Certification Standards for High-complexity Clinical Laboratory Director (HCLD)
To be eligible for certification as a High-complexity Clinical Laboratory Director (HCLD), an applicant must:
- Meet the qualifications as a laboratory director of a laboratory performing high complexity testing under the CLIA ’88 regulations, Subpart M, Section 493.1443. OR
- Hold an earned doctoral degree* from an accredited institution (see rule 11 under General Regulations) with a chemical, physical, biological, or clinical laboratory science as the major subject and have successfully completed 32 semester hours (minimum) in chemistry or the biological sciences acceptable to the Board.
In addition, applicants for HCLD certification must:
- Have a minimum of four (4) years** of
clinical laboratory training and/or experience on human specimens (excluding experience/training in a Waived, Moderate Complexity, or Provider Performed Microscopy Laboratory) within the ten (10) years immediately prior to the application date, including at least two (2) years of experience within the ten (10) years immediately prior to the application date directing or supervising high complexity testing in a clinical setting, and at least one (1) year in the technical discipline(s) in which the applicant will be taking the examinations.
For the specialty of Embryology, see General Regulations #19. For the specialty of Andrology, see General Regulations #20. AND
- Pass an ABB examination in General Knowledge and in at least one (1) of the following clinical laboratory disciplines or specialties: Andrology; Chemistry (including urinalysis, endocrinology and toxicology); Diagnostic Immunology; Embryology; Hematology (including flow cytometry); Microbiology (includes bacteriology, parasitology, virology, and mycology); Molecular Diagnostics; or Public Health Microbiology.
For applicants applying for the specialty of Andrology, see General Regulations #20.
Effective January 1, 2021, Molecular Diagnostics is defined as "testing that involves the manipulation and examination of nucleic acid in a high complexity testing environment." See General Regulations #21
* Individuals with an M.D. or D.O. degree, or the equivalent, must also be licensed to practice medicine in at least one (1) state in the U.S.
**Effective January 1, 2012, ABB will accept up to two (2) years of alternative experience toward the four-year experience requirement for HCLD certification. The two (2) years of acceptable alternative experience must be on human specimens within the ten (10) years immediately prior to the application date and must be applicable to a clinical setting. An additional two (2) years of clinical supervising or directing experience is still required in addition to the two years of “alternative” experience. (see General Regulations, rule 18).