Maine § 2023. - Rules and regulations

§ 2023.. Rules and regulations

The department shall prescribe and publish rules and regulations for medical laboratories. These rules and regulations shall relate to:   [PL 1993, c. 600, Pt. B, §8 (AMD).]

1.  Qualifications of directors and technical personnel.  The qualifications of directors and technical personnel of medical laboratories;

2.  Location and construction of laboratory.  The location and construction of the laboratory, including plumbing, heating, lighting, ventilation, electrical services and similar conditions which shall insure the conduct and operation of the laboratory in a manner which will protect the public health;

3.  Sanitary conditions.  All sanitary conditions within the laboratory and its surroundings, including water supply, sewage, the handling of specimens and general hygiene which shall ensure the protection of the public health;

4.  Equipment.  Equipment essential in the opinion of the department to proper conduct and operation of a medical laboratory; and

5.  Standards of performance.  Standards of performance essential to the achievement of accurate, reliable results and the protection of public health, including standards for maternal serum alpha-fetoprotein testing, covering, at a minimum, volume of testing, population-based reference data, adjustment for variables affecting interpretation of results, confirmatory analyses, reports, review and follow-up and procedures to ensure that patients and physicians are provided adequate and reliable follow-up testing and counseling services and that the department is provided with data on test results and pregnancy outcomes.