Causes behind error rates for predictive biomarker testing: the utility of sending post-EQA surveys
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ORIGINAL ARTICLE
Causes behind error rates for predictive biomarker testing: the utility of sending post-EQA surveys Cleo Keppens 1
&
Ed Schuuring 2
&
Elisabeth M. C. Dequeker 1
Received: 19 March 2020 / Revised: 29 October 2020 / Accepted: 1 November 2020 # The Author(s) 2020
Abstract 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. Keywords External quality assessment . Molecular pathology . Root cause analysis . Quality management . Biomarkers . ISO 15189 . Colorectal cancer . Non-small-cell lung cancer
This article is part of the Topical Collection on Quality in Pathology Supplementary Information The online version contains supplementary material available at https://doi.org/10.1007/s00428-02002966-7. * Elisabeth M. C. Dequeker [email protected] Cleo Keppens [email protected] Ed Schuuring [email protected] 1
Department of Public Health and Primary Care, Biomedical Quality Assurance Research Unit, University of Leuven, Kapucijnenvoer 35 block d, 1st floor, box 7001, 3000 Leuven, Belgium
2
Department of Pathology, University of Groningen, University Medical Center Groningen (UMCG), (HPC EA10), Hanzeplein 1, PO Box 30001, 9700 RB Groningen, The Netherlands
Abbreviations ALK ALK receptor tyrosine kinase BRAF B-Raf proto-oncogene CAPA Corrective/preventive action CI Confidence interval EGFR Epidermal growth factor receptor EQA Ext
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