US · guidance
CMS SOM App. K
State Operations Manual
Appendix K - Guidance to Surveyors: Comprehensive
Outpatient Rehabilitation Facilities
(Rev. 200, 02-21-20)
Transmittals for Appendix K
INDEX
§485.51 Definition
§485.54 Condition of Participation: Compliance With State and Local Laws
§485.54(a) Standard: Licensure of Facility
§485.54(b) Standard: Licensure of Personnel
§485.56 Condition of Participation: Governing Body and Administration
§485.56(a) Standards: Disclosure of Ownership
§485.56(b) Standard: Administrator
§485.56(c) Standard: Group of Professional Personnel
§485.56(d) Standard: Institutional Budget Plan
§485.56(e) Standard: Patient Care Policies
§485.56(f) Standard: Delegation of Authority
§485.58 Condition of Participation: Comprehensive Rehabilitation Program
§485.58(a) Standard: Physician Services
§485.58(b) Standard: Plan of treatment
§485.58(c) Standard: Coordination of Services
§485.58(d) Standard: Provision of Services
§485.58(e) Standard: Scope and Site of Services
§485.58(f) Standard: Patient Assessment
§485.60 Condition of Participation: Clinical Records
§485.60(a) Standard: Content
§485.60(b) Standard: Protection of Clinical Record Information
§485.60(c) Standard: Retention and Preservation
§485.62 Condition of Participation: Physical Environment
§485.62(a) Standard: Safety and Comfort of Patients
§485.62(b) Standard: Sanitary Environment
§485.62(c) Standard: Maintenance of Equipment, Physical Location and Grounds
§485.62(d) Standard: Access for the Physically Impaired
§485.64 Condition of Participation: Disaster Procedures
§485.64(a) Standard: Disaster Plan
§485.66 Condition of Participation: Utilization Review Plan
§485.66(a) Standard: Utilization Review Committee
§485.66(b) Standard: Utilization Review Plan
General Comments
Explanation of Conditions of Participation for
Comprehensive Outpatient Rehabilitation Facilities
42 CFR 485.51 Definition of a CORF
(Rev. 16, Issued: 01-10-06; Effective/Implementation Date: 11-21-05)
A CORF 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 and meets all the requirements of Subpart B—Conditions
of Participation: Comprehensive Outpatient Rehabilitation Facilities.
________________________________________________________________________
I-501
(Rev. 16, Issued: 01-10-06; Effective/Implementation Date: 11-21-05)
§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 - General
In order to assure that the Comprehensive Outpatient Rehabilitation Facilities (CORF) and
staff furnishing services are in possession of current licenses as required by State and local
laws, licenses should be available for review.
If the facility has not met local and State building, fire and safety codes or doesn’t have the
appropriate licenses, the facility should be refused admission into the program or termination
proceedings should be initiated, whichever is appropriate.
Review the licenses to assure the licenses are current and are applicable to the State in which
the provider is providing services.
B - Major Sources of Information
1. State and local laws governing health care; building, fire and safety codes;
2. Applicable State and local licenses and organization personnel records containing
up-to-date information; and
3. Written policies pertaining to communicable and reportable diseases, conforming to
applicable State and local laws.
I-502
(Rev. 16, Issued: 01-10-06; Effective/Implementation Date: 11-21-05)
§485.54(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.
The facility must meet all building, fire and safety codes where these are required for
licensure before a facility would be eligible for certification. Ascertain that all State and
local licenses, permits and approvals that govern the facility’s operation are current and
valid.
If the proper authorization(s) has not been granted, or has been temporarily revoked or
suspended, the facility should be found in noncompliance with this standard.
If a facility has been issued a provisional license, permit or approval, determine whether the
limitation(s) prevents the facility from complying with the conditions of participation.
Document the reason for this issuance including the limitation(s) imposed on the facility's
operation.
Facilities exempt from State licensure, must be approved by the State as meeting the
standards established for licensure. Examples of exempted facilities may include facilities
that operate on a Federal reservation under agreement with the Department of Health and
Human Services and facilities operated by a State, city or county health department.
__________________________________________________________________________
I-503
(Rev. 16, Issued: 01-10-06; Effective/Implementation Date: 11-21-05)
§485.54(b) Standard: Licensure of Personnel
Personnel that provide service must be licensed, certified, or registered in accordance
with applicable State and local laws.
Personnel providing services at the CORF must be licensed, registered or certified when
licensure, registration or certification is applicable. This includes employees, independent
contractors and individuals from organizations with which the CORF has an arrangement to
provide services.
Review policies and procedures regarding the CORF’s verification of qualified personnel.
Verify licensure or registration of personnel by reviewing a central State listing or other
evidence such as wallet size identification cards.
I-505
(Rev. 16, Issued: 01-10-06; Effective/Implementation Date: 11-21-05)
§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 - General
The CORF must have a governing body which is responsible for its policies and operation,
and which appoints an individual to act as the facility administrator. A group of professional
personnel must develop and review policies that govern the CORF services.
The governing body is the Board of Directors or Trustees of a corporation or the owner(s), in
the case of a proprietary agency, or others who assume legal responsibility for the facility.
While there are no requirements that the governing body follow a prescribed meeting
schedule, there should be evidence that the governing body takes an active role in the overall
operation of the CORF. This includes the development and review of the institutional budget
plan, and knowledge of and concurrence with all patient care and major operational policies,
utilization review and quality improvement activities.
B - Major Sources of Information
• Articles of incorporation, bylaws, policy statements, etc.
• Minutes of governing body, staff and patient care policy meetings.
• Organization chart showing administrative framework
• Personnel records -- job descriptions and personnel qualifications
• Institutional budget plan
• Management contracts
• Patient care policies
• Clinical records
• Utilization Review/Quality Improvement Reports
Assess the effectiveness and adequacy of the governing body's management and operation of
the facility by reviewing documentation of the governing body's activities. This
documentation should include minutes of the governing body, policy statements, bylaws and
delegations of authority.
I-506
(Rev. 16, Issued: 01-10-06; Effective/Implementation Date: 11-21-05)
§485.56(a) Standard: Disclosure of Ownership
The facility must comply with the provisions at 42 CFR Part 420, Subpart C that require
health care providers and fiscal agents to disclose certain information about ownership
and control.
The facility must disclose certain information about its ownership and control in complying
with 42 CFR Part 420, Subpart C. Fiscal Intermediaries will review and verify the
information provided on the Form CMS—855A (Application for Health Care Providers that
will Bill Medicare Fiscal Intermediaries), prior to the state’s survey of a new CORF or when
a CORF makes a change (e.g., change of ownership (CHOW) or change of address).
Review ownership documents for signature and completeness.
