(c) Standard; linen. The facility has available at all times a quantity of linen essential for the proper care and comfort of patients. Linens are handled, stored, and processed so as to control the spread of infection. The factors explaining the standard are as follows:

(1) The linen supply is at least three times the usual occupancy.

(2) Clean linen and clothing are stored in clear, dry, dust-free areas easily accessible to the nurses' station.

(3) Soiled linen is stored in separate well-ventilated areas, and is not permitted to accumulate in the facility. Soiled linen and clothing are stored separately in suitable bags or containers.

(4) Soiled linen is not sorted, laundered, rinsed, or stored in bathrooms, patient rooms, kitchens or food storage areas.

a

The extended care facility has written procedure to be followed in case of fire or other disaster.

(a) Standard; disaster plan. The facility has a written procedure to be followed in case of fire, explosion or other emergency. It specifies persons to be notified, locations of alarm signals and fire extinguishers, evacuation routes, procedures for evacuating helpless patients, frequency of fire drills, and assignment of specific tasks and responsibilities to the personnel of each shift.

(b) The factors explaining the standard are as follows:

(1) The plan is developed with the assistance of qualified fire and safety experts.

(2) All personnel are trained to perform assigned tasks.

(3) Simulated drills testing the effectiveness of the plan are conducted on each shift at least three times a year. (4) The plan is posted throughout the facility.

sional services furnished; and (2) review of each case of continuous extended duration.

(b) General. (1) There are many types of plans which can fulfill the requirements of title XVIII of the Act. Extended care facilities wishing to establish their eligibility to participate will be required to submit a written description of their utilization review plan and a certification that it is currently in effect or that it will be in effect no later than the first day on which the extended care facility expects to become a participating provider of services. Ordinarily, this will constitute sufficient evidence to support a finding that the utilization review plan of the extended care facility is or is not in conformity with the statutory requirements.

(2) The review plan of an extended care facility should have as its overall objectives the maintenance of high quality patient care, more effective utilization of extended care services (through the mechanism of an educational approach involving study of patterns of care), the encouragement of appropriate utilization, and the assurance of continuity of care upon discharge (through, among other things, the accumulation of appropriate data on the availability of other facilities and services).

(3) The review of professional services furnished might include study of such conditions as overuse or underuse of services, proper use of consultation, and whether the required nursing and related care is initiated and carried out promptly. While review of lengths of stay for purposes of determining whether continued inpatient stay in the extended care facility is medically necessary, must be based on medical factors, the plan should take into account the need to assure that assistance is available to the physician in arranging for discharge planning.

(4) Costs incurred in connection with the implementation of the utilization review plan are includable in reasonable costs and are reimbursable to the extent that such costs relate to health insurance program beneficiaries.

(c) Standard; responsibility for plan. The operation of the utilization review plan is a responsibility of the medical profession. The plan for reviewing utilization in the facility is developed with the advice of the facility's group of professional personnel referred to in § 405.1122 and has the approval of the facility's

medical staff, if any, and the facility's governing body.

(d) Standard; statement of plan. The extended care facility has a currently applicable, written description of its utilization review plan. Such description includes:

(1) The organization and composition of the committee(s) which will be responsible for the utilization review functions;

(2) Frequency of meetings;

(3) The type of records to be kept; (4) The method to be used in selecting cases on a sample or other basis;

(5) The definition of what constitutes the period or periods of extended duration;

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

(7) Arrangements for committee reports and their dissemination;

(8) Responsibilities of the facility's administrative staff in support of utilization review.

or

(ii) By a committee(s) or group(s) outside the facility composed as in subdivision (i) of this subparagraph which is established by the local medical society and some or all of the hospitals and extended care facilities in the locality; or (iii) Where a committee(s) group(s) as described in subdivision (1) or (ii) of this subparagraph has not been established to carry out all the utilization review functions prescribed by the Act, by a committee(s) or group(s) composed as in subdivision (1) of this subparagraph, and sponsored and organized in such manner as approved by the Secretary.

