President s report THIRD EFCC GENERAL ASSEMBLY 17 APRIL 2010, CORFU, GREECE
Goals of EFCC Promotion of science and education within CCLM Improve patient outcomes and the quality and safety of patient care Represent CCLM at European level Represent IFCC in Europe Represent professional interests of specialists Promote the profession of laboratory medicine Certify and register professionals (EC4 Register)
40 member countries Albania Austria Belgium Bosnia-Herzegovina Bulgaria Croatia Czech Republic Cyprus Denmark Estonia Finland France Germany Greece Hungary Iceland Ireland Israel Italy Kosovo (provisional member) Latvia Lithuania Luxembourg Macedonia Montenegro Netherlands Norway Poland Portugal Romania Russia Serbia Slovak Republic Slovenia Spain Sweden Switzerland Turkey Ukraine United Kingdom
Mariam Klouche (Germany) Past President: Vic Blaton (Belgium) President: Andrea Rita Horvath (Hungary) President-Elect: Ian Watson (United Kingdom) Secretary: Hans van Pelt (The Netherlands) Treasurer: Peter Schuff-Werner (Germany) Member-at-Large: Kari Pulkki (Finland) Member-at-Large: Mario Pazzagli (Italy) Sverre Sandberg (Norway) Jean-Claude Libeer (Belgium) Elizabeta Topic (Croatia) Simone Zerah (France) Peter Schuff-Werner (Germany) EFCC structure
EFCC Working Groups (WG) and Project Groups (PG)
Science Committee WG Biological Variation explores the sources of variation in and develops a critical appraisal checklist for papers on biological variation. WG Post-analytical external quality assessment which carries out international surveys amongst general practitioners and investigates how doctors use and interpret laboratory tests commonly used for managing patients in primary care. WG Test Evaluation sets evidence-based standards and develops practical tools for designing research studies for the evaluation of the clinical value and impact of new biomarkers.
The IVD Challenge From 21 March 2010, the European medical device regulation will require an evidence-based Clinical Evaluation Report for all (old and new) IVD devices with CE marking.
Meeting the IVD Challenge GHTF SG5: www.ghtf.org/sg5/ Clinical Evidence Key Definitions and Concepts - 2007 Clinical Evaluation - 2007 Clinical Investigations - 29 January 2008 Post-market Clinical Follow-up studies - 23 July 2008
Evaluation of a diagnostic biomarker PRE-MARKET Do patients with the target disorder have different test results from normals? Case control study What is the clinical purpose, pathway, population, setting and consequence of testing? Modelling Decision analysis POST-MARKET Do analytical performance goals fulfil clinical needs? In symptomatic patients will the test distinguish those with and without the disorder? Do patients who are tested have better health outcomes, than those who are not? What are the ethical, legal, social, financial consequences of testing? Sn, Sp trueness imprecision Diagnostic accuracy study RCT SR of RCTs HTA CPG Clinical audit
Science Committee WG Cardiac Markers investigates, via European surveys, how the reporting, interpretation and use of cardiac markers impact on patient outcomes in different countries. WG Creatinine Standardization investigates the effects of IVD 98/79 on creatinine standardisation and the clinical effects of creatinine re-standardisation. WG Guidelines develops standards for guidelines assesses the quality and content of guidelines on SMBG develops guidance for and website on reflective testing www.reflectivetesting.com
The SPIDIA project Standardisation and improvement of pre-analytical procedures for current and future in-vitro diagnostics. The project is coordinated by QIAGEN GmbH. www.spidia.eu
Quality Management Committee Supports the establishment of effective accreditation schemes and quality management systems in all European countries Liaises with ISO, CEN and the European Accreditation body (EA). WG Accreditation and ISO/CEN, represents EFCC in EA, ISO TC212 and CEN TC140. The WG focuses on influencing ISO/CEN standards and harmonisation of accreditation by international surveys, education and training of assessors related to specific professional standards of ISO 15189 and on setting European procedures for accreditation according to the flexible scope. WG IVD Directive, provides guidance for the application of the Directive in laboratory practice and during accreditation of laboratories..
Profession Committee Aims: to achieve legal recognition of the Register at European Commission/Parliament level via co-regulation, regulation, an act or a law to raise the profession s profile through lobbying of the European Parliament WG EC4Register Commission is independently funded EC4RC is member of CEPLIS WG on Healthcare: WG on Education: Simone Zerah, Janet Mc Murray, Rob Jansen, Mike Hallworth Thomas Zima from the C-ET CEPLIS assists in liaising with the European Commission and the European Economic and Social Committee
EC4RC activities at EC level The EC4 Register is accepted as an EC-approved self-regulation initiative by the European Economic and Social Committee (EESC) that provides a common basis for assessing laboratory professionals across the EU. Self-Regulation is a soft-law, i.e. a recommendation of the EC to EU countries The Register is included on the EESC/SMO (Single Market Observatory) database and website: www.eesc.europa.eu/selfandcoregulation/index.asp/full.asp?id=121
EC4 MEMBERSHIP (March2010) 1400 2500 1265 1200 2109 2109 1000 1781 1787 800 1408 1511 1883 1895 1922 1926 1926 1970 1596 1605 1618 2192 2000 1500 600 1000 400 200 40 13 53 67 3 70 0 70 0 70 103 85 143 139 96 9 13 6 12 27 4 0 44 83 0 B A us t el ria gi C ze u ch Cy m Re pru pu s D bli en c m Es ar k to Fi nia nl a Fr nd G anc er e m a G ny r H eec un e ga Ire ry la nd Lu xe It a N mb ly et o he ur rla g n Po ds Po lan rt d R ug om al Sl ani ov a Sl aki ov a en i Sp a U ni te Sw ain d K ede in n gd om 0 13 14 73 500 163 0
Registrations, March 2010 Austria 13 Italy 163 Belgium 42 Luxembourg 7 Cyprus 15 Netherlands 96 Czech Republic 3 Poland 12 Finland 73 Portugal 27 France 1265 Romania 4 Germany 103 Slovenia 44 Greece 86 Spain 139 Hungary 9 United Kingdom 83 Ireland 13 TOTAL 2197
Publications, surveys, pilots Code of conduct (The European Register for Specialists in Clinical Chemistry and Laboratory Medicine : Code of Conduct - Version 2-2008. Clin Chem Lab Med 2009; 47(3) : 372-375) Guide to EC4 Register (Accepted for publication in CCLM) Revision of the EC4 European Syllabus for post-graduate Training in Clinical Chemistry and laboratory medicine: Version 3 2005. Zerah S. et al. Clin Chem Lab Med 2006;44(1):110 120. UEMS-EFCC Questionnaire on the practice and training in LM in Europe Pilot with the Dutch Society linking the EC4 Register and the national official Register
Join the EC4 Register! On-line application form: www.ec4register.eu
EFCC-Roche Scientific Award for Laboratory Medicine Awarded every two years to honour an individual from an EFCC member country who has made unique contributions to the promotion and understanding of clinical chemistry throughout Europe or who has made one or more contributions that have had a major impact on clinical chemistry
The EFCC-Abbott Labs are Vital Award for Excellence in Outcomes Research in Laboratory Medicine Awarded every two years to the best published paper, as judged by an independent panel of experts, which demonstrated improved outcomes (clinical and/or economic) arising out of the application or improved utilisation of an in-vitro diagnostics test
If interested, please contact: rita.horvath@sesiahs.health.nsw.gov.au