Guideline on the requirements of external quality assessment programs in molecular pathology

J. Han Van Krieken, Nicola Normanno, Fiona Blackhall, Elke Boone, Gerardo Botti, Fatima Carneiro, Ilhan Celik, Fortunato Ciardiello, Ian A. Cree, Zandra C. Deans, Anders Edsjö, Patricia J T A Groenen, Outi Kamarainen, Hans H. Kreipe, Marjolijn J L Ligtenberg, Antonio Marchetti, Samuel Murray, Frank J M Opdam, Scott D. Patterson, Simon PattonCarmine Pinto, Etienne Rouleau, Ed Schuuring, Silke Sterck, Miquel Taron, Sabine Tejpar, Wim Timens, Erik Thunnissen, Peter M. Van De Ven, Albert G. Siebers, Elisabeth Dequeker

Research output: Contribution to journalArticlepeer-review


Molecular pathology is an integral part of daily diagnostic pathology and used for classification of tumors, for prediction of prognosis and response to therapy, and to support treatment decisions. For these reasons, analyses in molecular pathology must be highly reliable and hence external quality assessment (EQA) programs are called for. Several EQA programs exist to which laboratories can subscribe, but they vary in scope, number of subscribers, and execution. The guideline presented in this paper has been developed with the purpose to harmonize EQA in molecular pathology. It presents recommendations on how an EQA program should be organized, provides criteria for a reference laboratory, proposes requirements for EQA test samples, and defines the number of samples needed for an EQA program. Furthermore, a system for scoring of the results is proposed as well as measures to be taken for poorly performing laboratories. Proposals are made regarding the content requirements of an EQA report and how its results should be communicated. Finally, the need for an EQA database and a participant manual are elaborated. It is the intention of this guideline to improve EQA for molecular pathology in order to provide more reliable molecular analyses as well as optimal information regarding patient selection for treatment.

Original languageEnglish
Pages (from-to)27-37
Number of pages11
JournalVirchows Archiv
Issue number1
Publication statusPublished - Jan 2013


  • External quality assessment
  • Guideline
  • Molecular pathology
  • Oncology

ASJC Scopus subject areas

  • Pathology and Forensic Medicine
  • Cell Biology
  • Molecular Biology


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