________________________________________________________________________
I-507, I-508, I-509, I-510, I-511
(Rev. 16, Issued: 01-10-06; Effective/Implementation Date: 11-21-05)
§485.56(b) Standard: Administrator
The governing body must appoint an administrator who:
(1) Is responsible for the overall management of the facility under the authority
delegated by the governing body;
(2) Implements and enforces the facility’s policies and procedures;
(3) Designates, in writing, an individual who, in the absence of the administrator,
acts on behalf of the administrator; and
(4) Retains professional and administrative responsibility for all personnel
providing facility services.
The qualifications of an administrator may vary among facilities, i.e., some administrators
may be health professionals while others may be business managers. The administrator's
basic responsibility regardless of the field of expertise is to assure that services are rendered
in accordance with CORF policies and that there is efficient utilization of resources and
coordination of services. The administrator should have a thorough working knowledge of
the overall operation of the facility, including the scope of services provided, policies
governing these services, budgetary and fiscal matters and the utilization and qualification of
personnel.
Discussion with the administrator will assist in determining depth of facility knowledge.
An administrator, especially of a large facility, generally functions on a full- time basis.
However, a small facility may have a part-time administrator, e.g., one who also provides
services as one of the professional personnel.
Determine if services are being provided in accordance with facility policies, that policies are
current and reflect an acceptable standard of care, that care is coordinated among the
professional staff and that there is efficient use of resources. If system problems are identified
in any of these areas, consider a citation under governing body.
Facility policies must designate in writing an individual who acts on behalf of the
administrator during a period of absence.
Review facility policies to ensure the facility has named an individual who will serve as
administrator in the administrator’s absence.
I-512, I-513, I-514
(Rev. 16, Issued: 01-10-06; Effective/Implementation Date: 11-21-05)
§485.56(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.
The group of professional personnel serves a very specific facility function, that is, to
make certain that policies relating to patient care are realistic and best meet the needs of
the facility and patients alike. Effective facility operation is dependent, in part, on
workable policies especially those relating to: limitation of service capability, criteria for
patient admission, etc. These policies must be developed and periodically reviewed by the
group of professional personnel. The facility should be able to show that the group of
professional personnel is carrying out its policy formulation and review function. The
group must consist of at least one physician and one professional representing each of the
services provided by the facility. The names of all group members must be available and
evidence must confirm their participation in policy development and review.
All or part of the group of professional personnel, or a group of similar composition, can
serve as the facility's utilization review committee. Although a similarly comprised group
not associated with the facility can perform the utilization review function, it cannot
develop and periodically review the facility's policies
Review facility policies and/or procedures or other documentation that reflects this
function is being carried out (i.e., minutes of meetings, etc).
I-515, I-516, I-517
(Rev. 16, Issued: 01-10-06; Effective/Implementation Date: 11-21-05)
§485.56(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 three 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.
In reviewing the facility's institutional budget plan, there must be evidence the plan has been
prepared under the direction of the governing body (a committee composed of at least one
member of the governing body and at least one member of the administrative staff). The
CORF may have a 3-year capital expenditure plan if expenditures, in excess of $100,000 are
anticipated for that period of time (i.e., acquisition or improvement of land, replacement or
modernization of equipment, buildings, etc.).
Review the Institutional Budget Plan for evidence that the governing body annually reviews
and updates the institutional budget plan. If the administrator states that there is no capital
expenditure plan because no capital expenditure in excess of $100,000 is anticipated, note on
the Survey Report Form CMS -360.
I-518, I-519, I-520, I-521, I-522, I-523, I-524, I-525, I-526, I-527, I-528
(Rev. 16, Issued: 01-10-06; Effective/Implementation Date: 11-21-05)
§485.56(e) Standard: Patient Care Policies
The facility must have written 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’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 care established by a physician for each
patient; and
(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.
These policies comprise the basic operating framework of the CORF and are critical to its
effective operation. All policies must be in writing and documentation must verify the
input of the group of professional personnel in policy development and review. The
policies should be current, compatible with the CORF's provision of services and be
responsive to the needs of the patients.
Copies of all patient care policies should be reviewed.
In brief, patient care policies must reflect the following:
All services rendered by the CORF including those which are rendered by employees or by
others furnished under an arrangement;
A description of personnel tasks during medical emergencies and specific responsibilities,
where assigned;
The types of drugs and biologicals usually kept on the premises, their use, their manner of
storage, who has access to these materials and a procedure for periodic review to determine
the expiration date of the drugs and biologicals.
All criteria governing patient admission, continuing care and discharge. These criteria
should coincide with professional staffing and must be as specific as possible. Factors
governing admission may include geographic areas, ambulatory status of patients, specific
diagnoses, patient ability to carry through on a home program, etc. Criteria developed for
discharge may follow along the lines of specific levels of progress (attainment of goals), need
for higher level of care etc;
The manner in which clinical record documentation is to be prepared and maintained. At a
minimum, policies should state that all personnel performing services (i.e., those defined in
the conditions of participation) must authenticate any entry they place in the patient's clinical
record regardless of whether such personnel are employees of the facility or others. Clinical
records must be maintained so that easy access is afforded all CORF personnel.
The policy must require that documentation in the clinical records be sufficient to support
reasons for admission, care and treatment and discharge/transfer status;
A procedure for explaining a patient's treatment program to the patient and to the patient's
family. In most cases this procedure would include a discussion of the diagnosis (es), the
type and reasons for treatment, the treatment goal and the type of home program, where
applicable, which will be developed. In general, unless the referring physician specifically
notes that certain information is not to be revealed to the patient or family, the treatment
program is to be discussed in detail and procedures are to be in effect for continuing
discussions as they are warranted;
A policy that requires all patients to be under the care of a physician and that a plan of
treatment for each patient must be in effect;
A procedure to assist the referring physician in locating another level of care for patients
whose treatment has terminated and who are discharged; and
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.
Review clinical records and utilization review committee minutes, to determine if policies
have been developed for all aspects of care. Interview members of the professional staff to
determine if they have a working knowledge of the policies.
I-529, I-530, I-531
(Rev. 16, Issued: 01-10-06; Effective/Implementation Date: 11-21-05)
§485.56 (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 an operating budget;
(iii) Purchase of supplies in bulk form; and
(iv) The preparation of financial instruments.
(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 a term of more than 5 years;
(ii) Must be subject to termination within 60 days of written notice by either
party;
(iii) Must contain a clause requiring renegotiation of any provision that CMS
finds to be in contravention to any new, revised, or amended Federal
regulation or law;
(iv) Must state that only the facility may bill the Medicare program; and
(v) May not include clauses that state or imply that the contractor has power and
authority to act on behalf of the facility, or clauses that give the contractor
rights, duties, discretions, or responsibilities that enable it to dictate the
administration, management, or operations of the facility.
