'Allowable Limits of Performance' for External Quality Assurance Programs - an Approach to Application of the Stockholm Criteria by the RCPA Quality Assurance Programs.

'Allowable Limits of Performance' for External Quality Assurance Programs - an Approach to Application of the Stockholm Criteria by the RCPA Quality Assurance Programs.
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发表时间:
2012-11
期刊:
The Clinical biochemist. Reviews
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通讯作者:
G. Jones;K. Sikaris;J. Gill
G. Jones;K. Sikaris;J. Gill
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其他
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作者:
G. Jones;K. Sikaris;J. Gill

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外部质量保证(EQA)被描述为实验室标准化的第五支柱,被添加到标准物质、参考方法、参考实验室和可追溯的参考间隔和决策点这四个支柱中。1 EQA计划的一个重要组成部分是提供标准,允许参与的实验室评估其表现。这些标准也被称为质量标准,可以基于与同行的统计比较、专家意见、临床需求或其他标准。在澳大利亚,RCPA质量保证计划(RCPAQAP)质量标准被称为允许性能极限(ALP),用于帮助解释计划中的所有数值QAP结果。这些限制规定的目标是,它们是以临床为基础的,以提供对分析性能的临床重要变化的警告。由于这些限值是在几年前得出的,因此对它们进行审查是适当的。本文以RCPAQAP化学病理学所使用的方法为例,描述了为EQA项目设置质量标准的分级方法的评估和实施。
External quality assurance (EQA) has been described as the ‘fifth pillar’ of laboratory standardisation, added to the four pillars of reference materials, reference methods, reference laboratories and traceable reference intervals and decision points.1 One vital component of an EQA program is to provide criteria to allow participating laboratories to assess their performance. These criteria, also described as quality standards, may be based on statistical comparison with peers, expert opinion, clinical need or other criteria. In Australia, the RCPA Quality Assurance Programs (RCPAQAP) quality standards are known as the Allowable Limits of Performance (ALP) and are used to assist with interpretation of all numerical QAP results in the program. The stated goal of these limits is that they are clinically based to provide warning of clinically important changes in assay performance. As these limits were derived some years ago2 it is appropriate to review them. This document describes the assessment and implementation of a hierarchical approach to setting quality standards for EQA programs using the approach used by the RCPAQAP Chemical Pathology as an example.