1. Condition Of Participation—Compliance With Federal, State, And Local Laws.

The skilled nursing facility is in compliance with applicable Federal, State, and local laws and regulations.

(a)

Standard: Licensure. The facility, in any State in which State or applicable local law provides for licensing of facilities of this nature:

(1)

Is licensed pursuant to such law; or

(2)

If not subject to licensure, is approved by the agency of the State or locality responsible for licensing skilled nursing facilities as meeting fully the standards established for such licensing, and

(3)

Except that a facility which formerly met fully such licensure requirements, but is currently determined not to meet fully all such requirements, may be recognized for a period specified by the State standard-setting authority.

(b)

Standard: Licensure or registration of personnel. Staff of the facility are licensed or registered in accordance with applicable laws.

(c)

Standard: Conformity with other Federal, State, and local laws. The facility is in conformity with all Federal, State, and local laws relating to fire and safety, sanitation, communicable and reportable diseases, postmortem procedures, and other relevant health and safety requirements.

2. Condition Of Participation—Governing Body And Management.

The skilled nursing facility has an effective governing body, or designated persons so functioning, with full legal authority and responsibility for the operation of the facility. The governing body adopts and enforces rules and regulations relative to health care and safety of patients, to the protection of their personal and property rights, and to the general operation of the facility.

(a)

Standard: Disclosure of ownership. The facility complies with the disclosure requirements of 42 CFR 420.206

(b)

Standard: Staffing patterns. The facility furnishes to the State survey agency information from payroll records setting forth the average numbers and types of personnel (in full-time equivalents) on each tour of duty during at least 1 week of each quarter. Such week will be selected by the survey agency.

(c)

Standard: Bylaws. The governing body adopts effective patient care policies and administrative policies and bylaws governing the operation of the facility, in accordance with legal requirements. Such policies and bylaws are in writing, dated, and made available to all members of the governing body which ensures that they are operational, and reviews and revises them as necessary.

(d)

Standard: Independent medical evaluation (medical review). The governing body adopts policies to ensure that the facility cooperates in an effective program which provides for a regular program of independent medical evaluation and audit of the patients in the facility to the extent required by the programs in which the facility participates (including, at least annually, medical evaluation of each patient's need for skilled nursing facility care).

(e)

Standard: Administrator. The governing body appoints a qualified administrator who is responsible for the overall management of the facility, enforces the rules and regulations relative to the level of health care and safety of patients, and to the protection of their personal rights, and plans, organizes, and directs those responsibilities delegated to him by the governing body. Through meetings and periodic reports, the administrator maintains ongoing liaison among the governing body, medical and nursing staffs, and other professional and supervisory staff of the facility, and studies and acts upon recommendations made by the utilization review and other committees. In the absence of the administrator, an employee is authorized, in writing, to act on his behalf.

(f)

Standard: Institutional planning. The skilled nursing facility, under the direction of the governing body, prepares an overall plan and budget which provides for an annual operating budget and a capital expenditure plan.

(1)

Annual operating budget. There is an annual operating budget which includes all anticipated income and expenses related to items which would, under generally accepted accounting principles, be considered income and expense items (except that it is not required that there be prepared, in connection with any budget, an item by item identification of the components of each type of anticipated income or expense).

(2)

Capital expenditure plan. (i) There is a capital expenditure plan for at least a 3-year period (including the year to which the operating budget described in paragraph (f)(1) of this section is applicable), which includes and identifies in detail the anticipated sources of financing for, and the objectives of, each anticipated expenditure in excess of $100,000 for items which would, under generally accepted accounting principles, be considered capital items. In determining if a single capital expenditure exceeds $100,000, the cost of studies, surveys, designs, plans, working drawings, specifications and other activities essential to the acquisition, improvement, modernization, expansion, or replacement of land, plant, building, and equipment are included. Expenditures directly or indirectly related to capital expenditures, such as grading, paving, broker commissions, taxes assessed during the construction period, and costs involved in demolishing or razing structures on land are also included. Transactions which are separated in time but are components of an overall plan or patient care objective are viewed in their entirety without regard to their timing. Other costs related to capital expenditures include title fees, broker commissions, architect, legal, accounting, and appraisal fees; interest, finance, or carrying charges on bonds, notes and other costs incurred for borrowing funds. (ii) If the anticipated source of such financing is, in any part, the anticipated reimbursement from title V (Maternal and Child Health and Crippled Children's Services) or title XVIII (Health Insurance for the Aged and Disabled) or title XIX (Grants to States for Medical Assistance Programs) of the Social Security Act, the plan states: (a) Whether the proposed capital expenditure is required to conform, or is likely to be required to conform, to current standards, criteria, or plans developed pursuant to the Public Health Service Act of the Mental Retardation Facilities and Community Mental Health Centers Construction Act of 1963, to meet the need for adequate health care facilities in the area covered by the plan or plans so developed; (b) Whether a capital expenditure proposal has been submitted to the designated planning agency for approval pursuant to section 1122 of the Social Security Act (42 U.S.C. 1320a-1) and implementing regulations; (c) Whether the designated planning agency has approved or disapproved the proposed capital expenditure if it has been so presented.

(3)

Preparation of plan and budget. The overall plan and budget is prepared under the direction of the governing body of the skilled nursing facility by a committee consisting of representatives of the governing body, the administrative staff, and the medical staff (or chief medical officer, or patient care policies advisory group as described in 405.1122(a)) of the skilled nursing facility.

(4)

Annual review of plan and budget. The overall plan and budget is reviewed and updated at least annually by the committee referred to in paragraph (f)(3) of this section under the direction of the governing body of the skilled nursing facility.

(g)

Standard: Personnel policies and procedures. The governing body, through the administrator, is responsible for implementing and maintaining written personnel policies and procedures that support sound patient care and personnel practices. Personnel records are current and available for each employee and contain sufficient information to support placement in the position to which assigned. Written policies for control of communicable disease are in effect to ensure that employees with symptoms or signs of communicable disease or infected skin lesions are not permitted to work, and that a safe and sanitary environment for patients and personnel exists and incidents and accidents to patients and personnel are reviewed to identify health and safety hazards. Employees are provided, or referred for, periodic health examinations, to ensure freedom from communicable disease.

(h)

Standard: Staff development. An ongoing educational program is planned and conducted for the development and improvement of skills of all the facility's personnel, including training related to problems and needs of the aged, ill, and disabled. Each employee receives appropriate orientation to the facility and its policies, and to his position and duties. Inservice training includes at least prevention and control of infections, fire prevention and safety, accident prevention, confidentiality of patient information, and preservation of patient dignity, including protection of his privacy and personal and property rights. Records are maintained which indicate the content of, and attendance at, such staff development programs.

(i)

Standard: Use of outside resources. If the facility does not employ a qualified professional person to render a specific service to be provided by the facility, it makes arrangements to have such a service provided by an outside resource—a person or agency that will render direct service to patients or act as a consultant to the facility. The responsibilities, functions, and objectives, and the terms of agreement, including financial arrangements and charges, of each such outside resource are delineated in writing and signed by an authorized representative of the facility and the person or agency providing the service. Agreements pertaining to services must specify that the facility assumes professional and administrative responsibility for the services rendered. The outside resource, when acting as a consultant, appraises the administrator of recommendations, plans for implementation, and continuing assessment through dated, signed reports, which are retained by the administrator for followup action and evaluation of performance. (See requirement under each service—405.1125 through 405.1132.)

(j)

Standard: Notification of changes in patient status. The facility has appropriate written policies and procedures relating to notification of the patient's attending physician and other responsible persons in the · event of an accident involving the patient, or other significant change in the patient's physical, mental, or emotional status, or patient charges, billings, and related administrative matters. Except in a medical emergency, a patient is not transferred or discharged, nor is treatment altered radically, without consultation with the patient or, if he is incompetent, without prior notification of next of kin or sponsor.

(k)

Standard: Patients' rights. The governing body of the facility establishes written policies regarding the rights and responsibilities of patients and, through the administrator, is responsible for development of, and adherence to, procedures implementing such policies. These policies and procedures are made available to patients, to any guardians, next of kin, sponsoring agency(ies), or representative payees selected pursuant to section 205(j) of the Social Security Act, and Subpart Q of 20 CFR Part 404, and to the public. The staff of the facility is trained and involved in the implementation of these policies and procedures. These patients' rights policies and procedures ensure that, at least, each patient admitted to the facility:

(1)

Is fully informed, as evidenced by the patient's written acknowledgment, prior to or at the time of admission and during stay, of these rights and of all rules and regulations governing patient conduct and responsibilities;

(2)

Is fully informed, prior to or at the time of admission and during stay, of services available in the facility, and of related charges including any charges for services not covered under titles XVIII or XIX of the Social Security Act, or not covered by the facility's basic per diem rate;

(3)

Is fully informed, by a physician, of his medical condition unless medically contraindicated (as documented, by a physician, in his medical record), and is afforded the opportunity to participate in the planning of his medical treatment and to refuse to participate in experimental research;

(4)

Is transferred or discharged only for medical reasons, or for his welfare or that of other patients, or for nonpayment of his stay (except as prohibited by titles XVIII or XIX or the Social Security Act), and is given reasonable advance notice to ensure orderly transfer or discharge, and such actions are documented in his medical record;

(5)

Is encouraged and assisted, throughout his period of stay, to exercise his rights as a patient and as a citizen, and to this end may voice grievances and recommend changes in policies and services to facility staff and/or to outside representatives of his choice, free from restraint, interference, coercion, discrimination, or reprisal;

(6)

May manage his or her personal financial affairs, may designate another person to manage them, or may authorize the facility, in writing, to hold, safeguard, and account for his or her personal funds in accordance with paragraph (m) of this section. In the event that the Social Security Administration has determined that a Title II or Title XVI (SSI) benefit to which the patient is entitled should be paid through a representative payee, the provisions in 20 CFR 404.1601 through 404.1610 (for OASDI benefits) and 20 CFR 416.601 through 416.690 (for SSI benefits) apply;

(7)

Is free from mental and physical abuse, and free from chemical and (except in emergencies) physical restraints except as authorized in writing by a physician for a specified and limited period of time, or when necessary to protect the patient from injury to himself or to others;

(8)

Is assured confidential treatment of his personal and medical records, and may approve or refuse their release to any individual outside the facility, except, in case of his transfer to another health care institution, or as required by law or third-party payment contract;

(9)

Is treated with consideration, respect, and full recognition of his dignity and individuality, including privacy in treatment and in care for his personal needs;

(10)

Is not required to perform services for the facility that are not included for therapeutic purposes in his plan of care;

(11)

May associate and communicate privately with persons of his choice, and send and receive his personal mail unopened, unless medically contraindicated (as documented by his physician in his medical record);

(12)

May meet with, and participate in activities of, social, religious, and community groups at his discretion, unless medically contraindicated (as documented by his physician in his medical record);

(13)

May retain and use his personal clothing and possessions as space permits, unless to do so would infringe upon rights of other patients, and unless medically contraindicated (as documented by his physician in his medical record); and

(14)

If married, is assured privacy for visits by his/her spouse; if both are inpatients in the facility, they are permitted to share a room, unless medically contraindicated (as documented by the attending physician in the medical record).

