Skip to main content

Advertisement

SpringerLink
Log in

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

  • Meeting Report
  • Published:
Virchows Archiv Aims and scope Submit manuscript

Abstract

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Dancey JE, Bedard PL, Onetto N, Hudson TJ (2012) The genetic basis for cancer treatment decisions. Cell 148:409–420

    Article  PubMed  CAS  Google Scholar 

  2. Pao W, Chmielecki J (2010) Rational, biologically based treatment of EGFR-mutant non-small-cell lung cancer. Nat Rev Cancer 10:760–774

    Article  PubMed  CAS  Google Scholar 

  3. Penzel R et al (2011) EGFR mutation detection in NSCLC—assessment of diagnostic application and recommendations of the German Panel for Mutation Testing in NSCLC. Virchows Arch 458:95–98

    Article  PubMed  CAS  Google Scholar 

  4. Dequeker E, Ligtenberg MJL, Vander Borght S, Van Krieken JJM (2011) Mutation analysis of KRAS prior to targeted therapy in colorectal cancer: development and evaluation of quality by a European external quality assessment scheme. Virchows Arch 459:155–160

    Article  PubMed  Google Scholar 

  5. Bellon E et al (2011) External quality assessment for KRAS testing is needed: setup of a European program and report of the first joined regional quality assessment rounds. Oncologist 16:467–478

    Article  PubMed  CAS  Google Scholar 

  6. Wong NACS, Deans ZC, Ramsden SC (2012) The UK NEQAS for molecular genetics scheme for gastrointestinal stromal tumour: findings and recommendations following four rounds of circulation. J ClinPathol. doi:10.1136/jclinpath-2012-200851

  7. International Organization for Standardization. ISO 17043:2010 Conformity assessment—general requirements for proficiency testing. http://www.iso.org/iso/catalogue_detail.htm?csnumber=29366. Accessed 28 sept 2012

  8. Thunnissen FB et al (2004) Dutch Pathology Molecular Diagnostic Working Group. Quality control in diagnostic molecular pathology in the Netherlands; proficiency testing for patient identification in tissue samples. J Clin Pathol 57:717–720

    Article  PubMed  CAS  Google Scholar 

  9. von Wasielewski R, Krusche CA, Rüschoff J, Fisseler-Eckhoff A, Kreipe H (2008) Implementation of external quality assurance trials for immunohistochemically determined breast cancer biomarkers in Germany. Breast Care 3:128–133

    Article  Google Scholar 

  10. International Organization for Standardization. ISO 15189:2003 Medical laboratories—particular requirements for quality and competence. http://www.iso.org/iso/catalogue_detail?csnumber=42641. Accessed 28 Sept 2012

  11. Rudiger T, Hofler H, Kreipe HH, Nizze H, Pfeifer U, Stein H, Dallenbach FE, Fischer HP, Mengel M, von Wasielewski R, Muller-Hermelink HK (2002) Quality assurance in immunohistochemistry: results of an interlaboratory trial involving 172 pathologists. Am J Surg Pathol 26:873–882

    Article  PubMed  Google Scholar 

  12. Mengel M, von Wasielewski R, Wiese B, Rüdiger T, Müller-Hermelink HK, Kreipe H (2002) Interlaboratory and interobserver reproducibility of immunohistochemical assessment of the Ki67-labelling index in a large multi-centre trial. J Pathol 198:292–299

    Article  PubMed  Google Scholar 

  13. Thunnissen E, Bovée JV, Bruinsma H, van den Brule AJ, Dinjens W, Heideman DA, Meulemans E, Nederlof P, van Noesel C, Prinsen CR, Scheidel K, van de Ven PM, de Weger R, Schuuring E, Ligtenberg M (2011) EGFR and KRAS quality assurance schemes in pathology: generating normative data for molecular predictive marker analysis in targeted therapy. J Clin Pathol 64:884–892

    Article  PubMed  Google Scholar 

  14. Andrew G, Carlin JB, Stern HS, Rubin DB (2003) Bayesian data analysis. Chapman & Hall, Boca Raton

    Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Department of Pathology 824, Radboud University Nijmegen Medical Centre, PO Box 9101, 6500 HB, Nijmegen, The Netherlands

    J. Han van Krieken, Patricia J. T. A. Groenen, Marjolijn J. L. Ligtenberg & Albert G. Siebers

  2. Cell Biology and Biotherapy Unit, INT-Fondazione Pascale, Naples, Italy

    Nicola Normanno

  3. Manchester University and Christie Hospital NHS Foundation Trust, Manchester, UK

    Fiona Blackhall

  4. Laboratory for Molecular Diagnostics, H. Hartziekenhuis, Roeselare-Menen, Roeselare, Belgium

    Elke Boone

  5. Dipartimento di Anatomia Patologica e Citopatologia, IRCCS Istituto Nazionale Tumori, Fondazione G. Pascale, Naples, Italy

    Gerardo Botti

  6. Institute of Molecular Pathology and Immunology of the University of Porto (IPATIMUP) and Medical Faculty/ Centro Hospitalar de São João, Porto, Portugal

    Fatima Carneiro

  7. Merck Serono Global Research & Early Development—Oncology Platform, Merck KGaA, Darmstadt, Germany

    Ilhan Celik

  8. Dipartimento Medico-Chirurgico di Internistica Clinica e Sperimentale F. Magrassi e A. Lanzara, Seconda Università di Napoli, Naples, Italy

