happy holiday season

9
Issue n. 6/2017 Happy Holiday Season In this issue: It is with great gratitude I have served as President for EFLM in 2017. Gratitude because I have met so many clever, intelligent and professionally devoted people – who really care for laboratory medicine. Thanks to you, EFLM is moving rapidly forward. The visibility and importance of EFLM is increasing, directly with a new logo, new website and this new newsletter, indirectly with the publication of numerous papers as well as contributions on meetings and conferences. EFLM has a strong engagement with the regulatory bodies and is working with energy to take forward and to promote the profession. It is three years since we had the successful 1 th Strategic Conference on Defining analytical performance specifications. The 5 Task and Finish Groups established after this conference have now fulfilled their tasks and have been closed. Some of the projects will be further developed within the structure of EFLM. In 2018 EFLM will organize the 2 nd Strategic conference, “The End of Laboratory Medicine as we know it? Handling disruption of laboratory medicine in digital health”. This will help us pave the future way for EFLM. We will rest a little bit during the seasonal celebrations and then we will hurry forwards into 2018 with energy and a lot of new tasks and opportunities. Thank you for working so hard for EFLM and for the profession. by Sverre Sandberg, on behalf of the EFLM Execu- tive Board and the EFLM Office THE EFLM BI-MONTHLY NEWSLETTER HOT TOPICS IN LABORATORY MEDICINE Editorial information: Newsletter Editor: Dr. Harjit Bhattoa, Faculty of Medicine, Dept of Laboratory Medicine, University of Debrecen, Hungary EFLM Executive Board: S. Sandberg, M. Panteghini, M. Neumaier, A-M. Simundic, H. Storm, G. Sypniewska, T. Zima The EFLM Newsletter is published bi-monthly To send your news or advertisement for publication on the newsletter write to: [email protected] Contents may not be reproduced without the prior permission of the Newsletter Editor. Foreword With the festive season around the corner, this issue is inaugurated with the Season’s Greetings by the EFLM President Sverre Sandberg, on behalf of the EFLM Executive Board and the EFLM Office. Ian Watson is presenting an overview celebrating the 10 th Anniversary of the EFLM. Mario Plebani writes on the evergreen topic of Patient Safety and Laboratory-related errors in the regular section of Laboratory Hot Topics. “The end of Laboratory Medicine as we know it?” is the thought provoking banner of the 2 nd EFLM Strategic Conference to held at the upcoming EFLM meeting in Mannheim in June, 2018. Christa Cobbaert, WG-TE Chair introduces the EFLM-AACB Course on “Assessing the Value of Biomarkers” to be held at Sydney at the end of February, 2018. MariaStella Graziani, Chair of the EFLM Communications Committee presents recent additions to the EFLM publications list. As a regular column of the EuroLabNews, news from National Societies of Spain, Italy and Turkey give us an insight into their activities. Colleagues may mark their calendars to attend stimulating meetings as mentioned in the Calendar of Events. On behalf of the EuroLabNews team, I wish all our readers a joyful festive season and a prosperous new year. by Harjit Pal Bhattoa, Editor EFLM EuroLabNews President’s Season Greetings President's Season Greetings 10 th EFLM Anniversary Hot Topics in Laboratory Medicine Patient safety and laboratory-related errors EFLM events Announcement of the 2 nd EFLM Strategic Conference EFLM-AACB Test Evaluation Course 2018 Updates on EFLM Publications list News from National Societies News about EFLM National Societies Calendar of EFLM events and events under EFLM auspices

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Page 1: Happy Holiday Season

Issue n. 6/2017

Happy Holiday Season

In this issue:

It is with great gratitude I have served asPresident for EFLM in 2017. Gratitude becauseI have met so many clever, intelligent andprofessionally devoted people – who reallycare for laboratory medicine. Thanks to you,EFLM is moving rapidly forward. The visibilityand importance of EFLM is increasing, directlywith a new logo, new website and this newnewsletter, indirectly with the publication of

numerous papers as well as contributions on meetings and conferences.EFLM has a strong engagement with the regulatory bodies and is workingwith energy to take forward and to promote the profession. It is threeyears since we had the successful 1th Strategic Conference on Defininganalytical performance specifications. The 5 Task and Finish Groupsestablished after this conference have now fulfilled their tasks and havebeen closed. Some of the projects will be further developed within thestructure of EFLM. In 2018 EFLM will organize the 2nd Strategicconference, “The End of Laboratory Medicine as we know it? Handlingdisruption of laboratory medicine in digital health”. This will help us pavethe future way for EFLM. We will rest a little bit during the seasonal celebrations and then we willhurry forwards into 2018 with energy and a lot of new tasks andopportunities. Thank you for working so hard for EFLM and for theprofession.

