Transfusion-transmitted bacterial infection (TTBI) from platelet components is likely underrecognized and can be fatal. Twenty-four-hour prospective culture was felt to be insufficiently preventive after multiple TTBIs occurred and strategies to improve safety were sought.
Two fatal and one severe TTBIs occurred from a split-apheresis platelet donation contaminated with Klebsiella pneumoniae. Improvement opportunities were identified and corrective and preventive action (CAPA) followed.
To mitigate bacterial contamination and improve detection sensitivity, additional prospective culture 48 hours postcollection was implemented. Since implementation, secondary cultures have caught two true positives (0.01%) missed by 24-hour culture. Bacterial testing at issue and pathogen reduction were later implemented as an added layer of safety.
While rare, TTBI is a prominent cause of morbidity and mortality from contaminated platelets. The approach to CAPA presented here may lower the risk of future transfusion-transmitted infections but must be weighed against potential added costs.