ABB Examination Dates
May 13, 2015
Red Rock Resort
Las Vegas, Nevada
October 16, 2015
Two (2) years discontinued:
Three (3) or more years discontinued:
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.