All rights and responsibilities specified in paragraphs (k)(1) through (4) of this section—as they pertain to (i) a patient adjudicated incompetent in accordance with State law, (ii) a patient who is found, by his physician, to be medically incapable of understanding these rights, or (iii) a patient who exhibits a communication barrier—devolve to such patient's guardian, next of kin, sponsoring agency(ies), or representative payee (except when the facility itself is representative payee) selected pursuant to section 205(j) of the Social Security Act and Subpart Q of 20 CFR Part 404.

(l)

Standard: Patient care policies. The skilled nursing facility has written patient care policies to govern the continuing skilled nursing care and related medical or other services provided.

(1)

The facility has policies, which are developed by the medical director or the organized medical staff (see 405.1122), with the advice of (and with provision for review of such policies from time to time, but at least annually, by a group of professional personnel including one or more physicians and one or more registered nurses, to govern the skilled nursing care and related medical or other services it provides. The policies, which are available to admitting physicians, sponsoring agencies, patients, and the public, reflect awareness of, and provision for, meeting the total medical and psychosocial needs of patients, including admission, transfer, and discharge planning; and the range of services available to patients, including frequency of physician visits by each category of patients admitted. These policies also include provisions to protect patients' personal and property rights. Medical records and minutes of staff and committee meetings reflect that patient care is being rendered in accordance with the written patient care policies, and that utilization review committee recommendations regarding the policies are reviewed and necessary steps taken to ensure compliance.

(2)

The medical director or a registered nurse is designated, in writing, to be responsible for the execution of patient care policies. If the responsibility for day-to-day execution of patient care policies has been delegated to a registered nurse, the medical director serves as the advisory physician from whom she receives medical guidance. (See 405.1122(b).)

(m)

Standard protection of patients' funds.

(1)

Definition: Representative. ''Representative'' as used in this paragraph is a patient's legal guardian, conservator, or representative payee as designated by the Social Security Administration, or person designated in writing by the patient to manage his or her personal funds.

(2)

Statement provided at time of administration. The facility must provide each patient and representative with a written statement, at the time of admission, that: (i) Lists all services provided by the facility, distinguishing between those services included in the facility's basic rate and those services not included in the facility's basic rate, that can be charged to the patient's personal funds; (ii) States that there is no obligation for the patient to deposit funds with the facility; (iii) Describes the patient's right to select how personal funds will be handled. The following alternatives must be included: (A) The patient's right to receive, retain and manage his or her personal funds or have this done by a legal guardian, if any; (B) The patient's right to apply to the Social Security Administration to have a representative payee designated for purposes of Federal or State benefits to which he or she may be entitled; (C) Except when paragraph (B) of this section applies, the patient's right to designate, in writing, another person to act for the purpose of managing his or her personal funds; and (D) The facility's obligation, upon written authorization by the patient, to hold, safeguard, and account for the patient's personal funds in accordance with this paragraph. (iv) States that any charge for this service is included in the facility's basic rate. (v) States that the facility is permitted to accept a patient's funds to hold, safeguard, and account for, only upon the written authorization of the patient or representative, or if the facility is appointed as the patient's representative payee; (vi) States that, if the patient becomes incapable of managing his or her personal funds and does not have a representative, the facility is required to arrange for the management of his or her personal funds in accordance with paragraph (m)(14) of this section.

(3)

Basic requirements. The facility must, upon written authorization by the patient, accept responsibility for holding, safeguarding and accounting for the patient's personal funds. The facility may make arrangements with a Federally or State insured banking institution to provide these services but the responsibility for the quality and accuracy of compliance with the requirements of paragraph (m)(4) through (m)(13) of this section remains with the facility.

The facility may not charge the patient for these services, but must include any charges in the facility's basic daily rate.

(4)

Individual records. The facility must maintain current, written, individual records of all financial transactions involving patients' personal funds which the facility has been given for holding, safeguarding, and accounting. The facility must keep these records in accordance with the American Institute of Certified Public Accountants' Generally Accepted Accounting Standards, and the records must include at least the following: (i) Patient's name; (ii) Identification of patient's representative, if any; (iii) Admission date; (iv) Date and amount of each deposit and withdrawal, the name of the person who accepted the withdrawn funds, and the balance after each transaction; (v) Receipts indicating the purpose for which any withdrawn funds were spent; and (vi) Patient's earned interest, if any.

(5)

Access to records. The facility must provide each patient reasonable access to his or her own financial records.

(6)

Quarterly statements. The facility must provide a written statement, at least quarterly, to each patient or representative. The quarterly statement must reflect any patient funds which the facility has deposited in an interest bearing or a non-interest bearing account as well as any patient funds held by the facility in a petty cash account. The statement must include at least the following: (i) Balance at the beginning of the statement period; (ii) Total deposits and withdrawals; (iii) Interest earned, if any; (iv) Identification number and location of any account in which that patient's personal funds have been deposited; (v) Ending balance; and (vi) For patients eligible for Supplemental Security Income or Medical Assistance, the difference between the ending balance and the applicable benefits eligibility level.

(7)

Commingling prohibited. The facility must keep any funds received from a patient for holding, safeguarding, and accounting separate from the facility's funds, and from the funds of any person other than another patient in that facility.

(8)

Types of accounts; distribution of interest—(i) Petty cash. The facility may keep up to $150.00 of a patient's money in a non-interest bearing account or petty cash fund. If a patient's monthly personal needs allowance increases after October 22, 1980, the facility may increase the threshold amount by an amount equal to the increase in the personal needs allowance. (ii) Interest-bearing accounts. Unless precluded by State law, the facility must, within 15 days of receipt of the money, deposit in an interest bearing account any funds in excess of $150.00 from an individual patient. The account may be individual to the patient or pooled with other patients in the facility. If a pooled account is used, each patient must be individually identified. The account must be in a form that clearly indicates that the facility does not have an ownership interest in the funds. The account must be insured under Federal or State law. (iii) Distribution of interest. The interest earned on any pooled interest bearing account must be distributed in one of the following ways, at the election of the facility: (A) Pro-rated to each patient on an actual interest-earned basis; or (B) Pro-rated to each patient on the basis of his or her end-of-quarter balance.

(9)

Access to funds—(i) Funds held in the facility. The patient must have access to funds daily, at least two hours during normal business hours and for some reasonable time on Saturdays and Sundays. The facility must, upon request or upon the patient's transfer or discharge, return to the patient, the legal guardian, or the representative payee all or any part of the patient's personal funds that the facility has received for holding, safeguarding, and accounting, and that are maintained in a petty cash fund. (ii) Funds held outside the facility. For a patient's personal funds that the facility has received and that are deposited in an account outside the facility, the facility, upon request or upon the patient's transfer or discharge must, within 5 business days, return to the patient, the legal guardian, or the representative payee, all or any part of those funds.

(10)

Handling of monthly benefits. When a facility is a patient's representative payee and directly receives monthly benefits to which the patient is entitled, it must fulfill its duties as representative payee in accordance with 20 CFR 416.620 and 404.1603, that define those duties.

(11)

Accounting upon change of ownership. (i) Duties to new owner. Upon sale of the facility or other transfer of ownership, the facility must provide the new owner with a written accounting, prepared by a Certified Public Accountant in accordance with the American Institute of Certified Public Accountants' Generally Accepted Auditing Procedures, of all patient funds being transferred, and obtain a written receipt for those funds from the new owner. (ii) Duties to patient. The facility must give each patient or representative a written accounting of any personal funds held by the facility before any transfer of ownership occurs. (iii) Rights of patients. In the event of a disagreement with the accounting provided by the facility, the patient retains all rights and remedies provided under State law.

(12)

Accounting upon death of patient. Unless precluded by State law, the facility must provide the executor or administrator of a patient's estate with a written accounting of the patient's personal funds within 10 business days of a patient's death. If the deceased patient's estate has no executor or administrator, the facility must provide the accounting to: (i) The patient's next of kin; (ii) The patient's representative; and (iii) The Clerk of the probate court of the county in which the patient died.

(13)

Surety bond. The facility must purchase a surety bond to guarantee the security of a patient's funds retained in the facility. Facilities of less than 60 beds must purchase a surety bond only when the amount of patients' money it is holding in the facility exceeds $5,000.00.

(14)

Patient incapable of managing funds. If a patient is incapable of managing personal funds and has no representative, the facility must refer the patient to the Area Agency on Aging, to the State protective agency with appropriate jurisdiction, or to the State Guardian's Office, if one exists. If there is no such office, the facility must: (i) In the case of a patient who is eligible for Medical Assistance (Title XIX), or SSI (Title XVI), notify the local office of the Social Security Administration (SSA) and request that a representative payee be appointed. Whoever is appointed must fulfill the duties of representative payee in accordance with 20 CFR 416.620 and 404.1603 that defines those duties. (ii) In the case of a patient who is not eligible for Medical Assistance (Title XIX), or SSI (Title XVI), institute a proceeding in accordance with State law for the appointment of a guardian, conservator, or committee. Unless precluded by State law, the costs of instituting the proceeding and administering the patient's estate may be charged against the patient's estate; or, (iii) In the time period between notification to the appropriate agencies, institution of formal guardianship proceedings, or notification to the local SSA office and the actual appointment of a guardian or representative payee, the facility must serve as temporary representative payee for the patient. During this period, the facility must fulfill its duties in accordance with 20 CFR 416.620 and 404.1603.

(15)

Substitution of existing system. (i) If a State has adopted requirements for the protection of patients' funds, those requirements may be substituted for the provisions of this section: Provided, That (A) The State has first incorporated this substitution into its State Plan, and (B) It has been approved by HCFA as part of that Plan on the grounds that the State's requirements for each of these sections are equivalent or superior to those contained in this paragraph. (ii) If an individual facility has independently implemented a system for the protection of patients' funds, the facility's system may be substituted for the provisions of this section: Provided (A) This system is incorporated in the facility's provider agreement with the State, and (B) The State has incorporated this substitution into its State Plan, and (C) It has been approved by HCFA as part of that Plan on the grounds that the facility's system provides safeguards that are equivalent or superior to those contained in this paragraph.

(16)

Resident property records. (i) The facility must maintain a current, written record for each resident that includes written receipts for all personal possessions deposited with the facility by the resident. (ii) The property record must be available to the resident and resident representative (as defined by 405.1121(m)(1)).

