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如何在医学实验室认可过程中真正理解并完善内部质量控制和外部质量评估体系?

How to Really Understand and Improve the System of Internal Quality Control and External Quality Assessment in the Accreditation Process of the Medical Laboratory?

作者信息

Skitek Milan, Martinello Flávia, Jerin Aleš

机构信息

University Medical Centre Ljubljana, Clinical Institute of Clinical Chemistry and Biochemistry, Ljubljana, Slovenia.

Department of Clinical Analysis, Federal University of Santa Catarina, Florianopolis, Brazil.

出版信息

EJIFCC. 2022 Apr 11;33(1):23-27. eCollection 2022 Apr.

Abstract

Internal quality control (IQC) regarding process to monitor analytical stability has a long tradition in laboratory medicine. The satisfactory results with different quality specifications of the IQC ensure the acceptability of the examination results. Although the statistical IQC is satisfactory some problems exist, resulting in unreliable patients' results due several reasons (non-commutable control materials, lot to lot difference of reagents, false interpreting test results regarding autovalidation or autoverification, different analytical and clinical specifications or goals etc.). Therefore, the results and findings of IQC have to be connected with external quality assessment (EQA) in order to provide the system of measurement of uncertainty (MU) with correct interpretation of laboratory result and detection relevant and significant shifts and drifts in medical laboratory.

摘要

关于监测分析稳定性过程的内部质量控制(IQC)在检验医学中有着悠久的传统。IQC不同质量规格的满意结果确保了检验结果的可接受性。尽管统计性IQC令人满意,但仍存在一些问题,由于多种原因(不可互换的控制材料、试剂批次间差异、关于自动验证或自动核查的测试结果错误解读、不同的分析和临床规格或目标等)导致患者结果不可靠。因此,IQC的结果和发现必须与外部质量评估(EQA)相联系,以便为测量不确定度(MU)系统提供对实验室结果的正确解读,并检测医学实验室中相关且显著的偏移和漂移。

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