IFCC关于内部质量控制的建议与ISO标准之间的差异

IF 3.2 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta Pub Date : 2025-05-02 DOI:10.1016/j.cca.2025.120334

Marco Pradella

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引用次数: 0

摘要

国际临床化学和检验医学联合会的全球实验室质量工作组发布了关于IQC主题的建议，指出它们源自ISO 15189:20222标准。TF-GLQ在几个地方偏离了ISO 15189。对CLSI文档的一些引用是不正确的。然而，实验室和认可机构不得为ISO 15189的要求偏离ISO标准的原始文本和与之相符的指南。

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Divergences between IFCC recommendations for internal quality control and ISO standards

The Task Force on Global Lab Quality of the International Federation of Clinical Chemistry and Laboratory Medicine published its Recommendations on the topic of IQC, stating that they are derived from the ISO 15189:20222 standard. TF-GLQ deviates in several places from ISO 15189. Some references to CLSI documents are incorrect. Laboratories and Accreditation Bodies, however, may not deviate for the requirements of ISO 15189 from the original text of the ISO standard and the guides that remain compliant with it.

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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.