1. General acute hospitals shall have a well-organized, adequately supervised, clinical laboratory service available with the necessary space, facilities, and equipment and qualified, licensed staffing to perform these services commensurate with the hospital's needs for its patients. At a minimum, the hospital must adhere to the following:

a. Laboratory services must be provided in accordance with the clinical laboratory improvement amendments at 42 Code of Federal Regulations part 493.

b. Provisions must be made to assure twenty-four-hour availability of emergency laboratory services either directly or through contract.

c. All clinically relevant surgically removed tissues must be examined by a pathologist consistent with hospital policy and signed reports must be included in the patient's medical record. Anatomical pathology services may be provided either by the hospital directly or per contractual arrangement with a certified laboratory. Written policies and

procedures must be established through the medical staff and pathologist governing prompt transportation of specimens and submission of reports.

d. An autopsy service must be provided either directly by the hospital or by contractual arrangement with another institution having an approved laboratory. Hospitals providing the service directly must have adequate space, equipment, and personnel for services provided.

e. Each hospital shall provide appropriate facilities and equipment for the procurement, storage, safekeeping, and administration of whole blood and blood products either directly or through contractual arrangement. Written policies and procedures for all phases of operation of blood banks and transfusion services must be established and revised as needed.

2. Primary care hospitals are subject to the laboratory services requirements for general acute hospitals in this section.

3. Specialized hospitals shall provide laboratory services to meet the needs of patients served consistent with the laboratory services requirements for general acute hospitals in this section. If onsite laboratory services are not necessary to meet the needs of patients served, the laboratory services may be provided through a contractual agreement with a certified laboratory.

History: Effective April 1, 1994; amended effective July 1, 2020.

Law Implemented: NDCC 23-16-06