3. Condition of Participation—Medical Direction.

The facility retains, effective not later than 12 full calendar months from December 2, 1974, pursuant to a written agreement, a physician, licensed under State law to practice medicine or osteopathy, to serve as medical director on a part-time or full-time basis as is appropriate for the needs of the patients and the facility. If the facility has an organized medical staff, the medical director is designated by the medical staff with approval of the governing body. A medical director may be designated for a single facility or multiple facilities through arrangements with a group of physicians, a local medical society, a hospital medical staff, or through another similar arrangement. The medical director is responsible for the over-all coordination of the medical care in the facility to ensure the adequacy and appropriateness of the medical services provided to patients and to maintain surveillance of the health status of employees. (See 405.1911(b) regarding waiver of the requirement for a medical director.)

(a)

Standard: Coordination of medical care. Medical direction and coordination of medical care in the facility are provided by a medical director. The medical director is responsible for the development of written bylaws, rules, and regulations which are approved by the governing body and include delineation of the responsibilities of attending physicians. Coordination of medical care includes liaison with attending physicians to ensure their writing orders promptly upon admission of a patient, and periodic evaluation of the adequacy and appropriateness of health professional and supportive staff and services.

(b)

Standard: Responsibilities to the facility. The medical director is responsible for surveillance of the health status of the facility's employees. Incidents and accidents that occur on the premises are reviewed by the medical director to identify hazards to health and safety. The administrator is given appropriate information to help ensure a safe and sanitary environment for patients and personnel. The medical director is responsible for the execution of patient care policies in accordance with 405.1121(1).

4. Condition of Participation—Physician Services.

Patients in need of skilled nursing or rehabilitative care are admitted to the facility only upon the recommendation of and remain under the care of a physician. To the extent feasible, each patient or his sponsor designates a personal physician.

(a)

Standard: Medical findings and physicians' orders at time of admission. There is made available to the facility, prior to or at the time of admission, patient information which includes current medical findings, diagnoses, and orders from a physician for immediate care of the patient. Information about the rehabilitation potential of the patient and a summary of prior treatment are made available to the facility at the time of admission or within 48 hours thereafter.

(b)

Standard: Patient supervision by physician. The facility has a policy that the health care of every patient must be under the supervision of a physician who, based on a medical evaluation of the patient's immediate and long-term needs, prescribes a planned regimen of total patient care. Each attending physician is required to make arrangements for the medical care of his patients in his absence. The medical evaluation of the patient is based on a physical examination done within 48 hours of admission unless such examination was performed within 5 days prior to admission. The patient is seen by his attending physician at least once every 30 days for the first 90 days following admission. The patient's total program of care (including medications and treatments) is reviewed during a visit by the attending physician at least once every 30 days for the first 90 days, and revised as necessary. A progress note is written and signed by the physician at the time of each visit, and he signs all his orders. Subsequent to the 90th day following admission, an alternate schedule for physician visits may be adopted where the attending physician determines and so justifies in the patient's medical record that the patient's condition does not necessitate visits at 30-day intervals. This alternate schedule does not apply for patients who require specialized rehabilitative services, in which case the review must be in accordance with 405.1126(b). At no time may the alternate schedule exceed 60 days between visits. If the physician decides upon an alternate schedule of visits of more than 30 days for a patient, in the case of a Medicaid benefits recipient, the facility notifies the State Medicaid agency of the change in schedule, including justification, and the utilization review committee or the medical review team (see 405.1121(d)) promptly evaluates the patient's need for monthly physician visits as well as his continued need for skilled nursing facility services (see 405.1137(d)). If the utilization review committee or the medical review team does not concur in the schedule of visits at intervals of more than 30 days, the alternate schedule is not acceptable.

(c)

Standard: Availability of physicians for emergency patient care. The facility has written procedures, available at each nurses station, that provide for having a physician available to furnish necessary medical care in case of emergency.

5. Condition of Participation—Nursing Services.

The skilled nursing facility provides 24-hour service by licensed nurses, including the services of a registered nurse at least during the day tour of duty 7 days a week. There is an organized nursing service with a sufficient number of qualified nursing personnel to meet the total nursing needs of all patients in the facility. (See 405.1911(a) regarding waiver of the 7-day registered nurse requirement.)

(a)

Standard: Director of nursing services. The director of nursing services is a qualified registered nurse employed full-time who has, in writing, administrative authority, responsibility, and accountability for the functions, activities, and training of the nursing services staff, and serves only one facility in this capacity. If the director of nursing services has other institutional responsibilities, a qualified registered nurse serves as her assistant so that there is the equivalent of a full-time director of nursing services on duty. The director of nursing services is responsible for the development and maintenance of nursing service objectives, standards of nursing practice, nursing policy and procedures manuals, written job descriptions for each level of nursing personnel, scheduling of daily rounds to see all patients, methods for coordination of nursing services with other patient services, for recommending the number and levels of nursing personnel to be employed, and nursing staff development (see 405.1121(h)).

(b)

Standard: Charge nurse. A registered nurse, or a qualified licensed practical (vocational) nurse, is designated as charge nurse by the director of nursing services for each tour of duty, and is responsible for supervision of the total nursing activities in the facility during each tour of duty. The director of nursing services does not serve as charge nurse in a facility with an average daily total occupancy of 60 or more patients. The charge nurse delegates responsibility to nursing personnel for the direct nursing care of specific patients during each tour of duty, on the basis of staff qualifications, size and physical layout of the facility, characteristics of the patient load, and the emotional, social, and nursing care needs of patients.

(c)

Standard: Twenty-four-hour nursing service. The facility provides 24-hour nursing services which are sufficient to meet total nursing needs and which are in accordance with the patient care policies developed as provided in 405.1121(I). The policies are designed to ensure that each patient receives treatments, medications, and diet as prescribed, and rehabilitative nursing care as needed; receives proper care to prevent decubitus ulcers and deformities, and is kept comfortable, clean, well-groomed, and protected from accident, injury, and infection, and encouraged, assisted, and trained in self-care and group activities. Nursing personnel, including at least one registered nurse on the day tour of duty 7 days a week, licensed practical (vocational) nurses, nurse aides, orderlies, and ward clerks, are assigned duties consistent with their education and experience and based on the characteristics of the patient load. Weekly time schedules are maintained and indicate the number and classifications of nursing personnel, including relief personnel, who worked on each unit for each tour of duty.

(d)

Standard: Patient care plan. In coordination with the other patient care services to be provided, a written patient care plan for each patient is developed and maintained by the nursing service consonant with the attending physician's plan of medical care, and is implemented upon admission. The plan indicates care to be given and goals to be accomplished and which professional service is responsible for each element of care. The patient care plan is reviewed, evaluated, and updated as necessary by all professional personnel involved in the care of the patient.

(e)

Standard: Rehabilitative nursing care. Nursing personnel are trained in rehabilitative nursing, and the facility has an active program of rehabilitative nursing care which is an integral part of nursing service and is directed toward assisting each patient to achieve and maintain an optimal level of self-care and independence. Rehabilitative nursing care services are performed daily for those patients who require such service, and are recorded routinely.

(f)

Standard: Supervision of patient nutrition. Nursing personnel are aware of the nutritional needs and food and fluid intake of patients and assist promptly where necessary in the feeding of patients. A procedure is established to inform the dietetic service of physicians' diet orders and of patients' dietetic problems. Food and fluid intake of patients is observed, and deviations from normal are recorded and reported to the charge nurse and the physician.

(g)

Standard: Administration of drugs. Drugs and biologicals are administered only by physicians, licensed nursing personnel, or by other personnel who have completed a State-approved training program in medication administration. Procedures are established by the pharmaceutical services committee (see 405.1127(d)) to ensure that drugs to be administered are checked against physicians' orders, that the patient is identified prior to administration of a drug, and that each patient has an individual medication record and that the dose of drug administered to that patient is properly recorded therein by the person who administered the drug. Drugs and biologicals are administered as soon as possible after doses are prepared, and are administered by the same person who prepared the doses for administration, except under single unit dose package distribution systems. (See 405.1101 (h).)

(h)

Standard: Conformance with physicians' drug orders. Drugs are administered in accordance with written orders of the attending physician. Drugs not specifically limited as to time or number of doses when ordered are controlled by automatic stop orders or other methods in accordance with written policies. Physicians' verbal orders for drugs are given only to a licensed nurse, pharmacist, or physician and are immediately recorded and signed by the person receiving the order. (Verbal orders for Schedule II drugs are permitted only in the case of a bona fide emergency situation.) Such orders are countersigned by the attending physician within 48 hours. The attending physician is notified of an automatic stop order prior to the last dose so that he may decide if the administration of the drug or biological is to be continued or altered.

(i)

Standard: Storage of drugs and biologicals. Procedures for storing and disposing of drugs and biologicals are established by the pharmaceutical services committee. In accordance with State and Federal laws, all drugs and biologicals are stored in locked compartments under proper temperature controls and only authorized personnel have access to the keys. Separately locked, permanently affixed compartments are provided for storage of controlled drugs listed in Schedule II of the Comprehensive Drug Abuse Prevention & Control Act of 1970 and other drugs subject to abuse, except under single unit package drug distribution systems in which the quantity stored is minimal and a missing dose can be readily detected. An emergency medication kit approved by the pharmaceutical services committee is kept readily available.

6. Condition of Participation—Dietetic Services.

The skilled nursing facility provides a hygienic dietetic service that meets the daily nutritional needs of patients, ensures that special dietary needs are met, and provides palatable and attractive meals. A facility that has a contract with an outside food management company may be found to be in compliance with this condition provided the facility and/or company meets the standards listed herein.

(a)

Standard: Staffing. Overall supervisory responsibility for the dietetic service is assigned to a full-time qualified dietetic service supervisor. If the dietetic service supervisor is not a qualified dietitian he functions with frequent, regularly scheduled consultation from a person so qualified. (See 405.1121(i).) In addition, the facility employs sufficient supportive personnel competent to carry out the functions of the dietetic service. Food service personnel are on duty daily over a period of 12 or more hours. If consultant dietetic services are used, the consultant's visits are at appropriate times, and of sufficient duration and frequency to provide continuing liaison with medical and nursing staffs, advice to the administrator, patient counseling, guidance to the supervisor and staff of the dietetic service, approval of all menus, and participation in development or revision of dietetic policies and procedures and in planning and conducting inservice education programs (see 405.1121(h)).

(b)

Standard: Menus and nutritional adequacy. Menus are planned and followed to meet nutritional needs of patients in accordance with physicians' orders and, to the extent medically possible, in accordance with the recommended dietary allowances of the Food and Nutrition Board of the National Research Council National Academy of Sciences.

