Laboratory-Developed Tests

 

Price: $0.00

Presented by 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.

Learning 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.

Target audience: Clinical pathologists, laboratory directors and supervisors, clinical laboratory professionals, and industry scientists who are interested in laboratory-developed tests and their oversight.