(2) The factors explaining the standard are as follows:

(1) The medical care appraisal and educational aspects of review on a sample or other basis, and the review of longstay cases need not be done by the same committee or group.

(li) In a facility with an organized medical staff, all of the review functions may be carried out in the facility by a committee of the whole or a medical care appraisal committee.

(iii) No physician with a financial interest, direct or indirect, in an extended care facility may serve on the utilization review committee of that facility unless

(a) The Secretary determines that the financial interest held by such physician is not significant and presents no conflict of interest, or

(b) The Secretary determines that for an interim period of time utilization review cannot be made in any alternative manner in the facility because of the nonavailability of other physicians to serve as members of the committee.

(iv) Under subparagraph (1)(iii) of this paragraph, any sponsorship of a utilization review committee or group is ordinarily acceptable if it is composed as in subparagraph (1)(i) of this paragraph.

(f) Standard; basis for review. (1) Reviews are made, on a sample or other basis, of admissions, duration of stays, and professional services (including drugs and biologicals) furnished, with respect to the medical necessity of the services, and for the purpose of promoting the most efficient use of available health facilities and services. Such reviews emphasize identification and analysis of patterns of patient care in order to maintain consistent high quality. The review is accomplished by considering the data obtained by any one or any combination of the following:

(i) By use of services and facilities of external organizations which compile statistics, design profiles, and produce other comparative data; or

(ii) By cooperative endeavor with the fiscal intermediary or State agency; or (iii) By studies of medical records of patients of the institution.

(2) The factors explaining the standard are as follows:

(i) Some review functions are carried out on a continuing basis.

(ii) Reviews include a sample of physician recertifications of medical necessity for extended care facility services, as made for purposes of the Health Insurance for the Aged Program.

(g) Standard; extended duration cases. (1) Reviews are made of each beneficiary case of continuous extended duration. The definition of such extended

duration is reasonable and consonant with the intent of the benefit. The extended care facility's utilization review plan specifies the number of continuous days of stay in the extended care facility following which a review is made to determine whether further inpatient extended care services are medically necessary. The plan may specify a different number of days for different classes of

cases.

(2) Reviews for such purpose are made no later than the seventh day following the last day of the period of extended duration specified in the plan. No physician has review responsibility for any case of continuous extended duration in which he was professionally involved.

(3) If physician members of the committee decide, after opportunity for consultation is given the attending physician by the committee, that further inpatient stay is not medically necessary, there is to be prompt notification (within 48 hours) in writing to the facility, the physician responsible for the patient's care, and the patient or his representative. Because there are significant divergences in opinion among individual physicians with respect to evaluation of medical necessity for posthospital extended care services, the judgment of the attending physician in an extended stay case is given great weight, and is not rejected except under unusual circumstances.

(h) Standard; maintenance of records of review. Records are kept of the activities of the committee; and reports are regularly made by the committee to the executive committee of the medical staff (if any) or to the facilities, institutions, and organizations sponsoring the utilization review plan, and relevant information and recommendations are reported through usual channels to the entire medical staff and the governing body of the facility, and the sponsor of the plan. The factors explaining the standard are as follows:

(1) The extended care facility administration studies and acts upon Administrative recommendations made by the utilization review committee.

(2) A summary of the number and types of cases reviewed, and the findings, are part of the records of the committee and the participating facilities and institutions.

(3) Minutes of each committee meeting are maintained.

(4) Committee action in extended stay cases is recorded, with cases identified only by case number when possible.

