As used in this subpart, unless the context indicates otherwise:

(a) "Direct services " means services provided by the clinic's staff.

(b) "Nurse practitioner means a registered professional nurse who is currently licensed to practice in the State, who meets the State's requirements governing the qualifications of nurse practitioners, and who meets one of the following conditions:

(1) Is currently certified as a primary care nurse practitioner by the American Nurses' Association or by the National Board of Pediatric Nurse Practitioners and Associates; or

(2) Has satisfactorily completed a formal 1 academic year educational program that:

(i) Prepares registered nurses to perform an expanded role in the delivery of primary care;

(ii) Includes at least 4 months (in the aggregate) of classroom instruction and a component of supervised clinical practice; and

(iii) Awards a degree, diploma, or certificate to persons who successfully complete the program; or

(3) Has successfully completed a formal educational program (for preparing registered nurses to perform an expanded role in the delivery of primary care) that does not meet the requirements of paragraph (b)(2) of this section, and has been performing an expanded role in the delivery of primary care for a total of 12 months during the 18-month period immediately preceding the effective date of this subpart.

(c) "Physician" means a doctor of medicine or osteopathy legally authorized to practice medicine or surgery in the State.

a

(d) "Physician assistant" means person who meets the applicable State requirements governing the qualifications for assistants to primary care physicians, and who meets at least one of the following conditions:

(1) Is currently certified by the National Commission on Certification of Physician Assistants to assist primary care physicians; or

(2) Has satisfactorily completed a program for preparing physician's assistants that:

(i) Was at least 1 academic year in length;

(ii) Consisted of supervised clinical practice and at least 4 months (in the aggregate) of classroom instruction directed toward preparing students to deliver health care; and

(iii) Was accredited by the American Medical Association's Committee on Allied Health Education and Accreditation; or

(3) Has satisfactorily completed a formal educational program (for preparing physician assistants) that does not meet the requirements of paragraph (d)(2) of this section and has been assisting primary care physicians for a total of 12 months during the 18month period immediately preceding the effective date of this subpart.

(e) "Rural area" means an area that is not delineated as an urbanized area by the Bureau of the Census.

(f) "Rural health clinic" or "clinic" means a clinic that is located in a rural area designated as a shortage area, is not a rehabilitation agency or a facility primarily for the care and treatment of mental diseases, and meets all other requirements of this subpart.

(g) "Shortage area" means a defined geographic area designated by the Department as having either a shortage of personal health services (under section 1302(7) of the Public Health Service Act) or a shortage of primary medical care manpower (under section 332 of that Act).

(h) "Secretary" means the Secretary of Health and Human Services, or any official to whom he has delegated the pertinent authority.

(Secs. 1102, 1833 and 1902(a)(13), Social Security Act: 49 Stat. 647, 91 Stat. 1485 (42 U.S.C. 1302, 13951 and 1396(a)(13)))

[43 FR 5375, Feb. 8, 1978, as amended at 43 FR 30528, July 14, 1978]

§ 481.3 Certification procedures.

A rural health clinic will be certified for participation in Medicare in accordance with Subpart S of 42 CFR Part 405. The Secretary will notify the State Medicaid agency whenever he has certified or denied certification under Medicare for a prospective rural health clinic in that State. A clinic certified under Medicare will be deemed to meet the standards for certification under Medicaid.

§ 481.4 Compliance with Federal, State and local laws.

The rural health clinic and its staff are in compliance with applicable Federal, State and local laws and regulations.

(a) Licensure of clinic. The clinic is licensed pursuant to applicable State and local law.

(b) Licensure, certification or registration of personnel. Staff of the clinic are licensed, certified or registered in accordance with applicable State and local laws.

§ 481.5 Location of clinic.

(a) Basic requirement. The clinic is located in a rural area that is designated as a shortage area, and may be a permanent or a mobile unit.

(1) Permanent unit. The objects, equipment and supplies necessary for the provision of the services furnished directly by the clinic are housed in a permanent structure.

(2) Mobile unit. The objects, equipment, and supplies necessary for the provision of the services furnished directly by the clinic are housed in a mobile structure which has fixed, scheduled location(s).

Under this requirement, if clinic services are furnished at permanent units in more than one location, each unit will be independently considered for certification as a rural health clinic.

(b) Exceptions. (1) A facility certified under this subpart will not be disqualified if the area in which it is located subsequently fails to meet the definition of rural, shortage area.

(2) A private, nonprofit facility that meets all other conditions of this sub

part except for location in a shortage area will be certified if, on July 1, 1977, it was operating in a rural area that is determined by the Secretary (on the basis of the ratio of primary care physicians to the general population) to have an insufficient supply of physicians to meet the needs of the area served.

(3) Determinations on these exceptions will be made by the Secretary upon application by the facility.

(c) Criteria for designation of rural areas. (1) Rural areas are areas not delineated as urbanized areas in the last census conducted by the Census Bureau.

