Journal Information
Journal ID (publisher-id): BM
Journal ID (nlm-ta): Biochem Med (Zagreb)
Title: Biochemia Medica
Abbreviated Title: Biochem. Med. (Zagreb)
ISSN (print): 1330-0962
ISSN (electronic): 1846-7482
Publisher: Croatian Society of Medical Biochemistry and Laboratory Medicine
Article Information
Copyright statement: ©Croatian Society of Medical Biochemistry and Laboratory Medicine.
Copyright: 2021, Croatian Society of Medical Biochemistry
License (open-access):
This is an Open Access article distributed under the terms of the Creative Commons Attribution (http://creativecommons.org/licenses/by/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Date received: 13 November 2020
Date accepted: 28 January 2021
Publication date (electronic): 15 April 2021
Publication date (print): 15 June 2021
Volume: 31
Issue: 2
Electronic Location Identifier: 020501
Publisher ID: bm-31-2-020501
DOI: 10.11613/BM.2021.020501
Recommendations for the application and follow-up of quality controls in medical laboratories
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]
[1] Accredited Medical Laboratories Network (LABAC), Lyon, France
[2] Toulouse Center for Quality Control in Medical laboratories (CTCB), Toulouse, France
[3] Association for Promotion of Quality Control in Medical Laboratories (Probioqual), Lyon, France
[4] French Society for Medical Biology (SFBC), Paris, France
[5] Biologie Prospective, Villers-lès-Nancy, France
[6] Quality Assurance for Medical Laboratories (Asqualab), Paris, France
Author notes:
[*] Corresponding author: jeanmarc.giannoli@biogroup.fr
Authors’ statement
This translation is published with permission (Annales de Biologie Clinique). The authors are fully responsible for the accuracy of the translation.
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: risk analysis; internal quality control; external quality assessment; uncertainty
