IFCC对内部质量控制实践的建议:一个错失的机会。

IF 3.8 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY
Hikmet Can Çubukçu, Marc Thelen, Mario Plebani, Mauro Panteghini
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引用次数: 0

摘要

IFCC全球实验室质量工作组(TF-GLQ)最近发布了一份新的内部质量控制(IQC)实践指南,将ISO 15189:2022标准中规定的一般原则转化为一系列实用建议。然而,该论文包含重要的不准确和缺点,在我们看来,使它错过了为实验室专业人员提供最新指导的机会。特别讨论了四个重要问题:a)如何在可追溯时代设计IQC策略,b)如何定义IQC验收极限,c)如何使用IQC数据估计测量不确定度,以及d)如何管理同一实验室不同分析仪提供的结果之间的可比性。我们的分析强调,有必要采用一种更系统、更新和基于证据的方法,根据IFCC的传统提出IQC建议。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
IFCC recommendations for internal quality control practice: a missed opportunity.

The IFCC Task Force on Global Lab Quality (TF-GLQ) has recently released a new guidance for internal quality control (IQC) practice through an approach translating the general principles as stated in the ISO 15189:2022 standard to a series of practical recommendations. The paper contains however important inaccuracies and shortcomings that, in our opinion, make it a missed opportunity for providing a updated guidance for laboratory professionals. In particular, four important issues are discussed: a) how to design IQC strategies in the traceability era, b) how to define IQC acceptance limits, c) how to estimate measurement uncertainty using IQC data, and d) how to manage comparability between the results provided by different analyzers in the same laboratory. Our analysis underscores the necessity for a more systematic, updated, and evidence-based approach to produce an IQC recommendation in line with the IFCC tradition.

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来源期刊
Clinical chemistry and laboratory medicine
Clinical chemistry and laboratory medicine 医学-医学实验技术
CiteScore
11.30
自引率
16.20%
发文量
306
审稿时长
3 months
期刊介绍: Clinical Chemistry and Laboratory Medicine (CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor over 3. CCLM is issued monthly, and it is published in print and electronically. CCLM is the official journal of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and publishes regularly EFLM recommendations and news. CCLM is the official journal of the National Societies from Austria (ÖGLMKC); Belgium (RBSLM); Germany (DGKL); Hungary (MLDT); Ireland (ACBI); Italy (SIBioC); Portugal (SPML); and Slovenia (SZKK); and it is affiliated to AACB (Australia) and SFBC (France). Topics: - clinical biochemistry - clinical genomics and molecular biology - clinical haematology and coagulation - clinical immunology and autoimmunity - clinical microbiology - drug monitoring and analysis - evaluation of diagnostic biomarkers - disease-oriented topics (cardiovascular disease, cancer diagnostics, diabetes) - new reagents, instrumentation and technologies - new methodologies - reference materials and methods - reference values and decision limits - quality and safety in laboratory medicine - translational laboratory medicine - clinical metrology Follow @cclm_degruyter on Twitter!
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