efcc newsletter january 2011 - eflm

European Federation ofClinical Chemistry and Laboratory Medicine

http://www.efcclm.eu

Newsletter January 2011

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Editorial

Dear Colleagues,

EFCC had busy times at the end of last year and theearly winter frost and snow did not seem to stop us!This issue sums up some of the most recent activitiesof EFCC in the last quarter of 2010 and the full AnnualReport will be communicated to our membership inthe forthcoming issue of our news.

The first electronic voting on the amendments to theEFCC Statutes has been concluded successfully,thanks to the 27 National Societies who provided uswith their feedback. All respondents accepted the newStatutes which were also endorsed by the ExecutiveBoard of EFCC. The new Statutes of EFCC can bedownloaded from the EFCC website (www.efcclm.eu –About the EFCC – Statutes).

The EFCC Executive Board held its second meetingthis year in conjunction with the 1st EFCC-UEMSjoint Congress in Laboratory Medicine on 13-16 Octo-ber in Lisbon. Upon this historical occasion, EFCCsigned an agreement with EDMA and Abbott tostrengthen the collaboration between the professionand the in vitro diagnostics industry. During this mee-ting the Executive Board has reviewed EFCC’s pro-gress according to its strategic goals and activity plan(www.efcclm.eu) and established a new Task andFinish Group on Pre-analytical Quality. EFCC Com-mittees and Working Groups also held their meetingsin Lisbon and gave detailed accounts of their activitiesand results, some of which are reported in the currentNewsletter.

An important landmark in the ongoing strong collabo-ration between the European cooperation for Accredi-tation (EA) and the European Federation of ClinicalChemistry and Laboratory Medicine was EFCC’sofficial admission to Recognised Stakeholder Status inEA on 13 December 2010. Members of the QualityManagement Committee of EFCC also contributed tothe revision of an important EU document, the IVDDirective in collaboration with EDMA (see EDMA newsfor details).

The new EU IVD Directive will not only shape the IVDindustry in Europe but will strengthen the demand forstronger research collaboration between industry andthe profession in the determination of the clinicalutility and validity of IVDs and companion diagnosticslinked to the prescription of pharmaceutical drugs. Thenew IVD Directive will present a challenge for the useof in-house assays and will re-shape the IVD Regula-tory framework in Europe.

EFCC, in collaboration with IFCC, has recently sentout a call to European national societies for bids tohost the forthcoming EuroMedLab Congress in 2015.Details of the application procedure and the Euro-MedLab guidelines can be viewed on the IFCC web-site: http://www.ifcc.org/pdf/congresses/guidelines/euromedlab_guidelines.pdf. The deadline for submit-ting bids is 30 January 2011.

The EFCC Executive Board will hold the generalelections of the new Executive Board at the forth-coming General Assembly on 15 May next year thatwill be organized in conjunction with the WorldLab-EuroMedLab 2011 Congress in Berlin. The GeneralAssembly will also vote on the host society for Euro-MedLab 2015.

EFCC Executive Board has initiated several consulta-tions with national societies on key issues such asthe Memorandum of Understanding between IFCC andEFCC, the guidelines and rules for organizing Euro-MedLab congresses with IFCC in Europe and on theharmonization of the name of the profession. Resultsof these consultations will be published in the nextissue of the EFCC News.We thank all member national societies and individualmembers for their ongoing support and collaboration.

We wish all readers that the new decade, starting withthe year of 2011, will be marked by peace, happinessand success!

Andrea Rita HorváthEFCC President




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Committee and Working Group Activities

- EFCC Profession Committee ................................ 3

- Simone Zérah Elected Vice-President to theCEPLIS Executive Board....................................... 4

EFCC Education and Training Committee

- 10th EFCC Continuous Postgraduate Course inClinical Chemistry: "New Trends in Classification,Diagnosis and Management of Thrombophilia", 23-24 October 2010, Dubrovnik, Croatia ............... 5

- EFCC Auspices guidelines released ...................... 6

EFCC events in collaboration with partnerorganizations- President‘s Report about the First European Joint

Congress of EFCC and UEMS and 1st CongressoNacional do Laboratório Clínico Lisbon 2010 Labo-ratory Medicine in Health Care,13-16 October 2010, Lisbon, Portugal ................... 7

- First European Joint Congress of EFCC and UEMS1st Congresso Nacional do Laboratório ClínicoLisbon 2010, Portugal "Laboratory Medicine inHealth Care" at a glance ..................................... 10

- China-EU Laboratory Medicine Conference, 5-7September 2010, Shenyang, China ..................... 11

- EFCC/Bio-Rad Symposium in Portugal opens theGates to Challenges of Quality Management andAccreditation ....................................................... 12

EFCC partner organizations- EFCC has been granted recognised stakeholder

status in the EA .................................................. 13- AACC conference on "Improving Clinical Laboratory

Testing through Harmonization: an InternationalForum", 26-27 October 2010 at the National Instituteof Standards and Technology in Gaithersburg,Maryland ............................................................. 14

- Outcome of the AACC harmonization conference:"The Path Forward" ............................................. 15

- European session of the IFCC-Task Force for YoungScientists at the Journées Intenationales deBiologie, 4 November 2010, Paris, France ........... 16

News from EFCC National Societies- IV National Congress in Clinical Laboratory,

20-22 October 2010, Zaragoza, Spain .................. 17- Serbian Society Marks 55th Anniversary ............. 18

EFCC Awards- Call for nominations for the EFCC-Labs Are Vital

Award for Excellence in Outcomes Research inLaboratory Medicine ............................................ 20

- Call for nominations for the EFCC-RocheScientific Award for Laboratory Medicine ............. 20

EFCC Forthcoming Events- 1st EFCC-BD European Conference on Preanalyti-

cal Phase,1-2 April 2011, Parma, Italy ................................. 21

- Berlin 2011: Preparations for IFCC WorldLab/EuroMedLab Enter High Gear,15-20 May 2011 .................................................. 22

- BCLF 2011, 21-23 September 2011,Bucharest, Romania ........................................... 22

- 5th Congress of Clinical Chemistry and Lab Med,18-20 March 2011,Limassol, Cyprus ................................................ 22

EDMA News- EFCC and EDMA Enhance Cooperation .............. 23- Revision of IVD Directive to position the sector as

key to sustainable healthcare in the EU .............. 24

eHealth- EU: Towards enhanced eHealth governance ........ 24

Contents




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EFCC Profession Committee

Guide to the European Register of Specialists inClinical chemistry and laboratory medicine:Publication of Version 3-2010

Version 3 of the Guide to the EC4 European Registerhas been published in Clinical Chemistry and Labora-tory Medicine (CCLM 2010;48(7):999-1008; http://www.reference-global.com/doi/pdf/10.1515/CCLM.2010.223). This updates the previous versionpublished in 2003. The standards of education andprofessional training and the competencies requiredfor registration are described. The Guide details theoperation of the Register, the application procedure,the Register’s relationship to the national societiesand national registers, and the governance arrange-ments. Registration is valid for five years and theprocedure and criteria for re-registration are describedbelow.

EC4 register: how to join?

The Register is held and operated by the EuropeanCommunities Confederation of Clinical Chemistry andLaboratory Medicine (EC4) Foundation under thesupervision of the European Federation of ClinicalChemistry and Laboratory Medicine (EFCC). The EC4Board of Governors and the representatives on theEC4 Register Commission, which manages the Regi-ster, are elected by the national societies of the EUcountries that belong to EFCC. The EC4 Register is adatabase of senior professionals who have met theagreed education and training requirements to beindependent (consultant grade) practitioners. Version3 of the EC4 Guide to the Register (1) and the EC4Syllabus (2) detailing these requirements and theoperation of the Register have been published. Beforeregistration is possible, the national society musthave demonstrated equivalence of standards betweentheir national education and training program and therequirements of the EC4 Register. Registration iscarried out by the appropriate national society.

The EC4 European Register of Specialists in ClinicalChemistry and Laboratory Medicine opened in Janua-ry 1999, and by October 2010, it comprised more than2,000 practitioners from 21 countries, the numbers ofwhich are rising rapidly. Registrants include scientific,pharmacy, and medically qualified practitioners.

