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Published on: December 7, 2012
Implementation of a blood proficiency testing scheme for bacterial screening of platelet components
Marcel Prax1, Lea Debes1, Michael Chudy1
1Infectiology/Serology, Paul-Ehrlich-Institut (PEI), Langen, Germany.
Background And Objectives:
The European Directorate for the Quality of Medicines & HealthCare has been co-ordinating an external quality assessment programme for blood establishment (BE) laboratories since 2010. To further expand the study portfolio, a new bacterial blood proficiency testing scheme (B-PTS) for platelet components (PCs) has been developed and validated in a pilot study.
Materials And Methods:
Sterile samples and those containing a low-count quantity of bacteria were prepared in spiking devices. Suitability of storage and shipping conditions for the samples was evaluated under different environmental conditions. Participants received the spiking devices, prepared the potentially contaminated PCs on site and tested them according to their routine screening procedures.
Results:
Humidity compromised the quality of the samples. Optimized storage of the samples by adding a desiccant ensured satisfactory quality. In the pilot study, 9 of the 11 participants correctly identified the positive samples as being bacterially contaminated.
Conclusion:
The newly developed bacterial B-PTS was successfully implemented in a pilot study. It enables an inter-laboratory comparison to determine the performance of BEs for the testing of bacterial contaminations in PCs.
