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Electronic Code of Federal Regulations
Title 42: Public Health
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.
§483.480 Condition of participation: Dietetic services.
Source: 53 FR 20496, June 3, 1988, unless otherwise noted. Redesignated at 56 FR 48918, Sept. 26, 1991.
§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.
§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.
§483.410 Condition of participation: Governing body and management.
(a) Standard: Governing body. The facility must identify an individual or individuals to constitute the governing body of the facility. The governing body must—
(1) Exercise general policy, budget, and operating direction over the facility;
(2) Set the qualifications (in addition to those already set by State law, if any) for the administrator of the facility; and
(3) Appoint the administrator of the facility.
(b) Standard: Compliance with Federal, State, and local laws. The facility must be in compliance with all applicable provisions of Federal, State and local laws, regulations and codes pertaining to health, safety, and sanitation.
(c) Standard: Client records. (1) The facility must develop and maintain a recordkeeping system that includes a separate record for each client and that documents the client's health care, active treatment, social information, and protection of the client's rights.
(2) The facility must keep confidential all information contained in the clients' records, regardless of the form or storage method of the records.
(3) The facility must develop and implement policies and procedures governing the release of any client information, including consents necessary from the client, or parents (if the client is a minor) or legal guardian.
(4) Any individual who makes an entry in a client's record must make it legibly, date it, and sign it.
(5) The facility must provide a legend to explain any symbol or abbreviation used in a client's record.
(6) The facility must provide each identified residential living unit with appropriate aspects of each client's record.
(d) Standard: Services provided under agreements with outside sources. (1) If a service required under this subpart is not provided directly, the facility must have a written agreement with an outside program, resource, or service to furnish the necessary service, including emergency and other health care.
(2) The agreement must—
(i) Contain the responsibilities, functions, objectives, and other terms agreed to by both parties; and
(ii) Provide that the facility is responsible for assuring that the outside services meet the standards for quality of services contained in this subpart.
(3) The facility must assure that outside services meet the needs of each client.
(4) If living quarters are not provided in a facility owned by the ICF/IID, the ICF/IID remains directly responsible for the standards relating to physical environment that are specified in §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]
§483.420 Condition of participation: Client protections.
(a) Standard: Protection of clients' rights. The facility must ensure the rights of all clients. Therefore, the facility must—
(1) Inform each client, parent (if the client is a minor), or legal guardian, of the client's rights and the rules of the facility;
(2) Inform each client, parent (if the client is a minor), or legal guardian, of the client's medical condition, developmental and behavioral status, attendant risks of treatment, and of the right to refuse treatment;
(3) Allow and encourage individual clients to exercise their rights as clients of the facility, and as citizens of the United States, including the right to file complaints, and the right to due process;
(4) Allow individual clients to manage their financial affairs and teach them to do so to the extent of their capabilities;
(5) Ensure that clients are not subjected to physical, verbal, sexual or psychological abuse or punishment;
(6) Ensure that clients are free from unnecessary drugs and physical restraints and are provided active treatment to reduce dependency on drugs and physical restraints;
(7) Provide each client with the opportunity for personal privacy and ensure privacy during treatment and care of personal needs;
(8) Ensure that clients are not compelled to perform services for the facility and ensure that clients who do work for the facility are compensated for their efforts at prevailing wages and commensurate with their abilities;
(9) Ensure clients the opportunity to communicate, associate and meet privately with individuals of their choice, and to send and receive unopened mail;
(10) Ensure that clients have access to telephones with privacy for incoming and outgoing local and long distance calls except as contraindicated by factors identified within their individual program plans;
(11) Ensure clients the opportunity to participate in social, religious, and community group activities;
(12) Ensure that clients have the right to retain and use appropriate personal possessions and clothing, and ensure that each client is dressed in his or her own clothing each day; and
(13) Permit a husband and wife who both reside in the facility to share a room.
(b) Standard: Client finances. (1) The facility must establish and maintain a system that—
(i) Assures a full and complete accounting of clients' personal funds entrusted to the facility on behalf of clients; and
(ii) Precludes any commingling of client funds with facility funds or with the funds of any person other than another client.
