[Title 42 CFR ]
[Code of Federal Regulations (annual edition) - October 1, 2017 Edition]
[From the U.S. Government Publishing Office]
[[Page i]]
Title 42
Public Health
________________________
Part 482 to End
Revised as of October 1, 2017
Containing a codification of documents of general
applicability and future effect
As of October 1, 2017
Published by the Office of the Federal Register
National Archives and Records Administration as a
Special Edition of the Federal Register
[[Page ii]]
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Table of Contents
Page
Explanation................................................. v
Title 42:
Chapter IV--Centers for Medicare & Medicaid
Services, Department of Health and Human Services
(Continued) 3
Chapter V--Office of Inspector General-Health Care,
Department of Health and Human Services 981
Finding Aids:
Table of CFR Titles and Chapters........................ 1095
Alphabetical List of Agencies Appearing in the CFR...... 1115
List of CFR Sections Affected........................... 1125
[[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
regulation. Each title is divided into chapters which usually bear the
name of the issuing agency. Each chapter is further subdivided into
parts covering specific regulatory areas.
Each volume of the Code is revised at least once each calendar year
and issued on a quarterly basis approximately as follows:
Title 1 through Title 16.................................as of January 1
Title 17 through Title 27..................................as of April 1
Title 28 through Title 41...................................as of July 1
Title 42 through Title 50................................as of October 1
The appropriate revision date is printed on the cover of each
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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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[[Page vi]]
Many agencies have begun publishing numerous OMB control numbers as
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(b) The matter incorporated is in fact available to the extent
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this volume.
[[Page vii]]
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Oliver A. Potts,
Director,
Office of the Federal Register.
October 1, 2017.
[[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, 2017.
For this volume, Gabrielle E. Burns was Chief Editor. The Code of
Federal Regulations publication program is under the direction of John
Hyrum Martinez, assisted by Stephen J. Frattini.
[[Page 1]]
TITLE 42--PUBLIC HEALTH
(This book contains part 482 to End)
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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, 69 FR 18803, Apr. 9,
2004, and 77 FR 29028, May 16, 2012.
SUBCHAPTER G--STANDARDS AND CERTIFICATION
Part Page
482 Conditions of participation for hospitals... 5
483 Requirements for States and long term care
facilities.............................. 48
484 Home health services........................ 149
485 Conditions of participation: Specialized
providers............................... 192
486 Conditions for coverage of specialized
services furnished by suppliers......... 242
488 Survey, certification, and enforcement
procedures.............................. 264
489 Provider agreements and supplier approval... 572
491 Certification of certain health facilities.. 606
493 Laboratory requirements..................... 613
494 Conditions for coverage for end-stage renal
disease facilities...................... 735
495 Standards for the Electronic Health Record
Technology Incentive Program............ 754
498 Appeals procedures for determinations that
affect participation in the Medicare
program and for determinations that
affect the participation of ICFs/IID and
certain NFs in the Medicaid program..... 848
SUBCHAPTER H--HEALTH CARE INFRASTRUCTURE AND MODEL PROGRAMS
505 Establishment of the health care
infrastructure improvement program...... 867
510 Comprehensive care for joint replacement
model................................... 870
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512 Episode payment model....................... 910
SUBCHAPTER I--BASIC HEALTH PROGRAM
600 Administration, eligibility, essential
health benefits, performance standards,
service delivery requirements, premium
and cost sharing, allotments, and
reconciliation.......................... 961
601-699 [Reserved]
[[Page 5]]
SUBCHAPTER G_STANDARDS AND CERTIFICATION
PART 482_CONDITIONS OF PARTICIPATION FOR HOSPITALS--Table of Contents
Subpart A_General Provisions
Sec.
482.1 Basis and scope.
482.2 Provision of emergency services by nonparticipating hospitals.
Subpart B_Administration
482.11 Condition of participation: Compliance with Federal, State and
local laws.
482.12 Condition of participation: Governing body.
482.13 Condition of participation: Patient's rights.
482.15 Condition of participation: Emergency preparedness.
Subpart C_Basic Hospital Functions
482.21 Condition of participation: Quality assessment and performance
improvement program.
482.22 Condition of participation: Medical staff.
482.23 Condition of participation: Nursing services.
482.24 Condition of participation: Medical record services.
482.25 Condition of participation: Pharmaceutical services.
482.26 Condition of participation: Radiologic services.
482.27 Condition of participation: Laboratory services.
482.28 Condition of participation: Food and dietetic services.
482.30 Condition of participation: Utilization review.
482.41 Condition of participation: Physical environment.
482.42 Condition of participation: Infection control.
482.43 Condition of participation: Discharge planning.
482.45 Condition of participation: Organ, tissue, and eye procurement.
Subpart D_Optional Hospital Services
482.51 Condition of participation: Surgical services.
482.52 Condition of participation: Anesthesia services.
482.53 Condition of participation: Nuclear medicine services.
482.54 Condition of participation: Outpatient services.
482.55 Condition of participation: Emergency services.
482.56 Condition of participation: Rehabilitation services.
482.57 Condition of participation: Respiratory care services.
482.58 Special requirements for hospital providers of long-term care
services (``swing-beds'').
Subpart E_Requirements for Specialty Hospitals
482.60 Special provisions applying to psychiatric hospitals.
482.61 Condition of participation: Special medical record requirements
for psychiatric hospitals.
482.62 Condition of participation: Special staff requirements for
psychiatric hospitals.
482.68 Special requirements for transplant centers.
482.70 Definitions.
General Requirements for Transplant Centers
482.72 Condition of participation: OPTN Membership.
482.74 Condition of participation: Notification to CMS.
482.76 Condition of participation: Pediatric Transplants.
482.78 Condition of participation: Emergency preparedness for
transplant centers.
Transplant Center Data Submission, Clinical Experience, and Outcome
Requirements
482.80 Condition of participation: Data submission, clinical
experience, and outcome requirements for initial approval of
transplant centers.
482.82 Condition of participation: Data submission, clinical
experience, and outcome requirements for re-approval of
transplant centers.
Transplant Center Process Requirements
482.90 Condition of participation: Patient and living donor selection.
482.92 Condition of participation: Organ recovery and receipt.
482.94 Condition of participation: Patient and living donor management.
482.96 Condition of participation: Quality assessment and performance
improvement (QAPI).
482.98 Condition of participation: Human resources.
482.100 Condition of participation: Organ procurement.
482.102 Condition of participation: Patient and living donor rights.
[[Page 6]]
482.104 Condition of participation: Additional requirements for kidney
transplant centers.
Authority: Secs. 1102, 1871 and 1881 of the Social Security Act (42
U.S.C. 1302, 1395hh, and 1395rr), unless otherwise noted.
Source: 51 FR 22042, June 17, 1986, unless otherwise noted.
Subpart A_General Provisions
Sec. 482.1 Basis and scope.
(a) Statutory basis. (1) Section 1861(e) of the Act provides that--
(i) Hospitals participating in Medicare must meet certain specified
requirements; and
(ii) The Secretary may impose additional requirements if they are
found necessary in the interest of the health and safety of the
individuals who are furnished services in hospitals.
(2) Section 1861(f) of the Act provides that an institution
participating in Medicare as a psychiatric hospital must meet certain
specified requirements imposed on hospitals under section 1861(e), must
be primarily engaged in providing, by or under the supervision of a
physician, psychiatric services for the diagnosis and treatment of
mentally ill persons, must maintain clinical records and other records
that the Secretary finds necessary, and must meet staffing requirements
that the Secretary finds necessary to carry out an active program of
treatment for individuals who are furnished services in the hospital. A
distinct part of an institution can participate as a psychiatric
hospital if the institution meets the specified 1861(e) requirements and
is primarily engaged in providing psychiatric services, and if the
distinct part meets the records and staffing requirements that the
Secretary finds necessary.
(3) Sections 1861(k) and 1902(a)(30) of the Act provide that
hospitals participating in Medicare and Medicaid must have a utilization
review plan that meets specified requirements.
(4) Section 1883 of the Act sets forth the requirements for
hospitals that provide long term care under an agreement with the
Secretary.
(5) Section 1905(a) of the Act provides that ``medical assistance''
(Medicaid) payments may be applied to various hospital services.
Regulations interpreting those provisions specify that hospitals
receiving payment under Medicaid must meet the requirements for
participation in Medicare (except in the case of medical supervision of
nurse-midwife services. See Secs. 440.10 and 440.165 of this chapter.).
(b) Scope. Except as provided in subpart A of part 488 of this
chapter, the provisions of this part serve as the basis of survey
activities for the purpose of determining whether a hospital qualifies
for a provider agreement under Medicare and Medicaid.
[51 FR 22042, June 17, 1986, as amended at 60 FR 50442, Sept. 29, 1995]
Sec. 482.2 Provision of emergency services by nonparticipating
hospitals.
(a) The services of an institution that does not have an agreement
to participate in the Medicare program may, nevertheless, be reimbursed
under the program if--
(1) The services are emergency services; and
(2) The institution meets the requirements of section 1861(e) (1)
through (5) and (7) of the Act. Rules applicable to emergency services
furnished by nonparticipating hospitals are set forth in subpart G of
part 424 of this chapter.
(b) Section 440.170(e) of this chapter defines emergency hospital
services for purposes of Medicaid reimbursement.
[51 FR 22042, June 17, 1986, as amended at 53 FR 6648, Mar. 2, 1988]
Subpart B_Administration
Sec. 482.11 Condition of participation: Compliance with Federal,
State and local laws.
(a) The hospital must be in compliance with applicable Federal laws
related to the health and safety of patients.
(b) The hospital must be--
(1) Licensed; or
(2) Approved as meeting standards for licensing established by the
agency of the State or locality responsible for licensing hospitals.
(c) The hospital must assure that personnel are licensed or meet
other applicable standards that are required by State or local laws.
[[Page 7]]
Sec. 482.12 Condition of participation: Governing body.
There must be an effective governing body that is legally
responsible for the conduct of the hospital. If a hospital does not have
an organized governing body, the persons legally responsible for the
conduct of the hospital must carry out the functions specified in this
part that pertain to the governing body.
(a) Standard: Medical staff. The governing body must:
(1) Determine, in accordance with State law, which categories of
practitioners are eligible candidates for appointment to the medical
staff;
(2) Appoint members of the medical staff after considering the
recommendations of the existing members of the medical staff;
(3) Assure that the medical staff has bylaws;
(4) Approve medical staff bylaws and other medical staff rules and
regulations;
(5) Ensure that the medical staff is accountable to the governing
body for the quality of care provided to patients;
(6) Ensure the criteria for selection are individual character,
competence, training, experience, and judgment; and
(7) Ensure that under no circumstances is the accordance of staff
membership or professional privileges in the hospital dependent solely
upon certification, fellowship, or membership in a specialty body or
society.
(8) Ensure that, when telemedicine services are furnished to the
hospital's patients through an agreement with a distant-site hospital,
the agreement is written and that it specifies that it is the
responsibility of the governing body of the distant-site hospital to
meet the requirements in paragraphs (a)(1) through (a)(7) of this
section with regard to the distant-site hospital's physicians and
practitioners providing telemedicine services. The governing body of the
hospital whose patients are receiving the telemedicine services may, in
accordance with Sec. 482.22(a)(3) of this part, grant privileges based
on its medical staff recommendations that rely on information provided
by the distant-site hospital.
(9) Ensure that when telemedicine services are furnished to the
hospital's patients through an agreement with a distant-site
telemedicine entity, the written agreement specifies that the distant-
site telemedicine entity is a contractor of services to the hospital and
as such, in accordance with Sec. 482.12(e), furnishes the contracted
services in a manner that permits the hospital to comply with all
applicable conditions of participation for the contracted services,
including, but not limited to, the requirements in paragraphs (a)(1)
through (a)(7) of this section with regard to the distant-site
telemedicine entity's physicians and practitioners providing
telemedicine services. The governing body of the hospital whose patients
are receiving the telemedicine services may, in accordance with
Sec. 482.22(a)(4) of this part, grant privileges to physicians and
practitioners employed by the distant-site telemedicine entity based on
such hospital's medical staff recommendations; such staff
recommendations may rely on information provided by the distant-site
telemedicine entity.
(10) Consult directly with the individual assigned the
responsibility for the organization and conduct of the hospital's
medical staff, or his or her designee. At a minimum, this direct
consultation must occur periodically throughout the fiscal or calendar
year and include discussion of matters related to the quality of medical
care provided to patients of the hospital. For a multi-hospital system
using a single governing body, the single multi-hospital system
governing body must consult directly with the individual responsible for
the organized medical staff (or his or her designee) of each hospital
within its system in addition to the other requirements of this
paragraph (a).
(b) Standard: Chief executive officer. The governing body must
appoint a chief executive officer who is responsible for managing the
hospital.
(c) Standard: Care of patients. In accordance with hospital policy,
the governing body must ensure that the following requirements are met:
(1) Every Medicare patient is under the care of:
[[Page 8]]
(i) A doctor of medicine or osteopathy (This provision is not to be
construed to limit the authority of a doctor of medicine or osteopathy
to delegate tasks to other qualified health care personnel to the extent
recognized under State law or a State's regulatory mechanism.);
(ii) A doctor of dental surgery or dental medicine who is legally
authorized to practice dentistry by the State and who is acting within
the scope of his or her license;
(iii) A doctor of podiatric medicine, but only with respect to
functions which he or she is legally authorized by the State to perform;
(iv) A doctor of optometry who is legally authorized to practice
optometry by the State in which he or she practices;
(v) A chiropractor who is licensed by the State or legally
authorized to perform the services of a chiropractor, but only with
respect to treatment by means of manual manipulation of the spine to
correct a subluxation demonstrated by x-ray to exist; and
(vi) A clinical psychologist as defined in Sec. 410.71 of this
chapter, but only with respect to clinical psychologist services as
defined in Sec. 410.71 of this chapter and only to the extent permitted
by State law.
(2) Patients are admitted to the hospital only on the recommendation
of a licensed practitioner permitted by the State to admit patients to a
hospital. If a Medicare patient is admitted by a practitioner not
specified in paragraph (c)(1) of this section, that patient is under the
care of a doctor of medicine or osteopathy.
(3) A doctor of medicine or osteopathy is on duty or on call at all
times.
(4) A doctor of medicine or osteopathy is responsible for the care
of each Medicare patient with respect to any medical or psychiatric
problem that--
(i) is present on admission or develops during hospitalization; and
(ii) Is not specifically within the scope of practice of a doctor of
dental surgery, dental medicine, podiatric medicine, or optometry; a
chiropractor; or clinical psychologist, as that scope is--
(A) Defined by the medical staff;
(B) Permitted by State law; and
(C) Limited, under paragraph (c)(1)(v) of this section, with respect
to chiropractors.
(d) Standard: Institutional plan and budget. The institution must
have an overall institutional plan that meets the following conditions:
(1) The plan must include an annual operating budget that is
prepared according to generally accepted accounting principles.
(2) The budget must include all anticipated income and expenses.
This provision does not require that the budget identify item by item
the components of each anticipated income or expense.
(3) The plan must provide for capital expenditures for at least a 3-
year period, including the year in which the operating budget specified
in paragraph (d)(2) of this section is applicable.
(4) The plan must include and identify in detail the objective of,
and the anticipated sources of financing for, each anticipated capital
expenditure in excess of $600,000 (or a lesser amount that is
established, in accordance with section 1122(g)(1) of the Act, by the
State in which the hospital is located) that relates to any of the
following:
(i) Acquisition of land;
(ii) Improvement of land, buildings, and equipment; or
(iii) The replacement, modernization, and expansion of buildings and
equipment.
(5) The plan must be submitted for review to the planning agency
designated in accordance with section 1122(b) of the Act, or if an
agency is not designated, to the appropriate health planning agency in
the State. (See part 100 of this title.) A capital expenditure is not
subject to section 1122 review if 75 percent of the health care
facility's patients who are expected to use the service for which the
capital expenditure is made are individuals enrolled in a health
maintenance organization (HMO) or competitive medical plan (CMP) that
meets the requirements of section 1876(b) of the Act, and if the
Department determines that the capital expenditure is for services and
facilities that are needed by the HMO or CMP in order to operate
efficiently and
[[Page 9]]
economically and that are not otherwise readily accessible to the HMO or
CMP because--
(i) The facilities do not provide common services at the same site;
(ii) The facilities are not available under a contract of reasonable
duration;
(iii) Full and equal medical staff privileges in the facilities are
not available;
(iv) Arrangements with these facilities are not administratively
feasible; or
(v) The purchase of these services is more costly than if the HMO or
CMP provided the services directly.
(6) The plan must be reviewed and updated annually.
(7) The plan must be prepared--
(i) Under the direction of the governing body; and
(ii) By a committee consisting of representatives of the governing
body, the administrative staff, and the medical staff of the
institution.
(e) Standard: Contracted services. The governing body must be
responsible for services furnished in the hospital whether or not they
are furnished under contracts. The governing body must ensure that a
contractor of services (including one for shared services and joint
ventures) furnishes services that permit the hospital to comply with all
applicable conditions of participation and standards for the contracted
services.
(1) The governing body must ensure that the services performed under
a contract are provided in a safe and effective manner.
(2) The hospital must maintain a list of all contracted services,
including the scope and nature of the services provided.
(f) Standard: Emergency services. (1) If emergency services are
provided at the hospital, the hospital must comply with the requirements
of Sec. 482.55.
(2) If emergency services are not provided at the hospital, the
governing body must assure that the medical staff has written policies
and procedures for appraisal of emergencies, initial treatment, and
referral when appropriate.
(3) If emergency services are provided at the hospital but are not
provided at one or more off-campus departments of the hospital, the
governing body of the hospital must assure that the medical staff has
written policies and procedures in effect with respect to the off-campus
department(s) for appraisal of emergencies and referral when
appropriate.
[51 FR 22042, June 17, 1986; 51 FR 27847, Aug. 4, 1986, as amended at 53
FR 6549, Mar. 1, 1988; 53 FR 18987, May 26, 1988; 56 FR 8852, Mar. 1,
1991; 56 FR 23022, May 20, 1991; 59 FR 46514, Sept. 8, 1994; 63 FR
20130, Apr. 23, 1998; 63 FR 33874, June 22, 1998; 68 FR 53262, Sept. 9,
2003; 76 FR 25562, May 5, 2011; 77 FR 29074, May 16, 2012; 79 FR 27154,
May 12, 2014]
Sec. 482.13 Condition of participation: Patient's rights.
A hospital must protect and promote each patient's rights.
(a) Standard: Notice of rights--(1) A hospital must inform each
patient, or when appropriate, the patient's representative (as allowed
under State law), of the patient's rights, in advance of furnishing or
discontinuing patient care whenever possible.
(2) The hospital must establish a process for prompt resolution of
patient grievances and must inform each patient whom to contact to file
a grievance. The hospital's governing body must approve and be
responsible for the effective operation of the grievance process and
must review and resolve grievances, unless it delegates the
responsibility in writing to a grievance committee. The grievance
process must include a mechanism for timely referral of patient concerns
regarding quality of care or premature discharge to the appropriate
Utilization and Quality Control Quality Improvement Organization. At a
minimum:
(i) The hospital must establish a clearly explained procedure for
the submission of a patient's written or verbal grievance to the
hospital.
(ii) The grievance process must specify time frames for review of
the grievance and the provision of a response.
(iii) In its resolution of the grievance, the hospital must provide
the patient with written notice of its decision that contains the name
of the hospital contact person, the steps taken on behalf of the patient
to investigate the grievance, the results of the grievance process, and
the date of completion.
[[Page 10]]
(b) Standard: Exercise of rights. (1) The patient has the right to
participate in the development and implementation of his or her plan of
care.
(2) The patient or his or her representative (as allowed under State
law) has the right to make informed decisions regarding his or her care.
The patient's rights include being informed of his or her health status,
being involved in care planning and treatment, and being able to request
or refuse treatment. This right must not be construed as a mechanism to
demand the provision of treatment or services deemed medically
unnecessary or inappropriate.
(3) The patient has the right to formulate advance directives and to
have hospital staff and practitioners who provide care in the hospital
comply with these directives, in accordance with Sec. 489.100 of this
part (Definition), Sec. 489.102 of this part (Requirements for
providers), and Sec. 489.104 of this part (Effective dates).
(4) The patient has the right to have a family member or
representative of his or her choice and his or her own physician
notified promptly of his or her admission to the hospital.
(c) Standard: Privacy and safety. (1) The patient has the right to
personal privacy.
(2) The patient has the right to receive care in a safe setting.
(3) The patient has the right to be free from all forms of abuse or
harassment.
(d) Standard: Confidentiality of patient records. (1) The patient
has the right to the confidentiality of his or her clinical records.
(2) The patient has the right to access information contained in his
or her clinical records within a reasonable time frame. The hospital
must not frustrate the legitimate efforts of individuals to gain access
to their own medical records and must actively seek to meet these
requests as quickly as its record keeping system permits.
(e) Standard: Restraint or seclusion. All patients have the right to
be free from physical or mental abuse, and corporal punishment. All
patients have the right to be free from restraint or seclusion, of any
form, imposed as a means of coercion, discipline, convenience, or
retaliation by staff. Restraint or seclusion may only be imposed to
ensure the immediate physical safety of the patient, a staff member, or
others and must be discontinued at the earliest possible time.
(1) Definitions. (i) A restraint is--
(A) Any manual method, physical or mechanical device, material, or
equipment that immobilizes or reduces the ability of a patient to move
his or her arms, legs, body, or head freely; or
(B) A drug or medication when it is used as a restriction to manage
the patient's behavior or restrict the patient's freedom of movement and
is not a standard treatment or dosage for the patient's condition.
(C) A restraint does not include devices, such as orthopedically
prescribed devices, surgical dressings or bandages, protective helmets,
or other methods that involve the physical holding of a patient for the
purpose of conducting routine physical examinations or tests, or to
protect the patient from falling out of bed, or to permit the patient to
participate in activities without the risk of physical harm (this does
not include a physical escort).
(ii) Seclusion is the involuntary confinement of a patient alone in
a room or area from which the patient is physically prevented from
leaving. Seclusion may only be used for the management of violent or
self-destructive behavior.
(2) Restraint or seclusion may only be used when less restrictive
interventions have been determined to be ineffective to protect the
patient a staff member or others from harm.
(3) The type or technique of restraint or seclusion used must be the
least restrictive intervention that will be effective to protect the
patient, a staff member, or others from harm.
(4) The use of restraint or seclusion must be--
(i) In accordance with a written modification to the patient's plan
of care; and
(ii) Implemented in accordance with safe and appropriate restraint
and seclusion techniques as determined by hospital policy in accordance
with State law.
(5) The use of restraint or seclusion must be in accordance with the
order
[[Page 11]]
of a physician or other licensed independent practitioner who is
responsible for the care of the patient as specified under
Sec. 482.12(c) and authorized to order restraint or seclusion by
hospital policy in accordance with State law.
(6) Orders for the use of restraint or seclusion must never be
written as a standing order or on an as needed basis (PRN).
(7) The attending physician must be consulted as soon as possible if
the attending physician did not order the restraint or seclusion.
(8) Unless superseded by State law that is more restrictive--
(i) Each order for restraint or seclusion used for the management of
violent or self-destructive behavior that jeopardizes the immediate
physical safety of the patient, a staff member, or others may only be
renewed in accordance with the following limits for up to a total of 24
hours:
(A) 4 hours for adults 18 years of age or older;
(B) 2 hours for children and adolescents 9 to 17 years of age; or
(C) 1 hour for children under 9 years of age; and
(ii) After 24 hours, before writing a new order for the use of
restraint or seclusion for the management of violent or self-destructive
behavior, a physician or other licensed independent practitioner who is
responsible for the care of the patient as specified under
Sec. 482.12(c) of this part and authorized to order restraint or
seclusion by hospital policy in accordance with State law must see and
assess the patient.
(iii) Each order for restraint used to ensure the physical safety of
the non-violent or non-self-destructive patient may be renewed as
authorized by hospital policy.
(9) Restraint or seclusion must be discontinued at the earliest
possible time, regardless of the length of time identified in the order.
(10) The condition of the patient who is restrained or secluded must
be monitored by a physician, other licensed independent practitioner or
trained staff that have completed the training criteria specified in
paragraph (f) of this section at an interval determined by hospital
policy.
(11) Physician and other licensed independent practitioner training
requirements must be specified in hospital policy. At a minimum,
physicians and other licensed independent practitioners authorized to
order restraint or seclusion by hospital policy in accordance with State
law must have a working knowledge of hospital policy regarding the use
of restraint or seclusion.
(12) When restraint or seclusion is used for the management of
violent or self-destructive behavior that jeopardizes the immediate
physical safety of the patient, a staff member, or others, the patient
must be seen face-to-face within 1 hour after the initiation of the
intervention--
(i) By a--
(A) Physician or other licensed independent practitioner; or
(B) Registered nurse or physician assistant who has been trained in
accordance with the requirements specified in paragraph (f) of this
section.
(ii) To evaluate--
(A) The patient's immediate situation;
(B) The patient's reaction to the intervention;
(C) The patient's medical and behavioral condition; and
(D) The need to continue or terminate the restraint or seclusion.
(13) States are free to have requirements by statute or regulation
that are more restrictive than those contained in paragraph (e)(12)(i)
of this section.
(14) If the face-to-face evaluation specified in paragraph (e)(12)
of this section is conducted by a trained registered nurse or physician
assistant, the trained registered nurse or physician assistant must
consult the attending physician or other licensed independent
practitioner who is responsible for the care of the patient as specified
under Sec. 482.12(c) as soon as possible after the completion of the 1-
hour face-to-face evaluation.
(15) All requirements specified under this paragraph are applicable
to the simultaneous use of restraint and seclusion. Simultaneous
restraint and seclusion use is only permitted if the patient is
continually monitored--
(i) Face-to-face by an assigned, trained staff member; or
[[Page 12]]
(ii) By trained staff using both video and audio equipment. This
monitoring must be in close proximity to the patient.
(16) When restraint or seclusion is used, there must be
documentation in the patient's medical record of the following:
(i) The 1-hour face-to-face medical and behavioral evaluation if
restraint or seclusion is used to manage violent or self-destructive
behavior;
(ii) A description of the patient's behavior and the intervention
used;
(iii) Alternatives or other less restrictive interventions attempted
(as applicable);
(iv) The patient's condition or symptom(s) that warranted the use of
the restraint or seclusion; and
(v) The patient's response to the intervention(s) used, including
the rationale for continued use of the intervention.
(f) Standard: Restraint or seclusion: Staff training requirements.
The patient has the right to safe implementation of restraint or
seclusion by trained staff.
(1) Training intervals. Staff must be trained and able to
demonstrate competency in the application of restraints, implementation
of seclusion, monitoring, assessment, and providing care for a patient
in restraint or seclusion--
(i) Before performing any of the actions specified in this
paragraph;
(ii) As part of orientation; and
(iii) Subsequently on a periodic basis consistent with hospital
policy.
(2) Training content. The hospital must require appropriate staff to
have education, training, and demonstrated knowledge based on the
specific needs of the patient population in at least the following:
(i) Techniques to identify staff and patient behaviors, events, and
environmental factors that may trigger circumstances that require the
use of a restraint or seclusion.
(ii) The use of nonphysical intervention skills.
(iii) Choosing the least restrictive intervention based on an
individualized assessment of the patient's medical, or behavioral status
or condition.
(iv) The safe application and use of all types of restraint or
seclusion used in the hospital, including training in how to recognize
and respond to signs of physical and psychological distress (for
example, positional asphyxia);
(v) Clinical identification of specific behavioral changes that
indicate that restraint or seclusion is no longer necessary.
(vi) Monitoring the physical and psychological well-being of the
patient who is restrained or secluded, including but not limited to,
respiratory and circulatory status, skin integrity, vital signs, and any
special requirements specified by hospital policy associated with the 1-
hour face-to-face evaluation.
(vii) The use of first aid techniques and certification in the use
of cardiopulmonary resuscitation, including required periodic
recertification.
(3) Trainer requirements. Individuals providing staff training must
be qualified as evidenced by education, training, and experience in
techniques used to address patients' behaviors.
(4) Training documentation. The hospital must document in the staff
personnel records that the training and demonstration of competency were
successfully completed.
(g) Standard: Death reporting requirements: Hospitals must report
deaths associated with the use of seclusion or restraint.
(1) With the exception of deaths described under paragraph (g)(2) of
this section, the hospital must report the following information to CMS
by telephone, facsimile, or electronically, as determined by CMS, no
later than the close of business on the next business day following
knowledge of the patient's death:
(i) Each death that occurs while a patient is in restraint or
seclusion.
(ii) Each death that occurs within 24 hours after the patient has
been removed from restraint or seclusion.
(iii) Each death known to the hospital that occurs within 1 week
after restraint or seclusion where it is reasonable to assume that use
of restraint or placement in seclusion contributed directly or
indirectly to a patient's death, regardless of the type(s) of restraint
used on the patient during this time. ``Reasonable to assume'' in this
context includes, but is not limited to,
[[Page 13]]
deaths related to restrictions of movement for prolonged periods of
time, or death related to chest compression, restriction of breathing,
or asphyxiation.
(2) When no seclusion has been used and when the only restraints
used on the patient are those applied exclusively to the patient's
wrist(s), and which are composed solely of soft, non-rigid, cloth-like
materials, the hospital staff must record in an internal log or other
system, the following information:
(i) Any death that occurs while a patient is in such restraints.
(ii) Any death that occurs within 24 hours after a patient has been
removed from such restraints.
(3) The staff must document in the patient's medical record the date
and time the death was:
(i) Reported to CMS for deaths described in paragraph (g)(1) of this
section; or
(ii) Recorded in the internal log or other system for deaths
described in paragraph (g)(2) of this section.
(4) For deaths described in paragraph (g)(2) of this section,
entries into the internal log or other system must be documented as
follows:
(i) Each entry must be made not later than seven days after the date
of death of the patient.
(ii) Each entry must document the patient's name, date of birth,
date of death, name of attending physician or other licensed independent
practitioner who is responsible for the care of the patient as specified
under Sec. 482.12(c), medical record number, and primary diagnosis(es).
(iii) The information must be made available in either written or
electronic form to CMS immediately upon request.
(h) Standard: Patient visitation rights. A hospital must have
written policies and procedures regarding the visitation rights of
patients, including those setting forth any clinically necessary or
reasonable restriction or limitation that the hospital may need to place
on such rights and the reasons for the clinical restriction or
limitation. A hospital must meet the following requirements:
(1) Inform each patient (or support person, where appropriate) of
his or her visitation rights, including any clinical restriction or
limitation on such rights, when he or she is informed of his or her
other rights under this section.
(2) Inform each patient (or support person, where appropriate) of
the right, subject to his or her consent, to receive the visitors whom
he or she designates, including, but not limited to, a spouse, a
domestic partner (including a same-sex domestic partner), another family
member, or a friend, and his or her right to withdraw or deny such
consent at any time.
(3) Not restrict, limit, or otherwise deny visitation privileges on
the basis of race, color, national origin, religion, sex, gender
identity, sexual orientation, or disability.
(4) Ensure that all visitors enjoy full and equal visitation
privileges consistent with patient preferences.
[71 FR 71426, Dec. 8, 2006, as amended at 75 FR 70844, Nov. 19, 2010; 77
FR 29074, May 16, 2012]
Sec. 482.15 Condition of participation: Emergency preparedness.
The hospital must comply with all applicable Federal, State, and
local emergency preparedness requirements. The hospital must develop and
maintain a comprehensive emergency preparedness program that meets the
requirements of this section, utilizing an all-hazards approach. The
emergency preparedness program must include, but not be limited to, the
following elements:
(a) Emergency plan. The hospital must develop and maintain an
emergency preparedness plan that must be reviewed, and updated at least
annually. The plan must do the following:
(1) Be based on and include a documented, facility-based and
community-based risk assessment, utilizing an all-hazards approach.
(2) Include strategies for addressing emergency events identified by
the risk assessment.
(3) Address patient population, including, but not limited to,
persons at-risk; the type of services the hospital has the ability to
provide in an emergency; and continuity of operations, including
delegations of authority and succession plans.
[[Page 14]]
(4) Include a process for cooperation and collaboration with local,
tribal, regional, State, and Federal emergency preparedness officials'
efforts to maintain an integrated response during a disaster or
emergency situation, including documentation of the hospital's efforts
to contact such officials and, when applicable, its participation in
collaborative and cooperative planning efforts.
(b) Policies and procedures. The hospital must develop and implement
emergency preparedness policies and procedures, based on the emergency
plan set forth in paragraph (a) of this section, risk assessment at
paragraph (a)(1) of this section, and the communication plan at
paragraph (c) of this section. The policies and procedures must be
reviewed and updated at least annually. At a minimum, the policies and
procedures must address the following:
(1) The provision of subsistence needs for staff and patients,
whether they evacuate or shelter in place, include, but are not limited
to the following:
(i) Food, water, medical, and pharmaceutical supplies.
(ii) Alternate sources of energy to maintain the following:
(A) Temperatures to protect patient health and safety and for the
safe and sanitary storage of provisions.
(B) Emergency lighting.
(C) Fire detection, extinguishing, and alarm systems.
(D) Sewage and waste disposal.
(2) A system to track the location of on-duty staff and sheltered
patients in the hospital's care during an emergency. If on-duty staff
and sheltered patients are relocated during the emergency, the hospital
must document the specific name and location of the receiving facility
or other location.
(3) Safe evacuation from the hospital, which includes consideration
of care and treatment needs of evacuees; staff responsibilities;
transportation; identification of evacuation location(s); and primary
and alternate means of communication with external sources of
assistance.
(4) A means to shelter in place for patients, staff, and volunteers
who remain in the facility.
(5) A system of medical documentation that preserves patient
information, protects confidentiality of patient information, and
secures and maintains the availability of records.
(6) The use of volunteers in an emergency and other emergency
staffing strategies, including the process and role for integration of
State and Federally designated health care professionals to address
surge needs during an emergency.
(7) The development of arrangements with other hospitals and other
providers to receive patients in the event of limitations or cessation
of operations to maintain the continuity of services to hospital
patients.
(8) The role of the hospital under a waiver declared by the
Secretary, in accordance with section 1135 of the Act, in the provision
of care and treatment at an alternate care site identified by emergency
management officials.
(c) Communication plan. The hospital must develop and maintain an
emergency preparedness communication plan that complies with Federal,
State, and local laws and must be reviewed and updated at least
annually. The communication plan must include all of the following:
(1) Names and contact information for the following:
(i) Staff.
(ii) Entities providing services under arrangement.
(iii) Patients' physicians.
(iv) Other hospitals and CAHs
(v) Volunteers.
(2) Contact information for the following:
(i) Federal, State, tribal, regional, and local emergency
preparedness staff.
(ii) Other sources of assistance.
(3) Primary and alternate means for communicating with the
following:
(i) Hospital's staff.
(ii) Federal, State, tribal, regional, and local emergency
management agencies.
(4) A method for sharing information and medical documentation for
patients under the hospital's care, as necessary, with other health care
providers to maintain the continuity of care.
[[Page 15]]
(5) A means, in the event of an evacuation, to release patient
information as permitted under 45 CFR 164.510(b)(1)(ii).
(6) A means of providing information about the general condition and
location of patients under the facility's care as permitted under 45 CFR
164.510(b)(4).
(7) A means of providing information about the hospital's occupancy,
needs, and its ability to provide assistance, to the authority having
jurisdiction, the Incident Command Center, or designee.
(d) Training and testing. The hospital must develop and maintain an
emergency preparedness training and testing program that is based on the
emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, policies and procedures
at paragraph (b) of this section, and the communication plan at
paragraph (c) of this section. The training and testing program must be
reviewed and updated at least annually.
(1) Training program. The hospital must do all of the following:
(i) Initial training in emergency preparedness policies and
procedures to all new and existing staff, individuals providing services
under arrangement, and volunteers, consistent with their expected role.
(ii) Provide emergency preparedness training at least annually.
(iii) Maintain documentation of the training.
(iv) Demonstrate staff knowledge of emergency procedures.
(2) Testing. The hospital must conduct exercises to test the
emergency plan at least annually. The hospital must do all of the
following:
(i) Participate in a full-scale exercise that is community-based or
when a community-based exercise is not accessible, an individual,
facility-based. If the hospital experiences an actual natural or man-
made emergency that requires activation of the emergency plan, the
hospital is exempt from engaging in a community-based or individual,
facility-based full-scale exercise for 1 year following the onset of the
actual event.
(ii) Conduct an additional exercise that may include, but is not
limited to the following:
(A) A second full-scale exercise that is community-based or
individual, facility-based.
(B) A tabletop exercise that includes a group discussion led by a
facilitator, using a narrated, clinically-relevant emergency scenario,
and a set of problem statements, directed messages, or prepared
questions designed to challenge an emergency plan.
(iii) Analyze the hospital's response to and maintain documentation
of all drills, tabletop exercises, and emergency events, and revise the
hospital's emergency plan, as needed.
(e) Emergency and standby power systems. The hospital must implement
emergency and standby power systems based on the emergency plan set
forth in paragraph (a) of this section and in the policies and
procedures plan set forth in paragraphs (b)(1)(i) and (ii) of this
section.
(1) Emergency generator location. The generator must be located in
accordance with the location requirements found in the Health Care
Facilities Code (NFPA 99 and Tentative Interim Amendments TIA 12-2, TIA
12-3, TIA 12-4, TIA 12-5, and TIA 12-6), Life Safety Code (NFPA 101 and
Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-
4), and NFPA 110, when a new structure is built or when an existing
structure or building is renovated.
(2) Emergency generator inspection and testing. The hospital must
implement the emergency power system inspection, testing, and
maintenance requirements found in the Health Care Facilities Code, NFPA
110, and Life Safety Code.
(3) Emergency generator fuel. Hospitals that maintain an onsite fuel
source to power emergency generators must have a plan for how it will
keep emergency power systems operational during the emergency, unless it
evacuates.
(f) Integrated healthcare systems. If a hospital is part of a
healthcare system consisting of multiple separately certified healthcare
facilities that elects to have a unified and integrated emergency
preparedness program, the hospital may choose to participate in the
healthcare system's coordinated emergency preparedness program. If
elected,
[[Page 16]]
the unified and integrated emergency preparedness program must--
(1) Demonstrate that each separately certified facility within the
system actively participated in the development of the unified and
integrated emergency preparedness program.
(2) Be developed and maintained in a manner that takes into account
each separately certified facility's unique circumstances, patient
populations, and services offered.
(3) Demonstrate that each separately certified facility is capable
of actively using the unified and integrated emergency preparedness
program and is in compliance with the program.
(4) Include a unified and integrated emergency plan that meets the
requirements of paragraphs (a)(2), (3), and (4) of this section. The
unified and integrated emergency plan must also be based on and include
the following:
(i) A documented community-based risk assessment, utilizing an all-
hazards approach.
(ii) A documented individual facility-based risk assessment for each
separately certified facility within the health system, utilizing an
all-hazards approach.
(5) Include integrated policies and procedures that meet the
requirements set forth in paragraph (b) of this section, a coordinated
communication plan and training and testing programs that meet the
requirements of paragraphs (c) and (d) of this section, respectively.
(g) Transplant hospitals. If a hospital has one or more transplant
centers (as defined in Sec. 482.70)--
(1) A representative from each transplant center must be included in
the development and maintenance of the hospital's emergency preparedness
program; and
(2) The hospital must develop and maintain mutually agreed upon
protocols that address the duties and responsibilities of the hospital,
each transplant center, and the OPO for the DSA where the hospital is
situated, unless the hospital has been granted a waiver to work with
another OPO, during an emergency.
(h) The standards incorporated by reference in this section are
approved for incorporation by reference by the Director of the Office of
the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part
51. You may obtain the material from the sources listed below. You may
inspect a copy at the CMS Information Resource Center, 7500 Security
Boulevard, Baltimore, MD or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html. If any
changes in this edition of the Code are incorporated by reference, CMS
will publish a document in the Federal Register to announce the changes.
(1) National Fire Protection Association, 1 Batterymarch Park,
Quincy, MA 02169, www.nfpa.org, 1.617.770.3000.
(i) NFPA 99, Health Care Facilities Code, 2012 edition, issued
August 11, 2011.
(ii) Technical interim amendment (TIA) 12-2 to NFPA 99, issued
August 11, 2011.
(iii) TIA 12-3 to NFPA 99, issued August 9, 2012.
(iv) TIA 12-4 to NFPA 99, issued March 7, 2013.
(v) TIA 12-5 to NFPA 99, issued August 1, 2013.
(vi) TIA 12-6 to NFPA 99, issued March 3, 2014.
(vii) NFPA 101, Life Safety Code, 2012 edition, issued August 11,
2011.
(viii) TIA 12-1 to NFPA 101, issued August 11, 2011.
(ix) TIA 12-2 to NFPA 101, issued October 30, 2012.
(x) TIA 12-3 to NFPA 101, issued October 22, 2013.
(xi) TIA 12-4 to NFPA 101, issued October 22, 2013.
(xii) NFPA 110, Standard for Emergency and Standby Power Systems,
2010 edition, including TIAs to chapter 7, issued August 6, 2009.
(2) [Reserved]
[81 FR 64028, Sept. 16, 2016; 81 FR 80594, Nov. 16, 2016]
[[Page 17]]
Subpart C_Basic Hospital Functions
Sec. 482.21 Condition of participation: Quality assessment and
performance improvement program.
The hospital must develop, implement, and maintain an effective,
ongoing, hospital-wide, data-driven quality assessment and performance
improvement program. The hospital's governing body must ensure that the
program reflects the complexity of the hospital's organization and
services; involves all hospital departments and services (including
those services furnished under contract or arrangement); and focuses on
indicators related to improved health outcomes and the prevention and
reduction of medical errors. The hospital must maintain and demonstrate
evidence of its QAPI program for review by CMS.
(a) Standard: Program scope. (1) The program must include, but not
be limited to, an ongoing program that shows measurable improvement in
indicators for which there is evidence that it will improve health
outcomes and identify and reduce medical errors.
(2) The hospital must measure, analyze, and track quality
indicators, including adverse patient events, and other aspects of
performance that assess processes of care, hospital service and
operations.
(b) Standard: Program data. (1) The program must incorporate quality
indicator data including patient care data, and other relevant data, for
example, information submitted to, or received from, the hospital's
Quality Improvement Organization.
(2) The hospital must use the data collected to--
(i) Monitor the effectiveness and safety of services and quality of
care; and
(ii) Identify opportunities for improvement and changes that will
lead to improvement.
(3) The frequency and detail of data collection must be specified by
the hospital's governing body.
(c) Standard: Program activities. (1) The hospital must set
priorities for its performance improvement activities that--
(i) Focus on high-risk, high-volume, or problem-prone areas;
(ii) Consider the incidence, prevalence, and severity of problems in
those areas; and
(iii) Affect health outcomes, patient safety, and quality of care.
(2) Performance improvement activities must track medical errors and
adverse patient events, analyze their causes, and implement preventive
actions and mechanisms that include feedback and learning throughout the
hospital.
(3) The hospital must take actions aimed at performance improvement
and, after implementing those actions, the hospital must measure its
success, and track performance to ensure that improvements are
sustained.
(d) Standard: Performance improvement projects. As part of its
quality assessment and performance improvement program, the hospital
must conduct performance improvement projects.
(1) The number and scope of distinct improvement projects conducted
annually must be proportional to the scope and complexity of the
hospital's services and operations.
(2) A hospital may, as one of its projects, develop and implement an
information technology system explicitly designed to improve patient
safety and quality of care. This project, in its initial stage of
development, does not need to demonstrate measurable improvement in
indicators related to health outcomes.
(3) The hospital must document what quality improvement projects are
being conducted, the reasons for conducting these projects, and the
measurable progress achieved on these projects.
(4) A hospital is not required to participate in a QIO cooperative
project, but its own projects are required to be of comparable effort.
(e) Standard: Executive responsibilities. The hospital's governing
body (or organized group or individual who assumes full legal authority
and responsibility for operations of the hospital), medical staff, and
administrative officials are responsible and accountable for ensuring
the following:
(1) That an ongoing program for quality improvement and patient
safety,
[[Page 18]]
including the reduction of medical errors, is defined, implemented, and
maintained.
(2) That the hospital-wide quality assessment and performance
improvement efforts address priorities for improved quality of care and
patient safety; and that all improvement actions are evaluated.
(3) That clear expectations for safety are established.
(4) That adequate resources are allocated for measuring, assessing,
improving, and sustaining the hospital's performance and reducing risk
to patients.
(5) That the determination of the number of distinct improvement
projects is conducted annually.
[68 FR 3454, Jan. 24, 2003]
Sec. 482.22 Condition of participation: Medical staff.
The hospital must have an organized medical staff that operates
under bylaws approved by the governing body, and which is responsible
for the quality of medical care provided to patients by the hospital.
(a) Standard: Eligibility and process for appointment to medical
staff. The medical staff must be composed of doctors of medicine or
osteopathy. In accordance with State law, including scope-of-practice
laws, the medical staff may also include other categories of physicians
(as listed at Sec. 482.12(c)(1)) and non-physician practitioners who are
determined to be eligible for appointment by the governing body.
(1) The medical staff must periodically conduct appraisals of its
members.
(2) The medical staff must examine the credentials of all eligible
candidates for medical staff membership and make recommendations to the
governing body on the appointment of these candidates in accordance with
State law, including scope-of-practice laws, and the medical staff
bylaws, rules, and regulations. A candidate who has been recommended by
the medical staff and who has been appointed by the governing body is
subject to all medical staff bylaws, rules, and regulations, in addition
to the requirements contained in this section.
(3) When telemedicine services are furnished to the hospital's
patients through an agreement with a distant-site hospital, the
governing body of the hospital whose patients are receiving the
telemedicine services may choose, in lieu of the requirements in
paragraphs (a)(1) and (a)(2) of this section, to have its medical staff
rely upon the credentialing and privileging decisions made by the
distant-site hospital when making recommendations on privileges for the
individual distant-site physicians and practitioners providing such
services, if the hospital's governing body ensures, through its written
agreement with the distant-site hospital, that all of the following
provisions are met:
(i) The distant-site hospital providing the telemedicine services is
a Medicare-participating hospital.
(ii) The individual distant-site physician or practitioner is
privileged at the distant-site hospital providing the telemedicine
services, which provides a current list of the distant-site physician's
or practitioner's privileges at the distant-site hospital.
(iii) The individual distant-site physician or practitioner holds a
license issued or recognized by the State in which the hospital whose
patients are receiving the telemedicine services is located.
(iv) With respect to a distant-site physician or practitioner, who
holds current privileges at the hospital whose patients are receiving
the telemedicine services, the hospital has evidence of an internal
review of the distant-site physician's or practitioner's performance of
these privileges and sends the distant-site hospital such performance
information for use in the periodic appraisal of the distant-site
physician or practitioner. At a minimum, this information must include
all adverse events that result from the telemedicine services provided
by the distant-site physician or practitioner to the hospital's patients
and all complaints the hospital has received about the distant-site
physician or practitioner.
(4) When telemedicine services are furnished to the hospital's
patients through an agreement with a distant-site telemedicine entity,
the governing body of the hospital whose patients are receiving the
telemedicine services
[[Page 19]]
may choose, in lieu of the requirements in paragraphs (a)(1) and (a)(2)
of this section, to have its medical staff rely upon the credentialing
and privileging decisions made by the distant-site telemedicine entity
when making recommendations on privileges for the individual distant-
site physicians and practitioners providing such services, if the
hospital's governing body ensures, through its written agreement with
the distant-site telemedicine entity, that the distant-site telemedicine
entity furnishes services that, in accordance with Sec. 482.12(e),
permit the hospital to comply with all applicable conditions of
participation for the contracted services. The hospital's governing body
must also ensure, through its written agreement with the distant-site
telemedicine entity, that all of the following provisions are met:
(i) The distant-site telemedicine entity's medical staff
credentialing and privileging process and standards at least meet the
standards at Sec. 482.12(a)(1) through (a)(7) and Sec. 482.22(a)(1)
through (a)(2).
(ii) The individual distant-site physician or practitioner is
privileged at the distant-site telemedicine entity providing the
telemedicine services, which provides the hospital with a current list
of the distant-site physician's or practitioner's privileges at the
distant-site telemedicine entity.
(iii) The individual distant-site physician or practitioner holds a
license issued or recognized by the State in which the hospital whose
patients are receiving such telemedicine services is located.
(iv) With respect to a distant-site physician or practitioner, who
holds current privileges at the hospital whose patients are receiving
the telemedicine services, the hospital has evidence of an internal
review of the distant-site physician's or practitioner's performance of
these privileges and sends the distant-site telemedicine entity such
performance information for use in the periodic appraisal of the
distant-site physician or practitioner. At a minimum, this information
must include all adverse events that result from the telemedicine
services provided by the distant-site physician or practitioner to the
hospital's patients, and all complaints the hospital has received about
the distant-site physician or practitioner.
(b) Standard: Medical staff organization and accountability. The
medical staff must be well organized and accountable to the governing
body for the quality of the medical care provided to patients.
(1) The medical staff must be organized in a manner approved by the
governing body.
(2) If the medical staff has an executive committee, a majority of
the members of the committee must be doctors of medicine or osteopathy.
(3) The responsibility for organization and conduct of the medical
staff must be assigned only to one of the following:
(i) An individual doctor of medicine or osteopathy.
(ii) A doctor of dental surgery or dental medicine, when permitted
by State law of the State in which the hospital is located.
(iii) A doctor of podiatric medicine, when permitted by State law of
the State in which the hospital is located.
(4) If a hospital is part of a hospital system consisting of
multiple separately certified hospitals and the system elects to have a
unified and integrated medical staff for its member hospitals, after
determining that such a decision is in accordance with all applicable
State and local laws, each separately certified hospital must
demonstrate that:
(i) The medical staff members of each separately certified hospital
in the system (that is, all medical staff members who hold specific
privileges to practice at that hospital) have voted by majority, in
accordance with medical staff bylaws, either to accept a unified and
integrated medical staff structure or to opt out of such a structure and
to maintain a separate and distinct medical staff for their respective
hospital;
(ii) The unified and integrated medical staff has bylaws, rules, and
requirements that describe its processes for self-governance,
appointment, credentialing, privileging, and oversight, as well as its
peer review policies and due process rights guarantees, and
[[Page 20]]
which include a process for the members of the medical staff of each
separately certified hospital (that is, all medical staff members who
hold specific privileges to practice at that hospital) to be advised of
their rights to opt out of the unified and integrated medical staff
structure after a majority vote by the members to maintain a separate
and distinct medical staff for their hospital;
(iii) The unified and integrated medical staff is established in a
manner that takes into account each member hospital's unique
circumstances and any significant differences in patient populations and
services offered in each hospital; and
(iv) The unified and integrated medical staff establishes and
implements policies and procedures to ensure that the needs and concerns
expressed by members of the medical staff, at each of its separately
certified hospitals, regardless of practice or location, are given due
consideration, and that the unified and integrated medical staff has
mechanisms in place to ensure that issues localized to particular
hospitals are duly considered and addressed.
(c) Standard: Medical staff bylaws. The medical staff must adopt and
enforce bylaws to carry out its responsibilities. The bylaws must:
(1) Be approved by the governing body.
(2) Include a statement of the duties and privileges of each
category of medical staff (e.g., active, courtesy, etc.)
(3) Describe the organization of the medical staff.
(4) Describe the qualifications to be met by a candidate in order
for the medical staff to recommend that the candidate be appointed by
the governing body.
(5) Include a requirement that--
(i) A medical history and physical examination be completed and
documented for each patient no more than 30 days before or 24 hours
after admission or registration, but prior to surgery or a procedure
requiring anesthesia services. The medical history and physical
examination must be completed and documented by a physician (as defined
in section 1861(r) of the Act), an oromaxillofacial surgeon, or other
qualified licensed individual in accordance with State law and hospital
policy.
(ii) An updated examination of the patient, including any changes in
the patient's condition, be completed and documented within 24 hours
after admission or registration, but prior to surgery or a procedure
requiring anesthesia services, when the medical history and physical
examination are completed within 30 days before admission or
registration. The updated examination of the patient, including any
changes in the patient's condition, must be completed and documented by
a physician (as defined in section 1861(r) of the Act), an
oromaxillofacial surgeon, or other qualified licensed individual in
accordance with State law and hospital policy.
(6) Include criteria for determining the privileges to be granted to
individual practitioners and a procedure for applying the criteria to
individuals requesting privileges. For distant-site physicians and
practitioners requesting privileges to furnish telemedicine services
under an agreement with the hospital, the criteria for determining
privileges and the procedure for applying the criteria are also subject
to the requirements in Sec. 482.12(a)(8) and (a)(9), and
Sec. 482.22(a)(3) and (a)(4).
(d) Standard: Autopsies. The medical staff should attempt to secure
autopsies in all cases of unusual deaths and of medical-legal and
educational interest. The mechanism for documenting permission to
perform an autopsy must be defined. There must be a system for notifying
the medical staff, and specifically the attending practitioner, when an
autopsy is being performed.
[51 FR 22042, June 17, 1986, as amended at 59 FR 64152, Dec. 13, 1994;
71 FR 68694, Nov. 27, 2006; 72 FR 66933, Nov. 27, 2007; 76 FR 25563, May
5, 2011; 77 FR 29074, May 16, 2012; 79 FR 27154, May 12, 2014]
Sec. 482.23 Condition of participation: Nursing services.
The hospital must have an organized nursing service that provides
24-hour nursing services. The nursing services must be furnished or
supervised by a registered nurse.
[[Page 21]]
(a) Standard: Organization. The hospital must have a well-organized
service with a plan of administrative authority and delineation of
responsibilities for patient care. The director of the nursing service
must be a licensed registered nurse. He or she is responsible for the
operation of the service, including determining the types and numbers of
nursing personnel and staff necessary to provide nursing care for all
areas of the hospital.
(b) Standard: Staffing and delivery of care. The nursing service
must have adequate numbers of licensed registered nurses, licensed
practical (vocational) nurses, and other personnel to provide nursing
care to all patients as needed. There must be supervisory and staff
personnel for each department or nursing unit to ensure, when needed,
the immediate availability of a registered nurse for bedside care of any
patient.
(1) The hospital must provide 24-hour nursing services furnished or
supervised by a registered nurse, and have a licensed practical nurse or
registered nurse on duty at all times, except for rural hospitals that
have in effect a 24-hour nursing waiver granted under Sec. 488.54(c) of
this chapter.
(2) The nursing service must have a procedure to ensure that
hospital nursing personnel for whom licensure is required have valid and
current licensure.
(3) A registered nurse must supervise and evaluate the nursing care
for each patient.
(4) The hospital must ensure that the nursing staff develops, and
keeps current, a nursing care plan for each patient. The nursing care
plan may be part of an interdisciplinary care plan.
(5) A registered nurse must assign the nursing care of each patient
to other nursing personnel in accordance with the patient's needs and
the specialized qualifications and competence of the nursing staff
available.
(6) Non-employee licensed nurses who are working in the hospital
must adhere to the policies and procedures of the hospital. The director
of nursing service must provide for the adequate supervision and
evaluation of the clinical activities of non-employee nursing personnel
which occur within the responsibility of the nursing service.
(c) Standard: Preparation and administration of drugs. (1) Drugs and
biologicals must be prepared and administered in accordance with Federal
and State laws, the orders of the practitioner or practitioners
responsible for the patient's care as specified under Sec. 482.12(c),
and accepted standards of practice.
(i) Drugs and biologicals may be prepared and administered on the
orders of other practitioners not specified under Sec. 482.12(c) only if
such practitioners are acting in accordance with State law, including
scope-of-practice laws, hospital policies, and medical staff bylaws,
rules, and regulations.
(ii) Drugs and biologicals may be prepared and administered on the
orders contained within pre-printed and electronic standing orders,
order sets, and protocols for patient orders only if such orders meet
the requirements of Sec. 482.24(c)(3).
(2) All drugs and biologicals must be administered by, or under
supervision of, nursing or other personnel in accordance with Federal
and State laws and regulations, including applicable licensing
requirements, and in accordance with the approved medical staff policies
and procedures.
(3) With the exception of influenza and pneumococcal vaccines, which
may be administered per physician-approved hospital policy after an
assessment of contraindications, orders for drugs and biologicals must
be documented and signed by a practitioner who is authorized to write
orders in accordance with State law and hospital policy, and who is
responsible for the care of the patient as specified under
Sec. 482.12(c).
(i) If verbal orders are used, they are to be used infrequently.
(ii) When verbal orders are used, they must only be accepted by
persons who are authorized to do so by hospital policy and procedures
consistent with Federal and State law.
(iii) Orders for drugs and biologicals may be documented and signed
by other practitioners not specified under Sec. 482.12(c) only if such
practitioners are acting in accordance with State law,
[[Page 22]]
including scope-of-practice laws, hospital policies, and medical staff
bylaws, rules, and regulations.
(4) Blood transfusions and intravenous medications must be
administered in accordance with State law and approved medical staff
policies and procedures.
(5) There must be a hospital procedure for reporting transfusion
reactions, adverse drug reactions, and errors in administration of
drugs.
(6) The hospital may allow a patient (or his or her caregiver/
support person where appropriate) to self-administer both hospital-
issued medications and the patient's own medications brought into the
hospital, as defined and specified in the hospital's policies and
procedures.
(i) If the hospital allows a patient to self-administer specific
hospital-issued medications, then the hospital must have policies and
procedures in place to:
(A) Ensure that a practitioner responsible for the care of the
patient has issued an order, consistent with hospital policy, permitting
self-administration.
(B) Assess the capacity of the patient (or the patient's caregiver/
support person where appropriate) to self-administer the specified
medication(s).
(C) Instruct the patient (or the patient's caregiver/support person
where appropriate) in the safe and accurate administration of the
specified medication(s).
(D) Address the security of the medication(s) for each patient.
(E) Document the administration of each medication, as reported by
the patient (or the patient's caregiver/support person where
appropriate), in the patient's medical record.
(ii) If the hospital allows a patient to self-administer his or her
own specific medications brought into the hospital, then the hospital
must have policies and procedures in place to:
(A) Ensure that a practitioner responsible for the care of the
patient has issued an order, consistent with hospital policy, permitting
self-administration of medications the patient brought into the
hospital.
(B) Assess the capacity of the patient (or the patient's caregiver/
support person where appropriate) to self-administer the specified
medication(s), and also determine if the patient (or the patient's
caregiver/support person where appropriate) needs instruction in the
safe and accurate administration of the specified medication(s).
(C) Identify the specified medication(s) and visually evaluate the
medication(s) for integrity.
(D) Address the security of the medication(s) for each patient.
(E) Document the administration of each medication, as reported by
the patient (or the patient's caregiver/support person where
appropriate), in the patient's medical record.
[51 FR 22042, June 17, 1986, as amended at 67 FR 61814, Oct. 2, 2002; 71
FR 68694, Nov. 27, 2006; 72 FR 66933, Nov. 27, 2007; 77 FR 29074, May
16, 2012; 78 FR 50970, Aug. 19, 2013; 79 FR 44129, July 30, 2014]
Sec. 482.24 Condition of participation: Medical record services.
The hospital must have a medical record service that has
administrative responsibility for medical records. A medical record must
be maintained for every individual evaluated or treated in the hospital.
(a) Standard: Organization and staffing. The organization of the
medical record service must be appropriate to the scope and complexity
of the services performed. The hospital must employ adequate personnel
to ensure prompt completion, filing, and retrieval of records.
(b) Standard: Form and retention of record. The hospital must
maintain a medical record for each inpatient and outpatient. Medical
records must be accurately written, promptly completed, properly filed
and retained, and accessible. The hospital must use a system of author
identification and record maintenance that ensures the integrity of the
authentification and protects the security of all record entries.
(1) Medical records must be retained in their original or legally
reproduced form for a period of at least 5 years.
(2) The hospital must have a system of coding and indexing medical
records. The system must allow for timely retrieval by diagnosis and
procedure, in order to support medical care evaluation studies.
[[Page 23]]
(3) The hospital must have a procedure for ensuring the
confidentiality of patient records. In-formation from or copies of
records may be released only to authorized individuals, and the hospital
must ensure that unauthorized individuals cannot gain access to or alter
patient records. Original medical records must be released by the
hospital only in accordance with Federal or State laws, court orders, or
subpoenas.
(c) Standard: Content of record. The medical record must contain
information to justify admission and continued hospitalization, support
the diagnosis, and describe the patient's progress and response to
medications and services.
(1) All patient medical record entries must be legible, complete,
dated, timed, and authenticated in written or electronic form by the
person responsible for providing or evaluating the service provided,
consistent with hospital policies and procedures.
(2) All orders, including verbal orders, must be dated, timed, and
authenticated promptly by the ordering practitioner or by another
practitioner who is responsible for the care of the patient only if such
a practitioner is acting in accordance with State law, including scope-
of-practice laws, hospital policies, and medical staff bylaws, rules,
and regulations.
(3) Hospitals may use pre-printed and electronic standing orders,
order sets, and protocols for patient orders only if the hospital:
(i) Establishes that such orders and protocols have been reviewed
and approved by the medical staff and the hospital's nursing and
pharmacy leadership;
(ii) Demonstrates that such orders and protocols are consistent with
nationally recognized and evidence-based guidelines;
(iii) Ensures that the periodic and regular review of such orders
and protocols is conducted by the medical staff and the hospital's
nursing and pharmacy leadership to determine the continuing usefulness
and safety of the orders and protocols; and
(iv) Ensures that such orders and protocols are dated, timed, and
authenticated promptly in the patient's medical record by the ordering
practitioner or by another practitioner responsible for the care of the
patient only if such a practitioner is acting in accordance with State
law, including scope-of-practice laws, hospital policies, and medical
staff bylaws, rules, and regulations.
(4) All records must document the following, as appropriate:
(i) Evidence of--
(A) A medical history and physical examination completed and
documented no more than 30 days before or 24 hours after admission or
registration, but prior to surgery or a procedure requiring anesthesia
services. The medical history and physical examination must be placed in
the patient's medical record within 24 hours after admission or
registration, but prior to surgery or a procedure requiring anesthesia
services.
(B) An updated examination of the patient, including any changes in
the patient's condition, when the medical history and physical
examination are completed within 30 days before admission or
registration. Documentation of the updated examination must be placed in
the patient's medical record within 24 hours after admission or
registration, but prior to surgery or a procedure requiring anesthesia
services.
(ii) Admitting diagnosis.
(iii) Results of all consultative evaluations of the patient and
appropriate findings by clinical and other staff involved in the care of
the patient.
(iv) Documentation of complications, hospital acquired infections,
and unfavorable reactions to drugs and anesthesia.
(v) Properly executed informed consent forms for procedures and
treatments specified by the medical staff, or by Federal or State law if
applicable, to require written patient consent.
(vi) All practitioners' orders, nursing notes, reports of treatment,
medication records, radiology, and laboratory reports, and vital signs
and other information necessary to monitor the patient's condition.
(vii) Discharge summary with outcome of hospitalization, disposition
of case, and provisions for follow-up care.
[[Page 24]]
(viii) Final diagnosis with completion of medical records within 30
days following discharge.
[51 FR 22042, June 17, 1986, as amended at 71 FR 68694, Nov. 27, 2006;
72 FR 66933, Nov. 27, 2007; 77 FR 29074, May 16, 2012]
Sec. 482.25 Condition of participation: Pharmaceutical services.
The hospital must have pharmaceutical services that meet the needs
of the patients. The institution must have a pharmacy directed by a
registered pharmacist or a drug storage area under competent
supervision. The medical staff is responsible for developing policies
and procedures that minimize drug errors. This function may be delegated
to the hospital's organized pharmaceutical service.
(a) Standard: Pharmacy management and administration. The pharmacy
or drug storage area must be administered in accordance with accepted
professional principles.
(1) A full-time, part-time, or consulting pharmacist must be
responsible for developing, supervising, and coordinating all the
activities of the pharmacy services.
(2) The pharmaceutical service must have an adequate number of
personnel to ensure quality pharmaceutical services, including emergency
services.
(3) Current and accurate records must be kept of the receipt and
disposition of all scheduled drugs.
(b) Standard: Delivery of services. In order to provide patient
safety, drugs and biologicals must be controlled and distributed in
accordance with applicable standards of practice, consistent with
Federal and State law.
(1) All compounding, packaging, and dispensing of drugs and
biologicals must be under the supervision of a pharmacist and performed
consistent with State and Federal laws.
(2)(i) All drugs and biologicals must be kept in a secure area, and
locked when appropriate.
(ii) Drugs listed in Schedules II, III, IV, and V of the
Comprehensive Drug Abuse Prevention and Control Act of 1970 must be kept
locked within a secure area.
(iii) Only authorized personnel may have access to locked areas.
(3) Outdated, mislabeled, or otherwise unusable drugs and
biologicals must not be available for patient use.
(4) When a pharmacist is not available, drugs and biologicals must
be removed from the pharmacy or storage area only by personnel
designated in the policies of the medical staff and pharmaceutical
service, in accordance with Federal and State law.
(5) Drugs and biologicals not specifically prescribed as to time or
number of doses must automatically be stopped after a reasonable time
that is predetermined by the medical staff.
(6) Drug administration errors, adverse drug reactions, and
incompatibilities must be immediately reported to the attending
physician and, if appropriate, to the hospital's quality assessment and
performance improvement program.
(7) Abuses and losses of controlled substances must be reported, in
accordance with applicable Federal and State laws, to the individual
responsible for the pharmaceutical service, and to the chief executive
officer, as appropriate.
(8) Information relating to drug interactions and information of
drug therapy, side effects, toxicology, dosage, indications for use, and
routes of administration must be available to the professional staff.
(9) A formulary system must be established by the medical staff to
assure quality pharmaceuticals at reasonable costs.
[51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986; 71 FR 68694,
Nov. 27, 2006; 77 FR 29075, May 16, 2012]
Sec. 482.26 Condition of participation: Radiologic services.
The hospital must maintain, or have available, diagnostic radiologic
services. If therapeutic services are also provided, they, as well as
the diagnostic services, must meet professionally approved standards for
safety and personnel qualifications.
(a) Standard: Radiologic services. The hospital must maintain, or
have available, radiologic services according to needs of the patients.
[[Page 25]]
(b) Standard: Safety for patients and personnel. The radiologic
services, particularly ionizing radiology procedures, must be free from
hazards for patients and personnel.
(1) Proper safety precutions must be maintained against radiation
hazards. This includes adequate shielding for patients, personnel, and
facilities, as well as appropriate storage, use, and disposal of
radioactive materials.
(2) Periodic inspection of equipment must be made and hazards
identified must be promptly corrected.
(3) Radiation workers must be checked periodically, by the use of
exposure meters or badge tests, for amount of radiation exposure.
(4) Radiologic services must be provided only on the order of
practitioners with clinical privileges or, consistent with State law, of
other practitioners authorized by the medical staff and the governing
body to order the services.
(c) Standard: Personnel. (1) A qualified full-time, part-time, or
consulting radiologist must supervise the ionizing radiology services
and must interpret only those radiologic tests that are determined by
the medical staff to require a radiologist's specialized knowledge. For
purposes of this section, a radiologist is a doctor of medicine or
osteopathy who is qualified by education and experience in radiology.
(2) Only personnel designated as qualified by the medical staff may
use the radiologic equipment and administer procedures.
(d) Standard: Records. Records of radiologic services must be
maintained.
(1) The radiologist or other practitioner who performs radiology
services must sign reports of his or her interpretations.
(2) The hospital must maintain the following for at least 5 years:
(i) Copies of reports and printouts.
(ii) Films, scans, and other image records, as appropriate.
[51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986]
Sec. 482.27 Condition of participation: Laboratory services.
The hospital must maintain, or have available, adequate laboratory
services to meet the needs of its patients. The hospital must ensure
that all laboratory services provided to its patients are performed in a
facility certified in accordance with part 493 of this chapter.
(a) Standard: Adequacy of laboratory services. The hospital must
have laboratory services available, either directly or through a
contractual agreement with a certified laboratory that meets
requirements of part 493 of this chapter.
(1) Emergency laboratory services must be available 24 hours a day.
(2) A written description of services provided must be available to
the medical staff.
(3) The laboratory must make provision for proper receipt and
reporting of tissue specimens.
(4) The medical staff and a pathologist must determine which tissue
specimens require a macroscopic (gross) examination and which require
both macroscopic and microscopic examinations.
(b) Standard: Potentially infectious blood and blood components--(1)
Potentially human immunodeficiency virus (HIV) infectious blood and
blood components. Potentially HIV infectious blood and blood components
are prior collections from a donor--
(i) Who tested negative at the time of donation but tests reactive
for evidence of HIV infection on a later donation;
(ii) Who tests positive on the supplemental (additional, more
specific) test or other follow-up testing required by FDA; and
(iii) For whom the timing of seroconversion cannot be precisely
estimated.
(2) Potentially hepatitis C virus (HCV) infectious blood and blood
components. Potentially HCV infectious blood and blood components are
the blood and blood components identified in 21 CFR 610.47.
(3) Services furnished by an outside blood collecting establishment.
If a hospital regularly uses the services of an outside blood collecting
establishment, it must have an agreement with the blood collecting
establishment that governs the procurement, transfer, and availability
of blood and blood components. The agreement must require
[[Page 26]]
that the blood collecting establishment notify the hospital--
(i) Within 3 calendar days if the blood collecting establishment
supplied blood and blood components collected from a donor who tested
negative at the time of donation but tests reactive for evidence of HIV
or HCV infection on a later donation or who is determined to be at
increased risk for transmitting HIV or HCV infection;
(ii) Within 45 days of the test, of the results of the supplemental
(additional, more specific) test for HIV or HCV, as relevant, or other
follow-up testing required by FDA; and
(iii) Within 3 calendar days after the blood collecting
establishment supplied blood and blood components collected from an
infectious donor, whenever records are available, as set forth at 21 CFR
610.48(b)(3).
(4) Quarantine and disposition of blood and blood components pending
completion of testing. If the blood collecting establishment (either
internal or under an agreement) notifies the hospital of the reactive
HIV or HCV screening test results, the hospital must determine the
disposition of the blood or blood product and quarantine all blood and
blood components from previous donations in inventory.
(i) If the blood collecting establishment notifies the hospital that
the result of the supplemental (additional, more specific) test or other
follow-up testing required by FDA is negative, absent other informative
test results, the hospital may release the blood and blood components
from quarantine.
(ii) If the blood collecting establishment notifies the hospital
that the result of the supplemental, (additional, more specific) test or
other follow-up testing required by FDA is positive, the hospital must--
(A) Dispose of the blood and blood components; and
(B) Notify the transfusion beneficiaries as set forth in paragraph
(b)(6) of this section.
(iii) If the blood collecting establishment notifies the hospital
that the result of the supplemental, (additional, more specific) test or
other follow-up testing required by FDA is indeterminate, the hospital
must destroy or label prior collections of blood or blood components
held in quarantine as set forth at 21 CFR 610.46(b)(2), 610.47(b)(2),
and 610.48(c)(2).
(5) Recordkeeping by the hospital. The hospital must maintain--
(i) Records of the source and disposition of all units of blood and
blood components for at least 10 years from the date of disposition in a
manner that permits prompt retrieval; and
(ii) A fully funded plan to transfer these records to another
hospital or other entity if such hospital ceases operation for any
reason.
(6) Patient notification. If the hospital has administered
potentially HIV or HCV infectious blood or blood components (either
directly through its own blood collecting establishment or under an
agreement) or released such blood or blood components to another entity
or individual, the hospital must take the following actions:
(i) Make reasonable attempts to notify the patient, or to notify the
attending physician or the physician who ordered the blood or blood
component and ask the physician to notify the patient, or other
individual as permitted under paragraph (b)(10) of this section, that
potentially HIV or HCV infectious blood or blood components were
transfused to the patient and that there may be a need for HIV or HCV
testing and counseling.
(ii) If the physician is unavailable or declines to make the
notification, make reasonable attempts to give this notification to the
patient, legal guardian, or relative.
(iii) Document in the patient's medical record the notification or
attempts to give the required notification.
(7) Timeframe for notification--(i) For donors tested on or after
February 20, 2008. For notifications resulting from donors tested on or
after February 20, 2008 as set forth at 21 CFR 610.46 and 21 CFR 610.47
the notification effort begins when the blood collecting establishment
notifies the hospital that it received potentially HIV or HCV infectious
blood and blood components. The hospital must make reasonable attempts
to give notification over a period of 12 weeks unless--
(A) The patient is located and notified; or
[[Page 27]]
(B) The hospital is unable to locate the patient and documents in
the patient's medical record the extenuating circumstances beyond the
hospital's control that caused the notification timeframe to exceed 12
weeks.
(ii) For donors tested before February 20, 2008. For notifications
resulting from donors tested before February 20, 2008 as set forth at 21
CFR 610.48(b) and (c), the notification effort begins when the blood
collecting establishment notifies the hospital that it received
potentially HCV infectious blood and blood components. The hospital must
make reasonable attempts to give notification and must complete the
actions within 1 year of the date on which the hospital received
notification from the outside blood collecting establishment.
(8) Content of notification. The notification must include the
following information:
(i) A basic explanation of the need for HIV or HCV testing and
counseling;
(ii) Enough oral or written information so that an informed decision
can be made about whether to obtain HIV or HCV testing and counseling;
and
(iii) A list of programs or places where the person can obtain HIV
or HCV testing and counseling, including any requirements or
restrictions the program may impose.
(9) Policies and procedures. The hospital must establish policies
and procedures for notification and documentation that conform to
Federal, State, and local laws, including requirements for the
confidentiality of medical records and other patient information.
(10) Notification to legal representative or relative. If the
patient has been adjudged incompetent by a State court, the physician or
hospital must notify a legal representative designated in accordance
with State law. If the patient is competent, but State law permits a
legal representative or relative to receive the information on the
patient's behalf, the physician or hospital must notify the patient or
his or her legal representative or relative. For possible HIV infectious
transfusion beneficiaries that are deceased, the physician or hospital
must inform the deceased patient's legal representative or relative. If
the patient is a minor, the parents or legal guardian must be notified.
(11) Applicability. HCV notification requirements resulting from
donors tested before February 20, 2008 as set forth at 21 CFR 610.48
will expire on August 24, 2015.
(c) General blood safety issues. For lookback activities only
related to new blood safety issues that are identified after August 24,
2007, hospitals must comply with FDA regulations as they pertain to
blood safety issues in the following areas:
(1) Appropriate testing and quarantining of infectious blood and
blood components.
(2) Notification and counseling of beneficiaries that may have
received infectious blood and blood components.
[57 FR 7136, Feb. 28, 1992, as amended at 61 FR 47433, Sept. 9, 1996; 72
FR 48573, Aug. 24, 2007]
Sec. 482.28 Condition of participation: Food and dietetic services.
The hospital must have organized dietary services that are directed
and staffed by adequate qualified personnel. However, a hospital that
has a contract with an outside food management company may be found to
meet this Condition of participation if the company has a dietitian who
serves the hospital on a full-time, part-time, or consultant basis, and
if the company maintains at least the minimum standards specified in
this section and provides for constant liaison with the hospital medical
staff for recommendations on dietetic policies affecting patient
treatment.
(a) Standard: Organization. (1) The hospital must have a full-time
employee who--
(i) Serves as director of the food and dietetic service;
(ii) Is responsible for the daily management of the dietary
services; and
(iii) Is qualified by experience or training.
(2) There must be a qualified dietitian, full-time, part-time, or on
a consultant basis.
(3) There must be administrative and technical personnel competent
in their respective duties.
(b) Standard: Diets. Menus must meet the needs of the patients.
[[Page 28]]
(1) Individual patient nutritional needs must be met in accordance
with recognized dietary practices.
(2) All patient diets, including therapeutic diets, must be ordered
by a practitioner responsible for the care of the patient, or by a
qualified dietitian or qualified nutrition professional as authorized by
the medical staff and in accordance with State law governing dietitians
and nutrition professionals.
(3) A current therapeutic diet manual approved by the dietitian and
medical staff must be readily available to all medical, nursing, and
food service personnel.
[51 FR 22042, June 17, 1986, as amended at 79 FR 27154, May 12, 2014]
Sec. 482.30 Condition of participation: Utilization review.
The hospital must have in effect a utilization review (UR) plan that
provides for review of services furnished by the institution and by
members of the medical staff to patients entitled to benefits under the
Medicare and Medicaid programs.
(a) Applicability. The provisions of this section apply except in
either of the following circumstances:
(1) A Utilization and Quality Control Quality Improvement
Organization (QIO) has assumed binding review for the hospital.
(2) CMS has determined that the UR procedures established by the
State under title XIX of the Act are superior to the procedures required
in this section, and has required hospitals in that State to meet the UR
plan requirements under Secs. 456.50 through 456.245 of this chapter.
(b) Standard: Composition of utilization review committee. A UR
committee consisting of two or more practitioners must carry out the UR
function. At least two of the members of the committee must be doctors
of medicine or osteopathy. The other members may be any of the other
types of practitioners specified in Sec. 482.12(c)(1).
(1) Except as specified in paragraphs (b) (2) and (3) of this
section, the UR committee must be one of the following:
(i) A staff committee of the institution;
(ii) A group outside the institution--
(A) Established by the local medical society and some or all of the
hospitals in the locality; or
(B) Established in a manner approved by CMS.
(2) If, because of the small size of the institution, it is
impracticable to have a properly functioning staff committee, the UR
committee must be established as specified in paragraph (b)(1)(ii) of
this section.
(3) The committee's or group's reviews may not be conducted by any
individual who--
(i) Has a direct financial interest (for example, an ownership
interest) in that hospital; or
(ii) Was professionally involved in the care of the patient whose
case is being reviewed.
(c) Standard: Scope and frequency of review. (1) The UR plan must
provide for review for Medicare and Medicaid patients with respect to
the medical necessity of--
(i) Admissions to the institution;
(ii) The duration of stays; and
(iii) Professional services furnished, including drugs and
biologicals.
(2) Review of admissions may be performed before, at, or after
hospital admission.
(3) Except as specified in paragraph (e) of this section, reviews
may be conducted on a sample basis.
(4) Hospitals that are paid for inpatient hospital services under
the prospective payment system set forth in part 412 of this chapter
must conduct review of duration of stays and review of professional
services as follows:
(i) For duration of stays, these hospitals need review only cases
that they reasonably assume to be outlier cases based on extended length
of stay, as described in Sec. 412.80(a)(1)(i) of this chapter; and
(ii) For professional services, these hospitals need review only
cases that they reasonably assume to be outlier cases based on
extraordinarily high costs, as described in Sec. 412.80(a)(1)(ii) of
this chapter.
(d) Standard: Determination regarding admissions or continued stays.
(1) The determination that an admission or continued stay is not
medically necessary--
[[Page 29]]
(i) May be made by one member of the UR committee if the
practitioner or practitioners responsible for the care of the patient,
as specified of Sec. 482.12(c), concur with the determination or fail to
present their views when afforded the opportunity; and
(ii) Must be made by at least two members of the UR committee in all
other cases.
(2) Before making a determination that an admission or continued
stay is not medically necessary, the UR committee must consult the
practitioner or practitioners responsible for the care of the patient,
as specified in Sec. 482.12(c), and afford the practitioner or
practitioners the opportunity to present their views.
(3) If the committee decides that admission to or continued stay in
the hospital is not medically necessary, written notification must be
given, no later than 2 days after the determination, to the hospital,
the patient, and the practitioner or practitioners responsible for the
care of the patient, as specified in Sec. 482.12(c);
(e) Standard: Extended stay review. (1) In hospitals that are not
paid under the prospective payment system, the UR committee must make a
periodic review, as specified in the UR plan, of each current inpatient
receiving hospital services during a continuous period of extended
duration. The scheduling of the periodic reviews may--
(i) Be the same for all cases; or
(ii) Differ for different classes of cases.
(2) In hospitals paid under the prospective payment system, the UR
committee must review all cases reasonably assumed by the hospital to be
outlier cases because the extended length of stay exceeds the threshold
criteria for the diagnosis, as described in Sec. 412.80(a)(1)(i). The
hospital is not required to review an extended stay that does not exceed
the outlier threshold for the diagnosis.
(3) The UR committee must make the periodic review no later than 7
days after the day required in the UR plan.
(f) Standard: Review of professional services. The committee must
review professional services provided, to determine medical necessity
and to promote the most efficient use of available health facilities and
services.
Sec. 482.41 Condition of participation: Physical environment.
The hospital must be constructed, arranged, and maintained to ensure
the safety of the patient, and to provide facilities for diagnosis and
treatment and for special hospital services appropriate to the needs of
the community.
(a) Standard: Buildings. The condition of the physical plant and the
overall hospital environment must be developed and maintained in such a
manner that the safety and well-being of patients are assured.
(1) There must be emergency power and lighting in at least the
operating, recovery, intensive care, and emergency rooms, and
stairwells. In all other areas not serviced by the emergency supply
source, battery lamps and flashlights must be available.
(2) There must be facilities for emergency gas and water supply.
(b) Standard: Life safety from fire. (1) Except as otherwise
provided in this section--
(i) The hospital must meet the applicable provisions and must
proceed in accordance with the Life Safety Code (NFPA 101 and Tentative
Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4.)
Outpatient surgical departments must meet the provisions applicable to
Ambulatory Health Care Occupancies, regardless of the number of patients
served.
(ii) Notwithstanding paragraph (b)(1)(i) of this section, corridor
doors and doors to rooms containing flammable or combustible materials
must be provided with positive latching hardware. Roller latches are
prohibited on such doors.
(2) In consideration of a recommendation by the State survey agency
or Accrediting Organization or at the discretion of the Secretary, may
waive, for periods deemed appropriate, specific provisions of the Life
Safety Code, which would result in unreasonable hardship upon a
hospital, but only if the waiver will not adversely affect the health
and safety of the patients.
(3) The provisions of the Life Safety Code do not apply in a State
where CMS finds that a fire and safety code
[[Page 30]]
imposed by State law adequately protects patients in hospitals.
(4) The hospital must have procedures for the proper routine storage
and prompt disposal of trash.
(5) The hospital must have written fire control plans that contain
provisions for prompt reporting of fires; extinguishing fires;
protection of patients, personnel and guests; evacuation; and
cooperation with fire fighting authorities.
(6) The hospital must maintain written evidence of regular
inspection and approval by State or local fire control agencies.
(7) A hospital may install alcohol-based hand rub dispensers in its
facility if the dispensers are installed in a manner that adequately
protects against inappropriate access;
(8) When a sprinkler system is shut down for more than 10 hours, the
hospital must:
(i) Evacuate the building or portion of the building affected by the
system outage until the system is back in service, or
(ii) Establish a fire watch until the system is back in service.
(9) Buildings must have an outside window or outside door in every
sleeping room, and for any building constructed after July 5, 2016 the
sill height must not exceed 36 inches above the floor. Windows in atrium
walls are considered outside windows for the purposes of this
requirement.
(i) The sill height requirement does not apply to newborn nurseries
and rooms intended for occupancy for less than 24 hours.
(ii) The sill height in special nursing care areas of new
occupancies must not exceed 60 inches.
(c) Standard: Building safety. Except as otherwise provided in this
section, the hospital must meet the applicable provisions and must
proceed in accordance with the Health Care Facilities Code (NFPA 99 and
Tentative Interim Amendments TIA 12-2, TIA 12-3, TIA 12-4, TIA 12-5 and
TIA 12-6).
(1) Chapters 7, 8, 12, and 13 of the adopted Health Care Facilities
Code do not apply to a hospital.
(2) If application of the Health Care Facilities Code required under
paragraph (c) of this section would result in unreasonable hardship for
the hospital, CMS may waive specific provisions of the Health Care
Facilities Code, but only if the waiver does not adversely affect the
health and safety of patients.
(d) Standard: Facilities. The hospital must maintain adequate
facilities for its services.
(1) Diagnostic and therapeutic facilities must be located for the
safety of patients.
(2) Facilities, supplies, and equipment must be maintained to ensure
an acceptable level of safety and quality.
(3) The extent and complexity of facilities must be determined by
the services offered.
(4) There must be proper ventilation, light, and temperature
controls in pharmaceutical, food preparation, and other appropriate
areas.
(e) The standards incorporated by reference in this section are
approved for incorporation by reference by the Director of the Office of
the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part
51. You may inspect a copy at the CMS Information Resource Center, 7500
Security Boulevard, Baltimore, MD or at the National Archives and
Records Administration (NARA). For information on the availability of
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html. If any changes in this edition of the Code are
incorporated by reference, CMS will publish a document in the Federal
Register to announce the changes.
(1) National Fire Protection Association, 1 Batterymarch Park,
Quincy, MA 02169, www.nfpa.org, 1.617.770.3000.
(i) NFPA 99, Standards for Health Care Facilities Code of the
National Fire Protection Association 99, 2012 edition, issued August 11,
2011.
(ii) TIA 12-2 to NFPA 99, issued August 11, 2011.
(iii) TIA 12-3 to NFPA 99, issued August 9, 2012.
(iv) TIA 12-4 to NFPA 99, issued March 7, 2013.
(v) TIA 12-5 to NFPA 99, issued August 1, 2013.
(vi) TIA 12-6 to NFPA 99, issued March 3, 2014.
[[Page 31]]
(vii) NFPA 101, Life Safety Code, 2012 edition, issued August 11,
2011;
(viii) TIA 12-1 to NFPA 101, issued August 11, 2011.
(ix) TIA 12-2 to NFPA 101, issued October 30, 2012.
(x) TIA 12-3 to NFPA 101, issued October 22, 2013.
(xi) TIA 12-4 to NFPA 101, issued October 22, 2013.
(2) [Reserved]
[51 FR 22042, June 17, 1986, as amended at 53 FR 11509, Apr. 7, 1988; 68
FR 1386, Jan. 10, 2003; 69 FR 49267, Aug. 11, 2004; 70 FR 15238, Mar.
25, 2005; 71 FR 55340, Sept. 22, 2006; 81 FR 26899, May 4, 2016; 81 FR
42548, June 30, 2016]
Sec. 482.42 Condition of participation: Infection control.
The hospital must provide a sanitary environment to avoid sources
and transmission of infections and communicable diseases. There must be
an active program for the prevention, control, and investigation of
infections and communicable diseases.
(a) Standard: Organization and policies. A person or persons must be
designated as infection control officer or officers to develop and
implement policies governing control of infections and communicable
diseases. The infection control officer or officers must develop a
system for identifying, reporting, investigating, and controlling
infections and communicable diseases of patients and personnel.
