Section 1200-06-01-.22 - QUALIFICATIONS, RESPONSIBILITIES AND DUTIES OF TESTING PERSONNEL(1) Qualifications. All testing personnel shall hold a valid Tennessee license issued by the Board to perform or report a laboratory test.(a) To become licensed as a medical laboratory technologist, an applicant shall: 1. Submit satisfactory evidence of the successfully completing and passing a national certifying examination and being nationally certified at the technologist level by either the ASCP, NRCC, NRM, ABB, AMT, ASCPi (if taken after January 2015), or any other national certifying agency recognized by the Board (Successful completion of the Health and Human Services proficiency examination in clinical laboratory science does not meet this criteria for licensure); and2. In addition to possessing the national certification required by Part 1. of this subparagraph, submit satisfactory evidence of having met one (1) of the following educational criteria: (i) A baccalaureate degree in medical technology or in one of the biological, chemical, or physical sciences and completion of a medical laboratory technologist training program that was, at the time of graduation, either(I) Approved or under the auspices of the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS); or(II) Approved by a national accrediting agency acceptable to the Board; or(III) Completed in a specialty program conducted by a hospital or other institution approved pursuant to Rule 1200-06-02-.04; or(ii) A baccalaureate degree from an accredited college/university, completion of an accredited MLT/CLT training program and three (3) years of full time clinical laboratory work experience as defined in subparagraph (1)(h); the individual must have completed science coursework equivalent to that required in a laboratory science education program as defined by subparagraph (1)(g); or(iii) A baccalaureate degree from an accredited college/university, completion of an official military laboratory procedures course of at least fifty (50) weeks duration in residence and have held the military enlisted occupational specialty pertaining to laboratory medicine, and three (3) years of full time clinical laboratory work experience as defined in subparagraph (1)(h); the individual must have completed science coursework equivalent to that required in a laboratory science education program as defined by subparagraph (1)(g); or(iv) A baccalaureate degree from an accredited college/university and five (5) years of full time clinical laboratory work experience as defined in subparagraph (1)(h); the individual must have completed science coursework equivalent to that required in a laboratory science education program as defined by subparagraph (1)(g).(b) Those applicants for medical laboratory technologist licensure who do not possess a baccalaureate degree may be approved for licensure upon having submitted to the Board's administrative office directly from the national certifying agency satisfactory proof of having successfully completed on or before September 1, 1997 (the date on which CLIA required at a minimum an associate's degree or its equivalent for those who would be performing high complexity testing and the date on which the Board ceased providing the state licensure examination) a medical laboratory technologists national certification examination and submission to the Board's administrative office directly from the issuing authorities of satisfactory proof that the applicant met one (1) of the following criteria:1. The applicant had, on or before September 1, 1997, received a passing grade on a Health and Human Services proficiency examination in clinical laboratory science and had completed five (5) years of full time clinical laboratory work experience as defined in subparagraph (1)(h); or2. The applicant had, on or before September 1, 1997, completed a minimum of ninety (90) semester hours including science course work equivalent to that required in a laboratory science education program as defined by (1)(g) of this rule; and had, on or before September 1, 1997, completed a medical laboratory technologist training program that was approved at the time of graduation by the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS) or a national accrediting agency acceptable to the Board.(c) To become licensed as a medical laboratory technician an applicant shall:1. Submit satisfactory evidence of successfully completing and passing a national certifying examination and being nationally certified at the technician level; and2. In addition to possessing the national certification required by Part 1. of this subparagraph, submit satisfactory evidence of one (1) of the following educational criteria: (i) Having received an associate degree from an accredited college/university and having completed an accredited medical laboratory technician training program that was approved at the time of graduation by the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS) or a national accrediting agency acceptable to the Board; or(ii) Having received an associate degree from an accredited college/university and having completed an official military laboratory procedures course of at least fifty (50) weeks duration in residence and having held the military enlisted occupational specialty pertaining to laboratory medicine; or(iii) An associate degree from an accredited college/university which included at least six (6) semester hours of chemistry and six (6) semester hours of biology and three (3) years of full time clinical laboratory work experience as defined in subparagraph (1)(h).(d) To become licensed as a medical laboratory technologist in any of the following categories: chemistry, hematology, immunohematology, microbiology, or immunology, the applicant shall: 1. Present proof of national certification by a certifying body acceptable to the Board in the laboratory specialty in which licensure is being sought at the technologist level; and2. Meet one of the additional qualifications referred to in subparagraph (1)(a)2.(e) To become licensed as a special analyst, an applicant shall:1. Submit satisfactory evidence of certification by a national certification body approved by the Board, where such certification or qualification exists and possess a baccalaureate degree from an accredited college/university relevant to the subspecialty in which licensure is being sought, or2. In the absence of national certification, the individual must possess at least a baccalaureate degree from an accredited college/university relevant to the subspecialty in which licensure is being sought and proof of three (3) years of relevant work experience, as approved by the Board. The Board shall review all individuals qualifying in this manner before licensure may be obtained. Individuals must obtain national certification at such time as it becomes available and must request that proof of said national certification be sent directly to the Board's administrative office from the certifying agency in order to continue licensure. Failure to obtain national certification may result in revocation of the license.3. An individual may be issued a special analyst license to perform tests in a limited category (as listed on the license) if the procedure(s) for which licensure is being sought is a new, emerging technology in the clinical laboratory or represents a subspecialty not otherwise regulated. The procedure(s) shall not be a component of chemistry, hematology, microbiology, immunohematology, or immunology.