902 KAR 20:058. Operation and services; primary care center.

902 KAR 20:058. Operation and services; primary care center.

RELATES TO: KRS 216B.010, 216B.015, 216B.040, 216B.042, 216B.045-216B.055, 216B.075, 216B.105-216B.131, 216B.176, 216B.177, 216B.990

STATUTORY AUTHORITY: KRS 216B.042, 216B.105, EO 2004-726

NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042 requires that the Kentucky Cabinet for Health and Family Services regulate health facilities and health services. This administrative regulation provides licensure requirements for the operation of and services provided by primary care centers. EO 2004-726, effective July 9, 2004, reorganized the Cabinet for Health Services and placed the Office of Inspector General and its regulatory authority under the Cabinet for Health and Family Services.

Section 1. Definitions. (1) "Center" means a primary care center.

(2) "Qualified dietitian" or "nutritionist" means:

(a) A person who has a bachelor of science degree in foods and nutrition, food service management, institutional management or related services and has successfully completed a dietetic internship or coordinated undergraduate program accredited by the American Dietetic Association (ADA) and is a member of the ADA or is registered as a dietitian by ADA; or

(b) A person who has a master's degree in nutrition and is a member of ADA or is eligible for registration by ADA; or

(c) A person who has a bachelor of science degree in home economics and three (3) years of work experience with a registered dietitian.

Section 2. Requirement to Provide Services. (1) A primary care center shall:

(a) Have permanent facilities; and

(b) Provide basic health care services to patients of all ages.

(2) A primary care center shall provide:

(a) A variety of preventive, diagnostic, and therapeutic services by appropriately licensed or certified members of the health professions to meet usual health care needs in a manner that ensures the continuity of care; and

(b) Appropriate referrals to patients who require services that are above the level of basic health care services and not provided by the center.

Section 3. Administration and Operations. (1) Licensee.

(a) The licensee shall be legally responsible for the center and for compliance with federal, state and local laws and administrative regulations pertaining to the operation of the center.

(b) The licensee shall establish written policies, for the administration and operation of the service.

(2) Administrator. All centers shall have an administrator who shall be responsible for the operation of the center and shall delegate the responsibility in his absence.

(3) Policies.

(a) Administrative policies. The center shall have written administrative policies covering all aspects of the center's operation, including:

1. A description of organizational structure, staffing and allocation of responsibility and accountability;

2. A description of referral linkages with inpatient facilities and other providers;

3. Policies and procedures for the guidance and control of personnel performances;

4. A description of services directly provided by the center;

5. A description of the administrative and patient care records and reports;

6. A policy for an expense and accrual-based revenue accounting system following generally accepted accounting procedures; and

7. A policy to specify the provision of emergency medical services.

(b) Patient care policies. Patient care policies shall be developed by the staff physician(s) and other professional staff for all medical aspects of the center's program to include:

1. Written protocol(s), to include: standing orders, rules of practice, and medical directives applying to services provided by the center. The protocols shall be signed by the licensed staff physician of the center.

2. The center shall have patient care policies for patients held in the center's holding-observation accommodations.

(c) A system shall be established to ensure that, if feasible, the patient is always cared for by the same health professional or health team, to assure continuity of care.

(d) Patient rights policies. The center shall adopt written policies regarding the rights and responsibilities of patients. These patient rights policies shall assure that each patient:

1. Is informed of these rights and of all rules and administrative regulations governing patient conduct and responsibilities, including a procedure for handling patient grievances.

2. Is informed of services available at the center and of related charges including any charges not covered under Medicare, Medicaid, or other third-party payor arrangements.

3. Is informed of his medical condition, unless medically contraindicated (as documented 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 encouraged and assisted to understand and exercise his patient rights; to this end he may voice grievances and recommend changes in policies and services. Upon the patient's request the grievances and recommendations shall be conveyed within a reasonable time to an appropriate decision making level within the organization which has authority to take corrective action.

5. Is assured confidential treatment of his records and is afforded the opportunity to approve or refuse their release to any individual not involved in his care except as required by Kentucky law or third-party payment contract.

6. Is treated with consideration, respect, and full recognition of his dignity and individuality, including privacy in treatment and in the care of his personal health needs.

(4) Personnel.

(a) Primary care provider team. The center shall have a minimum of one (1) or more full-time licensed physician(s) and either one (1) or more full-time advanced practice registered nurse(s), one (1) or more physician assistant(s), or one (1) or more full-time registered nurse(s).

1. Physician. The physician shall be in active practice and shall be responsible for all medical aspects of the center, and shall provide direct medical services in accordance with KRS Chapter 311. Physicians employed by or having an agreement with the center to perform direct medical services shall be qualified to practice general medicine, for example, general practitioners, family practitioners, obstetrician/gynecologists, pediatricians, and internists. Physicians employed by or having an agreement with the center to perform direct medical services shall be members of the medical staff of, or hold at least courtesy staff privileges at, one (1) or more hospitals with which the center has a formal transfer agreement.

2. Nurse. An advanced practice registered nurse and a registered nurse shall provide services within their respective scopes of practice pursuant to KRS Chapter 314.

3. Physician's assistant. A physician assistant shall provide services within his or her scope of practice pursuant to KRS Chapter 311.

(b) In-service training. All center personnel shall participate in ongoing in-service training programs relating to their respective job activities. These programs shall include thorough job orientation for new personnel, regular in-service training programs, emphasizing professional competence and the human relationship necessary for effective health care.

(5) Medical records.

