††††† 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, Chapter 311, 314, 45 C.F.R. 160, 164, 42 U.S.C. 1320d-2 Ė 1320d-8
††††† STATUTORY AUTHORITY: KRS 216B.042, 216B.105
††††† 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 establishes licensure requirements for the operation of and services provided by primary care centers.
††††† Section 1. Definitions. (1) "Center" means a primary care center.
††††† (2) "Qualified dietitian" or "nutritionist" means a person who:
††††† (a)1. Has a bachelor of science degree in foods and nutrition, food service management, institutional management, or related services;
††††† 2. Has successfully completed a dietetic internship or coordinated undergraduate program accredited by the American Dietetic Association (ADA); and
††††† 3. Is a member of the ADA or is registered as a dietitian by ADA;
††††† (b)1. Has a master's degree in nutrition; and
††††† 2. Is a member of ADA or is eligible for registration by ADA; or
††††† (c)1. Has a bachelor of science degree in home economics; and
††††† 2. 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 health professionals 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. 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.
††††† (2) Administrator.
††††† (a) Each center shall have an administrator who shall be responsible for the operation of the center.
††††† (b) In the absence of the administrator, responsibility shall be delegated to a similarly qualified staff person.
††††† (3) Policies.
††††† (a) Administrative policies. The center shall have written administrative policies established by the licensee 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 medical director and other professional staff for all medical aspects of the center's program to include:
††††† 1. Written protocols, including standing orders, rules of practice, and medical directives that apply to services provided by the center. The protocols shall be signed by the medical director; and
††††† 2. 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 shall be 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 shall be:
††††† 1.a. Informed of these rights and of all rules and requirements of 902 KAR Chapter 20 governing patient conduct and responsibilities, including a procedure for allowing the patient to voice a grievance or recommend changes in policies and services.
††††† b. Upon the patient's request, a grievance or recommendation shall be conveyed within a reasonable time to a decision making level within the organization with the authority to take corrective action;
††††† 2. 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. Informed of his or her medical condition, unless medically contraindicated as documented in his or her medical record;
††††† 4. Afforded the opportunity to participate in the planning of his or her medical treatment and to refuse to participate in experimental research;
††††† 5. Encouraged and assisted to understand and exercise his or her patient rights;
††††† 6. Assured confidential treatment of his or her records and shall be afforded the opportunity to approve or refuse release of the records to any individual not involved in the patientís care, except as required by applicable law or third-party payment contract; and
††††† 7. Treated with consideration, respect, and full recognition of his or her dignity and individuality, including privacy in treatment and in the care of his or her personal health needs.
††††† (4) Personnel.
††††† (a) Primary care provider team. Except for extensions established in Section 4(4) of this administrative regulation, the center shall have a minimum of one (1) or more full-time licensed physicians and:
††††† 1. One (1) or more full-time advanced practice registered nurses;
††††† 2. One (1) or more full-time physician assistants; or
††††† 3. One (1) or more full-time registered nurses.
††††† (b) Medical Director. The center shall have a medical director who shall:
††††† 1. Be a licensed physician responsible for all medical aspects of the clinic; and
††††† 2. Provide direct medical services in accordance with the Medical Practice Act, KRS Chapter 311.
††††† (c) Physicians. Each physician employed by or having an agreement with the center to perform direct medical services shall be:
††††† 1. Qualified to practice general medicine, including as a general practitioner, family practitioner, obstetrician Ė gynecologist, pediatrician, or internist, or qualified to practice psychiatry; and
††††† 2. A member of the medical staff or hold courtesy staff privileges at one (1) or more hospitals with which the center has a formal transfer agreement.
††††† (d) Nurse. An advanced practice registered nurse or a registered nurse employed by the center directly or by contract shall provide services within his or her relative scope of practice pursuant to KRS Chapter 314.
††††† (e) Physician's assistant. A physician assistant shall provide services within his or her scope of practice pursuant to KRS Chapter 311.
††††† (f) In-service training.
††††† 1. All center personnel shall participate in ongoing in-service training programs relating to their respective job activities.
††††† 2. The training programs shall include:
††††† a. Thorough job orientation for new personnel; and
††††† b. Regular in-service training emphasizing professional competence and the human relationship necessary for effective health care.
††††† (5) Medical records.
††††† (a) Ownership.
††††† 1. Medical records shall be the property of the center.
††††† 2. The original medical record shall not be removed from the center except by court order.
††††† 3. Copies of a medical record or portions of the record may be used and disclosed. Use and disclosure shall be as established in this administrative regulation.
††††† (b) Confidentiality and security: use and disclosure.
††††† 1. The center shall maintain the confidentiality and security of medical records in compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164, as amended, including the security requirements mandated by subparts A and C of 45 C.F.R. Part 164, or as provided by applicable federal or state law.
††††† 2. The center may use and disclose medical records. Use and disclosure shall be as established or required by HIPAA, 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164, or as established in this administrative regulation.
††††† 3. This administrative regulation shall not be construed to forbid the center from establishing higher levels of confidentiality and security than required by HIPAA, 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164.
††††† (c) The center shall maintain a medical record for each patient. The medical record shall include:
††††† 1. The patientís medical and social history, including data obtained from other providers;
††††† 2. A description of each medical visit or contact, including the condition or reason necessitating the 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, including the reason for the referral, to whom the patient was referred, and any information obtained from the referral source.