(2) The client's financial record must be available on request to the client, parents (if the client is a minor) or legal guardian.
(c) Standard: Communication with clients, parents, and guardians. The facility must—
(1) Promote participation of parents (if the client is a minor) and legal guardians in the process of providing active treatment to a client unless their participation is unobtainable or inappropriate;
(2) Answer communications from clients' families and friends promptly and appropriately;
(3) Promote visits by individuals with a relationship to the client (such as family, close friends, legal guardians and advocates) at any reasonable hour, without prior notice, consistent with 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.
§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.
(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 §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 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.
§483.440 Condition of participation: Active treatment services.
(a) Standard: Active treatment. (1) Each client must receive a continuous active treatment program, which includes aggressive, consistent implementation of a program of specialized and generic training, treatment, health services and related services described in this subpart, that is directed toward—
(i) The acquisition of the behaviors necessary for the client to function with as much self determination and independence as possible; and
(ii) The prevention or deceleration of regression or loss of current optimal functional status.
(2) Active treatment does not include services to maintain generally independent clients who are able to function with little supervision or in the absence of a continuous active treatment program.
(b) Standard: Admissions, transfers, and discharge. (1) Clients who are admitted by the facility must be in need of and receiving active treatment services.
(2) Admission decisions must be based on a preliminary evaluation of the client that is conducted or updated by the facility or by outside sources.
(3) A preliminary evaluation must contain background information as well as currently valid assessments of functional developmental, behavioral, social, health and nutritional status to determine if the facility can provide for the client's needs and if the client is likely to benefit from placement in the facility.
(4) If a client is to be either transferred or discharged, the facility must—
(i) Have documentation in the client's record that the client was transferred or discharged for good cause; and
(ii) Provide a reasonable time to prepare the client and his or her parents or guardian for the transfer or discharge (except in emergencies).
(5) At the time of the discharge, the facility must—
(i) Develop a final summary of the client's developmental, behavioral, social, health and nutritional status and, with the consent of the client, parents (if the client is a minor) or legal guardian, provide a copy to authorized persons and agencies; and
(ii) Provide a post-discharge plan of care that will assist the client to adjust to the new living environment.
(c) Standard: Individual program plan. (1) Each client must have an individual program plan developed by an interdisciplinary team that represents the professions, disciplines or service areas that are relevant to—
(i) Identifying the client's needs, as described by the comprehensive functional assessments required in paragraph (c)(3) of this section; and
(ii) Designing programs that meet the client's needs.
(2) Appropriate facility staff must participate in interdisciplinary team meetings. Participation by other agencies serving the client is encouraged. Participation by the client, his or her parent (if the client is a minor), or the client's legal guardian is required unless that participation is unobtainable or inappropriate.
(3) Within 30 days after admission, the interdisciplinary team must perform accurate assessments or reassessments as needed to supplement the preliminary evaluation conducted prior to admission. The comprehensive functional assessment must take into consideration the client's age (for example, child, young adult, elderly person) and the implications for active treatment at each stage, as applicable, and must—
(i) Identify the presenting problems and disabilities and where possible, their causes;
(ii) Identify the client's specific developmental strengths;
(iii) Identify the client's specific developmental and behavioral management needs;
(iv) Identify the client's need for services without regard to the actual availability of the services needed; and
(v) Include physical development and health, nutritional status, sensorimotor development, affective development, speech and language development and auditory functioning, cognitive development, social development, adaptive behaviors or independent living skills necessary for the client to be able to function in the community, and as applicable, vocational skills.
(4) Within 30 days after admission, the interdisciplinary team must prepare for each client an individual program plan that states the specific objectives necessary to meet the client's needs, as identified by the comprehensive assessment required by paragraph (c)(3) of this section, and the planned sequence for dealing with those objectives. These objectives must—
(i) Be stated separately, in terms of a single behavioral outcome;
(ii) Be assigned projected completion dates;
(iii) Be expressed in behavioral terms that provide measurable indices of performance;
(iv) Be organized to reflect a developmental progression appropriate to the individual; and
(v) Be assigned priorities.