(c)

Standard: Therapeutic diets. Therapeutic diets are prescribed by the attending physician. Therapeutic menus are planned in writing, and prepared and served as ordered, with supervision or consultation from the dietitian and advice from the physician whenever necessary. A current therapeutic diet manual approved by the dietitian is readily available to attending physicians and nursing and dietetic service personnel.

(d)

Standard: Frequency of meals. At least three meals or their equivalent are served daily, at regular hours, with not more than a 14-hour span between substantial evening meal and breakfast. To the extent medically possible, bedtime nourishments are offered routinely to all patients.

(e)

Standard: Preparation and service of food. Foods are prepared by methods that conserve nutritive value, flavor, and appearance, and are attractively served at the proper temperatures and in a form to meet individual needs. If a patient refuses food served, appropriate substitutes of similar nutritive value are offered.

(f)

Standard: Hygiene of staff. Dietetic service personnel are free of communicable diseases and practice hygienic food-handling techniques. In the event food service employees are assigned duties outside the dietetic service, these duties do not interfere with the sanitation, safety, or time required for dietetic work assignments. (See 405.1121(g).)

(g)

Standard: Sanitary conditions. Food is procured from sources approved or considered satisfactory by Federal, State, or local authorities, and stored, prepared, distributed, and served under sanitary conditions. Waste is disposed of properly. Written reports of inspections by State and local health authorities are on file at the facility, with notation made of action taken by the facility to comply with any recommendations.

7. Condition of Participation—Specialized Rehabilitative Services.

In addition to rehabilitative nursing (405.1124(e)), the skilled nursing facility provides, or arranges for, under written agreement, specialized rehabilitative services by qualified personnel (i.e., physical therapy, speech pathology and audiology, and occupational therapy) as needed by patients to improve and maintain functioning. These services are provided upon the written order of the patient's attending physician. Safe and adequate space and equipment are available, commensurate with the services offered. If the facility does not offer such services directly, it does not admit nor retain patients in need of this care unless provision is made for such services under arrangement with qualified outside resources under which the facility assumes professional responsibilities for the services rendered. (See 450.1121(i).)

(a)

Standard: Organization and staffing. Specialized rehabilitative services are provided, in accordance with accepted professional practices, by qualified therapists or by qualified assistants or other supportive personnel under the supervision of qualified therapists. Other rehabilitative services may also be provided, but must be in a facility where all rehabilitative services are provided through an organized rehabilitative service under the supervision of a physician qualified in physical medicine who determines the goals and limitations of these services and assigns duties appropriate to the training and experience of those providing such services. Written administrative and patient care policies and procedures are developed for rehabilitative services by appropriate therapists and representatives of the medical, administrative, and nursing staffs.

(b)

Standard: Plan of care. Rehabilitative services are provided under a written plan of care initiated by the attending physician and developed in consultation with appropriate therapist(s) and the nursing service. Therapy is provided only upon written orders of the attending physician. A report of the patient's progress is communicated to the attending physician within 2 weeks of the initiation of specialized rehabilitative services. The patient's progress is thereafter reviewed regularly, and the plan of rehabilitative care is reevaluated as necessary, but at least every 30 days, by the physician and the therapist(s).

(c)

Standard: Documentation of services. The physician's orders, the plan of rehabilitative care, services rendered, evaluations of progress, and other pertinent information are recorded in the patient's medical record, and are dated and signed by the physician ordering the service and the person who provided the service.

(d)

Standard: Qualifying to provide outpatient physical therapy services. If the facility provides outpatient physical therapy services, it meets the applicable health and safety regulations pertaining to such services as are included in Subpart Q of these regulations.

8. Condition of Participation—Pharmaceutical Services.

The skilled nursing facility provides appropriate methods and procedures for the dispensing and administering of drugs and biologicals. Whether drugs and biologicals are obtained from community or institutional pharmacists or stocked by the facility, the facility is responsible for providing such drugs and biologicals for its patients, insofar as they are covered under the programs, and for ensuring that pharmaceutical services are provided in accordance with accepted professional principles and appropriate Federal, State, and local laws. (See 405.1124(g), (h), and (i).)

(a)

Standard: Supervision of services. The pharmaceutical services are under the general supervision of a qualified pharmacist who is responsible to the administrative staff for developing, coordinating, and supervising all pharmaceutical services. The pharmacist (if not a full-time employee) devotes a sufficient number of hours, based upon the needs of the facility, during regularly scheduled visits to carry out these responsibilities. The pharmacist reviews the drug regimen of each patient at least monthly, and reports any irregularities to the medical director and administrator. The pharmacist submits a written report at least quarterly to the pharmaceutical services committee on the status of the facility's pharmaceutical service and staff performance.

(b)

Standard: Control and accountability. The pharmaceutical service has procedures for control and accountability of all drugs and biologicals throughout the facility. Only approved drugs and biologicals are used in the facility, and are dispensed in compliance with Federal and State laws. Records of receipt and disposition of all controlled drugs are maintained in sufficient detail to enable an accurate reconciliation. The pharmacist determines that drug records are in order and that an account of all controlled drugs is maintained and reconciled.

(c)

Standard: Labeling of drugs and biologicals. The labeling of drugs and biologicals is based on currently accepted professional principles, and includes the appropriate accessory and cautionary instructions, as well as the expiration date when applicable.

(d)

Standard: Pharmaceutical services committee. A pharmaceutical services committee (or its equivalent) develops written policies and procedures for safe and effective drug therapy, distribution, control, and use. The committee is composed of at least the pharmacist, the director of nursing services, the administrator, and one physician. The committee oversees pharmaceutical service in the facility, makes recommendations for improvement, and monitors the service to ensure its accuracy and adequacy. The committee meets at least quarterly and documents its activities, findings, and recommendations.

9. Condition of Participation—Laboratory and Radiologic Services.

The skilled nursing facility has provision for promptly obtaining required laboratory, X-ray, and other diagnostic services.

(a)

Standard: Provision for services. If the facility provides its own laboratory and X-ray services, these meet the applicable conditions established for certification of hospitals that are contained in 405.1028 and 405.1029, respectively. If the facility itself does not provide such services, arrangements are made for obtaining these services from a physician's office, a participating hospital or skilled nursing facility, or a portable X-ray supplier or independent laboratory which is approved to provide these services under the program. All such services are provided only on the orders of the attending physician, who is notified promptly of the findings. The facility assists the patient, if necessary, in arranging for transportation to and from the source of service. Signed and dated reports of a clinical laboratory, X-ray, and other diagnostic services are filed with the patient's medical record.

(b)

Standard: Blood and blood products. Blood handling and storage facilities are safe, adequate, and properly supervised. If the facility provides for maintaining and transfusing blood and blood products, it meets the conditions established for certification of hospitals that are contained in 405.1028(j). If the facility does not provide its own facilities but does provide transfusion services alone, it meets at least the requirements of 405.1028(j)(1), (3), (4), (6), and (9).

10. Condition of Participation—Dental Services.

The skilled nursing facility has satisfactory arrangements to assist patients to obtain routine and emergency dental care. (See 405.1121(i).) (The basic Hospital Insurance Program does not cover the services of a dentist in a skilled nursing facility in connection with the care, treatment, filling, removal, or replacement of teeth or structures supporting the teeth; and only certain oral surgery is included in the Supplemental Medical insurance Program.)

(a)

Standard: Advisory dentist. An advisory dentist participates in the staff development program for nursing and other appropriate personnel (see 405.1121(h)), and recommends oral hygiene policies and practices for the care of patients.

(b)

Standard: Arrangements for outside services. The facility has a cooperative agreement with a dental service, and maintains a list of dentists in the community for patients who do not have a private dentist. The facility assists the patient, if necessary, in arranging for transportation to and from the dentist's office.

11. Condition of Participation—Social Services.

The skilled nursing facility has satisfactory arrangements for identifying the medically related social and emotional needs of the patient. It is not mandatory that the skilled nursing facility itself provide social services in order to participate in the program. If the facility does not provide social services, it has written procedures for referring patients in need of social services to appropriate social agencies. If social services are offered by the facility, they are provided under a clearly defined plan, by qualified persons, to assist each patient to adjust to the social and emotional aspects of his illness, treatment, and stay in the facility.

(a)

Standard: Social service functions. The medically related social and emotional needs of the patient are identified and services provided to meet them, either by qualified staff of the facility, or by referral, based on established procedures, to appropriate social agencies. If financial assistance is indicated, arrangements are made promptly for referral to an appropriate agency. The patient and his family or responsible person are fully informed of the patient's personal and property rights.

(b)

Standard: Staffing. If the facility offers social services, a member of the staff of the facility is designated as responsible for social services. If the designated person is not a qualified social worker, the facility has a written agreement with a qualified social worker or recognized social agency for consultation and assistance on a regularly scheduled basis. (See 405.1121(i).) The social service also has sufficient supportive personnel to meet patient needs. Facilities are adequate for social service personnel, easily accessible to patients and medical and other staff, and ensure privacy for interviews.

(c)

Standard: Records and confidentiality of social data. Records of pertinent social data about personal and family problems medically related to the patient's illness and care, and of action taken to meet his needs, are maintained in the patient's medical record. If social services are provided by an outside resource, a record is maintained of each referral to such resource. Policies and procedures are established for ensuring the confidentiality of all patients' social information.

12. Condition of Participation—Patient Activities.

The skilled nursing facility provides for an activities program, appropriate to the needs and interests of each patient, to encourage self care, resumption of normal activities, and maintenance of an optimal level of psychosocial functioning.

(a)

Standard: Responsibility for patient activities. A member of the facility's staff is designated as responsible for the patient activities program. If he is not a qualified patient activities coordinator, he functions with frequent, regularly scheduled consultation from a person so qualified. (See 405.1121(i).)

(b)

Standard: Patient activities program. Provision is made for an ongoing program of meaningful activities appropriate to the needs and interests of patients, designed to promote opportunities for engaging in normal pursuits, including religious activities of their choice, if any. Each patient's activities program is approved by the patient's attending physician as not in conflict with the treatment plan. The activities are designed to promote the physical, social, and mental well-being of the patients. The facility makes available adequate space and a variety of supplies and equipment to satisfy the individual interests of patients. (See 405.1134(g).)

13. Condition of Participation—Medical Records.

The facility maintains clinical (medical) records on all patients in accordance with accepted professional standards and practices. The medical record service has sufficient staff, facilities, and equipment to provide medical records that are completely and accurately documented, readily accessible, and systematically organized to facilitate retrieving and compiling information.

(a)

Standard: Staffing. Overall supervisory responsibility for the medical record service is assigned to a full-time employee of the facility. The facility also employs sufficient supportive personnel competent to carry out the functions of the medical record service. If the medical record supervisor is not a qualified medical record practitioner, this person functions with consultation from a person so qualified. (See 405.1121(i).)