The Perspective of the Registrant

Individual practitioners accepted on to the EC4 Re-gister of European Specialists in Clinical Chemistry andLaboratory Medicine may quote the registration on theirCV to indicate that they have reached a high level ofprofessional competence recognized throughout theEuropean Union (EU); quote the registration if they areconsidering moving to a post in another EU country;use the title European Specialist in Clinical Chemistryand Laboratory Medicine and the letters EurClinChemafter their name; receive information about the practiceof Clinical Chemistry and Laboratory Medicine withinthe EU; and expect a warm welcome when visitingclinical laboratories in any EU country.

The Perspective of the Profession

The existence of a strong EC4 Register of EuropeanSpecialists in Clinical Chemistry and Laboratory Medi-cine provides an important benchmark of quality acrossthe profession within the EU. It assists with greaterunderstanding and the promotion of Clinical Chemistryand Laboratory Medicine within the EU. It strengthensthe influence of EC4 RC/EFCC in dealings with otherprofessional societies, the diagnostics industry and theEuropean Commission. It provides a basis for pursuingagreed projects of common interest to the profession. Itprovides a pool of experts who may be willing to workfor the good of the profession.

Do I have to join?

The register is voluntary. However the more colleagueswho are registered, the more representation andinfluence we will have with the European Commissionand the Parliament to obtain legal status. Join us!

For more information

Websitehttp://www.ec4register.eu

ContactsSimone Zérah (Chairman), simone.Zé[email protected] Mc Murray (Secretary),[email protected]

or your National Representative (details on the website)




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References

1. McMurray J, Zérah S, Hallworth M et al. The Euro-pean Register for Specialists in Clinical Chemistryand Laboratory Medicine: Guide to the Register Versi-on 3-2010. Clinical Chemistry and Laboratory Medici-ne 2010:48;999-1008.

2. Zérah S et al. EC4 European Syllabus for Post-Graduate Training in Clinical Chemistry and Laborato-ry Medicine: version 3-2005. Clinical Chemistry andLaboratory Medicine 2006:44; 110-120.

Simone Zérah Elected Vice-Presidentto the CEPLIS Executive Board

by Janet McMurray

Many congratulations to Simone Zérah, chair of theEFCC Professional Committee and of the EC4 Regi-ster Commission, who was elected to the ExecutiveBoard of CEPLIS (Conseil Européen des ProfessionsLibérales, European Council of the Liberal Professi-ons; www.ceplis.org ) at its General Assembly inRome on June 10, 2010. The new Board then elected

her as one of the three vicepresidents. This is excellentnews for EFCC as it puts Simo-ne in a strong position within anorganization which has consi-derable influence within theEuropean Union and with whichshe has worked for many years.

CEPLIS is the only inter-professional associationrepresenting the liberal professions at EU level. It is arecognized organization of the European Economicand Social Committee (EESC) and has close con-tacts with the European Commission. It is based inBrussels and registered as a nongovernmental, non-profit international organization under Belgian law.

The members of CEPLIS are either European mono-professional associations or national inter-professio-nal associations. EFCC is a member of CEPLIS inthe first category. The members include several from

healthcare disciplines such as nurses, psychologists,osteopaths, and dentists, along with other professionssuch as lawyers, engineers, and architects.

The CEPLIS objectives are the coordi-nation and promotion of the liberalprofessions and their moral, cultural,scientific, and material interests, andthese are pursued by liaisons withrelevant organizations and by implementati-on of appropriate measures. CEPLIS is consulted onrelevant EU Directives, such as Directive 2005/36/ECon the Recognition of Professional Qualifications, andit submits advice to the European Commission onthese.

Thus clinical chemistry and laboratory medicine has ameans of influencing the European Commission onmatters of importance to the profession. EFCC partici-pates in the CEPLIS Working Groups on HealthcareProfessions and on Professional Training.

Simone’s position within CEPLIS will put EFCC in amuch stronger and more visible position at EU level.

Well done and many thanks for increasing the reputa-tion of EFCC!

3. Directive 2005/36/EC of the European Parliamentand of the Council of 7 September 2005 on the re-cognition of professional qualifications. Official Journalof the EU, L255/22, 30 September 2005.

4. McMurray J, Zérah S, Hallworth M et al: The Euro-pean Register of Specialists in Clinical Chemistry andLaboratory Medicine: Code of Conduct-V2-2008.Clinical Chemistry and Laboratory Medicine2009;47:372-375





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The EFCC Continuous Postgraduate Courses inClinical Chemistry have been established by theCommittee for Education and training (C-ET) of theEuropean Federation of Clinical Chemistry and Labo-ratory Medicine (EFCC) and during the past years co-organized by the Croatian Society for Medical Bioche-mists (http://www.hdmb.hr/), Slovenian Association forClinical Chemistry (http://www.szkk.si/) and Inter-University Centre (http://www.iuc.hr/) in Dubrovnik.EFCC is proud to offer this high level postgraduateeducation on an annual basis to more and more parti-cipants in Europe, including granting travel fellowshipsto a number of young participants, particularly fromless developed parts of Europe.

This 10th anniversary event aimed to provide an over-view on the pathophysiology, epidemiology and clini-cal and molecular characteristics of thrombophilia andwas organized in collaboration with the EuropeanThrombosis Research Organization (ETRO; http://www.etro.eu.org/), in accordance with EFCC’s strate-gy of fostering stronger links and collaborations withclinical scientific organizations in Europe (for EFCC’sstrategic plan, please visit www.efcclm.eu). The cour-se was attended by 60 participants. Lectures weredelivered by 14 outstanding invited speakers.

Course lectures covered the broad range of topicsrelated to hypercoagulable states, platelet structureand function and screening for thrombophilia. Somespecific entities like pediatric thrombosis, hyperhomo-cysteinemia and the role of coagulation markers incancer were also covered.

A whole half-day session of the course focused on themethodological shortcomings of genetic associationstudies in thrombophilia research as well as benefitsand disadvantages of pharmacogenetics-guided anti-coagulation therapy.

The course was highly interactive, and gave partici-pants an opportunity to examine and discuss in moredepth some current issues and controversies inthrombophilia.

For the first time we will deliver expert reviews cover-ing the topics of the course in a special issue of thejournal of Clinical Chemistry and Laboratory Medicine,scheduled for publication in December 2010.

10th EFCC Continuous Postgraduate Course in Clinical Chemistry:"NEW TRENDS IN CLASSIFICATION, DIAGNOSIS AND MANAGEMENT OF THROMBOPHILIA",

23-24 October 2010, Dubrovnik, Croatia

By Ana-Maria Simundic, Zagreb, Croatia; EFCC,WG-Conferences and Postgraduate Education

The EFCC Postgraduate Course for Continuing Education in Clinical Chemistry and Laboratory Medicine inDubrovnik celebrated its 10th Anniversary with the theme of ‘NEW TRENDS IN CLASSIFICATION, DIAGNOSISAND MANAGEMENT’ of specific conditions. A full report summarizing the events over the last decade will bepresented by Prof Elizabeta Topic in the next Newsletter.




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EFCC Auspices guidelines releasedBy Silvia Cattaneo ([email protected])

EFCC has released its guidelinesfor application for EFCC auspicesfor Congresses, Conferences andother educational or scientificevents held by National Societies.

We are looking forward toreceiving your applications!


We do hope that participants haveenjoyed their visit to this course for itsscientific content, but also because ofthe beauties of Dubrovnik. The extraordi-nary location and charm of this citytouched many individuals, such asGeorge Bernard Shaw, whose famousphrase after first visiting Dubrovnik was:"Those who seek paradise on Earthshould come to Dubrovnik". The 11thEFCC Continuous Postgraduate Coursein Clinical Chemistry (22-23 October2011) will deal with the topic of INFLAM-MATION.

We are looking forward to meeting youin Dubrovnik next year!

