Note Regarding New CLIA Regulations
On December 28, 2024, CLIA's updated regulations (published December 28, 2023) for high complexity clinical laboratory directors (42 CFR 493.1443) are effective.
The changes in Section 493.1443 (3)(i)(A) include the types of doctoral degrees that meet the new CLIA definition of "earned doctoral degree" under 42 CFR 493.2.
As amended, Section 493.1443 (3)(i)(A) now requires an “earned doctoral degree in a chemical, biological, clinical or medical laboratory science or medical technology.” For example, degrees in physics and veterinary medicine are specifically excluded, while a Doctor of Clinical Laboratory Science (DCLS) degree is included.
In addition, doctoral degrees that do not qualify as an earned doctoral degree, in the major areas listed in Section 493.1443(3)(i)(A) can be used to meet CLIA’s high complexity laboratory director requirements via an “alternate pathway,” as outlined in Section 493.1445 (3)(i)(B).
At this time, ABB will use CLIA’s new “alternate pathway” as a qualification route for doctoral degrees not specifically recognized under Section 493.1443 (3)(i)(A).
The new “alternate pathway” also will be used for individuals with a DCLS degree until CLIA’s updated Interpretive Guidelines are published and ABB has a chance to review those guidelines.
Director Certification, Five (5) Levels
Bioanalyst Clinical Laboratory Director (BCLD)
A generalist laboratory director who has technical experience in a minimum of three (3) of the following five (5) major clinical laboratory disciplines:
- Chemistry;
- Diagnostic Immunology;
- Hematology;
- Microbiology or Public Health Microbiology;
- Molecular Diagnostics
High-complexity Clinical Laboratory Director (HCLD)
A laboratory director who has expertise in high complexity testing 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.
Public Health Laboratory Director (PHLD)
A laboratory director who has expertise in high complexity testing in Public Health Microbiology.
Embryology Laboratory Director (ELD)
A laboratory director who has expertise in the specialty of assisted reproductive technology (ART) laboratory procedures in an embryology laboratory.
Andrology Laboratory Director (ALD)
A laboratory director who has expertise in the technical discipline of andrology.Consultant, One (1) Level
Clinical Consultant (CC)
A Clinical Consultant provides consultation to the clients of a laboratory performing moderate or high complexity testing regarding the appropriateness of the testing ordered and interpretation of test results.Supervisor, One (1) Level
Technical Supervisor (TS)
A Technical Supervisor is responsible for the technical and scientific oversight of a laboratory performing high complexity testing.