by Sverre Sandberg, on behalf of the EFLM Execu­tive Board and the EFLM Office

THE EFLM BI-MONTHLY NEWSLETTER

HOT TOPICS IN LABORATORY MEDICINE

Editorial information:Newsletter Editor: Dr. Harjit Bhattoa, Faculty of Medicine,Dept of Laboratory Medicine, University of Debrecen, Hungary

EFLM Executive Board:S. Sandberg, M. Panteghini, M. Neumaier, A­M. Simundic,H. Storm, G. Sypniewska, T. Zima

The EFLM Newsletter is published bi­monthly

To send your news or advertisement for publication onthe newsletter write to: [email protected]

Contents may not be reproduced without the priorpermission of the Newsletter Editor.

Foreword

With the festive season around the corner, this issue isinaugurated with the Season’s Greetings by the EFLMPresident Sverre Sandberg, on behalf of the EFLMExecutive Board and the EFLM Office. Ian Watson ispresenting an overview celebrating the 10th Anniversaryof the EFLM. Mario Plebani writes on the evergreen topicof Patient Safety and Laboratory­related errors in theregular section of Laboratory Hot Topics. “The end ofLaboratory Medicine as we know it?” is the thoughtprovoking banner of the 2nd EFLM Strategic Conferenceto held at the upcoming EFLM meeting in Mannheim inJune, 2018. Christa Cobbaert, WG­TE Chair introducesthe EFLM­AACB Course on “Assessing the Value ofBiomarkers” to be held at Sydney at the end of February,2018. MariaStella Graziani, Chair of the EFLMCommunications Committee presents recent additionsto the EFLM publications list. As a regular column of theEuroLabNews, news from National Societies of Spain,Italy and Turkey give us an insight into their activities.Colleagues may mark their calendars to attendstimulating meetings as mentioned in the Calendar ofEvents.On behalf of the EuroLabNews team, I wish all ourreaders a joyful festive season and a prosperous newyear.

by Harjit Pal Bhattoa, Editor EFLM EuroLabNews

President’s Season Greetings

President's Season Greetings

10th EFLM Anniversary

Hot Topics in Laboratory Medicine Patient safety and laboratory­related errors

EFLM eventsAnnouncement of the 2nd EFLM Strategic ConferenceEFLM­AACB Test Evaluation Course 2018

Updates on EFLM Publications list

News from National Societies

News about EFLM National Societies

Calendar of EFLM events and events under EFLM auspices

Page 2: Happy Holiday Season

It is 10 years since the creation of theEuropean Federation of ClinicalChemistry and Laboratory Medicineat EuroMedLab 2007. Puttingtogether the responses of the first 5Presidents recollections of their timein office provides a useful reflectionover what has been and continues tobe the dynamic development ofEFLM.The history of the progenitors ofEFLM is given on the EFLM web­site(click here). The merger recognisedthe converging interests of theFederation of European Societies ofClinical Chemistry (FESCC) and theEuropean Community Confederationof Clinical Chemistry (EC4) to formthe European Confederation ofClinical Chemistry and LaboratoryMedicine (EFCC). Followingformation FESCC President the lateProf Vic Blaton held office asPresident for the first year of thetwo­year Presidential term and wasthen followed by the ex­EC4President Mike Hallworth; therafterPresidents held office for two years:Rita Horvath 2009­11, Ian Watson2011­13, Mauro Panteghini 2014­15,Sverre Sandberg 2015­17.As Mike Hallworth says “the [initial]main challenge was the breadth ofthe agenda – to ensure thatEFCC/EFLM was properlyconstituted, financially viable,structured in a way that couldachieve its objectives and retainedthe strengths and goodwill of thefounding organizations in anefficient and forward­looking newbody”.Maturation of EFCC/EFLM throughit’s ‘childhood’ was ably addressedby Rita Horvath who claims‘motherhood’ helping the ‘baby’develop into now becoming a

