Survey of methods used to detect bacterial contamination of platelet products in the United States in 2011

Background Testing of platelets ( PLT s) for bacterial contamination is required by the AABB S tandards but is not fully standardized. On J anuary 31, 2011, a new AABB S tandard, 5.1.5.1.1, specified that bacterial detection methods for PLT components shall use assays either approved by the Food and Drug Administration ( FDA ) or validated to provide sensitivity equivalent to these FDA ‐approved methods. Methods An Internet‐based survey of AABB member institutions was conducted from M ay to J une 2012, to document current practices used in 2011 for bacterial detection in different PLT products and to assess the impact of the new standard. Results Of 1053 AABB member institutions surveyed, 40 of 99 blood centers (40.4%) and 184 of 954 hospital blood banks or transfusion services (19.3%) responded. Sixty‐four respondents manufactured PLT s. Apheresis PLTs ( APs ) were predominantly screened with the BacT / ALERT system (89.5%); the majority (95.2%) were cultured with at least 8 mL of product. There was substantial variation in the minimum incubation time of cultures before release of PLT s (range, 0 to >24 hr). Recalls of released AP for possible bacterial contamination were largely successful (67.3%); successful interdiction before transfusion was associated with incubation for more than 12 hours before release (p < 0.01). After S tandard 5.1.5.1.1 took effect, there was a decrease in production of whole blood–derived PLT concentrates ( WBPCs ). Point‐of‐issue (“rapid”) immunoassays were used to screen a substantial proportion of WBPC PLT s, but were rarely used as secondary tests for previously cultured APs . Conclusion The survey identified variability in culture methods and release times with AP , while use of WBPC decreased after AABB S tandard 5.1.5.1.1 became effective.