Kan. Admin. Regs. § 26-52-21 - Ancillary services

(a) Each licensee shall provide laboratory and pharmacy services in each crisis intervention center 24 hours per day, seven days per week. Laboratory and pharmacy services may be provided directly by center staff or through contractual arrangement.

(b) If the crisis intervention center provides its own clinical laboratory services, the following requirements shall be met:

(1) The laboratory performing analytical tests within the center shall hold a valid clinical laboratory improvement amendment (CLIA) certificate for the type and complexity of all tests performed.

(2) A professional staff member shall, through written or electronic means, request all tests performed by the laboratory.

(3) Each individual serving as the laboratory's clinical consultant shall meet the requirements of 42 C.F.R. 493.1417, as in effect on September 2, 2020, which is hereby adopted by reference, and 42 C.F.R. 493.1405(b)(1), (2), or (3)(i), as in effect on September 2, 2020, which is hereby adopted by reference.

(4) The original report or duplicate copies of written tests, reports, and supporting records shall be retained in a retrievable form by the laboratory for at least the following periods:

(A) Two years for routine test reports;

(B) five years for blood banking test reports; and

(C) 10 years for histologic or cytologic test reports.

(5) Resources and space for procurement, safekeeping, and transfusion of blood or blood products, or both, shall be provided or available. If blood products or transfusion services are provided by sources outside the center, the outside sources shall be provided by a CLIA-certified laboratory. The source shall be certified for the scope of testing performed or products provided.

(c) If the crisis intervention center contracts with an outside entity for laboratory services, the following requirements must be met:

(1) The outside entity must be a CLIA-certified, medicare-certified laboratory;

(2) The outside entity shall have resources and space for procurement, safekeeping, and transfusion of blood or blood products, or both, as required by 42 C.F.R. 493.1100, 42 C.F.R. 493.1101 and 42 C.F.R. 493.1103, as in effect on September 2, 2020, which are herein adopted by reference;

(3) A professional staff member shall, through written or electronic means, request all tests performed by the outside entity's laboratory.

(4) The licensee shall have a written agreement with the outside entity that provides CLIA-certified, medicare-certified laboratory services for patients, which is reviewed and updated every three years, and shall meet the following requirements:

(A) Prior to the effective date of the written agreement for laboratory services, the outside entity shall provide the center with a copy of the current CLIA certification and medicare certification for laboratory services;

(B) the outside entity shall maintain CLIA certification and medicare certification for the provision of laboratory services during the term of the contractual agreement with the center;

(C) the outside entity shall notify the department and the center's clinical director within three days of the occurrence if the outside entity receives a notification that its CLIA certification or medicare certification for laboratory services is conditioned, restricted, suspended, or revoked;

(D) the outside entity must be available to accept and process orders for lab tests 24 hours per day, 7 days per week;

(E) each person serving as the clinical consultant for the outside entity's laboratory shall meet the requirements of 42 C.F.R. 493.1417, as in effect on September 2, 2020, which is hereby adopted by reference, and 42 C.F.R. 493.1405(b)(1), (2), or (3)(i), as in effect on September 2, 2020, which is hereby adopted by reference;

(F) the outside entity shall provide to the center, by confidential and secure electronic means, copies of the written results of all tests, reports, and supporting records within two hours of completion of the laboratory test results and reports ordered for each patient; and

(G) the outside entity shall maintain copies of all written tests, reports, and supporting records for laboratory services provided for each patient in a retrievable form for the required retention period for CLIA-certified, medicare-certified laboratories established by 42 C.F.R. 493.1105, as in effect on September 2, 2020, which is hereby adopted by reference.

(d) If the crisis intervention center provides its own pharmacy services, the following requirements shall be met:

(1) The pharmacy must employ or contract with a pharmacist who possesses the requisite experience to serve as the pharmacist-in-charge, who shall be responsible for the operation and supervision of the center's pharmacy services.

(2) All pharmacists working in the center's pharmacy must be licensed by the Kansas board of pharmacy.

(3) All pharmacy technicians working in the center shall be appropriately trained and certified by the Kansas board of pharmacy.