(5) Each written training program designed to implement the objectives in the individual program plan must specify:
(i) The methods to be used;
(ii) The schedule for use of the method;
(iii) The person responsible for the program;
(iv) The type of data and frequency of data collection necessary to be able to assess progress toward the desired objectives;
(v) The inappropriate client behavior(s), if applicable; and
(vi) Provision for the appropriate expression of behavior and the replacement of inappropriate behavior, if applicable, with behavior that is adaptive or appropriate.
(6) The individual program plan must also:
(i) Describe relevant interventions to support the individual toward independence.
(ii) Identify the location where program strategy information (which must be accessible to any person responsible for implementation) can be found.
(iii) Include, for those clients who lack them, training in personal skills essential for privacy and independence (including, but not limited to, toilet training, personal hygiene, dental hygiene, self-feeding, bathing, dressing, grooming, and communication of basic needs), until it has been demonstrated that the client is developmentally incapable of acquiring them.
(iv) Identify mechanical supports, if needed, to achieve proper body position, balance, or alignment. The plan must specify the reason for each support, the situations in which each is to be applied, and a schedule for the use of each support.
(v) Provide that clients who have multiple disabling conditions spend a major portion of each waking day out of bed and outside the bedroom area, moving about by various methods and devices whenever possible.
(vi) Include opportunities for client choice and self-management.
(7) A copy of each client's individual program plan must be made available to all relevant staff, including staff of other agencies who work with the client, and to the client, parents (if the client is a minor) or legal guardian.
(d) Standard: Program implementation. (1) As soon as the interdisciplinary team has formulated a client's individual program plan, each client must receive a continuous active treatment program consisting of needed interventions and services in sufficient number 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.
(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.
§483.450 Condition of participation: Client behavior and facility practices.
(a) Standard: Facility practices—Conduct toward clients. (1) The facility must develop and implement written policies and procedures for the management of conduct between staff and clients. These policies and procedures must—
(i) Promote the growth, development and independence of the client;
(ii) Address the extent to which client choice will be accommodated in daily decision-making, emphasizing self-determination and self-management, to the extent possible;
(iii) Specify client conduct to be allowed or not allowed; and
(iv) Be available to all staff, clients, parents of minor children, and legal guardians.
(2) To the extent possible, clients must participate in the formulation of these policies and procedures.
(3) Clients must not discipline other clients, except as part of an organized system of self-government, as set forth in facility policy.
(b) Standard: Management of inappropriate client behavior. (1) The facility must develop and implement written policies and procedures that govern the management of inappropriate client behavior. These policies and procedures must be consistent with the provisions of paragraph (a) of this section. These procedures must—
(i) Specify all facility approved interventions to manage inappropriate client behavior;
(ii) Designate these interventions on a hierarchy to be implemented, ranging from most positive or least intrusive, to least positive or most intrusive;
(iii) Insure, prior to the use of more restrictive techniques, that the client's record documents that programs incorporating the use of less intrusive or more positive techniques have been tried systematically and demonstrated to be ineffective; and
(iv) Address the following:
(A) The use of time-out rooms.
(B) The use of physical restraints.
(C) The use of drugs to manage inappropriate behavior.
(D) The application of painful or noxious stimuli.
(E) The staff members who may authorize the use of specified interventions.
(F) A mechanism for monitoring and controlling the use of such interventions.
(2) Interventions to manage inappropriate client behavior must be employed with sufficient safeguards and supervision to ensure that the safety, welfare and civil and human rights of clients are adequately protected.
(3) Techniques to manage inappropriate client behavior must never be used for disciplinary purposes, for the convenience of staff or as a substitute for an active treatment program.
(4) The use of systematic interventions to manage inappropriate client behavior must be incorporated into the client's individual program plan, in accordance with §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 §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.