(b)

Standard: Protection of medical record information. The facility safeguards medical record information against loss, destruction, or unauthorized use.

(c)

Standard: Content. The medical record contains sufficient information to identify the patient clearly, to justify the diagnosis and treatment, and to document the results accurately. All medical records contain the following general categories of data: Documented evidence of assessment of the needs of the patient, of establishment of an appropriate plan of treatment, and of the care and services provided; authentication of hospital diagnoses (discharge summary, report from patient's attending physician, or transfer form), identification data and consent forms, medical and nursing history of patient, report of physical examination(s), diagnostic and therapeutic orders, observations and progress notes, reports of treatments and clinical findings, and discharge summary including final diagnosis and prognosis.

(d)

Standard: Physician documentation. Only physicians enter or authenticate in medical records opinions that require medical judgment (in accordance with medical staff bylaws, rules, and regulations, if applicable). Each physician signs his entries into the medical record.

(e)

Standard: Completion of records and centralization of reports. Current medical records and those of discharged patients are completed promptly. All clinical information pertaining to a patient's stay is centralized in the patient's medical record.

(f)

Standard: Retention and preservation. Medical records are retained for a period of time not less than that determined by the respective State statute, the statute of limitations in the State, or 5 years from the date of discharge in the absence of a State statute, or, in the case of a minor, 3 years after the patient becomes of age under State law.

(g)

Standard: Indexes. Patients' medical records are indexed according to name of patient and final diagnoses to facilitate acquisition of statistical medical information and retrieval of records for research or administrative action.

(h)

Standard: Location and facilities. The facility maintains adequate facilities and equipment, conveniently located, to provide efficient processing of medical records (reviewing, indexing, filing, and prompt retrieval).

14. Condition of Participation—Transfer Agreement.

The skilled nursing facility has in effect a transfer agreement with one or more hospitals approved for participation under the programs, which provides the basis for effective working arrangements under which inpatient hospital care or other hospital services are available promptly to the facility's patients when needed. (A facility that has been unable to establish a transfer agreement with the hospital(s) in the community or service area after documented attempts to do so is considered to have such an agreement in effect.)

(a)

Standard: Patient transfer. A hospital and a skilled nursing facility shall be considered to have a transfer agreement in effect if, by reason of a written agreement between them or (in case the two institutions are under common control) by reason of a written undertaking by the person or body which controls them, there is reasonable assurance that:

(1)

Transfer of patients will be effected between the hospital and the skilled nursing facility, ensuring timely admission, whenever such transfer is medically appropriate as determined by the attending physician, and

(2)

There will be interchange of medical and other information necessary or useful in the care and treatment of individuals transferred between the institutions, or in determining whether such individuals can be adequately cared for otherwise than in either of such institutions, and

(3)

Security and accountability for patients' personal effects are provided on transfer. Any skilled nursing facility which does not have such agreement in effect, but which is found by a State agency (of the State in which such facility is located) with which an agreement under section 1864 is in effect (or, in the case of a State in which no such agency has an agreement under 1864, by the Secretary) to have attempted in good faith to enter into such an agreement with a hospital sufficiently close to the facility to make feasible the transfer between them of patients and the information referred to in paragraph (a)(2) of this section, shall be considered to have such an agreement in effect if and for so long as such agency (or the Secretary, as the case may be) finds that to do so is in the public interest and essential to ensuring skilled nursing facility services for persons in the community who are eligible for payments with respect to such services under the programs.

15. Condition of Participation—Physical Environment.

The skilled nursing facility is constructed, equipped, and maintained to protect the health and safety of patients, personnel, and the public.

(a)

Standard: Life safety from fire. The skilled nursing facility meets such provisions of the Life Safety Code of the National Fire Protection Association (21st Edition, 1967) as are applicable to nursing homes; except that, in consideration of a recommendation by the State survey agency, the Secretary may waive, for such periods as deemed appropriate, specific provisions of such Code which, if rigidly applied, would result in unreasonable hardship upon a skilled nursing facility, but only if such waiver will not adversely affect the health and safety of the patients; and except that the provisions of such Code shall not apply in any State if the Secretary finds, in accordance with applicable provisions of section 1861(j)(13) of the Social Security Act, that in such State there is in effect a fire and safety code, imposed by State law, which adequately protects patients in skilled nursing facilities. Where waiver permits the participation of an existing facility of two or more stories which is not of at least 2-hour fire resistive construction, blind, nonambulatory, or physically handicapped patients are not housed above the street level floor unless the facility is of 1-hour protected noncombustible construction (as defined in National Fire Protection Association Standard No. 220), fully sprinklered 1-hour protected ordinary construction, or fully sprinklered 1-hour protected wood-frame construction. Nonflammable medical gas systems, such as oxygen and nitrous oxide, installed in the facility comply with applicable provisions of National Fire Protection Association Standard No. 56B (Standard for the Use of Inhalation Therapy) 1968 and National Fire Protection Association Standard No. 56F (Nonflammable Medical Gas Systems) 1970.

(b)

Standard: Emergency power. The facility provides an emergency source of electrical power necessary to protect the health and safety of patients in the event the normal electrical supply is interrupted. The emergency electrical power system must supply power adequate at least for lighting in all means of egress; equipment to maintain fire detection, alarm, and extinguishing systems; and life support systems. Where life support systems are used, emergency electrical service is provided by an emergency generator located on the premises.

(c)

Standard: Facilities for physically handicapped. The facility is accessible to, and functional for, patients, personnel, and the public. All necessary accommodations are made to meet the needs of persons with semiambulatory disabilities, sight and hearing disabilities, disabilities of coordination, as well as other disabilities, in accordance with the American National Standards Institute (ANSI) Standard No. Al 17.1, American Standard Specifications for Making Buildings and Facilities Accessible to, and Usable by, the Physically Handicapped. The Secretary (or in the case of a facility participating as a skilled nursing facility under title XIX only, the survey agency—see 42 CFR 449.33(a)(1)(i)) may waive in existing buildings, for such periods as deemed appropriate, specific provisions of ANSI Standard No. Al 17.1 which, if rigidly enforced, would result in unreasonable hardship upon the facility, but only if such waiver will not adversely affect the health and safety of patients.

(d)

Standard: Nursing unit. Each nursing unit has at least the following basic service areas: Nurses station, storage and preparation area(s) for drugs and biologicals, and utility and storage rooms that are adequate in size, conveniently located, and well-lighted to facilitate staff functioning. The nurses station is equipped to register patients' calls through a communication system from patient areas, including patient rooms and toilet and bathing facilities.

(e)

Standard: Patient rooms and toilet facilities. Patient rooms are designed and equipped for adequate nursing care and the comfort and privacy of patients, and have no more than four beds, except in facilities primarily for the care of the mentally ill and/or retarded where there shall be no more than 12 beds per room. (An institution primarily engaged in the care of the mentally retarded or in the treatment of mental diseases cannot qualify as a participating skilled nursing facility under Medicare.) Single patient rooms measure at least 100 square feet, and multipatient rooms provide a minimum of 80 square feet per bed. The Secretary (or in the case of a facility participating as a skilled nursing facility under title XIX only, the survey agency—see 42 CFR 449.33(a)(1)(i)) may permit variations in individual cases where the facility demonstrates in writing that such variations are in accordance with the particular needs of the patients and will not adversely affect their health and safety. Each room is equipped with, or is conveniently located near, adequate toilet and bathing facilities.

Each room has direct access to a corridor and outside exposure, with the floor at or above grade level.

(f)

Standard: Facilities for special care. Provision is made for isolating patients as necessary in single rooms ventilated to the outside, with private toilet and handwashing facilities. Procedures in aseptic and isolation techniques are established in writing and followed by all personnel. Such areas are identified by appropriate precautionary signs.

(g)

Standard: Dining and patient activities rooms. The facility provides one or more clean, orderly, and appropriately furnished rooms of adequate size designated for patient dining and for patient activities. These areas are well-lighted and well-ventilated. If a multipurpose room is used for dining and patient activities, there is sufficient space to accommodate all activities and prevent their interference with each other.

(h)

Standard: Kitchen and dietetic service areas. The facility has kitchen and dietetic service areas adequate to meet food service needs. These areas are properly ventilated, and arranged and equipped for sanitary refrigeration, storage, preparation, and serving of food as well as for dish and utensil cleaning and refuse storage and removal.

(i)

Standard: Maintenance of equipment, building, and grounds. The facility establishes a written preventive maintenance program to ensure that equipment is operative and that the interior and exterior of the building are clean and orderly. All essential mechanical, electrical, and patient care equipment is maintained in safe operating condition.

(j)

Standard: Other environmental considerations. The facility provides a functional, sanitary, and comfortable environment for patients, personnel, and the public. Provision is made for adequate and comfortable lighting levels in all areas, limitation of sounds at comfort levels, maintaining a comfortable room temperature, procedures to ensure water to all essential areas in the event of loss of normal water supply, and adequate ventilation through windows or mechanical means or a combination of both. Corridors are equipped with firmly secured handrails on each side.

16. Condition of Participation—Infection Control.

The skilled nursing facility establishes an infection control committee of representative professional staff with responsibility for overall infection control in the facility. All necessary housekeeping and maintenance services are provided to maintain a sanitary and comfortable environment and to help prevent the development and transmission of infection.

(a)

Standard: Infection control committee. The infection control committee is composed of members of the medical and nursing staffs, administration, and the dietetic, pharmacy, housekeeping, maintenance, and other services. The committee establishes policies and procedures for investigating, controlling, and preventing infections in the facility, and monitors staff performance to ensure that the policies and procedures are executed.

(b)

Standard: Aseptic and isolation techniques. Written effective procedures in aseptic and isolation techniques are followed by all personnel. Procedures are reviewed and revised annually for effectiveness and improvement.

(c)

Standard: Housekeeping. The facility employs sufficient housekeeping personnel and provides all necessary equipment to maintain a safe, clean, and orderly interior. A full-time employee is responsible for the services and for supervision and training of personnel. Nursing personnel are not assigned housekeeping duties. A facility that has a contract with an outside resource for housekeeping services may be found to be in compliance with this standard provided the facility and/or outside resource meets the requirements of the standard.

(d)

Standard: Linen. The facility has available at all times a quantity of linen essential for proper care and comfort of patients. Linens are handled, stored, processed, and transported in such a manner as to prevent the spread of infection.

(e)

Standard: Pest control. The facility is maintained free from insects and rodents through operation of a pest control program.

17. Condition of Participation—Disaster Preparedness.

The skilled nursing facility has a written plan, periodically rehearsed, with procedures to be followed in the event of an internal or external disaster and for the care of casualties (patients and personnel) arising from such disasters.

