(a) Notwithstanding any provisions of official compilation Rules and Regulations of the State of Tennessee, Rule 1200-6-1, or any other rule promulgated by the medical laboratory board to the contrary, a Tennessee medical laboratory shall be licensed in accordance with the rules promulgated under authority of this chapter and as provided in this section if the laboratory:
Department: means the state department of health, including the [former] public health council [repealed]. See Tennessee Code 68-29-103
Medical laboratory: means any institution, building, or place in which operations and procedures for the microbiological, serological, chemical, hematological, immunohematological, or biophysical examination of specimens taken from the human body are performed to obtain information for diagnosis, prophylaxis, or treatment or where any examination, determination, or test is made on any sample used as a basis for health advice, or where any sample is collected for the purpose of transfusion or processing of blood or blood fractions, or for the training of medical laboratory personnel. See Tennessee Code 68-29-103
Special analyst: means any person performing a singular or limited type of medical laboratory test or group of tests, such as, but not limited to, blood gases or pH tests, on human specimens, but who is not trained to perform the broad range of tests required of licensed medical laboratory personnel. See Tennessee Code 68-29-103
State: when applied to the different parts of the United States, includes the District of Columbia and the several territories of the United States. See Tennessee Code 1-3-105
United States: includes the District of Columbia and the several territories of the United States. See Tennessee Code 1-3-105
(1) Is engaged in advanced esoteric applied toxicological, forensic, or biochemical laboratory analysis utilizing emerging technologies, such as chromatographic and non-chromatographic techniques coupled with mass spectrometer based detector systems and molecular diagnostic techniques; and(2) Is licensed, certified, or accredited by the United Statesdepartment of health and human resources substance abuse and mental health service administrations (SAMHSA), the American Society of Crime Laboratory Directors Laboratory Accreditation Board (ASCLD/LAB), the American Board of Forensic Toxicology (ABFT), the College of American Pathologists Laboratory Accreditation Program (CAP LAP), or a state that has been determined to be exempt in accordance with § 353(p) of the Public Health Services Act (42 U.S.C. § 263a), as having enacted laboratory requirements that are equal to or more stringent than the statutory and regulatory requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA).(b) A laboratory licensed under subsection (a) shall be exempt from the provisions of this chapter, including any rules promulgated under this chapter, that require persons who accept specimens for laboratory examination and perform analytical testing or report the results of a laboratory examination, be licensed as a technologist, technician, laboratory trainee, or special analyst.(c) In such medical laboratories, laboratory personnel who analyze or report laboratory results shall possess a baccalaureate or advanced degree in the appropriate sciences with at least sixteen (16) semester hours of chemistry and/or biological science courses. Nothing in this section shall be construed to prohibit licensed personnel from performing the tasks for which they are appropriately licensed and trained in such medical laboratories.(d) Except as provided in subsection (b), such laboratories shall be subject to all other provisions of this chapter, including any rules promulgated under this chapter.