(f) Testing personnel performing blood gas (pCO2, pO2, and pH) analysis and co oximetry analysis (measurement of oxygen saturation) and reporting of the measurement(s) to include carboxyhemoglobin, total hemoglobin, methemoglobin, and oxyhemoglobin and sulfhemoglobin on automated instruments shall: 1. Hold a valid license as a special analyst limited to blood gases, or2. Hold a valid arterial blood gas (ABG) endorsement issued by the Board of Respiratory Care, pursuant to the Respiratory Care Practitioner Act and rules promulgated by that board.(g) The science coursework equivalent to that required in a laboratory science education program includes:1. Thirty-two (32) semester hours or forty-eight (48) quarter hours of chemical and biological sciences coursework including one class of microbiology (lecture and laboratory) and one course in organic or biochemistry (lecture and laboratory). These courses may be obtained online or on campus.2. Survey, audit, remedial courses, non-graded courses, or didactic courses from a medical laboratory technologist training program do not fulfill the biological and chemical science coursework requirement. College level examination program and advanced placement courses may qualify to fulfill the biological and chemical science coursework requirement.(h) Clinical laboratory work experience shall be: 1. Obtained in a licensed medical laboratory, CLIA-approved site where testing is done at moderate complexity or higher, or other facility approved by the Board with a director qualified under Rule 1200-06-01-.20;2. Acquired predominantly in the laboratory medicine specialty category in which the individual is seeking licensure; and3. Documented to the Board's satisfaction.(2) Responsibilities and Duties of Testing Personnel(a) Responsibilities and duties of the medical laboratory technologist and special analyst include: 1. Collecting and preparing specimens for analysis. Storing or transporting specimens using appropriate preservation methods.2. Following prescribed procedures, performing any of the tests within any of the laboratory specialties. Calculating the results of the tests performed if necessary.3. Operating, calibrating, conducting performance checks, and maintaining any clinical laboratory instrument or equipment.4. Recognizing and correcting basic instrument malfunctions. Notifying supervisory personnel when appropriate.5. Preparing reagents or media from a prescribed procedure, making any adjustments needed.6. Evaluating media, reagents, and calibrators according to established criteria.7. Conducting established quality control procedures on analytical tests, equipment, reagents, media, and products; evaluating results of quality control and implementing corrective action when indicated.8. Determining performance specifications for new methods.9. Establishing basic quality control procedures.10. Performing comparison studies of precision, accuracy, linearity, and validation on new or existing procedures and reporting results in an established format.11. Correlating and interpreting data based on knowledge of physiological conditions affecting test results. Assessing plausibility of laboratory results through correlation of data.12. Indicating the need for additional laboratory tests for definitive diagnostic information in prescribed instances.13. Confirming and verifying results through knowledge of techniques, principles, and instruments.14. Recognizing problems, identifying the cause, developing alternatives and determining solutions where no preset criteria are available.15. Establishing and monitoring quality assurance/continuous quality improvement programs.16. Establishing and monitoring safety programs in compliance with laboratory regulations.17. Maintaining records that demonstrate the proficiency testing samples are tested in the same manner as patient specimens.18. Utilizing laboratory information systems or other methods to accurately and effectively report patient results.19. Writing laboratory procedures conforming to standardized format.20. Performing clinical orientation and supervision for students and new or less skilled laboratory personnel.21. Participating and providing input in competency evaluations.(b) Responsibilities and duties of the medical laboratory technician include:1. Collecting and preparing specimens for analysis. Storing and transporting specimens using appropriate preservation methods.2. Following prescribed methods, performing analytical tests in laboratory specialties in which appropriate training has been received.3. Calibrating, conducting performance checks, and maintaining any clinical laboratory instrument or equipment. Performance of calibrations on clinical and point of care instruments, when and if those calibration procedures do not require sample manipulation beyond thawing of the calibration materials or simple reconstitution of the same materials; and where there are no procedures or possibilities for user intervention(s), to include mathematical manipulations of the slope or intercept of the calibration curve.4. Making calculations as needed to report test results.5. Operating equipment or instruments necessary to perform high volume analytical tests. Recognizing instrument malfunction and making corrections using preset strategies or notifying a technologist or supervisor.6. Preparing reagents and media according to prescribed procedures.7. Performing and recording quality control procedures required for tests assayed. Recognizing unacceptable quality control results. Correcting problems according to preset strategies or notifying a technologist or supervisor.8. Recognizing abnormal or unusual test results and following institutional procedures for reporting critical values.9. Utilizing laboratory information systems or other methods to accurately and effectively report patient results.10. Performing inventory of supplies according to prescribed lists.11. Observing all established laboratory safety procedures.12. Participating in laboratory quality assurance/continuous quality improvement activities.13. Maintaining records to demonstrate that proficiency testing samples are tested in the same manner as patient specimens.Tenn. Comp. R. & Regs. 1200-06-01-.22
Original rule filed May 3, 1995; effective July 17, 1995. Amendment filed September 9, 1996; effective November 23, 1996. Amendment filed January 7, 1997; effective March 23, 1997. Amendment filed March 25, 1997; effective June 6, 1997. Amendment filed March 4, 1998; effective May 20, 1998. Amendment filed August 23, 2001; November 6, 2001. Amendment filed January 31, 2003; effective April 16, 2003. Amendment filed August 25, 2003; effective November 8, 2003. Amendment filed April 17, 2007; effective July 1, 2007. Amendment filed April 1, 2009; effective June 15, 2009. Amendment filed April 22, 2010; effective July 21, 2010. 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, 68-29-117, and 68-29-118.