North Dakota Administrative Code › Title 33 - State Department of Health › Article 33-07 - Licensing Medical Hospitals › Chapter 33-07-01.1 - Hospitals › Section 33-07-01.1-22 - Laboratory services

Current through Supplement No. 393, July, 2024
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. The
				medical director of laboratory service must be a physician who is a member of
				the medical staff with delineated clinical privileges for interpretation of
				diagnostic studies.
b. The medical
				director of the laboratory service shall assure procedures and tests are within
				the scope of education, training, and experience of the individuals employed to
				perform technical procedures in the laboratory.
c. Provisions must be made to assure
				twenty-four-hour availability of emergency laboratory services either directly
				or through contract.
d.
				Examination in the fields of hematology, chemistry, microbiology,
				sero-immunology, clinical microscopy, and other services necessary to meet
				patient care needs must be provided within the hospital or by contractual
				agreement.
e. All surgically
				removed tissues must be examined by a pathologist and signed reports must be
				included in the patient's medical record. If the hospital provides anatomical
				pathology services, such 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.
f. There must be a quality control
				program designed to ensure reliability of the laboratory data and which
				includes written provisions for no less than:
(1) The method of quantitative and
				qualitative testing and the frequency of control performance, including control
				data and evaluation criteria.
(2)
				The frequency and method of quality control testing and calibration of
				instruments, equipment, and commercially prepared testing kits.
(3) A preventive and corrective maintenance
				program for instruments and equipment involved in laboratory testing.
(4) Participation in an approved
				external proficiency testing program if one is available.
(5) Maintenance of records documenting all
				quality control and related activities.
g. 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.
h. 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
				participation in a multifacility community blood collection, storage, and
				processing system. Written policies and procedures for all phases of operation
				of blood banks and transfusion services must be established and revised as
				needed.
i. Reports indicating the
				name and address of the testing laboratory must be authenticated, dated, and
				clearly indicate the results of all pathological and clinical laboratory
				examinations, including autopsies, and made part of the patient's medical
				record.