A CORF may obtain assistance in financial management and delegate certain services,
including bookkeeping, billing procedure and accounting system development, budget
development, supply purchasing, and financial statement preparation. Where a CORF
does obtain services from another entity, the CORF must have a contract for a term of not
more than 5 years in effect. Such a contract must provide a 60 day right of termination,,
permit renegotiation of any term which CMS determines as contravening a Federal law or
regulation, and not permit the contractor to act on behalf of the facility or to bill the
Medicare program.
Review CORF contracts for adherence to this Standard.
I-532
(Rev. 16, Issued: 01-10-06; Effective/Implementation Date: 11-21-05)
§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. The services must be furnished by personnel that meet the qualifications set
forth in §485.70 and must be consistent with the plan of treatment and the results of
comprehensive patient assessments.
A – General
CORFs must provide a coordinated, comprehensive, skilled rehabilitation program. In
this instance, comprehensive means a broad array of services that must include, at a
minimum, the following three “core” services: Physician services (rendered by a
physician and defined in Standard (a): Physician Services of this appendix), physical
therapy services and social work or psychological services.
Coordinated means the rehabilitation plan of treatment is developed, periodically reviewed
and modified as appropriate by the interdisciplinary treatment team members providing the
rehabilitative care to the patient. Progress notes should reflect on-going communication and
collaboration among the individual’s treatment team members, the individual being served
and members of the indi vidual’s family/support system, as appropriate. Review progress
notes and other medical record entries for examples of on-going communication.
Skilled rehabilitation program is defined as services requiring the skills of qualified
professional personnel who have the expertise necessary to identify and treat the individual’s
functional, psychological, social and medical needs , such as a physical therapist,
occupational therapist, social worker or psychologist. The skilled rehabilitation services
provided must be designed to minimize impairment, reduce activity limitation or lessen
participation restrictions.
Review medical record for examples of patient progress toward attaining rehabilitation goals
set in plan of treatment. Maintenance therapy programs are not considered reasonable and
necessary by Medicare. A therapist can develop a maintenance program for the patient to
follow at home—this does not require the ongoing skills of a therapist.
Review a listing of the facility’s CORF services to determine whether the required three
(“core”) services: physician services, physical therapy and social or psychological services
are furnished. Review medical records for indication that patients are receiving the “core”
CORF services and optional CORF services as indicated in the plan of treatment.
In addition, the CORF may provide any or all of the following optional CORF services:
Occupational therapy, speech-language pathology, respiratory therapy, prosthetic and
orthotic devices, nursing, drugs and biologicals, DME and a single home visit, and be
reimbursed for those services, only if they are part of a comprehensive, coordinated,
skilled rehabilitation program. Nursing services, specified in the plan of treatment and
any other nursing services necessary for the attainment of the rehabilitation goals, are
provided by or under the supervision of a professional registered nurse. The services
must be furnished by nursing personnel who meet the qualifications set in §485.70. The
services must be consistent with the plan of treatment.
Verify the CORF is providing the three “core” CORF services.
Ascertain, by record review and staff interview, whether the CORF is providing an
individualized comprehensive, coordinated, skilled rehabilitation services program. The
program should be directed at optimizing function and promoting interventions to increase
the function of the persons served.
NOTE: Physician diagnostic and therapeutic services (e.g., evaluation and management
services that are furnished to an individual patient) are not physician services
covered under the CORF outpatient therapy benefit. When a physician personally
performs these services, they are billable to the Part B carrier. Hyperbaric oxygen
(HBO) services are considered physician therapeutic services and are not CORF
services.
As always, the services provided must be considered reasonable and medically necessary.
B - Major Sources of Information
Assimilation of information from patient care policies, plans of treatment, clinical records
and staff interviews is necessary to obtain a clear picture of the CORF’s operations (i.e.,
is the CORF following the intent of the regulations and providing a comprehensive
rehabilitation program or is it primarily specializing in a particular type of the treatment
(i.e., HBO, psychiatric nursing, infusion therapy)?
1. Policies and Procedures: Determine whether the CORF offers a comprehensive,
integrated rehabilitation treatment approach. Review policies and procedures,
organizational charts and medical records for evidence of interdisciplinary treatment
team meetings.
2. Review organization chart showing administrative facility framework.
I-533, I-534
§485.58(a) Standard: Physician Services
(Rev. 16, Issued: 01-10-06; Effective/Implementation Date: 11-21-05)
(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 and consultation;
(ii) Establish the plan of treatment in cases where a plan has not been established
by the referring physician;
(ii) 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 reviews.
(2) The facility must provide for emergency physician services during the facility
operation hours.
Written documentation must indicate that a physician(s), (who meets the qualifications in the
conditions of participation regulation at §485.70(a)), performs the required CORF physician
services. Participation for at least one year in a residency program that provides training in
the medical management of patients needing services such as ortho pedics, neurology,
neurosurgery, rheumatology, physical medicine, etc., meets the definition of facility
physician. Specialization in pulmonary medicine does not by itself satisfy the requirements
for rehabilitation training. A facility physician who does not have specialized training in one
of the approved rehabilitation disciplines may satisfy the qualification requirements through
at least one year of work experience providing medical management services in a
rehabilitation setting. Such services must include developing plans of treatment,
participation in patient case review conferences, and establishing patient care policies for
rehabilitation patients. While it is preferable for this experience to have been full-time, part-time experience is acceptab le. However, part -time experience should have been on a
continuing weekly basis. The degree of time spent must confirm that required functions were
accomplished.
Review physician hours.
Documentation must verify this training or experience. It might consist of a résumé,
certificates of training or letters acknowledging completion of training or experience.
Review available material to verify compliance with physician qualification requirements
at §485.70.
The facility physician may be associated with the facility on either a part-time or full-time
basis. If part-time, it is important to determine that the physician is effectively
performing required responsibilities. Review the activities of the group of professional
personnel, utilization review process, patient records and reports of case review
conferences to ascertain the extent of physician participation in patient care activities. The
extent of physician participation can be determined, in part, by the type and volume of
patients, scope of services and need for consultation and medical care services. Normally,
greater physician participation will be required in a facility where the patients have
multiple chronic disabilities, require several services, and require frequent changes in the
plan of care than in a facility where the patients have acute disabilities.
Generally, a facility physician may refer patients to the facility. CORFs may have a
physician(s) providing physician services at the facility on a part -time basis and this
physician(s) may have an office practice distinct from the CORF. In such cases this
physician(s) may establish the CORF plan of treatment when referring patients to the CORF.