(b) Standard: Responsibilities of chief executive officer, medical
staff, and director of nursing services. The chief executive officer,
the medical staff, and the director of nursing services must--
(1) Ensure that the hospital-wide quality assessment and performance
improvement (QAPI) program and training programs address problems
identified by the infection control officer or officers; and
(2) Be responsible for the implementation of successful corrective
action plans in affected problem areas.
[51 FR 22042, June 17, 1986, as amended at 77 FR 29075, May 16, 2012; 79
FR 10396, Feb. 25, 2014]
Sec. 482.43 Condition of participation: Discharge planning.
The hospital must have in effect a discharge planning process that
applies to all patients. The hospital's policies and procedures must be
specified in writing.
(a) Standard: Identification of patients in need of discharge
planning. The hospital must identify at an early stage of
hospitalization all patients who are likely to suffer adverse health
consequences upon discharge if there is no adequate discharge planning.
(b) Standard: Discharge planning evaluation. (1) The hospital must
provide a discharge planning evaluation to the patients identified in
paragraph (a) of this section, and to other patients upon the patient's
request, the request of a person acting on the patient's behalf, or the
request of the physician.
(2) A registered nurse, social worker, or other appropriately
qualified personnel must develop, or supervise the development of, the
evaluation.
(3) The discharge planning evaluation must include an evaluation of
the likelihood of a patient needing post- hospital services and of the
availability of the services.
(4) The discharge planning evaluation must include an evaluation of
the likelihood of a patient's capacity for self-care or of the
possibility of the patient being cared for in the environment from which
he or she entered the hospital.
(5) The hospital personnel must complete the evaluation on a timely
basis so that appropriate arrangements for post-hospital care are made
before discharge, and to avoid unnecessary delays in discharge.
(6) The hospital must include the discharge planning evaluation in
the patient's medical record for use in establishing an appropriate
discharge plan and must discuss the results of the evaluation with the
patient or individual acting on his or her behalf.
(c) Standard: Discharge plan. (1) A registered nurse, social worker,
or other appropriately qualified personnel must develop, or supervise
the development of, a discharge plan if the discharge planning
evaluation indicates a need for a discharge plan.
(2) In the absence of a finding by the hospital that a patient needs
a discharge plan, the patient's physician may request a discharge plan.
In such a
[[Page 32]]
case, the hospital must develop a discharge plan for the patient.
(3) The hospital must arrange for the initial implementation of the
patient's discharge plan.
(4) The hospital must reassess the patient's discharge plan if there
are factors that may affect continuing care needs or the appropriateness
of the discharge plan.
(5) As needed, the patient and family members or interested persons
must be counseled to prepare them for post-hospital care.
(6) The hospital must include in the discharge plan a list of HHAs
or SNFs that are available to the patient, that are participating in the
Medicare program, and that serve the geographic area (as defined by the
HHA) in which the patient resides, or in the case of a SNF, in the
geographic area requested by the patient. HHAs must request to be listed
by the hospital as available.
(i) This list must only be presented to patients for whom home
health care or post-hospital extended care services are indicated and
appropriate as determined by the discharge planning evaluation.
(ii) For patients enrolled in managed care organizations, the
hospital must indicate the availability of home health and posthospital
extended care services through individuals and entities that have a
contract with the managed care organizations.
(iii) The hospital must document in the patient's medical record
that the list was presented to the patient or to the individual acting
on the patient's behalf.
(7) The hospital, as part of the discharge planning process, must
inform the patient or the patient's family of their freedom to choose
among participating Medicare providers of posthospital care services and
must, when possible, respect patient and family preferences when they
are expressed. The hospital must not specify or otherwise limit the
qualified providers that are available to the patient.
(8) The discharge plan must identify any HHA or SNF to which the
patient is referred in which the hospital has a disclosable financial
interest, as specified by the Secretary, and any HHA or SNF that has a
disclosable financial interest in a hospital under Medicare. Financial
interests that are disclosable under Medicare are determined in
accordance with the provisions of part 420, subpart C, of this chapter.
(d) Standard: Transfer or referral. The hospital must transfer or
refer patients, along with necessary medical information, to appropriate
facilities, agencies, or outpatient services, as needed, for followup or
ancillary care.
(e) Standard: Reassessment. The hospital must reassess its discharge
planning process on an on-going basis. The reassessment must include a
review of discharge plans to ensure that they are responsive to
discharge needs.
[59 FR 64152, Dec. 13, 1994, as amended at 69 FR 49268, Aug. 11, 2004]
Sec. 482.45 Condition of participation: Organ, tissue, and eye
procurement.
(a) Standard: Organ procurement responsibilities. The hospital must
have and implement written protocols that:
(1) Incorporate an agreement with an OPO designated under part 486
of this chapter, under which it must notify, in a timely manner, the OPO
or a third party designated by the OPO of individuals whose death is
imminent or who have died in the hospital. The OPO determines medical
suitability for organ donation and, in the absence of alternative
arrangements by the hospital, the OPO determines medical suitability for
tissue and eye donation, using the definition of potential tissue and
eye donor and the notification protocol developed in consultation with
the tissue and eye banks identified by the hospital for this purpose;
(2) Incorporate an agreement with at least one tissue bank and at
least one eye bank to cooperate in the retrieval, processing,
preservation, storage and distribution of tissues and eyes, as may be
appropriate to assure that all usable tissues and eyes are obtained from
potential donors, insofar as such an agreement does not interfere with
organ procurement;
(3) Ensure, in collaboration with the designated OPO, that the
family of each potential donor is informed of its options to donate
organs, tissues, or eyes or to decline to donate. The individual
designated by the hospital to initiate the request to the family must
[[Page 33]]
be an organ procurement representative or a designated requestor. A
designated requestor is an individual who has completed a course offered
or approved by the OPO and designed in conjunction with the tissue and
eye bank community in the methodology for approaching potential donor
families and requesting organ or tissue donation;
(4) Encourage discretion and sensitivity with respect to the
circumstances, views, and beliefs of the families of potential donors;
(5) Ensure that the hospital works cooperatively with the designated
OPO, tissue bank and eye bank in educating staff on donation issues,
reviewing death records to improve identification of potential donors,
and maintaining potential donors while necessary testing and placement
of potential donated organs, tissues, and eyes take place.
(b) Standard: Organ transplantation responsibilities. (1) A hospital
in which organ transplants are performed must be a member of the Organ
Procurement and Transplantation Network (OPTN) established and operated
in accordance with section 372 of the Public Health Service (PHS) Act
(42 U.S.C. 274) and abide by its rules. The term ``rules of the OPTN''
means those rules provided for in regulations issued by the Secretary in
accordance with section 372 of the PHS Act which are enforceable under
42 CFR 121.10. No hospital is considered to be out of compliance with
section 1138(a)(1)(B) of the Act, or with the requirements of this
paragraph, unless the Secretary has given the OPTN formal notice that he
or she approves the decision to exclude the hospital from the OPTN and
has notified the hospital in writing.
(2) For purposes of these standards, the term ``organ'' means a
human kidney, liver, heart, lung, or pancreas.
(3) If a hospital performs any type of transplants, it must provide
organ-transplant-related data, as requested by the OPTN, the Scientific
Registry, and the OPOs. The hospital must also provide such data
directly to the Department when requested by the Secretary.
[63 FR 33875, June 22, 1998]
Subpart D_Optional Hospital Services
Sec. 482.51 Condition of participation: Surgical services.
If the hospital provides surgical services, the services must be
well organized and provided in accordance with acceptable standards of
practice. If outpatient surgical services are offered the services must
be consistent in quality with inpatient care in accordance with the
complexity of services offered.
(a) Standard: Organization and staffing. The organization of the
surgical services must be appropriate to the scope of the services
offered.
(1) The operating rooms must be supervised by an experienced
registered nurse or a doctor of medicine or osteopathy.
(2) Licensed practical nurses (LPNs) and surgical technologists
(operating room technicians) may serve as ``scrub nurses'' under the
supervision of a registered nurse.
(3) Qualified registered nurses may perform circulating duties in
the operating room. In accordance with applicable State laws and
approved medical staff policies and procedures, LPNs and surgical
technologists may assist in circulatory duties under the surpervision of
a qualified registered nurse who is immediately available to respond to
emergencies.
(4) Surgical privileges must be delineated for all practitioners
performing surgery in accordance with the competencies of each
practitioner. The surgical service must maintain a roster of
practitioners specifying the surgical privileges of each practitioner.
(b) Standard: Delivery of service. Surgical services must be
consistent with needs and resources. Policies governing surgical care
must be designed to assure the achievement and maintenance of high
standards of medical practice and patient care.
(1) Prior to surgery or a procedure requiring anesthesia services
and except in the case of emergencies:
(i) A medical history and physical examination must be completed and
documented no more than 30 days before or 24 hours after admission or
registration.
[[Page 34]]
(ii) An updated examination of the patient, including any changes in
the patient's condition, must be completed and documented within 24
hours after admission or registration when the medical history and
physical examination are completed within 30 days before admission or
registration.
(2) A properly executed informed consent form for the operation must
be in the patient's chart before surgery, except in emergencies.
(3) The following equipment must be available to the operating room
suites: call-in-system, cardiac monitor, resuscitator, defibrillator,
aspirator, and tracheotomy set.
(4) There must be adequate provisions for immediate post-operative
care.
(5) The operating room register must be complete and up-to-date.
(6) An operative report describing techniques, findings, and tissues
removed or altered must be written or dictated immediately following
surgery and signed by the surgeon.
[51 FR 22042, June 17, 1986, as amended at 72 FR 66933, Nov. 27, 2007]
Sec. 482.52 Condition of participation: Anesthesia services.
If the hospital furnishes anesthesia services, they must be provided
in a well-organized manner under the direction of a qualified doctor of
medicine or osteopathy. The service is responsible for all anesthesia
administered in the hospital.
(a) Standard: Organization and staffing. The organization of
anesthesia services must be appropriate to the scope of the services
offered. Anesthesia must be administered only by--
(1) A qualified anesthesiologist;
(2) A doctor of medicine or osteopathy (other than an
anesthesiologist);
(3) A dentist, oral surgeon, or podiatrist who is qualified to
administer anesthesia under State law;
(4) A certified registered nurse anesthetist (CRNA), as defined in
Sec. 410.69(b) of this chapter, who, unless exempted in accordance with
paragraph (c)of this section, is under the supervision of the operating
practitioner or of an anesthesiologist who is immediately available if
needed; or
(5) An anesthesiologist's assistant, as defined in Sec. 410.69(b) of
this chapter, who is under the supervision of an anesthesiologist who is
immediately available if needed.
(b) Standard: Delivery of services. Anesthesia services must be
consistent with needs and resources. Policies on anesthesia procedures
must include the delineation of preanesthesia and post anesthesia
responsibilities. The policies must ensure that the following are
provided for each patient:
(1) A preanesthesia evaluation completed and documented by an
individual qualified to administer anesthesia, as specified in paragraph
(a) of this section, performed within 48 hours prior to surgery or a
procedure requiring anesthesia services.
(2) An intraoperative anesthesia record.
(3) A postanesthesia evaluation completed and documented by an
individual qualified to administer anesthesia, as specified in paragraph
(a) of this section, no later than 48 hours after surgery or a procedure
requiring anesthesia services. The postanesthesia evaluation for
anesthesia recovery must be completed in accordance with State law and
with hospital policies and procedures that have been approved by the
medical staff and that reflect current standards of anesthesia care.
(c) Standard: State exemption. (1) A hospital may be exempted from
the requirement for physician supervision of CRNAs as described in
paragraph (a)(4) of this section, if the State in which the hospital is
located submits a letter to CMS signed by the Governor, following
consultation with the State's Boards of Medicine and Nursing, requesting
exemption from physician supervision of CRNAs. The letter from the
Governor must attest that he or she has consulted with State Boards of
Medicine and Nursing about issues related to access to and the quality
of anesthesia services in the State and has concluded that it is in the
best interests of the State's citizens to opt-out of the current
physician supervision requirement, and that the opt-out is consistent
with State law.
(2) The request for exemption and recognition of State laws, and the
[[Page 35]]
withdrawal of the request may be submitted at any time, and are
effective upon submission.
[51 FR 22042, June 17, 1986, as amended at 57 FR 33900, July 31, 1992;
66 FR 56769, Nov. 13, 2001; 71 FR 68694, Nov. 27, 2006; 72 FR 66934,
Nov. 27, 2007]
Sec. 482.53 Condition of participation: Nuclear medicine services.
If the hospital provides nuclear medicine services, those services
must meet the needs of the patients in accordance with acceptable
standards of practice.
(a) Standard: Organization and staffing. The organization of the
nuclear medicine service must be appropriate to the scope and complexity
of the services offered.
(1) There must be a director who is a doctor of medicine or
osteopathy qualified in nuclear medicine.
(2) The qualifications, training, functions, and responsibilities of
nuclear medicine personnel must be specified by the service director and
approved by the medical staff.
(b) Standard: Delivery of service. Radioactive materials must be
prepared, labeled, used, transported, stored, and disposed of in
accordance with acceptable standards of practice.
(1) In-house preparation of radiopharmaceuticals is by, or under the
supervision of, an appropriately trained registered pharmacist or a
doctor of medicine or osteopathy.
(2) There is proper storage and disposal of radioactive material.
(3) If laboratory tests are performed in the nuclear medicine
service, the service must meet the applicable requirement for laboratory
services specified in Sec. 482.27.
(c) Standard: Facilities. Equipment and supplies must be appropriate
for the types of nuclear medicine services offered and must be
maintained for safe and efficient performance. The equipment must be--
(1) Maintained in safe operating condition; and
(2) Inspected, tested, and calibrated at least annually by qualified
personnel.
(d) Standard: Records. The hospital must maintain signed and dated
reports of nuclear medicine interpretations, consultations, and
procedures.
(1) The hospital must maintain copies of nuclear medicine reports
for at least 5 years.
(2) The practitioner approved by the medical staff to interpret
diagnostic procedures must sign and date the interpretation of these
tests.
(3) The hospital must maintain records of the receipt and
disposition of radiopharmaceuticals.
(4) Nuclear medicine services must be ordered only by practitioner
whose scope of Federal or State licensure and whose defined staff
privileges allow such referrals.
[51 FR 22042, June 17, 1986, as amended at 57 FR 7136, Feb. 28, 1992; 79
FR 27154, May 12, 2014]
Sec. 482.54 Condition of participation: Outpatient services.
If the hospital provides outpatient services, the services must meet
the needs of the patients in accordance with acceptable standards of
practice.
(a) Standard: Organization. Outpatient services must be
appropriately organized and integrated with inpatient services.
(b) Standard: Personnel. The hospital must--
(1) Assign one or more individuals to be responsible for outpatient
services.
(2) Have appropriate professional and nonprofessional personnel
available at each location where outpatient services are offered, based
on the scope and complexity of outpatient services.
(c) Standard: Orders for outpatient services. Outpatient services
must be ordered by a practitioner who meets the following conditions:
(1) Is responsible for the care of the patient.
(2) Is licensed in the State where he or she provides care to the
patient.
(3) Is acting within his or her scope of practice under State law.
(4) Is authorized in accordance with State law and policies adopted
by the medical staff, and approved by the governing body, to order the
applicable outpatient services. This applies to the following:
(i) All practitioners who are appointed to the hospital's medical
staff and who have been granted privileges to order the applicable
outpatient services.
[[Page 36]]
(ii) All practitioners not appointed to the medical staff, but who
satisfy the above criteria for authorization by the medical staff and
the hospital for ordering the applicable outpatient services for their
patients.
[51 FR 22042, June 17, 1986, as amended at 77 FR 29075, May 16, 2012; 79
FR 27154, May 12, 2014]
Sec. 482.55 Condition of participation: Emergency services.
The hospital must meet the emergency needs of patients in accordance
with acceptable standards of practice.
(a) Standard: Organization and direction. If emergency services are
provided at the hospital--
(1) The services must be organized under the direction of a
qualified member of the medical staff;
(2) The services must be integrated with other departments of the
hospital;
(3) The policies and procedures governing medical care provided in
the emergency service or department are established by and are a
continuing responsibility of the medical staff.
(b) Standard: Personnel. (1) The emergency services must be
supervised by a qualified member of the medical staff.
(2) There must be adequate medical and nursing personnel qualified
in emergency care to meet the written emergency procedures and needs
anticipated by the facility.
Sec. 482.56 Condition of participation: Rehabilitation services.
If the hospital provides rehabilitation, physical therapy,
occupational therapy, audiology, or speech pathology services, the
services must be organized and staffed to ensure the health and safety
of patients.
(a) Standard: Organization and staffing. The organization of the
service must be appropriate to the scope of the services offered.
(1) The director of the services must have the necessary knowledge,
experience, and capabilities to properly supervise and administer the
services.
(2) Physical therapy, occupational therapy, speech-language
pathology or audiology services, if provided, must be provided by
qualified physical therapists, physical therapist assistants,
occupational therapists, occupational therapy assistants, speech-
language pathologists, or audiologists as defined in part 484 of this
chapter.
(b) Standard: Delivery of services. Services must only be provided
under the orders of a qualified and licensed practitioner who is
responsible for the care of the patient, acting within his or her scope
of practice under State law, and who is authorized by the hospital's
medical staff to order the services in accordance with hospital policies
and procedures and State laws.
(1) All rehabilitation services orders must be documented in the
patient's medical record in accordance with the requirements at
Sec. 482.24.
(2) The provision of care and the personnel qualifications must be
in accordance with national acceptable standards of practice and must
also meet the requirements of Sec. 409.17 of this chapter.
[51 FR 22042, June 17, 1986, as amended at 72 FR 66406, Nov. 27, 2007;
75 FR 50418, Aug. 16, 2010]
Sec. 482.57 Condition of participation: Respiratory care services.
The hospital must meet the needs of the patients in accordance with
acceptable standards of practice. The following requirements apply if
the hospital provides respiratory care service.
(a) Standard: Organization and Staffing. The organization of the
respiratory care services must be appropriate to the scope and
complexity of the services offered.
(1) There must be a director of respiratory care services who is a
doctor of medicine or osteopathy with the knowledge experience, and
capabilities to supervise and administer the service properly. The
director may serve on either a full-time or part-time basis.
(2) There must be adequate numbers of respiratory therapists,
respiratory therapy technicians, and other personnel who meet the
qualifications specified by the medical staff, consistent with State
law.
(b) Standard: Delivery of Services. Services must be delivered in
accordance with medical staff directives.
(1) Personnel qualified to perform specific procedures and the
amount of supervision required for personnel to
[[Page 37]]
carry out specific procedures must be designated in writing.
(2) If blood gases or other laboratory tests are performed in the
respiratory care unit, the unit must meet the applicable requirements
for laboratory services specified in Sec. 482.27.
(3) Services must only be provided under the orders of a qualified
and licensed practitioner who is responsible for the care of the
patient, acting within his or her scope of practice under State law, and
who is authorized by the hospital's medical staff to order the services
in accordance with hospital policies and procedures and State laws.
(4) All respiratory care services orders must be documented in the
patient's medical record in accordance with the requirements at
Sec. 482.24.
[51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986, as amended at 57
FR 7136, Feb. 28, 1992; 75 FR 50418, Aug. 16, 2010]
Sec. 482.58 Special requirements for hospital providers of long-term
care services (``swing-beds'').
A hospital that has a Medicare provider agreement must meet the
following requirements in order to be granted an approval from CMS to
provide post-hospital extended care services, as specified in
Sec. 409.30 of this chapter, and be reimbursed as a swing-bed hospital,
as specified in Sec. 413.114 of this chapter:
(a) Eligibility. A hospital must meet the following eligibility
requirements:
(1) The facility has fewer than 100 hospital beds, excluding beds
for newborns and beds in intensive care type inpatient units (for
eligibility of hospitals with distinct parts electing the optional
reimbursement method, see Sec. 413.24(d)(5) of this chapter).
(2) The hospital is located in a rural area. This includes all areas
not delineated as ``urbanized'' areas by the Census Bureau, based on the
most recent census.
(3) The hospital does not have in effect a 24-hour nursing waiver
granted under Sec. 488.54(c) of this chapter.
(4) The hospital has not had a swing-bed approval terminated within
the two years previous to application.
(b) Skilled nursing facility services. The facility is substantially
in compliance with the following skilled nursing facility requirements
contained in subpart B of part 483 of this chapter.
(1) Resident rights (Sec. 483.10(b)(7), (c)(1), (c)(2)(iii), (c)(6),
(d), (e)(2), (e)(4), (f)(4)(ii), (f)(4)(iii), (f)(9), (h), (g)(8),
(g)(17), and (g)(18) introductory text.
(2) Admission, transfer, and discharge rights (Sec. 483.5 definition
of transfer and discharge, Sec. 483.15(c)(1), (c)(2)(i), (c)(2)(ii),
(c)(3), (c)(4), (c)(5), and (c)(7)).
(3) Freedom from abuse, neglect, and exploitation
(Sec. 483.12(a)(1), (a)(2), (a)(3)(i), (a)(3)(ii), (a)(4), (b)(1),
(b)(2), (c)).
(4) Patient activities (Sec. 483.24(c)).
(5) Social services (Sec. 483.40(d) and 483.70(p)).
(6) Discharge planning (Sec. 483.20(e)).
(7) Specialized rehabilitative services (Sec. 483.65).
(8) Dental services (Sec. 483.55).
[72 FR 60788, Oct. 26, 2007. Redesignated at 79 FR 27155, May 12, 2014,
as amended at 81 FR 68847, Oct. 4, 2016; 82 FR 32258, July 13, 2017]
Subpart E_Requirements for Specialty Hospitals
Source: 72 FR 15273, Mar. 30, 2007, unless otherwise noted.
Sec. 482.60 Special provisions applying to psychiatric hospitals.
Psychiatric hospital must--
(a) Be primarily engaged in providing, by or under the supervision
of a doctor of medicine or osteopathy, psychiatric services for the
diagnosis and treatment of mentally ill persons;
(b) Meet the conditions of participation specified in Secs. 482.1
through 482.23 and Secs. 482.25 through 482.57;
(c) Maintain clinical records on all patients, including records
sufficient to permit CMS to determine the degree and intensity of
treatment furnished to Medicare beneficiaries, as specified in
Sec. 482.61; and
(d) Meet the staffing requirements specified in Sec. 482.62.
[72 FR 60788, Oct. 26, 2007]
Sec. 482.61 Condition of participation: Special medical record
requirements for psychiatric hospitals.
The medical records maintained by a psychiatric hospital must permit
determination of the degree and intensity of
[[Page 38]]
the treatment provided to individuals who are furnished services in the
institution.
(a) Standard: Development of assessment/diagnostic data. Medical
records must stress the psychiatric components of the record, including
history of findings and treatment provided for the psychiatric condition
for which the patient is hospitalized.
(1) The identification data must include the patient's legal status.
(2) A provisional or admitting diagnosis must be made on every
patient at the time of admission, and must include the diagnoses of
intercurrent diseases as well as the psychiatric diagnoses.
(3) The reasons for admission must be clearly documented as stated
by the patient and/or others significantly involved.
(4) The social service records, including reports of interviews with
patients, family members, and others, must provide an assessment of home
plans and family attitudes, and community resource contacts as well as a
social history.
(5) When indicated, a complete neurological examination must be
recorded at the time of the admission physical examination.
(b) Standard: Psychiatric evaluation. Each patient must receive a
psychiatric evaluation that must--
(1) Be completed within 60 hours of admission;
(2) Include a medical history;
(3) Contain a record of mental status;
(4) Note the onset of illness and the circumstances leading to
admission;
(5) Describe attitudes and behavior;
(6) Estimate intellectual functioning, memory functioning, and
orientation; and
(7) Include an inventory of the patient's assets in descriptive, not
interpretative, fashion.
(c) Standard: Treatment plan. (1) Each patient must have an
individual comprehensive treatment plan that must be based on an
inventory of the patient's strengths and disabilities. The written plan
must include--
(i) A substantiated diagnosis;
(ii) Short-term and long-range goals;
(iii) The specific treatment modalities utilized;
(iv) The responsibilities of each member of the treatment team; and
(v) Adequate documentation to justify the diagnosis and the
treatment and rehabilitation activities carried out.
(2) The treatment received by the patient must be documented in such
a way to assure that all active therapeutic efforts are included.
(d) Standard: Recording progress. Progress notes must be recorded by
the doctor of medicine or osteopathy responsible for the care of the
patient as specified in Sec. 482.12(c), nurse, social worker and, when
appropriate, others significantly involved in active treatment
modalities. The frequency of progress notes is determined by the
condition of the patient but must be recorded at least weekly for the
first 2 months and at least once a month thereafter and must contain
recommendations for revisions in the treatment plan as indicated as well
as precise assessment of the patient's progress in accordance with the
original or revised treatment plan.
(e) Standard: Discharge planning and discharge summary. The record
of each patient who has been discharged must have a discharge summary
that includes a recapitulation of the patient's hospitalization and
recommendations from appropriate services concerning follow-up or
aftercare as well as a brief summary of the patient's condition on
discharge.
[72 FR 60788, Oct. 26, 2007]
Sec. 482.62 Condition of participation: Special staff requirements
for psychiatric hospitals.
The hospital must have adequate numbers of qualified professional
and supportive staff to evaluate patients, formulate written,
individualized comprehensive treatment plans, provide active treatment
measures, and engage in discharge planning.
(a) Standard: Personnel. The hospital must employ or undertake to
provide adequate numbers of qualified professional, technical, and
consultative personnel to:
(1) Evaluate patients;
(2) Formulate written individualized, comprehensive treatment plans;
[[Page 39]]
(3) Provide active treatment measures; and
(4) Engage in discharge planning.
(b) Standard: Director of inpatient psychiatric services; medical
staff. Inpatient psychiatric services must be under the supervision of a
clinical director, service chief, or equivalent who is qualified to
provide the leadership required for an intensive treatment program. The
number and qualifications of doctors of medicine and osteopathy must be
adequate to provide essential psychiatric services.
(1) The clinical director, service chief, or equivalent must meet
the training and experience requirements for examination by the American
Board of Psychiatry and Neurology or the American Osteopathic Board of
Neurology and Psychiatry.
(2) The director must monitor and evaluate the quality and
appropriateness of services and treatment provided by the medical staff.
(c) Standard: Availability of medical personnel. Doctors of medicine
or osteopathy and other appropriate professional personnel must be
available to provide necessary medical and surgical diagnostic and
treatment services. If medical and surgical diagnostic and treatment
services are not available within the institution, the institution must
have an agreement with an outside source of these services to ensure
that they are immediately available or a satisfactory agreement must be
established for transferring patients to a general hospital that
participates in the Medicare program.
(d) Standard: Nursing services. The hospital must have a qualified
director of psychiatric nursing services. In addition to the director of
nursing, there must be adequate numbers of registered nurses, licensed
practical nurses, and mental health workers to provide nursing care
necessary under each patient's active treatment program and to maintain
progress notes on each patient.
(1) The director of psychiatric nursing services must be a
registered nurse who has a master's degree in psychiatric or mental
health nursing, or its equivalent from a school of nursing accredited by
the National League for Nursing, or be qualified by education and
experience in the care of the mentally ill. The director must
demonstrate competence to participate in interdisciplinary formulation
of individual treatment plans; to give skilled nursing care and therapy;
and to direct, monitor, and evaluate the nursing care furnished.
(2) The staffing pattern must insure the availability of a
registered professional nurse 24 hours each day. There must be adequate
numbers of registered nurses, licensed practical nurses, and mental
health workers to provide the nursing care necessary under each
patient's active treatment program.
(e) Standard: Psychological services. The hospital must provide or
have available psychological services to meet the needs of the patients.
(f) Standard: Social services. There must be a director of social
services who monitors and evaluates the quality and appropriateness of
social services furnished. The services must be furnished in accordance
with accepted standards of practice and established policies and
procedures.
(1) The director of the social work department or service must have
a master's degree from an accredited school of social work or must be
qualified by education and experience in the social services needs of
the mentally ill. If the director does not hold a masters degree in
social work, at least one staff member must have this qualification.
(2) Social service staff responsibilities must include, but are not
limited to, participating in discharge planning, arranging for follow-up
care, and developing mechanisms for exchange of appropriate, information
with sources outside the hospital.
(g) Standard: Therapeutic activities. The hospital must provide a
therapeutic activities program.
(1) The program must be appropriate to the needs and interests of
patients and be directed toward restoring and maintaining optimal levels
of physical and psychosocial functioning.
[[Page 40]]
(2) The number of qualified therapists, support personnel, and
consultants must be adequate to provide comprehensive therapeutic
activities consistent with each patient's active treatment program.
[72 FR 60788, Oct. 26, 2007]
Sec. 482.68 Special requirement for transplant centers.
A transplant center located within a hospital that has a Medicare
provider agreement must meet the conditions of participation specified
in Secs. 482.72 through 482.104 in order to be granted approval from CMS
to provide transplant services.
(a) Unless specified otherwise, the conditions of participation at
Secs. 482.72 through 482.104 apply to heart, heart-lung, intestine,
kidney, liver, lung, and pancreas centers.
(b) In addition to meeting the conditions of participation specified
in Secs. 482.72 through 482.104, a transplant center must also meet the
conditions of participation in Secs. 482.1 through 482.57, except for
Sec. 482.15.
[81 FR 64030, Sept. 16, 2016]
Sec. 482.70 Definitions.
As used in this subpart, the following definitions apply:
Adverse event means an untoward, undesirable, and usually
unanticipated event that causes death or serious injury, or the risk
thereof. As applied to transplant centers, examples of adverse events
include (but are not limited to) serious medical complications or death
caused by living donation; unintentional transplantation of organs of
mismatched blood types; transplantation of organs to unintended
beneficiaries; and unintended transmission of infectious disease to a
beneficiary.
End-Stage Renal Disease (ESRD) means that stage of renal impairment
that appears irreversible and permanent, and requires a regular course
of dialysis or kidney transplantation to maintain life.
ESRD Network means all Medicare-approved ESRD facilities in a
designated geographic area specified by CMS.
Heart-Lung transplant center means a transplant center that is
located in a hospital with an existing Medicare-approved heart
transplant center and an existing Medicare-approved lung center that
performs combined heart-lung transplants.
Intestine transplant center means a Medicare-approved liver
transplant center that performs intestine transplants, combined liver-
intestine transplants, or multivisceral transplants.
Network organization means the administrative governing body to the
network and liaison to the Federal government.
Pancreas transplant center means a Medicare-approved kidney
transplant center that performs pancreas transplants alone or subsequent
to a kidney transplant as well as kidney-pancreas transplants.
Transplant center means an organ-specific transplant program (as
defined in this rule) within a transplant hospital (for example, a
hospital's lung transplant program may also be referred to as the
hospital's lung transplant center).
Transplant hospital means a hospital that furnishes organ
transplants and other medical and surgical specialty services required
for the care of transplant patients.
Transplant program means a component within a transplant hospital
(as defined in this rule) that provides transplantation of a particular
type of organ.
General Requirements for Transplant Centers
Sec. 482.72 Condition of participation: OPTN membership.
A transplant center must be located in a transplant hospital that is
a member of and abides by the rules and requirements of the Organ
Procurement and Transplantation Network (OPTN) established and operated
in accordance with section 372 of the Public Health Service (PHS) Act
(42 U.S.C. 274). The term ``rules and requirements of the OPTN'' means
those rules and requirements approved by the Secretary pursuant to
Sec. 121.4 of this title. No hospital that provides transplantation
services shall be deemed to be out of compliance with section
1138(a)(1)(B) of the
[[Page 41]]
Act or this section unless the Secretary has given the OPTN formal
notice that he or she approves the decision to exclude the transplant
hospital from the OPTN and also has notified the transplant hospital in
writing.
Sec. 482.74 Condition of participation: Notification to CMS.
(a) A transplant center must notify CMS immediately of any
significant changes related to the center's transplant program or
changes that could affect its compliance with the conditions of
participation. Instances in which CMS should receive information for
follow up, as appropriate, include, but are not limited to:
(1) Change in key staff members of the transplant team, such as a
change in the individual the transplant center designated to the OPTN as
the center's ``primary transplant surgeon'' or ``primary transplant
physician;'
(2) Termination of an agreement between the hospital in which the
transplant center is located and an OPO for the recovery and receipt of
organs as required by section 482.100; and
(3) Inactivation of the transplant center.
(b) Upon receiving notification of significant changes, CMS will
follow up with the transplant center as appropriate, including (but not
limited to):
(1) Requesting additional information;
(2) Analyzing the information; or
(3) Conducting an on-site review.
[72 FR 15273, Mar. 30, 2007, as amended at 79 FR 27155, May 12, 2014]
Sec. 482.76 Condition of participation: Pediatric Transplants.
A transplant center that seeks Medicare approval to provide
transplantation services to pediatric patients must submit to CMS a
request specifically for Medicare approval to perform pediatric
transplants using the procedures described at Sec. 488.61 of this
chapter.
(a) Except as specified in paragraph (d) of this section, a center
requesting Medicare approval to perform pediatric transplants must meet
all the conditions of participation at Secs. 482.72 through 482.74 and
Secs. 482.80 through 482.104 with respect to its pediatric patients.
(b) A center that performs 50 percent or more of its transplants in
a 12-month period on adult patients must be approved to perform adult
transplants in order to be approved to perform pediatric transplants.
(1) Loss of Medicare approval to perform adult transplants, whether
voluntary or involuntary, will result in loss of the center's approval
to perform pediatric transplants.
(2) Loss of Medicare approval to perform pediatric transplants,
whether voluntary or involuntary, may trigger a review of the center's
Medicare approval to perform adult transplants.
(c) A center that performs 50 percent or more of its transplants in
a 12-month period on pediatric patients must be approved to perform
pediatric transplants in order to be approved to perform adult
transplants.
(1) Loss of Medicare approval to perform pediatric transplants,
whether voluntary or involuntary, will result in loss of the center's
approval to perform adult transplants.
(2) Loss of Medicare approval to perform adult transplants, whether
voluntary or involuntary, may trigger a review of the center's Medicare
approval to perform pediatric transplants.
(3) A center that performs 50 percent or more of its transplants on
pediatric patients in a 12-month period is not required to meet the
clinical experience requirements prior to its request for approval as a
pediatric transplant center.
(d) Instead of meeting all conditions of participation at
Secs. 482.72 through 482.74 and Secs. 482.80 through 482.104, a heart
transplant center that wishes to provide transplantation services to
pediatric heart patients may be approved to perform pediatric heart
transplants by meeting the Omnibus Budget Reconciliation Act of 1987
criteria in section 4009(b) (Pub. L. 100-203), as follows:
(1) The center's pediatric transplant program must be operated
jointly by the hospital and another facility that is Medicare-approved;
(2) The unified program shares the same transplant surgeons and
quality
[[Page 42]]
improvement program (including oversight committee, patient protocol,
and patient selection criteria); and
(3) The center demonstrates to the satisfaction of the Secretary
that it is able to provide the specialized facilities, services, and
personnel that are required by pediatric heart transplant patients.
Sec. 482.78 Condition of participation: Emergency preparedness
for transplant centers.
A transplant center must be included in the emergency preparedness
planning and the emergency preparedness program as set forth in
Sec. 482.15 for the hospital in which it is located. However, a
transplant center is not individually responsible for the emergency
preparedness requirements set forth in Sec. 482.15.
(a) Standard: Policies and procedures. A transplant center must have
policies and procedures that address emergency preparedness. These
policies and procedures must be included in the hospital's emergency
preparedness program.
(b) Standard: Protocols with hospital and OPO. A transplant center
must develop and maintain mutually agreed upon protocols that address
the duties and responsibilities of the transplant center, the hospital
in which the transplant center is operated, and the OPO designated by
the Secretary, unless the hospital has an approved waiver to work with
another OPO, during an emergency.
[81 FR 64030, Sept. 16, 2016]
Transplant Center Data Submission, Clinical Experience, and Outcome
Requirements
Sec. 482.80 Condition of participation: Data submission, clinical
experience, and outcome requirements for initial approval of
transplant centers.
Except as specified in paragraph (d) of this section, and
Sec. 488.61 of this chapter, transplant centers must meet all data
submission, clinical experience, and outcome requirements to be granted
initial approval by CMS.
(a) Standard: Data submission. No later than 90 days after the due
date established by the OPTN, a transplant center must submit to the
OPTN at least 95 percent of required data on all transplants (deceased
and living donor) it has performed. Required data submissions include,
but are not limited to, submission of the appropriate OPTN forms for
transplant candidate registration, transplant beneficiary registration
and follow-up, and living donor registration and follow-up.
(b) Standard: Clinical experience. To be considered for initial
approval, an organ-specific transplant center must generally perform 10
transplants over a 12-month period.
(c) Standard: Outcome requirements. CMS will review outcomes for all
transplants performed at a center, including outcomes for living donor
transplants, if applicable. CMS will review adult and pediatric outcomes
separately when a center requests Medicare approval to perform both
adult and pediatric transplants.
(1) CMS will compare each transplant center's observed number of
patient deaths and graft failures 1-year post-transplant to the center's
expected number of patient deaths and graft failures 1-year post-
transplant using the data contained in the most recent Scientific
Registry of Transplant Beneficiaries (SRTR) center-specific report.
(2) CMS will not consider a center's patient and graft survival
rates to be acceptable if:
(i) A center's observed patient survival rate or observed graft
survival rate is lower than its expected patient survival rate or
expected graft survival rate; and
(ii) All three of the following thresholds are crossed over:
(A) The one-sided p-value is less than 0.05,
(B) The number of observed events (patient deaths or graft failures)
minus the number of expected events is greater than 3, and
(C) The number of observed events divided by the number of expected
events is greater than 1.85.
(d) Exceptions. (1) A heart-lung transplant center is not required
to comply with the clinical experience requirements in paragraph (b) of
this section
[[Page 43]]
or the outcome requirements in paragraph (c) of this section for heart-
lung transplants performed at the center.
(2) An intestine transplant center is not required to comply with
the outcome performance requirements in paragraph (c) of this section
for intestine, combined liver-intestine or multivisceral transplants
performed at the center.
(3) A pancreas transplant center is not required to comply with the
clinical experience requirements in paragraph (b) of this section or the
outcome requirements in paragraph (c) of this section for pancreas
transplants performed at the center.
(4) A center that is requesting initial Medicare approval to perform
pediatric transplants is not required to comply with the clinical
experience requirements in paragraph (b) of this section prior to its
request for approval as a pediatric transplant center.
(5) A kidney transplant center that is not Medicare-approved on the
effective date of this rule is required to perform at least 3
transplants over a 12-month period prior to its request for initial
approval.
[72 FR 15273, Mar. 30, 2007, as amended at 79 FR 27155, May 12, 2014; 81
FR 79880, Nov. 14, 2016]
Sec. 482.82 Condition of participation: Data submission, clinical
experience, and outcome requirements for re-approval of transplant
centers.
Except as specified in paragraph (d) of this section, and
Sec. 488.61 of this chapter, transplant centers must meet all data
submission, clinical experience, and outcome requirements in order to be
re-approved.
(a) Standard: Data submission. No later than 90 days after the due
date established by the OPTN, a transplant center must submit to the
OPTN at least 95 percent of the required data submissions on all
transplants (deceased and living donors) performed during the prior 3
years. Required data submissions include, but are not limited to,
submission of the appropriate OPTN forms for transplant candidate
registration, transplant recipient registration and follow-up, and
living donor registration and follow-up.
(b) Standard: Clinical experience. To be considered for re-approval,
an organ-specific transplant center must generally perform an average of
10 transplants per year during the prior 3 years.
(c) Standard: Outcome requirements. CMS will review outcomes for all
transplants performed at a center, including outcomes for living donor
transplants, if applicable. CMS will review adult and pediatric outcomes
separately when a center requests Medicare approval to perform both
adult and pediatric transplants.
(1) CMS will compare each transplant center's observed number of
patient deaths and graft failures 1-year post-transplant to the center's
expected number of patient deaths and graft failures 1-year post-
transplant using data contained in the most recent SRTR center-specific
report.
(2) CMS will not consider a center's patient and graft survival
rates to be acceptable if:
(i) A center's observed patient survival rate or observed graft
survival rate is lower than its expected patient survival rate and graft
survival rate; and
(ii) All three of the following thresholds are crossed over:
(A) The one-sided p-value is less than 0.05,
(B) The number of observed events (patient deaths or graft failures)
minus the number of expected events is greater than 3, and
(C) The number of observed events divided by the number of expected
events is greater than 1.85.
(d) Exceptions. (1) A heart-lung transplant center is not required
to comply with the clinical experience requirements in paragraph (b) of
this section or the outcome requirements in paragraph (c) of this
section for heart-lung transplants performed at the center.
(2) An intestine transplant center is not required to comply with
the outcome requirements in paragraph (c) of this section for intestine,
combined liver-intestine, and multivisceral transplants performed at the
center.
(3) A pancreas transplant center is not required to comply with the
clinical experience requirements in paragraph (b) of this section or the
outcome
[[Page 44]]
requirements in paragraph (c) of this section for pancreas transplants
performed at the center.
(4) A center that is approved to perform pediatric transplants is
not required to comply with the clinical experience requirements in
paragraph (b) of this section to be re-approved.
[72 FR 15273, Mar. 30, 2007, as amended at 79 FR 27155, May 12, 2014; 81
FR 79880, Nov. 14, 2016]
Transplant Center Process Requirements
Sec. 482.90 Condition of participation: Patient and living donor
selection.
The transplant center must use written patient selection criteria in
determining a patient's suitability for placement on the waiting list or
a patient's suitability for transplantation. If a center performs living
donor transplants, the center also must use written donor selection
criteria in determining the suitability of candidates for donation.
(a) Standard: Patient selection. Patient selection criteria must
ensure fair and non-discriminatory distribution of organs.
(1) Prior to placement on the center's waiting list, a prospective
transplant candidate must receive a psychosocial evaluation, if
possible.
(2) Before a transplant center places a transplant candidate on its
waiting list, the candidate's medical record must contain documentation
that the candidate's blood type has been determined.
(3) When a patient is placed on a center's waiting list or is
selected to receive a transplant, the center must document in the
patient's medical record the patient selection criteria used.
(4) A transplant center must provide a copy of its patient selection
criteria to a transplant patient, or a dialysis facility, as requested
by a patient or a dialysis facility.
(b) Standard: Living donor selection. The living donor selection
criteria must be consistent with the general principles of medical
ethics. Transplant centers must:
(1) Ensure that a prospective living donor receives a medical and
psychosocial evaluation prior to donation,
(2) Document in the living donor's medical records the living
donor's suitability for donation, and
(3) Document that the living donor has given informed consent, as
required under Sec. 482.102.
Sec. 482.92 Condition of participation: Organ recovery and receipt.
Transplant centers must have written protocols for validation of
donor-beneficiary blood type and other vital data for the deceased organ
recovery, organ receipt, and living donor organ transplantation
processes. The transplanting surgeon at the transplant center is
responsible for ensuring the medical suitability of donor organs for
transplantation into the intended beneficiary.
(a) Standard: Organ receipt. After an organ arrives at a transplant
center, prior to transplantation, the transplanting surgeon and another
licensed health care professional must verify that the donor's blood
type and other vital data are compatible with transplantation of the
intended beneficiary.
(b) Standard: Living donor transplantation. If a center performs
living donor transplants, the transplanting surgeon and another licensed
health care professional at the center must verify that the living
donor's blood type and other vital data are compatible with
transplantation of the intended beneficiary immediately before the
removal of the donor organ(s) and, if applicable, prior to the removal
of the beneficiary 's organ(s).
[51 FR 22042, June 17, 1986, as amended at 77 FR 29076, May 16, 2012]
Sec. 482.94 Condition of participation: Patient and living donor
management.
Transplant centers must have written patient management policies for
the transplant and discharge phases of transplantation. If a transplant
center performs living donor transplants, the center also must have
written donor management policies for the donor evaluation, donation,
and discharge phases of living organ donation.
(a) Standard: Patient and living donor care. The transplant center's
patient
[[Page 45]]
and donor management policies must ensure that:
(1) Each transplant patient is under the care of a multidisciplinary
patient care team coordinated by a physician throughout the transplant
and discharge phases of transplantation; and
(2) If a center performs living donor transplants, each living donor
is under the care of a multidisciplinary patient care team coordinated
by a physician throughout the donor evaluation, donation, and discharge
phases of donation.
(b) Standard: Waiting list management. Transplant centers must keep
their waiting lists up to date on an ongoing basis, including:
(1) Updating of waiting list patients' clinical information;
(2) Removing patients from the center's waiting list if a patient
receives a transplant or dies, or if there is any other reason the
patient should no longer be on a center's waiting list; and
(3) Notifying the OPTN no later than 24 hours after a patient's
removal from the center's waiting list.
(c) Standard: Patient records. Transplant centers must maintain up-
to-date and accurate patient management records for each patient who
receives an evaluation for placement on a center's waiting list and who
is admitted for organ transplantation.
(1) For each patient who receives an evaluation for placement on a
center's waiting list, the center must document in the patient's record
that the patient (and in the case of a kidney patient, the patient's
usual dialysis facility) has been informed of his or her transplant
status, including notification of:
(i) The patient's placement on the center's waiting list;
(ii) The center's decision not to place the patient on its waiting
list; or
(iii) The center's inability to make a determination regarding the
patient's placement on its waiting list because further clinical testing
or documentation is needed.
(2) If a patient on the waiting list is removed from the waiting
list for any reason other than death or transplantation, the transplant
center must document in the patient's record that the patient (and in
the case of a kidney patient, the patient's usual dialysis facility) was
notified no later than 10 days after the date the patient was removed
from the waiting list.
(3) In the case of patients admitted for organ transplants,
transplant centers must maintain written records of:
(i) Multidisciplinary patient care planning during the transplant
period; and
(ii) Multidisciplinary discharge planning for post-transplant care.
(d) Standard: Social services. The transplant center must make
social services available, furnished by qualified social workers, to
transplant patients, living donors, and their families. A qualified
social worker is an individual who meets licensing requirements in the
State in which he or she practices; and
(1) Completed a course of study with specialization in clinical
practice and holds a master's degree from a graduate school of social
work accredited by the Council on Social Work Education; or
(2) Is working as a social worker in a transplant center as of the
effective date of this final rule and has served for at least 2 years as
a social worker, 1 year of which was in a transplantation program, and
has established a consultative relationship with a social worker who is
qualified under (d)(1) of this paragraph.
(e) Standard: Nutritional services. Transplant centers must make
nutritional assessments and diet counseling services, furnished by a
qualified dietitian, available to all transplant patients and living
donors. A qualified dietitian is an individual who meets practice
requirements in the State in which he or she practices and is a
registered dietitian with the Commission on Dietetic Registration.
Sec. 482.96 Condition of participation: Quality assessment
and performance improvement (QAPI).
Transplant centers must develop, implement, and maintain a written,
comprehensive, data-driven QAPI program designed to monitor and evaluate
performance of all transplantation services, including services provided
under contract or arrangement.
(a) Standard: Components of a QAPI program. The transplant center's
QAPI program must use objective measures
[[Page 46]]
to evaluate the center's performance with regard to transplantation
activities and outcomes. Outcome measures may include, but are not
limited to, patient and donor selection criteria, accuracy of the
waiting list in accordance with the OPTN waiting list requirements,
accuracy of donor and beneficiary matching, patient and donor
management, techniques for organ recovery, consent practices, patient
education, patient satisfaction, and patient rights. The transplant
center must take actions that result in performance improvements and
track performance to ensure that improvements are sustained.
(b) Standard: Adverse events. A transplant center must establish and
implement written policies to address and document adverse events that
occur during any phase of an organ transplantation case.
(1) The policies must address, at a minimum, the process for the
identification, reporting, analysis, and prevention of adverse events.
(2) The transplant center must conduct a thorough analysis of and
document any adverse event and must utilize the analysis to effect
changes in the transplant center's policies and practices to prevent
repeat incidents.
Sec. 482.98 Condition of participation: Human resources.
The transplant center must ensure that all individuals who provide
services and/or supervise services at the center, including individuals
furnishing services under contract or arrangement, are qualified to
provide or supervise such services.
(a) Standard: Director of a transplant center. The transplant center
must be under the general supervision of a qualified transplant surgeon
or a qualified physician-director. The director of a transplant center
need not serve full-time and may also serve as a center's primary
transplant surgeon or transplant physician in accordance with
Sec. 482.98(b). The director is responsible for planning, organizing,
conducting, and directing the transplant center and must devote
sufficient time to carry out these responsibilities, which include but
are not limited to the following:
(1) Coordinating with the hospital in which the transplant center is
located to ensure adequate training of nursing staff and clinical
transplant coordinators in the care of transplant patients and living
donors.
(2) Ensuring that tissue typing and organ procurement services are
available.
(3) Ensuring that transplantation surgery is performed by, or under
the direct supervision of, a qualified transplant surgeon in accordance
with Sec. 482.98(b).
(b) Standard: Transplant surgeon and physician. The transplant
center must identify to the OPTN a primary transplant surgeon and a
transplant physician with the appropriate training and experience to
provide transplantation services, who are immediately available to
provide transplantation services when an organ is offered for
transplantation.
(1) The transplant surgeon is responsible for providing surgical
services related to transplantation.
(2) The transplant physician is responsible for providing and
coordinating transplantation care.
(c) Standard: Clinical transplant coordinator. The transplant center
must have a clinical transplant coordinator to ensure the continuity of
care of patients and living donors during the pre-transplant,
transplant, and discharge phases of transplantation and the donor
evaluation, donation, and discharge phases of donation. The clinical
transplant coordinator must be a registered nurse or clinician licensed
by the State in which the clinical transplant coordinator practices, who
has experience and knowledge of transplantation and living donation
issues. The clinical transplant coordinator's responsibilities must
include, but are not limited to, the following:
(1) Ensuring the coordination of the clinical aspects of transplant
patient and living donor care; and
(2) Acting as a liaison between a kidney transplant center and
dialysis facilities, as applicable.
(d) Standard: Independent living donor advocate or living donor
advocate team. The transplant center that performs living donor
transplantation must identify either an independent living
[[Page 47]]
donor advocate or an independent living donor advocate team to ensure
protection of the rights of living donors and prospective living donors.
(1) The living donor advocate or living donor advocate team must not
be involved in transplantation activities on a routine basis.
(2) The independent living donor advocate or living donor advocate
team must demonstrate:
(i) Knowledge of living organ donation, transplantation, medical
ethics, and informed consent; and
(ii) Understanding of the potential impact of family and other
external pressures on the prospective living donor's decision whether to
donate and the ability to discuss these issues with the donor.
(3) The independent living donor advocate or living donor advocate
team is responsible for:
(i) Representing and advising the donor;
(ii) Protecting and promoting the interests of the donor; and
(iii) Respecting the donor's decision and ensuring that the donor's
decision is informed and free from coercion.
(e) Standard: Transplant team. The transplant center must identify a
multidisciplinary transplant team and describe the responsibilities of
each member of the team. The team must be composed of individuals with
the appropriate qualifications, training, and experience in the relevant
areas of medicine, nursing, nutrition, social services, transplant
coordination, and pharmacology.
(f) Standard: Resource commitment. The transplant center must
demonstrate availability of expertise in internal medicine, surgery,
anesthesiology, immunology, infectious disease control, pathology,
radiology, blood banking, and patient education as related to the
provision of transplantation services.
Sec. 482.100 Condition of participation: Organ procurement.
The transplant center must ensure that the hospital in which it
operates has a written agreement for the receipt of organs with an OPO
designated by the Secretary that identifies specific responsibilities
for the hospital and for the OPO with respect to organ recovery and
organ allocation.
Sec. 482.102 Condition of participation: Patient and living donor
rights.
In addition to meeting the condition of participation ``Patients
rights'' requirements at Sec. 482.13, the transplant center must protect
and promote each transplant patient's and living donor's rights.
(a) Standard: Informed consent for transplant patients. Transplant
centers must implement written transplant patient informed consent
policies that inform each patient of:
(1) The evaluation process;
(2) The surgical procedure;
(3) Alternative treatments;
(4) Potential medical or psychosocial risks;
(5) National and transplant center-specific outcomes, from the most
recent SRTR center-specific report, including (but not limited to) the
transplant center's observed and expected 1-year patient and graft
survival, national 1-year patient and graft survival, and notification
about all Medicare outcome requirements not being met by the transplant
center;
(6) Organ donor risk factors that could affect the success of the
graft or the health of the patient, including, but not limited to, the
donor's history, condition or age of the organs used, or the patient's
potential risk of contracting the human immunodeficiency virus and other
infectious diseases if the disease cannot be detected in an infected
donor;
(7) His or her right to refuse transplantation; and
(8) The fact that if his or her transplant is not provided in a
Medicare-approved transplant center it could affect the transplant
beneficiary 's ability to have his or her immunosuppressive drugs paid
for under Medicare Part B.
(b) Standard: Informed consent for living donors. Transplant centers
must implement written living donor informed consent policies that
inform the prospective living donor of all aspects of, and potential
outcomes from, living donation. Transplant centers must ensure that the
prospective living donor is fully informed about the following:
[[Page 48]]
(1) The fact that communication between the donor and the transplant
center will remain confidential, in accordance with the requirements at
45 CFR parts 160 and 164.
(2) The evaluation process;
(3) The surgical procedure, including post-operative treatment;
(4) The availability of alternative treatments for the transplant
beneficiary;
(5) The potential medical or psychosocial risks to the donor;
(6) The national and transplant center-specific outcomes for
beneficiaries, and the national and center-specific outcomes for living
donors, as data are available;
(7) The possibility that future health problems related to the
donation may not be covered by the donor's insurance and that the
donor's ability to obtain health, disability, or life insurance may be
affected;
(8) The donor's right to opt out of donation at any time during the
donation process; and
(9) The fact that if a transplant is not provided in a Medicare-
approved transplant center it could affect the transplant beneficiary's
ability to have his or her immunosuppressive drugs paid for under
Medicare Part B.
(c) Standard: Notification to patients. Transplant centers must
notify patients placed on the center's waiting list of information about
the center that could impact the patient's ability to receive a
transplant should an organ become available, and what procedures are in
place to ensure the availability of a transplant team.
(1) A transplant center served by a single transplant surgeon or
physician must inform patients placed on the center's waiting list of:
(i) The potential unavailability of the transplant surgeon or
physician; and
(ii) Whether the center has a mechanism to provide an alternate
transplant surgeon or transplant physician.
(2) At least 30 days before a center's Medicare approval is
terminated, whether voluntarily or involuntarily, the center must:
(i) Inform patients on the center's waiting list and provide
assistance to waiting list patients who choose to transfer to the
waiting list of another Medicare-approved transplant center without loss
of time accrued on the waiting list; and
(ii) Inform Medicare beneficiaries on the center's waiting list that
Medicare will no longer pay for transplants performed at the center
after the effective date of the center's termination of approval.
(3) As soon as possible prior to a transplant center's voluntary
inactivation, the center must inform patients on the center's waiting
list and, as directed by the Secretary, provide assistance to waiting
list patients who choose to transfer to the waiting list of another
Medicare-approved transplant center without loss of time accrued on the
waiting list.
Sec. 482.104 Condition of participation: Additional requirements
for kidney transplant centers.
(a) Standard: End stage renal disease (ESRD) services. Kidney
transplant centers must directly furnish transplantation and other
medical and surgical specialty services required for the care of ESRD
patients. A kidney transplant center must have written policies and
procedures for ongoing communications with dialysis patients' local
dialysis facilities.
(b) Standard: Dialysis services. Kidney transplant centers must
furnish inpatient dialysis services directly or under arrangement.
(c) Standard: Participation in network activities. Kidney transplant
centers must cooperate with the ESRD Network designated for their
geographic area, in fulfilling the terms of the Network's current
statement of work.
PART 483_REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES--
Table of Contents
Subpart A [Reserved]
Subpart B_Requirements for Long Term Care Facilities
Sec.
483.1 Basis and scope.
483.5 Definitions.
483.10 Resident rights.
483.12 Freedom from abuse, neglect, and exploitation.
[[Page 49]]
483.15 Admission, transfer, and discharge rights.
483.20 Resident assessment.
483.21 Comprehensive person-centered care planning.
483.24 Quality of life.
483.25 Quality of care.
483.30 Physician services.
483.35 Nursing services.
483.40 Behavioral health services.
483.45 Pharmacy services.
483.50 Laboratory, radiology, and other diagnostic services.
483.55 Dental services.
483.60 Food and nutrition services.
483.65 Specialized rehabilitative services.
483.70 Administration.
483.73 Emergency preparedness.
483.75 Quality assurance and performance improvement.
483.80 Infection control.
483.85 Compliance and ethics program.
483.90 Physical environment.
483.95 Training requirements.
Subpart C_Preadmission Screening and Annual Review of Mentally Ill and
Mentally Retarded Individuals
483.100 Basis.
483.102 Applicability and definitions.
483.104 State plan requirement.
483.106 Basic rule.
483.108 Relationship of PASARR to other Medicaid processes.
483.110 Out-of-State arrangements.
483.112 Preadmission screening of applicants for admission to NFs.
483.114 Annual review of NF residents.
483.116 Residents and applicants determined to require NF level of
services.
483.118 Residents and applicants determined not to require NF level of
services.
483.120 Specialized services.
483.122 FFP for NF services.
483.124 FFP for specialized services.
483.126 Appropriate placement.
483.128 PASARR evaluation criteria.
483.130 PASARR determination criteria.
483.132 Evaluating the need for NF services and NF level of care
(PASARR/NF).
483.134 Evaluating whether an individual with mental illness requires
specialized services (PASARR/MI).
483.136 Evaluating whether an individual with intellectual disability
requires specialized services (PASARR/IID).
483.138 Maintenance of services and availability of FFP.
Subpart D_Requirements That Must Be Met by States and State Agencies:
Nurse Aide Training and Competency Evaluation; and Paid Feeding
Assistants
483.150 Statutory basis; Deemed meeting or waiver of requirements.
483.151 State review and approval of nurse aide training and competency
evaluation programs.
483.152 Requirements for approval of a nurse aide training and
competency evaluation program.
483.154 Nurse aide competency evaluation.
483.156 Registry of nurse aides.
483.158 FFP for nurse aide training and competency evaluation.
483.160 Requirements for training of paid feeding assistants.
Subpart E_Appeals of Discharges, Transfers, and Preadmission Screening
and Annual Resident Review (PASARR) Determinations
483.200 Statutory basis.
483.202 Definitions.
483.204 Provision of a hearing and appeal system.
483.206 Transfers, discharges and relocations subject to appeal.
Subpart F_Requirements That Must Be Met by States and State Agencies,
Resident Assessment
483.315 Specification of resident assessment instrument.
Subpart G_Condition of Participation for the Use of Restraint or
Seclusion in Psychiatric Residential Treatment Facilities Providing
Inpatient Psychiatric Services for Individuals Under Age 21
483.350 Basis and scope.
483.352 Definitions.
483.354 General requirements for psychiatric residential treatment
facilities.
483.356 Protection of residents.
483.358 Orders for the use of restraint or seclusion.
483.360 Consultation with treatment team physician.
483.362 Monitoring of the resident in and immediately after restraint.
483.364 Monitoring of the resident in and immediately after seclusion.
483.366 Notification of parent(s) or legal guardian(s).
483.368 Application of time out.
483.370 Postintervention debriefings.
483.372 Medical treatment for injuries resulting from an emergency
safety intervention.
483.374 Facility reporting.
483.376 Education and training.
[[Page 50]]
Subpart H [Reserved]
Subpart I_Conditions of Participation for Intermediate Care Facilities
for Individuals with Intellectual Disabilities
483.400 Basis and purpose.
483.405 Relationship to other HHS regulations.
483.410 Condition of participation: Governing body and management.
483.420 Condition of participation: Client protections.
483.430 Condition of participation: Facility staffing.
483.440 Condition of participation: Active treatment services.
483.450 Condition of participation: Client behavior and facility
practices.
483.460 Condition of participation: Health care services.
483.470 Condition of participation: Physical environment.
483.475 Condition of participation: Emergency preparedness.
483.480 Condition of participation: Dietetic services.
Authority: Secs. 1102, 1128I, 1819, 1871 and 1919 of the Social
Security Act (42 U.S.C. 1302, 1320a-7, 1395i, 1395hh and 1396r).
Subpart A [Reserved]
Subpart B_Requirements for Long Term Care Facilities
Source: 54 FR 5359, Feb. 2, 1989, unless otherwise noted.
Sec. 483.1 Basis and scope.
(a) Statutory basis. (1) Sections 1819(a), (b), (c), (d), and (f) of
the Act provide that--
(i) Skilled nursing facilities participating in Medicare must meet
certain specified requirements; and
(ii) The Secretary may impose additional requirements (see section
1819(d)(4)(B)) if they are necessary for the health and safety of
individuals to whom services are furnished in the facilities.
(2) Section 1861(l) of the Act requires the facility to have in
effect a transfer agreement with a hospital.
(3) Sections 1919(a), (b), (c), (d), and (f) of the Act provide that
nursing facilities participating in Medicaid must meet certain specific
requirements.
(4) Sections 1128I(b) and (c) require that--
(i) Skilled nursing facilities or nursing facility have in operation
a compliance and ethics program that is effective in preventing and
detecting criminal, civil, and administrative violations.
(ii) The Secretary establish and implement a quality assurance and
performance improvement program for facilities, including multi-unit
chains of facilities.
(5) Section 1150B establishes requirements for reporting to law
enforcement crimes occurring in federally funded LTC facilities.
(b) Scope. The provisions of this part contain the requirements that
an institution must meet in order to qualify to participate as a Skilled
Nursing Facility in the Medicare program, and as a nursing facility in
the Medicaid program. They serve as the basis for survey activities for
the purpose of determining whether a facility meets the requirements for
participation in Medicare and Medicaid.
[56 FR 48867, Sept. 26, 1991, as amended at 57 FR 43924, Sept. 23, 1992;
60 FR 50443, Sept. 29, 1995; 81 FR 68848, Oct. 4, 2016]
Sec. 483.5 Definitions.
As used in this subpart, the following definitions apply:
Abuse. Abuse is the willful infliction of injury, unreasonable
confinement, intimidation, or punishment with resulting physical harm,
pain or mental anguish. Abuse also includes the deprivation by an
individual, including a caretaker, of goods or services that are
necessary to attain or maintain physical, mental, and psychosocial well-
being. Instances of abuse of all residents, irrespective of any mental
or physical condition, cause physical harm, pain or mental anguish. It
includes verbal abuse, sexual abuse, physical abuse, and mental abuse
including abuse facilitated or enabled through the use of technology.
Willful, as used in this definition of abuse, means the individual must
have acted deliberately, not that the individual must have intended to
inflict injury or harm.
Adverse event. An adverse event is an untoward, undesirable, and
usually unanticipated event that causes death or serious injury, or the
risk thereof.
[[Page 51]]
Common area. Common areas are areas in the facility where residents
may gather together with other residents, visitors, and staff or engage
in individual pursuits, apart from their residential rooms. This
includes but is not limited to living rooms, dining rooms, activity
rooms, outdoor areas, and meeting rooms where residents are located on a
regular basis.
Composite distinct part--(1) Definition. A composite distinct part
is a distinct part consisting of two or more noncontiguous components
that are not located within the same campus, as defined in
Sec. 413.65(a)(2) of this chapter.
(2) Requirements. In addition to meeting the requirements of
specified in the definition of ``distinct part'' of this section, a
composite distinct part must meet all of the following requirements:
(i) A SNF or NF that is a composite of more than one location will
be treated as a single distinct part of the institution of which it is a
distinct part. As such, the composite distinct part will have only one
provider agreement and only one provider number.
(ii) If two or more institutions (each with a distinct part SNF or
NF) undergo a change of ownership, CMS must approve the existing SNFs or
NFs as meeting the requirements before they are considered a composite
distinct part of a single institution. In making such a determination,
CMS considers whether its approval or disapproval of a composite
distinct part promotes the effective and efficient use of public monies
without sacrificing the quality of care.
(iii) If there is a change of ownership of a composite distinct part
SNF or NF, the assignment of the provider agreement to the new owner
will apply to all of the approved locations that comprise the composite
distinct part SNF or NF.
(iv) To ensure quality of care and quality of life for all
residents, the various components of a composite distinct part must meet
all of the requirements for participation independently in each
location.
(v) Use of composite distinct parts to segregate residents by
payment source or on a basis other than care needs is prohibited.
Distinct part--(1) Definition. A distinct part SNF or NF is
physically distinguishable from the larger institution or institutional
complex that houses it, meets the requirements of this paragraph and of
paragraph (2) of this definition, and meets the applicable statutory
requirements for SNFs or NFs in sections 1819 or 1919 of the Act,
respectively. A distinct part SNF or NF may comprise one or more
buildings or designated parts of buildings (that is, wings, wards, or
floors) that are: In the same physical area immediately adjacent to the
institution's main buildings; other areas and structures that are not
strictly contiguous with the main buildings but are located within close
proximity to the main buildings; and any other areas that CMS determines
on an individual basis, to be part of the institution's campus. A
distinct part must include all of the beds within the designated area,
and cannot consist of a random collection of individual rooms or beds
that are scattered throughout the physical plant. The term ``distinct
part'' also includes a composite distinct part that meets the additional
requirements specified in the definition of ``composite distinct part''
of this section.
(2) Requirements. In addition to meeting the participation
requirements for long-term care facilities set forth elsewhere in this
subpart, a distinct part SNF or NF must meet all of the following
requirements:
(i) The SNF or NF must be operated under common ownership and
control (that is, common governance) by the institution of which it is a
distinct part, as evidenced by the following:
(A) The SNF or NF is wholly owned by the institution of which it is
a distinct part.
(B) The SNF or NF is subject to the by-laws and operating decisions
of a common governing body.
(C) The institution of which the SNF or NF is a distinct part has
final responsibility for the distinct part's administrative decisions
and personnel policies, and final approval for the distinct part's
personnel actions.
(D) The SNF or NF functions as an integral and subordinate part of
the institution of which it is a distinct part, with significant common
resource
[[Page 52]]
usage of buildings, equipment, personnel, and services.
(ii) The administrator of the SNF or NF reports to and is directly
accountable to the management of the institution of which the SNF or NF
is a distinct part.
(iii) The SNF or NF must have a designated medical director who is
responsible for implementing care policies and coordinating medical
care, and who is directly accountable to the management of the
institution of which it is a distinct part.
(iv) The SNF or NF is financially integrated with the institution of
which it is a distinct part, as evidenced by the sharing of income and
expenses with that institution, and the reporting of its costs on that
institution's cost report.
(v) A single institution can have a maximum of only one distinct
part SNF and one distinct part NF.
(vi) (A) An institution cannot designate a distinct part SNF or NF,
but instead must submit a written request with documentation that
demonstrates it meets the criteria set forth above to CMS to determine
if it may be considered a distinct part.
(B) The effective date of approval of a distinct part is the date
that CMS determines all requirements (including enrollment with the
fiscal intermediary (FI)) are met for approval, and cannot be made
retroactive.
(C) The institution must request approval from CMS for all proposed
changes in the number of beds in the approved distinct part.
Exploitation. Exploitation means taking advantage of a resident for
personal gain through the use of manipulation, intimidation, threats, or
coercion.
Facility. For purposes of this subpart, facility means a skilled
nursing facility (SNF) that meets the requirements of sections 1819(a),
(b), (c), and (d) of the Act, or a nursing facility (NF) that meets the
requirements of sections 1919(a), (b), (c), and (d) of the Act.
``Facility'' may include a distinct part of an institution (as defined
in paragraph (b) of this section and specified in Sec. 440.40 and
Sec. 440.155 of this chapter), but does not include an institution for
individuals with intellectual disabilities or persons with related
conditions described in Sec. 440.150 of this chapter. For Medicare and
Medicaid purposes (including eligibility, coverage, certification, and
payment), the ``facility'' is always the entity that participates in the
program, whether that entity is comprised of all of, or a distinct part
of, a larger institution. For Medicare, an SNF (see section 1819(a)(1)
of the Act), and for Medicaid, an NF (see section 1919(a)(1) of the Act)
may not be an institution for mental diseases as defined in
Sec. 435.1010 of this chapter.
Fully sprinklered. A fully sprinklered long term care facility is
one that has all areas sprinklered in accordance with National Fire
Protection Association 13 ``Standard for the Installation of Sprinkler
Systems'' without the use of waivers or the Fire Safety Evaluation
System.
Licensed health professional. A licensed health professional is a
physician; physician assistant; nurse practitioner; physical, speech, or
occupational therapist; physical or occupational therapy assistant;
registered professional nurse; licensed practical nurse; or licensed or
certified social worker; or registered respiratory therapist or
certified respiratory therapy technician.
Major modification means the modification of more than 50 percent,
or more than 4,500 square feet, of the smoke compartment.
Misappropriation of resident property means the deliberate
misplacement, exploitation, or wrongful, temporary, or permanent use of
a resident's belongings or money without the resident's consent.
Mistreatment means inappropriate treatment or exploitation of a
resident.
Neglect is the failure of the facility, its employees or service
providers to provide goods and services to a resident that are necessary
to avoid physical harm, pain, mental anguish, or emotional distress.
Nurse aide. A nurse aide is any individual providing nursing or
nursing-related services to residents in a facility. This term may also
include an individual who provides these services through an agency or
under a contract with the facility, but is not a licensed health
professional, a registered dietitian, or someone who volunteers to
[[Page 53]]
provide such services without pay. Nurse aides do not include those
individuals who furnish services to residents only as paid feeding
assistants as defined in Sec. 488.301 of this chapter.
Person-centered care. For purposes of this subpart, person-centered
care means to focus on the resident as the locus of control and support
the resident in making their own choices and having control over their
daily lives.
Resident representative. For purposes of this subpart, the term
resident representative means any of the following:
(1) An individual chosen by the resident to act on behalf of the
resident in order to support the resident in decision-making; access
medical, social or other personal information of the resident; manage
financial matters; or receive notifications;
(2) A person authorized by State or Federal law (including but not
limited to agents under power of attorney, representative payees, and
other fiduciaries) to act on behalf of the resident in order to support
the resident in decision-making; access medical, social or other
personal information of the resident; manage financial matters; or
receive notifications;
(3) Legal representative, as used in section 712 of the Older
Americans Act; or.
(4) The court-appointed guardian or conservator of a resident.
(5) Nothing in this rule is intended to expand the scope of
authority of any resident representative beyond that authority
specifically authorized by the resident, State or Federal law, or a
court of competent jurisdiction.
Sexual abuse is non-consensual sexual contact of any type with a
resident.
Transfer and discharge includes movement of a resident to a bed
outside of the certified facility whether that bed is in the same
physical plant or not. Transfer and discharge does not refer to movement
of a resident to a bed within the same certified facility.
[68 FR 46071, Aug. 4, 2003, as amended at 71 FR 39229, July 12, 2006; 71
FR 55340, Sept. 22, 2006; 79 FR 27155, May 12, 2014; 81 FR 68848, Oct.
4, 2016; 82 FR 32259, July 13, 2017]
Sec. 483.10 Resident rights.
(a) Residents rights. The resident has a right to a dignified
existence, self-determination, and communication with and access to
persons and services inside and outside the facility, including those
specified in this section.
(1) A facility must treat each resident with respect and dignity and
care for each resident in a manner and in an environment that promotes
maintenance or enhancement of his or her quality of life, recognizing
each resident's individuality. The facility must protect and promote the
rights of the resident.
(2) The facility must provide equal access to quality care
regardless of diagnosis, severity of condition, or payment source. A
facility must establish and maintain identical policies and practices
regarding transfer, discharge, and the provision of services under the
State plan for all residents regardless of payment source.
(b) Exercise of rights. The resident has the right to exercise his
or her rights as a resident of the facility and as a citizen or resident
of the United States.
(1) The facility must ensure that the resident can exercise his or
her rights without interference, coercion, discrimination, or reprisal
from the facility
(2) The resident has the right to be free of interference, coercion,
discrimination, and reprisal from the facility in exercising his or her
rights and to be supported by the facility in the exercise of his or her
rights as required under this subpart.
(3) In the case of a resident who has not been adjudged incompetent
by the state court, the resident has the right to designate a
representative, in accordance with State law and any legal surrogate so
designated may exercise the resident's rights to the extent provided by
state law. The same-sex spouse of a resident must be afforded treatment
equal to that afforded to an opposite-sex spouse if the marriage was
valid in the jurisdiction in which it was celebrated.
(i) The resident representative has the right to exercise the
resident's rights to the extent those rights are delegated to the
resident representative.
(ii) The resident retains the right to exercise those rights not
delegated to a
[[Page 54]]
resident representative, including the right to revoke a delegation of
rights, except as limited by State law.
(4) The facility must treat the decisions of a resident
representative as the decisions of the resident to the extent required
by the court or delegated by the resident, in accordance with applicable
law.
(5) The facility shall not extend the resident representative the
right to make decisions on behalf of the resident beyond the extent
required by the court or delegated by the resident, in accordance with
applicable law.
(6) If the facility has reason to believe that a resident
representative is making decisions or taking actions that are not in the
best interests of a resident, the facility shall report such concerns in
the manner required under State law.
(7) In the case of a resident adjudged incompetent under the laws of
a State by a court of competent jurisdiction, the rights of the resident
devolve to and are exercised by the resident representative appointed
under State law to act on the resident's behalf. The court-appointed
resident representative exercises the resident's rights to the extent
judged necessary by a court of competent jurisdiction, in accordance
with State law
(i) In the case of a resident representative whose decision-making
authority is limited by State law or court appointment, the resident
retains the right to make those decision outside the representative's
authority.
(ii) The resident's wishes and preferences must be considered in the
exercise of rights by the representative.
(iii) To the extent practicable, the resident must be provided with
opportunities to participate in the care planning process.
(c) Planning and implementing care. The resident has the right to be
informed of, and participate in, his or her treatment, including:
(1) The right to be fully informed in language that he or she can
understand of his or her total health status, including but not limited
to, his or her medical condition.
(2) The right to participate in the development and implementation
of his or her person-centered plan of care, including but not limited
to:
(i) The right to participate in the planning process, including the
right to identify individuals or roles to be included in the planning
process, the right to request meetings and the right to request
revisions to the person-centered plan of care.
(ii) The right to participate in establishing the expected goals and
outcomes of care, the type, amount, frequency, and duration of care, and
any other factors related to the effectiveness of the plan of care.
(iii) The right to be informed, in advance, of changes to the plan
of care.
(iv) The right to receive the services and/or items included in the
plan of care.
(v) The right to see the care plan, including the right to sign
after significant changes to the plan of care.
(3) The facility shall inform the resident of the right to
participate in his or her treatment and shall support the resident in
this right. The planning process must--
(i) Facilitate the inclusion of the resident and/or resident
representative.
(ii) Include an assessment of the resident's strengths and needs.
(iii) Incorporate the resident's personal and cultural preferences
in developing goals of care.
(4) The right to be informed, in advance, of the care to be
furnished and the type of care giver or professional that will furnish
care.
(5) The right to be informed in advance, by the physician or other
practitioner or professional, of the risks and benefits of proposed
care, of treatment and treatment alternatives or treatment options and
to choose the alternative or option he or she prefers.
(6) The right to request, refuse, and/or discontinue treatment, to
participate in or refuse to participate in experimental research, and to
formulate an advance directive.
(7) The right to self-administer medications if the
interdisciplinary team, as defined by Sec. 483.21(b)(2)(ii), has
determined that this practice is clinically appropriate.
[[Page 55]]
(8) Nothing in this paragraph should be construed as the right of
the resident to receive the provision of medical treatment or medical
services deemed medically unnecessary or inappropriate.
(d) Choice of attending physician. The resident has the right to
choose his or her attending physician.
(1) The physician must be licensed to practice, and
(2) If the physician chosen by the resident refuses to or does not
meet requirements specified in this part, the facility may seek
alternate physician participation as specified in paragraphs (d)(4) and
(5) of this section to assure provision of appropriate and adequate care
and treatment.
(3) The facility must ensure that each resident remains informed of
the name, specialty, and way of contacting the physician and other
primary care professionals responsible for his or her care.
(4) The facility must inform the resident if the facility determines
that the physician chosen by the resident is unable or unwilling to meet
requirements specified in this part and the facility seeks alternate
physician participation to assure provision of appropriate and adequate
care and treatment. The facility must discuss the alternative physician
participation with the resident and honor the resident's preferences, if
any, among options.
(5) If the resident subsequently selects another attending physician
who meets the requirements specified in this part, the facility must
honor that choice.
(e) Respect and dignity. The resident has a right to be treated with
respect and dignity, including:
(1) The right to be free from any physical or chemical restraints
imposed for purposes of discipline or convenience, and not required to
treat the resident's medical symptoms, consistent with
Sec. 483.12(a)(2).
(2) The right to retain and use personal possessions, including
furnishings, and clothing, as space permits, unless to do so would
infringe upon the rights or health and safety of other residents.
(3) The right to reside and receive services in the facility with
reasonable accommodation of resident needs and preferences except when
to do so would endanger the health or safety of the resident or other
residents.
(4) The right to share a room with his or her spouse when married
residents live in the same facility and both spouses consent to the
arrangement.
(5) The right to share a room with his or her roommate of choice
when practicable, when both residents live in the same facility and both
residents consent to the arrangement.
(6) The right to receive written notice, including the reason for
the change, before the resident's room or roommate in the facility is
changed.
(7) The right to refuse to transfer to another room in the facility,
if the purpose of the transfer is:
(i) To relocate a resident of a SNF from the distinct part of the
institution that is a SNF to a part of the institution that is not a
SNF, or
(ii) to relocate a resident of a NF from the distinct part of the
institution that is a NF to a distinct part of the institution that is a
SNF.
(iii) solely for the convenience of staff.
(8) A resident's exercise of the right to refuse transfer does not
affect the resident's eligibility or entitlement to Medicare or Medicaid
benefits.
(f) Self-determination. The resident has the right to and the
facility must promote and facilitate resident self-determination through
support of resident choice, including but not limited to the rights
specified in paragraphs (f)(1) through (11) of this section.
(1) The resident has a right to choose activities, schedules
(including sleeping and waking times), health care and providers of
health care services consistent with his or her interests, assessments,
plan of care and other applicable provisions of this part.
(2) The resident has the right to make choices about aspects of his
or her life in the facility that are significant to the resident.
(3) The resident has a right to interact with members of the
community and participate in community activities both inside and
outside the facility.
(4) The resident has a right to receive visitors of his or her
choosing at the
[[Page 56]]
time of his or her choosing, subject to the resident's right to deny
visitation when applicable, and in a manner that does not impose on the
rights of another resident.
(i) The facility must provide immediate access to any resident by--
(A) Any representative of the Secretary,
(B) Any representative of the State,
(C) Any representative of the Office of the State long term care
ombudsman, (established under section 712 of the Older Americans Act of
1965, as amended 2016 (42 U.S.C. 3001 et seq.),
(D) The resident's individual physician,
(E) Any representative of the protection and advocacy systems, as
designated by the state, and as established under the Developmental
Disabilities Assistance and Bill of Rights Act of 2000 (42 U.S.C. 15001
et seq.),
(F) Any representative of the agency responsible for the protection
and advocacy system for individuals with a mental disorder (established
under the Protection and Advocacy for Mentally Ill Individuals Act of
2000 (42 U.S.C. 10801 et seq.), and
(G) The resident representative.
(ii) The facility must provide immediate access to a resident by
immediate family and other relatives of the resident, subject to the
resident's right to deny or withdraw consent at any time;
(iii) The facility must provide immediate access to a resident by
others who are visiting with the consent of the resident, subject to
reasonable clinical and safety restrictions and the resident's right to
deny or withdraw consent at any time;
(iv) The facility must provide reasonable access to a resident by
any entity or individual that provides health, social, legal, or other
services to the resident, subject to the resident's right to deny or
withdraw consent at any time; and
(v) The facility must have written policies and procedures regarding
the visitation rights of residents, including those setting forth any
clinically necessary or reasonable restriction or limitation or safety
restriction or limitation, when such limitations may apply consistent
with the requirements of this subpart, that the facility may need to
place on such rights and the reasons for the clinical or safety
restriction or limitation.
(vi) A facility must meet the following requirements:
(A) Inform each resident (or resident representative, where
appropriate) of his or her visitation rights and related facility policy
and procedures, including any clinical or safety restriction or
limitation on such rights, consistent with the requirements of this
subpart, the reasons for the restriction or limitation, and to whom the
restrictions apply, when he or she is informed of his or her other
rights under this section.
(B) Inform each resident of the right, subject to his or her
consent, to receive the visitors whom he or she designates, including,
but not limited to, a spouse (including a same-sex spouse), a domestic
partner (including a same-sex domestic partner), another family member,
or a friend, and his or her right to withdraw or deny such consent at
any time.
(C) Not restrict, limit, or otherwise deny visitation privileges on
the basis of race, color, national origin, religion, sex, gender
identity, sexual orientation, or disability.
(D) Ensure that all visitors enjoy full and equal visitation
privileges consistent with resident preferences.
(5) The resident has a right to organize and participate in resident
groups in the facility.
(i) The facility must provide a resident or family group, if one
exists, with private space; and take reasonable steps, with the approval
of the group, to make residents and family members aware of upcoming
meetings in a timely manner.
(ii) Staff, visitors, or other guests may attend resident group or
family group meetings only at the respective group's invitation.
(iii) The facility must provide a designated staff person who is
approved by the resident or family group and the facility and who is
responsible for providing assistance and responding to written requests
that result from group meetings.
(iv) The facility must consider the views of a resident or family
group and act promptly upon the grievances and
[[Page 57]]
recommendations of such groups concerning issues of resident care and
life in the facility.
(A) The facility must be able to demonstrate their response and
rationale for such response.
(B) This should not be construed to mean that the facility must
implement as recommended every request of the resident or family group.
(6) The resident has a right to participate in family groups.
(7) The resident has a right to have family member(s) or other
resident representative(s) meet in the facility with the families or
resident representative(s) of other residents in the facility.
(8) The resident has a right to participate in other activities,
including social, religious, and community activities that do not
interfere with the rights of other residents in the facility.
(9) The resident has a right to choose to or refuse to perform
services for the facility and the facility must not require a resident
to perform services for the facility. The resident may perform services
for the facility, if he or she chooses, when--
(i) The facility has documented the resident's need or desire for
work in the plan of care;
(ii) The plan specifies the nature of the services performed and
whether the services are voluntary or paid;
(iii) Compensation for paid services is at or above prevailing
rates; and
(iv) The resident agrees to the work arrangement described in the
plan of care.
(10) The resident has a right to manage his or her financial
affairs. This includes the right to know, in advance, what charges a
facility may impose against a resident's personal funds.
(i) The facility must not require residents to deposit their
personal funds with the facility. If a resident chooses to deposit
personal funds with the facility, upon written authorization of a
resident, the facility must act as a fiduciary of the resident's funds
and hold, safeguard, manage, and account for the personal funds of the
resident deposited with the facility, as specified in this section.
(ii) Deposit of funds. (A) In general: Except as set out in
paragraph (f)(10)(ii)(B) of this section, the facility must deposit any
residents' personal funds in excess of $100 in an interest bearing
account (or accounts) that is separate from any of the facility's
operating accounts, and that credits all interest earned on resident's
funds to that account. (In pooled accounts, there must be a separate
accounting for each resident's share.) The facility must maintain a
resident's personal funds that do not exceed $100 in a non-interest
bearing account, interest-bearing account, or petty cash fund.
(B) Residents whose care is funded by Medicaid: The facility must
deposit the residents' personal funds in excess of $50 in an interest
bearing account (or accounts) that is separate from any of the
facility's operating accounts, and that credits all interest earned on
resident's funds to that account. (In pooled accounts, there must be a
separate accounting for each resident's share.) The facility must
maintain personal funds that do not exceed $50 in a non-interest bearing
account, interest-bearing account, or petty cash fund.
(iii) Accounting and records. (A) The facility must establish and
maintain a system that assures a full and complete and separate
accounting, according to generally accepted accounting principles, of
each resident's personal funds entrusted to the facility on the
resident's behalf.
(B) The system must preclude any commingling of resident funds with
facility funds or with the funds of any person other than another
resident.
(C) The individual financial record must be available to the
resident through quarterly statements and upon request.
(iv) Notice of certain balances. The facility must notify each
resident that receives Medicaid benefits--
(A) When the amount in the resident's account reaches $200 less than
the SSI resource limit for one person, specified in section
1611(a)(3)(B) of the Act; and
(B) That, if the amount in the account, in addition to the value of
the resident's other nonexempt resources, reaches the SSI resource limit
for one person, the resident may lose eligibility for Medicaid or SSI.
[[Page 58]]
(v) Conveyance upon discharge, eviction, or death. Upon the
discharge, eviction, or death of a resident with a personal fund
deposited with the facility, the facility must convey within 30 days the
resident's funds, and a final accounting of those funds, to the
resident, or in the case of death, the individual or probate
jurisdiction administering the resident's estate, in accordance with
State law.
(vi) Assurance of financial security. The facility must purchase a
surety bond, or otherwise provide assurance satisfactory to the
Secretary, to assure the security of all personal funds of residents
deposited with the facility.
(11) The facility must not impose a charge against the personal
funds of a resident for any item or service for which payment is made
under Medicaid or Medicare (except for applicable deductible and
coinsurance amounts). The facility may charge the resident for requested
services that are more expensive than or in excess of covered services
in accordance with Sec. 489.32 of this chapter. (This does not affect
the prohibition on facility charges for items and services for which
Medicaid has paid. See Sec. 447.15 of this chapter, which limits
participation in the Medicaid program to providers who accept, as
payment in full, Medicaid payment plus any deductible, coinsurance, or
copayment required by the plan to be paid by the individual.)
(i) Services included in Medicare or Medicaid payment. During the
course of a covered Medicare or Medicaid stay, facilities must not
charge a resident for the following categories of items and services:
(A) Nursing services as required at Sec. 483.35.
(B) Food and Nutrition services as required at Sec. 483.60.
(C) An activities program as required at Sec. 483.24(c).
(D) Room/bed maintenance services.
(E) Routine personal hygiene items and services as required to meet
the needs of residents, including, but not limited to, hair hygiene
supplies, comb, brush, bath soap, disinfecting soaps or specialized
cleansing agents when indicated to treat special skin problems or to
fight infection, razor, shaving cream, toothbrush, toothpaste, denture
adhesive, denture cleaner, dental floss, moisturizing lotion, tissues,
cotton balls, cotton swabs, deodorant, incontinence care and supplies,
sanitary napkins and related supplies, towels, washcloths, hospital
gowns, over the counter drugs, hair and nail hygiene services, bathing
assistance, and basic personal laundry.
