Section 1200-06-01-.01 - DEFINITIONSThis section sets forth the more important and/or frequently used terms and acronyms used in these rules and the meanings to be ascribed to them.
(1) Accrediting Bureau of Health Education Schools (ABHES). Accreditation organization in the United States specializing in the accreditation of institutions that offer allied health education programs leading to associate degrees or certificates for medical laboratory technicians and provides a pathway for certification by the American Medical Technologists.(2) The Act. The Tennessee Medical Laboratory Act.(3) Applicant. Any individual seeking licensure by the Board and who has submitted an official application and paid all required fees.(4) Board. The Tennessee Medical Laboratory Board.(5) Board Administrative Office. The office of the administrator assigned to the Board located at 665 Mainstream Drive, Nashville, TN 37243.(6) CLIA. The Clinical Laboratory Improvement Amendments of 1988 as found in 42 CFR Part 493.(7) Closed File. An administrative action which renders an incomplete or denied file inactive.(8) Commission on Accreditation of Allied Health Education Programs (CAAHEP). Accreditation agency that accredits laboratory training programs.(9) Committee. The Personnel and Education Licensure Committee which oversees all matters pertaining to the licensure of medical laboratory personnel and of medical laboratory education programs.(10) Continuing Education. Planned, organized learning acts acquired during licensure to maintain, improve, or expand a licensee's knowledge and skills relevant to medical laboratory practice in order for the licensee to develop knowledge and skills relevant to the practice, education, or theory development to improve the safety and welfare of the public.(11) Cytology Supervisor. A person who is responsible for day-to-day supervision or oversight of the cytology laboratory operation, personnel performing testing and reporting test results.(12) Cytotechnologist. A person who processes and interprets cellular material delineating data regarding cytopathological disease with minimal supervision by the director or supervisor.(13) Department. Tennessee Department of Health.(14) Esoteric Laboratory Personnel. Personnel performing testing in an esoteric laboratory licensed under T.C.A. § 68-29-138 who are exempt from requirements to be licensed as a technologist, technician, laboratory trainee, or special analyst.(15) Examination. Refers to national certification exams or other exams approved by the Board.(16) Full Time Work Experience. A minimum of thirty (30) hours per week or one thousand five hundred sixty (1,560) hours per year.(17) Internationally Trained. Having graduated from a degree program and/or a laboratory training program outside of the United States or its territories.(18) License. Document issued to an applicant who successfully completes the licensure process. The license takes the form of an "artistically designed" license as well as other versions bearing an expiration date.(19) Licensee. Any person duly licensed by the Board to engage in the practice of laboratory medicine.(21) Medical Laboratory. Any institution, building, or place in which operations and procedures for the microbiological, chemical, hematological, immunohematological, immunological, molecular, cytological, pharmacological, pharmacogenetical 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.(22) Medical Laboratory Director. A person who is responsible for the administration of the technical and scientific operation of a medical laboratory, including supervision of procedures for testing and the reporting of results.(23) Medical Laboratory Personnel. Individuals licensed by this board, including the medical laboratory director, supervisor, technologist, technician, or special analyst, but not including medical laboratory assistants, trainees or other persons employed by a medical laboratory to perform clerical or other administrative responsibilities involving no laboratory testing.(24) Medical Laboratory Supervisor. A person who under the general supervision of a medical laboratory director, supervises technical personnel, performs tests requiring special scientific skills, and, in the absence of the director, is held responsible for the proper performance of all medical laboratory procedures and the reporting of results.(25) Medical Laboratory Technician. A person other than the medical laboratory director, supervisor, technologist, or trainee who functions under the supervision of a medical laboratory director, supervisor, or technologist and performs medical laboratory procedures in which the technician is qualified by education, training, and experience.(26) Medical Laboratory Technologist. A person who performs tests which require the exercise of independent judgment and responsibility with minimal supervision by the director or supervisor, in only those specialties or subspecialties in which the technologist is qualified by education, training, and experience.(27) Medical Laboratory Trainee. A person who is enrolled in a medical laboratory approved training program seeking experience required to meet minimum qualifications for a license in the state. Trainees may perform procedures only under direct, responsible supervision of a duly licensed director, supervisor, technologist, or special analyst. Trainees shall only be employed within the laboratory where training is received.(28) Moderate/High Complexity. A clinical laboratory test category assigned by CLIA-88 based on the test characteristics. See 42 CFR § 493.17.(29) National Accrediting Agency for Clinical Laboratory Sciences (NAACLS). Accreditation agency that accredits laboratory training programs.(30) Person. Any individual, firm, partnership, association, corporation, municipality, political subdivision, or any other entity whether organized for profit or not.(31) Physician. Any doctor of medicine or doctor of osteopathy duly licensed to practice such doctor's profession in Tennessee.(32) Point of Care Laboratory Testing. Laboratory testing performed by health care personnel/professionals not licensed by the Medical Laboratory Act, T.C.A. §§ 68-29-101, et seq., and performed outside the duly licensed laboratory and under the auspices of a laboratory required to be licensed by the Department, pursuant to the Medical Laboratory Act.(33) Regionally Accredited College/University. An institution of higher education accredited by one of the following United States Associations of Colleges and Schools: Middle States, Northwest, North Central, New England, Southern or Western.(35) Special Analyst. Any person performing a singular or limited type of medical laboratory test or group of tests, such as, but not limited to, Andrology, Embryology, Cytology, Molecular Diagnostics, Cytogenetics, Toxicology, Flow Cytometry, Virology, Histocompatability/Immunogenetics, on human specimens but who is not trained to perform the broad range of tests required of licensed medical laboratory personnel.(36) Trainee Permit. A permit that is issued to a trainee that is valid during the training period provided that the facility where the training is being gained is approved for practice training. The trainee permit shall be onsite at the training facility during the student rotation.(37) Waived Laboratory Tests. Those tests, as defined by the Board, which may be performed by individuals not licensed under the Medical Laboratory Act, and which pose no reasonable risk of harm if performed incorrectly.Tenn. Comp. R. & Regs. 1200-06-01-.01
Original rule filed May 3, 1995; effective July 17, 1995. Amendment filed March 4, 1998; effective May 20, 1998. Amendment filed April 29, 2002; effective July 13, 2002. Amendment filed August 25, 2003; effective November 8, 2003. Amendments filed January 13, 2022; effective 4/13/2022.Authority: T.C.A. §§ 4-5-202, 4-5-204, 68-29-103, 68-29-105, 68-29-116, 68-29-117, 68-29-119, 68-29120, and 68-29-134.