If the referring physician has not established a plan of treatment, a facility physician is
responsible for establishing a plan of treatment.
CORF physician services are administrative in nature: consultation with and medical
supervision of non-physician staff, establishment and review of the plan of treatment, and
other medical and facility administration activities. Diagnostic and therapeutic services
are not CORF physician services.
(§410.100 clearly defines the types of services the professional staff may provide in a
CORF).
A facility physician need not perform emergency physician services. Rather, these services
may be provided by another physician(s) or by paramedics with hospital emergency room
back-up, or through other arrangements that ensures prompt delivery of emergency services.
These mechanisms must be in writing, readily available and familiar to all staff. Emergency
services must be available during the total operating hours of the CORF.
I-535, I-536, I-537, I-538, I-540
(Rev. 16, Issued: 01-10-06; Effective/Implementation Date: 11-21-05)
§485.58(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 and indicates the diagnosis and anticipated
rehabilitation goals;
(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 (the 60 day period begins with the
first day of skilled rehabilitation therapy) 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; and
(5) It must be revised if the comprehensive reassessment of the patient’s condition
indicates the need for revision.
Every patient must have a plan of treatment established, either by the facility physician, the
referring physician or both in collaboration prior to the facility c ommencing treatment.
Usually, a plan of treatment is written; however, it is acceptable in certain circumstances for
a verbal order and plan to be telephoned to the CORF by the referring physician. The time,
date, referring physician's name and contents of the verbal order must be documented and
signed by the person receiving the order, and countersigned by the referring physician as
soon as possible. Specific information relative to type, amount, frequency and duration of
services as well as anticipated goals, should routinely be incorporated with the physician
referral. The plan of treatment must include all of the services needed by the patient that
meet the definition of CORF services. (CORF services are: physician; physical therapy;
occupational therapy; speech-language pathology; respiratory; prosthetic; orthotic; social;
psychological; nursing; drugs and biologicals; and supplies, appliances and equipment). For
example, if a patient is in need of social services, physical therapy and speech -language
pathology, all three services must be included in the CORF plan of treatment. The plan of
treatment must, if appropriate, be developed in consultation with the facility physician and
the appropriate facility professional personnel.
After treatment has begun, any change in the plan of treatment should be supported in the
patient's clinical record by dated documentation signed by either the facility physician or
by the referring physician. Any change in the patient's condition must be accompanied by
a revised plan of treatment.
A facility physician must perform a 60 day review of the plan of treatment to determine if the
plan is being followed and whether or not the patient is making progress in attaining the
established goals. However, the referring physician should always be given the opportunity
to have continued input into the patient's treatment program.
In this regard, CORF staff must communicate either verbally or in writing the results of the
60-day review to the referring physician. Verbal communication should be by either a facility
physician or one of the professional personnel carrying out the plan of treatment. The
referring physician's verbal concurrence for revision of the plan of treatment should be
documented in the patient's clinical record by the individual communicating with the
referring physician. This documentation should include the date and the subject matter
discussed. The referring physician's response should be incorporated into the patient's
clinical record.
_________________________________________________________________________
I-541, I-542, I-543, I-544, I-545
(Rev. 16, Issued: 01-10-06; Effective/Implementation Date: 11-21-05)
§485.58(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 recommendation of one of the professionals providing services.
Patients receive maximum benefit from an individualized comprehensive, coordinated,
skilled rehabilitation outpatient program when services are provided in a coordinated
manner. In most CORFs, a multi-disciplinary team of professional personnel provides
several rehabilitation services to patients. The team may include full-time and part-time
employees as well as contract employees functioning on either a full-time or part-time
basis. It is, therefore, important that the facility take steps to assure that services are
provided in an efficient, effective and coordinated manner. The facility must designate in
writing one professional to oversee the coordination of CORF services that the facility
has developed. This responsibility can be performed concurrently with the assigned
person's normal professional duties. All personnel providing services at the CORF
should receive a schedule of the frequency and type of services provided at the CORF.
Review CORF policies/procedures to ensure the CORF provides in-service education
regarding the importance of coordinating patient services. Evidence may also appear in
the medical record in assessments, progress notes, interdisciplinary treatment team
meetings, discharge planning meetings, etc. Verify that the individual identified as the
coordinator is qualified to perform this function.
Frequency of clinical record entries may range from a brief entry in a patient's clinical record
each day the patient receives treatment, to entries of longer intervals. The facility must
establish some procedure detailing the frequency of clinical record documentation. Since
this documentation may be used as one of the factors in determining the outcome of the 60-day plan of treatment review, entries should appear frequently enough during each 60-day
period to provide an adequate picture of coordination of the care being given and the patient's
status relative to established goals.
The frequency, format, and criteria for patient case review conferences may vary among
facilities. These conferences generally will be convened to determine the appropriateness of
continuing treatment, changing a plan of treatment, or to coordinate treatment activities.
Conferences may routinely be scheduled for each patient after the patient has been
undergoing treatment for a specified period of time or has had a specified number of
treatments; or conferences may be scheduled only for patients who are not meeting
anticipated goals, who need a different level of care, or who are receiving an intensive multi-service rehabilitation program. There must be a written policy regarding patient case review
conferences, and it should be adhered to. There should be a formal procedure to familiarize
all personnel treating the patient with the results of the CORF's coord ination of service
activity.
Review past patient case review conference documentation and interview personnel
regarding its utilization. In reviewing case conference documentation, look for evidence that
the CORF has the three “core” services available.
I-546, I-547, I-548, I-549, I-550, I-551, I-552
(Rev. 16, Issued: 01-10-06; Effective/Implementation Date: 11-21-05)
§485.58(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;
(ii) 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 § 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 § 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 q ualified professional must be on the premises during the facility’s
operating hours; and
(7) All services must be provided consistent with accepted professional standards and
practice.
All CORF patients must be referred by a physician. The referral should contain the patient's
medical history, current medical findings, diagnosis, contraindications to any treatment
modality and rehabilitation goals, if determined. Current medical findings and a complete
and appropriate medical history do not always accom pany a physician's referral. In such
cases, a qualified professional or a facility physician should obtain this information from the
patient aanndd oobtain additional necessary information through follow -up with the referring
physician.
Review medical records to ensure the CORF patients have a referral and the information
listed above.
CORF services may be provided by employees or by others under arrangements, i.e.,
individuals from an organization that has a contract with the facility to provide services,
and individuals that contract directly with the CORF. A CORF need not expressly
employ professional personnel under an arrangement exclusively for a CORF. Personnel
may be associated with other organizations while they are associated with the CORF, but
must be available during operating hours. For example, a principal(s) of a skilled nursing
facility (SNF) may also own a CORF and share personnel between these two providers.
