by
persons who are authorized to do so by hospital policy and procedures
consistent with Federal and State law.
(3) Blood transfusions and intravenous medications must be
administered in accordance with State law and approved medical staff
policies and procedures. If blood transfusions and intravenous
medications are administered by personnel other than doctors of medicine
or osteopathy, the personnel must have special training for this duty.
(4) There must be a hospital procedure for reporting transfusion
reactions, adverse drug reactions, and errors in administration of
drugs.
[51 FR 22042, June 17, 1986, as amended at 67 FR 61814, Oct. 2, 2002; 71
FR 68694, Nov. 27, 2006; 72 FR 66933, Nov. 27, 2007]
Sec. 482.24 Condition of participation: Medical record services.
The hospital must have a medical record service that has
administrative responsibility for medical records. A medical record must
be maintained for every individual evaluated or treated in the hospital.
(a) Standard: Organization and staffing. The organization of the
medical record service must be appropriate to the scope and complexity
of the services performed. The hospital must employ adequate personnel
to ensure prompt completion, filing, and retrieval of records.
(b) Standard: Form and retention of record. The hospital must
maintain a medical record for each inpatient and outpatient. Medical
records must be accurately written, promptly completed, properly filed
and retained, and accessible. The hospital must use a system of author
identification and record maintenance that ensures the integrity of the
authentification and protects the security of all record entries.
(1) Medical records must be retained in their original or legally
reproduced form for a period of at least 5 years.
(2) The hospital must have a system of coding and indexing medical
records. The system must allow for timely retrieval by diagnosis and
procedure, in order to support medical care evaluation studies.
(3) The hospital must have a procedure for ensuring the
confidentiality of patient records. In-formation from or copies of
records may be released only
[[Page 16]]
to authorized individuals, and the hospital must ensure that
unauthorized individuals cannot gain access to or alter patient records.
Original medical records must be released by the hospital only in
accordance with Federal or State laws, court orders, or subpoenas.
(c) Standard: Content of record. The medical record must contain
information to justify admission and continued hospitalization, support
the diagnosis, and describe the patient's progress and response to
medications and services.
(1) All patient medical record entries must be legible, complete,
dated, timed, and authenticated in written or electronic form by the
person responsible for providing or evaluating the service provided,
consistent with hospital policies and procedures.
(i) All orders, including verbal orders, must be dated, timed, and
authenticated promptly by the ordering practitioner, except as noted in
paragraph (c)(1)(ii) of this section.
(ii) For the 5 year period following January 26, 2007, all orders,
including verbal orders, must be dated, timed, and authenticated by the
ordering practitioner or another practitioner who is responsible for the
care of the patient as specified under Sec. 482.12(c) and authorized to
write orders by hospital policy in accordance with State law.
(iii) All verbal orders must be authenticated based upon Federal and
State law. If there is no State law that designates a specific timeframe
for the authentication of verbal orders, verbal orders must be
authenticated within 48 hours.
(2) All records must document the following, as appropriate:
(i) Evidence of--
(A) A medical history and physical examination completed and
documented no more than 30 days before or 24 hours after admission or
registration, but prior to surgery or a procedure requiring anesthesia
services. The medical history and physical examination must be placed in
the patient's medical record within 24 hours after admission or
registration, but prior to surgery or a procedure requiring anesthesia
services.
(B) An updated examination of the patient, including any changes in
the patient's condition, when the medical history and physical
examination are completed within 30 days before admission or
registration. Documentation of the updated examination must be placed in
the patient's medical record within 24 hours after admission or
registration, but prior to surgery or a procedure requiring anesthesia
services.
(ii) Admitting diagnosis.
(iii) Results of all consultative evaluations of the patient and
appropriate findings by clinical and other staff involved in the care of
the patient.
(iv) Documentation of complications, hospital acquired infections,
and unfavorable reactions to drugs and anesthesia.
(v) Properly executed informed consent forms for procedures and
treatments specified by the medical staff, or by Federal or State law if
applicable, to require written patient consent.
(vi) All practitioners' orders, nursing notes, reports of treatment,
medication records, radiology, and laboratory reports, and vital signs
and other information necessary to monitor the patient's condition.
(vii) Discharge summary with outcome of hospitalization, disposition
of case, and provisions for follow-up care.
(viii) Final diagnosis with completion of medical records within 30
days following discharge.
[51 FR 22042, June 17, 1986, as amended at 71 FR 68694, Nov. 27, 2006;
72 FR 66933, Nov. 27, 2007]
Sec. 482.25 Condition of participation: Pharmaceutical services.
The hospital must have pharmaceutical services that meet the needs
of the patients. The institution must have a pharmacy directed by a
registered pharmacist or a drug storage area under competent
supervision. The medical staff is responsible for developing policies
and procedures that minimize drug errors. This function may be delegated
to the hospital's organized pharmaceutical service.
(a) Standard: Pharmacy management and administration. The pharmacy
or drug storage area must be administered in accordance with accepted
professional principles.
(1) A full-time, part-time, or consulting pharmacist must be
responsible
[[Page 17]]
for developing, supervising, and coordinating all the activities of the
pharmacy services.
(2) The pharmaceutical service must have an adequate number of
personnel to ensure quality pharmaceutical services, including emergency
services.
(3) Current and accurate records must be kept of the receipt and
disposition of all scheduled drugs.
(b) Standard: Delivery of services. In order to provide patient
safety, drugs and biologicals must be controlled and distributed in
accordance with applicable standards of practice, consistent with
Federal and State law.
(1) All compounding, packaging, and dispensing of drugs and
biologicals must be under the supervision of a pharmacist and performed
consistent with State and Federal laws.
(2)(i) All drugs and biologicals must be kept in a secure area, and
locked when appropriate.
(ii) Drugs listed in Schedules II, III, IV, and V of the
Comprehensive Drug Abuse Prevention and Control Act of 1970 must be kept
locked within a secure area.
(iii) Only authorized personnel may have access to locked areas.
(3) Outdated, mislabeled, or otherwise unusable drugs and
biologicals must not be available for patient use.
(4) When a pharmacist is not available, drugs and biologicals must
be removed from the pharmacy or storage area only by personnel
designated in the policies of the medical staff and pharmaceutical
service, in accordance with Federal and State law.
(5) Drugs and biologicals not specifically prescribed as to time or
number of doses must automatically be stopped after a reasonable time
that is predetermined by the medical staff.
(6) Drug administration errors, adverse drug reactions, and
incompatibilities must be immediately reported to the attending
physician and, if appropriate, to the hospital-wide quality assurance
program.
(7) Abuses and losses of controlled substances must be reported, in
accordance with applicable Federal and State laws, to the individual
responsible for the pharmaceutical service, and to the chief executive
officer, as appropriate.
(8) Information relating to drug interactions and information of
drug therapy, side effects, toxicology, dosage, indications for use, and
routes of administration must be available to the professional staff.
(9) A formulary system must be established by the medical staff to
assure quality pharmaceuticals at reasonable costs.
[51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986; 71 FR 68694,
Nov. 27, 2006]
Sec. 482.26 Condition of participation: Radiologic services.
The hospital must maintain, or have available, diagnostic radiologic
services. If therapeutic services are also provided, they, as well as
the diagnostic services, must meet professionally approved standards for
safety and personnel qualifications.
(a) Standard: Radiologic services. The hospital must maintain, or
have available, radiologic services according to needs of the patients.
(b) Standard: Safety for patients and personnel. The radiologic
services, particularly ionizing radiology procedures, must be free from
hazards for patients and personnel.
(1) Proper safety precutions must be maintained against radiation
hazards. This includes adequate shielding for patients, personnel, and
facilities, as well as appropriate storage, use, and disposal of
radioactive materials.
(2) Periodic inspection of equipment must be made and hazards
identified must be promptly corrected.
(3) Radiation workers must be checked periodically, by the use of
exposure meters or badge tests, for amount of radiation exposure.
(4) Radiologic services must be provided only on the order of
practitioners with clinical privileges or, consistent with State law, of
other practitioners authorized by the medical staff and the governing
body to order the services.
(c) Standard: Personnel. (1) A qualified full-time, part-time, or
consulting radiologist must supervise the ionizing radiology services
and must interpret
[[Page 18]]
only those radiologic tests that are determined by the medical staff to
require a radiologist's specialized knowledge. For purposes of this
section, a radiologist is a doctor of medicine or osteopathy who is
qualified by education and experience in radiology.
(2) Only personnel designated as qualified by the medical staff may
use the radiologic equipment and administer procedures.
(d) Standard: Records. Records of radiologic services must be
maintained.
(1) The radiologist or other practitioner who performs radiology
services must sign reports of his or her interpretations.
(2) The hospital must maintain the following for at least 5 years:
(i) Copies of reports and printouts.
(ii) Films, scans, and other image records, as appropriate.
[51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986]
Sec. 482.27 Condition of participation: Laboratory services.
The hospital must maintain, or have available, adequate laboratory
services to meet the needs of its patients. The hospital must ensure
that all laboratory services provided to its patients are performed in a
facility certified in accordance with part 493 of this chapter.
(a) Standard: Adequacy of laboratory services. The hospital must
have laboratory services available, either directly or through a
contractual agreement with a certified laboratory that meets
requirements of part 493 of this chapter.
(1) Emergency laboratory services must be available 24 hours a day.
(2) A written description of services provided must be available to
the medical staff.
(3) The laboratory must make provision for proper receipt and
reporting of tissue specimens.
(4) The medical staff and a pathologist must determine which tissue
specimens require a macroscopic (gross) examination and which require
both macroscopic and microscopic examinations.
(b) Standard: Potentially infectious blood and blood components--(1)
Potentially human immunodeficiency virus (HIV) infectious blood and
blood components. Potentially HIV infectious blood and blood components
are prior collections from a donor--
(i) Who tested negative at the time of donation but tests reactive
for evidence of HIV infection on a later donation;
(ii) Who tests positive on the supplemental (additional, more
specific) test or other follow-up testing required by FDA; and
(iii) For whom the timing of seroconversion cannot be precisely
estimated.
(2) Potentially hepatitis C virus (HCV) infectious blood and blood
components. Potentially HCV infectious blood and blood components are
the blood and blood components identified in 21 CFR 610.47.
(3) Services furnished by an outside blood collecting establishment.
If a hospital regularly uses the services of an outside blood collecting
establishment, it must have an agreement with the blood collecting
establishment that governs the procurement, transfer, and availability
of blood and blood components. The agreement must require that the blood
collecting establishment notify the hospital--
(i) Within 3 calendar days if the blood collecting establishment
supplied blood and blood components collected from a donor who tested
negative at the time of donation but tests reactive for evidence of HIV
or HCV infection on a later donation or who is determined to be at
increased risk for transmitting HIV or HCV infection;
(ii) Within 45 days of the test, of the results of the supplemental
(additional, more specific) test for HIV or HCV, as relevant, or other
follow-up testing required by FDA; and
(iii) Within 3 calendar days after the blood collecting
establishment supplied blood and blood components collected from an
infectious donor, whenever records are available, as set forth at 21 CFR
610.48(b)(3).
(4) Quarantine and disposition of blood and blood components pending
completion of testing. If the blood collecting establishment (either
internal or under an agreement) notifies the hospital of the
[[Page 19]]
reactive HIV or HCV screening test results, the hospital must determine
the disposition of the blood or blood product and quarantine all blood
and blood components from previous donations in inventory.
(i) If the blood collecting establishment notifies the hospital that
the result of the supplemental (additional, more specific) test or other
follow-up testing required by FDA is negative, absent other informative
test results, the hospital may release the blood and blood components
from quarantine.
(ii) If the blood collecting establishment notifies the hospital
that the result of the supplemental, (additional, more specific) test or
other follow-up testing required by FDA is positive, the hospital must--
(A) Dispose of the blood and blood components; and
(B) Notify the transfusion recipients as set forth in paragraph
(b)(6) of this section.
(iii) If the blood collecting establishment notifies the hospital
that the result of the supplemental, (additional, more specific) test or
other follow-up testing required by FDA is indeterminate, the hospital
must destroy or label prior collections of blood or blood components
held in quarantine as set forth at 21 CFR 610.46(b)(2), 610.47(b)(2),
and 610.48(c)(2).
(5) Recordkeeping by the hospital. The hospital must maintain--
(i) Records of the source and disposition of all units of blood and
blood components for at least 10 years from the date of disposition in a
manner that permits prompt retrieval; and
(ii) A fully funded plan to transfer these records to another
hospital or other entity if such hospital ceases operation for any
reason.
(6) Patient notification. If the hospital has administered
potentially HIV or HCV infectious blood or blood components (either
directly through its own blood collecting establishment or under an
agreement) or released such blood or blood components to another entity
or individual, the hospital must take the following actions:
(i) Make reasonable attempts to notify the patient, or to notify the
attending physician or the physician who ordered the blood or blood
component and ask the physician to notify the patient, or other
individual as permitted under paragraph (b)(10) of this section, that
potentially HIV or HCV infectious blood or blood components were
transfused to the patient and that there may be a need for HIV or HCV
testing and counseling.
(ii) If the physician is unavailable or declines to make the
notification, make reasonable attempts to give this notification to the
patient, legal guardian, or relative.
(iii) Document in the patient's medical record the notification or
attempts to give the required notification.
(7) Timeframe for notification--(i) For donors tested on or after
February 20, 2008. For notifications resulting from donors tested on or
after February 20, 2008 as set forth at 21 CFR 610.46 and 21 CFR 610.47
the notification effort begins when the blood collecting establishment
notifies the hospital that it received potentially HIV or HCV infectious
blood and blood components. The hospital must make reasonable attempts
to give notification over a period of 12 weeks unless--
(A) The patient is located and notified; or
(B) The hospital is unable to locate the patient and documents in
the patient's medical record the extenuating circumstances beyond the
hospital's control that caused the notification timeframe to exceed 12
weeks.
(ii) For donors tested before February 20, 2008. For notifications
resulting from donors tested before February 20, 2008 as set forth at 21
CFR 610.48(b) and (c), the notification effort begins when the blood
collecting establishment notifies the hospital that it received
potentially HCV infectious blood and blood components. The hospital must
make reasonable attempts to give notification and must complete the
actions within 1 year of the date on which the hospital received
notification from the outside blood collecting establishment.
(8) Content of notification. The notification must include the
following information:
(i) A basic explanation of the need for HIV or HCV testing and
counseling;
(ii) Enough oral or written information so that an informed decision
can
[[Page 20]]
be made about whether to obtain HIV or HCV testing and counseling; and
(iii) A list of programs or places where the person can obtain HIV
or HCV testing and counseling, including any requirements or
restrictions the program may impose.
(9) Policies and procedures. The hospital must establish policies
and procedures for notification and documentation that conform to
Federal, State, and local laws, including requirements for the
confidentiality of medical records and other patient information.
(10) Notification to legal representative or relative. If the
patient has been adjudged incompetent by a State court, the physician or
hospital must notify a legal representative designated in accordance
with State law. If the patient is competent, but State law permits a
legal representative or relative to receive the information on the
patient's behalf, the physician or hospital must notify the patient or
his or her legal representative or relative. For possible HIV infectious
transfusion recipients that are deceased, the physician or hospital must
inform the deceased patient's legal representative or relative. If the
patient is a minor, the parents or legal guardian must be notified.
(11) Applicability. HCV notification requirements resulting from
donors tested before February 20, 2008 as set forth at 21 CFR 610.48
will expire on August 24, 2015.
(c) General blood safety issues. For lookback activities only
related to new blood safety issues that are identified after August 24,
2007, hospitals must comply with FDA regulations as they pertain to
blood safety issues in the following areas:
(1) Appropriate testing and quarantining of infectious blood and
blood components.
(2) Notification and counseling of recipients that may have received
infectious blood and blood components.
[57 FR 7136, Feb. 28, 1992, as amended at 61 FR 47433, Sept. 9, 1996; 72
FR 48573, Aug. 24, 2007]
Sec. 482.28 Condition of participation: Food and dietetic services.
The hospital must have organized dietary services that are directed
and staffed by adequate qualified personnel. However, a hospital that
has a contract with an outside food management company may be found to
meet this Condition of participation if the company has a dietitian who
serves the hospital on a full-time, part-time, or consultant basis, and
if the company maintains at least the minimum standards specified in
this section and provides for constant liaison with the hospital medical
staff for recommendations on dietetic policies affecting patient
treatment.
(a) Standard: Organization. (1) The hospital must have a full-time
employee who--
(i) Serves as director of the food and dietetic service;
(ii) Is responsible for the daily management of the dietary
services; and
(iii) Is qualified by experience or training.
(2) There must be a qualified dietitian, full-time, part-time, or on
a consultant basis.
(3) There must be administrative and technical personnel competent
in their respective duties.
(b) Standard: Diets. Menus must meet the needs of the patients.
(1) Therapeutic diets must be prescribed by the practitioner or
practitioners responsible for the care of the patients.
(2) Nutritional needs must be met in accordance with recognized
dietary practices and in accordance with orders of the practitioner or
practitioners responsible for the care of the patients.
(3) A current therapeutic diet manual approved by the dietitian and
medical staff must be readily available to all medical, nursing, and
food service personnel.
Sec. 482.30 Condition of participation: Utilization review.
The hospital must have in effect a utilization review (UR) plan that
provides for review of services furnished by the institution and by
members of the medical staff to patients entitled to benefits under the
Medicare and Medicaid programs.
(a) Applicability. The provisions of this section apply except in
either of the following circumstances:
(1) A Utilization and Quality Control Quality Improvement
Organization
[[Page 21]]
(QIO) has assumed binding review for the hospital.
(2) CMS has determined that the UR procedures established by the
State under title XIX of the Act are superior to the procedures required
in this section, and has required hospitals in that State to meet the UR
plan requirements under Sec. Sec. 456.50 through 456.245 of this
chapter.
(b) Standard: Composition of utilization review committee. A UR
committee consisting of two or more practitioners must carry out the UR
function. At least two of the members of the committee must be doctors
of medicine or osteopathy. The other members may be any of the other
types of practitioners specified in Sec. 482.12(c)(1).
(1) Except as specified in paragraphs (b) (2) and (3) of this
section, the UR committee must be one of the following:
(i) A staff committee of the institution;
(ii) A group outside the institution--
(A) Established by the local medical society and some or all of the
hospitals in the locality; or
(B) Established in a manner approved by CMS.
(2) If, because of the small size of the institution, it is
impracticable to have a properly functioning staff committee, the UR
committee must be established as specified in paragraph (b)(1)(ii) of
this section.
(3) The committee's or group's reviews may not be conducted by any
individual who--
(i) Has a direct financial interest (for example, an ownership
interest) in that hospital; or
(ii) Was professionally involved in the care of the patient whose
case is being reviewed.
(c) Standard: Scope and frequency of review. (1) The UR plan must
provide for review for Medicare and Medicaid patients with respect to
the medical necessity of--
(i) Admissions to the institution;
(ii) The duration of stays; and
(iii) Professional services furnished, including drugs and
biologicals.
(2) Review of admissions may be performed before, at, or after
hospital admission.
(3) Except as specified in paragraph (e) of this section, reviews
may be conducted on a sample basis.
(4) Hospitals that are paid for inpatient hospital services under
the prospective payment system set forth in Part 412 of this chapter
must conduct review of duration of stays and review of professional
services as follows:
(i) For duration of stays, these hospitals need review only cases
that they reasonably assume to be outlier cases based on extended length
of stay, as described in Sec. 412.80(a)(1)(i) of this chapter; and
(ii) For professional services, these hospitals need review only
cases that they reasonably assume to be outlier cases based on
extraordinarily high costs, as described in Sec. 412.80(a)(1)(ii) of
this chapter.
(d) Standard: Determination regarding admissions or continued stays.
(1) The determination that an admission or continued stay is not
medically necessary--
(i) May be made by one member of the UR committee if the
practitioner or practitioners responsible for the care of the patient,
as specified of Sec. 482.12(c), concur with the determination or fail
to present their views when afforded the opportunity; and
(ii) Must be made by at least two members of the UR committee in all
other cases.
(2) Before making a determination that an admission or continued
stay is not medically necessary, the UR committee must consult the
practitioner or practitioners responsible for the care of the patient,
as specified in Sec. 482.12(c), and afford the practitioner or
practitioners the opportunity to present their views.
(3) If the committee decides that admission to or continued stay in
the hospital is not medically necessary, written notification must be
given, no later than 2 days after the determination, to the hospital,
the patient, and the practitioner or practitioners responsible for the
care of the patient, as specified in Sec. 482.12(c);
(e) Standard: Extended stay review. (1) In hospitals that are not
paid under the prospective payment system, the UR committee must make a
periodic review, as specified in the UR plan, of
[[Page 22]]
each current inpatient receiving hospital services during a continuous
period of extended duration. The scheduling of the periodic reviews
may--
(i) Be the same for all cases; or
(ii) Differ for different classes of cases.
(2) In hospitals paid under the prospective payment system, the UR
committee must review all cases reasonably assumed by the hospital to be
outlier cases because the extended length of stay exceeds the threshold
criteria for the diagnosis, as described in Sec. 412.80(a)(1)(i). The
hospital is not required to review an extended stay that does not exceed
the outlier threshold for the diagnosis.
(3) The UR committee must make the periodic review no later than 7
days after the day required in the UR plan.
(f) Standard: Review of professional services. The committee must
review professional services provided, to determine medical necessity
and to promote the most efficient use of available health facilities and
services.
Sec. 482.41 Condition of participation: Physical environment.
The hospital must be constructed, arranged, and maintained to ensure
the safety of the patient, and to provide facilities for diagnosis and
treatment and for special hospital services appropriate to the needs of
the community.
(a) Standard: Buildings. The condition of the physical plant and the
overall hospital environment must be developed and maintained in such a
manner that the safety and well-being of patients are assured.
(1) There must be emergency power and lighting in at least the
operating, recovery, intensive care, and emergency rooms, and
stairwells. In all other areas not serviced by the emergency supply
source, battery lamps and flashlights must be available.
(2) There must be facilities for emergency gas and water supply.
(b) Standard: Life safety from fire. (1) Except as otherwise
provided in this section--
(i) The hospital must meet the applicable provisions of the 2000
edition of the Life Safety Code of the National Fire Protection
Association. The Director of the Office of the Federal Register has
approved the NFPA 101 [reg] 2000 edition of the Life Safety
Code, issued January 14, 2000, for incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy of the Code is
available for inspection at the CMS Information Resource Center, 7500
Security Boulevard, Baltimore, MD or at the National Archives and
Records Administration (NARA). For information on the availability of
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal--register/code--of--federal--regulations/ibr--
locations.html. Copies may be obtained from the National Fire Protection
Association, 1 Batterymarch Park, Quincy, MA 02269. If any changes in
this edition of the Code are incorporated by reference, CMS will publish
notice in the Federal Register to announce the changes.
(ii) Chapter 19.3.6.3.2, exception number 2 of the adopted edition
of the LSC does not apply to hospitals.
(2) After consideration of State survey agency findings, CMS may
waive specific provisions of the Life Safety Code which, if rigidly
applied, would result in unreasonable hardship upon the facility, but
only if the waiver does not adversely affect the health and safety of
the patients.
(3) The provisions of the Life Safety Code do not apply in a State
where CMS finds that a fire and safety code imposed by State law
adequately protects patients in hospitals.
(4) Beginning March 13, 2006, a hospital must be in compliance with
Chapter 19.2.9, Emergency Lighting.
(5) Beginning March 13, 2006, Chapter 19.3.6.3.2, exception number 2
does not apply to hospitals.
(6) The hospital must have procedures for the proper routine storage
and prompt disposal of trash.
(7) The hospital must have written fire control plans that contain
provisions for prompt reporting of fires; extinguishing fires;
protection of patients, personnel and guests; evacuation; and
cooperation with fire fighting authorities.
(8) The hospital must maintain written evidence of regular
inspection and approval by State or local fire control agencies.
[[Page 23]]
(9) Notwithstanding any provisions of the 2000 edition of the Life
Safety Code to the contrary, a hospital may install alcohol-based hand
rub dispensers in its facility if--
(i) Use of alcohol-based hand rub dispensers does not conflict with
any State or local codes that prohibit or otherwise restrict the
placement of alcohol-based hand rub dispensers in health care
facilities;
(ii) The dispensers are installed in a manner that minimizes leaks
and spills that could lead to falls;
(iii) The dispensers are installed in a manner that adequately
protects against inappropriate access;
(iv) The dispensers are installed in accordance with chapter
18.3.2.7 or chapter 19.3.2.7 of the 2000 edition of the Life Safety
Code, as amended by NFPA Temporary Interim Amendment 00-1(101), issued
by the Standards Council of the National Fire Protection Association on
April 15, 2004. The Director of the Office of the Federal Register has
approved NFPA Temporary Interim Amendment 00-1(101) for incorporation by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy
of the amendment is available for inspection at the CMS Information
Resource Center, 7500 Security Boulevard, Baltimore, MD and at the
Office of the Federal Register, 800 North Capitol Street NW., Suite 700,
Washington, DC. Copies may be obtained from the National Fire Protection
Association, 1 Batterymarch Park, Quincy, MA 02269; and
(v) The dispensers are maintained in accordance with dispenser
manufacturer guidelines.
(c) Standard: Facilities. The hospital must maintain adequate
facilities for its services.
(1) Diagnostic and therapeutic facilities must be located for the
safety of patients.
(2) Facilities, supplies, and equipment must be maintained to ensure
an acceptable level of safety and quality.
(3) The extent and complexity of facilities must be determined by
the services offered.
(4) There must be proper ventilation, light, and temperature
controls in pharmaceutical, food preparation, and other appropriate
areas.
[51 FR 22042, June 17, 1986, as amended at 53 FR 11509, Apr. 7, 1988; 68
FR 1386, Jan. 10, 2003; 69 FR 49267, Aug. 11, 2004; 70 FR 15238, Mar.
25, 2005; 71 FR 55340, Sept. 22, 2006]
Sec. 482.42 Condition of participation: Infection control.
The hospital must provide a sanitary environment to avoid sources
and transmission of infections and communicable diseases. There must be
an active program for the prevention, control, and investigation of
infections and communicable diseases.
(a) Standard: Organization and policies. A person or persons must be
designated as infection control officer or officers to develop and
implement policies governing control of infections and communicable
diseases.
(1) The infection control officer or officers must develop a system
for identifying, reporting, investigating, and controlling infections
and communicable diseases of patients and personnel.
(2) The infection control officer or officers must maintain a log of
incidents related to infections and communicable diseases.
(b) Standard: Responsibilities of chief executive officer, medical
staff, and director of nursing services. The chief executive officer,
the medical staff, and the director of nursing services must--
(1) Ensure that the hospital-wide quality assurance program and
training programs address problems identified by the infection control
officer or officers; and
(2) Be responsible for the implementation of successful corrective
action plans in affected problem areas.
Sec. 482.43 Condition of participation: Discharge planning.
The hospital must have in effect a discharge planning process that
applies to all patients. The hospital's policies and procedures must be
specified in writing.
(a) Standard: Identification of patients in need of discharge
planning. The hospital must identify at an early stage of
hospitalization all patients who are
[[Page 24]]
likely to suffer adverse health consequences upon discharge if there is
no adequate discharge planning.
(b) Standard: Discharge planning evaluation. (1) The hospital must
provide a discharge planning evaluation to the patients identified in
paragraph (a) of this section, and to other patients upon the patient's
request, the request of a person acting on the patient's behalf, or the
request of the physician.
(2) A registered nurse, social worker, or other appropriately
qualified personnel must develop, or supervise the development of, the
evaluation.
(3) The discharge planning evaluation must include an evaluation of
the likelihood of a patient needing post- hospital services and of the
availability of the services.
(4) The discharge planning evaluation must include an evaluation of
the likelihood of a patient's capacity for self-care or of the
possibility of the patient being cared for in the environment from which
he or she entered the hospital.
(5) The hospital personnel must complete the evaluation on a timely
basis so that appropriate arrangements for post-hospital care are made
before discharge, and to avoid unnecessary delays in discharge.
(6) The hospital must include the discharge planning evaluation in
the patient's medical record for use in establishing an appropriate
discharge plan and must discuss the results of the evaluation with the
patient or individual acting on his or her behalf.
(c) Standard: Discharge plan. (1) A registered nurse, social worker,
or other appropriately qualified personnel must develop, or supervise
the development of, a discharge plan if the discharge planning
evaluation indicates a need for a discharge plan.
(2) In the absence of a finding by the hospital that a patient needs
a discharge plan, the patient's physician may request a discharge plan.
In such a case, the hospital must develop a discharge plan for the
patient.
(3) The hospital must arrange for the initial implementation of the
patient's discharge plan.
(4) The hospital must reassess the patient's discharge plan if there
are factors that may affect continuing care needs or the appropriateness
of the discharge plan.
(5) As needed, the patient and family members or interested persons
must be counseled to prepare them for post-hospital care.
(6) The hospital must include in the discharge plan a list of HHAs
or SNFs that are available to the patient, that are participating in the
Medicare program, and that serve the geographic area (as defined by the
HHA) in which the patient resides, or in the case of a SNF, in the
geographic area requested by the patient. HHAs must request to be listed
by the hospital as available.
(i) This list must only be presented to patients for whom home
health care or post-hospital extended care services are indicated and
appropriate as determined by the discharge planning evaluation.
(ii) For patients enrolled in managed care organizations, the
hospital must indicate the availability of home health and posthospital
extended care services through individuals and entities that have a
contract with the managed care organizations.
(iii) The hospital must document in the patient's medical record
that the list was presented to the patient or to the individual acting
on the patient's behalf.
(7) The hospital, as part of the discharge planning process, must
inform the patient or the patient's family of their freedom to choose
among participating Medicare providers of posthospital care services and
must, when possible, respect patient and family preferences when they
are expressed. The hospital must not specify or otherwise limit the
qualified providers that are available to the patient.
(8) The discharge plan must identify any HHA or SNF to which the
patient is referred in which the hospital has a disclosable financial
interest, as specified by the Secretary, and any HHA or SNF that has a
disclosable financial interest in a hospital under Medicare. Financial
interests that are disclosable under Medicare are determined in
accordance with the provisions of Part 420, Subpart C, of this chapter.
(d) Standard: Transfer or referral. The hospital must transfer or
refer patients, along with necessary medical
[[Page 25]]
information, to appropriate facilities, agencies, or outpatient
services, as needed, for followup or ancillary care.
(e) Standard: Reassessment. The hospital must reassess its discharge
planning process on an on-going basis. The reassessment must include a
review of discharge plans to ensure that they are responsive to
discharge needs.
[59 FR 64152, Dec. 13, 1994, as amended at 69 FR 49268, Aug. 11, 2004]
Sec. 482.45 Condition of participation: Organ, tissue, and eye procurement.
(a) Standard: Organ procurement responsibilities. The hospital must
have and implement written protocols that:
(1) Incorporate an agreement with an OPO designated under part 486
of this chapter, under which it must notify, in a timely manner, the OPO
or a third party designated by the OPO of individuals whose death is
imminent or who have died in the hospital. The OPO determines medical
suitability for organ donation and, in the absence of alternative
arrangements by the hospital, the OPO determines medical suitability for
tissue and eye donation, using the definition of potential tissue and
eye donor and the notification protocol developed in consultation with
the tissue and eye banks identified by the hospital for this purpose;
(2) Incorporate an agreement with at least one tissue bank and at
least one eye bank to cooperate in the retrieval, processing,
preservation, storage and distribution of tissues and eyes, as may be
appropriate to assure that all usable tissues and eyes are obtained from
potential donors, insofar as such an agreement does not interfere with
organ procurement;
(3) Ensure, in collaboration with the designated OPO, that the
family of each potential donor is informed of its options to donate
organs, tissues, or eyes or to decline to donate. The individual
designated by the hospital to initiate the request to the family must be
an organ procurement representative or a designated requestor. A
designated requestor is an individual who has completed a course offered
or approved by the OPO and designed in conjunction with the tissue and
eye bank community in the methodology for approaching potential donor
families and requesting organ or tissue donation;
(4) Encourage discretion and sensitivity with respect to the
circumstances, views, and beliefs of the families of potential donors;
(5) Ensure that the hospital works cooperatively with the designated
OPO, tissue bank and eye bank in educating staff on donation issues,
reviewing death records to improve identification of potential donors,
and maintaining potential donors while necessary testing and placement
of potential donated organs, tissues, and eyes take place.
(b) Standard: Organ transplantation responsibilities. (1) A hospital
in which organ transplants are performed must be a member of the Organ
Procurement and Transplantation Network (OPTN) established and operated
in accordance with section 372 of the Public Health Service (PHS) Act
(42 U.S.C. 274) and abide by its rules. The term ``rules of the OPTN''
means those rules provided for in regulations issued by the Secretary in
accordance with section 372 of the PHS Act which are enforceable under
42 CFR 121.10. No hospital is considered to be out of compliance with
section 1138(a)(1)(B) of the Act, or with the requirements of this
paragraph, unless the Secretary has given the OPTN formal notice that he
or she approves the decision to exclude the hospital from the OPTN and
has notified the hospital in writing.
(2) For purposes of these standards, the term ``organ'' means a
human kidney, liver, heart, lung, or pancreas.
(3) If a hospital performs any type of transplants, it must provide
organ-transplant-related data, as requested by the OPTN, the Scientific
Registry, and the OPOs. The hospital must also provide such data
directly to the Department when requested by the Secretary.
[63 FR 33875, June 22, 1998]
Subpart D_Optional Hospital Services
Sec. 482.51 Condition of participation: Surgical services.
If the hospital provides surgical services, the services must be
well organized and provided in accordance with
[[Page 26]]
acceptable standards of practice. If outpatient surgical services are
offered the services must be consistent in quality with inpatient care
in accordance with the complexity of services offered.
(a) Standard: Organization and staffing. The organization of the
surgical services must be appropriate to the scope of the services
offered.
(1) The operating rooms must be supervised by an experienced
registered nurse or a doctor of medicine or osteopathy.
(2) Licensed practical nurses (LPNs) and surgical technologists
(operating room technicians) may serve as ``scrub nurses'' under the
supervision of a registered nurse.
(3) Qualified registered nurses may perform circulating duties in
the operating room. In accordance with applicable State laws and
approved medical staff policies and procedures, LPNs and surgical
technologists may assist in circulatory duties under the surpervision of
a qualified registered nurse who is immediately available to respond to
emergencies.
(4) Surgical privileges must be delineated for all practitioners
performing surgery in accordance with the competencies of each
practitioner. The surgical service must maintain a roster of
practitioners specifying the surgical privileges of each practitioner.
(b) Standard: Delivery of service. Surgical services must be
consistent with needs and resources. Policies governing surgical care
must be designed to assure the achievement and maintenance of high
standards of medical practice and patient care.
(1) Prior to surgery or a procedure requiring anesthesia services
and except in the case of emergencies:
(i) A medical history and physical examination must be completed and
documented no more than 30 days before or 24 hours after admission or
registration.
(ii) An updated examination of the patient, including any changes in
the patient's condition, must be completed and documented within 24
hours after admission or registration when the medical history and
physical examination are completed within 30 days before admission or
registration.
(2) A properly executed informed consent form for the operation must
be in the patient's chart before surgery, except in emergencies.
(3) The following equipment must be available to the operating room
suites: call-in-system, cardiac monitor, resuscitator, defibrillator,
aspirator, and tracheotomy set.
(4) There must be adequate provisions for immediate post-operative
care.
(5) The operating room register must be complete and up-to-date.
(6) An operative report describing techniques, findings, and tissues
removed or altered must be written or dictated immediately following
surgery and signed by the surgeon.
[51 FR 22042, June 17, 1986, as amended at 72 FR 66933, Nov. 27, 2007]
Sec. 482.52 Condition of participation: Anesthesia services.
If the hospital furnishes anesthesia services, they must be provided
in a well-organized manner under the direction of a qualified doctor of
medicine or osteopathy. The service is responsible for all anesthesia
administered in the hospital.
(a) Standard: Organization and staffing. The organization of
anesthesia services must be appropriate to the scope of the services
offered. Anesthesia must be administered only by--
(1) A qualified anesthesiologist;
(2) A doctor of medicine or osteopathy (other than an
anesthesiologist);
(3) A dentist, oral surgeon, or podiatrist who is qualified to
administer anesthesia under State law;
(4) A certified registered nurse anesthetist (CRNA), as defined in
Sec. 410.69(b) of this chapter, who, unless exempted in accordance with
paragraph (c)of this section, is under the supervision of the operating
practitioner or of an anesthesiologist who is immediately available if
needed; or
(5) An anesthesiologist's assistant, as defined in Sec. 410.69(b)
of this chapter, who is under the supervision of an anesthesiologist who
is immediately available if needed.
(b) Standard: Delivery of services. Anesthesia services must be
consistent with needs and resources. Policies on anesthesia procedures
must include the
[[Page 27]]
delineation of preanesthesia and post anesthesia responsibilities. The
policies must ensure that the following are provided for each patient:
(1) A preanesthesia evaluation completed and documented by an
individual qualified to administer anesthesia, as specified in paragraph
(a) of this section, performed within 48 hours prior to surgery or a
procedure requiring anesthesia services.
(2) An intraoperative anesthesia record.
(3) A postanesthesia evaluation completed and documented by an
individual qualified to administer anesthesia, as specified in paragraph
(a) of this section, no later than 48 hours after surgery or a procedure
requiring anesthesia services. The postanesthesia evaluation for
anesthesia recovery must be completed in accordance with State law and
with hospital policies and procedures that have been approved by the
medical staff and that reflect current standards of anesthesia care.
(c) Standard: State exemption. (1) A hospital may be exempted from
the requirement for physician supervision of CRNAs as described in
paragraph (a)(4) of this section, if the State in which the hospital is
located submits a letter to CMS signed by the Governor, following
consultation with the State's Boards of Medicine and Nursing, requesting
exemption from physician supervision of CRNAs. The letter from the
Governor must attest that he or she has consulted with State Boards of
Medicine and Nursing about issues related to access to and the quality
of anesthesia services in the State and has concluded that it is in the
best interests of the State's citizens to opt-out of the current
physician supervision requirement, and that the opt-out is consistent
with State law.
(2) The request for exemption and recognition of State laws, and the
withdrawal of the request may be submitted at any time, and are
effective upon submission.
[51 FR 22042, June 17, 1986 as amended at 57 FR 33900, July 31, 1992; 66
FR 56769, Nov. 13, 2001; 71 FR 68694, Nov. 27, 2006; 72 FR 66934, Nov.
27, 2007]
Sec. 482.53 Condition of participation: Nuclear medicine services.
If the hospital provides nuclear medicine services, those services
must meet the needs of the patients in accordance with acceptable
standards of practice.
(a) Standard: Organization and staffing. The organization of the
nuclear medicine service must be appropriate to the scope and complexity
of the services offered.
(1) There must be a director who is a doctor of medicine or
osteopathy qualified in nuclear medicine.
(2) The qualifications, training, functions, and responsibilities of
nuclear medicine personnel must be specified by the service director and
approved by the medical staff.
(b) Standard: Delivery of service. Radioactive materials must be
prepared, labeled, used, transported, stored, and disposed of in
accordance with acceptable standards of practice.
(1) In-house preparation of radiopharmaceuticals is by, or under,
the direct supervision of an appropriately trained registered pharmacist
or a doctor of medicine or osteopathy.
(2) There is proper storage and disposal of radioactive material.
(3) If laboratory tests are performed in the nuclear medicine
service, the service must meet the applicable requirement for laboratory
services specified in Sec. 482.27.
(c) Standard: Facilities. Equipment and supplies must be appropriate
for the types of nuclear medicine services offered and must be
maintained for safe and efficient performance. The equipment must be--
(1) Maintained in safe operating condition; and
(2) Inspected, tested, and calibrated at least annually by qualified
personnel.
(d) Standard: Records. The hospital must maintain signed and dated
reports of nuclear medicine interpretations, consultations, and
procedures.
(1) The hospital must maintain copies of nuclear medicine reports
for at least 5 years.
(2) The practitioner approved by the medical staff to interpret
diagnostic procedures must sign and date the interpretation of these
tests.
[[Page 28]]
(3) The hospital must maintain records of the receipt and
disposition of radiopharmaceuticals.
(4) Nuclear medicine services must be ordered only by practitioner
whose scope of Federal or State licensure and whose defined staff
privileges allow such referrals.
[51 FR 22042, June 17, 1986, as amended at 57 FR 7136, Feb. 28, 1992]
Sec. 482.54 Condition of participation: Outpatient services.
If the hospital provides outpatient services, the services must meet
the needs of the patients in accordance with acceptable standards of
practice.
(a) Standard: Organization. Outpatient services must be
appropriately organized and integrated with inpatient services.
(b) Standard: Personnel. The hospitals must--
(1) Assign an individual to be responsible for outpatient services;
and
(2) Have appropriate professional and nonprofessional personnel
available.
Sec. 482.55 Condition of participation: Emergency services.
The hospital must meet the emergency needs of patients in accordance
with acceptable standards of practice.
(a) Standard: Organization and direction. If emergency services are
provided at the hospital--
(1) The services must be organized under the direction of a
qualified member of the medical staff;
(2) The services must be integrated with other departments of the
hospital;
(3) The policies and procedures governing medical care provided in
the emergency service or department are established by and are a
continuing responsibility of the medical staff.
(b) Standard: Personnel. (1) The emergency services must be
supervised by a qualified member of the medical staff.
(2) There must be adequate medical and nursing personnel qualified
in emergency care to meet the written emergency procedures and needs
anticipated by the facility.
Sec. 482.56 Condition of participation: Rehabilitation services.
If the hospital provides rehabilitation, physical therapy,
occupational therapy, audiology, or speech pathology services, the
services must be organized and staffed to ensure the health and safety
of patients.
(a) Standard: Organization and staffing. The organization of the
service must be appropriate to the scope of the services offered.
(1) The director of the services must have the necessary knowledge,
experience, and capabilities to properly supervise and administer the
services.
(2) Physical therapy, occupational therapy, speech-language
pathology or audiology services, if provided, must be provided by
qualified physical therapists, physical therapist assistants,
occupational therapists, occupational therapy assistants, speech-
language pathologists, or audiologists as defined in part 484 of this
chapter.
(b) Standard: Delivery of services. Services must 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
[[Page 29]]
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 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]
Subpart E_Requirements for Specialty Hospitals
Source: 72 FR 15273, Mar. 30, 2007, unless otherwise noted.