The EFCC auspices documents can be downloadedfrom:

http://www.efcclm.eu/about_efcc/downloads/EFCC_auspices_guidelines_and_procedures.pdf

and

http://www.efcclm.eu/about_efcc/downloads/EFCC_auspices_application_form.pdf




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EFCC events in collaboration with partner organizations

President‘s Report about the First European Joint Congress of EFCC and UEMS and1st Congresso Nacional do Laboratório Clínico Lisbon 2010Laboratory Medicine in Health Care

13-16 October 2010, Lisbon, Portugal

ByProf. Andrea Rita Horvath Prof Vic Blaton Prof. Sverre SandbergEFCC President EFCC Past President Chair of Scientific Committee

The European Federation of Clinical Chemistry andLaboratory Medicine (EFCC), the European Union ofMedical Specialists - Specialist Section and Board ofMedical Biopathology (UEMS-MBS&B) and JornadasInternacionais da Qualidade em Laboratórios de Análi-ses Clínicas (JIQLAC) organized the First EuropeanJoint Congress of EFCC and UEMS in association withthe 1st Portuguese Joint Congress of Laboratory Medi-cine, entitled "Laboratory Medicine in Healthcare".

This conference was historical in many ways. It wasthe very first European conference since EFCC wasestablished in 2007 after the merger of FESCC andEC4 into one European Federation. This was also thefirst joint conference with UEMS which paves the pathto further and stronger collaboration between EFCCand the European organization of medical specialists.This event was also the first conference of the Portu-guese JIQLAC. This prime European event of theprofession aimed not only to be the first in many waysbut also to be "different" by having sessions andspeakers focusing on clinically oriented topics thathighlighted the importance of the interface betweenclinical and laboratory medicine. This aim was reflec-ted in the conference slogan as well: "LaboratoryMedicine at the Clinical Interface".

Why did we choose this slogan, what was ourthinking behind organizing this event?

To answer this question we need to look back andreflect on the state of the art and the future challengesof laboratory medicine.

Medical laboratories play a vital role in modern healthcare, and qualified specialists in Clinical Chemistryand Laboratory Medicine are essential for the provisi-on of high-quality pre-analytical, analytical and consul-tative services. Laboratory medicine has undergonemajor transformations during the last decade. Ongoingtechnological developments have considerably im-proved the productivity of clinical laboratories. Informa-tion on laboratory services is globally available, andclinical laboratories face international competition andconstant pressure to reduce costs.

In response to these challenges business modelshave been developed and implemented that increaseefficiency and control cost increases by forming alli-ances and networks, consolidating, integrating oroutsourcing services. However these mostly economi-cally-driven initiatives have the potential to distancelaboratories from their clinical users and from their realroles of providing knowledge and consultative servicesrelated to the use of in vitro diagnostics.

There is growing gap between the science and the artof every day clinical practice. Biomedical sciencesand their innovations coming from translational re-search are supposed to form a bridge between thetwo. We face the dehumanizing effect of medical care:diseases are being defined at molecular and cellularlevel. Curative medicine is being replaced by preven-tive care and predictive medicine. The advancementsof IT communications turned laboratories into highturn-over information and data centres and doctorsdemand faster and faster services for rapid decision-




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making. These revolutionary developments in techno-logy not only present new challenges for better work-flow management but also provide great opportunitiesto convert laboratories into intelligence and knowledgecentres.

To achieve that, measuring the clinical and economicimpact of laboratory practice and understandingtesting-related outcomes are also key focus areasespecially for governments and health care fundingagencies. However, assessing clinical outcomes andvalue in relation to labora-tory diagnostics is verydifficult. In addition tosolving diagnostic pro-blems, clinical laborato-ries are more and moreinvolved in assistingmedical decision-makingon the appropriate use oftherapeutic interventions.

Key objectives for thefuture therefore remain todemonstrate the im-portance of Laboratory Medicine in the provision ofeffective health care. To that end the profession needsto provide an interface between clinical and laboratorymedicine and should be actively engaged in the de-velopment and dissemination of the results of highquality translational research and evidence-basedmedicine. Clinical audits and proactive discussionsbetween clinical and laboratory medicine will contribu-te to the rational utilization of diagnostic services andwill improve the quality, effectiveness and cost-effec-tiveness of health care.

Undoubtedly all these issues raise considerablechallenges for the profession and the medical educa-tors of the future. To meet these challenges, clinicalpathologists should redirect their thinking and engagein translational research and develop tools that enablemeasuring and monitoring the clinical value and im-pact of their services. This should be reflected in thescope and content of specialist training as well. Thecore curriculum and competency of clinical patholo-gists should be revised and should focus on approa-ches and skills that provide complementary know-ledge services related to diagnostic testing.

This conference aimed to address these needs and

tried to form a bridge between basic and appliedlaboratory sciences and clinical decision making byproviding educational sessions, state of the art lec-tures delivered both by laboratory professionals andclinicians, "Pros and Cons" sessions that presentedopposing views on contradictory topics and whichgenerated vivid professional debates, and interactivecase discussions with participants’ voting.

The conference was attended by 1220 participants ofwhom 40% were from other countries all over Europe

and beyond. One hund-red and one speakersdelivered the oral sessi-ons and 202 posters/oralcommunications werepresented at 4 pre-con-gress courses, 3 plenarysessions, 19 clinicalsessions and 6 manufac-turers’ symposia.

The conference enjoyedthe generous support of39 companies. On the

last day the 2nd BioRad-EFCC Symposium andvideoconference was presented in tandem with theCzech Republic on quality management in laboratorymedicine. The scientific program was of high profes-sional standards and run in a relaxed and friendlyatmosphere. The attendance rate of sessions wasimpressively high with a lot of interaction and discus-sion. The scientific program in itself proved that labo-ratory medicine is a clinical profession and we can actas valuable partners of clinicians. For EFCC andUEMS it was a very important and historical momentas this was the first collaborative project of the twoorganizations which demonstrated that the profession- medical and non-medical - is united at scientific,professional and collegial level.

These were very important messages to get across inEurope. We thank all colleagues and the local andinternational organizing and scientific committees aswell as the professional conference organizers andtranslators for an excellent conference that enabled usto discuss and communicate these issues in Lisbonto a large and enthusiastic audience.

We look forward to the 2nd EFCC-UEMS Conferencein 2012 in Europe!





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PresidentFranklim Marques - PT

ChairManuel Cirne de Carvalho - PT

Organising Committee

Chairman:Augusto Machado - PTVictor Blaton - BEGermano Sousa - PTLena Norlund - SEWytze Oosterhuis -NLFrederico Cerveira - PTFranklim Marques - PT

Scientific Committee

Chairman:Sverre Sandberg - NOMariam Klouche - DEAna-Maria Šimundic - HRGerhard Zlabinger - ATIlkka Mononen - FIJosé Eduardo Cortez - PTHenrique Reguengo - PT

Local Executive Committee

Chairman: Carvalho Rodrigues - PTAugusto Machado - PTCarlos Cardoso - PTFernando Jorge - PT

National Organising Committee

Chairman: Fernando Jorge - PTFranklim Marques - PTFrederico Cerveira - PTAna Lory - PTJorge Nunes de Oliveira - PT>José Luís Fleming Torrinha - PTNelson Tiago - PT

National Scientific Committee

Chairman:Carlos Cardoso - PTJosé Eduardo Cortez - PTHenrique Reguengo - PTLuísa Espinhaço - PTManuel Cirne Carvalho - PTPaulo Soares - PTTiago Guimarães - PT

EFCC wishes to acknowledge and thank the efforts of all individuals listed below, who have contribu-ted to the success of this event:





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First European Joint Congress of EFCC and UEMS

1st Congresso Nacional do Laboratório Clínico Lisbon 2010, Portugal"Laboratory Medicine in Health Care" at a glance

by

Dr. med. Utz P. Merten President SectionDr. Lena Norlund President BoardProf. Gerhard Zlabinger Secretary

For U.E.M.S Section and Board Laboratory Medicine /Medical Biopathology

The medical specialty "Laboratory Medi-cine" with its specialties - Haematology,Blood Banking, Clinical Chemistry,Clinical Immunology, Microbiology andMedical Genetics - are at a crossroads.Laboratory Physicians and Laboratory Professionalsmust evaluate their role in medicine and examine howto remain relevant in a rapidly evolving health careenvironment.