mature ‘adult’. Building on the initialwork of Vic and Mike, Rita says shesaw “my key task and possiblyachievement was at the initial stagesof EFCC's/EFLM's birth to basicallyestablish the organisational structureand to develop and deliver the firstmore elaborated strategic andactivity plans of this organisation,that were based on a survey ofNational Society needs. There was alot of basic founding work to buildup not only the organisation but alsoto formalize its relationship withmany European and internationalsister organisations, includingpositioning us in IFCC stronger, andto make EFCC/EFLM an entity that isboth legally and professionallyrecognised and viable”.Of course these new relationshipsled to opportunities and challengesand a greater ‘political awareness’ ofidentity as well as responsibilities. Aswell as consolidating the previousefforts consultation with theNational Societies led to EFLMreplacing EFCC as a clearerdescriptor and the adoption ofSpecialist in Laboratory Medicine asthe formal terminology whencommunicating with the EU,governments and otherorganisations; describing memberswho met the Registration standard.EFLM as a not­for profit Europeanorganisation became an AISBLregistered in Belgium, this protectedofficers’ liabilities and laid strictcompliance procedures on ourconduct of business and financialtransparency, achieving this complexregistration process was finalised in2013. Ian Watson said “ AISBL statuswhile time­consuming ensured thatwe have a legal framework for ouractivities through the Articles of

Association we adopted, these inform all rule changes andprocedures going forward”.When Mauro Panteghini became President he initiated theconcept of the Strategic Conference, designed to meet abroad, significant and clear professional need, the first was‘Defining analytical performance goals 15 years after theStockholm Conference’He also grasped other nettles by consolidating the EFLMProcedure Manual, initiated a Corporate Member policy andthe inclusion of the EC4 Register within the purview of EFLM.The journal Clinical Chemistry and Laboratory Medicine(CCLM) had been the preferred journal for EFLM publicationand with the adoption of CCLM as the journal of EFLM underMauro’s presidency this trend has been consolidated.As EFLM has matured there has been a concomitantexplosion of scientific activity with significant meeting cyclesbeing developed in addition to the pre­existing EuroMedLabjointly with IFCC. Pre­analytics has been a particularlysuccessful development, where EFLM is a global leader, therehas been a series of successful bi­annual meetings withUEMS as well as others niche topic areas. There is now asuccessful webinar programme highlighting the activities ofWorking Groups. The most important output from theScience Committee working groups has been an increasingnumber of high quality peer­reviewed scientific papers on awide range of topics; all these papers as well as presentationsgiven at international meetings are accessible through theEFLM home page. Presidents and their Executive Board members have activelyconsulted member National Societies and have made effortsto actively participate in regional and national meetingsstrengthening the relationships between EFLM and itsmembers. Of course the nature of a Presidency is leadership of a team,building on the efforts of predecessors and stewardship ofthe organizations values for the future. One is working withyour predecessors and successors from appointment todemitting office, hence there is a continuity to policies whichmay be initiated under one leader, but come to fruitionunder another, these transitions have been very successfulin ensuring the strength and vigour of EFLM which hasensured it’s place as a significant contributor to the scientific,educational and professional activities encompassinglaboratory medicine.

The EFLM Newsletter n. 6/2017 2

EFLM: Ten years ofgrowth!

prepared by Ian Watson, EFLM Former President

Celebrating our

Sverre SANDBERG (NO)President 2016-2018

Mauro PANTEGHINI (IT)President 2014-2016

Ian WATSON (UK)President 2011-2013

Andrea Rita HORVATH (HU)President 2009-2011

Mike HALLWORTH (UK)President 2008-2009

(Victor) Vic BLATON (BE) †President 2007-2008

Page 3: Happy Holiday Season

The principle “first does no harm” remainscentral to the provision of high­qualityhealthcare. Patient safety is an importantaspect of quality across, and between, allsettings of care including laboratorymedicine. At its core, patient safety is theprevention of errors associated withhealthcare and the mitigation of theireffects to reduce adverse events and harm

to patients. It is useful to outline the quality, economic andpolitical reasons why safety should be at the top of the agendafor improving healthcare systems. Quality: safety is an essentialcomponent of care quality. Economic: unsafe care is expensive,while safer care may reduce costs. Finally, from a politicalviewpoint, safety is an expectation for both political systems,leaders and citizens. During the past decades, awareness ofmedical errors has expanded rapidly focusing, in particular, onmedication errors and related adverse drug events, whilediagnostic errors have initially received relatively poor attention.Only in the last few years, evidence has been accumulated todemonstrate that diagnostic errors are common and are a leadingcause of patient dissatisfaction and malpractice suits. Inpatientand outpatient diagnosis­related malpractice not only arecommon but are more often associated with disability and deaththan other claim types (1). As a result of a series of recentlyperformed studies, we should conclude that diagnostic errors arecommon, costly and morbid, and that the economic burdenassociated with diagnostic errors is substantial. A diagnostic erroremerges when a diagnosis is missed, inappropriately delayed oris wrong (2). As recently highlighted, diagnostic errors should bebetter defined as a failure to provide an accurate and timelyexplanation of the patient’s health problems or communicate thatexplanation to the patient (3). All aspects of the diagnostic processare vulnerable to errors and usually a number of root causes areinvolved in each case. Causes may include cognitive errors, suchas failure to synthesize the available evidence correctly or failureto use test data appropriately. System flaws may also contributeto diagnostic errors as a result of problems with coordination ofcare, poor communication and insufficient access to specialists.Process breakdowns most frequently involved patient­practitionerclinical encounter (79%), followed by referral problems (20%),follow­up and tracking of diagnostic information (15%) andperformance and interpretation of diagnostic tests (14%). In somestudies, about 46% of diagnostic errors were found to be relatedto laboratory and radiology tests, and in particular failure torequest appropriate test as well as failure in result interpretationand utilization. Patient­practitioner encounter breakdowns were

