EQA Beyond the Lab: How External Quality Assessment Supports Regulators, IVD Surveillance, and Pandemic Response
This companion review examines how EQA data serves stakeholders beyond individual laboratories, including regulatory agencies, accreditation bodies, the IVD industry, and public health systems. Using commutable samples with reference measurement procedure-assigned values, EQA contributes to post-market surveillance of IVD medical devices and verification of metrological traceability. The COVID-19 pandemic demonstrated the critical role of EQA in rapidly validating new laboratory methods during health emergencies.
The original study
Behind the scenes of EQA – characteristics, capabilities, benefits and assets of external quality assessment (EQA): Part V – Benefits for stakeholders other than participants.
- Authors
- Buchta C, De la Salle B, Marrington R, Aburto Almonacid A, Albarède S, Badrick T, et al.
- Journal
- Clinical chemistry and laboratory medicine
- Type
- Journal Article, Review
- PMID
- 39753240
Original 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.