Sec. 482.60 Special provisions applying to psychiatric hospitals.
Psychiatric hospital must--
(a) Be primarily engaged in providing, by or under the supervision
of a doctor of medicine or osteopathy, psychiatric services for the
diagnosis and treatment of mentally ill persons;
(b) Meet the conditions of participation specified in Sec. Sec.
482.1 through 482.23 and Sec. Sec. 482.25 through 482.57;
(c) Maintain clinical records on all patients, including records
sufficient to permit CMS to determine the degree and intensity of
treatment furnished to Medicare beneficiaries, as specified in Sec.
482.61; and
(d) Meet the staffing requirements specified in Sec. 482.62.
[72 FR 60788, Oct. 26, 2007]
Sec. 482.61 Condition of participation: Special medical record requirements
for psychiatric hospitals.
The medical records maintained by a psychiatric hospital must permit
determination of the degree and intensity of the treatment provided to
individuals who are furnished services in the institution.
(a) Standard: Development of assessment/diagnostic data. Medical
records must stress the psychiatric components of the record, including
history of findings and treatment provided for the psychiatric condition
for which the patient is hospitalized.
(1) The identification data must include the patient's legal status.
(2) A provisional or admitting diagnosis must be made on every
patient at the time of admission, and must include the diagnoses of
intercurrent diseases as well as the psychiatric diagnoses.
(3) The reasons for admission must be clearly documented as stated
by the patient and/or others significantly involved.
(4) The social service records, including reports of interviews with
patients, family members, and others, must provide an assessment of home
plans and family attitudes, and community resource contacts as well as a
social history.
(5) When indicated, a complete neurological examination must be
recorded at the time of the admission physical examination.
(b) Standard: Psychiatric evaluation. Each patient must receive a
psychiatric evaluation that must--
(1) Be completed within 60 hours of admission;
(2) Include a medical history;
(3) Contain a record of mental status;
(4) Note the onset of illness and the circumstances leading to
admission;
(5) Describe attitudes and behavior;
[[Page 30]]
(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;
(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.
[[Page 31]]
(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.
(2) The number of qualified therapists, support personnel, and
consultants must be adequate to provide comprehensive therapeutic
activities consistent with each patient's active treatment program.
[72 FR 60788, Oct. 26, 2007]
Sec. 482.66 Special requirements for hospital providers of long-term care
services (``swing-beds'').
A hospital that has a Medicare provider agreement must meet the
following requirements in order to be granted an approval from CMS to
provide post-hospital extended care services, as specified in Sec.
409.30 of this chapter, and be reimbursed as a swing-bed hospital, as
specified in Sec. 413.114 of this chapter:
(a) Eligibility. A hospital must meet the following eligibility
requirements:
(1) The facility has fewer than 100 hospital beds, excluding beds
for newborns and beds in intensive care type inpatient units (for
eligibility of hospitals with distinct parts electing the optional
reimbursement method, see Sec. 413.24(d)(5) of this chapter).
(2) The hospital is located in a rural area. This includes all areas
not delineated as ``urbanized'' areas by the Census Bureau, based on the
most recent census.
(3) The hospital does not have in effect a 24-hour nursing waiver
granted under Sec. 488.54(c) of this chapter.
(4) The hospital has not had a swing-bed approval terminated within
the two years previous to application.
(b) Skilled nursing facility services. The facility is substantially
in compliance with the following skilled nursing facility requirements
contained in subpart B of part 483 of this chapter.
[[Page 32]]
(1) Resident rights (Sec. 483.10 (b)(3), (b)(4), (b)(5), (b)(6),
(d), (e), (h), (i), (j)(1)(vii), (j)(1)(viii), (l), and (m)).
(2) Admission, transfer, and discharge rights (Sec. 483.12 (a)(1),
(a)(2), (a)(3), (a)(4), (a)(5), (a)(6), and (a)(7)).
(3) Resident behavior and facility practices (Sec. 483.13).
(4) Patient activities (Sec. 483.15(f)).
(5) Social services (Sec. 483.15(g)).
(6) Discharge planning (Sec. 483.20(e)).
(7) Specialized rehabilitative services (Sec. 483.45).
(8) Dental services (Sec. 483.55).
[72 FR 60788, Oct. 26, 2007]
Sec. 482.68 Special requirements for transplant centers.
A transplant center located within a hospital that has a Medicare
provider agreement must meet the conditions of participation specified
in Sec. Sec. 482.72 through 482.104 in order to be granted approval
from CMS to provide transplant services.
(a) Unless specified otherwise, the conditions of participation at
Sec. Sec. 482.72 through 482.104 apply to heart, heart-lung, intestine,
kidney, liver, lung, and pancreas centers.
(b) In addition to meeting the conditions of participation specified
in Sec. Sec. 482.72 through 482.104, a transplant center must also meet
the conditions of participation specified in Sec. Sec. 482.1 through
482.57.
Sec. 482.70 Definitions.
As used in this subpart, the following definitions apply:
Adverse event means an untoward, undesirable, and usually
unanticipated event that causes death or serious injury, or the risk
thereof. As applied to transplant centers, examples of adverse events
include (but are not limited to) serious medical complications or death
caused by living donation; unintentional transplantation of organs of
mismatched blood types; transplantation of organs to unintended
recipients; and unintended transmission of infectious disease to a
recipient.
End-Stage Renal Disease (ESRD) means that stage of renal impairment
that appears irreversible and permanent, and requires a regular course
of dialysis or kidney transplantation to maintain life.
ESRD Network means all Medicare-approved ESRD facilities in a
designated geographic area specified by CMS.
Heart-Lung transplant center means a transplant center that is
located in a hospital with an existing Medicare-approved heart
transplant center and an existing Medicare-approved lung center that
performs combined heart-lung transplants.
Intestine transplant center means a Medicare-approved liver
transplant center that performs intestine transplants, combined liver-
intestine transplants, or multivisceral transplants.
Network organization means the administrative governing body to the
network and liaison to the Federal government.
Pancreas transplant center means a Medicare-approved kidney
transplant center that performs pancreas transplants alone or subsequent
to a kidney transplant as well as kidney-pancreas transplants.
Transplant center means an organ-specific transplant program (as
defined in this rule) within a transplant hospital (for example, a
hospital's lung transplant program may also be referred to as the
hospital's lung transplant center).
Transplant hospital means a hospital that furnishes organ
transplants and other medical and surgical specialty services required
for the care of transplant patients.
Transplant program means a component within a transplant hospital
(as defined in this rule) that provides transplantation of a particular
type of organ.
General Requirements for Transplant Centers
Sec. 482.72 Condition of participation: OPTN membership.
A transplant center must be located in a transplant hospital that is
a member of and abides by the rules and requirements of the Organ
Procurement and Transplantation Network (OPTN) established and operated
in accordance with section 372 of the Public Health Service (PHS) Act
(42 U.S.C. 274). The term ``rules and requirements of the
[[Page 33]]
OPTN'' means those rules and requirements approved by the Secretary
pursuant to Sec. 121.4 of this title. No hospital that provides
transplantation services shall be deemed to be out of compliance with
section 1138(a)(1)(B) of the Act or this section unless the Secretary
has given the OPTN formal notice that he or she approves the decision to
exclude the transplant hospital from the OPTN and also has notified the
transplant hospital in writing.
Sec. 482.74 Condition of participation: Notification to CMS.
(a) A transplant center must notify CMS immediately of any
significant changes related to the center's transplant program or
changes that could affect its compliance with the conditions of
participation. Instances in which CMS should receive information for
follow up, as appropriate, include, but are not limited to:
(1) Change in key staff members of the transplant team, such as a
change in the individual the transplant center designated to the OPTN as
the center's ``primary transplant surgeon'' or ``primary transplant
physician;'
(2) A decrease in the center's number of transplants or survival
rates that could result in the center being out of compliance with Sec.
482.82;
(3) Termination of an agreement between the hospital in which the
transplant center is located and an OPO for the recovery and receipt of
organs as required by section 482.100; and
(4) Inactivation of the transplant center.
(b) Upon receiving notification of significant changes, CMS will
follow up with the transplant center as appropriate, including (but not
limited to):
(1) Requesting additional information;
(2) Analyzing the information; or
(3) Conducting an on-site review.
Sec. 482.76 Condition of participation: Pediatric Transplants.
A transplant center that seeks Medicare approval to provide
transplantation services to pediatric patients must submit to CMS a
request specifically for Medicare approval to perform pediatric
transplants using the procedures described at Sec. 488.61 of this
chapter.
(a) Except as specified in paragraph (d) of this section, a center
requesting Medicare approval to perform pediatric transplants must meet
all the conditions of participation at Sec. Sec. 482.72 through 482.74
and Sec. Sec. 482.80 through 482.104 with respect to its pediatric
patients.
(b) A center that performs 50 percent or more of its transplants in
a 12-month period on adult patients must be approved to perform adult
transplants in order to be approved to perform pediatric transplants.
(1) Loss of Medicare approval to perform adult transplants, whether
voluntary or involuntary, will result in loss of the center's approval
to perform pediatric transplants.
(2) Loss of Medicare approval to perform pediatric transplants,
whether voluntary or involuntary, may trigger a review of the center's
Medicare approval to perform adult transplants.
(c) A center that performs 50 percent or more of its transplants in
a 12-month period on pediatric patients must be approved to perform
pediatric transplants in order to be approved to perform adult
transplants.
(1) Loss of Medicare approval to perform pediatric transplants,
whether voluntary or involuntary, will result in loss of the center's
approval to perform adult transplants.
(2) Loss of Medicare approval to perform adult transplants, whether
voluntary or involuntary, may trigger a review of the center's Medicare
approval to perform pediatric transplants.
(3) A center that performs 50 percent or more of its transplants on
pediatric patients in a 12-month period is not required to meet the
clinical experience requirements prior to its request for approval as a
pediatric transplant center.
(d) Instead of meeting all conditions of participation at Sec. Sec.
482.72 through 482.74 and Sec. Sec. 482.80 through 482.104, a heart
transplant center that wishes to provide transplantation services to
pediatric heart patients may be approved to perform pediatric heart
transplants
[[Page 34]]
by meeting the Omnibus Budget Reconciliation Act of 1987 criteria in
section 4009(b) (Pub. L. 100-203), as follows:
(1) The center's pediatric transplant program must be operated
jointly by the hospital and another facility that is Medicare-approved;
(2) The unified program shares the same transplant surgeons and
quality improvement program (including oversight committee, patient
protocol, and patient selection criteria); and
(3) The center demonstrates to the satisfaction of the Secretary
that it is able to provide the specialized facilities, services, and
personnel that are required by pediatric heart transplant patients.
Transplant Center Data Submission, Clinical Experience, and Outcome
Requirements
Sec. 482.80 Condition of participation: Data submission, clinical experience,
and outcome requirements for initial approval of transplant centers.
Except as specified in paragraph (d) of this section, and Sec.
488.61 of this chapter, transplant centers must meet all data
submission, clinical experience, and outcome requirements to be granted
initial approval by CMS.
(a) Standard: Data submission. No later than 90 days after the due
date established by the OPTN, a transplant center must submit to the
OPTN at least 95 percent of required data on all transplants (deceased
and living donor) it has performed. Required data submissions include,
but are not limited to, submission of the appropriate OPTN forms for
transplant candidate registration, transplant recipient registration and
follow-up, and living donor registration and follow-up.
(b) Standard: Clinical experience. To be considered for initial
approval, an organ-specific transplant center must generally perform 10
transplants over a 12-month period.
(c) Standard: Outcome requirements. CMS will review outcomes for all
transplants performed at a center, including outcomes for living donor
transplants, if applicable. Except for lung transplants, CMS will review
adult and pediatric outcomes separately when a center requests Medicare
approval to perform both adult and pediatric transplants.
(1) CMS will compare each transplant center's observed number of
patient deaths and graft failures 1-year post-transplant to the center's
expected number of patient deaths and graft failures 1-year post-
transplant using the data contained in the most recent Scientific
Registry of Transplant Recipients (SRTR) center-specific report.
(2) The required number of transplants must have been performed
during the time frame reported in the most recent SRTR center-specific
report.
(3) CMS will not consider a center's patient and graft survival
rates to be acceptable if:
(i) A center's observed patient survival rate or observed graft
survival rate is lower than its expected patient survival rate or
expected graft survival rate; and
(ii) All three of the following thresholds are crossed over:
(A) The one-sided p-value is less than 0.05,
(B) The number of observed events (patient deaths or graft failures)
minus the number of expected events is greater than 3, and
(C) The number of observed events divided by the number of expected
events is greater than 1.5.
(d) Exceptions. (1) A heart-lung transplant center is not required
to comply with the clinical experience requirements in paragraph (b) of
this section or the outcome requirements in paragraph (c) of this
section for heart-lung transplants performed at the center.
(2) An intestine transplant center is not required to comply with
the outcome performance requirements in paragraph (c) of this section
for intestine, combined liver-intestine or multivisceral transplants
performed at the center.
(3) A pancreas transplant center is not required to comply with the
clinical experience requirements in paragraph (b) of this section or the
outcome requirements in paragraph (c) of this section for pancreas
transplants performed at the center.
(4) A center that is requesting initial Medicare approval to perform
pediatric transplants is not required to comply
[[Page 35]]
with the clinical experience requirements in paragraph (b) of this
section prior to its request for approval as a pediatric transplant
center.
(5) A kidney transplant center that is not Medicare-approved on the
effective date of this rule is required to perform at least 3
transplants over a 12-month period prior to its request for initial
approval.
Sec. 482.82 Condition of participation: Data submission, clinical experience,
and outcome requirements for re-approval of transplant centers.
Except as specified in paragraph (d) of this section, and Sec.
488.61 of this chapter, transplant centers must meet all data
submission, clinical experience, and outcome requirements in order to be
re-approved.
(a) Standard: Data submission. No later than 90 days after the due
date established by the OPTN, a transplant center must submit to the
OPTN at least 95 percent of the required data submissions on all
transplants (deceased and living donor) it has performed over the 3-year
approval period. Required data submissions include, but are not limited
to, submission of the appropriate OPTN forms for transplant candidate
registration, transplant recipient registration and follow-up, and
living donor registration and follow-up.
(b) Standard: Clinical experience. To be considered for re-approval,
an organ-specific transplant center must generally perform an average of
10 transplants per year during the re-approval period.
(c) Standard: Outcome requirements. CMS will review outcomes for all
transplants performed at a center, including outcomes for living donor
transplants if applicable. Except for lung transplants, CMS will review
adult and pediatric outcomes separately when a center requests Medicare
approval to perform both adult and pediatric transplants.
(1) CMS will compare each transplant center's observed number of
patient deaths and graft failures 1-year post-transplant to the center's
expected number of patient deaths and graft failures 1-year post-
transplant using data contained in the most recent SRTR center-specific
report.
(2) The required number of transplants must have been performed
during the time frame reported in the most recent SRTR center-specific
report.
(3) CMS will not consider a center's patient and graft survival
rates to be acceptable if:
(i) A center's observed patient survival rate or observed graft
survival rate is lower than its expected patient survival rate and graft
survival rate; and
(ii) All three of the following thresholds are crossed over:
(A) The one-sided p-value is less than 0.05,
(B) The number of observed events (patient deaths or graft failures)
minus the number of expected events is greater than 3, and
(C) The number of observed events divided by the number of expected
events is greater than 1.5.
(d) Exceptions. (1) A heart-lung transplant center is not required
to comply with the clinical experience requirements in paragraph (b) of
this section or the outcome requirements in paragraph (c) of this
section for heart-lung transplants performed at the center.
(2) An intestine transplant center is not required to comply with
the outcome requirements in paragraph (c) of this section for intestine,
combined liver-intestine, and multivisceral transplants performed at the
center.
(3) A pancreas transplant center is not required to comply with the
clinical experience requirements in paragraph (b) of this section or the
outcome requirements in paragraph (c) of this section for pancreas
transplants performed at the center.
(4) A center that is approved to perform pediatric transplants is
not required to comply with the clinical experience requirements in
paragraph (b) of this section to be re-approved.
Transplant Center Process Requirements
Sec. 482.90 Condition of participation: Patient and living donor selection.
The transplant center must use written patient selection criteria in
determining a patient's suitability for placement on the waiting list or
a patient's suitability for transplantation.
[[Page 36]]
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-recipient blood type and other vital data for the deceased organ
recovery, organ receipt, and living donor organ transplantation
processes. The transplanting surgeon at the transplant center is
responsible for ensuring the medical suitability of donor organs for
transplantation into the intended recipient.
(a) Standard: Organ recovery. When the identity of an intended
transplant recipient is known and the transplant center sends a team to
recover the organ(s), the transplant center's recovery team must review
and compare the donor data with the recipient blood type and other vital
data before organ recovery takes place.
(b) Standard: Organ receipt. After an organ arrives at a transplant
center, prior to transplantation, the transplanting surgeon and another
licensed health care professional must verify that the donor's blood
type and other vital data are compatible with transplantation of the
intended recipient
(c) Standard: Living donor transplantation. If a center performs
living donor transplants, the transplanting surgeon and another licensed
health care professional at the center must verify that the living
donor's blood type and other vital data are compatible with
transplantation of the intended recipient immediately before the removal
of the donor organ(s) and, if applicable, prior to the removal of the
recipient's organ(s).
Sec. 482.94 Condition of participation: Patient and living donor management.
Transplant centers must have written patient management policies for
the transplant and discharge phases of transplantation. If a transplant
center performs living donor transplants, the center also must have
written donor management policies for the donor evaluation, donation,
and discharge phases of living organ donation.
(a) Standard: Patient and living donor care. The transplant center's
patient and donor management policies must ensure that:
(1) Each transplant patient is under the care of a multidisciplinary
patient care team coordinated by a physician throughout the transplant
and discharge phases of transplantation; and
(2) If a center performs living donor transplants, each living donor
is under the care of a multidisciplinary patient care team coordinated
by a physician throughout the donor evaluation, donation, and discharge
phases of donation.
(b) Standard: Waiting list management. Transplant centers must keep
their
[[Page 37]]
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 to evaluate the center's
performance with regard to transplantation activities and outcomes.
Outcome measures may include, but are not limited to, patient and donor
selection criteria, accuracy of the waiting list in accordance with the
OPTN waiting list requirements, accuracy of donor and recipient
matching, patient and donor management, techniques for organ recovery,
consent practices, patient education, patient satisfaction, and patient
rights. The transplant center
[[Page 38]]
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 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:
[[Page 39]]
(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
recipient's ability to have his or her immunosuppressive drugs paid for
under Medicare Part B.
(b) Standard: Informed consent for living donors. Transplant centers
must implement written living donor informed consent policies that
inform the prospective living donor of all aspects of, and potential
outcomes from, living donation. Transplant centers must ensure that the
prospective living donor is fully informed about the following:
(1) The fact that communication between the donor and the transplant
center will remain confidential, in accordance with the requirements at
45 CFR parts 160 and 164.
(2) The evaluation process;
(3) The surgical procedure, including post-operative treatment;
(4) The availability of alternative treatments for the transplant
recipient;
[[Page 40]]
(5) The potential medical or psychosocial risks to the donor;
(6) The national and transplant center-specific outcomes for
recipients, and the national and center-specific outcomes for living
donors, as data are available;
(7) The possibility that future health problems related to the
donation may not be covered by the donor's insurance and that the
donor's ability to obtain health, disability, or life insurance may be
affected;
(8) The donor's right to opt out of donation at any time during the
donation process; and
(9) The fact that if a transplant is not provided in a Medicare-
approved transplant center it could affect the transplant recipient's
ability to have his or her immunosuppressive drugs paid for under
Medicare Part B.
(c) Standard: Notification to patients. Transplant centers must
notify patients placed on the center's waiting list of information about
the center that could impact the patient's ability to receive a
transplant should an organ become available, and what procedures are in
place to ensure the availability of a transplant team.
(1) A transplant center served by a single transplant surgeon or
physician must inform patients placed on the center's waiting list of:
(i) The potential unavailability of the transplant surgeon or
physician; and
(ii) Whether the center has a mechanism to provide an alternate
transplant surgeon or transplant physician.
(2) At least 30 days before a center's Medicare approval is
terminated, whether voluntarily or involuntarily, the center must:
(i) Inform patients on the center's waiting list and provide
assistance to waiting list patients who choose to transfer to the
waiting list of another Medicare-approved transplant center without loss
of time accrued on the waiting list; and
(ii) Inform Medicare beneficiaries on the center's waiting list that
Medicare will no longer pay for transplants performed at the center
after the effective date of the center's termination of approval.
(3) As soon as possible prior to a transplant center's voluntary
inactivation, the center must inform patients on the center's waiting
list and, as directed by the Secretary, provide assistance to waiting
list patients who choose to transfer to the waiting list of another
Medicare-approved transplant center without loss of time accrued on the
waiting list.
Sec. 482.104 Condition of participation: Additional requirements for kidney
transplant centers.
(a) Standard: End stage renal disease (ESRD) services. Kidney
transplant centers must directly furnish transplantation and other
medical and surgical specialty services required for the care of ESRD
patients. A kidney transplant center must have written policies and
procedures for ongoing communications with dialysis patients' local
dialysis facilities.
(b) Standard: Dialysis services. Kidney transplant centers must
furnish inpatient dialysis services directly or under arrangement.
(c) Standard: Participation in network activities. Kidney transplant
centers must cooperate with the ESRD Network designated for their
geographic area, in fulfilling the terms of the Network's current
statement of work.
PART 483_REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES--Table of
Contents
Subpart A [Reserved]
Subpart B_Requirements for Long Term Care Facilities
Sec.
483.1 Basis and scope.
483.5 Definitions.
483.10 Resident rights.
483.12 Admission, transfer and discharge rights.
483.13 Resident behavior and facility practices.
483.15 Quality of life.
483.20 Resident assessment.
483.25 Quality of care.
483.30 Nursing services.
483.35 Dietary services.
483.40 Physician services.
483.45 Specialized rehabilitative services.
483.55 Dental services.
483.60 Pharmacy services.
483.65 Infection control.
[[Page 41]]
483.70 Physical environment.
483.75 Administration.
Subpart C_Preadmission Screening and Annual Review of Mentally Ill and
Mentally Retarded Individuals
483.100 Basis.
483.102 Applicability and definitions.
483.104 State plan requirement.
483.106 Basic rule.
483.108 Relationship of PASARR to other Medicaid processes.
483.110 Out-of-State arrangements.
483.112 Preadmission screening of applicants for admission to NFs.
483.114 Annual review of NF residents.
483.116 Residents and applicants determined to require NF level of
services.
483.118 Residents and applicants determined not to require NF level of
services.
483.120 Specialized services.
483.122 FFP for NF services.
483.124 FFP for specialized services.
483.126 Appropriate placement.
483.128 PASARR evaluation criteria.
483.130 PASARR determination criteria.
483.132 Evaluating the need for NF services and NF level of care
(PASARR/NF).
483.134 Evaluating whether an individual with mental illness requires
specialized services (PASARR/MI).
483.136 Evaluating whether an individual with mental retardation
requires specialized services (PASARR/MR).
483.138 Maintenance of services and availability of FFP.
Subpart D_Requirements That Must Be Met by States and State Agencies:
Nurse Aide Training and Competency Evaluation; and Paid Feeding
Assistants
483.150 Statutory basis; Deemed meeting or waiver of requirements.
483.151 State review and approval of nurse aide training and competency
evaluation programs.
483.152 Requirements for approval of a nurse aide training and
competency evaluation program.
483.154 Nurse aide competency evaluation.
483.156 Registry of nurse aides.
483.158 FFP for nurse aide training and competency evaluation.
483.160 Requirements for training of paid feeding assistants.
Subpart E_Appeals of Discharges, Transfers, and Preadmission Screening
and Annual Resident Review (PASARR) Determinations
483.200 Statutory basis.
483.202 Definitions.
483.204 Provision of a hearing and appeal system.
483.206 Transfers, discharges and relocations subject to appeal.
Subpart F_Requirements That Must Be Met by States and State Agencies,
Resident Assessment
483.315 Specification of resident assessment instrument.
Subpart G_Condition of Participation for the Use of Restraint or
Seclusion in Psychiatric Residential Treatment Facilities Providing
Inpatient Psychiatric Services for Individuals Under Age 21
483.350 Basis and scope.
483.352 Definitions.
483.354 General requirements for psychiatric residential treatment
facilities.
483.356 Protection of residents.
483.358 Orders for the use of restraint or seclusion.
483.360 Consultation with treatment team physician.
483.362 Monitoring of the resident in and immediately after restraint.
483.364 Monitoring of the resident in and immediately after seclusion.
483.366 Notification of parent(s) or legal guardian(s).
483.368 Application of time out.
483.370 Postintervention debriefings.
483.372 Medical treatment for injuries resulting from an emergency
safety intervention.
483.374 Facility reporting.
483.376 Education and training.
Subpart H [Reserved]
Subpart I_Conditions of Participation for Intermediate Care Facilities
for the Mentally Retarded
483.400 Basis and purpose.
483.405 Relationship to other HHS regulations.
483.410 Condition of participation: Governing body and management.
483.420 Condition of participation: Client protections.
483.430 Condition of participation: Facility staffing.
483.440 Condition of participation: Active treatment services.
483.450 Condition of participation: Client behavior and facility
practices.
483.460 Condition of participation: Health care services.
483.470 Condition of participation: Physical environment.
483.480 Condition of participation: Dietetic services.
Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C.
1302 and 1395hh).
[[Page 42]]
Subpart A [Reserved]
Subpart B_Requirements for Long Term Care Facilities
Source: 54 FR 5359, Feb. 2, 1989, unless otherwise noted.
Sec. 483.1 Basis and scope.
(a) Statutory basis. (1) Sections 1819 (a), (b), (c), and (d) of the
Act provide that--
(i) Skilled nursing facilities participating in Medicare must meet
certain specified requirements; and
(ii) The Secretary may impose additional requirements (see section
1819(d)(4)(B)) if they are necessary for the health and safety of
individuals to whom services are furnished in the facilities.
(2) Section 1861(l) of the Act requires the facility to have in
effect a transfer agreement with a hospital.
(3) Sections 1919 (a), (b), (c), and (d) of the Act provide that
nursing facilities participating in Medicaid must meet certain specific
requirements.
(b) Scope. The provisions of this part contain the requirements that
an institution must meet in order to qualify to participate as a SNF in
the Medicare program, and as a nursing facility in the Medicaid program.
They serve as the basis for survey activities for the purpose of
determining whether a facility meets the requirements for participation
in Medicare and Medicaid.
[56 FR 48867, Sept. 26, 1991, as amended at 57 FR 43924, Sept. 23, 1992;
60 FR 50443, Sept. 29, 1995]
Sec. 483.5 Definitions.
(a) Facility defined. For purposes of this subpart, facility means a
skilled nursing facility (SNF) that meets the requirements of sections
1819(a), (b), (c), and (d) of the Act, or a nursing facility (NF) that
meets the requirements of sections 1919(a), (b), (c), and (d) of the
Act. ``Facility'' may include a distinct part of an institution (as
defined in paragraph (b) of this section and specified in Sec. 440.40
and Sec. 440.155 of this chapter), but does not include an institution
for the mentally retarded or persons with related conditions described
in Sec. 440.150 of this chapter. For Medicare and Medicaid purposes
(including eligibility, coverage, certification, and payment), the
``facility'' is always the entity that participates in the program,
whether that entity is comprised of all of, or a distinct part of, a
larger institution. For Medicare, an SNF (see section 1819(a)(1) of the
Act), and for Medicaid, an NF (see section 1919(a)(1) of the Act) may
not be an institution for mental diseases as defined in Sec. 435.1010
of this chapter.
(b) Distinct part--(1) Definition. A distinct part SNF or NF is
physically distinguishable from the larger institution or institutional
complex that houses it, meets the requirements of this paragraph and of
paragraph (b)(2) of this section, and meets the applicable statutory
requirements for SNFs or NFs in sections 1819 or 1919 of the Act,
respectively. A distinct part SNF or NF may be comprised of one or more
buildings or designated parts of buildings (that is, wings, wards, or
floors) that are: In the same physical area immediately adjacent to the
institution's main buildings; other areas and structures that are not
strictly contiguous to the main buildings but are located within close
proximity of the main buildings; and any other areas that CMS determines
on an individual basis, to be part of the institution's campus. A
distinct part must include all of the beds within the designated area,
and cannot consist of a random collection of individual rooms or beds
that are scattered throughout the physical plant. The term ``distinct
part'' also includes a composite distinct part that meets the additional
requirements of paragraph (c) of this section.
(2) Requirements. In addition to meeting the participation
requirements for long-term care facilities set forth elsewhere in this
subpart, a distinct part SNF or NF must meet all of the following
requirements:
(i) The SNF or NF must be operated under common ownership and
control (that is, common governance) by the institution of which it is a
distinct part, as evidenced by the following:
(A) The SNF or NF is wholly owned by the institution of which it is
a distinct part.
[[Page 43]]
(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 usage of buildings, equipment, personnel, and services.
(ii) The administrator of the SNF or NF reports to and is directly
accountable to the management of the institution of which the SNF or NF
is a distinct part.
(iii) The SNF or NF must have a designated medical director who is
responsible for implementing care policies and coordinating medical
care, and who is directly accountable to the management of the
institution of which it is a distinct part.
(iv) The SNF or NF is financially integrated with the institution of
which it is a distinct part, as evidenced by the sharing of income and
expenses with that institution, and the reporting of its costs on that
institution's cost report.
(v) A single institution can have a maximum of only one distinct
part SNF and one distinct part NF.
(vi) (A) An institution cannot designate a distinct part SNF or NF,
but instead must submit a written request with documentation that
demonstrates it meets the criteria set forth above to CMS to determine
if it may be considered a distinct part.
(B) The effective date of approval of a distinct part is the date
that CMS determines all requirements (including enrollment with the
fiscal intermediary (FI)) are met for approval, and cannot be made
retroactive.
(C) The institution must request approval from CMS for all proposed
changes in the number of beds in the approved distinct part.
(c) Composite distinct part--(1) Definition. A composite distinct
part is a distinct part consisting of two or more noncontiguous
components that are not located within the same campus, as defined in
Sec. 413.65(a)(2) of this chapter.
(2) Requirements. In addition to meeting the requirements of
paragraph (b) of this section, a composite distinct part must meet all
of the following requirements:
(i) A SNF or NF that is a composite of more than one location will
be treated as a single distinct part of the institution of which it is a
distinct part. As such, the composite distinct part will have only one
provider agreement and only one provider number.
(ii) If two or more institutions (each with a distinct part SNF or
NF) undergo a change of ownership, CMS must approve the existing SNFs or
NFs as meeting the requirements before they are considered a composite
distinct part of a single institution. In making such a determination,
CMS considers whether its approval or disapproval of a composite
distinct part promotes the effective and efficient use of public monies
without sacrificing the quality of care.
(iii) If there is a change of ownership of a composite distinct part
SNF or NF, the assignment of the provider agreement to the new owner
will apply to all of the approved locations that comprise the composite
distinct part SNF or NF.
(iv) To ensure quality of care and quality of life for all
residents, the various components of a composite distinct part must meet
all of the requirements for participation independently in each
location.
(d) Common area. Common areas are dining rooms, activity rooms,
meeting rooms where residents are located on a regular basis, and other
areas in the facility where residents may gather together with other
residents, visitors, and staff.
(e) Fully sprinklered. A fully sprinklered long term care facility
is one that has all areas sprinklered in accordance with National Fire
Protection Association 13 ``Standard for the Installation of Sprinkler
Systems'' without the use of waivers or the Fire Safety Evaluation
System.
[68 FR 46071, Aug. 4, 2003, as amended at 71 FR 39229, July 12, 2006; 71
FR 55340, Sept. 22, 2006]
[[Page 44]]
Sec. 483.10 Resident rights.
The resident has a right to a dignified existence, self-
determination, and communication with and access to persons and services
inside and outside the facility. A facility must protect and promote the
rights of each resident, including each of the following rights:
(a) Exercise of rights. (1) The resident has the right to exercise
his or her rights as a resident of the facility and as a citizen or
resident of the United States.
(2) The resident has the right to be free of interference, coercion,
discrimination, and reprisal from the facility in exercising his or her
rights.
(3) In the case of a resident adjudged incompetent under the laws of
a State by a court of competent jurisdiction, the rights of the resident
are exercised by the person appointed under State law to act on the
resident's behalf.
(4) In the case of a resident who has not been adjudged incompetent
by the State court, any legal-surrogate designated in accordance with
State law may exercise the resident's rights to the extent provided by
State law.
(b) Notice of rights and services. (1) The facility must inform the
resident both orally and in writing in a language that the resident
understands of his or her rights and all rules and regulations governing
resident conduct and responsibilities during the stay in the facility.
The facility must also provide the resident with the notice (if any) of
the State developed under section 1919(e)(6) of the Act. Such
notification must be made prior to or upon admission and during the
resident's stay. Receipt of such information, and any amendments to it,
must be acknowledged in writing;
(2) The resident or his or her legal representative has the right--
(i) Upon an oral or written request, to access all records
pertaining to himself or herself including current clinical records
within 24 hours (excluding weekends and holidays); and
(ii) After receipt of his or her records for inspection, to purchase
at a cost not to exceed the community standard photocopies of the
records or any portions of them upon request and 2 working days advance
notice to the facility.
(3) The resident has the right to be fully informed in language that
he or she can understand of his or her total health status, including
but not limited to, his or her medical condition;
(4) The resident has the right to refuse treatment, to refuse to
participate in experimental research, and to formulate an advance
directive as specified in paragraph (8) of this section; and
(5) The facility must--
(i) Inform each resident who is entitled to Medicaid benefits, in
writing, at the time of admission to the nursing facility or, when the
resident becomes eligible for Medicaid of--
(A) The items and services that are included in nursing facility
services under the State plan and for which the resident may not be
charged;
(B) Those other items and services that the facility offers and for
which the resident may be charged, and the amount of charges for those
services; and
(ii) Inform each resident when changes are made to the items and
services specified in paragraphs (5)(i) (A) and (B) of this section.
(6) The facility must inform each resident before, or at the time of
admission, and periodically during the resident's stay, of services
available in the facility and of charges for those services, including
any charges for services not covered under Medicare or by the facility's
per diem rate.
(7) The facility must furnish a written description of legal rights
which includes--
(i) A description of the manner of protecting personal funds, under
paragraph (c) of this section;
(ii) A description of the requirements and procedures for
establishing eligibility for Medicaid, including the right to request an
assessment under section 1924(c) which determines the extent of a
couple's non-exempt resources at the time of institutionalization and
attributes to the community spouse an equitable share of resources which
cannot be considered available for payment toward the cost of the
institutionalized spouse's medical care in his or her process of
spending down to Medicaid eligibility levels;
[[Page 45]]
(iii) A posting of names, addresses, and telephone numbers of all
pertinent State client advocacy groups such as the State survey and
certification agency, the State licensure office, the State ombudsman
program, the protection and advocacy network, and the Medicaid fraud
control unit; and
(iv) A statement that the resident may file a complaint with the
State survey and certification agency concerning resident abuse,
neglect, misappropriation of resident property in the facility, and non-
compliance with the advance directives requirements.
(8) The facility must comply with the requirements specified in
subpart I of part 489 of this chapter relating to maintaining written
policies and procedures regarding advance directives. These requirements
include provisions to inform and provide written information to all
adult residents concerning the right to accept or refuse medical or
surgical treatment and, at the individual's option, formulate an advance
directive. This includes a written description of the facility's
policies to implement advance directives and applicable State law.
Facilities are permitted to contract with other entities to furnish this
information but are still legally responsible for ensuring that the
requirements of this section are met. If an adult individual is
incapacitated at the time of admission and is unable to receive
information (due to the incapacitating condition or a mental disorder)
or articulate whether or not he or she has executed an advance
directive, the facility may give advance directive information to the
individual's family or surrogate in the same manner that it issues other
materials about policies and procedures to the family of the
incapacitated individual or to a surrogate or other concerned persons in
accordance with State law. The facility is not relieved of its
obligation to provide this information to the individual once he or she
is no longer incapacitated or unable to receive such information.
Follow-up procedures must be in place to provide the information to the
individual directly at the appropriate time.
(9) The facility must inform each resident of the name, specialty,
and way of contacting the physician responsible for his or her care.
(10) The facility must prominently display in the facility written
information, and provide to residents and applicants for admission oral
and written information about how to apply for and use Medicare and
Medicaid benefits, and how to receive refunds for previous payments
covered by such benefits.
(11) Notification of changes. (i) A facility must immediately inform
the resident; consult with the resident's physician; and if known,
notify the resident's legal respresentative or an interested family
member when there is--
(A) An accident involving the resident which results in injury and
has the potential for requiring physician intervention;
(B) A significant change in the resident's physical, mental, or
psychosocial status (i.e., a deterioration in health, mental, or
psychosocial status in either life-threatening conditions or clinical
complications);
(C) A need to alter treatment significantly (i.e., a need to
discontinue an existing form of treatment due to adverse consequences,
or to commence a new form of treatment); or
(D) A decision to transfer or discharge the resident from the
facility as specified in Sec. 483.12(a).
(ii) The facility must also promptly notify the resident and, if
known, the resident's legal representative or interested family member
when there is--
(A) A change in room or roommate assignment as specified in Sec.
483.15(e)(2); or
(B) A change in resident rights under Federal or State law or
regulations as specified in paragraph (b)(1) of this section.
(iii) The facility must record and periodically update the address
and phone number of the resident's legal representative or interested
family member.
(12) Admission to a composite distinct part. A facility that is a
composite distinct part (as defined in Sec. 483.5(c) of this subpart)
must disclose in its admission agreement its physical configuration,
including the various locations that comprise the composite distinct
part, and must specify the policies that
[[Page 46]]
apply to room changes between its different locations under Sec.
483.12(a)(8).
(c) Protection of resident funds. (1) The resident has the right to
manage his or her financial affairs, and the facility may not require
residents to deposit their personal funds with the facility.
(2) Management of personal funds. Upon written authorization of a
resident, the facility must hold, safeguard, manage, and account for the
personal funds of the resident deposited with the facility, as specified
in paragraphs (c)(3)-(8) of this section.
(3) Deposit of funds. (i) Funds in excess of $50. The facility must
deposit any residents' personal funds in excess of $50 in an interest
bearing account (or accounts) that is separate from any of the
facility's operating accounts, and that credits all interest earned on
resident's funds to that account. (In pooled accounts, there must be a
separate accounting for each resident's share.)
(ii) Funds less than $50. The facility must maintain a resident's
personal funds that do not exceed $50 in a non-interest bearing account,
interest-bearing account, or petty cash fund.
(4) Accounting and records. The facility must establish and maintain
a system that assures a full and complete and separate accounting,
according to generally accepted accounting principles, of each
resident's personal funds entrusted to the facility on the resident's
behalf.
(i) The system must preclude any commingling of resident funds with
facility funds or with the funds of any person other than another
resident.
(ii) The individual financial record must be available through
quarterly statements and on request to the resident or his or her legal
representative.
(5) Notice of certain balances. The facility must notify each
resident that receives Medicaid benefits--
(i) When the amount in the resident's account reaches $200 less than
the SSI resource limit for one person, specified in section
1611(a)(3)(B) of the Act; and
(ii) That, if the amount in the account, in addition to the value of
the resident's other nonexempt resources, reaches the SSI resource limit
for one person, the resident may lose eligibility for Medicaid or SSI.
(6) Conveyance upon death. Upon the death of a resident with a
personal fund deposited with the facility, the facility must convey
within 30 days the resident's funds, and a final accounting of those
funds, to the individual or probate jurisdiction administering the
resident's estate.
(7) Assurance of financial security. The facility must purchase a
surety bond, or otherwise provide assurance satisfactory to the
Secretary, to assure the security of all personal funds of residents
deposited with the facility.
(8) Limitation on charges to personal funds. The facility may not
impose a charge against the personal funds of a resident for any item or
service for which payment is made under Medicaid or Medicare (except for
applicable deductible and coinsurance amounts). The facility may charge
the resident for requested services that are more expensive than or in
excess of covered services in accordance with Sec. 489.32 of this
chapter. (This does not affect the prohibition on facility charges for
items and services for which Medicaid has paid. See Sec. 447.15, which
limits participation in the Medicaid program to providers who accept, as
payment in full, Medicaid payment plus any deductible, coinsurance, or
copayment required by the plan to be paid by the individual.)
(i) Services included in Medicare or Medicaid payment. During the
course of a covered Medicare or Medicaid stay, facilities may not charge
a resident for the following categories of items and services:
(A) Nursing services as required at Sec. 483.30 of this subpart.
(B) Dietary services as required at Sec. 483.35 of this subpart.
(C) An activities program as required at Sec. 483.15(f) of this
subpart.
(D) Room/bed maintenance services.
(E) Routine personal hygiene items and services as required to meet
the needs of residents, including, but not limited to, hair hygiene
supplies, comb, brush, bath soap, disinfecting soaps or specialized
cleansing agents when indicated to treat special skin problems or to
fight infection, razor, shaving cream, toothbrush, toothpaste, denture
adhesive, denture cleaner, dental floss, moisturizing lotion, tissues,
[[Page 47]]
cotton balls, cotton swabs, deodorant, incontinence care and supplies,
sanitary napkins and related supplies, towels, washcloths, hospital
gowns, over the counter drugs, hair and nail hygiene services, bathing,
and basic personal laundry.
(F) Medically-related social services as required at Sec. 483.15(g)
of this subpart.
(ii) Items and services that may be charged to residents' funds.
Listed below are general categories and examples of items and services
that the facility may charge to residents' funds if they are requested
by a resident, if the facility informs the resident that there will be a
charge, and if payment is not made by Medicare or Medicaid:
(A) Telephone.
(B) Television/radio for personal use.
(C) Personal comfort items, including smoking materials, notions and
novelties, and confections.
(D) Cosmetic and grooming items and services in excess of those for
which payment is made under Medicaid or Medicare.
(E) Personal clothing.
(F) Personal reading matter.
(G) Gifts purchased on behalf of a resident.
(H) Flowers and plants.
(I) Social events and entertainment offered outside the scope of the
activities program, provided under Sec. 483.15(f) of this subpart.
(J) Noncovered special care services such as privately hired nurses
or aides.
(K) Private room, except when therapeutically required (for example,
isolation for infection control).
(L) Specially prepared or alternative food requested instead of the
food generally prepared by the facility, as required by Sec. 483.35 of
this subpart.