(2) Excluded from the rural area classification are:

(i) Central cities of 50,000 inhabitants or more;

(ii) Cities with at least 25,000 inhabitants which, together with contiguous areas having stipulated population density, have combined populations of 50,000 and constitute, for general economic and social purposes, single communities;

(iii) Closely settled territories surrounding cities and specifically designated by the Census Bureau as urban. (3) Included in the rural area classification are those portions of extended cities that the Census Bureau has determined to be rural.

(d) Criteria for designation of shortage areas. (1) The criteria for determination of shortage of personal health services (under section 1302(7) of the Public Health Services Act), are:

(i) The ratio of primary care physicians practicing within the area to the resident population;

(ii) The infant mortality rate;

(iii) The percent of the population 65 years of age or older; and

(iv) The percent of the population with a family income below the poverty level.

(2) The criteria for determination of shortage of primary medical care manpower (under section 332(a)(1)(A) of the Public Health Services Act) are:

(i) The area served is a rational area for the delivery of primary medical care services;

(ii) The ratio of primary care physicians practicing within the area to the resident population; and

(iii) The primary medical care manpower in contiguous areas is overutilized, excessively distant, or inaccessible to the population in this area.

CROSS REFERENCE: See 42 CFR 110.203(g) and 41 FR 45718, Oct. 15, 1976, and 42 CFR Part 5; 42 FR 1586, Jan. 10, 1978.

§ 481.6 Physical plant and environment.

(a) Construction. The clinic is constructed, arranged, and maintained to insure access to and safety of patients, and provides adequate space for the provision of direct services.

(b) Maintenance. The clinic has a preventive maintenance program to ensure that:

(1) All essential mechanical, electrical and patient-care equipment is maintained in safe operating condition;

(2) Drugs and biologicals are appropriately stored; and

(3) The premises are clean and orderly.

(c) Emergency procedures. The clinic assures the safety of patients in case of non-medical emergencies by:

(1) Training staff in handling emergencies;

(2) Placing exit signs in appropriate locations; and

(3) Taking other appropriate measures that are consistent with the particular conditions of the area in which the clinic is located.

§ 481.7 Organizational structure.

(a) Basic requirements. (1) The clinic is under the medical direction of a physician, and has a health care staff that meets the requirements of § 481.8.

(2) The organization's policies and its lines of authority and responsibilities are clearly set forth in writing.

(b) Disclosure. The clinic discloses the names and addresses of:

(1) Its owners, in accordance with section 1124 of the Social Security Act (42 USC 132 A-3);

(2) The person principally responsible for directing the operation of the clinic; and

(3) The person responsible for medical direction.

§ 481.8 Staffing and staff responsibilities.

(a) Staffing. (1) The clinic has a health care staff that includes one or more physicians and one or more physician's assistants or nurse practition

ers.

(2) The physician member of the staff may be the owner of the clinic, an employee of the clinic, or under agreement with the clinic to carry out the responsibilities required under this section.

(3) The physician's assistant or nurse practitioner member of the staff may be the owner of the clinic or an employee of the clinic.

(4) The staff may also include ancillary personnel who are supervised by the professional staff.

(5) The staff is sufficient to provide the services essential to the operation of the clinic.

(6) A physician, nurse practitioner, or physician assistant is available to furnish patient care services at all times the clinic operates. A nurse practitioner or a physician assistant is available to furnish patient care services at least 60 percent of the time the clinic operates.

(b) Physician responsibilities. (1) The physician:

(i) Provides medical direction for the clinic's health care activities and consultation for, and medical supervision of, the health care staff.

(ii) In conjunction with the physician's assistant and/or nurse practitioner member(s), participates in developing, executing, and periodically reviewing the clinic's written policies and the services provided to Federal program patients; and

(iii) Periodically reviews the clinic's patient records, provides medical orders, and provides medical care services to the patients of the clinic.

(2) A physician is present for sufficient periods of time, at least once in every 2 week period (except in extraordinary circumstances), to provide the medical direction, medical care services, consultation and supervision described in paragraph (b)(1) of this section, and is available through direct telecommunication for consultation, assistance with medical emergencies, or patient referral. The extraordinary

circumstances are documented in the records of the clinic.

(c) Physician assistant and nurse practitioner responsibilities. (1) The physician assistant and the nurse practitioner members of the clinic's staff:

(i) Participate in the development, execution and periodic review of the written policies governing the services the clinic furnishes;

(ii) Participate with a physician in a periodic review of the patients' health records.

(2) The physician assistant or nurse practitioner performs the following functions, to the extent they are not being performed by a physician:

(i) Provides services in accordance with the clinic's policies;

(ii) Arranges for, or refers patients to, needed services that cannot be provided at the clinic; and

(iii) Assures that adequate patient health records are maintained and transferred as required when patients are referred.

