Site Search
A podcast that explores the future of laboratory medicine
Join Dr. Brian Jackson, adjunct professor of pathology at the University of Utah and a medical director at ARUP Laboratories, as he interviews some of the top minds in diagnostic laboratory medicine. Listeners are privy to personal anecdotes and creative insights into important challenges facing laboratories and clinicians.
An Interview With With Beverly Rauch: Regulating the Safety and Effectiveness of Clinical Laboratory Testing
Many people in the healthcare profession know that clinical laboratories are under more rigorous regulatory scrutiny than just about any other area of medicine. What they may not know is that the New York State Department of Health (NY DOH) was the pioneer in laboratory regulation, starting long before the implementation of either the FDA Medical Device Amendments or the Clinical Laboratory Improvement Amendments (CLIA) of 1988. In this interview, Beverly Rauch, MS, director of the NY DOH’s Clinical Laboratory Evaluation Program (NY CLEP), describes its process for granting permits, inspecting laboratories, and approving assays, and what the new FDA LDT rule might mean for the program.
Related Information:
New York Clinical Laboratory Evaluation Program (NY CLEP)
Originally published December 12, 2024
*Please note: Our podcasts do not provide continuing education credits.