Work package 3 External Quality Assessment (EQA)

EQA is an important instrument to achieve the harmonization and quality improvement of laboratory tests, aimed for by EuroGentest2.

All genetic laboratories will need proof of their participation in interlaboratory comparisons (such as those organised by EQAs) as a prerequisite to become accredited under the International ISO 15189 norm, an important guarantee for the quality of their results and thus for the services they provide to the European citizens.

Many genetic laboratories in Europe still do not participate in External Quality Assessment (EQA) as there is not always easy access to a National EQA scheme, either because it does not exist at all or because the number of disease-specific tests is limited.

The ability to agree and harmonize appropriate standards of service is an important outcome of participation in EQA. In addition, the educational role of EQA schemes must not be underestimated. CEQA, for example, keeps all the previous cases available on line to be used as training tools.

Organisation and coordination of EQA schemes

Agreement on appropriate Best Practice standards in genetics, and how to measure them, will further assist in harmonizing the quality of service across the European Union. External assessment of new technology, as it moves from research to the diagnostic area (e.g. NIPD), is essential and agreement on best practice for standards and strategies can be achieved by consensus (link with Unit 3, New Technologies). Best Practice Meetings to produce new guidelines for rare disease in cytogenetics, molecular genetics and biochemical genetics will be made possible through the EuroGentest2 funding. These Best Practice Meetings, which will bring together experts across the three disciplines (NIPD and PGD are included within these three disciplines), will be necessary where a disease/technique is across the current artificial, historical discipline boundaries.

Accreditation of EQA schemes

Accreditation of EQA schemes to ISO 17043, together with further rationalization between National schemes and the availability of European EQA schemes, will be valuable in the harmonization of standards and strategies, as well as in the provision of support and education. These aspects will be particularly relevant to laboratories in those countries where the national infrastructure is deficient. It is clear that, in view of the increasing success of these European EQAs in all member states (MS) and the difficulty for most MS to organize National EQAs as accredited entities, these European EQA activities will need to be continued after 2010.

Assessing and decreasing poor performance

All the European EQA Schemes have introduced some poor performance criteria for genotyping (analytical performance). CEQA, CF Network, EMQN and ERNDIM also have introduced guidelines/criteria for identifying poor performance in the interpretative part of the report and are currently piloting the interpretative systems. A definition of generic satisfactory and poor performance criteria will also be proposed by EQA providers and discussed at the ESHG Quality Committee meeting.

The ESHG Quality Committee has requested that these European EQA Schemes submit an annual management review to the Committee for discussion, thereby assuring a harmonized approach to EQA across the genetic disciplines; this is a step forward in the preparation of accreditation of the EQA schemes.

 

WPLeader: Ros Hastings

Participants: Marta Rodriguez de Alba, Emmanuelle Girodon, Rob Elles, Brian Fowler, Els Dequeker

More information on EQA schemes can be found here.

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