Certification Standards for High-complexity Clinical Laboratory Director (HCLD)
Effective December 28, 2024

To be eligible for certification as a High-complexity Clinical Laboratory Director (HCLD), an applicant must:

1. Meet the qualifications as a laboratory director of a laboratory performing high complexity testing under CLIA ’88, Code of Federal Regulations, Title 42, Part 493, Subpart M, Section 493.1443(a)* and either 493.1443(b)(1), 493.1443(b)(2), OR
2. Hold a Doctor of Philosophy (Ph.D.) or Doctor of Science (Sc.D.) degree from an accredited institution (see rule 11 under General Regulations) in a chemical, biological, clinical or medical laboratory science, or medical technology as the major subject and have successfully completed at least 32 semester hours in chemistry or the biological sciences acceptable to the Board; OR
3. Hold an earned Doctor of Clinical Laboratory Science (DCLS) degree or other clinical/professional doctoral degree, or a doctoral degree in a field that is not in a chemical, biological, clinical or medical laboratory science, or medical technology that is acceptable to the ABB Board and either have completed:
   • at least 16 semester hours of doctoral-level coursework in biology, chemistry, medical technology, clinical laboratory science, or medical laboratory science; OR
   • an approved thesis or research project in biology, chemistry, medical technology, clinical laboratory science or medical laboratory science, related to laboratory testing for the diagnosis, prevention, or treatment of any disease or impairment of, or assessment of the health of, human beings.

In addition, applicants for HCLD certification must:

1. Have a minimum of four (4) years** of clinical laboratory training and/or experience in a CLIA-certified high complexity laboratory (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 CLIA-certified laboratory and at least one (1) year of experience in a CLIA-certified laboratory in the technical discipline(s) in which the applicant will be taking the examination(s).
   
   For the specialty of Embryology, see General Regulations #19. For the specialty of Andrology, see General Regulations #20. AND
2. Have at least 20 Continuing Education (CE) credit hours in laboratory practice that cover laboratory director responsibilities defined in Section 493.1445 of the December 28, 2024, CLIA regulations; AND
3. 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.

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., D.O., or DPM degree, or the equivalent, also must be licensed to practice medicine, osteopathy, or podiatry in the state in which the laboratory is located. However, if the laboratory is owned and operated by the U.S. government, the individual may be licensed in any U.S. state, so long as the individual is licensed to practice medicine, osteopathy, or podiatry in at least one (1) state in the U.S.

** NOTE: ABB General Regulations, rule 18, now is out-of-date. Under the new CLIA regulations effective December 28, 2024, laboratory training or experience must be obtained in a facility that meets the definition of a laboratory under 42 CFR 493.2 and is not excepted under Section 493.3(b) [exceptions to CLIA applicability]. In other words, the required training/experience must be in a CLIA-certified high complexity laboratory.

PLEASE READ - Instructions for completing the Application for ABB Certification

Application for ABB Certification