This is permissible and satisfies compliance with regulations when these personnel are
able to perform exclusively for each provider, respectively, in carrying out specific
responsibilities. This is especially important because each CORF is a separate
identifiable provider and must independently meet the conditions of participation.
Review contracts the CORF has for providing services under arrangement. The CORF
has the administrative responsibility for the services provided to its patient.
Ascertain that the CORF has the equipment and personnel necessary to adequately and
effectively provide the services as defined in the plan of treatment. Review medical records
to determine specific equipment requirements from the plans of treatment, and verify the
presence of such equipment.
A facility need not own all of the equipment required for implementing the plan of treatment.
It is permissible to rent or lease necessary equipment on an as needed basis. The CORF must
demonstrate that all required equipment will be readily procured, obtained and available on
the premises when providing t reatment services to the patients. The CORF cannot share
equipment with any other entity during its hours of operation. Ensure equipment levels are
sufficient to treat patients.
Adequacy of staffing levels of qualified professionals and other ssttaaffff sshhoouulldd be based upon
the types of patients treated and the frequency, duration and complexity of treatment
required, rather than general staff to patient ratios.
When non- professional personnel other than those that are noted in the personnel
qualification se ction of the conditions of participation (see §485.70) are used to assist
qualified professionals, their duties, responsibilities and qualifications should appear in the
facility's policies and be consistent with accepted standards and practices. Appropri ately
qualified personnel must instruct all non- professional personnel in specific patient care
techniques.
The form and extent of any instruction provided to non- professional personnel must be
appropriate to that person’s assigned responsibilities, educa tion, experience and types of
patients treated. The appropriately qualified professional must be on the premises, and
supervise the care given when non-professional personnel are utilized. Verify this through a
review of the treatment and staffing schedu le. For example, when non- professional
personnel are used in conjunction with the furnishing of physical therapy services, a person
meeting the qualification requirements of §485.70 (formerly §488.70) must be on the
premises.
Qualified professional personnel may initiate changes that need to be made concerning the
implementation of the plan of treatment. Assistant-level personnel (as defined in §485.70
and §484.4) must not initiate such changes without the approval of the appropriately
qualified professi onal. Qualified personnel must be available for duty on the CORF's
premises as needed for consultation and/or assistance or must be able to be contacted by
telephone.
Consultation and assistance cannot be provided to non-professional personnel by phone as
they require on the premises supervision.
At least one qualified professional must be on the facility's premises during its hours of
operation.
It may not be unusual to find that, in a CORF that furnishes a broad array of rehabilitation
services, sever al types of professionals are furnishing particular aspects of care. For
example, registered nurses with special training in respiratory care or physical therapists may
furnish respiratory therapy services.
The CORF is responsible for ensuring that a pra ctitioner furnishing a particular service is
qualified to do so under State law and does so within accepted professional standards and
practices. Carefully review the qualifications of a professional providing more than one
CORF service. Determine the scope of the particular service.
Verify that the practitioner is qualified to provide the service, and that it is provided pursuant
to State law and accepted professional standards and practices.
I-553
(Rev. 16, Issued: 01-10-06; Effective/Implementation Date: 11-21-05)
§485.58(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 pathology services
furnished away from the premises of the CORF may be covered as CORF services if
Medicare payment is not otherwise made for these services. In addition, a single
home visit is covered if there is need to evaluate the potential impact of the home
environment on the rehabilitation goals. The home evaluation is not covered as a
routine service for all CORF patients. It is covered only if, in establishing or
carrying out the plan of treatment, there is a clear indication that the home
environment might adversely affect the patient’s rehabilitation. Coverage is limited
to the services of one professional either physical or occupational therapist, (whose
services are covered by the CORF benefit) who is selected by the CORF.
In general, all services must be furnished on the premises of the CORF. The only exceptions
are the home evaluation visit. The provision allowing offsite therapy services does not
permit the CORF to establish extension locations and all records must be maintained on the
premises of the CORF. The purpose of the home visit is to evaluate the home environment
in relation to the patient's established treatment goals. The home visit evaluation may include
assessing the need for modifying the physical and/or social environment to maximize the
patient's functional capability. The home, for purposes of this home evaluation visit, is the
patient's legal residence. The visit may take place anytime between the implementation of
the plan of treatment and the discharge of the patient. A patient who is periodically
discharged and admitted for a chronic but stable problem would not normally receive more
than one home evaluation visit, even though the patient may be receiving more than one
service.
Ask the CORF if therapy services are provided off -site and if so, which services are
provided. Even though the CORF patients can be treated in off-site locations by therapists,
the CORF is ultimately responsible for the coordinated, comprehensive rehabilitation
program for each patient. All appropriate CoPs apply to the services provided at off -site
locations.
Review clinical records.
Notes in the patient's clinical record should indicate when the visit was made, who made it,
its purpose and the results of the evaluation.
Also, the CORF must provide all the CORF services required in the plan of treatment. Since
personnel may provide these services under arrangements, there should be minimal difficulty
in obtaining personnel to provide services regardless of the infrequency of demand for the
service. The unavailability of a service forces the patient to seek the service at another
location. This is contrary to one of the purposes of the CORF legislation, i.e., to remedy the
situation where beneficiaries needing several rehabilitation services are required to seek them
at more than one location.
NOTE: When completing the CORF Survey Report Form (CMS -360) do not mark
standard 485.58(e) (tag number 1- 553) "no" if the CORF provides physical
therapy, occupational therapy or speech pathology services offsite. We will revise
the CMS-360 to include this offsite provision when it is reprinted.
I-554, I-555, I-556
(Rev. 16, Issued: 01-10-06; Effective/Implementation Date: 11-21-05)
§485.58(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.
Each qualified individual, providing services to a patient, must conduct an initial patient
assessment with periodic reassessment of the patient to determine whether the patient is
meeting rehabilitation goals and to update the plan of treatment. Because the
reassessment usually consists of the same evaluative mechanisms (e.g., test procedures,
measurements, professional observations and subjective information from patient) used in
the initial assessment to obtain indicators of the patient's status, the patient's status at
different points in time can be compared. Since a reassessment must be performed when
significant changes in the patient's condition are noted, such a comparison is useful to
determine whether the current plan of treatment is appropriate. In contrast to the
information obtained in a reassessment, periodic entries in the clinical record as required
in §485.58(c)(3) usually contain information such as a patient's reaction to treatment,
general condition of patient, significant changes in patient's status and/or changes in the
intensity of treatment. These entries provide in chronological order a picture of the
patient's progress in relation to the care being given.
