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President’s report
THIRD EFCC GENERAL ASSEMBLY17 APRIL 2010, CORFU, GREECE
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Goals of EFCCPromotion of science and education within CCLMImprove patient outcomes and the quality and safety of patient careRepresent CCLM at European levelRepresent IFCC in EuropeRepresent professional interests of specialistsPromote the profession of laboratory medicineCertify and register professionals (EC4 Register)
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40 member countriesAlbaniaAustriaBelgium Bosnia-HerzegovinaBulgariaCroatiaCzech Republic CyprusDenmark Estonia Finland France Germany GreeceHungaryIceland Ireland Israel Italy Kosovo (provisional member)
LatviaLithuaniaLuxembourgMacedoniaMontenegroNetherlandsNorwayPolandPortugalRomaniaRussiaSerbiaSlovak RepublicSloveniaSpainSwedenSwitzerlandTurkeyUkraineUnited Kingdom
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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)
Mariam Klouche(Germany)
Sverre Sandberg(Norway)
Jean-Claude Libeer(Belgium)
Elizabeta Topic(Croatia)
Simone Zerah(France)
Peter Schuff-Werner(Germany)
EFCC structure
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EFCC Working Groups (WG) and Project Groups (PG)
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Science CommitteeWG 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.
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The IVD ChallengeFrom 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.
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GHTF SG5: www.ghtf.org/sg5/ Clinical Evidence – Key Definitions andConcepts - 2007Clinical Evaluation - 2007Clinical Investigations - 29 January 2008 Post-market Clinical Follow-up studies - 23 July 2008
Meeting the IVD Challenge
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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?
ModellingDecision analysis
Do analytical performance goals fulfil
clinical needs?
Diagnosticaccuracy
study
Sn, Sptrueness
imprecision
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?
RCTSR of RCTs
HTACPG
Clinical audit
Evaluation of a diagnostic biomarkerPRE-MARKET POST-MARKET
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Science CommitteeWG 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
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Standardisation and improvement of pre-analytical procedures for current and future in-vitro diagnostics.The project is coordinated by QIAGEN GmbH.
The SPIDIA project
www.spidia.eu
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Quality Management CommitteeSupports 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..
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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 fundedEC4RC is member of CEPLIS– WG on Healthcare: Simone Zerah, Janet Mc Murray,
Rob Jansen, Mike Hallworth– WG on Education: Thomas Zima from the C-ET
CEPLIS assists in liaising with the European Commission and the European Economic and Social Committee
Profession Committee
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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 countriesThe Register is included on the EESC/SMO (Single Market Observatory) database and website: www.eesc.europa.eu/selfandcoregulation/index.asp/full.asp?ID=121
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EC4 MEMBERSHIP (March2010)
13 40 14 3 0 073
1265
103 859 13 6
9612 27 4 0
44139
083
163
13 53 67 70 70 70 143
14081511
1596 1605 16181781 1787
1883 1895 1922 1926 1926 19702109 2109
2192
0
200
400
600
800
1000
1200
1400
Austri
a
Belgium
Cypru
s
Czech
Rep
ublic
Denmar
k
Estonia
Finland
France
German
y
Greec
e
Hungary
Irelan
dIta
ly
Luxembo
urg
Netherl
ands
Poland
Portugal
Roman
ia
Slovakia
Slovenia
Spain
Sweden
United
Kingdo
m
0
500
1000
1500
2000
2500
Registrations, March 2010
Austria 13 Italy 163Belgium 42 Luxembourg 7Cyprus 15 Netherlands 96Czech Republic
3 Poland 12
Finland 73 Portugal 27France 1265 Romania 4Germany 103 Slovenia 44Greece 86 Spain 139Hungary 9 United
Kingdom83
Ireland 13 TOTAL 2197
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Publications, surveys, pilotsCode 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 EuropePilot with the Dutch Society linking the EC4 Register and the national official Register
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On-line application form:www.ec4register.eu
Join the EC4 Register!
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”
EFCC-Roche Scientific Award for 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”
The EFCC-Abbott Labs are Vital Award for Excellence in Outcomes Research
in Laboratory Medicine
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