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医学生物学的室内质量控制实验室管理策略

IQC Laboratory management strategy for medical biology.

作者信息

Bugni Estelle, Cohen Richard, Mazellier Cécile

机构信息

SFC Formation Consulting, Lyon, France.

出版信息

Ann Biol Clin (Paris). 2017 Dec 1;75(6):637-645. doi: 10.1684/abc.2017.1290.

DOI:10.1684/abc.2017.1290
PMID:29072175
Abstract

Medical biology laboratories rely especially on internal quality control (IQC) to monitor the performance of equipment and ensure results reliability. Strategies for these controls vary considerably from one laboratory to another. Some laboratories use Westgard's rules to detect drifts and are faced with a large number of false rejections caused by frequent runs of control samples and strategies that activate all rejection rules, regardless of the analyte considered. To minimize these rejections, some laboratories have combined several theories, sometimes despite the relevance of the resulting strategy. In this article, we want to explain the foundations of the main IQC theories and set out a strategy to optimize the detection of problems while minimizing false IQC rejections. We will also address some frequently asked questions from laboratories as part of ISO 15189 accreditation.

摘要

医学生物学实验室特别依赖内部质量控制(IQC)来监测设备性能并确保结果的可靠性。这些控制策略在不同实验室之间差异很大。一些实验室使用韦斯特加德规则来检测偏差,但由于频繁进行控制样本检测以及无论所考虑的分析物如何都会激活所有拒绝规则的策略,面临大量错误拒绝的情况。为了尽量减少这些拒绝情况,一些实验室将多种理论结合起来,有时却不顾所得策略的相关性。在本文中,我们希望解释主要IQC理论的基础,并提出一种优化问题检测同时尽量减少IQC错误拒绝的策略。作为ISO 15189认可的一部分,我们还将解答实验室一些常见问题。

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