About The American Board of Bioanalysis (ABB)

The American Board of Bioanalysis (ABB) evaluates, through the certification process, individuals who wish to enter, continue or advance in the clinical laboratory profession. ABB identifies, on a non discriminatory basis, individuals who meet ABB’s requirements for clinical laboratory directors, consultants, and supervisors. ABB certification is based on an individual’s education, experience, and knowledge of the laboratory field in which certification is granted.

ABB requirements do not discriminate against any individual or group of individuals on the basis of race, color, sex, age, religion, or source of national origin.

In 1968, the American Board of Bioanalysis was established by the American Association of Bioanalysts (AAB) in response to the passage of the Medicare regulations (1966) and the Clinical Laboratories Improvement Act of 1967 (CLIA ’67), which defined the qualifications for a laboratory director. In 1972 ABB’s certification program was expanded to include supervisors, in 1982 to include managers (subsequently discontinued in July 1, 2005), and in 1993 to include consultants.

The 1974 Medicare regulations for independent laboratories recognized ABB as a certifying agency under section 405.1312 (b) (2) and (4). At that time, ABB revised its standards for director certification, creating three levels: Bioanalyst Clinical Laboratory Director (BCLD), Clinical Laboratory Director (CLD), and Bioanalyst Laboratory Director (BLD).

With the advent of the CLIA ’88 regulations, ABB again revised its certification standards and classifications. ABB now certifies directors in the following two categories: Bioanalyst Clinical Laboratory Director (BCLD) and High-complexity Clinical Laboratory Director (HCLD).

The regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) also recognize ABB as a certifying agency for laboratory directors and clinical consultants. In addition, most state laboratory regulatory programs recognize ABB’s director certification.

In 2002, ABB added a certification category for Embryology Laboratory Directors (ELDs). Although embryology laboratories have yet to be covered by CLIA, ABB has decided to implement an ELD certification that resembles the director qualifications contained in the minimum standards for assisted reproductive technologies of the American Society for Reproductive Medicine’s (ASRM’s) Practice Committee. 

Applicants for ELD certification should be aware that the ELD certification may or may not meet CLIA requirements should the Department of HHS decide at a future date that CLIA covers embryology laboratories. Applicants who are performing CLIA-covered tests and who wish to satisfy current CLIA requirements for high complexity testing should seek HCLD(ABB) or BCLD(ABB) certification.

To address the chronic shortage of laboratory scientists certified to direct a high complexity public health laboratory, ABB and the Association of Public Health Laboratories (APHL) agreed to offer a board certification in public health microbiology beginning in the fall of 2009.  The certification will afford doctoral-level scientists and technical supervisors in public health laboratories a new means to qualify for certification under CLIA.  The certification will be the first to examine specifically for the training and experience required to direct a state or large municipal public health laboratory.

In 2010 ABB created the certification designation Public Health Laboratory Director (PHLD) for directors certified in a public health discipline.