Section 1200-06-03-.22 - SPECIAL REGULATIONS REGARDING LABORATORIES LICENSED UNDER T.C.A. SECTION 68-29-138(1) Medical laboratories performing advanced esoteric applied toxicological, forensic, or biochemical analysis utilizing emerging technology shall be licensed. (a) Licensing procedures set out in Rule1200-06-03-.02 shall be met.(b) Laboratories licensed under T.C.A. § 68-29-138(a) are subject to all provisions of the Medical Laboratory Act except for the provisions of the Medical Laboratory Act and rules promulgated under the Act that require persons who accept specimens for laboratory examination and perform analytical testing or report the results of a laboratory examination to be licensed as a technologist, technician, laboratory trainee, or special analyst. 1. To be eligible for the licensed personnel exemption, a medical laboratory must obtain a license pursuant to T.C.A. § 68-29-138. This license shall be unique and in addition to other licenses for laboratories located in contiguous buildings on the same campus that do not fall within the exemption.(c) The application for licensure under this exemption shall require a specific testing menu.(2) Laboratories licensed under tills rule stiall be subject to on-site surveys by ttie Department. The survey siiali include inspection of the following: laboratories, tools therein, and educational requirements of personnel defined in T.C.A. § 68-29-138(c).(3) Only medical laboratories engaged in advanced esoteric applied toxicological, forensic, or biochemical laboratory analysis utilizing emerging technologies shall be given an exemption defined in subparagraph (1)(b). (a) Definition: advanced esoteric applied toxicological, forensic, or biochemical laboratory analysis is narrowly focused analysis that takes place within independent laboratories.(b) Emerging technologies include, but are not limited to, chromatographic and non-chromatographic techniques coupled with mass spectrometer based detector systems and molecular diagnostic techniques.(4) Personnel in laboratories licensed under T.C.A. § 68-29-138 shall not be required to complete the procedures for personnel licensure as provided in Rule 1200-06-01-.05. However, 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. (a) Licensed personnel shall be allowed to perform tasks for which they are appropriately licensed and trained in laboratories exempt from hiring licensed personnel.(b) Determining the appropriate sciences for baccalaureate or advanced degree for unlicensed personnel shall be left to the medical director of the laboratory.Tenn. Comp. R. & Regs. 1200-06-03-.22
Original rule filed April 1, 2015; effective 6/30/2015.Authority: T.C.A. §§ 4-5-202, 4-5-204, 68-29-103, 68-29-104, 68-29-105, 68-29-111, 68-29-113, 68-29-114, 68-29-115, and 68-29-138.