(Secs. 1102, 1833, and 1902(a)(13), Social Security Act: 49 Stat. 647, 91 Stat. 1485 (42 U.S.C. 1302, 13951 and 1396a(a)(13)))

[43 FR 5375, Feb. 8, 1978, as amended at 43 FR 30528, July 14, 1978]

§ 481.9 Provision of services.

(a) Basic requirements. (1) All services offered by the clinic are furnished in accordance with applicable Federal, State, and local laws; and (2) the clinic is primarily engaged in providing outpatient health services meets all other conditions of this subpart.

(b) Patient care policies. (1) The clinic's health care services are furnished in accordance with appropriate written policies which are consistent with applicable State law.

(2) The policies are developed with the advice of a group of professional personnel that includes one or more physicians and one or more physician assistants or nurse practitioners. At least one member is not a member of the clinic staff.

(3) The policies include:

(i) A description of the services the clinic furnishes directly and those furnished through agreement or arrangement.

(ii) Guidelines for the medical management of health problems which include the conditions requiring medical consultation and/or patient referral, the maintenance of health care records, and procedures for the periodic review and evaluation of the services furnished by the clinic.

(iii) Rules for the storage, handling, and administration of drugs and biologicals.

(4) These policies are reviewed at least annually by the group of professional personnel required under paragraph (b)(2) of this section, and reviewed as necessary by the clinic.

(c) Direct services—(1) General. The clinic staff furnishes those diagnostic and therapeutic services and supplies that are commonly furnished in a physician's office or at the entry point into the health care delivery system. These include medical history, physical examination, assessment of health status, and treatment for a variety of medical conditions.

(2) Laboratory. The clinic provides basic laboratory services essential to the immediate diagnosis and treatment of the patient, including:

(i) Chemical examinations of urine by stick or tablet methods or both (including urine ketones);

(ii) Microscopic examinations of urine sediment;

(iii) Hemoglobin or hematacrit; (iv) Blood sugar;

(v) Gram stain;

(vi) Examination of stool specimens for occult blood;

(vii) Pregnancy tests;

(viii) Primary culturing for transmittal to a certified laboratory; and (ix) Test for pinworm.

(3) Emergency. The clinic provides medical emergency procedures as a first response to common life-threatening injuries and acute illness, and has available the drugs and biologicals commonly used in life saving procedures, such as analgesics, anesthetics (local), antibiotics, anticonvulsants, antidotes and emetics, serums and toxoids.

(d) Services provided through agreements or arrangements. (1) The clinic has agreements or arrangements with one or more providers or suppliers participating under Medicare or Medicaid

60-131 0-81-50

to furnish other services to its patients, including:

(i) Inpatient hospital care;

(ii) Physician(s) services (whether furnished in the hospital, the office, the patient's home, a skilled nursing facility, or elsewhere); and

(iii) Additional and specialized diagnostic and laboratory services that are not available at the clinic.

(2) If the agreements are not in writing, there is evidence that patients referred by the clinic are being accepted and treated.

(Secs. 1102, 1833, and 1902(a)(13), Social Security Act: 49 Stat. 647, 91 Stat. 1485 (42 U.S.C. 1302, 13951 and 1396a(a)(13))) [43 FR 5375, Feb. 8, 1978, as amended at 43 FR 30528, July 14, 1978]

§ 481.10 Patient health records.

(a) Records system. (1) The clinic maintains a clinical record system in accordance with written policies and procedures.

(2) A designated member of the professional staff is responsible for maintaining the records and for insuring that they are completely and accurately documented, readily accessible, and systematically organized.

(3) For each patient receiving health care services, the clinic maintains a record that includes, as applicable:

(i) Identification and social data, evidence of consent forms, pertinent medical history, assessment of the health status and health care needs of the patient, and a brief summary of the episode, disposition, and instructions to the patient;

(ii) Reports of physical examinations, diagnostic and laboratory test results, and consultative findings;

(iii) All physician's orders, reports of treatments and medications, and other pertinent information necessary to monitor the patient's progress;

(iv) Signatures of the physician or other health care professional.

(b) Protection of record information. (1) The clinic maintains the confidentiality of record information and provides safeguards against loss, destruction or unauthorized use.

(2) Written policies and procedures govern the use and removal of records from the clinic and the conditions for release of information.

(3) The patient's written consent is required for release of information not authorized by law.

(c) Retention of records. The records are retained for at least 6 years from date of last entry, and longer if required by State statute.

(Secs. 1102, 1833 and 1902(a)(13), Social Security Act; 49 Stat. 647, 91 Stat. 1485 (42 U.S.C. 1302, 13951 and 1396a(a)(13)))

[43 FR 30529, July 14, 1978]

(1) The utilization of clinic services, including at least the number of patients served and the volume of services;

(2) A representative sample of both active and closed clinical records; and (3) The clinic's health care policies. (c) The purpose of the evaluation is to determine whether:

(1) The utilization of services was appropriate;

(2) The established policies were followed; and

(3) Any changes are needed.

(d) The clinic staff considers the findings of the evaluation and takes corrective action if necessary.