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 or experience within the ten (10) years immediately prior to the application date on human specimens, or both, 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;
For the specialty of Embryology, experience must include 60 personally performed, completed assisted reproductive procedures in humans.
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.
* 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 to meet this requirement (see General Regulations, rule 17).