Laboratory accreditation and participation in external quality assessment schemes: tools to improve the quality of genetic testing services

Background: Given the potential powerful health consequences of genetic test results, mechanisms should be in place to assure the quality of the tests and the interpretation of the data. In this context, accreditation of genetic testing laboratories and participation in external quality assessment (EQA) schemes are encouraged within Europe as relevant tools to assure and improve quality. The International Organization for Standardization (ISO) 15189 standard for accreditation of medical laboratories and the Organisation for Economic Cooperation and Development (OECD) Guidelines for quality assurance in molecular genetic testing are essential documents to assist towards the implementation of a quality management system. Methods: Information on quality management (QM) and quality assurance (QAu) of genetic laboratories was collected after surveying participants of the workshops on quality and accreditation, organized by the EU-funded project EuroGentest. Furthermore the EQA performance data of the participants in the cystic fibrosis (CF) EQA scheme, organized by the CF Network, were compared over the years (2004–2008). Results: Preliminary data show an increase of the implementation of quality parameters and of the amount of accredited laboratories in Europe. Further, improvement of the quality of interpretation and genotyping in genetic testing reports is noticed. Conclusions: Regular participation in EQA schemes and accreditation of laboratories both contribute to continuous improvement and monitoring of internal quality in laboratory performance.

Publication year:2010

BOF-keylabel:yes

IOF-keylabel:yes

BOF-publication weight:0.1

CSS-citation score:1

Authors:International

Authors from:Higher Education