Preparing for Inspection: Managing Regulations and Practices Surrounding Donors With Positive Infectious Disease Testing

Federal and local regulatory agencies mandate that all blood collection facilities test each allogeneic blood donation for evidence of infectious diseases. When a donation tests positive or reactive for any of the required screening tests, facilities are required to take appropriate action by deferring donors and removing potentially infectious products from inventory. Each required action must be performed in accordance with posted regulations and documented for record retention. Donor deferral records related to positive or reactive infectious disease testing are particularly vulnerable targets of inspection. There are currently numerous regulations and requirements for handling donors who test positive or reactive in infectious disease screening tests. Each of these regulations must be somehow organized and incorporated into written departmental procedures for staff to follow with confidence and accuracy. UMass Memorial Medical Center has implemented a process that equips staff members with the knowledge and confidence to respond in an organized way to an inspection of donor deferral records and related activities. The extraction of regulatory detail from written procedures into job aids and tools for staff to follow with ease and confidence ensures an inspection with zero findings in this area. J. Clin. Apheresis 23:191-195, 2008. (c) 2008 Wiley-Liss, Inc.