§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 §456.380 of this chapter that specified plan of care requirements for ICFs; and
(2) If appropriate, physicians must participate in the review and update of an individual program plan as part of the interdisciplinary team process either in person or through written report to the interdisciplinary team.
(c) Standard: Nursing services. The facility must provide clients with nursing services in accordance with their needs. These services must include—
(1) Participation as appropriate in the development, review, and update of an individual program plan as part of the interdisciplinary team process;
(2) The development, with a physician, of a medical care plan of treatment for a client when the physician has determined that an individual client requires such a plan;
(3) For those clients certified as not needing a medical care plan, a review of their health status which must—
(i) Be by a direct physical examination;
(ii) Be by a licensed nurse;
(iii) Be on a quarterly or more frequent basis depending on client need;
(iv) Be recorded in the client's record; and
(v) Result in any necessary action (including referral to a physician to address client health problems).
(4) Other nursing care as prescribed by the physician or as identified by client needs; and
(5) Implementing, with other members of the interdisciplinary team, appropriate protective and preventive health measures that include, but are not limited to—
(i) Training clients and staff as needed in appropriate health and hygiene methods;
(ii) Control of communicable diseases and infections, including the instruction of other personnel in methods of infection control; and
(iii) Training direct care staff in detecting signs and symptoms of illness or dysfunction, first aid for accidents or illness, and basic skills required to meet the health needs of the clients.
(d) Standard: Nursing staff. (1) Nurses providing services in the facility must have a current license to practice in the State.
(2) The facility must employ or arrange for licensed nursing services sufficient to care for clients health needs including those clients with medical care plans.
(3) The facility must utilize registered nurses as appropriate and required by State law to perform the health services specified in this section.
(4) If the facility utilizes only licensed practical or vocational nurses to provide health services, it must have a formal arrangement with a registered nurse to be available for verbal or onsite consultation to the licensed practical or vocational nurse.
(5) Non-licensed nursing personnel who work with clients under a medical care plan must do so under the supervision of licensed persons.
(e) Standard: Dental services. (1) The facility must provide or make arrangements for comprehensive diagnostic and treatment services for each client from qualified personnel, including licensed dentists and dental hygienists either through organized dental services in-house or through arrangement.
(2) If appropriate, dental professionals must participate, in the development, review and update of an individual program plan as part of the interdisciplinary process either in person or through written report to the interdisciplinary team.
(3) The facility must provide education and training in the maintenance of oral health.
(f) Standard: Comprehensive dental diagnostic services. Comprehensive dental diagnostic services include—
(1) A complete extraoral and intraoral examination, using all diagnostic aids necessary to properly evaluate the client's oral condition, not later than one month after admission to the facility (unless the examination was completed within twelve months before admission);
(2) Periodic examination and diagnosis performed at least annually, including radiographs when indicated and detection of manifestations of systemic disease; and
(3) A review of the results of examination and entry of the results in the client's dental record.
(g) Standard: Comprehensive dental treatment. The facility must ensure comprehensive dental treatment services that include—
(1) The availability for emergency dental treatment on a 24-hour-a-day basis by a licensed dentist; and
(2) Dental care needed for relief of pain and infections, restoration of teeth, and maintenance of dental health.
(h) Standard: Documentation of dental services. (1) If the facility maintains an in-house dental service, the facility must keep a permanent dental record for each client, with a dental summary maintained in the client's living unit.
(2) If the facility does not maintain an in-house dental service, the facility must obtain a dental summary of the results of dental visits and maintain the summary in the client's living unit.
(i) Standard: Pharmacy services. The facility must provide or make arrangements for the provision of routine and emergency drugs and biologicals to its clients. Drugs and biologicals may be obtained from community or contract pharmacists or the facility may maintain a licensed pharmacy.
(j) Standard: Drug regimen review. (1) A pharmacist with input from the interdisciplinary team must review the drug regimen of each client at least quarterly.
(2) The pharmacist must report any irregularities in clients' drug regimens to the prescribing physician and interdisciplinary team.
