Section 33-07-01.1-22 - Laboratory services1. 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. 2. The primary care hospital shall maintain, or have available through contract, clinical laboratory services adequate to fulfill the needs of its patients and meeting the following: a. The hospital, at a minimum, shall provide basic laboratory services essential to immediate diagnosis and treatment, including: (1) Chemical examinations of urine by stick or tablet methods, or both (including urine ketones). (2) Hemoglobin or spun hematocrit. (3) Blood sugar by whole blood testing device. (4) Examination of stool specimens for occult blood. (5) Primary culturing for transmittal to a certified laboratory. b. The hospital shall provide, or have a contractual agreement with a certified laboratory for, any additional laboratory services that are needed by a patient. c. Emergency provision of basic laboratory services must be available twenty-four hours a day. d. The hospital shall assign personnel to direct and conduct the laboratory services. e. Only personnel designated as qualified by the medical staff by virtue of education, experience, and training may perform and report laboratory test results. f. 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 periodically revised. 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, such as in hospitals serving only psychiatric or substance abuse patients, the laboratory services may be provided through a contractual agreement with a certified laboratory. N.D. Admin Code 33-07-01.1-22
General Authority: NDCC 23-01-03(3), 28-32-02
Law Implemented: NDCC 23-16-06