New diagnostic technologies, health information tech-nology, patient safety and quality care, public health,health reform and economics are areas presentingchallenges and opportunities for all specialties withinLaboratory Medicine. Science and technology esta-blish an indispensable value in patient care and withthis Laboratory Medicine plays an integral role infulfilling a system of cost-effective health manage-ment.

Laboratory Physicians and Professionals are steadilyincreasing the value of Laboratory Medicine by indica-ting to the community how that value arrives at thepatients, how it improved and will further improve overtime. Laboratory Physicians and Professionals mustand will create a strategic plan for determining thevalue of these contributions.

Today’s laboratory environment is changing and labo-ratory leaders must respond and create solutions toinfluence changes effectively. This is a challenge forthe profession. They should also aim and increasetranslational research to explain the clinical value andimpact of their services to patients and public. Thescientific program of the Congress demonstrated theinvaluable role that Laboratory Medicine plays inhealth care.

Congress participants learned how to strengthen theirskills in managing change, resolving conflict, encoura-ging innovation, fostering quality processes, andmore. They were inspired by national leaders in labo-ratory management, networked with colleagues facingsimilar challenges, learned new strategies, and beca-me more valuable members of their healthcare team.Conference sessions reflected in the conferenceslogan: "Laboratory Medicine at the Clinical Interface"successfully aiming to be different and focusing onclinically oriented topics and the importance of thecooperation between clinical and laboratory medicine.This interface between clinical and laboratory medi-cine becomes more and more important being suppor-ted by the development and increasing influence ofevidence-based medicine and laboratory results ofhigh quality. The Congress supported this new con-cept of lectures effectively.

During the past decades scientific and technicaldevelopment have created a gap between LaboratoryPhysicians and Professionals on one side and theirclinically active physicians and their patients - whobenefit from knowledge and consultation servicesrelated to laboratory tests - on the other. This growinggap between scientific and every day clinical practicehas to be bridged.

The UEMS and EFCC representatives at the Lisbon City Hall





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Solving diagnostic problems is only one side of thecoin, increasingly being involved in assisting medicaldecisions leading to an appropriate use of diagnosticand therapeutic intervention being the other side. Inthe future Laboratory Physicians and Professionalshave to demonstrate the importance of LaboratoryMedicine providing effective health care to patients.

U.E.M.S. Section Laboratory Medicine / MedicalBiopathology were impressed by the first jointly orga-nized project of EFCC and UEMS. Indeed, this was avery important and historical moment. The Sectionintends to foster the successful cooperation betweenEFCC and UEMS SLM and to organize jointly furtherCongresses of Laboratory Medicine. On behalf ofUEMS Section we thank all members of the organi-zing and scientific committees, the conference organi-zers and the translators for this successful confe-rence.

More information on:http://www.lisboncongress2010.org/files/newsletter/LMHC_Newsletter_October2010.pdf


China-EU Laboratory MedicineConference, Shenyang, China

September 5-7, 2010

by Vic Blaton, past President EFCC

The Chinese Society of Laboratory Medicine createdin 2001, at the occasion of the Shanghai meeting, aSino-European cooperation with FESCC together withProf A Gruenert (DE), Prof Andreas Hubert (CH) andthe IVD-industry (Diasys Compagny , DE and China).There was an exchange over the years for PhD stu-dents in the EU, participation in the scientific pro-grams of their meetings in Beijing and Shanghai andexchanges with leading experts in Europe. ProfShang Hong, the actual President of the Chinesesociety of Laboratory Medicine and Prof Pan Baishenorganised a conference meeting in Shenyang from 5-7September under the auspices of EFCC and theyinvited five EU experts. The one and half days meetingincluded conferences, free talk and round table dis-cussions. The main topic of the meeting was on "Newdevelopments in Laboratory Medicine and on theappropriate use of laboratory tests". European lectu-rers covered the topics of cardiac biomarkers, totalquality management of medical laboratories and tothe updates on endocrine diagnostics. There werealso excellent presentations of Chinese experts onLaboratory Medicine in China; Present and Future andalso on Major infectious diseases: The national infec-tion control strategy and the role of medical laborato-ries. At the end of the meeting there was a very activeand productive round table discussion. The meetingwas only for invited participants.

Prof. Shang Hong President Chinese Society, and Prof. PanBaishen Past president of Chinese Society (right to left)




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by Guiseppe Lippi, University of Parma

The 2nd European symposi-um on quality managementand accreditation was orga-nized in Lisbon (Portugal)under the auspices of EFCCin collaboration with Bio-RadLaboratories during the firstEuropean joint congress of

EFCC and UEMS. This second symposium afterParis in 2009 was an opportunity to address futurestrategies to promote accreditation following ISO15189 and ISO 22870.

One of the major goals of the medical laboratory is tomeet the current challenges of quality and medicalefficiency. The pre-analytical phase is a key issue.Results of laboratory testing are integral both to deci-sion-making and managed care, to assist diagnosis,guide or monitor therapy, and predict health outco-mes. Although there is a widespread perception thatmost laboratory errors fall in the analytical phase oftesting, several lines of evidence attest instead thatmost of them occur in extra-analytical processes,mostly in the manually intensive pre-analytical ones.Therefore, since pre-analytical variability exerts astrong influence on laboratory, healthcare organizationand clinical outcomes, governance of this crucialphase of the total testing process offer a great potenti-al for improving the total quality in laboratory diagno-stics and enhance satisfaction of stakeholders.

Most pre-analytical errors result from system flawsand insufficient audit with operators involved in speci-men collection/handling responsibilities.

Therefore, standardization and monitoring of most, ifnot all, pre-analytical variables is foremost, beingassociated with the best organizational and clinicalrevenues. The most reliable strategy should also betailored to both predict the onset of accidental events(incidents) developing through this process, ultimatelydecreasing the vulnerability of the single pre-analyticalsteps.

These targets can only be attained by implementing amultifaceted strategy, which should develop firstthrough process analysis by validated tools (e.g., sixsigma, hazard ratio, etc.), implementation of reliableprocedures for systematically identifying and trackingerrors (using reliable pre-analytical and universallyagreed indicators of performance), reduction of com-plexity and error-prone activities.

Since most pre-analytical uncertainties occur duringsample collection, education and training of health-care professionals by dissemination of operativeguidelines and best-practice recommendations is alsocrucial. Finally, reassessment and rearrangement ofquality requirements and continuous monitoring ofperformances would enable such changes to besystematically evaluated and eventually rearranged.

EFCC/Bio-Rad Symposium in Portugalopens the Gates to Challenges of Quality Management and Accreditation





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EFCC partner organizations

EFCC has been grantedrecognised stakeholder status in the EA

As a result of ongoing strong collaboration betweenthe European cooperation for Accreditation (EA) andthe European Federation of Clinical Chemistry andLaboratory Medicine (EFCC), EFCC has been admit-ted to Recognised Stakeholder Status in EA on 13December 2010.

The "European co-operation for Accreditation" is theassociation of nationally recognised AccreditationBodies of the Member States of the European Union(EU) and of the European Free Trade Association(EFTA) and of countries that have been formally identi-fied as candidates for membership of EU and EFTA.EA’s mission is to provide, through its members,effective and reliable accreditation services fulfilling atbest the needs of the European economy and society.Further information about EA can be found athttp://www.european-accreditation.org

Recognised Stakeholders of EA are organisations withsignificant membership from the EU and EFTA Mem-ber States which have a distinct international role andpredominantly a proactive contribution to Europeansocial and economic matters, and bear a clearinterest in and commitment towards accreditationactivities.

In the Recognised Stakeholder Agreement, signed byEA Chairman Graham Talbot and EFCC President

Andrea Rita Horvath, both parties agreed to cooperatewith the intention to further high standards in medicallaboratory practice by stimulating accreditation inEurope.

