1. History of EuroGentest Started in January 2005 with European Funding Jean-Jacques Cassiman, Els Dequeker, Robert Elles, Dolores Ibarreta, Emilio Rodriguez-Cerezo Ref: Nature Biotechnology 22, 1230 - 1235 (2004) doi:10.1038/nbt1004-1230 2004 - IPTS (Institute for prospective technological studies) - study identified a need to harmonise genetic testing in Europe.

2. Steering Committee Coordination JJ Cassiman, Leuven Management TeamAdvisory Board EuroGentest: Harmonizing genetic testing across Europe Unit 1Quality Management Unit 2Information Databases Unit 3Public Health Clinical Genetics Unit 6 Education/Information Unit 4 Ethical, Legal, Social Issues Unit 5Emerging technologies

3. Harmonization Dequeker, Hastings Quality management Dequeker, Morris WP1.5 Biochemical EQA WP1.4 Cytogenetics EQA WP1.3 Molecular EQA WP1.9 QM of EQA schemes EQA Schemes Elles, Fowler, Hastings, Müller Validation of diagnostic tests Matthijs, Macek Unit 1: Quality Management and Accreditation WP1.8 Technical aspects of QAu WP1.2 QAu database Reference systems & procedures Barton, Gancberg WP1.6 Reference materials WP1.7 Diagnostic validation WP1.1 Website, overall activities

4. Overall Objective of Unit 1 To measurably improve the quality of management and provision of genetic testing services for the benefit of the patients, laboratory accreditation considered to be the norm.

5. How is unit 1 helping? Benefits for labs and patients Contacts with other labsWhich labs offer a service in my area? Labs for referring specialised tests Information for patient Positive & negative controls for assays Assure correct results Validated Standard Operating Procedures (SOPs)‏Assure tests done correctly Generic SOPs for new technologies Assure tests done correctly Validation technologies / methods Assure precise results Access to EQA schemes External validation of quality (accuracy)‏ Accreditation advice Validation of quality service (overall service)‏

6. Workshops - Training on QAu and accreditation Aims and starting point: Share Genetic testing laboratories all face the same problems. They have all found solutions in the past Learn What do the accreditation standards require for genetic testing? How have accredited, expert and smaller labs dealt with similar situations? How can we use other labs’ experiences (and avoid mistakes!)? Apply Case studies and small-group discussion Role-playing and videos of internal audits Hands-on trials of quality management software

7. Workshops - Training on QAu and accreditation Sustainability of the workshops Network of training experts: 3 new trainers Business plan developed 5 workshops and 1 round table discussion Progress made in 2008: Updated report on workshops available online Guidance document for preparing for accreditation Chapter on accreditation, internal audit, motivation and change and IT support

8. Progress made since 2005: 13 different workshops, 5 topics 7 x accreditation and quality systems 2 x internal audit 2 x motivation and change 1 x IT support 1 x management review, IQC, EQA 33 different countries participated 238 unique participants Subscription list since 2007 85 people showed interest 25% of them registered including people from India, Mexico, Rwanda, United Arab Emirates, Qatar, Moldova, Argentina,... Workshops - Training on QAu and accreditation http://www.eurogentest.org/unit1/workshops.xhtml 12 x 8 x 7 x 6 x 5 x 4 x 3 x 2 x 1 x 0 x Number of times a certain country was present in one or more workshops

9. Workshops - Training on QAu and accreditation Plans for 2009: Workshops on: Accreditation for beginners Diagnostic validation (including CE labelling and IVD)‏ Management review, IQC, EQA Motivation and change National workshop (France)‏ Round-table session at the ESHG Further training of experts Laboratory and Quality Management symposium www.eurogentest.org

13. Validation of diagnostic tests in clinical molecular genetics Prague, Czech Republic 8-9 January 2009 Genetic tests must be validated before diagnostic use to ensure that they perform according to the laboratory's requirements, and test validation is a formal requirement of many accreditation standards including ISO 15189. In this workshop, we will examine the validation requirements of ISO 15189 and address practical ways of meeting them in your laboratory. Towards accreditation – Managing the human side of change Leuven, Belgium 20-21 April 2009 One of the biggest challenges in implementing a quality system lies in overcoming the natural reluctance of team members, and convincing them of the value of quality assurance. We will provide insight on the human and behavioural aspects of change, and will address techniques for their management. Case studies and role play will provide illustration and training, to help you apply these insights in your lab. Accreditation for beginners Vienna, Austria (before the ESHG)‏ 22-23 May 2009 This workshop is designed for labs at the beginning of the implementation of a quality management system (QMS) according ISO 15189. The aims are to compare and share experiences of implementing and living with quality systems. Effective ways to move towards accreditation, to improve quality assurance, and common deficiencies in a QMS will be discussed, in expert-led sessions and small groups. Fulfilling the requirements of ISO 15189 for management review, internal quality control and external quality assessment Vienna, Austria (before the ESHG)‏ 22-23 May 2009 Want to learn more on how to do a management review, on how to introduce internal quality controls in the laboratory or what participating in external quality assessment (EQA) means? These specific topics will be tackled by debate in small groups on concrete situations and interacting presentations. The cases are always based on the requirements of the ISO 15189 standard for medical laboratories. Case studies on quality assurance and quality control issues in genetic testing laboratories During the ESHG Vienna, timing will be announced later A 2-hour round-table session will be held on laboratory quality control and quality assurance. The aim is to interact with peers from diagnostic laboratories, to discuss concrete, every-day situations related to laboratory quality management and to find solutions that could be applied in your laboratory. The cases will be discussed in the context of international quality requirements such as the ISO 15189. Validation of diagnostic tests in clinical molecular genetics Bologna, Italy 26-27 October 2009 Genetic tests must be validated before diagnostic use to ensure that they perform according to the laboratory's requirements, and test validation is a formal requirement of many accreditation standards including ISO 15189. In this workshop, we will examine the validation requirements of ISO 15189 and address practical ways of meeting them in your laboratory. W ORKSHOPS O N Q UALITY A SSURANCE REGISTRATION AND MORE INFORMATION ON THE EUROGENTEST WEBSITE: www.eurogentest.org/unit1/workshops.xhtml

14. 2009 – 1 st Symposium of Quality Management 19 th June – Leuven. Prize for best ‘innovation’ in laboratory QM – free registration to EUGT workshop on accreditation 2010- UK workshop - ?Birmingham Further details from www.eurogentest.org Quality Award