(F) Medically-related social services as required at Sec. 483.40(d).
(G) Hospice services elected by the resident and paid for under the
Medicare Hospice Benefit or paid for by Medicaid under a state plan.
(ii) Items and services that may be charged to residents' funds.
Paragraphs (f)(11)(ii)(A) through (L) of this section are general
categories and examples of items and services that the facility may
charge to residents' funds if they are requested by a resident, if they
are not required to achieve the goals stated in the resident's care
plan, if the facility informs the resident that there will be a charge,
and if payment is not made by Medicare or Medicaid:
(A) Telephone, including a cellular phone.
(B) Television/radio, personal computer or other electronic device
for personal use.
(C) Personal comfort items, including smoking materials, notions and
novelties, and confections.
(D) Cosmetic and grooming items and services in excess of those for
which payment is made under Medicaid or Medicare.
(E) Personal clothing.
(F) Personal reading matter.
(G) Gifts purchased on behalf of a resident.
(H) Flowers and plants.
(I) Cost to participate in social events and entertainment outside
the scope of the activities program, provided under Sec. 483.24(c).
(J) Non-covered special care services such as privately hired nurses
or aides.
(K) Private room, except when therapeutically required (for example,
isolation for infection control).
(L) Except as provided in (e)(11)(ii)(L)(1) and (2) of this section,
specially prepared or alternative food requested instead of the food and
meals generally prepared by the facility, as required by Sec. 483.60.
[[Page 59]]
(1) The facility may not charge for special foods and meals,
including medically prescribed dietary supplements, ordered by the
resident's physician, physician assistant, nurse practitioner, or
clinical nurse specialist, as these are included in accordance with
Sec. 483.60.
(2) In accordance with Sec. 483.60(c) through (f), when preparing
foods and meals, a facility must take into consideration residents'
needs and preferences and the overall cultural and religious make-up of
the facility's population.
(iii) Requests for items and services. (A) The facility can only
charge a resident for any non-covered item or service if such item or
service is specifically requested by the resident.
(B) The facility must not require a resident to request any item or
service as a condition of admission or continued stay.
(C) The facility must inform, orally and in writing, the resident
requesting an item or service for which a charge will be made that there
will be a charge for the item or service and what the charge will be.
(g) Information and communication. (1) The resident has the right to
be informed of his or her rights and of all rules and regulations
governing resident conduct and responsibilities during his or her stay
in the facility.
(2) The resident has the right to access personal and medical
records pertaining to him or herself.
(i) The facility must provide the resident with access to personal
and medical records pertaining to him or herself, upon an oral or
written request, in the form and format requested by the individual, if
it is readily producible in such form and format (including in an
electronic form or format when such records are maintained
electronically); or, if not, in a readable hard copy form or such other
form and format as agreed to by the facility and the individual, within
24 hours (excluding weekends and holidays); and
(ii) The facility must allow the resident to obtain a copy of the
records or any portions thereof (including in an electronic form or
format when such records are maintained electronically) upon request and
2 working days advance notice to the facility. The facility may impose a
reasonable, cost-based fee on the provision of copies, provided that the
fee includes only the cost of:
(A) Labor for copying the records requested by the individual,
whether in paper or electronic form;
(B) Supplies for creating the paper copy or electronic media if the
individual requests that the electronic copy be provided on portable
media; and
(C) Postage, when the individual has requested the copy be mailed.
(3) With the exception of information described in paragraphs (g)(2)
and (g)(11) of this section, the facility must ensure that information
is provided to each resident in a form and manner the resident can
access and understand, including in an alternative format or in a
language that the resident can understand. Summaries that translate
information described in paragraph (g)(2) of this section may be made
available to the patient at their request and expense in accordance with
applicable law.
(4) The resident has the right to receive notices orally (meaning
spoken) and in writing (including Braille) in a format and a language he
or she understands, including;
(i) Required notices as specified in this section. The facility must
furnish to each resident a written description of legal rights which
includes--
(A) A description of the manner of protecting personal funds, under
paragraph (f)(10) of this section;
(B) A description of the requirements and procedures for
establishing eligibility for Medicaid, including the right to request an
assessment of resources under section 1924(c) of the Social Security
Act.
(C) A list of names, addresses (mailing and email), and telephone
numbers of all pertinent State regulatory and informational agencies,
resident advocacy groups such as the State Survey Agency, the State
licensure office, the State Long-Term Care Ombudsman program, the
protection and advocacy agency, adult protective services where state
law provides for jurisdiction in
[[Page 60]]
long-term care facilities, the local contact agency for information
about returning to the community and the Medicaid Fraud Control Unit;
and
(D) A statement that the resident may file a complaint with the
State Survey Agency concerning any suspected violation of state or
federal nursing facility regulations, including but not limited to
resident abuse, neglect, exploitation, misappropriation of resident
property in the facility, non-compliance with the advance directives
requirements and requests for information regarding returning to the
community.
(ii) Information and contact information for State and local
advocacy organizations, including but not limited to the State Survey
Agency, the State Long-Term Care Ombudsman program (established under
section 712 of the Older Americans Act of 1965, as amended 2016 (42
U.S.C. 3001 et seq.) and the protection and advocacy system (as
designated by the state, and as established under the Developmental
Disabilities Assistance and Bill of Rights Act of 2000 (42 U.S.C. 15001
et seq.);
(iii) Information regarding Medicare and Medicaid eligibility and
coverage;
(iv) Contact information for the Aging and Disability Resource
Center (established under Section 202(a)(20)(B)(iii) of the Older
Americans Act); or other No Wrong Door Program
(v) Contact information for the Medicaid Fraud Control Unit; and
(vi) Information and contact information for filing grievances or
complaints concerning any suspected violation of state or federal
nursing facility regulations, including but not limited to resident
abuse, neglect, exploitation, misappropriation of resident property in
the facility, non-compliance with the advance directives requirements
and requests for information regarding returning to the community.
(5) The facility must post, in a form and manner accessible and
understandable to residents, and resident representatives:
(i) A list of names, addresses (mailing and email), and telephone
numbers of all pertinent State agencies and advocacy groups, such as the
State Survey Agency, the State licensure office, adult protective
services where state law provides for jurisdiction in long-term care
facilities, the Office of the State Long-Term Care Ombudsman program,
the protection and advocacy network, home and community based service
programs, and the Medicaid Fraud Control Unit; and
(ii) A statement that the resident may file a complaint with the
State Survey Agency concerning any suspected violation of state or
federal nursing facility regulations, including but not limited to
resident abuse, neglect, exploitation, misappropriation of resident
property in the facility, non-compliance with the advance directives
requirements (42 CFR part 489 subpart I) and requests for information
regarding returning to the community.
(6) The resident has the right to have reasonable access to the use
of a telephone, including TTY and TDD services, and a place in the
facility where calls can be made without being overheard. This includes
the right to retain and use a cellular phone at the resident's own
expense.
(7) The facility must protect and facilitate that resident's right
to communicate with individuals and entities within and external to the
facility, including reasonable access to:
(i) A telephone, including TTY and TDD services;
(ii) The internet, to the extent available to the facility; and
(iii) Stationery, postage, writing implements and the ability to
send mail.
(8) The resident has the right to send and receive mail, and to
receive letters, packages and other materials delivered to the facility
for the resident through a means other than a postal service, including
the right to:
(i) Privacy of such communications consistent with this section; and
(ii) Access to stationery, postage, and writing implements at the
resident's own expense.
(9) The resident has the right to have reasonable access to and
privacy in their use of electronic communications such as email and
video communications and for Internet research.
(i) If the access is available to the facility
(ii) At the resident's expense, if any additional expense is
incurred by the
[[Page 61]]
facility to provide such access to the resident.
(iii) Such use must comply with state and federal law.
(10) The resident has the right to--
(i) Examine the results of the most recent survey of the facility
conducted by Federal or State surveyors and any plan of correction in
effect with respect to the facility; and
(ii) Receive information from agencies acting as client advocates,
and be afforded the opportunity to contact these agencies.
(11) The facility must--
(i) Post in a place readily accessible to residents, and family
members and legal representatives of residents, the results of the most
recent survey of the facility.
(ii) Have reports with respect to any surveys, certifications, and
complaint investigations made respecting the facility during the 3
preceding years, and any plan of correction in effect with respect to
the facility, available for any individual to review upon request; and
(iii) Post notice of the availability of such reports in areas of
the facility that are prominent and accessible to the public.
(iv) The facility shall not make available identifying information
about complainants or residents.
(12) The facility must comply with the requirements specified in 42
CFR part 489, subpart I (Advance Directives).
(i) These requirements include provisions to inform and provide
written information to all adult residents concerning the right to
accept or refuse medical or surgical treatment and, at the resident's
option, formulate an advance directive.
(ii) This includes a written description of the facility's policies
to implement advance directives and applicable State law.
(iii) Facilities are permitted to contract with other entities to
furnish this information but are still legally responsible for ensuring
that the requirements of this section are met.
(iv) If an adult individual is incapacitated at the time of
admission and is unable to receive information or articulate whether or
not he or she has executed an advance directive, the facility may give
advance directive information to the individual's resident
representative in accordance with State law.
(v) The facility is not relieved of its obligation to provide this
information to the individual once he or she is able to receive such
information. Follow-up procedures must be in place to provide the
information to the individual directly at the appropriate time.
(13) The facility must display in the facility written information,
and provide to residents and applicants for admission, oral and written
information about how to apply for and use Medicare and Medicaid
benefits, and how to receive refunds for previous payments covered by
such benefits.
(14) Notification of changes. (i) A facility must immediately inform
the resident; consult with the resident's physician; and notify,
consistent with his or her authority, the resident representative(s),
when there is--
(A) An accident involving the resident which results in injury and
has the potential for requiring physician intervention;
(B) A significant change in the resident's physical, mental, or
psychosocial status (that is, a deterioration in health, mental, or
psychosocial status in either life-threatening conditions or clinical
complications);
(C) A need to alter treatment significantly (that is, a need to
discontinue or change an existing form of treatment due to adverse
consequences, or to commence a new form of treatment); or
(D) A decision to transfer or discharge the resident from the
facility as specified in Sec. 483.15(c)(1)(ii).
(ii) When making notification under paragraph (g)(14)(i) of this
section, the facility must ensure that all pertinent information
specified in Sec. 483.15(c)(2) is available and provided upon request to
the physician.
(iii) The facility must also promptly notify the resident and the
resident representative, if any, when there is--
(A) A change in room or roommate assignment as specified in
Sec. 483.10(e)(6); or
(B) A change in resident rights under Federal or State law or
regulations as
[[Page 62]]
specified in paragraph (e)(10) of this section.
(iv) The facility must record and periodically update the address
(mailing and email) and phone number of the resident representative(s).
(15) Admission to a composite distinct part. A facility that is a
composite distinct part (as defined in Sec. 483.5 must disclose in its
admission agreement its physical configuration, including the various
locations that comprise the composite distinct part, and must specify
the policies that apply to room changes between its different locations
under Sec. 483.15(c)(9).
(16) The facility must provide a notice of rights and services to
the resident prior to or upon admission and during the resident's stay.
(i) The facility must inform the resident both orally and in writing
in a language that the resident understands of his or her rights and all
rules and regulations governing resident conduct and responsibilities
during the stay in the facility.
(ii) The facility must also provide the resident with the State-
developed notice of Medicaid rights and obligations, if any.
(iii) Receipt of such information, and any amendments to it, must be
acknowledged in writing;
(17) The facility must--
(i) Inform each Medicaid-eligible resident, in writing, at the time
of admission to the nursing facility and when the resident becomes
eligible for Medicaid of--
(A) The items and services that are included in nursing facility
services under the State plan and for which the resident may not be
charged;
(B) Those other items and services that the facility offers and for
which the resident may be charged, and the amount of charges for those
services; and
(ii) Inform each Medicaid-eligible resident when changes are made to
the items and services specified in Sec. 483.10(g)(17)(i)(A) and (B) of
this section.
(18) The facility must inform each resident before, or at the time
of admission, and periodically during the resident's stay, of services
available in the facility and of charges for those services, including
any charges for services not covered under Medicare/Medicaid or by the
facility's per diem rate.
(i) Where changes in coverage are made to items and services covered
by Medicare and/or by the Medicaid State plan, the facility must provide
notice to residents of the change as soon as is reasonably possible.
(ii) Where changes are made to charges for other items and services
that the facility offers, the facility must inform the resident in
writing at least 60 days prior to implementation of the change.
(iii) If a resident dies or is hospitalized or is transferred and
does not return to the facility, the facility must refund to the
resident, resident representative, or estate, as applicable, any deposit
or charges already paid, less the facility's per diem rate, for the days
the resident actually resided or reserved or retained a bed in the
facility, regardless of any minimum stay or discharge notice
requirements.
(iv) The facility must refund to the resident or resident
representative any and all refunds due the resident within 30 days from
the resident's date of discharge from the facility.
(v) The terms of an admission contract by or on behalf of an
individual seeking admission to the facility must not conflict with the
requirements of these regulations.
(h) Privacy and confidentiality. The resident has a right to
personal privacy and confidentiality of his or her personal and medical
records.
(1) Personal privacy includes accommodations, medical treatment,
written and telephone communications, personal care, visits, and
meetings of family and resident groups, but this does not require the
facility to provide a private room for each resident.
(2) The facility must respect the residents right to personal
privacy, including the right to privacy in his or her oral (that is,
spoken), written, and electronic communications, including the right to
send and promptly receive unopened mail and other letters, packages and
other materials delivered to the facility for the resident, including
those delivered through a means other than a postal service.
[[Page 63]]
(3) The resident has a right to secure and confidential personal and
medical records.
(i) The resident has the right to refuse the release of personal and
medical records except as provided at Sec. 483.70(i)(2) or other
applicable federal or state laws.
(ii) The facility must allow representatives of the Office of the
State Long-Term Care Ombudsman to examine a resident's medical, social,
and administrative records in accordance with State law.
(i) Safe environment. The resident has a right to a safe, clean,
comfortable and homelike environment, including but not limited to
receiving treatment and supports for daily living safely. The facility
must provide--
(1) A safe, clean, comfortable, and homelike environment, allowing
the resident to use his or her personal belongings to the extent
possible.
(i) This includes ensuring that the resident can receive care and
services safely and that the physical layout of the facility maximizes
resident independence and does not pose a safety risk.
(ii) The facility shall exercise reasonable care for the protection
of the resident's property from loss or theft.
(2) Housekeeping and maintenance services necessary to maintain a
sanitary, orderly, and comfortable interior;
(3) Clean bed and bath linens that are in good condition;
(4) Private closet space in each resident room, as specified in
Sec. 483.90(e)(2)(iv);
(5) Adequate and comfortable lighting levels in all areas;
(6) Comfortable and safe temperature levels. Facilities initially
certified after October 1, 1990 must maintain a temperature range of 71
to 81 [deg]F; and
(7) For the maintenance of comfortable sound levels.
(j) Grievances. (1) The resident has the right to voice grievances
to the facility or other agency or entity that hears grievances without
discrimination or reprisal and without fear of discrimination or
reprisal. Such grievances include those with respect to care and
treatment which has been furnished as well as that which has not been
furnished, the behavior of staff and of other residents; and other
concerns regarding their LTC facility stay.
(2) The resident has the right to and the facility must make prompt
efforts by the facility to resolve grievances the resident may have, in
accordance with this paragraph.
(3) The facility must make information on how to file a grievance or
complaint available to the resident.
(4) The facility must establish a grievance policy to ensure the
prompt resolution of all grievances regarding the residents' rights
contained in this paragraph. Upon request, the provider must give a copy
of the grievance policy to the resident. The grievance policy must
include:
(i) Notifying resident individually or through postings in prominent
locations throughout the facility of the right to file grievances orally
(meaning spoken) or in writing; the right to file grievances
anonymously; the contact information of the grievance official with whom
a grievance can be filed, that is, his or her name, business address
(mailing and email) and business phone number; a reasonable expected
time frame for completing the review of the grievance; the right to
obtain a written decision regarding his or her grievance; and the
contact information of independent entities with whom grievances may be
filed, that is, the pertinent State agency, Quality Improvement
Organization, State Survey Agency and State Long-Term Care Ombudsman
program or protection and advocacy system;
(ii) Identifying a Grievance Official who is responsible for
overseeing the grievance process, receiving and tracking grievances
through to their conclusion; leading any necessary investigations by the
facility; maintaining the confidentiality of all information associated
with grievances, for example, the identity of the resident for those
grievances submitted anonymously; issuing written grievance decisions to
the resident; and coordinating with state and federal agencies as
necessary in light of specific allegations;
(iii) As necessary, taking immediate action to prevent further
potential violations of any resident right while the alleged violation
is being investigated;
[[Page 64]]
(iv) Consistent with Sec. 483.12(c)(1), immediately reporting all
alleged violations involving neglect, abuse, including injuries of
unknown source, and/or misappropriation of resident property, by anyone
furnishing services on behalf of the provider, to the administrator of
the provider; and as required by State law;
(v) Ensuring that all written grievance decisions include the date
the grievance was received, a summary statement of the resident's
grievance, the steps taken to investigate the grievance, a summary of
the pertinent findings or conclusions regarding the resident's
concern(s), a statement as to whether the grievance was confirmed or not
confirmed, any corrective action taken or to be taken by the facility as
a result of the grievance, and the date the written decision was issued;
(vi) Taking appropriate corrective action in accordance with State
law if the alleged violation of the residents' rights is confirmed by
the facility or if an outside entity having jurisdiction, such as the
State Survey Agency, Quality Improvement Organization, or local law
enforcement agency confirms a violation of any of these residents'
rights within its area of responsibility; and
(vii) Maintaining evidence demonstrating the results of all
grievances for a period of no less than 3 years from the issuance of the
grievance decision.
(k) Contact with external entities. A facility must not prohibit or
in any way discourage a resident from communicating with federal, state,
or local officials, including, but not limited to, federal and state
surveyors, other federal or state health department employees, including
representatives of the Office of the State Long-Term Care Ombudsman, and
any representative of the agency responsible for the protection and
advocacy system for individuals with mental disorder (established under
the Protection and Advocacy for Mentally Ill Individuals Act of 2000 (42
U.S.C. 10801 et seq.), regarding any matter, whether or not subject to
arbitration or any other type of judicial or regulatory action.
[81 FR 68849, Oct. 4, 2016, as amended at 82 FR 32259, July 13, 2017]
Sec. 483.12 Freedom from abuse, neglect, and exploitation.
The resident has the right to be free from abuse, neglect,
misappropriation of resident property, and exploitation as defined in
this subpart. This includes but is not limited to freedom from corporal
punishment, involuntary seclusion and any physical or chemical restraint
not required to treat the resident's medical symptoms.
(a) The facility must--
(1) Not use verbal, mental, sexual, or physical abuse, corporal
punishment, or involuntary seclusion;
(2) Ensure that the resident is free from physical or chemical
restraints imposed for purposes of discipline or convenience and that
are not required to treat the resident's medical symptoms. When the use
of restraints is indicated, the facility must use the least restrictive
alternative for the least amount of time and document ongoing re-
evaluation of the need for restraints.
(3) Not employ or otherwise engage individuals who--
(i) Have been found guilty of abuse, neglect, exploitation,
misappropriation of property, or mistreatment by a court of law;
(ii) Have had a finding entered into the State nurse aide registry
concerning abuse, neglect, exploitation, mistreatment of residents or
misappropriation of their property; or
(iii) Have a disciplinary action in effect against his or her
professional license by a state licensure body as a result of a finding
of abuse, neglect, exploitation, mistreatment of residents or
misappropriation of resident property.
(4) Report to the State nurse aide registry or licensing authorities
any knowledge it has of actions by a court of law against an employee,
which would indicate unfitness for service as a nurse aide or other
facility staff.
(b) The facility must develop and implement written policies and
procedures that:
(1) Prohibit and prevent abuse, neglect, and exploitation of
residents and misappropriation of resident property,
(2) Establish policies and procedures to investigate any such
allegations, and
[[Page 65]]
(3) Include training as required at paragraph Sec. 483.95.
(4) Establish coordination with the QAPI program required under
Sec. 483.75.
(5) Ensure reporting of crimes occurring in federally-funded long-
term care facilities in accordance with section 1150B of the Act. The
policies and procedures must include but are not limited to the
following elements.
(i) Annually notifying covered individuals, as defined at section
1150B(a)(3) of the Act, of that individual's obligation to comply with
the following reporting requirements.
(A) Each covered individual shall report to the State Agency and one
or more law enforcement entities for the political subdivision in which
the facility is located any reasonable suspicion of a crime against any
individual who is a resident of, or is receiving care from, the
facility.
(B) Each covered individual shall report immediately, but not later
than 2 hours after forming the suspicion, if the events that cause the
suspicion result in serious bodily injury, or not later than 24 hours if
the events that cause the suspicion do not result in serious bodily
injury.
(ii) Posting a conspicuous notice of employee rights, as defined at
section 1150B(d)(3) of the Act.
(iii) Prohibiting and preventing retaliation, as defined at section
1150B(d)(1) and (2) of the Act.
(c) In response to allegations of abuse, neglect, exploitation, or
mistreatment, the facility must:
(1) Ensure that all alleged violations involving abuse, neglect,
exploitation or mistreatment, including injuries of unknown source and
misappropriation of resident property, are reported immediately, but not
later than 2 hours after the allegation is made, if the events that
cause the allegation involve abuse or result in serious bodily injury,
or not later than 24 hours if the events that cause the allegation do
not involve abuse and do not result in serious bodily injury, to the
administrator of the facility and to other officials (including to the
State Survey Agency and adult protective services where state law
provides for jurisdiction in long-term care facilities) in accordance
with State law through established procedures.
(2) Have evidence that all alleged violations are thoroughly
investigated.
(3) Prevent further potential abuse, neglect, exploitation, or
mistreatment while the investigation is in progress.
(4) Report the results of all investigations to the administrator or
his or her designated representative and to other officials in
accordance with State law, including to the State Survey Agency, within
5 working days of the incident, and if the alleged violation is verified
appropriate corrective action must be taken.
[81 FR 68855, Oct. 4, 2016]
Sec. 483.15 Admission, transfer, and discharge rights.
(a) Admissions policy. (1) The facility must establish and implement
an admissions policy.
(2) The facility must--
(i) Not request or require residents or potential residents to waive
their rights as set forth in this subpart and in applicable state,
federal or local licensing or certification laws, including but not
limited to their rights to Medicare or Medicaid; and
(ii) Not request or require oral or written assurance that residents
or potential residents are not eligible for, or will not apply for,
Medicare or Medicaid benefits.
(iii) Not request or require residents or potential residents to
waive potential facility liability for losses of personal property
(3) The facility must not request or require a third party guarantee
of payment to the facility as a condition of admission or expedited
admission, or continued stay in the facility. However, the facility may
request and require a resident representative who has legal access to a
resident's income or resources available to pay for facility care to
sign a contract, without incurring personal financial liability, to
provide facility payment from the resident's income or resources.
(4) In the case of a person eligible for Medicaid, a nursing
facility must not charge, solicit, accept, or receive, in addition to
any amount otherwise required to be paid under the State plan, any gift,
money, donation, or other
[[Page 66]]
consideration as a precondition of admission, expedited admission or
continued stay in the facility. However,--
(i) A nursing facility may charge a resident who is eligible for
Medicaid for items and services the resident has requested and received,
and that are not specified in the State plan as included in the term
``nursing facility services'' so long as the facility gives proper
notice of the availability and cost of these services to residents and
does not condition the resident's admission or continued stay on the
request for and receipt of such additional services; and
(ii) A nursing facility may solicit, accept, or receive a
charitable, religious, or philanthropic contribution from an
organization or from a person unrelated to a Medicaid eligible resident
or potential resident, but only to the extent that the contribution is
not a condition of admission, expedited admission, or continued stay in
the facility for a Medicaid eligible resident.
(5) States or political subdivisions may apply stricter admissions
standards under State or local laws than are specified in this section,
to prohibit discrimination against individuals entitled to Medicaid.
(6) A nursing facility must disclose and provide to a resident or
potential resident prior to time of admission, notice of special
characteristics or service limitations of the facility.
(7) A nursing facility that is a composite distinct part as defined
in Sec. 483.5 must disclose in its admission agreement its physical
configuration, including the various locations that comprise the
composite distinct part, and must specify the policies that apply to
room changes between its different locations under paragraph (c)(9) of
this section.
(b) Equal access to quality care. (1) A facility must establish,
maintain and implement identical policies and practices regarding
transfer and discharge, as defined in Sec. 483.5 and the provision of
services for all individuals regardless of source of payment, consistent
with Sec. 483.10(a)(2);
(2) The facility may charge any amount for services furnished to
non-Medicaid residents unless otherwise limited by state law and
consistent with the notice requirement in Sec. 483.10(g)(18)(i) and
(g)(4)(i) describing the charges; and
(3) The State is not required to offer additional services on behalf
of a resident other than services provided in the State plan.
(c) Transfer and discharge--(1) Facility requirements--(i) The
facility must permit each resident to remain in the facility, and not
transfer or discharge the resident from the facility unless--
(A) The transfer or discharge is necessary for the resident's
welfare and the resident's needs cannot be met in the facility;
(B) The transfer or discharge is appropriate because the resident's
health has improved sufficiently so the resident no longer needs the
services provided by the facility;
(C) The safety of individuals in the facility is endangered due to
the clinical or behavioral status of the resident;
(D) The health of individuals in the facility would otherwise be
endangered;
(E) The resident has failed, after reasonable and appropriate
notice, to pay for (or to have paid under Medicare or Medicaid) a stay
at the facility. Non-payment applies if the resident does not submit the
necessary paperwork for third party payment or after the third party,
including Medicare or Medicaid, denies the claim and the resident
refuses to pay for his or her stay. For a resident who becomes eligible
for Medicaid after admission to a facility, the facility may charge a
resident only allowable charges under Medicaid; or
(F) The facility ceases to operate.
(ii) The facility may not transfer or discharge the resident while
the appeal is pending, pursuant to Sec. 431.230 of this chapter, when a
resident exercises his or her right to appeal a transfer or discharge
notice from the facility pursuant to Sec. 431.220(a)(3) of this chapter,
unless the failure to discharge or transfer would endanger the health or
safety of the resident or other individuals in the facility. The
facility must document the danger that failure to transfer or discharge
would pose.
(2) Documentation. When the facility transfers or discharges a
resident under any of the circumstances specified in
[[Page 67]]
paragraphs (c)(1)(i)(A) through (F) of this section, the facility must
ensure that the transfer or discharge is documented in the resident's
medical record and appropriate information is communicated to the
receiving health care institution or provider.
(i) Documentation in the resident's medical record must include:
(A) The basis for the transfer per paragraph (c)(1)(i) of this
section.
(B) In the case of paragraph (c)(1)(i)(A) of this section, the
specific resident need(s) that cannot be met, facility attempts to meet
the resident needs, and the service available at the receiving facility
to meet the need(s).
(ii) The documentation required by paragraph (c)(2)(i) of this
section must be made by--
(A) The resident's physician when transfer or discharge is necessary
under paragraph (c)(1)(A) or (B) of this section; and
(B) A physician when transfer or discharge is necessary under
paragraph (c)(1)(i)(C) or (D) of this section.
(iii) Information provided to the receiving provider must include a
minimum of the following:
(A) Contact information of the practitioner responsible for the care
of the resident
(B) Resident representative information including contact
information.
(C) Advance Directive information.
(D) All special instructions or precautions for ongoing care, as
appropriate.
(E) Comprehensive care plan goals,
(F) All other necessary information, including a copy of the
resident's discharge summary, consistent with Sec. 483.21(c)(2), as
applicable, and any other documentation, as applicable, to ensure a safe
and effective transition of care.
(3) Notice before transfer. Before a facility transfers or
discharges a resident, the facility must--
(i) Notify the resident and the resident's representative(s) of the
transfer or discharge and the reasons for the move in writing and in a
language and manner they understand. The facility must send a copy of
the notice to a representative of the Office of the State Long-Term Care
Ombudsman.
(ii) Record the reasons for the transfer or discharge in the
resident's medical record in accordance with paragraph (c)(2) of this
section; and
(iii) Include in the notice the items described in paragraph (c)(5)
of this section.
(4) Timing of the notice. (i) Except as specified in paragraphs
(c)(4)(ii) and (8) of this section, the notice of transfer or discharge
required under this section must be made by the facility at least 30
days before the resident is transferred or discharged.
(ii) Notice must be made as soon as practicable before transfer or
discharge when--
(A) The safety of individuals in the facility would be endangered
under paragraph (c)(1)(i)(C) of this section;
(B) The health of individuals in the facility would be endangered,
under paragraph (c)(1)(i)(D) of this section;
(C) The resident's health improves sufficiently to allow a more
immediate transfer or discharge, under paragraph (c)(1)(i)(B) of this
section;
(D) An immediate transfer or discharge is required by the resident's
urgent medical needs, under paragraph (c)(1)(i)(A) of this section; or
(E) A resident has not resided in the facility for 30 days.
(5) Contents of the notice. The written notice specified in
paragraph (c)(3) of this section must include the following:
(i) The reason for transfer or discharge;
(ii) The effective date of transfer or discharge;
(iii) The location to which the resident is transferred or
discharged;
(iv) A statement of the resident's appeal rights, including the
name, address (mailing and email), and telephone number of the entity
which receives such requests; and information on how to obtain an appeal
form and assistance in completing the form and submitting the appeal
hearing request;
(v) The name, address (mailing and email) and telephone number of
the Office of the State Long-Term Care Ombudsman;
(vi) For nursing facility residents with intellectual and
developmental disabilities or related disabilities, the
[[Page 68]]
mailing and email address and telephone number of the agency responsible
for the protection and advocacy of individuals with developmental
disabilities established under Part C of the Developmental Disabilities
Assistance and Bill of Rights Act of 2000 (Pub. L. 106-402, codified at
42 U.S.C. 15001 et seq.); and
(vii) For nursing facility residents with a mental disorder or
related disabilities, the mailing and email address and telephone number
of the agency responsible for the protection and advocacy of individuals
with a mental disorder established under the Protection and Advocacy for
Mentally Ill Individuals Act.
(6) Changes to the notice. If the information in the notice changes
prior to effecting the transfer or discharge, the facility must update
the recipients of the notice as soon as practicable once the updated
information becomes available.
(7) Orientation for transfer or discharge. A facility must provide
and document sufficient preparation and orientation to residents to
ensure safe and orderly transfer or discharge from the facility. This
orientation must be provided in a form and manner that the resident can
understand.
(8) Notice in advance of facility closure. In the case of facility
closure, the individual who is the administrator of the facility must
provide written notification prior to the impending closure to the State
Survey Agency, the Office of the State Long-Term Care Ombudsman,
residents of the facility, and the resident representatives, as well as
the plan for the transfer and adequate relocation of the residents, as
required at Sec. 483.70(l).
(9) Room changes in a composite distinct part. Room changes in a
facility that is a composite distinct part (as defined in Sec. 483.5)
are subject to the requirements of Sec. 483.10(e)(7) and must be limited
to moves within the particular building in which the resident resides,
unless the resident voluntarily agrees to move to another of the
composite distinct part's locations.
(d) Notice of bed-hold policy and return--(1) Notice before
transfer. Before a nursing facility transfers a resident to a hospital
or the resident goes on therapeutic leave, the nursing facility must
provide written information to the resident or resident representative
that specifies--
(i) The duration of the state bed-hold policy, if any, during which
the resident is permitted to return and resume residence in the nursing
facility;
(ii) The reserve bed payment policy in the state plan, under
Sec. 447.40 of this chapter, if any;
(iii) The nursing facility's policies regarding bed-hold periods,
which must be consistent with paragraph (e)(1) of this section,
permitting a resident to return; and
(iv) The information specified in paragraph (e)(1) of this section.
(2) Bed-hold notice upon transfer. At the time of transfer of a
resident for hospitalization or therapeutic leave, a nursing facility
must provide to the resident and the resident representative written
notice which specifies the duration of the bed-hold policy described in
paragraph (d)(1) of this section.
(e)(1) Permitting residents to return to facility. A facility must
establish and follow a written policy on permitting residents to return
to the facility after they are hospitalized or placed on therapeutic
leave. The policy must provide for the following.
(i) A resident, whose hospitalization or therapeutic leave exceeds
the bed-hold period under the State plan, returns to the facility to
their previous room if available or immediately upon the first
availability of a bed in a semi-private room if the resident
(A) Requires the services provided by the facility; and
(B) Is eligible for Medicare skilled nursing facility services or
Medicaid nursing facility services.
(ii) If the facility that determines that a resident who was
transferred with an expectation of returning to the facility cannot
return to the facility, the facility must comply with the requirements
of paragraph (c) as they apply to discharges.
(2) Readmission to a composite distinct part. When the facility to
which a resident returns is a composite distinct part (as defined in
Sec. 483.5), the resident must be permitted to return to an available
bed in the particular location
[[Page 69]]
of the composite distinct part in which he or she resided previously. If
a bed is not available in that location at the time of return, the
resident must be given the option to return to that location upon the
first availability of a bed there.
[81 FR 68855, Oct. 4, 2016, as amended at 82 FR 32259, July 13, 2017]
Sec. 483.20 Resident assessment.
The facility must conduct initially and periodically a
comprehensive, accurate, standardized, reproducible assessment of each
resident's functional capacity.
(a) Admission orders. At the time each resident is admitted, the
facility must have physician orders for the resident's immediate care.
(b) Comprehensive assessments--(1) Resident assessment instrument. A
facility must make a comprehensive assessment of a resident's needs,
strengths, goals, life history and preferences, using the resident
assessment instrument (RAI) specified by CMS. The assessment must
include at least the following:
(i) Identification and demographic information.
(ii) Customary routine.
(iii) Cognitive patterns.
(iv) Communication.
(v) Vision.
(vi) Mood and behavior patterns.
(vii) Psychosocial well-being.
(viii) Physical functioning and structural problems.
(ix) Continence.
(x) Disease diagnoses and health conditions.
(xi) Dental and nutritional status.
(xii) Skin condition.
(xiii) Activity pursuit.
(xiv) Medications.
(xv) Special treatments and procedures.
(xvi) Discharge planning.
(xvii) Documentation of summary information regarding the additional
assessment performed on the care areas triggered by the completion of
the Minimum Data Set (MDS).
(xviii) Documentation of participation in assessment. The assessment
process must include direct observation and communication with the
resident, as well as communication with licensed and nonlicensed direct
care staff members on all shifts.
(2) When required. Subject to the timeframes prescribed in
Sec. 413.343(b) of this chapter, a facility must conduct a comprehensive
assessment of a resident in accordance with the timeframes specified in
paragraphs (b)(2) (i) through (iii) of this section. The timeframes
prescribed in Sec. 413.343(b) of this chapter do not apply to CAHs.
(i) Within 14 calendar days after admission, excluding readmissions
in which there is no significant change in the resident's physical or
mental condition. (For purposes of this section, ``readmission'' means a
return to the facility following a temporary absence for hospitalization
or for therapeutic leave.)
(ii) Within 14 calendar days after the facility determines, or
should have determined, that there has been a significant change in the
resident's physical or mental condition. (For purposes of this section,
a ``significant change'' means a major decline or improvement in the
resident's status that will not normally resolve itself without further
intervention by staff or by implementing standard disease-related
clinical interventions, that has an impact on more than one area of the
resident's health status, and requires interdisciplinary review or
revision of the care plan, or both.)
(iii) Not less often than once every 12 months.
(c) Quarterly review assessment. A facility must assess a resident
using the quarterly review instrument specified by the State and
approved by CMS not less frequently than once every 3 months.
(d) Use. A facility must maintain all resident assessments completed
within the previous 15 months in the resident's active record and use
the results of the assessments to develop, review, and revise the
resident's comprehensive plan of care.
(e) Coordination. A facility must coordinate assessments with the
preadmission screening and resident review (PASARR) program under
Medicaid in subpart C of this part to the maximum extent practicable to
avoid duplicative testing and effort. Coordination includes--
[[Page 70]]
(1) Incorporating the recommendations from the PASARR level II
determination and the PASARR evaluation report into a resident's
assessment, care planning, and transitions of care.
(2) Referring all level II residents and all residents with newly
evident or possible serious mental disorder, intellectual disability, or
a related condition for level II resident review upon a significant
change in status assessment.
(f) Automated data processing requirement--(1) Encoding data. Within
7 days after a facility completes a resident's assessment, a facility
must encode the following information for each resident in the facility:
(i) Admission assessment.
(ii) Annual assessment updates.
(iii) Significant change in status assessments.
(iv) Quarterly review assessments.
(v) A subset of items upon a resident's transfer, reentry,
discharge, and death.
(vi) Background (face-sheet) information, if there is no admission
assessment.
(2) Transmitting data. Within 7 days after a facility completes a
resident's assessment, a facility must be capable of transmitting to the
CMS System information for each resident contained in the MDS in a
format that conforms to standard record layouts and data dictionaries,
and that passes standardized edits defined by CMS and the State.
(3) Transmittal requirements. Within 14 days after a facility
completes a resident's assessment, a facility must electronically
transmit encoded, accurate, and complete MDS data to the CMS System,
including the following:
(i) Admission assessment.
(ii) Annual assessment.
(iii) Significant change in status assessment.
(iv) Significant correction of prior full assessment.
(v) Significant correction of prior quarterly assessment.
(vi) Quarterly review.
(vii) A subset of items upon a resident's transfer, reentry,
discharge, and death.
(viii) Background (face-sheet) information, for an initial
transmission of MDS data on a resident that does not have an admission
assessment.
(4) Data format. The facility must transmit data in the format
specified by CMS or, for a State which has an alternate RAI approved by
CMS, in the format specified by the State and approved by CMS.
(5) Resident-identifiable information. (i) A facility may not
release information that is resident-identifiable to the public.
(ii) The facility may release information that is resident-
identifiable to an agent only in accordance with a contract under which
the agent agrees not to use or disclose the information except to the
extent the facility itself is permitted to do so.
(g) Accuracy of assessments. The assessment must accurately reflect
the resident's status.
(h) Coordination. A registered nurse must conduct or coordinate each
assessment with the appropriate participation of health professionals.
(i) Certification. (1) A registered nurse must sign and certify that
the assessment is completed.
(2) Each individual who completes a portion of the assessment must
sign and certify the accuracy of that portion of the assessment.
(j) Penalty for falsification. (1) Under Medicare and Medicaid, an
individual who willfully and knowingly--
(i) Certifies a material and false statement in a resident
assessment is subject to a civil money penalty of not more than $1,000
as adjusted annually under 45 CFR part 102 for each assessment; or
(ii) Causes another individual to certify a material and false
statement in a resident assessment is subject to a civil money penalty
of not more than $5,000 as adjusted annually under 45 CFR part 102 for
each assessment.
(2) Clinical disagreement does not constitute a material and false
statement.
(k) Preadmission screening for individuals with a mental disorder
and individuals with intellectual disability. (1) A nursing facility
must not admit, on or after January 1, 1989, any new resident with--
(i) Mental disorder as defined in paragraph (k)(3)(i) of this
section, unless
[[Page 71]]
the State mental health authority has determined, based on an
independent physical and mental evaluation performed by a person or
entity other than the State mental health authority, prior to admission,
(A) That, because of the physical and mental condition of the
individual, the individual requires the level of services provided by a
nursing facility; and
(B) If the individual requires such level of services, whether the
individual requires specialized services; or
(ii) Intellectual disability, as defined in paragraph (k)(3)(ii) of
this section, unless the State intellectual disability or developmental
disability authority has determined prior to admission--
(A) That, because of the physical and mental condition of the
individual, the individual requires the level of services provided by a
nursing facility; and
(B) If the individual requires such level of services, whether the
individual requires specialized services for intellectual disability.
(2) Exceptions. For purposes of this section--
(i) The preadmission screening program under paragraph (k)(1) of
this section need not provide for determinations in the case of the
readmission to a nursing facility of an individual who, after being
admitted to the nursing facility, was transferred for care in a
hospital.
(ii) The State may choose not to apply the preadmission screening
program under paragraph (k)(1) of this section to the admission to a
nursing facility of an individual--
(A) Who is admitted to the facility directly from a hospital after
receiving acute inpatient care at the hospital,
(B) Who requires nursing facility services for the condition for
which the individual received care in the hospital, and
(C) Whose attending physician has certified, before admission to the
facility that the individual is likely to require less than 30 days of
nursing facility services.
(3) Definition. For purposes of this section--
(i) An individual is considered to have a mental disorder if the
individual has a serious mental disorder as defined in
Sec. 483.102(b)(1).
(ii) An individual is considered to have an intellectual disability
if the individual has an intellectual disability as defined in
Sec. 483.102(b)(3) or is a person with a related condition as described
in Sec. 435.1010 of this chapter.
(4) A nursing facility must notify the state mental health authority
or state intellectual disability authority, as applicable, promptly
after a significant change in the mental or physical condition of a
resident who has a mental disorder or intellectual disability for
resident review.
[56 FR 48871, Sept. 26, 1991, as amended at 57 FR 43924, Sept. 23, 1992;
62 FR 67211, Dec. 23, 1997; 63 FR 53307, Oct. 5, 1998; 64 FR 41543, July
30, 1999; 68 FR 46072, Aug. 4, 2003; 71 FR 39229, July 12, 2006; 74 FR
40363, Aug. 11, 2009; 81 FR 61563, Sept. 6, 2016; 81 FR 68857, Oct. 4,
2016]
Sec. 483.21 Comprehensive person-centered care planning.
(a) Baseline care plans. (1) The facility must develop and implement
a baseline care plan for each resident that includes the instructions
needed to provide effective and person-centered care of the resident
that meet professional standards of quality care. The baseline care plan
must--
(i) Be developed within 48 hours of a resident's admission.
(ii) Include the minimum healthcare information necessary to
properly care for a resident including, but not limited to:
(A) Initial goals based on admission orders.
(B) Physician orders.
(C) Dietary orders.
(D) Therapy services.
(E) Social services.
(F) PASARR recommendation, if applicable.
(2) The facility may develop a comprehensive care plan in place of
the baseline care plan if the comprehensive care plan--
(i) Is developed within 48 hours of the resident's admission.
(ii) Meets the requirements set forth in paragraph (b) of this
section (excepting paragraph (b)(2)(i) of this section).
(3) The facility must provide the resident and their representative
with a summary of the baseline care plan that includes but is not
limited to:
(i) The initial goals of the resident.
[[Page 72]]
(ii) A summary of the resident's medications and dietary
instructions.
(iii) Any services and treatments to be administered by the facility
and personnel acting on behalf of the facility.
(iv) Any updated information based on the details of the
comprehensive care plan, as necessary.
(b) Comprehensive care plans. (1) The facility must develop and
implement a comprehensive person-centered care plan for each resident,
consistent with the resident rights set forth at Sec. 483.10(c)(2) and
Sec. 483.10(c)(3), that includes measurable objectives and timeframes to
meet a resident's medical, nursing, and mental and psychosocial needs
that are identified in the comprehensive assessment. The comprehensive
care plan must describe the following:
(i) The services that are to be furnished to attain or maintain the
resident's highest practicable physical, mental, and psychosocial well-
being as required under Sec. 483.24, Sec. 483.25, or Sec. 483.40; and
(ii) Any services that would otherwise be required under
Sec. 483.24, Sec. 483.25, or Sec. 483.40 but are not provided due to the
resident's exercise of rights under Sec. 483.10, including the right to
refuse treatment under Sec. 483.10(c)(6).
(iii) Any specialized services or specialized rehabilitative
services the nursing facility will provide as a result of PASARR
recommendations. If a facility disagrees with the findings of the
PASARR, it must indicate its rationale in the resident's medical record.
(iv) In consultation with the resident and the resident's
representative(s)--
(A) The resident's goals for admission and desired outcomes.
(B) The resident's preference and potential for future discharge.
Facilities must document whether the resident's desire to return to the
community was assessed and any referrals to local contact agencies and/
or other appropriate entities, for this purpose.
(C) Discharge plans in the comprehensive care plan, as appropriate,
in accordance with the requirements set forth in paragraph (c) of this
section.
(2) A comprehensive care plan must be--
(i) Developed within 7 days after completion of the comprehensive
assessment.
(ii) Prepared by an interdisciplinary team, that includes but is not
limited to--
(A) The attending physician.
(B) A registered nurse with responsibility for the resident.
(C) A nurse aide with responsibility for the resident.
(D) A member of food and nutrition services staff.
(E) To the extent practicable, the participation of the resident and
the resident's representative(s). An explanation must be included in a
resident's medical record if the participation of the resident and their
resident representative is determined not practicable for the
development of the resident's care plan.
(F) Other appropriate staff or professionals in disciplines as
determined by the resident's needs or as requested by the resident.
(iii) Reviewed and revised by the interdisciplinary team after each
assessment, including both the comprehensive and quarterly review
assessments.
(3) The services provided or arranged by the facility, as outlined
by the comprehensive care plan, must--
(i) Meet professional standards of quality.
(ii) Be provided by qualified persons in accordance with each
resident's written plan of care.
(iii) Be culturally-competent and trauma-informed.
(c) Discharge planning--(1) Discharge planning process. The facility
must develop and implement an effective discharge planning process that
focuses on the resident's discharge goals, the preparation of residents
to be active partners and effectively transition them to post-discharge
care, and the reduction of factors leading to preventable readmissions.
The facility's discharge planning process must be consistent with the
discharge rights set forth at Sec. 483.15(b) as applicable and--
(i) Ensure that the discharge needs of each resident are identified
and result in the development of a discharge plan for each resident.
[[Page 73]]
(ii) Include regular re-evaluation of residents to identify changes
that require modification of the discharge plan. The discharge plan must
be updated, as needed, to reflect these changes.
(iii) Involve the interdisciplinary team, as defined by
Sec. 483.21(b)(2)(ii), in the ongoing process of developing the
discharge plan.
(iv) Consider caregiver/support person availability and the
resident's or caregiver's/support person(s) capacity and capability to
perform required care, as part of the identification of discharge needs.
(v) Involve the resident and resident representative in the
development of the discharge plan and inform the resident and resident
representative of the final plan.
(vi) Address the resident's goals of care and treatment preferences.
(vii) Document that a resident has been asked about their interest
in receiving information regarding returning to the community.
(A) If the resident indicates an interest in returning to the
community, the facility must document any referrals to local contact
agencies or other appropriate entities made for this purpose.
(B) Facilities must update a resident's comprehensive care plan and
discharge plan, as appropriate, in response to information received from
referrals to local contact agencies or other appropriate entities.
(C) If discharge to the community is determined to not be feasible,
the facility must document who made the determination and why.
(viii) For residents who are transferred to another SNF or who are
discharged to a HHA, IRF, or LTCH, assist residents and their resident
representatives in selecting a post-acute care provider by using data
that includes, but is not limited to SNF, HHA, IRF, or LTCH standardized
patient assessment data, data on quality measures, and data on resource
use to the extent the data is available. The facility must ensure that
the post-acute care standardized patient assessment data, data on
quality measures, and data on resource use is relevant and applicable to
the resident's goals of care and treatment preferences.
(ix) Document, complete on a timely basis based on the resident's
needs, and include in the clinical record, the evaluation of the
resident's discharge needs and discharge plan. The results of the
evaluation must be discussed with the resident or resident's
representative. All relevant resident information must be incorporated
into the discharge plan to facilitate its implementation and to avoid
unnecessary delays in the resident's discharge or transfer.
(2) Discharge summary. When the facility anticipates discharge a
resident must have a discharge summary that includes, but is not limited
to, the following:
(i) A recapitulation of the resident's stay that includes, but is
not limited to, diagnoses, course of illness/treatment or therapy, and
pertinent lab, radiology, and consultation results.
(ii) A final summary of the resident's status to include items in
paragraph (b)(1) of Sec. 483.20, at the time of the discharge that is
available for release to authorized persons and agencies, with the
consent of the resident or resident's representative.
(iii) Reconciliation of all pre-discharge medications with the
resident's post-discharge medications (both prescribed and over-the-
counter).
(iv) A post-discharge plan of care that is developed with the
participation of the resident and, with the resident's consent, the
resident representative(s), which will assist the resident to adjust to
his or her new living environment. The post-discharge plan of care must
indicate where the individual plans to reside, any arrangements that
have been made for the resident's follow up care and any post-discharge
medical and non-medical services.
[81 FR 68858, Oct. 4, 2016]
Sec. 483.24 Quality of life.
Quality of life is a fundamental principle that applies to all care
and services provided to facility residents. Each resident must receive
and the facility must provide the necessary care and services to attain
or maintain the highest practicable physical, mental, and psychosocial
well-being, consistent
[[Page 74]]
with the resident's comprehensive assessment and plan of care.
(a) Based on the comprehensive assessment of a resident and
consistent with the resident's needs and choices, the facility must
provide the necessary care and services to ensure that a resident's
abilities in activities of daily living do not diminish unless
circumstances of the individual's clinical condition demonstrate that
such diminution was unavoidable. This includes the facility ensuring
that:
(1) A resident is given the appropriate treatment and services to
maintain or improve his or her ability to carry out the activities of
daily living, including those specified in paragraph (b) of this
section,
(2) A resident who is unable to carry out activities of daily living
receives the necessary services to maintain good nutrition, grooming,
and personal and oral hygiene, and
(3) Personnel provide basic life support, including CPR, to a
resident requiring such emergency care prior to the arrival of emergency
medical personnel and subject to related physician orders and the
resident's advance directives.
(b) Activities of daily living. The facility must provide care and
services in accordance with paragraph (a) of this section for the
following activities of daily living:
(1) Hygiene--bathing, dressing, grooming, and oral care,
(2) Mobility--transfer and ambulation, including walking,
(3) Elimination--toileting,
(4) Dining--eating, including meals and snacks,
(5) Communication, including
(i) Speech,
(ii) Language,
(iii) Other functional communication systems.
(c) Activities. (1) The facility must provide, based on the
comprehensive assessment and care plan and the preferences of each
resident, an ongoing program to support residents in their choice of
activities, both facility-sponsored group and individual activities and
independent activities, designed to meet the interests of and support
the physical, mental, and psychosocial well-being of each resident,
encouraging both independence and interaction in the community.
(2) The activities program must be directed by a qualified
professional who is a qualified therapeutic recreation specialist or an
activities professional who--
(i) Is licensed or registered, if applicable, by the State in which
practicing; and
(ii) Is:
(A) Eligible for certification as a therapeutic recreation
specialist or as an activities professional by a recognized accrediting
body on or after October 1, 1990; or
(B) Has 2 years of experience in a social or recreational program
within the last 5 years, one of which was full-time in a therapeutic
activities program; or
(C) Is a qualified occupational therapist or occupational therapy
assistant; or
(D) Has completed a training course approved by the State.
[81 FR 68859, Oct. 4, 2016]
Sec. 483.25 Quality of care.
Quality of care is a fundamental principle that applies to all
treatment and care provided to facility residents. Based on the
comprehensive assessment of a resident, the facility must ensure that
residents receive treatment and care in accordance with professional
standards of practice, the comprehensive person-centered care plan, and
the resident's choices, including but not limited to the following:
(a) Vision and hearing. To ensure that residents receive proper
treatment and assistive devices to maintain vision and hearing
abilities, the facility must, if necessary, assist the resident--
(1) In making appointments, and
(2) By arranging for transportation to and from the office of a
practitioner specializing in the treatment of vision or hearing
impairment or the office of a professional specializing in the provision
of vision or hearing assistive devices.
(b) Skin integrity--(1) Pressure ulcers. Based on the comprehensive
assessment of a resident, the facility must ensure that--
(i) A resident receives care, consistent with professional standards
of practice, to prevent pressure ulcers and
[[Page 75]]
does not develop pressure ulcers unless the individual's clinical
condition demonstrates that they were unavoidable; and
(ii) A resident with pressure ulcers receives necessary treatment
and services, consistent with professional standards of practice, to
promote healing, prevent infection and prevent new ulcers from
developing.
(2) Foot care. To ensure that residents receive proper treatment and
care to maintain mobility and good foot health, the facility must--
(i) Provide foot care and treatment, in accordance with professional
standards of practice, including to prevent complications from the
resident's medical condition(s) and
(ii) If necessary, assist the resident in making appointments with a
qualified person, and arranging for transportation to and from such
appointments.
(c) Mobility. (1) The facility must ensure that a resident who
enters the facility without limited range of motion does not experience
reduction in range of motion unless the resident's clinical condition
demonstrates that a reduction in range of motion is unavoidable; and
(2) A resident with limited range of motion receives appropriate
treatment and services to increase range of motion and/or to prevent
further decrease in range of motion.
(3) A resident with limited mobility receives appropriate services,
equipment, and assistance to maintain or improve mobility with the
maximum practicable independence unless a reduction in mobility is
demonstrably unavoidable.
(d) Accidents.The facility must ensure that--
(1) The resident environment remains as free of accident hazards as
is possible; and
(2) Each resident receives adequate supervision and assistance
devices to prevent accidents.
(e) Incontinence. (1) The facility must ensure that a resident who
is continent of bladder and bowel on admission receives services and
assistance to maintain continence unless his or her clinical condition
is or becomes such that continence is not possible to maintain.
(2) For a resident with urinary incontinence, based on the
resident's comprehensive assessment, the facility must ensure that--
(i) A resident who enters the facility without an indwelling
catheter is not catheterized unless the resident's clinical condition
demonstrates that catheterization was necessary;
(ii) A resident who enters the facility with an indwelling catheter
or subsequently receives one is assessed for removal of the catheter as
soon as possible unless the resident's clinical condition demonstrates
that catheterization is necessary, and
(iii) A resident who is incontinent of bladder receives appropriate
treatment and services to prevent urinary tract infections and to
restore continence to the extent possible.
(3) For a resident with fecal incontinence, based on the resident's
comprehensive assessment, the facility must ensure that a resident who
is incontinent of bowel receives appropriate treatment and services to
restore as much normal bowel function as possible.
(f) Colostomy, urostomy, or ileostomy care. The facility must ensure
that residents who require colostomy, urostomy, or ileostomy services,
receive such care consistent with professional standards of practice,
the comprehensive person-centered care plan, and the residents' goals
and preferences.
(g) Assisted nutrition and hydration. (Includes naso-gastric and
gastrostomy tubes, both percutaneous endoscopic gastrostomy and
percutaneous endoscopic jejunostomy, and enteral fluids). Based on a
resident's comprehensive assessment, the facility must ensure that a
resident--
(1) Maintains acceptable parameters of nutritional status, such as
usual body weight or desirable body weight range and electrolyte
balance, unless the resident's clinical condition demonstrates that this
is not possible or resident preferences indicate otherwise;
(2) Is offered sufficient fluid intake to maintain proper hydration
and health; and
(3) Is offered a therapeutic diet when there is a nutritional
problem and the
[[Page 76]]
health care provider orders a therapeutic diet.
(4) A resident who has been able to eat enough alone or with
assistance is not fed by enteral methods unless the resident's clinical
condition demonstrates that enteral feeding was clinically indicated and
consented to by the resident; and
(5) A resident who is fed by enteral means receives the appropriate
treatment and services to restore, if possible, oral eating skills and
to prevent complications of enteral feeding including but not limited to
aspiration pneumonia, diarrhea, vomiting, dehydration, metabolic
abnormalities, and nasal-pharyngeal ulcers.
(h) Parenteral fluids. Parenteral fluids must be administered
consistent with professional standards of practice and in accordance
with physician orders, the comprehensive person-centered care plan, and
the resident's goals and preferences.
(i) Respiratory care, including tracheostomy care and tracheal
suctioning. The facility must ensure that a resident who needs
respiratory care, including tracheostomy care and tracheal suctioning,
is provided such care, consistent with professional standards of
practice, the comprehensive person-centered care plan, the residents'
goals and preferences, and Sec. 483.65 of this subpart.
(j) Prostheses. The facility must ensure that a resident who has a
prosthesis is provided care and assistance, consistent with professional
standards of practice, the comprehensive person-centered care plan, and
the residents' goals and preferences, to wear and be able to use the
prosthetic device.
(k) Pain management. The facility must ensure that pain management
is provided to residents who require such services, consistent with
professional standards of practice, the comprehensive person-centered
care plan, and the residents' goals and preferences.
(l) Dialysis. The facility must ensure that residents who require
dialysis receive such services, consistent with professional standards
of practice, the comprehensive person-centered care plan, and the
residents' goals and preferences.
(m) Trauma-informed care. The facility must ensure that residents
who are trauma survivors receive culturally-competent, trauma-informed
care in accordance with professional standards of practice and
accounting for residents' experiences and preferences in order to
eliminate or mitigate triggers that may cause re-traumatization of the
resident.
(n) Bed rails. The facility must attempt to use appropriate
alternatives prior to installing a side or bed rail. If a bed or side
rail is used, the facility must ensure correct installation, use, and
maintenance of bed rails, including but not limited to the following
elements.
(1) Assess the resident for risk of entrapment from bed rails prior
to installation.
(2) Review the risks and benefits of bed rails with the resident or
resident representative and obtain informed consent prior to
installation.
(3) Ensure that the bed's dimensions are appropriate for the
resident's size and weight.
(4) Follow the manufacturers' recommendations and specifications for
installing and maintaining bed rails.
[81 FR 68860, Oct. 4, 2016]
Sec. 483.30 Physician services.
A physician must personally approve in writing a recommendation that
an individual be admitted to a facility. Each resident must remain under
the care of a physician. A physician, physician assistant, nurse
practitioner, or clinical nurse specialist must provide orders for the
resident's immediate care and needs.
(a) Physician supervision. The facility must ensure that--
(1) The medical care of each resident is supervised by a physician;
and
(2) Another physician supervises the medical care of residents when
their attending physician is unavailable.
(b) Physician visits. The physician must--
(1) Review the resident's total program of care, including
medications and treatments, at each visit required by paragraph (c) of
this section;
(2) Write, sign, and date progress notes at each visit; and
[[Page 77]]
(3) Sign and date all orders with the exception of influenza and
pneumococcal vaccines, which may be administered per physician-approved
facility policy after an assessment for contraindications.
(c) Frequency of physician visits. (1) The resident must be seen by
a physician at least once every 30 days for the first 90 days after
admission, and at least once every 60 days thereafter.
(2) A physician visit is considered timely if it occurs not later
than 10 days after the date the visit was required.
(3) Except as provided in paragraphs (c)(4) and (f) of this section,
all required physician visits must be made by the physician personally.
(4) At the option of the physician, required visits in SNFs after
the initial visit may alternate between personal visits by the physician
and visits by a physician assistant, nurse practitioner, or clinical
nurse specialist in accordance with paragraph (e) of this section.
(d) Availability of physicians for emergency care. The facility must
provide or arrange for the provision of physician services 24 hours a
day, in case of an emergency.
(e) Physician delegation of tasks in SNFs. (1) Except as specified
in paragraph (e)(4) of this section, a physician may delegate tasks to a
physician assistant, nurse practitioner, or clinical nurse specialist
who--
(i) Meets the applicable definition in Sec. 491.2 of this chapter
or, in the case of a clinical nurse specialist, is licensed as such by
the State;
(ii) Is acting within the scope of practice as defined by State law;
and
(iii) Is under the supervision of the physician.
(2) A resident's attending physician may delegate the task of
writing dietary orders, consistent with Sec. 483.60, to a qualified
dietitian or other clinically qualified nutrition professional who--
(i) Is acting within the scope of practice as defined by State law;
and
(ii) Is under the supervision of the physician.
(3) A resident's attending physician may delegate the task of
writing therapy orders, consistent with Sec. 483.65, to a qualified
therapist who--
(i) Is acting within the scope of practice as defined by State law;
and
(ii) Is under the supervision of the physician.
(4) A physician may not delegate a task when the regulations specify
that the physician must perform it personally, or when the delegation is
prohibited under State law or by the facility's own policies.
(f) Performance of physician tasks in NFs. At the option of the
State, any required physician task in a NF (including tasks which the
regulations specify must be performed personally by the physician) may
also be satisfied when performed by a nurse practitioner, clinical nurse
specialist, or physician assistant who is not an employee of the
facility but who is working in collaboration with a physician.
[56 FR 48875, Sept. 26, 1991, as amended at 67 FR 61814, Oct. 2, 2002.
Redesignated and amended at 81 FR 68861, Oct. 4, 2016]
Sec. 483.35 Nursing services.
The facility must have sufficient nursing staff with the appropriate
competencies and skills sets to provide nursing and related services to
assure resident safety and attain or maintain the highest practicable
physical, mental, and psychosocial well-being of each resident, as
determined by resident assessments and individual plans of care and
considering the number, acuity and diagnoses of the facility's resident
population in accordance with the facility assessment required at
Sec. 483.70(e).
(a) Sufficient staff. (1) The facility must provide services by
sufficient numbers of each of the following types of personnel on a 24-
hour basis to provide nursing care to all residents in accordance with
resident care plans:
(i) Except when waived under paragraph (e) of this section, licensed
nurses; and
(ii) Other nursing personnel, including but not limited to nurse
aides.
(2) Except when waived under paragraph (c) of this section, the
facility must designate a licensed nurse to serve as a charge nurse on
each tour of duty.
(3) The facility must ensure that licensed nurses have the specific
competencies and skill sets necessary to care for residents' needs, as
identified
[[Page 78]]
through resident assessments, and described in the plan of care.
(4) Providing care includes but is not limited to assessing,
evaluating, planning and implementing resident care plans and responding
to resident's needs.
(b) Registered nurse. (1) Except when waived under paragraph (e) or
(f) of this section, the facility must use the services of a registered
nurse for at least 8 consecutive hours a day, 7 days a week.
(2) Except when waived under paragraph (e) or (f) of this section,
the facility must designate a registered nurse to serve as the director
of nursing on a full time basis.
(3) The director of nursing may serve as a charge nurse only when
the facility has an average daily occupancy of 60 or fewer residents.
(c) Proficiency of nurse aides. The facility must ensure that nurse
aides are able to demonstrate competency in skills and techniques
necessary to care for residents' needs, as identified through resident
assessments, and described in the plan of care.
(d) Requirements for facility hiring and use of nursing aides--(1)
General rule. A facility must not use any individual working in the
facility as a nurse aide for more than 4 months, on a full-time basis,
unless--
(i) That individual is competent to provide nursing and nursing
related services; and
(ii)(A) That individual has completed a training and competency
evaluation program, or a competency evaluation program approved by the
State as meeting the requirements of Secs. 483.151 through 483.154; or
(B) That individual has been deemed or determined competent as
provided in Sec. 483.150(a) and (b).
(2) Non-permanent employees. A facility must not use on a temporary,
per diem, leased, or any basis other than a permanent employee any
individual who does not meet the requirements in paragraphs (d)(1) (i)
and (ii) of this section.
(3) Minimum competency. A facility must not use any individual who
has worked less than 4 months as a nurse aide in that facility unless
the individual--
(i) Is a full-time employee in a State-approved training and
competency evaluation program;
(ii) Has demonstrated competence through satisfactory participation
in a State-approved nurse aide training and competency evaluation
program or competency evaluation program; or
(iii) Has been deemed or determined competent as provided in
Sec. 483.150(a) and (b).
(4) Registry verification. Before allowing an individual to serve as
a nurse aide, a facility must receive registry verification that the
individual has met competency evaluation requirements unless--
(i) The individual is a full-time employee in a training and
competency evaluation program approved by the State; or
(ii) The individual can prove that he or she has recently
successfully completed a training and competency evaluation program or
competency evaluation program approved by the State and has not yet been
included in the registry. Facilities must follow up to ensure that such
an individual actually becomes registered.
(5) Multi-State registry verification. Before allowing an individual
to serve as a nurse aide, a facility must seek information from every
State registry established under sections 1819(e)(2)(A) or 1919(e)(2)(A)
of the Act that the facility believes will include information on the
individual.
(6) Required retraining. If, since an individual's most recent
completion of a training and competency evaluation program, there has
been a continuous period of 24 consecutive months during none of which
the individual provided nursing or nursing-related services for monetary
compensation, the individual must complete a new training and competency
evaluation program or a new competency evaluation program.
(7) Regular in-service education. The facility must complete a
performance review of every nurse aide at least once every 12 months,
and must provide regular in-service education based on the outcome of
these reviews. In-service training must comply with the requirements of
Sec. 483.95(g).
(e) Nursing facilities: Waiver of requirement to provide licensed
nurses on a 24-
[[Page 79]]
hour basis. To the extent that a facility is unable to meet the
requirements of paragraphs (a)(2) and (b)(1) of this section, a State
may waive such requirements with respect to the facility if--
(1) The facility demonstrates to the satisfaction of the State that
the facility has been unable, despite diligent efforts (including
offering wages at the community prevailing rate for nursing facilities),
to recruit appropriate personnel;
(2) The State determines that a waiver of the requirement will not
endanger the health or safety of individuals staying in the facility;
(3) The State finds that, for any periods in which licensed nursing
services are not available, a registered nurse or a physician is
obligated to respond immediately to telephone calls from the facility;
(4) A waiver granted under the conditions listed in paragraph (c) of
this section is subject to annual State review;
(5) In granting or renewing a waiver, a facility may be required by
the State to use other qualified, licensed personnel;
(6) The State agency granting a waiver of such requirements provides
notice of the waiver to the Office of the State Long-Term Care Ombudsman
(established under section 712 of the Older Americans Act of 1965) and
the protection and advocacy system in the State for individuals with a
mental disorder who are eligible for such services as provided by the
protection and advocacy agency; and
(7) The nursing facility that is granted such a waiver by a State
notifies residents of the facility and their resident representatives of
the waiver.
(f) SNFs: Waiver of the requirement to provide services of a
registered nurse for more than 40 hours a week. (1) The Secretary may
waive the requirement that a SNF provide the services of a registered
nurse for more than 40 hours a week, including a director of nursing
specified in paragraph (b) of this section, if the Secretary finds
that--
(i) The facility is located in a rural area and the supply of
skilled nursing facility services in the area is not sufficient to meet
the needs of individuals residing in the area;
(ii) The facility has one full-time registered nurse who is
regularly on duty at the facility 40 hours a week; and
(iii) The facility either--
(A) Has only patients whose physicians have indicated (through
physicians' orders or admission notes) that they do not require the
services of a registered nurse or a physician for a 48-hours period, or
(B) Has made arrangements for a registered nurse or a physician to
spend time at the facility, as determined necessary by the physician, to
provide necessary skilled nursing services on days when the regular
full-time registered nurse is not on duty;
(iv) The Secretary provides notice of the waiver to the Office of
the State Long-Term Care Ombudsman (established under section 712 of the
Older Americans Act of 1965) and the protection and advocacy system in
the State for individuals with developmental disabilities or mental
disorders; and
(v) The facility that is granted such a waiver notifies residents of
the facility and their resident representatives of the waiver.
(2) A waiver of the registered nurse requirement under paragraph
(d)(1) of this section is subject to annual renewal by the Secretary.
(g) Nurse staffing information--(1) Data requirements. The facility
must post the following information on a daily basis:
(i) Facility name.
(ii) The current date.
(iii) The total number and the actual hours worked by the following
categories of licensed and unlicensed nursing staff directly responsible
for resident care per shift:
(A) Registered nurses.
(B) Licensed practical nurses or licensed vocational nurses (as
defined under State law).
(C) Certified nurse aides.
(iv) Resident census.
(2) Posting requirements. (i) The facility must post the nurse
staffing data specified in paragraph (e)(1) of this section on a daily
basis at the beginning of each shift.
(ii) Data must be posted as follows:
(A) Clear and readable format.
(B) In a prominent place readily accessible to residents and
visitors.
[[Page 80]]
(3) Public access to posted nurse staffing data. The facility must,
upon oral or written request, make nurse staffing data available to the
public for review at a cost not to exceed the community standard.
(4) Facility data retention requirements. The facility must maintain
the posted daily nurse staffing data for a minimum of 18 months, or as
required by State law, whichever is greater.
[56 FR 48873, Sept. 26, 1991, as amended at 57 FR 43925, Sept. 23, 1992;
70 FR 62073, Oct. 28, 2005. Redesignated and amended at 81 FR 68861,
Oct. 4, 2016]
Sec. 483.40 Behavioral health services.
Each resident must receive and the facility must provide the
necessary behavioral health care and services to attain or maintain the
highest practicable physical, mental, and psychosocial well-being, in
accordance with the comprehensive assessment and plan of care.
Behavioral health encompasses a resident's whole emotional and mental
well-being, which includes, but is not limited to, the prevention and
treatment of mental and substance use disorders.
(a) The facility must have sufficient staff who provide direct
services to residents with the appropriate competencies and skills sets
to provide nursing and related services to assure resident safety and
attain or maintain the highest practicable physical, mental and
psychosocial well-being of each resident, as determined by resident
assessments and individual plans of care and considering the number,
acuity and diagnoses of the facility's resident population in accordance
with Sec. 483.70(e). These competencies and skills sets include, but are
not limited to, knowledge of and appropriate training and supervision
for:
(1) Caring for residents with mental and psychosocial disorders, as
well as residents with a history of trauma and/or post-traumatic stress
disorder, that have been identified in the facility assessment conducted
pursuant to Sec. 483.70(e), and
(2) Implementing non-pharmacological interventions.
(b) Based on the comprehensive assessment of a resident, the
facility must ensure that--
(1) A resident who displays or is diagnosed with mental disorder or
psychosocial adjustment difficulty, or who has a history of trauma and/
or post-traumatic stress disorder, receives appropriate treatment and
services to correct the assessed problem or to attain the highest
practicable mental and psychosocial well-being;
(2) A resident whose assessment did not reveal or who does not have
a diagnosis of a mental or psychosocial adjustment difficulty or a
documented history of trauma and/or post-traumatic stress disorder does
not display a pattern of decreased social interaction and/or increased
withdrawn, angry, or depressive behaviors, unless the resident's
clinical condition demonstrates that development of such a pattern was
unavoidable; and
(3) A resident who displays or is diagnosed with dementia, receives
the appropriate treatment and services to attain or maintain his or her
highest practicable physical, mental, and psychosocial well-being.
(c) If rehabilitative services such as but not limited to physical
therapy, speech-language pathology, occupational therapy, and
rehabilitative services for mental disorders and intellectual
disability, are required in the resident's comprehensive plan of care,
the facility must--
(1) Provide the required services, including specialized
rehabilitation services as required in Sec. 483.65; or
(2) Obtain the required services from an outside resource (in
accordance with Sec. 483.70(g) of this part) from a Medicare and/or
Medicaid provider of specialized rehabilitative services.
(d) The facility must provide medically-related social services to
attain or maintain the highest practicable physical, mental and
psychosocial well-being of each resident.
[81 FR 68862, Oct. 4, 2016]
Sec. 483.45 Pharmacy services.
The facility must provide routine and emergency drugs and
biologicals to its residents, or obtain them under an agreement
described in Sec. 483.70(g). The facility may permit unlicensed
personnel to administer drugs if State law permits, but only under the
general supervision of a licensed nurse.
[[Page 81]]
(a) Procedures. A facility must provide pharmaceutical services
(including procedures that assure the accurate acquiring, receiving,
dispensing, and administering of all drugs and biologicals) to meet the
needs of each resident.
(b) Service consultation. The facility must employ or obtain the
services of a licensed pharmacist who--
(1) Provides consultation on all aspects of the provision of
pharmacy services in the facility;
(2) Establishes a system of records of receipt and disposition of
all controlled drugs in sufficient detail to enable an accurate
reconciliation; and
(3) Determines that drug records are in order and that an account of
all controlled drugs is maintained and periodically reconciled.
(c) Drug regimen review. (1) The drug regimen of each resident must
be reviewed at least once a month by a licensed pharmacist.
(2) This review must include a review of the resident's medical
chart.
(3) A psychotropic drug is any drug that affects brain activities
associated with mental processes and behavior. These drugs include, but
are not limited to, drugs in the following categories:
(i) Anti-psychotic;
(ii) Anti-depressant;
(iii) Anti-anxiety; and
(iv) Hypnotic.
(4) The pharmacist must report any irregularities to the attending
physician and the facility's medical director and director of nursing,
and these reports must be acted upon.
(i) Irregularities include, but are not limited to, any drug that
meets the criteria set forth in paragraph (d) of this section for an
unnecessary drug.
(ii) Any irregularities noted by the pharmacist during this review
must be documented on a separate, written report that is sent to the
attending physician and the facility's medical director and director of
nursing and lists, at a minimum, the resident's name, the relevant drug,
and the irregularity the pharmacist identified.
(iii) The attending physician must document in the resident's
medical record that the identified irregularity has been reviewed and
what, if any, action has been taken to address it. If there is to be no
change in the medication, the attending physician should document his or
her rationale in the resident's medical record.
(5) The facility must develop and maintain policies and procedures
for the monthly drug regimen review that include, but are not limited
to, time frames for the different steps in the process and steps the
pharmacist must take when he or she identifies an irregularity that
requires urgent action to protect the resident.
(d) Unnecessary drugs--General. Each resident's drug regimen must be
free from unnecessary drugs. An unnecessary drug is any drug when used--
(1) In excessive dose (including duplicate drug therapy); or
(2) For excessive duration; or
(3) Without adequate monitoring; or
(4) Without adequate indications for its use; or
(5) In the presence of adverse consequences which indicate the dose
should be reduced or discontinued; or
(6) Any combinations of the reasons stated in paragraphs (d)(1)
through (5) of this section.
(e) Psychotropic drugs. Based on a comprehensive assessment of a
resident, the facility must ensure that--
(1) Residents who have not used psychotropic drugs are not given
these drugs unless the medication is necessary to treat a specific
condition as diagnosed and documented in the clinical record;
(2) Residents who use psychotropic drugs receive gradual dose
reductions, and behavioral interventions, unless clinically
contraindicated, in an effort to discontinue these drugs;
(3) Residents do not receive psychotropic drugs pursuant to a PRN
order unless that medication is necessary to treat a diagnosed specific
condition that is documented in the clinical record; and
(4) PRN orders for psychotropic drugs are limited to 14 days. Except
as provided in Sec. 483.45(e)(5), if the attending physician or
prescribing practitioner believes that it is appropriate for the PRN
order to be extended beyond 14 days, he or she should document their
rationale in the resident's medical
[[Page 82]]
record and indicate the duration for the PRN order.
(5) PRN orders for anti-psychotic drugs are limited to 14 days and
cannot be renewed unless the attending physician or prescribing
practitioner evaluates the resident for the appropriateness of that
medication.
(f) Medication errors. The facility must ensure that its--
(1) Medication error rates are not 5 percent or greater; and
(2) Residents are free of any significant medication errors.
(g) Labeling of drugs and biologicals. Drugs and biologicals used in
the facility must be labeled in accordance with currently accepted
professional principles, and include the appropriate accessory and
cautionary instructions, and the expiration date when applicable.
(h) Storage of drugs and biologicals. (1) In accordance with State
and Federal laws, the facility must store all drugs and biologicals in
locked compartments under proper temperature controls, and permit only
authorized personnel to have access to the keys.
(2) The facility must provide separately locked, permanently affixed
compartments for storage of controlled drugs listed in Schedule II of
the Comprehensive Drug Abuse Prevention and Control Act of 1976 and
other drugs subject to abuse, except when the facility uses single unit
package drug distribution systems in which the quantity stored is
minimal and a missing dose can be readily detected.
[56 FR 48875, Sept. 26, 1991, as amended at 57 FR 43925, Sept. 23, 1992.
Redesignated and amended at 81 FR 68861, 68863, Oct. 4, 2016; 82 FR
32259, July 13, 2017]
Sec. 483.50 Laboratory, radiology, and other diagnostic services.
(a) Laboratory services. (1) The facility must provide or obtain
laboratory services to meet the needs of its residents. The facility is
responsible for the quality and timeliness of the services.
(i) If the facility provides its own laboratory services, the
services must meet the applicable requirements for laboratories
specified in part 493 of this chapter.
(ii) If the facility provides blood bank and transfusion services,
it must meet the applicable requirements for laboratories specified in
part 493 of this chapter.
(iii) If the laboratory chooses to refer specimens for testing to
another laboratory, the referral laboratory must be certified in the
appropriate specialties and subspecialties of services in accordance
with the requirements of part 493 of this chapter.
(iv) If the facility does not provide laboratory services on site,
it must have an agreement to obtain these services from a laboratory
that meets the applicable requirements of part 493 of this chapter.
(2) The facility must:
(i) Provide or obtain laboratory services only when ordered by a
physician; physician assistant; nurse practitioner or clinical nurse
specialist in accordance with State law, including scope of practice
laws.
(ii) Promptly notify the ordering physician, physician assistant,
nurse practitioner, or clinical nurse specialist of laboratory results
that fall outside of clinical reference ranges in accordance with
facility policies and procedures for notification of a practitioner or
per the ordering physician's orders.
(iii) Assist the resident in making transportation arrangements to
and from the source of service, if the resident needs assistance; and
(iv) File in the resident's clinical record laboratory reports that
are dated and contain the name and address of the testing laboratory.
(b) Radiology and other diagnostic services. (1) The facility must
provide or obtain radiology and other diagnostic services to meet the
needs of its residents. The facility is responsible for the quality and
timeliness of the services.
(i) If the facility provides its own diagnostic services, the
services must meet the applicable conditions of participation for
hospitals contained in Sec. 482.26 of this subchapter.
(ii) If the facility does not provide its own diagnostic services,
it must have an agreement to obtain these services from a provider or
supplier that is approved to provide these services under Medicare.
(2) The facility must:
[[Page 83]]
(i) Provide or obtain radiology and other diagnostic services only
when ordered by a physician; physician assistant; nurse practitioner or
clinical nurse specialist in accordance with State law, including scope
of practice laws.
(ii) Promptly notify the ordering physician, physician assistant,
nurse practitioner, or clinical nurse specialist of results that fall
outside of clinical reference ranges in accordance with facility
policies and procedures for notification of a practitioner or per the
ordering physician's orders.
(iii) Assist the resident in making transportation arrangements to
and from the source of service, if the resident needs assistance; and
(iv) File in the resident's clinical record signed and dated reports
of x-ray and other diagnostic services.
[81 FR 68863, Oct. 4, 2016, as amended at 82 FR 32259, July 13, 2017]
Sec. 483.55 Dental services.
The facility must assist residents in obtaining routine and 24-hour
emergency dental care.
(a) Skilled nursing facilities. A facility (1) Must provide or
obtain from an outside resource, in accordance with Sec. 483.70(g),
routine and emergency dental services to meet the needs of each
resident;
(2) May charge a Medicare resident an additional amount for routine
and emergency dental services;
(3) Must have a policy identifying those circumstances when the loss
or damage of dentures is the facility's responsibility and may not
charge a resident for the loss or damage of dentures determined in
accordance with facility policy to be the facility's responsibility;
(4) Must if necessary or if requested, assist the resident--
(i) In making appointments; and
(ii) By arranging for transportation to and from the dental services
location; and
(5) Must promptly, within 3 days, refer residents with lost or
damaged dentures for dental services. If a referral does not occur
within 3 days, the facility must provide documentation of what they did
to ensure the resident could still eat and drink adequately while
awaiting dental services and the extenuating circumstances that led to
the delay.
(b) Nursing facilities. The facility (1) Must provide or obtain from
an outside resource, in accordance with Sec. 483.70(g), the following
dental services to meet the needs of each resident:
(i) Routine dental services (to the extent covered under the State
plan); and
(ii) Emergency dental services;
(2) Must, if necessary or if requested, assist the resident--
(i) In making appointments; and
(ii) By arranging for transportation to and from the dental services
locations;
(3) Must promptly, within 3 days, refer residents with lost or
damaged dentures for dental services. If a referral does not occur
within 3 days, the facility must provide documentation of what they did
to ensure the resident could still eat and drink adequately while
awaiting dental services and the extenuating circumstances that led to
the delay;
(4) Must have a policy identifying those circumstances when the loss
or damage of dentures is the facility's responsibility and may not
charge a resident for the loss or damage of dentures determined in
accordance with facility policy to be the facility's responsibility; and
(5) Must assist residents who are eligible and wish to participate
to apply for reimbursement of dental services as an incurred medical
expense under the State plan.
[56 FR 48875, Sept. 26, 1991, as amended at 81 FR 68864, Oct. 4, 2016]
Sec. 483.60 Food and nutrition services.
The facility must provide each resident with a nourishing,
palatable, well-balanced diet that meets his or her daily nutritional
and special dietary needs, taking into consideration the preferences of
each resident.
(a) Staffing. The facility must employ sufficient staff with the
appropriate competencies and skills sets to carry out the functions of
the food and nutrition service, taking into consideration resident
assessments, individual plans of care and the number, acuity and
diagnoses of the facility's resident population in accordance with the
facility
[[Page 84]]
assessment required at Sec. 483.70(e). This includes:
(1) A qualified dietitian or other clinically qualified nutrition
professional either full-time, part-time, or on a consultant basis. A
qualified dietitian or other clinically qualified nutrition professional
is one who--
(i) Holds a bachelor's or higher degree granted by a regionally
accredited college or university in the United States (or an equivalent
foreign degree) with completion of the academic requirements of a
program in nutrition or dietetics accredited by an appropriate national
accreditation organization recognized for this purpose.
(ii) Has completed at least 900 hours of supervised dietetics
practice under the supervision of a registered dietitian or nutrition
professional.
(iii) Is licensed or certified as a dietitian or nutrition
professional by the State in which the services are performed. In a
state that does not provide for licensure or certification, the
individual will be deemed to have met this requirement if he or she is
recognized as a ``registered dietitian'' by the Commission on Dietetic
Registration or its successor organization, or meets the requirements of
paragraphs (a)(1)(i) and (ii) of this section.
(iv) For dietitians hired or contracted with prior to November 28,
2016, meets these requirements no later than 5 years after November 28,
2016 or as required by state law.
(2) If a qualified dietitian or other clinically qualified nutrition
professional is not employed full-time, the facility must designate a
person to serve as the director of food and nutrition services who--
(i) For designations prior to November 28, 2016, meets the following
requirements no later than 5 years after November 28, 2016, or no later
than 1 year after November 28, 2016 for designations after November 28,
2016, is:
(A) A certified dietary manager; or
(B) A certified food service manager, or
(C) Has similar national certification for food service management
and safety from a national certifying body; or
(D) Has an associate's or higher degree in food service management
or in hospitality, if the course study includes food service or
restaurant management, from an accredited institution of higher
learning; and
(ii) In States that have established standards for food service
managers or dietary managers, meets State requirements for food service
managers or dietary managers, and
(iii) Receives frequently scheduled consultations from a qualified
dietitian or other clinically qualified nutrition professional.
(3) Support staff. The facility must provide sufficient support
personnel to safely and effectively carry out the functions of the food
and nutrition service.
(b) A member of the Food and Nutrition Services staff must
participate on the interdisciplinary team as required in
Sec. 483.21(b)(2)(ii).
(c) Menus and nutritional adequacy. Menus must--
(1) Meet the nutritional needs of residents in accordance with
established national guidelines.;
(2) Be prepared in advance;
(3) Be followed;
(4) Reflect, based on a facility's reasonable efforts, the
religious, cultural, and ethnic needs of the resident population, as
well as input received from residents and resident groups;
(5) Be updated periodically;
(6) Be reviewed by the facility's dietitian or other clinically
qualified nutrition professional for nutritional adequacy; and
(7) Nothing in this paragraph should be construed to limit the
resident's right to make personal dietary choices.
(d) Food and drink. Each resident receives and the facility
provides--
(1) Food prepared by methods that conserve nutritive value, flavor,
and appearance;
(2) Food and drink that is palatable, attractive, and at a safe and
appetizing temperature;
(3) Food prepared in a form designed to meet individual needs;
(4) Food that accommodates resident allergies, intolerances, and
preferences;
(5) Appealing options of similar nutritive value to residents who
choose not to eat food that is initially served or who request a
different meal choice; and
[[Page 85]]
(6) Drinks, including water and other liquids consistent with
resident needs and preferences and sufficient to maintain resident
hydration.
(e) Therapeutic diets. (1) Therapeutic diets must be prescribed by
the attending physician.
(2) The attending physician may delegate to a registered or licensed
dietitian the task of prescribing a resident's diet, including a
therapeutic diet, to the extent allowed by State law.
(f) Frequency of meals. (1) Each resident must receive and the
facility must provide at least three meals daily, at regular times
comparable to normal mealtimes in the community or in accordance with
resident needs, preferences, requests, and plan of care.
(2) There must be no more than 14 hours between a substantial
evening meal and breakfast the following day, except when a nourishing
snack is served at bedtime, up to 16 hours may elapse between a
substantial evening meal and breakfast the following day if a resident
group agrees to this meal span.
(3) Suitable, nourishing alternative meals and snacks must be
provided to residents who want to eat at non-traditional times or
outside of scheduled meal service times, consistent with the resident
plan of care.
(g) Assistive devices. The facility must provide special eating
equipment and utensils for residents who need them and appropriate
assistance to ensure that the resident can use the assistive devices
when consuming meals and snacks.
(h) Paid feeding assistants--(1) State-approved training course. A
facility may use a paid feeding assistant, as defined in Sec. 488.301 of
this chapter, if--
(i) The feeding assistant has successfully completed a State-
approved training course that meets the requirements of Sec. 483.160
before feeding residents; and
(ii) The use of feeding assistants is consistent with State law.
(2) Supervision. (i) A feeding assistant must work under the
supervision of a registered nurse (RN) or licensed practical nurse
(LPN).
(ii) In an emergency, a feeding assistant must call a supervisory
nurse for help.
(3) Resident selection criteria. (i) A facility must ensure that a
feeding assistant provides dining assistance only for residents who have
no complicated feeding problems.
(ii) Complicated feeding problems include, but are not limited to,
difficulty swallowing, recurrent lung aspirations, and tube or
parenteral/IV feedings.
(iii) The facility must base resident selection on the
interdisciplinary team's assessment and the resident's latest assessment
and plan of care. Appropriateness for this program should be reflected
in the comprehensive care plan.
(i) Food safety requirements. The facility must--
(1) Procure food from sources approved or considered satisfactory by
federal, state, or local authorities;
(i) This may include food items obtained directly from local
producers, subject to applicable State and local laws or regulations.
(ii) This provision does not prohibit or prevent facilities from
using produce grown in facility gardens, subject to compliance with
applicable safe growing and food-handling practices.
(iii) This provision does not preclude residents from consuming
foods not procured by the facility.
(2) Store, prepare, distribute, and serve food in accordance with
professional standards for food service safety.