Due to the agreement, representatives of EFCC will beentitled to formally participate in the work of technicalcommittees, working groups and task forces of EAand will be informed and consulted about relevantpolicy and technical documents to provide inputs andcomments representing the views of the medicallaboratory profession.

EA and EFCC may arrange joint cultural/educationalinitiatives, such as conferences, seminars, work-shops, training courses for the dissemination of activi-ties related to accreditation.

EFCC delegated Wim Huisman, chairman of EFCC’sWorking Group on Accreditation and ISO/CEN Stan-dards, and Simone Zérah, chair of EFCC’s ProfessionCommittee, as official representatives in EA. BothEFCC officers have been having long professionalrelationships with EA and their valuable contributionover the years has resulted in this international re-cognition.




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Notwithstanding the publication of the European Di-rective 98/79/EC in 1998, and the establishment ofthe Joint Committee on Traceability in LaboratoryMedicine in 2002, standardization of clinical che-mistry analytes progresses slowly. So far, less than10% of the common clinical chemistry analytes hasbeen standardized. Against that background AACCrecently organized an inspiring conference on "Impro-ving Clinical Laboratory Testing through Harmonizati-on: an International Forum".

The conference was set up as an invitation-only confe-rence and not as an educational conference. Therewas international representation from many stakehol-ders involved in traceability of laboratory measure-ments (NMIs, CCQM/BIPM, IFCC, AACC, CDC, FDA,WHO, IRMM, NIST, national clinical chemistry socie-ties, EQA/PT providers …). About 100 attendeesparticipated in the conference. The attendees weredivided in four breakout groups in order to cover diffe-rent aspects needed for analyte harmonization.

Topics discussed in the breakout groups

Working group 1, the policy makers, discussed theprocess on how to prioritize analytes (especially type4 and type 5 analytes – see table below) for harmoni-zation. This working group gave input upon the pro-cess and organizational structure that is needed toprioritize analytes by importance to clinical practice;on how to seek cooperation between laboratory andclinical organization and on how to identify analytes inearly stages.

Working group 2 discussed the process to conduct asituational gap analysis in order to determine thecurrent status of harmonization for an analyte at whatspecifications for harmonization are required for clini-cal practice. This group recommended that to closethe gap the development of a risk assessment modelto prioritize tests for harmonization is needed.

Also, the communication between lab and clinicshould be improved; in addition, EQA/PT provision andsharing of information should be ameliorated andmethod comparisons should be organized to obtainadditional information. This working group stressedthat the feasibility of standardization should always beconsidered before proceeding to harmonization.

Working group 3 discussed the technical process toachieve harmonization for analytes, and Workinggroup 4 discussed the process for assessment ofsuccess of harmonization for analytes in routineclinical laboratories.

Analyte traceability is dependent on the availability of SI units,an international reference measurement procedure and areference material. If all three are available, which is the casefor type 1 analytes, standardization can be accomplished. Iftwo or three elements are lacking, which is the case for type 3-5analytes, the traceability chain is incomplete and harmonizationshould be considered.

AACC conference on “Improving Clinical Laboratory Testing through Harmonization:an International Forum"

October 26-27, 2010 at the National Institute of Standards and Technology in Gaithersburg, Maryland

By Christa Cobbaert Eur Clin Chem, LUMC , Afdeling Klinische Chemie, Leiden (NL)and Linda Thienpont, University of Ghent





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The recommendations of the four breakout groupswere presented and discussed with the attendees. Atthe end of the conference Greg Miller summarized, onbehalf of the AACC organizing committee, the input ofthe breakout group sessions into a final sessionentitled "The Path Forward". It was decided that thefollowing organizational structure should be esta-blished soon in order to improve Clinical LaboratoryTesting through Harmonization:

· a HOG -Harmonization Oversight Group- administra-tive structure (in which IFCC should be involved atthe highest level);

· formation of specialty groups and a working groupfor reviewing checklists regarding prioritizing analy-tes (part A) and gap analysis (part B);

· establishment of a harmonization working groupresponsible for the technical and the surveillanceplans.

Many issues were raised that should be addressed inorder to make harmonization efforts feasible:

· Regulatory barriers (how to fit in harmonization inthe traceability chains)

· Funding

· Vehicle to assess harmonization

· Criteria for ‘not to harmonize now’

· Criteria for a designated comparison method

· Role of certification

· Criteria for commutability

· Performance requirements based on medical needs

The outcome of this meeting will likely be published inearly 2011 in a special issue of Clinical Chemistry.

The Tortuous Road to Standardization

When standardization of clinically relevant analytes isnot feasible within a reasonable time frame, harmoni-zation might be a pragmatic alternative. Of course, inorder to not hamper SI-standardization in a laterphase, the approach to harmonization should be adynamic one, that can be updated according to scien-tific progress and technical possibilities.

The harmonization concept is particularly important foranalysis of "mixture" components, a category towhich many common biomarkers from category 4 and5 (table 1) belong. Although not tackled in this stageof the conference, the concepts for mixture analysisalso apply to SI-components (e.g., the concept ofstandardization of triglycerides by their surrogateglycerol).

With regard to testing of common biomarkers, it wasemphasized that harmonization efforts are essential toenable comparison of study data and clinical outco-mes at a global scale. Moreover, it was stressed byresearchers that there is also a need for early harmo-nization of tests developed for new and emergingbiomarkers (e.g., peptides related to nutrition anddiabetes, cytokines, growth factors etc).

Due to the fact that these biomarkers often are analy-zed only by a restricted number of laboratories thatdiscovered the biomarker and developed the firsttests, literature on clinical studies is currently notcomparable due to issues of intellectual propertyrights, which might necessitate a process to establi-shing a relationship with those laboratories long beforethe test is commercialized.

Outcome of the AACC harmonization conference: "The Path Forward"





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The IFCC Task Force for Young Scientists (TFYS)organized on November 4th a workshop entitled "Map-ping the future of European Laboratory Medicine forYoung Scientists" under the auspices of IFCC andEFCC. This workshop was held within the J.I.B (Jour-nées Internationales de Biologie), one of the largestEuropean of Laboratory Medicine taking place everyyear in November in Paris.

The TF-YS is focused on facilitating communication,education, and training among young scientists in thenumerous IFCC member organizations. Throughsurveys, conferences, and one-on-one interactions,the IFCC TF-YS has identified a need for networkingamong young scientists globally in both industrializedand emerging nations.

The objective of the JIB’s workshop was to facilitatecommunication and interaction between young scien-tists, to share experiences and challenges that labo-ratorians face around the world, and to leave with newcolleagues. Different round tables allowed youngscientists and experts to discuss the process, per-spectives, and principles of laboratory managementand leadership for young scientists working aroundthe world, to explain the major challenges that youngscientists face globally and to identify new contactsamong other young laboratorians from around theworld.

The session was started with the overview of theEFCC presented by Prof Victor Blaton and with theintroduction to IFCC missions by Bernard Gouget whoreminded the audience of a sentence from LouisPasteur fitting for the future of young scientists "in thefield of observation, chance only favors the preparedmind". This morning session was composed by threemain round tables. The first one devoted to a clinicaland critical vision of the lab med specialists by Prof.F. Verschuren and Dr. V. Costigliola.

The second round table was focused on the trainingand competency testing of laboratory professionalsand was presented by Prof. P. Wallemacq and Dr. C.

McCudden.The thirdround table wasdedicated to pre-senting and com-menting on thedifferent careerperspectives foryoung scientistsand allowed Dr. J.P.Lavigne, Dr. E.Cavalier, Dr. G.Ghafour, C. Tarrajat,

European session of the IFCC-Task Force for Young Scientistsat the Journées Intenationales de Biologie

4 November 2010, Paris, France

By Damien Gruson, chair IFCC-TFYS


Chris McCudden and Gabriel Ko(Photo: Christian Bamale)

T. Nenninger and R. Berenger presented their currentactivities and the trends.

This session was also moderated by experts fromIFCC, EFCC and SFBC such as Graham Beastall,IFCC President, Simone Zérah, EFCC-EC4, chair,Philippe. Gambert and Philmippe Gillery, SFBC presi-dent and past Président

Interactive events like this may help young scientiststo learn about the changing laboratory environmentand to prepare their future in a dynamic way. We canrecall as a source of inspiration the key conclusionsof the IFCC president G. Beastall: "Who dares wins".