(iii) Requests for items and services. (A) The facility must not
charge a resident (or his or her representative) for any item or service
not requested by the resident.
(B) The facility must not require a resident (or his or her
representative) to request any item or service as a condition of
admission or continued stay.
(C) The facility must inform the resident (or his or her
representative) requesting an item or service for which a charge will be
made that there will be a charge for the item or service and what the
charge will be.
(d) Free choice. The resident has the right to--
(1) Choose a personal attending physician;
(2) Be fully informed in advance about care and treatment and of any
changes in that care or treatment that may affect the resident's well-
being; and
(3) Unless adjudged incompetent or otherwise found to be
incapacitated under the laws of the State, participate in planning care
and treatment or changes in care and treatment.
(e) Privacy and confidentiality. The resident has the right to
personal privacy and confidentiality of his or her personal and clinical
records.
(1) Personal privacy includes accommodations, medical treatment,
written and telephone communications, personal care, visits, and
meetings of family and resident groups, but this does not require the
facility to provide a private room for each resident;
(2) Except as provided in paragraph (e)(3) of this section, the
resident may approve or refuse the release of personal and clinical
records to any individual outside the facility;
(3) The resident's right to refuse release of personal and clinical
records does not apply when--
(i) The resident is transferred to another health care institution;
or
(ii) Record release is required by law.
(f) Grievances. A resident has the right to--
(1) Voice grievances without discrimination or reprisal. Such
grievances include those with respect to treatment which has been
furnished as well as that which has not been furnished; and
(2) Prompt efforts by the facility to resolve grievances the
resident may have, including those with respect to the behavior of other
residents.
(g) Examination of survey results. A resident has the right to--
(1) Examine the results of the most recent survey of the facility
conducted by Federal or State surveyors and any plan of correction in
effect with respect to the facility. The facility must make the results
available for examination in a place readily accessible to
[[Page 48]]
residents, and must post a notice of their availability; and
(2) Receive information from agencies acting as client advocates,
and be afforded the opportunity to contact these agencies.
(h) Work. The resident has the right to--
(1) Refuse to perform services for the facility;
(2) Perform services for the facility, if he or she chooses, when--
(i) The facility has documented the need or desire for work in the
plan of care;
(ii) The plan specifies the nature of the services performed and
whether the services are voluntary or paid;
(iii) Compensation for paid services is at or above prevailing
rates; and
(iv) The resident agrees to the work arrangement described in the
plan of care.
(i) Mail. The resident has the right to privacy in written
communications, including the right to--
(1) Send and promptly receive mail that is unopened; and
(2) Have access to stationery, postage, and writing implements at
the resident's own expense.
(j) Access and visitation rights. (1) The resident has the right and
the facility must provide immediate access to any resident by the
following:
(i) Any representative of the Secretary;
(ii) Any representative of the State:
(iii) The resident's individual physician;
(iv) The State long term care ombudsman (established under section
307(a)(12) of the Older Americans Act of 1965);
(v) The agency responsible for the protection and advocacy system
for developmentally disabled individuals (established under part C of
the Developmental Disabilities Assistance and Bill of Rights Act);
(vi) The agency responsible for the protection and advocacy system
for mentally ill individuals (established under the Protection and
Advocacy for Mentally Ill Individuals Act);
(vii) Subject to the resident's right to deny or withdraw consent at
any time, immediate family or other relatives of the resident; and
(viii) Subject to reasonable restrictions and the resident's right
to deny or withdraw consent at any time, others who are visiting with
the consent of the resident.
(2) The facility must provide reasonable access to any resident by
any entity or individual that provides health, social, legal, or other
services to the resident, subject to the resident's right to deny or
withdraw consent at any time.
(3) The facility must allow representatives of the State Ombudsman,
described in paragraph (j)(1)(iv) of this section, to examine a
resident's clinical records with the permission of the resident or the
resident's legal representative, and consistent with State law.
(k) Telephone. The resident has the right to have reasonable access
to the use of a telephone where calls can be made without being
overheard.
(l) Personal property. The resident has the right to retain and use
personal possessions, including some furnishings, and appropriate
clothing, as space permits, unless to do so would infringe upon the
rights or health and safety of other residents.
(m) Married couples. The resident has the right to share a room with
his or her spouse when married residents live in the same facility and
both spouses consent to the arrangement.
(n) Self-Administration of Drugs. An individual resident may self-
administer drugs if the interdisciplinary team, as defined by Sec.
483.20(d)(2)(ii), has determined that this practice is safe.
(o) Refusal of certain transfers. (1) An individual has the right to
refuse a transfer to another room within the institution, if the purpose
of the transfer is to relocate--
(i) A resident of a SNF from the distinct part of the institution
that is a SNF to a part of the institution that is not a SNF, or
(ii) A resident of a NF from the distinct part of the institution
that is a NF to a distinct part of the institution that is a SNF.
(2) A resident's exercise of the right to refuse transfer under
paragraph (o)(1) of this section does not affect the
[[Page 49]]
individual's eligibility or entitlement to Medicare or Medicaid
benefits.
[56 FR 48867, Sept. 26, 1991, as amended at 57 FR 8202, Mar. 6, 1992; 57
FR 43924, Sept. 23, 1992; 57 FR 53587, Nov. 12, 1992; 60 FR 33293, June
27, 1995; 68 FR 46072, Aug. 4, 2003]
Sec. 483.12 Admission, transfer and discharge rights.
(a) Transfer and discharge--
(1) Definition: Transfer and discharge includes movement of a
resident to a bed outside of the certified facility whether that bed is
in the same physical plant or not. Transfer and discharge does not refer
to movement of a resident to a bed within the same certified facility.
(2) Transfer and discharge requirements. The facility must permit
each resident to remain in the facility, and not transfer or discharge
the resident from the facility unless--
(i) The transfer or discharge is necessary for the resident's
welfare and the resident's needs cannot be met in the facility;
(ii) The transfer or discharge is appropriate because the resident's
health has improved sufficiently so the resident no longer needs the
services provided by the facility;
(iii) The safety of individuals in the facility is endangered;
(iv) The health of individuals in the facility would otherwise be
endangered;
(v) The resident has failed, after reasonable and appropriate
notice, to pay for (or to have paid under Medicare or Medicaid) a stay
at the facility. For a resident who becomes eligible for Medicaid after
admission to a facility, the facility may charge a resident only
allowable charges under Medicaid; or
(vi) The facility ceases to operate.
(3) Documentation. When the facility transfers or discharges a
resident under any of the circumstances specified in paragraphs
(a)(2)(i) through (v) of this section, the resident's clinical record
must be documented. The documentation must be made by--
(i) The resident's physician when transfer or discharge is necessary
under paragraph (a)(2)(i) or paragraph (a)(2)(ii) of this section; and
(ii) A physician when transfer or discharge is necessary under
paragraph (a)(2)(iv) of this section.
(4) Notice before transfer. Before a facility transfers or
discharges a resident, the facility must--
(i) Notify the resident and, if known, a family member or legal
representative of the resident of the transfer or discharge and the
reasons for the move in writing and in a language and manner they
understand.
(ii) Record the reasons in the resident's clinical record; and
(iii) Include in the notice the items described in paragraph (a)(6)
of this section.
(5) Timing of the notice. (i) Except when specified in paragraph
(a)(5)(ii) of this section, the notice of transfer or discharge required
under paragraph (a)(4) of this section must be made by the facility at
least 30 days before the resident is transferred or discharged.
(ii) Notice may be made as soon as practicable before transfer or
discharge when--
(A) the safety of individuals in the facility would be endangered
under paragraph (a)(2)(iii) of this section;
(B) The health of individuals in the facility would be endangered,
under paragraph (a)(2)(iv) of this section;
(C) The resident's health improves sufficiently to allow a more
immediate transfer or discharge, under paragraph (a)(2)(ii) of this
section;
(D) An immediate transfer or discharge is required by the resident's
urgent medical needs, under paragraph (a)(2)(i) of this section; or
(E) A resident has not resided in the facility for 30 days.
(6) Contents of the notice. The written notice specified in
paragraph (a)(4) of this section must include the following:
(i) The reason for transfer or discharge;
(ii) The effective date of transfer or discharge;
(iii) The location to which the resident is transferred or
discharged;
(iv) A statement that the resident has the right to appeal the
action to the State;
(v) The name, address and telephone number of the State long term
care ombudsman;
(vi) For nursing facility residents with developmental disabilities,
the mailing address and telephone number
[[Page 50]]
of the agency responsible for the protection and advocacy of
developmentally disabled individuals established under Part C of the
Developmental Disabilities Assistance and Bill of Rights Act; and
(vii) For nursing facility residents who are mentally ill, the
mailing address and telephone number of the agency responsible for the
protection and advocacy of mentally ill individuals established under
the Protection and Advocacy for Mentally Ill Individuals Act.
(7) Orientation for transfer or discharge. A facility must provide
sufficient preparation and orientation to residents to ensure safe and
orderly transfer or discharge from the facility.
(8) Room changes in a composite distinct part. Room changes in a
facility that is a composite distinct part (as defined in Sec.
483.5(c)) must be limited to moves within the particular building in
which the resident resides, unless the resident voluntarily agrees to
move to another of the composite distinct part's locations.
(b) Notice of bed-hold policy and readmission--(1) Notice before
transfer. Before a nursing facility transfers a resident to a hospital
or allows a resident to go on therapeutic leave, the nursing facility
must provide written information to the resident and a family member or
legal representative that specifies--
(i) The duration of the bed-hold policy under the State plan, if
any, during which the resident is permitted to return and resume
residence in the nursing facility; and
(ii) The nursing facility's policies regarding bed-hold periods,
which must be consistent with paragraph (b)(3) of this section,
permitting a resident to return.
(2) Bed-hold notice upon transfer. At the time of transfer of a
resident for hospitalization or therapeutic leave, a nursing facility
must provide to the resident and a family member or legal representative
written notice which specifies the duration of the bed-hold policy
described in paragraph (b)(1) of this section.
(3) Permitting resident to return to facility. A nursing facility
must establish and follow a written policy under which a resident, whose
hospitalization or therapeutic leave exceeds the bed-hold period under
the State plan, is readmitted to the facility immediately upon the first
availability of a bed in a semi-private room if the resident--
(i) Requires the services provided by the facility; and
(ii) Is eligible for Medicaid nursing facility services.
(4) Readmission to a composite distinct part. When the nursing
facility to which a resident is readmitted is a composite distinct part
(as defined in Sec. 483.5(c) of this subpart), the resident must be
permitted to return to an available bed in the particular location of
the composite distinct part in which he or she resided previously. If a
bed is not available in that location at the time of readmission, the
resident must be given the option to return to that location upon the
first availability of a bed there.
(c) Equal access to quality care. (1) A facility must establish and
maintain identical policies and practices regarding transfer, discharge,
and the provision of services under the State plan for all individuals
regardless of source of payment;
(2) The facility may charge any amount for services furnished to
non-Medicaid residents consistent with the notice requirement in Sec.
483.10(b)(5)(i) and (b)(6) describing the charges; and
(3) The State is not required to offer additional services on behalf
of a resident other than services provided in the State plan.
(d) Admissions policy. (1) The facility must--
(i) Not require residents or potential residents to waive their
rights to Medicare or Medicaid; and
(ii) Not require oral or written assurance that residents or
potential residents are not eligible for, or will not apply for,
Medicare or Medicaid benefits.
(2) The facility must not require a third party guarantee of payment
to the facility as a condition of admission or expedited admission, or
continued stay in the facility. However, the facility may require an
individual who has legal access to a resident's income or resources
available to pay for facility
[[Page 51]]
care to sign a contract, without incurring personal financial liability,
to provide facility payment from the resident's income or resources.
(3) In the case of a person eligible for Medicaid, a nursing
facility must not charge, solicit, accept, or receive, in addition to
any amount otherwise required to be paid under the State plan, any gift,
money, donation, or other consideration as a precondition of admission,
expedited admission or continued stay in the facility. However,--
(i) A nursing facility may charge a resident who is eligible for
Medicaid for items and services the resident has requested and received,
and that are not specified in the State plan as included in the term
``nursing facility services'' so long as the facility gives proper
notice of the availability and cost of these services to residents and
does not condition the resident's admission or continued stay on the
request for and receipt of such additional services; and
(ii) A nursing facility may solicit, accept, or receive a
charitable, religious, or philanthropic contribution from an
organization or from a person unrelated to a Medicaid eligible resident
or potential resident, but only to the extent that the contribution is
not a condition of admission, expedited admission, or continued stay in
the facility for a Medicaid eligible resident.
(4) States or political subdivisions may apply stricter admissions
standards under State or local laws than are specified in this section,
to prohibit discrimination against individuals entitled to Medicaid.
[56 FR 48869, Sept. 26, 1991, as amended at 57 FR 43924, Sept. 23, 1992;
68 FR 46072, Aug. 4, 2003]
Sec. 483.13 Resident behavior and facility practices.
(a) Restraints. The resident has the right to be free from any
physical or chemical restraints imposed for purposes of discipline or
convenience, and not required to treat the resident's medical symptoms.
(b) Abuse. The resident has the right to be free from verbal,
sexual, physical, and mental abuse, corporal punishment, and involuntary
seclusion.
(c) Staff treatment of residents. The facility must develop and
implement written policies and procedures that prohibit mistreatment,
neglect, and abuse of residents and misappropriation of resident
property.
(1) The facility must--
(i) Not use verbal, mental, sexual, or physical abuse, corporal
punishment, or involuntary seclusion;
(ii) Not employ individuals who have been--
(A) Found guilty of abusing, neglecting, or mistreating residents by
a court of law; or
(B) Have had a finding entered into the State nurse aide registry
concerning abuse, neglect, mistreatment of residents or misappropriation
of their property; and
(iii) Report any knowledge it has of actions by a court of law
against an employee, which would indicate unfitness for service as a
nurse aide or other facility staff to the State nurse aide registry or
licensing authorities.
(2) The facility must ensure that all alleged violations involving
mistreatment, neglect, or abuse, including injuries of unknown source,
and misappropriation of resident property are reported immediately to
the administrator of the facility and to other officials in accordance
with State law through established procedures (including to the State
survey and certification agency).
(3) The facility must have evidence that all alleged violations are
thoroughly investigated, and must prevent further potential abuse while
the investigation is in progress.
(4) The results of all investigations must be reported to the
administrator or his designated representative and to other officials in
accordance with State law (including to the State survey and
certification agency) within 5 working days of the incident, and if the
alleged violation is verified appropriate corrective action must be
taken.
[56 FR 48870, Sept. 26, 1991, as amended at 57 FR 43924, Sept. 23, 1992]
Sec. 483.15 Quality of life.
A facility must care for its residents in a manner and in an
environment
[[Page 52]]
that promotes maintenance or enhancement of each resident's quality of
life.
(a) Dignity. The facility must promote care for residents in a
manner and in an environment that maintains or enhances each resident's
dignity and respect in full recognition of his or her individuality.
(b) Self-determination and participation. The resident has the right
to--
(1) Choose activities, schedules, and health care consistent with
his or her interests, assessments, and plans of care;
(2) Interact with members of the community both inside and outside
the facility; and
(3) Make choices about aspects of his or her life in the facility
that are significant to the resident.
(c) Participation in resident and family groups. (1) A resident has
the right to organize and participate in resident groups in the
facility;
(2) A resident's family has the right to meet in the facility with
the families of other residents in the facility;
(3) The facility must provide a resident or family group, if one
exists, with private space;
(4) Staff or visitors may attend meetings at the group's invitation;
(5) The facility must provide a designated staff person responsible
for providing assistance and responding to written requests that result
from group meetings;
(6) When a resident or family group exists, the facility must listen
to the views and act upon the grievances and recommendations of
residents and families concerning proposed policy and operational
decisions affecting resident care and life in the facility.
(d) Participation in other activities. A resident has the right to
participate in social, religious, and community activities that do not
interfere with the rights of other residents in the facility.
(e) Accommodation of needs. A resident has the right to--
(1) Reside and receive services in the facility with reasonable
accommodation of individual needs and preferences, except when the
health or safety of the individual or other residents would be
endangered; and
(2) Receive notice before the resident's room or roommate in the
facility is changed.
(f) Activities. (1) The facility must provide for an ongoing program
of activities designed to meet, in accordance with the comprehensive
assessment, the interests and the physical, mental, and psychosocial
well-being of each resident.
(2) The activities program must be directed by a qualified
professional who--
(i) Is a qualified therapeutic recreation specialist or an
activities professional who--
(A) Is licensed or registered, if applicable, by the State in which
practicing; and
(B) Is eligible for certification as a therapeutic recreation
specialist or as an activities professional by a recognized accrediting
body on or after October 1, 1990; or
(ii) Has 2 years of experience in a social or recreational program
within the last 5 years, 1 of which was full-time in a patient
activities program in a health care setting; or
(iii) Is a qualified occupational therapist or occupational therapy
assistant; or
(iv) Has completed a training course approved by the State.
(g) Social Services. (1) The facility must provide medically-related
social services to attain or maintain the highest practicable physical,
mental, and psychosocial well-being of each resident.
(2) A facility with more than 120 beds must employ a qualified
social worker on a full-time basis.
(3) Qualifications of social worker. A qualified social worker is an
individual with--
(i) A bachelor's degree in social work or a bachelor's degree in a
human services field including but not limited to sociology, special
education, rehabilitation counseling, and psychology; and
(ii) One year of supervised social work experience in a health care
setting working directly with individuals.
(h) Environment. The facility must provide--
(1) A safe, clean, comfortable, and homelike environment, allowing
the
[[Page 53]]
resident to use his or her personal belongings to the extent possible;
(2) Housekeeping and maintenance services necessary to maintain a
sanitary, orderly, and comfortable interior;
(3) Clean bed and bath linens that are in good condition;
(4) Private closet space in each resident room, as specified in
Sec. 483.70(d)(2)(iv) of this part;
(5) Adequate and comfortable lighting levels in all areas;
(6) Comfortable and safe temperature levels. Facilities initially
certified after October 1, 1990 must maintain a temperature range of 71-
81[deg]F; and
(7) For the maintenance of comfortable sound levels.
[56 FR 48871, Sept. 26, 1991, as amended at 57 FR 43924, Sept. 23, 1992]
Sec. 483.20 Resident assessment.
The facility must conduct initially and periodically a
comprehensive, accurate, standardized, reproducible assessment of each
resident's functional capacity.
(a) Admission orders. At the time each resident is admitted, the
facility must have physician orders for the resident's immediate care.
(b) Comprehensive assessments--(1) Resident assessment instrument. A
facility must make a comprehensive assessment of a resident's needs,
using the resident assessment instrument (RAI) specified by the State.
The assessment must include at least the following:
(i) Identification and demographic information.
(ii) Customary routine.
(iii) Cognitive patterns.
(iv) Communication.
(v) Vision.
(vi) Mood and behavior patterns.
(vii) Psychosocial well-being.
(viii) Physical functioning and structural problems.
(ix) Continence.
(x) Disease diagnoses and health conditions.
(xi) Dental and nutritional status.
(xii) Skin condition.
(xiii) Activity pursuit.
(xiv) Medications.
(xv) Special treatments and procedures.
(xvi) Discharge potential.
(xvii) Documentation of summary information regarding the additional
assessment performed on the care areas triggered by the completion of
the Minimum Data Set (MDS).
(xviii) Documentation of participation in assessment.
The assessment process must include direct observation and
communication with the resident, as well as communication with licensed
and nonlicensed direct care staff members on all shifts.
(2) When required. Subject to the timeframes prescribed in Sec.
413.343(b) of this chapter, a facility must conduct a comprehensive
assessment of a resident in accordance with the timeframes specified in
paragraphs (b)(2) (i) through (iii) of this section. The timeframes
prescribed in Sec. 413.343(b) of this chapter do not apply to CAHs.
(i) Within 14 calendar days after admission, excluding readmissions
in which there is no significant change in the resident's physical or
mental condition. (For purposes of this section, ``readmission'' means a
return to the facility following a temporary absence for hospitalization
or for therapeutic leave.)
(ii) Within 14 calendar days after the facility determines, or
should have determined, that there has been a significant change in the
resident's physical or mental condition. (For purposes of this section,
a ``significant change'' means a major decline or improvement in the
resident's status that will not normally resolve itself without further
intervention by staff or by implementing standard disease-related
clinical interventions, that has an impact on more than one area of the
resident's health status, and requires interdisciplinary review or
revision of the care plan, or both.)
(iii) Not less often than once every 12 months.
(c) Quarterly review assessment. A facility must assess a resident
using the quarterly review instrument specified by the State and
approved by CMS not less frequently than once every 3 months.
(d) Use. A facility must maintain all resident assessments completed
within the previous 15 months in the resident's active record and use
the results of the assessments to develop, review,
[[Page 54]]
and revise the resident's comprehensive plan f care.
(e) Coordination. A facility must coordinate assessments with the
preadmission screening and resident review program under Medicaid in
part 483, subpart C to the maximum extent practicable to avoid
duplicative testing and effort.
(f) Automated data processing requirement--(1) Encoding data. Within
7 days after a facility completes a resident's assessment, a facility
must encode the following information for each resident in the facility:
(i) Admission assessment.
(ii) Annual assessment updates.
(iii) Significant change in status assessments.
(iv) Quarterly review assessments.
(v) A subset of items upon a resident's transfer, reentry,
discharge, and death.
(vi) Background (face-sheet) information, if there is no admission
assessment.
(2) Transmitting data. Within 7 days after a facility completes a
resident's assessment, a facility must be capable of transmitting to the
CMS System information for each resident contained in the MDS in a
format that conforms to standard record layouts and data dictionaries,
and that passes standardized edits defined by CMS and the State.
(3) Transmittal requirements. Within 14 days after a facility
completes a resident's assessment, a facility must electronically
transmit encoded, accurate, and complete MDS data to the CMS System,
including the following:
(i) Admission assessment.
(ii) Annual assessment.
(iii) Significant change in status assessment.
(iv) Significant correction of prior full assessment.
(v) Significant correction of prior quarterly assessment.
(vi) Quarterly review.
(vii) A subset of items upon a resident's transfer, reentry,
discharge, and death.
(viii) Background (face-sheet) information, for an initial
transmission of MDS data on a resident that does not have an admission
assessment.
(4) Data format. The facility must transmit data in the format
specified by CMS or, for a State which has an alternate RAI approved by
CMS, in the format specified by the State and approved by CMS.
(5) Resident-identifiable information. (i) A facility may not
release information that is resident-identifiable to the public.
(ii) The facility may release information that is resident-
identifiable to an agent only in accordance with a contract under which
the agent agrees not to use or disclose the information except to the
extent the facility itself is permitted to do so.
(g) Accuracy of assessments. The assessment must accurately reflect
the resident's status.
(h) Coordination. A registered nurse must conduct or coordinate each
assessment with the appropriate participation of health professionals.
(i) Certification. (1) A registered nurse must sign and certify that
the assessment is completed.
(2) Each individual who completes a portion of the assessment must
sign and certify the accuracy of that portion of the assessment.
(j) Penalty for falsification. (1) Under Medicare and Medicaid, an
individual who willfully and knowingly--
(i) Certifies a material and false statement in a resident
assessment is subject to a civil money penalty of not more than $1,000
for each assessment; or
(ii) Causes another individual to certify a material and false
statement in a resident assessment is subject to a civil money penalty
of not more than $5,000 for each assessment.
(2) Clinical disagreement does not constitute a material and false
statement.
(k) Comprehensive care plans. (1) The facility must develop a
comprehensive care plan for each resident that includes measurable
objectives and timetables to meet a resident's medical, nursing, and
mental and psychosocial needs that are identified in the comprehensive
assessment. The care plan must describe the following--
(i) The services that are to be furnished to attain or maintain the
resident's highest practicable physical,
[[Page 55]]
mental, and psychosocial well-being as required under Sec. 483.25; and
(ii) Any services that would otherwise be required under Sec.
483.25 but are not provided due to the resident's exercise of rights
under Sec. 483.10, including the right to refuse treatment under Sec.
483.10(b)(4).
(2) A comprehensive care plan must be--
(i) Developed within 7 days after completion of the comprehensive
assessment;
(ii) Prepared by an interdisciplinary team, that includes the
attending physician, a registered nurse with responsibility for the
resident, and other appropriate staff in disciplines as determined by
the resident's needs, and, to the extent practicable, the participation
of the resident, the resident's family or the resident's legal
representative; and
(iii) Periodically reviewed and revised by a team of qualified
persons after each assessment.
(3) The services provided or arranged by the facility must--
(i) Meet professional standards of quality; and
(ii) Be provided by qualified persons in accordance with each
resident's written plan of care.
(l) Discharge summary. When the facility anticipates discharge a
resident must have a discharge summary that includes--
(1) A recapitulation of the resident's stay;
(2) A final summary of the resident's status to include items in
paragraph (b)(2) of this section, at the time of the discharge that is
available for release to authorized persons and agencies, with the
consent of the resident or legal representative; and
(3) A post-discharge plan of care that is developed with the
participation of the resident and his or her family, which will assist
the resident to adjust to his or her new living environment.
(m) Preadmission screening for mentally ill individuals and
individuals with mental retardation. (1) A nursing facility must not
admit, on or after January 1, 1989, any new resident with--
(i) Mental illness as defined in paragraph (f)(2)(i) of this
section, unless the State mental health authority has determined, based
on an independent physical and mental evaluation performed by a person
or entity other than the State mental health authority, prior to
admission,
(A) That, because of the physical and mental condition of the
individual, the individual requires the level of services provided by a
nursing facility; and
(B) If the individual requires such level of services, whether the
individual requires specialized services; or
(ii) Mental retardation, as defined in paragraph (f)(2)(ii) of this
section, unless the State mental retardation or developmental disability
authority has determined prior to admission--
(A) That, because of the physical and mental condition of the
individual, the individual requires the level of services provided by a
nursing facility; and
(B) If the individual requires such level of services, whether the
individual requires specialized services for mental retardation.
(2) Definition. For purposes of this section--
(i) An individual is considered to have mental illness if the
individual has a serious mental illness as defined in Sec.
483.102(b)(1).
(ii) An individual is considered to be mentally retarded if the
individual is mentally retarded as defined in Sec. 483.102(b)(3) or is
a person with a related condition as described in 42 CFR 435.1010 of
this chapter.
[56 FR 48871, Sept. 26, 1991, as amended at 57 FR 43924, Sept. 23, 1992;
62 FR 67211, Dec. 23, 1997; 63 FR 53307, Oct. 5, 1998; 64 FR 41543, July
30, 1999; 68 FR 46072, Aug. 4, 2003; 71 FR 39229, July 12, 2006; 74 FR
40363, Aug.11, 2009]
Sec. 483.25 Quality of care.
Each resident must receive and the facility must provide the
necessary care and services to attain or maintain the highest
practicable physical, mental, and psychosocial well-being, in accordance
with the comprehensive assessment and plan of care.
(a) Activities of daily living. Based on the comprehensive
assessment of a resident, the facility must ensure that--
(1) A resident's abilities in activities of daily living do not
diminish unless
[[Page 56]]
circumstances of the individual's clinical condition demonstrate that
diminution was unavoidable. This includes the resident's ability to--
(i) Bathe, dress, and groom;
(ii) Transfer and ambulate;
(iii) Toilet;
(iv) Eat; and
(v) Use speech, language, or other functional communication systems.
(2) A resident is given the appropriate treatment and services to
maintain or improve his or her abilities specified in paragraph (a)(1)
of this section; and
(3) A resident who is unable to carry out activities of daily living
receives the necessary services to maintain good nutrition, grooming,
and personal and oral hygiene.
(b) Vision and hearing. To ensure that residents receive proper
treatment and assistive devices to maintain vision and hearing
abilities, the facility must, if necessary, assist the resident--
(1) In making appointments, and
(2) By arranging for transportation to and from the office of a
practitioner specializing in the treatment of vision or hearing
impairment or the office of a professional specializing in the provision
of vision or hearing assistive devices.
(c) Pressure sores. Based on the comprehensive assessment of a
resident, the facility must ensure that--
(1) A resident who enters the facility without pressure sores does
not develop pressure sores unless the individual's clinical condition
demonstrates that they were unavoidable; and
(2) A resident having pressure sores receives necessary treatment
and services to promote healing, prevent infection and prevent new sores
from developing.
(d) Urinary Incontinence. Based on the resident's comprehensive
assessment, the facility must ensure that--
(1) A resident who enters the facility without an indwelling
catheter is not catheterized unless the resident's clinical condition
demonstrates that catheterization was necessary; and
(2) A resident who is incontinent of bladder receives appropriate
treatment and services to prevent urinary tract infections and to
restore as much normal bladder function as possible.
(e) Range of motion. Based on the comprehensive assessment of a
resident, the facility must ensure that--
(1) A resident who enters the facility without a limited range of
motion does not experience reduction in range of motion unless the
resident's clinical condition demonstrates that a reduction in range of
motion is unavoidable; and
(2) A resident with a limited range of motion receives appropriate
treatment and services to increase range of motion and/or to prevent
further decrease in range of motion.
(f) Mental and Psychosocial functioning. Based on the comprehensive
assessment of a resident, the facility must ensure that--
(1) A resident who displays mental or psychosocial adjustment
difficulty, receives appropriate treatment and services to correct the
assessed problem, and
(2) A resident whose assessment did not reveal a mental or
psychosocial adjustment difficulty does not display a pattern of
decreased social interaction and/or increased withdrawn, angry, or
depressive behaviors, unless the resident's clinical condition
demonstrates that such a pattern was unavoidable.
(g) Naso-gastric tubes. Based on the comprehensive assessment of a
resident, the facility must ensure that--
(1) A resident who has been able to eat enough alone or with
assistance is not fed by naso-gastric tube unless the resident's
clinical condition demonstrates that use of a naso-gastric tube was
unavoidable; and
(2) A resident who is fed by a naso-gastric or gastrostomy tube
receives the appropriate treatment and services to prevent aspiration
pneumonia, diarrhea, vomiting, dehydration, metabolic abnormalities, and
nasal-pharyngeal ulcers and to restore, if possible, normal eating
skills.
(h) Accidents. The facility must ensure that--
(1) The resident environment remains as free of accident hazards as
is possible; and
(2) Each resident receives adequate supervision and assistance
devices to prevent accidents.
[[Page 57]]
(i) Nutrition. Based on a resident's comprehensive assessment, the
facility must ensure that a resident--
(1) Maintains acceptable parameters of nutritional status, such as
body weight and protein levels, unless the resident's clinical condition
demonstrates that this is not possible; and
(2) Receives a therapeutic diet when there is a nutritional problem.
(j) Hydration. The facility must provide each resident with
sufficient fluid intake to maintain proper hydration and health.
(k) Special needs. The facility must ensure that residents receive
proper treatment and care for the following special services:
(1) Injections;
(2) Parenteral and enteral fluids;
(3) Colostomy, ureterostomy, or ileostomy care;
(4) Tracheostomy care;
(5) Tracheal suctioning;
(6) Respiratory care;
(7) Foot care; and
(8) Prostheses.
(l) Unnecessary drugs--(1) General. Each resident's drug regimen
must be free from unnecessary drugs. An unnecessary drug is any drug
when used:
(i) In excessive dose (including duplicate drug therapy); or
(ii) For excessive duration; or
(iii) Without adequate monitoring; or
(iv) Without adequate indications for its use; or
(v) In the presence of adverse consequences which indicate the dose
should be reduced or discontinued; or
(vi) Any combinations of the reasons above.
(2) Antipsychotic Drugs. Based on a comprehensive assessment of a
resident, the facility must ensure that--
(i) Residents who have not used antipsychotic drugs are not given
these drugs unless antipsychotic drug therapy is necessary to treat a
specific condition as diagnosed and documented in the clinical record;
and
(ii) Residents who use antipsychotic drugs receive gradual dose
reductions, and behavioral interventions, unless clinically
contraindicated, in an effort to discontinue these drugs.
(m) Medication Errors. The facility must ensure that--
(1) It is free of medication error rates of five percent or greater;
and
(2) Residents are free of any significant medication errors.
(n) Influenza and pneumococcal immunizations--(1) Influenza. The
facility must develop policies and procedures that ensure that--
(i) Before offering the influenza immunization, each resident or the
resident's legal representative receives education regarding the
benefits and potential side effects of the immunization;
(ii) Each resident is offered an influenza immunization October 1
through March 31 annually, unless the immunization is medically
contraindicated or the resident has already been immunized during this
time period;
(iii) The resident or the resident's legal representative has the
opportunity to refuse immunization; and
(iv) The resident's medical record includes documentation that
indicates, at a minimum, the following:
(A) That the resident or resident's legal representative was
provided education regarding the benefits and potential side effects of
influenza immunization; and
(B) That the resident either received the influenza immunization or
did not receive the influenza immunization due to medical
contraindications or refusal.
(2) Pneumococcal disease. The facility must develop policies and
procedures that ensure that--
(i) Before offering the pneumococcal immunization, each resident or
the resident's legal representative receives education regarding the
benefits and potential side effects of the immunization;
(ii) Each resident is offered a pneumococcal immunization, unless
the immunization is medically contraindicated or the resident has
already been immunized;
(iii) The resident or the resident's legal representative has the
opportunity to refuse immunization; and
(iv) The resident's medical record includes documentation that
indicates, at a minimum, the following:
[[Page 58]]
(A) That the resident or resident's legal representative was
provided education regarding the benefits and potential side effects of
pneumococcal immunization; and
(B) That the resident either received the pneumococcal immunization
or did not receive the pneumococcal immunization due to medical
contraindication or refusal.
(v) Exception. As an alternative, based on an assessment and
practitioner recommendation, a second pneumococcal immunization may be
given after 5 years following the first pneumococcal immunization,
unless medically contraindicated or the resident or the resident's legal
representative refuses the second immunization.
[56 FR 48873, Sept. 26, 1991, as amended at 57 FR 43925, Sept. 23, 1992;
70 FR 58851, Oct. 7, 2005]
Sec. 483.30 Nursing services.
The facility must have sufficient nursing staff to provide nursing
and related services to attain or maintain the highest practicable
physical, mental, and psychosocial well-being of each resident, as
determined by resident assessments and individual plans of care.
(a) Sufficient staff. (1) The facility must provide services by
sufficient numbers of each of the following types of personnel on a 24-
hour basis to provide nursing care to all residents in accordance with
resident care plans:
(i) Except when waived under paragraph (c) of this section, licensed
nurses; and
(ii) Other nursing personnel.
(2) Except when waived under paragraph (c) of this section, the
facility must designate a licensed nurse to serve as a charge nurse on
each tour of duty.
(b) Registered nurse. (1) Except when waived under paragraph (c) or
(d) of this section, the facility must use the services of a registered
nurse for at least 8 consecutive hours a day, 7 days a week.
(2) Except when waived under paragraph (c) or (d) of this section,
the facility must designate a registered nurse to serve as the director
of nursing on a full time basis.
(3) The director of nursing may serve as a charge nurse only when
the facility has an average daily occupancy of 60 or fewer residents.
(c) Nursing facilities: Waiver of requirement to provide licensed
nurses on a 24-hour basis. To the extent that a facility is unable to
meet the requirements of paragraphs (a)(2) and (b)(1) of this section, a
State may waive such requirements with respect to the facility if--
(1) The facility demonstrates to the satisfaction of the State that
the facility has been unable, despite diligent efforts (including
offering wages at the community prevailing rate for nursing facilities),
to recruit appropriate personnel;
(2) The State determines that a waiver of the requirement will not
endanger the health or safety of individuals staying in the facility;
(3) The State finds that, for any periods in which licensed nursing
services are not available, a registered nurse or a physician is
obligated to respond immediately to telephone calls from the facility;
(4) A waiver granted under the conditions listed in paragraph (c) of
this section is subject to annual State review;
(5) In granting or renewing a waiver, a facility may be required by
the State to use other qualified, licensed personnel;
(6) The State agency granting a waiver of such requirements provides
notice of the waiver to the State long term care ombudsman (established
under section 307(a)(12) of the Older Americans Act of 1965) and the
protection and advocacy system in the State for the mentally ill and
mentally retarded; and
(7) The nursing facility that is granted such a waiver by a State
notifies residents of the facility (or, where appropriate, the guardians
or legal representatives of such residents) and members of their
immediate families of the waiver.
(d) SNFs: Waiver of the requirement to provide services of a
registered nurse for more than 40 hours a week. (1) The Secretary may
waive the requirement that a SNF provide the services of a registered
nurse for more than 40 hours a week, including a director of nursing
specified in paragraph (b) of this section, if the Secretary finds
that--
[[Page 59]]
(i) The facility is located in a rural area and the supply of
skilled nursing facility services in the area is not sufficient to meet
the needs of individuals residing in the area;
(ii) The facility has one full-time registered nurse who is
regularly on duty at the facility 40 hours a week; and
(iii) The facility either--
(A) Has only patients whose physicians have indicated (through
physicians' orders or admission notes) that they do not require the
services of a registered nurse or a physician for a 48-hours period, or
(B) Has made arrangements for a registered nurse or a physician to
spend time at the facility, as determined necessary by the physician, to
provide necessary skilled nursing services on days when the regular
full-time registered nurse is not on duty;
(iv) The Secretary provides notice of the waiver to the State long
term care ombudsman (established under section 307(a)(12) of the Older
Americans Act of 1965) and the protection and advocacy system in the
State for the mentally ill and mentally retarded; and
(v) The facility that is granted such a waiver notifies residents of
the facility (or, where appropriate, the guardians or legal
representatives of such residents) and members of their immediate
families of the waiver.
(2) A waiver of the registered nurse requirement under paragraph
(d)(1) of this section is subject to annual renewal by the Secretary.
(e) Nurse staffing information--(1) Data requirements. The facility
must post the following information on a daily basis:
(i) Facility name.
(ii) The current date.
(iii) The total number and the actual hours worked by the following
categories of licensed and unlicensed nursing staff directly responsible
for resident care per shift:
(A) Registered nurses.
(B) Licensed practical nurses or licensed vocational nurses (as
defined under State law).
(C) Certified nurse aides.
(iv) Resident census.
(2) Posting requirements. (i) The facility must post the nurse
staffing data specified in paragraph (e)(1) of this section on a daily
basis at the beginning of each shift.
(ii) Data must be posted as follows:
(A) Clear and readable format.
(B) In a prominent place readily accessible to residents and
visitors.
(3) Public access to posted nurse staffing data. The facility must,
upon oral or written request, make nurse staffing data available to the
public for review at a cost not to exceed the community standard.
(4) Facility data retention requirements. The facility must maintain
the posted daily nurse staffing data for a minimum of 18 months, or as
required by State law, whichever is greater.
[56 FR 48873, Sept. 26, 1991, as amended at 57 FR 43925, Sept. 23, 1992;
70 FR 62073, Oct. 28, 2005]
Sec. 483.35 Dietary services.
The facility must provide each resident with a nourishing,
palatable, well-balanced diet that meets the daily nutritional and
special dietary needs of each resident.
(a) Staffing. The facility must employ a qualified dietitian either
full-time, part-time, or on a consultant basis.
(1) If a qualified dietitian is not employed full-time, the facility
must designate a person to serve as the director of food service who
receives frequently scheduled consultation from a qualified dietitian.
(2) A qualified dietitian is one who is qualified based upon either
registration by the Commission on Dietetic Registration of the American
Dietetic Association, or on the basis of education, training, or
experience in identification of dietary needs, planning, and
implementation of dietary programs.
(b) Sufficient staff. The facility must employ sufficient support
personnel competent to carry out the functions of the dietary service.
(c) Menus and nutritional adequacy. Menus must--
(1) Meet the nutritional needs of residents in accordance with the
recommended dietary allowances of the Food and Nutrition Board of the
National Research Council, National Academy of Sciences;
(2) Be prepared in advance; and
(3) Be followed.
[[Page 60]]
(d) Food. Each resident receives and the facility provides--
(1) Food prepared by methods that conserve nutritive value, flavor,
and appearance;
(2) Food that is palatable, attractive, and at the proper
temperature;
(3) Food prepared in a form designed to meet individual needs; and
(4) Substitutes offered of similar nutritive value to residents who
refuse food served.
(e) Therapeutic diets. Therapeutic diets must be prescribed by the
attending physician.
(f) Frequency of meals. (1) Each resident receives and the facility
provides at least three meals daily, at regular times comparable to
normal mealtimes in the community.
(2) There must be no more than 14 hours between a substantial
evening meal and breakfast the following day, except as provided in (4)
below.
(3) The facility must offer snacks at bedtime daily.
(4) When a nourishing snack is provided at bedtime, up to 16 hours
may elapse between a substantial evening meal and breakfast the
following day if a resident group agrees to this meal span, and a
nourishing snack is served.
(g) Assistive devices. The facility must provide special eating
equipment and utensils for residents who need them.
(h) Paid feeding assistants--(1) State-approved training course. A
facility may use a paid feeding assistant, as defined in Sec. 488.301
of this chapter, if--
(i) The feeding assistant has successfully completed a State-
approved training course that meets the requirements of Sec. 483.160
before feeding residents; and
(ii) The use of feeding assistants is consistent with State law.
(2) Supervision. (i) A feeding assistant must work under the
supervision of a registered nurse (RN) or licensed practical nurse
(LPN).
(ii) In an emergency, a feeding assistant must call a supervisory
nurse for help on the resident call system.
(3) Resident selection criteria. (i) A facility must ensure that a
feeding assistant feeds only residents who have no complicated feeding
problems.
(ii) Complicated feeding problems include, but are not limited to,
difficulty swallowing, recurrent lung aspirations, and tube or
parenteral/IV feedings.
(iii) The facility must base resident selection on the charge
nurse's assessment and the resident's latest assessment and plan of
care.
(i) Sanitary conditions. The facility must--
(1) Procure food from sources approved or considered satisfactory by
Federal, State, or local authorities;
(2) Store, prepare, distribute, and serve food under sanitary
conditions; and
(3) Dispose of garbage and refuse properly.
[56 FR 48874, Sept. 26, 1991, as amended at 68 FR 55539, Sept. 26, 2003]
Sec. 483.40 Physician services.
A physician must personally approve in writing a recommendation that
an individual be admitted to a facility. Each resident must remain under
the care of a physician.
(a) Physician supervision. The facility must ensure that--
(1) The medical care of each resident is supervised by a physician;
and
(2) Another physician supervises the medical care of residents when
their attending physician is unavailable.
