Quality control of blood components in Polish blood centers inspected in the period 2015-2016

Abstract

Summary Background: Quality control of blood components is a process that indirectly verifies the adherence to standard operating procedures (SOP) of all preparation activities. The entire preparation process is performed correctly if at least 75% of the tested blood components comply with standard reference range (90% - for leukoreduced blood components). Materials and methods: Analysis of data provided by Polish blood centers and investigation of post-control recommendations issued by the inspection team from the Institute of Hematology and Transfusion (IHT). Aim: The study aim was to investigate the results of blood component quality control tests from blood centers in the period 2015-2016 and to analyze the recommendations referring to the process of quality control of blood components. Results: the percentage of quality control parameters that complied with the standard reference range was high and amounted to 87.0-100% in 2015 and 87.0-99.8% in 2016. The most frequent nonconformity found during inspections was incorrect management of documentation. In some blood centers test samples were collected by personnel not employed in the quality assurance department. No regular analysis of quality control test results was also determined so implementation of corrective actions was delayed which resulted in higher percentage of blood components not complying with acceptance criteria. Two centers discarded blood components that did not comply with standard reference range. In five blood centers the procedure of sample collection for quality control tests was improperly performed. Conclusions: Although the percentage of blood components that comply with the standard reference range is high, there are still significant non-conformities found in the process of quality control of blood components. Special attention should therefore be paid to regular training with regard to the process of quality control of blood components.