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如何进行分析前阶段的外部质量评估方案?

How to conduct External Quality Assessment Schemes for the pre-analytical phase?

机构信息

The Norwegian EQA Program (NKK), Bergen, Norway.

The Norwegian EQA Program (NKK), Bergen, Norway ; Laboratory of Clinical Biochemistry, Haukeland University Hospital, Bergen, Norway.

出版信息

Biochem Med (Zagreb). 2014 Feb 15;24(1):114-22. doi: 10.11613/BM.2014.013. eCollection 2014.

Abstract

In laboratory medicine, several studies have described the most frequent errors in the different phases of the total testing process, and a large proportion of these errors occur in the pre-analytical phase. Schemes for registration of errors and subsequent feedback to the participants have been conducted for decades concerning the analytical phase by External Quality Assessment (EQA) organizations operating in most countries. The aim of the paper is to present an overview of different types of EQA schemes for the pre-analytical phase, and give examples of some existing schemes. So far, very few EQA organizations have focused on the pre-analytical phase, and most EQA organizations do not offer pre-analytical EQA schemes (EQAS). It is more difficult to perform and standardize pre-analytical EQAS and also, accreditation bodies do not ask the laboratories for results from such schemes. However, some ongoing EQA programs for the pre-analytical phase do exist, and some examples are given in this paper. The methods used can be divided into three different types; collecting information about pre-analytical laboratory procedures, circulating real samples to collect information about interferences that might affect the measurement procedure, or register actual laboratory errors and relate these to quality indicators. These three types have different focus and different challenges regarding implementation, and a combination of the three is probably necessary to be able to detect and monitor the wide range of errors occurring in the pre-analytical phase.

摘要

在实验室医学中,已有多项研究描述了总检测过程的不同阶段中最常见的错误,其中很大一部分错误发生在分析前阶段。几十年来,大多数国家的外部质量评估(EQA)机构一直在对分析阶段的错误进行登记,并将后续反馈提供给参与者。本文旨在介绍分析前阶段不同类型的 EQA 计划,并举例说明一些现有的计划。到目前为止,很少有 EQA 组织关注分析前阶段,并且大多数 EQA 组织不提供分析前 EQA 计划(EQAS)。进行分析前 EQAS 并使其标准化更加困难,并且认可机构也不会要求实验室提供此类计划的结果。但是,确实存在一些针对分析前阶段的正在进行的 EQA 计划,本文也给出了一些示例。所使用的方法可以分为三种不同类型;收集有关分析前实验室程序的信息,循环使用真实样本以收集可能影响测量程序的干扰信息,或记录实际的实验室错误并将其与质量指标相关联。这三种类型的重点和实施方面的挑战各不相同,可能需要将这三种类型结合起来,才能检测和监测分析前阶段发生的各种错误。

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