(a)

Standard: Disaster plan. The facility has an acceptable written plan in operation, with procedures to be followed in the event of fire, explosion, or other disaster. The plan is developed and maintained with the assistance of qualified fire, safety, and other · appropriate experts, and includes procedures for prompt transfer of casualties and records, instructions regarding the location and use of alarm systems and signals and of fire-fighting equipment, information regarding methods of containing fire, procedures for notification of appropriate persons, and specifications of evacuation routes and procedures.

(b)

Standard: Staff training and drills. All employees are trained, as part of their employment orientation, in all aspects of preparedness for any disaster. The disaster program includes orientation and ongoing training and drills for all personnel in all procedures so that each employee promptly and correctly carries out his specific role in case of disaster.

18. Condition of Participation—Utilization Review.

The skilled nursing facility carries out utilization review of the services provided in the facility at least to inpatients who are entitled to benefits under the program(s). Utilization review has as its overall objectives both the maintenance of high quality patient care and assurance of appropriate and efficient utilization of facility services. There are two elements to utilization review: medical care evaluation studies that identify and examine patterns of care provided in the facility, and review of extended duration cases which is concerned with efficiency, appropriateness, and cost effectiveness of care.

(a)

Standard: Written plan of utilization review activity. The skilled nursing facility has a currently applicable written description of its utilization review plan. Such description includes:

(1)

The organization and composition of the committee or group which will be responsible for the utilization review function;

(2)

Frequency of meetings;

(3)

The type of records to be kept;

(4)

The methods and criteria (including norms where available) to be used to define periods of continuous extended duration and to assign or select subsequent dates for continued stay review;

(5)

Methods for selection and conduct of medical care evaluation studies;

(6)

The relationship of the utilization review plan to claims administration by a third party;

(7)

Arrangements of committee reports and their dissemination;

(8)

Responsibilities of the skilled nursing facility's administrative staff.

(b)

Standard: Composition and organization of utilization review committee.

(1)

The utilization review function is conducted by a staff committee of the skilled nursing facility composed of two or more physicians, with participation of other professional personnel, or by a group outside the facility which is similarly composed and which is established by the local medical or osteopathic society and some or all of the hospitals and skilled nursing facilities in the locality, or by a group established and organized in a manner approved by the Secretary that is capable of performing such a function.

(2)

The medical care evaluation studies, as described in paragraph (c) of this section, and educational duties of the review program, and the review of admissions and long-stay cases need not be performed by the same committee or group and they need not be performed by a specially established group.

(3)

Review by the committee or group may not be conducted by any person who is employed by or who is financially interested in any skilled nursing facility or by any person who was professionally involved in the care of the patient whose case is being reviewed.

(c)

Standard: Medical care evaluation studies. Medical care evaluation studies are performed to promote the most effective and efficient use of available health facilities and services consistent with patient needs and professionally recognized standards of health care. Studies emphasize identification and analysis of patterns of patient care, and suggest, where appropriate, possible changes for maintaining consistently high quality patient care and effective and efficient use of services. Each medical care evaluation study (whether medical or administrative in emphasis) identifies and analyzes factors related to the patient care rendered in the facility, and where indicated, results in recommendations for change beneficial to patients, staff, the facility and the community. Studies on a sample or other basis include, but need not be limited to: admissions, durations of stay, ancillary services furnished (including drugs and biologicals) and professional services performed on facility premises. At least one study must be in progress at any given time, and at least one study must be completed each year. The study will be accomplished by considering and analyzing data obtained from any one or a combination of the following sources:

(1)

Medical records or other appropriate data;

(2)

External organizations which compile statistics, design profiles, and produce other comparative data; and

(3)

By cooperative endeavor with the PSRO, fiscal intermediary(ies), providers of services, or appropriate agencies. The committee or group shall document the results of each medical care evaluation study and how such results have, where appropriate, been used to institute changes to improve the quality of care and promote more effective and efficient use of facilities and services.

(d)

Standard: Extended stay review.

(1)

Periodic review is made of each current inpatient skilled nursing facility beneficiary case of continuous extended duration, the length of which is defined in the utilization review plan, to determine whether further inpatient stay is necessary. The plan may specify a different number of days for different diagnostic classes of cases, or may use the same number of days for all cases. In any event the period(s) specified bears a reasonable relationship to current average length-of-stay statistics and does not exceed 30 days after admission. An exception to this 30-day limit may be made where the extended stay review date is based on: (i) The average, or some other appropriate point (e.g., median) of current length of stay data for diagnostic classes of cases selected by the committee or group in accordance with guidelines established by the Secretary, when the average (or other length of stay review point) for the individual's specific diagnostic class or category, based on functional capability, exceeds 30 days; or (ii) A period, established pursuant to section 1814(h)(1) of the Act, which exceeds 20 days.

(2)

The initial extended stay review takes place prior to or at the end of the period of extended duration specified pursuant to paragraph (d)(1) of this section. The review is based on the attending physician's reasons for and plan for continued stay and any other documentation the committee or group deems appropriate. Cases may be screened by a qualified nonphysician representative of the committee or group who uses criteria established by the physician members of the committee, provided that cases are referred to a physician member for further review when it appears that the patient no longer requires further inpatient care. Where the committee or group selects a nonphysician representative to screen extended stay review cases, it will select an individual with experience in such screening or appropriate training in the application of the screening criteria used, or both. The Secretary may grant an additional period of time, beyond July 1, 1975, the effective date of this paragraph, for a committee or group of a skilled nursing facility to select or develop the written criteria and standards required by this paragraph: (i) Where the committee or group documents that it made every effort to comply by July 1, 1975, and that it is currently making substantial progress in developing the criteria and standards; and (ii) where the committee or group establishes a timetable for meeting the requirements which is acceptable to the Secretary.

(3)

Where a finding is made that the individual continues to need inpatient skilled nursing care, an additional stay is approved for a period the committee or group deems appropriate, provided that reviews are made at least every 30 days for the first 90 days and at least every 90 days thereafter. Before the expiration of each new period, the case must be reviewed again in like manner, with such reviews being repeated as long as the stay continues beyond the scheduled review dates and notice has not been given pursuant to paragraph (e) of this section.

(e)

Standard: Admission or further stay not medically necessary.

(1)

A final determination of the committee or group that an admission or continued stay is not medically necessary is made by at least two physician members of the committee or groups, except that the final determination may be made by one physician member where the attending physician, when given an opportunity to express his views, does not do so, or does not contest the finding that the admission or continued stay is not medically necessary. (See 405.166 regarding the restriction on payment after an adverse decision by the committee or group.)

(2)

If the committee or group, or its nonphysician representative where a physician member concurs, has reason to believe from the review of an admission or an extended duration case or a case reviewed as part of a medical care evaluation study that further stay is no longer medically necessary (or that admissions were not medically necessary), the committee or group shall notify the individual's attending physician and afford him an opportunity to present his views before it makes a final determination. If the final determination of the committee or group is that further stay is no longer medically necessary, written notification of the finding is given to the facility, the attending physician, and the individual (or where appropriate, his next of kin) no later than two days after such final determination is made and, in no event in the case of an extended duration case, later than 3 working days after the end of the extended duration period specified pursuant to paragraph (d) of this section.

(f)

Standard: Administrative responsibilities. The administrative staff of the facility is kept directly and fully informed of committee activities to facilitate support and assistance. The administrator studies and acts upon recommendations made by the committee, coordinating such functions with appropriate staff members.

(g)

Standard: Utilization review records. Written records of committee activities are maintained. Appropriate reports, signed by the committee chairman, are made regularly to the medical staff, administrative staff, governing body, and sponsors (if any). Minutes of each committee meeting are maintained and include at least:

(1)

Name of committee,

(2)

Date and duration of meeting,

(3)

Names of committee members present and absent,

(4)

Description of activities presently in progress to satisfy the requirements for medical care evaluation studies, including the subject and reason for study, dates of commencement and expected completion, summary of studies completed since the last meeting, conclusions, and follow-up on implementation of recommendations made from previous studies, and

(5)

Summary of extended duration cases reviewed, including the number of cases, case identification numbers, admission and review dates, and decisions reached, including the basis for each determination and action taken for each case not approved for extended care.

(h)

Standard: Discharge planning. The facility maintains a centralized, coordinated program to ensure that each patient has a planned program of continuing care which meets his postdischarge needs.

(1)

The facility has in operation an organized discharge planning program. The utilization review committee, in its evaluation of the current status of each extended duration case, has available to it the results of such discharge planning and information on alternative available community resources to which the patient may be referred.

(2)

The administrator delegates responsibility for discharge planning , in writing, to one or more members of the facility's staff, with consultation, if necessary, or arranges for this service to be provided by a health, social, or welfare agency (see 405.1121(i)).

(3)

The facility maintains written discharge planning procedures which describe (i) how the discharge coordinator will function, and his authority and relationships with the facility's staff; (ii) the time period in which each patient's need for discharge planning is determined (preferably within 7 days after the clay of admission); (iii) the maximum time period after which a reevaluation of each patient's discharge plan is made; (iv) local resources available to the facility, the patient, and the attending physician to assist in developing and implementing individual discharge plans; and (v) provisions for periodic review and reevaluation of the facility's discharge planning program.

(4)

At the time of discharge, the facility provides those responsible for the patient's postdischarge care with an appropriate summary of information about the discharged patient to ensure the optimal continuity of care. The discharge summary includes at least current information relative to diagnoses, rehabilitation potential, a summary of the course of prior treatment, physician orders for the immediate care of the patient, and pertinent social information.

(i)

Standard: Applicability of utilization review requirements approved under Title XIX. Notwithstanding the preceding paragraphs of this section, if the Secretary determines that the utilization review procedures established by a State pursuant to Title XIX of the Social Security Act are superior in their effectiveness to the procedures required under this section, any provision of the State plan for which the waiver of the requirements set forth in this section for utilization review in skilled nursing facilities is granted shall, to the extent deemed appropriate by the Secretary, be utilized by skilled nursing facilities in that State, instead of the procedures specified in this section.

(j)

Correlation of PSRO review-Medicare utilization review activities. Review activities under section 1158(a) of the Act shall be in lieu of the requirements of this section if a Professional Standards Review Organization (PSRO) has assumed review responsibility in accordance with the applicable provisions of Part 463 of this chapter for services provided by or in the facility to inpatients who are entitled to benefits under this Part 405. (See 463.25, 463.26, and 463.28 for provisions concerning the correlation of functions under Titles XI-B and XVIII of the Act.

Administration

1.

Methods of Administration. An ICF must have methods of administrative management that insure that it meets the requirements of Standards (2) through (15).

2.

Staffing. The ICF must have staff on duty 24 hours a day sufficient in number and qualifications to carry out the policies, responsibilities, and programs of the ICF.

3.

Administrator.

