- ABB has vested authority for final decisions pertaining to all aspects of Board functions.
- ABB shall establish all regulations, standards, and requirements for certification and the maintenance of certification as a Bioanalyst Clinical Laboratory Director (BCLD), High-complexity Clinical Laboratory Director (HCLD), Public Health Laboratory Director (PHLD), Embryology Laboratory Director (ELD), Andrology Laboratory Director (ALD), Clinical Consultant (CC), and Technical Supervisor (TS).
- Certification is valid until December 31 of the year in which it is granted. Revalidation is annual. All fees are determined by ABB.
- Certificants are required to participate in the PEER (Professional Enrichment Education Renewal) program and meet the minimum requirements of ABB as a condition for maintaining ABB certification.
- An individual must at all times continue to meet the ABB requirements for maintaining certification (e.g., documenting continuing education credit) in order to continue to use the ABB certification initials. Should an individual cease at any time to meet the ABB qualifications for certification, or the certification lapses or is rescinded, the right to use the ABB certification initials automatically terminates, and may not be reused until such time as the ABB Board determines that such individual once again meets ABB certification requirements currently in effect.
- Certificants will be notified if they are deficient in meeting the PEER requirements or in paying revalidation fees, and will be given an opportunity to correct such deficiency.
If the deficiency is not remedied by the deadline date provided, the individual’s certification will be placed on "inactive" status.
- Falsifying, misrepresenting, or misstating information submitted as part of, or in addition to, an application shall be grounds for denying, revoking or suspending certification.
- Falsifying, misrepresenting, or misstating information regarding an individual’s certification, including the disciplines in which an individual is certified or the status of an individual’s certification, shall be grounds for denying, revoking or suspending certification.
- ABB certification may be denied, revoked or suspended at the discretion of ABB upon a finding by it that the certificant does not possess the character or fitness suitable for ABB certification. Grounds for denial, revocation or suspension include, but are not limited to, conviction of a felony or of a health care offense; sanction by a federal or state governmental body; an act of moral turpitude; falsifying, misrepresenting, or misstating information submitted on or with an application for certification; falsifying, misrepresenting, or misstating information regarding an individual’s certification; or illegal residency.
- Requests for certification shall be submitted to the Board on official forms with fee attached. Fees are specified on the official applications form and are non-refundable. All applications must be notarized.
- Degrees earned in the United States must be from a college, university or other institution accredited by an accreditation organization recognized by the U.S. Department of Education. All degrees received from educational institutions outside the United States must be evaluated by an agency approved by ABB. Fees for such an evaluation shall be paid by the applicant.
All international transcripts must be provided in English. Transcripts that are not provided in English must be translated by a service approved by ABB. The cost of the translation shall be paid by the applicant.
- An accredited institution is defined as an institution accredited by an accreditation organization recognized by the U.S. Department of Education.
- An "acceptable clinical laboratory" is a laboratory certified or licensed under federal, state or municipal law that performs nonwaived testing (as defined under CLIA) for the biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, genetic, pathological, or other examination of material derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings, or other laboratories acceptable to the board.
- All experience must be obtained within the ten (10) years immediately prior to the application date.
- 2,080 clock hours equal one (1) year of full-time employment.
- Reinstatement Policy.
One (1) – Two (2) years discontinued:
- pay annual fees for prior and current year;
- pay late fee of $95;
- bring continuing education records up-to-date; and
- pay any other fees due.
Two (2) – Three (3) years discontinued:
- reapply as new applicant and take appropriate examinations, OR
- pay past and current annual fees plus continuing education fees;
- pay late fee of $190;
- bring continuing education records up-to-date;* and
- pay any other fees due.
More than Three (3) years discontinued:
- reapply as new applicant and take appropriate examinations.
- ABB certification is determined by the certification requirements currently in effect. If an individual's certification has lapsed or been rescinded for any reason, such individual's certification may not be reinstated until such time as he/she demonstrates to the satisfaction of the ABB that he/she meets current certification requirements.
Effective January 1, 2012, ABB will accept up to two (2) years of alternative experience to meet the experience requirements for BCLD and HCLD. The two (2) years of acceptable alternative experience must be on human specimens within the ten (10) years immediately prior to the application date and must be applicable to a clinical setting. The following examples illustrate the types of experience/training that will be considered:
Case 1. Alternative/Specialized laboratory experience in a CLIA/CAP certified laboratory. There can be useful laboratory experience within the framework of a CLIA certified laboratory that is not directly involved in the reporting of laboratory results for patient care. For example, this position might have a title of (1) director of technology transfer, (2) technical training director, (3) QC manager, (4) test development/validation manager, etc.
Case 2. Laboratory experience in a university departmental specialty laboratory. These laboratories (e.g. Department of Genetics, Division of Rheumatology & Immunology, etc.) may or may not be CLIA/CAP certified but they test human specimens for research projects, clinical studies, etc. This type of testing is typically performed at major academic medical centers. Some of these test results do get into the patient record and may impact patient care.
Case 3. Experience with an In Vitro Diagnostic (IVD) company. The development and validation of a clinical test under FDA’s Good Manufacturing Practices (GMP) Regulations may involve useful clinical laboratory testing. For example, the applicant may have worked at an in vitro diagnostic manufacturer to develop new clinical tests. This work may involve significant experience with the design, production and use of control materials, evaluation of the clinical efficacy of tests, experience with the submission of FDA documents, etc.
Case 4. Experience in a Contract Research Organization (CRO) laboratory. Large Contract Research Organizations frequently run clinical tests in their own laboratory facilities. These laboratories operate at a very high standard of regulatory compliance, and this experience can be valuable.
- For the specialty of Embryology, experience must include 60 personally performed, completed assisted reproductive procedures in humans. The sixty procedures do not have to be performed on the same sixty cycles/patients.
- 60 oocyte isolation from follicular aspirations
- 60 sperm preparations
- 60 intracytoplasmic sperm injections cycles
- 60 documentation of fertilization
- 60 preparation of embryos for embryo transfer**
- 60 cryopreservation procedures of oocyte/embryos
- Effective January 1, 2021, ABB applicants for Technical Supervisor and High-complexity Clinical Laboratory Director certification in the discipline of Andrology must have experience in a laboratory that has Andrology listed on the laboratory’s CLIA certificate.
- Effective January 1, 2021, Molecular Diagnostics is defined as "testing that involves the manipulation and examination of nucleic acid in a high complexity testing environment."
*Maximum of two consecutive years on “Provisional Status”
**Activities included in the “Preparation of embryos for embryo transfer” will be laboratory Specific and are limited to the laboratory portion of the transfer process (e.g., embryo grading, selection and sequestration of embryos to be transferred; loading of transfer catheter; transportation of catheter to transfer location; and checking the catheter for retained embryos following transfer). Regardless of the laboratories specific processes, the applicant must be involved in the preparation of embryos for transfer as stated in the laboratories Standard Operating Procedures.