primarily related to problems with ordering diagnostic tests forfurther workup (57%), history­taking (56%) and examination(47%).Access to diagnostic test, namely laboratory tests, couldsignificantly reduce diagnostic errors, and interventions forimproving diagnostic services are considered a high priority.Laboratory­associated errors have a completely different meaningtoday than it did a half century ago. A dramatic change inaddressing the issue of laboratory­associated errors started at theend of the 1990’s, when a body of evidence began to accumulatedemonstrating vulnerability in the pre­ and post­analytic phases.By that time, the data collected and reported in the literatureshowed that analytical error rates had decreased from 162,116 permillion laboratory tests (part per million, ppm) to 447 ppm. Thisdramatic and impressive reduction in errors, by about 300 fold,derived from automation, improved laboratory technology, assaystandardization, well­defined rules for internal quality control,effective quality assurance schemes and better trained staff. Inparticular, the definition and setting of intra­analytical qualityindicators (analytical performance specifications) did play afundamental role in documenting and reducing analytical errors.Recent studies have led to a better understanding of thefrequency and nature laboratory testing error: data on errors inthe pre­pre analytical phase (initial procedures performed neitherin the clinical laboratory nor, at least in part, under the control oflaboratory personnel) underline that failures to order appropriatediagnostic tests, including laboratory tests, accounted for 55% ofobserved breakdowns in missed and delayed diagnosis in theambulatory setting and 58% of errors in the Emergencydepartment . In the final steps of the TTP loop, the incorrectinterpretation of diagnostic or laboratory tests was found to beresponsible for a high percentage of errors in the ambulatorysetting as well as in Emergency departments (4). The search forvaluable quality indicators (QIs) for extra­analytical phases of thetesting process and for harmonizing all steps, including testordering and data interpretation, represents a fundamental issuein projects aiming to improve quality and patient safety. TheModel of Quality Indicators (MQI) launched by the IFCC WorkingGroup of the International Federation of Clinical Chemistry andLaboratory Medicine (IFCC) and the work done by the EuropeanFederation of Laboratory medicine (EFLM) Task Force onPerformance Specifications for the extra­analytical phases areessential tools for improving the ultimate quality of laboratoryinformation (5). In fact, only through an harmonized list of QIs anda common reporting system it should be possible the definitionof appropriate performance specifications in all phases of thetesting process which, in turn, may allow improvement actions toreduce laboratory­associated errors and risks for patient safety.

References1) Gupta A, Snyder A, Kachalia A, Flanders S, Saint S, Chopra V.

Malpractice claims related to diagnostic errors in the hospital.BMJ Qual Saf. 2017 Aug 9. pii: bmjqs­2017­006774. doi:10.1136/bmjqs­2017­006774. [Epub ahead of print]

2) Graber ML, Franklin N, Gordon R. Diagnostic error in internalmedicine. Arch Intern Med 2005,165:1493­9.

3) Improving diagnosis in healthcare. National Academy Press2015. http://www.nap.edu/21794. (accessed 2 Oct 2017)

4) Plebani M. Diagnostic Errors and Laboratory Medicine ­Causes and Strategies. EJIFCC. 2015; 26:7­14.

5) Plebani M; EFLM Task Force on Performance Specifications forthe extra­analytical phases. Performance specifications for theextra­analytical phases of laboratory testing: Why and how.Clin Biochem. 2017;50:550­554.

by Mario Plebani, Laboratory Medicine, University of Padova, Italy

HOT TOPICS IN LABORATORY MEDICINE

Patient safety and laboratory­related errors

FIGURE 1. The hourglass model of laboratory­related diagnostic errors.

The EFLM Newsletter n. 6/2017 3

Page 4: Happy Holiday Season

EFLM is proud to officially announce the 2nd EFLM StrategicConference “The end of laboratory medicine as we know it?”that will take place in Mannheim (DE) on June 18­19, 2018at the Congress Center Rosengarten.

