EQA的幕后——外部质量评估(EQA)的特征、能力、效益和资产。

IF 3.8 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY
Christoph Buchta, Barbara De la Salle, Rachel Marrington, Andrés Aburto Almonacid, Stéphanie Albarède, Tony Badrick, David Bullock, Christa M Cobbaert, Wim Coucke, Vincent Delatour, Ana Paula Faria, Wolf-Jochen Geilenkeuser, Andrea Griesmacher, Jim F Huggett, Viktoriia Ianovska, Martin Kammel, Anja Kessler, Günther F Körmöczi, Piet Meijer, Armandina Miranda, Dina Patel, Paola Pezzati, Sverre Sandberg, Harald Schennach, Christian R Schweiger, Karin Schwenoha, Michael Spannagl, Heungsup Sung, Marc Thelen, Cas Weykamp, Heinz Zeichhardt, Veronica Restelli, Lucy A Perrone
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引用次数: 0

摘要

外部质量评估(EQA)通过评估实验室和护理点检测的质量来提高患者安全。监管机构和认可组织利用结果和实验室的回应,作为评估实验室适合实践的一部分。此外,如果EQA样品是可交换的,并且指定值已使用参考测量程序(RMPs)确定,EQA数据有助于验证测定的计量可追溯性,作为体外诊断(IVD)医疗器械(IVD- mds)上市后监督的一部分。更广泛地说,科学界和医学界使用EQA数据来证明医学实验室检查程序适合临床目的,评估共同参考区间,并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研究所可以与EQA提供者合作,确定测量方法,这应该得到参考材料或方法开发的迫切支持。卫生系统有效应对快速演变的医疗挑战(如2019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的信心。除了个别实验室和测试站点之外,EQA提供商在评估ivd - md的性能方面具有独特的优势。尽管EQA供应商的主要关注点仍然是提高单个实验室的绩效,但也有许多利益相关者从EQA绩效数据中受益。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Behind the scenes of EQA - characteristics, capabilities, benefits and assets of external quality assessment (EQA).

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.

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来源期刊
Clinical chemistry and laboratory medicine
Clinical chemistry and laboratory medicine 医学-医学实验技术
CiteScore
11.30
自引率
16.20%
发文量
306
审稿时长
3 months
期刊介绍: Clinical Chemistry and Laboratory Medicine (CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor over 3. CCLM is issued monthly, and it is published in print and electronically. CCLM is the official journal of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and publishes regularly EFLM recommendations and news. CCLM is the official journal of the National Societies from Austria (ÖGLMKC); Belgium (RBSLM); Germany (DGKL); Hungary (MLDT); Ireland (ACBI); Italy (SIBioC); Portugal (SPML); and Slovenia (SZKK); and it is affiliated to AACB (Australia) and SFBC (France). Topics: - clinical biochemistry - clinical genomics and molecular biology - clinical haematology and coagulation - clinical immunology and autoimmunity - clinical microbiology - drug monitoring and analysis - evaluation of diagnostic biomarkers - disease-oriented topics (cardiovascular disease, cancer diagnostics, diabetes) - new reagents, instrumentation and technologies - new methodologies - reference materials and methods - reference values and decision limits - quality and safety in laboratory medicine - translational laboratory medicine - clinical metrology Follow @cclm_degruyter on Twitter!
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