(1) Standard; staff cooperation with review committee. The committee(s) having responsibility for utilization review functions have the support and assistance of the facility's administrative staff in assembling information, facilitating chart reviews, conducting studies, exploring ways to improve procedures, maintaining committee records, promoting the most efficient use of available health services and facilities, and in planning for the patient's continuity of care upon discharge. The factors explaining the standard are as follows:

(1) With respect to each of these activities, an individual or department is designated as being responsible for the particular service.

as

(2) In order to encourage the most efficient use of available health services and facilities, assistance to the physician in timely planning for care following extended facility care is initiated promptly as possible, either by the facility's staff, or by arrangement with other agencies. For this purpose, the facility makes available to the attending physician current information on resources available for continued noninstitutional or custodial care of patients and arranges for prompt transfer of appropriate medical and nursing information in order to assure continuity of care upon discharge of a patient.

[32 F.R. 14931, Oct. 28, 1967, as amended at 35 F.R. 12890, Aug. 14, 1970]

Subpart L-Conditions of Participa

tion; Home Health Agencies

AUTHORITY: The provisions of this Subpart L issued under sections 1102, 1861 (o), 1863, 1864, 1871; 49 Stat. 647, as amended, 79 Stat. 320, 79 Stat. 325-326, 79 Stat. 331; 42 U.S.C. 1302, 1395 et seq.

SOURCE: The provisions of this Subpart L appear at 33 F.R. 12090, Aug. 27, 1968, unless otherwise noted.

§ 405.1201 General.

(a) In order to participate as a home health agency in the health insurance program for the aged, an institution must be a "home health agency" within the meaning of section 1861 (o) of the Social Security Act. This section of the law states a number of specific requirements which must be met by participating home health agencies and authorizes the Secretary of Health, Education, and Welfare to

(0) The term "home health agency" means a public agency or private organization, or a subdivision of such an agency or organization, which

(1) Is primarily engaged in providing skilled nursing services and other therapeutic services;

(2) Has policies, established by a group of professional personnel (associated with the agency or organization), including one or more physicians and one or more registered professional nurses, to govern the services (referred to in paragraph (1)) which it provides, and provides for supervision of such services by a physician or registered professional nurse;

(4) In the case of an agency or organization in any State in which State or applicable local law provides for the licensing of agencies or organizations of this nature, (A) is licensed pursuant to such law, or (B) is approved, by the agency of such State or locality responsible for licensing agencies or organizations of this nature, as meeting the standards established for such licensing; and

(5) Meets such other conditions of participation as the Secretary may find necessary in the interest of the health and safety of individuals who are furnished services by such agency or organization;

except that such term shall not include a private organization which is not a nonprofit organization exempt from Federal income taxation under section 501 of the Internal Revenue Code of 1954 (or a subdivision of such organization) unless it is licensed pursuant to State law and it meets such additional standards and requirements as may be prescribed in regulations; and except that for purposes of Part A such term shall not include any agency or organization which is primarily for the care and treatment of mental diseases.

(b) The requirements included in the statute and the additional health and safety requirements prescribed by the Secretary are set forth in the Conditions of Participation for Home Health Agencies. A home health agency which meets all of the specific statutory requirements and which is found to be in substantial compliance with the additional conditions prescribed by the Secretary may, if it so desires, agree to become a participating home health agency.

(c) The Secretary may, at the request of a State, approve higher health

and safety requirements for that State. Also, where a State or political subdivision imposes higher requirements on home health agencies as a condition for the purchase of services under a State plan approved under title I, XVI, or XIX of the Social Security Act, the Secretary is required to impose like requirements as a condition to the payment for services by such home health agencies in that State or subdivision. (See Addenda to §§ 405.1222 and 405.1223.)

(d) Attention is invited to the requirements of Title VI of the Civil Rights Act of 1964 (78 Stat. 252; P.L. 88-352) which provides that no person in the United States shall, on the ground of race, color, or national origin be excluded from participation in, be denied the benefits of, or be subject to discrimination under any program or activity receiving Federal financial assistance (sec. 601), and to the implementing regulation issued by the Secretary of Health, Education, and Welfare with the approval of the President (Part 80 of title 45 of the Code of Federal Regulations). § 405.1202 Conditions of participation;

general.