The conference will consider the impact that the on­goingdigitalization of technologies and a digitalized society willhave on the medical laboratory in future health care. Wecontend that such changes enable Digital Health that willbe disruptive for Laboratory Medicine as we know it,because they will change our capabilities to compile,integrate and visualize complex diagnostic data as well asproviding the opportunity for radical changes todiagnostic health strategies.

With the digital revolution spreading into every realm ofmodern medicine, we will experience a democratisation ofhealth care, i.e. a comprehensive data usage not just beingin the hands of health care professionals, but also in thepatients´. Indeed, a central concept of digital healthmedicine is patient empowerment as demonstrated by keywords like “electronic health record”, “patient access”,“health apps”, “wearable health tech” etc. In this rapidlychanging health care environment, Laboratory Medicinemust redefine its positions, not only acting in its classicalrole as provider of laboratory results, but also adoptingnew roles and responsibilities in the clinical dialogue.

Mark this event in your agenda and be part of thechange!

The EFLM Newsletter n. 6/2017 4

2nd EFLM Strategic Conference

The end of laboratory medicine as we know it?Handling disruption ofLaboratory Medicine in digital health

EFLM EVENTS

Mannheim (DE) 18­19 June

For EFLM National Society Members: the annual EFLMGeneral Meeting will take place at end of the StrategicConference on June 19 from h. 16.00 to h. 19.00

The Test Evaluation Working Group, a joint activity of the EFLM andAACB, is hosting a 2­day course on “Assessing the Value ofBiomarkers” in Sydney in February 28 ­ March 1, 2018. Throughouthealthcare there is an increasing focus on demonstrating the value ofany intervention including medical or laboratory tests. This course willaddress that challenge by providing an introduction to the principles ofbiomarker research for the development and evaluation of biomarkersto improve healthcare as well as address regulatory and healthtechnology assessment issues. The program can be found athttps://www.eflm.eu/site/events/The needs and interests of the diverse group of professionals involvedin the test development process from biomarker discovery toimplementation in clinical practice will be covered. To get an idea ofother activities of the EFLM WG on Test Evaluation, click here.

EFLM­AACB Course on“Assessing the Value of

Biomarkers”by Christa Cobbaert, EFLM Chair WG­Test Evaluation

EFLM­AACB COURSE ON “ASSESSING THEVALUE OF BIOMARKERS”

The EFLM­AACB Working Group on Test Evaluation

Assessing the Value of Biomarkers: an interactive workshop

February 28 ­ March 1, 2018Mercure Hotel, Sidney Central

Page 5: Happy Holiday Season

EFLM can count on four more papers by EFLM functional units:the scientific relevance of these papers demonstrates thecontinuous commitment of the Working Groups and Task Forcesto the advancement of our profession.

THE EUROPEAN BIOLOGICAL VARIATION STUDY (EUBIVAS): DELIVERY OFUPDATED BIOLOGICAL VARIATION ESTIMATES, A PROJECT BY THE WORKINGGROUP ON BIOLOGICAL VARIATION IN THE EUROPEAN FEDERATION OFCLINICAL CHEMISTRY AND LABORATORY MEDICINE

Carobene A. On behalf of the EFLM Working Group on Biological VariationJ Lab Precis Med doi: 10.21037/jlpm.2017.08.13This Letter to the Editor is a reply of a comment written by CGFraser on a previous paper by the same group published in ClinicalChemistry, also included in the EFLM publication list. Thankingprof Fraser for his kind words of appreciation, the Authordescribes in more details the EuBIVAS project emphasizing thedesign of the study that allows the collection of robust data onbiological variation (both within and between subjects). Thesedata could be used to define sounder analytical qualityspecifications that are the basis for the evaluation of newanalytical systems and for setting criteria of acceptability ofinternal quality control results and proficiency testing.

STRATEGIES TO DEFINE PERFORMANCE SPECIFICATIONS IN LABORATORYMEDICINE: 3 YEARS ON FROM THE MILAN STRATEGIC CONFERENCE

Panteghini M, Ceriotti F, Jones G, Oosterhuis W, Plebani M,Sandberg S. On behalf of the Task Force on PerformanceSpecifications in Laboratory Medicine of the European Federationof Clinical Chemistry and Laboratory MedicineClin Chem Lab Med 2017;55:1849­56This paper describes the deliverables from the five EFLM Task &Finishing groups established after the 1st Strategic Conferencethat was aimed to address the definition of different models toset performance specifications (PS) for analytical quality. Thedeliverables are related to concepts about PS for EQAS, how toset PS for the extra­analytical phases, the need for more qualitydata on biological variation and the use of the “total error”concept. These concepts help the definition of what quality isneeded and what measurement errors can be tolerated withoutjeopardizing patient safety and should therefore be defined foreach analyte having clinical use. It is expected that this work willnow be taken forward, possibly by consolidating some of theseactivities in a permanent structure within EFLM.

