Effective date March 17, 2008
All applicants for a Director license must meet the qualifications for a high complexity laboratory director that are defined in 42 CFR 493.1443 as published on October 1, 2007.
A licensed physician may direct a clinical laboratory without a separate laboratory director's license if he / she is certified in clinical pathology by the American Board of Pathology (ABP) or the American Osteopathic Board of Pathology (AOBP); is board-certified in the pertinent laboratory speciality; and/or has four years of pertinent clinical laboratory experience (post-graduate) with two years experience in the speciality that will he/she will direct.
A non-physician may obtain a director's license for a specialty area if he / she:
- 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
A director can oversee up to five laboratories.