(3) Have a policy regarding use and storage of foods brought to
residents by family and other visitors to ensure safe and sanitary
storage, handling, and consumption, and
(4) Dispose of garbage and refuse properly.
[81 FR 68864, Oct. 4, 2016]
Sec. 483.65 Specialized rehabilitative services.
(a) Provision of services. If specialized rehabilitative services
such as but not limited to physical therapy, speech-language pathology,
occupational therapy, respiratory therapy, and rehabilitative services
for a mental disorder and intellectual disability or services of a
lesser intensity as set forth at Sec. 483.120(c), are required in the
resident's comprehensive plan of care, the facility must--
(1) Provide the required services; or
[[Page 86]]
(2) In accordance with Sec. 483.70(g), obtain the required services
from an outside resource that is a provider of specialized
rehabilitative services and is not excluded from participating in any
federal or state health care programs pursuant to section 1128 and 1156
of the Act.
(b) Qualifications. Specialized rehabilitative services must be
provided under the written order of a physician by qualified personnel.
[56 FR 48875, Sept. 26, 1991, as amended at 57 FR 43925, Sept. 23, 1992.
Redesignated and amended at 81 FR 68861, 68865, Oct. 4, 2016]
Sec. 483.70 Administration.
A facility must be administered in a manner that enables it to use
its resources effectively and efficiently to attain or maintain the
highest practicable physical, mental, and psychosocial well-being of
each resident.
(a) Licensure. A facility must be licensed under applicable State
and local law.
(b) Compliance with Federal, State, and local laws and professional
standards. The facility must operate and provide services in compliance
with all applicable Federal, State, and local laws, regulations, and
codes, and with accepted professional standards and principles that
apply to professionals providing services in such a facility.
(c) Relationship to other HHS regulations. In addition to compliance
with the regulations set forth in this subpart, facilities are obliged
to meet the applicable provisions of other HHS regulations, including
but not limited to those pertaining to nondiscrimination on the basis of
race, color, or national origin (45 CFR part 80); nondiscrimination on
the basis of disability (45 CFR part 84); nondiscrimination on the basis
of age (45 CFR part 91); nondiscrimination on the basis of race, color,
national origin, sex, age, or disability (45 CFR part 92); protection of
human subjects of research (45 CFR part 46); and fraud and abuse (42 CFR
part 455) and protection of individually identifiable health information
(45 CFR parts 160 and 164). Violations of such other provisions may
result in a finding of non-compliance with this paragraph.
(d) Governing body. (1) The facility must have a governing body, or
designated persons functioning as a governing body, that is legally
responsible for establishing and implementing policies regarding the
management and operation of the facility; and
(2) The governing body appoints the administrator who is--
(i) Licensed by the State, where licensing is required;
(ii) Responsible for management of the facility; and
(iii) Reports to and is accountable to the governing body.
(3) The governing body is responsible and accountable for the QAPI
program, in accordance with Sec. 483.75(f).
(e) Facility assessment. The facility must conduct and document a
facility-wide assessment to determine what resources are necessary to
care for its residents competently during both day-to-day operations and
emergencies. The facility must review and update that assessment, as
necessary, and at least annually. The facility must also review and
update this assessment whenever there is, or the facility plans for, any
change that would require a substantial modification to any part of this
assessment. The facility assessment must address or include:
(1) The facility's resident population, including, but not limited
to,
(i) Both the number of residents and the facility's resident
capacity;
(ii) The care required by the resident population considering the
types of diseases, conditions, physical and cognitive disabilities,
overall acuity, and other pertinent facts that are present within that
population;
(iii) The staff competencies that are necessary to provide the level
and types of care needed for the resident population;
(iv) The physical environment, equipment, services, and other
physical plant considerations that are necessary to care for this
population; and
(v) Any ethnic, cultural, or religious factors that may potentially
affect the care provided by the facility, including, but not limited to,
activities and food and nutrition services.
(2) The facility's resources, including but not limited to,
[[Page 87]]
(i) All buildings and/or other physical structures and vehicles;
(ii) Equipment (medical and non-medical);
(iii) Services provided, such as physical therapy, pharmacy, and
specific rehabilitation therapies;
(iv) All personnel, including managers, staff (both employees and
those who provide services under contract), and volunteers, as well as
their education and/or training and any competencies related to resident
care;
(v) Contracts, memorandums of understanding, or other agreements
with third parties to provide services or equipment to the facility
during both normal operations and emergencies; and
(vi) Health information technology resources, such as systems for
electronically managing patient records and electronically sharing
information with other organizations.
(3) A facility-based and community-based risk assessment, utilizing
an all-hazards approach.
(f) Staff qualifications. (1) The facility must employ on a full-
time, part-time or consultant basis those professionals necessary to
carry out the provisions of these requirements.
(2) Professional staff must be licensed, certified, or registered in
accordance with applicable State laws.
(g) Use of outside resources. (1) If the facility does not employ a
qualified professional person to furnish a specific service to be
provided by the facility, the facility must have that service furnished
to residents by a person or agency outside the facility under an
arrangement described in section 1861(w) of the Act or (with respect to
services furnished to NF residents and dental services furnished to SNF
residents) an agreement described in paragraph (g)(2) of this section.
(2) Arrangements as described in section 1861(w) of the Act or
agreements pertaining to services furnished by outside resources must
specify in writing that the facility assumes responsibility for--
(i) Obtaining services that meet professional standards and
principles that apply to professionals providing services in such a
facility; and
(ii) The timeliness of the services.
(h) Medical director. (1) The facility must designate a physician to
serve as medical director.
(2) The medical director is responsible for--
(i) Implementation of resident care policies; and
(ii) The coordination of medical care in the facility.
(i) Medical records. (1) In accordance with accepted professional
standards and practices, the facility must maintain medical records on
each resident that are--
(i) Complete;
(ii) Accurately documented;
(iii) Readily accessible; and
(iv) Systematically organized.
(2) The facility must keep confidential all information contained in
the resident's records, regardless of the form or storage method of the
records, except when release is--
(i) To the individual, or their resident representative where
permitted by applicable law;
(ii) Required by law;
(iii) For treatment, payment, or health care operations, as
permitted by and in compliance with 45 CFR 164.506;
(iv) For public health activities, reporting of abuse, neglect, or
domestic violence, health oversight activities, judicial and
administrative proceedings, law enforcement purposes, organ donation
purposes, research purposes, or to coroners, medical examiners, funeral
directors, and to avert a serious threat to health or safety as
permitted by and in compliance with 45 CFR 164.512.
(3) The facility must safeguard medical record information against
loss, destruction, or unauthorized use;
(4) Medical records must be retained for--
(i) The period of time required by State law; or
(ii) Five years from the date of discharge when there is no
requirement in State law; or
(iii) For a minor, 3 years after a resident reaches legal age under
State law.
(5) The medical record must contain--
(i) Sufficient information to identify the resident;
(ii) A record of the resident's assessments;
[[Page 88]]
(iii) The comprehensive plan of care and services provided;
(iv) The results of any preadmission screening and resident review
evaluations and determinations conducted by the State;
(v) Physician's, nurse's, and other licensed professional's progress
notes; and
(vi) Laboratory, radiology and other diagnostic services reports as
required under Sec. 483.50.
(j) Transfer agreement. (1) In accordance with section 1861(l) of
the Act, the facility (other than a nursing facility which is located in
a State on an Indian reservation) must have in effect a written transfer
agreement with one or more hospitals approved for participation under
the Medicare and Medicaid programs that reasonably assures that--
(i) Residents will be transferred from the facility to the hospital,
and ensured of timely admission to the hospital when transfer is
medically appropriate as determined by the attending physician or, in an
emergency situation, by another practitioner in accordance with facility
policy and consistent with state law; and
(ii) Medical and other information needed for care and treatment of
residents and, when the transferring facility deems it appropriate, for
determining whether such residents can receive appropriate services or
receive services in a less restrictive setting than either the facility
or the hospital, or reintegrated into the community, will be exchanged
between the providers, including but not limited to the information
required under Sec. 483.15(c)(2)(iii).
(2) The facility is considered to have a transfer agreement in
effect if the facility has attempted in good faith to enter into an
agreement with a hospital sufficiently close to the facility to make
transfer feasible.
(k) Disclosure of ownership. (1) The facility must comply with the
disclosure requirements of Secs. 420.206 and 455.104 of this chapter.
(2) The facility must provide written notice to the State agency
responsible for licensing the facility at the time of change, if a
change occurs in--
(i) Persons with an ownership or control interest, as defined in
Secs. 420.201 and 455.101 of this chapter;
(ii) The officers, directors, agents, or managing employees;
(iii) The corporation, association, or other company responsible for
the management of the facility; or
(iv) The facility's administrator or director of nursing.
(3) The notice specified in paragraph (k)(2) of this section must
include the identity of each new individual or company.
(l) Facility closure-Administrator. Any individual who is the
administrator of the facility must:
(1) Submit to the State Survey Agency, the State LTC ombudsman,
residents of the facility, and the legal representatives of such
residents or other responsible parties, written notification of an
impending closure:
(i) At least 60 days prior to the date of closure; or
(ii) In the case of a facility where the Secretary or a State
terminates the facility's participation in the Medicare and/or Medicaid
programs, not later than the date that the Secretary determines
appropriate;
(2) Ensure that the facility does not admit any new residents on or
after the date on which such written notification is submitted; and
(3) Include in the notice the plan, that has been approved by the
State, for the transfer and adequate relocation of the residents of the
facility by a date that would be specified by the State prior to
closure, including assurances that the residents would be transferred to
the most appropriate facility or other setting in terms of quality,
services, and location, taking into consideration the needs, choice, and
best interests of each resident.
(m) Facility closure. The facility must have in place policies and
procedures to ensure that the administrator's duties and
responsibilities involve providing the appropriate notices in the event
of a facility closure, as required at paragraph (l) of this section.
(n) Binding arbitration agreements. (1) A facility must not enter
into a pre-dispute agreement for binding arbitration with any resident
or resident's
[[Page 89]]
representative nor require that a resident sign an arbitration agreement
as a condition of admission to the LTC facility.
(2) If, after a dispute between the facility and a resident arises,
and a facility chooses to ask a resident or his or her representative to
enter into an agreement for binding arbitration, the facility must
comply with all of the requirements in this section.
(i) The facility must ensure that:
(A) The agreement is explained to the resident and their
representative in a form and manner that he or she understands,
including in a language the resident and their representative
understands, and
(B) The resident acknowledges that he or she understands the
agreement.
(ii) The agreement must:
(A) Be entered into by the resident voluntarily.
(B) Provide for the selection of a neutral arbitrator agreed upon by
both parties.
(C) Provide for selection of a venue convenient to both parties.
(iii) A resident's continuing right to remain in the facility must
not be contingent upon the resident or the resident's representative
signing a binding arbitration agreement.
(iv) The agreement must not contain any language that prohibits or
discourages the resident or anyone else from communicating with federal,
state, or local officials, including but not limited to, federal and
state surveyors, other federal or state health department employees, and
representatives of the Office of the State Long-Term Care Ombudsman, in
accordance with Sec. 483.10(k).
(v) The agreement may be signed by another individual if:
(A) Allowed by state law;
(B) All of the requirements in this section are met; and
(C) That individual has no interest in the facility.
(vi) When the facility and a resident resolve a dispute with
arbitration, a copy of the signed agreement for binding arbitration and
the arbitrator's final decision must be retained by the facility for 5
years and be available for inspection upon request by CMS or its
designee.
(o) Hospice services. (1) A long-term care (LTC) facility may do
either of the following:
(i) Arrange for the provision of hospice services through an
agreement with one or more Medicare-certified hospices.
(ii) Not arrange for the provision of hospice services at the
facility through an agreement with a Medicare-certified hospice and
assist the resident in transferring to a facility that will arrange for
the provision of hospice services when a resident requests a transfer.
(2) If hospice care is furnished in an LTC facility through an
agreement as specified in paragraph (o)(1)(i) of this section with a
hospice, the LTC facility must meet the following requirements:
(i) Ensure that the hospice services meet professional standards and
principles that apply to individuals providing services in the facility,
and to the timeliness of the services.
(ii) Have a written agreement with the hospice that is signed by an
authorized representative of the hospice and an authorized
representative of the LTC facility before hospice care is furnished to
any resident. The written agreement must set out at least the following:
(A) The services the hospice will provide.
(B) The hospice's responsibilities for determining the appropriate
hospice plan of care as specified in Sec. 418.112 (d) of this chapter.
(C) The services the LTC facility will continue to provide, based on
each resident's plan of care.
(D) A communication process, including how the communication will be
documented between the LTC facility and the hospice provider, to ensure
that the needs of the resident are addressed and met 24 hours per day.
(E) A provision that the LTC facility immediately notifies the
hospice about the following:
(1) A significant change in the resident's physical, mental, social,
or emotional status.
(2) Clinical complications that suggest a need to alter the plan of
care.
(3) A need to transfer the resident from the facility for any
condition.
(4) The resident's death.
[[Page 90]]
(F) A provision stating that the hospice assumes responsibility for
determining the appropriate course of hospice care, including the
determination to change the level of services provided.
(G) An agreement that it is the LTC facility's responsibility to
furnish 24-hour room and board care, meet the resident's personal care
and nursing needs in coordination with the hospice representative, and
ensure that the level of care provided is appropriately based on the
individual resident's needs.
(H) A delineation of the hospice's responsibilities, including but
not limited to, providing medical direction and management of the
patient; nursing; counseling (including spiritual, dietary, and
bereavement); social work; providing medical supplies, durable medical
equipment, and drugs necessary for the palliation of pain and symptoms
associated with the terminal illness and related conditions; and all
other hospice services that are necessary for the care of the resident's
terminal illness and related conditions.
(I) A provision that when the LTC facility personnel are responsible
for the administration of prescribed therapies, including those
therapies determined appropriate by the hospice and delineated in the
hospice plan of care, the LTC facility personnel may administer the
therapies where permitted by State law and as specified by the LTC
facility.
(J) A provision stating that the LTC facility must report all
alleged violations involving mistreatment, neglect, or verbal, mental,
sexual, and physical abuse, including injuries of unknown source, and
misappropriation of patient property by hospice personnel, to the
hospice administrator immediately when the LTC facility becomes aware of
the alleged violation.
(K) A delineation of the responsibilities of the hospice and the LTC
facility to provide bereavement services to LTC facility staff.
(3) Each LTC facility arranging for the provision of hospice care
under a written agreement must designate a member of the facility's
interdisciplinary team who is responsible for working with hospice
representatives to coordinate care to the resident provided by the LTC
facility staff and hospice staff. The interdisciplinary team member must
have a clinical background, function within their State scope of
practice act, and have the ability to assess the resident or have access
to someone that has the skills and capabilities to assess the resident.
The designated interdisciplinary team member is responsible for the
following:
(i) Collaborating with hospice representatives and coordinating LTC
facility staff participation in the hospice care planning process for
those residents receiving these services.
(ii) Communicating with hospice representatives and other healthcare
providers participating in the provision of care for the terminal
illness, related conditions, and other conditions, to ensure quality of
care for the patient and family.
(iii) Ensuring that the LTC facility communicates with the hospice
medical director, the patient's attending physician, and other
practitioners participating in the provision of care to the patient as
needed to coordinate the hospice care with the medical care provided by
other physicians.
(iv) Obtaining the following information from the hospice:
(A) The most recent hospice plan of care specific to each patient.
(B) Hospice election form.
(C) Physician certification and recertification of the terminal
illness specific to each patient.
(D) Names and contact information for hospice personnel involved in
hospice care of each patient.
(E) Instructions on how to access the hospice's 24-hour on-call
system.
(F) Hospice medication information specific to each patient.
(G) Hospice physician and attending physician (if any) orders
specific to each patient.
(v) Ensuring that the LTC facility staff provides orientation in the
policies and procedures of the facility, including patient rights,
appropriate forms, and record keeping requirements, to hospice staff
furnishing care to LTC residents.
(4) Each LTC facility providing hospice care under a written
agreement
[[Page 91]]
must ensure that each resident's written plan of care includes both the
most recent hospice plan of care and a description of the services
furnished by the LTC facility to attain or maintain the resident's
highest practicable physical, mental, and psychosocial well-being, as
required at Sec. 483.25.
(p) Social worker. Any facility with more than 120 beds must employ
a qualified social worker on a full-time basis. A qualified social
worker is:
(1) An individual with a minimum of a bachelor's degree in social
work or a bachelor's degree in a human services field including, but not
limited to, sociology, gerontology, special education, rehabilitation
counseling, and psychology; and
(2) One year of supervised social work experience in a health care
setting working directly with individuals.
(q) Mandatory submission of staffing information based on payroll
data in a uniform format. Long-term care facilities must electronically
submit to CMS complete and accurate direct care staffing information,
including information for agency and contract staff, based on payroll
and other verifiable and auditable data in a uniform format according to
specifications established by CMS.
(1) Direct Care Staff. Direct Care Staff are those individuals who,
through interpersonal contact with residents or resident care
management, provide care and services to allow residents to attain or
maintain the highest practicable physical, mental, and psychosocial
well-being. Direct care staff does not include individuals whose primary
duty is maintaining the physical environment of the long term care
facility (for example, housekeeping).
(2) Submission requirements. The facility must electronically submit
to CMS complete and accurate direct care staffing information, including
the following:
(i) The category of work for each person on direct care staff
(including, but not limited to, whether the individual is a registered
nurse, licensed practical nurse, licensed vocational nurse, certified
nursing assistant, therapist, or other type of medical personnel as
specified by CMS);
(ii) Resident census data; and
(iii) Information on direct care staff turnover and tenure, and on
the hours of care provided by each category of staff per resident per
day (including, but not limited to, start date, end date (as
applicable), and hours worked for each individual).
(3) Distinguishing employee from agency and contract staff. When
reporting information about direct care staff, the facility must specify
whether the individual is an employee of the facility, or is engaged by
the facility under contract or through an agency.
(4) Data format. The facility must submit direct care staffing
information in the uniform format specified by CMS.
(5) Submission schedule. The facility must submit direct care
staffing information on the schedule specified by CMS, but no less
frequently than quarterly.
[56 FR 48877, Sept. 26, 1991, as amended at 56 FR 48918, Sept. 26, 1991;
57 FR 7136, Feb. 28, 1992; 57 FR 43925, Sept. 23, 1992; 59 FR 56237,
Nov. 10, 1994; 63 FR 26311, May 12, 1998; 68 FR 55539, Sept. 26, 2003;
74 FR 40363, Aug. 11, 2009; 76 FR 9511, Feb. 18, 2011; 78 FR 16805, Mar.
19, 2013; 78 FR 38605, June 27, 2013; 80 FR 46477, Aug. 4, 2015; 81 FR
64032, Sept. 16, 2016. Redesignated and amended at 81 FR 68861, 68865,
Oct. 4, 2016; 82 FR 32259, July 13, 2017]
Sec. 483.73 Emergency preparedness.
The LTC facility must comply with all applicable Federal, State and
local emergency preparedness requirements. The LTC facility must
establish and maintain an emergency preparedness program that meets the
requirements of this section. The emergency preparedness program must
include, but not be limited to, the following elements:
(a) Emergency plan. The LTC facility must develop and maintain an
emergency preparedness plan that must be reviewed, and updated at least
annually. The plan must do all of the following:
(1) Be based on and include a documented, facility-based and
community-based risk assessment, utilizing an all-hazards approach,
including missing residents.
(2) Include strategies for addressing emergency events identified by
the risk assessment.
[[Page 92]]
(3) Address resident population, including, but not limited to,
persons at-risk; the type of services the LTC facility has the ability
to provide in an emergency; and continuity of operations, including
delegations of authority and succession plans.
(4) Include a process for cooperation and collaboration with local,
tribal, regional, State, or Federal emergency preparedness officials'
efforts to maintain an integrated response during a disaster or
emergency situation, including documentation of the LTC facility's
efforts to contact such officials and, when applicable, of its
participation in collaborative and cooperative planning efforts.
(b) Policies and procedures. The LTC facility must develop and
implement emergency preparedness policies and procedures, based on the
emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, and the communication
plan at paragraph (c) of this section. The policies and procedures must
be reviewed and updated at least annually. At a minimum, the policies
and procedures must address the following:
(1) The provision of subsistence needs for staff and residents,
whether they evacuate or shelter in place, include, but are not limited
to the following:
(i) Food, water, medical, and pharmaceutical supplies.
(ii) Alternate sources of energy to maintain--
(A) Temperatures to protect resident health and safety and for the
safe and sanitary storage of provisions;
(B) Emergency lighting;
(C) Fire detection, extinguishing, and alarm systems; and
(D) Sewage and waste disposal.
(2) A system to track the location of on-duty staff and sheltered
residents in the LTC facility's care during and after an emergency. If
on-duty staff and sheltered residents are relocated during the
emergency, the LTC facility must document the specific name and location
of the receiving facility or other location.
(3) Safe evacuation from the LTC facility, which includes
consideration of care and treatment needs of evacuees; staff
responsibilities; transportation; identification of evacuation
location(s); and primary and alternate means of communication with
external sources of assistance.
(4) A means to shelter in place for residents, staff, and volunteers
who remain in the LTC facility.
(5) A system of medical documentation that preserves resident
information, protects confidentiality of resident information, and
secures and maintains the availability of records.
(6) The use of volunteers in an emergency or other emergency
staffing strategies, including the process and role for integration of
State or Federally designated health care professionals to address surge
needs during an emergency.
(7) The development of arrangements with other LTC facilities and
other providers to receive residents in the event of limitations or
cessation of operations to maintain the continuity of services to LTC
residents.
(8) The role of the LTC facility under a waiver declared by the
Secretary, in accordance with section 1135 of the Act, in the provision
of care and treatment at an alternate care site identified by emergency
management officials.
(c) Communication plan. The LTC facility must develop and maintain
an emergency preparedness communication plan that complies with Federal,
State, and local laws and must be reviewed and updated at least
annually. The communication plan must include all of the following:
(1) Names and contact information for the following:
(i) Staff.
(ii) Entities providing services under arrangement.
(iii) Residents' physicians.
(iv) Other LTC facilities.
(v) Volunteers.
(2) Contact information for the following:
(i) Federal, State, tribal, regional, or local emergency
preparedness staff.
(ii) The State Licensing and Certification Agency.
(iii) The Office of the State Long-Term Care Ombudsman.
(iv) Other sources of assistance.
(3) Primary and alternate means for communicating with the
following:
[[Page 93]]
(i) LTC facility's staff.
(ii) Federal, State, tribal, regional, or local emergency management
agencies.
(4) A method for sharing information and medical documentation for
residents under the LTC facility's care, as necessary, with other health
care providers to maintain the continuity of care.
(5) A means, in the event of an evacuation, to release resident
information as permitted under 45 CFR 164.510(b)(1)(ii).
(6) A means of providing information about the general condition and
location of residents under the facility's care as permitted under 45
CFR 164.510(b)(4).
(7) A means of providing information about the LTC facility's
occupancy, needs, and its ability to provide assistance, to the
authority having jurisdiction or the Incident Command Center, or
designee.
(8) A method for sharing information from the emergency plan that
the facility has determined is appropriate with residents and their
families or representatives.
(d) Training and testing. The LTC facility must develop and maintain
an emergency preparedness training and testing program that is based on
the emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, policies and procedures
at paragraph (b) of this section, and the communication plan at
paragraph (c) of this section. The training and testing program must be
reviewed and updated at least annually.
(1) Training program. The LTC facility must do all of the following:
(i) Initial training in emergency preparedness policies and
procedures to all new and existing staff, individuals providing services
under arrangement, and volunteers, consistent with their expected roles.
(ii) Provide emergency preparedness training at least annually.
(iii) Maintain documentation of the training.
(iv) Demonstrate staff knowledge of emergency procedures.
(2) Testing. The LTC facility must conduct exercises to test the
emergency plan at least annually, including unannounced staff drills
using the emergency procedures. The LTC facility must do the following:
(i) Participate in a full-scale exercise that is community-based or
when a community-based exercise is not accessible, an individual,
facility-based. If the LTC facility experiences an actual natural or
man-made emergency that requires activation of the emergency plan, the
LTC facility is exempt from engaging in a community-based or individual,
facility-based full-scale exercise for 1 year following the onset of the
actual event.
(ii) Conduct an additional exercise that may include, but is not
limited to the following:
(A) A second full-scale exercise that is community-based or
individual, facility-based.
(B) A tabletop exercise that includes a group discussion led by a
facilitator, using a narrated, clinically-relevant emergency scenario,
and a set of problem statements, directed messages, or prepared
questions designed to challenge an emergency plan.
(iii) Analyze the LTC facility's response to and maintain
documentation of all drills, tabletop exercises, and emergency events,
and revise the LTC facility's emergency plan, as needed.
(e) Emergency and standby power systems. The LTC facility must
implement emergency and standby power systems based on the emergency
plan set forth in paragraph (a) of this section.
(1) Emergency generator location. The generator must be located in
accordance with the location requirements found in the Health Care
Facilities Code (NFPA 99 and Tentative Interim Amendments TIA 12-2, TIA
12-3, TIA 12-4, TIA 12-5, and TIA 12-6), Life Safety Code (NFPA 101 and
Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-
4), and NFPA 110, when a new structure is built or when an existing
structure or building is renovated.
(2) Emergency generator inspection and testing. The LTC facility
must implement the emergency power system inspection, testing, and
maintenance requirements found in the Health Care Facilities Code, NFPA
110, and Life Safety Code.
[[Page 94]]
(3) Emergency generator fuel. LTC facilities that maintain an onsite
fuel source to power emergency generators must have a plan for how it
will keep emergency power systems operational during the emergency,
unless it evacuates.
(f) Integrated healthcare systems. If a LTC facility is part of a
healthcare system consisting of multiple separately certified healthcare
facilities that elects to have a unified and integrated emergency
preparedness program, the LTC facility may choose to participate in the
healthcare system's coordinated emergency preparedness program. If
elected, the unified and integrated emergency preparedness program must
do all of the following:
(1) Demonstrate that each separately certified facility within the
system actively participated in the development of the unified and
integrated emergency preparedness program.
(2) Be developed and maintained in a manner that takes into account
each separately certified facility's unique circumstances, patient
populations, and services offered.
(3) Demonstrate that each separately certified facility is capable
of actively using the unified and integrated emergency preparedness
program and is in compliance with the program.
(4) Include a unified and integrated emergency plan that meets the
requirements of paragraphs (a)(2), (3), and (4) of this section. The
unified and integrated emergency plan must also be based on and
include--
(i) A documented community-based risk assessment, utilizing an all-
hazards approach.
(ii) A documented individual facility-based risk assessment for each
separately certified facility within the health system, utilizing an
all-hazards approach.
(5) Include integrated policies and procedures that meet the
requirements set forth in paragraph (b) of this section, a coordinated
communication plan and training and testing programs that meet the
requirements of paragraphs (c) and (d) of this section, respectively.
(g) The standards incorporated by reference in this section are
approved for incorporation by reference by the Director of the Office of
the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part
51. You may obtain the material from the sources listed below. You may
inspect a copy at the CMS Information Resource Center, 7500 Security
Boulevard, Baltimore, MD or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html. If any
changes in this edition of the Code are incorporated by reference, CMS
will publish a document in the Federal Register to announce the changes.
(1) National Fire Protection Association, 1 Batterymarch Park,
Quincy, MA 02169, www.nfpa.org, 1.617.770.3000.
(i) NFPA 99, Health Care Facilities Code 2012 edition, issued August
11, 2011.
(ii) Technical interim amendment (TIA) 12-2 to NFPA 99, issued
August 11, 2011.
(iii) TIA 12-3 to NFPA 99, issued August 9, 2012.
(iv) TIA 12-4 to NFPA 99, issued March 7, 2013.
(v) TIA 12-5 to NFPA 99, issued August 1, 2013.
(vi) TIA 12-6 to NFPA 99, issued March 3, 2014.
(vii) NFPA 101, Life Safety Code, 2012 edition, issued August 11,
2011.
(viii) TIA 12-1 to NFPA 101, issued August 11, 2011.
(ix) TIA 12-2 to NFPA 101, issued October 30, 2012.
(x) TIA 12-3 to NFPA 101, issued October 22, 2013.
(xi) TIA 12-4 to NFPA 101, issued October 22, 2013.
(xii) NFPA 110, Standard for Emergency and Standby Power Systems,
2010 edition, including TIAs to chapter 7, issued August 6, 2009.
(2) [Reserved]
[81 FR 64030, Sept. 16, 2016; 81 FR 80594, Nov. 16, 2016]
Sec. 483.75 Quality assurance and performance improvement.
(a) Quality assurance and performance improvement (QAPI) program.
Each LTC facility, including a facility that is
[[Page 95]]
part of a multiunit chain, must develop, implement, and maintain an
effective, comprehensive, data-driven QAPI program that focuses on
indicators of the outcomes of care and quality of life. The facility
must--
(1) Maintain documentation and demonstrate evidence of its ongoing
QAPI program that meets the requirements of this section. This may
include but is not limited to systems and reports demonstrating
systematic identification, reporting, investigation, analysis, and
prevention of adverse events; and documentation demonstrating the
development, implementation, and evaluation of corrective actions or
performance improvement activities;
(2) Present its QAPI plan to the State Survey Agency no later than 1
year after the promulgation of this regulation;
(3) Present its QAPI plan to a State Survey Agency or Federal
surveyor at each annual recertification survey and upon request during
any other survey and to CMS upon request; and
(4) Present documentation and evidence of its ongoing QAPI program's
implementation and the facility's compliance with requirements to a
State Survey Agency, Federal surveyor or CMS upon request.
(b) Program design and scope. A facility must design its QAPI
program to be ongoing, comprehensive, and to address the full range of
care and services provided by the facility. It must:
(1) Address all systems of care and management practices;
(2) Include clinical care, quality of life, and resident choice;
(3) Utilize the best available evidence to define and measure
indicators of quality and facility goals that reflect processes of care
and facility operations that have been shown to be predictive of desired
outcomes for residents of a SNF or NF.
(4) Reflect the complexities, unique care, and services that the
facility provides.
(c) Program feedback, data systems and monitoring. A facility must
establish and implement written policies and procedures for feedback,
data collections systems, and monitoring, including adverse event
monitoring. The policies and procedures must include, at a minimum, the
following:
(1) Facility maintenance of effective systems to obtain and use of
feedback and input from direct care staff, other staff, residents, and
resident representatives, including how such information will be used to
identify problems that are high risk, high volume, or problem-prone, and
opportunities for improvement.
(2) Facility maintenance of effective systems to identify, collect,
and use data and information from all departments, including but not
limited to the facility assessment required at Sec. 483.70(e) and
including how such information will be used to develop and monitor
performance indicators.
(3) Facility development, monitoring, and evaluation of performance
indicators, including the methodology and frequency for such
development, monitoring, and evaluation.
(4) Facility adverse event monitoring, including the methods by
which the facility will systematically identify, report, track,
investigate, analyze and use data and information relating to adverse
events in the facility, including how the facility will use the data to
develop activities to prevent adverse events.
(d) Program systematic analysis and systemic action. (1) The
facility must take actions aimed at performance improvement and, after
implementing those actions, measure its success, and track performance
to ensure that improvements are realized and sustained.
(2) The facility will develop and implement policies addressing:
(i) How they will use a systematic approach to determine underlying
causes of problems impacting larger systems;
(ii) How they will develop corrective actions that will be designed
to effect change at the systems level to prevent quality of care,
quality of life, or safety problems ; and
(iii) How the facility will monitor the effectiveness of its
performance improvement activities to ensure that improvements are
sustained.
(e) Program activities. (1) The facility must set priorities for its
performance improvement activities that focus on high-risk, high-volume,
or problem-prone areas; consider the incidence,
[[Page 96]]
prevalence, and severity of problems in those areas; and affect health
outcomes, resident safety, resident autonomy, resident choice, and
quality of care.
(2) Performance improvement activities must track medical errors and
adverse resident events, analyze their causes, and implement preventive
actions and mechanisms that include feedback and learning throughout the
facility.
(3) As a part of their performance improvement activities, the
facility must conduct distinct performance improvement projects. The
number and frequency of improvement projects conducted by the facility
must reflect the scope and complexity of the facility's services and
available resources, as reflected in the facility assessment required at
Sec. 483.70(e). Improvement projects must include at least annually a
project that focuses on high risk or problem-prone areas identified
through the data collection and analysis described in paragraphs (c) and
(d) of this section.
(f) Governance and leadership. The governing body and/or executive
leadership (or organized group or individual who assumes full legal
authority and responsibility for operation of the facility) is
responsible and accountable for ensuring that--
(1) An ongoing QAPI program is defined, implemented, and maintained
and addresses identified priorities.
(2) The QAPI program is sustained during transitions in leadership
and staffing;
(3) The QAPI program is adequately resourced, including ensuring
staff time, equipment, and technical training as needed;
(4) The QAPI program identifies and prioritizes problems and
opportunities that reflect organizational process, functions, and
services provided to resident based on performance indicator data, and
resident and staff input, and other information.
(5) Corrective actions address gaps in systems, and are evaluated
for effectiveness; and
(6) Clear expectations are set around safety, quality, rights,
choice, and respect.
(g) Quality assessment and assurance. (1) A facility must maintain a
quality assessment and assurance committee consisting at a minimum of:
(i) The director of nursing services;
(ii) The Medical Director or his or her designee;
(iii) At least three other members of the facility's staff, at least
one of who must be the administrator, owner, a board member or other
individual in a leadership role; and
(iv) The infection preventionist.
(2) The quality assessment and assurance committee reports to the
facility's governing body, or designated person(s) functioning as a
governing body regarding its activities, including implementation of the
QAPI program required under paragraphs (a) through (e) of this section.
The committee must:
(i) Meet at least quarterly and as needed to coordinate and evaluate
activities under the QAPI program, such as identifying issues with
respect to which quality assessment and assurance activities, including
performance improvement projects required under the QAPI program, are
necessary; and
(ii) Develop and implement appropriate plans of action to correct
identified quality deficiencies; and
(iii) Regularly review and analyze data, including data collected
under the QAPI program and data resulting from drug regimen reviews, and
act on available data to make improvements.
(h) Disclosure of information. A State or the Secretary may not
require disclosure of the records of such committee except in so far as
such disclosure is related to the compliance of such committee with the
requirements of this section.
(i) Sanctions. Good faith attempts by the committee to identify and
correct quality deficiencies will not be used as a basis for sanctions.
[81 FR 68867, Oct. 4, 2016, as amended at 82 FR 32259, July 13, 2017]
Sec. 483.80 Infection control.
The facility must establish and maintain an infection prevention and
control program designed to provide a safe, sanitary, and comfortable
environment and to help prevent the development and transmission of
communicable diseases and infections.
[[Page 97]]
(a) Infection prevention and control program. The facility must
establish an infection prevention and control program (IPCP) that must
include, at a minimum, the following elements:
(1) A system for preventing, identifying, reporting, investigating,
and controlling infections and communicable diseases for all residents,
staff, volunteers, visitors, and other individuals providing services
under a contractual arrangement based upon the facility assessment
conducted according to Sec. 483.70(e) and following accepted national
standards;
(2) Written standards, policies, and procedures for the program,
which must include, but are not limited to:
(i) A system of surveillance designed to identify possible
communicable diseases or infections before they can spread to other
persons in the facility;
(ii) When and to whom possible incidents of communicable disease or
infections should be reported;
(iii) Standard and transmission-based precautions to be followed to
prevent spread of infections;
(iv) When and how isolation should be used for a resident; including
but not limited to:
(A) The type and duration of the isolation, depending upon the
infectious agent or organism involved, and
(B) A requirement that the isolation should be the least restrictive
possible for the resident under the circumstances.
(v) The circumstances under which the facility must prohibit
employees with a communicable disease or infected skin lesions from
direct contact with residents or their food, if direct contact will
transmit the disease; and
(vi) The hand hygiene procedures to be followed by staff involved in
direct resident contact.
(3) An antibiotic stewardship program that includes antibiotic use
protocols and a system to monitor antibiotic use.
(4) A system for recording incidents identified under the facility's
IPCP and the corrective actions taken by the facility.
(b) Infection preventionist. The facility must designate one or more
individual(s) as the infection preventionist(s) (IPs) who are
responsible for the facility's IPCP. The IP must:
(1) Have primary professional training in nursing, medical
technology, microbiology, epidemiology, or other related field;
(2) Be qualified by education, training, experience or
certification;
(3) Work at least part-time at the facility; and
(4) Have completed specialized training in infection prevention and
control.
(c) IP participation on quality assessment and assurance committee.
The individual designated as the IP, or at least one of the individuals
if there is more than one IP, must be a member of the facility's quality
assessment and assurance committee and report to the committee on the
IPCP on a regular basis.
(d) Influenza and pneumococcal immunizations--(1) Influenza. The
facility must develop policies and procedures to ensure that--
(i) Before offering the influenza immunization, each resident or the
resident's representative receives education regarding the benefits and
potential side effects of the immunization;
(ii) Each resident is offered an influenza immunization October 1
through March 31 annually, unless the immunization is medically
contraindicated or the resident has already been immunized during this
time period;
(iii) The resident or the resident's representative has the
opportunity to refuse immunization; and
(iv) The resident's medical record includes documentation that
indicates, at a minimum, the following:
(A) That the resident or resident's representative was provided
education regarding the benefits and potential side effects of influenza
immunization; and
(B) That the resident either received the influenza immunization or
did not receive the influenza immunization due to medical
contraindications or refusal.
(2) Pneumococcal disease. The facility must develop policies and
procedures to ensure that--
(i) Before offering the pneumococcal immunization, each resident or
the
[[Page 98]]
resident's representative receives education regarding the benefits and
potential side effects of the immunization;
(ii) Each resident is offered a pneumococcal immunization, unless
the immunization is medically contraindicated or the resident has
already been immunized;
(iii) The resident or the resident's representative has the
opportunity to refuse immunization; and
(iv) The resident's medical record includes documentation that
indicates, at a minimum, the following:
(A) That the resident or resident's representative was provided
education regarding the benefits and potential side effects of
pneumococcal immunization; and
(B) That the resident either received the pneumococcal immunization
or did not receive the pneumococcal immunization due to medical
contraindication or refusal.
(e) Linens. Personnel must handle, store, process, and transport
linens so as to prevent the spread of infection.
(f) Annual review. The facility will conduct an annual review of its
IPCP and update their program, as necessary.
[81 FR 68868, Oct. 4, 2016]
Sec. 483.85 Compliance and ethics program.
(a) Definitions. For purposes of this section, the following
definitions apply:
Compliance and ethics program means, with respect to a facility, a
program of the operating organization that--
(1) Has been reasonably designed, implemented, and enforced so that
it is likely to be effective in preventing and detecting criminal,
civil, and administrative violations under the Act and in promoting
quality of care; and
(2) Includes, at a minimum, the required components specified in
paragraph (c) of this section.
High-level personnel means individual(s) who have substantial
control over the operating organization or who have a substantial role
in the making of policy within the operating organization.
Operating organization means the individual(s) or entity that
operates a facility.
(b) General rule. Beginning November 28, 2019, the operating
organization for each facility must have in operation a compliance and
ethics program (as defined in paragraph (a) of this section) that meets
the requirements of this section.
(c) Required components for all facilities. The operating
organization for each facility must develop, implement, and maintain an
effective compliance and ethics program that contains, at a minimum, the
following components:
(1) Established written compliance and ethics standards, policies,
and procedures to follow that are reasonably capable of reducing the
prospect of criminal, civil, and administrative violations under the Act
and promote quality of care, which include, but are not limited to, the
designation of an appropriate compliance and ethics program contact to
which individuals may report suspected violations, as well as an
alternate method of reporting suspected violations anonymously without
fear of retribution; and disciplinary standards that set out the
consequences for committing violations for the operating organization's
entire staff; individuals providing services under a contractual
arrangement; and volunteers, consistent with the volunteers' expected
roles.
(2) Assignment of specific individuals within the high-level
personnel of the operating organization with the overall responsibility
to oversee compliance with the operating organization's compliance and
ethics program's standards, policies, and procedures, such as, but not
limited to, the chief executive officer (CEO), members of the board of
directors, or directors of major divisions in the operating
organization.
(3) Sufficient resources and authority to the specific individuals
designated in paragraph (c)(2) of this section to reasonably assure
compliance with such standards, policies, and procedures.
(4) Due care not to delegate substantial discretionary authority to
individuals who the operating organization knew, or should have known
through
[[Page 99]]
the exercise of due diligence, had a propensity to engage in criminal,
civil, and administrative violations under the Social Security Act.
(5) The facility takes steps to effectively communicate the
standards, policies, and procedures in the operating organization's
compliance and ethics program to the operating organization's entire
staff; individuals providing services under a contractual arrangement;
and volunteers, consistent with the volunteers' expected roles.
Requirements include, but are not limited to, mandatory participation in
training as set forth at Sec. 483.95(f) or orientation programs, or
disseminating information that explains in a practical manner what is
required under the program.
(6) The facility takes reasonable steps to achieve compliance with
the program's standards, policies, and procedures. Such steps include,
but are not limited to, utilizing monitoring and auditing systems
reasonably designed to detect criminal, civil, and administrative
violations under the Act by any of the operating organization's staff,
individuals providing services under a contractual arrangement, or
volunteers, having in place and publicizing a reporting system whereby
any of these individuals could report violations by others anonymously
within the operating organization without fear of retribution, and
having a process for ensuring the integrity of any reported data.
(7) Consistent enforcement of the operating organization's
standards, policies, and procedures through appropriate disciplinary
mechanisms, including, as appropriate, discipline of individuals
responsible for the failure to detect and report a violation to the
compliance and ethics program contact identified in the operating
organization's compliance and ethics program.
(8) After a violation is detected, the operating organization must
ensure that all reasonable steps identified in its program are taken to
respond appropriately to the violation and to prevent further similar
violations, including any necessary modification to the operating
organization's program to prevent and detect criminal, civil, and
administrative violations under the Act.
(d) Additional required components for operating organizations with
five or more facilities. In addition to all of the other requirements in
paragraphs (a), (b), (c), and (e) of this section, operating
organizations that operate five or more facilities must also include, at
a minimum, the following components in their compliance and ethics
program:
(1) A mandatory annual training program on the operating
organization's compliance and ethics program that meets the requirements
set forth in Sec. 483.95(f).
(2) A designated compliance officer for whom the operating
organization's compliance and ethics program is a major responsibility.
This individual must report directly to the operating organization's
governing body and not be subordinate to the general counsel, chief
financial officer or chief operating officer.
(3) Designated compliance liaisons located at each of the operating
organization's facilities.
(e) Annual review. The operating organization for each facility must
review its compliance and ethics program annually and revise its program
as needed to reflect changes in all applicable laws or regulations and
within the operating organization and its facilities to improve its
performance in deterring, reducing, and detecting violations under the
Act and in promoting quality of care.
[81 FR 68869, Oct. 4, 2016, as amended at 82 FR 32259, July 13, 2017]
Sec. 483.90 Physical environment.
The facility must be designed, constructed, equipped, and maintained
to protect the health and safety of residents, personnel and the public.
(a) Life safety from fire. (1) Except as otherwise provided in this
section--
(i) The LTC facility must meet the applicable provisions and must
proceed in accordance with the Life Safety Code (NFPA 101 and Tentative
Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4.)
(ii) Notwithstanding paragraph (a)(1)(i) of this section, corridor
doors and doors to rooms containing flammable or combustible materials
must
[[Page 100]]
be provided with positive latching hardware. Roller latches are
prohibited on such doors.
(2) In consideration of a recommendation by the State survey agency
or Accrediting Organization or at the discretion of the Secretary, may
waive, for periods deemed appropriate, specific provisions of the Life
Safety Code, which would result in unreasonable hardship upon a long-
term care facility, but only if the waiver will not adversely affect the
health and safety of the patients.
(3) The provisions of the Life safety Code do not apply in a State
where CMS finds, in accordance with applicable provisions of sections
1819(d)(2)(B)(ii) and 1919(d)(2)(B)(ii) of the Act, that a fire and
safety code imposed by State law adequately protects patients, residents
and personnel in long term care facilities.
(4) A long-term care facility may install alcohol-based hand rub
dispensers in its facility if the dispensers are installed in a manner
that adequately protects against inappropriate access.
(5) A long term care facility must:
(i) Install, at least, battery-operated single station smoke alarms
in accordance with the manufacturer's recommendations in resident
sleeping rooms and common areas.
(ii) Have a program for inspection, testing, maintenance, and
battery replacement that conforms to the manufacturer's recommendations
and that verifies correct operation of the smoke alarms.
(iii) Exception:
(A) The facility has system-based smoke detectors in patient rooms
and common areas that are installed, tested, and maintained in
accordance with NFPA 72, National Fire Alarm Code, for system-based
smoke detectors; or
(B) The facility is fully sprinklered in accordance with NFPA 13,
Standard for the Installation of Sprinkler Systems.
(6) A long term care facility must:
(i) Install an approved, supervised automatic sprinkler system in
accordance with the 1999 edition of NFPA 13, Standard for the
Installation of Sprinkler Systems, as incorporated by reference,
throughout the building by August 13, 2013. The Director of the Office
of the Federal Register has approved the NFPA 13 1999 edition of the
Standard for the Installation of Sprinkler Systems, issued July 22, 1999
for incorporation by reference in accordance with 5 U.S.C. 552(a) and 1
CFR part 51. A copy of the Code is available for inspection at the CMS
Information Resource Center, 7500 Security Boulevard, Baltimore, MD or
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html. Copies may be obtained
from the National Fire Protection Association, 1 Batterymarch Park,
Quincy, MA 02269.
(ii) Test, inspect, and maintain an approved, supervised automatic
sprinkler system in accordance with the 1998 edition of NFPA 25,
Standard for the Inspection, Testing, and Maintenance of Water-Based
Fire Protection Systems, as incorporated by reference. The Director of
the Office of the Federal Register has approved the NFPA 25, Standard
for the Inspection, Testing, and Maintenance of Water-Based Fire
Protection Systems, 1998 edition, issued January 16, 1998 for
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. A copy of the Code is available for inspection at the CMS
Information Resource Center, 7500 Security Boulevard, Baltimore, MD or
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html. Copies may be obtained
from the National Fire Protection Association, 1 Batterymarch Park,
Quincy, MA 02269.
(iii) Subject to approval by CMS, a long term care facility may be
granted an extension of the sprinkler installation deadline for a time
period not to exceed 2 years from August 13, 2013, if the facility meets
all of the following conditions:
(A) It is in the process of replacing its current building, or
undergoing major modifications to improve the living conditions for
residents in all
[[Page 101]]
unsprinklered living areas that requires the movement of corridor, room,
partition, or structural walls or supports, in addition to the
installation of a sprinkler system; or, has had its planned sprinkler
installation so impaired by a disaster or emergency, as indicated by a
declaration under section 319 of the Public Health Service Act, that CMS
finds it would be impractical to meet the sprinkler installation due
date.
(B) It demonstrates that it has made the necessary financial
commitments to complete the building replacement or modification; or
pursuant to a declared disaster or emergency, CMS finds it impractical
to make reasonable and necessary financial commitments.
(C) Before applying for the deadline extension, it has submitted
plans to State and local authorities that are necessary for approval of
the replacement building or major modification that includes the
required sprinkler installation, and has received approval of the plans
from State and local authorities.
(D) It agrees to complete interim steps to improve fire safety, as
determined by CMS.
(iv) An extension granted under paragraph (a)(8)(iii) of this
section may be renewed once, for an additional period not to exceed 1
year, if the following conditions are met:
(A) CMS finds that extenuating circumstances beyond the control of
the facility will prevent full compliance with the provisions in
paragraph (a)(8)(i) of this section by the end of the first waiver
period.
(B) All other conditions of paragraph (a)(8)(iii) of this section
are met.
(7) Buildings must have an outside window or outside door in every
sleeping room, and for any building constructed after July 5, 2016 the
sill height must not exceed 36 inches above the floor. Windows in atrium
walls are considered outside windows for the purposes of this
requirement.
(8) When a sprinkler system is shut down for more than 10 hours, the
LTC facility must:
(i) Evacuate the building or portion of the building affected by the
system outage until the system is back in service, or
(ii) Establish a fire watch until the system is back in service.
(b) Standard: Building safety. Except as otherwise provided in this
section, the LTC facility must meet the applicable provisions and must
proceed in accordance with the Health Care Facilities Code (NFPA 99 and
Tentative Interim Amendments TIA 12-2, TIA 12-3, TIA 12-4, TIA 12-5 and
TIA 12-6).
(1) Chapters 7, 8, 12, and 13 of the adopted Health Care Facilities
Code do not apply to a LTC facility.
(2) If application of the Health Care Facilities Code required under
paragraph (b) of this section would result in unreasonable hardship for
the LTC facility, CMS may waive specific provisions of the Health Care
Facilities Code, but only if the waiver does not adversely affect the
health and safety of residents.
(c) Emergency power. (1) An emergency electrical power system must
supply power adequate at least for lighting all entrances and exits;
equipment to maintain the fire detection, alarm, and extinguishing
systems; and life support systems in the event the normal electrical
supply is interrupted.
(2) When life support systems are used, the facility must provide
emergency electrical power with an emergency generator (as defined in
NFPA 99, Health Care Facilities) that is located on the premises.
(d) Space and equipment. The facility must--
(1) Provide sufficient space and equipment in dining, health
services, recreation, and program areas to enable staff to provide
residents with needed services as required by these standards and as
identified in each resident's plan of care; and
(2) Maintain all essential mechanical, electrical, and patient care
equipment in safe operating condition.
(e) Resident rooms. Resident rooms must be designed and equipped for
adequate nursing care, comfort, and privacy of residents.
(1) Bedrooms must--
(i) Accommodate no more than four residents. For facilities that
receive
[[Page 102]]
approval of construction or reconstruction plans by State and local
authorities or are newly certified after November 28, 2016, bedrooms
must accommodate no more than two residents.
(ii) Measure at least 80 square feet per resident in multiple
resident bedrooms, and at least 100 square feet in single resident
rooms;
(iii) Have direct access to an exit corridor;
(iv) Be designed or equipped to assure full visual privacy for each
resident;
(v) In facilities initially certified after March 31, 1992, except
in private rooms, each bed must have ceiling suspended curtains, which
extend around the bed to provide total visual privacy in combination
with adjacent walls and curtains;
(vi) Have at least one window to the outside; and
(vii) Have a floor at or above grade level.
(2) The facility must provide each resident with--
(i) A separate bed of proper size and height for the safety and
convenience of the resident;
(ii) A clean, comfortable mattress;
(iii) Bedding appropriate to the weather and climate; and
(iv) Functional furniture appropriate to the resident's needs, and
individual closet space in the resident's bedroom with clothes racks and
shelves accessible to the resident.
(3) CMS, or in the case of a nursing facility the survey agency, may
permit variations in requirements specified in paragraphs (d)(1) (i) and
(ii) of this section relating to rooms in individual cases when the
facility demonstrates in writing that the variations--
(i) Are in accordance with the special needs of the residents; and
(ii) Will not adversely affect residents' health and safety.
(f) Bathroom facilities. Each resident room must be equipped with or
located near toilet and bathing facilities. For facilities that receive
approval of construction from State and local authorities or are newly
certified after November 28, 2016, each resident room must have its own
bathroom equipped with at least a commode and sink.
(g) Resident call system. The facility must be adequately equipped
to allow residents to call for staff assistance through a communication
system which relays the call directly to a staff member or to a
centralized staff work area from--
(1) Each resident's bedside; and
(2) Toilet and bathing facilities.
(h) Dining and resident activities. The facility must provide one or
more rooms designated for resident dining and activities. These rooms
must--
(1) Be well lighted;
(2) Be well ventilated;
(3) Be adequately furnished; and
(4) Have sufficient space to accommodate all activities.
(i) Other environmental conditions. The facility must provide a
safe, functional, sanitary, and comfortable environment for the
residents, staff and the public. The facility must--
(1) Establish procedures to ensure that water is available to
essential areas when there is a loss of normal water supply;
(2) Have adequate outside ventilation by means of windows, or
mechanical ventilation, or a combination of the two;
(3) Equip corridors with firmly secured handrails on each side; and
(4) Maintain an effective pest control program so that the facility
is free of pests and rodents.
(5) Establish policies, in accordance with applicable Federal,
State, and local laws and regulations, regarding smoking, smoking areas,
and smoking safety that also take into account non-smoking residents.
(j) The standards incorporated by reference in this section are
approved for incorporation by reference by the Director of the Office of
the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part
51. You may inspect a copy at the CMS Information Resource Center, 7500
Security Boulevard, Baltimore, MD or at the National Archives and
Records Administration (NARA). For information on the availability of
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html. If any changes in this edition of the Code are
incorporated by reference, CMS will publish
[[Page 103]]
a document in the Federal Register to announce the changes.
(1) National Fire Protection Association, 1 Batterymarch Park,
Quincy, MA 02169, www.nfpa.org, 1.617.770.3000.
(i) NFPA 99, Standards for Health Care Facilities Code of the
National Fire Protection Association 99, 2012 edition, issued August 11,
2011.
(ii) TIA 12-2 to NFPA 99, issued August 11, 2011.
(iii) TIA 12-3 to NFPA 99, issued August 9, 2012.
(iv) TIA 12-4 to NFPA 99, issued March 7, 2013.
(v) TIA 12-5 to NFPA 99, issued August 1, 2013.
(vi) TIA 12-6 to NFPA 99, issued March 3, 2014.
(vii) NFPA 101, Life Safety Code, 2012 edition, issued August 11,
2011;
(viii) TIA 12-1 to NFPA 101, issued August 11, 2011.
(ix) TIA 12-2 to NFPA 101, issued October 30, 2012.
(x) TIA 12-3 to NFPA 101, issued October 22, 2013.
(xi) TIA 12-4 to NFPA 101, issued October 22, 2013.
(2) [Reserved]
[56 FR 48876, Sept. 26, 1991, as amended at 57 FR 43925, Sept. 23, 1992;
68 FR 1386, Jan. 10, 2003; 69 FR 49268, Aug. 11, 2004; 70 FR 15238, Mar.
25, 2005; 71 FR 55340, Sept. 22, 2006; 73 FR 47091, Aug. 13, 2008; 79 FR
27155, May 12, 2014; 81 FR 26899, May 4, 2016; 81 FR 42548, June 30,
2016. Redesignated and amended at 81 FR 68861, 68870, Oct. 4, 2016; 82
FR 32259, July 13, 2017]
Sec. 483.95 Training requirements.
A facility must develop, implement, and maintain an effective
training program for all new and existing staff; individuals providing
services under a contractual arrangement; and volunteers, consistent
with their expected roles. A facility must determine the amount and
types of training necessary based on a facility assessment as specified
at Sec. 483.70(e). Training topics must include but are not limited to--
(a) Communication. A facility must include effective communications
as mandatory training for direct care staff.
(b) Resident's rights and facility responsibilities. A facility must
ensure that staff members are educated on the rights of the resident and
the responsibilities of a facility to properly care for its residents as
set forth at Sec. 483.10, respectively.
(c) Abuse, neglect, and exploitation. In addition to the freedom
from abuse, neglect, and exploitation requirements in Sec. 483.12,
facilities must also provide training to their staff that at a minimum
educates staff on--
(1) Activities that constitute abuse, neglect, exploitation, and
misappropriation of resident property as set forth at Sec. 483.12.
(2) Procedures for reporting incidents of abuse, neglect,
exploitation, or the misappropriation of resident property.
(3) Dementia management and resident abuse prevention.
(d) Quality assurance and performance improvement. A facility must
include as part of its QAPI program mandatory training that outlines and
informs staff of the elements and goals of the facility's QAPI program
as set forth at Sec. 483.75.
(e) Infection control. A facility must include as part of its
infection prevention and control program mandatory training that
includes the written standards, policies, and procedures for the program
as described at Sec. 483.80(a)(2).
(f) Compliance and ethics. The operating organization for each
facility must include as part of its compliance and ethics program, as
set forth at Sec. 483.85--
(1) An effective way to communicate that program's standards,
policies, and procedures through a training program or in another
practical manner which explains the requirements under the program.
(2) Annual training if the operating organization operates five or
more facilities.
(g) Required in-service training for nurse aides. In-service
training must--
(1) Be sufficient to ensure the continuing competence of nurse
aides, but must be no less than 12 hours per year.
(2) Include dementia management training and resident abuse
prevention training.
(3) Address areas of weakness as determined in nurse aides'
performance reviews and facility assessment at Sec. 483.70(e) and may
address the special
[[Page 104]]
needs of residents as determined by the facility staff.
(4) For nurse aides providing services to individuals with cognitive
impairments, also address the care of the cognitively impaired.
(h) Required training of feeding assistants. A facility must not use
any individual working in the facility as a paid feeding assistant
unless that individual has successfully completed a State-approved
training program for feeding assistants, as specified in Sec. 483.160.
(i) Behavioral health. A facility must provide behavioral health
training consistent with the requirements at Sec. 483.40 and as
determined by the facility assessment at Sec. 483.70(e).
[81 FR 68870, Oct. 4, 2016]
Subpart C_Preadmission Screening and Annual Review of Mentally Ill and
Mentally Retarded Individuals
Source: 57 FR 56506, Nov. 30, 1992, unless otherwise noted.
Sec. 483.100 Basis.
The requirements of Secs. 483.100 through 483.138 governing the
State's responsibility for preadmission screening and annual resident
review (PASARR) of individuals with mental illness and intellectual
disability are based on section 1919(e)(7) of the Act.
Sec. 483.102 Applicability and definitions.
(a) This subpart applies to the screening or reviewing of all
individuals with mental illness or intellectual disability who apply to
or reside in Medicaid certified NFs regardless of the source of payment
for the NF services, and regardless of the individual's or resident's
known diagnoses.
(b) Definitions. As used in this subpart--
(1) An individual is considered to have a serious mental illness
(MI) if the individual meets the following requirements on diagnosis,
level of impairment and duration of illness:
(i) Diagnosis. The individual has a major mental disorder
diagnosable under the Diagnostic and Statistical Manual of Mental
Disorders, 3rd edition, revised in 1987.
Incorporation of the 1987 edition of the Diagnostic and Statistical
Manual of Mental Disorders, 3rd edition, was approved by the Director of
the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part
51 that govern the use of incorporation by reference. \1\
---------------------------------------------------------------------------
\1\ The Diagnostic and Statistical Manual of Mental Disorders is
available for inspection at the Centers for Medicare & Medicaid
Services, room 132, East High Rise Building, 6325 Security Boulevard,
Baltimore, Maryland, or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html. Copies
may be obtained from the American Psychiatric Association, Division of
Publications and Marketing, 1400 K Street, NW., Washington, DC 20005.
---------------------------------------------------------------------------
This mental disorder is--
(A) A schizophrenic, mood, paranoid, panic or other severe anxiety
disorder; somatoform disorder; personality disorder; other psychotic
disorder; or another mental disorder that may lead to a chronic
disability; but
(B) Not a primary diagnosis of dementia, including Alzheimer's
disease or a related disorder, or a non-primary diagnosis of dementia
unless the primary diagnosis is a major mental disorder as defined in
paragraph (b)(1)(i)(A) of this section.
(ii) Level of impairment. The disorder results in functional
limitations in major life activities within the past 3 to 6 months that
would be appropriate for the individual's developmental stage. An
individual typically has at least one of the following characteristics
on a continuing or intermittent basis:
(A) Interpersonal functioning. The individual has serious difficulty
interacting appropriately and communicating effectively with other
persons, has a possible history of altercations, evictions, firing, fear
of strangers, avoidance of interpersonal relationships and social
isolation;
(B) Concentration, persistence, and pace. The individual has serious
difficulty in sustaining focused attention for a long enough period to
permit the completion of tasks commonly found in work settings or in
work-like structured activities occurring in school or
[[Page 105]]
home settings, manifests difficulties in concentration, inability to
complete simple tasks within an established time period, makes frequent
errors, or requires assistance in the completion of these tasks; and
(C) Adaptation to change. The individual has serious difficulty in
adapting to typical changes in circumstances associated with work,
school, family, or social interaction, manifests agitation, exacerbated
signs and symptoms associated with the illness, or withdrawal from the
situation, or requires intervention by the mental health or judicial
system.
(iii) Recent treatment. The treatment history indicates that the
individual has experienced at least one of the following:
(A) Psychiatric treatment more intensive than outpatient care more
than once in the past 2 years (e.g., partial hospitalization or
inpatient hospitalization); or
(B) Within the last 2 years, due to the mental disorder, experienced
an episode of significant disruption to the normal living situation, for
which supportive services were required to maintain functioning at home,
or in a residential treatment environment, or which resulted in
intervention by housing or law enforcement officials.
(2) An individual is considered to have dementia if he or she has a
primary diagnosis of dementia, as described in the Diagnostic and
Statistical Manual of Mental Disorders, 3rd edition, revised in 1987, or
a non-primary diagnosis of dementia unless the primary diagnosis is a
major mental disorder as defined in paragraph (b)(1)(i)(A) of this
section.
(3) An individual is considered to have intellectual disability
(IID) if he or she has--
(i) A level of retardation (mild, moderate, severe or profound)
described in the American Association on Intellectual Disability's
Manual on Classification in Intellectual Disability (1983).
Incorporation by reference of the 1983 edition of the American
Association on Intellectual Disability's Manual on Classification in
Intellectual Disability was approved by the Director of the Federal
Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 that
govern the use of incorporations by reference;\2\ or
---------------------------------------------------------------------------
\2\ The American Association on Intellectual Disability's Manual on
Classification in Intellectual Disability is available for inspection at
the Centers for Medicare & Medicaid Services, Room 132, East High Rise
Building, 6325 Security Boulevard, Baltimore, Maryland, or at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call 202-741-6030, or go to:
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html. Copies may be obtained from the American Association
on Intellectual Disability, 1719 Kalorama Rd., NW., Washington, DC
20009.
---------------------------------------------------------------------------
(ii) A related condition as defined by Sec. 435.1010 of this
chapter.
[57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr. 28, 1993; 71 FR 39229,
July 12, 2006]
Sec. 483.104 State plan requirement.
As a condition of approval of the State plan, the State must operate
a preadmission screening and annual resident review program that meets
the requirements of Secs. 483.100 through 438.138.
Sec. 483.106 Basic rule.
(a) Requirement. The State PASARR program must require--(1)
Preadmission screening of all individuals with mental illness or
intellectual disability who apply as new admissions to Medicaid NFs on
or after January 1, 1989;
(2) Initial review, by April 1, 1990, of all current residents with
intellectual disability or mental illness who entered Medicaid NFs prior
to January 1, 1989; and
(3) At least annual review, as of April 1, 1990, of all residents
with mental illness or intellectual disability, regardless of whether
they were first screened under the preadmission screening or annual
resident review requirements.
(b) Admissions, readmissions and interfacility transfers--(1) New
admission. An individual is a new admission if he or she is admitted to
any NF for the first time or does not qualify as a readmission. With the
exception of certain hospital discharges described in paragraph (b)(2)
of this section, new admissions are subject to preadmission screening.
[[Page 106]]
(2) Exempted hospital discharge. (i) An exempted hospital discharge
means an individual--
(A) Who is admitted to any NF directly from a hospital after
receiving acute inpatient care at the hospital;
(B) Who requires NF services for the condition for which he or she
received care in the hospital; and
(C) Whose attending physician has certified before admission to the
facility that the individual is likely to require less than 30 days
nursing facility services.
(ii) If an individual who enters a NF as an exempted hospital
discharge is later found to require more than 30 days of NF care, the
State mental health or intellectual disability authority must conduct an
annual resident review within 40 calendar days of admission.
(3) Readmissions. An individual is a readmission if he or she was
readmitted to a facility from a hospital to which he or she was
transferred for the purpose of receiving care. Readmissions are subject
to annual resident review rather than preadmission screening.
(4) Interfacility transfers--(i) An interfacility transfer occurs
when an individual is transferred from one NF to another NF, with or
without an intervening hospital stay. Interfacility transfers are
subject to annual resident review rather than preadmission screening.
(ii) In cases of transfer of a resident with MI or IID from a NF to
a hospital or to another NF, the transferring NF is responsible for
ensuring that copies of the resident's most recent PASARR and resident
assessment reports accompany the transferring resident.
(c) Purpose. The preadmission screening and annual resident review
process must result in determinations based on a physical and mental
evaluation of each individual with mental illness or intellectual
disability, that are described in Secs. 483.112 and 483.114.
(d) Responsibility for evaluations and determinations. The PASARR
determinations of whether an individual requires the level of services
provided by a NF and whether specialized services are needed--
(1) For individuals with mental illness, must be made by the State
mental health authority and be based on an independent physical and
mental evaluation performed by a person or entity other than the State
mental health authority; and
(2) For individuals with intellectual disability, must be made by
the State intellectual disability or developmental disabilities
authority.
(e) Delegation of responsibility--(1) The State mental health and
intellectual disability authorities may delegate by subcontract or
otherwise the evaluation and determination functions for which they are
responsible to another entity only if--
(i) The State mental health and intellectual disability authorities
retain ultimate control and responsibility for the performance of their
statutory obligations;
(ii) The two determinations as to the need for NF services and for
specialized services are made, based on a consistent analysis of the
data; and
(iii) The entity to which the delegation is made is not a NF or an
entity that has a direct or indirect affiliation or relationship with a
NF.
(2) The State intellectual disability authority has responsibility
for both the evaluation and determination functions for individuals with
IID whereas the State mental health authority has responsibility only
for the determination function.
(3) The evaluation of individuals with MI cannot be delegated by the
State mental health authority because it does not have responsibility
for this function. The evaluation function must be performed by a person
or entity other than the State mental health authority. In designating
an independent person or entity to perform MI evaluations, the State
must not use a NF or an entity that has a direct or indirect affiliation
or relationship with a NF.
[57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr. 28, 1993]
Sec. 483.108 Relationship of PASARR to other Medicaid processes.
(a) PASARR determinations made by the State mental health or
intellectual
[[Page 107]]
disability authorities cannot be countermanded by the State Medicaid
agency, either in the claims process or through other utilization
control/review processes or by the State survey and certification
agency. Only appeals determinations made through the system specified in
subpart E of this part may overturn a PASARR determination made by the
State mental health or intellectual disability authorities.
(b) In making their determinations, however, the State mental health
and intellectual disability authorities must not use criteria relating
to the need for NF care or specialized services that are inconsistent
with this regulation and any supplementary criteria adopted by the State
Medicaid agency under its approved State plan.
(c) To the maximum extent practicable, in order to avoid duplicative
testing and effort, the PASARR must be coordinated with the routine
resident assessments required by Sec. 483.20(b).
Sec. 483.110 Out-of-State arrangements.
(a) Basic rule. The State in which the individual is a State
resident (or would be a State resident at the time he or she becomes
eligible for Medicaid), as defined in Sec. 435.403 of this chapter, must
pay for the PASARR and make the required determinations, in accordance
with Sec. 431.52(b).
(b) Agreements. A State may include arrangements for PASARR in its
provider agreements with out-of-State facilities or reciprocal
interstate agreements.
[57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr. 28, 1993]
Sec. 483.112 Preadmission screening of applicants for admission
to NFs.
(a) Determination of need for NF services. For each NF applicant
with MI or IID, the State mental health or intellectual disability
authority (as appropriate) must determine, in accordance with
Sec. 483.130, whether, because of the resident's physical and mental
condition, the individual requires the level of services provided by a
NF.
(b) Determination of need for specialized services. If the
individual with mental illness or intellectual disability is determined
to require a NF level of care, the State mental health or intellectual
disability authority (as appropriate) must also determine, in accordance
with Sec. 483.130, whether the individual requires specialized services
for the mental illness or intellectual disability, as defined in
Sec. 483.120.
(c) Timeliness--(1) Except as specified in paragraph (c)(4) of this
section, a preadmission screening determination must be made in writing
within an annual average of 7 to 9 working days of referral of the
individual with MI or IID by whatever agent performs the Level I
identification, under Sec. 483.128(a) of this part, to the State mental
health or intellectual disability authority for screening. (See
Sec. 483.128(a) for discussion of Level I evaluation.)
(2) The State may convey determinations verbally to nursing
facilities and the individual and confirm them in writing.
(3) The State may compute separate annual averages for the mentally
ill and individuals with intellectual disabilities/developmentally
disabled populations.
(4) The Secretary may grant an exception to the timeliness standard
in paragraph (c)(1) of this section when the State--
(i) Exceeds the annual average; and
(ii) Provides justification satisfactory to the Secretary that a
longer time period was necessary.
Sec. 483.114 Annual review of NF residents.
(a) Individuals with mental illness. For each resident of a NF who
has mental illness, the State mental health authority must determine in
accordance with Sec. 483.130 whether, because of the resident's physical
and mental condition, the resident requires--
(1) The level of services provided by--
(i) A NF;
(ii) An inpatient psychiatric hospital for individuals under age 21,
as described in section 1905(h) of the Act; or
(iii) An institution for mental diseases providing medical
assistance to individuals age 65 or older; and
(2) Specialized services for mental illness, as defined in
Sec. 483.120.
(b) Individuals with intellectual disability. For each resident of a
NF who has intellectual disability, the State
[[Page 108]]
intellectual disability or developmental disability authority must
determine in accordance with Sec. 483.130 whether, because of his or her
physical or mental condition, the resident requires--
(1) The level of services provided by a NF or an intermediate care
facility for individuals with intellectual disabilities; and
(2) Specialized services for intellectual disability as defined in
Sec. 483.120.
(c) Frequency of review--(1) A review and determination must be
conducted for each resident of a Medicaid NF who has mental illness or
intellectual disability not less often than annually.
(2) ``Annually'' is defined as occurring within every fourth quarter
after the previous preadmission screen or annual resident review.
(d) April 1, 1990 deadline for initial reviews. The first set of
annual reviews on residents who entered the NF prior to January 1, 1989,
must be completed by April 1, 1990.
Sec. 483.116 Residents and applicants determined to require NF level
of services.
(a) Individuals needing NF services. If the State mental health or
intellectual disability authority determines that a resident or
applicant for admission to a NF requires a NF level of services, the NF
may admit or retain the individual.
(b) Individuals needing NF services and specialized services. If the
State mental health or intellectual disability authority determines that
a resident or applicant for admission requires both a NF level of
services and specialized services for the mental illness or intellectual
disability--
(1) The NF may admit or retain the individual; and
(2) The State must provide or arrange for the provision of the
specialized services needed by the individual while he or she resides in
the NF.
Sec. 483.118 Residents and applicants determined not to require NF
level of services.
(a) Applicants who do not require NF services. If the State mental
health or intellectual disability authority determines that an applicant
for admission to a NF does not require NF services, the applicant cannot
be admitted. NF services are not a covered Medicaid service for that
individual, and further screening is not required.
(b) Residents who require neither NF services nor specialized
services for MI or IID. If the State mental health or intellectual
disability authority determines that a resident requires neither the
level of services provided by a NF nor specialized services for MI or
IID, regardless of the length of stay in the facility, the State must--
(1) Arrange for the safe and orderly discharge of the resident from
the facility in accordance with Sec. 483.15(b); and
(2) Prepare and orient the resident for discharge.
(c) Residents who do not require NF services but require specialized
services for MI or IID--(1) Long term residents. Except as otherwise may
be provided in an alternative disposition plan adopted under section
1919(e)(7)(E) of the Act, for any resident who has continuously resided
in a NF for at least 30 months before the date of the determination, and
who requires only specialized services as defined in Sec. 483.120, the
State must, in consultation with the resident's family or legal
representative and caregivers--
(i) Offer the resident the choice of remaining in the facility or of
receiving services in an alternative appropriate setting;
(ii) Inform the resident of the institutional and noninstitutional
alternatives covered under the State Medicaid plan for the resident;
(iii) Clarify the effect on eligibility for Medicaid services under
the State plan if the resident chooses to leave the facility, including
its effect on readmission to the facility; and
(iv) Regardless of the resident's choice, provide for, or arrange
for the provision of specialized services for the mental illness or
intellectual disability.
(2) Short term residents. Except as otherwise may be provided in an
alternative disposition plan adopted under section 1919(e)(7)(E) of the
Act, for any resident who requires only specialized services, as defined
in Sec. 483.120, and who has not continuously resided in a NF for at
least 30 months before the date of the determination, the State must,
[[Page 109]]
in consultation with the resident's family or legal representative and
caregivers--
(i) Arrange for the safe and orderly discharge of the resident from
the facility in accordance with Sec. 483.15(b);
(ii) Prepare and orient the resident for discharge; and
(iii) Provide for, or arrange for the provision of, specialized
services for the mental illness or intellectual disability.
(3) For the purpose of establishing length of stay in a NF, the 30
months of continuous residence in a NF or longer--
(i) Is calculated back from the date of the first annual resident
review determination which finds that the individual is not in need of
NF level of services;
(ii) May include temporary absences for hospitalization or
therapeutic leave; and
(iii) May consist of consecutive residences in more than one NF.
[57 FR 56506, Nov. 30, 1992, as amended at 81 FR 68871, Oct. 4, 2016]
Sec. 483.120 Specialized services.
(a) Definition--(1) For mental illness, specialized services means
the services specified by the State which, combined with services
provided by the NF, results in the continuous and aggressive
implementation of an individualized plan of care that--
(i) Is developed and supervised by an interdisciplinary team, which
includes a physician, qualified mental health professionals and, as
appropriate, other professionals.
(ii) Prescribes specific therapies and activities for the treatment
of persons experiencing an acute episode of serious mental illness,
which necessitates supervision by trained mental health personnel; and
(iii) Is directed toward diagnosing and reducing the resident's
behavioral symptoms that necessitated institutionalization, improving
his or her level of independent functioning, and achieving a functioning
level that permits reduction in the intensity of mental health services
to below the level of specialized services at the earliest possible
time.
(2) For intellectual disability, specialized services means the
services specified by the State which, combined with services provided
by the NF or other service providers, results in treatment which meets
the requirements of Sec. 483.440(a)(1).
(b) Who must receive specialized services. The State must provide or
arrange for the provision of specialized services, in accordance with
this subpart, to all NF residents with MI or IID whose needs are such
that continuous supervision, treatment and training by qualified mental
health or intellectual disability personnel is necessary, as identified
by the screening provided in Sec. 483.130 or Secs. 483.134 and 483.136.
(c) Services of lesser intensity than specialized services. The NF
must provide mental health or intellectual disability services which are
of a lesser intensity than specialized services to all residents who
need such services.
Sec. 483.122 FFP for NF services.
(a) Basic rule. Except as otherwise may be provided in an
alternative disposition plan adopted under section 1919(e)(7)(E) of the
Act, FFP is available in State expenditures for NF services provided to
a Medicaid eligible individual subject to the requirements of this part
only if the individual has been determined--
(1) To need NF care under Sec. 483.116(a) or
(2) Not to need NF services but to need specialized services, meets
the requirements of Sec. 483.118(c)(1), and elects to stay in the NF.
(b) FFP for late reviews. When a preadmission screening has not been
performed prior to admission or an annual review is not performed
timely, in accordance with Sec. 483.114(c), but either is performed at a
later date, FFP is available only for services furnished after the
screening or review has been performed, subject to the provisions of
paragraph (a) of this section.
Sec. 483.124 FFP for specialized services.
FFP is not available for specialized services furnished to NF
residents as NF services.
[[Page 110]]
Sec. 483.126 Appropriate placement.
Placement of an individual with MI or IID in a NF may be considered
appropriate only when the individual's needs are such that he or she
meets the minimum standards for admission and the individual's needs for
treatment do not exceed the level of services which can be delivered in
the NF to which the individual is admitted either through NF services
alone or, where necessary, through NF services supplemented by
specialized services provided by or arranged for by the State.
Sec. 483.128 PASARR evaluation criteria.
(a) Level I: Identification of individuals with MI or IID. The
State's PASARR program must identify all individuals who are suspected
of having MI or IID as defined in Sec. 483.102. This identification
function is termed Level I. Level II is the function of evaluating and
determining whether NF services and specialized services are needed. The
State's performance of the Level I identification function must provide
at least, in the case of first time identifications, for the issuance of
written notice to the individual or resident and his or her legal
representative that the individual or resident is suspected of having MI
or IID and is being referred to the State mental health or intellectual
disability authority for Level II screening.
(b) Adaptation to culture, language, ethnic origin. Evaluations
performed under PASARR and PASARR notices must be adapted to the
cultural background, language, ethnic origin and means of communication
used by the individual being evaluated.
(c) Participation by individual and family. PASARR evaluations must
involve--
(1) The individual being evaluated;
(2) The individual's legal representative, if one has been
designated under State law; and
(3) The individual's family if--
(i) Available; and
(ii) The individual or the legal representative agrees to family
participation.
(d) Interdisciplinary coordination. When parts of a PASARR
evaluation are performed by more than one evaluator, the State must
ensure that there is interdisciplinary coordination among the
evaluators.
(e) The State's PASARR program must use at least the evaluative
criteria of Sec. 483.130 (if one or both determinations can easily be
made categorically as described in Sec. 483.130) or of Secs. 483.132 and
483.134 or Sec. 483.136 (or, in the case of individuals with both MI and
IID, Secs. 483.132, 483.134 and 483.136 if a more extensive
individualized evaluation is required).
(f) Data. In the case of individualized evaluations, information
that is necessary for determining whether it is appropriate for the
individual with MI or IID to be placed in an NF or in another
appropriate setting should be gathered throughout all applicable
portions of the PASARR evaluation (Secs. 483.132 and 483.134 and/or
Sec. 483.136). The two determinations relating to the need for NF level
of care and specialized services are interrelated and must be based upon
a comprehensive analysis of all data concerning the individual.
(g) Preexisting data. Evaluators may use relevant evaluative data,
obtained prior to initiation of preadmission screening or annual
resident review, if the data are considered valid and accurate and
reflect the current functional status of the individual. However, in the
case of individualized evaluations, to supplement and verify the
currency and accuracy of existing data, the State's PASARR program may
need to gather additional information necessary to assess proper
placement and treatment.
(h) Findings. For both categorical and individualized
determinations, findings of the evaluation must correspond to the
person's current functional status as documented in medical and social
history records.
(i) Evaluation report: Individualized determinations. For
individualized PASARR determinations, findings must be issued in the
form of a written evaluative report which--
(1) Identifies the name and professional title of person(s) who
performed the evaluation(s) and the date on which each portion of the
evaluation was administered;
(2) Provides a summary of the medical and social history, including
the
[[Page 111]]
positive traits or developmental strengths and weaknesses or
developmental needs of the evaluated individual;
(3) If NF services are recommended, identifies the specific services
which are required to meet the evaluated individual's needs, including
services required in paragraph (i)(5) of this section;
(4) If specialized services are not recommended, identifies any
specific intellectual disability or mental health services which are of
a lesser intensity than specialized services that are required to meet
the evaluated individual's needs;
(5) If specialized services are recommended, identifies the specific
intellectual disability or mental health services required to meet the
evaluated individual's needs; and
(6) Includes the bases for the report's conclusions.
(j) Evaluation report: Categorical determinations. For categorical
PASARR determinations, findings must be issued in the form of an
abbreviated written evaluative report which--
(1) Identifies the name and professional title of the person
applying the categorical determination and the data on which the
application was made;
(2) Explains the categorical determination(s) that has (have) been
made and, if only one of the two required determinations can be made
categorically, describes the nature of any further screening which is
required;
(3) Identifies, to the extent possible, based on the available data,
NF services, including any mental health or specialized psychiatric
rehabilitative services, that may be needed; and
(4) Includes the bases for the report's conclusions.
(k) Interpretation of findings to individual. For both categorical
and individualized determinations, findings of the evaluation must be
interpreted and explained to the individual and, where applicable, to a
legal representative designated under State law.
(l) Evaluation report. The evaluator must send a copy of the
evaluation report to the--
(1) Individual or resident and his or her legal representative;
(2) Appropriate State authority in sufficient time for the State
authorities to meet the times identified in Sec. 483.112(c) for PASs and
Sec. 483.114(c) for ARRs;
(3) Admitting or retaining NF;
(4) Individual's attending physician; and
(5) The discharging hospital if the individual is seeking NF
admission from a hospital.
(m) The evaluation may be terminated if the evaluator finds at any
time during the evaluation that the individual being evaluated--
(1) Does not have MI or IID; or
(2) Has--
(i) A primary diagnosis of dementia (including Alzheimer's Disease
or a related disorder); or
(ii) A non-primary diagnosis of dementia without a primary diagnosis
that is a serious mental illness, and does not have a diagnosis of IID
or a related condition.
[57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr. 28, 1993]
Sec. 483.130 PASARR determination criteria.
(a) Basis for determinations. Determinations made by the State
mental health or intellectual disability authority as to whether NF
level of services and specialized services are needed must be based on
an evaluation of data concerning the individual, as specified in
paragraph (b) of this section.
(b) Types of determinations. Determinations may be--
(1) Advance group determinations, in accordance with this section,
by category that take into account that certain diagnoses, levels of
severity of illness, or need for a particular service clearly indicate
that admission to or residence in a NF is normally needed, or that the
provision of specialized services is not normally needed; or
(2) Individualized determinations based on more extensive
individualized evaluations as required in Sec. 483.132, Sec. 483.134, or
Sec. 483.136 (or, in the case of an individual having both IID and MI,
Secs. 483.134 and 483.136).
(c) Group determinations by category. Advance group determinations
by category developed by the State mental
[[Page 112]]
health or intellectual disability authorities may be made applicable to
individuals by the NF or other evaluator following Level I review only
if existing data on the individual appear to be current and accurate and
are sufficient to allow the evaluator readily to determine that the
individual fits into the category established by the State authorities
(see Sec. 483.132(c)). Sources of existing data on the individual that
could form the basis for applying a categorical determination by the
State authorities would be hospital records, physician's evaluations,
election of hospice status, records of community mental health centers
or community intellectual disability or developmental disability
providers.
(d) Examples of categories. Examples of categories for which the
State mental health or intellectual disability authority may make an
advance group determination that NF services are needed are--
(1) Convalescent care from an acute physical illness which--
(i) Required hospitalization; and
(ii) Does not meet all the criteria for an exempt hospital
discharge, which is not subject to preadmission screening, as specified
in Sec. 483.106(b)(2).
(2) Terminal illness, as defined for hospice purposes in Sec. 418.3
of this chapter;
(3) Severe physical illnesses such as coma, ventilator dependence,
functioning at a brain stem level, or diagnoses such as chronic
obstructive pulmonary disease, Parkinson's disease, Huntington's
disease, amyotrophic lateral sclerosis, and congestive heart failure
which result in a level of impairment so severe that the individual
could not be expected to benefit from specialized services;
(4) Provisional admissions pending further assessment in cases of
delirium where an accurate diagnosis cannot be made until the delirium
clears;
(5) Provisional admissions pending further assessment in emergency
situations requiring protective services, with placement in a nursing
facility not to exceed 7 days; and
(6) Very brief and finite stays of up to a fixed number of days to
provide respite to in-home caregivers to whom the individual with MI or
IID is expected to return following the brief NF stay.
(e) Time limits. The State may specify time limits for categorical
determinations that NF services are needed and in the case of paragraphs
(d)(4), (5) and (6) of this section, must specify a time limit which is
appropriate for provisional admissions pending further assessment and
for emergency situations and respite care. If an individual is later
determined to need a longer stay than the State's limit allows, the
individual must be subjected to an annual resident review before
continuation of the stay may be permitted and payment made for days of
NF care beyond the State's time limit.
(f) The State mental health and intellectual disability authorities
may make categorical determinations that specialized services are not
needed in the provisional, emergency and respite admission situations
identified in Sec. 483.130(d)(4)-(6). In all other cases, except for
Sec. 483.130(h), a determination that specialized services are not
needed must be based on a more extensive individualized evaluation under
Sec. 483.134 or Sec. 483.136.
(g) Categorical determinations: No positive specialized treatment
determinations. The State mental health and intellectual disability
authorities must not make categorical determinations that specialized
services are needed. Such a determination must be based on a more
extensive individualized evaluation under Sec. 483.134 or Sec. 483.136
to determine the exact nature of the specialized services that are
needed.
(h) Categorical determinations: Dementia and IID. The State
intellectual disability authority may make categorical determinations
that individuals with dementia, which exists in combination with
intellectual disability or a related condition, do not need specialized
services.
(i) If a State mental health or intellectual disability authority
determines NF needs by category, it may not waive the specialized
services determination. The appropriate State authority must also
determine whether specialized services are needed either by category (if
permitted) or by individualized evaluations, as specified in
Sec. 483.134 or Sec. 483.136.
[[Page 113]]
(j) Recording determinations. All determinations made by the State
mental health and intellectual disability authority, regardless of how
they are arrived at, must be recorded in the individual's record.
(k) Notice of determination. The State mental health or intellectual
disability authority must notify in writing the following entities of a
determination made under this subpart:
(1) The evaluated individual and his or her legal representative;
(2) The admitting or retaining NF;
(3) The individual or resident's attending physician; and
(4) The discharging hospital, unless the individual is exempt from
preadmission screening as provided for at Sec. 483.106(b)(2).
(l) Contents of notice. Each notice of the determination made by the
State mental health or intellectual disability authority must include--
(1) Whether a NF level of services is needed;
(2) Whether specialized services are needed;
(3) The placement options that are available to the individual
consistent with these determinations; and
(4) The rights of the individual to appeal the determination under
subpart E of this part.
(m) Placement options. Except as otherwise may be provided in an
alternative disposition plan adopted under section 1919(e)(7)(E) of the
Act, the placement options and the required State actions are as
follows:
(1) Can be admitted to a NF. Any applicant for admission to a NF who
has MI or IID and who requires the level of services provided by a NF,
regardless of whether specialized services are also needed, may be
admitted to a NF, if the placement is appropriate, as determined in
Sec. 483.126. If specialized services are also needed, the State is
responsible for providing or arranging for the provision of the
specialized services.
(2) Cannot be admitted to a NF. Any applicant for admission to a NF
who has MI or IID and who does not require the level of services
provided by a NF, regardless of whether specialized services are also
needed, is inappropriate for NF placement and must not be admitted.
(3) Can be considered appropriate for continued placement in a NF.
Any NF resident with MI or IID who requires the level of services
provided by a NF, regardless of the length of his or her stay or the
need for specialized services, can continue to reside in the NF, if the
placement is appropriate, as determined in Sec. 483.126.
