Tenn. Comp. R. & Regs. 1200-06-01-.20 - QUALIFICATIONS AND DUTIES OF THE MEDICAL LABORATORY DIRECTOR

(1) Qualifications. It shall not be necessary for an individual who is licensed as a medical laboratory director to be licensed in any other category under these rules. Pathologists and any other person who is duly licensed and registered to practice medicine in the State of Tennessee and boarded by a national boarding agency acceptable to the Board will not be required to obtain a medical laboratory license in addition to their medical license. This medical license shall be current and in good standing. Individuals that hold an earned doctoral degree (non-medical) are required to obtain a license as a laboratory director from the Board. To be eligible to direct a medical laboratory a person shall meet one (1) or more of the following requirements:

(a) Be a physician licensed in Tennessee and certified or eligible for certification in anatomic or clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology. Physicians who are eligible for certification must become certified within three (3) years of assuming directorship.

1. The director of an anatomic laboratory must be certified or eligible for certification in anatomic pathology.

2. The director of a clinical laboratory must be certified or eligible for certification in clinical pathology.

3. The director of a laboratory that conducts anatomic and clinical pathology must be certified or eligible for certification in anatomic and clinical pathology.

(b) Be a physician licensed in Tennessee and certified by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysis, American Board of Medical Laboratory Immunology, or other certifying boards acceptable to the Board in one or more of the laboratory specialties for which approval for directorship is being sought. Board certifications must be current.

(c) Hold an earned doctoral degree in a chemical, physical, biological, or clinical laboratory science, from an accredited institution or equivalent and be certified by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysis, American Board of Medical Laboratory Immunology or other certifying boards acceptable to the Board in one or more of the laboratory specialties for which approval for directorship is being sought. Board certifications must be current.

(d) Be a physician licensed in Tennessee, who subsequent to graduation has had four (4) years or more experience in pulmonary function. The directorship is limited to blood gas analysis (pH, pO2, pCO2) and co-oximetry analysis (measurement of oxygen saturation), and reporting of the measurement(s) to include carboxyhemoglobin, total hemoglobin, oxyhemoglobin, methemoglobin, and sulfhemoglobin on automated instruments.

1. The phrase "subsequent to graduation" means laboratory training and experience acquired after receipt of the specified degree.

2. The term "experience" means broad, relevant experience gained in a clinical laboratory located in the United States. The Board will evaluate the experience required for qualification within these rules.

(e) Hold an earned doctoral degree from an accredited college/university and, in the opinion of the Board, have appropriate work experience in a subspecialty for which there is no national certification. If boarding is available in a closely related field, that boarding must be sought. These individuals must obtain national boarding in the subspecialty when it becomes available.

(2) The Board shall review and approve all director licenses.

(3) A physician who was qualified and acting as a medical laboratory director at a facility on or before July 16, 1995, may continue acting as the medical laboratory director at that facility. Otherwise, to qualify as a medical laboratory director the individual must meet the minimum licensure requirements stated in Rule 1200-06-01-.20(1).

(4) Oral Pathology Laboratory Director

(a) A dentist may serve as a medical laboratory director limited to the specialty of oral pathology without obtaining medical laboratory licensure if

1. The dentist has a current, unrestricted, and unencumbered license to practice dentistry in Tennessee; and

2. The dentist is currently certified by the American Board of Oral and Maxillofacial Pathology; and

3. The dentist is currently certified in oral pathology by the Tennessee Board of Dentistry.

(b) Otherwise, to qualify as a medical laboratory director the individual must meet the minimum licensure requirements stated in Rule 1200-06-01-.20(1) or (3).

(c) Oral pathology laboratory directors shall limit their responsibilities to only those specimens obtained from the oral cavity.

(5) Duties. The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations.

(a) The laboratory director, if qualified, may perform the duties of the medical laboratory supervisor and of testing personnel or may delegate those responsibilities to personnel meeting the qualifications for those respective positions.

(b) The laboratory director may delegate duties to the medical laboratory supervisor. However, the director remains responsible for ensuring that all duties are properly performed.

(c) The laboratory director must be accessible to the laboratory to provide onsite, telephone, or electronic consultation as needed. The director shall make periodic and documented on-site visits at a minimum of once per month.

(d) The laboratory director must not direct more than three (3) clinical labs without an exemption from the Board. Collection stations are not considered clinical laboratories.

(e) The laboratory director must -

1. Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing;

2. Ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed and provide a safe environment in which employees are protected from physical, chemical and biological hazards;

3. Ensure that -

(i) The test methodologies selected have the capability of providing the quality of results required for patient care,

(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and

(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results;

4. Ensure that the laboratory is enrolled in a proficiency testing program approved by the U.S. Department of Health and Human Services for the testing which is performed and that -

(i) The proficiency testing samples are tested as required under these rules;

(ii) The results are returned within the timeframes established by the proficiency testing program;

(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require corrective action;

(iv) An approved corrective action plan is followed when any proficiency testing result is found to be unacceptable or unsatisfactory; and

(v) The regional surveyor is notified in the event the proficiency testing scores are unacceptable or unsatisfactory. The response form shall be completed to include any corrective action implemented to solve the problem(s).

5. Ensure that the quality control and quality assurance programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur;

6. Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system;

7. Ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory's established performance characteristics are identified, and that patient test results are reported only when the system is functioning properly;

8. Ensure that reports of test results include pertinent information required for interpretation;

9. Ensure that consultation is available to the laboratory's clients on matters relating to the quality of the test results reported and their interpretation concerning specific patient conditions;

10. Ensure that a general supervisor provides supervision of test performance by testing personnel;

11. Ensure that a sufficient number of laboratory personnel are employed who possess the appropriate education and experience or training to provide appropriate consultation, to properly supervise and to accurately perform tests and report test results in accordance with the personnel responsibilities described in Rule 1200-06-01-.22;

12. Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and scope of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results;

13. Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills;

14. Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process:

15. Ensure, in writing, the responsibilities and duties of each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results; and

16. Provide consultation regarding the appropriateness of the testing ordered and interpretation of test results.

Notes

Tenn. Comp. R. & Regs. 1200-06-01-.20

Original rule filed May 3, 1995; effective July 17, 1995. Amendment filed September 11, 1996; effective November 25, 1996. Amendment filed January 7, 1997; effective March 23, 1997. Amendment filed March 4, 1998; effective May 20, 1998. Amendment filed April 29, 2002; effective July 13, 2002. Amendment filed May 23, 2003; effective August 6, 2003. Amendment filed August 25, 2003; effective November 8, 2003. Amendment filed June 2, 2004; effective August 16, 2004. Amendment filed October 11, 2004; effective December 25, 2004. 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, 68-29-111, 68-29-114, 68-29116, 68-29-118, 68-29-129, and 68-29-137.