From left to right: A. Legrand, J. Benoit, V. Blaton; D. Gruson, B.Gouget, J. Begue and G. Beastall (Photo: Christian Bamale)




17

News from EFCC National Societies

Spain

IV National Congress in Clinical Laboratory

Zaragoza, Spain, 2010, 10, 20-22

by Miguel García Montes, Presidente de la AEBMand Camilllo Fernandez, AEFA

Alter Seville, Coruña and Valencia; Zaragoza was thevenue to host the Annual Spanish Clinical LaboratoryCongress. This 4th congress that unified the threeSpanish scientific societies in clinical laboratory: theSpanish Association of Medical Biopathology (Asocia-ción Española de Biopatología Médica, AEBM), theSpanish Association of Pharmaceutical Analists (Aso-ciación Española de Farmacéuticos Analistas, AEFA)and the Spanish Society of Clinical Biochemistry andMolecular Pathology (Sociedad Española de Bioquí-mica Clínica y Patología Molecular, SEQC).

Previously, on October 19th, there were four indepen-dent pre-congress courses entitled: "Learn how tospeak in public. How to communicate science","Functional study of suprarenal cortex. Fascicularlayer", "Method evaluation and diagnostic testingvalidation", and "Genetic study of the couple withdisorders in reproduction".

During the congress, there were 10 symposia, 2 hourseach, that were devoted to different topics related to

clinical laboratory: pneumonia acquired in the regis-tered community and the laboratory; the laboratory inthe new global learning of obesity; the clinical labora-tory in the diagnosis of recurrent renal lithiasis; diag-nostic utility of new biochemical markers in hepaticfibrosis; thalassemias; the clinical laboratory in allergydiagnosis; patient safety and the clinical laboratory;digital clinic cases and its effect in the laboratory;extend neonatal screening; and research and theclinical laboratory.

In addition, two conferences were presented on "Vita-min D, further than bone metabolism", and "Seminalquality. Genetic factors vs. environmental conditions".

The third meeting of residents took place, there were20 workshops sponsored by diagnostic industry, andselected oral presentations were presented as well.There were more than 1.100 congress attendees thatactively participated in all the events. The "Vth Natio-nal Congress in Clinical Laboratory" will take place inMalaga, in November of 2011.




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4-year advanced training are being successfully com-pleted. A very important role in establishing the spe-cialization of medical biochemistry in Yugoslavia andSerbia was played by Prof. Ivan Berke, as the founderof medical biochemistry and clinical enzymology.

The Society of Medical Biochemists of Serbia hascollaborated with the Ministry of Health, for the organi-zation of laboratory services within all segments of thehealthcare service (primary, secondary, and tertiaryhealthcare) in terms of implementing plans of action,education, organization, equipment, etc. In addition, aprogram of external quality control has been carriedout since 1965 within the laboratories organized bythe Society of Medical Biochemists of Yugoslavia(YUNEQAS),recently known as SNEQAS program.

External quality assessment is implemented through-out our health system, which allows continual im-provement of the workflow in all clinical-biochemicallaboratories in Serbia. To improve and maintain thequality of services, the Society, together with theInstitute of Medical Biochemistry of the Clinical Centerof Serbia and the Accreditation Body of Serbia (ATS)in 2000 started working on the introduction of qualitymanagement system according to standard ISO 9001,and accreditation to ISO 17025 and ISO 15189.

The Society is involved in significant publishing activi-ty. Experts of the Society have participated in thepreparation of published professional methodologicalguidebooks for the field of medical biochemistrythrough the Republic and Federal Ministries of Health.For over 25 years, the Society has published thejournal Jugoslovenska Medicinska Biohemija (Yugo-slav Medical Biochemistry), renamed in 2007 to Jour-nal of Medical Biochemistry, as well as a series ofbooks and scientific literature written by its members.

The first professional and scientific meeting of medicalbiochemists in Yugoslavia was held in 1955 in Zagreb,and the first Congress of Medical Biochemists ofYugoslavia was held in 1963 in the same town. Eachnew congress was a step forward in the development

In 2010 the Society of Medical Biochemists of Serbiacelebrated 55 years of its existence and work. Thesociety is a member of the International Federation ofClinical Chemistry (IFCC) and the European Federati-on for Clinical Chemistry and Laboratory Medicine(EFCC). On the occasion of the 55th Anniversary, theSociety organized the 6th EFCC Symposium for theBalkan region and 17th Serbian Congress of MedicalBiochemistry and Laboratory Medicine (Belgrade,October 2010) with important participants from IFCC,EFCC, and the Balkan Clinical Laboratory Federation(BCLF).

The Society of Medical Biochemists of Serbia (SMBS)(former Yugoslavia, YuSMB) was established in 1955,although medical biochemists (clinical chemists) ofSerbia had already joined together in professionalassociations after the World War II. Even before 1950,the Pharmaceutical Society of Serbia hosted labora-tory experts, among whom the most active were Prof.Dr. Aleksandar Damanski in Bromatology, Prof. Dr.Momãilo Mokranjac in Toxicology and Asst. Prof. Dr.Pavle Trpinac in Biochemistry.

Firstly, the Section for Sanitary Chemistry, combiningmedical biochemists, sanitary chemists and toxicolo-gists, was founded on January 1, 1951. Later on, thisSection grew to become the Serbian Section forMedical Biochemistry, the first president of which wasDr. Pavle Trpinac. In May 1971, the Society of MedicalBiochemists of Yugoslavia became the 28th memberof the IFCC. At that time, the president of YuSMB wasTatjana Pleça-Drljaa, a Serbian medical biochemist.The SMBS is also a member of EFCC and the regio-nal BCLF organization.

The main activities of the SMBS are in the fields ofeducation, and the organization of laboratory services,external quality control, conferences, and publishing.In collaboration with the Faculty of Pharmacy, theSociety has devised education programs for undergra-duate and postgraduate clinical chemists (master’sdegree and residency) through which full-time 5-yearstudies for medical biochemists and subsequent

Serbia

Serbian Society Marks 55th Anniversary

by Prof. Dr. Nada Majkic-Singh, President of the Society of Medical Biochemists of Serbia




19


of science and quality. The Society is also involved inthe organization of congresses (biennial), and eventssuch as the yearly Biochemical days, and Innovationsin laboratory medicine (International Fair on MedicalEquipment Medipharm, Belgrade). The Society esta-blished the "Professor Ivan Berkes" Scientific Confe-rence, devoted to the founder of clinical chemistry andmedical biochemistry in Yugoslavia and Serbia, whichtakes place in Belgrade every year.

The members of the Society of Medical Biochemistsof Serbia actively participate in all IFCC and otherrelevant Congresses and Conferences in the field ofclinical chemistry and laboratory medicine. This parti-cipation promotes the implementation of standardprocedures for diagnosis, protocols and implementinguniform organization in all laboratories in the country.

The Society is run by the Executive Board and theAssembly and acts through various committees for:science, education, standardization, organization andtechnology of laboratory services, quality control, aswell as quality management accreditation, cooperati-on with industry, history of medical biochemistry andclinical chemistry, award committee, ethics commit-tee, and committee for cooperation with IFCC, EFCC,BCLF, and related organization in country and abroad.The Society of Medical Biochemists of Serbia foundedtwo awards on behalf of Prof. Ivan Berkes and Magi-ster Milica Markoviç. During the scientific and profes-sional conferences organized each year the Societyawarded the best students of the PharmaceuticalFaculty and clinical chemists, Society members.

On October 4-9, 2010, Belgrade hosted the 17thCongress of Medical Biochemistry and LaboratoryMedicine marking the 55th jubilee anniversary ofSMBS, with international participation, and held underthe auspices of the IFCC, EFCC, BCLF, as well asthe Ministry of Science and Health of the Republic ofSerbia.. Plenary sessions addressed the most recentfindings on the application of biochemical markers forvarious diseases and states, primarily markers ofacute renal diseases and heart conditions.

