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Verification policies in Croatian medical biochemistry laboratories: a survey of the practice
INTRODUCTION: The aim of this study was to screen practices used in verification procedures for methods/analysers among medical biochemistry laboratories (MBLs) in Croatia. We hypothesized that these procedures differ widely from laboratory to laboratory and wanted to gather specific data on steps u...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Croatian Society of Medical Biochemistry and Laboratory Medicine
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8996323/ https://www.ncbi.nlm.nih.gov/pubmed/35464743 http://dx.doi.org/10.11613/BM.2022.020703 |
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author | Milevoj Kopčinović, Lara Juričić, Gordana Bokulić, Adriana Vukasović, Ines Ćelap, Ivana Čičak, Helena Kocijančić, Marija Miloš, Marija Lovrić, Mila Siter Kuprešanin, Marija Hrabrić Vlah, Snježana Miletić, Manuela |
author_facet | Milevoj Kopčinović, Lara Juričić, Gordana Bokulić, Adriana Vukasović, Ines Ćelap, Ivana Čičak, Helena Kocijančić, Marija Miloš, Marija Lovrić, Mila Siter Kuprešanin, Marija Hrabrić Vlah, Snježana Miletić, Manuela |
author_sort | Milevoj Kopčinović, Lara |
collection | PubMed |
description | INTRODUCTION: The aim of this study was to screen practices used in verification procedures for methods/analysers among medical biochemistry laboratories (MBLs) in Croatia. We hypothesized that these procedures differ widely from laboratory to laboratory and wanted to gather specific data on steps used in the verification workflow. MATERIALS AND METHODS: In order to obtain data, an online survey was conducted. The survey, divided in two sections, contained 29 questions and statements addressing general characteristics and specific steps of the verification workflow of each individual MBL. The survey was disseminated among managers of all MBLs in Croatia. RESULTS: A total of 108/196 (55%) laboratories participated in the survey. Forty nine MBLs were excluded from the second part of the survey: 14 have not implemented verification procedures, and 35 MBLs due to the absence of answers. The most relevant results of the second part of the survey showed that: 18/59 (0.31) of the responding MBLs have difficulties when defining acceptance criteria, 27/59 (0.46) used the Clinical and Laboratory Standards Institute protocol for precision estimation; the majority of MBLs used a median of 20 samples for method/analyser comparisons and estimated bias using internal quality control samples; reference intervals provided by external sources are mainly adopted; 60% of MBLs do not include linearity verification in their protocol and do not use the national document for the estimation of measurement uncertainty. CONCLUSIONS: Heterogeneous verification protocols are routinely utilized across Croatian MBLs which clearly confirms that a national document might help in the harmonization of verification procedures. |
format | Online Article Text |
id | pubmed-8996323 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Croatian Society of Medical Biochemistry and Laboratory Medicine |
record_format | MEDLINE/PubMed |
spelling | pubmed-89963232022-04-22 Verification policies in Croatian medical biochemistry laboratories: a survey of the practice Milevoj Kopčinović, Lara Juričić, Gordana Bokulić, Adriana Vukasović, Ines Ćelap, Ivana Čičak, Helena Kocijančić, Marija Miloš, Marija Lovrić, Mila Siter Kuprešanin, Marija Hrabrić Vlah, Snježana Miletić, Manuela Biochem Med (Zagreb) Original Articles INTRODUCTION: The aim of this study was to screen practices used in verification procedures for methods/analysers among medical biochemistry laboratories (MBLs) in Croatia. We hypothesized that these procedures differ widely from laboratory to laboratory and wanted to gather specific data on steps used in the verification workflow. MATERIALS AND METHODS: In order to obtain data, an online survey was conducted. The survey, divided in two sections, contained 29 questions and statements addressing general characteristics and specific steps of the verification workflow of each individual MBL. The survey was disseminated among managers of all MBLs in Croatia. RESULTS: A total of 108/196 (55%) laboratories participated in the survey. Forty nine MBLs were excluded from the second part of the survey: 14 have not implemented verification procedures, and 35 MBLs due to the absence of answers. The most relevant results of the second part of the survey showed that: 18/59 (0.31) of the responding MBLs have difficulties when defining acceptance criteria, 27/59 (0.46) used the Clinical and Laboratory Standards Institute protocol for precision estimation; the majority of MBLs used a median of 20 samples for method/analyser comparisons and estimated bias using internal quality control samples; reference intervals provided by external sources are mainly adopted; 60% of MBLs do not include linearity verification in their protocol and do not use the national document for the estimation of measurement uncertainty. CONCLUSIONS: Heterogeneous verification protocols are routinely utilized across Croatian MBLs which clearly confirms that a national document might help in the harmonization of verification procedures. Croatian Society of Medical Biochemistry and Laboratory Medicine 2022-04-15 2022-06-15 /pmc/articles/PMC8996323/ /pubmed/35464743 http://dx.doi.org/10.11613/BM.2022.020703 Text en Croatian Society of Medical Biochemistry and Laboratory Medicine. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution (http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) ) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Original Articles Milevoj Kopčinović, Lara Juričić, Gordana Bokulić, Adriana Vukasović, Ines Ćelap, Ivana Čičak, Helena Kocijančić, Marija Miloš, Marija Lovrić, Mila Siter Kuprešanin, Marija Hrabrić Vlah, Snježana Miletić, Manuela Verification policies in Croatian medical biochemistry laboratories: a survey of the practice |
title | Verification policies in Croatian medical biochemistry laboratories: a survey of the practice |
title_full | Verification policies in Croatian medical biochemistry laboratories: a survey of the practice |
title_fullStr | Verification policies in Croatian medical biochemistry laboratories: a survey of the practice |
title_full_unstemmed | Verification policies in Croatian medical biochemistry laboratories: a survey of the practice |
title_short | Verification policies in Croatian medical biochemistry laboratories: a survey of the practice |
title_sort | verification policies in croatian medical biochemistry laboratories: a survey of the practice |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8996323/ https://www.ncbi.nlm.nih.gov/pubmed/35464743 http://dx.doi.org/10.11613/BM.2022.020703 |
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