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

(iii) Have at least 2 years of:

(A) Laboratory training or experience, or both: and

(B) Laboratory experience directing or supervising high complexity testing; and

(iv) Have at least 20 CE credit hours in laboratory practice that cover the director responsibilities defined in § 493.1445; or

(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) 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.