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- Title
Residual risk of bacterial contamination of platelets: six years of experience with sterility testing.
- Authors
Ramirez‐Arcos, Sandra; DiFranco, Caesar; McIntyre, Terri; Goldman, Mindy
- Abstract
<bold>Background: </bold>Canadian Blood Services screens 100% of platelet concentrates (PCs) for bacterial contamination with the BacT/ALERT system. Quality-control sterility testing of 1% (≥10 units) of outdated PCs is performed monthly. Data from routine screening, quality-control testing, and septic reactions obtained from 2010 to 2016 are presented herein.<bold>Study Design and Methods: </bold>In total, 601,988 buffy coat PC pools and 186,737 apheresis PCs were routinely screened with aerobic cultures over 6 years. Outdate quality-control testing of 8535 buffy coat and 8498 apheresis PCs was performed using aerobic and anaerobic cultures during the same period. Results were classified as "true-positives" when the same bacterium was isolated in initial and confirmatory cultures or "false-negatives" when bacteria were missed in early screening and were captured during quality-control sterility testing or through investigation of sepsis cases.<bold>Results: </bold>During routine screening, the true-positive rates between buffy coat (0.94 per 10,000) and apheresis (0.96 per 10,000) PCs were similar (p = 0.9473). Seventy-five bacteria isolated during PC screening included Gram-positive and Gram-negative organisms. Six false-negative septic reactions were reported that implicated coagulase-negative staphylococci (n = 3) and Staphylococcus aureus (n = 3) for approximate rates of 1 per 100,000 transfusion reactions and 1 per 500,000 fatalities. During quality-control testing, the false-negative rates between buffy coat (8 per 10,000) and apheresis (9 per 10,000) PCs were similar (p = 0.7897). All 15 quality-control isolates were Gram-positive bacteria.<bold>Conclusion: </bold>The current bacterial screening protocol is efficacious for identifying Gram-negative bacteria. However, the high proportion of Gram-positive organisms detected on outdate quality-control testing and septic transfusion events demonstrates a residual safety risk that merits further intervention.
- Subjects
CANADA; BACTERIAL contamination; BLOOD platelets; CANADIAN Blood Services; MEDICAL screening; SEPSIS; BACTERIOLOGY technique; BLOOD collection; PREVENTION of communicable diseases; DIAGNOSTIC errors; GRAM-negative bacteria; GRAM-positive bacteria; QUALITY control; STAPHYLOCOCCAL diseases; STERILIZATION (Disinfection)
- Publication
Transfusion, 2017, Vol 57, Issue 9, p2174
- ISSN
0041-1132
- Publication type
journal article
- DOI
10.1111/trf.14202