    Fortunato Ciardiello

  9. Warwick Medical School, Clinical Sciences Building, University Hospitals Coventry and Warwickshire, Walsgrave, Coventry, UK

    Ian A. Cree

  10. UK NEQAS for Molecular Genetics, UK NEQAS, The Royal Infirmary of Edinburgh, Edinburgh, UK

    Zandra C. Deans

  11. Clinical Molecular Pathology Unit, Clinical Pathology and Cytology, Sahlgrenska University Hospital and Sahlgrenska Cancer Center, the Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden

    Anders Edsjö

  12. European Molecular Genetics Quality Network (EMQN) Genetic Medicine, St. Mary’s Hospital, Manchester, UK

    Outi Kamarainen

  13. Institute of Pathology, Hannover Medical School, Hannover, Germany

    Hans H. Kreipe

  14. Department of Human Genetics, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands

    Marjolijn J. L. Ligtenberg

  15. Center of Predictive Molecular Medicine, University-Foundation, Chieti, Italy

    Antonio Marchetti

  16. BioMarker Solutions Ltd., London UK & GeneKor A.E., Athens, Greece

    Samuel Murray

  17. Molecular Diagnostics; Quality Control Business, Life Technologies Europe BV, Bleiswijk, The Netherlands

    Frank J. M. Opdam

  18. Medical Sciences Amgen Inc., Thousand Oaks, CA, USA

    Scott D. Patterson

  19. European Molecular Genetics Quality Network (EMQN) Genetic Medicine, St. Mary’s Hospital, Manchester, UK

    Simon Patton

  20. Medical Oncology, S.Orsola-Malpighi Hospital, Bologna, Italy

    Carmine Pinto

  21. Institut Curie, Paris, France

    Etienne Rouleau

  22. Department of Pathology and Medical Biology, University Hospital Groningen and University of Groningen, Groningen, The Netherlands

    Ed Schuuring

  23. Department of Public Health, Biomedical Quality Assurance Research Unit, University of Leuven, Leuven, Belgium

    Silke Sterck & Elisabeth Dequeker

  24. Medical Oncology Service, Catalan Institute of Oncology, Hospital Germans TriasiPujol, Badalona, Spain

    Miquel Taron

  25. Department of Oncology, Laboratory of Molecular Digestive Oncology, University of Leuven, Leuven, Belgium

    Sabine Tejpar

  26. Department of Pathology and Medical Biology, University of Groningen and University Medical Center Groningen, Groningen, The Netherlands

    Wim Timens

  27. Pathology, VU University Medical Center, Amsterdam, The Netherlands

    Erik Thunnissen

  28. Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands

    Peter M. van de Ven

  29. Pangaea Biotech-Dexeus Institute, Barcelona, Spain

    Miquel Taron

Authors
  1. J. Han van Krieken
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Nicola Normanno
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Fiona Blackhall
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Elke Boone
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Gerardo Botti
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Fatima Carneiro
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Ilhan Celik
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Fortunato Ciardiello
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Ian A. Cree
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Zandra C. Deans
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. Anders Edsjö
    View author publications

    You can also search for this author in PubMed Google Scholar

  12. Patricia J. T. A. Groenen
    View author publications

    You can also search for this author in PubMed Google Scholar

  13. Outi Kamarainen
    View author publications

    You can also search for this author in PubMed Google Scholar

  14. Hans H. Kreipe
    View author publications

    You can also search for this author in PubMed Google Scholar

  15. Marjolijn J. L. Ligtenberg
    View author publications

    You can also search for this author in PubMed Google Scholar

  16. Antonio Marchetti
    View author publications

    You can also search for this author in PubMed Google Scholar

  17. Samuel Murray
    View author publications

    You can also search for this author in PubMed Google Scholar

  18. Frank J. M. Opdam
    View author publications

    You can also search for this author in PubMed Google Scholar

  19. Scott D. Patterson
    View author publications

    You can also search for this author in PubMed Google Scholar

  20. Simon Patton
    View author publications

    You can also search for this author in PubMed Google Scholar

  21. Carmine Pinto
    View author publications

    You can also search for this author in PubMed Google Scholar

  22. Etienne Rouleau
    View author publications

    You can also search for this author in PubMed Google Scholar

  23. Ed Schuuring
    View author publications

    You can also search for this author in PubMed Google Scholar

  24. Silke Sterck
    View author publications

    You can also search for this author in PubMed Google Scholar

  25. Miquel Taron
    View author publications

    You can also search for this author in PubMed Google Scholar

  26. Sabine Tejpar
    View author publications

    You can also search for this author in PubMed Google Scholar

  27. Wim Timens
    View author publications

    You can also search for this author in PubMed Google Scholar

  28. Erik Thunnissen
    View author publications

    You can also search for this author in PubMed Google Scholar

  29. Peter M. van de Ven
    View author publications

    You can also search for this author in PubMed Google Scholar

  30. Albert G. Siebers
    View author publications

    You can also search for this author in PubMed Google Scholar

  31. Elisabeth Dequeker
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to J. Han van Krieken.

Rights and permissions

Reprints and permissions

About this article

Cite this article

van Krieken, J.H., Normanno, N., Blackhall, F. et al. Guideline on the requirements of external quality assessment programs in molecular pathology. Virchows Arch 462, 27–37 (2013). https://doi.org/10.1007/s00428-012-1354-4

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00428-012-1354-4

Keywords

Search

Navigation