James Nichols, PhD, Professor of Pathology at Tufts University School of
Medicine, Medical Director for Clinical Chemistry of Baystate Health System,
Springfield, MA, Judith Yost, MA, MT (ASCP), Director of the Division of
Laboratory Services, Centers for Medicare and Medicaid Services, Baltimore, MD,
and Katherine Serrano, Biomedical Engineer, Office of In Vitro Diagnostic Device
Evaluation and Safety, Food and Drug Administration, Silver Spring, MD. Approved
for 1.0 ACCENT Category 1 Credit.
objectives: Learners will be
able to discuss the challenges and oversight involved with using and producing
laboratory-developed tests (LDTs) and the specific requirements for LDTs set
forward by CLIA and the FDA.
pathologists, laboratory directors and supervisors, clinical laboratory
professionals, and industry scientists who are interested in
laboratory-developed tests and their