Behind the scenes of EQA - characteristics, capabilities, benefits and assets of external quality assessment (EQA)
Buchta, Christoph De la Salle, Barbara Marrington, Rachel Aburto Almonacid, Andrés Albarède, Stéphanie Badrick, Tony Bullock, David Cobbaert, Christa M Coucke, Wim Delatour, Vincent
Buchta, Christoph
De la Salle, Barbara
Marrington, Rachel
Aburto Almonacid, Andrés
Albarède, Stéphanie
Badrick, Tony
Bullock, David
Cobbaert, Christa M
Coucke, Wim
Delatour, Vincent
Affiliation
Austrian Association for Quality Assurance and Standardization of Medical and Diagnostic Tests; UK National External Quality Assessment Scheme (UK NEQAS) for Haematology; University Hospitals Birmingham NHS Foundation Trust; Instituto de Salud Pública de Chile; Centre Toulousain Pour le Contrôle de Qualité en Biologie Clinique; Royal College of Pathologists of Australasia Quality Assurance Program; Leiden University; EFLM Task Force on European Regulatory Affairs; Sciensano; Laboratoire National de Métrologie et d'Essais; National Institute of Health Doutor Ricardo Jorge; Reference Institute for Bioanalytics; University Hospital of Innsbruck; National Measurement Laboratory; University of Surrey; NGO AQALM; INSTAND e.V. Society for Promoting Quality Assurance in Medical Laboratories; GBD Gesellschaft für Biotechnologische Diagnostik mbH; Reference Institute for Bioanalytics; Medical University of Vienna; ECAT Foundation; UK National External Quality Assessment Scheme (UK NEQAS) Immunology; SOD Sicurezza e Qualità AOU Careggi Firenze; The Norwegian Organization for Quality Improvement of Laboratory Examinations; Zentralinstitut für Bluttransfusion und Immunologische Abteilung; University of Ulsan; Foundation for Quality Assessment in laboratory medicine; Radboud Medical Center; Queen Beatrix Hospital; Institut für Qualitätssicherung in der Virusdiagnostik; University of British Columbia
Other Contributors
Publication date
2025-01-06
Collections
Research Projects
Organizational Units
Journal Issue
Abstract
External quality assessment (EQA) enhances patient safety through the evaluation of the quality of laboratory-based and point of care testing. Regulatory agencies and accreditation organizations utilize the results and the laboratory's response to them as part of assessing the laboratory's fitness to practice. In addition, where EQA samples are commutable and the assigned value has been determined using reference measurement procedures (RMPs), EQA data contributes to the verification of metrological traceability of assays as part of the post-market surveillance of in vitro diagnostic (IVD) medical devices (IVD-MDs). More broadly, the scientific and medical communities use EQA data to demonstrate that medical laboratory examination procedures are fit for clinical purposes, to evaluate common reference intervals, and inclusion of data in clinical databases. Scientific groups, the IVD industry, reference laboratories and National Metrology Institutes can work with EQA providers to identify measurands, which should urgently be supported by the development of reference materials or methods. The ability of health systems to respond effectively to fast-evolving medical challenges, such as the Coronavirus Disease-19 (COVID-19) pandemic, is reliant on EQA to demonstrate confidence in the performance of new laboratory methods and testing services. EQA providers are uniquely positioned to assess the performance of IVD-MDs in addition to individual laboratories and testing sites. Although the primary focus of EQA providers remains the improvement of the performance of individual laboratories, there are many stakeholders who benefit from EQA performance data.
Citation
Buchta C, De la Salle B, Marrington R, Aburto Almonacid A, Albarède S, Badrick T, Bullock D, Cobbaert CM, Coucke W, Delatour V, Faria AP, Geilenkeuser WJ, Griesmacher A, Huggett JF, Ianovska V, Kammel M, Kessler A, Körmöczi GF, Meijer P, Miranda A, Patel D, Pezzati P, Sandberg S, Schennach H, Schweiger CR, Schwenoha K, Spannagl M, Sung H, Thelen M, Weykamp C, Zeichhardt H, Restelli V, Perrone LA. Behind the scenes of EQA - characteristics, capabilities, benefits and assets of external quality assessment (EQA). Clin Chem Lab Med. 2025 Jan 6;63(5):898-915. doi: 10.1515/cclm-2024-1293.
Type
Article