Prospective surveillance of D- recipients of D+ apheresis platelets: alloimmunization against D is not detected.

BACKGROUND: Recent retrospective studies indicate that D- recipients of D+ apheresis platelets (PLTs) are not alloimmunized to D. Our hospital policy is to offer RhIG to D- women of childbearing age who received D+ apheresis PLTs but not to other D- recipients of D+ apheresis PLTs. We instituted prospective surveillance of the D- recipients who were not given RhIG. STUDY DESIGN AND METHODS: All apheresis PLT recipients were prospectively entered into a database that recorded the patient's age, sex, diagnosis, D status, apheresis PLT transfusions, and antibody screen results from before and after PLT transfusions. Data are reported for PLTs transfused between October 16, 2012, and April 16, 2014, and antibody screens obtained through June 16, 2014. The analysis excludes neonates; women not more than 50 years of age; and patients who also received D+ red blood cells, received only D- PLTs, received RhIG, were previously alloimmunized to D, and did not have a follow-up antibody screen after the first D-incompatible apheresis PLT transfusion. RESULTS: A total of 158 of 1107 apheresis PLT recipients were D-. Seventy-nine were eligible for analysis based on the exclusion criteria listed above. None became alloimmunized to D during the observation interval. In 45 (57%) cases the last follow-up antibody screen was obtained at least 4 weeks after the first D-incompatible apheresis PLT transfusion. CONCLUSION: Prospective surveillance confirms prior retrospective observations that D- patients do not appear to risk D alloimmunization after receiving D+ apheresis PLTs.

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.