Zusammenfassung
Quality assurance is mandatory in transfusion medicine. Though the resource requirements for quality management are usually obvious, the benefits are sometimes more obscure. We report retrospectively on the first 22 months of experience with the introduction of a quality management program in a laboratory and transfusion medical institute of an university hospital. Among the introduced measures ...
Zusammenfassung
Quality assurance is mandatory in transfusion medicine. Though the resource requirements for quality management are usually obvious, the benefits are sometimes more obscure. We report retrospectively on the first 22 months of experience with the introduction of a quality management program in a laboratory and transfusion medical institute of an university hospital. Among the introduced measures were, apart from qualification, validation and standard operating procedures, the systematic acquisition of deviations, corrective action requests, and out-ofspecification (OOS) procedures as well as quality reviews. An average of 3.0% OOS per apheresis and 5.9 corrective action requests were recorded per month since their introduction. Three types of errors became obvious with some of them being particularly trivial. In one instance, a batchrelated problem of starting materials was observed. In three instances, deviations were related to the equipment and could be compensated by adjustment settings of the equipment or by renewal of necessary components. The quantification of equipment reliance showed to be advantageous both for patient safety and economically in negotiation settings. In two instances, staff-related errors were identified that could be addressed by cutting unnecessary procedure steps or by targeted training measures. The introduction of a quality management system started to create transparency and resulted in optimizations especially in procedures that involve more than one team.
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