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

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

doi:10.11613/bm.2021.020501

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.

Highlights

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
The recommendations proposed in this document come mainly from the conference jointly organized 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) in Paris on January 30th, 2019
Calculation of the CV from all the internal quality control (IQC) values corresponding to the results reported by the patients, excluding major errors (CV operating rules defined by the laboratory)

Summary

Introduction

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 Recommended practices (deemed to comply with the requirements of standard ISO 15189:2012 [3]): These are derived from reference documents, consensus data from various publications or may be based on at least one publication with robust methodology and interpretation criteria (expert opinion). They represent best practice, the “state of the art”. Inappropriate practices (deemed not to comply with the requirements of the ISO standard 15189:2012): Unacceptable practice for which there is a consensus after reading the different publications or a defect based on at least one publication for which the methodology and interpretation criteria are sound and robust (expert opinion) Such inappropriate practices may compromise the reliability of the results. The list below is non-exhaustive and includes the main risks identified: 1. Reagent defect during shipment

Faulty or insufficient maintenance

Blocking and non-blocking anomaly or drift of the analytical system

Findings

Conclusion