What is it about?
Biological variation data (BVD) have many applications in laboratory medicine. They represent a class of reference data that are used widely and as such delivers standards requirements for production and reporting of BVD to enable transportablity into safe accurate and effective clinical application. This article explores current developments undertaken and resources and tools developed to address the quality and confidence issues pertaining BVD as reference data.
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Why is it important?
Accrediation of clinical laboratories to the EN ISO15189 2022 standard requires quality management systems designed to manage risk and deliver patient centerdness. Delivering examinations that utilise analytical methods that meet required analytical perfomance and delver results and reports that can be correctly interpreted are therefore important areas for focus.. The article signposts service providers to quality assessed biological variation data for use in thse contexts and highlights important initiatives aimed at increasing the understanding of biological variation data and their application
Perspectives
Biological variation data are in fact reference data. As such there is a requirment that they should be made available to users accompanied by a minimum data set to enable their transportability into clinical practice across time, populations and health care systems. A standards requirment also emerges from this perspective for both data production and reoprting. The article explorese these issues and points users towards work being undertaken to enable reporting of quality assesed data accompanied by mininmum data set. It adreeses the standards issue including reference to the recently proposed standards for reporting biological variation data studies (STARBIV). There is an ongoing drive to ensure that existing biological variation studies have delivered data sets that meet a standard and are accessible in a published format to enable safe and effective applications (www.biologicalvariation.eu). New inititiatives such as STARBIV provide tools to drive up the quality of future studies to expand the database and also deliver educational materials to increase the knowledge of those those using these important reference data.
Dr William Alexander Bartlett
Read the Original
This page is a summary of: Biological variation data: An important old topic with new standards and new look resources, Annals of Clinical Biochemistry International Journal of Laboratory Medicine, January 2025, SAGE Publications,
DOI: 10.1177/00045632241311453.
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