For an agency to be eligible for participation in the program, it must meet the statutory requirements of section 1861(0) and there must be a finding of substantial compliance on the part of the agency with all the other conditions. These conditions which include both the statutory requirements and the additional health and safety requirements prescribed by the Secretary are set forth in § 405.1220 et seq. They are requirements relating to the quality of care and the adequacy of the services and facilities which the agency provides. Variations in the type and size of agencies and the nature and scope of services offered will be reflected in differences in the details of organization and staffing. However, the test is whether there is substantial compliance with each of the conditions. § 405.1203 Standards; general.

As a basis for a determination as to whether or not there is substantial compliance with the prescribed conditions in the case of any particular home health agency, explanations are given under each condition. These explanations provide an indication of the various ways in which such agencies may carry out the functions embodied in the conditions. Reference to these explanations will enable the State agency surveying a home

health agency to document the activities of the agency, to establish the nature and extent of its deficiencies, if any, with respect to any particular function, and to assess the agency's need for improvement in relation to the prescribed conditions. In substance, the explanations will help the State agency determine the extent and degree to which a home health agency is complying with each condition.

§ 405.1204 Certification by State agency.

(a) The Health Insurance for the Aged Act provides that the services of State agencies, operating under agreements with the Secretary, will be used by the Secretary in determining whether institutions meet the conditions of participation. Pursuant to these agreements, State agencies will certify to the Secretary home health agencies which are found to be in substantial compliance with the conditions. Such certifications shall include findings as to whether each of the conditions is substantially met. The Secretary, on the basis of such certification from the State agency, will determine whether or not an entity is a home health agency eligible to participate in the health insurance program as a provider of services.

(b) The decisions of the State agency represent recommendations to the Secretary. Notice of determination of eligibility or noneligibility made by the Secretary on the basis of a State agency decision will be sent to the home health agency by the Social Security Administration after such review and professional consultation with the Public Health Service as may be required. If it is determined that the home health agency does not comply with the conditions of participation, the home health agency may request that the determination be reviewed. For procedures relating to appeals process, see Subpart O of this Part 405.

[33 F.R. 12090, Aug. 27, 1968, as amended at 33 F.R. 18647, Dec. 18, 1968]

§ 405.1205 Principles for the evaluation of home health agencies to determine whether they meet the conditions of participation.

Home health agencies will be considered in substantial compliance with the conditions of participation upon acceptance by the Secretary of findings, adequately documented and certified to by the State agency, showing that:

(a) The home health agency meets the specific statutory requirements of section 1861 (o) and is found to be operating in accordance with all other conditions of participation with no significant deficiencies, or

(b) The home health agency meets the specific statutory requirements of section 1861(0) but is found to have deficiencies with respect to one or more other conditions of participation which: (1) It is making reasonable plans and efforts to correct, and

(2) Notwithstanding the deficiencies, is rendering adequate care and without hazard to the health and safety of individuals being served, taking into account special procedures or precautionary measures which have been or are being instituted.

§ 405.1206 Time limitations on certifications of substantial compliance.

(a) All initial certifications by the State agency to the effect that a home health agency is in substantial compliance with the conditions of participation will be for a period of 2 years, beginning with July 1, 1966, or, if later, with the date on which the home health agency is first found to be in substantial compliance with the conditions. State agencies may visit or resurvey home health agencies where necessary to ascertain continued compliance or to accommodate to periodic or cyclical survey programs. A State finding and certification to the Secretary that an agency is no longer in compliance may occur within a 2-year or subsequent period of certification and will thereby terminate the State's certification as to compliance.

(b) If a home health agency is in substantial compliance under the provisions of 405.1205 (b), the following information will be incorporated in the Secretary's finding and into the notice of eligibility to the home health agency:

(1) A statement of the deficiencies which were found; and

(2) A description of progress which has been made and further action which is being taken to remove the deficiencies: and

(3) A scheduled time for a resurvey of the home health agency to be conducted not later than the 18th month (or earlier, depending on the nature of the deficiencies) of the period of certification.