††††† (d) Confidentiality of all patient records shall be maintained at all times.
††††† (e) Transfer of records. The center shall:
††††† 1. Establish systematic procedures to assist in continuity of care if the patient moves to another source of care; and
††††† 2. Upon proper release, transfer medical records or an abstract if requested.
††††† (f) Retention of records. After the patient's death or discharge, the completed medical record shall be placed in an inactive file and:
††††† 1. Retained for six (6) years; or
††††† 2. 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 that 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:
††††† 1. Appropriate referral and acceptance of patients from the center;
††††† 2. Appropriate coordination of discharge planning with center staff; and
††††† 3. The center to receive a copy of the discharge summary for each patient referred to the center.
††††† (c) The written transfer agreements shall include designation of responsibility for:
††††† 1. Transfer of information;
††††† 2. Provision of transportation;
††††† 3. Sharing of services, equipment, and personnel;
††††† 4. Provision of total care or portions thereof in relation to facility and agency capability; and
††††† 5. Patient record confidentiality pursuant to all applicable federal and state law.
††††† (d)1. A linkage agreement shall not be required to transfer medical records to any other treating health care facility or provider.
††††† 2. The center may use and disclose medical records. Use and disclosure shall be as established or required by HIPAA, 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164, or as expressly established in this administrative regulation.
††††† (7) Quality assurance program. The center shall have an ongoing, written quality assurance program approved by the licensee that:
††††† (a) Includes effective mechanisms for reviewing and evaluating patient care in order to identify problems or opportunities to improve care;
††††† (b) Provides for appropriate responses to findings;
††††† (c) Assigns responsibility for monitoring and evaluating patient care;
††††† (d) Delineates the scope of care provided by the center;
††††† (e) Identifies the aspects of care that the center provides;
††††† (f) Identifies indicators and appropriate clinical criteria that can be used to monitor these aspects of care;
††††† (g) Collects and organizes data for each indicator;
††††† (h) Contains written procedures for taking appropriate corrective action;
††††† (i) Assesses the effectiveness of the actions taken to correct problems and documents the improvement in care; and
††††† (j) Communicates relevant information to other individuals, departments, or services as to the quality assurance program.
††††† Section 4. Provision of Services. (1)(a) Hours of operation and coverage. Scheduled hours of the center's operation shall reasonably accommodate the various segments of the population served.
††††† (b) Provisions shall be made for scheduled evening hours and weekend hours, if needed.
††††† (2) Basic services. The center shall provide directly at least the following services:
††††† (a) Medical diagnostic and treatment services of sufficiently broad scope to accommodate the basic health needs of all age groups, including prenatal and postnatal care;
††††† (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:
††††† a. The hours that emergency medical services will be available in the center; and
††††† b. 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 or her own health;
††††† (e) Chronic illness management; and
††††† (f) Laboratory, x-ray, and treatment services provided directly or arranged through other providers.
††††† (3) Supplemental services.
††††† (a) The center shall provide professional services to complement the basic services provided in accordance with subsection (2) of this section.
††††† (b) 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 supplemental services that currently exist in the service area and that are not provided directly or by contract by the center, including:
††††† 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;
††††† 8. Home health: licensed home health agency; and
††††† 9. Behavioral health services.
††††† (c) A center that does not have a linkage agreement with the supplemental services pursuant to paragraph (b) of this subsection, but documents a good faith attempt to enter into the linkage agreement, shall be exempt from the linkage agreement requirement.
††††† (4) Extension services.
††††† (a)1. The center may provide primary care services in locations separate from its permanent facility.
††††† 2. The extension locations shall be listed on the licensure application, incorporated by reference in 902 KAR 20:008.
††††† (b) Except for an extension located at a school, each extension shall be staffed with at least:
††††† 1. One (1) full-time advanced practice registered nurse or physician assistant; and
††††† 2. One (1) physician who is:
††††† a. Except in extraordinary circumstances, which shall be documented in the extensionís records, present no less than once in every two (2) week period to provide medical direction, medical care services, consultation, and supervision; and
††††† b. Available through direct telecommunication for consultation, assistance with medical emergencies, or patient referral.
††††† (c) If a not-for-profit centerís extension operates in a school, the extension shall comply with the staffing requirements of KRS 216B.176(3) and (4).
††††† (d) The center shall have written policies and procedures pertaining to all aspects of the extension service, including:
††††† 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.
††††† (e) The extension service shall be located within the primary care center's service area.
††††† (f) The center's utilization review program shall include any extension services.
††††† (5) Outreach activities. The center or extensionís physician, advanced practice registered nurse, midwife, physician assistant, dentist, or dental hygienist licensed to function with indirect supervision may engage in outreach activities to provide medical service within the primary care center's service areas.
††††† (6) Holding-observation accommodations. If holding-observation accommodations are maintained by the center, the center shall comply with the following requirements:
††††† (a) Use of holding-observation accommodations shall not exceed twenty-four (24) hour 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 employed directly or under contract with the center; and
††††† (c) A physician or a registered nurse shall be on duty at the center while a patient is held in the center's holding-observation accommodations beyond regular scheduled hours.
††††† (7) Plan of care. The center shall establish and periodically update a written plan of care of all patients or family units, reflecting staff discussion of all medical and social information obtained relative to the patient and the patientís 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; 40 Ky.R. 1144; 1399; eff. 1-15-2014.)