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Detection of bacterial contamination in apheresis platelet products: American Red Cross experience, 2004
Chyang T Fang1, Linda A Chambers, Jean Kennedy
1American Red Cross Biomedical Services Research and Development, Rockville, Maryland, USA.
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.
Insights
Routine bacterial testing of apheresis platelet (PLT) products effectively identified contaminated units, preventing many transfusions. This quality control measure significantly improved blood safety, though vigilance for septic reactions remains crucial.
Area of Science:
- Transfusion Medicine
- Microbiology
- Blood Safety
Background:
- Implementation of routine bacterial contamination quality control (QC) testing for apheresis platelet (PLT) products across 36 American Red Cross blood centers in March 2004.
- Objective to assess the efficacy and impact of this new QC measure on blood product safety.
Observation:
- During the initial 10 months, 226 of 350,658 apheresis PLT collections initially tested positive for bacterial contamination.
- Sixty-eight units were confirmed positive upon resampling, yielding a confirmed-positive rate of 0.019% (1 in 5157).
- Staphylococcus spp. and Streptococcus spp. were the most common bacteria identified.
Findings:
- Of 354 PLT products from initially positive cases, 38 were transfused before confirmation; none were confirmed positive, and no septic reactions occurred in recipients.
- Three cases of high-probability septic transfusion reactions were identified in recipients of screened, negative components, with coagulase-negative Staphylococcus implicated.
Implications:
- Bacterial testing of apheresis PLTs is an effective QC measure for identifying and preventing transfusion of contaminated units.
- While significantly enhancing blood safety, the system is not infallible, necessitating continued monitoring for septic transfusion reactions.
- The findings support the widespread adoption of bacterial screening for apheresis PLT products to minimize transfusion-transmitted bacterial infections.