(b) Physician visits. The physician must--
(1) Review the resident's total program of care, including
medications and treatments, at each visit required by paragraph (c) of
this section;
(2) Write, sign, and date progress notes at each visit; and
(3) Sign and date all orders with the exception of influenza and
pneumococcal polysaccharide vaccines, which may be administered per
physician-approved facility policy after an assessment for
contraindications.
(c) Frequency of physician visits. (1) The resident must be seen by
a physician at least once every 30 days for the first 90 days after
admission, and at least once every 60 days thereafter.
(2) A physician visit is considered timely if it occurs not later
than 10 days after the date the visit was required.
(3) Except as provided in paragraphs (c)(4) and (f) of this section,
all required physician visits must be made by the physician personally.
[[Page 61]]
(4) At the option of the physician, required visits in SNFs after
the initial visit may alternate between personal visits by the physician
and visits by a physician assistant, nurse practitioner, or clinical
nurse specialist in accordance with paragraph (e) of this section.
(d) Availability of physicians for emergency care. The facility must
provide or arrange for the provision of physician services 24 hours a
day, in case of an emergency.
(e) Physician delegation of tasks in SNFs. (1) Except as specified
in paragraph (e)(2) of this section, a physician may delegate tasks to a
physician assistant, nurse practitioner, or clinical nurse specialist
who--
(i) Meets the applicable definition in Sec. 491.2 of this chapter
or, in the case of a clinical nurse specialist, is licensed as such by
the State;
(ii) Is acting within the scope of practice as defined by State law;
and
(iii) Is under the supervision of the physician.
(2) A physician may not delegate a task when the regulations specify
that the physician must perform it personally, or when the delegation is
prohibited under State law or by the facility's own policies.
(f) Performance of physician tasks in NFs. At the option of the
State, any required physician task in a NF (including tasks which the
regulations specify must be performed personally by the physician) may
also be satisfied when performed by a nurse practitioner, clinical nurse
specialist, or physician assistant who is not an employee of the
facility but who is working in collaboration with a physician.
[56 FR 48875, Sept. 26, 1991, as amended at 67 FR 61814, Oct. 2, 2002]
Sec. 483.45 Specialized rehabilitative services.
(a) Provision of services. If specialized rehabilitative services
such as but not limited to physical therapy, speech-language pathology,
occupational therapy, and mental health rehabilitative services for
mental illness and mental retardation, are required in the resident's
comprehensive plan of care, the facility must--
(1) Provide the required services; or
(2) Obtain the required services from an outside resource (in
accordance with Sec. 483.75(h) of this part) from a provider of
specialized rehabilitative services.
(b) Qualifications. Specialized rehabilitative services must be
provided under the written order of a physician by qualified personnel.
[56 FR 48875, Sept. 26, 1991, as amended at 57 FR 43925, Sept. 23, 1992]
Sec. 483.55 Dental services.
The facility must assist residents in obtaining routine and 24-hour
emergency dental care.
(a) Skilled nursing facilities. A facility (1) Must provide or
obtain from an outside resource, in accordance with Sec. 483.75(h) of
this part, routine and emergency dental services to meet the needs of
each resident;
(2) May charge a Medicare resident an additional amount for routine
and emergency dental services;
(3) Must if necessary, assist the resident--
(i) In making appointments; and
(ii) By arranging for transportation to and from the dentist's
office; and
(4) Promptly refer residents with lost or damaged dentures to a
dentist.
(b) Nursing facilities. The facility (1) Must provide or obtain from
an outside resource, in accordance with Sec. 483.75(h) of this part,
the following dental services to meet the needs of each resident:
(i) Routine dental services (to the extent covered under the State
plan); and
(ii) Emergency dental services;
(2) Must, if necessary, assist the resident--
(i) In making appointments; and
(ii) By arranging for transportation to and from the dentist's
office; and
(3) Must promptly refer residents with lost or damaged dentures to a
dentist.
[56 FR 48875, Sept. 26, 1991]
Sec. 483.60 Pharmacy services.
The facility must provide routine and emergency drugs and
biologicals to its residents, or obtain them under an agreement
described in Sec. 483.75(h) of this part. The facility may permit
unlicensed personnel to administer drugs if State law permits, but only
under the general supervision of a licensed nurse.
[[Page 62]]
(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) The pharmacist must report any irregularities to the attending
physician and the director of nursing, and these reports must be acted
upon.
(d) Labeling of drugs and biologicals. Drugs and biologicals used in
the facility must be labeled in accordance with currently accepted
professional principles, and include the appropriate accessory and
cautionary instructions, and the expiration date when applicable.
(e) Storage of drugs and biologicals. (1) In accordance with State
and Federal laws, the facility must store all drugs and biologicals in
locked compartments under proper temperature controls, and permit only
authorized personnel to have access to the keys.
(2) The facility must provide separately locked, permanently affixed
compartments for storage of controlled drugs listed in Schedule II of
the Comprehensive Drug Abuse Prevention and Control Act of 1976 and
other drugs subject to abuse, except when the facility uses single unit
package drug distribution systems in which the quantity stored is
minimal and a missing dose can be readily detected.
[56 FR 48875, Sept. 26, 1991, as amended at 57 FR 43925, Sept. 23, 1992]
Sec. 483.65 Infection control.
The facility must establish and maintain an infection control
program designed to provide a safe, sanitary, and comfortable
environment and to help prevent the development and transmission of
disease and infection.
(a) Infection control program. The facility must establish an
infection control program under which it--
(1) Investigates, controls, and prevents infections in the facility;
(2) Decides what procedures, such as isolation, should be applied to
an individual resident; and
(3) Maintains a record of incidents and corrective actions related
to infections.
(b) Preventing spread of infection. (1) When the infection control
program determines that a resident needs isolation to prevent the spread
of infection, the facility must isolate the resident.
(2) The facility must prohibit employees with a communicable disease
or infected skin lesions from direct contact with residents or their
food, if direct contact will transmit the disease.
(3) The facility must require staff to wash their hands after each
direct resident contact for which handwashing is indicated by accepted
professional practice.
(c) Linens. Personnel must handle, store, process, and transport
linens so as to prevent the spread of infection.
[56 FR 48876, Sept. 26, 1991, as amended at 57 FR 43925, Sept. 23, 1992]
Sec. 483.70 Physical environment.
The facility must be designed, constructed, equipped, and maintained
to protect the health and safety of residents, personnel and the public.
(a) Life safety from fire. (1) Except as otherwise provided in this
section--
(i) The facility must meet the applicable provisions of the 2000
edition of the Life Safety Code of the National Fire Protection
Association. The Director of the Office of the Federal Register has
approved the NFPA 101 [reg] 2000 edition of the Life Safety
Code, issued January 14, 2000, for incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy of the Code is
available for inspection at the
[[Page 63]]
CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD
or at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal--register/code--of--
federal--regulations/ibr--locations.html. Copies may be obtained from
the National Fire Protection Association, 1 Batterymarch Park, Quincy,
MA 02269. If any changes in this edition of the Code are incorporated by
reference, CMS will publish notice in the Federal Register to announce
the changes.
(ii) Chapter 19.3.6.3.2, exception number 2 of the adopted edition
of the LSC does not apply to long-term care facilities.
(2) After consideration of State survey agency findings, CMS may
waive specific provisions of the Life Safety ode which, if rigidly
applied, would result in unreasonable hardship upon the facility, but
only if the waiver does not adversely affect the health and safety of
the patients.
(3) The provisions of the Life safety Code do not apply in a State
where CMS finds, in accordance with applicable provisions of sections
1819(d)(2)(B)(ii) and 1919(d)(2)(B)(ii) of the Act, that a fire and
safety code imposed by State law adequately protects patients, residents
and personnel in long term care facilities.
(4) Beginning March 13, 2006, a long-term care facility must be in
compliance with Chapter 19.2.9, Emergency Lighting.
(5) Beginning March 13, 2006, Chapter 19.3.6.3.2, exception number 2
does not apply to long-term care facilities.
(6) Notwithstanding any provisions of the 2000 edition of the Life
Safety Code to the contrary, a long-term care facility may install
alcohol-based hand rub dispensers in its facility if--
(i) Use of alcohol-based hand rub dispensers does not conflict with
any State or local codes that prohibit or otherwise restrict the
placement of alcohol-based hand rub dispensers in health care
facilities;
(ii) The dispensers are installed in a manner that minimizes leaks
and spills that could lead to falls;
(iii) The dispensers are installed in a manner that adequately
protects against inappropriate access;
(iv) The dispensers are installed in accordance with chapter
18.3.2.7 or chapter 19.3.2.7 of the 2000 edition of the Life Safety
Code, as amended by NFPA Temporary Interim Amendment 00-1(101), issued
by the Standards Council of the National Fire Protection Association on
April 15, 2004. The Director of the Office of the Federal Register has
approved NFPA Temporary Interim Amendment 00-1(101) for incorporation by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy
of the amendment is available for inspection at the CMS Information
Resource Center, 7500 Security Boulevard, Baltimore, MD and at the
Office of the Federal Register, 800 North Capitol Street NW., Suite 700,
Washington, DC. Copies may be obtained from the National Fire Protection
Association, 1 Batterymarch Park, Quincy, MA 02269; and
(v) The dispensers are maintained in accordance with dispenser
manufacturer guidelines.
(7) A long term care facility must:
(i) Install, at least, battery-operated single station smoke alarms
in accordance with the manufacturer's recommendations in resident
sleeping rooms and common areas.
(ii) Have a program for inspection, testing, maintenance, and
battery replacement that conforms to the manufacturer's recommendations
and that verifies correct operation of the smoke alarms.
(iii) Exception:
(A) The facility has system-based smoke detectors in patient rooms
and common areas that are installed, tested, and maintained in
accordance with NFPA 72, National Fire Alarm Code, for system-based
smoke detectors; or
(B) The facility is fully sprinklered in accordance with NFPA 13,
Standard for the Installation of Sprinkler Systems.
(8) A long term care facility must:
(i) Install an approved, supervised automatic sprinkler system in
accordance with the 1999 edition of NFPA 13, Standard for the
Installation of Sprinkler Systems, as incorporated by reference,
throughout the building by August 13, 2013. The Director of the Office
of the
[[Page 64]]
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.
(b) Emergency power. (1) An emergency electrical power system must
supply power adequate at least for lighting all entrances and exits;
equipment to maintain the fire detection, alarm, and extinguishing
systems; and life support systems in the event the normal electrical
supply is interrupted.
(2) When life support systems are used, the facility must provide
emergency electrical power with an emergency generator (as defined in
NFPA 99, Health Care Facilities) that is located on the premises.
(c) Space and equipment. The facility must--
(1) Provide sufficient space and equipment in dining, health
services, recreation, and program areas to enable staff to provide
residents with needed services as required by these standards and as
identified in each resident's plan of care; and
(2) Maintain all essential mechanical, electrical, and patient care
equipment in safe operating condition.
(d) Resident rooms. Resident rooms must be designed and equipped for
adequate nursing care, comfort, and privacy of residents.
(1) Bedrooms must--
(i) Accommodate no more than four residents;
(ii) Measure at least 80 square feet per resident in multiple
resident bedrooms, and at least 100 square feet in single resident
rooms;
(iii) Have direct access to an exit corridor;
(iv) Be designed or equipped to assure full visual privacy for each
resident;
(v) In facilities initially certified after March 31, 1992, except
in private rooms, each bed must have ceiling suspended curtains, which
extend around the bed to provide total visual privacy in combination
with adjacent walls and curtains;
(vi) Have at least one window to the outside; and
(vii) Have a floor at or above grade level.
(2) The facility must provide each resident with--
(i) A separate bed of proper size and height for the convenience of
the resident;
(ii) A clean, comfortable mattress;
(iii) Bedding appropriate to the weather and climate; and
(iv) Functional furniture appropriate to the resident's needs, and
individual closet space in the resident's bedroom with clothes racks and
shelves accessible to the resident.
(3) CMS, or in the case of a nursing facility the survey agency, may
permit variations in requirements specified in paragraphs (d)(1) (i) and
(ii) of this section relating to rooms in individual
[[Page 65]]
cases when the facility demonstrates in writing that the variations--
(i) Are in accordance with the special needs of the residents; and
(ii) Will not adversely affect residents' health and safety.
(e) Toilet facilities. Each resident room must be equipped with or
located near toilet and bathing facilities.
(f) Resident call system. The nurse's station must be equipped to
receive resident calls through a communication system from--
(1) Resident rooms; and
(2) Toilet and bathing facilities.
(g) Dining and resident activities. The facility must provide one or
more rooms designated for resident dining and activities. These rooms
must--
(1) Be well lighted;
(2) Be well ventilated, with nonsmoking areas identified;
(3) Be adequately furnished; and
(4) Have sufficient space to accommodate all activities.
(h) Other environmental conditions. The facility must provide a
safe, functional, sanitary, and comfortable environment for the
residents, staff and the public. The facility must--
(1) Establish procedures to ensure that water is available to
essential areas when there is a loss of normal water supply;
(2) Have adequate outside ventilation by means of windows, or
mechanical ventilation, or a combination of the two;
(3) Equip corridors with firmly secured handrails on each side; and
(4) Maintain an effective pest control program so that the facility
is free of pests and rodents.
[56 FR 48876, Sept. 26, 1991, as amended at 57 FR 43925, Sept. 23, 1992;
68 FR 1386, Jan. 10, 2003; 69 FR 49268, Aug. 11, 2004; 70 FR 15238, Mar.
25, 2005; 71 FR 55340, Sept. 22, 2006; 73 FR 47091, Aug. 13, 2008]
Sec. 483.75 Administration.
A facility must be administered in a manner that enables it to use
its resources effectively and efficiently to attain or maintain the
highest practicable physical, mental, and psychosocial well-being of
each resident.
(a) Licensure. A facility must be licensed under applicable State
and local law.
(b) Compliance with Federal, State, and local laws and professional
standards. The facility must operate and provide services in compliance
with all applicable Federal, State, and local laws, regulations, and
codes, and with accepted professional standards and principles that
apply to professionals providing services in such a facility.
(c) Relationship to other HHS regulations. In addition to compliance
with the regulations set forth in this subpart, facilities are obliged
to meet the applicable provisions of other HHS regulations, including
but not limited to those pertaining to nondiscrimination on the basis of
race, color, or national origin (45 CFR part 80); nondiscrimination on
the basis of handicap (45 CFR part 84); nondiscrimination on the basis
of age (45 CFR part 91); protection of human subjects of research (45
CFR part 46); and fraud and abuse (42 CFR part 455). Although these
regulations are not in themselves considered requirements under this
part, their violation may result in the termination or suspension of, or
the refusal to grant or continue payment with Federal funds.
(d) Governing body. (1) The facility must have a governing body, or
designated persons functioning as a governing body, that is legally
responsible for establishing and implementing policies regarding the
management and operation of the facility; and
(2) The governing body appoints the administrator who is--
(i) Licensed by the State where licensing is required; and
(ii) Responsible for management of the facility.
(e) Required training of nursing aides--(1) Definitions.
Licensed health professional means a physician; physician assistant;
nurse practitioner; physical, speech, or occupational therapist;
physical or occupational therapy assistant; registered professional
nurse; licensed practical nurse; or licensed or certified social worker.
Nurse aide means any individual providing nursing or nursing-related
services to residents in a facility who is not a licensed health
professional, a registered dietitian, or someone who volunteers to
provide such services without pay. Nurse aides do not include
[[Page 66]]
those individuals who furnish services to residents only as paid feeding
assistants as defined in Sec. 488.301 of this chapter.
(2) General rule. A facility must not use any individual working in
the facility as a nurse aide for more than 4 months, on a full-time
basis, unless:
(i) That individual is competent to provide nursing and nursing
related services; and
(ii)(A) That individual has completed a training and competency
evaluation program, or a competency evaluation program approved by the
State as meeting the requirements of Sec. Sec. 483.151-483.154 of this
part; or
(B) That individual has been deemed or determined competent as
provided in Sec. 483.150 (a) and (b).
(3) Non-permanent employees. A facility must not use on a temporary,
per diem, leased, or any basis other than a permanent employee any
individual who does not meet the requirements in paragraphs (e)(2) (i)
and (ii) of this section.
(4) Competency. A facility must not use any individual who has
worked less than 4 months as a nurse aide in that facility unless the
individual--
(i) Is a full-time employee in a State-approved training and
competency evaluation program;
(ii) Has demonstrated competence through satisfactory participation
in a State-approved nurse aide training and competency evaluation
program or competency evaluation program; or
(iii) Has been deemed or determined competent as provided in Sec.
483.150 (a) and (b).
(5) Registry verification. Before allowing an individual to serve as
a nurse aide, a facility must receive registry verification that the
individual has met competency evaluation requirements unless--
(i) The individual is a full-time employee in a training and
competency evaluation program approved by the State; or
(ii) The individual can prove that he or she has recently
successfully completed a training and competency evaluation program or
competency evaluation program approved by the State and has not yet been
included in the registry. Facilities must follow up to ensure that such
an individual actually becomes registered.
(6) Multi-State registry verification. Before allowing an individual
to serve as a nurse aide, a facility must seek information from every
State registry established under sections 1819(e)(2)(A) or 1919(e)(2)(A)
of the Act the facility believes will include information on the
individual.
(7) Required retraining. If, since an individual's most recent
completion of a training and competency evaluation program, there has
been a continuous period of 24 consecutive months during none of which
the individual provided nursing or nursing-related services for monetary
compensation, the individual must complete a new training and competency
evaluation program or a new competency evaluation program.
(8) Regular in-service education. The facility must complete a
performance review of every nurse aide at least once every 12 months,
and must provide regular in-service education based on the outcome of
these reviews. The in-service training must--
(i) Be sufficient to ensure the continuing competence of nurse
aides, but must be no less than 12 hours per year;
(ii) Address areas of weakness as determined in nurse aides'
performance reviews and may address the special needs of residents as
determined by the facility staff; and
(iii) For nurse aides providing services to individuals with
cognitive impairments, also address the care of the cognitively
impaired.
(f) Proficiency of Nurse aides. The facility must ensure that nurse
aides are able to demonstrate competency in skills and techniques
necessary to care for residents' needs, as identified through resident
assessments, and described in the plan of care.
(g) Staff qualifications. (1) The facility must employ on a full-
time, part-time or consultant basis those professionals necessary to
carry out the provisions of these requirements.
(2) Professional staff must be licensed, certified, or registered in
accordance with applicable State laws.
(h) Use of outside resources. (1) If the facility does not employ a
qualified professional person to furnish a specific service to be
provided by the facility,
[[Page 67]]
the facility must have that service furnished to residents by a person
or agency outside the facility under an arrangement described in section
1861(w) of the Act or (with respect to services furnished to NF
residents and dental services furnished to SNF residents) an agreement
described in paragraph (h)(2) of this section.
(2) Arrangements as described in section 1861(w) of the Act or
agreements pertaining to services furnished by outside resources must
specify in writing that the facility assumes responsibility for--
(i) Obtaining services that meet professional standards and
principles that apply to professionals providing services in such a
facility; and
(ii) The timeliness of the services.
(i) Medical director. (1) The facility must designate a physician to
serve as medical director.
(2) The medical director is responsible for--
(i) Implementation of resident care policies; and
(ii) The coordination of medical care in the facility.
(j) Laboratory services. (1) The facility must provide or obtain
laboratory services to meet the needs of its residents. The facility is
responsible for the quality and timeliness of the services.
(i) If the facility provides its own laboratory services, the
services must meet the applicable requirements for laboratories
specified in part 493 of this chapter.
(ii) If the facility provides blood bank and transfusion services,
it must meet the applicable requirements for laboratories specified in
part 493 of this chapter.
(iii) If the laboratory chooses to refer specimens for testing to
another laboratory, the referral laboratory must be certified in the
appropriate specialties and subspecialties of services in accordance
with the requirements of part 493 of this chapter.
(iv) If the facility does not provide laboratory services on site,
it must have an agreement to obtain these services from a laboratory
that meets the applicable requirements of part 493 of this chapter.
(2) The facility must--
(i) Provide or obtain laboratory services only when ordered by the
attending physician;
(ii) Promptly notify the attending physican of the findings;
(iii) Assist the resident in making transportation arrangements to
and from the source of service, if the resident needs asistance; and
(iv) File in the resident's clinical record laboratory reports that
are dated and contain the name and address of the testing laboratory.
(k) Radiology and other diagnostic services. (1) The facility must
provide or obtain radiology and other diagnostic services to meet the
needs of its residents. The facility is responsible for the quality and
timeliness of the services.
(i) If the facility provides its own diagnostic services, the
services must meet the applicable conditions of participation for
hospitals contained in Sec. 482.26 of this subchapter.
(ii) If the facility does not provide its own diagnostic services,
it must have an agreement to obtain these services from a provider or
supplier that is approved to provide these services under Medicare.
(2) The facility must--
(i) Provide or obtain radiology and other diagnostic services only
when ordered by the attending physician;
(ii) Promptly notify the attending physician of the findings;
(iii) Assist the resident in making transportation arrangements to
and from the source of service, if the resident needs assistance; and
(iv) File in the resident's clinical record signed and dated reports
of x-ray and other diagnostic services.
(l) Clinical records. (1) The facility must maintain clinical
records on each resident in accordance with accepted professional
standards and practices that are--
(i) Complete;
(ii) Accurately documented;
(iii) Readily accessible; and
(iv) Systematically organized.
(2) Clinical records must be retained for--
(i) The period of time required by State law; or
[[Page 68]]
(ii) Five years from the date of discharge when there is no
requirement in State law; or
(iii) For a minor, three years after a resident reaches legal age
under State law.
(3) The facility must safeguard clinical record information against
loss, destruction, or unauthorized use;
(4) The facility must keep confidential all information contained in
the resident's records, regardless of the form or storage method of the
records, except when release is required by--
(i) Transfer to another health care institution;
(ii) Law;
(iii) Third party payment contract; or
(iv) The resident.
(5) The clinical record must contain--
(i) Sufficient information to identify the resident;
(ii) A record of the resident's assessments;
(iii) The plan of care and services provided;
(iv) The results of any preadmission screening conducted by the
State; and
(v) Progress notes.
(m) Disaster and emergency preparedness. (1) The facility must have
detailed written plans and procedures to meet all potential emergencies
and disasters, such as fire, severe weather, and missing residents.
(2) The facility must train all employees in emergency procedures
when they begin to work in the facility, periodically review the
procedures with existing staff, and carry out unannounced staff drills
using those procedures.
(n) Transfer agreement. (1) In accordance with section 1861(l) of
the Act, the facility (other than a nursing facility which is located in
a State on an Indian reservation) must have in effect a written transfer
agreement with one or more hospitals approved for participation under
the Medicare and Medicaid programs that reasonably assures that--
(i) Residents will be transferred from the facility to the hospital,
and ensured of timely admission to the hospital when transfer is
medically appropriate as determined by the attending physician; and
(ii) Medical and other information needed for care and treatment of
residents, and, when the transferring facility deems it appropriate, for
determining whether such residents can be adequately cared for in a less
expensive setting than either the facility or the hospital, will be
exchanged between the institutions.
(2) The facility is considered to have a transfer agreement in
effect if the facility has attempted in good faith to enter into an
agreement with a hospital sufficiently close to the facility to make
transfer feasible.
(o) Quality assessment and assurance. (1) A facility must maintain a
quality assessment and assurance committee consisting of--
(i) The director of nursing services;
(ii) A physician designated by the facility; and
(iii) At least 3 other members of the facility's staff.
(2) The quality assessment and assurance committee--
(i) Meets at least quarterly to identify issues with respect to
which quality assessment and assurance activities are necessary; and
(ii) Develops and implements appropriate plans of action to correct
identified quality deficiencies.
(3) A State or the Secretary may not require disclosure of the
records of such committee except in so far as such disclosure is related
to the compliance of such committee with the requirements of this
section.
(4) Good faith attempts by the committee to identify and correct
quality deficiencies will not be used as a basis for sanctions.
(p) Disclosure of ownership. (1) The facility must comply with the
disclosure requirements of Sec. Sec. 420.206 and 455.104 of this
chapter.
(2) The facility must provide written notice to the State agency
responsible for licensing the facility at the time of change, if a
change occurs in--
(i) Persons with an ownership or control interest, as defined in
Sec. Sec. 420.201 and 455.101 of this chapter;
(ii) The officers, directors, agents, or managing employees;
(iii) The corporation, association, or other company responsible for
the management of the facility; or
[[Page 69]]
(iv) The facility's administrator or director of nursing.
(3) The notice specified in paragraph (p)(2) of this section must
include the identity of each new individual or company.
(q) Required training of feeding assistants. A facility must not use
any individual working in the facility as a paid feeding assistant
unless that individual has successfully completed a State-approved
training program for feeding assistants, as specified in Sec. 483.160
of this part.
[56 FR 48877, Sept. 26, 1991, as amended at 56 FR 48918, Sept. 26, 1991;
57 FR 7136, Feb. 28, 1992; 57 FR 43925, Sept. 23, 1992; 59 FR 56237,
Nov. 10, 1994; 63 FR 26311, May 12, 1998; 68 FR 55539, Sept. 26, 2003;
74 FR 40363, Aug. 11, 2009]
Subpart C_Preadmission Screening and Annual Review of Mentally Ill and
Mentally Retarded Individuals
Source: 57 FR 56506, Nov. 30, 1992, unless otherwise noted.
Sec. 483.100 Basis.
The requirements of Sec. Sec. 483.100 through 483.138 governing the
State's responsibility for preadmission screening and annual resident
review (PASARR) of individuals with mental illness and mental
retardation are based on section 1919(e)(7) of the Act.
Sec. 483.102 Applicability and definitions.
(a) This subpart applies to the screening or reviewing of all
individuals with mental illness or mental retardation who apply to or
reside in Medicaid certified NFs regardless of the source of payment for
the NF services, and regardless of the individual's or resident's known
diagnoses.
(b) Definitions. As used in this subpart--
(1) An individual is considered to have a serious mental illness
(MI) if the individual meets the following requirements on diagnosis,
level of impairment and duration of illness:
(i) Diagnosis. The individual has a major mental disorder
diagnosable under the Diagnostic and Statistical Manual of Mental
Disorders, 3rd edition, revised in 1987.
Incorporation of the 1987 edition of the Diagnostic and Statistical
Manual of Mental Disorders, 3rd edition, was approved by the Director of
the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part
51 that govern the use of incorporation by reference. \1\
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\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.
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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 70]]
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 mental retardation (MR) if
he or she has--
(i) A level of retardation (mild, moderate, severe or profound)
described in the American Association on Mental Retardation's Manual on
Classification in Mental Retardation (1983). Incorporation by reference
of the 1983 edition of the American Association on Mental Retardation's
Manual on Classification in Mental Retardation was approved by the
Director of the Federal Register in accordance with 5 U.S.C. 552(a) and
1 CFR part 51 that govern the use of incorporations by reference;\2\ or
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\2\ The American Association on Mental Retardation's Manual on
Classification in Mental Retardation is available for inspection at the
Centers for Medicare & Medicaid Services, Room 132, East High Rise
Building, 6325 Security Boulevard, Baltimore, Maryland, or at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call 202-741-6030, or go to:
http://www.archives.gov/federal--register/code--of--federal--
regulations/ibr--locations.html. Copies may be obtained from the
American Association on Mental Retardation, 1719 Kalorama Rd., NW.,
Washington, DC 20009.
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(ii) A related condition as defined by Sec. 435.1010 of this
chapter.
[57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr. 28, 1993; 71 FR 39229,
July 12, 2006]
Sec. 483.104 State plan requirement.
As a condition of approval of the State plan, the State must operate
a preadmission screening and annual resident review program that meets
the requirements of Sec. Sec. 483.100 through 438.138.
Sec. 483.106 Basic rule.
(a) Requirement. The State PASARR program must require--(1)
Preadmission screening of all individuals with mental illness or mental
retardation who apply as new admissions to Medicaid NFs on or after
January 1, 1989;
(2) Initial review, by April 1, 1990, of all current residents with
mental retardation or mental illness who entered Medicaid NFs prior to
January 1, 1989; and
(3) At least annual review, as of April 1, 1990, of all residents
with mental illness or mental retardation, regardless of whether they
were first screened under the preadmission screening or annual resident
review requirements.
(b) Admissions, readmissions and interfacility transfers--(1) New
admission. An individual is a new admission if he or she is admitted to
any NF for the first time or does not qualify as a readmission. With the
exception of certain hospital discharges described in paragraph (b)(2)
of this section, new admissions are subject to preadmission screening.
[[Page 71]]
(2) Exempted hospital discharge. (i) An exempted hospital discharge
means an individual--
(A) Who is admitted to any NF directly from a hospital after
receiving acute inpatient care at the hospital;
(B) Who requires NF services for the condition for which he or she
received care in the hospital; and
(C) Whose attending physician has certified before admission to the
facility that the individual is likely to require less than 30 days
nursing facility services.
(ii) If an individual who enters a NF as an exempted hospital
discharge is later found to require more than 30 days of NF care, the
State mental health or mental retardation authority must conduct an
annual resident review within 40 calendar days of admission.
(3) Readmissions. An individual is a readmission if he or she was
readmitted to a facility from a hospital to which he or she was
transferred for the purpose of receiving care. Readmissions are subject
to annual resident review rather than preadmission screening.
(4) Interfacility transfers--(i) An interfacility transfer occurs
when an individual is transferred from one NF to another NF, with or
without an intervening hospital stay. Interfacility transfers are
subject to annual resident review rather than preadmission screening.
(ii) In cases of transfer of a resident with MI or MR from a NF to a
hospital or to another NF, the transferring NF is responsible for
ensuring that copies of the resident's most recent PASARR and resident
assessment reports accompany the transferring resident.
(c) Purpose. The preadmission screening and annual resident review
process must result in determinations based on a physical and mental
evaluation of each individual with mental illness or mental retardation,
that are described in Sec. Sec. 483.112 and 483.114.
(d) Responsibility for evaluations and determinations. The PASARR
determinations of whether an individual requires the level of services
provided by a NF and whether specialized services are needed--
(1) For individuals with mental illness, must be made by the State
mental health authority and be based on an independent physical and
mental evaluation performed by a person or entity other than the State
mental health authority; and
(2) For individuals with mental retardation, must be made by the
State mental retardation or developmental disabilities authority.
(e) Delegation of responsibility--(1) The State mental health and
mental retardation authorities may delegate by subcontract or otherwise
the evaluation and determination functions for which they are
responsible to another entity only if--
(i) The State mental health and mental retardation authorities
retain ultimate control and responsibility for the performance of their
statutory obligations;
(ii) The two determinations as to the need for NF services and for
specialized services are made, based on a consistent analysis of the
data; and
(iii) The entity to which the delegation is made is not a NF or an
entity that has a direct or indirect affiliation or relationship with a
NF.
(2) The State mental retardation authority has responsibility for
both the evaluation and determination functions for individuals with MR
whereas the State mental health authority has responsibility only for
the determination function.
(3) The evaluation of individuals with MI cannot be delegated by the
State mental health authority because it does not have responsibility
for this function. The evaluation function must be performed by a person
or entity other than the State mental health authority. In designating
an independent person or entity to perform MI evaluations, the State
must not use a NF or an entity that has a direct or indirect affiliation
or relationship with a NF.
[57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr. 28, 1993]
[[Page 72]]
Sec. 483.108 Relationship of PASARR to other Medicaid processes.
(a) PASARR determinations made by the State mental health or mental
retardation authorities cannot be countermanded by the State Medicaid
agency, either in the claims process or through other utilization
control/review processes or by the State survey and certification
agency. Only appeals determinations made through the system specified in
subpart E of this part may overturn a PASARR determination made by the
State mental health or mental retardation authorities.
(b) In making their determinations, however, the State mental health
and mental retardation authorities must not use criteria relating to the
need for NF care or specialized services that are inconsistent with this
regulation and any supplementary criteria adopted by the State Medicaid
agency under its approved State plan.
(c) To the maximum extent practicable, in order to avoid duplicative
testing and effort, the PASARR must be coordinated with the routine
resident assessments required by Sec. 483.20(b).
Sec. 483.110 Out-of-State arrangements.
(a) Basic rule. The State in which the individual is a State
resident (or would be a State resident at the time he or she becomes
eligible for Medicaid), as defined in Sec. 435.403 of this chapter,
must pay for the PASARR and make the required determinations, in
accordance with Sec. 431.52(b).
(b) Agreements. A State may include arrangements for PASARR in its
provider agreements with out-of-State facilities or reciprocal
interstate agreements.
[57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr. 28, 1993]
Sec. 483.112 Preadmission screening of applicants for admission to NFs.
(a) Determination of need for NF services. For each NF applicant
with MI or MR, the State mental health or mental retardation authority
(as appropriate) must determine, in accordance with Sec. 483.130,
whether, because of the resident's physical and mental condition, the
individual requires the level of services provided by a NF.
(b) Determination of need for specialized services. If the
individual with mental illness or mental retardation is determined to
require a NF level of care, the State mental health or mental
retardation authority (as appropriate) must also determine, in
accordance with Sec. 483.130, whether the individual requires
specialized services for the mental illness or mental retardation, as
defined in Sec. 483.120.
(c) Timeliness--(1) Except as specified in paragraph (c)(4) of this
section, a preadmission screening determination must be made in writing
within an annual average of 7 to 9 working days of referral of the
individual with MI or MR by whatever agent performs the Level I
identification, under Sec. 483.128(a) of this part, to the State mental
health or mental retardation authority for screening. (See Sec.
483.128(a) for discussion of Level I evaluation.)
(2) The State may convey determinations verbally to nursing
facilities and the individual and confirm them in writing.
(3) The State may compute separate annual averages for the mentally
ill and the mentally retarded/developmentally disabled populations.
(4) The Secretary may grant an exception to the timeliness standard
in paragraph (c)(1) of this section when the State--
(i) Exceeds the annual average; and
(ii) Provides justification satisfactory to the Secretary that a
longer time period was necessary.
Sec. 483.114 Annual review of NF residents.
(a) Individuals with mental illness. For each resident of a NF who
has mental illness, the State mental health authority must determine in
accordance with Sec. 483.130 whether, because of the resident's
physical and mental condition, the resident requires--
(1) The level of services provided by--
(i) A NF;
(ii) An inpatient psychiatric hospital for individuals under age 21,
as described in section 1905(h) of the Act; or
(iii) An institution for mental diseases providing medical
assistance to individuals age 65 or older; and
(2) Specialized services for mental illness, as defined in Sec.
483.120.
[[Page 73]]
(b) Individuals with mental retardation. For each resident of a NF
who has mental retardation, the State mental retardation or
developmental disability authority must determine in accordance with
Sec. 483.130 whether, because of his or her physical or mental
condition, the resident requires--
(1) The level of services provided by a NF or an intermediate care
facility for the mentally retarded; and
(2) Specialized services for mental retardation as defined in Sec.
483.120.
(c) Frequency of review--(1) A review and determination must be
conducted for each resident of a Medicaid NF who has mental illness or
mental retardation not less often than annually.
(2) ``Annually'' is defined as occurring within every fourth quarter
after the previous preadmission screen or annual resident review.
(d) April 1, 1990 deadline for initial reviews. The first set of
annual reviews on residents who entered the NF prior to January 1, 1989,
must be completed by April 1, 1990.
Sec. 483.116 Residents and applicants determined to require NF level of
services.
(a) Individuals needing NF services. If the State mental health or
mental retardation authority determines that a resident or applicant for
admission to a NF requires a NF level of services, the NF may admit or
retain the individual.
(b) Individuals needing NF services and specialized services. If the
State mental health or mental retardation authority determines that a
resident or applicant for admission requires both a NF level of services
and specialized services for the mental illness or mental retardation--
(1) The NF may admit or retain the individual; and
(2) The State must provide or arrange for the provision of the
specialized services needed by the individual while he or she resides in
the NF.
Sec. 483.118 Residents and applicants determined not to require NF level of
services.
(a) Applicants who do not require NF services. If the State mental
health or mental retardation authority determines that an applicant for
admission to a NF does not require NF services, the applicant cannot be
admitted. NF services are not a covered Medicaid service for that
individual, and further screening is not required.
(b) Residents who require neither NF services nor specialized
services for MI or MR. If the State mental health or mental retardation
authority determines that a resident requires neither the level of
services provided by a NF nor specialized services for MI or MR,
regardless of the length of stay in the facility, the State must--
(1) Arrange for the safe and orderly discharge of the resident from
the facility in accordance with Sec. 483.12(a); and
(2) Prepare and orient the resident for discharge.
(c) Residents who do not require NF services but require specialized
services for MI or MR--(1) Long term residents. Except as otherwise may
be provided in an alternative disposition plan adopted under section
1919(e)(7)(E) of the Act, for any resident who has continuously resided
in a NF for at least 30 months before the date of the determination, and
who requires only specialized services as defined in Sec. 483.120, the
State must, in consultation with the resident's family or legal
representative and caregivers--
(i) Offer the resident the choice of remaining in the facility or of
receiving services in an alternative appropriate setting;
(ii) Inform the resident of the institutional and noninstitutional
alternatives covered under the State Medicaid plan for the resident;
(iii) Clarify the effect on eligibility for Medicaid services under
the State plan if the resident chooses to leave the facility, including
its effect on readmission to the facility; and
(iv) Regardless of the resident's choice, provide for, or arrange
for the provision of specialized services for the mental illness or
mental retardation.
(2) Short term residents. Except as otherwise may be provided in an
alternative disposition plan adopted under section 1919(e)(7)(E) of the
Act, for any resident who requires only specialized services, as defined
in Sec. 483.120, and who has not continuously resided in a NF for at
least 30 months before the date of the determination, the State must,
[[Page 74]]
in consultation with the resident's family or legal representative and
caregivers--
(i) Arrange for the safe and orderly discharge of the resident from
the facility in accordance with Sec. 483.12(a);
(ii) Prepare and orient the resident for discharge; and
(iii) Provide for, or arrange for the provision of, specialized
services for the mental illness or mental retardation.
(3) For the purpose of establishing length of stay in a NF, the 30
months of continuous residence in a NF or longer--
(i) Is calculated back from the date of the first annual resident
review determination which finds that the individual is not in need of
NF level of services;
(ii) May include temporary absences for hospitalization or
therapeutic leave; and
(iii) May consist of consecutive residences in more than one NF.
Sec. 483.120 Specialized services.
(a) Definition--(1) For mental illness, specialized services means
the services specified by the State which, combined with services
provided by the NF, results in the continuous and aggressive
implementation of an individualized plan of care that--
(i) Is developed and supervised by an interdisciplinary team, which
includes a physician, qualified mental health professionals and, as
appropriate, other professionals.
(ii) Prescribes specific therapies and activities for the treatment
of persons experiencing an acute episode of serious mental illness,
which necessitates supervision by trained mental health personnel; and
(iii) Is directed toward diagnosing and reducing the resident's
behavioral symptoms that necessitated institutionalization, improving
his or her level of independent functioning, and achieving a functioning
level that permits reduction in the intensity of mental health services
to below the level of specialized services at the earliest possible
time.
(2) For mental retardation, specialized services means the services
specified by the State which, combined with services provided by the NF
or other service providers, results in treatment which meets the
requirements of Sec. 483.440(a)(1).
(b) Who must receive specialized services. The State must provide or
arrange for the provision of specialized services, in accordance with
this subpart, to all NF residents with MI or MR whose needs are such
that continuous supervision, treatment and training by qualified mental
health or mental retardation personnel is necessary, as identified by
the screening provided in Sec. 483.130 or Sec. Sec. 483.134 and
483.136.
(c) Services of lesser intensity than specialized services. The NF
must provide mental health or mental retardation services which are of a
lesser intensity than specialized services to all residents who need
such services.
Sec. 483.122 FFP for NF services.
(a) Basic rule. Except as otherwise may be provided in an
alternative disposition plan adopted under section 1919(e)(7)(E) of the
Act, FFP is available in State expenditures for NF services provided to
a Medicaid eligible individual subject to the requirements of this part
only if the individual has been determined--
(1) To need NF care under Sec. 483.116(a) or
(2) Not to need NF services but to need specialized services, meets
the requirements of Sec. 483.118(c)(1), and elects to stay in the NF.
(b) FFP for late reviews. When a preadmission screening has not been
performed prior to admission or an annual review is not performed
timely, in accordance with Sec. 483.114(c), but either is performed at
a later date, FFP is available only for services furnished after the
screening or review has been performed, subject to the provisions of
paragraph (a) of this section.
Sec. 483.124 FFP for specialized services.
FFP is not available for specialized services furnished to NF
residents as NF services.
Sec. 483.126 Appropriate placement.
Placement of an individual with MI or MR in a NF may be considered
appropriate only when the individual's needs are such that he or she
meets the
[[Page 75]]
minimum standards for admission and the individual's needs for treatment
do not exceed the level of services which can be delivered in the NF to
which the individual is admitted either through NF services alone or,
where necessary, through NF services supplemented by specialized
services provided by or arranged for by the State.
Sec. 483.128 PASARR evaluation criteria.
(a) Level I: Identification of individuals with MI or MR. The
State's PASARR program must identify all individuals who are suspected
of having MI or MR as defined in Sec. 483.102. This identification
function is termed Level I. Level II is the function of evaluating and
determining whether NF services and specialized services are needed. The
State's performance of the Level I identification function must provide
at least, in the case of first time identifications, for the issuance of
written notice to the individual or resident and his or her legal
representative that the individual or resident is suspected of having MI
or MR and is being referred to the State mental health or mental
retardation authority for Level II screening.
(b) Adaptation to culture, language, ethnic origin. Evaluations
performed under PASARR and PASARR notices must be adapted to the
cultural background, language, ethnic origin and means of communication
used by the individual being evaluated.
(c) Participation by individual and family. PASARR evaluations must
involve--
(1) The individual being evaluated;
(2) The individual's legal representative, if one has been
designated under State law; and
(3) The individual's family if--
(i) Available; and
(ii) The individual or the legal representative agrees to family
participation.
(d) Interdisciplinary coordination. When parts of a PASARR
evaluation are performed by more than one evaluator, the State must
ensure that there is interdisciplinary coordination among the
evaluators.
(e) The State's PASARR program must use at least the evaluative
criteria of Sec. 483.130 (if one or both determinations can easily be
made categorically as described in Sec. 483.130) or of Sec. Sec.
483.132 and 483.134 or Sec. 483.136 (or, in the case of individuals
with both MI and MR, Sec. Sec. 483.132, 483.134 and 483.136 if a more
extensive individualized evaluation is required).
