Buchta Christoph, De la Salle Barbara, Marrington Rachel, Albarède Stéphanie, Badrick Tony, Bicker Wolfgang, Bietenbeck Andreas, Bullock David, Delatour Vincent, Dequeker Elisabeth, Flasch Mira, Geilenkeuser Wolf-Jochen, van Hellemond Jaap, Huggett Jim F, Ianovska Viktoriia, Kaiser Patricia, Kammel Martin, Kessler Anja, Laudus Nele, Luppa Peter B, Morandi Pierre-Alain, O'Connor Gavin, Panteghini Mauro, Pezzati Paola, Rosendahl Jennifer, Sandberg Sverre, Scheiblauer Heinrich, Skitek Milan, Spannagl Michael, Stavelin Anne, Thelen Marc, Unterberger Ursula, Zeichhardt Heinz, Restelli Veronica, Perrone Lucy A
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.
Clin Chem Lab Med. 2025 Jan 6;63(5):879-897. doi: 10.1515/cclm-2024-1292. Print 2025 Apr 28.
The main stakeholders in external quality assessment (EQA) programs are the participants, in whose interests these challenges are ultimately organised. EQA schemes in the medical field contribute to improving the quality of patient care by evaluating the analytical and diagnostic quality of laboratory and point-of-care tests (POCT) by independent third parties and, if necessary, pointing out erroneous measurement results and analytical or diagnostic improvement potential. Other benefits include the option of using EQA samples for other important laboratory procedures, such as the verification or validation of diagnostic medical devices (IVD-MDs), a contribution to the estimation of measurement uncertainty, a means of training and educating laboratory staff through educational EQA programmes or samples, or even for independent and documented monitoring of staff competence, such as on samples with unusual or even exceptional characteristics. Participation in an EQA scheme for beneficiaries like medical, microbiological and histo- and molecular pathology laboratories, users of POCT and self-testing systems as well as National Metrology Institutes, calibration laboratories and reference laboratories that are dedicated to specific tasks and have particular expectations of the EQA scheme are presented here.
外部质量评估(EQA)计划的主要利益相关者是参与者,组织这些挑战最终也是为了他们的利益。医学领域的EQA计划通过由独立第三方评估实验室检测和即时检验(POCT)的分析和诊断质量,并在必要时指出错误的测量结果以及分析或诊断方面的改进潜力,来促进提高患者护理质量。其他好处包括可将EQA样本用于其他重要的实验室程序,例如诊断医疗设备(IVD-MD)的验证或确认、有助于估计测量不确定度、通过教育性EQA计划或样本培训和教育实验室工作人员的一种方式,甚至用于对工作人员能力进行独立且有记录的监测,比如针对具有异常甚至特殊特征的样本。本文介绍了医学、微生物学以及组织病理学和分子病理学实验室、POCT和自检系统用户以及国家计量机构、校准实验室和参考实验室等受益者参与EQA计划的情况,这些机构致力于特定任务并对EQA计划有特殊期望。