THE EFLM STRATEGY FOR HARMONIZATION OF THE PREANALYTICAL PHASE

Lippi G, Simundic AM. On behalf of the European Federation for Clinical Chemistry andLaboratory Medicine (EFLM) Working Group for PreanalyticalPhase (WG­PRE).Clin Chem Lab Med. 2017 DOI 10.1515/cclm­2017­0277The EFLM Working Group on preanalytical phase (WG­PRE) wasestablished four years ago with the aim to promote harmonizationin the preanalytical phase. This article describes the achievementsof the group and illustrates future projects. Among the completedprojects: harmonizing the definition of fasting status, patient andblood tubes identification, colour coding of blood collectiontubes, sequence of tubes during blood drawing and developmentof suitable preanalytical quality indicators. The WG­PRE has alsoprovided guidance on local validation of blood collection tubes,and has organized four European meetings to promote theimportance of quality in the preanalytical phase. The futureactivities include development of an external quality assessmentscheme on preanalytical variables, dissemination of a survey aboutthe local management of unsuitable samples in clinicallaboratories, as well as release of EFLM phlebotomy guidelines.

PRE­ AND POST­TEST PROBABILITIES OF VENOUS THROMBOEMBOLISM ANDDIAGNOSTIC ACCURACY OF D­DIMER, ESTIMATED BY CLINICIANS WORKINGIN EMERGENCY DEPARTMENTS

Kristoffersen AH, Ajzner E, Bauça JM, Carraro P, Faria AP, HillarpA, Rogic D, Sozmen EY, Watine J, Meijer P, Sandberg S.Thromb Res 2017;159:19­23This letter to the Editor has been written on behalf of the jointWorking Group on Postanalytical Phase (WG­POST) of EFLM andthe European Organisation for External Quality AssuranceProviders in Laboratory Medicine (EQALM). It follows a paperpublished in the same Journal in 2016 (also included in the EFLMpublication list) describing the results of a questionnaire sent toclinicians working in Emergency Departments in Europe. Thepresent study illustrates the results of questions about pre­ andpost­test probability before and after receiving D­dimer resultsthat were not included in the previous report. The conclusions arethat the clinicians estimated the diagnostic accuracy (LR) of theD­dimer test for venous thromboembolism in line with what isfound in the literature, but they estimated a too high pre­testprobability which also resulted in a too high post­test probability.

The EFLM Newsletter n. 6/2017 5

Updates on the EFLM Publication Listby Maria Stella Graziani, Chair of the EFLM Communication Committee

The list of the EFLM publications is available on www.eflm.eu under EFLM Publications, where the available papers can be downloaded.

Currently, there is variability in lipidvalues considered to be advisable byclinical laboratories, which may generateconfusion and pose a barrier to the

correct treatment of dyslipidemia.The document´s aim is to recommend to all clinical laboratoriesthe adoption of homogeneous recommended values for thevariables that make up the lipid profile.

This consensus includes wide­reaching and documentedinformation, such as epidemiological data for our country,existing barriers to achieving control of dyslipidemia andstrategies to avoid them, and recommendations on which valuesof lipid constituents should be reported as altered.In Spain, it is estimated that 48% of men and 52% of womenover 18 years of age have high total cholesterol levels, while 23%of men and 12% of women have hypertriglyceridemia.

NEWS FROM THE SPANISH SOCIETY OF LABORATORY MEDICINE (SEQCML)

Experts produce a Spanish consensus on recommended values for the lipid profile

by dr Jordi Ordóñez Llanos, Spanish Society of Laboratory Medicine (SEQCML)

NEWS FROM NATIONAL SOCIETIES

Under the auspices of the scientific societies for Arteriosclerosis, Primary Care, Cardiology, Family andCommunity Medicine and Laboratory Medicine

