Following the Food and Drug Administration’s (FDA’s) release of draft guidance for the use of point-of-care (POC) blood glucose meters, AACC is hosting a webinar to discuss how the Centers for Medicare and Medicaid Services (CMS) and the College of American Pathologists (CAP) oversees POC blood glucose meters.
"When AACC held its program on the new blood glucose meter guidance document with the FDA's Courtney Lias, it was apparent from the questions we received that there is some confusion about how to comply with current CLIA requirements governing the use of these meters in the hospital,” said Vince Stein, AACC’s director of government affairs. “We hope to clear up some of that confusion with this webinar."
Deborah Perry, MD, CAP point-of-care testing committee chair, will participate in the webinar. “The presentation will address the definitions of ‘off-label’ test use, test ‘modification,’ laboratory-developed tests, and the differences in proficiency testing and personnel requirements for waived versus high-complexity tests, as it relates to the performance of hospital bedside glucose testing,” she said. “The recent FDA draft guidance documents on bedside glucose testing, prescription (hospital) versus self-use will be referenced.”
Karen Dyer, MT (ASCP), DLM, and Judy Yost, MA, MT (ASCP), will speak on behalf of CMS during the webinar. The three speakers will explain which personnel can use blood glucose meters and address current requirements for POC blood glucose meters, how performance is verified when using new meters, and validating POC meters for off-label use. They will also discuss how to distinguish between special general hospital populations and the regulatory responsibilities for each, as well as common errors inspectors find and how to handle them.
The webinar, part of AACC’s government affairs series, will be held July 16 from 2:30 p.m. to 3:30 p.m. Register today.(insert internal link)