Buchta Christoph, Marrington Rachel, De la Salle Barbara, Albarède Stéphanie, Badrick Tony, Bietenbeck Andreas, Bullock David, Cadamuro Janne, Delatour Vincent, Dusinovic Enes, Geilenkeuser Wolf-Jochen, Gidske Gro, Griesmacher Andrea, Haliassos Alexander, Holzhauser Derek, Huggett Jim F, Karathanos Serafeim, Pezzati Paola, Sandberg Sverre, Sarkar Aditi, Solsvik Anne Elisabeth, Spannagl Michael, Thelen Marc, Restelli Veronica, Perrone Lucy A
Austrian Association for Quality Assurance and Standardization of Medical and Diagnostic Tests (ÖQUASTA), Vienna, Austria.
Birmingham Quality (UK NEQAS), Part of University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
Clin Chem Lab Med. 2025 Jan 6;63(5):844-858. doi: 10.1515/cclm-2024-1289. Print 2025 Apr 28.
This is the first in a series of five papers that detail the role and substantial impact that external quality assessment (EQA) and their providers' services play in ensuring diagnostic (IVD) performance quality. The aim is to give readers and users of EQA services an insight into the processes in EQA, explain to them what happens before EQA samples are delivered and after examination results are submitted to the provider, how they are assessed, what benefits participants can expect, but also who are stakeholders other than participants and what significance do EQA data and assessment results have for them. This first paper presents the history of EQA, insights into legal, financing and ethical matters, information technology used in EQA, structure and lifecycle of EQA programs, frequency and intensity of challenges, and unique requirements of extra-examination and educational EQA programs.
这是五篇系列论文中的第一篇,详细阐述了外部质量评估(EQA)及其提供者的服务在确保诊断(IVD)性能质量方面所起的作用和产生的重大影响。目的是让EQA服务的读者和用户深入了解EQA的流程,向他们解释在EQA样本交付之前以及检查结果提交给提供者之后会发生什么,这些结果是如何评估的,参与者可以期待哪些好处,同时也介绍除参与者之外的其他利益相关者是谁,以及EQA数据和评估结果对他们有何意义。第一篇论文介绍了EQA的历史、对法律、资金和伦理问题的见解、EQA中使用的信息技术、EQA计划的结构和生命周期、挑战的频率和强度,以及额外检查和教育性EQA计划的独特要求。