The American Red Cross donor hemovigilance program: complications of blood donation reported in 2006.

BACKGROUND: The American Red Cross (ARC) initiated a comprehensive donor hemovigilance program in 2003. We provide an overview of reported complications after whole blood (WB), apheresis platelet (PLT), or automated red cell (R2) donation and analyze factors contributing to the variability in reported complication rates in our national program., STUDY DESIGN AND METHODS: Complications recorded at the collection site or reported after allogeneic WB, apheresis PLT, and R2 donation procedures in 36 regional blood centers in 2006 were analyzed by univariate and multivariate logistic regression., RESULTS: Complications after 6,014,472 WB, 449,594 PLT, and 228,183 R2 procedures totaled 209,815, 25,966, and 12,282 (348.9, 577.5, and 538.3 per 10,000 donations), respectively, the vast majority of which were minor presyncopal reactions and small hematomas. Regional center, donor age, sex, and donation status were independently associated with complication rates after WB, PLT, and R2 donation. Seasonal variability in complications rates after WB and R2 donation correlated with the proportion of donors under 20 years old. Excluding large hematomas, the overall rate of major complications was 7.4, 5.2, and 3.3 per 10,000 collections for WB, PLT, and R2 procedures, respectively. Outside medical care was recorded at similar rates for both WB and automated collections (3.2 vs. 2.9 per 10,000 donations, respectively)., CONCLUSION: The ARC data describe the current risks of blood donation in a model multicenter hemovigilance system using standardized definitions and reporting protocols. Reported reaction rates varied by regional center independently of donor demographics, limiting direct comparison of different regional blood centers.