902 KAR 20:145. Operations and services; rural health clinics.
RELATES TO: KRS 216B.010-216B.130, 216B.990(1), (2), 42 U.S.C. Part 254r
STATUTORY AUTHORITY: KRS 216B.042(1)
NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042(1) requires the Kentucky Cabinet for Health Services to regulate health facilities and health services. This administrative regulation establishes requirements for the operation and services of rural health clinics.
Section 1. Location and Requirement to Provide Services. (1) A health facility shall not be licensed or relicensed as a rural health clinic unless it:
(a) Is located in an area designated by the United States Public Health Service, Division of Shortage Designation as a:
1. Health professional shortage area; or
2. Medically-underserved area; and
(b) Complies with the requirements established in Sections 2 and 3 of this administrative regulation.
(2) The rural health clinic may be freestanding, or may be a subordinate part of a licensed health facility, or health service.
Section 2. Administration and Operation. (1) The licensee shall be legally responsible for the operation of the clinic and for compliance with federal, state, and local law pertaining to the operation of the clinic.
(2) The rural health clinic shall be under the medical direction of a physician.
(3) The licensee shall establish written policies and lines of authority, and shall designate the person who shall be principally responsible for the daily operation of the clinic.
(4) The licensee shall develop patient care policies with the advice of a group of professional personnel that includes one (1) or more physician, and one (1) or more advanced practice registered nurse or physician assistant. At least one (1) member shall not be an employee of the rural health clinic. The policies shall include:
(a) A description of the services provided directly by the rural health clinic and those provided through agreement;
(b) Guidelines for the medical management of health problems which include the conditions requiring medical consultation and patient referral, and the maintenance of health records;
(c) Procedures to be followed in the storage, handling, and administration of drugs and biologicals; and
(d) Procedures for an annual review and evaluation of the services provided by the clinic.
(5) Personnel. The rural health clinic shall have a staff that includes at least one (1) physician and at least one (1) advanced practice registered nurse or physician assistant. The clinic shall employ other staff or ancillary personnel necessary to provide the services essential to the clinic's operation.
(a) The physician shall:
1. Be responsible for all medical aspects of the center and shall provide direct medical services in accordance with the Medical Practice Act, KRS Chapter 311;
2. Provide medical direction, supervision, and consultation to the staff;
3. In conjunction with the advanced practice registered nurse(s) or physician assistant(s), participate in developing, executing, and periodically reviewing the rural health clinic's written policies and services;
4. Periodically review the rural health clinic's patient records;
5. Provide medical orders and medical care services to patients of the rural health clinic; and
6. Be physically present for weekly consultation;
7. Be available within one (1) hour, through direct telecommunication, for consultation, assistance with medical emergencies, or patient referral.
(b) The advanced practice registered nurse or physician assistant shall:
1. Participate in the development, execution and periodic review of the written policies governing the services the rural health clinic provides;
2. Participate with the physician in periodic review of patient health records;
3. Provide services in accordance with rural health clinic policies, established protocols; and
a. For an advanced practice registered nurse, the Nurse Practice Act, KRS Chapter 314, and administrative regulations relating to the practice of an advanced practice registered nurse; or
b. For a physician assistant, KRS 311.565 and administrative regulations relating to the practice of a physician assistant:
4. Arrange for, or refer a patient to, a needed service that is not provided at the rural health clinic; and
5. Assure that adequate patient health records are maintained and transferred when a patient is referred.
(6) The rural health clinic shall have a linkage agreement or an arrangement for patient referral with each of the following:
(a) Inpatient hospital care;
(b) Physician services in a hospital, patient's home, or long term care facility;
(c) Additional and specialized diagnostic and laboratory services that are not available at the rural health clinic;
(d) Home health agency;
(e) Local health department;
(f) Emergency medical services; and
(g) Pharmacy services.
(7) The rural health clinic shall maintain a clinical record system in accordance with written policies and procedures. A member of the professional staff shall be designated to be responsible for maintaining the records and for insuring that the records are systematically organized, readily accessible and accurately documented.
(8) For a patient receiving health care services, the rural health clinic shall maintain a record that includes, as applicable:
(a) 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 for each contact;
(b) Reports of physical examinations, diagnostic and laboratory test results, and consultative findings;
(c) All orders, reports of treatments rendered and medications given and other pertinent information necessary to monitor the patient's progress;
(d) Signature of the physician or other health care professional on each order written or treatment provided.
(9) The rural health clinic shall maintain the confidentiality of medical record information and shall safeguard against loss, destruction, or unauthorized use. Written policies and procedures shall govern the use and removal of records from the clinic and the condition for release of information.
(10) Medical records shall be retained for a minimum of five (5) years or in the case of a minor, three (3) years after the patient reaches the age of majority under state law, whichever is the longer.
(11) The rural health clinic shall carry out or arrange for an annual evaluation of its total program, consider the findings of the evaluation, and take corrective action, if necessary. The evaluation shall include:
(a) The utilization of clinic services including at least the number of patients served and the volume of services;
(b) A representative sample of both active and closed clinical records;
(c) The rural health clinic's health care policies.
Section 3. Services. (1) The rural health clinic shall develop and maintain written protocols that:
(a) Are signed by a staff physician;
(b) Explicitly direct the step-by-step collection of subjective and objective medical data from a patient;
(c) Direct explicit medical action depending on the medical data collected; and
1. Standing orders;
2. Rules of practice; and
3. Medical directives.
(2) The rural health clinic staff shall furnish diagnostic and therapeutic services and supplies 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.
(3) The rural health clinic shall provide basic laboratory services essential to the immediate diagnosis and treatment of the patient, including:
(a) Chemical examinations of urine by stick or tablet methods, or both, including urine ketones;
(b) Hemoglobin or hematocrit;
(d) Examination of stool specimens for occult blood;
(e) Pregnancy tests; and
(f) Primary culturing for transmittal to a hospital laboratory or licensed laboratory.
(4) The rural health clinic shall provide medical emergency procedures as a first response to common life-threatening injuries and acute illness, and shall have available the drugs and biologicals commonly used in lifesaving procedures, such as analgesics, local anesthetics, antibiotics, anticonvulsants, antidotes and emetics, serums and toxoids.
(5) The clinic shall post in a conspicuous area at the entrance, visible from the outside of the clinic, the hours that emergency medical services will be available in the clinic, and where emergency medical services not provided by the clinic can be obtained during and after the clinic's regular scheduled hours of operation. (8 Ky.R. 420; eff. 1-6-1982; Am. 16 Ky.R. 1010; eff. 1-12-1990; 21 Ky.R. 608; 1056; eff. 9-21-1994; 28 Ky.R. 715; 1149; eff. 10-17-2001; TAm eff. 3-11-2011.)