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Causes behind error rates for predictive biomarker testing: the utility of sending post-EQA surveys

External quality assessment (EQA) schemes assess the performance of predictive biomarker testing in lung and colorectal cancer and have previously demonstrated variable error rates. No information is currently available on the underlying causes of incorrect EQA results in the laboratories. Participa...

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Autores principales: Keppens, Cleo, Schuuring, Ed, Dequeker, Elisabeth M. C.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8099794/
https://www.ncbi.nlm.nih.gov/pubmed/33225398
http://dx.doi.org/10.1007/s00428-020-02966-7
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author Keppens, Cleo
Schuuring, Ed
Dequeker, Elisabeth M. C.
author_facet Keppens, Cleo
Schuuring, Ed
Dequeker, Elisabeth M. C.
author_sort Keppens, Cleo
collection PubMed
description External quality assessment (EQA) schemes assess the performance of predictive biomarker testing in lung and colorectal cancer and have previously demonstrated variable error rates. No information is currently available on the underlying causes of incorrect EQA results in the laboratories. Participants in EQA schemes by the European Society of Pathology between 2014 and 2018 for lung and colorectal cancer were contacted to complete a survey if they had at least one analysis error or test failure in the provided cases. Of the 791 surveys that were sent, 325 were completed including data from 185 unique laboratories on 514 incorrectly analyzed or failed cases. For the digital cases and immunohistochemistry, the majority of errors were interpretation-related. For fluorescence in situ hybridization, problems with the EQA materials were reported frequently. For variant analysis, the causes were mainly methodological for lung cancer but variable for colorectal cancer. Post-analytical (clerical and interpretation) errors were more likely detected after release of the EQA results compared to pre-analytical and analytical issues. Accredited laboratories encountered fewer reagent problems and more often responded to the survey. A recent change in test methodology resulted in method-related problems. Testing more samples annually introduced personnel errors and lead to a lower performance in future schemes. Participation to quality improvement projects is important to reduce deviating test results in laboratories, as the different error causes differently affect the test performance. EQA providers could benefit from requesting root cause analyses behind errors to offer even more tailored feedback, subschemes, and cases. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00428-020-02966-7.
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spelling pubmed-80997942021-05-11 Causes behind error rates for predictive biomarker testing: the utility of sending post-EQA surveys Keppens, Cleo Schuuring, Ed Dequeker, Elisabeth M. C. Virchows Arch Original Article External quality assessment (EQA) schemes assess the performance of predictive biomarker testing in lung and colorectal cancer and have previously demonstrated variable error rates. No information is currently available on the underlying causes of incorrect EQA results in the laboratories. Participants in EQA schemes by the European Society of Pathology between 2014 and 2018 for lung and colorectal cancer were contacted to complete a survey if they had at least one analysis error or test failure in the provided cases. Of the 791 surveys that were sent, 325 were completed including data from 185 unique laboratories on 514 incorrectly analyzed or failed cases. For the digital cases and immunohistochemistry, the majority of errors were interpretation-related. For fluorescence in situ hybridization, problems with the EQA materials were reported frequently. For variant analysis, the causes were mainly methodological for lung cancer but variable for colorectal cancer. Post-analytical (clerical and interpretation) errors were more likely detected after release of the EQA results compared to pre-analytical and analytical issues. Accredited laboratories encountered fewer reagent problems and more often responded to the survey. A recent change in test methodology resulted in method-related problems. Testing more samples annually introduced personnel errors and lead to a lower performance in future schemes. Participation to quality improvement projects is important to reduce deviating test results in laboratories, as the different error causes differently affect the test performance. EQA providers could benefit from requesting root cause analyses behind errors to offer even more tailored feedback, subschemes, and cases. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00428-020-02966-7. Springer Berlin Heidelberg 2020-11-23 2021 /pmc/articles/PMC8099794/ /pubmed/33225398 http://dx.doi.org/10.1007/s00428-020-02966-7 Text en © The Author(s) 2020 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Original Article
Keppens, Cleo
Schuuring, Ed
Dequeker, Elisabeth M. C.
Causes behind error rates for predictive biomarker testing: the utility of sending post-EQA surveys
title Causes behind error rates for predictive biomarker testing: the utility of sending post-EQA surveys
title_full Causes behind error rates for predictive biomarker testing: the utility of sending post-EQA surveys
title_fullStr Causes behind error rates for predictive biomarker testing: the utility of sending post-EQA surveys
title_full_unstemmed Causes behind error rates for predictive biomarker testing: the utility of sending post-EQA surveys
title_short Causes behind error rates for predictive biomarker testing: the utility of sending post-EQA surveys
title_sort causes behind error rates for predictive biomarker testing: the utility of sending post-eqa surveys
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8099794/
https://www.ncbi.nlm.nih.gov/pubmed/33225398
http://dx.doi.org/10.1007/s00428-020-02966-7
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