This session will review the impact of FDA’s draft recommendations to reduce the risks for (1) transfusion-transmitted Babesia (JUL 2018), and (2) bacterial contamination of platelets for transfusion (DEC 2018). Final recommendations for each are expected to have a substantial impact on blood collection, processing, testing, inventory, and other areas of operations. The session will include presentations on blood donor screening for Babesia, testing options based on the withdrawal of certain serological blood donor screening platforms that were evaluated under IND, the high rate of false positives on at least some of the platforms, and the advantages of nucleic acid-based screening in both potential yield, ability to be scaled to national screening and, so far, its lower rates of donor deferral compared to serological testing. Speakers will address the potential effect of implementing NAT screening of donors in 7,13, >20 states or even universal screening in both cost/yield, Babesia TTD cases prevented etc. Presentations on FDA’s 3rd draft guidance on bacterial risk from platelets will address the need for timely implementation of strategies to prevent the leading cause of transfusion-related morbidity and mortality. Speakers will describe the challenges associated with implementation without a decrease in product availability which could also lead to morbidity and mortality. They will discuss how the available options affect blood centers and transfusion services and how to overcome the obstacles posed by the different methods.
Contrast the draft guidance on Babesia screening with practically implementable donor screening using NAT platforms and the impact of various models of donor screening from geographically limited to universal screening in terms of cost, yield and donors deferred.
Identify the potential challenges both blood centers and transfusion services might face in implementing the selected mitigation method or methods for bacterial contamination in platelets and estimate the impact of the guidance on the availability of platelets for transfusion.
Propose rational approaches to final guidance preparation.
Associate Professor; Associate Director, Transfusion Medicine,
Johns Hopkins University School of Medicine
Medical Director and Vice President, Quality and Regulatory Affairs, Co-Director, Transfusion Medicine, Associate Clinical Professor, Laboratory Medicine and Pediatrics, Innovative Blood Resources,
Innovative Blood Resources