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Review
. 2021 Jun 15;31(2):020501.
doi: 10.11613/BM.2021.020501. Epub 2021 Apr 15.

Recommendations for the application and follow-up of quality controls in medical laboratories

Jean-Marc Giannoli  1 , Stéphanie Albarede  2 , Thierry Avellan  1 , Jean-Pierre Bouilloux  1 , Régine Cartier  3 , Richard Cohen  3 , Nathalie Colard  1 , Luc Essemilaire  1 , Jean-Louis Galinier  2 , Mathieu Kuentz  4 , Mickaël Paris  1 , Henri Portugal  1 , Florian Scherrer  1 , Jean-Pascal Siest  5 , Anne Vassault  6 , Jean-Michel Vialle  1
Affiliations
Review

Recommendations for the application and follow-up of quality controls in medical laboratories

Jean-Marc Giannoli et al. Biochem Med (Zagreb). .

Abstract

This is a translation of the paper "Recommendations for the application and follow-up of quality controls in medical biology laboratories" published in French in the journal Annales de Biologie Clinique (Recommandations pour la mise en place et le suivi des contrôles de qualité dans les laboratoires de biologie médicale. Ann Biol Clin (Paris). 2019;77:577-97.). The recommendations proposed in this document are the result of work conducted jointly by the Network of Accredited Medical Laboratories (LABAC), the French Society of Medical Biology (SFBC) and the Federation of Associations for External Quality Assessment (FAEEQ). The different steps of the implementation of quality controls, based on a risk analysis, are described. The changes of reagent or internal quality control (IQC) materials batches, the action to be taken in case of non-conform IQC results, the choice of external quality assessment (EQA) scheme and interpretation of their results as well as the new issue of analyses performed on several automatic systems available in the same laboratory are discussed. Finally, the concept of measurement uncertainty, the robustness of the methods as well as the specificities of near-patient testing and rapid tests are described. These recommendations cannot apply for all cases we can find in medical laboratories. The implementation of an objective alternative strategy, supported with documented evidence, might be equally considered.

Keywords: external quality assessment; internal quality control; risk analysis; uncertainty.

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Conflict of interest statement

Potential conflict of interest None declared.

Figures

Figure 1
Figure 1
Westgard Sigma rules with run sizes for the numbers of patient samples between statistical quality control (SQC) events. Note the Sigma scale at the bottom of the diagram. To apply, determine Sigma-metric, locate on the Sigma scale, identify control rules, total number of control measurements (N), and frequency of SQC events specified as run size. CV - coefficient of variation. TEa - total allowable error.
See this image and copyright information in PMC

References

    1. Giannoli JM, Albarede S, Avellan T, Bouilloux JP, Cartier R, Cohen R, et al. Recommendations for the application and the follow-up of quality controls in medical biology laboratories. Ann Biol Clin (Paris). 2019;77:577–97. (in French) 10.1684/abc.2019.1481 - DOI - PubMed
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    1. International Organization for Standardization (ISO). Medical laboratories - Requirements for quality and competence. ISO 15149:2012. Geneva: ISO; 2012.
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    1. International Organization for Standardization (ISO). General requirements for the competence of testing and calibration laboratories. ISO/CEI 17025. Geneva: ISO; 2017.