Abstract
Quality control in the laboratory setting requires the establishment of a quality management system (QMS) that covers training, standard operating procedures, internal quality control, validation of tests, and external quality assessment (EQA). Laboratory accreditation through inspection by an external body is also desirable as this provides an effective procedure for assuring quality and also reassures the patient that the laboratory is working to acceptable international standards. The implementation of fluorescence in situ hybridisation (FISH) in the routine diagnostic laboratory requires rigorous quality control with attention to when it is appropriate to apply the technology, a systematic approach to the validation of probes, policies and procedures documenting the analytical validity of all FISH tests performed, technical procedures involved, and a comprehensive means of reporting results. Knowledge of the limitations of any FISH test is required in relation to the probe and/or tissue being examined, since errors of analysis and interpretation can result in incorrect patient management. A structured QMS with internal quality control and regular audits will minimise the error rate.
This is a preview of subscription content, log in via an institution.
Buying options
Tax calculation will be finalised at checkout
Purchases are for personal use only
Learn about institutional subscriptionsSpringer Nature is developing a new tool to find and evaluate Protocols. Learn more
References
OECD (2005) Quality assurance and proficiency testing for molecular genetic testing: survey of 18 OECD member countries. www.oecd.org/sti/biotechnology/ (also applicable to Cytogenetic laboratories).
Hastings, R.J., Maher, E.J., Quellhorst-Pawley, B., Howell. R. (2008) An internet-based External Quality Assessment (EQA) in cytogenetics that audits a laboratory’s analytical and interpretative performance. Eur. J. Hum. Genet. 16, 1217–1224.
Mascarello, J.T., Brothman, A. R., Davison, K., Dewald, G.W., Herrman, M., McCandless, D., Park , P., Persons, D. L., Rao, K.W., Schneider, N. R., Vance, G. H., Cooley, L. D. (2002) Proficiency testing for laboratories performing fluorescence in situ hybridization with chromosome-specific DNA probes. Arch. Pathol. Lab. Med. 126, 1458–1624.
ISO 15189. (2003) Medical laboratories – particular requirements for quality and competence. http://www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_committees.htm
Howell, R., Hastings, R.J. (2006) The current scope of cytogenetics external quality assessment schemes and key recommendations for harmonization of external quality assessment in Europe. www.eurogentest.org
College of American Pathologists website. www.cap.org
European Cytogenetic Quality Assurance website. www.cyto-ceqa.eu
UK NEQAS for Clinical Cytogenetics website. www.ccneqas.org.uk
EA website.www.european-accreditation.org/content/database/Links.mpi
Bethesda, M.D. ed. (1999) ACMG Standards and Guidelines for Clinical Genetics Laboratories. 2nd: American College of Medical Genetics.
Hastings, R.J., Cavani, S., Dagna Bricarelli, F., Patsalis, P.C., Kristoffersson, U. (2006) Cytogenetic guidelines and quality assurance: A common European framework for quality assessment for constitutional and acquired cytogenetic investigations. ECA newsl. 17, 13–32. www.biologia.uniba.it/eca and www.eurogentest.org
Hastings, R.J., Cavani, S., Dagna Bricarelli, F., Patsalis, P.C., Kristoffersson, U. (2007) Cytogenetic guidelines and quality assurance: A common European framework for quality assessment for constitutional and acquired cytogenetic investigations. A summary. Eur. J. Hum. Genet. 15, 525–527.
Wolff, D.J., Bagg, A., Cooley, L.D., Dewald, G.W., Hirsch, B.A., Jacky, P.B., Rao, K.W., Rao, P.N. (2007) Guidance for fluorescence in situ hybridization testing in hematologic disorders. J. Med. Diagn. 9, 134–143.
Wiktor, A.E., Van Dyke, D.L., Stupca, P.J., Ketterling, R.P., Thorland, E.C., Shearer, B.M., Fink, S.R., Stockero, K.J., Majorowicz, J.R., Dewald, G.W. (2006) Preclinical validation of FISH assays for clinical practice. Genet. Med. 8, 16–23.
Reinhold, U., Hening, E., Leiblein, S., Niederweiser, D., Deininger, N.W.N. (2003) FISH for BCR-ABL interphases of peripheral blood neutrophils but not of unselected white cells correlates with bone marrow cytogeneitcs in CML patients treated with imatinib. Leukaemia 17, 1925–1929.
Association for Clinical Cytogenetics. Professional guidelines for clinical cytogenetics.www.cytogenetics.org
Shaffer, L.G., Slovak, M.L., Campbell, L.J. eds. (2009) ISCN (2009): An International System for Human Cytogenetic Nomenclature. S. Karger, Basel
Tefferi, A., Dewald, G.W., Litzow, M.L., Cortes, J., Mauro, M.J., Talpaz, M., Kantarjian, H.M. (2005) Chronic myeloid leukemia: Current application of cytogenetics and molecular testing for diagnosis and treatment. Mayo Clin. Proc. 80, 390–402.
Acknowledgments
The author would like to thank Rod Howell and Mike Griffiths (UK NEQAS Steering Committee), for reviewing and giving helpful suggestions on this manuscript.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2010 Springer Science+Business Media, LLC
About this protocol
Cite this protocol
Hastings, R. (2010). Quality Control in FISH as Part of a Laboratory’s Quality Management System. In: Bridger, J., Volpi, E. (eds) Fluorescence in situ Hybridization (FISH). Methods in Molecular Biology, vol 659. Humana Press, Totowa, NJ. https://doi.org/10.1007/978-1-60761-789-1_18
Download citation
DOI: https://doi.org/10.1007/978-1-60761-789-1_18
Published:
Publisher Name: Humana Press, Totowa, NJ
Print ISBN: 978-1-60761-788-4
Online ISBN: 978-1-60761-789-1
eBook Packages: Springer Protocols