(3) The pharmacist must prepare a record of each client's drug regimen reviews and the facility must maintain that record.
(4) An individual medication administration record must be maintained for each client.
(5) As appropriate the pharmacist must participate in the development, implementation, and review of each client's individual program plan either in person or through written report to the interdisciplinary team.
(k) Standard: Drug administration. The facility must have an organized system for drug administration that identifies each drug up to the point of administration. The system must assure that—
(1) All drugs are administered in compliance with the physician's orders;
(2) All drugs, including those that are self-administered, are administered without error;
(3) Unlicensed personnel are allowed to administer drugs only if State law permits;
(4) Clients are taught how to administer their own medications if the interdisciplinary team determines that self administration of medications is an appropriate objective, and if the physician does not specify otherwise;
(5) The client's physician is informed of the interdisciplinary team's decision that self-administration of medications is an objective for the client;
(6) No client self-administers medications until he or she demonstrates the competency to do so;
(7) Drugs used by clients while not under the direct care of the facility are packaged and labeled in accordance with State law; and
(8) Drug administration errors and adverse drug reactions are recorded and reported immediately to a physician.
(l) Standard: Drug storage and recordkeeping. (1) The facility must store drugs under proper conditions of sanitation, temperature, light, humidity, and security.
(2) The facility must keep all drugs and biologicals locked except when being prepared for administration. Only authorized persons may have access to the keys to the drug storage area. Clients who have been trained to self administer drugs in accordance with §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]
§483.470 Condition of participation: Physical environment.
(a) Standard: Client living environment. (1) The facility must not house clients of grossly different ages, developmental levels, and social needs in close physical or social proximity unless the housing is planned to promote the growth and development of all those housed together.
(2) The facility must not segregate clients solely on the basis of their physical disabilities. It must integrate clients who have ambulation deficits or who are deaf, blind, or have seizure disorders, etc., with others of comparable social and intellectual development.
(b) Standard: Client bedrooms. (1) Bedrooms must—
(i) Be rooms that have at least one outside wall;
(ii) Be equipped with or located near toilet and bathing facilities;
(iii) Accommodate no more than four clients unless granted a variance under paragraph (b)(3) of this section;
(iv) Measure at least 60 square feet per client in multiple client bedrooms and at least 80 square feet in single client bedrooms; and
(v) In all facilities initially certified, or in buildings constructed or with major renovations or conversions on or after October 3, 1988, have walls that extend from floor to ceiling.
(2) If a bedroom is below grade level, it must have a window that—
(i) Is usable as a second means of escape by the client(s) occupying the room; and
(ii) Is no more than 44 inches (measured to the window sill) above the floor unless the facility is surveyed under the Health Care Occupancy Chapter of the Life Safety Code, in which case the window must be no more than 36 inches (measured to the window sill) above the floor.
(3) The survey agency may grant a variance from the limit of four clients per room only if a physician who is a member of the interdisciplinary team and who is a qualified 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 °Fahrenheit.
(e) Standard: Heating and ventilation. (1) Each client bedroom in the facility must have—
(i) At least one window to the outside; and
(ii) Direct outside ventilation by means of windows, air conditioning, or mechanical ventilation.
(2) The facility must—
(i) Maintain the temperature and humidity within a normal comfort range by heating, air conditioning or other means; and
(ii) Ensure that the heating apparatus does not constitute a burn or smoke hazard to clients.
(f) Standard: Floors. The facility must have—
(1) Floors that have a resilient, nonabrasive, and slip-resistant surface;
(2) Nonabrasive carpeting, if the area used by clients is carpeted and serves clients who lie on the floor or ambulate with parts of their bodies, other than feet, touching the floor; and
(3) Exposed floor surfaces and floor coverings that promote mobility in areas used by clients, and promote maintenance of sanitary conditions.
(g) Standard: Space and equipment. The facility must—
(1) Provide sufficient space and equipment in dining, living, health services, recreation, and program areas (including adequately equipped and sound treated areas for hearing and other evaluations if they are conducted in the facility) to enable staff to provide clients with needed services as required by this subpart and as identified in each client's individual program plan.