(4) May choose to remain in the NF even though the placement would
otherwise be inappropriate. Any NF resident with MI or IID who does not
require the level of services provided by a NF but does require
specialized services and who has continuously resided in a NF for at
least 30 consecutive months before the date of determination may choose
to continue to reside in the facility or to receive covered services in
an alternative appropriate institutional or noninstitutional setting.
Wherever the resident chooses to reside, the State must meet his or her
specialized services needs. The determination notice must provide
information concerning how, when, and by whom the various placement
options available to the resident will be fully explained to the
resident.
(5) Cannot be considered appropriate for continued placement in a NF
and must be discharged (short-term residents). Any NF resident with MI
or IID who does not require the level of services provided by a NF but
does require specialized services and who has resided in a NF for less
than 30 consecutive months must be discharged in accordance with
Sec. 483.15(b) to an appropriate setting where the State must provide
specialized services. The determination notice must provide information
on how, when, and by whom the resident will be advised of discharge
arrangements and of his/her appeal rights under both PASARR and
discharge provisions.
(6) Cannot be considered appropriate for continued placement in a NF
and must be discharged (short or long-term residents). Any NF resident
with MI or IID who does not require the level of services provided by a
NF and does not require specialized services regardless of his or her
length of stay, must be discharged
[[Page 114]]
in accordance with Sec. 483.15(b). The determination notice must provide
information on how, when, and by whom the resident will be advised of
discharge arrangements and of his or her appeal rights under both PASARR
and discharge provisions.
(n) Specialized services needed in a NF. If a determination is made
to admit or allow to remain in a NF any individual who requires
specialized services, the determination must be supported by assurances
that the specialized services that are needed can and will be provided
or arranged for by the State while the individual resides in the NF.
(o) Record retention. The State PASARR system must maintain records
of evaluations and determinations, regardless of whether they are
performed categorically or individually, in order to support its
determinations and actions and to protect the appeal rights of
individuals subjected to PASARR; and
(p) Tracking system. The State PASARR system must establish and
maintain a tracking system for all individuals with MI or IID in NFs to
ensure that appeals and future reviews are performed in accordance with
this subpart and subpart E.
[57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr. 28, 1993, as amended at
81 FR 68871, Oct. 4, 2016]
Sec. 483.132 Evaluating the need for NF services and NF level of care
(PASARR/NF).
(a) Basic rule. For each applicant for admission to a NF and each NF
resident who has MI or IID, the evaluator must assess whether--
(1) The individual's total needs are such that his or her needs can
be met in an appropriate community setting;
(2) The individual's total needs are such that they can be met only
on an inpatient basis, which may include the option of placement in a
home and community-based services waiver program, but for which the
inpatient care would be required;
(3) If inpatient care is appropriate and desired, the NF is an
appropriate institutional setting for meeting those needs in accordance
with Sec. 483.126; or
(4) If the inpatient care is appropriate and desired but the NF is
not the appropriate setting for meeting the individual's needs in
accordance with Sec. 483.126, another setting such as an ICF/IID
(including small, community-based facilities), an IMD providing services
to individuals aged 65 or older, or a psychiatric hospital is an
appropriate institutional setting for meeting those needs.
(b) Determining appropriate placement. In determining appropriate
placement, the evaluator must prioritize the physical and mental needs
of the individual being evaluated, taking into account the severity of
each condition.
(c) Data. At a minimum, the data relied on to make a determination
must include:
(1) Evaluation of physical status (for example, diagnoses, date of
onset, medical history, and prognosis);
(2) Evaluation of mental status (for example, diagnoses, date of
onset, medical history, likelihood that the individual may be a danger
to himself/herself or others); and
(3) Functional assessment (activities of daily living).
(d) Based on the data compiled in Sec. 483.132 and, as appropriate,
in Secs. 483.134 and 483.136, the State mental health or intellectual
disability authority must determine whether an NF level of services is
needed.
Sec. 483.134 Evaluating whether an individual with mental illness
requires specialized services (PASARR/MI).
(a) Purpose. The purpose of this section is to identify the minimum
data needs and process requirements for the State mental health
authority, which is responsible for determining whether or not the
applicant or resident with MI, as defined in Sec. 483.102(b)(1) of this
part, needs a specialized services program for mental illness as defined
in Sec. 483.120.
(b) Data. Minimum data collected must include--(1) A comprehensive
history and physical examination of the person. The following areas must
be included (if not previously addressed):
(i) Complete medical history;
(ii) Review of all body systems;
(iii) Specific evaluation of the person's neurological system in the
areas
[[Page 115]]
of motor functioning, sensory functioning, gait, deep tendon reflexes,
cranial nerves, and abnormal reflexes; and
(iv) In case of abnormal findings which are the basis for an NF
placement, additional evaluations conducted by appropriate specialists.
(2) A comprehensive drug history including current or immediate past
use of medications that could mask symptoms or mimic mental illness.
(3) A psychosocial evaluation of the person, including current
living arrangements and medical and support systems.
(4) A comprehensive psychiatric evaluation including a complete
psychiatric history, evaluation of intellectual functioning, memory
functioning, and orientation, description of current attitudes and overt
behaviors, affect, suicidal or homicidal ideation, paranoia, and degree
of reality testing (presence and content of delusions) and
hallucinations.
(5) A functional assessment of the individual's ability to engage in
activities of daily living and the level of support that would be needed
to assist the individual to perform these activities while living in the
community. The assessment must determine whether this level of support
can be provided to the individual in an alternative community setting or
whether the level of support needed is such that NF placement is
required.
(6) The functional assessment must address the following areas:
Self-monitoring of health status, self-administering and scheduling of
medical treatment, including medication compliance, or both, self-
monitoring of nutritional status, handling money, dressing
appropriately, and grooming.
(c) Personnel requirements. (1) If the history and physical
examination are not performed by a physician, then a physician must
review and concur with the conclusions.
(2) The State may designate the mental health professionals who are
qualified--
(i) To perform the evaluations required under paragraph (b) (2)-(6)
of this section including the--
(A) Comprehensive drug history;
(B) Psychosocial evaluation;
(C) Comprehensive psychiatric evaluation;
(D) Functional assessment; and
(ii) To make the determination required in paragraph (d) of this
section.
(d) Data interpretation. Based on the data compiled, a qualified
mental health professional, as designated by the State, must validate
the diagnosis of mental illness and determine whether a program of
psychiatric specialized services is needed.
Sec. 483.136 Evaluating whether an individual with intellectual
disability requires specialized services (PASARR/IID).
(a) Purpose. The purpose of this section is to identify the minimum
data needs and process requirements for the State intellectual
disability authority to determine whether or not the applicant or
resident with intellectual disability, as defined in Sec. 483.102(b)(3)
of this part, needs a continuous specialized services program, which is
analogous to active treatment, as defined in Sec. 435.1010 of this
chapter and Sec. 483.440.
(b) Data. Minimum data collected must include the individual's
comprehensive history and physical examination results to identify the
following information or, in the absence of data, must include
information that permits a reviewer specifically to assess:
(1) The individual's medical problems;
(2) The level of impact these problems have on the individual's
independent functioning;
(3) All current medications used by the individual and the current
response of the individual to any prescribed medications in the
following drug groups:
(i) Hypnotics,
(ii) Antipsychotics (neuroleptics),
(iii) Mood stabilizers and antidepressants,
(iv) Antianxiety-sedative agents, and
(v) Anti-Parkinson agents.
(4) Self-monitoring of health status;
(5) Self-administering and scheduling of medical treatments;
(6) Self-monitoring of nutritional status;
(7) Self-help development such as toileting, dressing, grooming, and
eating;
[[Page 116]]
(8) Sensorimotor development, such as ambulation, positioning,
transfer skills, gross motor dexterity, visual motor perception, fine
motor dexterity, eye-hand coordination, and extent to which prosthetic,
orthotic, corrective or mechanical supportive devices can improve the
individual's functional capacity;
(9) Speech and language (communication) development, such as
expressive language (verbal and nonverbal), receptive language (verbal
and nonverbal), extent to which non-oral communication systems can
improve the individual's function capacity, auditory functioning, and
extent to which amplification devices (for example, hearing aid) or a
program of amplification can improve the individual's functional
capacity;
(10) Social development, such as interpersonal skills, recreation-
leisure skills, and relationships with others;
(11) Academic/educational development, including functional learning
skills;
(12) Independent living development such as meal preparation,
budgeting and personal finances, survival skills, mobility skills
(orientation to the neighborhood, town, city), laundry, housekeeping,
shopping, bedmaking, care of clothing, and orientation skills (for
individuals with visual impairments);
(13) Vocational development, including present vocational skills;
(14) Affective development such as interests, and skills involved
with expressing emotions, making judgments, and making independent
decisions; and
(15) The presence of identifiable maladaptive or inappropriate
behaviors of the individual based on systematic observation (including,
but not limited to, the frequency and intensity of identified
maladaptive or inappropriate behaviors).
(c) Data interpretation--(1) The State must ensure that a licensed
psychologist identifies the intellectual functioning measurement of
individuals with IID or a related condition.
(2) Based on the data compiled in paragraph (b) of this section, the
State intellectual disability authority, using appropriate personnel, as
designated by the State, must validate that the individual has IID or is
a person with a related condition and must determine whether specialized
services for intellectual disability are needed. In making this
determination, the State intellectual disability authority must make a
qualitative judgment on the extent to which the person's status
reflects, singly and collectively, the characteristics commonly
associated with the need for specialized services, including--
(i) Inability to--
(A) Take care of the most personal care needs;
(B) Understand simple commands;
(C) Communicate basic needs and wants;
(D) Be employed at a productive wage level without systematic long
term supervision or support;
(E) Learn new skills without aggressive and consistent training;
(F) Apply skills learned in a training situation to other
environments or settings without aggressive and consistent training;
(G) Demonstrate behavior appropriate to the time, situation or place
without direct supervision; and
(H) Make decisions requiring informed consent without extreme
difficulty;
(ii) Demonstration of severe maladaptive behavior(s) that place the
person or others in jeopardy to health and safety; and
(iii) Presence of other skill deficits or specialized training needs
that necessitate the availability of trained IID personnel, 24 hours per
day, to teach the person functional skills.
[57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr. 28, 1993, as amended at
71 FR 39229, July 12, 2006]
Sec. 483.138 Maintenance of services and availability of FFP.
(a) Maintenance of services. If a NF mails a 30 day notice of its
intent to transfer or discharge a resident, under Sec. 483.15(b) of this
chapter, the agency may not terminate or reduce services until--
(1) The expiration of the notice period; or
(2) A subpart E appeal, if one has been filed, has been resolved.
[[Page 117]]
(b) Availability of FFP. FFP is available for expenditures for
services provided to Medicaid beneficiaries during--
(1) The 30 day notice period specified in Sec. 483.15(b) of this
chapter; or
(2) During the period an appeal is in progress.
[57 FR 56506, Nov. 30, 1992, as amended at 81 FR 68871, Oct. 4, 2016]
Subpart D_Requirements That Must Be Met by States and State Agencies:
Nurse Aide Training and Competency Evaluation, and Paid Feeding
Assistants
Source: 56 FR 48919, Sept. 26, 1991, unless otherwise noted.
Sec. 483.150 Statutory basis; Deemed meeting or waiver of
requirements.
(a) Statutory basis. This subpart is based on sections 1819(b)(5),
1819(f)(2), 1919(b)(5), and 1919(f)(2) of the Act, which establish
standards for training nurse-aides and for evaluating their competency.
(b) Deemed meeting of requirements. A nurse aide is deemed to
satisfy the requirement of completing a training and competency
evaluation approved by the State if he or she successfully completed a
training and competency evaluation program before July 1, 1989 if--
(1) The aide would have satisfied this requirement if--
(i) At least 60 hours were substituted for 75 hours in sections
1819(f)(2) and 1919(f)(2) of the Act, and
(ii) The individual has made up at least the difference in the
number of hours in the program he or she completed and 75 hours in
supervised practical nurse aide training or in regular in-service nurse
aide education;
or
(2) The individual was found to be competent (whether or not by the
State) after the completion of nurse aide training of at least 100 hours
duration.
(c) Waiver of requirements. A State may--
(1) Waive the requirement for an individual to complete a competency
evaluation program approved by the State for any individual who can
demonstrate to the satisfaction of the State that he or she has served
as a nurse aide at one or more facilities of the same employer in the
state for at least 24 consecutive months before December 19, 1989; or
(2) Deem an individual to have completed a nurse aide training and
competency evaluation program approved by the State if the individual
completed, before July 1, 1989, such a program that the State determines
would have met the requirements for approval at the time it was offered.
[56 FR 48919, Sept. 26, 1991; 56 FR 59331, Nov. 25, 1991, as amended at
60 FR 50443, Sept. 29, 1995; 75 FR 21179, Apr. 23, 2010]
Sec. 483.151 State review and approval of nurse aide training
and competency evaluation programs.
(a) State review and administration. (1) The State--
(i) Must specify any nurse aide training and competency evaluation
programs that the State approves as meeting the requirements of
Sec. 483.152 and/or competency evaluations programs that the State
approves as meeting the requirements of Sec. 483.154; and
(ii) May choose to offer a nurse aide training and competency
evaluation program that meets the requirements of Sec. 483.152 and/or a
competency evaluation program that meets the requirements of
Sec. 483.154.
(2) If the State does not choose to offer a nurse aide training and
competency evaluation program or competency evaluation program, the
State must review and approve or disapprove nurse aide training and
competency evaluation programs and nurse aide competency evaluation
programs upon request.
(3) The State survey agency must in the course of all surveys,
determine whether the nurse aide training and competency evaluation
requirements of Secs. 483.35(c) and (d) and 483.95(g) are met.
(b) Requirements for approval of programs. (1) Before the State
approves a nurse aide training and competency evaluation program or
competency evaluation program, the State must--
(i) Determine whether the nurse aide training and competency
evaluation
[[Page 118]]
program meets the course requirements of Sec. 483.152:
(ii) Determine whether the nurse aide competency evaluation program
meets the requirements of Sec. 483.154; and
(iii) In all reviews other than the initial review, visit the entity
providing the program.
(2) The State may not approve a nurse aide training and competency
evaluation program or competency evaluation program offered by or in a
facility which, in the previous two years--
(i) In the case of a skilled nursing facility, has operated under a
waiver under section 1819(b)(4)(C)(ii)(II) of the Act;
(ii) In the case of a nursing facility, has operated under a waiver
under section 1919(b)(4)(C)(ii) of the Act that was granted on the basis
of a demonstration that the facility is unable to provide nursing care
required under section 1919(b)(4)(C)(i) of the Act for a period in
excess of 48 hours per week;
(iii) Has been subject to an extended (or partial extended) survey
under sections 1819(g)(2)(B)(i) or 1919(g)(2)(B)(i) of the Act;
(iv) Has been assessed a civil money penalty described in section
1819(h)(2)(B)(ii) of 1919(h)(2)(A)(ii) of the Act of not less than
$5,000 as adjusted annually under 45 CFR part 102; or
(v) Has been subject to a remedy described in sections 1819(h)(2)(B)
(i) or (iii), 1819(h)(4), 1919(h)(1)(B)(i), or 1919(h)(2)(A) (i), (iii)
or (iv) of the Act.
(3) A State may not, until two years since the assessment of the
penalty (or penalties) has elapsed, approve a nurse aide training and
competency evaluation program or competency evaluation program offered
by or in a facility that, within the two-year period beginning October
1, 1988--
(i) Had its participation terminated under title XVIII of the Act or
under the State plan under title XIX of the Act;
(ii) Was subject to a denial of payment under title XVIII or title
XIX;
(iii) Was assessed a civil money penalty of not less than $5,000 as
adjusted annually under 45 CFR part 102 for deficiencies in nursing
facility standards;
(iv) Operated under temporary management appointed to oversee the
operation of the facility and to ensure the health and safety of its
residents; or
(v) Pursuant to State action, was closed or had its residents
transferred.
(c) Waiver of disapproval of nurse aide training programs. (1) A
facility may request that CMS waive the disapproval of its nurse aide
training program when the facility has been assessed a civil money
penalty of not less than $5,000 as adjusted annually under 45 CFR part
102 if the civil money penalty was not related to the quality of care
furnished to residents in the facility.
(2) For purposes of this provision, ``quality of care furnished to
residents'' means the direct hands-on care and treatment that a health
care professional or direct care staff furnished to a resident.
(3) Any waiver of disapproval of a nurse aide training program does
not waive any requirement upon the facility to pay any civil money
penalty.
(d) Time frame for acting on a request for approval. The State must,
within 90 days of the date of a request under paragraph (a)(3) of this
section or receipt of additional information from the requester--
(1) Advise the requester whether or not the program has been
approved; or
(2) Request additional information form the requesting entity.
(e) Duration of approval. The State may not grant approval of a
nurse aide training and competency evaluation program for a period
longer than 2 years. A program must notify the State and the State must
review that program when there are substantive changes made to that
program within the 2-year period.
(f) Withdrawal of approval. (1) The State must withdraw approval of
a nurse aide training and competency evaluation program or nurse aide
competency evaluation program offered by or in a facility described in
paragraph (b)(2) of this section.
(2) The State may withdraw approval of a nurse aide training and
competency evaluation program or nurse aide competency evaluation
program if the State determines that any of the applicable requirements
of Sec. 483.152 or Sec. 483.154 are not met by the program.
(3) The State must withdraw approval of a nurse aide training and
[[Page 119]]
competency evaluation program or a nurse aide competency evaluation
program if the entity providing the program refuses to permit
unannounced visits by the State.
(4) If a State withdraws approval of a nurse aide training and
competency evaluation program or competency evaluation program--
(i) The State must notify the program in writing, indicating the
reason(s) for withdrawal of approval of the program.
(ii) Students who have started a training and competency evaluation
program from which approval has been withdrawn must be allowed to
complete the course.
[56 FR 48919, Sept. 26, 1991, as amended at 75 FR 21179, Apr. 23, 2010;
81 FR 61563, Sept. 6, 2016; 81 FR 68871, Oct. 4, 2016]
Sec. 483.152 Requirements for approval of a nurse aide training
and competency evaluation program.
(a) For a nurse aide training and competency evaluation program to
be approved by the State, it must, at a minimum--
(1) Consist of no less than 75 clock hours of training;
(2) Include at least the subjects specified in paragraph (b) of this
section;
(3) Include at least 16 hours of supervised practical training.
Supervised practical training means training in a laboratory or other
setting in which the trainee demonstrates knowledge while performing
tasks on an individual under the direct supervision of a registered
nurse or a licensed practical nurse;
(4) Ensure that--
(i) Students do not perform any services for which they have not
trained and been found proficient by the instructor; and
(ii) Students who are providing services to residents are under the
general supervision of a licensed nurse or a registered nurse;
(5) Meet the following requirements for instructors who train nurse
aides;
(i) The training of nurse aides must be performed by or under the
general supervision of a registered nurse who possesses a minimum of 2
years of nursing experience, at least 1 year of which must be in the
provision of long term care facility services;
(ii) Instructors must have completed a course in teaching adults or
have experience in teaching adults or supervising nurse aides;
(iii) In a facility-based program, the training of nurse aides may
be performed under the general supervision of the director of nursing
for the facility who is prohibited from performing the actual training;
and
(iv) Other personnel from the health professions may supplement the
instructor, including, but not limited to, registered nurses, licensed
practical/vocational nurses, pharmacists, dietitians, social workers,
sanitarians, fire safety experts, nursing home administrators,
gerontologists, psychologists, physical and occupational therapists,
activities specialists, speech/language/hearing therapists, and resident
rights experts. Supplemental personnel must have at least 1 year of
experience in their fields;
(6) Contain competency evaluation procedures specified in
Sec. 483.154.
(b) The curriculum of the nurse aide training program must include--
(1) At least a total of 16 hours of training in the following areas
prior to any direct contact with a resident:
(i) Communication and interpersonal skills;
(ii) Infection control;
(iii) Safety/emergency procedures, including the Heimlich maneuver;
(iv) Promoting residents' independence; and
(v) Respecting residents' rights.
(2) Basic nursing skills;
(i) Taking and recording vital signs;
(ii) Measuring and recording height and weight;
(iii) Caring for the residents' environment;
(iv) Recognizing abnormal changes in body functioning and the
importance of reporting such changes to a supervisor; and
(v) Caring for residents when death is imminent.
(3) Personal care skills, including, but not limited to--
(i) Bathing;
(ii) Grooming, including mouth care;
(iii) Dressing;
(iv) Toileting;
[[Page 120]]
(v) Assisting with eating and hydration;
(vi) Proper feeding techniques;
(vii) Skin care; and
(viii) Transfers, positioning, and turning.
(4) Mental health and social service needs:
(i) Modifying aide's behavior in response to residents' behavior;
(ii) Awareness of developmental tasks associated with the aging
process;
(iii) How to respond to resident behavior;
(iv) Allowing the resident to make personal choices, providing and
reinforcing other behavior consistent with the resident's dignity; and
(v) Using the resident's family as a source of emotional support.
(5) Care of cognitively impaired residents:
(i) Techniques for addressing the unique needs and behaviors of
individual with dementia (Alzheimer's and others);
(ii) Communicating with cognitively impaired residents;
(iii) Understanding the behavior of cognitively impaired residents;
(iv) Appropriate responses to the behavior of cognitively impaired
residents; and
(v) Methods of reducing the effects of cognitive impairments.
(6) Basic restorative services:
(i) Training the resident in self care according to the resident's
abilities;
(ii) Use of assistive devices in transferring, ambulation, eating,
and dressing;
(iii) Maintenance of range of motion;
(iv) Proper turning and positioning in bed and chair;
(v) Bowel and bladder training; and
(vi) Care and use of prosthetic and orthotic devices.
(7) Residents' Rights.
(i) Providing privacy and maintenance of confidentiality;
(ii) Promoting the residents' right to make personal choices to
accommodate their needs;
(iii) Giving assistance in resolving grievances and disputes;
(iv) Providing needed assistance in getting to and participating in
resident and family groups and other activities;
(v) Maintaining care and security of residents' personal
possessions;
(vi) Promoting the resident's right to be free from abuse,
mistreatment, and neglect and the need to report any instances of such
treatment to appropriate facility staff;
(vii) Avoiding the need for restraints in accordance with current
professional standards.
(c) Prohibition of charges. (1) No nurse aide who is employed by, or
who has received an offer of employment from, a facility on the date on
which the aide begins a nurse aide training and competency evaluation
program may be charged for any portion of the program (including any
fees for textbooks or other required course materials).
(2) If an individual who is not employed, or does not have an offer
to be employed, as a nurse aide becomes employed by, or receives an
offer of employment from, a facility not later than 12 months after
completing a nurse aide training and competency evaluation program, the
State must provide for the reimbursement of costs incurred in completing
the program on a pro rata basis during the period in which the
individual is employed as a nurse aide.
Sec. 483.154 Nurse aide competency evaluation.
(a) Notification to Individual. The State must advise in advance any
individual who takes the competency evaluation that a record of the
successful completion of the evaluation will be included in the State's
nurse aid registry.
(b) Content of the competency evaluation program--(1) Written or
oral examinations. The competency evaluation must--
(i) Allow an aide to choose between a written and an oral
examination;
(ii) Address each course requirement specified in Sec. 483.152(b);
(iii) Be developed from a pool of test questions, only a portion of
which is used in any one examination;
(iv) Use a system that prevents disclosure of both the pool of
questions and the individual competency evaluations; and
[[Page 121]]
(v) If oral, must be read from a prepared text in a neutral manner.
(2) Demonstration of skills. The skills demonstration must consist
of a demonstration of randomly selected items drawn from a pool
consisting of the tasks generally performed by nurse aides. This pool of
skills must include all of the personal care skills listed in
Sec. 483.152(b)(3).
(c) Administration of the competency evaluation. (1) The competency
examination must be administered and evaluated only by--
(i) The State directly; or
(ii) A State approved entity which is neither a skilled nursing
facility that participates in Medicare nor a nursing facility that
participates in Medicaid.
(2) No nurse aide who is employed by, or who has received an offer
of employment from, a facility on the date on which the aide begins a
nurse aide competency evaluation program may be charged for any portion
of the program.
(3) If an individual who is not employed, or does not have an offer
to be employed, as a nurse aide becomes employed by, or receives an
offer of employment from, a facility not later than 12 months after
completing a nurse aide competency evaluation program, the State must
provide for the reimbursement of costs incurred in completing the
program on a pro rata basis during the period in which the individual is
employed as a nurse aide.
(4) The skills demonstration part of the evaluation must be--
(i) Performed in a facility or laboratory setting comparable to the
setting in which the individual will function as a nurse aide; and
(ii) Administered and evaluated by a registered nurse with at least
one year's experience in providing care for the elderly or the
chronically ill of any age.
(d) Facility proctoring of the competency evaluation. (1) The
competency evaluation may, at the nurse aide's option, be conducted at
the facility in which the nurse aide is or will be employed unless the
facility is described in Sec. 483.151(b)(2).
(2) The State may permit the competency evaluation to be proctored
by facility personnel if the State finds that the procedure adopted by
the facility assures that the competency evaluation program--
(i) Is secure from tampering;
(ii) Is standardized and scored by a testing, educational, or other
organization approved by the State; and
(iii) Requires no scoring by facility personnel.
(3) The State must retract the right to proctor nurse aide
competency evaluations from facilities in which the State finds any
evidence of impropriety, including evidence of tampering by facility
staff.
(e) Successful completion of the competency evaluation program. (1)
The State must establish a standard for satisfactory completion of the
competency evaluation. To complete the competency evaluation
successfully an individual must pass both the written or oral
examination and the skills demonstration.
(2) A record of successful completion of the competency evaluation
must be included in the nurse aide registry provided in Sec. 483.156
within 30 days of the date if the individual is found to be competent.
(f) Unsuccessful completion of the competency evaluation program.
(1) If the individual does not complete the evaluation satisfactorily,
the individual must be advised--
(i) Of the areas which he or she; did not pass; and
(ii) That he or she has at least three opportunities to take the
evaluation.
(2) The State may impose a maximum upon the number of times an
individual upon the number of times an individual may attempt to
complete the competency evaluation successfully, but the maximum may be
no less than three.
Sec. 483.156 Registry of nurse aides.
(a) Establishment of registry. The State must establish and maintain
a registry of nurse aides that meets the requirement of this section.
The registry--
(1) Must include as a minimum the information contained in paragraph
(c) of this section:
(2) Must be sufficiently accessible to meet the needs of the public
and health care providers promptly;
[[Page 122]]
(3) May include home health aides who have successfully completed a
home health aide competency evaluation program approved by the State if
home health aides are differentiated from nurse aides; and
(4) Must provide that any response to an inquiry that includes a
finding of abuse, neglect, or misappropriation of property also include
any statement disputing the finding made by the nurse aide, as provided
under paragraph (c)(1)(ix) of this section.
(b) Registry operation. (1) The State may contract the daily
operation and maintenance of the registry to a non-State entity.
However, the State must maintain accountability for overall operation of
the registry and compliance with these regulations.
(2) Only the State survey and certification agency may place on the
registry findings of abuse, neglect, or misappropriation of property.
(3) The State must determine which individuals who (i) have
successfully completed a nurse aide training and competency evaluation
program or nurse aide competency evaluation program; (ii) have been
deemed as meeting these requirements; or (iii) have had these
requirements waived by the State do not qualify to remain on the
registry because they have performed no nursing or nursing-related
services for a period of 24 consecutive months.
(4) The State may not impose any charges related to registration on
individuals listed in the registry.
(5) The State must provide information on the registry promptly.
(c) Registry Content. (1) The registry must contain at least the
following information on each individual who has successfully completed
a nurse aide training and competency evaluation program which meets the
requirements of Sec. 483.152 or a competency evaluation which meets the
requirements of Sec. 483.154 and has been found by the State to be
competent to function as a nurse aide or who may function as a nurse
aide because of meeting criteria in Sec. 483.150:
(i) The individual's full name.
(ii) Information necessary to identify each individual;
(iii) The date the individual became eligible for placement in the
registry through successfully completing a nurse aide training and
competency evaluation program or competency evaluation program or by
meeting the requirements of Sec. 483.150; and
(iv) The following information on any finding by the State survey
agency of abuse, neglect, or misappropriation of property by the
individual:
(A) Documentation of the State's investigation, including the nature
of the allegation and the evidence that led the State to conclude that
the allegation was valid;
(B) The date of the hearing, if the individual chose to have one,
and its outcome; and
(C) A statement by the individual disputing the allegation, if he or
she chooses to make one; and
(D) This information must be included in the registry within 10
working days of the finding and must remain in the registry permanently,
unless the finding was made in error, the individual was found not
guilty in a court of law, or the State is notified of the individual's
death.
(2) The registry must remove entries for individuals who have
performed no nursing or nursing-related services for a period of 24
consecutive months, unless the individual's registry entry includes
documented findings of abuse, neglect, or misappropriation of property.
(d) Disclosure of information. The State must--
(1) Disclose all of the information in Sec. 483.156(c)(1) (iii) and
(iv) to all requesters and may disclose additional information it deems
necessary; and
(2) Promptly provide individuals with all information contained in
the registry on them when adverse findings are placed on the registry
and upon request. Individuals on the registry must have sufficient
opportunity to correct any misstatements or inaccuracies contained in
the registry.
[56 FR 48919, Sept. 26, 1991; 56 FR 59331, Nov. 25, 1991]
Sec. 483.158 FFP for nurse aide training and competency evaluation.
(a) State expenditures for nurse aide training and competency
evaluation programs and competency evaluation programs are
administrative costs.
[[Page 123]]
They are matched as indicated in Sec. 433.15(b)(8) of this chapter.
(b) FFP is available for State expenditures associated with nurse
aide training and competency evaluation programs and competency
evaluation programs only for--
(1) Nurse aides employed by a facility;
(2) Nurse aides who have an offer of employment from a facility;
(3) Nurse aides who become employed by a facility not later than 12
months after completing a nurse aide training and competency evaluation
program or competency evaluation program; or
(4) Nurse aides who receive an offer of employment from a facility
not later than 12 months after completing a nurse aide training and
competency evaluation program or competency evaluation program.
Sec. 483.160 Requirements for training of paid feeding assistants.
(a) Minimum training course contents. A State-approved training
course for paid feeding assistants must include, at a minimum, 8 hours
of training in the following:
(1) Feeding techniques.
(2) Assistance with feeding and hydration.
(3) Communication and interpersonal skills.
(4) Appropriate responses to resident behavior.
(5) Safety and emergency procedures, including the Heimlich
maneuver.
(6) Infection control.
(7) Resident rights.
(8) Recognizing changes in residents that are inconsistent with
their normal behavior and the importance of reporting those changes to
the supervisory nurse.
(b) Maintenance of records. A facility must maintain a record of all
individuals, used by the facility as feeding assistants, who have
successfully completed the training course for paid feeding assistants.
[68 FR 55539, Sept. 26, 2003]
Subpart E_Appeals of Discharges, Transfers, and Preadmission Screening
and Annual Resident Review (PASARR) Determinations
Source: 57 FR 56514, Nov. 30, 1992, unless otherwise noted.
Sec. 483.200 Statutory basis.
This subpart is based on sections 1819(e)(3) and (f)(3) and
1919(e)(3) and (f)(3) of the Act, which require States to make
available, to individuals who are discharged or transferred from SNFs or
NFs, an appeals process that complies with guidelines issued by the
Secretary.
[60 FR 50443, Sept. 29, 1995]
Sec. 483.202 Definitions.
For purposes of this subpart and subparts B and C--
Discharge means movement from an entity that participates in
Medicare as a skilled nursing facility, a Medicare certified distinct
part, an entity that participates in Medicaid as a nursing facility, or
a Medicaid certified distinct part to a noninstitutional setting when
the discharging facility ceases to be legally responsible for the care
of the resident.
Individual means an individual or any legal representative of the
individual.
Resident means a resident of a SNF or NF or any legal representative
of the resident.
Transfer means movement from an entity that participates in Medicare
as a skilled nursing facility, a Medicare certified distinct part, an
entity that participates in Medicaid as a nursing facility or a Medicaid
certified distinct part to another institutional setting when the legal
responsibility for the care of the resident changes from the
transferring facility to the receiving facility.
Sec. 483.204 Provision of a hearing and appeal system.
(a) Each State must provide a system for:
(1) A resident of a SNF or a NF to appeal a notice from the SNF or
NF of intent to discharge or transfer the resident; and
[[Page 124]]
(2) An individual who has been adversely affected by any PASARR
determination made by the State in the context of either a preadmission
screening or an annual resident review under subpart C of part 483 to
appeal that determination.
(b) The State must provide an appeals system that meets the
requirements of this subpart, Sec. 483.15(h), and part 431 subpart E of
this chapter.
[57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr. 28, 1993, as amended at
81 FR 68871, Oct. 4, 2016]
Sec. 483.206 Transfers, discharges and relocations subject to appeal.
(a) ``Facility'' means a certified entity, either a Medicare SNF or
a Medicaid NF (See Sec. 483.5).
(b) A resident has appeal rights when he or she is transferred
from--
(1) A certified bed into a noncertified bed; and
(2) A bed in a certified entity to a bed in an entity which is
certified as a different provider.
(c) A resident has no appeal rights when he or she is moved from one
bed in the certified entity to another bed in the same certified entity.
[57 FR 56514, Nov. 30, 1992, as amended at 81 FR 68871, Oct. 4, 2016]
Subpart F_Requirements That Must be Met by States and State Agencies,
Resident Assessment
Sec. 483.315 Specification of resident assessment instrument.
(a) Statutory basis. Sections 1819(e)(5) and 1919(e)(5) of the Act
require that a State specify the resident assessment instrument (RAI) to
be used by long term care facilities in the State when conducting
initial and periodic assessments of each resident's functional capacity,
in accordance with Sec. 483.20.
(b) State options in specifying an RAI. The RAI that the State
specifies must be one of the following:
(1) The instrument designated by CMS.
(2) An alternate instrument specified by the State and approved by
CMS, using the criteria specified in the State Operations Manual issued
by CMS (CMS Pub. 7) which is available for purchase through the National
Technical Information Service, 5285 Port Royal Rd., Springfield, VA
22151.
(c) State requirements in specifying an RAI. (1) Within 30 days
after CMS notifies the State of the CMS-designated RAI or changes to it,
the State must do one of the following:
(i) Specify the CMS-designated RAI.
(ii) Notify CMS of its intent to specify an alternate instrument.
(2) Within 60 days after receiving CMS approval of an alternate RAI,
the State must specify the RAI for use by all long term care facilities
participating in the Medicare and Medicaid programs.
(3) After specifying an instrument, the State must provide periodic
educational programs for facility staff to assist with implementation of
the RAI.
(4) A State must audit implementation of the RAI through the survey
process.
(5) A State must obtain approval from CMS before making any
modifications to its RAI.
(6) A State must adopt revisions to the RAI that are specified by
CMS.
(d) CMS-designated RAI. The CMS-designated RAI is published in the
State Operations Manual issued by CMS (CMS Pub. 7), as updated
periodically, and consists of the following:
(1) The minimum data set (MDS) and common definitions.
(2) Care area assessment (CAA) guidelines and care area triggers
(CATs) that are necessary to accurately assess residents, established by
CMS.
(3) The quarterly review, based on a subset of the MDS specified by
CMS.
(4) The requirements for use of the RAI that appear at Sec. 483.20.
(e) Minimum data set (MDS). The MDS includes assessment in the areas
specified in Sec. 483.20(b)(i) through (xviii) of this chapter, and as
defined in the RAI manual published in the State Operations Manual
issued by CMS (CMS Pub. 100-07).
(f) [Reserved]
(g) Criteria for CMS approval of alternate instrument. To receive
CMS approval, a State's alternate instrument must use the standardized
format, organization, item labels and definitions, and instructions
specified by CMS in
[[Page 125]]
the latest issuance of the State Operations Manual issued by CMS (CMS
Pub. 7).
(h) State MDS system and database requirements. As part of facility
agency responsibilities, the State Survey Agency must:
(1) Support and maintain the CMS State system and database.
(2) Specify to a facility the method of transmission of data, and
instruct the facility on this method.
(3) Upon receipt of facility data from CMS, ensure that a facility
resolves errors.
(4) Analyze data and generate reports, as specified by CMS.
(i) State identification of agency that receives RAI data. The State
must identify the component agency that receives RAI data, and ensure
that this agency restricts access to the data except for the following:
(1) Reports that contain no resident-identifiable data.
(2) Transmission of reports to CMS.
(3) Transmission of data and reports to the State agency that
conducts surveys to ensure compliance with Medicare and Medicaid
participation requirements, for purposes related to this function.
(4) Transmission of data and reports to the State Medicaid agency
for purposes directly related to the administration of the State
Medicaid plan.
(5) Transmission of data and reports to other entities only when
authorized as a routine use by CMS.
(j) Resident-identifiable data. (1) The State may not release
information that is resident-identifiable to the public.
(2) The State may not release RAI data that is resident-identifiable
except in accordance with a written agreement under which the
beneficiary agrees to be bound by the restrictions described in
paragraph (i) of this section.
[62 FR 67212, Dec. 23, 1997, as amended at 74 FR 40363, Aug. 11, 2009]
Subpart G_Condition of Participation for the Use of Restraint or
Seclusion in Psychiatric Residential Treatment Facilities Providing
Inpatient Psychiatric Services for Individuals Under Age 21
Source: 66 FR 7161, Jan. 22, 2001, unless otherwise noted.
Sec. 483.350 Basis and scope.
(a) Statutory basis. Sections 1905(a)(16) and (h) of the Act provide
that inpatient psychiatric services for individuals under age 21 include
only inpatient services that are provided in an institution (or distinct
part thereof) that is a psychiatric hospital as defined in section
1861(f) of the Act or in another inpatient setting that the Secretary
has specified in regulations. Additionally, the Children's Health Act of
2000 (Pub. L. 106-310) imposes procedural reporting and training
requirements regarding the use of restraints and involuntary seclusion
in facilities, specifically including facilities that provide inpatient
psychiatric services for children under the age of 21 as defined by
sections 1905(a)(16) and (h) of the Act.
(b) Scope. This subpart imposes requirements regarding the use of
restraint or seclusion in psychiatric residential treatment facilities,
that are not hospitals, providing inpatient psychiatric services to
individuals under age 21.
Sec. 483.352 Definitions.
For purposes of this subpart, the following definitions apply:
Drug used as a restraint means any drug that--
(1) Is administered to manage a resident's behavior in a way that
reduces the safety risk to the resident or others;
(2) Has the temporary effect of restricting the resident's freedom
of movement; and
(3) Is not a standard treatment for the resident's medical or
psychiatric condition.
Emergency safety intervention means the use of restraint or
seclusion as an
[[Page 126]]
immediate response to an emergency safety situation.
Emergency safety situation means unanticipated resident behavior
that places the resident or others at serious threat of violence or
injury if no intervention occurs and that calls for an emergency safety
intervention as defined in this section.
Mechanical restraint means any device attached or adjacent to the
resident's body that he or she cannot easily remove that restricts
freedom of movement or normal access to his or her body.
Minor means a minor as defined under State law and, for the purpose
of this subpart, includes a resident who has been declared legally
incompetent by the applicable State court.
Personal restraint means the application of physical force without
the use of any device, for the purposes of restraining the free movement
of a resident's body. The term personal restraint does not include
briefly holding without undue force a resident in order to calm or
comfort him or her, or holding a resident's hand to safely escort a
resident from one area to another.
Psychiatric Residential Treatment Facility means a facility other
than a hospital, that provides psychiatric services, as described in
subpart D of part 441 of this chapter, to individuals under age 21, in
an inpatient setting.
Restraint means a ``personal restraint,'' ``mechanical restraint,''
or ``drug used as a restraint'' as defined in this section.
Seclusion means the involuntary confinement of a resident alone in a
room or an area from which the resident is physically prevented from
leaving.
Serious injury means any significant impairment of the physical
condition of the resident as determined by qualified medical personnel.
This includes, but is not limited to, burns, lacerations, bone
fractures, substantial hematoma, and injuries to internal organs,
whether self-inflicted or inflicted by someone else.
Staff means those individuals with responsibility for managing a
resident's health or participating in an emergency safety intervention
and who are employed by the facility on a full-time, part-time, or
contract basis.
Time out means the restriction of a resident for a period of time to
a designated area from which the resident is not physically prevented
from leaving, for the purpose of providing the resident an opportunity
to regain self-control.
[66 FR 7161, Jan. 22, 2001, as amended at 66 FR 28116, May 22, 2001]
Sec. 483.354 General requirements for psychiatric residential
treatment facilities.
A psychiatric residential treatment facility must meet the
requirements in Sec. 441.151 through Sec. 441.182 of this chapter.
Sec. 483.356 Protection of residents.
(a) Restraint and seclusion policy for the protection of residents.
(1) Each resident has the right to be free from restraint or seclusion,
of any form, used as a means of coercion, discipline, convenience, or
retaliation.
(2) An order for restraint or seclusion must not be written as a
standing order or on an as-needed basis.
(3) Restraint or seclusion must not result in harm or injury to the
resident and must be used only--
(i) To ensure the safety of the resident or others during an
emergency safety situation; and
(ii) Until the emergency safety situation has ceased and the
resident's safety and the safety of others can be ensured, even if the
restraint or seclusion order has not expired.
(4) Restraint and seclusion must not be used simultaneously.
(b) Emergency safety intervention. An emergency safety intervention
must be performed in a manner that is safe, proportionate, and
appropriate to the severity of the behavior, and the resident's
chronological and developmental age; size; gender; physical, medical,
and psychiatric condition; and personal history (including any history
of physical or sexual abuse).
(c) Notification of facility policy. At admission, the facility
must--
(1) Inform both the incoming resident and, in the case of a minor,
the resident's parent(s) or legal guardian(s) of the facility's policy
regarding the use of restraint or seclusion during an emergency safety
situation that may
[[Page 127]]
occur while the resident is in the program;
(2) Communicate its restraint and seclusion policy in a language
that the resident, or his or her parent(s) or legal guardian(s)
understands (including American Sign Language, if appropriate) and when
necessary, the facility must provide interpreters or translators;
(3) Obtain an acknowledgment, in writing, from the resident, or in
the case of a minor, from the parent(s) or legal guardian(s) that he or
she has been informed of the facility's policy on the use of restraint
or seclusion during an emergency safety situation. Staff must file this
acknowledgment in the resident's record; and
(4) Provide a copy of the facility policy to the resident and in the
case of a minor, to the resident's parent(s) or legal guardian(s).
(d) Contact information. The facility's policy must provide contact
information, including the phone number and mailing address, for the
appropriate State Protection and Advocacy organization.
Sec. 483.358 Orders for the use of restraint or seclusion.
(a) Orders for restraint or seclusion must be by a physician, or
other licensed practitioner permitted by the State and the facility to
order restraint or seclusion and trained in the use of emergency safety
interventions. Federal regulations at 42 CFR 441.151 require that
inpatient psychiatric services for beneficiaries under age 21 be
provided under the direction of a physician.
(b) If the resident's treatment team physician is available, only he
or she can order restraint or seclusion.
(c) A physician or other licensed practitioner permitted by the
state and the facility to order restraint or seclusion must order the
least restrictive emergency safety intervention that is most likely to
be effective in resolving the emergency safety situation based on
consultation with staff.
(d) If the order for restraint or seclusion is verbal, the verbal
order must be received by a registered nurse or other licensed staff
such as a licensed practical nurse, while the emergency safety
intervention is being initiated by staff or immediately after the
emergency safety situation ends. The physician or other licensed
practitioner permitted by the state and the facility to order restraint
or seclusion must verify the verbal order in a signed written form in
the resident's record. The physician or other licensed practitioner
permitted by the state and the facility to order restraint or seclusion
must be available to staff for consultation, at least by telephone,
throughout the period of the emergency safety intervention.
(e) Each order for restraint or seclusion must:
(1) Be limited to no longer than the duration of the emergency
safety situation; and
(2) Under no circumstances exceed 4 hours for residents ages 18 to
21; 2 hours for residents ages 9 to 17; or 1 hour for residents under
age 9.
(f) Within 1 hour of the initiation of the emergency safety
intervention a physician, or other licensed practitioner trained in the
use of emergency safety interventions and permitted by the state and the
facility to assess the physical and psychological well being of
residents, must conduct a face-to-face assessment of the physical and
psychological well being of the resident, including but not limited to--
(1) The resident's physical and psychological status;
(2) The resident's behavior;
(3) The appropriateness of the intervention measures; and
(4) Any complications resulting from the intervention.
(g) Each order for restraint or seclusion must include--
(1) The name of the ordering physician or other licensed
practitioner permitted by the state and the facility to order restraint
or seclusion;
(2) The date and time the order was obtained; and
(3) The emergency safety intervention ordered, including the length
of time for which the physician or other licensed practitioner permitted
by the state and the facility to order restraint or seclusion authorized
its use.
(h) Staff must document the intervention in the resident's record.
That documentation must be completed by
[[Page 128]]
the end of the shift in which the intervention occurs. If the
intervention does not end during the shift in which it began,
documentation must be completed during the shift in which it ends.
Documentation must include all of the following:
(1) Each order for restraint or seclusion as required in paragraph
(g) of this section.
(2) The time the emergency safety intervention actually began and
ended.
(3) The time and results of the 1-hour assessment required in
paragraph (f) of this section.
(4) The emergency safety situation that required the resident to be
restrained or put in seclusion.
(5) The name of staff involved in the emergency safety intervention.
(i) The facility must maintain a record of each emergency safety
situation, the interventions used, and their outcomes.
(j) The physician or other licensed practitioner permitted by the
state and the facility to order restraint or seclusion must sign the
restraint or seclusion order in the resident's record as soon as
possible.
[66 FR 7161, Jan. 22, 2001, as amended at 66 FR 28116, May 22, 2001]
Sec. 483.360 Consultation with treatment team physician.
If a physician or other licensed practitioner permitted by the state
and the facility to order restraint or seclusion orders the use of
restraint or seclusion, that person must contact the resident's
treatment team physician, unless the ordering physician is in fact the
resident's treatment team physician. The person ordering the use of
restraint or seclusion must--
(a) Consult with the resident's treatment team physician as soon as
possible and inform the team physician of the emergency safety situation
that required the resident to be restrained or placed in seclusion; and
(b) Document in the resident's record the date and time the team
physician was consulted.
[66 FR 7161, Jan. 22, 2001, as amended at 66 FR 28117, May 22, 2001]
Sec. 483.362 Monitoring of the resident in and immediately after
restraint.
(a) Clinical staff trained in the use of emergency safety
interventions must be physically present, continually assessing and
monitoring the physical and psychological well-being of the resident and
the safe use of restraint throughout the duration of the emergency
safety intervention.
(b) If the emergency safety situation continues beyond the time
limit of the order for the use of restraint, a registered nurse or other
licensed staff, such as a licensed practical nurse, must immediately
contact the ordering physician or other licensed practitioner permitted
by the state and the facility to order restraint or seclusion to receive
further instructions.
(c) A physician, or other licensed practitioner permitted by the
state and the facility to evaluate the resident's well-being and trained
in the use of emergency safety interventions, must evaluate the
resident's well-being immediately after the restraint is removed.
[66 FR 7161, Jan. 22, 2001, as amended at 66 FR 28117, May 22, 2001]
Sec. 483.364 Monitoring of the resident in and immediately after
seclusion.
(a) Clinical staff, trained in the use of emergency safety
interventions, must be physically present in or immediately outside the
seclusion room, continually assessing, monitoring, and evaluating the
physical and psychological well-being of the resident in seclusion.
Video monitoring does not meet this requirement.
(b) A room used for seclusion must--
(1) Allow staff full view of the resident in all areas of the room;
and
(2) Be free of potentially hazardous conditions such as unprotected
light fixtures and electrical outlets.
(c) If the emergency safety situation continues beyond the time
limit of the order for the use of seclusion, a registered nurse or other
licensed staff, such as a licensed practical nurse, must immediately
contact the ordering physician or other licensed practitioner permitted
by the state and the facility to order restraint or seclusion to receive
further instructions.
[[Page 129]]
(d) A physician, or other licensed practitioner permitted by the
state and the facility to evaluate the resident's well-being and trained
in the use of emergency safety interventions, must evaluate the
resident's well-being immediately after the resident is removed from
seclusion.
[66 FR 7161, Jan. 22, 2001, as amended at 66 FR 28117, May 22, 2001]
Sec. 483.366 Notification of parent(s) or legal guardian(s).
If the resident is a minor as defined in this subpart:
(a) The facility must notify the parent(s) or legal guardian(s) of
the resident who has been restrained or placed in seclusion as soon as
possible after the initiation of each emergency safety intervention.
(b) The facility must document in the resident's record that the
parent(s) or legal guardian(s) has been notified of the emergency safety
intervention, including the date and time of notification and the name
of the staff person providing the notification.
Sec. 483.368 Application of time out.
(a) A resident in time out must never be physically prevented from
leaving the time out area.
(b) Time out may take place away from the area of activity or from
other residents, such as in the resident's room (exclusionary), or in
the area of activity or other residents (inclusionary).
(c) Staff must monitor the resident while he or she is in time out.
Sec. 483.370 Postintervention debriefings.
(a) Within 24 hours after the use of restraint or seclusion, staff
involved in an emergency safety intervention and the resident must have
a face-to-face discussion. This discussion must include all staff
involved in the intervention except when the presence of a particular
staff person may jeopardize the well-being of the resident. Other staff
and the resident's parent(s) or legal guardian(s) may participate in the
disussion when it is deemed appropriate by the facility. The facility
must conduct such discussion in a language that is understood by the
resident's parent(s) or legal guardian(s). The discussion must provide
both the resident and staff the opportunity to discuss the circumstances
resulting in the use of restraint or seclusion and strategies to be used
by the staff, the resident, or others that could prevent the future use
of restraint or seclusion.
(b) Within 24 hours after the use of restraint or seclusion, all
staff involved in the emergency safety intervention, and appropriate
supervisory and administrative staff, must conduct a debriefing session
that includes, at a minimum, a review and discussion of--
(1) The emergency safety situation that required the intervention,
including a discussion of the precipitating factors that led up to the
intervention;
(2) Alternative techniques that might have prevented the use of the
restraint or seclusion;
(3) The procedures, if any, that staff are to implement to prevent
any recurrence of the use of restraint or seclusion; and
(4) The outcome of the intervention, including any injuries that may
have resulted from the use of restraint or seclusion.
(c) Staff must document in the resident's record that both
debriefing sessions took place and must include in that documentation
the names of staff who were present for the debriefing, names of staff
that were excused from the debriefing, and any changes to the resident's
treatment plan that result from the debriefings.
Sec. 483.372 Medical treatment for injuries resulting from an
emergency safety intervention.
(a) Staff must immediately obtain medical treatment from qualified
medical personnel for a resident injured as a result of an emergency
safety intervention.
(b) The psychiatric residential treatment facility must have
affiliations or written transfer agreements in effect with one or more
hospitals approved for participation under the Medicaid program that
reasonably ensure that--
(1) A resident will be transferred from the facility to a hospital
and admitted in a timely manner when a transfer is medically necessary
for medical care or acute psychiatric care;
[[Page 130]]
(2) Medical and other information needed for care of the resident in
light of such a transfer, will be exchanged between the institutions in
accordance with State medical privacy law, including any information
needed to determine whether the appropriate care can be provided in a
less restrictive setting; and
(3) Services are available to each resident 24 hours a day, 7 days a
week.
(c) Staff must document in the resident's record, all injuries that
occur as a result of an emergency safety intervention, including
injuries to staff resulting from that intervention.
(d) Staff involved in an emergency safety intervention that results
in an injury to a resident or staff must meet with supervisory staff and
evaluate the circumstances that caused the injury and develop a plan to
prevent future injuries.
Sec. 483.374 Facility reporting.
(a) Attestation of facility compliance. Each psychiatric residential
treatment facility that provides inpatient psychiatric services to
individuals under age 21 must attest, in writing, that the facility is
in compliance with CMS's standards governing the use of restraint and
seclusion. This attestation must be signed by the facility director.
(1) A facility with a current provider agreement with the Medicaid
agency must provide its attestation to the State Medicaid agency by July
21, 2001.
(2) A facility enrolling as a Medicaid provider must meet this
requirement at the time it executes a provider agreement with the
Medicaid agency.
(b) Reporting of serious occurrences. The facility must report each
serious occurrence to both the State Medicaid agency and, unless
prohibited by State law, the State-designated Protection and Advocacy
system. Serious occurrences that must be reported include a resident's
death, a serious injury to a resident as defined in Sec. 483.352 of this
part, and a resident's suicide attempt.
(1) Staff must report any serious occurrence involving a resident to
both the State Medicaid agency and the State-designated Protection and
Advocacy system by no later than close of business the next business day
after a serious occurrence. The report must include the name of the
resident involved in the serious occurrence, a description of the
occurrence, and the name, street address, and telephone number of the
facility.
(2) In the case of a minor, the facility must notify the resident's
parent(s) or legal guardian(s) as soon as possible, and in no case later
than 24 hours after the serious occurrence.
(3) Staff must document in the resident's record that the serious
occurrence was reported to both the State Medicaid agency and the State-
designated Protection and Advocacy system, including the name of the
person to whom the incident was reported. A copy of the report must be
maintained in the resident's record, as well as in the incident and
accident report logs kept by the facility.
(c) Reporting of deaths. In addition to the reporting requirements
contained in paragraph (b) of this section, facilities must report the
death of any resident to the Centers for Medicare & Medicaid Services
(CMS) regional office.
(1) Staff must report the death of any resident to the CMS regional
office by no later than close of business the next business day after
the resident's death.
(2) Staff must document in the resident's record that the death was
reported to the CMS regional office.
[66 FR 7161, Jan. 22, 2001, as amended at 66 FR 28117, May 22, 2001]
Sec. 483.376 Education and training.
(a) The facility must require staff to have ongoing education,
training, and demonstrated knowledge of--
(1) Techniques to identify staff and resident behaviors, events, and
environmental factors that may trigger emergency safety situations;
(2) The use of nonphysical intervention skills, such as de-
escalation, mediation conflict resolution, active listening, and verbal
and observational methods, to prevent emergency safety situations; and
(3) The safe use of restraint and the safe use of seclusion,
including the ability to recognize and respond to signs of physical
distress in residents who are restrained or in seclusion.
[[Page 131]]
(b) Certification in the use of cardiopulmonary resuscitation,
including periodic recertification, is required.
(c) Individuals who are qualified by education, training, and
experience must provide staff training.
(d) Staff training must include training exercises in which staff
members successfully demonstrate in practice the techniques they have
learned for managing emergency safety situations.
(e) Staff must be trained and demonstrate competency before
participating in an emergency safety intervention.
(f) Staff must demonstrate their competencies as specified in
paragraph (a) of this section on a semiannual basis and their
competencies as specified in paragraph (b) of this section on an annual
basis.
(g) The facility must document in the staff personnel records that
the training and demonstration of competency were successfully
completed. Documentation must include the date training was completed
and the name of persons certifying the completion of training.
(h) All training programs and materials used by the facility must be
available for review by CMS, the State Medicaid agency, and the State
survey agency.
Subpart H [Reserved]
Subpart I_Conditions of Participation for Intermediate Care Facilities
for Individuals with Intellectual Disabilities
Source: 53 FR 20496, June 3, 1988, unless otherwise noted.
Redesignated at 56 FR 48918, Sept. 26, 1991.
Sec. 483.400 Basis and purpose.
This subpart implements section 1905 (c) and (d) of the Act which
gives the Secretary authority to prescribe regulations for intermediate
care facility services in facilities for individuals with intellectual
disabilities or persons with related conditions.
Sec. 483.405 Relationship to other HHS regulations.
In addition to compliance with the regulations set forth in this
subpart, facilities are obliged to meet the applicable provisions of
other HHS regulations, including but not limited to those pertaining to
nondiscrimination on the basis of race, color, or national origin (45
CFR part 80), nondiscrimination on the basis of handicap (45 CFR part
84), nondiscrimination on the basis of age (45 CFR part 91), protection
of human subjects of research (45 CFR part 46), and fraud and abuse (42
CFR part 455). Although those regulations are not in themselves
considered conditions of participation under this part, their violation
may result in the termination or suspension of, or the refusal to grant
or continue, Federal financial assistance.
Sec. 483.410 Condition of participation: Governing body and
management.
(a) Standard: Governing body. The facility must identify an
individual or individuals to constitute the governing body of the
facility. The governing body must--
(1) Exercise general policy, budget, and operating direction over
the facility;
(2) Set the qualifications (in addition to those already set by
State law, if any) for the administrator of the facility; and
(3) Appoint the administrator of the facility.
(b) Standard: Compliance with Federal, State, and local laws. The
facility must be in compliance with all applicable provisions of
Federal, State and local laws, regulations and codes pertaining to
health, safety, and sanitation.
(c) Standard: Client records. (1) The facility must develop and
maintain a recordkeeping system that includes a separate record for each
client and that documents the client's health care, active treatment,
social information, and protection of the client's rights.
(2) The facility must keep confidential all information contained in
the clients' records, regardless of the form or storage method of the
records.
[[Page 132]]
(3) The facility must develop and implement policies and procedures
governing the release of any client information, including consents
necessary from the client, or parents (if the client is a minor) or
legal guardian.
(4) Any individual who makes an entry in a client's record must make
it legibly, date it, and sign it.
(5) The facility must provide a legend to explain any symbol or
abbreviation used in a client's record.
(6) The facility must provide each identified residential living
unit with appropriate aspects of each client's record.
(d) Standard: Services provided under agreements with outside
sources. (1) If a service required under this subpart is not provided
directly, the facility must have a written agreement with an outside
program, resource, or service to furnish the necessary service,
including emergency and other health care.
(2) The agreement must--
(i) Contain the responsibilities, functions, objectives, and other
terms agreed to by both parties; and
(ii) Provide that the facility is responsible for assuring that the
outside services meet the standards for quality of services contained in
this subpart.
(3) The facility must assure that outside services meet the needs of
each client.
(4) If living quarters are not provided in a facility owned by the
ICF/IID, the ICF/IID remains directly responsible for the standards
relating to physical environment that are specified in Sec. 483.470 (a)
through (g), (j) and (k).
(e) Standard: Licensure. The facility must be licensed under
applicable State and local law.
[53 FR 20496, June 3, 1988. Redesignated at 56 FR 48918, Sept. 26, 1991,
and amended at 57 FR 43925, Sept. 23, 1992]
Sec. 483.420 Condition of participation: Client protections.
(a) Standard: Protection of clients' rights. The facility must
ensure the rights of all clients. Therefore, the facility must--
(1) Inform each client, parent (if the client is a minor), or legal
guardian, of the client's rights and the rules of the facility;
(2) Inform each client, parent (if the client is a minor), or legal
guardian, of the client's medical condition, developmental and
behavioral status, attendant risks of treatment, and of the right to
refuse treatment;
(3) Allow and encourage individual clients to exercise their rights
as clients of the facility, and as citizens of the United States,
including the right to file complaints, and the right to due process;
(4) Allow individual clients to manage their financial affairs and
teach them to do so to the extent of their capabilities;
(5) Ensure that clients are not subjected to physical, verbal,
sexual or psychological abuse or punishment;
(6) Ensure that clients are free from unnecessary drugs and physical
restraints and are provided active treatment to reduce dependency on
drugs and physical restraints;
(7) Provide each client with the opportunity for personal privacy
and ensure privacy during treatment and care of personal needs;
(8) Ensure that clients are not compelled to perform services for
the facility and ensure that clients who do work for the facility are
compensated for their efforts at prevailing wages and commensurate with
their abilities;
(9) Ensure clients the opportunity to communicate, associate and
meet privately with individuals of their choice, and to send and receive
unopened mail;
(10) Ensure that clients have access to telephones with privacy for
incoming and outgoing local and long distance calls except as
contraindicated by factors identified within their individual program
plans;
(11) Ensure clients the opportunity to participate in social,
religious, and community group activities;
(12) Ensure that clients have the right to retain and use
appropriate personal possessions and clothing, and ensure that each
client is dressed in his or her own clothing each day; and
(13) Permit a husband and wife who both reside in the facility to
share a room.
(b) Standard: Client finances. (1) The facility must establish and
maintain a system that--
[[Page 133]]
(i) Assures a full and complete accounting of clients' personal
funds entrusted to the facility on behalf of clients; and
(ii) Precludes any commingling of client funds with facility funds
or with the funds of any person other than another client.
(2) The client's financial record must be available on request to
the client, parents (if the client is a minor) or legal guardian.
(c) Standard: Communication with clients, parents, and guardians.
The facility must--
(1) Promote participation of parents (if the client is a minor) and
legal guardians in the process of providing active treatment to a client
unless their participation is unobtainable or inappropriate;
(2) Answer communications from clients' families and friends
promptly and appropriately;
(3) Promote visits by individuals with a relationship to the client
(such as family, close friends, legal guardians and advocates) at any
reasonable hour, without prior notice, consistent with the right of that
client's and other clients' privacy, unless the interdisciplinary team
determines that the visit would not be appropriate;
(4) Promote visits by parents or guardians to any area of the
facility that provides direct client care services to the client,
consistent with the right of that client's and other clients' privacy;
(5) Promote frequent and informal leaves from the facility for
visits, trips, or vacations; and
(6) Notify promptly the client's parents or guardian of any
significant incidents, or changes in the client's condition including,
but not limited to, serious illness, accident, death, abuse, or
unauthorized absence.
(d) Standard: Staff treatment of clients. (1) The facility must
develop and implement written policies and procedures that prohibit
mistreatment, neglect or abuse of the client.
(i) Staff of the facility must not use physical, verbal, sexual or
psychological abuse or punishment.
(ii) Staff must not punish a client by withholding food or hydration
that contributes to a nutritionally adequate diet.
(iii) The facility must prohibit the employment of individuals with
a conviction or prior employment history of child or client abuse,
neglect or mistreatment.
(2) The facility must ensure that all allegations of mistreatment,
neglect or abuse, as well as injuries of unknown source, are reported
immediately to the administrator or to other officials in accordance
with State law through established procedures.
(3) The facility must have evidence that all alleged violations are
thoroughly investigated and must prevent further potential abuse while
the investigation is in progress.
(4) The results of all investigations must be reported to the
administrator or designated representative or to other officials in
accordance with State law within five working days of the incident and,
if the alleged violation is verified, appropriate corrective action must
be taken.
Sec. 483.430 Condition of participation: Facility staffing.
(a) Standard: Qualified intellectual disability professional. Each
client's active treatment program must be integrated, coordinated and
monitored by a qualified intellectual disability professional who--
(1) Has at least one year of experience working directly with
persons with intellectual disability or other developmental
disabilities; and
(2) Is one of the following:
(i) A doctor of medicine or osteopathy.
(ii) A registered nurse.
(iii) An individual who holds at least a bachelor's degree in a
professional category specified in paragraph (b)(5) of this section.
(b) Standard: Professional program services. (1) Each client must
receive the professional program services needed to implement the active
treatment program defined by each client's individual program plan.
Professional program staff must work directly with clients and with
paraprofessional, nonprofessional and other professional program staff
who work with clients.
[[Page 134]]
(2) The facility must have available enough qualified professional
staff to carry out and monitor the various professional interventions in
accordance with the stated goals and objectives of every individual
program plan.
(3) Professional program staff must participate as members of the
interdisciplinary team in relevant aspects of the active treatment
process.
(4) Professional program staff must participate in on-going staff
development and training in both formal and informal settings with other
professional, paraprofessional, and nonprofessional staff members.
(5) Professional program staff must be licensed, certified, or
registered, as applicable, to provide professional services by the State
in which he or she practices. Those professional program staff who do
not fall under the jurisdiction of State licensure, certification, or
registration requirements, specified in Sec. 483.410(b), must meet the
following qualifications:
(i) To be designated as an occupational therapist, an individual
must be eligible for certification as an occupational therapist by the
American Occupational Therapy Association or another comparable body.
(ii) To be designated as an occupational therapy assistant, an
individual must be eligible for certification as a certified
occupational therapy assistant by the American Occupational Therapy
Association or another comparable body.
(iii) To be designated as a physical therapist, an individual must
be eligible for certification as a physical therapist by the American
Physical Therapy Association or another comparable body.
(iv) To be designated as a physical therapy assistant, an individual
must be eligible for registration by the American Physical Therapy
Association or be a graduate of a two year college-level program
approved by the American Physical Therapy Association or another
comparable body.
(v) To be designated as a psychologist, an individual must have at
least a master's degree in psychology from an accredited school.
(vi) To be designated as a social worker, an individual must--
(A) Hold a graduate degree from a school of social work accredited
or approved by the Council on Social Work Education or another
comparable body; or
(B) Hold a Bachelor of Social Work degree from a college or
university accredited or approved by the Council on Social Work
Education or another comparable body.
(vii) To be designated as a speech-language pathologist or
audiologist, an individual must--
(A) Be eligible for a Certificate of Clinical Competence in Speech-
Language Pathology or Audiology granted by the American Speech-Language-
Hearing Association or another comparable body; or
(B) Meet the educational requirements for certification and be in
the process of accumulating the supervised experience required for
certification.
(viii) To be designated as a professional recreation staff member,
an individual must have a bachelor's degree in recreation or in a
specialty area such as art, dance, music or physical education.
(ix) To be designated as a professional dietitian, an individual
must be eligible for registration by the American Dietetics Association.
(x) To be designated as a human services professional an individual
must have at least a bachelor's degree in a human services field
(including, but not limited to: sociology, special education,
rehabilitation counseling, and psychology).
(xi) If the client's individual program plan is being successfully
implemented by facility staff, professional program staff meeting the
qualifications of paragraph (b)(5) (i) through (x) of this section are
not required--
(A) Except for qualified intellectual disability professionals;
(B) Except for the requirements of paragraph (b)(2) of this section
concerning the facility's provision of enough qualified professional
program staff; and
(C) Unless otherwise specified by State licensure and certification
requirements.
(c) Standard: Facility staffing. (1) The facility must not depend
upon clients
[[Page 135]]
or volunteers to perform direct care services for the facility.
(2) There must be responsible direct care staff on duty and awake on
a 24-hour basis, when clients are present, to take prompt, appropriate
action in case of injury, illness, fire or other emergency, in each
defined residential living unit housing--
(i) Clients for whom a physician has ordered a medical care plan;
(ii) Clients who are aggressive, assaultive or security risks;
(iii) More than 16 clients; or
(iv) Fewer than 16 clients within a multi-unit building.
(3) There must be a responsible direct care staff person on duty on
a 24 hour basis (when clients are present) to respond to injuries and
symptoms of illness, and to handle emergencies, in each defined
residential living unit housing--
(i) Clients for whom a physician has not ordered a medical care
plan;
(ii) Clients who are not aggressive, assaultive or security risks;
and
(iii) Sixteen or fewer clients,
(4) The facility must provide sufficient support staff so that
direct care staff are not required to perform support services to the
extent that these duties interfere with the exercise of their primary
direct client care duties.
(d) Standard: Direct care (residential living unit) staff. (1) The
facility must provide sufficient direct care staff to manage and
supervise clients in accordance with their individual program plans.
(2) Direct care staff are defined as the present on-duty staff
calculated over all shifts in a 24-hour period for each defined
residential living unit.
(3) Direct care staff must be provided by the facility in the
following minimum ratios of direct care staff to clients:
(i) For each defined residential living unit serving children under
the age of 12, severely and profoundly retarded clients, clients with
severe physical disabilities, or clients who are aggressive, assaultive,
or security risks, or who manifest severely hyperactive or psychotic-
like behavior, the staff to client ratio is 1 to 3.2.
(ii) For each defined residential living unit serving moderately
retarded clients, the staff to client ratio is 1 to 4.
(iii) For each defined residential living unit serving clients who
function within the range of mild retardation, the staff to client ratio
is 1 to 6.4.
(4) When there are no clients present in the living unit, a
responsible staff member must be available by telephone.
(e) Standard: Staff training program. (1) The facility must provide
each employee with initial and continuing training that enables the
employee to perform his or her duties effectively, efficiently, and
competently.
(2) For employees who work with clients, training must focus on
skills and competencies directed toward clients' developmental,
behavioral, and health needs.
(3) Staff must be able to demonstrate the skills and techniques
necessary to administer interventions to manage the inappropriate
behavior of clients.
(4) Staff must be able to demonstrate the skills and techniques
necessary to implement the individual program plans for each client for
whom they are responsible.
Sec. 483.440 Condition of participation: Active treatment services.
(a) Standard: Active treatment. (1) Each client must receive a
continuous active treatment program, which includes aggressive,
consistent implementation of a program of specialized and generic
training, treatment, health services and related services described in
this subpart, that is directed toward--
(i) The acquisition of the behaviors necessary for the client to
function with as much self determination and independence as possible;
and
(ii) The prevention or deceleration of regression or loss of current
optimal functional status.
(2) Active treatment does not include services to maintain generally
independent clients who are able to function with little supervision or
in the absence of a continuous active treatment program.
(b) Standard: Admissions, transfers, and discharge. (1) Clients who
are admitted by the facility must be in need
[[Page 136]]
of and receiving active treatment services.
(2) Admission decisions must be based on a preliminary evaluation of
the client that is conducted or updated by the facility or by outside
sources.
(3) A preliminary evaluation must contain background information as
well as currently valid assessments of functional developmental,
behavioral, social, health and nutritional status to determine if the
facility can provide for the client's needs and if the client is likely
to benefit from placement in the facility.
(4) If a client is to be either transferred or discharged, the
facility must--
(i) Have documentation in the client's record that the client was
transferred or discharged for good cause; and
(ii) Provide a reasonable time to prepare the client and his or her
parents or guardian for the transfer or discharge (except in
emergencies).
(5) At the time of the discharge, the facility must--
(i) Develop a final summary of the client's developmental,
behavioral, social, health and nutritional status and, with the consent
of the client, parents (if the client is a minor) or legal guardian,
provide a copy to authorized persons and agencies; and
(ii) Provide a post-discharge plan of care that will assist the
client to adjust to the new living environment.
(c) Standard: Individual program plan. (1) Each client must have an
individual program plan developed by an interdisciplinary team that
represents the professions, disciplines or service areas that are
relevant to--
(i) Identifying the client's needs, as described by the
comprehensive functional assessments required in paragraph (c)(3) of
this section; and
(ii) Designing programs that meet the client's needs.
(2) Appropriate facility staff must participate in interdisciplinary
team meetings. Participation by other agencies serving the client is
encouraged. Participation by the client, his or her parent (if the
client is a minor), or the client's legal guardian is required unless
that participation is unobtainable or inappropriate.
(3) Within 30 days after admission, the interdisciplinary team must
perform accurate assessments or reassessments as needed to supplement
the preliminary evaluation conducted prior to admission. The
comprehensive functional assessment must take into consideration the
client's age (for example, child, young adult, elderly person) and the
implications for active treatment at each stage, as applicable, and
must--
(i) Identify the presenting problems and disabilities and where
possible, their causes;
(ii) Identify the client's specific developmental strengths;
(iii) Identify the client's specific developmental and behavioral
management needs;
(iv) Identify the client's need for services without regard to the
actual availability of the services needed; and
(v) Include physical development and health, nutritional status,
sensorimotor development, affective development, speech and language
development and auditory functioning, cognitive development, social
development, adaptive behaviors or independent living skills necessary
for the client to be able to function in the community, and as
applicable, vocational skills.
(4) Within 30 days after admission, the interdisciplinary team must
prepare for each client an individual program plan that states the
specific objectives necessary to meet the client's needs, as identified
by the comprehensive assessment required by paragraph (c)(3) of this
section, and the planned sequence for dealing with those objectives.
These objectives must--
(i) Be stated separately, in terms of a single behavioral outcome;
(ii) Be assigned projected completion dates;
(iii) Be expressed in behavioral terms that provide measurable
indices of performance;
(iv) Be organized to reflect a developmental progression appropriate
to the individual; and
(v) Be assigned priorities.
(5) Each written training program designed to implement the
objectives in the individual program plan must specify:
[[Page 137]]
(i) The methods to be used;
(ii) The schedule for use of the method;
(iii) The person responsible for the program;
(iv) The type of data and frequency of data collection necessary to
be able to assess progress toward the desired objectives;
(v) The inappropriate client behavior(s), if applicable; and
(vi) Provision for the appropriate expression of behavior and the
replacement of inappropriate behavior, if applicable, with behavior that
is adaptive or appropriate.
(6) The individual program plan must also:
(i) Describe relevant interventions to support the individual toward
independence.
(ii) Identify the location where program strategy information (which
must be accessible to any person responsible for implementation) can be
found.
(iii) Include, for those clients who lack them, training in personal
skills essential for privacy and independence (including, but not
limited to, toilet training, personal hygiene, dental hygiene, self-
feeding, bathing, dressing, grooming, and communication of basic needs),
until it has been demonstrated that the client is developmentally
incapable of acquiring them.
(iv) Identify mechanical supports, if needed, to achieve proper body
position, balance, or alignment. The plan must specify the reason for
each support, the situations in which each is to be applied, and a
schedule for the use of each support.
(v) Provide that clients who have multiple disabling conditions
spend a major portion of each waking day out of bed and outside the
bedroom area, moving about by various methods and devices whenever
possible.
(vi) Include opportunities for client choice and self-management.
(7) A copy of each client's individual program plan must be made
available to all relevant staff, including staff of other agencies who
work with the client, and to the client, parents (if the client is a
minor) or legal guardian.
(d) Standard: Program implementation. (1) As soon as the
interdisciplinary team has formulated a client's individual program
plan, each client must receive a continuous active treatment program
consisting of needed interventions and services in sufficient number and
frequency to support the achievement of the objectives identified in the
individual program plan.
(2) The facility must develop an active treatment schedule that
outlines the current active treatment program and that is readily
available for review by relevant staff.
(3) Except for those facets of the individual program plan that must
be implemented only by licensed personnel, each client's individual
program plan must be implemented by all staff who work with the client,
including professional, paraprofessional and nonprofessional staff.
(e) Standard: Program documentation. (1) Data relative to
accomplishment of the criteria specified in client individual program
plan objectives must be documented in measureable terms.
(2) The facility must document significant events that are related
to the client's individual program plan and assessments and that
contribute to an overall understanding of the client's ongoing level and
quality of functioning.
(f) Standard: Program monitoring and change. (1) The individual
program plan must be reviewed at least by the qualified intellectual
disability professional and revised as necessary, including, but not
limited to situations in which the client--
(i) Has successfully completed an objective or objectives identified
in the individual program plan;
(ii) Is regressing or losing skills already gained;
(iii) Is failing to progress toward identified objectives after
reasonable efforts have been made; or
(iv) Is being considered for training towards new objectives.
(2) At least annually, the comprehensive functional assessment of
each client must be reviewed by the interdisciplinary team for relevancy
and updated as needed, and the individual program plan must be revised,
as appropriate, repeating the process set forth in paragraph (c) of this
section.
[[Page 138]]
(3) The facility must designate and use a specially constituted
committee or committees consisting of members of facility staff,
parents, legal guardians, clients (as appropriate), qualified persons
who have either experience or training in contemporary practices to
change inappropriate client behavior, and persons with no ownership or
controlling interest in the facility to--
(i) Review, approve, and monitor individual programs designed to
manage inappropriate behavior and other programs that, in the opinion of
the committee, involve risks to client protection and rights;
(ii) Insure that these programs are conducted only with the written
informed consent of the client, parent (if the client is a minor), or
legal guardian; and
(iii) Review, monitor and make suggestions to the facility about its
practices and programs as they relate to drug usage, physical
restraints, time-out rooms, application of painful or noxious stimuli,
control of inappropriate behavior, protection of client rights and
funds, and any other area that the committee believes need to be
addressed.
(4) The provisions of paragraph (f)(3) of this section may be
modified only if, in the judgment of the State survey agency, Court
decrees, State law or regulations provide for equivalent client
protection and consultation.
Sec. 483.450 Condition of participation: Client behavior and facility
practices.
(a) Standard: Facility practices--Conduct toward clients. (1) The
facility must develop and implement written policies and procedures for
the management of conduct between staff and clients. These policies and
procedures must--
(i) Promote the growth, development and independence of the client;
(ii) Address the extent to which client choice will be accommodated
in daily decision-making, emphasizing self-determination and self-
management, to the extent possible;
(iii) Specify client conduct to be allowed or not allowed; and
(iv) Be available to all staff, clients, parents of minor children,
and legal guardians.
(2) To the extent possible, clients must participate in the
formulation of these policies and procedures.
(3) Clients must not discipline other clients, except as part of an
organized system of self-government, as set forth in facility policy.
(b) Standard: Management of inappropriate client behavior. (1) The
facility must develop and implement written policies and procedures that
govern the management of inappropriate client behavior. These policies
and procedures must be consistent with the provisions of paragraph (a)
of this section. These procedures must--
(i) Specify all facility approved interventions to manage
inappropriate client behavior;
(ii) Designate these interventions on a hierarchy to be implemented,
ranging from most positive or least intrusive, to least positive or most
intrusive;
(iii) Insure, prior to the use of more restrictive techniques, that
the client's record documents that programs incorporating the use of
less intrusive or more positive techniques have been tried
systematically and demonstrated to be ineffective; and
(iv) Address the following:
(A) The use of time-out rooms.
(B) The use of physical restraints.
(C) The use of drugs to manage inappropriate behavior.
(D) The application of painful or noxious stimuli.
(E) The staff members who may authorize the use of specified
interventions.
(F) A mechanism for monitoring and controlling the use of such
interventions.
(2) Interventions to manage inappropriate client behavior must be
employed with sufficient safeguards and supervision to ensure that the
safety, welfare and civil and human rights of clients are adequately
protected.
(3) Techniques to manage inappropriate client behavior must never be
used for disciplinary purposes, for the convenience of staff or as a
substitute for an active treatment program.
(4) The use of systematic interventions to manage inappropriate
client
[[Page 139]]
behavior must be incorporated into the client's individual program plan,
in accordance with Sec. 483.440(c) (4) and (5) of this subpart.
(5) Standing or as needed programs to control inappropriate behavior
are not permitted.
(c) Standard: Time-out rooms. (1) A client may be placed in a room
from which egress is prevented only if the following conditions are met:
(i) The placement is a part of an approved systematic time-out
program as required by paragraph (b) of this section. (Thus, emergency
placement of a client into a time-out room is not allowed.)
(ii) The client is under the direct constant visual supervision of
designated staff.
(iii) The door to the room is held shut by staff or by a mechanism
requiring constant physical pressure from a staff member to keep the
mechanism engaged.
(2) Placement of a client in a time-out room must not exceed one
hour.
(3) Clients placed in time-out rooms must be protected from
hazardous conditions including, but not limited to, presence of sharp
corners and objects, uncovered light fixtures, unprotected electrical
outlets.
(4) A record of time-out activities must be kept.
(d) Standard: Physical restraints. (1) The facility may employ
physical restraint only--
(i) As an integral part of an individual program plan that is
intended to lead to less restrictive means of managing and eliminating
the behavior for which the restraint is applied;
(ii) As an emergency measure, but only if absolutely necessary to
protect the client or others from injury; or
(iii) As a health-related protection prescribed by a physician, but
only if absolutely necessary during the conduct of a specific medical or
surgical procedure, or only if absolutely necessary for client
protection during the time that a medical condition exists.
(2) Authorizations to use or extend restraints as an emergency must
be:
(i) In effect no longer than 12 consecutive hours; and
(ii) Obtained as soon as the client is restrained or stable.
(3) The facility must not issue orders for restraint on a standing
or as needed basis.
(4) A client placed in restraint must be checked at least every 30
minutes by staff trained in the use of restraints, released from the
restraint as quickly as possible, and a record of these checks and usage
must be kept.
(5) Restraints must be designed and used so as not to cause physical
injury to the client and so as to cause the least possible discomfort.
(6) Opportunity for motion and exercise must be provided for a
period of not less than 10 minutes during each two hour period in which
restraint is employed, and a record of such activity must be kept.
(7) Barred enclosures must not be more than three feet in height and
must not have tops.
(e) Standard: Drug usage. (1) The facility must not use drugs in
doses that interfere with the individual client's daily living
activities.
(2) Drugs used for control of inappropriate behavior must be
approved by the interdisciplinary team and be used only as an integral
part of the client's individual program plan that is directed
specifically towards the reduction of and eventual elimination of the
behaviors for which the drugs are employed.
(3) Drugs used for control of inappropriate behavior must not be
used until it can be justified that the harmful effects of the behavior
clearly outweigh the potentially harmful effects of the drugs.
(4) Drugs used for control of inappropriate behavior must be--
(i) Monitored closely, in conjunction with the physician and the
drug regimen review requirement at Sec. 483.460(j), for desired
responses and adverse consequences by facility staff; and
(ii) Gradually withdrawn at least annually in a carefully monitored
program conducted in conjunction with the interdisciplinary team, unless
clinical evidence justifies that this is contraindicated.
[[Page 140]]
Sec. 483.460 Condition of participation: Health care services.
(a) Standard: Physician services. (1) The facility must ensure the
availability of physician services 24 hours a day.
(2) The physician must develop, in coordination with licensed
nursing personnel, a medical care plan of treatment for a client if the
physician determines that an individual client requires 24-hour licensed
nursing care. This plan must be integrated in the individual program
plan.
(3) The facility must provide or obtain preventive and general
medical care as well as annual physical examinations of each client that
at a minimum include the following:
(i) Evaluation of vision and hearing.
(ii) Immunizations, using as a guide the recommendations of the
Public Health Service Advisory Committee on Immunization Practices or of
the Committee on the Control of Infectious Diseases of the American
Academy of Pediatrics.
(iii) Routine screening laboratory examinations as determined
necessary by the physician, and special studies when needed.
(iv) Tuberculosis control, appropriate to the facility's population,
and in accordance with the recommendations of the American College of
Chest Physicians or the section of diseases of the chest of the American
Academy of Pediatrics, or both.
(4) To the extent permitted by State law, the facility may utilize
physician assistants and nurse practitioners to provide physician
services as described in this section.
(b) Standard: Physician participation in the individual program
plan. A physician must participate in--
(1) The establishment of each newly admitted client's initial
individual program plan as required by Sec. 456.380 of this chapter that
specified plan of care requirements for ICFs; and
(2) If appropriate, physicians must participate in the review and
update of an individual program plan as part of the interdisciplinary
team process either in person or through written report to the
interdisciplinary team.
(c) Standard: Nursing services. The facility must provide clients
with nursing services in accordance with their needs. These services
must include--
(1) Participation as appropriate in the development, review, and
update of an individual program plan as part of the interdisciplinary
team process;
(2) The development, with a physician, of a medical care plan of
treatment for a client when the physician has determined that an
individual client requires such a plan;
(3) For those clients certified as not needing a medical care plan,
a review of their health status which must--
(i) Be by a direct physical examination;
(ii) Be by a licensed nurse;
(iii) Be on a quarterly or more frequent basis depending on client
need;
(iv) Be recorded in the client's record; and
(v) Result in any necessary action (including referral to a
physician to address client health problems).
(4) Other nursing care as prescribed by the physician or as
identified by client needs; and
(5) Implementing, with other members of the interdisciplinary team,
appropriate protective and preventive health measures that include, but
are not limited to--
(i) Training clients and staff as needed in appropriate health and
hygiene methods;
(ii) Control of communicable diseases and infections, including the
instruction of other personnel in methods of infection control; and
(iii) Training direct care staff in detecting signs and symptoms of
illness or dysfunction, first aid for accidents or illness, and basic
skills required to meet the health needs of the clients.
(d) Standard: Nursing staff. (1) Nurses providing services in the
facility must have a current license to practice in the State.
(2) The facility must employ or arrange for licensed nursing
services sufficient to care for clients health needs including those
clients with medical care plans.
(3) The facility must utilize registered nurses as appropriate and
required by State law to perform the health services specified in this
section.
[[Page 141]]
(4) If the facility utilizes only licensed practical or vocational
nurses to provide health services, it must have a formal arrangement
with a registered nurse to be available for verbal or onsite
consultation to the licensed practical or vocational nurse.
(5) Non-licensed nursing personnel who work with clients under a
medical care plan must do so under the supervision of licensed persons.
(e) Standard: Dental services. (1) The facility must provide or make
arrangements for comprehensive diagnostic and treatment services for
each client from qualified personnel, including licensed dentists and
dental hygienists either through organized dental services in-house or
through arrangement.
(2) If appropriate, dental professionals must participate, in the
development, review and update of an individual program plan as part of
the interdisciplinary process either in person or through written report
to the interdisciplinary team.
(3) The facility must provide education and training in the
maintenance of oral health.
(f) Standard: Comprehensive dental diagnostic services.
Comprehensive dental diagnostic services include--
(1) A complete extraoral and intraoral examination, using all
diagnostic aids necessary to properly evaluate the client's oral
condition, not later than one month after admission to the facility
(unless the examination was completed within twelve months before
admission);
(2) Periodic examination and diagnosis performed at least annually,
including radiographs when indicated and detection of manifestations of
systemic disease; and
(3) A review of the results of examination and entry of the results
in the client's dental record.
(g) Standard: Comprehensive dental treatment. The facility must
ensure comprehensive dental treatment services that include--
(1) The availability for emergency dental treatment on a 24-hour-a-
day basis by a licensed dentist; and
(2) Dental care needed for relief of pain and infections,
restoration of teeth, and maintenance of dental health.
(h) Standard: Documentation of dental services. (1) If the facility
maintains an in-house dental service, the facility must keep a permanent
dental record for each client, with a dental summary maintained in the
client's living unit.
(2) If the facility does not maintain an in-house dental service,
the facility must obtain a dental summary of the results of dental
visits and maintain the summary in the client's living unit.
(i) Standard: Pharmacy services. The facility must provide or make
arrangements for the provision of routine and emergency drugs and
biologicals to its clients. Drugs and biologicals may be obtained from
community or contract pharmacists or the facility may maintain a
licensed pharmacy.
(j) Standard: Drug regimen review. (1) A pharmacist with input from
the interdisciplinary team must review the drug regimen of each client
at least quarterly.
(2) The pharmacist must report any irregularities in clients' drug
regimens to the prescribing physician and interdisciplinary team.
(3) The pharmacist must prepare a record of each client's drug
regimen reviews and the facility must maintain that record.
(4) An individual medication administration record must be
maintained for each client.
(5) As appropriate the pharmacist must participate in the
development, implementation, and review of each client's individual
program plan either in person or through written report to the
interdisciplinary team.
