Detection of bacterial contamination in apheresis platelet products: American Red Cross experience, 2004.

BACKGROUND: Routine quality control (QC) testing for bacterial contamination in apheresis platelet (PLT) products was implemented in all 36 regional blood centers of the American Red Cross in March 2004. STUDY DESIGN AND METHODS: PLT samples were cultured under aerobic conditions until the end of the product shelf life or when a positive reaction was indicated. To confirm the initial positive reaction, a new sample was taken from the unit for reculturing. All positive culture bottles were referred for bacterial isolation and identification. Bacterial testing data along with apheresis PLT collection information were collected for analysis. Reports and investigations of potential septic reactions to apheresis PLTs were reviewed. RESULTS: In the first 10 months of bacterial testing, 226 of 350,658 collections tested initially positive. Sixty-eight were confirmed on resampling to be bacterially contaminated for an overall confirmed-positive rate of 0.019 percent or 1 in 5157. Staphylococcus spp. (47.1%) and Streptococcus spp. (26.5%) were the most frequently isolated bacteria; Gram-negative bacteria accounted for 17.6 percent of the confirmed-positive products. Of the 354 apheresis PLT products derived from all 226 initial test-positive cases, 38 (10.7%) were transfused by the time the initial positive reaction was indicated. None of these transfused products, however, had a confirmed-positive bacterial screen and no patient who had been transfused with an unconfirmed-positive product had evidence of a septic transfusion reaction. Three high-probability septic transfusion reactions to screened, negative components were identified. In all three cases, a coagulase-negative Staphylococcus was implicated. CONCLUSION: Our experience demonstrates that bacterial testing of apheresis PLT products as a QC measure was efficiently implemented throughout the American Red Cross system and that this new procedure has been effective in identifying and preventing the transfusion of many, although not all, bacterially contaminated PLT units.