Eurogentest: research, harmonization and education in Quality Assurance in Europe
Genetic services in Europe are of high competence but their multinational, multilingual nature leads to wide variability of techniques and quality assurance. The EU Network of Excellence EuroGentest (EUGT) is bringing together initiatives to develop the necessary infrastructure, tools and resources to improve and harmonize the overall quality of genetic services throughout Europe. EUGT Unit 1 is designed to help and encourage laboratories to implement quality systems and reach and maintain accreditation, by contributing to guidelines and Best Practice statements concerning quality assurance (QAu) with an emphasis on harmonization, and by providing workshops for laboratory personnel. The development of a harmonized approach linked to training is extended to analytical validation of tests. A first survey of the QAu status of laboratories in Europe has been performed; the resulting public database will benefit consumers through by facilitating a better-informed choice of partners, and laboratories by providing recognition of their investment in QAu. EUGT Unit 1 will in addition validate SOPs for various tests in a network of accredited expert laboratories and distribute the data, to reduce the depth of validation required in individual laboratories. The current situation of EQA providers and schemes has been analysed and providers brought together to harmonize schemes, to facilitate and encourage participation, and in the longer term to provide sustainable and harmonized EQA for all genetic labs, through national and international schemes. Finally research into the requirements for high quality reference materials will lead to production of such materials for use in test development, validation, internal quality control and EQA.
The common aim of these initiatives is harmonize and improve the quality of genetic services for patients throughout Europe. The EUGT experience will provide both concrete help and models for other international networks and collaborations.