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Vol 11, No 4 (2018)
ORIGINAL PAPERS
Published online: 2019-03-11
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Quality control of blood components in Polish blood centers inspected in the period 2015-2016

Jolanta Kubis, Elżbieta Lachert, Jolanta Antoniewicz-Papis, Aleksandra Rosiek, Agata Mikołowska, Magdalena Łętowska
Journal of Transfusion Medicine 2018;11(4):131-136.

open access

Vol 11, No 4 (2018)
ORIGINAL PAPERS
Published online: 2019-03-11

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.

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.
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Keywords

blood components; quality control; blood donation

About this article
Title

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

Journal

Journal of Transfusion Medicine

Issue

Vol 11, No 4 (2018)

Pages

131-136

Published online

2019-03-11

Bibliographic record

Journal of Transfusion Medicine 2018;11(4):131-136.

Keywords

blood components
quality control
blood donation

Authors

Jolanta Kubis
Elżbieta Lachert
Jolanta Antoniewicz-Papis
Aleksandra Rosiek
Agata Mikołowska
Magdalena Łętowska

References (5)
  1. Obwieszczenie Ministra Zdrowia z dnia 11 września 2018 r. w sprawie wymagań dobrej praktyki pobierania krwi i jej składników, badania, preparatyki, przechowywania, wydawania i transportu dla jednostek organizacyjnych publicznej służby krwi.
  2. Sabliński J., Łętowska M. (red.). Krwiodawstwo. Zbiór przepisów dla placówek służby krwi. PZWL–IHiT, Warszawa 1996.
  3. Łętowska M. Medyczne zasady pobierania krwi, oddzielania jej składników i wydawania, obowiązujące w jednostkach organizacyjnych publicznej służby krwi. IHiT, Warszawa 2006.
  4. Łętowska M. Medyczne zasady pobierania krwi, oddzielania jej składników i wydawania, obowiązujące w jednostkach organizacyjnych publicznej służby krwi. Wyd. 2. IHiT, Warszawa 2011.
  5. Guide for the Preparation, Use and Quality Assurance of Blood Components. European Directoratefor the Quality of Medicines and HealthCare. 19th Edition.

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