(2) Furnish, maintain in good repair, and teach clients to use and to make informed choices about the use of dentures, eyeglasses, hearing and other communications aids, braces, and other devices identified by the interdisciplinary team as needed by the client.
(3) Provide adequate clean linen and dirty linen storage areas.
(h) Standard: Emergency plan and procedures. (1) The facility must develop and implement detailed written plans and procedures to meet all potential emergencies and disasters such as fire, severe weather, and missing clients.
(2) The facility must communicate, periodically review, make the plan available, and provide training to the staff.
(i) Standard: Evacuation drills. (1) The facility must hold evacuation drills at least quarterly for each shift of personnel and under varied conditions to—
(i) Ensure that all personnel on all shifts are trained to perform assigned tasks;
(ii) Ensure that all personnel on all shifts are familiar with the use of the facility's fire protection features; and
(iii) Evaluate the effectiveness of emergency and disaster plans and procedures.
(2) The facility must—
(i) Actually evacuate clients during at least one drill each year on each shift;
(ii) Make special provisions for the evacuation of clients with physical disabilities;
(iii) File a report and evaluation on each evacuation drill;
(iv) Investigate all problems with evacuation drills, including accidents, and take corrective action; and
(v) During fire drills, clients may be evacuated to a safe area in facilities certified under the Health Care Occupancies Chapter of the Life Safety Code.
(3) Facilities must meet the requirements of paragraphs (i)(1) and (2) of this section for any live-in and relief staff they utilize.
(j) Standard: Fire protection—(1) General. Except as otherwise provided in this section—
(i) The facility must meet the applicable provisions of either the Health Care Occupancies Chapters or the Residential Board and Care Occupancies Chapter of the 2000 edition of the Life Safety Code of the National Fire Protection Association. The Director of the Office of the Federal Register has approved the NFPA 101® 2000 edition of the Life Safety Code, issued January 14, 2000, for incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy of the Code is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Copies may be obtained from the National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02269. If any changes in this edition of the Code are incorporated by reference, CMS will publish notice in the Federal Register to announce the changes.
(ii) Chapter 184.108.40.206.2, exception number 2 of the adopted LSC does not apply to a facility.
(2) The State survey agency may apply a single chapter of the LSC to the entire facility or may apply different chapters to different buildings or parts of buildings as permitted by the LSC.
(3) A facility that meets the LSC definition of a residential board and care occupancy must have its evacuation capability evaluated in accordance with the Evacuation Difficulty Index of the Fire Safety Evaluation System for Board and Care facilities (FSES/BC).
(4) If CMS finds that the State has a fire and safety code imposed by State law that adequately protects a facility's clients, CMS may allow the State survey agency to apply the State's fire and safety code instead of the LSC.
(5) Beginning March 13, 2006, a facility must be in compliance with Chapter 19.2.9, Emergency Lighting.
(6) Beginning March 13, 2006, Chapter 220.127.116.11.2, exception number 2 does not apply to a facility.
(7) Facilities that meet the LSC definition of a health care occupancy. (i) After consideration of State survey agency recommendations, CMS may waive, for appropriate periods, specific provisions of the Life Safety Code if the following requirements are met:
(A) The waiver would not adversely affect the health and safety of the clients.
(B) Rigid application of specific provisions would result in an unreasonable hardship for the facility.
(ii) Notwithstanding any provisions of the 2000 edition of the Life Safety Code to the contrary, a facility may install alcohol-based hand rub dispensers if—
(A) Use of alcohol-based hand rub dispensers does not conflict with any State or local codes that prohibit or otherwise restrict the placement of alcohol-based hand rub dispensers in health care facilities;
(B) The dispensers are installed in a manner that minimizes leaks and spills that could lead to falls;
(C) The dispensers are installed in a manner that adequately protects against inappropriate access;
(D) The dispensers are installed in accordance with chapter 18.104.22.168 or chapter 22.214.171.124 of the 2000 edition of the Life Safety Code, as amended by NFPA Temporary Interim Amendment 00-1(101), issued by the Standards Council of the National Fire Protection Association on April 15, 2004. The Director of the Office of the Federal Register has approved NFPA Temporary Interim Amendment 00-1(101) for incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy of the amendment is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD and at the Office of the Federal Register, 800 North Capitol Street NW., Suite 700, Washington, DC. Copies may be obtained from the National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02269; and
(E) The dispensers are maintained in accordance with dispenser manufacturer guidelines.
