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

1. (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

2. (b) The laboratory director must—

   1. (1)

      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
      2. (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. (2)

      1. (i) Be a doctor of medicine, a 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
      2. (ii) Have at least 2 years of experience directing or supervising high complexity testing; and
      3. (iii) Have at least 20 CE credit hours in laboratory practice that cover the director responsibilities defined in § 493.1445; or

   3. (3)

      1. (i)

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

         2. (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

      2. (ii) Be certified and continue to be certified by a board approved by HHS; and

      3. (iii) Have at least 2 years of:

         1. (A) Laboratory training or experience, or both: and
         2. (B) Laboratory experience directing or supervising high complexity testing; and
      4. (iv) Have at least 20 CE credit hours in laboratory practice that cover the director responsibilities defined in § 493.1445; or
   4. (4) Notwithstanding any other provision of this section, an individual is considered qualified as a laboratory director of high complexity testing under this section if they were qualified and serving as a laboratory director of high complexity testing in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024.
   5. (5) For the subspecialty of oral pathology, be certified by the American Board of Oral Pathology, American Board of Pathology, or the American Osteopathic Board of Pathology.

[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5234, Jan. 19, 1993; 59 FR 62609, Dec. 6, 1994; 62 FR 25858, May 12, 1997; 63 FR 55034, Oct. 14, 1998; 65 FR 82944, Dec. 29, 2000; 68 FR 3713, Jan. 24, 2003; 88 FR 90041, Dec. 28, 2023]