(f) Data. In the case of individualized evaluations, information
that is necessary for determining whether it is appropriate for the
individual with MI or MR to be placed in an NF or in another appropriate
setting should be gathered throughout all applicable portions of the
PASARR evaluation (Sec. Sec. 483.132 and 483.134 and/or Sec. 483.136).
The two determinations relating to the need for NF level of care and
specialized services are interrelated and must be based upon a
comprehensive analysis of all data concerning the individual.
(g) Preexisting data. Evaluators may use relevant evaluative data,
obtained prior to initiation of preadmission screening or annual
resident review, if the data are considered valid and accurate and
reflect the current functional status of the individual. However, in the
case of individualized evaluations, to supplement and verify the
currency and accuracy of existing data, the State's PASARR program may
need to gather additional information necessary to assess proper
placement and treatment.
(h) Findings. For both categorical and individualized
determinations, findings of the evaluation must correspond to the
person's current functional status as documented in medical and social
history records.
(i) Evaluation report: Individualized determinations. For
individualized PASARR determinations, findings must be issued in the
form of a written evaluative report which--
(1) Identifies the name and professional title of person(s) who
performed the evaluation(s) and the date on which each portion of the
evaluation was administered;
(2) Provides a summary of the medical and social history, including
the positive traits or developmental strengths and weaknesses or
developmental needs of the evaluated individual;
[[Page 76]]
(3) If NF services are recommended, identifies the specific services
which are required to meet the evaluated individual's needs, including
services required in paragraph (i)(5) of this section;
(4) If specialized services are not recommended, identifies any
specific mental retardation or mental health services which are of a
lesser intensity than specialized services that are required to meet the
evaluated individual's needs;
(5) If specialized services are recommended, identifies the specific
mental retardation or mental health services required to meet the
evaluated individual's needs; and
(6) Includes the bases for the report's conclusions.
(j) Evaluation report: Categorical determinations. For categorical
PASARR determinations, findings must be issued in the form of an
abbreviated written evaluative report which--
(1) Identifies the name and professional title of the person
applying the categorical determination and the data on which the
application was made;
(2) Explains the categorical determination(s) that has (have) been
made and, if only one of the two required determinations can be made
categorically, describes the nature of any further screening which is
required;
(3) Identifies, to the extent possible, based on the available data,
NF services, including any mental health or specialized psychiatric
rehabilitative services, that may be needed; and
(4) Includes the bases for the report's conclusions.
(k) Interpretation of findings to individual. For both categorical
and individualized determinations, findings of the evaluation must be
interpreted and explained to the individual and, where applicable, to a
legal representative designated under State law.
(l) Evaluation report. The evaluator must send a copy of the
evaluation report to the--
(1) Individual or resident and his or her legal representative;
(2) Appropriate State authority in sufficient time for the State
authorities to meet the times identified in Sec. 483.112(c) for PASs
and Sec. 483.114(c) for ARRs;
(3) Admitting or retaining NF;
(4) Individual's attending physician; and
(5) The discharging hospital if the individual is seeking NF
admission from a hospital.
(m) The evaluation may be terminated if the evaluator finds at any
time during the evaluation that the individual being evaluated--
(1) Does not have MI or MR; or
(2) Has--
(i) A primary diagnosis of dementia (including Alzheimer's Disease
or a related disorder); or
(ii) A non-primary diagnosis of dementia without a primary diagnosis
that is a serious mental illness, and does not have a diagnosis of MR or
a related condition.
[57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr. 28, 1993]
Sec. 483.130 PASARR determination criteria.
(a) Basis for determinations. Determinations made by the State
mental health or mental retardation authority as to whether NF level of
services and specialized services are needed must be based on an
evaluation of data concerning the individual, as specified in paragraph
(b) of this section.
(b) Types of determinations. Determinations may be--
(1) Advance group determinations, in accordance with this section,
by category that take into account that certain diagnoses, levels of
severity of illness, or need for a particular service clearly indicate
that admission to or residence in a NF is normally needed, or that the
provision of specialized services is not normally needed; or
(2) Individualized determinations based on more extensive
individualized evaluations as required in Sec. 483.132, Sec. 483.134,
or Sec. 483.136 (or, in the case of an individual having both MR and
MI, Sec. Sec. 483.134 and 483.136).
(c) Group determinations by category. Advance group determinations
by category developed by the State mental health or mental retardation
authorities may be made applicable to individuals by the NF or other
evaluator following Level I review only if existing data on the
individual appear to be current and accurate and are sufficient to
[[Page 77]]
allow the evaluator readily to determine that the individual fits into
the category established by the State authorities (see Sec.
483.132(c)). Sources of existing data on the individual that could form
the basis for applying a categorical determination by the State
authorities would be hospital records, physician's evaluations, election
of hospice status, records of community mental health centers or
community mental retardation or developmental disability providers.
(d) Examples of categories. Examples of categories for which the
State mental health or mental retardation authority may make an advance
group determination that NF services are needed are--
(1) Convalescent care from an acute physical illness which--
(i) Required hospitalization; and
(ii) Does not meet all the criteria for an exempt hospital
discharge, which is not subject to preadmission screening, as specified
in Sec. 483.106(b)(2).
(2) Terminal illness, as defined for hospice purposes in Sec. 418.3
of this chapter;
(3) Severe physical illnesses such as coma, ventilator dependence,
functioning at a brain stem level, or diagnoses such as chronic
obstructive pulmonary disease, Parkinson's disease, Huntington's
disease, amyotrophic lateral sclerosis, and congestive heart failure
which result in a level of impairment so severe that the individual
could not be expected to benefit from specialized services;
(4) Provisional admissions pending further assessment in cases of
delirium where an accurate diagnosis cannot be made until the delirium
clears;
(5) Provisional admissions pending further assessment in emergency
situations requiring protective services, with placement in a nursing
facility not to exceed 7 days; and
(6) Very brief and finite stays of up to a fixed number of days to
provide respite to in-home caregivers to whom the individual with MI or
MR is expected to return following the brief NF stay.
(e) Time limits. The State may specify time limits for categorical
determinations that NF services are needed and in the case of paragraphs
(d)(4), (5) and (6) of this section, must specify a time limit which is
appropriate for provisional admissions pending further assessment and
for emergency situations and respite care. If an individual is later
determined to need a longer stay than the State's limit allows, the
individual must be subjected to an annual resident review before
continuation of the stay may be permitted and payment made for days of
NF care beyond the State's time limit.
(f) The State mental health and mental retardation authorities may
make categorical determinations that specialized services are not needed
in the provisional, emergency and respite admission situations
identified in Sec. 483.130(d)(4)-(6). In all other cases, except for
Sec. 483.130(h), a determination that specialized services are not
needed must be based on a more extensive individualized evaluation under
Sec. 483.134 or Sec. 483.136.
(g) Categorical determinations: No positive specialized treatment
determinations. The State mental health and mental retardation
authorities must not make categorical determinations that specialized
services are needed. Such a determination must be based on a more
extensive individualized evaluation under Sec. 483.134 or Sec. 483.136
to determine the exact nature of the specialized services that are
needed.
(h) Categorical determinations: Dementia and MR. The State mental
retardation authority may make categorical determinations that
individuals with dementia, which exists in combination with mental
retardation or a related condition, do not need specialized services.
(i) If a State mental health or mental retardation authority
determines NF needs by category, it may not waive the specialized
services determination. The appropriate State authority must also
determine whether specialized services are needed either by category (if
permitted) or by individualized evaluations, as specified in Sec.
483.134 or Sec. 483.136.
(j) Recording determinations. All determinations made by the State
mental health and mental retardation authority, regardless of how they
are arrived at, must be recorded in the individual's record.
[[Page 78]]
(k) Notice of determination. The State mental health or mental
retardation authority must notify in writing the following entities of a
determination made under this subpart:
(1) The evaluated individual and his or her legal representative;
(2) The admitting or retaining NF;
(3) The individual or resident's attending physician; and
(4) The discharging hospital, unless the individual is exempt from
preadmission screening as provided for at Sec. 483.106(b)(2).
(l) Contents of notice. Each notice of the determination made by the
State mental health or mental retardation authority must include--
(1) Whether a NF level of services is needed;
(2) Whether specialized services are needed;
(3) The placement options that are available to the individual
consistent with these determinations; and
(4) The rights of the individual to appeal the determination under
subpart E of this part.
(m) Placement options. Except as otherwise may be provided in an
alternative disposition plan adopted under section 1919(e)(7)(E) of the
Act, the placement options and the required State actions are as
follows:
(1) Can be admitted to a NF. Any applicant for admission to a NF who
has MI or MR and who requires the level of services provided by a NF,
regardless of whether specialized services are also needed, may be
admitted to a NF, if the placement is appropriate, as determined in
Sec. 483.126. If specialized services are also needed, the State is
responsible for providing or arranging for the provision of the
specialized services.
(2) Cannot be admitted to a NF. Any applicant for admission to a NF
who has MI or MR and who does not require the level of services provided
by a NF, regardless of whether specialized services are also needed, is
inappropriate for NF placement and must not be admitted.
(3) Can be considered appropriate for continued placement in a NF.
Any NF resident with MI or MR who requires the level of services
provided by a NF, regardless of the length of his or her stay or the
need for specialized services, can continue to reside in the NF, if the
placement is appropriate, as determined in Sec. 483.126.
(4) May choose to remain in the NF even though the placement would
otherwise be inappropriate. Any NF resident with MI or MR who does not
require the level of services provided by a NF but does require
specialized services and who has continuously resided in a NF for at
least 30 consecutive months before the date of determination may choose
to continue to reside in the facility or to receive covered services in
an alternative appropriate institutional or noninstitutional setting.
Wherever the resident chooses to reside, the State must meet his or her
specialized services needs. The determination notice must provide
information concerning how, when, and by whom the various placement
options available to the resident will be fully explained to the
resident.
(5) Cannot be considered appropriate for continued placement in a NF
and must be discharged (short-term residents). Any NF resident with MI
or MR who does not require the level of services provided by a NF but
does require specialized services and who has resided in a NF for less
than 30 consecutive months must be discharged in accordance with Sec.
483.12(a) to an appropriate setting where the State must provide
specialized services. The determination notice must provide information
on how, when, and by whom the resident will be advised of discharge
arrangements and of his/her appeal rights under both PASARR and
discharge provisions.
(6) Cannot be considered appropriate for continued placement in a NF
and must be discharged (short or long-term residents). Any NF resident
with MI or MR who does not require the level of services provided by a
NF and does not require specialized services regardless of his or her
length of stay, must be discharged in accordance with Sec. 483.12(a).
The determination notice must provide information on how, when, and by
whom the resident will be advised of discharge arrangements and of his
or her appeal rights under both PASARR and discharge provisions.
(n) Specialized services needed in a NF. If a determination is made
to admit or
[[Page 79]]
allow to remain in a NF any individual who requires specialized
services, the determination must be supported by assurances that the
specialized services that are needed can and will be provided or
arranged for by the State while the individual resides in the NF.
(o) Record retention. The State PASARR system must maintain records
of evaluations and determinations, regardless of whether they are
performed categorically or individually, in order to support its
determinations and actions and to protect the appeal rights of
individuals subjected to PASARR; and
(p) Tracking system. The State PASARR system must establish and
maintain a tracking system for all individuals with MI or MR in NFs to
ensure that appeals and future reviews are performed in accordance with
this subpart and subpart E.
[57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr. 28, 1993]
Sec. 483.132 Evaluating the need for NF services and NF level of care
(PASARR/NF).
(a) Basic rule. For each applicant for admission to a NF and each NF
resident who has MI or MR, the evaluator must assess whether--
(1) The individual's total needs are such that his or her needs can
be met in an appropriate community setting;
(2) The individual's total needs are such that they can be met only
on an inpatient basis, which may include the option of placement in a
home and community-based services waiver program, but for which the
inpatient care would be required;
(3) If inpatient care is appropriate and desired, the NF is an
appropriate institutional setting for meeting those needs in accordance
with Sec. 483.126; or
(4) If the inpatient care is appropriate and desired but the NF is
not the appropriate setting for meeting the individual's needs in
accordance with Sec. 483.126, another setting such as an ICF/MR
(including small, community-based facilities), an IMD providing services
to individuals aged 65 or older, or a psychiatric hospital is an
appropriate institutional setting for meeting those needs.
(b) Determining appropriate placement. In determining appropriate
placement, the evaluator must prioritize the physical and mental needs
of the individual being evaluated, taking into account the severity of
each condition.
(c) Data. At a minimum, the data relied on to make a determination
must include:
(1) Evaluation of physical status (for example, diagnoses, date of
onset, medical history, and prognosis);
(2) Evaluation of mental status (for example, diagnoses, date of
onset, medical history, likelihood that the individual may be a danger
to himself/herself or others); and
(3) Functional assessment (activities of daily living).
(d) Based on the data compiled in Sec. 483.132 and, as appropriate,
in Sec. Sec. 483.134 and 483.136, the State mental health or mental
retardation authority must determine whether an NF level of services is
needed.
Sec. 483.134 Evaluating whether an individual with mental illness requires
specialized services (PASARR/MI).
(a) Purpose. The purpose of this section is to identify the minimum
data needs and process requirements for the State mental health
authority, which is responsible for determining whether or not the
applicant or resident with MI, as defined in Sec. 483.102(b)(1) of this
part, needs a specialized services program for mental illness as defined
in Sec. 483.120.
(b) Data. Minimum data collected must include--(1) A comprehensive
history and physical examination of the person. The following areas must
be included (if not previously addressed):
(i) Complete medical history;
(ii) Review of all body systems;
(iii) Specific evaluation of the person's neurological system in the
areas of motor functioning, sensory functioning, gait, deep tendon
reflexes, cranial nerves, and abnormal reflexes; and
(iv) In case of abnormal findings which are the basis for an NF
placement, additional evaluations conducted by appropriate specialists.
(2) A comprehensive drug history including current or immediate past
use of medications that could mask symptoms or mimic mental illness.
[[Page 80]]
(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 mental retardation
requires specialized services (PASARR/MR).
(a) Purpose. The purpose of this section is to identify the minimum
data needs and process requirements for the State mental retardation
authority to determine whether or not the applicant or resident with
mental retardation, as defined in Sec. 483.102(b)(3) of this part,
needs a continuous specialized services program, which is analogous to
active treatment, as defined in Sec. 435.1010 of this chapter and Sec.
483.440.
(b) Data. Minimum data collected must include the individual's
comprehensive history and physical examination results to identify the
following information or, in the absence of data, must include
information that permits a reviewer specifically to assess:
(1) The individual's medical problems;
(2) The level of impact these problems have on the individual's
independent functioning;
(3) All current medications used by the individual and the current
response of the individual to any prescribed medications in the
following drug groups:
(i) Hypnotics,
(ii) Antipsychotics (neuroleptics),
(iii) Mood stabilizers and antidepressants,
(iv) Antianxiety-sedative agents, and
(v) Anti-Parkinson agents.
(4) Self-monitoring of health status;
(5) Self-administering and scheduling of medical treatments;
(6) Self-monitoring of nutritional status;
(7) Self-help development such as toileting, dressing, grooming, and
eating;
(8) Sensorimotor development, such as ambulation, positioning,
transfer skills, gross motor dexterity, visual motor perception, fine
motor dexterity, eye-hand coordination, and extent to which prosthetic,
orthotic, corrective or mechanical supportive devices can improve the
individual's functional capacity;
(9) Speech and language (communication) development, such as
expressive
[[Page 81]]
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 MR or a related condition.
(2) Based on the data compiled in paragraph (b) of this section, the
State mental retardation authority, using appropriate personnel, as
designated by the State, must validate that the individual has MR or is
a person with a related condition and must determine whether specialized
services for mental retardation are needed. In making this
determination, the State mental retardation authority must make a
qualitative judgment on the extent to which the person's status
reflects, singly and collectively, the characteristics commonly
associated with the need for specialized services, including--
(i) Inability to--
(A) Take care of the most personal care needs;
(B) Understand simple commands;
(C) Communicate basic needs and wants;
(D) Be employed at a productive wage level without systematic long
term supervision or support;
(E) Learn new skills without aggressive and consistent training;
(F) Apply skills learned in a training situation to other
environments or settings without aggressive and consistent training;
(G) Demonstrate behavior appropriate to the time, situation or place
without direct supervision; and
(H) Make decisions requiring informed consent without extreme
difficulty;
(ii) Demonstration of severe maladaptive behavior(s) that place the
person or others in jeopardy to health and safety; and
(iii) Presence of other skill deficits or specialized training needs
that necessitate the availability of trained MR personnel, 24 hours per
day, to teach the person functional skills.
[57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr. 28, 1993, as amended at
71 FR 39229, July 12, 2006]
Sec. 483.138 Maintenance of services and availability of FFP.
(a) Maintenance of services. If a NF mails a 30 day notice of its
intent to transfer or discharge a resident, under Sec. 483.12(a) of
this chapter, the agency may not terminate or reduce services until--
(1) The expiration of the notice period; or
(2) A subpart E appeal, if one has been filed, has been resolved.
(b) Availability of FFP. FFP is available for expenditures for
services provided to Medicaid recipients during--
(1) The 30 day notice period specified in Sec. 483.12(a) of this
chapter; or
(2) During the period an appeal is in progress.
[[Page 82]]
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 Sec. 483.75(e) are met.
(b) Requirements for approval of programs. (1) Before the State
approves a nurse aide training and competency evaluation program or
competency evaluation program, the State must--
(i) Determine whether the nurse aide training and competency
evaluation program meets the course requirements of Sec. Sec. 483.152:
(ii) Determine whether the nurse aide competency evaluation program
meets the requirements of Sec. 483.154; and
(iii) In all reviews other than the initial review, visit the entity
providing the program.
(2) The State may not approve a nurse aide training and competency
evaluation program or competency evaluation program offered by or in a
[[Page 83]]
facility which, in the previous two years--
(i) In the case of a skilled nursing facility, has operated under a
waiver under section 1819(b)(4)(C)(ii)(II) of the Act;
(ii) In the case of a nursing facility, has operated under a waiver
under section 1919(b)(4)(C)(ii) of the Act that was granted on the basis
of a demonstration that the facility is unable to provide nursing care
required under section 1919(b)(4)(C)(i) of the Act for a period in
excess of 48 hours per week;
(iii) Has been subject to an extended (or partial extended) survey
under sections 1819(g)(2)(B)(i) or 1919(g)(2)(B)(i) of the Act;
(iv) Has been assessed a civil money penalty described in section
1819(h)(2)(B)(ii) of 1919(h)(2)(A)(ii) of the Act of not less than
$5,000; or
(v) Has been subject to a remedy described in sections 1819(h)(2)(B)
(i) or (iii), 1819(h)(4), 1919(h)(1)(B)(i), or 1919(h)(2)(A) (i), (iii)
or (iv) of the Act.
(3) A State may not, until two years since the assessment of the
penalty (or penalties) has elapsed, approve a nurse aide training and
competency evaluation program or competency evaluation program offered
by or in a facility that, within the two-year period beginning October
1, 1988--
(i) Had its participation terminated under title XVIII of the Act or
under the State plan under title XIX of the Act;
(ii) Was subject to a denial of payment under title XVIII or title
XIX;
(iii) Was assessed a civil money penalty of not less than $5,000 for
deficiencies in nursing facility standards;
(iv) Operated under temporary management appointed to oversee the
operation of the facility and to ensure the health and safety of its
residents; or
(v) Pursuant to State action, was closed or had its residents
transferred.
(c) 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 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. Sec. 483.152 or 483.154 are not met by the program.
(3) The State must withdraw approval of a nurse aide training and
competency evaluation program or a nurse aide competency evaluation
program if the entity providing the program refuses to permit
unannounced visits by the State.
(4) If a State withdraws approval of a nurse aide training and
competency evaluation program or competency evaluation program--
(i) The State must notify the program in writing, indicating the
reason(s) for withdrawal of approval of the program.
[[Page 84]]
(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]
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;
(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;
[[Page 85]]
(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
(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
[[Page 86]]
(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;
(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-
[[Page 87]]
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. 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
[[Page 88]]
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
(2) An individual who has been adversely affected by any PASARR
determination made by the State in the context of either a preadmission
screening or an annual resident review under subpart C of part 483 to
appeal that determination.
(b) The State must provide an appeals system that meets the
requirements of this subpart, Sec. 483.12 of this part, and part 431
subpart E of this chapter.
[57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr. 28, 1993]
[[Page 89]]
Sec. 483.206 Transfers, discharges and relocations subject to appeal.
(a) ``Facility'' means a certified entity, either a Medicare SNF or
a Medicaid NF (see Sec. Sec. 483.5 and 483.12(a)(1)).
(b) A resident has appeal rights when he or she is transferred
from--
(1) A certified bed into a noncertified bed; and
(2) A bed in a certified entity to a bed in an entity which is
certified as a different provider.
(c) A resident has no appeal rights when he or she is moved from one
bed in the certified entity to another bed in the same certified entity.
Subpart F_Requirements That Must be Met by States and State Agencies,
Resident Assessment
Sec. 483.315 Specification of resident assessment instrument.
(a) Statutory basis. Sections 1819(e)(5) and 1919(e)(5) of the Act
require that a State specify the resident assessment instrument (RAI) to
be used by long term care facilities in the State when conducting
initial and periodic assessments of each resident's functional capacity,
in accordance with Sec. 483.20.
(b) State options in specifying an RAI. The RAI that the State
specifies must be one of the following:
(1) The instrument designated by CMS.
(2) An alternate instrument specified by the State and approved by
CMS, using the criteria specified in the State Operations Manual issued
by CMS (CMS Pub. 7) which is available for purchase through the National
Technical Information Service, 5285 Port Royal Rd., Springfield, VA
22151.
(c) State requirements in specifying an RAI. (1) Within 30 days
after CMS notifies the State of the CMS-designated RAI or changes to it,
the State must do one of the following:
(i) Specify the CMS-designated RAI.
(ii) Notify CMS of its intent to specify an alternate instrument.
(2) Within 60 days after receiving CMS approval of an alternate RAI,
the State must specify the RAI for use by all long term care facilities
participating in the Medicare and Medicaid programs.
(3) After specifying an instrument, the State must provide periodic
educational programs for facility staff to assist with implementation of
the RAI.
(4) A State must audit implementation of the RAI through the survey
process.
(5) A State must obtain approval from CMS before making any
modifications to its RAI.
(6) A State must adopt revisions to the RAI that are specified by
CMS.
(d) CMS-designated RAI. The CMS-designated RAI is published in the
State Operations Manual issued by CMS (CMS Pub. 7), as updated
periodically, and consists of the following:
(1) The minimum data set (MDS) and common definitions.
(2) Care area assessment (CAA) guidelines and care area triggers
(CATs) that are necessary to accurately assess residents, established by
CMS.
(3) The quarterly review, based on a subset of the MDS specified by
CMS.
(4) The requirements for use of the RAI that appear at Sec. 483.20.
(e) Minimum data set (MDS). The MDS includes assessment in the areas
specified in Sec. 483.20(b)(i) through (xviii) of this chapter, and as
defined in the RAI manual published in the State Operations Manual
issued by CMS (CMS Pub. 100-07).
(f) [Reserved]
(g) Criteria for CMS approval of alternate instrument. To receive
CMS approval, a State's alternate instrument must use the standardized
format, organization, item labels and definitions, and instructions
specified by CMS in the latest issuance of the State Operations Manual
issued by CMS (CMS Pub. 7).
(h) State MDS system and database requirements. As part of facility
agency responsibilities, the State Survey Agency must:
(1) Support and maintain the CMS State system and database.
(2) Specify to a facility the method of transmission of data, and
instruct the facility on this method.
(3) Upon receipt of facility data from CMS, ensure that a facility
resolves errors.
[[Page 90]]
(4) Analyze data and generate reports, as specified by CMS.
(i) State identification of agency that receives RAI data. The State
must identify the component agency that receives RAI data, and ensure
that this agency restricts access to the data except for the following:
(1) Reports that contain no resident-identifiable data.
(2) Transmission of reports to CMS.
(3) Transmission of data and reports to the State agency that
conducts surveys to ensure compliance with Medicare and Medicaid
participation requirements, for purposes related to this function.
(4) Transmission of data and reports to the State Medicaid agency
for purposes directly related to the administration of the State
Medicaid plan.
(5) Transmission of data and reports to other entities only when
authorized as a routine use by CMS.
(j) Resident-identifiable data. (1) The State may not release
information that is resident-identifiable to the public.
(2) The State may not release RAI data that is resident-identifiable
except in accordance with a written agreement under which the recipient
agrees to be bound by the restrictions described in paragraph (i) of
this section.
[62 FR 67212, Dec. 23, 1997, as amended at 74 FR 40363, Aug. 11, 2009]
Subpart G_Condition of Participation for the Use of Restraint or
Seclusion in Psychiatric Residential Treatment Facilities Providing
Inpatient Psychiatric Services for Individuals Under Age 21
Source: 66 FR 7161, Jan. 22, 2001, unless otherwise noted.
Sec. 483.350 Basis and scope.
(a) Statutory basis. Sections 1905(a)(16) and (h) of the Act provide
that inpatient psychiatric services for individuals under age 21 include
only inpatient services that are provided in an institution (or distinct
part thereof) that is a psychiatric hospital as defined in section
1861(f) of the Act or in another inpatient setting that the Secretary
has specified in regulations. Additionally, the Children's Health Act of
2000 (Pub. L. 106-310) imposes procedural reporting and training
requirements regarding the use of restraints and involuntary seclusion
in facilities, specifically including facilities that provide inpatient
psychiatric services for children under the age of 21 as defined by
sections 1905(a)(16) and (h) of the Act.
(b) Scope. This subpart imposes requirements regarding the use of
restraint or seclusion in psychiatric residential treatment facilities,
that are not hospitals, providing inpatient psychiatric services to
individuals under age 21.
Sec. 483.352 Definitions.
For purposes of this subpart, the following definitions apply:
Drug used as a restraint means any drug that--
(1) Is administered to manage a resident's behavior in a way that
reduces the safety risk to the resident or others;
(2) Has the temporary effect of restricting the resident's freedom
of movement; and
(3) Is not a standard treatment for the resident's medical or
psychiatric condition.
Emergency safety intervention means the use of restraint or
seclusion as an immediate response to an emergency safety situation.
Emergency safety situation means unanticipated resident behavior
that places the resident or others at serious threat of violence or
injury if no intervention occurs and that calls for an emergency safety
intervention as defined in this section.
Mechanical restraint means any device attached or adjacent to the
resident's body that he or she cannot easily remove that restricts
freedom of movement or normal access to his or her body.
Minor means a minor as defined under State law and, for the purpose
of this subpart, includes a resident who has been declared legally
incompetent by the applicable State court.
Personal restraint means the application of physical force without
the use
[[Page 91]]
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 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
[[Page 92]]
minor, to the resident's parent(s) or legal guardian(s).
(d) Contact information. The facility's policy must provide contact
information, including the phone number and mailing address, for the
appropriate State Protection and Advocacy organization.
Sec. 483.358 Orders for the use of restraint or seclusion.
(a) Orders for restraint or seclusion must be by a physician, or
other licensed practitioner permitted by the State and the facility to
order restraint or seclusion and trained in the use of emergency safety
interventions. Federal regulations at 42 CFR 441.151 require that
inpatient psychiatric services for recipients under age 21 be provided
under the direction of a physician.
(b) If the resident's treatment team physician is available, only he
or she can order restraint or seclusion.
(c) A physician or other licensed practitioner permitted by the
state and the facility to order restraint or seclusion must order the
least restrictive emergency safety intervention that is most likely to
be effective in resolving the emergency safety situation based on
consultation with staff.
(d) If the order for restraint or seclusion is verbal, the verbal
order must be received by a registered nurse or other licensed staff
such as a licensed practical nurse, while the emergency safety
intervention is being initiated by staff or immediately after the
emergency safety situation ends. The physician or other licensed
practitioner permitted by the state and the facility to order restraint
or seclusion must verify the verbal order in a signed written form in
the resident's record. The physician or other licensed practitioner
permitted by the state and the facility to order restraint or seclusion
must be available to staff for consultation, at least by telephone,
throughout the period of the emergency safety intervention.
(e) Each order for restraint or seclusion must:
(1) Be limited to no longer than the duration of the emergency
safety situation; and
(2) Under no circumstances exceed 4 hours for residents ages 18 to
21; 2 hours for residents ages 9 to 17; or 1 hour for residents under
age 9.
(f) Within 1 hour of the initiation of the emergency safety
intervention a physician, or other licensed practitioner trained in the
use of emergency safety interventions and permitted by the state and the
facility to assess the physical and psychological well being of
residents, must conduct a face-to-face assessment of the physical and
psychological well being of the resident, including but not limited to--
(1) The resident's physical and psychological status;
(2) The resident's behavior;
(3) The appropriateness of the intervention measures; and
(4) Any complications resulting from the intervention.
(g) Each order for restraint or seclusion must include--
(1) The name of the ordering physician or other licensed
practitioner permitted by the state and the facility to order restraint
or seclusion;
(2) The date and time the order was obtained; and
(3) The emergency safety intervention ordered, including the length
of time for which the physician or other licensed practitioner permitted
by the state and the facility to order restraint or seclusion authorized
its use.
(h) Staff must document the intervention in the resident's record.
That documentation must be completed by the end of the shift in which
the intervention occurs. If the intervention does not end during the
shift in which it began, documentation must be completed during the
shift in which it ends. Documentation must include all of the following:
(1) Each order for restraint or seclusion as required in paragraph
(g) of this section.
(2) The time the emergency safety intervention actually began and
ended.
(3) The time and results of the 1-hour assessment required in
paragraph (f) of this section.
(4) The emergency safety situation that required the resident to be
restrained or put in seclusion.
(5) The name of staff involved in the emergency safety intervention.
[[Page 93]]
(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.
(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
[[Page 94]]
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;
(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.
[[Page 95]]
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.
(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
[[Page 96]]
were successfully completed. Documentation must include the date
training was completed and the name of persons certifying the completion
of training.
(h) All training programs and materials used by the facility must be
available for review by CMS, the State Medicaid agency, and the State
survey agency.
Subpart H [Reserved]
Subpart I_Conditions of Participation for Intermediate Care Facilities
for the Mentally Retarded
Source: 53 FR 20496, June 3, 1988, unless otherwise noted.
Redesignated at 56 FR 48918, Sept. 26, 1991.
Sec. 483.400 Basis and purpose.
This subpart implements section 1905 (c) and (d) of the Act which
gives the Secretary authority to prescribe regulations for intermediate
care facility services in facilities for the mentally retarded or
persons with related conditions.
Sec. 483.405 Relationship to other HHS regulations.
In addition to compliance with the regulations set forth in this
subpart, facilities are obliged to meet the applicable provisions of
other HHS regulations, including but not limited to those pertaining to
nondiscrimination on the basis of race, color, or national origin (45
CFR Part 80), nondiscrimination on the basis of handicap (45 CFR Part
84), nondiscrimination on the basis of age (45 CFR Part 91), protection
of human subjects of research (45 CFR Part 46), and fraud and abuse (42
CFR Part 455). Although those regulations are not in themselves
considered conditions of participation under this Part, their violation
may result in the termination or suspension of, or the refusal to grant
or continue, Federal financial assistance.
Sec. 483.410 Condition of participation: Governing body and management.
(a) Standard: Governing body. The facility must identify an
individual or individuals to constitute the governing body of the
facility. The governing body must--
(1) Exercise general policy, budget, and operating direction over
the facility;
(2) Set the qualifications (in addition to those already set by
State law, if any) for the administrator of the facility; and
(3) Appoint the administrator of the facility.
(b) Standard: Compliance with Federal, State, and local laws. The
facility must be in compliance with all applicable provisions of
Federal, State and local laws, regulations and codes pertaining to
health, safety, and sanitation.
(c) Standard: Client records. (1) The facility must develop and
maintain a recordkeeping system that includes a separate record for each
client and that documents the client's health care, active treatment,
social information, and protection of the client's rights.
(2) The facility must keep confidential all information contained in
the clients' records, regardless of the form or storage method of the
records.
(3) The facility must develop and implement policies and procedures
governing the release of any client information, including consents
necessary from the client, or parents (if the client is a minor) or
legal guardian.
(4) Any individual who makes an entry in a client's record must make
it legibly, date it, and sign it.
(5) The facility must provide a legend to explain any symbol or
abbreviation used in a client's record.
(6) The facility must provide each identified residential living
unit with appropriate aspects of each client's record.
(d) Standard: Services provided under agreements with outside
sources. (1) If a service required under this subpart is not provided
directly, the facility must have a written agreement with an outside
program, resource, or service to furnish the necessary service,
including emergency and other health care.
(2) The agreement must--
(i) Contain the responsibilities, functions, objectives, and other
terms agreed to by both parties; and
(ii) Provide that the facility is responsible for assuring that the
outside
[[Page 97]]
services meet the standards for quality of services contained in this
subpart.
(3) The facility must assure that outside services meet the needs of
each client.
(4) If living quarters are not provided in a facility owned by the
ICF/MR, the ICF/MR remains directly responsible for the standards
relating to physical environment that are specified in Sec. 483.470 (a)
through (g), (j) and (k).
(e) Standard: Licensure. The facility must be licensed under
applicable State and local law.
[53 FR 20496, June 3, 1988. Redesignated at 56 FR 48918, Sept. 26, 1991,
and amended at 57 FR 43925, Sept. 23, 1992]
Sec. 483.420 Condition of participation: Client protections.
(a) Standard: Protection of clients' rights. The facility must
ensure the rights of all clients. Therefore, the facility must--
(1) Inform each client, parent (if the client is a minor), or legal
guardian, of the client's rights and the rules of the facility;
(2) Inform each client, parent (if the client is a minor), or legal
guardian, of the client's medical condition, developmental and
behavioral status, attendant risks of treatment, and of the right to
refuse treatment;
(3) Allow and encourage individual clients to exercise their rights
as clients of the facility, and as citizens of the United States,
including the right to file complaints, and the right to due process;
(4) Allow individual clients to manage their financial affairs and
teach them to do so to the extent of their capabilities;
(5) Ensure that clients are not subjected to physical, verbal,
sexual or psychological abuse or punishment;
(6) Ensure that clients are free from unnecessary drugs and physical
restraints and are provided active treatment to reduce dependency on
drugs and physical restraints;
(7) Provide each client with the opportunity for personal privacy
and ensure privacy during treatment and care of personal needs;
(8) Ensure that clients are not compelled to perform services for
the facility and ensure that clients who do work for the facility are
compensated for their efforts at prevailing wages and commensurate with
their abilities;
(9) Ensure clients the opportunity to communicate, associate and
meet privately with individuals of their choice, and to send and receive
unopened mail;
(10) Ensure that clients have access to telephones with privacy for
incoming and outgoing local and long distance calls except as
contraindicated by factors identified within their individual program
plans;
(11) Ensure clients the opportunity to participate in social,
religious, and community group activities;
(12) Ensure that clients have the right to retain and use
appropriate personal possessions and clothing, and ensure that each
client is dressed in his or her own clothing each day; and
(13) Permit a husband and wife who both reside in the facility to
share a room.
(b) Standard: Client finances. (1) The facility must establish and
maintain a system that--
(i) Assures a full and complete accounting of clients' personal
funds entrusted to the facility on behalf of clients; and
(ii) Precludes any commingling of client funds with facility funds
or with the funds of any person other than another client.
(2) The client's financial record must be available on request to
the client, parents (if the client is a minor) or legal guardian.
(c) Standard: Communication with clients, parents, and guardians.
The facility must--
(1) Promote participation of parents (if the client is a minor) and
legal guardians in the process of providing active treatment to a client
unless their participation is unobtainable or inappropriate;
(2) Answer communications from clients' families and friends
promptly and appropriately;
(3) Promote visits by individuals with a relationship to the client
(such as family, close friends, legal guardians and advocates) at any
reasonable hour, without prior notice, consistent with
[[Page 98]]
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 mental retardation professional. Each
client's active treatment program must be integrated, coordinated and
monitored by a qualified mental retardation professional who--
(1) Has at least one year of experience working directly with
persons with mental retardation or other developmental disabilities; and
(2) Is one of the following:
(i) A doctor of medicine or osteopathy.
(ii) A registered nurse.
(iii) An individual who holds at least a bachelor's degree in a
professional category specified in paragraph (b)(5) of this section.
(b) Standard: Professional program services. (1) Each client must
receive the professional program services needed to implement the active
treatment program defined by each client's individual program plan.
Professional program staff must work directly with clients and with
paraprofessional, nonprofessional and other professional program staff
who work with clients.
(2) The facility must have available enough qualified professional
staff to carry out and monitor the various professional interventions in
accordance with the stated goals and objectives of every individual
program plan.
(3) Professional program staff must participate as members of the
interdisciplinary team in relevant aspects of the active treatment
process.
(4) Professional program staff must participate in on-going staff
development and training in both formal and informal settings with other
professional, paraprofessional, and nonprofessional staff members.
(5) Professional program staff must be licensed, certified, or
registered, as applicable, to provide professional services by the State
in which he or she practices. Those professional program staff who do
not fall under the jurisdiction of State licensure, certification, or
registration requirements, specified in Sec. 483.410(b), must meet the
following qualifications:
(i) To be designated as an occupational therapist, an individual
must be
[[Page 99]]
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 mental retardation professionals;
(B) Except for the requirements of paragraph (b)(2) of this section
concerning the facility's provision of enough qualified professional
program staff; and
(C) Unless otherwise specified by State licensure and certification
requirements.
(c) Standard: Facility staffing. (1) The facility must not depend
upon clients or volunteers to perform direct care services for the
facility.
(2) There must be responsible direct care staff on duty and awake on
a 24-hour basis, when clients are present, to take prompt, appropriate
action in case of injury, illness, fire or other emergency, in each
defined residential living unit housing--
(i) Clients for whom a physician has ordered a medical care plan;
(ii) Clients who are aggressive, assaultive or security risks;
(iii) More than 16 clients; or
(iv) Fewer than 16 clients within a multi-unit building.
(3) There must be a responsible direct care staff person on duty on
a 24 hour basis (when clients are present) to respond to injuries and
symptoms of illness, and to handle emergencies, in each defined
residential living unit housing--
(i) Clients for whom a physician has not ordered a medical care
plan;
(ii) Clients who are not aggressive, assaultive or security risks;
and
(iii) Sixteen or fewer clients,
[[Page 100]]
(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 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--
[[Page 101]]
(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:
(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
[[Page 102]]
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 mental
retardation professional and revised as necessary, including, but not
limited to situations in which the client--
(i) Has successfully completed an objective or objectives identified
in the individual program plan;
(ii) Is regressing or losing skills already gained;
(iii) Is failing to progress toward identified objectives after
reasonable efforts have been made; or
(iv) Is being considered for training towards new objectives.
(2) At least annually, the comprehensive functional assessment of
each client must be reviewed by the interdisciplinary team for relevancy
and updated as needed, and the individual program plan must be revised,
as appropriate, repeating the process set forth in paragraph (c) of this
section.
(3) The facility must designate and use a specially constituted
committee or committees consisting of members of facility staff,
parents, legal guardians, clients (as appropriate), qualified persons
who have either experience or training in contemporary practices to
change inappropriate client behavior, and persons with no ownership or
controlling interest in the facility to--
(i) Review, approve, and monitor individual programs designed to
manage inappropriate behavior and other programs that, in the opinion of
the committee, involve risks to client protection and rights;
(ii) Insure that these programs are conducted only with the written
informed consent of the client, parent (if the client is a minor), or
legal guardian; and
(iii) Review, monitor and make suggestions to the facility about its
practices and programs as they relate to drug usage, physical
restraints, time-out rooms, application of painful or noxious stimuli,
control of inappropriate behavior, protection of client rights and
funds, and any other area
[[Page 103]]
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 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,
[[Page 104]]
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.
Sec. 483.460 Condition of participation: Health care services.
(a) Standard: Physician services. (1) The facility must ensure the
availability of physician services 24 hours a day.
(2) The physician must develop, in coordination with licensed
nursing personnel, a medical care plan of treatment for a client if the
physician determines that an individual client requires 24-hour licensed
nursing care. This plan must be integrated in the individual program
plan.
(3) The facility must provide or obtain preventive and general
medical care as well as annual physical examinations of each client that
at a minimum include the following:
(i) Evaluation of vision and hearing.
(ii) Immunizations, using as a guide the recommendations of the
Public Health Service Advisory Commitee on Immunization Practices or of
the Committee on the Control of Infectious Diseases of the American
Academy of Pediatrics.
(iii) Routine screening laboratory examinations as determined
necessary by the physician, and special studies when needed.
(iv) Tuberculosis control, appropriate to the facility's population,
and in accordance with the recommendations of
[[Page 105]]
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.
(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--
[[Page 106]]
(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 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.
[[Page 107]]
(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--
(i) Is usable as a second means of escape by the client(s) occupying
the room; and
(ii) Is no more than 44 inches (measured to the window sill) above
the floor unless the facility is surveyed under the Health Care
Occupancy Chapter of the Life Safety Code, in which case the window must
be no more than 36 inches (measured to the window sill) above the floor.
(3) The survey agency may grant a variance from the limit of four
clients per room only if a physician who is a member of the
interdisciplinary team and who is a qualified mental retardation
professional--
(i) Certifies that each client to be placed in a bedroom housing
more than four persons is so severely medically impaired as to require
direct and continuous monitoring during sleeping hours; and
(ii) Documents the reasons why housing in a room of only four or
fewer persons would not be medically feasible.
(4) The facility must provide each client with--
(i) A separate bed of proper size and height for the convenience of
the client;
(ii) A clean, comfortable, mattress;
[[Page 108]]
(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) Standard: Emergency plan and procedures. (1) The facility must
develop and implement detailed written plans and procedures to meet all
potential emergencies and disasters such as fire, severe weather, and
missing clients.
(2) The facility must communicate, periodically review, make the
plan available, and provide training to the staff.
(i) Standard: Evacuation drills. (1) The facility must hold
evacuation drills at least quarterly for each shift of personnel and
under varied conditions to--
(i) Ensure that all personnel on all shifts are trained to perform
assigned tasks;
(ii) Ensure that all personnel on all shifts are familiar with the
use of the facility's fire protection features; and
(iii) Evaluate the effectiveness of emergency and disaster plans and
procedures.