A special session dealt with the principles and pro-blems of thyroid disease diagnostics, the significanceof protein and hormone determination, and the gene-tics of thyroid gland carcinoma.

The latest findings on the detection and clinical im-portance of free radicals in circulation, protein analy-sis on the molecular level, and the significance ofgenetic polymorphism as a marker for proneness todisease formation, e.g., in relation to genetic predis-position to type 1 diabetes mellitus, and renal andurinary bladder tumors were presented.

Simultaneously the 6th EFCC Symposium for theBalkan Region also took place, organized separatelyunder the topic "Implementing Laboratory Automation,Quality and Efficiency," where prominent foreign andlocal experts introduced to the participants the meansfor achieving full automation and laboratory consolida-tion, with the goal of adhering to the philosophy ofLean and Six Sigma laboratory efficiencies.

Members of Executive Board of the Society of MedicalBiochemists of Serbia.




20

EFCC Awards

Call for nominations for the EFCC-Labs AreVital Award for Excellence in OutcomesResearch in Laboratory Medicine

EFCC together with Abbotthave established the presti-gious EFCC/Labs-are-VitalAward for Excellence in Outcomes Research in Labo-ratory Medicine.

The Award will be issued for the first time during theEuromedlab/Worldlab Congress in May 2011 in Berlin.The Award is combined with a certificate of recog-nition as well as a sum of 15.000 Euros.

Please find further information related to this Awardand details of the application procedure in the atta-ched leaflet and at EFCC’s website (www.efcclm.eu –About the EFCC – Awards). Any member of yourNational Society who fulfils the criteria of the Awardcan be nominated or can apply. Therefore we kindlyask your support in publicizing the Award in yourrespective national professional journals or in yourSociety's electronic or printed newsletters and web-site.

Applications, clearly marked "EFCC-Labs Are VitalAward" should be submitted electronically to:SilviaCattaneo ([email protected]) at the EFCC/IFCCOffice (Via Carlo Farini 81, 20159 Milano, Italy) by theclosing date of 1 February 2011.If you need moreinformation on the submission process please contactthe Chair of the EFCC Scientific Committee, Prof.Sverre Sandberg ([email protected]).

We await your applications and look forward to mee-ting you at the 19th IFCC/EFCC European Congressof Clinical Chemistry and Laboratory Medicine "Euro-medlab 2011" on 15-19 May 2011 in Berlin.

Call for nominations for theEFCC-Roche Scientific Awardfor Laboratory Medicine

The EFCC-Roche Award has beencreated to honour a distinguishedcolleague who has made unique con-tributions to the promotion and understanding ofclinical chemistry throughout Europe, or who hasmade one or more contributions that have had a majorimpact on clinical chemistry. Past recipients of thisprestigious award were:

- Hermann Wisser (2001)

- Gerard Sanders (2003)

- Graham Beastall (2005)

- Matthias Müller (2007)

- Rob Jansen (2009)

All European Societies that are full members of theEFCC organization can propose one candidate fromtheir own country or any other European EFCC mem-ber state. The EFCC Executive Board encouragesnominations of individuals from a country different fromthat of the nominating society. The rules for nominati-ons can be downloaded from the EFCC website(www.efcclm.eu – About the EFCC – Awards). TheEFCC-Roche Scientific Award for Laboratory Medicineattracts a generous sum of CHF10,000, kindly sup-ported by Roche Diagnostics.

The final closing date for nominations is 15 January,2011. All nominations should be sent electronically toEFCC Secretary, Dr. Hans vanPelt. We await yournominations and look forward to meeting you at the19th IFCC/EFCC European Congress of ClinicalChemistry and Laboratory Medicine "Euromedlab2011" on 15-19 May 2011 in Berlin!




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On behalf of the conference organi-zers, we announce with greatpleasure the 1st EFCC-BD Euro-pean Conference on Preanalytical Phase jointly orga-nized by the European Federation of Clinical Chemi-stry and Laboratory Medicine (EFCC) and BD Diag-nostics, Preanalytical Systems, to be held on 1-2April 2011 in Parma, Italy.

The major focus of this conference is the quality of thepreanalytical phase of laboratory practices - a promi-nent and topical issue in the era of increasing aware-ness of patient safety and implementing total qualitymanagement practices in clinical laboratories. This isthe first such conference jointly organized by EFCCand BD Diagnostics, Preanalytical Systems.

The joint organization of this event is the result of theformally recognized need for a stronger collaborationbetween the in vitro diagnostic (IVD) industry and theprofession at European level towards the commongoals of improving laboratory productivity and qualityof laboratory work to the benefit of patient care.

Topics to be included in this high-level scientific eventare:

· Errors in Laboratory Diagnostics

· Governance of preanalytical variability

· Models for analysis of workflows and bottlenecks inthe preanalytical phase

· The impact of biological variability on laboratorytesting

· Preanalytical quality indicators

· Sources of in vivo and in vitro hemolysis

· Detection and management of hemolytic specimens

· Hemolysis index as indicator of preanalytical samp-le quality

· Primary sample collection systems - how usefulthey are in reducing preanalytical variability?

· Standards of safety in blood collection

· Patient identification errors

· Requirements for sample transport, handling anddelivery to the laboratory

· Serum or plasma sample – which one is better?

· Preanalytical errors in Point of Care Testing

· What is the (un)suitable urine sample?

· Automation of the preanalytical phase: models andpersonal experience

· Accreditation of clinical laboratories according toISO15189: focus on the preanalytical phase

For the detailed scientific program and all other info onthe conference please visit: http://www.preanalytical-phase.org/.

1st EFCC-BD European Conference on Preanalytical Phase

Preanalytical quality – dream or reality?

1-2 April 2011, Parma, Italy

ByAndrea Rita Horvath, EFCC PresidentBrian Smith, BD Diagnostics, Preanalytical systemsGiuseppe Lippi, Conference Scientific Committee, chairAna-Maria Simundic, Conference Organizing Committee, chair

EFCC Forthcoming Events




22

EFCC Forthcoming Events

Berlin 2011: Preparations for IFCCWorldLab/EuroMedLab Enter High Gear

Rudolf Tauber, President of the joint IFCC WorldLaband EuroMedLab Berlin 2011

The 21st International Congress of Clinical Chemistryand Laboratory Medicine will take place with the 19thEuropean Congress of Clinical Chemistry and Labora-tory Medicine and the 8th Annual Meeting of theGerman Society of Clinical Chemistry and LaboratoryMedicine in Berlin next May 15-19 2011.

An attractive scientific program has been developedtogether with the International Scientific Committeeand the International Scientific Advisory Board, whichrepresent IFCC, EFCC and DGKL. As one wouldexpect there is a wide-ranging high quality scientificprogram covering the cutting edge developments inlaboratory medicine. These include the role of preven-tion, theragnostics, new technologies, and biomarkersin the era of "omics", the relevance of automation andIT and the education and training of our future profes-sionals to cope with these challenges, particularly in ademanding and difficult economic environment. Thisconference will be an opportunity to meet old friendsand make new ones to interact with like-minded col-leagues in the pursuit of common goals and interestsin the ongoing development of clinical chemistry andlaboratory medicine.

BCLF 2011

The 19th Meeting of the Balkan Clinical LaboratoryFederation will take place in Bucharest, Romania (21-23 September 2011), see www.bclf-2011.org.

The BCLF president and his board have the pleasureto invite you to contribute to the success of the 19thMeeting of the Balkan Clinical Laboratory Federation(BCLF 2011) which will be held in Bucharest in Sep-tember 2011, by your participation and sponsorship.Your contribution will be highly valued, since we aimto bring together specialists working in all fields ofLaboratory Medicine, in order to promote an exchangeof information and to create links of communicationbetween specialists of BCLF member countries andother countries. We also aim to establish links be-tween clinical laboratory experts and physicians ofother specialty (general practitioners, clinicians etc).

