Certification Standards for Embryology Laboratory Director (ELD)

(Effective December 28, 2024)

To be eligible for certification as an Embryology Laboratory Director (ELD), an applicant must fulfill the following requirements:

1. 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), regulations, Subpart M, Section 493.1443. OR
   
   
2. Hold an Doctor of Philosophy (Ph.D.) or Doctor of Science (Sc.D.) degree earned doctoral 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 (minimum) 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:
   
   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

In addition, applicants for ELD certification must:

1. Have a minimum of two (2) years of experience within the ten (10) years immediately prior to the application date on human specimens directing or supervising embryology testing in an embryology laboratory. This experience must include 60 personally performed, completed assisted reproductive procedures in humans administered under current standards of care. 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 ABB’s examinations in Embryology Laboratory Administration and Embryology.

For the specialty of Embryology, see General Regulations #19. 

*ELD and TS certification have different requirements. For TS certification individuals who hold 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. This is not a requirement for ELD certification.

***Effective December 28, 2024, CLIA Regulations for high-complexity clinical laboratory directors were updated. See ABB's certification overview page...

PLEASE READ - Instructions for completing the Application for ABB Certification

Application for ABB Certification