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The EFLM Office is delighted to inform you that...

The EFLM Working Group "Accreditation and ISO/CEN standards" has just published the following scientific papers:

EFLM Working Group accreditation and ISO/CEN standards on dealing with ISO 15189 demands for retention of documents and examination objects

Mesko Brguljan P, Thelen M, Bernabeu-Andreu F, Kroupis C, Boursier G, Vukasovic I, Barrett E, Brugnoni D, Lohmander M, Sprongl L, Vodnik T, Ghita I, Vanstapel F, Vaubourdolle M, Huisman W

Adv Lab Med 2024

https://doi.org/10.1515/almed-2023-0053

Abstract: Many aspects of the activity of a medical laboratory have to be documented so as to facilitate the maintenance of the ongoing quality of service. As a consequence, many documents, forms and reports are generated. The retention time for each of these has to be specified. In addition to medical laboratory reports as part of the patient’s medical record, the medical laboratory has to retain many documents and specimens according to national legislation or guidance from professional organizations, if these exist. If not, the laboratory management needs to define a retention schedule, which shall define the storage conditions and period of storage, according to ISO 15189:2022 requirements for retention of general quality management documents and records. The EFLM Working Group on Accreditation and ISO/CEN standards provides here a proposal on retention periods of documentation and specimens based on a failure-mode-effects-analysis (FMEA) risk-based approach, a concept of risk reduction that has become an integral part of modern standards. Click to read the full paper

APS calculator: a data-driven tool for setting outcome-based analytical performance specifications for measurement uncertainty using specific clinical requirements and population data

Cubukcu HC, Vanstapel F, Thelen M, van Schrojenstein Lantman M, Bernabeu-Andreu FA, Mesko Brguljan P, Milinkovic N, Linko S, Panteghini M, Boursier G

Clin Chem Lab Med 2023

https://doi.org/10.1515/cclm-2023-0740

Abstract: Objectives - According to ISO 15189:2022, analytical performance specifications (APS) should relate to intended clinical use and impact on patient care. Therefore, we aimed to develop a web application for laboratory professionals to calculate APS based on a simulation of the impact of measurement uncertainty (MU) on the outcome using the chosen decision limits, agreement thresholds, and data of the population of interest. Methods - We developed the “APS Calculator” allowing users to upload and select data of concern, specify decision limits and agreement thresholds, and conduct simulations to determine APS for MU. The simulation involved categorizing original measurand concentrations, generating measured (simulated) results by introducing different degrees of MU, and recategorizing measured concentrations based on clinical decision limits and acceptable clinical misclassification rates. The agreements between original and simulated result categories were assessed, and values that met or exceeded user-specified agreement thresholds that set goals for the between-category agreement were considered acceptable. The application generates contour plots of agreement rates and corresponding MU values. We tested the application using National Health and Nutrition Examination Survey data, with decision limits from relevant guidelines. Results - We determined APS for MU of six measurands (blood total hemoglobin, plasma fasting glucose, serum total and high-density lipoprotein cholesterol, triglycerides, and total folate) to demonstrate the potential of the application to generate APS. Conclusions - The developed data-driven web application offers a flexible tool for laboratory professionals to calculate APS for MU using their chosen decision limits and agreement thresholds, and the data of the population of interest. Click to read the full paper

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