(2) The facility must--
(i) Actually evacuate clients during at least one drill each year on
each shift;
(ii) Make special provisions for the evacuation of clients with
physical disabilities;
(iii) File a report and evaluation on each evacuation drill;
(iv) Investigate all problems with evacuation drills, including
accidents, and take corrective action; and
[[Page 109]]
(v) During fire drills, clients may be evacuated to a safe area in
facilities certified under the Health Care Occupancies Chapter of the
Life Safety Code.
(3) Facilities must meet the requirements of paragraphs (i)(1) and
(2) of this section for any live-in and relief staff they utilize.
(j) Standard: Fire protection--(1) General. Except as otherwise
provided in this section--
(i) The facility must meet the applicable provisions of either the
Health Care Occupancies Chapters or the Residential Board and Care
Occupancies Chapter of the 2000 edition of the Life Safety Code of the
National Fire Protection Association. The Director of the Office of the
Federal Register has approved the NFPA 101 [reg] 2000 edition
of the Life Safety Code, issued January 14, 2000, for incorporation by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy
of the Code is available for inspection at the CMS Information Resource
Center, 7500 Security Boulevard, Baltimore, MD or at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call 202-741-6030, or go to:
http://www.archives.gov/federal--register/code--of--federal--
regulations/ibr--locations.html. Copies may be obtained from the
National Fire Protection Association, 1 Batterymarch Park, Quincy, MA
02269. If any changes in this edition of the Code are incorporated by
reference, CMS will publish notice in the Federal Register to announce
the changes.
(ii) Chapter 19.3.6.3.2, exception number 2 of the adopted LSC does
not apply to a facility.
(2) The State survey agency may apply a single chapter of the LSC to
the entire facility or may apply different chapters to different
buildings or parts of buildings as permitted by the LSC.
(3) A facility that meets the LSC definition of a residential board
and care occupancy must have its evacuation capability evaluated in
accordance with the Evacuation Difficulty Index of the Fire Safety
Evaluation System for Board and Care facilities (FSES/BC).
(4) If CMS finds that the State has a fire and safety code imposed
by State law that adequately protects a facility's clients, CMS may
allow the State survey agency to apply the State's fire and safety code
instead of the LSC.
(5) Beginning March 13, 2006, a facility must be in compliance with
Chapter 19.2.9, Emergency Lighting.
(6) Beginning March 13, 2006, Chapter 19.3.6.3.2, exception number 2
does not apply to a facility.
(7) Facilities that meet the LSC definition of a health care
occupancy. (i) After consideration of State survey agency
recommendations, CMS may waive, for appropriate periods, specific
provisions of the Life Safety Code if the following requirements are
met:
(A) The waiver would not adversely affect the health and safety of
the clients.
(B) Rigid application of specific provisions would result in an
unreasonable hardship for the facility.
(ii) Notwithstanding any provisions of the 2000 edition of the Life
Safety Code to the contrary, a facility may install alcohol-based hand
rub dispensers if--
(A) Use of alcohol-based hand rub dispensers does not conflict with
any State or local codes that prohibit or otherwise restrict the
placement of alcohol-based hand rub dispensers in health care
facilities;
(B) The dispensers are installed in a manner that minimizes leaks
and spills that could lead to falls;
(C) The dispensers are installed in a manner that adequately
protects against inappropriate access;
(D) The dispensers are installed in accordance with chapter 18.3.2.7
or chapter 19.3.2.7 of the 2000 edition of the Life Safety Code, as
amended by NFPA Temporary Interim Amendment 00-1(101), issued by the
Standards Council of the National Fire Protection Association on April
15, 2004. The Director of the Office of the Federal Register has
approved NFPA Temporary Interim Amendment 00-1(101) for incorporation by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy
of the amendment is available for inspection at the CMS Information
Resource Center, 7500 Security Boulevard, Baltimore, MD and at the
Office of the
[[Page 110]]
Federal Register, 800 North Capitol Street NW., Suite 700, Washington,
DC. Copies may be obtained from the National Fire Protection
Association, 1 Batterymarch Park, Quincy, MA 02269; and
(E) The dispensers are maintained in accordance with dispenser
manufacturer guidelines.
(k) Standard: Paint. The facility must--
(1) Use lead-free paint inside the facility; and
(2) Remove or cover interior paint or plaster containing lead so
that it is not accessible to clients.
(l) Standard: Infection control. (1) The facility must provide a
sanitary environment to avoid sources and transmission of infections.
There must be an active program for the prevention, control, and
investigation of infection and communicable diseases.
(2) The facility must implement successful corrective action in
affected problem areas.
(3) The facility must maintain a record of incidents and corrective
actions related to infections.
(4) The facility must prohibit employees with symptoms or signs of a
communicable disease from direct contact with clients and their food.
[53 FR 20496, June 3, 1988. Redesignated at 56 FR 48918, Sept. 26, 1991,
as amended at 68 FR 1387, Jan. 10, 2003; 69 FR 49271, Aug. 11, 2004; 70
FR 15239, Mar. 25, 2005; 71 FR 55340, Sept. 22, 2006]
Sec. 483.480 Condition of participation: Dietetic services.
(a) Standard: Food and nutrition services. (1) Each client must
receive a nourishing, well-balanced diet including modified and
specially-prescribed diets.
(2) A qualified dietitian must be employed either full-time, part-
time, or on a consultant basis at the facility's discretion.
(3) If a qualified dietitian is not employed full-time, the facility
must designate a person to serve as the director of food services.
(4) The client's interdisciplinary team, including a qualified
dietitian and physician, must prescribe all modified and special diets
including those used as a part of a program to manage inappropriate
client behavior.
(5) Foods proposed for use as a primary reinforcement of adaptive
behavior are evaluated in light of the client's nutritional status and
needs.
(6) Unless otherwise specified by medical needs, the diet must be
prepared at least in accordance with the latest edition of the
recommended dietary allowances of the Food and Nutrition Board of the
National Research Council, National Academy of Sciences, adjusted for
age, sex, disability and activity.
(b) Standard: Meal services. (1) Each client must receive at least
three meals daily, at regular times comparable to normal mealtimes in
the community with--
(i) Not more than 14 hours between a substantial evening meal and
breakfast of the following day, except on weekends and holidays when a
nourishing snack is provided at bedtime, 16 hours may elapse between a
substantial evening meal and breakfast; and
(ii) Not less than 10 hours between breakfast and the evening meal
of the same day, except as provided under paragraph (b)(1)(i) of this
section.
(2) Food must be served--
(i) In appropriate quantity;
(ii) At appropriate temperature;
(iii) In a form consistent with the developmental level of the
client; and
(iv) With appropriate utensils.
(3) Food served to clients individually and uneaten must be
discarded.
(c) Standard: Menus. (1) Menus must--
(i) Be prepared in advance;
(ii) Provide a variety of foods at each meal;
(iii) Be different for the same days of each week and adjusted for
seasonal changes; and
(iv) Include the average portion sizes for menu items.
(2) Menus for food actually served must be kept on file for 30 days.
(d) Standard: Dining areas and service. The facility must--
(1) Serve meals for all clients, including persons with ambulation
deficits, in dining areas, unless otherwise specified by the
interdisciplinary team or a physician;
(2) Provide table service for all clients who can and will eat at a
table, including clients in wheelchairs;
[[Page 111]]
(3) Equip areas with tables, chairs, eating utensils, and dishes
designed to meet the developmental needs of each client;
(4) Supervise and staff dining rooms adequately to direct self-help
dining procedure, to assure that each client receives enough food and to
assure that each client eats in a manner consistent with his or her
developmental level: and
(5) Ensure that each client eats in an upright position, unless
otherwise specified by the interdisciplinary team or a physician.
PART 484_HOME HEALTH SERVICES--Table of Contents
Subpart A_General Provisions
Sec.
484.1 Basis and scope.
484.2 Definitions.
484.4 Personnel qualifications.
Subpart B_Administration
484.10 Condition of participation: Patient rights.
484.11 Condition of participation: Release of patient identifiable OASIS
information.
484.12 Condition of participation: Compliance with Federal, State, and
local laws, disclosure and ownership information, and accepted
professional standards and principles.
484.14 Condition of participation: Organization, services, and
administration.
484.16 Condition of participation: Group of professional personnel.
484.18 Condition of participation: Acceptance of patients, plan of care,
and medical supervision.
484.20 Condition of participation: Reporting OASIS information.
Subpart C_Furnishing of Services
484.30 Condition of participation: Skilled nursing services.
484.32 Condition of participation: Therapy services.
484.34 Condition of participation: Medical social services.
484.36 Condition of participation: Home health aide services.
484.38 Condition of participation: Qualifying to furnish outpatient
physical therapy or speech pathology services.
484.48 Condition of participation: Clinical records.
484.52 Condition of participation: Evaluation of the agency's program.
484.55 Condition of participation: Comprehensive assessment of patients.
Subpart D [Reserved]
Subpart E_Prospective Payment System for Home Health Agencies
484.200 Basis and scope.
484.202 Definitions.
484.205 Basis of payment.
484.210 Data used for the calculation of the national prospective 60-day
episode payment.
484.215 Initial establishment of the calculation of the national 60-day
episode payment.
484.220 Calculation of the national adjusted prospective 60-day episode
payment rate for case-mix and area wage levels.
484.225 Annual update of the national adjusted prospective 60-day
episode payment rate.
484.230 Methodology used for the calculation of the low-utilization
payment adjustment.
484.235 Methodology used for the calculation of the partial episode
payment adjustment.
484.240 Methodology used for the calculation of the outlier payment.
484.245 Accelerated payments for home health agencies.
484.250 Patient assessment data.
484.260 Limitation on review.
484.265 Additional payment.
Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C.
1302 and 1395(hh)) unless otherwise indicated.
Source: 54 FR 33367, Aug. 14, 1989, unless otherwise noted.
Subpart A_General Provisions
Sec. 484.1 Basis and scope.
(a) Basis and scope. This part is based on the indicated provisions
of the following sections of the Act:
(1) Sections 1861(o) and 1891 establish the conditions that an HHA
must meet in order to participate in Medicare.
(2) Section 1861(z) specifies the Institutional planning standards
that HHAs must meet.
(3) Section 1895 provides for the establishment of a prospective
payment system for home health services covered under Medicare.
[[Page 112]]
(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
(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
[[Page 113]]
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.
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.
[[Page 114]]
(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 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
[[Page 115]]
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 therapist assistant and has achieved a satisfactory grade on a
proficiency examination conducted, approved, or sponsored by the U.S.
Public Health Service.
[[Page 116]]
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 meets either of the
following requirements:
(a) The education and experience requirements for a Certificate of
Clinical Competence in speech-language pathology granted by the American
Speech-Language-Hearing Association.
(b) The educational requirements for certification and is in the
process of accumulating the supervised experience required for
certification.
[54 FR 33367, August 14, 1989, as amended at 56 FR 32973, July 18, 1991;
69 FR 66426, Nov. 15, 2004; 72 FR 66406, Nov. 27, 2007; 73 FR 2433, Jan.
15, 2008]
Subpart B_Administration
Sec. 484.10 Condition of participation: Patient rights.
The patient has the right to be informed of his or her rights. The
HHA must protect and promote the exercise of these rights.
(a) Standard: Notice of rights. (1) The HHA must provide the patient
with a written notice of the patient's rights in advance of furnishing
care to the patient or during the initial evaluation visit before the
initiation of treatment.
(2) The HHA must maintain documentation showing that it has complied
with the requirements of this section.
(b) Standard: Exercise of rights and respect for property and
person. (1) The patient has the right to exercise his or her rights as a
patient of the HHA.
(2) The patient's family or guardian may exercise the patient's
rights when the patient has been judged incompetent.
(3) The patient has the right to have his or her property treated
with respect.
(4) The patient has the right to voice grievances regarding
treatment or care that is (or fails to be) furnished, or regarding the
lack of respect for property by anyone who is furnishing services on
behalf of the HHA and must not be subjected to discrimination or
reprisal for doing so.
(5) The HHA must investigate complaints made by a patient or the
patient's family or guardian regarding treatment or care that is (or
fails to be) furnished, or regarding the lack of respect for the
patient's property by anyone furnishing services on behalf of the HHA,
and must document both the existence of the complaint and the resolution
of the complaint.
(c) Standard: Right to be informed and to participate in planning
care and treatment. (1) The patient has the right to be informed, in
advance about the care
[[Page 117]]
to be furnished, and of any changes in the care to be furnished.
(i) The HHA must advise the patient in advance of the disciplines
that will furnish care, and the frequency of visits proposed to be
furnished.
(ii) The HHA must advise the patient in advance of any change in the
plan of care before the change is made.
(2) The patient has the right to participate in the planning of the
care.
(i) The HHA must advise the patient in advance of the right to
participate in planning the care or treatment and in planning changes in
the care or treatment.
(ii) The HHA complies with the requirements of subpart I of part 489
of this chapter relating to maintaining written policies and procedures
regarding advance directives. The HHA must inform and distribute written
information to the patient, in advance, concerning its policies on
advance directives, including a description of applicable State law. The
HHA may furnish advance directives information to a patient at the time
of the first home visit, as long as the information is furnished before
care is provided.
(d) Standard: Confidentiality of medical records. The patient has
the right to confidentiality of the clinical records maintained by the
HHA. The HHA must advise the patient of the agency's policies and
procedures regarding disclosure of clinical records.
(e) Standard: Patient liability for payment. (1) The patient has the
right to be advised, before care is initiated, of the extent to which
payment for the HHA services may be expected from Medicare or other
sources, and the extent to which payment may be required from the
patient. Before the care is initiated, the HHA must inform the patient,
orally and in writing, of--
(i) The extent to which payment may be expected from Medicare,
Medicaid, or any other Federally funded or aided program known to the
HHA;
(ii) The charges for services that will not be covered by Medicare;
and
(iii) The charges that the individual may have to pay.
(2) The patient has the right to be advised orally and in writing of
any changes in the information provided in accordance with paragraph
(e)(1) of this section when they occur. The HHA must advise the patient
of these changes orally and in writing as soon as possible, but no later
than 30 calendar days from the date that the HHA becomes aware of a
change.
(f) Standard: Home health hotline. The patient has the right to be
advised of the availability of the toll-free HHA hotline in the State.
When the agency accepts the patient for treatment or care, the HHA must
advise the patient in writing of the telephone number of the home health
hotline established by the State, the hours of its operation, and that
the purpose of the hotline is to receive complaints or questions about
local HHAs. The patient also has the right to use this hotline to lodge
complaints concerning the implementation of the advance directives
requirements.
[54 FR 33367, August 14, 1989, as amended at 56 FR 32973, July 18, 1991;
57 FR 8203, Mar. 6, 1992; 60 FR 33293, June 27, 1995]
Sec. 484.11 Condition of participation: Release of patient identifiable OASIS
information.
The HHA and agent acting on behalf of the HHA in accordance with a
written contract must ensure the confidentiality of all patient
identifiable information contained in the clinical record, including
OASIS data, and may not release patient identifiable OASIS information
to the public.
[64 FR 3763, Jan. 25, 1999]
Sec. 484.12 Condition of participation: Compliance with Federal, State, and
local laws, disclosure and ownership information, and accepted professional
standards and principles.
(a) Standard: Compliance with Federal, State, and local laws and
regulations. The HHA and its staff must operate and furnish services in
compliance with all applicable Federal, State, and local laws and
regulations. If State or applicable local law provides for the licensure
of HHAs, an agency not subject to licensure is approved by the licensing
authority as meeting the standards established for licensure.
(b) Standard: Disclosure of ownership and management information.
The HHA must comply with the requirements of
[[Page 118]]
Part 420, Subpart C of this chapter. The HHA also must disclose the
following information to the State survey agency at the time of the
HHA's initial request for certification, for each survey, and at the
time of any change in ownership or management:
(1) The name and address of all persons with an ownership or control
interest in the HHA as defined in Sec. Sec. 420.201, 420.202, and
420.206 of this chapter.
(2) The name and address of each person who is an officer, a
director, an agent or a managing employee of the HHA as defined in
Sec. Sec. 420.201, 420.202, and 420.206 of this chapter.
(3) The name and address of the corporation, association, or other
company that is responsible for the management of the HHA, and the name
and address of the chief executive officer and the chairman of the board
of directors of that corporation, association, or other company
responsible for the management of the HHA.
(c) Standard: Compliance with accepted professional standards and
principles. The HHA and its staff must comply with accepted professional
standards and principles that apply to professionals furnishing services
in an HHA.
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
[[Page 119]]
by the HHA, there is a written contract between those personnel and the
agency that specifies the following:
(1) Patients are accepted for care only by the primary HHA.
(2) The services to be furnished.
(3) The necessity to conform to all applicable agency policies,
including personnel qualifications.
(4) The responsibility for participating in developing plans of
care.
(5) The manner in which services will be controlled, coordinated,
and evaluated by the primary HHA.
(6) The procedures for submitting clinical and progress notes,
scheduling of visits, periodic patient evaluation.
(7) The procedures for payment for services furnished under the
contract.
(g) Standard: Coordination of patient services. All personnel
furnishing services maintain liaison to ensure that their efforts are
coordinated effectively and support the objectives outlined in the plan
of care. The clinical record or minutes of case conferences establish
that effective interchange, reporting, and coordination of patient care
does occur. A written summary report for each patient is sent to the
attending physician at least every 60 days.
(h) Standard: Services under arrangements. Services furnished under
arrangements are subject to a written contract conforming with the
requirements specified in paragraph (f) of this section and with the
requirements of section 1861(w) of the Act (42 U.S.C. 1495x(w)).
(i) Standard: Institutional planning. The HHA, under the direction
of the governing body, prepares an overall plan and a budget that
includes an annual operating budget and capital expenditure plan.
(1) Annual operating budget. There is an annual operating budget
that includes all anticipated income and expenses related to items that
would, under generally accepted accounting principles, be considered
income and expense items. However, it is not required that there be
prepared, in connection with any budget, an item by item identification
of the components of each type of anticipated income or expense.
(2) Capital expenditure plan. (i) There is a capital expenditure
plan for at least a 3-year period, including the operating budget year.
The plan includes and identifies in detail the anticipated sources of
financing for, and the objectives of, each anticipated expenditure of
more than $600,000 for items that would under generally accepted
accounting principles, be considered capital items. In determining if a
single capital expenditure exceeds $600,000, the cost of studies,
surveys, designs, plans, working drawings, specifications, and other
activities essential to the acquisition, improvement, modernization,
expansion, or replacement of land, plant, building, and equipment are
included. Expenditures directly or indirectly related to capital
expenditures, such as grading, paving, broker commissions, taxes
assessed during the construction period, and costs involved in
demolishing or razing structures on land are also included. Transactions
that are separated in time, but are components of an overall plan or
patient care objective, are viewed in their entirety without regard to
their timing. Other costs related to capital expenditures include title
fees, permit and license fees, broker commissions, architect, legal,
accounting, and appraisal fees; interest, finance, or carrying charges
on bonds, notes and other costs incurred for borrowing funds.
(ii) If the anticipated source of financing is, in any part, the
anticipated payment from title V (Maternal and Child Health and Crippled
Children's Services) or title XVIII (Medicare) or title XIX (Medicaid)
of the Social Security Act, the plan specifies the following:
(A) Whether the proposed capital expenditure is required to comform,
or is likely to be required to conform, to current standards, criteria,
or plans developed in accordance with the Public Health Service Act or
the Mental Retardation Facilities and Community Mental Health Centers
Construction Act of 1963.
(B) Whether a capital expenditure proposal has been submitted to the
designated planning agency for approval in accordance with section 1122
of the Act (42 U.S.C. 1320a-1) and implementing regulations.
[[Page 120]]
(C) Whether the designated planning agency has approved or
disapproved the proposed capital expenditure if it was presented to that
agency.
(3) Preparation of plan and budget. The overall plan and budget is
prepared under the direction of the governing body of the HHA by a
committee consisting of representatives of the governing body, the
administrative staff, and the medical staff (if any) of the HHA.
(4) Annual review of plan and budget. The overall plan and budget is
reviewed and updated at least annually by the committee referred to in
paragraph (i)(3) of this section under the direction of the governing
body of the HHA.
(j) Standard: Laboratory services. (1) If the HHA engages in
laboratory testing outside of the context of assisting an individual in
self-administering a test with an appliance that has been cleared for
that purpose by the FDA, such testing must be in compliance with all
applicable requirements of part 493 of this chapter.
(2) If the HHA chooses to refer specimens for laboratory testing to
another laboratory, the referral laboratory must be certified in the
appropriate specialties and subspecialties of services in accordance
with the applicable requirements of part 493 of this chapter.
[54 FR 33367, August 14, 1989, as amended at 56 FR 32973, July 18, 1991;
56 FR 51334, Oct. 11, 1991; 57 FR 7136, Feb. 28, 1992; 66 FR 32778, June
18, 2001]
Sec. 484.16 Condition of participation: Group of professional personnel.
A group of professional personnel, which includes at least one
physician and one registered nurse (preferably a public health nurse),
and with appropriate representation from other professional disciplines,
establishes and annually reviews the agency's policies governing scope
of services offered, admission and discharge policies, medical
supervision and plans of care, emergency care, clinical records,
personnel qualifications, and program evaluation. At least one member of
the group is neither an owner nor an employee of the agency.
(a) Standard: Advisory and evaluation function. The group of
professional personnel meets frequently to advise the agency on
professional issues, to participate in the evaluation of the agency's
program, and to assist the agency in maintaining liaison with other
health care providers in the community and in the agency's community
information program. The meetings are documented by dated minutes.
[54 FR 33367, August 14, 1989, as amended at 56 FR 32974, July 18, 1991]
Sec. 484.18 Condition of participation: Acceptance of patients, plan of care,
and medical supervision.
Patients are accepted for treatment on the basis of a reasonable
expectation that the patient's medical, nursing, and social needs can be
met adequately by the agency in the patient's place of residence. Care
follows a written plan of care established and periodically reviewed by
a doctor of medicine, osteopathy, or podiatric medicine.
(a) Standard: Plan of care. The plan of care developed in
consultation with the agency staff covers all pertinent diagnoses,
including mental status, types of services and equipment required,
frequency of visits, prognosis, rehabilitation potential, functional
limitations, activities permitted, nutritional requirements, medications
and treatments, any safety measures to protect against injury,
instructions for timely discharge or referral, and any other appropriate
items. If a physician refers a patient under a plan of care that cannot
be completed until after an evaluation visit, the physician is consulted
to approve additions or modifications to the original plan. Orders for
therapy services include the specific procedures and modalities to be
used and the amount, frequency, and duration. The therapist and other
agency personnel participate in developing the plan of care.
(b) Standard: Periodic review of plan of care. The total plan of
care is reviewed by the attending physician and HHA personnel as often
as the severity of the patient's condition requires, but at least once
every 60 days or more frequently when there is a beneficiary elected
transfer; a significant change in condition resulting in a change in
[[Page 121]]
the case-mix assignment; or a discharge and return to the same HHA
during the 60-day episode. Agency professional staff promptly alert the
physician to any changes that suggest a need to alter the plan of care.
(c) Standard: Conformance with physician orders. Drugs and
treatments are administered by agency staff only as ordered by the
physician with the exception of influenza and pneumococcal
polysaccharide vaccines, which may be administered per agency policy
developed in consultation with a physician, and after an assessment for
contraindications. Verbal orders are put in writing and signed and dated
with the date of receipt by the registered nurse or qualified therapist
(as defined in Sec. 484.4 of this chapter) responsible for furnishing
or supervising the ordered services. Verbal orders are only accepted by
personnel authorized to do so by applicable State and Federal laws and
regulations as well as by the HHA's internal policies.
[54 FR 33367, August 14, 1989, as amended at 56 FR 32974, July 18, 1991;
64 FR 3784, Jan. 25, 1999; 65 FR 41211, July 3, 2000; 67 FR 61814, Oct.
2, 2002]
Sec. 484.20 Condition of participation: Reporting OASIS information.
HHAs must electronically report all OASIS data collected in
accordance with Sec. 484.55.
(a) Standard: Encoding and transmitting OASIS data. An HHA must
encode and electronically transmit each completed OASIS assessment to
the State agency or the CMS OASIS contractor, regarding each beneficiary
with respect to which such information is required to be transmitted (as
determined by the Secretary), within 30 days of completing the
assessment of the beneficiary.
(b) Standard: Accuracy of encoded OASIS data. The encoded OASIS data
must accurately reflect the patient's status at the time of assessment.
(c) Standard: Transmittal of OASIS data. An HHA must--
(1) For all completed assessments, transmit OASIS data in a format
that meets the requirements of paragraph (d) of this section.
(2) Successfully transmit test data to the State agency or CMS OASIS
contractor.
(3) Transmit data using electronics communications software that
provides a direct telephone connection from the HHA to the State agency
or CMS OASIS contractor.
(4) Transmit data that includes the CMS-assigned branch
identification number, as applicable.
(d) Standard: Data Format. The HHA must encode and transmit data
using the software available from CMS or software that conforms to CMS
standard electronic record layout, edit specifications, and data
dictionary, and that includes the required OASIS data set.
[64 FR 3763, Jan. 25, 1999, as amended at 70 FR 76208, Dec. 23, 2005]
Subpart C_Furnishing of Services
Sec. 484.30 Condition of participation: Skilled nursing services.
The HHA furnishes skilled nursing services by or under the
supervision of a registered nurse and in accordance with the plan of
care.
(a) Standard: Duties of the registered nurse. The registered nurse
makes the initial evaluation visit, regularly reevaluates the patient's
nursing needs, initiates the plan of care and necessary revisions,
furnishes those services requiring substantial and specialized nursing
skill, initiates appropriate preventive and rehabilitative nursing
procedures, prepares clinical and progress notes, coordinates services,
informs the physician and other personnel of changes in the patient's
condition and needs, counsels the patient and family in meeting nursing
and related needs, participates in in-service programs, and supervises
and teaches other nursing personnel.
(b) Standard: Duties of the licensed practical nurse. The licensed
practical nurse furnishes services in accordance with agency policies,
prepares clinical and progress notes, assists the physician and
registered nurse in performing specialized procedures, prepares
equipment and materials for treatments observing aseptic technique as
required,
[[Page 122]]
and assists the patient in learning appropriate self-care techniques.
[54 FR 33367, August 14, 1989, as amended at 56 FR 32974, July 18, 1991]
Sec. 484.32 Condition of participation: Therapy services.
Any therapy services offered by the HHA directly or under
arrangement are given by a qualified therapist or by a qualified therapy
assistant under the supervision of a qualified therapist and in
accordance with the plan of care. The qualified therapist assists the
physician in evaluating level of function, helps develop the plan of
care (revising it as necessary), prepares clinical and progress notes,
advises and consults with the family and other agency personnel, and
participates in in-service programs.
(a) Standard: Supervision of physical therapy assistant and
occupational therapy assistant. Services furnished by a qualified
physical therapy assistant or qualified occupational therapy assistant
may be furnished under the supervision of a qualified physical or
occupational therapist. A physical therapy assistant or occupational
therapy assistant performs services planned, delegated, and supervised
by the therapist, assists in preparing clinical notes and progress
reports, and participates in educating the patient and family, and in
in-service programs.
(b) Standard: Supervision of speech therapy services. Speech therapy
services are furnished only by or under supervision of a qualified
speech pathologist or audiologist.
[54 FR 33367, August 14, 1989, as amended at 56 FR 32974, July 18, 1991]
Sec. 484.34 Condition of participation: Medical social services.
If the agency furnishes medical social services, those services are
given by a qualified social worker or by a qualified social work
assistant under the supervision of a qualified social worker, and in
accordance with the plan of care. The social worker assists the
physician and other team members in understanding the significant social
and emotional factors related to the health problems, participates in
the development of the plan of care, prepares clinical and progress
notes, works with the family, uses appropriate community resources,
participates in discharge planning and in-service programs, and acts as
a consultant to other agency personnel.
Sec. 484.36 Condition of participation: Home health aide services.
Home health aides are selected on the basis of such factors as a
sympathetic attitude toward the care of the sick, ability to read,
write, and carry out directions, and maturity and ability to deal
effectively with the demands of the job. They are closely supervised to
ensure their competence in providing care. For home health services
furnished (either directly or through arrangements with other
organizations) after August 14, 1990, the HHA must use individuals who
meet the personnel qualifications specified in Sec. 484.4 for ``home
health aide''.
(a) Standard: Home health aide training--(1) Content and duration of
training. The aide training program must address each of the following
subject areas through classroom and supervised practical training
totalling at least 75 hours, with at least 16 hours devoted to
supervised practical training. The individual being trained must
complete at least 16 hours of classroom training before beginning the
supervisied practical training.
(i) Communications skills.
(ii) Observation, reporting and documentation of patient status and
the care or service furnished.
(iii) Reading and recording temperature, pulse, and respiration.
(iv) Basic infection control procedures.
(v) Basic elements of body functioning and changes in body function
that must be reported to an aide's supervisor.
(vi) Maintenance of a clean, safe, and healthy environment.
(vii) Recognizing emergencies and knowledge of emergency procedures.
(viii) The physical, emotional, and developmental needs of and ways
to work with the populations served by the HHA, including the need for
respect for the patient, his or her privacy and his or her property.
[[Page 123]]
(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 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.
[[Page 124]]
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.
(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
[[Page 125]]
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, August 14, 1989, as amended at 56 FR 32974, July 18, 1991;
56 FR 51334, Oct. 11, 1991; 59 FR 65498, Dec. 20, 1994; 60 FR 39123,
Aug. 1, 1995; 66 FR 32778, June 18, 2001]
Sec. 484.38 Condition of participation: Qualifying to furnish outpatient
physical therapy or speech pathology services.
An HHA that wishes to furnish outpatient physical therapy or speech
pathology services must meet all the pertinent conditions of this part
and also meet the additional health and safety requirements set forth in
Sec. Sec. 485.711, 485.713, 485.715, 485.719, 485.723, and 485.727 of
this chapter to implement section 1861(p) of the Act.
[54 FR 33367, Aug. 14, 1989, as amended at 60 FR 2329, Jan. 9, 1995; 60
FR 11632, Mar. 2, 1995]
Sec. 484.48 Condition of participation: Clinical records.
A clinical record containing pertinent past and current findings in
accordance with accepted professional standards is maintained for every
patient receiving home health services. In addition to the plan of care,
the record contains appropriate identifying information; name of
physician; drug, dietary, treatment, and activity orders; signed and
dated clinical and progress notes; copies of summary reports sent to the
attending physician; and a discharge summary. The HHA must inform the
attending physician of the availability of a discharge summary. The
discharge summary must be sent to the attending physician upon request
and must include the patient's medical and health status at discharge.
(a) Standards: Retention of records. Clinical records are retained
for 5 years after the month the cost report to which the records apply
is filed with the intermediary, unless State law stipulates a longer
period of time. Policies provide for retention even if the HHA
discontinues operations. If a patient is transferred to another health
facility, a copy of the record or abstract is sent with the patient.
(b) Standards: Protection of records. Clinical record information is
safe-guarded against loss or unauthorized use. Written procedures govern
use and removal of records and the conditions for release of
information. Patient's written consent is required for release of
information not authorized by law.
[54 FR 33367, Aug. 14, 1989, as amended at 60 FR 65498, Dec. 20, 1994]
Sec. 484.52 Condition of participation: Evaluation of the agency's program.
The HHA has written policies requiring an overall evaluation of the
agency's total program at least once a year by the group of professional
personnel (or a committee of this group), HHA staff, and consumers, or
by professional people outside the agency working in conjunction with
consumers. The evaluation consists of an overall policy and
administrative review and a clinical record review. The evaluation
assesses
[[Page 126]]
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 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
[[Page 127]]
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 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]
Subpart D [Reserved]
Subpart E_Prospective Payment System for Home Health Agencies
Source: 65 FR 41212, July 3, 2000, unless otherwise noted.
Sec. 484.200 Basis and scope.
(a) Basis. This subpart implements section 1895 of the Act, which
provides for the implementation of a prospective payment system (PPS)
for HHAs for portions of cost reporting periods occurring on or after
October 1, 2000.
(b) Scope. This subpart sets forth the framework for the HHA PPS,
including the methodology used for the development of the payment rates,
associated adjustments, and related rules.
Sec. 484.202 Definitions.
As used in this subpart--
Case-mix index means a scale that measures the relative difference
in resource intensity among different groups in the clinical model.
Discipline means one of the six home health disciplines covered
under the Medicare home health benefit (skilled nursing services, home
health aide services, physical therapy services, occupational therapy
services, speech- language pathology services, and medical social
services).
Home health market basket index means an index that reflects changes
over time in the prices of an appropriate mix of goods and services
included in home health services.
Rural area means, with respect to home health episodes ending on or
after January 1, 2006, an area defined in Sec. 412.64(b)(1)(ii)(C) of
this chapter.
Urban area means, with respect to home health episodes ending on or
after January 1, 2006, an area defined in Sec. 412.64(b)(1)(ii)(A) and
(B) of this chapter.
[70 FR 68142, Nov. 9, 2005]
Sec. 484.205 Basis of payment.
(a) Method of payment. An HHA receives a national prospective 60-day
episode payment of a predetermined rate for a home health service
previously paid on a reasonable cost basis (except the osteoporosis drug
defined in section 1861(kk) of the Act) as of August 5, 1997. The
national 60-day episode payment is determined in accordance with Sec.
484.215. The national prospective 60-day episode payment is subject to
the following adjustments and additional payments:
(1) A low-utilization payment adjustment (LUPA) of a predetermined
per-visit rate as specified in Sec. 484.230.
(2) A partial episode payment (PEP) adjustment due to an intervening
event
[[Page 128]]
defined as a beneficiary elected transfer or a discharge and return to
the same HHA during the 60-day episode, that warrants a new 60-day
episode payment during an existing 60-day episode, that initiates the
start of a new 60-day episode payment and a new physician certification
of the new plan of care. The PEP adjustment is determined in accordance
with Sec. 484.235.
(3) An outlier payment is determined in accordance with Sec.
484.240.
(b) Episode payment. The national prospective 60-day episode payment
represents payment in full for all costs associated with furnishing home
health services previously paid on a reasonable cost basis (except the
osteoporosis drug listed in section 1861(m) of the Act as defined in
section 1861(kk) of the Act) as of August 5, 1997 unless the national
60-day episode payment is subject to a low-utilization payment
adjustment set forth in Sec. 484.230, a partial episode payment
adjustment set forth at Sec. 484.235, or an additional outlier payment
set forth in Sec. 484.240. All payments under this system may be
subject to a medical review adjustment reflecting beneficiary
eligibility, medical necessity determinations, and HHRG assignment. DME
provided as a home health service as defined in section 1861(m) of the
Act continues to be paid the fee schedule amount.
(1) Split percentage payment for initial episodes. The initial
percentage payment for initial episodes is paid to an HHA at 60 percent
of the case-mix and wage adjusted 60-day episode rate. The residual
final payment for initial episodes is paid at 40 percent of the case-mix
and wage adjusted 60-day episode rate. Split percentage payments are
made in accordance with requirements at Sec. 409.43(c) of this chapter.
(2) Split percentage payment for subsequent episodes. The initial
percentage payment for subsequent episodes is paid to an HHA at 50
percent of the case-mix and wage adjusted 60-day episode rate. The
residual final payment for subsequent episodes is paid at 50 percent of
the case-mix and wage adjusted 60-day episode rate. Split percentage
payments are made in accordance with requirements at Sec. 409.43(c) of
this chapter.
(c) Low-utilization payment. An HHA receives a national 60-day
episode payment of a predetermined rate for home health services
previously paid on a reasonable cost basis as of August 5, 1997, unless
CMS determines at the end of the 60-day episode that the HHA furnished
minimal services to a patient during the 60-day episode. A low-
utilization payment adjustment is determined in accordance with Sec.
484.230.
(d) Partial episode payment adjustment. An HHA receives a national
60-day episode payment of a predetermined rate for home health services
previously paid on a reasonable cost basis as of August 5, 1997, unless
CMS determines an intervening event, defined as a beneficiary elected
transfer, or discharge and return to the same HHA during a 60-day
episode, warrants a new 60-day episode payment. The PEP adjustment would
not apply in situations of transfers among HHAs of common ownership as
defined in Sec. 424.22 of this chapter. Those situations would be
considered services provided under arrangement on behalf of the
originating HHA by the receiving HHA with the common ownership interest
for the balance of the 60-day episode. The common ownership exception to
the transfer PEP adjustment does not apply if the beneficiary moves to a
different MSA or Non-MSA during the 60-day episode before the transfer
to the receiving HHA. The transferring HHA in situations of common
ownership not only serves as a billing agent, but must also exercise
professional responsibility over the arranged-for services in order for
services provided under arrangements to be paid. The discharge and
return to the same HHA during the 60-day episode is only recognized in
those circumstances when a beneficiary reached the goals in the original
plan of care. The original plan of care must have been terminated with
no anticipated need for additional home health services for the balance
of the 60-day episode. If the intervening event warrants a new 60-day
episode payment and the new physician certification of a new plan of
care, the initial HHA receives a partial episode payment adjustment
reflecting the length of time the patient remained under its
[[Page 129]]
care. A partial episode payment adjustment is determined in accordance
with Sec. 484.235.
(e) Outlier payment. An HHA receives a national 60-day episode
payment of a predetermined rate for a home health service paid on a
reasonable cost basis as of August 5, 1997, unless the imputed cost of
the 60-day episode exceeds a threshold amount. The outlier payment is
defined to be a proportion of the imputed costs beyond the threshold. An
outlier payment is a payment in addition to the national 60-day episode
payment. The total of all outlier payments is limited to 5 percent of
total outlays under the HHA PPS. An outlier payment is determined in
accordance with Sec. 484.240.
[65 FR 41212, July 3, 2000, as amended at 72 FR 49878]
Sec. 484.210 Data used for the calculation of the national prospective 60-day
episode payment.
To calculate the national prospective 60-day episode payment, CMS
uses the following:
(a) Medicare cost data on the most recent audited cost report data
available.
(b) Utilization data based on Medicare claims.
(c) An appropriate wage index to adjust for area wage differences.
(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 Sec. Sec. 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 130]]
Sec. 484.220 Calculation of the adjusted national prospective 60-day episode
payment rate for case-mix and area wage levels.
CMS adjusts the national prospective 60-day episode payment rate to
account for the following:
(a) HHA case-mix using a case-mix index to explain the relative
resource utilization of different patients. To address changes to the
case-mix that are a result of changes in the coding or classification of
different units of service that do not reflect real changes in case-mix,
the national prospective 60-day episode payment rate will be adjusted
downward as follows:
(1) For CY 2008, the adjustment is 2.75 percent.
(2) For CY 2009 and CY 2010, the adjustment is 2.75 percent in each
year.
(3) For CY 2011, the adjustment is 2.71 percent.
(b) Geographic differences in wage levels using an appropriate wage
index based on the site of service of the beneficiary.
[72 FR 49879, Aug. 29, 2007]
Sec. 484.225 Annual update of the unadjusted national prospective 60-day
episode payment rate.
(a) CMS updates the unadjusted national 60-day episode payment rate
on a fiscal year basis.
(b) For fiscal year 2001, the unadjusted national 60-day episode
payment rate is adjusted using the latest available home health market
basket index factors.
(c) For fiscal years 2002 and 2003, the unadjusted national
prospective 60-day episode payment rate is updated by a factor equal to
the applicable home health market basket minus 1.1 percentage points.
(d) For the last calendar quarter of 2003 and the first calendar
quarter of 2004, the unadjusted national prospective 60-day episode
payment rate is equal to the rate from the previous fiscal year (FY
2003) increased by the applicable home health market basket index
amount.
(e) For the last the 3 calendar quarters of 2004, the unadjusted
national prospective 60-day episode payment rate is equal to the rate
from the previous fiscal year (FY 2003) increased by the applicable home
health market basket minus 0.8 percentage points.
(f) For calendar year 2005, the unadjusted national prospective 60-
day episode payment rate is equal to the rate from the previous calendar
year, increased by the applicable home health market basket minus 0.8
percentage points.
(g) For calendar year 2006, the unadjusted national prospective 60-
day episode payment rate is equal to the rate from calendar year 2005.
(h) For 2007 and subsequent calendar years, in the case of a home
health agency that submits home health quality data, as specified by the
Secretary, the unadjusted national prospective 60-day episode rate is
equal to the rate for the previous calendar year increased by the
applicable home health market basket index amount.
(i) For 2007 and subsequent calendar years, in the case of a home
health agency that does not submit home health quality data, as
specified by the Secretary, the unadjusted national prospective 60-day
episode rate is equal to the rate for the previous calendar year
increased by the applicable home health market basket index amount minus
2 percentage points. Any reduction of the percentage change will apply
only to the calendar year involved and will not be taken into account in
computing the prospective payment amount for a subsequent calendar year.
[65 FR 41212, July 3, 2000, as amended at 69 FR 62138, Oct. 22, 2004; 71
FR 65935, Nov. 9, 2006]
Sec. 484.230 Methodology used for the calculation of the low-utilization
payment adjustment.
An episode with four or fewer visits is paid the national per-visit
amount by discipline updated annually by the applicable market basket
for each visit type. The national per-visit amount is determined by
using cost data set forth in Sec. 484.210(a) and adjusting by the
appropriate wage index based on the site of service for the beneficiary.
For 2008 and subsequent calendar years, an amount will be added to low-
utilization payment adjustments for low-utilization episodes that occur
as the beneficiary's only episode or initial episode
[[Page 131]]
in a sequence of adjacent episodes. For purposes of the home health PPS,
a sequence of adjacent episodes for a beneficiary is a series of claims
with no more than 60 days without home care between the end of one
episode, which is the 60th day (except for episodes that have been PEP-
adjusted), and the beginning of the next episode. This additional amount
will be updated annually after 2008 by a factor equal to the applicable
home health market basket percentage.
[65 FR 41212, July 3, 2000, as amended at 72 FR 69879, Aug. 29, 2007]
Sec. 484.235 Methodology used for the calculation of the partial episode
payment adjustment.
(a) CMS makes a PEP adjustment to the original 60-day episode
payment that is interrupted by an intervening event described in Sec.
484.205(d).
(b) The original 60-day episode payment is adjusted to reflect the
length of time the beneficiary remained under the care of the original
HHA based on the first billable visit date through and including the
last billable visit date.
(c) The partial episode payment is calculated by determining the
actual days served by the original HHA as a proportion of 60 multiplied
by the initial 60-day episode payment.
Sec. 484.240 Methodology used for the calculation of the outlier payment.
(a) CMS makes an outlier payment for an episode whose estimated cost
exceeds a threshold amount for each case-mix group.
