Exemption for Laboratories Certified by Certain Organizations
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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:
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
Is licensed, certified, or accredited by the United States department 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).
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.
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.
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.