(k) Standard: Drug administration. The facility must have an
organized system for drug administration that identifies each drug up to
the point of administration. The system must assure that--
(1) All drugs are administered in compliance with the physician's
orders;
(2) All drugs, including those that are self-administered, are
administered without error;
(3) Unlicensed personnel are allowed to administer drugs only if
State law permits;
(4) Clients are taught how to administer their own medications if
the interdisciplinary team determines that self administration of
medications is
[[Page 142]]
an appropriate objective, and if the physician does not specify
otherwise;
(5) The client's physician is informed of the interdisciplinary
team's decision that self-administration of medications is an objective
for the client;
(6) No client self-administers medications until he or she
demonstrates the competency to do so;
(7) Drugs used by clients while not under the direct care of the
facility are packaged and labeled in accordance with State law; and
(8) Drug administration errors and adverse drug reactions are
recorded and reported immediately to a physician.
(l) Standard: Drug storage and recordkeeping. (1) The facility must
store drugs under proper conditions of sanitation, temperature, light,
humidity, and security.
(2) The facility must keep all drugs and biologicals locked except
when being prepared for administration. Only authorized persons may have
access to the keys to the drug storage area. Clients who have been
trained to self administer drugs in accordance with Sec. 483.460(k)(4)
may have access to keys to their individual drug supply.
(3) The facility must maintain records of the receipt and
disposition of all controlled drugs.
(4) The facility must, on a sample basis, periodically reconcile the
receipt and disposition of all controlled drugs in schedules II through
IV (drugs subject to the Comprehensive Drug Abuse Prevention and Control
Act of 1970, 21 U.S.C. 801 et seq., as implemented by 21 CFR part 308).
(5) If the facility maintains a licensed pharmacy, the facility must
comply with the regulations for controlled drugs.
(m) Standard: Drug labeling. (1) Labeling of drugs and biologicals
must--
(i) Be based on currently accepted professional principles and
practices; and
(ii) Include the appropriate accessory and cautionary instructions,
as well as the expiration date, if applicable.
(2) The facility must remove from use--
(i) Outdated drugs; and
(ii) Drug containers with worn, illegible, or missing labels.
(3) Drugs and biologicals packaged in containers designated for a
particular client must be immediately removed from the client's current
medication supply if discontinued by the physician.
(n) Standard: Laboratory services. (1) If a facility chooses to
provide laboratory services, the laboratory must meet the requirements
specified in part 493 of this chapter.
(2) If the laboratory chooses to refer specimens for testing to
another laboratory, the referral laboratory must be certified in the
appropriate specialties and subspecialities of service in accordance
with the requirements of part 493 of this chapter.
[53 FR 20496, June 3, 1988, as amended at 57 FR 7136, Feb. 28, 1992]
Sec. 483.470 Condition of participation: Physical environment.
(a) Standard: Client living environment. (1) The facility must not
house clients of grossly different ages, developmental levels, and
social needs in close physical or social proximity unless the housing is
planned to promote the growth and development of all those housed
together.
(2) The facility must not segregate clients solely on the basis of
their physical disabilities. It must integrate clients who have
ambulation deficits or who are deaf, blind, or have seizure disorders,
etc., with others of comparable social and intellectual development.
(b) Standard: Client bedrooms. (1) Bedrooms must--
(i) Be rooms that have at least one outside wall;
(ii) Be equipped with or located near toilet and bathing facilities;
(iii) Accommodate no more than four clients unless granted a
variance under paragraph (b)(3) of this section;
(iv) Measure at least 60 square feet per client in multiple client
bedrooms and at least 80 square feet in single client bedrooms; and
(v) In all facilities initially certified, or in buildings
constructed or with major renovations or conversions on or after October
3, 1988, have walls that extend from floor to ceiling.
(2) If a bedroom is below grade level, it must have a window that--
[[Page 143]]
(i) Is usable as a second means of escape by the client(s) occupying
the room; and
(ii) Is no more than 44 inches (measured to the window sill) above
the floor unless the facility is surveyed under the Health Care
Occupancy Chapter of the Life Safety Code, in which case the window must
be no more than 36 inches (measured to the window sill) above the floor.
(3) The survey agency may grant a variance from the limit of four
clients per room only if a physician who is a member of the
interdisciplinary team and who is a qualified intellectual disability
professional--
(i) Certifies that each client to be placed in a bedroom housing
more than four persons is so severely medically impaired as to require
direct and continuous monitoring during sleeping hours; and
(ii) Documents the reasons why housing in a room of only four or
fewer persons would not be medically feasible.
(4) The facility must provide each client with--
(i) A separate bed of proper size and height for the convenience of
the client;
(ii) A clean, comfortable, mattress;
(iii) Bedding appropriate to the weather and climate; and
(iv) Functional furniture appropriate to the client's needs, and
individual closet space in the client's bedroom with clothes racks and
shelves accessible to the client.
(c) Standard: Storage space in bedroom. The facility must provide--
(1) Space and equipment for daily out-of-bed activity for all
clients who are not yet mobile, except those who have a short-term
illness or those few clients for whom out-of-bed activity is a threat to
health and safety; and
(2) Suitable storage space, accessible to clients, for personal
possessions, such as TVs, radios, prosthetic equipment and clothing.
(d) Standard: Client bathrooms. The facility must--
(1) Provide toilet and bathing facilities appropriate in number,
size, and design to meet the needs of the clients;
(2) Provide for individual privacy in toilets, bathtubs, and
showers; and
(3) In areas of the facility where clients who have not been trained
to regulate water temperature are exposed to hot water, ensure that the
temperature of the water does not exceed 110 [deg]Fahrenheit.
(e) Standard: Heating and ventilation. (1) Each client bedroom in
the facility must have--
(i) At least one window to the outside; and
(ii) Direct outside ventilation by means of windows, air
conditioning, or mechanical ventilation.
(2) The facility must--
(i) Maintain the temperature and humidity within a normal comfort
range by heating, air conditioning or other means; and
(ii) Ensure that the heating apparatus does not constitute a burn or
smoke hazard to clients.
(f) Standard: Floors. The facility must have--
(1) Floors that have a resilient, nonabrasive, and slip-resistant
surface;
(2) Nonabrasive carpeting, if the area used by clients is carpeted
and serves clients who lie on the floor or ambulate with parts of their
bodies, other than feet, touching the floor; and
(3) Exposed floor surfaces and floor coverings that promote mobility
in areas used by clients, and promote maintenance of sanitary
conditions.
(g) Standard: Space and equipment. The facility must--
(1) Provide sufficient space and equipment in dining, living, health
services, recreation, and program areas (including adequately equipped
and sound treated areas for hearing and other evaluations if they are
conducted in the facility) to enable staff to provide clients with
needed services as required by this subpart and as identified in each
client's individual program plan.
(2) Furnish, maintain in good repair, and teach clients to use and
to make informed choices about the use of dentures, eyeglasses, hearing
and other communications aids, braces, and other devices identified by
the interdisciplinary team as needed by the client.
(3) Provide adequate clean linen and dirty linen storage areas.
(h) [Reserved]
[[Page 144]]
(i) Standard: Evacuation drills. (1) The facility must hold
evacuation drills at least quarterly for each shift of personnel and
under varied conditions to--
(i) Ensure that all personnel on all shifts are trained to perform
assigned tasks;
(ii) Ensure that all personnel on all shifts are familiar with the
use of the facility's fire protection features; and
(iii) Evaluate the effectiveness of emergency and disaster plans and
procedures.
(2) The facility must--
(i) Actually evacuate clients during at least one drill each year on
each shift;
(ii) Make special provisions for the evacuation of clients with
physical disabilities;
(iii) File a report and evaluation on each evacuation drill;
(iv) Investigate all problems with evacuation drills, including
accidents, and take corrective action; and
(v) During fire drills, clients may be evacuated to a safe area in
facilities certified under the Health Care Occupancies Chapter of the
Life Safety Code.
(3) Facilities must meet the requirements of paragraphs (i)(1) and
(2) of this section for any live-in and relief staff they utilize.
(j) Standard: Fire protection--(1) General. Except as otherwise
provided in this section--
(i) The facility must meet the applicable provisions of either the
Health Care Occupancies Chapters or the Residential Board and Care
Occupancies Chapter and must proceed in accordance with the Life Safety
Code (NFPA 101 and Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA
12-3, and TIA 12-4.)
(ii) Notwithstanding paragraph (j)(1)(i) of this section, corridor
doors and doors to rooms containing flammable or combustible materials
must be provided with positive latching hardware. Roller latches are
prohibited on such doors.
(iii) Chapters 32.3.2.11.2 and 33.3.2.11.2 of the adopted 2012 Life
Safety Code do not apply to a facility.
(iv) Beginning July 5, 2019, an ICF-IID must be in compliance with
Chapter 33.2.3.5.7.1, Sprinklers in attics, or Chapter 33.2.3.5.7.2,
Heat detection systems in attics of the Life Safety Code.
(2) The State survey agency may apply a single chapter of the LSC to
the entire facility or may apply different chapters to different
buildings or parts of buildings as permitted by the LSC.
(3) A facility that meets the LSC definition of a residential board
and care occupancy must have its evacuation capability evaluated in
accordance with the Evacuation Difficulty Index of the Fire Safety
Evaluation System for Board and Care facilities (FSES/BC).
(4) If CMS finds that the State has a fire and safety code imposed
by State law that adequately protects a facility's clients, CMS may
allow the State survey agency to apply the State's fire and safety code
instead of the LSC.
(5) Facilities that meet the Life Safety Code definition of a health
care occupancy. (i) In consideration of a recommendation by the State
survey agency or Accrediting Organization or at the discretion of the
Secretary, may waive, for periods deemed appropriate, specific
provisions of the Life Safety Code, which would result in unreasonable
hardship upon a residential board and care facility, but only if the
waiver will not adversely affect the health and safety of the patients.
(ii) A facility may install alcohol-based hand rub dispensers if the
dispensers are installed in a manner that adequately protects against
inappropriate access.
(iii) When a sprinkler system is shut down for more than 10 hours,
the ICF-IID must:
(A) Evacuate the building or portion of the building affected by the
system outage until the system is back in service, or
(B) Establish a fire watch until the system is back in service.
(iv) Beginning July 5, 2019, an ICF-IID must be in compliance with
Chapter 33.2.3.5.7.1, sprinklers in attics, or Chapter 33.2.3.5.7.2,
heat detection systems in attics of the Life Safety Code.
(v) Except as otherwise provided in this section, ICF-IIDs must meet
the applicable provisions and must proceed in accordance with the Health
Care Facilities Code (NFPA 99 and Tentative
[[Page 145]]
Interim Amendments TIA 12-2, TIA 12-3, TIA 12-4, TIA 12-5 and TIA 12-6).
(A) Chapter 7,8,12 and 13 of the adopted Health Care Facilities Code
does not apply to an ICF-IID.
(B) If application of the Health Care Facilities Code required under
paragraph (j)(5)(iv) of this section would result in unreasonable
hardship for the ICF-IID, CMS may waive specific provisions of the
Health Care Facilities Code, but only if the waiver does not adversely
affect the health and safety of clients.
(k) Standard: Paint. The facility must--
(1) Use lead-free paint inside the facility; and
(2) Remove or cover interior paint or plaster containing lead so
that it is not accessible to clients.
(l) Standard: Infection control. (1) The facility must provide a
sanitary environment to avoid sources and transmission of infections.
There must be an active program for the prevention, control, and
investigation of infection and communicable diseases.
(2) The facility must implement successful corrective action in
affected problem areas.
(3) The facility must maintain a record of incidents and corrective
actions related to infections.
(4) The facility must prohibit employees with symptoms or signs of a
communicable disease from direct contact with clients and their food.
(m) The standards incorporated by reference in this section are
approved for incorporation by reference by the Director of the Office of
the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part
51. You may inspect a copy at the CMS Information Resource Center, 7500
Security Boulevard, Baltimore, MD or at the National Archives and
Records Administration (NARA). For information on the availability of
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html. If any changes in this edition of the Code are
incorporated by reference, CMS will publish a document in the Federal
Register to announce the changes.
(1) National Fire Protection Association, 1 Batterymarch Park,
Quincy, MA 02169, www.nfpa.org, 1.617.770.3000.
(i) NFPA 99, Standards for Health Care Facilities Code of the
National Fire Protection Association 99, 2012 edition, issued August 11,
2011.
(ii) TIA 12-2 to NFPA 99, issued August 11, 2011.
(iii) TIA 12-3 to NFPA 99, issued August 9, 2012.
(iv) TIA 12-4 to NFPA 99, issued March 7, 2013.
(v) TIA 12-5 to NFPA 99, issued August 1, 2013.
(vi) TIA 12-6 to NFPA 99, issued March 3, 2014.
(vii) NFPA 101, Life Safety Code, 2012 edition, issued August 11,
2011;
(viii) TIA 12-1 to NFPA 101, issued August 11, 2011.
(ix) TIA 12-2 to NFPA 101, issued October 30, 2012.
(x) TIA 12-3 to NFPA 101, issued October 22, 2013.
(xi) TIA 12-4 to NFPA 101, issued October 22, 2013.
(2) [Reserved]
[53 FR 20496, June 3, 1988. Redesignated at 56 FR 48918, Sept. 26, 1991,
as amended at 68 FR 1387, Jan. 10, 2003; 69 FR 49271, Aug. 11, 2004; 70
FR 15239, Mar. 25, 2005; 71 FR 55340, Sept. 22, 2006; 81 FR 26900, May
4, 2016; 81 FR 64032, Sept. 16, 2016]
Sec. 483.475 Condition of participation: Emergency preparedness.
The Intermediate Care Facility for Individuals with Intellectual
Disabilities (ICF/IID) must comply with all applicable Federal, State,
and local emergency preparedness requirements. The ICF/IID must
establish and maintain an emergency preparedness program that meets the
requirements of this section. The emergency preparedness program must
include, but not be limited to, the following elements:
(a) Emergency plan. The ICF/IID must develop and maintain an
emergency preparedness plan that must be reviewed, and updated at least
annually. The plan must do all of the following:
(1) Be based on and include a documented, facility-based and
community-based risk assessment, utilizing an all-hazards approach,
including missing clients.
[[Page 146]]
(2) Include strategies for addressing emergency events identified by
the risk assessment.
(3) Address the special needs of its client population, including,
but not limited to, persons at-risk; the type of services the ICF/IID
has the ability to provide in an emergency; and continuity of
operations, including delegations of authority and succession plans.
(4) Include a process for cooperation and collaboration with local,
tribal, regional, State, and Federal emergency preparedness officials'
efforts to maintain an integrated response during a disaster or
emergency situation, including documentation of the ICF/IID efforts to
contact such officials and, when applicable, of its participation in
collaborative and cooperative planning efforts.
(b) Policies and procedures. The ICF/IID must develop and implement
emergency preparedness policies and procedures, based on the emergency
plan set forth in paragraph (a) of this section, risk assessment at
paragraph (a)(1) of this section, and the communication plan at
paragraph (c) of this section. The policies and procedures must be
reviewed and updated at least annually. At a minimum, the policies and
procedures must address the following:
(1) The provision of subsistence needs for staff and clients,
whether they evacuate or shelter in place, include, but are not limited
to the following:
(i) Food, water, medical, and pharmaceutical supplies.
(ii) Alternate sources of energy to maintain the following:
(A) Temperatures to protect client health and safety and for the
safe and sanitary storage of provisions.
(B) Emergency lighting.
(C) Fire detection, extinguishing, and alarm systems.
(D) Sewage and waste disposal.
(2) A system to track the location of on-duty staff and sheltered
clients in the ICF/IID's care during and after an emergency. If on-duty
staff and sheltered clients are relocated during the emergency, the ICF/
IID must document the specific name and location of the receiving
facility or other location.
(3) Safe evacuation from the ICF/IID, which includes consideration
of care and treatment needs of evacuees; staff responsibilities;
transportation; identification of evacuation location(s); and primary
and alternate means of communication with external sources of
assistance.
(4) A means to shelter in place for clients, staff, and volunteers
who remain in the facility.
(5) A system of medical documentation that preserves client
information, protects confidentiality of client information, and secures
and maintains the availability of records.
(6) The use of volunteers in an emergency or other emergency
staffing strategies, including the process and role for integration of
State or Federally designated health care professionals to address surge
needs during an emergency.
(7) The development of arrangements with other ICF/IIDs or other
providers to receive clients in the event of limitations or cessation of
operations to maintain the continuity of services to ICF/IID clients.
(8) The role of the ICF/IID under a waiver declared by the
Secretary, in accordance with section 1135 of the Act, in the provision
of care and treatment at an alternate care site identified by emergency
management officials.
(c) Communication plan. The ICF/IID must develop and maintain an
emergency preparedness communication plan that complies with Federal,
State, and local laws and must be reviewed and updated at least
annually. The communication plan must include the following:
(1) Names and contact information for the following:
(i) Staff.
(ii) Entities providing services under arrangement.
(iii) Clients' physicians.
(iv) Other ICF/IIDs.
(v) Volunteers.
(2) Contact information for the following:
(i) Federal, State, tribal, regional, and local emergency
preparedness staff.
(ii) Other sources of assistance.
(iii) The State Licensing and Certification Agency.
[[Page 147]]
(iv) The State Protection and Advocacy Agency.
(3) Primary and alternate means for communicating with the ICF/IID's
staff, Federal, State, tribal, regional, and local emergency management
agencies.
(4) A method for sharing information and medical documentation for
clients under the ICF/IID's care, as necessary, with other health care
providers to maintain the continuity of care.
(5) A means, in the event of an evacuation, to release client
information as permitted under 45 CFR 164.510(b)(1)(ii).
(6) A means of providing information about the general condition and
location of clients under the facility's care as permitted under 45 CFR
164.510(b)(4).
(7) A means of providing information about the ICF/IID's occupancy,
needs, and its ability to provide assistance, to the authority having
jurisdiction, the Incident Command Center, or designee.
(8) A method for sharing information from the emergency plan that
the facility has determined is appropriate with clients and their
families or representatives.
(d) Training and testing. The ICF/IID must develop and maintain an
emergency preparedness training and testing program that is based on the
emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, policies and procedures
at paragraph (b) of this section, and the communication plan at
paragraph (c) of this section. The training and testing program must be
reviewed and updated at least annually. The ICF/IID must meet the
requirements for evacuation drills and training at Sec. 483.470(h).
(1) Training program. The ICF/IID must do all the following:
(i) Initial training in emergency preparedness policies and
procedures to all new and existing staff, individuals providing services
under arrangement, and volunteers, consistent with their expected roles.
(ii) Provide emergency preparedness training at least annually.
(iii) Maintain documentation of the training.
(iv) Demonstrate staff knowledge of emergency procedures.
(2) Testing. The ICF/IID must conduct exercises to test the
emergency plan at least annually. The ICF/IID must do the following:
(i) Participate in a full-scale exercise that is community-based or
when a community-based exercise is not accessible, an individual,
facility-based. If the ICF/IID experiences an actual natural or man-made
emergency that requires activation of the emergency plan, the ICF/IID is
exempt from engaging in a community-based or individual, facility-based
full-scale exercise for 1 year following the onset of the actual event.
(ii) Conduct an additional exercise that may include, but is not
limited to the following:
(A) A second full-scale exercise that is community-based or
individual, facility-based.
(B) A tabletop exercise that includes a group discussion led by a
facilitator, using a narrated, clinically-relevant emergency scenario,
and a set of problem statements, directed messages, or prepared
questions designed to challenge an emergency plan.
(iii) Analyze the ICF/IID's response to and maintain documentation
of all drills, tabletop exercises, and emergency events, and revise the
ICF/IID's emergency plan, as needed.
(e) Integrated healthcare systems. If an ICF/IID is part of a
healthcare system consisting of multiple separately certified healthcare
facilities that elects to have a unified and integrated emergency
preparedness program, the ICF/IID may choose to participate in the
healthcare system's coordinated emergency preparedness program. If
elected, the unified and integrated emergency preparedness program must
do all of the following:
(1) Demonstrate that each separately certified facility within the
system actively participated in the development of the unified and
integrated emergency preparedness program.
(2) Be developed and maintained in a manner that takes into account
each separately certified facility's unique circumstances, patient
populations, and services offered.
(3) Demonstrate that each separately certified facility is capable
of actively
[[Page 148]]
using the unified and integrated emergency preparedness program and is
in compliance with the program.
(4) Include a unified and integrated emergency plan that meets the
requirements of paragraphs (a)(2), (3), and (4) of this section. The
unified and integrated emergency plan must also be based on and include
all of the following:
(i) A documented community-based risk assessment, utilizing an all-
hazards approach.
(ii) A documented individual facility-based risk assessment for each
separately certified facility within the health system, utilizing an
all-hazards approach.
(5) Include integrated policies and procedures that meet the
requirements set forth in paragraph (b) of this section, a coordinated
communication plan and training and testing programs that meet the
requirements of paragraphs (c) and (d) of this section, respectively.
[81 FR 64032, Sept. 16, 2016]
Sec. 483.480 Condition of participation: Dietetic services.
(a) Standard: Food and nutrition services. (1) Each client must
receive a nourishing, well-balanced diet including modified and
specially-prescribed diets.
(2) A qualified dietitian must be employed either full-time, part-
time, or on a consultant basis at the facility's discretion.
(3) If a qualified dietitian is not employed full-time, the facility
must designate a person to serve as the director of food services.
(4) The client's interdisciplinary team, including a qualified
dietitian and physician, must prescribe all modified and special diets
including those used as a part of a program to manage inappropriate
client behavior.
(5) Foods proposed for use as a primary reinforcement of adaptive
behavior are evaluated in light of the client's nutritional status and
needs.
(6) Unless otherwise specified by medical needs, the diet must be
prepared at least in accordance with the latest edition of the
recommended dietary allowances of the Food and Nutrition Board of the
National Research Council, National Academy of Sciences, adjusted for
age, sex, disability and activity.
(b) Standard: Meal services. (1) Each client must receive at least
three meals daily, at regular times comparable to normal mealtimes in
the community with--
(i) Not more than 14 hours between a substantial evening meal and
breakfast of the following day, except on weekends and holidays when a
nourishing snack is provided at bedtime, 16 hours may elapse between a
substantial evening meal and breakfast; and
(ii) Not less than 10 hours between breakfast and the evening meal
of the same day, except as provided under paragraph (b)(1)(i) of this
section.
(2) Food must be served--
(i) In appropriate quantity;
(ii) At appropriate temperature;
(iii) In a form consistent with the developmental level of the
client; and
(iv) With appropriate utensils.
(3) Food served to clients individually and uneaten must be
discarded.
(c) Standard: Menus. (1) Menus must--
(i) Be prepared in advance;
(ii) Provide a variety of foods at each meal;
(iii) Be different for the same days of each week and adjusted for
seasonal changes; and
(iv) Include the average portion sizes for menu items.
(2) Menus for food actually served must be kept on file for 30 days.
(d) Standard: Dining areas and service. The facility must--
(1) Serve meals for all clients, including persons with ambulation
deficits, in dining areas, unless otherwise specified by the
interdisciplinary team or a physician;
(2) Provide table service for all clients who can and will eat at a
table, including clients in wheelchairs;
(3) Equip areas with tables, chairs, eating utensils, and dishes
designed to meet the developmental needs of each client;
(4) Supervise and staff dining rooms adequately to direct self-help
dining procedure, to assure that each client receives enough food and to
assure that each client eats in a manner consistent with his or her
developmental level: and
[[Page 149]]
(5) Ensure that each client eats in an upright position, unless
otherwise specified by the interdisciplinary team or a physician.
PART 484_HOME HEALTH SERVICES--Table of Contents
Subpart A_General Provisions
Sec.
484.1 Basis and scope.
484.2 Definitions.
484.4 Personnel qualifications.
Subpart B_Administration
484.10 Condition of participation: Patient rights.
484.11 Condition of participation: Release of patient identifiable
OASIS information.
484.12 Condition of participation: Compliance with Federal, State, and
local laws, disclosure and ownership information, and accepted
professional standards and principles.
484.14 Condition of participation: Organization, services, and
administration.
484.16 Condition of participation: Group of professional personnel.
484.18 Condition of participation: Acceptance of patients, plan of
care, and medical supervision.
484.20 Condition of participation: Reporting OASIS information.
484.22 Condition of participation: Emergency preparedness.
Subpart C_Furnishing of Services
484.30 Condition of participation: Skilled nursing services.
484.32 Condition of participation: Therapy services.
484.34 Condition of participation: Medical social services.
484.36 Condition of participation: Home health aide services.
484.38 Condition of participation: Qualifying to furnish outpatient
physical therapy or speech pathology services.
484.48 Condition of participation: Clinical records.
484.52 Condition of participation: Evaluation of the agency's program.
484.55 Condition of participation: Comprehensive assessment of
patients.
Subpart D [Reserved]
Subpart E_Prospective Payment System for Home Health Agencies
484.200 Basis and scope.
484.202 Definitions.
484.205 Basis of payment.
484.210 Data used for the calculation of the national prospective 60-
day episode payment.
484.215 Initial establishment of the calculation of the national 60-day
episode payment.
484.220 Calculation of the national adjusted prospective 60-day episode
payment rate for case-mix and area wage levels.
484.225 Annual update of the unadjusted national prospective 60-day
episode payment rate.
484.230 Methodology used for the calculation of the low-utilization
payment adjustment.
484.235 Methodology used for the calculation of the partial episode
payment adjustment.
484.240 Methodology used for the calculation of the outlier payment.
484.245 [Reserved]
484.250 Patient assessment data.
484.260 Limitation on review.
484.265 Additional payment.
Subpart F_Home Health Value-Based Purchasing (HHVBP) Model Components
for Competing Home Health Agencies Within State Boundaries
484.300 Basis and scope of subpart.
484.305 Definitions.
484.310 Applicability of the Home Health Value-Based Purchasing (HHVBP)
Model.
484.315 Data reporting for measures and evaluation under the Home
Health Value-Based Purchasing (HHVBP) Model.
484.320 Calculation of the Total Performance Score.
484.325 Payments for home health services under Home Health Value-Based
Purchasing (HHVBP) Model.
484.330 Process for determining and applying the value-based payment
adjustment under the Home Health Value-Based Purchasing
(HHVBP) Model.
484.335 Appeals process for the Home Health Value-Based Purchasing
(HHVBP) Model.
Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C.
1302 and 1395(hh)) unless otherwise indicated.
Source: 54 FR 33367, Aug. 14, 1989, unless otherwise noted.
Subpart A_General Provisions
Sec. 484.1 Basis and scope.
(a) Basis and scope. This part is based on the indicated provisions
of the following sections of the Act:
(1) Sections 1861(o) and 1891 establish the conditions that an HHA
must meet in order to participate in Medicare.
[[Page 150]]
(2) Section 1861(z) specifies the Institutional planning standards
that HHAs must meet.
(3) Section 1895 provides for the establishment of a prospective
payment system for home health services covered under Medicare.
(b) This part also sets forth additional requirements that are
considered necessary to ensure the health and safety of patients.
[60 FR 50443, Sept. 29, 1995, as amended at 65 FR 41211, July 3, 2000]
Sec. 484.2 Definitions.
As used in this part, unless the context indicates otherwise--Bylaws
or equivalent means a set of rules adopted by an HHA for governing the
agency's operation.
Branch office means a location or site from which a home health
agency provides services within a portion of the total geographic area
served by the parent agency. The branch office is part of the home
health agency and is located sufficiently close to share administration,
supervision, and services in a manner that renders it unnecessary for
the branch independently to meet the conditions of participation as a
home health agency.
Clinical note means a notation of a contact with a patient that is
written and dated by a member of the health team, and that describes
signs and symptoms, treatment and drugs administered and the patient's
reaction, and any changes in physical or emotional condition.
HHA stands for home health agency.
Nonprofit agency means an agency exempt from Federal income taxation
under section 501 of the Internal Revenue Code of 1954.
Parent home health agency means the agency that develops and
maintains administrative controls of subunits and/or branch offices.
Primary home health agency means the agency that is responsible for
the services furnished to patients and for implementation of the plan of
care.
Progress note means a written notation, dated and signed by a member
of the health team, that summarizes facts about care furnished and the
patient's response during a given period of time.
Proprietary agency means a private profit-making agency licensed by
the State.
Public agency means an agency operated by a State or local
government.
Subdivision means a component of a multi-function health agency,
such as the home care department of a hospital or the nursing division
of a health department, which independently meets the conditions of
participation for HHAs. A subdivision that has subunits or branch
offices is considered a parent agency.
Subunit means a semi-autonomous organization that--
(1) Serves patients in a geographic area different from that of the
parent agency; and
(2) Must independently meet the conditions of participation for HHAs
because it is too far from the parent agency to share administration,
supervision, and services on a daily basis.
Summary report means the compilation of the pertinent factors of a
patient's clinical notes and progress notes that is submitted to the
patient's physician.
Supervision means authoritative procedural guidance by a qualified
person for the accomplishment of a function or activity. Unless
otherwise specified in this part, the supervisor must be on the premises
to supervise an individual who does not meet the qualifications
specified in Sec. 484.4.
Sec. 484.4 Personnel qualifications.
Staff required to meet the conditions set forth in this part are
staff who meet the qualifications specified in this section.
Administrator, home health agency. A person who:
(a) Is a licensed physician; or
(b) Is a registered nurse; or
(c) Has training and experience in health service administration and
at least 1 year of supervisory or administrative experience in home
health care or related health programs.
Audiologist. A person who:
(a) Meets the education and experience requirements for a
Certificate of Clinical Competence in audiology granted by the American
Speech-Language-Hearing Association; or
[[Page 151]]
(b) Meets the educational requirements for certification and is in
the process of accumulating the supervised experience required for
certification.
Home health aide. Effective for services furnished after August 14,
1990, a person who has successfully completed a State-established or
other training program that meets the requirements of Sec. 484.36(a) and
a competency evaluation program or State licensure program that meets
the requirements of Sec. 484.36 (b) or (e), or a competency evaluation
program or State licensure program that meets the requirements of
Sec. 484.36 (b) or (e). An individual is not considered to have
completed a training and competency evaluation program, or a competency
evaluation program if, since the individual's most recent completion of
this program(s), there has been a continuous period of 24 consecutive
months during none of which the individual furnished services described
in Sec. 409.40 of this chapter for compensation.
Occupational therapist. A person who--
(a)(1) Is licensed or otherwise regulated, if applicable, as an
occupational therapist by the State in which practicing, unless
licensure does not apply;
(2) Graduated after successful completion of an occupational
therapist education program accredited by the Accreditation Council for
Occupational Therapy Education (ACOTE) of the American Occupational
Therapy Association, Inc. (AOTA), or successor organizations of ACOTE;
and
(3) Is eligible to take, or has successfully completed the entry-
level certification examination for occupational therapists developed
and administered by the National Board for Certification in Occupational
Therapy, Inc. (NBCOT).
(b) On or before December 31, 2009--
(1) Is licensed or otherwise regulated, if applicable, as an
occupational therapist by the State in which practicing; or
(2) When licensure or other regulation does not apply--
(i) Graduated after successful completion of an occupational
therapist education program accredited by the Accreditation Council for
Occupational Therapy Education (ACOTE) of the American Occupational
Therapy Association, Inc. (AOTA) or successor organizations of ACOTE;
and
(ii) Is eligible to take, or has successfully completed the entry-
level certification examination for occupational therapists developed
and administered by the National Board for Certification in Occupational
Therapy, Inc., (NBCOT).
(c) On or before January 1, 2008--
(1) Graduated after successful completion of an occupational therapy
program accredited jointly by the committee on Allied Health Education
and Accreditation of the American Medical Association and the American
Occupational Therapy Association; or
(2) Is eligible for the National Registration Examination of the
American Occupational Therapy Association or the National Board for
Certification in Occupational Therapy.
(d) On or before December 31, 1977--
(1) Had 2 years of appropriate experience as an occupational
therapist; and
(2) Had achieved a satisfactory grade on an occupational therapist
proficiency examination conducted, approved, or sponsored by the U.S.
Public Health Service.
(e) If educated outside the United States, must meet all of the
following:
(1) Graduated after successful completion of an occupational
therapist education program accredited as substantially equivalent to
occupational therapist entry level education in the United States by one
of the following:
(i) The Accreditation Council for Occupational Therapy Education
(ACOTE).
(ii) Successor organizations of ACOTE.
(iii) The World Federation of Occupational Therapists.
(iv) A credentialing body approved by the American Occupational
Therapy Association.
(2) Successfully completed the entry-level certification examination
for occupational therapists developed and administered by the National
Board for Certification in Occupational Therapy, Inc. (NBCOT).
(3) On or before December 31, 2009, is licensed or otherwise
regulated, if applicable, as an occupational therapist by the State in
which practicing.
[[Page 152]]
Occupational therapy assistant. A person who--
(a) Meets all of the following:
(1) Is licensed, unless licensure does not apply, or otherwise
regulated, if applicable, as an occupational therapy assistant by the
State in which practicing.
(2) Graduated after successful completion of an occupational therapy
assistant education program accredited by the Accreditation Council for
Occupational Therapy Education, (ACOTE) of the American Occupational
Therapy Association, Inc. (AOTA) or its successor organizations.
(3) Is eligible to take or successfully completed the entry-level
certification examination for occupational therapy assistants developed
and administered by the National Board for Certification in Occupational
Therapy, Inc. (NBCOT).
(b) On or before December 31, 2009--
(1) Is licensed or otherwise regulated as an occupational therapy
assistant, if applicable, by the State in which practicing; or any
qualifications defined by the State in which practicing, unless
licensure does not apply; or
(2) Must meet both of the following:
(i) Completed certification requirements to practice as an
occupational therapy assistant established by a credentialing
organization approved by the American Occupational Therapy Association.
(ii) After January 1, 2010, meets the requirements in paragraph (a)
of this section.
(c) After December 31, 1977 and on or before December 31, 2007--
(1) Completed certification requirements to practice as an
occupational therapy assistant established by a credentialing
organization approved by the American Occupational Therapy Association;
or
(2) Completed the requirements to practice as an occupational
therapy assistant applicable in the State in which practicing.
(d) On or before December 31, 1977--
(1) Had 2 years of appropriate experience as an occupational therapy
assistant; and
(2) Had achieved a satisfactory grade on an occupational therapy
assistant proficiency examination conducted, approved, or sponsored by
the U.S. Public Health Service.
(e) If educated outside the United States, on or after January 1,
2008--
(1) Graduated after successful completion of an occupational therapy
assistant education program that is accredited as substantially
equivalent to occupational therapist assistant entry level education in
the United States by--
(i) The Accreditation Council for Occupational Therapy Education
(ACOTE).
(ii) Its successor organizations.
(iii) The World Federation of Occupational Therapists.
(iv) By a credentialing body approved by the American Occupational
Therapy Association; and
(2) Successfully completed the entry-level certification examination
for occupational therapy assistants developed and administered by the
National Board for Certification in Occupational Therapy, Inc. (NBCOT).
Physical therapist. A person who is licensed, if applicable, by the
State in which practicing, unless licensure does not apply and meets one
of the following requirements:
(a)(1) Graduated after successful completion of a physical therapist
education program approved by one of the following:
(i) The Commission on Accreditation in Physical Therapy Education
(CAPTE).
(ii) Successor organizations of CAPTE.
(iii) An education program outside the United States determined to
be substantially equivalent to physical therapist entry-level education
in the United States by a credentials evaluation organization approved
by the American Physical Therapy Association or an organization
identified in 8 CFR 212.15(e) as it relates to physical therapists; and
(2) Passed an examination for physical therapists approved by the
State in which physical therapy services are provided.
(b) On or before December 31, 2009--
(1) Graduated after successful completion of a physical therapy
curriculum approved by the Commission
[[Page 153]]
on Accreditation in Physical Therapy Education (CAPTE); or
(2) Meets both of the following:
(i) Graduated after successful completion of an education program
determined to be substantially equivalent to physical therapist entry
level education in the United States by a credentials evaluation
organization approved by the American Physical Therapy Association or
identified in 8 CFR 212.15(e) as it relates to physical therapists.
(ii) Passed an examination for physical therapists approved by the
State in which physical therapy services are provided.
(c) Before January 1, 2008--
(1) Graduated from a physical therapy curriculum approved by one of
the following:
(i) The American Physical Therapy Association.
(ii) The Committee on Allied Health Education and Accreditation of
the American Medical Association.
(iii) The Council on Medical Education of the American Medical
Association and the American Physical Therapy Association.
(d) On or before December 31, 1977 was licensed or qualified as a
physical therapist and meets both of the following:
(1) Has 2 years of appropriate experience as a physical therapist.
(2) Has achieved a satisfactory grade on a proficiency examination
conducted, approved, or sponsored by the U.S. Public Health Service.
(e) Before January 1, 1966--
(1) Was admitted to membership by the American Physical Therapy
Association; or
(2) Was admitted to registration by the American Registry of
Physical Therapists; or
(3) Has graduated from a physical therapy curriculum in a 4-year
college or university approved by a State department of education.
(f) Before January 1, 1966 was licensed or registered, and before
January 1, 1970, had 15 years of full-time experience in the treatment
of illness or injury through the practice of physical therapy in which
services were rendered under the order and direction of attending and
referring doctors of medicine or osteopathy.
(g) If trained outside the United States before January 1, 2008,
meets the following requirements:
(1) Was graduated since 1928 from a physical therapy curriculum
approved in the country in which the curriculum was located and in which
there is a member organization of the World Confederation for Physical
Therapy.
(2) Meets the requirements for membership in a member organization
of the World Confederation for Physical Therapy.
Physical therapist assistant. A person who is licensed, unless
licensure does not apply, registered, or certified as a physical
therapist assistant, if applicable, by the State in which practicing,
and meets one of the following requirements:
(a)(1) Graduated from a physical therapist assistant curriculum
approved by the Commission on Accreditation in Physical Therapy
Education of the American Physical Therapy Association; or if educated
outside the United States or trained in the United States military,
graduated from an education program determined to be substantially
equivalent to physical therapist assistant entry level education in the
United States by a credentials evaluation organization approved by the
American Physical Therapy Association or identified at 8 CFR 212.15(e);
and
(2) Passed a national examination for physical therapist assistants.
(b) On or before December 31, 2009, meets one of the following:
(1) Is licensed, or otherwise regulated in the State in which
practicing.
(2) In States where licensure or other regulations do not apply,
graduated on or before December 31, 2009, from a 2-year college-level
program approved by the American Physical Therapy Association and,
effective January 1, 2010 meets the requirements of paragraph (a) of
this definition.
(c) Before January 1, 2008, where licensure or other regulation does
not apply, graduated from a 2-year college-level program approved by the
American Physical Therapy Association.
(d) On or before December 31, 1977, was licensed or qualified as a
physical
[[Page 154]]
therapist assistant and has achieved a satisfactory grade on a
proficiency examination conducted, approved, or sponsored by the U.S.
Public Health Service.
Physician. A doctor of medicine, osteophathy or podiatry legally
authorized to practice medicine and surgery by the State in which such
function or action is performed.
Practical (vocational) nurse. A person who is licensed as a
practical (vocational) nurse by the State in which practicing.
Public health nurse. A registered nurse who has completed a
baccalaureate degree program approved by the National League for Nursing
for public health nursing preparation or postregistered nurse study that
includes content aproved by the National League for Nursing for public
health nursing preparation.
Registered nurse (RN). A graduate of an approved school of
professional nursing, who is licensed as a registered nurse by the State
in which practicing.
Social work assistant. A person who:
(1) Has a baccalaureate degree in social work, psychology,
sociology, or other field related to social work, and has had at least 1
year of social work experience in a health care setting; or
(2) Has 2 years of appropriate experience as a social work
assistant, and has achieved a satisfactory grade on a proficiency
examination conducted, approved, or sponsored by the U.S. Public Health
Service, except that these determinations of proficiency do not apply
with respect to persons initially licensed by a State or seeking initial
qualification as a social work assistant after December 31, 1977.
Social worker. A person who has a master's degree from a school of
social work accredited by the Council on Social Work Education, and has
1 year of social work experience in a health care setting.
Speech-language pathologist. A person who has a master's or doctoral
degree in speech-language pathology, and who meets either of the
following requirements:
(a) Is licensed as a speech-language pathologist by the State in
which the individual furnishes such services; or
(b) In the case of an individual who furnishes services in a State
which does not license speech-language pathologists:
(1) Has successfully completed 350 clock hours of supervised
clinical practicum (or is in the process of accumulating such supervised
clinical experience);
(2) Performed not less than 9 months of supervised full-time speech-
language pathology services after obtaining a master's or doctoral
degree in speech-language pathology or a related field; and
(3) Successfully completed a national examination in speech-language
pathology approved by the Secretary.
[54 FR 33367, Aug. 14, 1989, as amended at 56 FR 32973, July 18, 1991;
69 FR 66426, Nov. 15, 2004; 72 FR 66406, Nov. 27, 2007; 73 FR 2433, Jan.
15, 2008; 79 FR 66118, Nov. 6, 2014]
Effective Date Note: At 82 FR 4578, Jan. 13, 2017, subpart A was
revised, effective July 13, 2017. At 82 FR 31729, July 10, 2017, this
amendment was delayed until Jan. 13, 2018. For the convenience of the
user, the revised text is set forth as follows:
Subpart A_General Provisions
Sec. 484.1 Basis and scope.
(a) Basis. This part is based on:
(1) Sections 1861(o) and 1891 of the Act, which establish the
conditions that an HHA must meet in order to participate in the Medicare
program and which, along with the additional requirements set forth in
this part, are considered necessary to ensure the health and safety of
patients; and
(2) Section 1861(z) of the Act, which specifies the institutional
planning standards that HHAs must meet.
(b) Scope. The provisions of this part serve as the basis for survey
activities for the purpose of determining whether an agency meets the
requirements for participation in the Medicare program.
Sec. 484.2 Definitions.
As used in subparts A, B, and C, of this part--
Branch office means an approved location or site from which a home
health agency provides services within a portion of the total geographic
area served by the parent agency. The parent home health agency must
provide supervision and administrative control of any branch office. It
is unnecessary for the branch office to independently meet the
conditions of participation as a home health agency.
[[Page 155]]
Clinical note means a notation of a contact with a patient that is
written, timed, and dated, and which describes signs and symptoms,
treatment, drugs administered and the patient's reaction or response,
and any changes in physical or emotional condition during a given period
of time.
In advance means that HHA staff must complete the task prior to
performing any hands-on care or any patient education.
Parent home health agency means the agency that provides direct
support and administrative control of a branch.
Primary home health agency means the HHA which accepts the initial
referral of a patient, and which provides services directly to the
patient or via another health care provider under arrangements (as
applicable).
Proprietary agency means a private, for-profit agency.
Public agency means an agency operated by a state or local
government.
Quality indicator means a specific, valid, and reliable measure of
access, care outcomes, or satisfaction, or a measure of a process of
care.
Representative means the patient's legal representative, such as a
guardian, who makes health-care decisions on the patient's behalf, or a
patient-selected representative who participates in making decisions
related to the patient's care or well-being, including but not limited
to, a family member or an advocate for the patient. The patient
determines the role of the representative, to the extent possible.
Subdivision means a component of a multi-function health agency,
such as the home care department of a hospital or the nursing division
of a health department, which independently meets the conditions of
participation for HHAs. A subdivision that has branch offices is
considered a parent agency.
Summary report means the compilation of the pertinent factors of a
patient's clinical notes that is submitted to the patient's physician.
Supervised practical training means training in a practicum
laboratory or other setting in which the trainee demonstrates knowledge
while providing covered services to an individual under the direct
supervision of either a registered nurse or a licensed practical nurse
who is under the supervision of a registered nurse.
Verbal order means a physician order that is spoken to appropriate
personnel and later put in writing for the purposes of documenting as
well as establishing or revising the patient's plan of care.
Subpart B_Administration
Sec. 484.10 Condition of participation: Patient rights.
The patient has the right to be informed of his or her rights. The
HHA must protect and promote the exercise of these rights.
(a) Standard: Notice of rights. (1) The HHA must provide the patient
with a written notice of the patient's rights in advance of furnishing
care to the patient or during the initial evaluation visit before the
initiation of treatment.
(2) The HHA must maintain documentation showing that it has complied
with the requirements of this section.
(b) Standard: Exercise of rights and respect for property and
person. (1) The patient has the right to exercise his or her rights as a
patient of the HHA.
(2) The patient's family or guardian may exercise the patient's
rights when the patient has been judged incompetent.
(3) The patient has the right to have his or her property treated
with respect.
(4) The patient has the right to voice grievances regarding
treatment or care that is (or fails to be) furnished, or regarding the
lack of respect for property by anyone who is furnishing services on
behalf of the HHA and must not be subjected to discrimination or
reprisal for doing so.
(5) The HHA must investigate complaints made by a patient or the
patient's family or guardian regarding treatment or care that is (or
fails to be) furnished, or regarding the lack of respect for the
patient's property by anyone furnishing services on behalf of the HHA,
and must document both the existence of the complaint and the resolution
of the complaint.
(c) Standard: Right to be informed and to participate in planning
care and treatment. (1) The patient has the right to be informed, in
advance about the care to be furnished, and of any changes in the care
to be furnished.
(i) The HHA must advise the patient in advance of the disciplines
that will furnish care, and the frequency of visits proposed to be
furnished.
[[Page 156]]
(ii) The HHA must advise the patient in advance of any change in the
plan of care before the change is made.
(2) The patient has the right to participate in the planning of the
care.
(i) The HHA must advise the patient in advance of the right to
participate in planning the care or treatment and in planning changes in
the care or treatment.
(ii) The HHA complies with the requirements of subpart I of part 489
of this chapter relating to maintaining written policies and procedures
regarding advance directives. The HHA must inform and distribute written
information to the patient, in advance, concerning its policies on
advance directives, including a description of applicable State law. The
HHA may furnish advance directives information to a patient at the time
of the first home visit, as long as the information is furnished before
care is provided.
(d) Standard: Confidentiality of medical records. The patient has
the right to confidentiality of the clinical records maintained by the
HHA. The HHA must advise the patient of the agency's policies and
procedures regarding disclosure of clinical records.
(e) Standard: Patient liability for payment. (1) The patient has the
right to be advised, before care is initiated, of the extent to which
payment for the HHA services may be expected from Medicare or other
sources, and the extent to which payment may be required from the
patient. Before the care is initiated, the HHA must inform the patient,
orally and in writing, of--
(i) The extent to which payment may be expected from Medicare,
Medicaid, or any other Federally funded or aided program known to the
HHA;
(ii) The charges for services that will not be covered by Medicare;
and
(iii) The charges that the individual may have to pay.
(2) The patient has the right to be advised orally and in writing of
any changes in the information provided in accordance with paragraph
(e)(1) of this section when they occur. The HHA must advise the patient
of these changes orally and in writing as soon as possible, but no later
than 30 calendar days from the date that the HHA becomes aware of a
change.
(f) Standard: Home health hotline. The patient has the right to be
advised of the availability of the toll-free HHA hotline in the State.
When the agency accepts the patient for treatment or care, the HHA must
advise the patient in writing of the telephone number of the home health
hotline established by the State, the hours of its operation, and that
the purpose of the hotline is to receive complaints or questions about
local HHAs. The patient also has the right to use this hotline to lodge
complaints concerning the implementation of the advance directives
requirements.
[54 FR 33367, Aug. 14, 1989, as amended at 56 FR 32973, July 18, 1991;
57 FR 8203, Mar. 6, 1992; 60 FR 33293, June 27, 1995]
Sec. 484.11 Condition of participation: Release of patient
identifiable OASIS information.
The HHA and agent acting on behalf of the HHA in accordance with a
written contract must ensure the confidentiality of all patient
identifiable information contained in the clinical record, including
OASIS data, and may not release patient identifiable OASIS information
to the public.
[64 FR 3763, Jan. 25, 1999]
Sec. 484.12 Condition of participation: Compliance with Federal,
State, and local laws, disclosure and ownership information,
and accepted professional standards and principles.
(a) Standard: Compliance with Federal, State, and local laws and
regulations. The HHA and its staff must operate and furnish services in
compliance with all applicable Federal, State, and local laws and
regulations. If State or applicable local law provides for the licensure
of HHAs, an agency not subject to licensure is approved by the licensing
authority as meeting the standards established for licensure.
(b) Standard: Disclosure of ownership and management information.
The HHA must comply with the requirements of part 420, Subpart C of this
chapter. The HHA also must disclose the following information to the
State survey agency at the time of the HHA's initial request for
certification, for each survey, and
[[Page 157]]
at the time of any change in ownership or management:
(1) The name and address of all persons with an ownership or control
interest in the HHA as defined in Secs. 420.201, 420.202, and 420.206 of
this chapter.
(2) The name and address of each person who is an officer, a
director, an agent or a managing employee of the HHA as defined in
Secs. 420.201, 420.202, and 420.206 of this chapter.
(3) The name and address of the corporation, association, or other
company that is responsible for the management of the HHA, and the name
and address of the chief executive officer and the chairman of the board
of directors of that corporation, association, or other company
responsible for the management of the HHA.
(c) Standard: Compliance with accepted professional standards and
principles. The HHA and its staff must comply with accepted professional
standards and principles that apply to professionals furnishing services
in an HHA.
Sec. 484.14 Condition of participation: Organization, services,
and administration.
Organization, services furnished, administrative control, and lines
of authority for the delegation of responsibility down to the patient
care level are clearly set forth in writing and are readily
identifiable. Administrative and supervisory functions are not delegated
to another agency or organization and all services not furnished
directly, including services provided through subunits are monitored and
controlled by the parent agency. If an agency has subunits, appropriate
administrative records are maintained for each subunit.
(a) Standard: Services furnished. Part-time or intermittent skilled
nursing services and at least one other therapeutic service (physical,
speech, or occupational therapy; medical social services; or home health
aide services) are made available on a visiting basis, in a place of
residence used as a patient's home. An HHA must provide at least one of
the qualifying services directly through agency employees, but may
provide the second qualifying service and additional services under
arrangements with another agency or organization.
(b) Standard: Governing body. A governing body (or designated
persons so functioning) assumes full legal authority and responsibility
for the operation of the agency. The governing body appoints a qualified
administrator, arranges for professional advice as required under
Sec. 484.16, adopts and periodically reviews written bylaws or an
acceptable equivalent, and oversees the management and fiscal affairs of
the agency.
(c) Standard: Administrator. The administrator, who may also be the
supervising physician or registered nurse required under paragraph (d)
of this section, organizes and directs the agency's ongoing functions;
maintains ongoing liaison among the governing body, the group of
professional personnel, and the staff; employs qualified personnel and
ensures adequate staff education and evaluations; ensures the accuracy
of public information materials and activities; and implements an
effective budgeting and accounting system. A qualified person is
authorized in writing to act in the absence of the administrator.
(d) Standard: Supervising physician or registered nurse. The skilled
nursing and other therapeutic services furnished are under the
supervision and direction of a physician or a registered nurse (who
preferably has at least 1 year of nursing experience and is a public
health nurse). This person, or similarly qualified alternate, is
available at all times during operating hours and participates in all
activities relevant to the professional services furnished, including
the development of qualifications and the assignment of personnel.
(e) Standard: Personnel policies. Personnel practices and patient
care are supported by appropriate, written personnel policies. Personnel
records include qualifications and licensure that are kept current.
(f) Standard: Personnel under hourly or per visit contracts. If
personnel under hourly or per visit contracts are used by the HHA, there
is a written contract between those personnel and the agency that
specifies the following:
(1) Patients are accepted for care only by the primary HHA.
[[Page 158]]
(2) The services to be furnished.
(3) The necessity to conform to all applicable agency policies,
including personnel qualifications.
(4) The responsibility for participating in developing plans of
care.
(5) The manner in which services will be controlled, coordinated,
and evaluated by the primary HHA.
(6) The procedures for submitting clinical and progress notes,
scheduling of visits, periodic patient evaluation.
(7) The procedures for payment for services furnished under the
contract.
(g) Standard: Coordination of patient services. All personnel
furnishing services maintain liaison to ensure that their efforts are
coordinated effectively and support the objectives outlined in the plan
of care. The clinical record or minutes of case conferences establish
that effective interchange, reporting, and coordination of patient care
does occur. A written summary report for each patient is sent to the
attending physician at least every 60 days.
(h) Standard: Services under arrangements. Services furnished under
arrangements are subject to a written contract conforming with the
requirements specified in paragraph (f) of this section and with the
requirements of section 1861(w) of the Act (42 U.S.C. 1495x(w)).
(i) Standard: Institutional planning. The HHA, under the direction
of the governing body, prepares an overall plan and a budget that
includes an annual operating budget and capital expenditure plan.
(1) Annual operating budget. There is an annual operating budget
that includes all anticipated income and expenses related to items that
would, under generally accepted accounting principles, be considered
income and expense items. However, it is not required that there be
prepared, in connection with any budget, an item by item identification
of the components of each type of anticipated income or expense.
(2) Capital expenditure plan. (i) There is a capital expenditure
plan for at least a 3-year period, including the operating budget year.
The plan includes and identifies in detail the anticipated sources of
financing for, and the objectives of, each anticipated expenditure of
more than $600,000 for items that would under generally accepted
accounting principles, be considered capital items. In determining if a
single capital expenditure exceeds $600,000, the cost of studies,
surveys, designs, plans, working drawings, specifications, and other
activities essential to the acquisition, improvement, modernization,
expansion, or replacement of land, plant, building, and equipment are
included. Expenditures directly or indirectly related to capital
expenditures, such as grading, paving, broker commissions, taxes
assessed during the construction period, and costs involved in
demolishing or razing structures on land are also included. Transactions
that are separated in time, but are components of an overall plan or
patient care objective, are viewed in their entirety without regard to
their timing. Other costs related to capital expenditures include title
fees, permit and license fees, broker commissions, architect, legal,
accounting, and appraisal fees; interest, finance, or carrying charges
on bonds, notes and other costs incurred for borrowing funds.
(ii) If the anticipated source of financing is, in any part, the
anticipated payment from title V (Maternal and Child Health and Crippled
Children's Services) or title XVIII (Medicare) or title XIX (Medicaid)
of the Social Security Act, the plan specifies the following:
(A) Whether the proposed capital expenditure is required to comform,
or is likely to be required to conform, to current standards, criteria,
or plans developed in accordance with the Public Health Service Act or
the Intellectual Disability Facilities and Community Mental Health
Centers Construction Act of 1963.
(B) Whether a capital expenditure proposal has been submitted to the
designated planning agency for approval in accordance with section 1122
of the Act (42 U.S.C. 1320a-1) and implementing regulations.
(C) Whether the designated planning agency has approved or
disapproved the proposed capital expenditure if it was presented to that
agency.
(3) Preparation of plan and budget. The overall plan and budget is
prepared
[[Page 159]]
under the direction of the governing body of the HHA by a committee
consisting of representatives of the governing body, the administrative
staff, and the medical staff (if any) of the HHA.
(4) Annual review of plan and budget. The overall plan and budget is
reviewed and updated at least annually by the committee referred to in
paragraph (i)(3) of this section under the direction of the governing
body of the HHA.
(j) Standard: Laboratory services. (1) If the HHA engages in
laboratory testing outside of the context of assisting an individual in
self-administering a test with an appliance that has been cleared for
that purpose by the FDA, such testing must be in compliance with all
applicable requirements of part 493 of this chapter.
(2) If the HHA chooses to refer specimens for laboratory testing to
another laboratory, the referral laboratory must be certified in the
appropriate specialties and subspecialties of services in accordance
with the applicable requirements of part 493 of this chapter.
[54 FR 33367, Aug. 14, 1989, as amended at 56 FR 32973, July 18, 1991;
56 FR 51334, Oct. 11, 1991; 57 FR 7136, Feb. 28, 1992; 66 FR 32778, June
18, 2001]
Sec. 484.16 Condition of participation: Group of professional
personnel.
A group of professional personnel, which includes at least one
physician and one registered nurse (preferably a public health nurse),
and with appropriate representation from other professional disciplines,
establishes and annually reviews the agency's policies governing scope
of services offered, admission and discharge policies, medical
supervision and plans of care, emergency care, clinical records,
personnel qualifications, and program evaluation. At least one member of
the group is neither an owner nor an employee of the agency.
(a) Standard: Advisory and evaluation function. The group of
professional personnel meets frequently to advise the agency on
professional issues, to participate in the evaluation of the agency's
program, and to assist the agency in maintaining liaison with other
health care providers in the community and in the agency's community
information program. The meetings are documented by dated minutes.
[54 FR 33367, Aug. 14, 1989, as amended at 56 FR 32974, July 18, 1991]
Sec. 484.18 Condition of participation: Acceptance of patients,
plan of care, and medical supervision.
Patients are accepted for treatment on the basis of a reasonable
expectation that the patient's medical, nursing, and social needs can be
met adequately by the agency in the patient's place of residence. Care
follows a written plan of care established and periodically reviewed by
a doctor of medicine, osteopathy, or podiatric medicine.
(a) Standard: Plan of care. The plan of care developed in
consultation with the agency staff covers all pertinent diagnoses,
including mental status, types of services and equipment required,
frequency of visits, prognosis, rehabilitation potential, functional
limitations, activities permitted, nutritional requirements, medications
and treatments, any safety measures to protect against injury,
instructions for timely discharge or referral, and any other appropriate
items. If a physician refers a patient under a plan of care that cannot
be completed until after an evaluation visit, the physician is consulted
to approve additions or modifications to the original plan. Orders for
therapy services include the specific procedures and modalities to be
used and the amount, frequency, and duration. The therapist and other
agency personnel participate in developing the plan of care.
(b) Standard: Periodic review of plan of care. The total plan of
care is reviewed by the attending physician and HHA personnel as often
as the severity of the patient's condition requires, but at least once
every 60 days or more frequently when there is a beneficiary elected
transfer; a significant change in condition resulting in a change in the
case-mix assignment; or a discharge and return to the same HHA during
the 60-day episode. Agency professional staff promptly alert the
physician to any changes that suggest a need to alter the plan of care.
[[Page 160]]
(c) Standard: Conformance with physician orders. Drugs and
treatments are administered by agency staff only as ordered by the
physician with the exception of influenza and pneumococcal
polysaccharide vaccines, which may be administered per agency policy
developed in consultation with a physician, and after an assessment for
contraindications. Verbal orders are put in writing and signed and dated
with the date of receipt by the registered nurse or qualified therapist
(as defined in Sec. 484.4 of this chapter) responsible for furnishing or
supervising the ordered services. Verbal orders are only accepted by
personnel authorized to do so by applicable State and Federal laws and
regulations as well as by the HHA's internal policies.
[54 FR 33367, Aug. 14, 1989, as amended at 56 FR 32974, July 18, 1991;
64 FR 3784, Jan. 25, 1999; 65 FR 41211, July 3, 2000; 67 FR 61814, Oct.
2, 2002]
Sec. 484.20 Condition of participation: Reporting OASIS information.
HHAs must electronically report all OASIS data collected in
accordance with Sec. 484.55.
(a) Standard: Encoding and transmitting OASIS data. An HHA must
encode and electronically transmit each completed OASIS assessment to
the State agency or the CMS OASIS contractor, regarding each beneficiary
with respect to which such information is required to be transmitted (as
determined by the Secretary), within 30 days of completing the
assessment of the beneficiary.
(b) Standard: Accuracy of encoded OASIS data. The encoded OASIS data
must accurately reflect the patient's status at the time of assessment.
(c) Standard: Transmittal of OASIS data. An HHA must--
(1) For all completed assessments, transmit OASIS data in a format
that meets the requirements of paragraph (d) of this section.
(2) Successfully transmit test data to the State agency or CMS OASIS
contractor.
(3) Transmit data using electronics communications software that
provides a direct telephone connection from the HHA to the State agency
or CMS OASIS contractor.
(4) Transmit data that includes the CMS-assigned branch
identification number, as applicable.
(d) Standard: Data Format. The HHA must encode and transmit data
using the software available from CMS or software that conforms to CMS
standard electronic record layout, edit specifications, and data
dictionary, and that includes the required OASIS data set.
[64 FR 3763, Jan. 25, 1999, as amended at 70 FR 76208, Dec. 23, 2005]
Sec. 484.22 Condition of participation: Emergency preparedness.
The Home Health Agency (HHA) must comply with all applicable
Federal, State, and local emergency preparedness requirements. The HHA
must establish and maintain an emergency preparedness program that meets
the requirements of this section. The emergency preparedness program
must include, but not be limited to, the following elements:
(a) Emergency plan. The HHA must develop and maintain an emergency
preparedness plan that must be reviewed, and updated at least annually.
The plan must do all of the following:
(1) Be based on and include a documented, facility-based and
community-based risk assessment, utilizing an all-hazards approach.
(2) Include strategies for addressing emergency events identified by
the risk assessment.
(3) Address patient population, including, but not limited to, the
type of services the HHA has the ability to provide in an emergency; and
continuity of operations, including delegations of authority and
succession plans.
(4) Include a process for cooperation and collaboration with local,
tribal, regional, State, and Federal emergency preparedness officials'
efforts to maintain an integrated response during a disaster or
emergency situation, including documentation of the HHA's efforts to
contact such officials and, when applicable, of its participation in
collaborative and cooperative planning efforts.
(b) Policies and procedures. The HHA must develop and implement
emergency preparedness policies and procedures, based on the emergency
plan set
[[Page 161]]
forth in paragraph (a) of this section, risk assessment at paragraph
(a)(1) of this section, and the communication plan at paragraph (c) of
this section. The policies and procedures must be reviewed and updated
at least annually. At a minimum, the policies and procedures must
address the following:
(1) The plans for the HHA's patients during a natural or man-made
disaster. Individual plans for each patient must be included as part of
the comprehensive patient assessment, which must be conducted according
to the provisions at Sec. 484.55.
(2) The procedures to inform State and local emergency preparedness
officials about HHA patients in need of evacuation from their residences
at any time due to an emergency situation based on the patient's medical
and psychiatric condition and home environment.
(3) The procedures to follow up with on-duty staff and patients to
determine services that are needed, in the event that there is an
interruption in services during or due to an emergency. The HHA must
inform State and local officials of any on-duty staff or patients that
they are unable to contact.
(4) A system of medical documentation that preserves patient
information, protects confidentiality of patient information, and
secures and maintains the availability of records.
(5) The use of volunteers in an emergency or other emergency
staffing strategies, including the process and role for integration of
State or Federally designated health care professionals to address surge
needs during an emergency.
(c) Communication plan. The HHA must develop and maintain an
emergency preparedness communication plan that complies with Federal,
State, and local laws and must be reviewed and updated at least
annually. The communication plan must include all of the following:
(1) Names and contact information for the following:
(i) Staff.
(ii) Entities providing services under arrangement.
(iii) Patients' physicians.
(iv) Volunteers.
(2) Contact information for the following:
(i) Federal, State, tribal, regional, or local emergency
preparedness staff.
(ii) Other sources of assistance.
(3) Primary and alternate means for communicating with the HHA's
staff, Federal, State, tribal, regional, and local emergency management
agencies.
(4) A method for sharing information and medical documentation for
patients under the HHA's care, as necessary, with other health care
providers to maintain the continuity of care.
(5) A means of providing information about the general condition and
location of patients under the facility's care as permitted under 45 CFR
164.510(b)(4).
(6) A means of providing information about the HHA's needs, and its
ability to provide assistance, to the authority having jurisdiction, the
Incident Command Center, or designee.
(d) Training and testing. The HHA must develop and maintain an
emergency preparedness training and testing program that is based on the
emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, policies and procedures
at paragraph (b) of this section, and the communication plan at
paragraph (c) of this section. The training and testing program must be
reviewed and updated at least annually.
(1) Training program. The HHA must do all of the following:
(i) Initial training in emergency preparedness policies and
procedures to all new and existing staff, individuals providing services
under arrangement, and volunteers, consistent with their expected roles.
(ii) Provide emergency preparedness training at least annually.
(iii) Maintain documentation of the training.
(iv) Demonstrate staff knowledge of emergency procedures.
(2) Testing. The HHA must conduct exercises to test the emergency
plan at least annually. The HHA must do the following:
(i) Participate in a full-scale exercise that is community-based or
when a community-based exercise is not accessible, an individual,
facility-based. If
[[Page 162]]
the HHA experiences an actual natural or man-made emergency that
requires activation of the emergency plan, the HHA is exempt from
engaging in a community-based or individual, facility-based full-scale
exercise for 1 year following the onset of the actual event.
(ii) Conduct an additional exercise that may include, but is not
limited to the following:
(A) A second full-scale exercise that is community-based or
individual, facility-based.
(B) A tabletop exercise that includes a group discussion led by a
facilitator, using a narrated, clinically-relevant emergency scenario,
and a set of problem statements, directed messages, or prepared
questions designed to challenge an emergency plan.
(iii) Analyze the HHA's response to and maintain documentation of
all drills, tabletop exercises, and emergency events, and revise the
HHA's emergency plan, as needed.
(e) Integrated healthcare systems. If a HHA is part of a healthcare
system consisting of multiple separately certified healthcare facilities
that elects to have a unified and integrated emergency preparedness
program, the HHA may choose to participate in the healthcare system's
coordinated emergency preparedness program. If elected, the unified and
integrated emergency preparedness program must do all of the following:
(1) Demonstrate that each separately certified facility within the
system actively participated in the development of the unified and
integrated emergency preparedness program.
(2) Be developed and maintained in a manner that takes into account
each separately certified facility's unique circumstances, patient
populations, and services offered.
(3) Demonstrate that each separately certified facility is capable
of actively using the unified and integrated emergency preparedness
program and is in compliance with the program.
(4) Include a unified and integrated emergency plan that meets the
requirements of paragraphs (a)(2), (3), and (4) of this section. The
unified and integrated emergency plan must also be based on and include
all of the following:
(i) A documented community-based risk assessment, utilizing an all-
hazards approach.
(ii) A documented individual facility-based risk assessment for each
separately certified facility within the health system, utilizing an
all-hazards approach.
(5) Include integrated policies and procedures that meet the
requirements set forth in paragraph (b) of this section, a coordinated
communication plan and training and testing programs that meet the
requirements of paragraphs (c) and (d) of this section, respectively.
[81 FR 64033, Sept. 16, 2016; 81 FR 80594, Nov. 16, 2016]
Effective Date Note: At 82 FR 4578, Jan. 13, 2017, subpart B was
revised, effective July 13, 2017. At 82 FR 31732, July 10, 2017, this
amendment was corrected. At 82 FR 31729, July 10, 2010, this amendment
was delayed until Jan. 13, 2018. For the convenience of the user, the
revised text is set forth as follows:
Subpart B_Patient Care
Sec. 484.40 Condition of participation: Release of patient identifiable
OASIS information.
The HHA and agent acting on behalf of the HHA in accordance with a
written contract must ensure the confidentiality of all patient
identifiable information contained in the clinical record, including
OASIS data, and may not release patient identifiable OASIS information
to the public.
Sec. 484.45 Condition of participation: Reporting OASIS information.
HHAs must electronically report all OASIS data collected in
accordance with Sec. 484.55.
(a) Standard: Encoding and transmitting OASIS data. An HHA must
encode and electronically transmit each completed OASIS assessment to
the CMS system, regarding each beneficiary with respect to which
information is required to be transmitted (as determined by the
Secretary), within 30 days of completing the assessment of the
beneficiary.
(b) Standard: Accuracy of encoded OASIS data. The encoded OASIS data
must accurately reflect the patient's status at the time of assessment.
(c) Standard: Transmittal of OASIS data. An HHA must--
(1) For all completed assessments, transmit OASIS data in a format
that meets the requirements of paragraph (d) of this section.
(2) Successfully transmit test data to the QIES ASAP System or CMS
OASIS contractor.
[[Page 163]]
(3) Transmit data using electronic communications software that
complies with the Federal Information Processing Standard (FIPS 140-2,
issued May 25, 2001) from the HHA or the HHA contractor to the CMS
collection site.
(4) Transmit data that includes the CMS-assigned branch
identification number, as applicable.
(d) Standard: Data Format. The HHA must encode and transmit data
using the software available from CMS or software that conforms to CMS
standard electronic record layout, edit specifications, and data
dictionary, and that includes the required OASIS data set.
Sec. 484.50 Condition of participation: Patient rights.
The patient and representative (if any), have the right to be
informed of the patient's rights in a language and manner the individual
understands. The HHA must protect and promote the exercise of these
rights.
(a) Standard: Notice of rights. The HHA must--
(1) Provide the patient and the patient's legal representative (if
any), the following information during the initial evaluation visit, in
advance of furnishing care to the patient:
(i) Written notice of the patient's rights and responsibilities
under this rule, and the HHA's transfer and discharge policies as set
forth in paragraph (d) of this section. Written notice must be
understandable to persons who have limited English proficiency and
accessible to individuals with disabilities;
(ii) Contact information for the HHA administrator, including the
administrator's name, business address, and business phone number in
order to receive complaints.
(iii) An OASIS privacy notice to all patients for whom the OASIS
data is collected.
(2) Obtain the patient's or legal representative's signature
confirming that he or she has received a copy of the notice of rights
and responsibilities.
(3) Provide verbal notice of the patient's rights and
responsibilities in the individual's primary or preferred language and
in a manner the individual understands, free of charge, with the use of
a competent interpreter if necessary, no later than the completion of
the second visit from a skilled professional as described in
Sec. 484.75.
(4) Provide written notice of the patient's rights and
responsibilities under this rule and the HHA's transfer and discharge
policies as set forth in paragraph (d) of this section to a patient-
selected representative within 4 business days of the initial evaluation
visit.
(b) Standard: Exercise of rights. (1) If a patient has been adjudged
to lack legal capacity to make health care decisions as established by
state law by a court of proper jurisdiction, the rights of the patient
may be exercised by the person appointed by the state court to act on
the patient's behalf.
(2) If a state court has not adjudged a patient to lack legal
capacity to make health care decisions as defined by state law, the
patient's representative may exercise the patient's rights.
(3) If a patient has been adjudged to lack legal capacity to make
health care decisions under state law by a court of proper jurisdiction,
the patient may exercise his or her rights to the extent allowed by
court order.
(c) Standard: Rights of the patient. The patient has the right to--
(1) Have his or her property and person treated with respect;
(2) Be free from verbal, mental, sexual, and physical abuse,
including injuries of unknown source, neglect and misappropriation of
property;
(3) Make complaints to the HHA regarding treatment or care that is
(or fails to be) furnished, and the lack of respect for property and/or
person by anyone who is furnishing services on behalf of the HHA;
(4) Participate in, be informed about, and consent or refuse care in
advance of and during treatment, where appropriate, with respect to--
(i) Completion of all assessments;
(ii) The care to be furnished, based on the comprehensive
assessment;
(iii) Establishing and revising the plan of care;
(iv) The disciplines that will furnish the care;
(v) The frequency of visits;
(vi) Expected outcomes of care, including patient-identified goals,
and anticipated risks and benefits;
(vii) Any factors that could impact treatment effectiveness; and
(viii) Any changes in the care to be furnished.
(5) Receive all services outlined in the plan of care.
(6) Have a confidential clinical record. Access to or release of
patient information and clinical records is permitted in accordance with
45 CFR parts 160 and 164.
(7) Be advised of--
(i) The extent to which payment for HHA services may be expected
from Medicare, Medicaid, or any other federally-funded or federal aid
program known to the HHA,
(ii) The charges for services that may not be covered by Medicare,
Medicaid, or any other federally-funded or federal aid program known to
the HHA,
(iii) The charges the individual may have to pay before care is
initiated; and
(iv) Any changes in the information provided in accordance with
paragraph (c)(7) of this section when they occur. The HHA must advise
the patient and representative (if
[[Page 164]]
any), of these changes as soon as possible, in advance of the next home
health visit. The HHA must comply with the patient notice requirements
at 42 CFR 411.408(d)(2) and 42 CFR 411.408(f).
(8) Receive proper written notice, in advance of a specific service
being furnished, if the HHA believes that the service may be non-covered
care; or in advance of the HHA reducing or terminating on-going care.
The HHA must also comply with the requirements of 42 CFR 405.1200
through 405.1204.
(9) Be advised of the state toll free home health telephone hot
line, its contact information, its hours of operation, and that its
purpose is to receive complaints or questions about local HHAs.
(10) Be advised of the names, addresses, and telephone numbers of
the following Federally-funded and state-funded entities that serve the
area where the patient resides:
(i) Agency on Aging,
(ii) Center for Independent Living,
(iii) Protection and Advocacy Agency,
(iv) Aging and Disability Resource Center; and
(v) Quality Improvement Organization.
(11) Be free from any discrimination or reprisal for exercising his
or her rights or for voicing grievances to the HHA or an outside entity.
(12) Be informed of the right to access auxiliary aids and language
services as described in paragraph (f) of this section, and how to
access these services.
(d) Standard: Transfer and discharge. The patient and representative
(if any), have a right to be informed of the HHA's policies for transfer
and discharge. The HHA may only transfer or discharge the patient from
the HHA if:
(1) The transfer or discharge is necessary for the patient's welfare
because the HHA and the physician who is responsible for the home health
plan of care agree that the HHA can no longer meet the patient's needs,
based on the patient's acuity. The HHA must arrange a safe and
appropriate transfer to other care entities when the needs of the
patient exceed the HHA's capabilities;
(2) The patient or payer will no longer pay for the services
provided by the HHA;
(3) The transfer or discharge is appropriate because the physician
who is responsible for the home health plan of care and the HHA agree
that the measurable outcomes and goals set forth in the plan of care in
accordance with Sec. 484.60(a)(2)(xiv) have been achieved, and the HHA
and the physician who is responsible for the home health plan of care
agree that the patient no longer needs the HHA's services;
(4) The patient refuses services, or elects to be transferred or
discharged;
(5) The HHA determines, under a policy set by the HHA for the
purpose of addressing discharge for cause that meets the requirements of
paragraphs (d)(5)(i) through (d)(5)(iii) of this section, that the
patient's (or other persons in the patient's home) behavior is
disruptive, abusive, or uncooperative to the extent that delivery of
care to the patient or the ability of the HHA to operate effectively is
seriously impaired. The HHA must do the following before it discharges a
patient for cause:
(i) Advise the patient, representative (if any), the physician(s)
issuing orders for the home health plan of care, and the patient's
primary care practitioner or other health care professional who will be
responsible for providing care and services to the patient after
discharge from the HHA (if any) that a discharge for cause is being
considered;
(ii) Make efforts to resolve the problem(s) presented by the
patient's behavior, the behavior of other persons in the patient's home,
or situation;
(iii) Provide the patient and representative (if any), with contact
information for other agencies or providers who may be able to provide
care; and
(iv) Document the problem(s) and efforts made to resolve the
problem(s), and enter this documentation into its clinical records;
(6) The patient dies; or
(7) The HHA ceases to operate.
(e) Standard: Investigation of complaints. (1) The HHA must--
(i) Investigate complaints made by a patient, the patient's
representative (if any), and the patient's caregivers and family,
including, but not limited to, the following topics:
(A) Treatment or care that is (or fails to be) furnished, is
furnished inconsistently, or is furnished inappropriately; and
(B) Mistreatment, neglect, or verbal, mental, sexual, and physical
abuse, including injuries of unknown source, and/or misappropriation of
patient property by anyone furnishing services on behalf of the HHA.
(ii) Document both the existence of the complaint and the resolution
of the complaint; and
(iii) Take action to prevent further potential violations, including
retaliation, while the complaint is being investigated.
(2) Any HHA staff (whether employed directly or under arrangements)
in the normal course of providing services to patients, who identifies,
notices, or recognizes incidences or circumstances of mistreatment,
neglect, verbal, mental, sexual, and/or physical abuse, including
injuries of unknown source, or misappropriation of patient property,
must report these findings immediately to the HHA and other appropriate
authorities in accordance with state law.
(f) Standard: Accessibility. Information must be provided to
patients in plain language and in a manner that is accessible and timely
to--
[[Page 165]]
(1) Persons with disabilities, including accessible Web sites and
the provision of auxiliary aids and services at no cost to the
individual in accordance with the Americans with Disabilities Act and
Section 504 of the Rehabilitation Act.
(2) Persons with limited English proficiency through the provision
of language services at no cost to the individual, including oral
interpretation and written translations.
Sec. 484.55 Condition of participation: Comprehensive assessment of
patients.
Each patient must receive, and an HHA must provide, a patient-
specific, comprehensive assessment. For Medicare beneficiaries, the HHA
must verify the patient's eligibility for the Medicare home health
benefit including homebound status, both at the time of the initial
assessment visit and at the time of the comprehensive assessment.
(a) Standard: Initial assessment visit. (1) A registered nurse must
conduct an initial assessment visit to determine the immediate care and
support needs of the patient; and, for Medicare patients, to determine
eligibility for the Medicare home health benefit, including homebound
status. The initial assessment visit must be held either within 48 hours
of referral, or within 48 hours of the patient's return home, or on the
physician-ordered start of care date.
(2) When rehabilitation therapy service (speech language pathology,
physical therapy, or occupational therapy) is the only service ordered
by the physician who is responsible for the home health plan of care,
and if the need for that service establishes program eligibility, the
initial assessment visit may be made by the appropriate rehabilitation
skilled professional.
(b) Standard: Completion of the comprehensive assessment. (1) The
comprehensive assessment must be completed in a timely manner,
consistent with the patient's immediate needs, but no later than 5
calendar days after the start of care.
(2) Except as provided in paragraph (b)(3) of this section, a
registered nurse must complete the comprehensive assessment and for
Medicare patients, determine eligibility for the Medicare home health
benefit, including homebound status.
(3) When physical therapy, speech-language pathology, or
occupational therapy is the only service ordered by the physician, a
physical therapist, speech-language pathologist or occupational
therapist may complete the comprehensive assessment, and for Medicare
patients, determine eligibility for the Medicare home health benefit,
including homebound status. The occupational therapist may complete the
comprehensive assessment if the need for occupational therapy
establishes program eligibility.
(c) Standard: Content of the comprehensive assessment. The
comprehensive assessment must accurately reflect the patient's status,
and must include, at a minimum, the following information:
(1) The patient's current health, psychosocial, functional, and
cognitive status;
(2) The patient's strengths, goals, and care preferences, including
information that may be used to demonstrate the patient's progress
toward achievement of the goals identified by the patient and the
measurable outcomes identified by the HHA;
(3) The patient's continuing need for home care;
(4) The patient's medical, nursing, rehabilitative, social, and
discharge planning needs;
(5) A review of all medications the patient is currently using in
order to identify any potential adverse effects and drug reactions,
including ineffective drug therapy, significant side effects,
significant drug interactions, duplicate drug therapy, and noncompliance
with drug therapy.
(6) The patient's primary caregiver(s), if any, and other available
supports, including their:
(i) Willingness and ability to provide care, and
(ii) Availability and schedules;
(7) The patient's representative (if any);
(8) Incorporation of the current version of the Outcome and
Assessment Information Set (OASIS) items, using the language and
groupings of the OASIS items, as specified by the Secretary. The OASIS
data items determined by the Secretary must include: clinical record
items, demographics and patient history, living arrangements, supportive
assistance, sensory status, integumentary status, respiratory status,
elimination status, neuro/emotional/behavioral status, activities of
daily living, medications, equipment management, emergent care, and data
items collected at inpatient facility admission or discharge only.
(d) Standard: Update of the comprehensive assessment. The
comprehensive assessment must be updated and revised (including the
administration of the OASIS) as frequently as the patient's condition
warrants due to a major decline or improvement in the patient's health
status, but not less frequently than--
(1) The last 5 days of every 60 days beginning with the start-of-
care date, unless there is a--
(i) Beneficiary elected transfer;
(ii) Significant change in condition; or
(iii) Discharge and return to the same HHA during the 60-day
episode.
(2) Within 48 hours of the patient's return to the home from a
hospital admission of 24 hours or more for any reason other than
diagnostic tests, or on physician-ordered resumption date;
[[Page 166]]
(3) At discharge.
Sec. 484.60 Condition of participation: Care planning, coordination of
services, and quality of care.
Patients are accepted for treatment on the reasonable expectation
that an HHA can meet the patient's medical, nursing, rehabilitative, and
social needs in his or her place of residence. Each patient must receive
an individualized written plan of care, including any revisions or
additions. The individualized plan of care must specify the care and
services necessary to meet the patient-specific needs as identified in
the comprehensive assessment, including identification of the
responsible discipline(s), and the measurable outcomes that the HHA
anticipates will occur as a result of implementing and coordinating the
plan of care. The individualized plan of care must also specify the
patient and caregiver education and training. Services must be furnished
in accordance with accepted standards of practice.
(a) Standard: Plan of care. (1) Each patient must receive the home
health services that are written in an individualized plan of care that
identifies patient-specific measurable outcomes and goals, and which is
established, periodically reviewed, and signed by a doctor of medicine,
osteopathy, or podiatry acting within the scope of his or her state
license, certification, or registration. If a physician refers a patient
under a plan of care that cannot be completed until after an evaluation
visit, the physician is consulted to approve additions or modifications
to the original plan.
(2) The individualized plan of care must include the following:
(i) All pertinent diagnoses;
(ii) The patient's mental, psychosocial, and cognitive status;
(iii) The types of services, supplies, and equipment required;
(iv) The frequency and duration of visits to be made;
(v) Prognosis;
(vi) Rehabilitation potential;
(vii) Functional limitations;
(viii) Activities permitted;
(ix) Nutritional requirements;
(x) All medications and treatments;
(xi) Safety measures to protect against injury;
(xii) A description of the patient's risk for emergency department
visits and hospital re-admission, and all necessary interventions to
address the underlying risk factors.
(xiii) Patient and caregiver education and training to facilitate
timely discharge;
(xiv) Patient-specific interventions and education; measurable
outcomes and goals identified by the HHA and the patient;
(xv) Information related to any advanced directives; and
(xvi) Any additional items the HHA or physician may choose to
include.
(3) All patient care orders, including verbal orders, must be
recorded in the plan of care.
(b) Standard: Conformance with physician orders. (1) Drugs,
services, and treatments are administered only as ordered by a
physician.
(2) Influenza and pneumococcal vaccines may be administered per
agency policy developed in consultation with a physician, and after an
assessment of the patient to determine for contraindications.
(3) Verbal orders must be accepted only by personnel authorized to
do so by applicable state laws and regulations and by the HHA's internal
policies.
(4) When services are provided on the basis of a physician's verbal
orders, a nurse acting in accordance with state licensure requirements,
or other qualified practitioner responsible for furnishing or
supervising the ordered services, in accordance with state law and the
HHA's policies, must document the orders in the patient's clinical
record, and sign, date, and time the orders. Verbal orders must be
authenticated and dated by the physician in accordance with applicable
state laws and regulations, as well as the HHA's internal policies.
(c) Standard: Review and revision of the plan of care. (1) The
individualized plan of care must be reviewed and revised by the
physician who is responsible for the home health plan of care and the
HHA as frequently as the patient's condition or needs require, but no
less frequently than once every 60 days, beginning with the start of
care date. The HHA must promptly alert the relevant physician(s) to any
changes in the patient's condition or needs that suggest that outcomes
are not being achieved and/or that the plan of care should be altered.
(2) A revised plan of care must reflect current information from the
patient's updated comprehensive assessment, and contain information
concerning the patient's progress toward the measurable outcomes and
goals identified by the HHA and patient in the plan of care.
(3) Revisions to the plan of care must be communicated as follows:
(i) Any revision to the plan of care due to a change in patient
health status must be communicated to the patient, representative (if
any), caregiver, and all physicians issuing orders for the HHA plan of
care.
(ii) Any revisions related to plans for the patient's discharge must
be communicated to the patient, representative, caregiver, all
physicians issuing orders for the HHA plan of care, and the patient's
primary care practitioner or other health care professional who will be
responsible for providing care and services to the patient after
discharge from the HHA (if any).
(d) Standard: Coordination of care. The HHA must:
[[Page 167]]
(1) Assure communication with all physicians involved in the plan of
care.
(2) Integrate orders from all physicians involved in the plan of
care to assure the coordination of all services and interventions
provided to the patient.
(3) Integrate services, whether services are provided directly or
under arrangement, to assure the identification of patient needs and
factors that could affect patient safety and treatment effectiveness and
the coordination of care provided by all disciplines.
(4) Coordinate care delivery to meet the patient's needs, and
involve the patient, representative (if any), and caregiver(s), as
appropriate, in the coordination of care activities.
(5) Ensure that each patient, and his or her caregiver(s) where
applicable, receive ongoing education and training provided by the HHA,
as appropriate, regarding the care and services identified in the plan
of care. The HHA must provide training, as necessary, to ensure a timely
discharge.
(e) Standard: Written information to the patient. The HHA must
provide the patient and caregiver with a copy of written instructions
outlining:
(1) Visit schedule, including frequency of visits by HHA personnel
and personnel acting on behalf of the HHA.
(2) Patient medication schedule/instructions, including: medication
name, dosage and frequency and which medications will be administered by
HHA personnel and personnel acting on behalf of the HHA.
(3) Any treatments to be administered by HHA personnel and personnel
acting on behalf of the HHA, including therapy services.
(4) Any other pertinent instruction related to the patient's care
and treatments that the HHA will provide, specific to the patient's care
needs.
(5) Name and contact information of the HHA clinical manager.
Sec. 484.65 Condition of participation: Quality assessment and
performance improvement (QAPI).
The HHA must develop, implement, evaluate, and maintain an
effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's
governing body must ensure that the program reflects the complexity of
its organization and services; involves all HHA services (including
those services provided under contract or arrangement); focuses on
indicators related to improved outcomes, including the use of emergent
care services, hospital admissions and re-admissions; and takes actions
that address the HHA's performance across the spectrum of care,
including the prevention and reduction of medical errors. The HHA must
maintain documentary evidence of its QAPI program and be able to
demonstrate its operation to CMS.
(a) Standard: Program scope. (1) The program must at least be
capable of showing measurable improvement in indicators for which there
is evidence that improvement in those indicators will improve health
outcomes, patient safety, and quality of care.
(2) The HHA must measure, analyze, and track quality indicators,
including adverse patient events, and other aspects of performance that
enable the HHA to assess processes of care, HHA services, and
operations.
(b) Standard: Program data. (1) The program must utilize quality
indicator data, including measures derived from OASIS, where applicable,
and other relevant data, in the design of its program.
(2) The HHA must use the data collected to--
(i) Monitor the effectiveness and safety of services and quality of
care; and
(ii) Identify opportunities for improvement.
(3) The frequency and detail of the data collection must be approved
by the HHA's governing body.
(c) Standard: Program activities. (1) The HHA's performance
improvement activities must--
(i) Focus on high risk, high volume, or problem-prone areas;
(ii) Consider incidence, prevalence, and severity of problems in
those areas; and
(iii) Lead to an immediate correction of any identified problem that
directly or potentially threaten the health and safety of patients.
