Section 1200-06-01-.21 - QUALIFICATIONS AND DUTIES OF THE MEDICAL LABORATORY SUPERVISOR(1) The laboratory must have one or more medical laboratory supervisors who, under the direction of the laboratory director, provide day-to-day supervision of testing personnel and reporting of test results. In the absence of the director, the medical laboratory supervisor must be responsible for the proper performance of all laboratory procedures and reporting of test results. An individual who qualifies as medical laboratory director is considered to be qualified as a medical laboratory supervisor. (a) The medical laboratory supervisor shall meet one of the following qualifications:1. Be a physician licensed in Tennessee or hold a doctoral degree from an accredited college/university in a chemical, physical, biological, or clinical laboratory science. Subsequent to obtaining a doctoral degree, the applicant must have at least two (2) years of full time clinical laboratory work experience as defined in Rule 1200-06-01-.22(1)(h) in the area they wish to supervise.2. Hold a valid general medical laboratory technologist license in Tennessee or meet one (1) of the requirements under Rule 1200-06-01-.22(1)(a) 1. through 5. and provide all required documentation in support of that qualification and have at least three (3) years of full time clinical laboratory work experience as defined in Rule 1200-06-01-.22(1)(h).3. Hold a valid medical laboratory technologist license in Tennessee limited to one of the categories of chemistry, hematology, immunohematology, microbiology, or immunology and meet the requirements under Rule 1200-06-01-.22(1)(c) and provide all required documentation in support of that qualification and have at least three (3) years of full time clinical laboratory work experience as defined in Rule 1200-06-01-.22(1)(h) subsequent to qualifying as a technologist. The license shall be limited to the category for which the applicant is qualified.4. Hold a valid special analyst license limited to one (1) subspecialty or meet one (1) of the requirements under Rule 1200-06-01-.22(1)(d) and provide all required documentation in support of that qualification and have at least three (3) years of full time clinical laboratory work experience as defined in Rule 1200-06-01-.22(1)(h) subsequent to qualifying as a special analyst. The license shall be limited to the subspecialty for which the applicant is qualified.(b) Clinical laboratory work experience, as required in Rule 1200-06-01-.21(1)(b) 2., 3., or 4. begins when the applicant either receives a national certification or state licensure at the technologist or special analyst level.(c) Unless qualified as a medical laboratory director, in addition to the requirements indicated in subparagraph (1)(b) to be licensed as a medical laboratory supervisor the individual must also provide the following documentation:1. Proof of at least forty-five (45) clock hours of management continuing education through professional workshops, seminars or courses (on campus or online) relating to management. Fifteen (15) clock hours will be awarded for each semester hour earned at a college or university; and2. The management clock hours shall be completed subsequent to qualifying as a medical technologist or special analyst as defined in subparagraph (1)(b).(2) Duties. (a) The medical laboratory supervisor - 1. Shall be responsible for laboratory operations as delegated by the medical laboratory director.2. Shall be on the laboratory premises at a minimum of thirty (30) hours per week and be readily available for consultations during all other hours when tests are performed.3. Shall be responsible for providing day-to-day supervision of test performance by testing personnel.4. Shall be responsible for monitoring test analyses and specimen examinations to ensure that acceptable levels of analytic performance are maintained.(b) The medical laboratory director may delegate, pursuant to written policy, to the medical laboratory supervisor specific duties that do not comprise the practice of medicine, including the following:1. Assuring that all remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications;2. Ensuring that patient test results are not reported until all corrective actions have been taken and the test system is properly functioning;3. Providing orientation to all testing personnel, and4. Annually evaluating and documenting the performance of all testing personnel.Tenn. Comp. R. & Regs. 1200-06-01-.21
Original rule filed May 3, 1995; effective July 17, 1995. Amendment filed September 11, 1996; effective November 25, 1996. Amendment filed August 25, 2003; effective November 8, 2003. Amendment filed February 15, 2006; effective May 1, 2006. Amendments filed January 13, 2022; effective 4/13/2022.Authority: T.C.A. §§ 4-5-202, 4-5-204, 68-29-103, 68-29-104, 68-29-105, 68-29-116, and 68-29-118.