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.

Steering Committee

Coordination JJ Cassiman, Leuven

Management Team Advisory Board

EuroGentest: Harmonizing genetic testing across Europe

Un

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Qu

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Info

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Pu

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Hea

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Clin

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Gen

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HarmonizationDequeker, Hastings

QualitymanagementDequeker, Morris

WP1.5Biochemical

EQA

WP1.4Cytogenetics

EQA

WP1.3Molecular

EQA

WP1.9QM of EQA

schemes

EQA SchemesElles, Fowler, Hastings, Müller

Validationof diagnostic tests

Matthijs, Macek

Unit 1: Quality Management and Accreditation

WP1.8Technical

aspects of QAu

WP1.2QAu database

Reference systems & procedures

Barton, Gancberg

WP1.6Referencematerials

WP1.7Diagnostic validation

WP1.1Website, overall

activities

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.

How is unit 1 helping?

Benefits for labs and patients

Contacts with other labs Which 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)

Workshops - Training on QAu and accreditationAims and starting point:ShareGenetic testing laboratories all face the same problems. They have all found solutions in the past

LearnWhat 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 discussionRole-playing and videos of internal auditsHands-on trials of quality management software

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 accreditationChapter on accreditation, internal audit, motivation and change and IT support

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 x8 x7 x6 x5 x4 x3 x2 x1 x0 x

Number of times a certain countrywas present in one or more workshops

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

www.eurogentest.org

Validation of diagnostic tests in clinical molecular geneticsPrague, Czech Republic8-9 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 changeLeuven, Belgium20-21 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 beginnersVienna, 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 assessmentVienna, 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 geneticsBologna, Italy26-27 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.

WORKSHOPS ON QUALITY ASSURANCE

REGISTRATION AND MORE INFORMATION ON THE EUROGENTEST WEBSITE:www.eurogentest.org/unit1/workshops.xhtml

2009 – 1st Symposium of Quality Management19th 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