Page 6: Happy Holiday Season

Madrid, October 2017. Alterations in circulating lipid concentrations(total cholesterol and its high (HDL) and low (LDL) density andtriglycerides fractions), commonly referred to as dyslipemias, correlatewith the development of cardiovascular diseases of ischemic origin. Thus,numerous studies have shown that interventions that "normalize"circulating lipid concentrations protect against these diseases.However, in Spain, there is no unanimous agreement on circulating lipidconcentrations that can be considered as “baseline” or “recommended”and, therefore, used to define dyslipidemia when they are altered.In addition, the recommendations in international literature are based onpopulation studies that are not universally applicable. For this reason, thereference or recommended values that accompany analytical laboratoryreports may vary between different clinical laboratories.This variability can create confusion among clinicians who receivelaboratory results and may be a barrier to the correct treatment of lipidabnormalities (or dyslipidemias) and reduction of ischemic cardiovasculardisease.Recently, the European Society of Arteriosclerosis (EAS) and Cardiology(ESC) have developed a recommendation for the control of dyslipidemia,which includes several novel aspects. One of them is the non­need forfasting to obtain the lipid profile, which requires the varying ofconcentrations of triglycerides that are considered desirable.Faced with this situation, a group of professionals has developed theconsensus document 'Homogenization of lipid profile values', under theauspices of the five scientific societies of which they are part: SpanishSociety of Arteriosclerosis, Spanish Society of Primary Care Physicians,Spanish Society of Cardiology, Spanish Society of Family and CommunityMedicine, and Spanish Society of Laboratory Medicine."The objective of creating this consensus is to recommend to alllaboratories the adoption of homogeneous values, considered asrecommended, for the variables that make up the lipid profile," says Dr.Jordi Ordóñez Llanos, one of the authors of the work and member of theSpanish Society of Laboratory Medicine (SEQCML).According to this expert, this consensus not only reflects therecommendations of the EAS­ESC, but also includes epidemiologicalinformation for our country, and the details of the pre­analytical,analytical and post­analytic sources of variation that may influence lipidconcentrations or their evaluation; it also identifies the barriers that existto achieving control of dyslipidemia, and recommends strategies to avoidthem. “In addition,” he adds, “it establishes a recommendation for thelipid constituents that the lipid profile should include and, veryimportantly, what values of the same should be reported as altered in theanalytical report provided by clinical laboratories. In addition, itestablishes values for blood tests obtained both with and without fasting”.The consensus is directed particularly at clinical laboratory specialists andrecommends, in particular, the adoption by the laboratories of limit valuesto consider the concentrations of circulating lipids as altered. "Althoughit is also useful for any medical professional who has responsibility in thediagnosis, treatment, and treatment monitoring of dyslipemias,"concludes Dr. Ordóñez.

High prevalenceDifferent studies estimate that in our country, 48% of menand 52% of women older than 18 years of age have totalcholesterol levels above 200 mg/dL, whilehypertriglyceridemia (triglycerides >150 mg/dL, 1.67mmol/L) occurs in 23% of men and 12% of women. The SEQCML

The Spanish Society of Laboratory Medicine (SEQCML),founded in 1976, currently comprises more than 2,000professionals and has as its main objective to bring togetherall scientists interested in the Clinical Laboratory field, topromote the diffusion of scientific and technical publications,to organize meetings, courses and congresses of nationaland international character, and to cooperate with otherScientific Societies. Likewise, the Society wants to contributeto the study and recommendation of standardized methods,and to establish guidelines and recommendations fortraining in the field of Laboratory Medicine. For moreinformation: www.seqc.es.

In 2005, interest arose within theSpanish Society of LaboratoryMedicine (SEQCML) in creating aworking group focused on Point­of­

Care Testing (POCT). This group created a “Guide for theimplementation of laboratory tests at the point of patientcare”, published in 2006. Subsequently, in 2012, the SEQCML promoted theincorporation of new professionals, which ultimately led tothe creation of the current Point­of­Care TestingCommission.During its first few years, the Commission developed manyactivities, such as the creation of documents, surveys, andpublications, the organization of courses and seminars, andalso participated in research and development projectsrelated to POCT. All of this was done in collaboration withother SEQCML Commissions as well as other scientificsocieties, such as the Spanish Diabetes Society, whichgranted to this Commission the interdisciplinary role soimportant in this type of tests.One of the latest activities of the Commission has been thecreation of a database on POCT equipment, called POCTONLINE. Within both the Commission itself and our differentwork environments, we have always shared the view of thegreat difficulty that existed in quickly and easily finding thePOCT equipment and/or devices for measuring a specifictest. The development and growth of this technology isexponential, which is why we began to see the crucial needto create a consultation tool that would resolve all of theseobserved limitations.The SEQCML supported this idea from the beginning throughits later development and incorporation into the website. ThePOCT Commission began conversations with different in vitrodiagnostic companies, with the aim of inviting them to freely

The EFLM Newsletter n. 6/2017 6

Presentation of the SEQCML

POCT Online Database by dr Paloma Oliver Sáez, Chairman of thePoint­of­Care Testing (POCT) Commission,Spanish Society of Laboratory Medicine(SEQCML)

