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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. The ELD certification 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 and the Centers for Disease
Control and Prevention’s (CDC’s) model program for the certification
of embryology laboratories under the Fertility Clinic Success Rate
and Certification Act of 1992 (Federal Register, Vol. 64, No.
139, July 21, 1999).
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.
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1996-2006 ABB |