Donor Dilemmas and Management of Nonconforming Cellular Therapy Products
Program Code: 074588
Wednesday, October 3, 2007
2:00 PM to 3:30 PM (ET)

MODERATOR
Jay H. Herman, MD, Thomas Jefferson University

SPEAKERS
Elizabeth Read, MD, University of California, San Francisco
Donna Regan, MT(ASCP)SBB, St. Louis Cord Blood Bank
Brenda Alder, MS, MT(ASCP)SBB, Northside Hospital

DESCRIPTION
Arguably, determining donor eligibility can be one of the most challenging steps in establishing product quality and suitability. The lack of uniform HPC product specifications and unique donor/patient relationship make the application of standard algorithms designed for transfusion services difficult to apply. This audioconference will address the screening and qualification of donors and provide details and guidance on the use of the donor history questionnaire for allogeneic PBSC and bone marrow donors. The unique challenges of screening UCB donors will also be discussed, focusing on successful approaches that increase consumer confidence and the challenges that complicate the ability to enhance the ethnic diversity in a cord blood bank inventory. Finally, a review of what constitutes an exception to FDA's donor eligibility criteria, as opposed to a reportable HCT/P deviation, and how to manage them will be presented.