The laboratory director must be qualified to manage and direct the laboratory personnel and the performance of moderate complexity tests and must be eligible to be an operator of a laboratory within the requirements of subpart R of this part.

(a) The laboratory director must possess a current license as a laboratory director issued by the State in which the laboratory is located, if such licensing is required; and

(b) The laboratory director must—

(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and

(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology; or

(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and

(ii) Have had laboratory training or experience consisting of:

(A) At least 1 year directing or supervising nonwaived laboratory testing; and

(B) Have at least 20 CE credit hours in laboratory practice that cover the laboratory director responsibilities defined in § 493.1407; or

(3)(i)(A) Hold an earned doctoral degree in a chemical, biological, clinical or medical laboratory science or medical technology from an accredited institution; or

(B) Hold an earned doctoral degree; and

(1) Have at least 16 semester hours of doctoral level coursework in biology, chemistry, medical technology (MT), clinical laboratory science (CLS), or medical laboratory science (MLS); or

(2) An approved thesis or research project in biology/chemistry/MT/CLS/MLS related to laboratory testing for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings; and

(ii) Have at least 20 CE credit hours in laboratory practice that cover the laboratory director responsibilities defined in § 493.1407; and

(A) Be certified and continue to be certified by a board approved by HHS; and

(B) Have had at least 1 year of experience directing or supervising nonwaived laboratory testing; or

(4)(i)(A) Have earned a master's degree in a chemical, biological, clinical or medical laboratory science or medical technology from an accredited institution; or

(B)(1) Meet bachelor's degree equivalency; and

(2) Have at least 16 semester hours of additional graduate level coursework in biology, chemistry, medical technology, clinical or medical laboratory science; or

(C)(1) Meet bachelor's degree equivalency; and

(2) Have at least 16 semester hours in a combination of graduate level coursework in biology, chemistry, medical technology, clinical or medical laboratory science and an approved thesis or research project related to laboratory testing for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings; and

(ii) Have at least 1 year of laboratory training or experience, or both, in nonwaived testing; and

(iii) Have at least 1 year of supervisory laboratory experience in nonwaived testing; and

(iv) Have at least 20 CE credit hours in laboratory practice that cover the director responsibilities defined in § 493.1407; or

(5)(i)(A) Have earned a bachelor's degree in a chemical, biological, clinical or medical laboratory science or medical technology from an accredited institution; or

(B) At least 120 semester hours, or equivalent, from an accredited institution that, at a minimum, includes either—

(1) Forty-eight (48) semester hours of medical laboratory science or medical laboratory technology courses; or

(2) Forty-eight (48) semester hours of science courses that include—

(i) Twelve (12) semester hours of chemistry, which must include general chemistry and biochemistry or organic chemistry;

(ii) Twelve (12) semester hours of biology, which must include general biology and molecular biology, cell biology or genetics; and

(iii) Twenty-four (24) semester hours of chemistry, biology, or medical laboratory science or medical laboratory technology in any combination; and

(ii) Have at least 2 years of laboratory training or experience, or both, in nonwaived testing; and

(iii) Have at least 2 years of supervisory laboratory experience in nonwaived testing; and

(iv) Have at least 20 CE credit hours in laboratory practice that cover the director responsibilities defined in § 493.1407.

(6) Notwithstanding any other provision of this section, an individual is considered qualified as a laboratory director of moderate complexity testing under this section if they were qualified and serving as a laboratory director of moderate complexity testing in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024.

[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5233, Jan. 19, 1993; 88 FR 90039, Dec. 28, 2023]