Verify that each patient is assessed by each qualified professional personnel involved in
the patient's care prior to the implementation of the plan of treatment. During a review of
the clinical records compare the date the plan of treatment was established to the date of
the initial assessment by the appropriate professional defined in §485.70. If the plan of
treatment specifies several rehabilitation services, the professional personnel responsible
for initiating the plan may be unable to complete their respective assessments on the same
day. For example, the physical therapist may complete an assessment of the patient and
initiate the physical therapy service portion of the plan before the speech pathologist
assesses the patient. However, if the physician ordered all therapies to assess and begin
treatment upon receipt of the plan of care, it is reasonable to expect all assessments be
completed in the first week of receiving the plan of treatment.
Review the clinical records for availability of an initial assessment and re-assessments as
appropriate.
I-557, I-558
(Rev. 16, Issued: 01-10-06; Effective/Implementation Date: 11-21-05)
§485.58(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.
A CORF may either conduct its own laboratory services or refer specimens to another
laboratory. Either laboratory must meet the applicable requirements at 42 CFR §493. The
laboratory must meet any and all State requirements for certification or licensure.
Review certification/licensure if the CORF offers laboratory services.
I-559
(Rev. 16, Issued: 01-10-06; Effective/Implementation Date: 11-21-05)
§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,
systematically organized to facilitate retrieval and compilation of information.
A - General
The clinical record serves as a basis for documentation of care rendered to the patient and
communication between all personnel furnishing services. Determine whether the content of
the clinical record presents a total, or at a minimum, an adequate picture of the care being
given.
B - Major Sources of Information
• Active and closed clinical records; and
• Policies regarding protection and retention of clinical records.
________________________________________________________________________
I-560, I-561, I-562, I-563, I-564, I-565, I-566, I-567
(Rev. 16, Issued: 01-10-06; Effective/Implementation Date: 11-21-05)
§485.60(a) Standard: Content
Each clinical record must contain sufficient information to identify the patient clearly and
to justify the diagnosis and treatment. Entries in the clinical record must be made as
frequently as is necessary to insure effective treatment, and must be signed by personnel
providing services. All entries made by assistant level personnel must be countersigned
by the corresponding professional. Documentation on each patient must be consolidated
into one clinical record that must contain:
(1) The initial assessment and subsequent reassessments of the patient’s needs;
(2) Current plan of treatment;
(3) Identification data and consent or authorization forms;
(4) Pertinent medical history, past and present;
(5) A report of pertinent physical examinations if any;
(6) Progress notes or other documentation that reflect patient reaction to
treatment, tests, or injury, or the need to change the established plan of
treatment; and
(7) Upon discharge, a discharge summary including patient status relative to goal
achievement, prognosis, and future treatment considerations.
All medical records must be maintained according to accepted professional standards of
practice. The medical records must be readily available to staff and surveyors.
Examine a substantial number of both active and closed clinical records and ascertain that the
required material is included. If any of the material required in this standard (§485.60(a) is
absent from the clinical records, review additional records to determine the prevalence of
such omissions. Record the number of records reviewed and the number and types of
deficiencies observed. In determining the number of records to be reviewed, be guided by
the size of the CORF's patient caseload. The larger the caseload, the larger the review
sample should be.
Each patient's record should contain a summary of each patient’s case review conference,
where appropriate, and indicate the purpose and recommendation resulting from the
conference. All reports generated as a result of any meetings concerning patient care issues
should be dated, signed and made a part of the record.
Ascertain that periodic progress notes are entered in the clinical records at intervals
commensurate with the type and frequency of treatment. These notes are to address the
progress of the patient in attaining stated plan of treatment goals. Some facilities may require
a brief entry in the clinical record each day the patient receives a treatment while other
facilities may require routine progress reports at longer intervals. Ascertain the time interval
between progress reports. Determine whether the time interval is impeding coordination and
communication in patient care activities. Regardless of the frequency of progress notes, the
notes should record the patient's status in relation to the stated treatment goals.
A discharge summary should include the date and reason for discharge, a brief summary of
the patient's current status and, where applicable, details regarding referral of the patient to
another level of care.
All information appearing in the clinical record must be dated, appropriately signed and
promptly incorporated in the record. Regulations require that entries written by therapy
assistants be countersigned even though some state practice acts may not require this. All
entries in the clinical record must be legible.
A physician must certify that CORF services are required because the individual needs
skilled rehabilitation services. The treatment plan must include a diagnosis and must address
rehabilitation goals associated with that particular diagnosis. Throughout the course of
rehabilitation treatment, the medical records must indicate the ongoing services provided by
a physical therapist, social worker or psychologist.
Verify the medical records contain signed and dated certifications and re-certifications.
I-568
(Rev. 16, Issued: 01-10-06; Effective/Implementation Date: 11-21-05)
§485.60(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 by law.
Verify that active and closed clinical records are stored where they are protected from fire
and unauthorized use.
Review the CORFs written procedures governing the use of records which specify to whom
the records or copies of records may be provided, the use to which the material may be put
and the circumstances describing the return of such material. Also, review the medical
records to determine that written patient consent is present to allow the release of all material
not authorized by law.
I-569
(Rev. 16, Issued: 01-10-06; Effective/Implementation Date: 11-21-05)
§485.60(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.
The facility must provide for the maintenance of clinical records in cases where the
CORF ceases to function.
Review the CORF’s policy for the preservation and retention of clinical records and
verify that applicable State laws or regulations are met.
I-570
(Rev. 16, Issued: 01-10-06; Effective/Implementation Date: 11-21-05)
§485.62 Condition of Participation: Physical Environment
The facility must provide a physical environment that protects the health and safety of
patients, personnel, and the public.
A - General
A CORF must provide a physical environment that protects the health and safety of the staff,
patients and public.
B - Major Sources of Information
1. Applicable State and local laws;
2. Inspection reports of State and local building and fire authorities; and
3. Organization policies and procedures regarding maintenance of equipment, buildings
and grounds.
________________________________________________________________________
I-571, I-572, I-573, I-574, I-575, I-576, I-577, I-578
(Rev. 16, Issued: 01-10-06; Effective/Implementation Date: 11-21-05)
485.62(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 musts 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; and
(7) Safe and sufficient space must be available for the scope of services offered.
Review available reports of State and local personnel responsible for enforcement of
building, fire and safety codes and verify that the CORF is in compliance with applicable
codes.
All areas occupied or accessible to the facility for use during emergency or non-emergency
activity, including corridors and stairways, are to be protected by easily accessible fire
extinguishers. Lights, supported by an emergency power source, must be placed at exits.
Where there is a CORF established on the premises of another health entity, also survey
those areas which are common to both, i.e., corridors, stairways, storage areas, etc.
