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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Published in:Virchows Archiv: European Journal of Pathology Vol. 478; no. 5; pp. 995 - 1007
Main Authors: Keppens, Cleo, Schuuring, Ed, Dequeker, Elisabeth M. C.
Format: Journal Article
Published: Springer Nature May2021
Online Access:View this record in EBSCOhost
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      dt: May2021
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      pub: Springer Nature
      place: New York, New York
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        10.1007/s00428-020-02966-7
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        atl: Causes behind error rates for predictive biomarker testing: the utility of sending post-EQA surveys.
      aug:
        au:
          Keppens, Cleo
          Schuuring, Ed
          Dequeker, Elisabeth M. C.
        affil: Department of Public Health and Primary Care, Biomedical Quality Assurance Research Unit, University of Leuven, box 7001, Kapucijnenvoer 35 block d, 1st floor, 3000, Leuven, Belgium
      sug:
        subj:
          In Situ Hybridization, Fluorescence Standards
          Lung Neoplasms Diagnosis
          Immunohistochemistry Standards
          Clinical Indicators Standards
          Colorectal Neoplasms Diagnosis
          Carcinoma, Non-Small-Cell Lung Diagnosis
          Reproducibility of Results
          Carcinoma, Non-Small-Cell Lung
          Pilot Studies
          Lung Neoplasms
          Colorectal Neoplasms
          Quality Improvement Standards
          Predictive Value of Tests
          Observer Bias
          Surveys
          Quality Assurance Standards
          Ferrans and Powers Quality of Life Index
      ab: 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.
      pubtype: Academic Journal
      doctype: Journal Article
      ougenre: Article
    language: English
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