(2) Performance improvement activities must track adverse patient
events, analyze their causes, and implement preventive actions.
(3) The HHA must take actions aimed at performance improvement, and,
after implementing those actions, the HHA must measure its success and
track performance to ensure that improvements are sustained.
(d) Standard: Performance improvement projects. Beginning July 13,
2018 HHAs must conduct performance improvement projects.
(1) The number and scope of distinct improvement projects conducted
annually must reflect the scope, complexity, and past performance of the
HHA's services and operations.
(2) The HHA must document the quality improvement projects
undertaken, the reasons for conducting these projects, and the
measurable progress achieved on these projects.
(e) Standard: Executive responsibilities. The HHA's governing body
is responsible for ensuring the following:
(1) That an ongoing program for quality improvement and patient
safety is defined, implemented, and maintained;
(2) That the HHA-wide quality assessment and performance improvement
efforts address priorities for improved quality of care
[[Page 168]]
and patient safety, and that all improvement actions are evaluated for
effectiveness;
(3) That clear expectations for patient safety are established,
implemented, and maintained; and
(4) That any findings of fraud or waste are appropriately addressed.
Sec. 484.70 Condition of participation: Infection prevention and
control.
The HHA must maintain and document an infection control program
which has as its goal the prevention and control of infections and
communicable diseases.
(a) Standard: Prevention. The HHA must follow accepted standards of
practice, including the use of standard precautions, to prevent the
transmission of infections and communicable diseases.
(b) Standard: Control. The HHA must maintain a coordinated agency-
wide program for the surveillance, identification, prevention, control,
and investigation of infectious and communicable diseases that is an
integral part of the HHA's quality assessment and performance
improvement (QAPI) program. The infection control program must include:
(1) A method for identifying infectious and communicable disease
problems; and
(2) A plan for the appropriate actions that are expected to result
in improvement and disease prevention.
(c) Standard: Education. The HHA must provide infection control
education to staff, patients, and caregiver(s).
Sec. 484.75 Condition of participation: Skilled professional services.
Skilled professional services include skilled nursing services,
physical therapy, speech-language pathology services, and occupational
therapy, as specified in Sec. 409.44 of this chapter, and physician and
medical social work services as specified in Sec. 409.45 of this
chapter. Skilled professionals who provide services to HHA patients
directly or under arrangement must participate in the coordination of
care.
(a) Standard: Provision of services by skilled professionals.
Skilled professional services are authorized, delivered, and supervised
only by health care professionals who meet the appropriate
qualifications specified under Sec. 484.115 and who practice according
to the HHA's policies and procedures.
(b) Standard: Responsibilities of skilled professionals. Skilled
professionals must assume responsibility for, but not be restricted to,
the following:
(1) Ongoing interdisciplinary assessment of the patient;
(2) Development and evaluation of the plan of care in partnership
with the patient, representative (if any), and caregiver(s);
(3) Providing services that are ordered by the physician as
indicated in the plan of care;
(4) Patient, caregiver, and family counseling;
(5) Patient and caregiver education;
(6) Preparing clinical notes;
(7) Communication with all physicians involved in the plan of care
and other health care practitioners (as appropriate) related to the
current plan of care;
(8) Participation in the HHA's QAPI program; and
(9) Participation in HHA-sponsored in-service training.
(c) Supervision of skilled professional assistants. (1) Nursing
services are provided under the supervision of a registered nurse that
meets the requirements of Sec. 484.115(k).
(2) Rehabilitative therapy services are provided under the
supervision of an occupational therapist or physical therapist that
meets the requirements of Sec. 484.115(f) or (h), respectively.
(3) Medical social services are provided under the supervision of a
social worker that meets the requirements of Sec. 484.115(m).
Sec. 484.80 Condition of participation: Home health aide services.
All home health aide services must be provided by individuals who
meet the personnel requirements specified in paragraph (a) of this
section.
(a) Standard: Home health aide qualifications. (1) A qualified home
health aide is a person who has successfully completed:
(i) A training and competency evaluation program as specified in
paragraphs (b) and (c) respectively of this section; or
(ii) A competency evaluation program that meets the requirements of
paragraph (c) of this section; or
(iii) A nurse aide training and competency evaluation program
approved by the state as meeting the requirements of Sec. 483.151
through Sec. 483.154 of this chapter, and is currently listed in good
standing on the state nurse aide registry; or
(iv) The requirements of a state licensure program that meets the
provisions of paragraphs (b) and (c) of this section.
(2) A home health aide or nurse aide is not considered to have
completed a program, as specified in paragraph (a)(1) of this section,
if, since the individual's most recent completion of the program(s),
there has been a continuous period of 24 consecutive months during which
none of the services furnished by the individual as described in
Sec. 409.40 of this chapter were for compensation. If there has been a
24-month lapse in furnishing services for compensation, the individual
must complete another program, as specified in paragraph (a)(1) of this
section, before providing services.
(b) Standard: Content and duration of home health aide classroom and
supervised practical training. (1) Home health aide training must
include classroom and supervised practical
[[Page 169]]
training in a practicum laboratory or other setting in which the trainee
demonstrates knowledge while providing services to an individual under
the direct supervision of a registered nurse, or a licensed practical
nurse who is under the supervision of a registered nurse. Classroom and
supervised practical training must total at least 75 hours.
(2) A minimum of 16 hours of classroom training must precede a
minimum of 16 hours of supervised practical training as part of the 75
hours.
(3) A home health aide training program must address each of the
following subject areas:
(i) Communication skills, including the ability to read, write, and
verbally report clinical information to patients, representatives, and
caregivers, as well as to other HHA staff.
(ii) Observation, reporting, and documentation of patient status and
the care or service furnished.
(iii) Reading and recording temperature, pulse, and respiration.
(iv) Basic infection prevention and control procedures.
(v) Basic elements of body functioning and changes in body function
that must be reported to an aide's supervisor.
(vi) Maintenance of a clean, safe, and healthy environment.
(vii) Recognizing emergencies and the knowledge of instituting
emergency procedures and their application.
(viii) The physical, emotional, and developmental needs of and ways
to work with the populations served by the HHA, including the need for
respect for the patient, his or her privacy, and his or her property.
(ix) Appropriate and safe techniques in performing personal hygiene
and grooming tasks that include--
(A) Bed bath;
(B) Sponge, tub, and shower bath;
(C) Hair shampooing in sink, tub, and bed;
(D) Nail and skin care;
(E) Oral hygiene;
(F) Toileting and elimination;
(x) Safe transfer techniques and ambulation;
(xi) Normal range of motion and positioning;
(xii) Adequate nutrition and fluid intake;
(xiii) Recognizing and reporting changes in skin condition; and
(xiv) Any other task that the HHA may choose to have an aide perform
as permitted under state law.
(xv) The HHA is responsible for training home health aides, as
needed, for skills not covered in the basic checklist, as described in
paragraph (b)(3)(ix) of this section.
(4) The HHA must maintain documentation that demonstrates that the
requirements of this standard have been met.
(c) Standard: Competency evaluation. An individual may furnish home
health services on behalf of an HHA only after that individual has
successfully completed a competency evaluation program as described in
this section.
(1) The competency evaluation must address each of the subjects
listed in paragraph (b)(3) of this section. Subject areas specified
under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section
must be evaluated by observing an aide's performance of the task with a
patient. The remaining subject areas may be evaluated through written
examination, oral examination, or after observation of a home health
aide with a patient.
(2) A home health aide competency evaluation program may be offered
by any organization, except as specified in paragraph (f) of this
section.
(3) The competency evaluation must be performed by a registered
nurse in consultation with other skilled professionals, as appropriate.
(4) A home health aide is not considered competent in any task for
which he or she is evaluated as unsatisfactory. An aide must not perform
that task without direct supervision by a registered nurse until after
he or she has received training in the task for which he or she was
evaluated as ``unsatisfactory,'' and has successfully completed a
subsequent evaluation. A home health aide is not considered to have
successfully passed a competency evaluation if the aide has an
``unsatisfactory'' rating in more than one of the required areas.
(5) The HHA must maintain documentation which demonstrates that the
requirements of this standard have been met.
(d) Standard: In-service training. A home health aide must receive
at least 12 hours of in-service training during each 12-month period.
In-service training may occur while an aide is furnishing care to a
patient.
(1) In-service training may be offered by any organization and must
be supervised by a registered nurse.
(2) The HHA must maintain documentation that demonstrates the
requirements of this standard have been met.
(e) Standard: Qualifications for instructors conducting classroom
and supervised practical training. Classroom and supervised practical
training must be performed by a registered nurse who possesses a minimum
of 2 years nursing experience, at least 1 year of which must be in home
health care, or by other individuals under the general supervision of
the registered nurse.
(f) Standard: Eligible training and competency evaluation
organizations. A home health aide training program and competency
evaluation program may be offered by any organization except by an HHA
that, within the previous 2 years:
[[Page 170]]
(1) Was out of compliance with the requirements of paragraphs (b),
(c), (d), or (e) of this section; or
(2) Permitted an individual who does not meet the definition of a
``qualified home health aide'' as specified in paragraph (a) of this
section to furnish home health aide services (with the exception of
licensed health professionals and volunteers); or
(3) Was subjected to an extended (or partially extended) survey as a
result of having been found to have furnished substandard care (or for
other reasons as determined by CMS or the state); or
(4) Was assessed a civil monetary penalty of $5,000 or more as an
intermediate sanction; or
(5) Was found to have compliance deficiencies that endangered the
health and safety of the HHA's patients, and had temporary management
appointed to oversee the management of the HHA; or
(6) Had all or part of its Medicare payments suspended; or
(7) Was found under any federal or state law to have:
(i) Had its participation in the Medicare program terminated; or
(ii) Been assessed a penalty of $5,000 or more for deficiencies in
federal or state standards for HHAs; or
(iii) Been subjected to a suspension of Medicare payments to which
it otherwise would have been entitled; or
(iv) Operated under temporary management that was appointed to
oversee the operation of the HHA and to ensure the health and safety of
the HHA's patients; or
(v) Been closed, or had its patients transferred by the state; or
(vi) Been excluded from participating in federal health care
programs or debarred from participating in any government program.
(g) Standard: Home health aide assignments and duties. (1) Home
health aides are assigned to a specific patient by a registered nurse or
other appropriate skilled professional, with written patient care
instructions for a home health aide prepared by that registered nurse or
other appropriate skilled professional (that is, physical therapist,
speech-language pathologist, or occupational therapist).
(2) A home health aide provides services that are:
(i) Ordered by the physician;
(ii) Included in the plan of care;
(iii) Permitted to be performed under state law; and
(iv) Consistent with the home health aide training.
(3) The duties of a home health aide include:
(i) The provision of hands-on personal care;
(ii) The performance of simple procedures as an extension of therapy
or nursing services;
(iii) Assistance in ambulation or exercises; and
(iv) Assistance in administering medications ordinarily self-
administered.
(4) Home health aides must be members of the interdisciplinary team,
must report changes in the patient's condition to a registered nurse or
other appropriate skilled professional, and must complete appropriate
records in compliance with the HHA's policies and procedures.
(h) Standard: Supervision of home health aides. (1)(i) If home
health aide services are provided to a patient who is receiving skilled
nursing, physical or occupational therapy, or speech-language pathology
services, a registered nurse or other appropriate skilled professional
who is familiar with the patient, the patient's plan of care, and the
written patient care instructions described in Sec. 484.80(g), must make
an onsite visit to the patient's home no less frequently than every 14
days. The home health aide does not have to be present during this
visit.
(ii) If an area of concern in aide services is noted by the
supervising registered nurse or other appropriate skilled professional,
then the supervising individual must make an on-site visit to the
location where the patient is receiving care in order to observe and
assess the aide while he or she is performing care.
(iii) A registered nurse or other appropriate skilled professional
must make an annual on-site visit to the location where a patient is
receiving care in order to observe and assess each aide while he or she
is performing care.
(2) If home health aide services are provided to a patient who is
not receiving skilled nursing care, physical or occupational therapy, or
speech-language pathology services, the registered nurse must make an
on-site visit to the location where the patient is receiving care no
less frequently than every 60 days in order to observe and assess each
aide while he or she is performing care.
(3) If a deficiency in aide services is verified by the registered
nurse or other appropriate skilled professional during an on-site visit,
then the agency must conduct, and the home health aide must complete a
competency evaluation in accordance with paragraph (c) of this section.
(4) Home health aide supervision must ensure that aides furnish care
in a safe and effective manner, including, but not limited to, the
following elements:
(i) Following the patient's plan of care for completion of tasks
assigned to a home health aide by the registered nurse or other
appropriate skilled professional;
[[Page 171]]
(ii) Maintaining an open communication process with the patient,
representative (if any), caregivers, and family;
(iii) Demonstrating competency with assigned tasks;
(iv) Complying with infection prevention and control policies and
procedures;
(v) Reporting changes in the patient's condition; and
(vi) Honoring patient rights.
(5) If the home health agency chooses to provide home health aide
services under arrangements, as defined in section 1861(w)(1) of the
Act, the HHA's responsibilities also include, but are not limited to:
(i) Ensuring the overall quality of care provided by an aide;
(ii) Supervising aide services as described in paragraphs (h)(1) and
(2) of this section; and
(iii) Ensuring that home health aides who provide services under
arrangement have met the training or competency evaluation requirements,
or both, of this part.
(i) Standard: Individuals furnishing Medicaid personal care aide-
only services under a Medicaid personal care benefit. An individual may
furnish personal care services, as defined in Sec. 440.167 of this
chapter, on behalf of an HHA. Before the individual may furnish personal
care services, the individual must meet all qualification standards
established by the state. The individual only needs to demonstrate
competency in the services the individual is required to furnish.
Subpart C_Furnishing of Services
Sec. 484.30 Condition of participation: Skilled nursing services.
The HHA furnishes skilled nursing services by or under the
supervision of a registered nurse and in accordance with the plan of
care.
(a) Standard: Duties of the registered nurse. The registered nurse
makes the initial evaluation visit, regularly reevaluates the patient's
nursing needs, initiates the plan of care and necessary revisions,
furnishes those services requiring substantial and specialized nursing
skill, initiates appropriate preventive and rehabilitative nursing
procedures, prepares clinical and progress notes, coordinates services,
informs the physician and other personnel of changes in the patient's
condition and needs, counsels the patient and family in meeting nursing
and related needs, participates in in-service programs, and supervises
and teaches other nursing personnel.
(b) Standard: Duties of the licensed practical nurse. The licensed
practical nurse furnishes services in accordance with agency policies,
prepares clinical and progress notes, assists the physician and
registered nurse in performing specialized procedures, prepares
equipment and materials for treatments observing aseptic technique as
required, and assists the patient in learning appropriate self-care
techniques.
[54 FR 33367, Aug. 14, 1989, as amended at 56 FR 32974, July 18, 1991]
Sec. 484.32 Condition of participation: Therapy services.
Any therapy services offered by the HHA directly or under
arrangement are given by a qualified therapist or by a qualified therapy
assistant under the supervision of a qualified therapist and in
accordance with the plan of care. The qualified therapist assists the
physician in evaluating level of function, helps develop the plan of
care (revising it as necessary), prepares clinical and progress notes,
advises and consults with the family and other agency personnel, and
participates in in-service programs.
(a) Standard: Supervision of physical therapy assistant and
occupational therapy assistant. Services furnished by a qualified
physical therapy assistant or qualified occupational therapy assistant
may be furnished under the supervision of a qualified physical or
occupational therapist. A physical therapy assistant or occupational
therapy assistant performs services planned, delegated, and supervised
by the therapist, assists in preparing clinical notes and progress
reports, and participates in educating the patient and family, and in
in-service programs.
(b) Standard: Supervision of speech therapy services. Speech therapy
services are furnished only by or under supervision of a qualified
speech pathologist or audiologist.
[54 FR 33367, Aug. 14, 1989, as amended at 56 FR 32974, July 18, 1991]
Sec. 484.34 Condition of participation: Medical social services.
If the agency furnishes medical social services, those services are
given by a qualified social worker or by a qualified social work
assistant under
[[Page 172]]
the supervision of a qualified social worker, and in accordance with the
plan of care. The social worker assists the physician and other team
members in understanding the significant social and emotional factors
related to the health problems, participates in the development of the
plan of care, prepares clinical and progress notes, works with the
family, uses appropriate community resources, participates in discharge
planning and in-service programs, and acts as a consultant to other
agency personnel.
Sec. 484.36 Condition of participation: Home health aide services.
Home health aides are selected on the basis of such factors as a
sympathetic attitude toward the care of the sick, ability to read,
write, and carry out directions, and maturity and ability to deal
effectively with the demands of the job. They are closely supervised to
ensure their competence in providing care. For home health services
furnished (either directly or through arrangements with other
organizations) after August 14, 1990, the HHA must use individuals who
meet the personnel qualifications specified in Sec. 484.4 for ``home
health aide''.
(a) Standard: Home health aide training--(1) Content and duration of
training. The aide training program must address each of the following
subject areas through classroom and supervised practical training
totalling at least 75 hours, with at least 16 hours devoted to
supervised practical training. The individual being trained must
complete at least 16 hours of classroom training before beginning the
supervisied practical training.
(i) Communications skills.
(ii) Observation, reporting and documentation of patient status and
the care or service furnished.
(iii) Reading and recording temperature, pulse, and respiration.
(iv) Basic infection control procedures.
(v) Basic elements of body functioning and changes in body function
that must be reported to an aide's supervisor.
(vi) Maintenance of a clean, safe, and healthy environment.
(vii) Recognizing emergencies and knowledge of emergency procedures.
(viii) The physical, emotional, and developmental needs of and ways
to work with the populations served by the HHA, including the need for
respect for the patient, his or her privacy and his or her property.
(ix) Appropriate and safe techniques in personal hygiene and
grooming that include--
(A) Bed bath.
(B) Sponge, tub, or shower bath.
(C) Shampoo, sink, tub, or bed.
(D) Nail and skin care.
(E) Oral hygiene.
(F) Toileting and elimination.
(x) Safe transfer techniques and ambulation.
(xi) Normal range of motion and positioning.
(xii) Adequate nutrition and fluid intake.
(xiii) Any other task that the HHA may choose to have the home
health aide perform.
``Supervised practical training'' means training in a laboratory or
other setting in which the trainee demonstrates knowledge while
performing tasks on an individual under the direct supervision of a
registered nurse or licensed practical nurse.
(2) Conduct of training--(i) Organizations. A home health aide
training program may be offered by any organization except an HHA that,
within the previous 2 years has been found--
(A) Out of compliance with requirements of this paragraph (a) or
paragraph (b) of this section;
(B) To permit an individual that does not meet the definition of
``home health aide'' as specified in Sec. 484.4 to furnish home health
aide services (with the exception of licensed health professionals and
volunteers);
(C) Has been subject to an extended (or partial extended) survey as
a result of having been found to have furnished substandard care (or for
other reasons at the discretion of the CMS or the State);
(D) Has been assessed a civil monetary penalty of not less than
$5,000 as an intermediate sanction;
(E) Has been found to have compliance deficiencies that endanger the
health and safety of the HHA's patients
[[Page 173]]
and has had a temporary management appointed to oversee the management
of the HHA;
(F) Has had all or part of its Medicare payments suspended; or
(G) Under any Federal or State law within the 2-year period
beginning on October 1, 1988--
(1) Has had its participation in the Medicare program terminated;
(2) Has been assessed a penalty of not less than $5,000 for
deficiencies in Federal or State standards for HHAs;
(3) Was subject to a suspension of Medicare payments to which it
otherwise would have been entitled;
(4) Had operated under a temporary management that was appointed to
oversee the operation of the HHA and to ensure the health and safety of
the HHA's patients; or
(5) Was closed or had it's residents transferred by the State.
(ii) Qualifications for instructors. The training of home health
aides and the supervision of home health aides during the supervised
practical portion of the training must be performed by or under the
general supervision of a registered nurse who possesses a minimum of 2
years of nursing experience, at least 1 year of which must be in the
provision of home health care. Other individuals may be used to provide
instruction under the supervision of a qualified registered nurse.
(3) Documentation of training. The HHA must maintain sufficient
documentation to demonstrate that the requirements of this standard are
met.
(b) Standard: Competency evaluation and in-service training--(1)
Applicability. An individual may furnish home health aide services on
behalf of an HHA only after that individual has successfully completed a
competency evaluation program as described in this paragraph. The HHA is
responsible for ensuring that the individuals who furnish home health
aide services on its behalf meet the competency evaluation requirements
of this section.
(2) Content and frequency of evaluations and amount of in-service
training. (i) The competency evaluation must address each of the
subjects listed in paragraph (a)(1) (ii) through (xiii) of this section.
(ii) The HHA must complete a performance review of each home health
aide no less frequently than every 12 months.
(iii) The home health aide must receive at least 12 hours of in-
service training during each 12-month period. The in-service training
may be furnished while the aide is furnishing care to the patient.
(3) Conduct of evaluation and training--(i) Organizations. A home
health aide competency evaluation program may be offered by any
organization except as specified in paragraph (a)(2)(i) of this section.
The in-service training may be offered by any organization.
(ii) Evaluators and instructors. The competency evaluation must be
performed by a registered nurse. The in-service training generally must
be supervised by a registered nurse who possesses a minimum of 2 years
of nursing experience at least 1 year of which must be in the provision
of home health care.
(iii) Subject areas. The subject areas listed at paragraphs (a)(1)
(iii), (ix), (x), and (xi) of this section must be evaluated after
observation of the aide's performance of the tasks with a patient. The
other subject areas in paragraph (a)(1) of this section may be evaluated
through written examination, oral examination, or after observation of a
home health aide with a patient.
(4) Competency determination. (i) A home health aide is not
considered competent in any task for which he or she is evaluated as
``unsatisfactory''. The aide must not perform that task without direct
supervision by a licensed nurse until after he or she receives training
in the task for which he or she was evaluated as ``unsatisfactory'' and
passes a subsequent evaluation with ``satisfactory''.
(ii) A home health aide is not considered to have successfully
passed a competency evaluation if the aide has an ``unsatisfactory''
rating in more than one of the required areas.
(5) Documentation of competency evaluation. The HHA must maintain
documentation which demonstrates that the requirements of this standard
are met.
[[Page 174]]
(6) Effective date. The HHA must implement a competency evaluation
program that meets the requirements of this paragraph before February
14, 1990. The HHA must provide the preparation necessary for the
individual to successfully complete the competency evaluation program.
After August 14, 1990, the HHA may use only those aides that have been
found to be competent in accordance with Sec. 484.36(b).
(c) Standard: Assignment and duties of the home health aide--(1)
Assignment. The home health aide is assigned to a specific patient by
the registered nurse. Written patient care instructions for the home
health aide must be prepared by the registered nurse or other
appropriate professional who is responsible for the supervision of the
home health aide under paragraph (d) of this section.
(2) Duties. The home health aide provides services that are ordered
by the physician in the plan of care and that the aide is permitted to
perform under State law. The duties of a home health aide include the
provision of hands-on personal care, performance of simple procedures as
an extension of therapy or nursing services, assistance in ambulation or
exercises, and assistance in administering medications that are
ordinarily self-administered. Any home health aide services offered by
an HHA must be provided by a qualified home health aide.
(d) Standard: Supervision. (1) If the patient receives skilled
nursing care, the registered nurse must perform the supervisory visit
required by paragraph (d)(2) of this section. If the patient is not
receiving skilled nursing care, but is receiving another skilled service
(that is, physical therapy, occupational therapy, or speech-language
pathology services), supervision may be provided by the appropriate
therapist.
(2) The registered nurse (or another professional described in
paragraph (d)(1) of this section) must make an on-site visit to the
patient's home no less frequently than every 2 weeks.
(3) If home health aide services are provided to a patient who is
not receiving skilled nursing care, physical or occupational therapy or
speech-language pathology services, the registered nurse must make a
supervisory visit to the patient's home no less frequently than every 60
days. In these cases, to ensure that the aide is properly caring for the
patient, each supervisory visit must occur while the home health aide is
providing patient care.
(4) If home health aide services are provided by an individual who
is not employed directly by the HHA (or hospice), the services of the
home health aide must be provided under arrangements, as defined in
section 1861(w)(1) of the Act. If the HHA (or hospice) chooses to
provide home health aide services under arrangements with another
organization, the HHA's (or hospice's) responsibilities include, but are
not limited to--
(i) Ensuring the overall quality of the care provided by the aide;
(ii) Supervision of the aide's services as described in paragraphs
(d)(1) and (d)(2) of this section; and
(iii) Ensuring that home health aides providing services under
arrangements have met the training requirements of paragraphs (a) and
(b) of this section.
(e) Personal care attendant: Evaluation requirements--(1)
Applicability. This paragraph applies to individuals who are employed by
HHAs exclusively to furnish personal care attendant services under a
Medicaid personal care benefit.
(2) Rule. An individual may furnish personal care services, as
defined in Sec. 440.170 of this chapter, on behalf of an HHA after the
individual has been found competent by the State to furnish those
services for which a competency evaluation is required by paragraph (b)
of this section and which the individual is required to perform. The
individual need not be determined competent in those services listed in
paragraph (a) of this section that the individual is not required to
furnish.
[54 FR 33367, Aug. 14, 1989, as amended at 56 FR 32974, July 18, 1991;
56 FR 51334, Oct. 11, 1991; 59 FR 65498, Dec. 20, 1994; 60 FR 39123,
Aug. 1, 1995; 66 FR 32778, June 18, 2001]
[[Page 175]]
Sec. 484.38 Condition of participation: Qualifying to furnish
outpatient physical therapy or speech pathology services.
An HHA that wishes to furnish outpatient physical therapy or speech
pathology services must meet all the pertinent conditions of this part
and also meet the additional health and safety requirements set forth in
Secs. 485.711, 485.713, 485.715, 485.719, 485.723, and 485.727 of this
chapter to implement section 1861(p) of the Act.
[54 FR 33367, Aug. 14, 1989, as amended at 60 FR 2329, Jan. 9, 1995; 60
FR 11632, Mar. 2, 1995]
Sec. 484.48 Condition of participation: Clinical records.
A clinical record containing pertinent past and current findings in
accordance with accepted professional standards is maintained for every
patient receiving home health services. In addition to the plan of care,
the record contains appropriate identifying information; name of
physician; drug, dietary, treatment, and activity orders; signed and
dated clinical and progress notes; copies of summary reports sent to the
attending physician; and a discharge summary. The HHA must inform the
attending physician of the availability of a discharge summary. The
discharge summary must be sent to the attending physician upon request
and must include the patient's medical and health status at discharge.
(a) Standards: Retention of records. Clinical records are retained
for 5 years after the month the cost report to which the records apply
is filed with the intermediary, unless State law stipulates a longer
period of time. Policies provide for retention even if the HHA
discontinues operations. If a patient is transferred to another health
facility, a copy of the record or abstract is sent with the patient.
(b) Standards: Protection of records. Clinical record information is
safe-guarded against loss or unauthorized use. Written procedures govern
use and removal of records and the conditions for release of
information. Patient's written consent is required for release of
information not authorized by law.
[54 FR 33367, Aug. 14, 1989, as amended at 60 FR 65498, Dec. 20, 1994]
Sec. 484.52 Condition of participation: Evaluation of the agency's
program.
The HHA has written policies requiring an overall evaluation of the
agency's total program at least once a year by the group of professional
personnel (or a committee of this group), HHA staff, and consumers, or
by professional people outside the agency working in conjunction with
consumers. The evaluation consists of an overall policy and
administrative review and a clinical record review. The evaluation
assesses the extent to which the agency's program is appropriate,
adequate, effective, and efficient. Results of the evaluation are
reported to and acted upon by those responsible for the operation of the
agency and are maintained separately as administrative records.
(a) Standard: Policy and administrative review. As a part of the
evaluation process the policies and administrative practices of the
agency are reviewed to determine the extent to which they promote
patient care that is appropriate, adequate, effective, and efficient.
Mechanisms are established in writing for the collection of pertinent
data to assist in evaluation.
(b) Standard: Clinical record review. At least quarterly,
appropriate health professionals, representing at least the scope of the
program, review a sample of both active and closed clinical records to
determine whether established policies are followed in furnishing
services directly or under arrangement. There is a continuing review of
clinical records for each 60-day period that a patient receives home
health services to determine adequacy of the plan of care and
appropriateness of continuation of care.
[54 FR 33367, Aug. 14, 1989; 66 FR 32778, June 18, 2001]
Sec. 484.55 Condition of participation: Comprehensive assessment
of patients.
Each patient must receive, and an HHA must provide, a patient-
specific, comprehensive assessment that accurately reflects the
patient's current health status and includes information that may be
used to demonstrate the patient's progress toward achievement
[[Page 176]]
of desired outcomes. The comprehensive assessment must identify the
patient's continuing need for home care and meet the patient's medical,
nursing, rehabilitative, social, and discharge planning needs. For
Medicare beneficiaries, the HHA must verify the patient's eligibility
for the Medicare home health benefit including homebound status, both at
the time of the initial assessment visit and at the time of the
comprehensive assessment. The comprehensive assessment must also
incorporate the use of the current version of the Outcome and Assessment
Information Set (OASIS) items, using the language and groupings of the
OASIS items, as specified by the Secretary.
(a) Standard: Initial assessment visit. (1) A registered nurse must
conduct an initial assessment visit to determine the immediate care and
support needs of the patient; and, for Medicare patients, to determine
eligibility for the Medicare home health benefit, including homebound
status. The initial assessment visit must be held either within 48 hours
of referral, or within 48 hours of the patient's return home, or on the
physician-ordered start of care date.
(2) When rehabilitation therapy service (speech language pathology,
physical therapy, or occupational therapy) is the only service ordered
by the physician, and if the need for that service establishes program
eligibility, the initial assessment visit may be made by the appropriate
rehabilitation skilled professional.
(b) Standard: Completion of the comprehensive assessment. (1) The
comprehensive assessment must be completed in a timely manner,
consistent with the patient's immediate needs, but no later than 5
calendar days after the start of care.
(2) Except as provided in paragraph (b)(3) of this section, a
registered nurse must complete the comprehensive assessment and for
Medicare patients, determine eligibility for the Medicare home health
benefit, including homebound status.
(3) When physical therapy, speech-language pathology, or
occupational therapy is the only service ordered by the physician, a
physical therapist, speech-language pathologist or occupational
therapist may complete the comprehensive assessment, and for Medicare
patients, determine eligibility for the Medicare home health benefit,
including homebound status. The occupational therapist may complete the
comprehensive assessment if the need for occupational therapy
establishes program eligibility.
(c) Standard: Drug regimen review. The comprehensive assessment must
include a review of all medications the patient is currently using in
order to identify any potential adverse effects and drug reactions,
including ineffective drug therapy, significant side effects,
significant drug interactions, duplicate drug therapy, and noncompliance
with drug therapy.
(d) Standard: Update of the comprehensive assessment. The
comprehensive assessment must be updated and revised (including the
administration of the OASIS) as frequently as the patient's condition
warrants due to a major decline or improvement in the patient's health
status, but not less frequently than--
(1) The last five days of every 60 days beginning with the start-of-
care date, unless there is a--
(i) Beneficiary elected transfer;
(ii) Significant change in condition; or
(iii) Discharge and return to the same HHA during the 60-day
episode.
(2) Within 48 hours of the patient's return to the home from a
hospital admission of 24 hours or more for any reason other than
diagnostic tests;
(3) At discharge.
(e) Standard: Incorporation of OASIS data items. The OASIS data
items determined by the Secretary must be incorporated into the HHA's
own assessment and must include: clinical record items, demographics and
patient history, living arrangements, supportive assistance, sensory
status, integumentary status, respiratory status, elimination status,
neuro/emotional/behavioral status, activities of daily living,
medications, equipment management, emergent care, and data
[[Page 177]]
items collected at inpatient facility admission or discharge only.
[64 FR 3784, Jan. 25, 1999, as amended at 65 FR 41211, July 3, 2000; 74
FR 58134, Nov. 10, 2009]
Effective Date Note: At 82 FR 4578, Jan. 13, 2017, subpart C was
revised, effective July 13, 2017. At 82 FR 31732, July 10, 2017, this
amendment was corrected. At 82 FR 31729, July 10, 2017, this amendment
was delayed until Jan. 13, 2018. For the convenience of the user, the
revised text is set forth as follows:
Subpart C_Organizational Environment
Sec. 484.100 Condition of participation: Compliance with Federal,
State, and local laws and regulations related to the health
and safety of patients.
The HHA and its staff must operate and furnish services in
compliance with all applicable federal, state, and local laws and
regulations related to the health and safety of patients. If state or
local law provides licensing of HHAs, the HHA must be licensed.
(a) Standard: Disclosure of ownership and management information.
The HHA must comply with the requirements of part 420 subpart C, of this
chapter. The HHA also must disclose the following information to the
state survey agency at the time of the HHA's initial request for
certification, for each survey, and at the time of any change in
ownership or management:
(1) The names and addresses of all persons with an ownership or
controlling interest in the HHA as defined in Sec. 420.201,
Sec. 420.202, and Sec. 420.206 of this chapter.
(2) The name and address of each person who is an officer, a
director, an agent, or a managing employee of the HHA as defined in
Sec. 420.201, Sec. 420.202, and Sec. 420.206 of this chapter.
(3) The name and business address of the corporation, association,
or other company that is responsible for the management of the HHA, and
the names and addresses of the chief executive officer and the
chairperson of the board of directors of that corporation, association,
or other company responsible for the management of the HHA.
(b) Standard: Licensing. The HHA, its branches, and all persons
furnishing services to patients must be licensed, certified, or
registered, as applicable, in accordance with the state licensing
authority as meeting those requirements.
(c) Standard: Laboratory services. (1) If the HHA engages in
laboratory testing outside of the context of assisting an individual in
self-administering a test with an appliance that has been cleared for
that purpose by the Food and Drug Administration, the testing must be in
compliance with all applicable requirements of part 493 of this chapter.
The HHA may not substitute its equipment for a patient's equipment when
assisting with self-administered tests.
(2) If the HHA refers specimens for laboratory testing, the referral
laboratory must be certified in the appropriate specialties and
subspecialties of services in accordance with the applicable
requirements of part 493 of this chapter.
Sec. 484.102 Condition of participation: Emergency preparedness.
The Home Health Agency (HHA) must comply with all applicable
Federal, State, and local emergency preparedness requirements. The HHA
must establish and maintain an emergency preparedness program that meets
the requirements of this section. The emergency preparedness program
must include, but not be limited to, the following elements:
(a) Emergency plan. The HHA must develop and maintain an emergency
preparedness plan that must be reviewed, and updated at least annually.
The plan must do all of the following:
(1) Be based on and include a documented, facility-based and
community-based risk assessment, utilizing an all-hazards approach.
(2) Include strategies for addressing emergency events identified by
the risk assessment.
(3) Address patient population, including, but not limited to, the
type of services the HHA has the ability to provide in an emergency; and
continuity of operations, including delegations of authority and
succession plans.
(4) Include a process for cooperation and collaboration with local,
tribal, regional, State, and Federal emergency preparedness officials'
efforts to maintain an integrated response during a disaster or
emergency situation, including documentation of the HHA's efforts to
contact such officials and, when applicable, of its participation in
collaborative and cooperative planning efforts.
(b) Policies and procedures. The HHA must develop and implement
emergency preparedness policies and procedures, based on the emergency
plan set forth in paragraph (a) of this section, risk assessment at
paragraph (a)(1) of this section, and the communication plan at
paragraph (c) of this section. The policies and procedures must be
reviewed and updated at least annually. At a minimum, the policies and
procedures must address the following:
(1) The plans for the HHA's patients during a natural or man-made
disaster. Individual plans for each patient must be included as part of
the comprehensive patient assessment, which must be conducted according
to the provisions at Sec. 484.55.
(2) The procedures to inform State and local emergency preparedness
officials about HHA patients in need of evacuation from
[[Page 178]]
their residences at any time due to an emergency situation based on the
patient's medical and psychiatric condition and home environment.
(3) The procedures to follow up with on-duty staff and patients to
determine services that are needed, in the event that there is an
interruption in services during or due to an emergency. The HHA must
inform State and local officials of any on-duty staff or patients that
they are unable to contact.
(4) A system of medical documentation that preserves patient
information, protects confidentiality of patient information, and
secures and maintains the availability of records.
(5) The use of volunteers in an emergency or other emergency
staffing strategies, including the process and role for integration of
State or Federally designated health care professionals to address surge
needs during an emergency.
(c) Communication plan. The HHA must develop and maintain an
emergency preparedness communication plan that complies with Federal,
State, and local laws and must be reviewed and updated at least
annually. The communication plan must include all of the following:
(1) Names and contact information for the following:
(i) Staff.
(ii) Entities providing services under arrangement.
(iii) Patients' physicians.
(iv) Volunteers.
(2) Contact information for the following:
(i) Federal, State, tribal, regional, or local emergency
preparedness staff.
(ii) Other sources of assistance.
(3) Primary and alternate means for communicating with the HHA's
staff, Federal, State, tribal, regional, and local emergency management
agencies.
(4) A method for sharing information and medical documentation for
patients under the HHA's care, as necessary, with other health care
providers to maintain the continuity of care.
(5) A means of providing information about the general condition and
location of patients under the facility's care as permitted under 45 CFR
164.510(b)(4).
(6) A means of providing information about the HHA's needs, and its
ability to provide assistance, to the authority having jurisdiction, the
Incident Command Center, or designee.
(d) Training and testing. The HHA must develop and maintain an
emergency preparedness training and testing program that is based on the
emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, policies and procedures
at paragraph (b) of this section, and the communication plan at
paragraph (c) of this section. The training and testing program must be
reviewed and updated at least annually.
(1) Training program. The HHA must do all of the following:
(i) Initial training in emergency preparedness policies and
procedures to all new and existing staff, individuals providing services
under arrangement, and volunteers, consistent with their expected roles.
(ii) Provide emergency preparedness training at least annually.
(iii) Maintain documentation of the training.
(ii) Demonstrate staff knowledge of emergency procedures.
(2) Testing. The HHA must conduct exercises to test the emergency
plan at least annually. The HHA must do the following:
(i) Participate in a full-scale exercise that is community-based or
when a community-based exercise is not accessible, an individual,
facility-based. If the HHA experiences an actual natural or man-made
emergency that requires activation of the emergency plan, the HHA is
exempt from engaging in a community-based or individual, facility-based
full-scale exercise for 1 year following the onset of the actual event.
(ii) Conduct an additional exercise that may include, but is not
limited to the following:
(A) A second full-scale exercise that is community-based or
individual, facility-based.
(B) A tabletop exercise that includes a group discussion led by a
facilitator, using a narrated, clinically-relevant emergency scenario,
and a set of problem statements, directed messages, or prepared
questions designed to challenge an emergency plan.
(iii) Analyze the HHA's response to and maintain documentation of
all drills, tabletop exercises, and emergency events, and revise the
HHA's emergency plan, as needed.
(e) Integrated healthcare systems. If a HHA is part of a healthcare
system consisting of multiple separately certified healthcare facilities
that elects to have a unified and integrated emergency preparedness
program, the HHA may choose to participate in the healthcare system's
coordinated emergency preparedness program. If elected, the unified and
integrated emergency preparedness program must do all of the following:
(1) Demonstrate that each separately certified facility within the
system actively participated in the development of the unified and
integrated emergency preparedness program.
(2) Be developed and maintained in a manner that takes into account
each separately certified facility's unique circumstances, patient
populations, and services offered.
(3) Demonstrate that each separately certified facility is capable
of actively using the
[[Page 179]]
unified and integrated emergency preparedness program and is in
compliance with the program.
(4) Include a unified and integrated emergency plan that meets the
requirements of paragraphs (a)(2), (3), and (4) of this section. The
unified and integrated emergency plan must also be based on and include
all of the following:
(i) A documented community-based risk assessment, utilizing an all-
hazards approach.
(ii) A documented individual facility-based risk assessment for each
separately certified facility within the health system, utilizing an
all-hazards approach.
(5) Include integrated policies and procedures that meet the
requirements set forth in paragraph (b) of this section, a coordinated
communication plan and training and testing programs that meet the
requirements of paragraphs (c) and (d) of this section, respectively.
Sec. 484.105 Condition of participation: Organization and
administration of services.
The HHA must organize, manage, and administer its resources to
attain and maintain the highest practicable functional capacity,
including providing optimal care to achieve the goals and outcomes
identified in the patient's plan of care, for each patient's medical,
nursing, and rehabilitative needs. The HHA must assure that
administrative and supervisory functions are not delegated to another
agency or organization, and all services not furnished directly are
monitored and controlled. The HHA must set forth, in writing, its
organizational structure, including lines of authority, and services
furnished.
(a) Standard: Governing body. A governing body (or designated
persons so functioning) must assume full legal authority and
responsibility for the agency's overall management and operation, the
provision of all home health services, fiscal operations, review of the
agency's budget and its operational plans, and its quality assessment
and performance improvement program.
(b) Standard: Administrator. (1) The administrator must:
(i) Be appointed by and report to the governing body;
(ii) Be responsible for all day-to-day operations of the HHA;
(iii) Ensure that a clinical manager as described in paragraph (c)
of this section is available during all operating hours;
(iv) Ensure that the HHA employs qualified personnel, including
assuring the development of personnel qualifications and policies.
(2) When the administrator is not available, a qualified, pre-
designated person, who is authorized in writing by the administrator and
the governing body, assumes the same responsibilities and obligations as
the administrator. The pre-designated person may be the clinical manager
as described in paragraph (c) of this section.
(3) The administrator or a pre-designated person is available during
all operating hours.
(c) Clinical manager. One or more qualified individuals must provide
oversight of all patient care services and personnel. Oversight must
include the following--
(1) Making patient and personnel assignments,
(2) Coordinating patient care,
(3) Coordinating referrals,
(4) Assuring that patient needs are continually assessed, and
(5) Assuring the development, implementation, and updates of the
individualized plan of care.
(d) Standard: Parent-branch relationship. (1) The parent HHA is
responsible for reporting all branch locations of the HHA to the state
survey agency at the time of the HHA's request for initial
certification, at each survey, and at the time the parent proposes to
add or delete a branch.
(2) The parent HHA provides direct support and administrative
control of its branches.
(e) Standard: Services under arrangement. (1) The HHA must ensure
that all services furnished under arrangement provided by other entities
or individuals meet the requirements of this part and the requirements
of section 1861(w) of the Act (42 U.S.C. 1395x (w)).
(2) An HHA must have a written agreement with another agency, with
an organization, or with an individual when that entity or individual
furnishes services under arrangement to the HHA's patients. The HHA must
maintain overall responsibility for the services provided under
arrangement, as well as the manner in which they are furnished. The
agency, organization, or individual providing services under arrangement
may not have been:
(i) Denied Medicare or Medicaid enrollment;
(ii) Been excluded or terminated from any federal health care
program or Medicaid;
(iii) Had its Medicare or Medicaid billing privileges revoked; or
(iv) Been debarred from participating in any government program.
(3) The primary HHA is responsible for patient care, and must
conduct and provide, either directly or under arrangements, all services
rendered to patients.
(f) Standard: Services furnished. (1) Skilled nursing services and
at least one other therapeutic service (physical therapy, speech-
language pathology, or occupational therapy; medical social services; or
home health aide services) are made available on a visiting basis, in a
place of residence used as a patient's home. An HHA must provide at
[[Page 180]]
least one of the services described in this subsection directly, but may
provide the second service and additional services under arrangement
with another agency or organization.
(2) All HHA services must be provided in accordance with current
clinical practice guidelines and accepted professional standards of
practice.
(g) Standard: Outpatient physical therapy or speech-language
pathology services. An HHA that furnishes outpatient physical therapy or
speech-language pathology services must meet all of the applicable
conditions of this part and the additional health and safety
requirements set forth in Sec. 485.711, Sec. 485.713, Sec. 485.715,
Sec. 485.719, Sec. 485.723, and Sec. 485.727 of this chapter to
implement section 1861(p) of the Act.
(h) Standard: Institutional planning. The HHA, under the direction
of the governing body, prepares an overall plan and a budget that
includes an annual operating budget and capital expenditure plan.
(1) Annual operating budget. There is an annual operating budget
that includes all anticipated income and expenses related to items that
would, under generally accepted accounting principles, be considered
income and expense items. However, it is not required that there be
prepared, in connection with any budget, an item by item identification
of the components of each type of anticipated income or expense.
(2) Capital expenditure plan. (i) There is a capital expenditure
plan for at least a 3-year period, including the operating budget year.
The plan includes and identifies in detail the anticipated sources of
financing for, and the objectives of, each anticipated expenditure of
more than $600,000 for items that would under generally accepted
accounting principles, be considered capital items. In determining if a
single capital expenditure exceeds $600,000, the cost of studies,
surveys, designs, plans, working drawings, specifications, and other
activities essential to the acquisition, improvement, modernization,
expansion, or replacement of land, plant, building, and equipment are
included. Expenditures directly or indirectly related to capital
expenditures, such as grading, paving, broker commissions, taxes
assessed during the construction period, and costs involved in
demolishing or razing structures on land are also included. Transactions
that are separated in time, but are components of an overall plan or
patient care objective, are viewed in their entirety without regard to
their timing. Other costs related to capital expenditures include title
fees, permit and license fees, broker commissions, architect, legal,
accounting, and appraisal fees; interest, finance, or carrying charges
on bonds, notes and other costs incurred for borrowing funds.
(ii) If the anticipated source of financing is, in any part, the
anticipated payment from title V (Maternal and Child Health Services
Block Grant) or title XVIII (Medicare) or title XIX (Medicaid) of the
Social Security Act, the plan specifies the following:
(A) Whether the proposed capital expenditure is required to conform,
or is likely to be required to conform, to current standards, criteria,
or plans developed in accordance with the Public Health Service Act or
the Mental Retardation Facilities and Community Mental Health Centers
Construction Act of 1963.
(B) Whether a capital expenditure proposal has been submitted to the
designated planning agency for approval in accordance with section 1122
of the Act (42 U.S.C. 1320a-1) and implementing regulations.
(C) Whether the designated planning agency has approved or
disapproved the proposed capital expenditure if it was presented to that
agency.
(3) Preparation of plan and budget. The overall plan and budget is
prepared under the direction of the governing body of the HHA by a
committee consisting of representatives of the governing body, the
administrative staff, and the medical staff (if any) of the HHA.
(4) Annual review of plan and budget. The overall plan and budget is
reviewed and updated at least annually by the committee referred to in
paragraph (i)(3) of this section under the direction of the governing
body of the HHA.
Sec. 484.110 Condition of participation: Clinical records.
The HHA must maintain a clinical record containing past and current
information for every patient accepted by the HHA and receiving home
health services. Information contained in the clinical record must be
accurate, adhere to current clinical record documentation standards of
practice, and be available to the physician(s) issuing orders for the
home health plan of care, and appropriate HHA staff. This information
may be maintained electronically.
(a) Standard: Contents of clinical record. The record must include:
(1) The patient's current comprehensive assessment, including all of
the assessments from the most recent home health admission, clinical
notes, plans of care, and physician orders;
(2) All interventions, including medication administration,
treatments, and services, and responses to those interventions;
(3) Goals in the patient's plans of care and the patient's progress
toward achieving them;
(4) Contact information for the patient, the patient's
representative (if any), and the patient's primary caregiver(s);
[[Page 181]]
(5) Contact information for the primary care practitioner or other
health care professional who will be responsible for providing care and
services to the patient after discharge from the HHA; and
(6)(i) A completed discharge summary that is sent to the primary
care practitioner or other health care professional who will be
responsible for providing care and services to the patient after
discharge from the HHA (if any) within 5 business days of the patient's
discharge; or
(ii) A completed transfer summary that is sent within 2 business
days of a planned transfer, if the patient's care will be immediately
continued in a health care facility; or
(iii) A completed transfer summary that is sent within 2 business
days of becoming aware of an unplanned transfer, if the patient is still
receiving care in a health care facility at the time when the HHA
becomes aware of the transfer.
(b) Standard: Authentication. All entries must be legible, clear,
complete, and appropriately authenticated, dated, and timed.
Authentication must include a signature and a title (occupation), or a
secured computer entry by a unique identifier, of a primary author who
has reviewed and approved the entry.
(c) Standard: Retention of records. (1) Clinical records must be
retained for 5 years after the discharge of the patient, unless state
law stipulates a longer period of time.
(2) The HHA's policies must provide for retention of clinical
records even if it discontinues operation. When an HHA discontinues
operation, it must inform the state agency where clinical records will
be maintained.
(d) Standard: Protection of records. The clinical record, its
contents, and the information contained therein must be safeguarded
against loss or unauthorized use. The HHA must be in compliance with the
rules regarding protected health information set out at 45 CFR parts 160
and 164.
(e) Standard: Retrieval of clinical records. A patient's clinical
record (whether hard copy or electronic form) must be made available to
a patient, free of charge, upon request at the next home visit, or
within 4 business days (whichever comes first).
Sec. 484.115 Condition of participation: Personnel qualifications.
HHA staff are required to meet the following standards:
(a) Standard: Administrator, home health agency. (1) For individuals
that began employment with the HHA prior to January 13, 2018, a person
who:
(i) Is a licensed physician;
(ii) Is a registered nurse; or
(iii) Has training and experience in health service administration
and at least 1 year of supervisory administrative experience in home
health care or a related health care program.
(2) For individuals that begin employment with an HHA on or after
July 13, 2017, a person who:
(i) Is a licensed physician, a registered nurse, or holds an
undergraduate degree; and
(ii) Has experience in health service administration, with at least
1 year of supervisory or administrative experience in home health care
or a related health care program.
(b) Standard: Audiologist. A person who:
(1) Meets the education and experience requirements for a
Certificate of Clinical Competence in audiology granted by the American
Speech-Language-Hearing Association; or
(2) Meets the educational requirements for certification and is in
the process of accumulating the supervised experience required for
certification.
(c) Standard: Clinical manager. A person who is a licensed
physician, physical therapist, speech-language pathologist, occupational
therapist, audiologist, social worker, or a registered nurse.
(d) Standard: Home health aide. A person who meets the
qualifications for home health aides specified in section 1891(a)(3) of
the Act and implemented at Sec. 484.80.
(e) Standard: Licensed practical (vocational) nurse. A person who
has completed a practical (vocational) nursing program, is licensed in
the state where practicing, and who furnishes services under the
supervision of a qualified registered nurse.
(f) Standard: Occupational therapist. A person who--
(1)(i) Is licensed or otherwise regulated, if applicable, as an
occupational therapist by the state in which practicing, unless
licensure does not apply;
(ii) Graduated after successful completion of an occupational
therapist education program accredited by the Accreditation Council for
Occupational Therapy Education (ACOTE) of the American Occupational
Therapy Association, Inc. (AOTA), or successor organizations of ACOTE;
and
(iii) Is eligible to take, or has successfully completed the entry-
level certification examination for occupational therapists developed
and administered by the National Board for Certification in Occupational
Therapy, Inc. (NBCOT).
(2) On or before December 31, 2009--
(i) Is licensed or otherwise regulated, if applicable, as an
occupational therapist by the state in which practicing; or
(ii) When licensure or other regulation does not apply--
(A) Graduated after successful completion of an occupational
therapist education program accredited by the accreditation Council for
Occupational Therapy Education (ACOTE) of the American Occupational
[[Page 182]]
Therapy Association, Inc. (AOTA) or successor organizations of ACOTE;
and
(B) Is eligible to take, or has successfully completed the entry-
level certification examination for occupational therapists developed
and administered by the National Board for Certification in Occupational
Therapy, Inc., (NBCOT).
(3) On or before January 1, 2008--
(i) Graduated after successful completion of an occupational therapy
program accredited jointly by the Committee on Allied Health Education
and Accreditation of the American Medical Association and the American
Occupational Therapy Association; or
(ii) Is eligible for the National Registration Examination of the
American Occupational Therapy Association or the National Board for
Certification in Occupational Therapy.
(4) On or before December 31, 1977--
(i) Had 2 years of appropriate experience as an occupational
therapist; and
(ii) Had achieved a satisfactory grade on an occupational therapist
proficiency examination conducted, approved, or sponsored by the U.S.
Public Health Service.
(5) If educated outside the United States, must meet both of the
following:
(i) Graduated after successful completion of an occupational
therapist education program accredited as substantially equivalent to
occupational therapist entry level education in the United States by one
of the following:
(A) The Accreditation Council for Occupational Therapy Education
(ACOTE).
(B) Successor organizations of ACOTE.
(C) The World Federation of Occupational Therapists.
(D) A credentialing body approved by the American Occupational
Therapy Association.
(E) Successfully completed the entry level certification examination
for occupational therapists developed and administered by the National
Board for Certification in Occupational Therapy, Inc. (NBCOT).
(ii) On or before December 31, 2009, is licensed or otherwise
regulated, if applicable, as an occupational therapist by the state in
which practicing.
(g) Standard: Occupational therapy assistant. A person who--
(1) Meets all of the following:
(i) Is licensed or otherwise regulated, if applicable, as an
occupational therapy assistant by the state in which practicing, unless
licensure does apply.
(ii) Graduated after successful completion of an occupational
therapy assistant education program accredited by the Accreditation
Council for Occupational Therapy Education, (ACOTE) of the American
Occupational Therapy Association, Inc. (AOTA) or its successor
organizations.
(iii) Is eligible to take or successfully completed the entry-level
certification examination for occupational therapy assistants developed
and administered by the National Board for Certification in Occupational
Therapy, Inc. (NBCOT).
(2) On or before December 31, 2009--
(i) Is licensed or otherwise regulated as an occupational therapy
assistant, if applicable, by the state in which practicing; or any
qualifications defined by the state in which practicing, unless
licensure does not apply; or
(ii) Must meet both of the following:
(A) Completed certification requirements to practice as an
occupational therapy assistant established by a credentialing
organization approved by the American Occupational Therapy Association.
(B) After January 1, 2010, meets the requirements in paragraph
(f)(1) of this section.
(3) After December 31, 1977 and on or before December 31, 2007--
(i) Completed certification requirements to practice as an
occupational therapy assistant established by a credentialing
organization approved by the American Occupational Therapy Association;
or
(ii) Completed the requirements to practice as an occupational
therapy assistant applicable in the state in which practicing.
(4) On or before December 31, 1977--
(i) Had 2 years of appropriate experience as an occupational therapy
assistant; and
(ii) Had achieved a satisfactory grade on an occupational therapy
assistant proficiency examination conducted, approved, or sponsored by
the U.S. Public Health Service.
(5) If educated outside the United States, on or after January 1,
2008--
(i) Graduated after successful completion of an occupational therapy
assistant education program that is accredited as substantially
equivalent to occupational therapist assistant entry level education in
the United States by--
(A) The Accreditation Council for Occupational Therapy Education
(ACOTE).
(B) Its successor organizations.
(C) The World Federation of Occupational Therapists.
(D) By a credentialing body approved by the American Occupational
Therapy Association; and
(E) Successfully completed the entry level certification examination
for occupational therapy assistants developed and administered by the
National Board for Certification in Occupational Therapy, Inc. (NBCOT).
(ii) [Reserved]
(h) Standard: Physical therapist. A person who is licensed, if
applicable, by the state in which practicing, unless licensure does not
apply and meets one of the following requirements:
[[Page 183]]
(1)(i) Graduated after successful completion of a physical therapist
education program approved by one of the following:
(A) The Commission on Accreditation in Physical Therapy Education
(CAPTE).
(B) Successor organizations of CAPTE.
(C) An education program outside the United States determined to be
substantially equivalent to physical therapist entry level education in
the United States by a credentials evaluation organization approved by
the American Physical Therapy Association or an organization identified
in 8 CFR 212.15(e) as it relates to physical therapists.
(ii) Passed an examination for physical therapists approved by the
state in which physical therapy services are provided.
(2) On or before December 31, 2009--
(i) Graduated after successful completion of a physical therapy
curriculum approved by the Commission on Accreditation in Physical
Therapy Education (CAPTE); or
(ii) Meets both of the following:
(A) Graduated after successful completion of an education program
determined to be substantially equivalent to physical therapist entry
level education in the United States by a credentials evaluation
organization approved by the American Physical Therapy Association or
identified in 8 CFR 212.15(e) as it relates to physical therapists.
(B) Passed an examination for physical therapists approved by the
state in which physical therapy services are provided.
(3) Before January 1, 2008 graduated from a physical therapy
curriculum approved by one of the following:
(i) The American Physical Therapy Association.
(ii) The Committee on Allied Health Education and Accreditation of
the American Medical Association.
(iii) The Council on Medical Education of the American Medical
Association and the American Physical Therapy Association.
(4) On or before December 31, 1977 was licensed or qualified as a
physical therapist and meets both of the following:
(i) Has 2 years of appropriate experience as a physical therapist.
(ii) Has achieved a satisfactory grade on a proficiency examination
conducted, approved, or sponsored by the U.S. Public Health Service.
(5) Before January 1, 1966--
(i) Was admitted to membership by the American Physical Therapy
Association;
(ii) Was admitted to registration by the American Registry of
Physical Therapists; or
(iii) Graduated from a physical therapy curriculum in a 4-year
college or university approved by a state department of education.
(6) Before January 1, 1966 was licensed or registered, and before
January 1, 1970, had 15 years of fulltime experience in the treatment of
illness or injury through the practice of physical therapy in which
services were rendered under the order and direction of attending and
referring doctors of medicine or osteopathy.
(7) If trained outside the United States before January 1, 2008,
meets the following requirements:
(i) Was graduated since 1928 from a physical therapy curriculum
approved in the country in which the curriculum was located and in which
there is a member organization of the World Confederation for Physical
Therapy.
(ii) Meets the requirements for membership in a member organization
of the World Confederation for Physical Therapy.
(i) Standard: Physical therapist assistant. A person who is
licensed, registered or certified as a physical therapist assistant, if
applicable, by the state in which practicing, unless licensure does not
apply and meets one of the following requirements:
(1)(i) Graduated from a physical therapist assistant curriculum
approved by the Commission on Accreditation in Physical Therapy
Education of the American Physical Therapy Association; or if educated
outside the United States or trained in the United States military,
graduated from an education program determined to be substantially
equivalent to physical therapist assistant entry level education in the
United States by a credentials evaluation organization approved by the
American Physical Therapy Association or identified at 8 CFR 212.15(e);
and
(ii) Passed a national examination for physical therapist
assistants.
(2) On or before December 31, 2009, meets one of the following:
(i) Is licensed, or otherwise regulated in the state in which
practicing.
(ii) In states where licensure or other regulations do not apply,
graduated before December 31, 2009, from a 2-year college-level program
approved by the American Physical Therapy Association and after January
1, 2010, meets the requirements of paragraph (h)(1) of this section.
(3) Before January 1, 2008, where licensure or other regulation does
not apply, graduated from a 2-year college level program approved by the
American Physical Therapy Association.
(4) On or before December 31, 1977, was licensed or qualified as a
physical therapist assistant and has achieved a satisfactory grade on a
proficiency examination conducted, approved, or sponsored by the U.S.
Public Health Service.
(j) Standard: Physician. A person who meets the qualifications and
conditions specified in section 1861(r) of the Act and implemented at
Sec. 410.20(b) of this chapter.
(k) Standard: Registered nurse. A graduate of an approved school of
professional nursing who is licensed in the state where practicing.
[[Page 184]]
(l) Standard: Social Work Assistant. A person who provides services
under the supervision of a qualified social worker and:
(1) Has a baccalaureate degree in social work, psychology,
sociology, or other field related to social work, and has had at least 1
year of social work experience in a health care setting; or
(2) Has 2 years of appropriate experience as a social work
assistant, and has achieved a satisfactory grade on a proficiency
examination conducted, approved, or sponsored by the U.S. Public Health
Service, except that the determinations of proficiency do not apply with
respect to persons initially licensed by a state or seeking initial
qualification as a social work assistant after December 31, 1977.
(m) Standard: Social worker. A person who has a master's or doctoral
degree from a school of social work accredited by the Council on Social
Work Education, and has 1 year of social work experience in a health
care setting.
(n) Standard: Speech-language pathologist. A person who has a
master's or doctoral degree in speech-language pathology, and who meets
either of the following requirements:
(1) Is licensed as a speech-language pathologist by the state in
which the individual furnishes such services; or
(2) In the case of an individual who furnishes services in a state
which does not license speech-language pathologists:
(i) Has successfully completed 350 clock hours of supervised
clinical practicum (or is in the process of accumulating supervised
clinical experience);
(ii) Performed not less than 9 months of supervised full-time
speech-language pathology services after obtaining a master's or
doctoral degree in speech-language pathology or a related field; and
(iii) Successfully completed a national examination in speech-
language pathology approved by the Secretary.
Subpart D [Reserved]
Subpart E_Prospective Payment System for Home Health Agencies
Source: 65 FR 41212, July 3, 2000, unless otherwise noted.
Sec. 484.200 Basis and scope.
(a) Basis. This subpart implements section 1895 of the Act, which
provides for the implementation of a prospective payment system (PPS)
for HHAs for portions of cost reporting periods occurring on or after
October 1, 2000.
(b) Scope. This subpart sets forth the framework for the HHA PPS,
including the methodology used for the development of the payment rates,
associated adjustments, and related rules.
Sec. 484.202 Definitions.
As used in this subpart--
Case-mix index means a scale that measures the relative difference
in resource intensity among different groups in the clinical model.
Discipline means one of the six home health disciplines covered
under the Medicare home health benefit (skilled nursing services, home
health aide services, physical therapy services, occupational therapy
services, speech- language pathology services, and medical social
services).
Furnishing Negative Pressure Wound Therapy (NPWT) using a disposable
device means the application of a new applicable disposable device, as
that term is defined in section 1834(s)(2) of the Act, which includes
the professional services (specified by the assigned CPT[supreg] code)
that are provided.
Home health market basket index means an index that reflects changes
over time in the prices of an appropriate mix of goods and services
included in home health services.
Rural area means, with respect to home health episodes ending on or
after January 1, 2006, an area defined in Sec. 412.64(b)(1)(ii)(C) of
this chapter.
Urban area means, with respect to home health episodes ending on or
after January 1, 2006, an area defined in Sec. 412.64(b)(1)(ii)(A) and
(B) of this chapter.
[70 FR 68142, Nov. 9, 2005, as amended at 81 FR 76796, Nov. 3, 2016]
Sec. 484.205 Basis of payment.
(a) Method of payment. An HHA receives a national prospective 60-day
episode payment of a predetermined rate for a home health service
previously paid on a reasonable cost basis (except the osteoporosis drug
defined in section 1861(kk) of the Act) as of August 5, 1997. The
national 60-day episode payment is determined in accordance with
Sec. 484.215. The national prospective 60-day episode payment is subject
to the following adjustments and additional payments:
[[Page 185]]
(1) A low-utilization payment adjustment (LUPA) of a predetermined
per-visit rate as specified in Sec. 484.230.
(2) A partial episode payment (PEP) adjustment due to an intervening
event defined as a beneficiary elected transfer or a discharge and
return to the same HHA during the 60-day episode, that warrants a new
60-day episode payment during an existing 60-day episode, that initiates
the start of a new 60-day episode payment and a new physician
certification of the new plan of care. The PEP adjustment is determined
in accordance with Sec. 484.235.
(3) An outlier payment is determined in accordance with
Sec. 484.240.
(b) Episode payment The national, standardized prospective 60-day
episode payment represents payment in full for all costs associated with
furnishing home health services previously paid on a reasonable cost
basis (except the osteoporosis drug listed in section 1861(m) of the Act
as defined in section 1861(kk) of the Act) as of August 5, 1997 unless
the national 60-day episode payment is subject to a low-utilization
payment adjustment set forth in Sec. 484.230, a partial episode payment
adjustment set forth at Sec. 484.235, or an additional outlier payment
set forth in Sec. 484.240. All payments under this system may be subject
to a medical review adjustment reflecting beneficiary eligibility,
medical necessity determinations, and HHRG assignment. DME provided as a
home health service as defined in section 1861(m) of the Act continues
to be paid the fee schedule amount. Separate payment is made for
``furnishing NPWT using a disposable device,'' as that term is defined
in Sec. 484.202, which is not included in the episode payment.
(1) Split percentage payment for initial episodes. The initial
percentage payment for initial episodes is paid to an HHA at 60 percent
of the case-mix and wage adjusted 60-day episode rate. The residual
final payment for initial episodes is paid at 40 percent of the case-mix
and wage adjusted 60-day episode rate. Split percentage payments are
made in accordance with requirements at Sec. 409.43(c) of this chapter.
(2) Split percentage payment for subsequent episodes. The initial
percentage payment for subsequent episodes is paid to an HHA at 50
percent of the case-mix and wage adjusted 60-day episode rate. The
residual final payment for subsequent episodes is paid at 50 percent of
the case-mix and wage adjusted 60-day episode rate. Split percentage
payments are made in accordance with requirements at Sec. 409.43(c) of
this chapter.
(c) Low-utilization payment. An HHA receives a national 60-day
episode payment of a predetermined rate for home health services
previously paid on a reasonable cost basis as of August 5, 1997, unless
CMS determines at the end of the 60-day episode that the HHA furnished
minimal services to a patient during the 60-day episode. A low-
utilization payment adjustment is determined in accordance with
Sec. 484.230.
(d) Partial episode payment adjustment. (1) An HHA receives a
national 60-day episode payment of a predetermined rate for home health
services unless CMS determines an intervening event, defined as a
beneficiary elected transfer or discharge with goals met or no
expectation of return to home health and the beneficiary returned to
home health during the 60-day episode, warrants a new 60-day episode for
purposes of payment. A start of care OASIS assessment and physician
certification of the new plan of care are required.
(2) The PEP adjustment will not apply in situations of transfers
among HHAs of common ownership. Those situations will be considered
services provided under arrangement on behalf of the originating HHA by
the receiving HHA with the common ownership interest for the balance of
the 60-day episode. The common ownership exception to the transfer PEP
adjustment does not apply if the beneficiary moves to a different MSA or
Non-MSA during the 60-day episode before the transfer to the receiving
HHA. The transferring HHA in situations of common ownership not only
serves as a billing agent, but must also exercise professional
responsibility over the arranged-for services in order for services
provided under arrangements to be paid.
(3) If the intervening event warrants a new 60-day episode payment
and a new physician certification and a new plan of care, the initial
HHA receives a
[[Page 186]]
partial episode payment adjustment reflecting the length of time the
patient remained under its care. A partial episode payment adjustment is
determined in accordance with Sec. 484.235.
(e) Outlier payment. An HHA receives a national 60-day episode
payment of a predetermined rate for a home health service, unless the
imputed cost of the 60-day episode exceeds a threshold amount. The
outlier payment is defined to be a proportion of the imputed costs
beyond the threshold. An outlier payment is a payment in addition to the
national 60-day episode payment. The total of all outlier payments is
limited to no more than 2.5 percent of total outlays under the HHA PPS.
An outlier payment is determined in accordance with Sec. 484.240.
[65 FR 41212, July 3, 2000, as amended at 72 FR 49878, Aug. 29, 2007; 80
FR 68717, Nov. 5, 2015; 81 FR 76796, Nov. 3, 2016]
Sec. 484.210 Data used for the calculation of the national
prospective 60-day episode payment.
To calculate the national prospective 60-day episode payment, CMS
uses the following:
(a) Medicare cost data on the most recent audited cost report data
available.
(b) Utilization data based on Medicare claims.
(c) An appropriate wage index to adjust for area wage differences.
(d) The most recent projections of increases in costs from the HHA
market basket index.
(e) OASIS assessment data and other data that account for the
relative resource utilization for different HHA Medicare patient case-
mix. An HHA must submit to CMS the OASIS data described at
Sec. 484.55(b)(1) and (d)(1) in order for CMS to administer the payment
rate methodologies described in Secs. 484.215, 484.230 and 484.235.
[65 FR 41212, July 3, 2000, as amended at 74 FR 58134, Nov. 10, 2009]
Sec. 484.215 Initial establishment of the calculation of the national
60-day episode payment.
(a) Determining an HHA's costs. In calculating the initial
unadjusted national 60-day episode payment applicable for a service
furnished by an HHA using data on the most recent available audited cost
reports, CMS determines each HHA's costs by summing its allowable costs
for the period. CMS determines the national mean cost per visit.
(b) Determining HHA utilization. In calculating the initial
unadjusted national 60-day episode payment, CMS determines the national
mean utilization for each of the six disciplines using home health
claims data.
(c) Use of the market basket index. CMS uses the HHA market basket
index to adjust the HHA cost data to reflect cost increases occurring
between October 1, 1996 through September 30, 2001.
(d) Calculation of the unadjusted national average prospective
payment amount for the 60-day episode. CMS calculates the unadjusted
national 60-day episode payment in the following manner:
(1) By computing the mean national cost per visit.
(2) By computing the national mean utilization for each discipline.
(3) By multiplying the mean national cost per visit by the national
mean utilization summed in the aggregate for the six disciplines.
(4) By adding to the amount derived in paragraph (d)(3) of this
section, amounts for nonroutine medical supplies, an OASIS adjustment
for estimated ongoing reporting costs, an OASIS adjustment for the one
time implementation costs associated with assessment scheduling form
changes and amounts for Part B therapies that could have been unbundled
to Part B prior to October 1, 2000. The resulting amount is the
unadjusted national 60-day episode rate.
(e) Standardization of the data for variation in area wage levels
and case-mix. CMS standardizes--
(1) The cost data described in paragraph (a) of this section to
remove the effects of geographic variation in wage levels and variation
in case-mix;
(2) The cost data for geographic variation in wage levels using the
hospital wage index; and
(3) The cost data for HHA variation in case-mix using the case-mix
indices and other data that indicate HHA case-mix.
[[Page 187]]
Sec. 484.220 Calculation of the adjusted national prospective 60-day
episode payment rate for case-mix and area wage levels.
CMS adjusts the national prospective 60-day episode payment rate to
account for the following:
(a) HHA case-mix using a case-mix index to explain the relative
resource utilization of different patients. To address changes to the
case-mix that are a result of changes in the coding or classification of
different units of service that do not reflect real changes in case-mix,
the national prospective 60-day episode payment rate will be adjusted
downward as follows:
(1) For CY 2008, the adjustment is 2.75 percent.
(2) For CY 2009 and CY 2010, the adjustment is 2.75 percent in each
year.
(3) For CY 2011, the adjustment is 3.79 percent.
(4) For CY 2012, the adjustment is 3.79 percent.
(5) For CY 2013, the adjustment is 1.32 percent.
(6) For CY 2016, CY 2017, and CY 2018, the adjustment is 0.97
percent in each year.
(b) Geographic differences in wage levels using an appropriate wage
index based on the site of service of the beneficiary.
[72 FR 49879, Aug. 29, 2007, as amended at 80 FR 68717, Nov. 5, 2015]
Sec. 484.225 Annual update of the unadjusted national prospective
60-day episode payment rate.
(a) CMS updates the unadjusted national 60-day episode payment rate
on a fiscal year basis (as defined in section 1895(b)(1)(B) of the Act).
(b) For 2007 and subsequent calendar years, in accordance with
section 1895(b)(3)(B)(v) of the Act, in the case of a home health agency
that submits home health quality data, as specified by the Secretary,
the unadjusted national prospective 60-day episode rate is equal to the
rate for the previous calendar year increased by the applicable home
health market basket index amount.
(c) For 2007 and subsequent calendar years, in accordance with
section 1895(b)(3)(B)(v) of the Act, in the case of a home health agency
that does not submit home health quality data, as specified by the
Secretary, the unadjusted national prospective 60-day episode rate is
equal to the rate for the previous calendar year increased by the
applicable home health market basket index amount minus 2 percentage
points. Any reduction of the percentage change will apply only to the
calendar year involved and will not be taken into account in computing
the prospective payment amount for a subsequent calendar year.
[80 FR 68717, Nov. 5, 2015]
Sec. 484.230 Methodology used for the calculation of the
low-utilization payment adjustment.
An episode with four or fewer visits is paid the national per-visit
amount by discipline updated annually by the applicable market basket
for each visit type. The national per-visit amount is determined by
using cost data set forth in Sec. 484.210(a) and adjusting by the
appropriate wage index based on the site of service for the beneficiary.
For 2008 and subsequent calendar years, an amount will be added to low-
utilization payment adjustments for low-utilization episodes that occur
as the beneficiary's only episode or initial episode in a sequence of
adjacent episodes. For purposes of the home health PPS, a sequence of
adjacent episodes for a beneficiary is a series of claims with no more
than 60 days without home care between the end of one episode, which is
the 60th day (except for episodes that have been PEP-adjusted), and the
beginning of the next episode.
[65 FR 41212, July 3, 2000, as amended at 72 FR 69879, Aug. 29, 2007; 80
FR 68717, Nov. 5, 2015]
Sec. 484.235 Methodology used for the calculation of the partial
episode payment adjustment.
(a) CMS makes a PEP adjustment to the original 60-day episode
payment that is interrupted by an intervening event described in
Sec. 484.205(d).
(b) The original 60-day episode payment is adjusted to reflect the
length of time the beneficiary remained under the care of the original
HHA based on the first billable visit date through and including the
last billable visit date.
[[Page 188]]
(c) The partial episode payment is calculated by determining the
actual days served by the original HHA as a proportion of 60 multiplied
by the initial 60-day episode payment.
Sec. 484.240 Methodology used for the calculation of the outlier
payment.
(a) CMS makes an outlier payment for an episode whose estimated cost
exceeds a threshold amount for each case-mix group.
(b) The outlier threshold for each case-mix group is the episode
payment amount for that group, or the PEP adjustment amount for the
episode, plus a fixed dollar loss amount that is the same for all case-
mix groups.
(c) The outlier payment is a proportion of the amount of estimated
cost beyond the threshold.
(d) CMS imputes the cost for each episode by multiplying the
national per-15 minute unit amount of each discipline by the number of
15 minute units in the discipline and computing the total imputed cost
for all disciplines.
(e) The fixed dollar loss amount and the loss sharing proportion are
chosen so that the estimated total outlier payment is no more than 2.5
percent of total payment under home health PPS.
(f) The total amount of outlier payments to a specific home health
agency for a year may not exceed an amount equal to 10 percent of the
total payments to the specific agency under home health PPS for the
year.
[65 FR 41212, July 3, 2000, as amended at 72 FR 69879, Aug. 29, 2007; 80
FR 68717, Nov. 5, 2015; 81 FR 76796, Nov. 3, 2016]
Sec. 484.245 [Reserved]
Sec. 484.250 Patient assessment data.
(a) Data submission. An HHA must submit the following data to CMS:
(1) The OASIS data described at Sec. 484.55(b)(1) and (d)(1) for CMS
to administer the payment rate methodologies described in Secs. 484.215,
484.230, and 484.235, and to meet the quality reporting requirements of
section 1895(b)(3)(B)(v) of the Act.
(2) The Home Health Care CAHPS survey data for CMS to administer the
payment rate methodologies described in Sec. 484.225(c), and to meet the
quality reporting requirements of section 1895(b)(3)(B)(v) of the Act.
(b) Patient count. An HHA that has less than 60 eligible unique
HHCAHPS patients annually must annually submit to CMS their total
HHCAHPS patient count to CMS to be exempt from the HHCAHPS reporting
requirements for a calendar year period.
(c) Survey requirements. An HHA must contract with an approved,
independent HHCAHPS survey vendor to administer the HHCAHPS Survey on
its behalf.
(1) CMS approves an HHCAHPS survey vendor if such applicant has been
in business for a minimum of 3 years and has conducted surveys of
individuals and samples for at least 2 years.
(i) For HHCAHPS, a ``survey of individuals'' is defined as the
collection of data from at least 600 individuals selected by statistical
sampling methods and the data collected are used for statistical
purposes.
(ii) All applicants that meet these requirements will be approved by
CMS.
(2) No organization, firm, or business that owns, operates, or
provides staffing for a HHA is permitted to administer its own Home
Health Care CAHPS (HHCAHPS) Survey or administer the survey on behalf of
any other HHA in the capacity as an HHCAHPS survey vendor. Such
organizations will not be approved by CMS as HHCAHPS survey vendors.
(3) Approved HHCAHPS survey vendors must fully comply with all
HHCAHPS oversight activities, including allowing CMS and its HHCAHPS
program team to perform site visits at the vendors' company locations.
[76 FR 68606, Nov. 4, 2011, as amended at 77 FR 67164, Nov. 8, 2012; 79
FR 66118, Nov. 6, 2014; 80 FR 68718, Nov. 5, 2015]
Sec. 484.260 Limitation on review.
An HHA is not entitled to judicial or administrative review under
sections 1869 or 1878 of the Act, or otherwise, with regard to the
establishment of the payment unit, including the national 60-day
prospective episode payment rate, adjustments and outlier payments. An
HHA is not entitled to the review regarding the establishment of the
transition period, definition and application of the unit of payments,
[[Page 189]]
the computation of initial standard prospective payment amounts, the
establishment of the adjustment for outliers, and the establishment of
case-mix and area wage adjustment factors.
Sec. 484.265 Additional payment.
QIO photocopy and mailing costs. An additional payment is made to a
home health agency in accordance with Sec. 476.78 of this chapter for
the costs of photocopying and mailing medical records requested by a
QIO.
[68 FR 67960, Dec. 5, 2003]
Subpart F_Home Health Value-Based Purchasing (HHVBP) Model Components
for Competing Home Health Agencies Within State Boundaries
Source: 80 FR 68718, Nov. 5, 2015, unless otherwise noted.
Sec. 484.300 Basis and scope of subpart.
This subpart is established under sections 1102, 1115A, and 1871 of
the Act (42 U.S.C. 1315a), which authorizes the Secretary to issue
regulations to operate the Medicare program and test innovative payment
and service delivery models to improve coordination, quality, and
efficiency of health care services furnished under Title XVIII.
Sec. 484.305 Definitions.
As used in this subpart--
Applicable measure means a measure for which the competing HHA has
provided 20 home health episodes of care per year.
Applicable percent means a maximum upward or downward adjustment for
a given performance year, not to exceed the following:
(1) For CY 2018, 3-percent.
(2) For CY 2019, 5-percent.
(3) For CY 2020, 6-percent.
(4) For CY 2021, 7-percent.
(5) For CY 2022, 8-percent.
Benchmark refers to the mean of the top decile of Medicare-certified
HHA performance on the specified quality measure during the baseline
period, calculated for each state.
Competing home health agency or agencies means an agency or
agencies:
(1) That has or have a current Medicare certification; and,
(2) Is or are being paid by CMS for home health care delivered
within any of the states specified in Sec. 484.310.
Home health prospective payment system (HH PPS) refers to the basis
of payment for home health agencies as set forth in Secs. 484.200
through 484.245.
Larger-volume cohort means the group of competing home health
agencies within the boundaries of selected states that are participating
in HHCAHPs in accordance with Sec. 484.250.
Linear exchange function is the means to translate a competing HHA's
Total Performance Score into a value-based payment adjustment
percentage.
New measures means those measures to be reported by competing HHAs
under the HHVBP Model that are not otherwise reported by Medicare-
certified HHAs to CMS and were identified to fill gaps to cover National
Quality Strategy Domains not completely covered by existing measures in
the home health setting.
Payment adjustment means the amount by which a competing HHA's final
claim payment amount under the HH PPS is changed in accordance with the
methodology described in Sec. 484.325.
Performance period means the time period during which data are
collected for the purpose of calculating a competing HHA's performance
on measures.
Selected state(s) means those nine states that were randomly
selected to compete/participate in the HHVBP Model via a computer
algorithm designed for random selection and identified at
Sec. 484.310(b).
Smaller-volume cohort means the group of competing home health
agencies within the boundaries of selected states that are exempt from
participation in HHCAHPs in accordance with Sec. 484.250.
Total Performance Score means the numeric score ranging from 0 to
100 awarded to each competing HHA based on its performance under the
HHVBP Model.
Value-based purchasing means measuring, reporting, and rewarding
excellence in health care delivery that takes into consideration
quality, efficiency, and alignment of incentives. Effective
[[Page 190]]
health care services and high performing health care providers may be
rewarded with improved reputations through public reporting, enhanced
payments through differential reimbursements, and increased market share
through purchaser, payer, and/or consumer selection.
[80 FR 68718, Nov. 5, 2015, as amended at 81 FR 76796, Nov. 3, 2016]
Sec. 484.310 Applicability of the Home Health Value-Based Purchasing
(HHVBP) Model.
(a) General rule. The HHVBP Model applies to all Medicare-certified
home health agencies (HHAs) in selected states.
(b) Selected states. Nine states have been selected in accordance
with CMS's selection methodology. All Medicare-certified HHAs that
provide services in Massachusetts, Maryland, North Carolina, Florida,
Washington, Arizona, Iowa, Nebraska, and Tennessee will be required to
compete in this model.
Sec. 484.315 Data reporting for measures and evaluation under the
Home Health Value-Based Purchasing (HHVBP) Model.
(a) Competing home health agencies will be evaluated using a set of
quality measures.
(b) Competing home health agencies in selected states will be
required to report information on New Measures, as determined
appropriate by the Secretary, to CMS in the form, manner, and at a time
specified by the Secretary.
(c) Competing home health agencies in selected states will be
required to collect and report such information as the Secretary
determines is necessary for purposes of monitoring and evaluating the
HHVBP Model under section 1115A(b)(4) of the Act (42 U.S.C. 1315a).
[80 FR 68718, Nov. 5, 2015, as amended at 81 FR 76796, Nov. 3, 2016]
Sec. 484.320 Calculation of the Total Performance Score.
A competing home health agency's Total Performance Score for a model
year is calculated as follows:
(a) CMS will award points to the competing home health agency for
performance on each of the applicable measures excluding the New
Measures.
(b) CMS will award points to the competing home health agency for
reporting on each of the New Measures worth up to ten percent of the
Total Performance Score.
(c) CMS will sum all points awarded for each applicable measure
excluding the New Measures weighted equally at the individual measure
level, to calculate a value worth 90-percent of the Total Performance
Score.
(d) The sum of the points awarded to a competing HHA for each
applicable measure and the points awarded to a competing HHA for
reporting data on each New Measure is the competing HHA's Total
Performance Score for the calendar year.
[80 FR 68718, Nov. 5, 2015, as amended at 81 FR 76796, Nov. 3, 2016]
Sec. 484.325 Payments for home health services under Home Health
Value-Based Purchasing (HHVBP) Model.
CMS will determine a payment adjustment up to the maximum applicable
percentage, upward or downward, under the HHVBP Model for each competing
home health agency based on the agency's Total Performance Score using a
linear exchange function. Payment adjustments made under the HHVBP Model
will be calculated as a percentage of otherwise-applicable payments for
home health services provided under section 1895 of the Act (42 U.S.C.
1395fff).
Sec. 484.330 Process for determining and applying the value-based
payment adjustment under the Home Health Value-Based Purchasing
(HHVBP) Model.
(a) General. Competing home health agencies will be ranked within
the larger-volume and smaller-volume cohorts in selected states based on
the performance standards that apply to the HHVBP Model for the baseline
year, and CMS will make value-based payment adjustments to the competing
HHAs as specified in this section.
(b) Calculation of the value-based payment adjustment amount. The
value-based payment adjustment amount is calculated by multiplying the
Home Health Prospective Payment final
[[Page 191]]
claim payment amount as calculated in accordance with Sec. 484.205 by
the payment adjustment percentage.
(c) Calculation of the payment adjustment percentage. The payment
adjustment percentage is calculated as the product of: The applicable
percent as defined in Sec. 484.320, the competing HHA's Total
Performance Score divided by 100, and the linear exchange function
slope.
Sec. 484.335 Appeals process for the Home Health Value-Based
Purchasing (HHVBP) Model.
(a) Requests for recalculation--(1) Matters for recalculation.
Subject to the limitations on review under section 1115A of the Act, a
HHA may submit a request for recalculation under this section if it
wishes to dispute the calculation of the following:
(i) Interim performance scores.
(ii) Annual total performance scores.
(iii) Application of the formula to calculate annual payment
adjustment percentages.
(2) Time for filing a request for recalculation. A recalculation
request must be submitted in writing within 15 calendar days after CMS
posts the HHA-specific information on the HHVBP Secure Portal, in a time
and manner specified by CMS.
(3) Content of request. (i) The provider's name, address associated
with the services delivered, and CMS Certification Number (CCN).
(ii) The basis for requesting recalculation to include the specific
quality measure data that the HHA believes is inaccurate or the
calculation the HHA believes is incorrect.
(iii) Contact information for a person at the HHA with whom CMS or
its agent can communicate about this request, including name, email
address, telephone number, and mailing address (must include physical
address, not just a post office box).
(iv) The HHA may include in the request for recalculation additional
documentary evidence that CMS should consider. Such documents may not
include data that was to have been filed by the applicable data
submission deadline, but may include evidence of timely submission.
(4) Scope of review for recalculation. In conducting the
recalculation, CMS will review the applicable measures and performance
scores, the evidence and findings upon which the determination was
based, and any additional documentary evidence submitted by the home
health agency. CMS may also review any other evidence it believes to be
relevant to the recalculation.
(5) Recalculation decision. CMS will issue a written notification of
findings. A recalculation decision is subject to the request for
reconsideration process in accordance with paragraph (b) of this
section.
(b) Requests for reconsideration--(1) Matters for reconsideration. A
home health agency may request reconsideration of the recalculation of
its annual total performance score and payment adjustment percentage
following a decision on the home health agency's recalculation request
submitted under paragraph (a) of this section, or the decision to deny
the recalculation request submitted under paragraph (a) of this section.
(2) Time for filing a request for reconsideration. The request for
reconsideration must be submitted via the HHVBP Secure Portal within 15
calendar days from CMS' notification to the HHA contact of the outcome
of the recalculation process.
(3) Content of request. (i) The name of the HHA, address associated
with the services delivered, and CMS Certification Number (CCN).
(ii) The basis for requesting reconsideration to include the
specific quality measure data that the HHA believes is inaccurate or the
calculation the HHA believes is incorrect.
(iii) Contact information for a person at the HHA with whom CMS or
its agent can communicate about this request, including name, email
address, telephone number, and mailing address (must include physical
address, not just a post office box).
(iv) The HHA may include in the request for reconsideration
additional documentary evidence that CMS should consider. Such documents
may not include data that was to have been filed by the applicable data
submission deadline, but may include evidence of timely submission.
[[Page 192]]
(4) Scope of review for reconsideration. In conducting the
reconsideration review, CMS will review the applicable measures and
performance scores, the evidence and findings upon which the
determination was based, and any additional documentary evidence
submitted by the HHA. CMS may also review any other evidence it believes
to be relevant to the reconsideration. The HHA must prove its case by a
preponderance of the evidence with respect to issues of fact.
