Kan. Admin. Regs. § 28-34-59a

Current through Register Vol. 43, No. 49, December 5, 2024

Section 28-34-59a - Ancillary services

(a) The ambulatory surgical center shall provide, either directly or through agreement, laboratory, radiology, and pharmacy services to meet the needs of the patients.

(b) Laboratory services. If the ambulatory surgical center provides its own clinical laboratory services, the following criteria shall be met:

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

(2) An authorized individual shall, through written or electronic means, request all tests performed by the laboratory. The individual or individuals serving as the laboratory's clinical consultant or consultants shall be as defined in 42 C.F.R. 493.1417(b), as in effect on October 1, 1996 and hereby adopted by reference.

(3) 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.

(4) Facilities for procurement, safekeeping, and transfusion of blood, blood products, or both shall be provided or available. If blood products or transfusion services are provided by sources outside the ambulatory surgical center, 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 ambulatory surgical center contracts for laboratory services, the center shall have a written agreement with that CLIA-certified laboratory.

(d) Radiology services. If the ambulatory surgical center provides its own radiology services, the services shall meet the requirements specified in K.S.A. 48-1607, and amendments thereto.

(e) The ambulatory surgical center staff shall meet the following standards:

(1) Allow only trained and qualified individuals to operate radiology equipment;

(2) document annual checks and calibration of all radiology equipment and maintain records of such;

(3) ensure that all radiology and diagnostic services are provided only on the order of a physician; and

(4) document the presence of signed and dated clinical reports of the radiological or diagnostic findings in the patient's record.

(f) If the ambulatory surgical center contracts for radiology services, it shall have a written agreement with a medicare-approved radiology provider or supplier.

(g) Pharmacy services. Each ambulatory surgical center shall provide pharmaceutical services that are appropriate for the services offered by the ambulatory surgical center.

(h) The pharmaceutical service shall be under the direction of an individual designed responsible for the service and shall be provided in accordance with K.A.R. 68-7-11.

(i) Policies and procedures. There shall be policies and procedures developed by a pharmacist, and approved by the governing authority, related to the following:

(1) Storage of drugs;

(2) security of drugs;

(3) labeling and preparation of drugs;

(4) administration of drugs; and

(5) disposal of drugs.

(j) All drugs and biologicals shall be ordered pursuant to a written order issued by a licensed physician.

(k) Each adverse drug reaction shall be reported to the physician responsible for the patient and shall be documented in the patient's record.

(l) Drugs requiring refrigeration shall be stored in a refrigerator that is used only for drug storage.

(m) Quality assurance. There shall be a mechanism for the ongoing review and evaluation of the quality and scope of radiological, laboratory, and pharmacy services.

Kan. Admin. Regs. § 28-34-59a

Authorized by and implementing K.S.A. 65-431; effective April 20, 2001.