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检验医学中的外部质量控制。进展与未来。

External quality control in laboratory medicine. Progresses and future.

作者信息

Ricós Carmen, Fernández-Calle Pilar, Perich Carmen, Sandberg Sverre

机构信息

Sociedad Española de Medicina del Laboratorio (SEQCML), Barcelona, Spain.

Departamento de Medicina del Laboratorio, Hospital Universitario La Paz, Madrid, Spain.

出版信息

Adv Lab Med. 2022 Aug 17;3(3):221-242. doi: 10.1515/almed-2022-0058. eCollection 2022 Oct.

Abstract

OBJECTIVES

An external quality control program distributes same control samples to various laboratories and evaluates results obtained with a common criterion. The aim of this work is to summarize the evolution of various types of external programs, to point out the progresses ant to preclude practical consequences of the participant laboratories.

CONTENT

The material consists on a brief revision of the different types of external programs that have been used for the last forty years. The method is the critical analysis of the strong and weak points of each program model, from the light of our experience. External quality assessment (EQA) programs were initiated at half the XX century, evidencing big discrepancies among laboratory results. EQA were developed in various countries and some mechanisms to harmonize them were proposed: to establish common performance specifications derived from biological variation, to use EQS as educational tool. Since the 2000 important advances were seen: to focus EQA to assure the adequate clinical use of laboratory tests, to use commutable controls, to harmonize the different EQA models, to promote a forum for co-operation and exchange of knowledge on quality-related matters for EQA organizers.

SUMMARY AND OUTLOOK

To participate in an EQA with commutable-reference method assigned values controls allows to know the real inaccuracy of results and their impact on patient' samples. To participate in a EQA with non commutable controls allows to know whether the individual laboratory performance agrees with that from other laboratories using same analytical method.

摘要

目的

外部质量控制计划向各个实验室分发相同的对照样本,并根据共同标准评估所得结果。这项工作的目的是总结各类外部计划的演变,指出进展,并避免参与实验室产生实际后果。

内容

材料包括对过去40年中使用的不同类型外部计划的简要回顾。方法是根据我们的经验,对每个计划模型的优缺点进行批判性分析。外部质量评估(EQA)计划始于20世纪中叶,当时实验室结果之间存在很大差异。EQA在各个国家得到发展,并提出了一些使其协调统一的机制:根据生物学变异确定共同的性能规范,将EQA用作教育工具。自2000年以来,取得了重要进展:将EQA重点放在确保实验室检测的临床合理应用上,使用可互换的对照,协调不同的EQA模型,为EQA组织者建立一个就质量相关问题进行合作和知识交流的论坛。

总结与展望

采用具有指定值对照的可互换参考方法参与EQA,能够了解结果的实际不准确性及其对患者样本的影响。采用不可互换对照参与EQA,能够了解单个实验室的表现是否与使用相同分析方法的其他实验室一致。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ca04/10197337/89ca5da8befc/j_almed-2022-0058_fig_001.jpg

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