(5) Reconsideration decision. CMS reconsideration officials will
issue a written determination.
[81 FR 76796, Nov. 3, 2016]
PART 485_CONDITIONS OF PARTICIPATION: SPECIALIZED PROVIDERS--
Table of Contents
Subpart A [Reserved]
Subpart B_Conditions of Participation: Comprehensive Outpatient
Rehabilitation Facilities
Sec.
485.50 Basis and scope.
485.51 Definition.
485.54 Condition of participation: Compliance with State and local
laws.
485.56 Condition of participation: Governing body and administration.
485.58 Condition of participation: Comprehensive rehabilitation
program.
485.60 Condition of participation: Clinical records.
485.62 Condition of participation: Physical environment.
485.64 [Reserved]
485.66 Condition of participation: Utilization review plan.
485.68 Condition of participation: Emergency preparedness.
485.70 Personnel qualifications.
485.74 Appeal rights.
Subparts C-E [Reserved]
Subpart F_Conditions of Participation: Critical Access Hospitals (CAHs)
485.601 Basis and scope.
485.603 Rural health network.
485.604 Personnel qualifications.
485.606 Designation and certification of CAHs.
485.608 Condition of participation: Compliance with Federal, State, and
local laws and regulations.
485.610 Condition of participation: Status and location.
485.612 Condition of participation: Compliance with hospital
requirements at the time of application.
485.616 Condition of participation: Agreements.
485.618 Condition of participation: Emergency services.
485.620 Condition of participation: Number of beds and length of stay.
485.623 Condition of participation: Physical plant and environment.
485.625 Condition of participation: Emergency preparedness.
485.627 Condition of participation: Organizational structure.
485.631 Condition of participation: Staffing and staff
responsibilities.
485.635 Condition of participation: Provision of services.
485.638 Condition of participation: Clinical records.
485.639 Condition of participation: Surgical services.
485.641 Condition of participation: Periodic evaluation and quality
assurance review.
485.643 Condition of participation: Organ, tissue, and eye procurement.
485.645 Special requirements for CAH providers of long-term care
services (``swing-beds'').
485.647 Condition of participation: psychiatric and rehabilitation
distinct part units.
Subpart G [Reserved]
Subpart H_Conditions of Participation for Clinics, Rehabilitation
Agencies, and Public Health Agencies as Providers of Outpatient Physical
Therapy and Speech-Language Pathology Services
485.701 Basis and scope.
485.703 Definitions.
485.705 Personnel qualifications.
485.707 Condition of participation: Compliance with Federal, State, and
local laws.
485.709 Condition of participation: Administrative management.
485.711 Condition of participation: Plan of care and physician
involvement.
485.713 Condition of participation: Physical therapy services.
485.715 Condition of participation: Speech pathology services.
485.717 Condition of participation: Rehabilitation program.
485.719 Condition of participation: Arrangements for physical therapy
and speech pathology services to be performed by other than
salaried organization personnel.
485.721 Condition of participation: Clinical records.
[[Page 193]]
485.723 Condition of participation: Physical environment.
485.725 Condition of participation: Infection control.
485.727 Condition of participation: Emergency preparedness.
485.729 Condition of participation: Program evaluation.
Subpart I [Reserved]
Subpart J_Conditions of Participation: Community Mental Health Centers
(CMHCs)
485.900 Basis and scope.
485.902 Definitions.
485.904 Condition of participation: Personnel qualifications.
485.910 Condition of participation: Client rights.
485.914 Condition of participation: Admission, initial evaluation,
comprehensive assessment, and discharge or transfer of the
client.
485.916 Condition of participation: Treatment team, person-centered
active treatment plan, and coordination of services.
485.917 Condition of participation: Quality assessment and performance
improvement.
485.918 Condition of participation: Organization, governance,
administration of services, and partial hospitalization
services.
485.920 Condition of participation: Emergency preparedness.
Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C.
1302 and 1395(hh)).
Source: 48 FR 56293, Dec. 15, 1982, unless otherwise noted.
Redesignated at 50 FR 33034, Aug. 16, 1985.
Subpart A [Reserved]
Subpart B_Conditions of Participation: Comprehensive Outpatient
Rehabilitation Facilities
Sec. 485.50 Basis and scope.
This subpart sets forth the conditions that facilities must meet to
be certified as comprehensive outpatient rehabilitation facilities
(CORFs) under section 1861(cc)(2) of the Social Security Act and be
accepted for participation in Medicare in accordance with part 489 of
this chapter.
Sec. 485.51 Definition.
As used in this subpart, unless the context indicates otherwise,
``comprehensive outpatient rehabilitation facility'', ``CORF'', or
``facility'' means a nonresidential facility that--
(a) Is established and operated exclusively for the purpose of
providing diagnostic, therapeutic, and restorative services to
outpatients for the rehabilitation of injured, disabled, or sick
persons, at a single fixed location, by or under the supervision of a
physician except as provided in paragraph (c) of this section;
(b) Meets all the requirements of this subpart.
(c) Exception. May provide influenza, pneumococcal and Hepatitis B
vaccines provided the applicable conditions of coverage under
Sec. 410.58 and Sec. 410.63 of this chapter are met.
[48 FR 56293, Dec. 15, 1982, as amended at 72 FR 66408, Nov. 27, 2007]
Sec. 485.54 Condition of participation: Compliance with State and
local laws.
The facility and all personnel who provide services must be in
compliance with applicable State and local laws and regulations.
(a) Standard: Licensure of facility. If State or local law provides
for licensing, the facility must be currently licensed or approved as
meeting the standards established for licensure.
(b) Standard: Licensure of personnel. Personnel that provide service
must be licensed, certified, or registered in accordance with applicable
State and local laws.
Sec. 485.56 Condition of participation: Governing body and
administration.
The facility must have a governing body that assumes full legal
responsibility for establishing and implementing policies regarding the
management and operation of the facility.
(a) Standard: Disclosure of ownership. The facility must comply with
the provisions of part 420, subpart C of this chapter that require
health care providers and fiscal agents to disclose certain information
about ownership and control.
(b) Standard: Administrator. The governing body must appoint an
administrator who--
[[Page 194]]
(1) Is responsible for the overall management of the facility under
the authority delegated by the governing body;
(2) Implements and enforces the facility's policies and procedures;
(3) Designates, in writing, an individual who, in the absence of the
administrator, acts on behalf of the administrator; and
(4) Retains professional and administrative responsibility for all
personnel providing facility services.
(c) Standard: Group of professional personnel. The facility must
have a group of professional personnel associated with the facility
that--
(1) Develops and periodically reviews policies to govern the
services provided by the facility; and
(2) Consists of at least one physician and one professional
representing each of the services provided by the facility.
(d) Standard: Institutional budget plan. The facility must have an
institutional budget plan that meets the following conditions:
(1) It is prepared, under the direction of the governing body, by a
committee consisting of representatives of the governing body and the
administrative staff.
(2) It provides for--
(i) An annual operating budget prepared according to generally
accepted accounting principles;
(ii) A 3-year capital expenditure plan if expenditures in excess of
$100,000 are anticipated, for that period, for the acquisition of land;
the improvement of land, buildings, and equipment; and the replacement,
modernization, and expansion of buildings and equipment; and
(iii) Annual review and updating by the governing body.
(e) Standard: Patient care policies. The facility must have written
patient care policies that govern the services it furnishes. The patient
care policies must include the following:
(1) A description of the services the facility furnishes through
employees and those furnished under arrangements.
(2) Rules for and personnel responsibilities in handling medical
emergencies.
(3) Rules for the storage, handling, and administration of drugs and
biologicals.
(4) Criteria for patient admission, continuing care, and discharge.
(5) Procedures for preparing and maintaining clinical records on all
patients.
(6) A procedure for explaining to the patient and the patient's
family the extent and purpose of the services to be provided.
(7) A procedure to assist the referring physician in locating
another level of care for--patients whose treatment has terminated and
who are discharged.
(8) A requirement that patients accepted by the facility must be
under the care of a physician.
(9) A requirement that there be a plan of treatment established by a
physician for each patient.
(10) A procedure to ensure that the group of professional personnel
reviews and takes appropriate action on recommendations from the
utilization review committee regarding patient care policies.
(f) Standard: Delegation of authority. The responsibility for
overall administration, management, and operation must be retained by
the facility itself and not delegated to others.
(1) The facility may enter into a contract for purposes of
assistance in financial management and may delegate to others the
following and similar services:
(i) Bookkeeping.
(ii) Assistance in the development of procedures for billing and
accounting systems.
(iii) Assistance in the development of an operating budget.
(iv) Purchase of supplies in bulk form.
(v) The preparation of financial statements.
(2) When the services listed in paragraph (f)(1) of this section are
delegated, a contract must be in effect and:
(i) May not be for a term of more than 5 years;
(ii) Must be subject to termination within 60 days of written notice
by either party;
(iii) Must contain a clause requiring renegotiation of any provision
that CMS finds to be in contravention to
[[Page 195]]
any new, revised or amended Federal regulation or law;
(iv) Must state that only the facility may bill the Medicare
program; and
(v) May not include clauses that state or imply that the contractor
has power and authority to act on behalf of the facility, or clauses
that give the contractor rights, duties, discretions, or
responsibilities that enable it to dictate the administration,
mangement, or operations of the facility.
Sec. 485.58 Condition of participation: Comprehensive rehabilitation
program.
The facility must provide a coordinated rehabilitation program that
includes, at a minimum, physicians' services, physical therapy services,
and social or psychological services. These services must be furnished
by personnel that meet the qualifications set forth in Secs. 485.70 and
484.4 of this chapter and must be consistent with the plan of treatment
and the results of comprehensive patient assessments.
(a) Standard: Physician services. (1) A facility physician must be
present in the facility for a sufficient time to--
(i) Provide, in accordance with accepted principles of medical
practice, medical direction, medical care services, consultation, and
medical supervision of nonphysician staff;
(ii) Establish the plan of treatment in cases where a plan has not
been established by the referring physician;
(iii) Assist in establishing and implementing the facility's patient
care policies; and
(iv) Participate in plan of treatment reviews, patient case review
conferences, comprehensive patient assessment and reassessments, and
utilization review.
(2) The facility must provide for emergency physician services
during the facility operating hours.
(b) Standard: Plan of treatment. For each patient, a physician must
establish a plan of treatment before the facility initiates treatment.
The plan of treatment must meet the following requirements:
(1) It must delineate anticipated goals and specify the type,
amount, frequency and duration of services to be provided.
(2) It must be promptly evaluated after changes in the patient's
condition and revised when necessary.
(3) It must, if appropriate, be developed in consultation with the
facility physician and the appropriate facility professional personnel.
(4) It must be reviewed at least every 60 days by a facility
physician who, when appropriate, consults with the professional
personnel providing services. The results of this review must be
communicated to the patient's referring physician for concurrence before
treatment is continued or discontinued.
(5) It must be revised if the comprehensive reassessment of the
patient's status or the results of the patient case review conference
indicate the need for revision.
(c) Standard: Coordination of services. The facility must designate,
in writing, a qualified professional to ensure that professional
personnel coordinate their related activities and exchange information
about each patient under their care. Mechanisms to assist in the
coordination of services must include--
(1) Providing to all personnel associated with the facility, a
schedule indicating the frequency and type of services provided at the
facility;
(2) A procedure for communicating to all patient care personnel
pertinent information concerning significant changes in the patient's
status;
(3) Periodic clinical record entries, noting at least the patient's
status in relationship to goal attainment; and
(4) Scheduling patient case review conferences for purposes of
determining appropriateness of treatment, when indicated by the results
of the initial comprehensive patient assessment, reassessment(s), the
recommendation of the facility physician (or other physician who
established the plan of treatment), or upon the recommendation of one of
the professionals providing services.
(d) Standard: Provision of services. (1) All patients must be
referred to the facility by a physician who provides the following
information to the facility before treatment is initiated:
(i) The patient's significant medical history.
(ii) Current medical findings.
[[Page 196]]
(iii) Diagnosis(es) and contraindications to any treatment modality.
(iv) Rehabilitation goals, if determined.
(2) Services may be provided by facility employees or by others
under arrangements made by the facility.
(3) The facility must have on its premises the necessary equipment
to implement the plan of treatment and sufficient space to allow
adequate care.
(4) The services must be furnished by personnel that meet the
qualifications of Sec. 485.70 and the number of qualified personnel must
be adequate for the volume and diversity of services offered. Personnel
that do not meet the qualifications specified in Sec. 485.70 may be used
by the facility in assisting qualified staff. When a qualified
individual is assisted by these personnel, the qualified individual must
be on the premises, and must instruct these personnel in appropriate
patient care service techniques and retain responsibility for their
activities.
(5) A qualified professional must initiate and coordinate the
appropriate portions of the plan of treatment, monitor the patient's
progress, and recommend changes, in the plan, if necessary.
(6) A qualified professional representing each service made
available at the facility must be either on the premises of the facility
or must be available through direct telecommunication for consultation
and assistance during the facility's operating hours. At least one
qualified professional must be on the premises during the facility's
operating hours.
(7) All services must be provided consistent with accepted
professional standards and practice.
(e) Standard: Scope and site of services--(1) Basic requirements.
The facility must provide all the CORF services required in the plan of
treatment and, except as provided in paragraph (e)(2) of this section,
must provide the services on its premises.
(2) Exceptions. Physical therapy, occupational therapy, and speech-
language pathology services may be furnished away from the premises of
the CORF including the individual's home when payment is not otherwise
made under Title XVIII of the Act. In addition, a single home
environment evaluation is covered if there is a need to evaluate the
potential impact of the home environment on the rehabilitation goals.
The single home environment evaluation requires the presence of the
patient and the physical therapist, occupational therapist, or speech-
language pathologist, as appropriate.
(f) Standard: Patient assessment. Each qualified professional
involved in the patient's care, as specified in the plan of treatment,
must--
(1) Carry out an initial patient assessment; and
(2) In order to identify whether or not the current plan of
treatment is appropriate, perform a patient reassessment after
significant changes in the patient's status.
(g) Standard: Laboratory services. (1) If the facility provides its
own laboratory services, the services must meet the applicable
requirements for laboratories specified in part 493 of this chapter.
(2) If the facility chooses to refer specimens for laboratory
testing, the referral laboratory must be certified in the appropriate
specialties and subspecialties of services in accordance with the
requirements of part 493 of this chapter.
[48 FR 56293, Dec. 15, 1982, as amended at 56 FR 8852, Mar. 1, 1991; 57
FR 7137, Feb. 28, 1992; 73 FR 69941, Nov. 19, 2008]
Effective Date Note: At 82 FR 4591, Jan. 13, 2017, Sec. 485.58
introductory text was amended by removing ``and 484.4'' and adding in
its place ``and 484.115'', effective July 13, 2017. At 82 FR 31729, July
10, 2017, this amendment was delayed until Jan. 13, 2018.
Sec. 485.60 Condition of participation: Clinical records.
The facility must maintain clinical records on all patients in
accordance with accepted professional standards and practice. The
clinical records must be completely, promptly, and accurately
documented, readily accessible, and systematically organized to
facilitate retrieval and compilation of information.
(a) Standard: Content. Each clinical record must contain sufficient
information to identify the patient clearly and to justify the diagnosis
and treatment. Entries in the clinical record
[[Page 197]]
must be made as frequently as is necessary to insure effective treatment
and must be signed by personnel providing services. All entries made by
assistant level personnel must be countersigned by the corresponding
professional. Documentation on each patient must be consolidated into
one clinical record that must contain--
(1) The initial assessment and subsequent reassessments of the
patient's needs;
(2) Current plan of treatment;
(3) Identification data and consent or authorization forms;
(4) Pertinent medical history, past and present;
(5) A report of pertinent physical examinations if any;
(6) Progress notes or other documentation that reflect patient
reaction to treatment, tests, or injury, or the need to change the
established plan of treatment; and
(7) Upon discharge, a discharge summary including patient status
relative to goal achievement, prognosis, and future treatment
considerations.
(b) Standard: Protection of clinical record information. The
facility must safeguard clinical record information against loss,
destruction, or unauthorized use. The facility must have procedures that
govern the use and removal of records and the conditions for release of
information. The facility must obtain the patient's written consent
before releasing information not required to be released by law.
(c) Standard: Retention and preservation. The facility must retain
clinical record information for 5 years after patient discharge and must
make provision for the maintenance of such records in the event that it
is no longer able to treat patients.
Sec. 485.62 Condition of participation: Physical environment.
The facility must provide a physical environment that protects the
health and safety or patients, personnel, and the public.
(a) Standard: Safety and comfort of patients. The physical premises
of the facility and those areas of its surrounding physical structure
that are used by the patients (including at least all stairwells,
corridors and passageways) must meet the following requirements:
(1) Applicable Federal, State, and local building, fire, and safety
codes must be met.
(2) Fire extinguishers must be easily accessible and fire
regulations must be prominently posted.
(3) A fire alarm system with local (in-house) capability must be
functional, and where power is generated by electricity, an alternate
power source with automatic triggering must be present.
(4) Lights, supported by an emergency power source, must be placed
at exits.
(5) A sufficient number of staff to evacuate patients during a
disaster must be on the premises of the facility whenever patients are
being treated.
(6) Lighting must be sufficient to carry out services safely; room
temperature must be maintained at comfortable levels; and ventilation
through windows, mechanical means, or a combination of both must be
provided.
(7) Safe and sufficient space must be available for the scope of
services offered.
(b) Standard: Sanitary environment. The facility must maintain a
sanitary environment and establish a program to identify, investigate,
prevent, and control the cause of patient infections.
(1) The facility must establish written policies and procedures
designed to control and prevent infection in the facility and to
investigate and identify possible causes of infection.
(2) The facility must monitor the infection control program to
ensure that the staff implement the policies and procedures and that the
policies and procedures are consistent with current practices in the
field.
(3) The facility must make available at all times a quantity of
laundered linen adequate for proper care and comfort of patients. Linens
must be handled, stored, and processed in a manner that prevents the
spread of infection.
(4) Provisions must be in effect to ensure that the facility's
premises are maintained free of rodent and insect infestation.
(c) Standard: Maintenance of equipment, physical location, and
grounds. The facility must establish a written
[[Page 198]]
preventive maintenance program to ensure that--
(1) All equipment is properly maintained and equipment needing
periodic calibration is calibrated consistent with the manufacturer's
recommendations; and
(2) The interior of the facility, the exterior of the physical
structure housing the facility, and the exterior walkways and parking
areas are clean and orderly and maintained free of any defects that are
a hazard to patients, personnel, and the public.
(d) Standard: Access for the physically impaired. The facility must
ensure the following:
(1) Doorways, stairwells, corridors, and passageways used by
patients are--
(i) Of adequate width to allow for easy movement of all patients
(including those on stretchers or in wheelchairs); and
(ii) In the case of stairwells, equipped with firmly attached
handrails on at least one side.
(2) At least one toilet facility is accessible and constructed to
allow utilization by ambulatory and nonambulatory individuals.
(3) At least one entrance is usable by individuals in wheelchairs.
(4) In multi-story buildings, elevators are accessible to and usable
by the physically impaired on the level that they use to enter the
building and all levels normally used by the patients of the facility.
(5) Parking spaces are large enough and close enough to the facility
to allow safe access by the physically impaired.
Sec. 485.64 [Reserved]
Sec. 485.66 Condition of participation: Utilization review plan.
The facility must have in effect a written utilization review plan
that is implemented at least each quarter, to assess the necessity of
services and promotes the most efficient use of services provided by the
facility.
(a) Standard: Utilization review committee. The utilization review
committee, consisting of the group of professional personnel specified
in Sec. 485.56(c), a committee of this group, or a group of similar
composition, comprised by professional personnel not associated with the
facility, must carry out the utilization review plan.
(b) Standard: Utilization review plan. The utilization review plan
must contain written procedures for evaluating--
(1) Admissions, continued care, and discharges using, at a minimum,
the criteria established in the patient care policies;
(2) The applicability of the plan of treatment to established goals;
and
(3) The adequacy of clinical records with regard to--
(i) Assessing the quality of services provided; and
(ii) Determining whether the facility's policies and clinical
practices are compatible and promote appropriate and efficient
utilization of services.
Sec. 485.68 Condition of participation: Emergency preparedness.
The Comprehensive Outpatient Rehabilitation Facility (CORF) must
comply with all applicable Federal, State, and local emergency
preparedness requirements. The CORF must establish and maintain an
emergency preparedness program that meets the requirements of this
section. The emergency preparedness program must include, but not be
limited to, the following elements:
(a) Emergency plan. The CORF must develop and maintain an emergency
preparedness plan that must be reviewed and updated at least annually.
The plan must do all of the following:
(1) Be based on and include a documented, facility-based and
community-based risk assessment, utilizing an all-hazards approach.
(2) Include strategies for addressing emergency events identified by
the risk assessment.
(3) Address patient population, including, but not limited to, the
type of services the CORF has the ability to provide in an emergency;
and continuity of operations, including delegations of authority and
succession plans.
(4) Include a process for cooperation and collaboration with local,
tribal, regional, State, and Federal emergency preparedness officials'
efforts to maintain an integrated response during a
[[Page 199]]
disaster or emergency situation, including documentation of the CORF's
efforts to contact such officials and, when applicable, of its
participation in collaborative and cooperative planning efforts;
(5) Be developed and maintained with assistance from fire, safety,
and other appropriate experts.
(b) Policies and procedures. The CORF must develop and implement
emergency preparedness policies and procedures, based on the emergency
plan set forth in paragraph (a) of this section, risk assessment at
paragraph (a)(1) of this section, and the communication plan at
paragraph (c) of this section. The policies and procedures must be
reviewed and updated at least annually. At a minimum, the policies and
procedures must address the following:
(1) Safe evacuation from the CORF, which includes staff
responsibilities, and needs of the patients.
(2) A means to shelter in place for patients, staff, and volunteers
who remain in the facility.
(3) A system of medical documentation that preserves patient
information, protects confidentiality of patient information, and
secures and maintains the availability of records.
(4) The use of volunteers in an emergency and other emergency
staffing strategies, including the process and role for integration of
State or Federally designated health care professionals to address surge
needs during an emergency.
(c) Communication plan. The CORF must develop and maintain an
emergency preparedness communication plan that complies with Federal,
State, and local laws and must be reviewed and updated at least
annually. The communication plan must include all of the following:
(1) Names and contact information for the following:
(i) Staff.
(ii) Entities providing services under arrangement.
(iii) Patients' physicians.
(iv) Other CORFs.
(v) Volunteers.
(2) Contact information for the following:
(i) Federal, State, tribal, regional and local emergency
preparedness staff.
(ii) Other sources of assistance.
(3) Primary and alternate means for communicating with the CORF's
staff, Federal, State, tribal, regional, and local emergency management
agencies.
(4) A method for sharing information and medical documentation for
patients under the CORF's care, as necessary, with other health care
providers to maintain the continuity of care.
(5) A means of providing information about the CORF's needs, and its
ability to provide assistance, to the authority having jurisdiction or
the Incident Command Center, or designee.
(d) Training and testing. The CORF must develop and maintain an
emergency preparedness training and testing program that is based on the
emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, policies and procedures
at paragraph (b) of this section, and the communication plan at
paragraph (c) of this section. The training and testing program must be
reviewed and updated at least annually.
(1) Training program. The CORF must do all of the following:
(i) Provide initial training in emergency preparedness policies and
procedures to all new and existing staff, individuals providing services
under arrangement, and volunteers, consistent with their expected roles.
(ii) Provide emergency preparedness training at least annually.
(iii) Maintain documentation of the training.
(iv) Demonstrate staff knowledge of emergency procedures. All new
personnel must be oriented and assigned specific responsibilities
regarding the CORF's emergency plan within 2 weeks of their first
workday. The training program must include instruction in the location
and use of alarm systems and signals and firefighting equipment.
(2) Testing. The CORF must conduct exercises to test the emergency
plan at least annually. The CORF must do the following:
(i) Participate in a full-scale exercise that is community-based or
when a
[[Page 200]]
community-based exercise is not accessible, an individual, facility-
based. If the CORF experiences an actual natural or man-made emergency
that requires activation of the emergency plan, the CORF is exempt from
engaging in a community-based or individual, facility-based full-scale
exercise for 1 year following the onset of the actual event.
(ii) Conduct an additional exercise that may include, but is not
limited to the following:
(A) A second full-scale exercise that is community-based or
individual, facility-based.
(B) A tabletop exercise that includes a group discussion led by a
facilitator, using a narrated, clinically-relevant emergency scenario,
and a set of problem statements, directed messages, or prepared
questions designed to challenge an emergency plan.
(iii) Analyze the CORF's response to and maintain documentation of
all drills, tabletop exercises, and emergency events, and revise the
CORF's emergency plan, as needed.
(e) Integrated healthcare systems. If a CORF is part of a healthcare
system consisting of multiple separately certified healthcare facilities
that elects to have a unified and integrated emergency preparedness
program, the CORF may choose to participate in the healthcare system's
coordinated emergency preparedness program. If elected, the unified and
integrated emergency preparedness program must do all of the following:
(1) Demonstrate that each separately certified facility within the
system actively participated in the development of the unified and
integrated emergency preparedness program.
(2) Be developed and maintained in a manner that takes into account
each separately certified facility's unique circumstances, patient
populations, and services offered.
(3) Demonstrate that each separately certified facility is capable
of actively using the unified and integrated emergency preparedness
program and is in compliance with the program.
(4) Include a unified and integrated emergency plan that meets the
requirements of paragraphs (a)(2), (3), and (4) of this section. The
unified and integrated emergency plan must also be based on and include
the following:
(i) A documented community-based risk assessment, utilizing an all-
hazards approach.
(ii) A documented individual facility-based risk assessment for each
separately certified facility within the health system, utilizing an
all-hazards approach.
(5) Include integrated policies and procedures that meet the
requirements set forth in paragraph (b) of this section, a coordinated
communication plan and training and testing programs that meet the
requirements of paragraphs (c) and (d) of this section, respectively.
[81 FR 64035, Sept. 16, 2016]
Sec. 485.70 Personnel qualifications.
This section sets forth the qualifications that must be met, as a
condition of participation, under Sec. 485.58, and as a condition of
coverage of services under Sec. 410.100 of this chapter.
(a) A facility physician must be a doctor of medicine or osteopathy
who--
(1) Is licensed under State law to practice medicine or surgery; and
(2) Has had, subsequent to completing a 1-year hospital internship,
at least 1 year of training in the medical management of patients
requiring rehabilitation services; or
(3) Has had at least 1 year of full-time or part-time experience in
a rehabilitation setting providing physicians' services similar to those
required in this subpart.
(b) A licensed practical nurse must be licensed as a practical or
vocational nurse by the State in which practicing, if applicable.
(c) An occupational therapist and an occupational therapy assistant
must meet the qualifications in Sec. 484.4 of this chapter.
(d) An orthotist must--
(1) Be licensed by the State in which practicing, if applicable;
(2) Have successfully completed a training program in orthotics that
is jointly recognized by the American Council on Education and the
American Board for Certification in Orthotics and Prosthetics; and
(3) Be eligible to take that Board's certification examination in
orthotics.
[[Page 201]]
(e) A physical therapist and a physical therapist assistant must
meet the qualifications in Sec. 484.4 of this chapter.
(f) A prosthetist must--
(1) Be licensed by the State in which practicing, if applicable;
(2) Have successfully completed a training program in prosthetics
that is jointly recognized by the American Council on Education and the
American Board for Certification in Orthotics and Prosthetics; and
(3) Be eligible to take that Board's certification examination in
prosthetics.
(g) A psychologist must be certified or licensed by the State in
which he or she is practicing, if that State requires certification or
licensing, and must hold a masters degree in psychology from and
educational institution approved by the State in which the institution
is located.
(h) A registered nurse must be a graduate of an approved school of
nursing and be licensed as a registered nurse by the State in which
practicing, if applicable.
(i) A rehabilitation counselor must--
(1) Be licensed by the State in which practicing, if applicable;
(2) Hold at least a bachelor's degree; and
(3) Be eligible to take the certification examination administered
by the Commission on Rehabilitation Counselor Certification.
(j) A respiratory therapist must complete one the following
criteria:
(1) Criterion 1. All of the following must be completed:
(i) Be licensed by the State in which practicing, if applicable.
(ii) Have successfully completed a nationally-accredited educational
program for respiratory therapists.
(iii)(A) Be eligible to take the registry examination administered
by the National Board for Respiratory Care for respiratory therapists;
or
(B) Have passed the registry examination administered by the
National Board for Respiratory Care for respiratory therapists.
(2) Criterion 2: All of the following must be completed:
(i) Be licensed by the State in which practicing, if applicable.
(ii) Have equivalent training and experience as determined by the
National Board for Respiratory Care.
(k) A respiratory therapy technician must--
(1) Be licensed by the State in which practicing, if applicable;
(2) Have successfully completed a training program accredited by the
Committees on Allied Health Education and Accreditation (CAHEA) in
collaboration with the Joint Review Committee for Respiratory Therapy
Education; and
(3) Either--
(i) Be eligible to take the certification examination for
respiratory therapy technicians administered by the National Board for
Respiratory Therapy, Inc,; or
(ii) Have equivalent training and experience as determined by the
National Board for Respiratory Therapy, Inc.
(l) A social worker must--
(1) Be licensed by the State in which practicing, if applicable;
(2) Hold at least a bachelor's degree from a school accredited or
approved by the Council on Social Work Education; and
(3) Have 1 year of social work experience in a health care setting.
(m) A speech-language pathologist must meet the qualifications set
forth in part 484 of this chapter.
[48 FR 56293, Dec. 15, 1982. Redesignated and amended at 50 FR 33034,
Aug. 16, 1985; 51 FR 41352, Nov. 14, 1986; 60 FR 2327, Jan. 9, 1995; 72
FR 66408, Nov. 27, 2007; 73 FR 69941, Nov. 19, 2008; 74 FR 62014, Nov.
25, 2009]
Effective Date Note: At 82 FR 4591, Jan. 13, 2017, Sec. 485.70(c)
and (e) was amended by removing ``Sec. 484.4'' and adding in its place
``Sec. 484.115'', effective July 13, 2017. At 82 FR 31729, July 10,
2017, this amendment was delayed until Jan. 13, 2018.
Sec. 485.74 Appeal rights.
The appeal provisions set forth in part 498 of this chapter, for
providers, are applicable to any entity that is participating or seeks
to participate in the Medicare program as a CORF.
[48 FR 56293, Dec. 15, 1982, as amended at 52 FR 22454, June 12, 1987]
Subparts C-E [Reserved]
[[Page 202]]
Subpart F_Conditions of Participation: Critical Access Hospitals (CAHs)
Source: 58 FR 30671, May 26, 1993, unless otherwise noted.
Sec. 485.601 Basis and scope.
(a) Statutory basis. This subpart is based on section 1820 of the
Act which sets forth the conditions for designating certain hospitals as
CAHs.
(b) Scope. This subpart sets forth the conditions that a hospital
must meet to be designated as a CAH.
[58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997]
Sec. 485.603 Rural health network.
A rural health network is an organization that meets the following
specifications:
(a) It includes--
(1) At least one hospital that the State has designated or plans to
designate as a CAH; and
(2) At least one hospital that furnishes acute care services.
(b) The members of the organization have entered into agreements
regarding--
(1) Patient referral and transfer;
(2) The development and use of communications systems, including,
where feasible, telemetry systems and systems for electronic sharing of
patient data; and
(3) The provision of emergency and nonemergency transportation among
members.
(c) Each CAH has an agreement with respect to credentialing and
quality assurance with at least--
(1) One hospital that is a member of the network when applicable;
(2) One QIO or equivalent entity; or
(3) One other appropriate and qualified entity identified in the
State rural health care plan.
[58 FR 30671, May 26, 1993, as amended at 62 FR 46035, Aug. 29, 1997; 63
FR 26359, May 12, 1998]
Sec. 485.604 Personnel qualifications.
Staff that furnish services in a CAH must meet the applicable
requirements of this section.
(a) Clinical nurse specialist. A clinical nurse specialist must be a
person who--
(1) Is a registered nurse and is licensed to practice nursing in the
State in which the clinical nurse specialist services are performed in
accordance with State nurse licensing laws and regulations; and
(2) Holds a master's or doctoral level degree in a defined clinical
area of nursing from an accredited educational institution.
(b) Nurse practitioner. A nurse practitioner must be a registered
professional nurse who is currently licensed to practice in the State,
who meets the State's requirements governing the qualification of nurse
practitioners, and who meets one of the following conditions:
(1) Is currently certified as a primary care nurse practitioner by
the American Nurses' Association or by the National Board of Pediatric
Nurse Practitioners and Associates.
(2) Has successfully completed a 1 academic year program that--
(i) Prepares registered nurses to perform an expanded role in the
delivery of primary care;
(ii) Includes at least 4 months (in the aggregate) of classroom
instruction and a component of supervised clinical practice; and
(iii) Awards a degree, diploma, or certificate to persons who
successfully complete the program.
(3) Has successfully completed a formal educational program (for
preparing registered nurses to perform an expanded role in the delivery
of primary care) that does not meet the requirements of paragraph (a)(2)
of this section, and has been performing an expanded role in the
delivery of primary care for a total of 12 months during the 18-month
period immediately preceding June 25, 1993.
(c) Physician assistant. A physician assistant must be a person who
meets the applicable State requirements governing the qualifications for
assistants to primary care physicians, and who meets at least one of the
following conditions:
(1) Is currently certified by the National Commission on
Certification of Physician Assistants to assist primary care physicians.
[[Page 203]]
(2) Has satisfactorily completed a program for preparing physician
assistants that--
(i) Was at least one academic year in length;
(ii) Consisted of supervised clinical practice and at least 4 months
(in the aggregate) of classroom instruction directed toward preparing
students to deliver health care; and
(iii) Was accredited by the American Medical Association's Committee
on Allied Health Education and Accreditation.
(3) Has satisfactorily completed a formal educational program (for
preparing physician assistants) that does not meet the requirements of
paragraph (c)(2) of this section and has been assisting primary care
physicians for a total of 12 months during the 18-month period
immediately preceding June 25, 1993.
[58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997; 77
FR 29076, May 16, 2012]
Sec. 485.606 Designation and certification of CAHs.
(a) Criteria for State designation. (1) A State that has established
a Medicare rural hospital flexibility program described in section
1820(c) of the Act may designate one or more facilities as CAHs if each
facility meets the CAH conditions of participation in this subpart F.
(2) The State must not deny any hospital that is otherwise eligible
for designation as a CAH under this paragraph (a) solely because the
hospital has entered into an agreement under which the hospital may
provide posthospital SNF care as described in Sec. 482.58 of this
chapter.
(b) Criteria for CMS certification. CMS certifies a facility as a
CAH if--
(1) The facility is designated as a CAH by the State in which it is
located and has been surveyed by the State survey agency or by CMS and
found to meet all conditions of participation in this part and all other
applicable requirements for participation in part 489 of this chapter.
(2) The facility is a medical assistance facility operating in
Montana or a rural primary care hospital designated by CMS before August
5, 1997, and is otherwise eligible to be designated as a CAH by the
State under the rules in this subpart.
[62 FR 46036, Aug. 29, 1997, as amended at 63 FR 26359, May 12, 1998; 79
FR 27155, May 12, 2014]
Sec. 485.608 Condition of participation: Compliance with Federal,
State, and local laws and regulations.
The CAH and its staff are in compliance with applicable Federal,
State and local laws and regulations.
(a) Standard: Compliance with Federal laws and regulations. The CAH
is in compliance with applicable Federal laws and regulations related to
the health and safety of patients.
(b) Standard: Compliance with State and local laws and regulations.
All patient care services are furnished in accordance with applicable
State and local laws and regulations.
(c) Standard: Licensure of CAH. The CAH is licensed in accordance
with applicable Federal, State and local laws and regulations.
(d) Standard: Licensure, certification or registration of personnel.
Staff of the CAH are licensed, certified, or registered in accordance
with applicable Federal, State, and local laws and regulations.
[58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997]
Sec. 485.610 Condition of participation: Status and location.
(a) Standard: Status. The facility is--
(1) A currently participating hospital that meets all conditions of
participation set forth in this subpart;
(2) A recently closed facility, provided that the facility--
(i) Was a hospital that ceased operations on or after the date that
is 10 years before November 29, 1999; and
(ii) Meets the criteria for designation under this subpart as of the
effective date of its designation; or
(3) A health clinic or a health center (as defined by the State)
that--
(i) Is licensed by the State as a health clinic or a health center;
(ii) Was a hospital that was downsized to a health clinic or a
health center; and
[[Page 204]]
(iii) As of the effective date of its designation, meets the
criteria for designation set forth in this subpart.
(b) Standard: Location in a rural area or treatment as rural. The
CAH meets the requirements of either paragraph (b)(1) or (b)(2) of this
section or the requirements of paragraph (b)(3), (b)(4), or (b)(5) of
this section.
(1) The CAH meets the following requirements:
(i) The CAH is located outside any area that is a Metropolitan
Statistical Area, as defined by the Office of Management and Budget, or
that has been recognized as urban under Sec. 412.64(b), excluding
paragraph (b)(3) of this chapter;
(ii) The CAH has not been classified as an urban hospital for
purposes of the standardized payment amount by CMS or the Medicare
Geographic Classification Review Board under Sec. 412.230(e) of this
chapter, and is not among a group of hospitals that have been
redesignated to an adjacent urban area under Sec. 412.232 of this
chapter.
(2) The CAH is located within a Metropolitan Statistical Area, as
defined by the Office of Management and Budget, but is being treated as
being located in a rural area in accordance with Sec. 412.103 of this
chapter.
(3) Effective for October 1, 2004 through September 30, 2006, the
CAH does not meet the location requirements in either paragraph (b)(1)
or (b)(2) of this section and is located in a county that, in FY 2004,
was not part of a Metropolitan Statistical Area as defined by the Office
of Management and Budget, but as of FY 2005 was included as part of such
a Metropolitan Statistical Area as a result of the most recent census
data and implementation of the new Metropolitan Statistical Area
definitions announced by the Office of Management and Budget on June 3,
2003.
(4) Effective for October 1, 2009 through September 30, 2011, the
CAH does not meet the location requirements in either paragraph (b)(1)
or (b)(2) of this section and is located in a county that, in FY 2009,
was not part of a Metropolitan Statistical Area as defined by the Office
of Management and Budget, but, as of FY 2010, was included as part of
such a Metropolitan Statistical Area as a result of the most recent
census data and implementation of the new Metropolitan Statistical Area
definitions announced by the Office of Management and Budget on November
20, 2008.
(5) Effective on or after October 1, 2014, for a period of 2 years
beginning with the effective date of the most recent Office of
Management and Budget (OMB) standards for delineating statistical areas
adopted by CMS, the CAH no longer meets the location requirements in
either paragraph (b)(1) or (b)(2) of this section and is located in a
county that, prior to the most recent OMB standards for delineating
statistical areas adopted by CMS and the most recent Census Bureau data,
was located in a rural area as defined by OMB, but under the most recent
OMB standards for delineating statistical areas adopted by CMS and the
most recent Census Bureau data, is located in an urban area.
(c) Standard: Location relative to other facilities or necessary
provider certification. The CAH is located more than a 35-mile drive
(or, in the case of mountainous terrain or in areas with only secondary
roads available, a 15-mile drive) from a hospital or another CAH, or
before January 1, 2006, the CAH is certified by the State as being a
necessary provider of health care services to residents in the area. A
CAH that is designated as a necessary provider on or before December 31,
2005, will maintain its necessary provider designation after January 1,
2006.
(d) Standard: Relocation of CAHs with a necessary provider
designation. A CAH that has a necessary provider designation from the
State that was in effect prior to January 1, 2006, and relocates its
facility after January 1, 2006, can continue to meet the location
requirement of paragraph (c) of this section based on the necessary
provider designation only if the relocated facility meets the
requirements as specified in paragraph (d)(1) of this section.
(1) If a necessary provider CAH relocates its facility and begins
providing services in a new location, the CAH can continue to meet the
location requirement of paragraph (c) of this section
[[Page 205]]
based on the necessary provider designation only if the CAH in its new
location--
(i) Serves at least 75 percent of the same service area that it
served prior to its relocation;
(ii) Provides at least 75 percent of the same services that it
provided prior to the relocation; and
(iii) Is staffed by 75 percent of the same staff (including medical
staff, contracted staff, and employees) that were on staff at the
original location.
(2) If a CAH that has been designated as a necessary provider by the
State begins providing services at another location after January 1,
2006, and does not meet the requirements in paragraph (d)(1) of this
section, the action will be considered a cessation of business as
described in Sec. 489.52(b)(3).
(e) Standard: Off-campus and co-location requirements for CAHs. A
CAH may continue to meet the location requirements of paragraph (c) of
this section only if the CAH meets the following:
(1) If a CAH with a necessary provider designation is co-located
(that is, it shares a campus, as defined in Sec. 413.65(a)(2) of this
chapter, with another hospital or CAH), the necessary provider CAH can
continue to meet the location requirement of paragraph (c) of this
section only if the co-location arrangement was in effect before January
1, 2008, and the type and scope of services offered by the facility co-
located with the necessary provider CAH do not change. A change of
ownership of any of the facilities with a co-location arrangement that
was in effect before January 1, 2008, will not be considered to be a new
co-location arrangement.
(2) If a CAH or a necessary provider CAH operates an off-campus
provider-based location, excluding an RHC as defined in Sec. 405.2401(b)
of this chapter, but including a department or remote location, as
defined in Sec. 413.65(a)(2) of this chapter, or an off-campus distinct
part psychiatric or rehabilitation unit, as defined in Sec. 485.647,
that was created or acquired by the CAH on or after January 1, 2008, the
CAH can continue to meet the location requirement of paragraph (c) of
this section only if the off-campus provider-based location or off-
campus distinct part unit is located more than a 35-mile drive (or, in
the case of mountainous terrain or in areas with only secondary roads
available, a 15-mile drive) from a hospital or another CAH.
(3) If either a CAH or a CAH that has been designated as a necessary
provider by the State does not meet the requirements in paragraph (e)(1)
of this section, by co-locating with another hospital or CAH on or after
January 1, 2008, or creates or acquires an off-campus provider-based
location or off-campus distinct part unit on or after January 1, 2008,
that does not meet the requirements in paragraph (e)(2) of this section,
the CAH's provider agreement will be subject to termination in
accordance with the provisions of Sec. 489.53(a)(3) of this subchapter,
unless the CAH terminates the off-campus arrangement or the co-location
arrangement, or both.
[62 FR 46036, Aug. 29, 1997, as amended at 65 FR 47052, Aug. 1, 2000; 66
FR 39938, Aug. 1, 2001; 69 FR 49271, Aug. 11, 2004; 69 FR 60252, Oct. 7,
2004; 70 FR 47490, Aug. 12, 2005; 71 FR 48143, Aug. 18, 2006; 72 FR
66934, Nov. 27, 2007; 73 FR 9862, Feb. 22, 2008; 74 FR 44001, Aug. 27,
2009; 75 FR 50418, Aug. 16, 2010; 79 FR 50359, Aug. 22, 2014]
Sec. 485.612 Condition of participation: Compliance with hospital
requirements at the time of application.
Except for recently closed facilities as described in
Sec. 485.610(a)(2), or health clinics or health centers as described in
Sec. 485.610(a)(3), the facility is a hospital that has a provider
agreement to participate in the Medicare program as a hospital at the
time the hospital applies for designation as a CAH.
[66 FR 32196, June 13, 2001]
Sec. 485.616 Condition of participation: Agreements.
(a) Standard: Agreements with network hospitals. In the case of a
CAH that is a member of a rural health network as defined in
Sec. 485.603 of this chapter, the CAH has in effect an agreement with at
least one hospital that is a member of the network for--
(1) Patient referral and transfer;
(2) The development and use of communications systems of the
network, including the network's system for the electronic sharing of
patient data, and
[[Page 206]]
telemetry and medical records, if the network has in operation such a
system; and
(3) The provision of emergency and nonemergency transportation
between the facility and the hospital.
(b) Standard: Agreements for credentialing and quality assurance.
Each CAH that is a member of a rural health network shall have an
agreement with respect to credentialing and quality assurance with at
least--
(1) One hospital that is a member of the network;
(2) One QIO or equivalent entity; or
(3) One other appropriate and qualified entity identified in the
State rural health care plan.
(c) Standard: Agreements for credentialing and privileging of
telemedicine physicians and practitioners. (1) The governing body of the
CAH must ensure that, when telemedicine services are furnished to the
CAH's patients through an agreement with a distant-site hospital, the
agreement is written and specifies that it is the responsibility of the
governing body of the distant-site hospital to meet the following
requirements with regard to its physicians or practitioners providing
telemedicine services:
(i) Determine, in accordance with State law, which categories of
practitioners are eligible candidates for appointment to the medical
staff.
(ii) Appoint members of the medical staff after considering the
recommendations of the existing members of the medical staff.
(iii) Assure that the medical staff has bylaws.
(iv) Approve medical staff bylaws and other medical staff rules and
regulations.
(v) Ensure that the medical staff is accountable to the governing
body for the quality of care provided to patients.
(vi) Ensure the criteria for selection are individual character,
competence, training, experience, and judgment.
(vii) Ensure that under no circumstances is the accordance of staff
membership or professional privileges in the hospital dependent solely
upon certification, fellowship or membership in a specialty body or
society.
(2) When telemedicine services are furnished to the CAH's patients
through an agreement with a distant-site hospital, the CAH's governing
body or responsible individual may choose to rely upon the credentialing
and privileging decisions made by the governing body of the distant-site
hospital regarding individual distant-site physicians or practitioners.
The CAH's governing body or responsible individual must ensure, through
its written agreement with the distant-site hospital, that the following
provisions are met:
(i) The distant-site hospital providing telemedicine services is a
Medicare-participating hospital.
(ii) The individual distant-site physician or practitioner is
privileged at the distant-site hospital providing the telemedicine
services, which provides a current list of the distant-site physician's
or practitioner's privileges at the distant-site hospital;
(iii) The individual distant-site physician or practitioner holds a
license issued or recognized by the State in which the CAH is located;
and
(iv) With respect to a distant-site physician or practitioner, who
holds current privileges at the CAH whose patients are receiving the
telemedicine services, the CAH has evidence of an internal review of the
distant-site physician's or practitioner's performance of these
privileges and sends the distant-site hospital such information for use
in the periodic appraisal of the individual distant-site physician or
practitioner. At a minimum, this information must include all adverse
events that result from the telemedicine services provided by the
distant-site physician or practitioner to the CAH's patients and all
complaints the CAH has received about the distant-site physician or
practitioner.
(3) The governing body of the CAH must ensure that when telemedicine
services are furnished to the CAH's patients through an agreement with a
distant-site telemedicine entity, the agreement is written and specifies
that the distant-site telemedicine entity is a contractor of services to
the CAH and as such, in accordance with
[[Page 207]]
Sec. 485.635(c)(4)(ii), furnishes the contracted services in a manner
that enables the CAH to comply with all applicable conditions of
participation for the contracted services, including, but not limited
to, the requirements in this section with regard to its physicians and
practitioners providing telemedicine services.
(4) When telemedicine services are furnished to the CAH's patients
through an agreement with a distant-site telemedicine entity, the CAH's
governing body or responsible individual may choose to rely upon the
credentialing and privileging decisions made by the governing body of
the distant-site telemedicine entity regarding individual distant-site
physicians or practitioners. The CAH's governing body or responsible
individual must ensure, through its written agreement with the distant-
site telemedicine entity, that the following provisions are met:
(i) The distant-site telemedicine entity's medical staff
credentialing and privileging process and standards at least meet the
standards at paragraphs (c)(1)(i) through (c)(1)(vii) of this section.
(ii) The individual distant-site physician or practitioner is
privileged at the distant-site telemedicine entity providing the
telemedicine services, which provides a current list to the CAH of the
distant-site physician's or practitioner's privileges at the distant-
site telemedicine entity.
(iii) The individual distant-site physician or practitioner holds a
license issued or recognized by the State in which the CAH whose
patients are receiving the telemedicine services is located.
(iv) With respect to a distant-site physician or practitioner, who
holds current privileges at the CAH whose patients are receiving the
telemedicine services, the CAH has evidence of an internal review of the
distant-site physician's or practitioner's performance of these
privileges and sends the distant-site telemedicine entity such
information for use in the periodic appraisal of the distant-site
physician or practitioner. At a minimum, this information must include
all adverse events that result from the telemedicine services provided
by the distant-site physician or practitioner to the CAH's patients and
all complaints the CAH has received about the distant-site physician or
practitioner.
[62 FR 46036, Aug. 29, 1997, as amended at 76 FR 25564, May 5, 2011]
Sec. 485.618 Condition of participation: Emergency services.
The CAH provides emergency care necessary to meet the needs of its
inpatients and outpatients.
(a) Standard: Availability. Emergency services are available on a
24-hours a day basis.
(b) Standard: Equipment, supplies, and medication. Equipment,
supplies, and medication used in treating emergency cases are kept at
the CAH and are readily available for treating emergency cases. The
items available must include the following:
(1) Drugs and biologicals commonly used in life-saving procedures,
including analgesics, local anesthetics, antibiotics, anticonvulsants,
antidotes and emetics, serums and toxoids, antiarrythmics, cardiac
glycosides, antihypertensives, diuretics, and electrolytes and
replacement solutions.
(2) Equipment and supplies commonly used in life-saving procedures,
including airways, endotracheal tubes, ambu bag/valve/mask, oxygen,
tourniquets, immobilization devices, nasogastric tubes, splints, IV
therapy supplies, suction machine, defibrillator, cardiac monitor, chest
tubes, and indwelling urinary catheters.
(c) Standard: Blood and blood products. The facility provides,
either directly or under arrangements, the following:
(1) Services for the procurement, safekeeping, and transfusion of
blood, including the availability of blood products needed for
emergencies on a 24-hours a day basis.
(2) Blood storage facilities that meet the requirements of 42 CFR
part 493, subpart K, and are under the control and supervision of a
pathologist or other qualified doctor of medicine or osteopathy. If
blood banking services are provided under an arrangement, the
arrangement is approved by the facility's medical staff and by the
persons directly responsible for the operation of the facility.
[[Page 208]]
(d) Standard: Personnel. (1) Except as specified in paragraph (d)(3)
of this section, there must be a doctor of medicine or osteopathy, a
physician assistant, a nurse practitioner, or a clinical nurse
specialist, with training or experience in emergency care, on call and
immediately available by telephone or radio contact, and available on
site within the following timeframes:
(i) Within 30 minutes, on a 24-hour a day basis, if the CAH is
located in an area other than an area described in paragraph (d)(1)(ii)
of this section; or
(ii) Within 60 minutes, on a 24-hour a day basis, if all of the
following requirements are met:
(A) The CAH is located in an area designated as a frontier area
(that is, an area with fewer than six residents per square mile based on
the latest population data published by the Bureau of the Census) or in
an area that meets the criteria for a remote location adopted by the
State in its rural health care plan, and approved by CMS, under section
1820(b) of the Act.
(B) The State has determined, under criteria in its rural health
care plan, that allowing an emergency response time longer than 30
minutes is the only feasible method of providing emergency care to
residents of the area served by the CAH.
(C) The State maintains documentation showing that the response time
of up to 60 minutes at a particular CAH it designates is justified
because other available alternatives would increase the time needed to
stabilize a patient in an emergency.
(2) A registered nurse with training and experience in emergency
care can be utilized to conduct specific medical screening examinations
only if--
(i) The registered nurse is on site and immediately available at the
CAH when a patient requests medical care; and
(ii) The nature of the patient's request for medical care is within
the scope of practice of a registered nurse and consistent with
applicable State laws and the CAH's bylaws or rules and regulations.
(3) A registered nurse satisfies the personnel requirement specified
in paragraph (d)(1) of this section for a temporary period if--
(i) The CAH has no greater than 10 beds;
(ii) The CAH is located in an area designated as a frontier area or
remote location as described in paragraph (d)(1)(ii)(A) of this section;
(iii) The State in which the CAH is located submits a letter to CMS
signed by the Governor, following consultation on the issue of using RNs
on a temporary basis as part of their State rural healthcare plan with
the State Boards of Medicine and Nursing, and in accordance with State
law, requesting that a registered nurse with training and experience in
emergency care be included in the list of personnel specified in
paragraph (d)(1) of this section. The letter from the Governor must
attest that he or she has consulted with State Boards of Medicine and
Nursing about issues related to access to and the quality of emergency
services in the States. The letter from the Governor must also describe
the circumstances and duration of the temporary request to include the
registered nurses on the list of personnel specified in paragraph (d)(1)
of this section;
(iv) Once a Governor submits a letter, as specified in paragraph
(d)(3)(iii) of this section, a CAH must submit documentation to the
State survey agency demonstrating that it has been unable, due to the
shortage of such personnel in the area, to provide adequate coverage as
specified in this paragraph (d).
(4) The request, as specified in paragraph (d)(3)(iii) of this
section, and the withdrawal of the request, may be submitted to us at
any time, and are effective upon submission.
(e) Standard: Coordination with emergency response systems. The CAH
must, in coordination with emergency response systems in the area,
establish procedures under which a doctor of medicine or osteopathy is
immediately available by telephone or radio contact on a 24-hours a day
basis to receive emergency calls, provide information on treatment of
emergency patients,
[[Page 209]]
and refer patients to the CAH or other appropriate locations for
treatment.
[58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997; 64
FR 41544, July 30, 1999; 67 FR 80041, Dec. 31, 2002; 69 FR 49271, Aug.
11, 2004; 71 FR 68230, Nov. 24, 2006]
Sec. 485.620 Condition of participation: Number of beds and length
of stay.
(a) Standard: Number of beds. Except as permitted for CAHs having
distinct part units under Sec. 485.647, the CAH maintains no more than
25 inpatient beds. Inpatient beds may be used for either inpatient or
swing-bed services.
(b) Standard: Length of stay. The CAH provides acute inpatient care
for a period that does not exceed, on an annual average basis, 96 hours
per patient.
[62 FR 46036, Aug. 29, 1997, as amended at 65 FR 47052, Aug. 1, 2000; 69
FR 49271, Aug. 11, 2004; 69 FR 60252, Oct. 7, 2004; 78 FR 50970, Aug.
19, 2013]
Sec. 485.623 Condition of participation: Physical plant and
environment.
(a) Standard: Construction. The CAH is constructed, arranged, and
maintained to ensure access to and safety of patients, and provides
adequate space for the provision of services.
(b) Standard: Maintenance. The CAH has housekeeping and preventive
maintenance programs to ensure that--
(1) All essential mechanical, electrical, and patient-care equipment
is maintained in safe operating condition;
(2) There is proper routine storage and prompt disposal of trash;
(3) Drugs and biologicals are appropriately stored;
(4) The premises are clean and orderly; and
(5) There is proper ventilation, lighting, and temperature control
in all pharmaceutical, patient care, and food preparation areas.
(c) Standard: Life safety from fire. (1) Except as otherwise
provided in this section--
(i) The CAH must meet the applicable provisions and must proceed in
accordance with the Life Safety Code (NFPA 101 and Tentative Interim
Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4.)
(ii) Notwithstanding paragraph (d)(1)(i) of this section, corridor
doors and doors to rooms containing flammable or combustible materials
must be provided with positive latching hardware. Roller latches are
prohibited on such doors.
(2) In consideration of a recommendation by the State survey agency
or Accrediting Organization or at the discretion of the Secretary, may
waive, for periods deemed appropriate, specific provisions of the Life
Safety Code, which would result in unreasonable hardship upon a CAH, but
only if the waiver will not adversely affect the health and safety of
the patients.
(3) After consideration of State survey agency findings, CMS may
waive specific provisions of the Life Safety Code that, if rigidly
applied, would result in unreasonable hardship on the CAH, but only if
the waiver does not adversely affect the health and safety of patients.
(4) The CAH maintains written evidence of regular inspection and
approval by State or local fire control agencies.
(5) A CAH may install alcohol-based hand rub dispensers in its
facility if the dispensers are installed in a manner that adequately
protects against inappropriate access.
(6) When a sprinkler system is shut down for more than 10 hours, the
CAH must:
(i) Evacuate the building or portion of the building affected by the
system outage until the system is back in service, or
(ii) Establish a fire watch until the system is back in service.
(7) Buildings must have an outside window or outside door in every
sleeping room, and for any building constructed after July 5, 2016 the
sill height must not exceed 36 inches above the floor. Windows in atrium
walls are considered outside windows for the purposes of this
requirement.
(i) The sill height requirement does not apply to newborn nurseries
and rooms intended for occupancy for less than 24 hours.
(ii) Special nursing care areas of new occupancies shall not exceed
60 inches.
(d) Standard: Building safety. Except as otherwise provided in this
section, the CAH must meet the applicable provisions and must proceed in
accordance with the Health Care Facilities Code
[[Page 210]]
(NFPA 99 and Tentative Interim Amendments TIA 12-2, TIA 12-3, TIA 12-4,
TIA 12-5 and TIA 12-6).
(1) Chapters 7, 8, 12, and 13 of the adopted Health Care Facilities
Code do not apply to a CAH.
(2) If application of the Health Care Facilities Code required under
paragraph (e) of this section would result in unreasonable hardship for
the CAH, CMS may waive specific provisions of the Health Care Facilities
Code, but only if the waiver does not adversely affect the health and
safety of patients.
(e) The standards incorporated by reference in this section are
approved for incorporation by reference by the Director of the Office of
the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part
51. You may inspect a copy at the CMS Information Resource Center, 7500
Security Boulevard, Baltimore, MD or at the National Archives and
Records Administration (NARA). For information on the availability of
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html. If any changes in this edition of the Code are
incorporated by reference, CMS will publish a document in the Federal
Register to announce the changes.
(1) National Fire Protection Association, 1 Batterymarch Park,
Quincy, MA 02169, www.nfpa.org, 1.617.770.3000.
(i) NFPA 99, Standards for Health Care Facilities Code of the
National Fire Protection Association 99, 2012 edition, issued August 11,
2011.
(ii) TIA 12-2 to NFPA 99, issued August 11, 2011.
(iii) TIA 12-3 to NFPA 99, issued August 9, 2012.
(iv) TIA 12-4 to NFPA 99, issued March 7, 2013.
(v) TIA 12-5 to NFPA 99, issued August 1, 2013.
(vi) TIA 12-6 to NFPA 99, issued March 3, 2014.
(vii) NFPA 101, Life Safety Code, 2012 edition, issued August 11,
2011;
(viii) TIA 12-1 to NFPA 101, issued August 11, 2011.
(ix) TIA 12-2 to NFPA 101, issued October 30, 2012.
(x) TIA 12-3 to NFPA 101, issued October 22, 2013.
(xi) TIA 12-4 to NFPA 101, issued October 22, 2013.
(2) [Reserved]
[58 FR 30671, May 26, 1993, as amended at 62 FR 46036, 46037, Aug. 29,
1997; 68 FR 1387, Jan. 10, 2003; 69 FR 49271, Aug. 11, 2004; 70 FR
15239, Mar. 25, 2005; 71 FR 55341, Sept. 22, 2006; 77 FR 29076, May 16,
2012; 81 FR 26901, May 4, 2016; 81 FR 64036, Sept. 16, 2016]
Sec. 485.625 Condition of participation: Emergency preparedness.
The CAH must comply with all applicable Federal, State, and local
emergency preparedness requirements. The CAH must develop and maintain a
comprehensive emergency preparedness program, utilizing an all-hazards
approach. The emergency preparedness plan must include, but not be
limited to, the following elements:
(a) Emergency plan. The CAH must develop and maintain an emergency
preparedness plan that must be reviewed and updated at least annually.
The plan must do all of the following:
(1) Be based on and include a documented, facility-based and
community-based risk assessment, utilizing an all-hazards approach.
(2) Include strategies for addressing emergency events identified by
the risk assessment.
(3) Address patient population, including, but not limited to,
persons at-risk; the type of services the CAH has the ability to provide
in an emergency; and continuity of operations, including delegations of
authority and succession plans.
(4) Include a process for cooperation and collaboration with local,
tribal, regional, State, and Federal emergency preparedness officials'
efforts to maintain an integrated response during a disaster or
emergency situation, including documentation of the CAH's efforts to
contact such officials and, when applicable, of its participation in
collaborative and cooperative planning efforts.
(b) Policies and procedures. The CAH must develop and implement
emergency preparedness policies and procedures, based on the emergency
plan set forth in paragraph (a) of this section, risk assessment at
paragraph (a)(1) of this section, and the communication plan at
paragraph (c) of this section.
[[Page 211]]
The policies and procedures must be reviewed and updated at least
annually. At a minimum, the policies and procedures must address the
following:
(1) The provision of subsistence needs for staff and patients,
whether they evacuate or shelter in place, include, but are not limited
to--
(i) Food, water, medical, and pharmaceutical supplies;
(ii) Alternate sources of energy to maintain:
(A) Temperatures to protect patient health and safety and for the
safe and sanitary storage of provisions;
(B) Emergency lighting;
(C) Fire detection, extinguishing, and alarm systems; and
(D) Sewage and waste disposal.
(2) A system to track the location of on-duty staff and sheltered
patients in the CAH's care during an emergency. If on-duty staff and
sheltered patients are relocated during the emergency, the CAH must
document the specific name and location of the receiving facility or
other location.
(3) Safe evacuation from the CAH, which includes consideration of
care and treatment needs of evacuees; staff responsibilities;
transportation; identification of evacuation location(s); and primary
and alternate means of communication with external sources of
assistance.
(4) A means to shelter in place for patients, staff, and volunteers
who remain in the facility.
(5) A system of medical documentation that preserves patient
information, protects confidentiality of patient information, and
secures and maintains the availability of records.
(6) The use of volunteers in an emergency or other emergency
staffing strategies, including the process and role for integration of
State or Federally designated health care professionals to address surge
needs during an emergency.
(7) The development of arrangements with other CAHs or other
providers to receive patients in the event of limitations or cessation
of operations to maintain the continuity of services to CAH patients.
(8) The role of the CAH under a waiver declared by the Secretary, in
accordance with section 1135 of the Act, in the provision of care and
treatment at an alternate care site identified by emergency management
officials.
(c) Communication plan. The CAH must develop and maintain an
emergency preparedness communication plan that complies with Federal,
State, and local laws and must be reviewed and updated at least
annually. The communication plan must include all of the following:
(1) Names and contact information for the following:
(i) Staff.
(ii) Entities providing services under arrangement.
(iii) Patients' physicians.
(iv) Other CAHs and hospitals.
(v) Volunteers.
(2) Contact information for the following:
(i) Federal, State, tribal, regional, and local emergency
preparedness staff.
(ii) Other sources of assistance.
(3) Primary and alternate means for communicating with the
following:
(i) CAH's staff.
(ii) Federal, State, tribal, regional, and local emergency
management agencies.
(4) A method for sharing information and medical documentation for
patients under the CAH's care, as necessary, with other health care
providers to maintain the continuity of care.
(5) A means, in the event of an evacuation, to release patient
information as permitted under 45 CFR 164.510(b)(1)(ii).
(6) A means of providing information about the general condition and
location of patients under the facility's care as permitted under 45 CFR
164.510(b)(4).
(7) A means of providing information about the CAH's occupancy,
needs, and its ability to provide assistance, to the authority having
jurisdiction or the Incident Command Center, or designee.
(d) Training and testing. The CAH must develop and maintain an
emergency preparedness training and testing program that is based on the
emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, policies and procedures
at paragraph (b) of this section, and the communication plan at
[[Page 212]]
paragraph (c) of this section. The training and testing program must be
reviewed and updated at least annually.
(1) Training program. The CAH must do all of the following:
(i) Initial training in emergency preparedness policies and
procedures, including prompt reporting and extinguishing of fires,
protection, and where necessary, evacuation of patients, personnel, and
guests, fire prevention, and cooperation with firefighting and disaster
authorities, to all new and existing staff, individuals providing
services under arrangement, and volunteers, consistent with their
expected roles.
(ii) Provide emergency preparedness training at least annually.
(iii) Maintain documentation of the training.
(iv) Demonstrate staff knowledge of emergency procedures.
(2) Testing. The CAH must conduct exercises to test the emergency
plan at least annually. The CAH must do the following:
(i) Participate in a full-scale exercise that is community-based or
when a community-based exercise is not accessible, an individual,
facility-based exercise. If the CAH experiences an actual natural or
man-made emergency that requires activation of the emergency plan, the
CAH is exempt from engaging in a community-based or individual,
facility-based full-scale exercise for 1 year following the onset of the
actual event.
(ii) Conduct an additional exercise that may include, but is not
limited to the following:
(A) A second full-scale exercise that is community-based or
individual, facility-based.
(B) A tabletop exercise that includes a group discussion led by a
facilitator, using a narrated, clinically-relevant emergency scenario,
and a set of problem statements, directed messages, or prepared
questions designed to challenge an emergency plan.
(iii) Analyze the CAH's response to and maintain documentation of
all drills, tabletop exercises, and emergency events, and revise the
CAH's emergency plan, as needed.
(e) Emergency and standby power systems. The CAH must implement
emergency and standby power systems based on the emergency plan set
forth in paragraph (a) of this section.
(1) Emergency generator location. The generator must be located in
accordance with the location requirements found in the Health Care
Facilities Code (NFPA 99 and Tentative Interim Amendments TIA 12-2, TIA
12-3, TIA 12-4, TIA 12-5, and TIA 12-6), Life Safety Code (NFPA 101 and
Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-
4), and NFPA 110, when a new structure is built or when an existing
structure or building is renovated.
(2) Emergency generator inspection and testing. The CAH must
implement emergency power system inspection and testing requirements
found in the Health Care Facilities Code, NFPA 110, and the Life Safety
Code.
(3) Emergency generator fuel. CAHs that maintain an onsite fuel
source to power emergency generators must have a plan for how it will
keep emergency power systems operational during the emergency, unless it
evacuates.
(f) Integrated healthcare systems. If a CAH is part of a healthcare
system consisting of multiple separately certified healthcare facilities
that elects to have a unified and integrated emergency preparedness
program, the CAH may choose to participate in the healthcare system's
coordinated emergency preparedness program. If elected, the unified and
integrated emergency preparedness program must do all of the following:
(1) Demonstrate that each separately certified facility within the
system actively participated in the development of the unified and
integrated emergency preparedness program.
(2) Be developed and maintained in a manner that takes into account
each separately certified facility's unique circumstances, patient
populations, and services offered.
(3) Demonstrate that each separately certified facility is capable
of actively using the unified and integrated emergency preparedness
program and is in compliance with the program.
(4) Include a unified and integrated emergency plan that meets the
requirements of paragraphs (a)(2), (3), and (4)
[[Page 213]]
of this section. The unified and integrated emergency plan must also be
based on and include--
(i) A documented community-based risk assessment, utilizing an all-
hazards approach.
(ii) A documented individual facility-based risk assessment for each
separately certified facility within the health system, utilizing an
all-hazards approach.
(5) Include integrated policies and procedures that meet the
requirements set forth in paragraph (b) of this section, a coordinated
communication plan and training and testing programs that meet the
requirements of paragraphs (c) and (d) of this section, respectively.
(g) The standards incorporated by reference in this section are
approved for incorporation by reference by the Director of the Office of
the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part
51. You may obtain the material from the sources listed below. You may
inspect a copy at the CMS Information Resource Center, 7500 Security
Boulevard, Baltimore, MD or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html. If any
changes in this edition of the Code are incorporated by reference, CMS
will publish a document in the Federal Register to announce the changes.
(1) National Fire Protection Association, 1 Batterymarch Park,
Quincy, MA 02169, www.nfpa.org, 1.617.770.3000.
(i) NFPA 99, Health Care Facilities Code, 2012 edition, issued
August 11, 2011.
(ii) Technical interim amendment (TIA) 12-2 to NFPA 99, issued
August 11, 2011.
(iii) TIA 12-3 to NFPA 99, issued August 9, 2012.
(iv) TIA 12-4 to NFPA 99, issued March 7, 2013.
(v) TIA 12-5 to NFPA 99, issued August 1, 2013.
(vi) TIA 12-6 to NFPA 99, issued March 3, 2014.
(vii) NFPA 101, Life Safety Code, 2012 edition, issued August 11,
2011.
(viii) TIA 12-1 to NFPA 101, issued August 11, 2011.
(ix) TIA 12-2 to NFPA 101, issued October 30, 2012.
(x) TIA 12-3 to NFPA 101, issued October 22, 2013.
(xi) TIA 12-4 to NFPA 101, issued October 22, 2013.
(xii) NFPA 110, Standard for Emergency and Standby Power Systems,
2010 edition, including TIAs to chapter 7, issued August 6, 2009.
(2) [Reserved]
[81 FR 64036, Sept. 16, 2016; 81 FR 80594, Nov. 16, 2016]
Sec. 485.627 Condition of participation: Organizational structure.
(a) Standard: Governing body or responsible individual. The CAH has
a governing body or an individual that assumes full legal responsibility
for determining, implementing and monitoring policies governing the
CAH's total operation and for ensuring that those policies are
administered so as to provide quality health care in a safe environment.
(b) Standard: Disclosure. The CAH discloses the names and addresses
of--
(1) Its owners, or those with a controlling interest in the CAH or
in any subcontractor in which the CAH directly or indirectly has a 5
percent or more ownership interest, in accordance with subpart C of part
420 of this chapter;
(2) The person principally responsible for the operation of the CAH;
and
(3) The person responsible for medical direction.
[58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997]
Sec. 485.631 Condition of participation: Staffing and staff
responsibilities.
(a) Standard: Staffing--(1) The CAH has a professional health care
staff that includes one or more doctors of medicine or osteopathy, and
may include one or more physician assistants, nurse practitioners, or
clinical nurse specialists.
(2) Any ancillary personnel are supervised by the professional
staff.
[[Page 214]]
(3) The staff is sufficient to provide the services essential to the
operation of the CAH.
(4) A doctor of medicine or osteopathy, nurse practitioner, clinical
nurse specialist, or physician assistant is available to furnish patient
care services at all times the CAH operates.
(5) A registered nurse, clinical nurse specialist, or licensed
practical nurse is on duty whenever the CAH has one or more inpatients.
(b) Standard: Responsibilities of the doctor of medicine or
osteopathy. (1) The doctor of medicine or osteopathy--
(i) Provides medical direction for the CAH's health care activities
and consultation for, and medical supervision of, the health care staff;
(ii) In conjunction with the physician assistant and/or nurse
practitioner member(s), participates in developing, executing, and
periodically reviewing the CAH's written policies governing the services
it furnishes.
(iii) In conjunction with the physician assistant and/or nurse
practitioner members, periodically reviews the CAH's patient records,
provides medical orders, and provides medical care services to the
patients of the CAH; and
(iv) Periodically reviews and signs the records of all inpatients
cared for by nurse practitioners, clinical nurse specialists, certified
nurse midwives, or physician assistants.
(v) Periodically reviews and signs a sample of outpatient records of
patients cared for by nurse practitioners, clinical nurse specialists,
certified nurse midwives, or physician assistants only to the extent
required under State law where State law requires record reviews or co-
signatures, or both, by a collaborating physician.
(2) A doctor of medicine or osteopathy is present for sufficient
periods of time to provide medical direction, consultation, and
supervision for the services provided in the CAH, and is available
through direct radio or telephone communication or electronic
communication for consultation, assistance with medical emergencies, or
patient referral.
(c) Standard: Physician assistant, nurse practitioner, and clinical
nurse specialist responsibilities. (1) The physician assistant, the
nurse practitioner, or clinical nurse specialist members of the CAH's
staff--
(i) Participate in the development, execution and periodic review of
the written policies governing the services the CAH furnishes; and
(ii) Participate with a doctor of medicine or osteopathy in a
periodic review of the patients' health records.
(2) The physician assistant, nurse practitioner, or clinical nurse
specialist performs the following functions to the extent they are not
being performed by a doctor of medicine or osteopathy:
(i) Provides services in accordance with the CAH's policies.
(ii) Arranges for, or refers patients to, needed services that
cannot be furnished at the CAH, and assures that adequate patient health
records are maintained and transferred as required when patients are
referred.
(3) Whenever a patient is admitted to the CAH by a nurse
practitioner, physician assistant, or clinical nurse specialist, a
doctor of medicine or osteopathy on the staff of the CAH is notified of
the admission.
[58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997; 70
FR 68728, Nov. 10, 2005; 79 FR 27155, May 12, 2014]
Sec. 485.635 Condition of participation: Provision of services.
(a) Standard: Patient care policies. (1) The CAH's health care
services are furnished in accordance with appropriate written policies
that are consistent with applicable State law.
(2) The policies are developed with the advice of members of the
CAH's professional healthcare staff, including one or more doctors of
medicine or osteopathy and one or more physician assistants, nurse
practitioners, or clinical nurse specialists, if they are on staff under
the provisions of Sec. 485.631(a)(1).
(3) The policies include the following: (i) A description of the
services the CAH furnishes, including those furnished through agreement
or arrangement.
(ii) Policies and procedures for emergency medical services.
[[Page 215]]
(iii) Guidelines for the medical management of health problems that
include the conditions requiring medical consultation and/or patient
referral, the maintenance of health care records, and procedures for the
periodic review and evaluation of the services furnished by the CAH.
(iv) Rules for the storage, handling, dispensation, and
administration of drugs and biologicals. These rules must provide that
there is a drug storage area that is administered in accordance with
accepted professional principles, that current and accurate records are
kept of the receipt and disposition of all scheduled drugs, and that
outdated, mislabeled, or otherwise unusable drugs are not available for
patient use.
(v) Procedures for reporting adverse drug reactions and errors in
the administration of drugs.
(vi) A system for identifying, reporting, investigating and
controlling infections and communicable diseases of patients and
personnel.
(vii) Procedures that ensure that the nutritional needs of
inpatients are met in accordance with recognized dietary practices and
the orders of the practitioner responsible for the care of the patients,
and that the requirement of Sec. 483.25(g) of this chapter is met with
respect to inpatients receiving posthospital SNF care.
(4) These policies are reviewed at least annually by the group of
professional personnel required under paragraph (a)(2) of this section,
and reviewed as necessary by the CAH.
(b) Standard: Patient services--(1) General: (i) The CAH provides
those diagnostic and therapeutic services and supplies that are commonly
furnished in a physician's office or at another entry point into the
health care delivery system, such as a low intensity hospital outpatient
department or emergency department. These CAH services include medical
history, physical examination, specimen collection, assessment of health
status, and treatment for a variety of medical conditions.
(ii) The CAH furnishes acute care inpatient services.
(2) Laboratory services. The CAH provides basic laboratory services
essential to the immediate diagnosis and treatment of the patient that
meet the standards imposed under section 353 of the Public Health
Service Act (42 U.S.C. 236a). (See the laboratory requirements specified
in part 493 of this chapter.) The services provided include the
following:
(i) Chemical examination of urine by stick or tablet method or both
(including urine ketones).
(ii) Hemoglobin or hematocrit.
(iii) Blood glucose.
(iv) Examination of stool specimens for occult blood.
(v) Pregnancy tests.
(vi) Primary culturing for transmittal to a certified laboratory.
(3) Radiology services. Radiology services furnished by the CAH are
provided by personnel qualified under State law, and do not expose CAH
patients or personnel to radiation hazards.
(4) Emergency procedures. In accordance with requirements of
Sec. 485.618, the CAH provides medical services as a first response to
common life-threatening injuries and acute illness.
(c) Standard: Services provided through agreements or arrangements.
(1) The CAH has agreements or arrangements (as appropriate) with one or
more providers or suppliers participating under Medicare to furnish
other services to its patients, including--
(i) Services of doctors of medicine or osteopathy;
(ii) Additional or specialized diagnostic and clinical laboratory
services that are not available at the CAH; and
(iii) Food and other services to meet inpatients' nutritional needs
to the extent these services are not provided directly by the CAH.
(2) If the agreements or arrangements are not in writing, the CAH is
able to present evidence that patients referred by the CAH are being
accepted and treated.
(3) The CAH maintains a list of all services furnished under
arrangements or agreements. The list describes the nature and scope of
the services provided.
(4) The person principally responsible for the operation of the CAH
under Sec. 485.627(b)(2) of this chapter is also responsible for the
following:
[[Page 216]]
(i) Services furnished in the CAH whether or not they are furnished
under arrangements or agreements.
(ii) Ensuring that a contractor of services (including one for
shared services and joint ventures) furnishes services that enable the
CAH to comply with all applicable conditions of participation and
standards for the contracted services.
(5) In the case of distant-site physicians and practitioners
providing telemedicine services to the CAH's patients under a written
agreement between the CAH and a distant-site telemedicine entity, the
distant-site telemedicine entity is not required to be a Medicare-
participating provider or supplier.
(d) Standard: Nursing services. Nursing services must meet the needs
of patients.
(1) A registered nurse must provide (or assign to other personnel)
the nursing care of each patient, including patients at a SNF level of
care in a swing-bed CAH. The care must be provided in accordance with
the patient's needs and the specialized qualifications and competence of
the staff available.
(2) A registered nurse or, where permitted by State law, a physician
assistant, must supervise and evaluate the nursing care for each
patient, including patients at a SNF level of care in a swing-bed CAH.
(3) All drugs, biologicals, and intravenous medications must be
administered by or under the supervision of a registered nurse, a doctor
of medicine or osteopathy, or, where permitted by State law, a physician
assistant, in accordance with written and signed orders, accepted
standards of practice, and Federal and State laws.
(4) A nursing care plan must be developed and kept current for each
inpatient.
(e) Standard: Rehabilitation Therapy Services. Physical therapy,
occupational therapy, and speech-language pathology services furnished
at the CAH, if provided, are provided by staff qualified under State
law, and consistent with the requirements for therapy services in
Sec. 409.17 of this subpart.
(f) Standard: Patient visitation rights. A CAH must have written
policies and procedures regarding the visitation rights of patients,
including those setting forth any clinically necessary or reasonable
restriction or limitation that the CAH may need to place on such rights
and the reasons for the clinical restriction or limitation. A CAH must
meet the following requirements:
(1) Inform each patient (or support person, where appropriate) of
his or her visitation rights, including any clinical restriction or
limitation on such rights, in advance of furnishing patient care
whenever possible.
(2) Inform each patient (or support person, where appropriate) of
the right, subject to his or her consent, to receive the visitors whom
he or she designates, including, but not limited to, a spouse, a
domestic partner (including a same-sex domestic partner), another family
member, or a friend, and his or her right to withdraw or deny such
consent at any time.
(3) Not restrict, limit, or otherwise deny visitation privileges on
the basis of race, color, national origin, religion, sex, gender
identity, sexual orientation, or disability.
(4) Ensure that all visitors enjoy full and equal visitation
privileges consistent with patient preferences.
[58 FR 30671, May 26, 1993; 58 FR 49935, Sept. 24, 1993, as amended at
59 FR 45403, Sept. 1, 1994; 62 FR 46037, Aug. 29, 1997; 72 FR 66408,
Nov. 27, 2007; 73 FR 69941, Nov. 19, 2008; 75 FR 70844, Nov. 19, 2010;
76 FR 25564, May 5, 2011; 77 FR 29076, May 16, 2012; 78 FR 50970, Aug.
19, 2013; 79 FR 27156, May 12, 2014; 81 FR 68871, Oct. 4, 2016; 82 FR
32260, July 13, 2017]
Sec. 485.638 Conditions of participation: Clinical records.
(a) Standard: Records system--(1) The CAH maintains a clinical
records system in accordance with written policies and procedures.
(2) The records are legible, complete, accurately documented,
readily accessible, and systematically organized.
(3) A designated member of the professional staff is responsible for
maintaining the records and for ensuring that they are completely and
accurately documented, readily accessible, and systematically organized.
(4) For each patient receiving health care services, the CAH
maintains a record that includes, as applicable--
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(i) Identification and social data, evidence of properly executed
informed consent forms, pertinent medical history, assessment of the
health status and health care needs of the patient, and a brief summary
of the episode, disposition, and instructions to the patient;
(ii) Reports of physical examinations, diagnostic and laboratory
test results, including clinical laboratory services, and consultative
findings;
(iii) All orders of doctors of medicine or osteopathy or other
practitioners, reports of treatments and medications, nursing notes and
documentation of complications, and other pertinent information
necessary to monitor the patient's progress, such as temperature
graphics, progress notes describing the patient's response to treatment;
and
(iv) Dated signatures of the doctor of medicine or osteopathy or
other health care professional.
(b) Standard: Protection of record information--(1) The CAH
maintains the confidentiality of record information and provides
safeguards against loss, destruction, or unauthorized use.
(2) Written policies and procedures govern the use and removal of
records from the CAH and the conditions for the release of information.
(3) The patient's written consent is required for release of
information not required by law.
(c) Standard: Retention of records. The records are retained for at
least 6 years from date of last entry, and longer if required by State
statute, or if the records may be needed in any pending proceeding.
[58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997]
Sec. 485.639 Condition of participation: Surgical services.
If a CAH provides surgical services, surgical procedures must be
performed in a safe manner by qualified practitioners who have been
granted clinical privileges by the governing body, or responsible
individual, of the CAH in accordance with the designation requirements
under paragraph (a) of this section.
(a) Designation of qualified practitioners. The CAH designates the
practitioners who are allowed to perform surgery for CAH patients, in
accordance with its approved policies and procedures, and with State
scope of practice laws. Surgery is performed only by--
(1) A doctor of medicine or osteopathy, including an osteopathic
practitioner recognized under section 1101(a)(7) of the Act;
(2) A doctor of dental surgery or dental medicine; or
(3) A doctor of podiatric medicine.
(b) Anesthetic risk and evaluation. (1) A qualified practitioner, as
specified in paragraph (a) of this section, must examine the patient
immediately before surgery to evaluate the risk of the procedure to be
performed.
(2) A qualified practitioner, as specified in paragraph (c) of this
section, must examine each patient before surgery to evaluate the risk
of anesthesia.
(3) Before discharge from the CAH, each patient must be evaluated
for proper anesthesia recovery by a qualified practitioner, as specified
in paragraph (c) of this section.
(c) Administration of anesthesia. The CAH designates the person who
is allowed to administer anesthesia to CAH patients in accordance with
its approved policies and procedures and with State scope-of-practice
laws.
(1) Anesthesia must be administered by only--
(i) A qualified anesthesiologist;
(ii) A doctor of medicine or osteopathy other than an
anesthesiologist; including an osteopathic practitioner recognized under
section 1101(a)(7) of the Act;
(iii) A doctor of dental surgery or dental medicine;
(iv) A doctor of podiatric medicine;
(v) A certified registered nurse anesthetist (CRNA), as defined in
Sec. 410.69(b) of this chapter;
(vi) An anesthesiologist's assistant, as defined in Sec. 410.69(b)
of this chapter; or
(vii) A supervised trainee in an approved educational program, as
described in Sec. 413.85 or Sec. 413.86 of this chapter.
(2) In those cases in which a CRNA administers the anesthesia, the
anesthetist must be under the supervision of the operating practitioner
except as provided in paragraph (e) of this section. An
anesthesiologist's assistant
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who administers anesthesia must be under the supervision of an
anesthesiologist.
(d) Discharge. All patients are discharged in the company of a
responsible adult, except those exempted by the practitioner who
performed the surgical procedure.
(e) Standard: State exemption. (1) A CAH may be exempted from the
requirement for physician supervision of CRNAs as described in paragraph
(c)(2) of this section, if the State in which the CAH is located submits
a letter to CMS signed by the Governor, following consultation with the
State's Boards of Medicine and Nursing, requesting exemption from
physician supervision for CRNAs. The letter from the Governor must
attest that he or she has consulted with the State Boards of Medicine
and Nursing about issues related to access to and the quality of
anesthesia services in the State and has concluded that it is in the
best interests of the State's citizens to opt-out of the current
physician supervision requirement, and that the opt-out is consistent
with State law.
(2) The request for exemption and recognition of State laws and the
withdrawal of the request may be submitted at any time, and are
effective upon submission.
[60 FR 45851, Sept. 1, 1995, as amended at 62 FR 46037, Aug. 29, 1997;
66 FR 39938, Aug. 1, 2001; 66 FR 56769, Nov. 13, 2001; 77 FR 29076, May
16, 2012]
Sec. 485.641 Condition of participation: Periodic evaluation
and quality assurance review.
(a) Standard: Periodic evaluation--(1) The CAH carries out or
arranges for a periodic evaluation of its total program. The evaluation
is done at least once a year and includes review of--
(i) The utilization of CAH services, including at least the number
of patients served and the volume of services;
(ii) A representative sample of both active and closed clinical
records; and
(iii) The CAH's health care policies.
(2) The purpose of the evaluation is to determine whether the
utilization of services was appropriate, the established policies were
followed, and any changes are needed.
(b) Standard: Quality assurance. The CAH has an effective quality
assurance program to evaluate the quality and appropriateness of the
diagnosis and treatment furnished in the CAH and of the treatment
outcomes. The program requires that--
(1) All patient care services and other services affecting patient
health and safety, are evaluated;
(2) Nosocomial infections and medication therapy are evaluated;
(3) The quality and appropriateness of the diagnosis and treatment
furnished by nurse practitioners, clinical nurse specialists, and
physician assistants at the CAH are evaluated by a member of the CAH
staff who is a doctor of medicine or osteopathy or by another doctor of
medicine or osteopathy under contract with the CAH;
(4) The quality and appropriateness of the diagnosis and treatment
furnished by doctors of medicine or osteopathy at the CAH are evaluated
by--
(i) One hospital that is a member of the network, when applicable;
(ii) One QIO or equivalent entity;
(iii) One other appropriate and qualified entity identified in the
State rural health care plan;
(iv) In the case of distant-site physicians and practitioners
providing telemedicine services to the CAH's patients under a written
agreement between the CAH and a distant-site hospital, the distant-site
hospital; or
(v) In the case of distant-site physicians and practitioners
providing telemedicine services to the CAH's patients under a written
agreement between the CAH and a distant-site telemedicine entity, one of
the entities listed in paragraphs (b)(4)(i) through (iii) of this
section; and
(5)(i) The CAH staff considers the findings of the evaluations,
including any findings or recommendations of the QIO, and takes
corrective action if necessary.
(ii) The CAH also takes appropriate remedial action to address
deficiencies found through the quality assurance program.
(iii) The CAH documents the outcome of all remedial action.
[58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997; 63
FR 26359, May 12, 1998; 76 FR 25564, May 5, 2011]
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