(b) The outlier threshold for each case-mix group is the episode
payment amount for that group, the PEP adjustment amount for the episode
plus a fixed dollar loss amount that is the same for all case-mix
groups.
(c) The outlier payment is a proportion of the amount of estimated
cost beyond the threshold.
(d) CMS imputes the cost for each episode by multiplying the
national per-visit amount of each discipline by the number of visits in
the discipline and computing the total imputed cost for all disciplines.
(e) The fixed dollar loss amount and the loss sharing proportion are
chosen so that the estimated total outlier payment is no more than 5
percent of total payment under home health PPS.
[65 FR 41212, July 3, 2000, as amended at 72 FR 69879, Aug. 29, 2007]
Sec. 484.245 Accelerated payments for home health agencies.
(a) General rule. Upon request, an accelerated payment may be made
to an HHA that is receiving payment under the home health prospective
payment system if the HHA is experiencing financial difficulties because
there is a delay by the intermediary in making payment to the HHA.
(b) Approval of payment. An HHA's request for an accelerated payment
must be approved by the intermediary and CMS.
(c) Amount of payment. The amount of the accelerated payment is
computed as a percentage of the net payment for unbilled or unpaid
covered services.
(d) Recovery of payment. Recovery of the accelerated payment is made
by recoupment as HHA bills are processed or by direct payment by the
HHA.
Sec. 484.250 Patient assessment data.
An HHA must submit to CMS the OASIS data described at Sec.
484.55(b)(1) and (d)(1) in order for CMS to administer the payment rate
methodologies described in Sec. Sec. 484.215, 484.230, and 484.235.
[74 FR 58134, Nov. 10, 2009]
Sec. 484.260 Limitation on review.
An HHA is not entitled to judicial or administrative review under
sections 1869 or 1878 of the Act, or otherwise, with regard to the
establishment of the payment unit, including the national 60-day
prospective episode payment rate, adjustments and outlier payments. An
HHA is not entitled to the review regarding the establishment of the
transition period, definition and application of the unit of payments,
the computation of initial standard prospective payment amounts, the
establishment of the adjustment for outliers, and the establishment of
case-mix and area wage adjustment factors.
Sec. 484.265 Additional payment.
QIO photocopy and mailing costs. An additional payment is made to a
home
[[Page 132]]
health agency in accordance with Sec. 476.78 of this chapter for the
costs of photocopying and mailing medical records requested by a QIO.
[68 FR 67960, Dec. 5, 2003]
PART 485_CONDITIONS OF PARTICIPATION: SPECIALIZED PROVIDERS--Table of Contents
Subpart A [Reserved]
Subpart B_Conditions of Participation: Comprehensive Outpatient
Rehabilitation Facilities
Sec.
485.50 Basis and scope.
485.51 Definition.
485.54 Condition of participation: Compliance with State and local laws.
485.56 Condition of participation: Governing body and administration.
485.58 Condition of participation: Comprehensive rehabilitation program.
485.60 Condition of participation: Clinical records.
485.62 Condition of participation: Physical environment.
485.64 Condition of participation: Disaster procedures.
485.66 Condition of participation: Utilization review plan.
485.70 Personnel qualifications.
485.74 Appeal rights.
Subparts C-E [Reserved]
Subpart F_Conditions of Participation: Critical Access Hospitals (CAHs)
485.601 Basis and scope.
485.602 Definitions.
485.603 Rural health network.
485.604 Personnel qualifications.
485.606 Designation and certification of CAHs.
485.608 Condition of participation: Compliance with Federal, State, and
local laws and regulations.
485.610 Condition of participation: Status and location.
485.612 Condition of participation: Compliance with hospital
requirements at the time of application.
485.616 Condition of participation: Agreements.
485.618 Condition of participation: Emergency services.
485.620 Condition of participation: Number of beds and length of stay.
485.623 Condition of participation: Physical plant and environment.
485.627 Condition of participation: Organizational structure.
485.631 Condition of participation: Staffing and staff responsibilities.
485.635 Condition of participation: Provision of services.
485.638 Condition of participation: Clinical records.
485.639 Condition of participation: Surgical services.
485.641 Condition of participation: Periodic evaluation and quality
assurance review.
485.643 Condition of participation: Organ, tissue, and eye procurement.
485.645 Special requirements for CAH providers of long-term care
services (``swing-beds'').
485.647 Condition of participation: psychiatric and rehabilitation
distinct part units.
Subpart G [Reserved]
Subpart H_Conditions of Participation for Clinics, Rehabilitation
Agencies, and Public Health Agencies as Providers of Outpatient Physical
Therapy and Speech-Language Pathology Services
485.701 Basis and scope.
485.703 Definitions.
485.705 Personnel qualifications.
485.707 Condition of participation: Compliance with Federal, State, and
local laws.
485.709 Condition of participation: Administrative management.
485.711 Condition of participation: Plan of care and physician
involvement.
485.713 Condition of participation: Physical therapy services.
485.715 Condition of participation: Speech pathology services.
485.717 Condition of participation: Rehabilitation program.
485.719 Condition of participation: Arrangements for physical therapy
and speech pathology services to be performed by other than
salaried organization personnel.
485.721 Condition of participation: Clinical records.
485.723 Condition of participation: Physical environment.
485.725 Condition of participation: Infection control.
485.727 Condition of participation: Disaster preparedness.
485.729 Condition of participation: Program evaluation.
Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C.
1302 and 1395(hh)).
Source: 48 FR 56293, Dec. 15, 1982, unless otherwise noted.
Redesignated at 50 FR 33034, Aug. 16, 1985.
Subpart A [Reserved]
[[Page 133]]
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--
(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
[[Page 134]]
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 any new, revised or amended
Federal regulation or law;
(iv) Must state that only the facility may bill the Medicare
program; and
(v) May not include clauses that state or imply that the contractor
has power and authority to act on behalf of the facility, or clauses
that give the contractor rights, duties, discretions, or
responsibilities that enable it to dictate the administration,
mangement, or operations of the facility.
Sec. 485.58 Condition of participation: Comprehensive rehabilitation program.
The facility must provide a coordinated rehabilitation program that
includes, at a minimum, physicians' services, physical therapy services,
and social or psychological services. These services must be furnished
by personnel that meet the qualifications set forth in Sec. Sec. 485.70
and 484.4 of this chapter and must be consistent with the plan of
treatment and the results of comprehensive patient assessments.
(a) Standard: Physician services. (1) A facility physician must be
present in the facility for a sufficient time to--
(i) Provide, in accordance with accepted principles of medical
practice, medical direction, medical care services, consultation, and
medical supervision of nonphysician staff;
(ii) Establish the plan of treatment in cases where a plan has not
been established by the referring physician;
(iii) Assist in establishing and implementing the facility's patient
care policies; and
[[Page 135]]
(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.
(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
[[Page 136]]
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]
Sec. 485.60 Condition of participation: Clinical records.
The facility must maintain clinical records on all patients in
accordance with accepted professional standards and practice. The
clinical records must be completely, promptly, and accurately
documented, readily accessible, and systematically organized to
facilitate retrieval and compilation of information.
(a) Standard: Content. Each clinical record must contain sufficient
information to identify the patient clearly and to justify the diagnosis
and treatment. Entries in the clinical record must be made as frequently
as is necessary to insure effective treatment and must be signed by
personnel providing services. All entries made by assistant level
personnel must be countersigned by the corresponding professional.
Documentation on each patient must be consolidated into one clinical
record that must contain--
(1) The initial assessment and subsequent reassessments of the
patient's needs;
(2) Current plan of treatment;
(3) Identification data and consent or authorization forms;
(4) Pertinent medical history, past and present;
(5) A report of pertinent physical examinations if any;
(6) Progress notes or other documentation that reflect patient
reaction to treatment, tests, or injury, or the need to change the
established plan of treatment; and
(7) Upon discharge, a discharge summary including patient status
relative to goal achievement, prognosis, and future treatment
considerations.
(b) Standard: Protection of clinical record information. The
facility must safeguard clinical record information against loss,
destruction, or unauthorized use. The facility must have procedures that
govern the use and removal of records and the conditions for release of
information. The facility must obtain the patient's written consent
before releasing information not required to be released by law.
(c) Standard: Retention and preservation. The facility must retain
clinical
[[Page 137]]
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 mannner that prevents the
spread of infection.
(4) Provisions must be in effect to ensure that the facility's
premises are maintained free of rodent and insect infestation.
(c) Standard: Maintenance of equipment, physical location, and
grounds. The facility must establish a written preventive maintenance
program to ensure that--
(1) All equipment is properly maintained and equipment needing
periodic calibration is calibrated consistent with the manufacturer's
recommendations; and
(2) The interior of the facility, the exterior of the physical
structure housing the facility, and the exterior walkways and parking
areas are clean and orderly and maintained free of any defects that are
a hazard to patients, personnel, and the public.
(d) Standard: Access for the physically impaired. The facility must
ensure the following:
(1) Doorways, stairwells, corridors, and passageways used by
patients are--
(i) Of adequate width to allow for easy movement of all patients
(including those on stretchers or in wheelchairs); and
(ii) In the case of stairwells, equipped with firmly attached
handrails on at least one side.
(2) At least one toilet facility is accessible and constructed to
allow utilization by ambulatory and nonambulatory individuals.
(3) At least one entrance is usable by individuals in wheelchairs.
(4) In multi-story buildings, elevators are accessible to and usable
by the physically impaired on the level that they use to enter the
building and all levels normally used by the patients of the facility.
(5) Parking spaces are large enough and close enough to the facility
to
[[Page 138]]
allow safe access by the physically impaired.
Sec. 485.64 Condition of participation: Disaster procedures.
The facility must have written policies and procedures that
specifically define the handling of patients, personnel, records, and
the public during disasters. All personnel associated with the facility
must be knowledgeable with respect to these procedures, be trained in
their application, and be assigned specific responsibilities.
(a) Standard: Disaster plan. The facility's written disaster plan
must be developed and maintained with assistance of qualified fire,
safety, and other appropriate experts. The plan must include--
(1) Procedures for prompt transfer of casualties and records;
(2) Procedures for notifying community emergency personnel (for
example, fire department, ambulance, etc.);
(3) Instructions regarding the location and use of alarm systems and
signals and fire fighting equipment; and
(4) Specification of evacuation routes and procedures for leaving
the facility.
(b) Standard: Drills and staff training. (1) The facility must
provide ongoing training and drills for all personnel associated with
the facility in all aspects of disaster preparedness.
(2) All new personnel must be oriented and assigned specific
responsibilities regarding the facility's disaster plan within two weeks
of their first workday.
Sec. 485.66 Condition of participation: Utilization review plan.
The facility must have in effect a written utilization review plan
that is implemented at least each quarter, to assess the necessity of
services and promotes the most efficient use of services provided by the
facility.
(a) Standard: Utilization review committee. The utilization review
committee, consisting of the group of professional personnel specified
in Sec. 485.56(c), a committee of this group, or a group of similar
composition, comprised by professional personnel not associated with the
facility, must carry out the utilization review plan.
(b) Standard: Utilization review plan. The utilization review plan
must contain written procedures for evaluating--
(1) Admissions, continued care, and discharges using, at a minimum,
the criteria established in the patient care policies;
(2) The applicability of the plan of treatment to established goals;
and
(3) The adequacy of clinical records with regard to--
(i) Assessing the quality of services provided; and
(ii) Determining whether the facility's policies and clinical
practices are compatible and promote appropriate and efficient
utilization of services.
Sec. 485.70 Personnel qualifications.
This section sets forth the qualifications that must be met, as a
condition of participation, under Sec. 485.58, and as a condition of
coverage of services under Sec. 410.100 of this chapter.
(a) A facility physician must be a doctor of medicine or osteopathy
who--
(1) Is licensed under State law to practice medicine or surgery; and
(2) Has had, subsequent to completing a 1-year hospital internship,
at least 1 year of training in the medical management of patients
requiring rehabilitation services; or
(3) Has had at least 1 year of full-time or part-time experience in
a rehabilitation setting providing physicians' services similar to those
required in this subpart.
(b) A licensed practical nurse must be licensed as a practical or
vocational nurse by the State in which practicing, if applicable.
(c) An occupational therapist and an occupational therapy assistant
must meet the qualifications in Sec. 484.4 of this chapter.
(d) An orthotist must--
(1) Be licensed by the State in which practicing, if applicable;
(2) Have successfully completed a training program in orthotics that
is jointly recognized by the American Council on Education and the
American Board for Certification in Orthotics and Prosthetics; and
(3) Be eligible to take that Board's certification examination in
orthotics.
[[Page 139]]
(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]
Sec. 485.74 Appeal rights.
The appeal provisions set forth in part 498 of this chapter, for
providers, are applicable to any entity that is participating or seeks
to participate in the Medicare program as a CORF.
[48 FR 56293, Dec. 15, 1982, as amended at 52 FR 22454, June 12, 1987]
Subparts C-E [Reserved]
Subpart F_Conditions of Participation: Critical Access Hospitals (CAHs)
Source: 58 FR 30671, May 26, 1993, unless otherwise noted.
[[Page 140]]
Sec. 485.601 Basis and scope.
(a) Statutory basis. This subpart is based on section 1820 of the
Act which sets forth the conditions for designating certain hospitals as
CAHs.
(b) Scope. This subpart sets forth the conditions that a hospital
must meet to be designated as a CAH.
[58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997]
Sec. 485.602 Definitions.
As used in this subpart, unless the context indicates otherwise:
Direct services means services provided by employed staff of the
CAH, not services provided through arrangements or agreements.
[59 FR 45403, Sept. 1, 1994, as amended at 62 FR 46037, Aug. 29, 1997]
Sec. 485.603 Rural health network.
A rural health network is an organization that meets the following
specifications:
(a) It includes--
(1) At least one hospital that the State has designated or plans to
designate as a CAH; and
(2) At least one hospital that furnishes acute care services.
(b) The members of the organization have entered into agreements
regarding--
(1) Patient referral and transfer;
(2) The development and use of communications systems, including,
where feasible, telemetry systems and systems for electronic sharing of
patient data; and
(3) The provision of emergency and nonemergency transportation among
members.
(c) Each CAH has an agreement with respect to credentialing and
quality assurance with at least--
(1) One hospital that is a member of the network when applicable;
(2) One QIO or equivalent entity; or
(3) One other appropriate and qualified entity identified in the
State rural health care plan.
[58 FR 30671, May 26, 1993, as amended at 62 FR 46035, Aug. 29, 1997; 63
FR 26359, May 12, 1998]
Sec. 485.604 Personnel qualifications.
Staff that furnish services in a CAH must meet the applicable
requirements of this section.
(a) Clinical nurse specialist. A clinical nurse specialist must be a
person who performs the services of a clinical nurse specialist as
authorized by the State, in accordance with State law or the State
regulatory mechanism provided by State law.
(b) Nurse practitioner. A nurse practitioner must be a registered
professional nurse who is currently licensed to practice in the State,
who meets the State's requirements governing the qualification of nurse
practitioners, and who meets one of the following conditions:
(1) Is currently certified as a primary care nurse practitioner by
the American Nurses' Association or by the National Board of Pediatric
Nurse Practitioners and Associates.
(2) Has successfully completed a 1 academic year program that--
(i) Prepares registered nurses to perform an expanded role in the
delivery of primary care;
(ii) Includes at least 4 months (in the aggregate) of classroom
instruction and a component of supervised clinical practice; and
(iii) Awards a degree, diploma, or certificate to persons who
successfully complete the program.
(3) Has successfully completed a formal educational program (for
preparing registered nurses to perform an expanded role in the delivery
of primary care) that does not meet the requirements of paragraph (a)(2)
of this section, and has been performing an expanded role in the
delivery of primary care for a total of 12 months during the 18-month
period immediately preceding June 25, 1993.
(c) Physician assistant. A physician assistant must be a person who
meets the applicable State requirements governing the qualifications for
assistants to primary care physicians, and who meets at least one of the
following conditions:
(1) Is currently certified by the National Commission on
Certification of Physician Assistants to assist primary care physicians.
[[Page 141]]
(2) Has satisfactorily completed a program for preparing physician
assistants that--
(i) Was at least one academic year in length;
(ii) Consisted of supervised clinical practice and at least 4 months
(in the aggregate) of classroom instruction directed toward preparing
students to deliver health care; and
(iii) Was accredited by the American Medical Association's Committee
on Allied Health Education and Accreditation.
(3) Has satisfactorily completed a formal educational program (for
preparing physician assistants) that does not meet the requirements of
paragraph (c)(2) of this section and has been assisting primary care
physicians for a total of 12 months during the 18-month period
immediately preceding June 25, 1993.
[58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997]
Sec. 485.606 Designation and certification of CAHs.
(a) Criteria for State designation. (1) A State that has established
a Medicare rural hospital flexibility program described in section
1820(c) of the Act may designate one or more facilities as CAHs if each
facility meets the CAH conditions of participation in this subpart F.
(2) The State must not deny any hospital that is otherwise eligible
for designation as a CAH under this paragraph (a) solely because the
hospital has entered into an agreement under which the hospital may
provide posthospital SNF care as described in Sec. 482.66 of this
chapter.
(b) Criteria for CMS certification. CMS certifies a facility as a
CAH if--
(1) The facility is designated as a CAH by the State in which it is
located and has been surveyed by the State survey agency or by CMS and
found to meet all conditions of participation in this Part and all other
applicable requirements for participation in Part 489 of this chapter.
(2) The facility is a medical assistance facility operating in
Montana or a rural primary care hospital designated by CMS before August
5, 1997, and is otherwise eligible to be designated as a CAH by the
State under the rules in this subpart.
[62 FR 46036, Aug. 29, 1997, as amended at 63 FR 26359, May 12, 1998]
Sec. 485.608 Condition of participation: Compliance with Federal, State, and
local laws and regulations.
The CAH and its staff are in compliance with applicable Federal,
State and local laws and regulations.
(a) Standard: Compliance with Federal laws and regulations. The CAH
is in compliance with applicable Federal laws and regulations related to
the health and safety of patients.
(b) Standard: Compliance with State and local laws and regulations.
All patient care services are furnished in accordance with applicable
State and local laws and regulations.
(c) Standard: Licensure of CAH. The CAH is licensed in accordance
with applicable Federal, State and local laws and regulations.
(d) Standard: Licensure, certification or registration of personnel.
Staff of the CAH are licensed, certified, or registered in accordance
with applicable Federal, State, and local laws and regulations.
[58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997]
Sec. 485.610 Condition of participation: Status and location.
(a) Standard: Status. The facility is--
(1) A currently participating hospital that meets all conditions of
participation set forth in this subpart;
(2) A recently closed facility, provided that the facility--
(i) Was a hospital that ceased operations on or after the date that
is 10 years before November 29, 1999; and
(ii) Meets the criteria for designation under this subpart as of the
effective date of its designation; or
(3) A health clinic or a health center (as defined by the State)
that--
(i) Is licensed by the State as a health clinic or a health center;
(ii) Was a hospital that was downsized to a health clinic or a
health center; and
(iii) As of the effective date of its designation, meets the
criteria for designation set forth in this subpart.
[[Page 142]]
(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 either (b)(3) or (b)(4) 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.
(c) Standard: Location relative to other facilities or necessary
provider certification. The CAH is located more than a 35-mile drive
(or, in the case of mountainous terrain or in areas with only secondary
roads available, a 15-mile drive) from a hospital or another CAH, or
before January 1, 2006, the CAH is certified by the State as being a
necessary provider of health care services to residents in the area. A
CAH that is designated as a necessary provider on or before December 31,
2005, will maintain its necessary provider designation after January 1,
2006.
(d) Standard: Relocation of CAHs with a necessary provider
designation. A CAH that has a necessary provider designation from the
State that was in effect prior to January 1, 2006, and relocates its
facility after January 1, 2006, can continue to meet the location
requirement of paragraph (c) of this section based on the necessary
provider designation only if the relocated facility meets the
requirements as specified in paragraph (d)(1) of this section.
(1) If a necessary provider CAH relocates its facility and begins
providing services in a new location, the CAH can continue to meet the
location requirement of paragraph (c) of this section based on the
necessary provider designation only if the CAH in its new location--
(i) Serves at least 75 percent of the same service area that it
served prior to its relocation;
(ii) Provides at least 75 percent of the same services that it
provided prior to the relocation; and
(iii) Is staffed by 75 percent of the same staff (including medical
staff, contracted staff, and employees) that were on staff at the
original location.
(2) If a CAH that has been designated as a necessary provider by the
State begins providing services at another location after January 1,
2006, and does not meet the requirements in paragraph (d)(1) of this
section, the action will be considered a cessation of business as
described in Sec. 489.52(b)(3).
(e) Standard: Off-campus and co-location requirements for CAHs. A
CAH may
[[Page 143]]
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]
Sec. 485.612 Condition of participation: Compliance with hospital
requirements at the time of application.
Except for recently closed facilities as described in Sec.
485.610(a)(2), or health clinics or health centers as described in Sec.
485.610(a)(3), the facility is a hospital that has a provider agreement
to participate in the Medicare program as a hospital at the time the
hospital applies for designation as a CAH.
[66 FR 32196, June 13, 2001]
Sec. 485.616 Condition of participation: Agreements.
(a) Standard: Agreements with network hospitals. In the case of a
CAH that is a member of a rural health network as defined in Sec.
485.603 of this chapter, the CAH has in effect an agreement with at
least one hospital that is a member of the network for--
(1) Patient referral and transfer;
(2) The development and use of communications systems of the
network, including the network's system for the electronic sharing of
patient data, and telemetry and medical records, if the network has in
operation such a system; and
(3) The provision of emergency and nonemergency transportation
between the facility and the hospital.
(b) Standard: Agreements for credentialing and quality assurance.
Each CAH that is a member of a rural health network shall have an
agreement with respect to credentialing and quality assurance with at
least--
(1) One hospital that is a member of the network;
(2) One QIO or equivalent entity; or
(3) One other appropriate and qualified entity identified in the
State rural health care plan.
[62 FR 46036, Aug. 29, 1997]
[[Page 144]]
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.
(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
[[Page 145]]
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, and refer patients to the CAH or other appropriate
locations for treatment.
[58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997; 64
FR 41544, July 30, 1999; 67 FR 80041, Dec. 31, 2002; 69 FR 49271, Aug.
11, 2004; 71 FR 68230, Nov. 24, 2006]
Sec. 485.620 Condition of participation: Number of beds and length of stay.
(a) Standard: Number of beds. Except as permitted for CAHs having
distinct part units under Sec. 485.647, the CAH maintains no more than
25 inpatient beds after January 1, 2004, that can be used for either
inpatient or swing-bed services.
(b) Standard: Length of stay. The CAH provides acute inpatient care
for a period that does not exceed, on an annual average basis, 96 hours
per patient.
[62 FR 46036, Aug. 29, 1997, as amended at 65 FR 47052, Aug. 1, 2000; 69
FR 49271, Aug. 11, 2004; 69 FR 60252, Oct. 7, 2004]
Sec. 485.623 Condition of participation: Physical plant and environment.
(a) Standard: Construction. The CAH is constructed, arranged, and
maintained to ensure access to and safety of patients, and provides
adequate space for the provision of direct services.
(b) Standard: Maintenance. The CAH has housekeeping and preventive
maintenance programs to ensure that--
(1) All essential mechanical, electrical, and patient-care equipment
is maintained in safe operating condition;
(2) There is proper routine storage and prompt disposal of trash;
(3) Drugs and biologicals are appropriately stored;
(4) The premises are clean and orderly; and
(5) There is proper ventilation, lighting, and temperature control
in all pharmaceutical, patient care, and food preparation areas.
(c) Standard: Emergency procedures. The CAH assures the safety of
patients in non-medical emergencies by--
(1) Training staff in handling emergencies, including prompt
reporting of fires, extinguishing of fires, protection and, where
necessary, evacuation of patients, personnel, and guests, and
cooperation with fire fighting and disaster authorities;
(2) Providing for emergency power and lighting in the emergency room
and for battery lamps and flashlights in other areas;
(3) Providing for an emergency fuel and water supply; and
(4) Taking other appropriate measures that are consistent with the
particular conditions of the area in which the CAH is located.
(d) Standard: Life safety from fire. (1) Except as otherwise
provided in this section--
(i) The CAH must meet the applicable provisions of the 2000 edition
of the
[[Page 146]]
Life Safety Code of the National Fire Protection Association. The
Director of the Office of the Federal Register has approved the NFPA 101
[reg] 2000 edition of the Life Safety Code, issued January
14, 2000, for incorporation by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. A copy of the Code is available for inspection
at the CMS Information Resource Center, 7500 Security Boulevard,
Baltimore, MD or at the National Archives and Records Administration
(NARA). For information on the availability of this material at NARA,
call 202-741-6030, or go to: http://www.archives.gov/federal--register/
code--of--federal--regulations/ibr--locations.html. Copies may be
obtained from the National Fire Protection Association, 1 Batterymarch
Park, Quincy, MA 02269. If any changes in this edition of the Code are
incorporated by reference, CMS will publish notice in the Federal
Register to announce the changes.
(ii) Chapter 19.3.6.3.2, exception number 2 of the adopted edition
of the Life Safety Code does not apply to a CAH.
(2) If CMS finds that the State has a fire and safety code imposed
by State law that adequately protects patients, CMS may allow the State
survey agency to apply the State's fire and safety code instead of the
LSC.
(3) After consideration of State survey agency findings, CMS may
waive specific provisions of the Life Safety Code that, if rigidly
applied, would result in unreasonable hardship on the CAH, but only if
the waiver does not adversely affect the health and safety of patients.
(4) The CAH maintains written evidence of regular inspection and
approval by State or local fire control agencies.
(5) Beginning March 13, 2006, a critical access hospital must be in
compliance with Chapter 9.2.9, Emergency Lighting.
(6) Beginning March 13, 2006, Chapter 19.3.6.3.2, exception number 2
does not apply to critical access hospitals.
(7) Notwithstanding any provisions of the 2000 edition of the Life
Safety Code to the contrary, a critical access hospital may install
alcohol-based hand rub dispensers in its facility if--
(i) Use of alcohol-based hand rub dispensers does not conflict with
any State or local codes that prohibit or otherwise restrict the
placement of alcohol-based hand rub dispensers in health care
facilities;
(ii) The dispensers are installed in a manner that minimizes leaks
and spills that could lead to falls;
(iii) The dispensers are installed in a manner that adequately
protects against inappropriate access;
(iv) The dispensers are installed in accordance with chapter
18.3.2.7 or chapter 19.3.2.7 of the 2000 edition of the Life Safety
Code, as amended by NFPA Temporary Interim Amendment 00-1(101), issued
by the Standards Council of the National Fire Protection Association on
April 15, 2004. The Director of the Office of the Federal Register has
approved NFPA Temporary Interim Amendment 00-1(101) for incorporation by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy
of the amendment is available for inspection at the CMS Information
Resource Center, 7500 Security Boulevard, Baltimore, MD and at the
Office of the Federal Register, 800 North Capitol Street NW., Suite 700,
Washington, DC. Copies may be obtained from the National Fire Protection
Association, 1 Batterymarch Park, Quincy, MA 02269; and
(v) The dispensers are maintained in accordance with dispenser
manufacturer guidelines.
[58 FR 30671, May 26, 1993, as amended at 62 FR 46036, 46037, Aug. 29,
1997; 68 FR 1387, Jan. 10, 2003; 69 FR 49271, Aug. 11, 2004; 70 FR
15239, Mar. 25, 2005; 71 FR 55341, Sept. 22, 2006]
Sec. 485.627 Condition of participation: Organizational structure.
(a) Standard: Governing body or responsible individual. The CAH has
a governing body or an individual that assumes full legal responsibility
for determining, implementing and monitoring policies governing the
CAH's total operation and for ensuring that those policies are
administered so as to provide quality health care in a safe environment.
(b) Standard: Disclosure. The CAH discloses the names and addresses
of--
(1) Its owners, or those with a controlling interest in the CAH or
in any
[[Page 147]]
subcontractor in which the CAH directly or indirectly has a 5 percent or
more ownership interest, in accordance with subpart C of part 420 of
this chapter;
(2) The person principally responsible for the operation of the CAH;
and
(3) The person responsible for medical direction.
[58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997]
Sec. 485.631 Condition of participation: Staffing and staff responsibilities.
(a) Standard: Staffing--(1) The CAH has a professional health care
staff that includes one or more doctors of medicine or osteopathy, and
may include one or more physician assistants, nurse practitioners, or
clinical nurse specialists.
(2) Any ancillary personnel are supervised by the professional
staff.
(3) The staff is sufficient to provide the services essential to the
operation of the CAH.
(4) A doctor of medicine or osteopathy, nurse practitioner, clinical
nurse specialist, or physician assistant is available to furnish patient
care services at all times the CAH operates.
(5) A registered nurse, clinical nurse specialist, or licensed
practical nurse is on duty whenever the CAH has one or more inpatients.
(b) Standard: Responsibilities of the doctor of medicine or
osteopathy. (1) The doctor of medicine or osteopathy--
(i) Provides medical direction for the CAH's health care activities
and consultation for, and medical supervision of, the health care staff;
(ii) In conjunction with the physician assistant and/or nurse
practitioner member(s), participates in developing, executing, and
periodically reviewing the CAH's written policies governing the services
it furnishes.
(iii) In conjunction with the physician assistant and/or nurse
practitioner members, periodically reviews the CAH's patient records,
provides medical orders, and provides medical care services to the
patients of the CAH; and
(iv) Periodically reviews and signs the records of all inpatients
cared for by nurse practitioners, clinical nurse specialists, certified
nurse midwives, or physician assistants.
(v) Periodically, but not less than every 2 weeks, reviews and signs
a sample of outpatient records of patients cared for by nurse
practitioners, clinical nurse specialists, certified nurse midwives, or
physician assistants according to the policies of the CAH and according
to current standards of practice where State law requires record reviews
or co-signatures, or both, by a collaborating physician.
(vi) Is not required to review and sign outpatient records of
patients cared for by nurse practitioners, clinical nurse specialists,
certified nurse midwives, or physician assistants where State law does
not require record reviews or co-signatures, or both, by a collaborating
physician.
(2) A doctor of medicine or osteopathy is present for sufficient
periods of time, at least once in every 2 week period (except in
extraordinary circumstances) to provide the medical direction, medical
care services, consultation, and supervision described in this
paragraph, and is available through direct radio or telephone
communication for consultation, assistance with medical emergencies, or
patient referral. The extraordinary circumstances are documented in the
records of the CAH. A site visit is not required if no patients have
been treated since the latest site visit.
(c) Standard: Physician assistant, nurse practitioner, and clinical
nurse specialist responsibilities. (1) The physician assistant, the
nurse practitioner, or clinical nurse specialist members of the CAH's
staff--
(i) Participate in the development, execution and periodic review of
the written policies governing the services the CAH furnishes; and
(ii) Participate with a doctor of medicine or osteopathy in a
periodic review of the patients' health records.
(2) The physician assistant, nurse practitioner, or clinical nurse
specialist performs the following functions to the extent they are not
being performed by a doctor of medicine or osteopathy:
(i) Provides services in accordance with the CAH's policies.
[[Page 148]]
(ii) Arranges for, or refers patients to, needed services that
cannot be furnished at the CAH, and assures that adequate patient health
records are maintained and transferred as required when patients are
referred.
(3) Whenever a patient is admitted to the CAH by a nurse
practitioner, physician assistant, or clinical nurse specialist, a
doctor of medicine or osteopathy on the staff of the CAH is notified of
the admission.
[58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997; 70
FR 68728, Nov. 10, 2005]
Sec. 485.635 Condition of participation: Provision of services.
(a) Standard: Patient care policies. (1) The CAH's health care
services are furnished in accordance with appropriate written policies
that are consistent with applicable State law.
(2) The policies are developed with the advice of a group of
professional personnel that includes one or more doctors of medicine or
osteopathy and one or more physician assistants, nurse practitioners, or
clinical nurse specialists, if they are on staff under the provisions of
Sec. 485.631(a)(1); at least one member is not a member of the CAH
staff.
(3) The policies include the following: (i) A description of the
services the CAH furnishes directly and those furnished through
agreement or arrangement.
(ii) Policies and procedures for emergency medical services.
(iii) Guidelines for the medical management of health problems that
include the conditions requiring medical consultation and/or patient
referral, the maintenance of health care records, and procedures for the
periodic review and evaluation of the services furnished by the CAH.
(iv) Rules for the storage, handling, dispensation, and
administration of drugs and biologicals. These rules must provide that
there is a drug storage area that is administered in accordance with
accepted professional principles, that current and accurate records are
kept of the receipt and disposition of all scheduled drugs, and that
outdated, mislabeled, or otherwise unusable drugs are not available for
patient use.
(v) Procedures for reporting adverse drug reactions and errors in
the administration of drugs.
(vi) A system for identifying, reporting, investigating and
controlling infections and communicable diseases of patients and
personnel.
(vii) If the CAH furnishes inpatient services, procedures that
ensure that the nutritional needs of inpatients are met in accordance
with recognized dietary practices and the orders of the practitioner
responsible for the care of the patients, and that the requirement of
Sec. 483.25(i) is met with respect to inpatients receiving posthospital
SNF care.
(4) These policies are reviewed at least annually by the group of
professional personnel required under paragraph (a)(2) of this section,
and reviewed as necessary by the CAH.
(b) Standard: Direct services--(1) General. The CAH staff furnishes,
as direct services, those diagnostic and therapeutic services and
supplies that are commonly furnished in a physician's office or at
another entry point into the health care delivery system, such as a low
intensity hospital outpatient department or emergency department. These
direct services include medical history, physical examination, specimen
collection, assessment of health status, and treatment for a variety of
medical conditions.
(2) Laboratory services. The CAH provides, as direct services, basic
laboratory services essential to the immediate diagnosis and treatment
of the patient that meet the standards imposed under section 353 of the
Public Health Service Act (42 U.S.C. 236a). (See the laboratory
requirements specified in part 493 of this chapter.) The services
provided include:
(i) Chemical examination of urine by stick or tablet method or both
(including urine ketones);
(ii) Hemoglobin or hematocrit;
(iii) Blood glucose:
(iv) Examination of stool specimens for occult blood;
(v) Pregnancy tests; and
(vi) Primary culturing for transmittal to a certified laboratory.
(3) Radiology services. Radiology services furnished at the CAH are
provided as direct services by staff qualified under State law, and do
not expose
[[Page 149]]
CAH patients or staff to radiation hazards.
(4) Emergency procedures. In accordance with the requirements of
Sec. 485.618, the CAH provides as direct services medical emergency
procedures as a first response to common life-threatening injuries and
acute illness.
(c) Standard: Services provided through agreements or arrangements.
(1) The CAH has agreements or arrangements (as appropriate) with one or
more providers or suppliers participating under Medicare to furnish
other services to its patients, including--
(i) Inpatient hospital care;
(ii) Services of doctors of medicine or osteopathy; and
(iii) Additional or specialized diagnostic and clinical laboratory
services that are not available at the CAH.
(iv) Food and other services to meet inpatients' nutritional needs
to the extent these services are not provided directly by the CAH.
(2) If the agreements or arrangements are not in writing, the CAH is
able to present evidence that patients referred by the CAH are being
accepted and treated.
(3) The CAH maintains a list of all services furnished under
arrangements or agreements. The list describes the nature and scope of
the services provided.
(4) The person principally responsible for the operation of the CAH
under Sec. 485.627(b)(2) of this chapter is also responsible for the
following:
(i) Services furnished in the CAH whether or not they are furnished
under arrangements or agreements.
(ii) Ensuring that a contractor of services (including one for
shared services and joint ventures) furnishes services that enable the
CAH to comply with all applicable conditions of participation and
standards for the contracted services.
(d) Standard: Nursing services. Nursing services must meet the needs
of patients.
(1) A registered nurse must provide (or assign to other personnel)
the nursing care of each patient, including patients at a SNF level of
care in a swing-bed CAH. The care must be provided in accordance with
the patient's needs and the specialized qualifications and competence of
the staff available.
(2) A registered nurse or, where permitted by State law, a physician
assistant, must supervise and evaluate the nursing care for each
patient, including patients at a SNF level of care in a swing-bed CAH.
(3) All drugs, biologicals, and intravenous medications must be
administered by or under the supervision of a registered nurse, a doctor
of medicine or osteopathy, or, where permitted by State law, a physician
assistant, in accordance with written and signed orders, accepted
standards of practice, and Federal and State laws.
(4) A nursing care plan must be developed and kept current for each
inpatient.
(e) Standard: Rehabilitation Therapy Services. Physical therapy,
occupational therapy, and speech-language pathology services furnished
at the CAH, if provided, are provided by staff qualified under State
law, and consistent with the requirements for therapy services in Sec.
409.17 of this subpart.
[58 FR 30671, May 26, 1993; 58 FR 49935, Sept. 24, 1993, as amended at
59 FR 45403, Sept. 1, 1994; 62 FR 46037, Aug. 29, 1997; 72 FR 66408,
Nov. 27, 2007; 73 FR 69941, Nov. 19, 2008]
Sec. 485.638 Conditions of participation: Clinical records.
(a) Standard: Records system--(1) The CAH maintains a clinical
records system in accordance with written policies and procedures.
(2) The records are legible, complete, accurately documented,
readily accessible, and systematically organized.
(3) A designated member of the professional staff is responsible for
maintaining the records and for ensuring that they are completely and
accurately documented, readily accessible, and systematically organized.
(4) For each patient receiving health care services, the CAH
maintains a record that includes, as applicable--
(i) Identification and social data, evidence of properly executed
informed consent forms, pertinent medical history, assessment of the
health status and health care needs of the patient, and a brief summary
of the episode, disposition, and instructions to the patient;
[[Page 150]]
(ii) Reports of physical examinations, diagnostic and laboratory
test results, including clinical laboratory services, and consultative
findings;
(iii) All orders of doctors of medicine or osteopathy or other
practitioners, reports of treatments and medications, nursing notes and
documentation of complications, and other pertinent information
necessary to monitor the patient's progress, such as temperature
graphics, progress notes describing the patient's response to treatment;
and
(iv) Dated signatures of the doctor of medicine or osteopathy or
other health care professional.
(b) Standard: Protection of record information--(1) The CAH
maintains the confidentiality of record information and provides
safeguards against loss, destruction, or unauthorized use.
(2) Written policies and procedures govern the use and removal of
records from the CAH and the conditions for the release of information.
(3) The patient's written consent is required for release of
information not required by law.
(c) Standard: Retention of records. The records are retained for at
least 6 years from date of last entry, and longer if required by State
statute, or if the records may be needed in any pending proceeding.
[58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997]
Sec. 485.639 Condition of participation: Surgical services.
Surgical procedures must be performed in a safe manner by qualified
practitioners who have been granted clinical privileges by the governing
body of the CAH in accordance with the designation requirements under
paragraph (a) of this section.
(a) Designation of qualified practitioners. The CAH designates the
practitioners who are allowed to perform surgery for CAH patients, in
accordance with its approved policies and procedures, and with State
scope of practice laws. Surgery is performed only by--
(1) A doctor of medicine or osteopathy, including an osteopathic
practitioner recognized under section 1101(a)(7) of the Act;
(2) A doctor of dental surgery or dental medicine; or
(3) A doctor of podiatric medicine.
(b) Anesthetic risk and evaluation. (1) A qualified practitioner, as
specified in paragraph (a) of this section, must examine the patient
immediately before surgery to evaluate the risk of the procedure to be
performed.
(2) A qualified practitioner, as specified in paragraph (c) of this
section, must examine each patient before surgery to evaluate the risk
of anesthesia.
(3) Before discharge from the CAH, each patient must be evaluated
for proper anesthesia recovery by a qualified practitioner, as specified
in paragraph (c) of this section.
(c) Administration of anesthesia. The CAH designates the person who
is allowed to administer anesthesia to CAH patients in accordance with
its approved policies and procedures and with State scope-of-practice
laws.
(1) Anesthesia must be administered by only--
(i) A qualified anesthesiologist;
(ii) A doctor of medicine or osteopathy other than an
anesthesiologist; including an osteopathic practitioner recognized under
section 1101(a)(7) of the Act;
(iii) A doctor of dental surgery or dental medicine;
(iv) A doctor of podiatric medicine;
(v) A certified registered nurse anesthetist (CRNA), as defined in
Sec. 410.69(b) of this chapter;
(vi) An anesthesiologist's assistant, as defined in Sec. 410.69(b)
of this chapter; or
(vii) A supervised trainee in an approved educational program, as
described in Sec. Sec. 413.85 or 413.86 of this chapter.
(2) In those cases in which a CRNA administers the anesthesia, the
anesthetist must be under the supervision of the operating practitioner
except as provided in paragraph (e) of this section. An
anesthesiologist's assistant who administers anesthesia must be under
the supervision of an anesthesiologist.
(d) Discharge. All patients are discharged in the company of a
responsible adult, except those exempted by the practitioner who
performed the surgical procedure.
[[Page 151]]
(e) Standard: State exemption. (1) A CAH may be exempted from the
requirement for physician supervision of CRNAs as described in paragraph
(c)(2) of this section, if the State in which the CAH is located submits
a letter to CMS signed by the Governor, following consultation with the
State's Boards of Medicine and Nursing, requesting exemption from
physician supervision for CRNAs. The letter from the Governor must
attest that he or she has consulted with the State Boards of Medicine
and Nursing about issues related to access to and the quality of
anesthesia services in the State and has concluded that it is in the
best interests of the State's citizens to opt-out of the current
physician supervision requirement, and that the opt-out is consistent
with State law.
(2) The request for exemption and recognition of State laws and the
withdrawal of the request may be submitted at any time, and are
effective upon submission.
[60 FR 45851, Sept. 1, 1995, as amended at 62 FR 46037, Aug. 29, 1997;
66 FR 39938, Aug. 1, 2001; 66 FR 56769, Nov. 13, 2001]
Sec. 485.641 Condition of participation: Periodic evaluation and quality
assurance review.
(a) Standard: Periodic evaluation--(1) The CAH carries out or
arranges for a periodic evaluation of its total program. The evaluation
is done at least once a year and includes review of--
(i) The utilization of CAH services, including at least the number
of patients served and the volume of services;
(ii) A representative sample of both active and closed clinical
records; and
(iii) The CAH's health care policies.
(2) The purpose of the evaluation is to determine whether the
utilization of services was appropriate, the established policies were
followed, and any changes are needed.
