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A comparison of proficiency testing evaluation criteria approaches for fitness-for-purpose
Accreditation and Quality Assurance ( IF 0.9 ) Pub Date : 2024-04-09 , DOI: 10.1007/s00769-024-01590-1
Kelly Black , Polona Carson , Emmie Jenkins

Proficiency testing (PT) plays a crucial role in assessing the competence and performance of laboratories by subjecting them to interlaboratory comparisons. This paper focuses on evaluation and comparison of approaches for determining the standard deviation for proficiency assessment (\(\text{SDPA or}\; {\sigma }_{{\text{PT}}}\)) used for establishing performance criteria in PT schemes. It explores options provided in ISO 13528:2022 that utilize laboratory method precision, information from previous PT rounds, regulatory or expert set acceptance criteria, criteria based on a general model for repeatability or reproducibility, and data from the same round of PT for setting evaluation criteria. The advantages and disadvantages of each option are examined alongside practical examples of their application. The insights into the various strategies to establish SDPA provided in this paper are aimed to help laboratories, and PT providers with the selection of appropriate criteria that align with their specific needs and objectives and ensure a fit-for-purpose performance assessment that enhances comparability among laboratories, and promotes continual quality improvement in PT programs.



中文翻译:

能力验证适用性评估标准方法的比较

能力验证(PT)通过对实验室进行实验室间比较,在评估实验室的能力和绩效方面发挥着至关重要的作用。本文重点评估和比较用于确定用于建立绩效标准的能力评估标准差的方法( \(\text{SDPA or}\; {\sigma }_{{\text{PT}}}\) )在 PT 计划中。它探索了 ISO 13528:2022 中提供的选项,这些选项利用实验室方法精度、前几轮 PT 的信息、监管或专家设定的验收标准、基于重复性或再现性通用模型的标准以及来自同一轮 PT 的数据进行设置评估标准。每个选项的优点和缺点及其应用的实际示例都得到了检验。本文提供的对建立 SDPA 的各种策略的见解旨在帮助实验室和 PT 提供者选择符合其特定需求和目标的适当标准,并确保进行适合目的的绩效评估,从而增强各个实验室和 PT 提供商之间的可比性。实验室,并促进 PT 项目质量的持续改进。

更新日期:2024-04-10
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