The fire alarm system must be adequate to alert personnel in time for safe evacuation of the
building. The system should consist of either a manual (pull type) fire alarm system with or
without automatic fire department response, or an automatic detection system along with an
audible manual alarm. An y system should have the capacity for manual activation that
triggers an audible in -house alarm which alerts personnel, patients and the public to the
present danger and need for action. Where the alarm system is activated by a disruption of
the electrical system or in other ways dependent on it, an emergency power source with
automatic triggering, e.g., battery or auxiliary generator, must be available to serve as a
backup. In the absence of State or local requirements, the above systems are to be approved
by the State Fire Marshall's Office.
Verify the availability of fire extinguishers and fire alarms.
The number of staff necessary to evacuate patients during an emergency depends largely on
the number and types of patients scheduled to be on the premises at any one time. A patient
population consisting largely of patients dependent on assistive devices for ambulating (e.g.,
canes, crutches and walkers), wheelchair bound patients and other patients who would need
assistance from CORF personnel for a quick, safe evacuation, would require the presence of
more staff than a patient population which is not dependent on ambulatory assistive devices.
Obbserve the number of staff and the types of patients to determine the efficiency of an
evacuation in case of an emergency.
An emergency power source must be supplied, e.g., by battery or auxiliary generator, to
assure adequate lighting during emergency operation within the treatment areas or those
passageways, stairwells and exits (as noted above) accessible to the CORF. In cases of
power outage, the emergency power source should respond either automatically or require
only minimal activation effort.
Verify that the temperature and ventilation is maintained at a comfortable level.
______________________________________________________________________
I-579, I-580, I-581, I-582, I-583
(Rev. 16, Issued: 01-10-06; Effective/Implementation Date: 11-21-05)
§485.62(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; and
(4) Provisions must be in effect that the facility’s premises are maintained free of
rodent and insect infestation.
Verify that the facility maintains a sanitary environment and has established a program to
identify, investigate, prevent and control the cause of patient infections.
Review the written policies and procedures regarding infection control and maintenance of a
sanitary environment.
Verify that they are sufficient in light of the volume and types of patients and services
provided, and that there is consistency with current practices of infection control.
Identify the individual or group responsible for establishing, implementing and monitoring
the policies and procedures. The facility must monitor the infection control program to
ensure that policies and procedures are being complied with and are consistent with currently
accepted practices, if applicable. Pay particular attention to the policies, procedures and
reports concerning the care and debridement of wounds, and the cleaning and disinfection of
equipment such as whirlpools and paraffin baths and respiratory therapy equipment.
Verify the general sanitation, cleanliness and orderliness of the premises and verify that clean
and soiled linen is handled in an orderly and sanitary manner that will prevent the spread of
infection. There must be an adequate supply of fresh linen (sheets, towels, pillowcases)
which must be stored and processed separate from soiled linen. Soiled linen must be
processed and stored in an area away from patients, personnel and the public.
Review the CORF policies and procedures regarding preventive maintenance and infection
control to determine if they are compatible with the scope of services, the type of equipment
used and type of patients accepted for treatment.
I-584, I-585, I-586
(Rev. 16, Issued: 01-10-06; Effective/Implementation Date: 11-21-05)
§485.62(c) Standard: Maintenance of Equipment, Physical Location and
Grounds
The facility must establish a written preventive maintenance program to ensure that:
(1) All equipment is properly maintained and equipment needing periodic
calibration is calibrated consistent with the manufacturer’s recommendations;
and
(2) The interior of the facility, the exterior of the physical structure housing the
facility, and the exterior walkways and parking areas are clean and orderly
and maintained free of any defects that are a hazard to patients, personnel,
and the public.
CORF personnel should inspect all equipment as per the manufacturer’s directions or more
frequently depending on equipment condition and its frequency of use. Written procedures
regarding the preventive maintenance program must include the following: equipment to be
inspected, a brief statement concerning the general inspection process and frequency of
inspection for each piece of equipment. For all electrically powered patient care equipment,
appropriate manufacturer's operating and maintenance information must be on file.
Review this information and ascertain what specific manufacturer's recommendations, if any,
are made for equipment calibration checks, periodic maintenance procedures, etc. Then,
through copies of service repair statements or other documentation, determine whether such
recommendations were followed.
The facility must be free of hazards to the health and safety of pati ents, personnel and the
public, e.g., broken window and door panes, obstruction of passageways and dangerous floor
surfaces, and any hazardous exterior walkways or parking areas. Hazards are to be brought
to the attention of CORF personnel.
I-587, I-588, I-589, I590, I-591, I-592
(Rev. 16, Issued: 01-10-06; Effective/Implementation Date: 11-21-05)
§485.62(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 non-ambulatory 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.
The CORF must ensure the exits and entrances are wide enough to allow for easy
movement of all patients whether they are ambulatory, in a wheelchair or on a stretcher
and that the exits and entrances are not blocked with furniture or equipment. For patients
who use a stairwell, rails must be firmly attached on one wall. A wheelchair entrance
must be equipped with a suitable ramp if needed.
Inspect the premises to verify whether the facility ensures safe access and adequate space
to maneuver in waiting areas, treatment areas and toilet facilities for all physically
impaired patients including those on stretchers or in wheelchairs. Verify that at least one
toilet facility can be used by ambulatory and nonambulatory patients, that is, grab bars are
provided, elevated toilets seats are available, etc. If the CORF is in a multi-story building
at least one elevator is available and functioning for the physically impaired who are
entering or leaving the premises as well as to all patient areas that are part of the CORF.
I-593
(Rev. 16, Issued: 01-10-06; Effective/Implementation Date: 11-21-05)
§485.64 Condition of Participation: Disaster Procedures
The facility must have written policies and procedures that specifically define the
handling of patients, personnel, records, and the public during disasters. All personnel
associated with the facility must be knowledgeable with respect to these procedures, be
trained in their application, and be assigned specific responsibilities.
A - General
A well -developed disaster plan is to be documented and posted in areas accessible for
continuing personnel review and where the public can see it.
B - Major Sources of Information
• Disaster plan; and
• Documentation as to ongoing training sessions and dates of disaster drills
_____________________________________________________________________
I-594, I-595, I-596, I-597, I-598
(Rev. 16, Issued: 01-10-06; Effective/Implementation Date: 11-21-05)
§485.64(a) Standard: Disaster Plan
The facility’s written disaster plan must be developed and maintained with assistance of
qualified fire, safety, and other appropriate experts. The plan must include:
(1) Procedures for prompt transfer of casualties and records;
(2) Procedures for notifying community emergency personnel (for example, fire
department, ambulance, etc.);
(3) Instructions regarding the location and use of alarm systems and signals and
fire fighting equipment; and
(4) Specification of evacuation routes and procedures for leaving the facility.