(k) Standard: Paint. The facility must—
(1) Use lead-free paint inside the facility; and
(2) Remove or cover interior paint or plaster containing lead so that it is not accessible to clients.
(l) Standard: Infection control. (1) The facility must provide a sanitary environment to avoid sources and transmission of infections. There must be an active program for the prevention, control, and investigation of infection and communicable diseases.
(2) The facility must implement successful corrective action in affected problem areas.
(3) The facility must maintain a record of incidents and corrective actions related to infections.
(4) The facility must prohibit employees with symptoms or signs of a communicable disease from direct contact with clients and their food.
[53 FR 20496, June 3, 1988. Redesignated at 56 FR 48918, Sept. 26, 1991, as amended at 68 FR 1387, Jan. 10, 2003; 69 FR 49271, Aug. 11, 2004; 70 FR 15239, Mar. 25, 2005; 71 FR 55340, Sept. 22, 2006]
§483.480 Condition of participation: Dietetic services.
(a) Standard: Food and nutrition services. (1) Each client must receive a nourishing, well-balanced diet including modified and specially-prescribed diets.
(2) A qualified dietitian must be employed either full-time, part-time, or on a consultant basis at the facility's discretion.
(3) If a qualified dietitian is not employed full-time, the facility must designate a person to serve as the director of food services.
(4) The client's interdisciplinary team, including a qualified dietitian and physician, must prescribe all modified and special diets including those used as a part of a program to manage inappropriate client behavior.
(5) Foods proposed for use as a primary reinforcement of adaptive behavior are evaluated in light of the client's nutritional status and needs.
(6) Unless otherwise specified by medical needs, the diet must be prepared at least in accordance with the latest edition of the recommended dietary allowances of the Food and Nutrition Board of the National Research Council, National Academy of Sciences, adjusted for age, sex, disability and activity.
(b) Standard: Meal services. (1) Each client must receive at least three meals daily, at regular times comparable to normal mealtimes in the community with—
(i) Not more than 14 hours between a substantial evening meal and breakfast of the following day, except on weekends and holidays when a nourishing snack is provided at bedtime, 16 hours may elapse between a substantial evening meal and breakfast; and
(ii) Not less than 10 hours between breakfast and the evening meal of the same day, except as provided under paragraph (b)(1)(i) of this section.
(2) Food must be served—
(i) In appropriate quantity;
(ii) At appropriate temperature;
(iii) In a form consistent with the developmental level of the client; and
(iv) With appropriate utensils.
(3) Food served to clients individually and uneaten must be discarded.
(c) Standard: Menus. (1) Menus must—
(i) Be prepared in advance;
(ii) Provide a variety of foods at each meal;
(iii) Be different for the same days of each week and adjusted for seasonal changes; and
(iv) Include the average portion sizes for menu items.
(2) Menus for food actually served must be kept on file for 30 days.
(d) Standard: Dining areas and service. The facility must—
(1) Serve meals for all clients, including persons with ambulation deficits, in dining areas, unless otherwise specified by the interdisciplinary team or a physician;
(2) Provide table service for all clients who can and will eat at a table, including clients in wheelchairs;
(3) Equip areas with tables, chairs, eating utensils, and dishes designed to meet the developmental needs of each client;
(4) Supervise and staff dining rooms adequately to direct self-help dining procedure, to assure that each client receives enough food and to assure that each client eats in a manner consistent with his or her developmental level: and
(5) Ensure that each client eats in an upright position, unless otherwise specified by the interdisciplinary team or a physician.