(a)

The ICF must have an administrator who is:

(1)

A nursing home administrator with a current State license; or

(2)

A hospital administrator, if the ICF is a hospital qualifying as an intermediate care facility.

(b)

The administrator's responsibilities must include:

(1)

Managing the ICF; and

(2)

Implementing established policies and procedures.

4.

Resident Services Director.

(a)

The ICF must designate the administrator or a professional staff member as resident services director.

(b)

The duties of the resident services director must include coordinating and monitoring each resident's overall plan of care.

5.

Written Policies and Procedures: General Requirements. The ICF must have written policies and procedures that:

(a)

Govern all services provided by the ICF; and

(b)

Are available to the staff, residents, members of the family and legal representatives of residents, and the public.

6.

Written Policies and Procedures: Admission. The ICF must have written policies and procedures that insure that it admits as residents only those individuals whose needs can be met:

(a)

By the ICF itself;

(b)

By the ICF in cooperation with community resources; or

(c)

By the ICF in cooperation with other providers of care affiliated with or under contract to the ICF.

7.

Written Policies and Procedures: Transfer and Discharge. The ICF must have written policies and procedures that insure that:

(a)

It transfers a resident promptly to a hospital, skilled nursing facility, or other appropriate facility, when a change occurs in the resident's physical or mental condition that requires care or service that the ICF cannot adequately provide; and

(b)

Except in an emergency, it:

(1)

Consults the resident, his next of kin, the attending physician, and the responsible agency, if any, at least 5 clays before a transfer or discharge; and

(2)

Uses casework services or other means to insure that adequate arrangements are made to meet the resident's needs through other resources.

8.

Written Policies and Procedures: Chemical and Physical Restraints. The ICF must have written policies and procedures that:

(a)

Define the uses of chemical and physical restraints;

(b)

Identify the professional personnel who may, under 442.311(h), authorize use of these restraints in emergencies; and

(c)

Describe the procedures for monitoring and controlling the use of these restraints.

9.

Written Policies and Procedures: Resident Complaints and Recommendations. The ICF must have written policies and procedures that:

(a)

Describe the procedures that the ICF uses to receive complaints and recommendations from its residents; and

(b)

Insure that the ICF responds to these complaints and recommendations.

10.

Written Policies and Procedures: Resident Records. The ICF must have written policies and procedures governing access to, duplication of, and dissemination of information from the resident's record.

11.

Written Policies and Procedures: Residents' Bill of Rights. The ICF must have written policies and procedures that insure the following rights for each resident:

(a)

Information.

(1)

Each resident must be fully informed, before or at the time of admission, of his rights and responsibilities and of all rules governing resident conduct.

(2)

If the ICF amends its policies on residents' rights and responsibilities and its rules governing conduct, each resident in the ICF at that time must be informed.

(3)

Each resident must acknowledge in writing receipt of the information and any amendments to it.

(4)

Each resident must be fully informed in writing of all services available in the ICF and of the charges for these services including any charges for services not paid for by Medicaid or not included in the ICF's basic rate per day. The ICF must provide this information either before or at the time of admission and on a continuing basis as changes occur in services or charges during the resident's stay.

(b)

Medical condition and treatment.

(1)

Each resident must (i) Be fully informed by a physician of his health and medical condition unless the physician decides that informing the resident is medically contraindicated; (ii) Be given the opportunity to participate in planning his total care and medical treatment; (iii) Be given the opportunity to refuse treatment; and (iv) Give informed, written consent before participating in experimental research.

(2)

If the physician decides that informing the resident of his health and medical condition is medically contraindicated, the physician must document this decision in the resident's record.

(c)

Transfer and discharge. Each resident must be transferred or discharged only for:

(1)

Medical reasons;

(2)

His welfare or that of the other residents; or

(3)

Nonpayment except as prohibited by the Medicaid program.

(d)

Exercising rights. Each resident must be:

(1)

Encouraged and assisted to exercise his rights as a resident of the ICF and as a citizen; and

(2)

Allowed to submit complaints or recommendations concerning the policies and services of the ICF to staff or to outside representatives of the resident's choice or both, free from restraint, interference, coercion, discrimination, or reprisal.

(e)

Financial affairs. Each resident must be allowed to manage his personal financial affairs. If a resident requests assistance from the ICF in managing his personal financial affairs:

(1)

The request must be in writing; and

(2)

The ICF must comply with the recordkeeping requirements of 442.320.

(f)

Freedom from abuse and restraints.

(1)

Each resident must be free from mental and physical abuse.

(2)

Each resident must be free from chemical and physical restraints unless the restraints are (i) Authorized by a physician in writing for a specified period of time; or (ii) Used in an emergency under the following conditions: (A) The use is necessary to protect the resident from injuring himself or others. (B) The use is authorized by a professional staff member identified in the written policies and procedures of the facility as having the authority to do so. (C) The use is reported promptly to the resident's physician by that staff member.

(g)

Privacy.

(1)

Each resident must be treated with consideration, respect, and full recognition of his or her dignity and individuality.

(2)

Each resident must be given privacy during treatment and care of personal needs.

(3)

Each resident's records, including information in an automatic data bank, must be treated confidentially.

(4)

Each resident must give written consent before the ICF may release information from his record to someone not otherwise authorized by law to receive it.

(5)

A married resident must be given privacy during visits by his spouse.

(6)

If both husband and wife are residents of the ICF, they must be permitted to share a room.

(h)

Work. No resident may be required to perform services for the ICF.

(i)

Freedom of association and correspondence. Each resident must be allowed to:

(1)

Communicate, associate, and meet privately with individuals of his choice, unless this infringes on the rights of another resident; and

(2)

Send and receive personal mail unopened.

(j)

Activities. Each resident must be allowed to participate in social, religious, and community group activities.

(k)

Personal possessions. Each resident must be allowed to retain and use his personal possessions and clothing as space permits.

12.

Written Policies and Procedures: Delegation of Rights and Responsibilities.

(a)

The ICF must have written policies and procedures that provide that all rights and responsibilities of a resident pass to the resident's guardian, next of kin, or sponsoring agency or agencies if the resident:

(1)

Is adjudicated incompetent under State law; or

(2)

Is determined by his physician to be incapable of understanding his rights and responsibilities.

(b)

If the resident is determined to be incapable of understanding his rights and responsibilities, the physician who made the determination must record the specific reason in the resident's record.

13.

Emergencies. The ICF must:

(a)

Have a written plan for staff and residents to follow in case of an emergency such as a fire or an explosion and rehearse the plan regularly; and

(b)

Have written procedures for the staff to follow in case of an emergency involving a resident. These emergency procedures must include directions for:

(1)

Caring for the resident;

(2)

Notifying the attending physician and other individuals responsible for the resident; and

(3)

Arranging for transportation, hospitalization, or other appropriate services.

14.

Staff Training Programs. The ICF must:

(a)

Conduct an orientation program for all new employees that includes a review of all its policies;

(b)

Plan and conduct an inservice staff development program for all personnel to assist them in developing and improving their skills; and

(c)

Maintain a record of each orientation and staff development program it conducts. The record must include the content of the program and the names of the participants.

15.

Health and Safety Laws. The ICF must meet all Federal, State, and local laws, regulations, and codes pertaining to health and safety, such as provisions regulating:

(a)

Buying, dispensing, safeguarding, administering, and disposing of medications and controlled substances;

(b)

Construction, maintenance, and equipment for the ICF;

(c)

Sanitation;

(d)

Communicable and reportable diseases; and

(e)

Post mortem procedures.

16.

Transfer Agreements.

(a)

Except as provided in paragraph (b) of this section, the ICF must have in effect a transfer agreement with one or more hospitals sufficiently close by to make feasible the prompt transfer of the resident and his records to the hospital and to support a working arrangement between the ICF and the hospital for providing inpatient hospital services to residents when needed.

(b)

If the survey agency finds that the ICF tried in good faith to enter into an agreement but could not, the ICF will be considered to meet the requirements of paragraph (a) of this section, as long as the survey agency finds that it is in the public interest and essential to assuring ICF services for eligible individuals in the community.

17.

Arrangements with outside resources.

(a)

If the ICF does not employ a qualified professional to furnish a required institutional service, it must have in effect a written agreement with a qualified professional outside the ICF to furnish the required service.

(b)

The agreement must:

(1)

Contain the responsibilities, functions, objectives, and other terms agreed to by the ICF and the qualified professional; and

(2)

Be signed by the administrator or his representative and by the qualified professional.

(c)

The ICF must maintain effective arrangements with outside resources for promptly providing medical and remedial services required by a resident but not regularly provided within the ICF.

18.

Resident Record System.

(a)

The ICF must maintain an organized resident record system that contains a record for each resident.

(b)

The ICF must make resident records available to staff directly involved with the resident and to appropriate representatives of the Medicaid agency.

(c)

Each resident's record must contain:

(1)

Identification information;

(2)

Admission information, including the medical and social history of the resident;

(3)

An overall plan of care as described in 442.319;

(4)

Copies of the initial and periodic examinations, evaluations, progress notes, all plans of care with subsequent changes, and discharge summaries;

(5)

Description of treatments and services provided and medications administered; and

(6)

All indications of illness or injury including the date, time, and action taken regarding each.

(d)

The ICF must protect the resident records against destruction, loss, and unauthorized use.

(e)

The ICF must keep a resident's record for at least 3 years after the date the resident is discharged.

19.

Overall Plan of Care. The overall plan of care required by 442.318 must:

(a)

Set the goals to be accomplished by the resident;

(b)

Prescribe an integrated program of activities, therapies, and treatments designed to help each resident achieve his goals; and

(c)

Indicate which professional service or individual is responsible for each service prescribed in the plan.

20.

Resident Financial Records.

(a)

The ICF must maintain a current, written financial record for each resident that includes written receipts for:

(1)

All personal possessions and funds received by or deposited with the ICF; and

(2)

All disbursements made to or for the resident.

(b)

The financial record must be available to the resident and his family.

Safety Standards

21.

Fire Protection.

(a)

Except as provided in 442.322 and 442.323 and paragraph (b) of this section, the ICF must meet the provisions of the Life Safety Code of the National Fire Protection Association, 1967 edition, that apply to institutional occupancies.

(b)

If the Secretary finds that the State has a fire and safety code imposed by State law that adequately protects residents in ICF's, the State survey agency may apply the State code for the purposes of the Medicaid certification instead of the Life Safety Code.

22.

Fire Protection: Exception For Smaller Icf's. The State survey agency may apply the lodgings or rooming houses section of the residential occupancy requirements of the Life Safety Code of the National Fire Protection Association, 1967 edition, instead of the institutional occupancy provisions required by 442.321 to an ICF that has 15 beds or less if the ICF is primarily engaged in the treatment of alcoholism and drug abuse and a physician certifies that each resident is:

(a)

Ambulatory;

(b)

Engaged in an active program for rehabilitation designed to and reasonably expected to lead to independent living; and

(c)

Capable of following directions and taking appropriate action for self-preservation under emergency conditions.

