Certification Standards for Public Health Laboratory Director (PHLD)
(Effective December 28, 2024)
To be eligible for certification as Public Health Laboratory Director (PHLD), an applicant must:
- Meet the qualifications as a laboratory director of a laboratory performing high complexity testing under the 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 493.1443(b)(4)* and have successfully completed at least 32 semester hours in chemistry or biological sciences acceptable to the Board. These hours can be earned from both undergraduate and graduate courses; OR
- 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 32 semester hours in chemistry or the biological sciences acceptable to the Board. These hours can be earned from both undergraduate and graduate courses; OR
- Hold an earned Doctor of Clinical Laboratory Science (DCLS) degree or other clinical/professional doctoral degree in a chemical, biological, clinical or medical laboratory science, or medical technology, 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:
a. at least 16 semester hours of doctoral-level coursework in biology, chemistry, medical technology, clinical laboratory science, or medical laboratory science; OR
b. 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.AND
c. at least 32 semester hours in chemistry or biological sciences acceptable to the Board. These hours can be earned from both under¬graduate and graduate courses.
In addition, applicants for PHLD certification must:
- Have a minimum of four (4) years of clinical laboratory 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, testing on human specimens or testing of microbiological material for diagnosis and/or identification of diseases/pathogens related to human or human disease/pathogen outbreaks or both. This experience must include:
a. A minimum of two (2) years of experience, within the ten (10) years immediately prior to the application date, directing or supervising high complexity testing on human specimens in a CLIA-certified laboratory**; AND
b. A minimum of two (2) years of training or experience in a CLIA-certified laboratory** that includes one (1) year of experience in a Public Health Microbiology Laboratory or a Clinical Microbiology Laboratory doing testing on human or microbiological material for diagnosis of diseases/pathogens; AND
- Have at least 20 Continuing Education (CE) credit hours in laboratory practice that cover laboratory director responsibilities defined in Section 493.1445 of the CLIA Regulations effective December 28, 2024; AND
- Pass an ABB examination in General Knowledge and in Public Health Microbiology.
*Individuals with an M.D., D.O., or DPM degree must also be licensed to practice medicine, osteopathy, or podiatry in the state in which the laboratory is located. If the laboratory is owned and operated by the U.S. government, then the individual with an M.D., D.O., or DPM degree must be licensed to practice medicine, osteopathy, or podiatry in at least one (1) state in the U.S.
**NOTE: ABB General Regulation #18 is now out-of-date. Under the new CLIA regulations effective December 28, 2024, laboratory experience must be earned in a CLIA-certified high-complexity laboratory or a clinical laboratory that meets the definition of a laboratory in 42 CFR 493.2 of the CLIA Regulations and is not excepted under Section 493.3(b) [exceptions to CLIA applicability]. For clarification on which laboratories may meet this requirement, see General Regulation #13.
PLEASE READ - Instructions for completing the Application for ABB Certification
