Ensuring internal quality control practices in medical Laboratories: IFCC recommendations for practical applications based on ISO 15189:2022

IF 3.2 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta Pub Date : 2025-03-08 DOI:10.1016/j.cca.2025.120240

Jean-Marc Giannoli , Anne Vassault , Anna Carobene , Armand Perret Liaudet , Ivan M Blasutig , Pradeep Kumar Dabla , Ji Lin , Annette Thomas , José Antonio Tesser Poloni , Qing H Meng , Egon P Amann , on behalf of the International Federation of Clinical Chemistry, Laboratory Medicine Task Force on Global Lab Quality TF-GLQ

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引用次数: 0

Abstract

This document describes the guidance on implementing and monitoring an IQC strategy that fulfills the requirements of the Standard ISO 15189:2022. It also explores the practical application of these principles in daily IQC processes within medical laboratories. The goal is to provide a practical, user-friendly resource that not only explains the Standard’s requirements but also equips laboratory professionals with the tools and knowledge needed to enhance diagnostic reliability.

To support laboratory professionals in this task, this document follows the structure and content of the ISO 15189:2022 Standard and provides a risk-based approach in consideration of the practical needs for quantitative results. Specific aspects such as the selection and assessment of IQC materials, the definition of control frequency, the definition of acceptable limits, the application of statistical rules, results from different sources comparability and strategies for handling non-conformities, quality indicators and determination of uncertainty of measurement are discussed in depth. Where relevant, excerpts from the ISO 15189:2022 Standard are included, with clarifications and actionable recommendations to facilitate implementation.

This document focuses on the crucial role of IQC in the accreditation process, particularly in the identification of risks, their mitigation through corrective actions and the implementation of improvements to prevent errors and control potential risks in the medical laboratory, ensuring patient safety in daily practice.

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确保医学实验室的内部质量控制做法：IFCC基于ISO 15189:2022的实际应用建议。

本文件描述了实施和监控IQC战略的指南，该战略满足ISO 15189:2022标准的要求。它还探讨了这些原则在医学实验室日常IQC过程中的实际应用。目标是提供一个实用的、用户友好的资源，不仅解释了标准的要求，而且为实验室专业人员提供了提高诊断可靠性所需的工具和知识。为了支持实验室专业人员完成这项任务，本文件遵循ISO 15189:2022标准的结构和内容，并考虑到定量结果的实际需求，提供了基于风险的方法。对IQC材料的选择和评定、控制频率的定义、可接受限度的定义、统计规则的应用、不同来源结果的可比性和不合格处理策略、质量指标和测量不确定度的确定等具体方面进行了深入的讨论。在相关的情况下，包括ISO 15189:2022标准的摘录，以及澄清和可操作的建议，以促进实施。本文件重点介绍了IQC在认证过程中的关键作用，特别是在识别风险、通过纠正行动减轻风险和实施改进措施以预防错误和控制医学实验室的潜在风险方面，确保患者在日常实践中的安全。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinica Chimica Acta 医学-医学实验技术

CiteScore

10.10

自引率

2.00%

发文量

1268

审稿时长

23 days

期刊介绍： The Official Journal of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Clinica Chimica Acta is a high-quality journal which publishes original Research Communications in the field of clinical chemistry and laboratory medicine, defined as the diagnostic application of chemistry, biochemistry, immunochemistry, biochemical aspects of hematology, toxicology, and molecular biology to the study of human disease in body fluids and cells. The objective of the journal is to publish novel information leading to a better understanding of biological mechanisms of human diseases, their prevention, diagnosis, and patient management. Reports of an applied clinical character are also welcome. Papers concerned with normal metabolic processes or with constituents of normal cells or body fluids, such as reports of experimental or clinical studies in animals, are only considered when they are clearly and directly relevant to human disease. Evaluation of commercial products have a low priority for publication, unless they are novel or represent a technological breakthrough. Studies dealing with effects of drugs and natural products and studies dealing with the redox status in various diseases are not within the journal''s scope. Development and evaluation of novel analytical methodologies where applicable to diagnostic clinical chemistry and laboratory medicine, including point-of-care testing, and topics on laboratory management and informatics will also be considered. Studies focused on emerging diagnostic technologies and (big) data analysis procedures including digitalization, mobile Health, and artificial Intelligence applied to Laboratory Medicine are also of interest.