23.

Fire protection: Waivers.

(a)

The State survey agency may waive specific provisions of the Life Safety Code required by 442.321, for as long as it considers appropriate, if:

(1)

The waiver would not adversely affect the health and safety of the residents;

(2)

Rigid application of specific provisions of the Code would result in unreasonable hardship for the ICF as determined under guidelines contained in the HCFA Long-Term Care Manual; and

(3)

The waiver is granted in accordance with criteria contained in the Long-Term Care Manual.

(b)

If the State survey agency waives provisions of the Code for an existing building of two or more stories that is not built of at least 2-hour fire-resistive construction, the ICF may not house a blind, nonambulatory, or physically handicapped resident above the street-level floor unless it is built of:

(1)

One-hour protected, noncombustible construction as defined in National Fire Protection Association Standard No. 220;

(2)

Fully sprinklered, 1-hour protected, ordinary construction; or

(3)

Fully sprinklered, 1-hour protected, wood frame construction.

Environmental and Sanitation Standards

24.

Resident living areas. The ICF must:

(a)

Design and equip the resident living areas for the comfort and privacy of each resident; and

(b)

Have handrails that are firmly attached to the walls in all corridors used by residents.

25.

Residents' rooms.

(a)

Each resident room must:

(1)

Be equipped with or conveniently located near toilet and bathing facilities;

(2)

Be at or above grade level;

(3)

Contain a suitable bed for each resident and other appropriate furniture;

(4)

Have closet space that provides security and privacy for clothing and personal belongings;

(5)

Contain no more than four beds

(6)

Measure at least 100 square feet for a single-resident room or 80 square feet for each resident for a multi-resident room; and

(7)

Be equipped with a device for calling the staff member on duty.

(b)

For an existing building, the State survey agency may waive the space and occupancy requirements of paragraphs (a)(5) and (6) of this section for as long as it is considered appropriate if it finds that:

(1)

The requirements would result in unreasonable hardship on the ICF if strictly enforced; and

(2)

The waiver serves the particular needs of the residents and does not adversely affect their health and safety.

26.

Bathroom facilities. The ICF must:

(a)

Have toilet and bathing facilities that are located in or near residents' rooms and are appropriate in number, size, and design to meet the needs of the residents;

(b)

Provide an adequate supply of hot water at all times for resident use; and

(c)

Have plumbing fixtures with control valves that automatically regulate the temperature of the hot water used by residents.

27.

Linen supplies. The ICF must have available at all times enough linen for the proper care and comfort of the residents and have clean linen on each bed.

28.

Therapy and isolation areas.

(a)

The ICF's therapy area must be of sufficient size and appropriate design to:

(1)

Accommodate the necessary equipment;

(2)

Conduct an examination; and

(3)

Provide treatment.

(b)

The ICF must make provision for isolating residents with infectious diseases.

29.

Dining, recreation, and social rooms.

(a)

The ICF must provide one or more areas, not used for corridor traffic, for dining, recreation, and social activities.

(b)

A multipurpose room may be used if it is large enough to accommodate all of the activities without their interfering with each other.

30.

Building accessibility and use.

(a)

The ICF must:

(1)

Be accessible to and usable by all residents, personnel, and the public, including individuals with disabilities; and

(2)

Meet the requirements of American National Standards Institute (ANSI) standard No. A117.1 (1961), American standard specifications for making building and facilities accessible to and usable by the physically handicapped.

(b)

The State survey agency may waive, for as long as it considers appropriate, provisions of ANSI standard No. A117.1 (1961) if:

(1)

The construction plans for the ICF or a part of it were approved and stamped by the responsible State agency before March 18, 1974;

(2)

The provisions would result in unreasonable hardship on the ICF if strictly enforced; and

(3)

The waiver does not adversely affect the health and safety of the residents.

Meal Service

31.

Meal service. The ICF must:

(a)

Serve at least three meals or their equivalent each day at regular times, with not more than 14 hours between a substantial evening meal and breakfast;

(b)

Procure, store, prepare, distribute, and serve all food under sanitary conditions; and

(c)

Provide special eating equipment and utensils for residents who need them.

32.

Menu planning and supervision.

(a)

The ICF must have a staff member trained or experienced in food management or nutrition who is responsible for:

(1)

Planning menus that meet the nutritional needs of each resident, following the orders of the resident's physician and, to the extent medically possible, the recommended dietary, allowances of the Food and Nutrition Board of the National Research Council, National Academy of Sciences (Recommended Dietary Allowances (8th ed., 1974) is available from the Printing and Publications Office, National Academy of Sciences, Washington, D.C. 20418); and

(2)

Supervising the meal preparation and service to insure that the menu plan is followed.

(b)

If the ICF has residents who require medically prescribed special diets, the ICF must:

(1)

Have the menus for those residents planned by a professionally qualified dietitian, or reviewed and approved by the attending physician; and

(2)

Supervise the preparation and serving of meals to insure that the resident accepts the special diet.

(c)

The ICF must keep for 30 days a record of each menu as served.

Medications

33.

Licensed pharmacist. The ICF must either:

(a)

employ a licensed pharmacist; or

(b)

Have a formal arrangement with a licensed pharmacist to advise the ICF on ordering, storage, administration, disposal, and recordkeeping of drugs and biologicals.

34.

Orders for medications.

(a)

The resident's attending or staff physician must order all medications for the resident.

(b)

The order may be either oral or written.

(c)

If the order is oral:

(1)

The physician must give it only to a licensed nurse, pharmacist, or another physician; and

(2)

The individual receiving the order must record and sign it immediately and have the attending physician sign it in a manner consistent with good medical practice.

35.

Methods to control medication dosage. The ICF must have written policies and procedures for controlling medication dosage, by automatic stop orders or other methods, when the physician does not include in the order a specific limit on the time or number of doses. These procedures must include notice to the attending physician that the medication is being stopped as of a certain date or after a certain number of doses.

36.

Review of medications.

(a)

A registered nurse must review medications monthly for each resident and notify the physician if changes are appropriate.

(b)

The attending or staff physician must review the medications quarterly.

37.

Administering medications.

(a)

Before administering any medication to a resident, a staff member must complete a State-approved training program in medication administration.

(b)

The ICF may allow a resident to give himself a medication only if the attending physician gives permission.

Health Services

38.

Health services.

(a)

The ICF must provide for each resident health services that:

(1)

Meet the requirements of 442.339 through 442.342; and

(2)

Include treatment, medications, diet, and any other health service prescribed or planned for the resident.

(b)

The ICF must provide these services 24 hours a day.

39.

Supervision.

(a)

The ICF must have a registered nurse or a licensed practical or vocational nurse to supervise the ICF's health services full time, 7 days a week, on the day shift.

(b)

The nurse must have a current license to practice in the State.

(c)

If the ICF employs a licensed or practical or vocational nurse to supervise health services, the ICF must have a formal contract with a registered nurse to consult with the licensed practical or vocational nurse at regular intervals, but not less than 4 hours each week.

(d)

To be qualified to serve as a health services supervisor, a licensed practical or vocational nurse must:

(1)

Be a graduate of a State-approved school of practical nursing;

(2)

Have education or other training that the State authority responsible for licensing practical nurses considers equal to graduation from a State-approved school of practical nursing; or

(3)

Have passed the Public Health Service examination for waivered licensed practical or vocational nurses.

(e)

The ICF may employ as charge nurse an individual who is licensed by the State in a category other than registered nurse or licensed practical or vocational nurse if:

(1)

The individual has completed a training program to get the license that included at least the same number of classroom and practice hours in all nursing subjects as in the program of a State-approved school of practical or vocational nursing; and

(2)

The State agency responsible for licensing the individual submits a report to the Medicaid agency comparing State-licensed practical nurse or vocational nurse course requirements with those for the program completed by the individual.

40.

24-hour staffing. The ICF must have responsible staff members on duty and awake 24 hours a day to take prompt, appropriate action in case of injury, illness, fire, or other emergency.

41.

Individual health care plan.

(a)

Appropriate staff must develop and implement a written health care plan for each resident according to the instructions of the attending or staff physician.

(b)

The plan must be reviewed and revised as needed but at least quarterly.

42.

Nursing care. The ICF must provide nursing care for each resident as needed, including restorative nursing care that enables each resident to achieve and maintain the highest possible degree of function, self-care, and independence.

Other Services

43.

Rehabilitative services.

(a)

The ICF must provide rehabilitative services for each resident as needed.

(b)

The ICF must either provide these services itself or arrange for them with qualified outside resources.

(c)

The rehabilitative services must be designed to:

(1)

Maintain and improve the resident's ability to function independently;

(2)

Prevent, as much as possible, advancement of progressive disabilities; and

(3)

Restore maximum function.

(d)

The rehabilitative services must be provided by:

(1)

Qualified therapists or qualified assistants, as defined in 42 CFR 405.1101(m), (n), (q), (r), and (t), in accordance with accepted professional practices; and

(2)

Other supportive personnel under appropriate supervision.

(e)

The rehabilitative services must be provided under a written plan of care that is:

(1)

Developed in consultation with the attending physician and, if necessary, an appropriate therapist; and

(2)

Based on the attending physician's orders and an assessment of the resident's needs.

(f)

The resident's progress under the plan must be reviewed regularly and the plan must be changed as necessary.

44.

Social services.

(a)

The ICF must provide social services for each resident as needed.

(b)

The ICF must either provide these services itself or arrange for them with qualified outside resources.

(c)

The ICF must designate one staff member, qualified by training or experience, to be responsible for:

(1)

Arranging for social services; and

(2)

Integrating social services with other elements of the plan of care.

(d)

These services must be provided under a written plan of care that is:

(1)

Placed in the resident's record; and

(2)

Evaluated periodically in conjunction with the resident's overall plan of care.

45.

Activities program. The ICF must:

(a)

Provide an activities program designed to encourage each resident to maintain normal activity and to return to self-care;

(b)

Designate one staff member, qualified by training or experience in directing group activity, to be responsible for it;

(c)

Have a plan for independent and group activities for each resident that is:

(1)

Developed according to his needs and interests;

(2)

Incorporated in his overall plan of care;

(3)

Reviewed, with his participation, at least quarterly; and

(4)

Changed as needed.

(d)

Provide adequate recreation areas with sufficient equipment and materials to support the program.

46.

Physician services.

(a)

The ICF must have policies and procedures to insure that the health care of each resident is under the continuing supervision of a physician.

(b)

The physician must see the resident whenever necessary but at least once every 60 days unless the physician decides that this frequency is unnecessary and records the reasons for that decision.