All applicants for a Director license must meet the qualifications for a high-complexity laboratory director, as defined in 42 CFR 493.1443.
A licensed physician may direct a clinical laboratory without a separate laboratory director's license if they are certified in clinical pathology by the American Board of Pathology (ABP) or the American Osteopathic Board of Pathology (AOBP); is board-certified in the appropriate laboratory specialty; and/or has four years of pertinent clinical laboratory experience (post-graduate) with two years experience in the specialty that will they will direct.
A non-physician may obtain a director's license for a specialty area if they:
- Holds an earned doctoral degree in a chemical, biological, or clinical laboratory science
- Is certified in the pertinent laboratory specialty by an approved national board
- completes the Board-approved courses in Medical Errors and HIV/AIDS
A director can oversee up to five laboratories.