(b) Standard: Quality assurance. The CAH has an effective quality
assurance program to evaluate the quality and appropriateness of the
diagnosis and treatment furnished in the CAH and of the treatment
outcomes. The program requires that--
(1) All patient care services and other services affecting patient
health and safety, are evaluated;
(2) Nosocomial infections and medication therapy are evaluated;
(3) The quality and appropriateness of the diagnosis and treatment
furnished by nurse practitioners, clinical nurse specialists, and
physician assistants at the CAH are evaluated by a member of the CAH
staff who is a doctor of medicine or osteopathy or by another doctor of
medicine or osteopathy under contract with the CAH;
(4) The quality and appropriateness of the diagnosis and treatment
furnished by doctors of medicine or osteopathy at the CAH are evaluated
by--
(i) One hospital that is a member of the network, when applicable;
(ii) One QIO or equivalent entity; or
(iii) One other appropriate and qualified entity identified in the
State rural health care plan; and
(5)(i) The CAH staff considers the findings of the evaluations,
including any findings or recommendations of the QIO, and takes
corrective action if necessary.
(ii) The CAH also takes appropriate remedial action to address
deficiencies found through the quality assurance program.
(iii) The CAH documents the outcome of all remedial action.
[58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997; 63
FR 26359, May 12, 1998]
Sec. 485.643 Condition of participation: Organ, tissue, and eye procurement.
The CAH must have and implement written protocols that:
(a) Incorporate an agreement with an OPO designated under part 486
of this chapter, under which it must notify, in a timely manner, the OPO
or a third party designated by the OPO of individuals whose death is
imminent or who have died in the CAH. The OPO determines medical
suitability for organ donation and, in the absence of alternative
arrangements by the CAH, the OPO determines medical suitability for
tissue and eye donation, using the definition of potential tissue and
eye donor and the notification protocol developed in consultation with
the tissue and eye
[[Page 152]]
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 paragraph (a) of this section
is made in accordance with Sec. 413.70 of this chapter. Payment for
post-hospital SNF-level of care services is made in accordance with the
payment provisions in Sec. 413.114 of this chapter.
(d) SNF services. The CAH is substantially in compliance with the
following SNF requirements contained in subpart B of part 483 of this
chapter:
(1) Residents rights (Sec. 483.10(b)(3) through (b)(6), (d) (e),
(h), (i), (j)(1)(vii) and (viii), (l), and (m) of this chapter).
(2) Admission, transfer, and discharge rights (Sec. 483.12(a) of
this chapter).
(3) Resident behavior and facility practices (Sec. 483.13 of this
chapter).
(4) Patient activities (Sec. 483.15(f) of this chapter), except
that the services
[[Page 153]]
may be directed either by a qualified professional meeting the
requirements of Sec. 485.15(f)(2), or by an individual on the facility
staff who is designated as the activities director and who serves in
consultation with a therapeutic recreation specialist, occupational
therapist, or other professional with experience or education in
recreational therapy.
(5) Social services (Sec. 483.15(g) of this chapter).
(6) Comprehensive assessment, comprehensive care plan, and discharge
planning (Sec. 483.20(b), (k), and (l) of this chapter, except that the
CAH is not required to use the resident assessment instrument (RAI)
specified by the State that is required under Sec. 483.20(b), or to
comply with the requirements for frequency, scope, and number of
assessments prescribed in Sec. 413.343(b) of this chapter).
(7) Specialized rehabilitative services (Sec. 483.45 of this
chapter).
(8) Dental services (Sec. 483.55 of this chapter).
(9) Nutrition (Sec. 483.25(i) of this chapter).
[63 FR 26359, May 12, 1998 as amended at 64 FR 41544, July 30, 1999; 67
FR 50120, Aug. 1, 2002; 69 FR 49272, Aug. 11, 2004]
Sec. 485.647 Condition of participation: psychiatric and rehabilitation
distinct part units.
(a) Conditions. (1) If a CAH provides inpatient psychiatric services
in a distinct part unit, the services furnished by the distinct part
unit must comply with the hospital requirements specified in Subparts A,
B, C, and D of Part 482 of this subchapter, the common requirements of
Sec. 412.25(a)(2) through (f) of Part 412 of this chapter for hospital
units excluded from the prospective payment systems, and the additional
requirements of Sec. 412.27 of Part 412 of this chapter for excluded
psychiatric units.
(2) If a CAH provides inpatient rehabilitation services in a
distinct part unit, the services furnished by the distinct part unit
must comply with the hospital requirements specified in Subparts A, B,
C, and D of Part 482 of this subchapter, the common requirements of
Sec. 412.25(a)(2) through (f) of Part 412 of this chapter for hospital
units excluded from the prospective payments systems, and the additional
requirements of Sec. Sec. 412.29 and Sec. 412.30 of Part 412 of this
chapter related specifically to rehabilitation units.
(b) Eligibility requirements. (1) To be eligible to receive Medicare
payments for psychiatric or rehabilitation services as a distinct part
unit, the facility provides no more than 10 beds in the distinct part
unit.
(2) The beds in the distinct part are excluded from the 25
inpatient-bed count limit specified in Sec. 485.620(a).
(3) The average annual 96-hour length of stay requirement specified
under Sec. 485.620(b) does not apply to the 10 beds in the distinct
part units specified in paragraph (b)(1) of this section, and admissions
and days of inpatient care in the distinct part units are not taken into
account in determining the CAH's compliance with the limits on the
number of beds and length of stay in Sec. 485.620.
[69 FR 49272, Aug. 11, 2004]
Subpart G [Reserved]
Subpart H_Conditions of Participation for Clinics, Rehabilitation
Agencies, and Public Health Agencies as Providers of Outpatient Physical
Therapy and Speech-Language Pathology Services
Sec. 485.701 Basis and scope.
This subpart implements section 1861(p)(4) of the Act, which--
(a) Defines outpatient physical therapy and speech pathology
services;
(b) Imposes requirements with respect to adequate program,
facilities, policies, staffing, and clinical records; and
(c) Authorizes the Secretary to establish by regulation other health
and safety requirements.
[60 FR 2327, Jan. 9, 1995]
Sec. 485.703 Definitions.
Clinic. A facility that is established primarily to furnish
outpatient physician services and that meets the following tests of
physician involvement:
[[Page 154]]
(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 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.
[[Page 155]]
(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]
Sec. 485.707 Condition of participation: Compliance with Federal, State, and
local laws.
The organization and its staff are in compliance with all applicable
Federal, State, and local laws and regulations.
(a) Standard: Licensure of organization. In any State in which State
or applicable local law provides for the licensing of organizations, a
clinic, rehabilitation agency, or public health agency is licensed in
accordance with applicable laws.
(b) Standard: Licensure or registration of personnel. Staff of the
organization are licensed or registered in accordance with applicable
laws.
[41 FR 20865, May 21, 1976, unless otherwise noted. Redesignated at 42
FR 52826, Sept. 30, 1977. Further redesignated and amended at 60 FR
2326, 2327, Jan. 9, 1995]
Sec. 485.709 Condition of participation: Administrative management.
The clinic or rehabilitation agency has an effective governing body
that is legally responsible for the conduct of the clinic or
rehabilitation agency. The
[[Page 156]]
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
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.
[[Page 157]]
(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]
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
[[Page 158]]
and diversity of speech pathology services offered. At least one
qualified speech pathologist is present at all times when speech
pathology services are furnished.
[41 FR 20865, May 21, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977.
Further redesignated and amended at 60 FR 2326-2328, Jan. 9, 1995]
Sec. 485.717 Condition of participation: Rehabilitation program.
This condition and standards apply only to a rehabilitation agency's
own patients, not to patients of hospitals, skilled nursing facilities
(SNFs), or Medicaid nursing facilities (NFs) to which the agency
furnishes services. The hospital, SNF, or NF is responsible for ensuring
that qualified staff furnish services for which they arrange or contract
for their patients. The rehabilitation agency provides physical therapy
and speech-language pathology services to all of its patients who need
them.
(a) Standard: Qualification of staff. The agency's therapy services
are furnished by qualified individuals as direct services and/or
services provided under contract.
(b) Standard: Arrangements for services. If services are provided
under contract, the contract must specify the term of the contract, the
manner of termination or renewal and provide that the agency retains
responsibility for the control and supervision of the services.
[73 FR 69942, Nov. 19, 2008]
Sec. 485.719 Condition of participation: Arrangements for physical therapy
and speech pathology services to be performed by other than salaried
organization personnel.
(a) Conditions. If an organization provides outpatient physical
therapy or speech pathology services under an arrangement with others,
the services are to be furnished in accordance with the terms of a
written contract, which provides that the organization retains of
professional and administrative responsibility for, and control and
supervision of, the services.
(b) Standard: Contract provisions. The contract--
(1) Specifies the term of the contract and the manner of termination
or renewal;
(2) Requires that personnel who furnish the services meet the
requirements that are set forth in this subpart for salaried personnel;
and
(3) Provides that the contracting outside resource may not bill the
patient or Medicare for the services. This limitation is based on
section 1861(w)(1) of the Act, which provides that--
(i) Only the provider may bill the beneficiary for covered services
furnished under arrangements; and
(ii) Receipt of Medicare payment by the provider, on behalf of an
entitled individual, discharges the liability of the individual or any
other person to pay for those services.
[56 FR 46562, Sept. 13, 1991. Redesignated and amended at 60 FR 2326,
2328, Jan. 9, 1995; 60 FR 50447, Sept. 29, 1995]
Sec. 485.721 Condition of participation: Clinical records.
The organization maintains clinical records on all patients in
accordance with accepted professional standards, and practices. The
clinical records are completely and accurately documented, readily
accessible, and systematically organized to facilitate retrieving and
compiling information.
(a) Standard: Protection of clinical record information. The
organization recognizes the confidentiality of clinical record
information and provides safeguards against loss, destruction, or
unauthorized use. Written procedures govern the use and removal of
records and the conditions for release of information. The patient's
written consent is required for release of information not authorized by
law.
(b) Standard: Content. The clinical record contains sufficient
information to identify the patient clearly, to justify the
diagnosis(es) and treatment, and to document the results accurately. All
clinical records contain the following general categories of data:
(1) Documented evidence of the assessment of the needs of the
patient, of an appropriate plan of care, and of the care and services
furnished.
(2) Identification data and consent forms.
(3) Medical history.
(4) Report of physical examinations, if any.
(5) Observations and progress notes.
[[Page 159]]
(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 2326-2328, Jan. 9, 1995]
Sec. 485.723 Condition of participation: Physical environment.
The building housing the organization is constructed, equipped, and
maintained to protect the health and safety of patients, personnel, and
the public and provides a functional, sanitary, and comfortable
environment.
(a) Standard: Safety of patients. The organization satisfies the
following requirements:
(1) It complies with all applicable State and local building, fire,
and safety codes.
(2) Permanently attached automatic fire-extinguishing systems of
adequate capacity are installed in all areas of the premises considered
to have special fire hazards. Fire extinguishers are conveniently
located on each floor of the premises. Fire regulations are prominently
posted.
(3) Doorways, passageways and stairwells negotiated by patients are:
(i) Of adequate width to allow for easy movement of all patients
(including those on stretchers or in wheelchairs), (ii) free from
obstruction at all times, and (iii) in the case of stairwells, equipped
with firmly attached handrails on at least one side.
(4) Lights are placed at exits and in corridors used by patients and
are supported by an emergency power source.
(5) A fire alarm system with local alarm capability and, where
applicable, an emergency power source, is functional.
(6) At least two persons are on duty on the premises of the
organization whenever a patient is being treated.
(7) No occupancies or activities undesirable or injurious to the
health and safety of patients are located in the building.
(b) Standard: Maintenance of equipment, building, and grounds. The
organization establishes a written preventive-maintenance program to
ensure that--
(1) The equipment is operative, and is properly calibrated; and
(2) The interior and exterior of the building are clean and orderly
and maintained free of any defects that are a potential hazard to
patients, personnel, and the public.
(c) Standard: Other environmental considerations. The organization
provides a functional, sanitary, and comfortable environment for
patients, personnel, and the public.
(1) Provision is made for adequate and comfortable lighting levels
in all areas; limitation of sounds at comfort levels; a comfortable room
temperature; and adequate ventilation through windows, mechanical means,
or a combination of both.
(2) Toilet rooms, toilet stalls, and lavatories are accessible and
constructed so as to allow use by nonambulatory and semiambulatory
individuals.
(3) Whatever the size of the building, there is an adequate amount
of space
[[Page 160]]
for the services provided and disabilities treated, including reception
area, staff space, examining room, treatment areas, and storage.
[41 FR 20865, May 21, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977.
Further redesignated and amended at 60 FR 2326-2328, Jan. 9, 1995]
Sec. 485.725 Condition of participation: Infection control.
The organization that provides outpatient physical therapy services
establishes an infection-control committee of representative
professional staff with responsibility for overall infection control.
All necessary housekeeping and maintenance services are provided to
maintain a sanitary and comfortable environment and to help prevent the
development and transmission of infection.
(a) Standard: Infection-control committee. The infection-control
committee establishes policies and procedures for investigating,
controlling, and preventing infections in the organization and monitors
staff performance to ensure that the policies and procedures are
executed.
(b) All personnel follow written procedures for effective aseptic
techniques. The procedures are reviewed annually and revised if
necessary to improve them.
(c) Standard: Housekeeping. (1) The organization employs sufficient
housekeeping personnel and provides all necessary equipment to maintain
a safe, clean, and orderly interior. A full-time employee is designated
as the one responsible for the housekeeping services and for supervision
and training of housekeeping personnel.
(2) An organization that has a contract with an outside resource for
housekeeping services may be found to be in compliance with this
standard provided the organization or outside resource or both meet the
requirements of the standard.
(d) Standard: Linen. The organization has available at all times a
quantity of linen essential for proper care and comfort of patients.
Linens are handled, stored, processed, and transported in such a manner
as to prevent the spread of infection.
(e) Standard: Pest control. The organization's premises are
maintained free from insects and rodents through operation of a pest-
control program.
[41 FR 20865, May 21, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977.
Further redesignated and amended at 60 FR 2326, 2328, Jan. 9, 1995; 60
FR 50447, Sept. 29, 1995]
Sec. 485.727 Condition of participation: Disaster preparedness.
The organization has a written plan, periodically rehearsed, with
procedures to be followed in the event of an internal or external
disaster and for the care of casualties (patients and personnel) arising
from a disaster.
(a) Standard: Disaster plan. The organization has a written plan in
operation, with procedures to be followed in the event of fire,
explosion, or other disaster. The plan is developed and maintained with
the assistance of qualified fire, safety, and other appropriate experts,
and includes:
(1) Transfer of casualties and records;
(2) The location and use of alarm systems and signals;
(3) Methods of containing fire;
(4) Notification of appropriate persons; and
(5) Evacuation routes and procedures.
(b) Standard: Staff training and drills. All employees are trained,
as part of their employment orientation, in all aspects of preparedness
for any disaster. The disaster program includes orientation and ongoing
training and drills for all personnel in all procedures so that each
employee promptly and correctly carries out his assigned role in case of
a disaster.
[41 FR 20865, May 21, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977,
and amended at 53 FR 12015, Apr. 12, 1988. Redesignated and amended at
60 FR 2326-2327, 2329, Jan. 9, 1995]
Sec. 485.729 Condition of participation: Program evaluation.
The organization has procedures that provide for a systematic
evaluation of its total program to ensure appropriate utilization of
services and to determine whether the organization's policies are
followed in providing services to patients through employees or under
arrangements with others.
(a) Standard: Clinical-record review. A sample of active and closed
clinical records is reviewed quarterly by the
[[Page 161]]
appropriate health professionals to ensure that established policies are
followed in providing services.
(b) Standard: Annual statistical evaluation. An evaluation is
conducted annually of statistical data such as number of different
patients treated, number of patient visits, condition on admission and
discharge, number of new patients, number of patients by diagnosis(es),
sources of referral, number and cost of units of service by treatment
given, and total staff days or work hours by discipline.
[41 FR 20865, May 21, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977.
Further redesignated and amended at 60 FR 2326-2327, 2329, Jan. 9, 1995]
PART 486_CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES FURNISHED BY
SUPPLIERS--Table of Contents
Subpart A_General Provisions
Sec.
486.1 Basis and scope.
Subpart B [Reserved]
Subpart C_Conditions for Coverage: Portable X-Ray Services
486.100 Condition for coverage: Compliance with Federal, State, and
local laws and regulations.
486.102 Condition for coverage: Supervision by a qualified physician.
486.104 Condition for coverage: Qualifications, orientation, and health
of technical personnel.
486.106 Condition for coverage: Referral for service and preservation of
records.
486.108 Condition for coverage: Safety standards.
486.110 Condition for coverage: Inspection of equipment.
Subparts D-F [Reserved]
Subpart G_Requirements for Certification and Designation and Conditions
for Coverage: Organ Procurement Organizations
486.301 Basis and scope.
486.302 Definitions.
Requirements for Certification and Designation
486.303 Requirements for certification.
486.304 Requirements for designation.
486.306 OPO service area size designation and documentation
requirements.
486.308 Designation of one OPO for each service area.
486.309 Re-certification from August 1, 2006 through July 31, 2010.
486.310 Changes in control or ownership or service area.
Re-certification and De-certification
486.312 De-certification.
486.314 Appeals.
486.316 Re-certification and competition processes.
Organ Procurement Organization Outcome Requirements
486.318 Condition: Outcome measures.
Organ Procurement Organization Process Performance Measures
486.320 Condition: Participation in Organ Procurement and
Transplantation Network.
486.322 Condition: Relationships with hospitals, critical access
hospitals, and tissue banks.
486.324 Condition: Administration and governing body.
486.326 Condition: Human resources.
486.328 Condition: Reporting of data.
486.330 Condition: Information management.
486.342 Condition: Requesting consent.
486.344 Condition: Evaluation and management of potential donors and
organ placement and recovery.
486.346 Condition: Organ preparation and transport.
486.348 Condition: Quality assessment and performance improvement
(QAPI).
Authority: Secs. 1102, 1138, and 1871 of the Social Security Act (42
U.S.C. 1302, 1320b-8, and 1395hh) and section 371 of the Public Health
Service Act (42 U.S.C 273).
Subpart A_General Provisions
Sec. 486.1 Basis and scope.
(a) Statutory basis. This part is based on the following sections of
the Act:
1102 and 1138(b), 1871 of the Social Security Act, section 371(b) of
the Public Health Service Act--for coverage of organ procurement
services.
1861(p)--for coverage of outpatient physical therapy services
furnished by physical therapists in independent practice.
1861(s) (3), (15), and (17)--for coverage of portable X-ray
services.
(b) Scope. (1) This part sets forth the conditions for coverage of
certain specialized services that are furnished by
[[Page 162]]
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 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
[[Page 163]]
(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;
(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
[[Page 164]]
(2) Employees receive adequate health supervision.
[34 FR 388, Jan. 10, 1969. Redesignated at 42 FR 52826, Sept. 30, 1977,
and amended at 53 FR 12015, Apr. 12, 1988; 60 FR 45086, Aug. 30, 1995;
73 FR 69942, Nov. 19, 2008]
Sec. 486.106 Condition for coverage: Referral for service and preservation of
records.
All portable X-ray services performed for Medicare beneficiaries are
ordered by a doctor of medicine or doctor of osteopathy and records are
properly preserved.
(a) Standard--referral by a physician. Portable X-ray examinations
are performed only on the order of a doctor of medicine or doctor of
osteopathy licensed to practice in the State. The supplier's records
show that:
(1) The X-ray test was ordered by a licensed doctor of medicine or
doctor of osteopathy, and
(2) Such physician's written, signed order specifies the reason an
X-ray test is required, the area of the body to be exposed, the number
of radiographs to be obtained, and the views needed; it also includes a
statement concerning the condition of the patient which indicates why
portable X-ray services are necessary.
(b) Standard--records of examinations performed. The supplier makes
for each patient a record of the date of the X-ray examination, the name
of the patient, a description of the procedures ordered and performed,
the referring physician, the operator(s) of the portable X-ray equipment
who performed the examination, the physician to whom the radiograph was
sent, and the date it was sent.
(c) Standard--preservation of records. Such reports are maintained
for a period of at least 2 years, or for the period of time required by
State law for such records (as distinguished from requirements as to the
radiograph itself), whichever is longer.
[34 FR 388, Jan. 10, 1969. Redesignated at 42 FR 52826, Sept. 30, 1977.
Further redesignated and amended at 60 FR 2326, Jan. 9, 1995; 60 FR
45086, Aug. 30, 1995]
Sec. 486.108 Condition for coverage: Safety standards.
X-ray examinations are conducted through the use of equipment which
is free of unnecessary hazards for patients, personnel, and other
persons in the immediate environment, and through operating procedures
which provide minimum radiation exposure to patients, personnel, and
other persons in the immediate environment.
(a) Standard--tube housing and devices to restrict the useful beam.
The tube housing is of diagnostic type. Diaphragms, cones, or adjustable
collimators capable of restricting the useful beam to the area of
clinical interest are used and provide the same degree of protection as
is required of the housing.
(b) Standard--total filtration. (1) The aluminum equivalent of the
total filtration in the primary beam is not less than that shown in the
following table except when contraindicated for a particular diagnostic
procedure.
------------------------------------------------------------------------
Total filtration (inherent
Operating kVp plus added)
------------------------------------------------------------------------
Below 50 kVp............................. 0.5 millimeters aluminum.
50-70 kVp................................ 1.5 millimeters aluminum.
Above 70 kVp............................. 2.5 millimeters aluminum.
------------------------------------------------------------------------
(2) If the filter in the machine is not accessible for examination
or the total filtration is unknown, it can be assumed that the
requirements are met if the half-value layer is not less than that shown
in the following table:
------------------------------------------------------------------------
Operating kVp Half-value layer
------------------------------------------------------------------------
50 kVp................................... 0.6 millimeters aluminum.
70 kVp................................... 1.6 millimeters aluminum.
90 kVp................................... 2.6 millimeters aluminum.
100 kVp.................................. 2.8 millimeters aluminum.
110 kVp.................................. 3.0 millimeters aluminum.
120 kVp.................................. 3.3 millimeters aluminum.
------------------------------------------------------------------------
(c) Standard--termination of exposure. A device is provided to
terminate the exposure after a preset time or exposure.
(d) Standard--control panel. The control panel provides a device
(usually a milliammeter or a means for an audible signal to give
positive indication of the production of X-rays whenever the X-ray tube
is energized. The control panel includes appropriate indicators
(labelled control settings and/or meters) which show the physical
factors
[[Page 165]]
(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.
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--
[[Page 166]]
(1) The conditions and requirements that an OPO must meet;
(2) The procedures for certification and designation of OPOs; and
(3) The terms of the agreement with CMS and the basis for and the
effect of de-certification.
(4) The requirements for an OPO to be re-certified.
Sec. 486.302 Definitions.
As used in this subpart, the following definitions apply:
Adverse event means an untoward, undesirable, and usually
unanticipated event that causes death or serious injury or the risk
thereof. As applied to OPOs, adverse events include but are not limited
to transmission of disease from a donor to a recipient, avoidable loss
of a medically suitable potential donor for whom consent for donation
has been obtained, or delivery to a transplant center of the wrong organ
or an organ whose blood type does not match the blood type of the
intended recipient.
Agreement cycle refers to the time period of at least 4 years when
an agreement is in effect between CMS and an OPO.
Certification means a CMS determination that an OPO meets the
requirements for certification at Sec. 486.303.
Death record review means an assessment of the medical chart of a
deceased patient to evaluate potential for organ donation.
Decertification means a CMS determination that an OPO no longer
meets the requirements for certification at Sec. 486.303.
Designated requestor or effective requestor is an individual
(generally employed by a hospital), who is trained to handle or
participate in the donation consent process. The designated requestor
may request consent for donation from the family of a potential donor or
from the individual(s) responsible for making the donation decision in
circumstances permitted under State law, provide information about
donation to the family or decision-maker(s), or provide support to or
collaborate with the OPO in the donation consent process.
Designation means CMS assignment of a geographic service area to an
OPO. Once an OPO is certified and assigned a geographic service area,
organ procurement costs of the OPO are eligible for Medicare and
Medicaid payment under section 1138(b)(1)(F) of the Act.
Donation service area (DSA) means a geographical area of sufficient
size to ensure maximum effectiveness in the procurement and equitable
distribution of organs and that either includes an entire metropolitan
statistical area or does not include any part of such an area and that
meets the standards of this subpart.
Donor means a deceased individual from whom at least one
vascularized organ (heart, liver, lung, kidney, pancreas, or intestine)
is recovered for the purpose of transplantation.
Donor after cardiac death (DCD) means an individual who donates
after his or her heart has irreversibly stopped beating. A donor after
cardiac death may be termed a non-heartbeating or asystolic donor.
Donor document is any documented indication of an individual's
choice in regard to donation that meets the requirements of the
governing state law.
Eligible death for organ donation means the death of a patient 70
years old or younger, who ultimately is legally declared brain dead
according to hospital policy independent of family decision regarding
donation or availability of next-of-kin, independent of medical examiner
or coroner involvement in the case, and independent of local acceptance
criteria or transplant center practice, who exhibits none of the
following:
(1) Active infections (specific diagnoses).
(i) Bacterial:
(A) Tuberculosis.
(B) Gangrenous bowel or perforated bowel and/or intra-abdominal
sepsis.
(ii) Viral:
(A) HIV infection by serologic or molecular detection.
(B) Rabies.
(C) Reactive Hepatitis B Surface Antigen.
(D) Retroviral infections including HTLV I/II.
(E) Viral Encephalitis or Meningitis.
(F) Active Herpes simplex, varicella zoster, or cytomegalovirus
viremia or pneumonia.
[[Page 167]]
(G) Acute Epstein Barr Virus (mononucleosis).
(H) West Nile Virus infection.
(I) Severe acute respiratory syndrome (SARS).
(iii) Fungal:
(A) Active infection with Cryptococcus, Aspergillus, Histoplasma,
Coccidioides.
(B) Active candidemia or invasive yeast infection.
(iv) Parasites: active infection with Trypanosoma cruzi (Chagas'),
Leishmania, Strongyloides, or Malaria (Plasmodium sp.).
(v) Prion: Creutzfeldt-Jacob Disease.
(2) General:
(i) Aplastic Anemia.
(ii) Agranulocytosis.
(iii) Extreme Immaturity (<500 grams or gestational age of <32
weeks).
(iv) Current malignant neoplasms except non-melanoma skin cancers
such as basal cell and squamous cell cancer and primary CNS tumors
without evident metastatic disease.
(v) Previous malignant neoplasms with current evident metastatic
disease.
(vi) A history of melanoma.
(vii) Hematologic malignancies: Leukemia, Hodgkin's Disease,
Lymphoma, Multiple Myeloma.
(viii) Multi-system organ failure (MSOF) due to overwhelming sepsis
or MSOF without sepsis defined as 3 or more systems in simultaneous
failure for a period of 24 hours or more without response to treatment
or resuscitation.
(ix) Active Fungal, Parasitic, viral, or Bacterial Meningitis or
encephalitis.
(3) The number of eligible deaths is the denominator for the
donation rate outcome performance measure as described at Sec.
486.318(a)(1).
Eligible donor means any donor that meets the eligible death
criteria. The number of eligible donors is the numerator of the donation
rate outcome performance measure.
Entire metropolitan statistical area means a metropolitan
statistical area (MSA), a consolidated metropolitan statistical area
(CMSA), or a primary metropolitan statistical area (PMSA) listed in the
State and Metropolitan Area Data Book published by the U.S. Bureau of
the Census. CMS does not recognize a CMSA as a metropolitan area for the
purposes of establishing a geographical area for an OPO.
Expected donation rate means the donation rate expected for an OPO
based on the national experience for OPOs serving similar hospitals and
donation service areas. This rate is adjusted for the following hospital
characteristics: Level I or Level II trauma center, Metropolitan
Statistical Area size, MS Case Mix Index, total bed size, number of
intensive care unit (ICU) beds, primary service, presence of a
neurosurgery unit, and hospital control/ownership.
Observed donation rate is the number of donors meeting the
eligibility criteria per 100 deaths.
Open area means an OPO service area for which CMS has notified the
public that it is accepting applications for designation.
Organ means a human kidney, liver, heart, lung, pancreas, or
intestine (or multivisceral organs when transplanted at the same time as
an intestine).
Organ procurement organization (OPO) means an organization that
performs or coordinates the procurement, preservation, and transport of
organs and maintains a system for locating prospective recipients for
available organs.
Re-certification cycle means the 4-year cycle during which an OPO is
certified.
Standard criteria donor (SCD) means a donor that meets the
eligibility criteria for an eligible donor and does not meet the
criteria to be a donor after cardiac death or expanded criteria donor.
Transplant hospital means a hospital that provides organ transplants
and other medical and surgical specialty services required for the care
of transplant patients. There may be one or more types of organ
transplant centers operating within the same transplant hospital.
Urgent need occurs when an OPO's noncompliance with one or more
conditions for coverage has caused, or is likely to cause, serious
injury, harm, impairment, or death to a potential or actual donor or an
organ recipient.
[[Page 168]]
Requirements for Certification and Designation
Sec. 486.303 Requirements for certification.
In order to be certified as a qualified organ procurement
organization, an organ procurement organization must:
(a) Have received a grant under 42 U.S.C. 273(a) or have been
certified or re-certified by the Secretary within the previous 4 years
as being a qualified OPO.
(b) Be a non-profit entity that is exempt from Federal income
taxation under section 501 of the Internal Revenue Code of 1986.
(c) Have accounting and other fiscal procedures necessary to assure
the fiscal stability of the organization, including procedures to obtain
payment for kidneys and non-renal organs provided to transplant
hospitals.
(d) Have an agreement with CMS, as the Secretary's designated
representative, to be reimbursed under title XVIII for the procurement
of kidneys.
(e) Have been re-certified as an OPO under the Medicare program from
January 1, 2002 through December 31, 2005.
(f) Have procedures to obtain payment for non-renal organs provided
to transplant centers.
(g) Agree to enter into an agreement with any hospital or critical
access hospital in the OPO's service area, including a transplant
hospital that requests an agreement.
(h) Meet the conditions for coverage for organ procurement
organizations, which include both outcome and process performance
measures.
(i) Meet the provisions of titles XI, XVIII, and XIX of the Act,
section 371(b) of the Public Health Services Act, and any other
applicable Federal regulations.
Sec. 486.304 Requirements for designation.
(a) Designation is a condition for payment. Payment may be made
under the Medicare and Medicaid programs for organ procurement costs
attributable to payments made to an OPO by a hospital only if the OPO
has been designated by CMS as an OPO.
(b) An OPO must be certified as a qualified OPO by CMS under 42
U.S.C. 273(b) and Sec. 486.303 to be eligible for designation.
(c) An OPO must enter into an agreement with CMS in order for the
organ procurement costs attributable to the OPO to be reimbursed under
Medicare and Medicaid.
Sec. 486.306 OPO service area size designation and documentation
requirements.
(a) General documentation requirement. An OPO must make available to
CMS documentation verifying that the OPO meets the requirements of
paragraphs (b) through (d) of this section at the time of application
and throughout the period of its designation.
(b) Service area designation. The defined service area either
includes an entire metropolitan statistical area or a New England county
metropolitan statistical area as specified by the Director of the Office
of Management and Budget or does not include any part of such an area.
(c) Service area location and characteristics. An OPO must define
and document a proposed service area's location through the following
information:
(1) The names of counties (or parishes in Louisiana) served or, if
the service area includes an entire State, the name of the State.
(2) Geographic boundaries of the service area.
(3) The number and the names of all hospitals and critical access
hospitals in the service area that have both a ventilator and an
operating room.
Sec. 486.308 Designation of one OPO for each service area.
(a) CMS designates only one OPO per service area. A service area is
open for competition when the OPO for the service area is de-certified
and all administrative appeals under Sec. 486.314 are exhausted.
(b) Designation periods--
(1) General. An OPO is normally designated for a 4-year agreement
cycle. The period may be shorter, for example, if an OPO has voluntarily
terminated its agreement with CMS and CMS selects a successor OPO for
the balance of the 4-year agreement cycle. In rare situations, a
designation period
[[Page 169]]
may be longer, for example, a designation may be extended if additional
time is needed to select a successor OPO to an OPO that has been de-
certified.
(2) Re-Certification. Re-certification must occur not more
frequently than once every 4 years.
(c) Unless CMS has granted a hospital a waiver under paragraphs
(d) through (f) of this section, the hospital must enter into an
agreement only with the OPO designated to serve the area in which the
hospital is located.
(d) If CMS changes the OPO designated for an area, hospitals located
in that area must enter into agreements with the newly designated OPO or
submit a request for a waiver in accordance with paragraph (e) of this
section within 30 days of notice of the change in designation.
(e) A hospital may request and CMS may grant a waiver permitting the
hospital to have an agreement with a designated OPO other than the OPO
designated for the service area in which the hospital is located. To
qualify for a waiver, the hospital must submit data to CMS establishing
that--
(1) The waiver is expected to increase organ donations; and
(2) The waiver will ensure equitable treatment of patients listed
for transplants within the service area served by the hospital's
designated OPO and within the service area served by the OPO with which
the hospital seeks to enter into an agreement.
(f) In making a determination on waiver requests, CMS considers--
(1) Cost effectiveness;
(2) Improvements in quality;
(3) Changes in a hospital's designated OPO due to changes in the
definitions of metropolitan statistical areas, if applicable; and
(4) The length and continuity of a hospital's relationship with an
OPO other than the hospital's designated OPO.
(g) A hospital may continue to operate under its existing agreement
with an out-of-area OPO while CMS is processing the waiver request. If a
waiver request is denied, a hospital must enter into an agreement with
the designated OPO within 30 days of notification of the final
determination.
Sec. 486.309 Re-certification from August 1, 2006 through July 31, 2010.
An OPO will be considered to be re-certified for the period of
August 1, 2006 through July 31, 2010 if an OPO met the standards to be a
qualified OPO within a 4-year period ending December 31, 2001 and has an
agreement with the Secretary that is scheduled to terminate on July 31,
2006. Agreements based on the August 1, 2006 through July 31, 2010 re-
certification cycle will end on January 31, 2011.
Sec. 486.310 Changes in control or ownership or service area.
(a) OPO requirements. (1) A designated OPO considering a change in
control (see Sec. 413.17(b)(3)) or ownership or in its service area
must notify CMS before putting it into effect. This notification is
required to ensure that the OPO, if changed, will continue to satisfy
Medicare and Medicaid requirements. The merger of one OPO into another
or the consolidation of one OPO with another is considered a change in
control or ownership.
(2) A designated OPO considering a change in its service area must
obtain prior CMS approval. In the case of a service area change that
results from a change of control or ownership due to merger or
consolidation, the OPOs must resubmit the information required in an
application for designation. The OPO must provide information specific
to the board structure of the new organization, as well as operating
budgets, financial information, and other written documentation CMS
determines to be necessary for designation.
(b) CMS requirements. (1) If CMS finds that the OPO has changed to
such an extent that it no longer satisfies the requirements for OPO
designation, CMS may de-certify the OPO and declare the OPO's service
area to be an open area. An OPO may appeal such a de-certification as
set forth in Sec. 486.314. The OPO's service area is not opened for
competition until the conclusion of the administrative appeals process.
[[Page 170]]
(2) If CMS finds that the changed OPO continues to satisfy the
requirements for OPO designation, the period of designation of the
changed OPO is the remaining portion of the 4-year term of the OPO that
was reorganized. If more than one designated OPO is involved in the
reorganization, the remaining designation term is the longest of the
remaining periods unless CMS determines that a shorter period is in the
best interest of the Medicare and Medicaid programs. The changed OPO
must continue to meet the requirements for certification at Sec.
486.303 throughout the remaining period.
Re-Certification and De-Certification
Sec. 486.312 De-certification.
(a) Voluntary termination of agreement. If an OPO wishes to
terminate its agreement, the OPO must send CMS written notice of its
intention to terminate its agreement and the proposed effective date.
CMS may approve the proposed date, set a different date no later than 6
months after the proposed effective date, or set a date less than 6
months after the proposed effective date if it determines that a
different date would not disrupt services to the service area. If CMS
determines that a designated OPO has ceased to furnish organ procurement
services to its service area, the cessation of services is deemed to
constitute a voluntary termination by the OPO, effective on a date
determined by CMS. CMS will de-certify the OPO as of the effective date
of the voluntary termination.
(b) Involuntary termination of agreement. During the term of the
agreement, CMS may terminate an agreement with an OPO if the OPO no
longer meets the requirements for certification at Sec. 486.303. CMS
may also terminate an agreement immediately in cases of urgent need,
such as the discovery of unsound medical practices. CMS will de-certify
the OPO as of the effective date of the involuntary termination.
(c) Non-renewal of agreement. CMS will not voluntarily renew its
agreement with an OPO if the OPO fails to meet the requirements for
certification at Sec. 486.318, based on findings from the most recent
re-certification cycle, or the other requirements for certification at
Sec. 486.303. CMS will de-certify the OPO as of the ending date of the
agreement.
(d) Notice to OPO. Except in cases of urgent need, CMS gives written
notice of de-certification to an OPO at least 90 days before the
effective date of the de-certification. In cases of urgent need, CMS
gives written notice of de-certification to an OPO at least 3 calendar
days prior to the effective date of the de-certification. The notice of
de-certification states the reasons for de-certification and the
effective date.
(e) Public notice. Once CMS approves the date for a voluntary
termination, the OPO must provide prompt public notice of the date of
de-certification and such other information as CMS may require through
publication in local newspapers in the service area. In the case of
involuntary termination or non-renewal of an agreement, CMS provides
public notice of the date of de-certification through publication in
local newspapers in the service area. No payment under titles XVIII or
XIX of the Act will be made with respect to organ procurement costs
attributable to the OPO on or after the effective date of de-
certification.
Sec. 486.314 Appeals.
If an OPO's de-certification is due to involuntary termination or
non-renewal of its agreement with CMS, the OPO may appeal the de-
certification on substantive and procedural grounds.
(a) Notice of initial determination. CMS mails notice to the OPO of
an initial de-certification determination. The notice contains the
reasons for the determination, the effect of the determination, and the
OPO's right to seek reconsideration.
(b) Reconsideration. (1) Filing request. If the OPO is dissatisfied
with the de-certification determination, it has 15 business days from
receipt of the notice of de-certification to seek reconsideration from
CMS. The request for reconsideration must state the issues or findings
of fact with which the OPO disagrees and the reasons for disagreement.
(2) An OPO must seek reconsideration before it is entitled to seek a
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hearing before a hearing officer. If an OPO does not request
reconsideration or its request is not made timely, the OPO has no right
to further administrative review.
(3) Reconsideration determination. CMS makes a written reconsidered
determination within 10 business days of receipt of the request for
reconsideration, affirming, reversing, or modifying the initial
determination and the findings on which it was based. CMS augments the
administrative record to include any additional materials submitted by
the OPO, and a copy of the reconsideration decision and sends the
supplemented administrative record to the CMS hearing officer.
(c) Request for hearing. An OPO dissatisfied with the CMS
reconsideration decision, must file a request for a hearing before a CMS
hearing officer within 40 business days of receipt of the notice of the
reconsideration determination. If an OPO does not request a hearing or
its request is not received timely, the OPO has no right to further
administrative review.
(d) Administrative record. The hearing officer sends the
administrative record to both parties within 10 business days of receipt
of the request for a hearing.
(1) The administrative record consists of, but is not limited to,
the following:
(i) Factual findings from the survey(s) on the OPO conditions for
coverage.
(ii) Data from the outcome measures.
(iii) Rankings of OPOs based on the outcome data.
(iv) Correspondence between CMS and the affected OPO.
(2) The administrative record will not include any privileged
information.
(e) Pre-Hearing conference. At any time before the hearing, the CMS
hearing officer may call a pre-hearing conference if he or she believes
that a conference would more clearly define the issues. At the pre-
hearing conference, the hearing officer may establish the briefing
schedule, sets the hearing date, and addresses other administrative
matters. The hearing officer will issue an order reflecting the results
of the pre-hearing conference.
(f) Date of hearing. The hearing officer sets a date for the hearing
that is no more than 60 calendar days following the receipt of the
request for a hearing.
(g) Conduct of hearing. (1) The hearing is open to both parties, CMS
and the OPO.
(2) The hearing officer inquires fully into all the matters at issue
and receives in evidence the testimony of witnesses and any documents
that are relevant and material.
(3) The hearing officer provides the parties with an opportunity to
enter an objection to the inclusion of any document. The hearing officer
will consider the objection and will rule on the document's
admissibility.
(4) The hearing officer decides the order in which the evidence and
the arguments of the parties are presented and the conduct of the
hearing.
(5) The hearing officer rules on the admissibility of evidence and
may admit evidence that would be inadmissible under rules applicable to
court procedures.
(6) The hearing officer rules on motions and other procedural items.
(7) The hearing officer regulates the course of the hearing and
conduct of counsel.
(8) The hearing officer may examine witnesses.
(9) The hearing officer takes any action authorized by the rules in
this subpart.
(h) Parties' rights. CMS and the OPO may:
(1) Appear by counsel or other authorized representative, in all
hearing proceedings.
(2) Participate in any pre-hearing conference held by the hearing
officer.
(3) Agree to stipulations as to facts which will be made a part of
the record.
(4) Make opening statements at the hearing.
(5) Present relevant evidence on the issues at the hearing.
(6) Present witnesses, who then must be available for cross-
examination, and cross-examine witnesses presented by the other party.
(7) Present oral arguments at the hearing.
(i) Hearing officer's decision. The hearing officer renders a
decision on
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the appeal of the notice of de-certification within 20 business days of
the hearing.
(1) Reversal of de-certification. If the hearing officer reverses
CMS' determination to de-certify an OPO in a case involving the
involuntary termination of the OPO's agreement, CMS will not terminate
the OPO's agreement and will not de-certify the OPO.
(2) De-certification is upheld. If the de-certification
determination is upheld by the hearing officer, the OPO is de-certified
and it has no further administrative appeal rights.
(j) Extension of agreement. If there is insufficient time prior to
expiration of an agreement with CMS to allow for competition of the
service area and, if necessary, transition of the service area to a
successor OPO, CMS may choose to extend the OPO's agreement with CMS.
(k) Effects of de-certification. Medicare and Medicaid payments may
not be made for organ procurement services the OPO furnishes on or after
the effective date of de-certification. CMS will then open the de-
certified OPO's service area for competition as set forth in Sec.
486.316(c).