The disaster plan should document the assignment of responsibilities to CORF personnel
providing services to the CORF, evacuation routes, and procedures for the transfer of records
and casualties. In addition, the plan should include procedures for notifying community
emergency personnel, procedures for leaving the facility and instructions regarding the
location and use of alarms and fire fighting equipment.
Review the disaster plan to determine if the plan documents all of the above procedures and
instructions. If CORF employees are working at off-site locations, it is incumbent upon the
CORF to ensure those employees have been trained and are knowledgeable regarding disaster
plans, evacuation routes for those locations, etc. Surveyors should interview staff to
determine whether the CORF has provided training in the off-site locations.
I-599, I-600 - I-601
(Rev. 16, Issued: 01-10-06; Effective/Implementation Date: 11-21-05)
§485.64(b) Standard: Drills and Staff Training
(1) The facility must provide ongoing training and drills for all personnel associated
with the facility in all aspects of disaster preparedness; and
(2) All new personnel must be oriented and assigned specific responsibilities
regarding the facility’s disaster plan within 2 weeks of their first workday.
Every CORF must provide ongoing training and drills for all personnel associated with
the facility in all aspects of disaster preparedness. Larger, more complex CORFs would
most likely provide ongoing training more frequently than smaller CORFs. All new
employees must be oriented and assigned specific responsibilities as part of the disaster
plan within 2 weeks of their first workday. This includes all employees who provide
services to the CORF under an arrangement. The date of training and names of those
persons taking part are to be documented.
Review the CORF’s written Disaster Plan. Verify that all personnel have been instructed
and trained in their responsibilities and that all new personnel are properly trained within
2 weeks of their first workday. Interview the staff to ensure that they are familiar with the
plan as well as being familiar with their role in the plan.
I-602
(Rev. 200, Issued: 02-21-20; Effective: 02-21-20, Implementation: 02-21-20)
§485.66 Condition of Participation: Utilization Review Plan
The facility must have in effect a written utilization review plan that is implemented
annually, without modification, to assess the necessity of services and promotes the most
efficient use of services provided by the facility.
A - General
(I-602) Each facility must have in effect, a written utilization review plan. An established
utilization review plan serves to indicate how well policies are functioning, how effective
treatment regimens have been, and how well the CORF has adapted its particular program to
selected patients.
B - Major Sources of Information
• Clinical records; and
• Written utilization plan
_________________________________________________________________________
I-603
(Rev. 16, Issued: 01-10-06; Effective/Implementation Date: 11-21-05)
§485.66(a) Standard: Utilization Review Committee
The utilization review committee, consisting of the group of professional personnel
specified in §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.
The Utilization Review (UR) Committee must meet at least quarterly. The composition of
this committee should be written into the utilization review plan and should be representative
of the professional personnel that provide services in the CORF. A facility physician or non-
CORF physician must be a member of the UR committee.
____________________________________________________________________
I-604, I-605, I-606, I-607
(Rev. 16, Issued: 01-10-06; Effective/Implementation Date: 11-21-05)
§485.66(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;
(ii) Determining whether the facility’s policies and clinical practices are
compatible and promote appropriate and efficient utilization of services.
The plan should contain specific procedures and standards necessary to assess the
effectiveness and efficiency of the services provided . The number of cases selected for
review should be representative of the types of patients treated at the CORF and the types of
services provided. The frequency of reviews should be outlined in the plan.
Reports and outcomes of evaluations should be reflected in the minutes of the utilization
review committee. Those minutes should also indicate the extent to which the CORF
program, policies and practices are being followed. Review the minutes of the utilization
review committee to determine if the plan is being followed.
Results of utilization review activities should be made available to all professional personnel.
Identify whether the results of the review prompted recommendations concerning CORF
policies and practices and whether the recommendations were communicated to the
administrator and governing body and the group of professional personnel (if different from
the utilization review committee).
GENERAL COMMENTS:
(Rev. 16, Issued: 01-10-06; Effective/Implementation Date: 11-21-05)
A CORF may be established on the premises of another health entity irrespective of whether
this entity is already certified under Medicare as a provider or supplier of services. For
example, a CORF may be established on the premises of a skilled nursing facility (SNF) and
the SNF's owner(s) may either have legal responsibility for both the SNF and the CORF, or
merely rent space within the SNF to the CORF's owner(s). In either situation, the CORF
must be certified sep arately and be functionally and operationally independent. The
regulatory definition of a CORF precludes the CORF, and another entity from mixing
functions and operations in a common space during concurrent or overlapping hours of
operation.
In the same manner as space may be shared, equipment may also be shared. All common
equipment must be available (on the premises of the CORF) during the CORF's hours of
operation and not, at that time, be utilized by the other entity for any purpose.
The CORFs must be surveyed pursuant to the CORF conditions of participation and all
standards must be surveyed independent of any findings resulting from the completed
survey of the other entity. That is, although there may have been no deficiencies noted
during the survey of the other entity, this fact must not influence any determination with
respect to the survey pursuant to the CORF conditions of participation.
Transmittals Issued for this Appendix
Rev # Issue Date Subject Impl Date CR#
R200SOMA 02/21/2020 Revisions to the State Operations Manual
(SOM) Appendix A -
Hospitals, Appendix AA – Psychiatric
Hospitals, Appendix B – Home Health
Agency, Appendix D - Portable X-Ray,
Appendix G - Rural Health Clinics/Federally
Qualified Health Centers, Appendix H- End
Stage Renal Disease Facilities (ESRD),
Appendix K – Comprehensive Outpatient
Rehabilitation Facility, Appendix L -
Ambulatory Surgical Centers, Appendix M –
Hospice, Appendix U - Religious
Nonmedical Healthcare Institutions,
Appendix W - Critical Access Hospitals
(CAHs), Appendix X-Organ Transplant
Program and Appendix Z - Emergency
Preparedness
02/21/2020 N/A
R016SOMA 01/10/2006 Revisions to Chapter 2, Appendix E and
Appendix K
10/21/2005 N/A
R013SOM 10/21/2005 Revisions to Chapter 2, Appendix E and
Appendix K
10/21/2005 N/A
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
a628dd1489c4d4e7b301e998598c288f3af274d58a8159030c6f8f1986939364
The link goes to the issuing authority’s own document — the one we read to produce this record. Where a source publishes whole titles rather than sections, your browser may need a moment to jump to the provision.
Unofficial copy of government-published law, reproduced from official sources with full provenance. Not an official publication; verify against official sources before relying on it in a filing. Records in the 'guidance' corpus, and only that corpus, are sub-regulatory (interpretive guidelines, survey procedures) and are not binding law. Validity bounds follow each jurisdiction's declared temporalBasis.