On the other hand, the BCLF 2011 is aimed to provideup-dated information regarding the best methodology,modern equipment, cost – benefit relationships, clini-cal value of all procedures used in laboratories. Inaddition, an exchange of information between specia-lists of various background (physicians, biochemists,pharmacists, chemists, biologists etc) working inlaboratories will be promoted. In conclusion BCLF2011 will contribute to a better appreciation of Labora-tory Medicine and to the improvement of health carein Balkan countries.

Contact: Gheorghe Benga, President of BCLF, Presi-dent of BCLF 2011 [[email protected]]

5th Congress ofClinical Chemistry andLab MedMarch 18-20 2011 AmathusBeach Hotel Limassol, Cyprus;

Contact: Pr Charis Charilaou,President of the congress(www.cyprusassociation.org)

Pr Rudolf Tauber,in company of his family

the city's cosmopolitan flair should motivate everybodyto extend the scientific and cultural exchange beyondthe official program of the congress and take aglimpse at today's Germany. Berlin looks forward towelcoming the IFCC/EFCC and international partici-pants to Berlin 2011.

is one of the mostvibrant cities in Germa-ny and Europe and islocated in the heart ofEurope. The internatio-nal congress center ICCwill offer all amenitiesfor an open exchangebetween the delegates,speakers, officials, andexhibitors. In addition,




23

EDMA News

EFCC and EDMA Enhance Cooperation

The European Federation of Clinical Chemistry andLaboratory Medicine (EFCC) and the European Diag-nostic Manufacturers Association (EDMA) havesigned a Memorandum of Understanding which willtake to a new level their coordination and collaborationon a number of mutually important European policyissues.

At a ceremony held on 13 October 2010 in Lisbon inconjunction with the First European Joint Congress ofEFCC and UEMS, EFCC President Andrea Rita Hor-vath and EDMA Director General Christine Tarrajatsigned a Memorandum of Understanding (MoU) aimedat further strengthening the ties between the twoorganisations.

EDMA, the European Diagnostic Manufacturers Asso-ciation, represents national associations and majorcompanies engaged in the research, development,manufacture or distribution of In Vitro Diagnostic (IVD)tests in Europe. Through its membership, EDMArepresents in total more than 500 companies (or over700 legal entities) across Europe.

The mission of EDMA is to raise awareness of theimportance, usefulness and added value that diagnos-tic information can provide to healthcare. For thispurpose, EDMA cooperates with European institu-tions, patients groups, trade associations, healthprofessionals and academia to support an appropriateregulatory system, to work towards a realistic econo-mic environment for healthcare in Europe and to be aneffective voice in globalisation. For more information,please visit the EDMA website.

EFCC and EDMA have already been working togethersuccessfully on a number of issues, such as the re-vision of the IVD Directive and coordinating the launchin Europe of Lab Tests Online, a patient-centred, peer-reviewed, and non-commercial online portal thatprovides information to patients on laboratory tests(www.labtestsonline.info).

"The overall objective of this MoU is to give our com-mon contribution to the formulation of policies thatcould impact the industry and the professional userswithin Europe," EDMA Director General ChristineTarrajat explains.

EFCC President Andrea Rita Horvath further points outthat "collaboration of the profession with the IVDindustry will improve the quality, effectiveness andimpact of laboratory medicine and this relationship willbe based on the principles of cooperation, coordinati-on and transparency."

EDMA and EFCC have identified a number of priorityissues for an initial work program, including

· EU Commission: Revision of the IVD Directive andsetting research priorities at EU level

· Development of a framework and tools for the provi-sion of clinical evidence for IVDs in collaborationwith industry and the Global Harmonisation TaskForce (GHTF)

· Laboratory accreditation in Europe

· LabTestsOnline: Joint initiatives to promote thedifferent European websites.

· Awareness of the value of IVD testing and access ofpatients to good laboratory testing

· Cooperating with the European Commission throughthe European partnership for action against cancer.

The collaboration is expected to enhance the influ-ence of the profession on EU policies and strengthenthe partnership between the users and manufacturersof IVD tests

The EFCC President Rita Horvath and Christine Tarrajatsigning the EFCC-EDMA agreement in Lisbon




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EDMA News

Revision of IVD Directive to position thesector as key to sustainable healthcarein the EUThe European Diagnostic Manufac-turers Association (EDMA) hashosted an open dialogue betweenkey members of the IVD industry,the EU Commission and Member States to maintainmomentum in the discussions on the revision of theIVD Directive. The outcome of this revision is expec-ted to shape the sector in Europe for the foreseeablefuture.

Key industry decision makers were able to meet andexchange views on the revision of the IVD Directivewith Sabine Lecrenier (Head of Unit for Cosmetics andMedical Devices at the Directorate General for Healthand Consumers) who emphasized the need to obtaina high level of protection for public health while ensu-ring that the IVD industry remains a competitive andinnovative economic motor within Europe.

One of the key pillars of the revision is the adoption ofthe recommendations from the Global HarmonizationTask Force, a group of industry and regulators whichfor the last 18 years has been developing a frameworkwhich would allow easier access to devices acrossthe globe. Celine Bourgignon (Policy Officer for Cos-metics and Medical Devices at the Directorate Gene-ral for Health and Consumers) described one of theproposals which potentially will have the greatestimpact within the GHTF framework - the determinationof the clinical utility and validity of IVDs. The newopportunity offered by companion diagnostics, wherethe prescription of a pharmaceutical to a specificpatient is intimately linked to a diagnostic result, anarea known as personalized medicine, was describedby Anne Van Neerom (IVD Coordinator, Belgian Insti-tute of Public Health). This will be the object of furtherdiscussion with EU authorities.

Authorities support the idea of a revision, and hope formore clear measures which will allow a better adaptati-on of regulations to technical progress as explained byDr. Jean-Claude Ghislain (Director, Agence Francaisede Sécurité Sanitaire des Produits de Santé). Ques-tions arise in particular to the placing on the marketand use of genetic tests, and the role which in houseassays as well as the future involvement of authoritiesin other areas of the IVD Regulatory framework.

EU: Towards enhanced eHealthgovernance

On the 12th October, Antonyia Parvanova MEP hosteda workshop entitled "Towards enhanced eHealthgovernance: what next for cross border healthcare andfurther deployment of sustainable ICT applied tohealth?" in the European Parliament. This event wassupported by Hanover communications and the Asso-ciation of Chartered Certified Accountants (ACCA).

The event brought together over 130 participantsincluding high level representatives of the EuropeanCommission, the European Parliament and theCouncil of Ministers, academics, as well as othereHealth stakeholders including patients, doctors,NGOs and businesses.

Coinciding with the debates in the European Parlia-ment and the Council on the Commission’s proposalfor a Directive on the application of patients’ rights incross-border healthcare, the aim of this half-day eventwas to exchange views and propose solutions regar-ding the concrete challenges and opportunities foreHealth and its potential contribution towards moreefficient and sustainable healthcare systems in Europe,for the benefits of patients, healthcare providers andthe society as a whole.

A full report of the event is downloadable from the ACCAwebsites, alongside the speakers’ presentations andpodcasts:www.accaglobal.com/databases/pressandpolicy/westernsoutherneurope/towardseHealth

www.hanovercomms.eu/news-events/past-events/ehealth-governance-in-europe/default.aspx

eHealth




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EFCC Newsletter is published by the European Feder-ation of Clinical Chemistry and Laboratory Medicine.

EFCC

European Federation ofClinical Chemistry and Laboratory MedicineVia Carlo Farini 8120159 Milano - ItalyTel. +39-02-66809912e-mail: [email protected]

Web Editordtp studio oldenburghttp://www.dtpstudio.dee-Mail: [email protected]

Contributions to the EFCC Newsletter should be sentto the Editor at the address below:

EFCC Newsletter Editor

Bernard GougetSocieté Francaise de Biologie Clinique1bis rue Cabanis – CS 4140275993 PARIS cedex 14 – FranceTel. +33-144068444-8470-8525e-Mail [email protected]

About the EFCC Newsletter

efcc newsletter january 2011 - eflm

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