(4) Each center's pharmacist-in-charge shall develop and implement policies and procedures for operation and supervision of the center's pharmacy services in compliance with the requirements of the Kansas board of pharmacy, including the following:

(A) Storage of drugs;

(B) security and control of drugs;

(C) distribution of drugs;

(D) supervision and maintenance of emergency kits;

(E) labeling and preparation of drugs;

(F) administration of drugs;

(G) accounting for drugs;

(H) disposal of drugs;

(I) record keeping;

(J) reporting requirements; and

(K) training and supervision of pharmacists and pharmacy technicians.

(5) the center shall provide for a confidential and secure method for a prescribing physician, physician's assistant, or advanced practice registered nurse to submit orders for prescriptions to the pharmacy 24 hours per day, 7 days per week;

(6) The pharmacy shall be open at least during the hours of 8 a.m. to 8 p.m. Monday through Friday, and 10 a.m. to 8 p.m. Saturday through Sunday. The pharmacy shall allow for storage on-site at the center and administration of prescription medications commonly ordered by a physician, physician's assistant, or advanced practice registered nurse for patients during any period the pharmacy is closed. The pharmacist-in-charge shall be responsible for accounting for, documenting, and proper disposal of prescription medication kept on-site at the center for use during periods when the pharmacy is closed.

(7) All drugs and biologicals shall be administered pursuant to a written order or properly documented verbal order issued by a physician, physician's assistant, or advanced practice registered nurse pursuant K.S.A. 59-29c10, and amendments thereto, and the requirements of this article. For purposes of this regulation, "biologicals" shall mean medications developed from blood, proteins, viruses, or living organisms.

(8) Each adverse drug reaction for a patient shall be reported to the prescribing physician, physician's assistant, or advanced practice registered nurse and the pharmacist-in-charge and shall be documented in the patient's record.

(e) If the crisis intervention center contracts with an outside entity for pharmacy services, the following requirements must be met:

(1) The crisis intervention center shall enter into a written agreement with an outside entity for pharmacy services which complies with the requirements of this regulation;

(2) the outside entity who provides pharmacy services to the center shall be licensed by the Kansas board of pharmacy in good standing;

(3) the outside entity that provides pharmacy services to the center shall maintain its licensure by the Kansas board of pharmacy in good standing;

(4) the outside entity that provides pharmacy services to the center shall provide written notification to the department and the center's clinical director within three days of the outside entity's receipt of any order from the Kansas board of pharmacy that the outside entity's licensure to provide pharmacy services is conditioned, restricted, suspended or revoked;

(5) the pharmacy shall provide for a confidential and secure method for a prescribing physician, physician's assistant, or advanced practice registered nurse to submit orders for prescriptions to the center 24 hours per day, 7 days per week;

(6) the pharmacy shall be open at and provide deliveries to the center during the hours of 8 a.m. to 8 p.m. Monday through Friday, and 10 a.m. to 8 p.m. Saturday through Sunday. The pharmacy shall allow for storage on-site at the center and administration of prescription medications commonly ordered by a physician, physician's assistant, or advanced practice registered nurse for patients during any period the pharmacy is closed. The clinical director or designee shall be responsible for accounting for, documenting, and proper disposal of prescription medication kept on-site at the center for use during periods when the pharmacy is closed.

(7) All drugs and biologicals shall be administered pursuant to a written order or properly documented verbal order issued by a physician, physician's assistant, or advanced practice registered nurse pursuant to K.S.A. 59-29c10 and amendments thereto, and the requirements of this article.

(8) Each adverse drug reaction for a patient shall be reported to the prescribing physician, physician's assistant, or advanced practice registered nurse and shall be documented in the patient's record.

(f) Each licensee shall ensure the performance of an ongoing review and evaluation of the quality and scope of laboratory and pharmacy services.

Notes

Kan. Admin. Regs. § 26-52-21

Authorized by and implementing K.S.A. 39-2004; effective, T-26-2-16-24, Feb. 16, 2024; effective, T-26-6-10-24, June 10, 2024; adopted by Kansas Register Volume 43, No. 24; effective 6/28/2024.