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European follow-up of incorrect biomarker results for colorectal cancer demonstrates the importance of quality improvement projects.
Keppens, Cleo; Dufraing, Kelly; van Krieken, Han J; Siebers, Albert G; Kafatos, George; Lowe, Kimberly; Demonty, Gaston; Dequeker, Elisabeth M C.
  • Keppens C; 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.
  • Dufraing K; 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.
  • van Krieken HJ; Department of Pathology, Radboud University Medical Center, Geert Grooteplein 10 (route 812), P.O.Box 9101, 6500 HB, Nijmegen (824), The Netherlands.
  • Siebers AG; Department of Pathology, Radboud University Medical Center, Geert Grooteplein 10 (route 812), P.O.Box 9101, 6500 HB, Nijmegen (824), The Netherlands.
  • Kafatos G; Amgen Ltd, 1 Uxbridge Business Park, Sanderson Road, Uxbridge, UB8 1DH, UK.
  • Lowe K; Amgen Inc, One Amgen Center Drive, MS 17-2-A, Thousand Oaks, CA, 91320, USA.
  • Demonty G; Amgen Belgium S.A./N.V, Arianelaan 5, 1200, Brussels, Belgium.
  • Dequeker EMC; 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. els.dequeker@kuleuven.be.
Virchows Arch ; 475(1): 25-37, 2019 Jul.
Article en En | MEDLINE | ID: mdl-30719547
ABSTRACT
Biomarker analysis for colorectal cancer has been shown to be reliable in Europe with 97% of samples tested by EQA participants to be correctly classified. This study focuses on errors during the annual EQA assessment. The aim was to explore the causes and actions related to the observed errors and to provide feedback and assess any improvement between 2016 and 2017. An electronic survey was sent to all laboratories with minimum one genotyping error or technical failure on ten tumor samples. A workshop was organized based on 2016 survey responses. Improvement of performance in 2017 was assessed for returning participants (n = 76), survey respondents (n = 13) and workshop participants (n = 4). Survey respondents and workshop participants improved in terms of (maximum) analysis score, successful participation, and genotyping errors compared to all returning participants. In 2016, mostly pre- and post-analytical errors (both 25%) were observed caused by unsuitability of the tumor tissue for molecular analysis. In 2017, most errors were due to analytical problems (50.0%) caused by methodological problems. The most common actions taken (n = 58) were protocol revisions (34.5%) and staff training (15.5%). In 24.1% of issues identified no action was performed. Corrective actions were linked to an improved performance, especially if performed by the pathologist. Although biomarker testing has improved over time, error occurrence at different phases stresses the need for quality improvement throughout the test process. Participation to quality improvement projects and a close collaboration with the pathologist can have a positive influence on performance.
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Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Neoplasias Colorrectales / Biomarcadores de Tumor / Indicadores de Calidad de la Atención de Salud / Técnicas de Diagnóstico Molecular / Errores Diagnósticos / Mejoramiento de la Calidad / Ensayos de Aptitud de Laboratorios Tipo de estudio: Clinical_trials / Diagnostic_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Humans País como asunto: Europa Idioma: En Año: 2019 Tipo del documento: Article

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Neoplasias Colorrectales / Biomarcadores de Tumor / Indicadores de Calidad de la Atención de Salud / Técnicas de Diagnóstico Molecular / Errores Diagnósticos / Mejoramiento de la Calidad / Ensayos de Aptitud de Laboratorios Tipo de estudio: Clinical_trials / Diagnostic_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Humans País como asunto: Europa Idioma: En Año: 2019 Tipo del documento: Article