(a) The center shall maintain a medical record for a patient to include at least the following:

1. Medical and social history, including data obtainable from other providers;

2. Description of each medical visit or contact, to include condition or reason necessitating visit or contact, assessment, diagnosis, services provided, medications and treatments prescribed, and disposition made;

3. Reports of all laboratory, x-ray, and other test findings; and

4. Documentation of all referrals made, to include reason for referral, to whom patient was referred, and any information obtained from referral source.

(b) Confidentiality of all patient records shall be maintained at all times.

(c) Transfer of records. The center shall establish systematic procedures to assist in continuity of care if the patient moves to another source of care, and the center shall, upon proper release, transfer medical records or an abstract thereof if requested.

(d) Retention of records. After the patient's death or discharge the completed medical record shall be placed in an inactive file and retained for five (5) years or if a minor, three (3) years after the patient reaches the age of majority under state law, whichever is the longest.

(6) Linkage agreements.

(a) The center shall have linkages through written agreements with providers of other levels of care which may be medically indicated to supplement the services available in the center. These linkages shall include:

1. Hospitals; and

2. Emergency medical transportation services in the service area.

(b) Linkage agreements with inpatient care facilities shall incorporate provisions for appropriate referral and acceptance of patients from the center, provisions for appropriate coordination of discharge planning with center staff, and provisions for the center to receive a copy of the discharge summary for each patient referred to the center.

1. Responsibility for transfer of information;

2. Responsibility for provision of transportation;

3. Responsibility for sharing of services, equipment, and personnel;

4. Responsibility for provision of total care or portions thereof in relation to facility and agency capability; and

5. Responsibility for patient record confidentiality pursuant to all applicable federal and state law.

(7) Utilization review and medical audit. In order to determine the appropriateness of the services delivered, the center shall establish procedures for the medical audit and utilization review of services provided in the center. The center may use professional capabilities and assistance obtainable from other agencies and sources. There shall be a written plan for utilization review developed by the center including frequency of reviews and composition of the body conducting the review.

Section 4. Provision of Services. (1) Hours of operation and coverage. Scheduled hours of the center's operation shall reasonably accommodate the various segments of the population served. Provisions shall be made for scheduled evening hours and/or weekend hours if needed.

(2) Basic services. The center shall provide directly (except as noted) at least the following services:

(a) Medical diagnostic and treatment services of sufficiently broad scope to accommodate the basic health needs (including prenatal and postnatal care) of all age groups;

(b) Emergency services.

1. The center shall provide emergency medical services during the regularly-scheduled hours for treatment of injuries and minor trauma.

2. The center shall post in a conspicuous area at the entrance, visible from the outside of the center, the hours that emergency medical services will be available in the center, and where emergency medical services not provided by the center can be obtained during and after the center's regular scheduled hours of operation.

(c) Preventive health services of sufficiently broad scope to provide for the usual and expected health needs of persons in all age groups.

(d) Education in the appropriate use of health services and in the contribution each individual can make to the maintenance of his own health.

(e) Chronic illness management.

(f) Laboratory, x-ray and treatment services shall be provided directly or arranged through other providers.

(3) Supplemental services.

(a) The center shall provide additional professional services to complement the basic services provided in the program of the center. At least two (2) of the following services shall be provided by the center at some time during the scheduled hours of operation, either directly or by contract on site. The center shall establish linkages with those supplemental services which currently exist in the service area and which are not provided directly or by contract by the center to include:

1. Pharmacy: licensed pharmacist;

2. Dentistry: licensed dentist;

3. Optometry: licensed optometrist or ophthalmologist;

4. Midwifery services: certified nurse midwife;

5. Family planning;

6. Nutrition: qualified dietitian or nutritionist;

7. Social service counseling: licensed social worker; and

8. Home health: licensed home health agency.

(b) Any center which does not have a linkage agreement with the above listed supplemental services but which documents a good faith attempt to enter into the linkage agreement, shall be exempt from the linkage agreement requirement.

(4) Extension services.

(a) The center may provide primary care services on a temporary or regular basis in locations separate from its permanent facility. The extension locations shall be listed on the licensure application.

(b) With the exception of an extension located at a school and operated under an agreement between the center and a board of education pursuant to KRS 216B.176, the extension shall comply with the minimum staffing requirements of Section 3(4) of this administrative regulation.

1. Patient care;

2. Treatment protocols;

3. Patient rights;

4. Provided services;

5. Medical records;

6. Linkage agreements; and

7. Hours of operation and staffing.

(d) The extension service shall be located within the primary care center's service area.

(e) The center's utilization review program shall include any extension services.

(5) Outreach activities. The physician may engage in outreach activities to provide medical service within the primary care center's service areas.

(6) Holding-observation accommodations. Utilization of holding-observation accommodations maintained by the center will be allowed within the limitations outlined below:

(a) Utilization of these accommodations shall not exceed twenty-four (24) hours medical observation or recuperation in anticipation of transfer to an inpatient facility or to the patient's home.

(b) The decision to hold a patient shall be the responsibility of a physician(s) on the medical staff of the center.

(c) A physician or a registered nurse shall be on duty at the center when a patient is held in the center's accommodations beyond regular scheduled hours.

(7) Plan of care. The center shall establish and periodically update a written plan of care of all patients and/or family units, reflecting staff discussion of all medical and social information obtained relative to the patient and his family.

(8) Telephone screening and referral. The center shall provide telephone screening and referral services for prospective patients after regularly-scheduled hours of operation. (8 Ky.R. 412; eff. 1-6-1982; Am. 16 Ky.R. 989; eff. 1-12-1990; 24 Ky.R. 1959; eff. 5-18-1998; 30 Ky.R. 1612; 1929; eff. 2-16-2004; 31 Ky.R. 445; eff. 11-5-2004; TAm eff. 3-11-2011.)