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EQA的幕后故事——外部质量评估(EQA)的特点、能力、益处及优势

Behind the scenes of EQA - characteristics, capabilities, benefits and assets of external quality assessment (EQA).

作者信息

Buchta Christoph, De la Salle Barbara, Marrington Rachel, Aburto Almonacid Andrés, Albarède Stéphanie, Badrick Tony, Bullock David, Cobbaert Christa M, Coucke Wim, Delatour Vincent, Faria Ana Paula, Geilenkeuser Wolf-Jochen, Griesmacher Andrea, Huggett Jim F, Ianovska Viktoriia, Kammel Martin, Kessler Anja, Körmöczi Günther F, Meijer Piet, Miranda Armandina, Patel Dina, Pezzati Paola, Sandberg Sverre, Schennach Harald, Schweiger Christian R, Schwenoha Karin, Spannagl Michael, Sung Heungsup, Thelen Marc, Weykamp Cas, Zeichhardt Heinz, Restelli Veronica, Perrone Lucy A

机构信息

Austrian Association for Quality Assurance and Standardization of Medical and Diagnostic Tests (ÖQUASTA), Vienna, Austria.

UK National External Quality Assessment Scheme (UK NEQAS) for Haematology, Watford, UK.

出版信息

Clin Chem Lab Med. 2025 Jan 6;63(5):898-915. doi: 10.1515/cclm-2024-1293. Print 2025 Apr 28.

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 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.

摘要

外部质量评估(EQA)通过评估基于实验室的检测和即时检测的质量来提高患者安全。监管机构和认证组织将结果以及实验室对结果的回应作为评估实验室执业适用性的一部分。此外,在EQA样本具有互换性且已使用参考测量程序(RMP)确定赋值的情况下,EQA数据有助于作为诊断(IVD)医疗器械(IVD-MD)上市后监督的一部分,验证检测的计量溯源性。更广泛地说,科学和医学界使用EQA数据来证明医学实验室检查程序适用于临床目的、评估通用参考区间以及将数据纳入临床数据库。科学团体、IVD行业、参考实验室和国家计量机构可以与EQA提供者合作,确定被测量物,而这迫切需要通过开发参考物质或方法来支持。卫生系统有效应对快速演变的医学挑战(如冠状病毒病19(COVID-19)大流行)的能力依赖于EQA来证明对新实验室方法和检测服务性能的信心。EQA提供者除了评估单个实验室和检测点外,还具有独特的地位来评估IVD-MD的性能。尽管EQA提供者的主要重点仍然是提高单个实验室的性能,但有许多利益相关者从EQA性能数据中受益。

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