Page 7: Happy Holiday Season

InnovaSIBioC: A Laboratory of Ideas for Laboratory Medicineby Giuseppe Lippi, National Representative and Rossella Tomaiuolo, Coordinator of the project

and voluntarily collaborate. Thus, the information offered in thisdatabase has always been provided by the suppliers. The POCTand the SEQCML claim no responsibility for the truth of theinformation or the quality of the equipment. As noted on thewebsite, once the database has been consulted, it is the user´sresponsibility to make the appropriate evaluations to choose theoption that best meets their needs and quality requirements.The POCT ONLINE database will be updated periodically incollaboration with the companies involved, and will continue tobe developed further with the incorporation of additionalinformation that could be useful for users.Behind every announced result in the POCT environment thereare many activities carried out by numerous professionals, suchas the evaluation of methods, quality assurance, training and

qualification of personnel, connectivity, daily monitoring of theequipment that makes up the network, reports of results, etc. Once the benefits of the use of POCT technology in the clinicalenvironment is evaluated, a process begins with the correctchoice of equipment. POCT ONLINE was specifically created toprovide, in a user­friendly format, extensive information that canhelp users find and evaluate the equipment that best meets theirneeds. As always, patient care is the main objective of ouractivities.

Information on the Point­of­Care Testing (POCT) Commission,as well as the database, can be found in the following link:http://www.seqc.es/es/comisiones/comision­de­pruebas­de­laboratorio­en­el­lugar­de­asistencia­poct/_id:22/.

What is InnovaSIBIoCIt is a training and communication program aimed to convertinnovative ideas in laboratory medicine into concreteentrepreneurial initiatives.

Why InnovaSIBioCItaly has an excellent worldwide position in terms of totalnumber of publications in journals with high impact factor, butmodest performance pertaining patent activity. Thetransformation of research data into marketable products isplagued by economic (capital focuses on patent research),organizational (fragmented and complex frameworks) andbehavioural (little entrepreneurial culture of researchers) barriers.A tighter collaboration among the world of science, enterpriseand investors can support entrepreneurial culture and helpmaking biomedical sector a driving force for growth anddevelopment.SIBioC, always focused on innovation, is willing to face a newchallenge that is creating a network between research andenterprise that can spread, share and enhance Italian excellencein Laboratory Medicine. For this purpose, the Society haspropelled the launch of InnovaSIBioC.

AimsThrough InnovaSIBioC, SIBioC intends to stimulate, validate and

assist youth entrepreneurship in Laboratory Medicine, since theSociety trusts in the great potential of young people. Supportingcultural renewal means giving shape to talent, skill andleadership of younger members.

FeaturesThe project, funded by Roche, is divided into several stages (i.e.,scouting, presenting, evaluating and awarding entrepreneurialideas), in which training sessions and business developmentactivities will be alternated. The project has started June 2017and the best “ideas” will be awarded throughout 2018.

The EFLM Newsletter n. 6/2017 7

NEWS FROM NATIONAL SOCIETIES

NEWS FROM THE ITALIAN SOCIETY OF CLINICAL BIOCHEMISTRY AND CLINICAL MOLECULAR BIOLOGY

Il Laboratorio di Ideeper la Medicina di Laboratorio

Insulin Resistance Symposium in Turkey

NEWS FROM NATIONAL SOCIETIES

NEWS FROM THE TURKISH BIOMEDICAL SOCIETY

Turkish Biochemical Society İzmir Branch organized the “InsulinResistance Symposium – How do the research in recent yearsreflect to the laboratory and clinic?” in İzmir­Turkey on March22, 2017. The symposium focused on one of the most importanthealth problems of today, insulin resistance and related diseasesthus drew great attention. Over 220 participants attended thesymposium and shared the existing knowledge on this importanthealth problem and listened to the recent developments fromthe specialists in the field. Laboratory and endocrine specialists as well as assistants,lecturers and university students in the field of health and manypeople from all walks of life who are interested in the issueshowed great interest in the symposium organized with the

valuable support of Ege University and the Municipality ofBornova. The main goals of the symposium included:• Having the scientists and specialists working in the field of

laboratory and clinic come together and share the recentdevelopments.

• Taking the steps with the representatives of the relatedadministrative and scientific institutions for an action plandirected towards community health care in preventing theoccurrence or progression of insulin resistance.

• Increasing the awareness about the issue by informing thepublic with the light of the scientific developments about thepreventive measures that could be taken in daily life.

Page 8: Happy Holiday Season

Within this framework, the symposium included 2 plenaries, poster andoral presentations as well as a panel and a Public Conference. The firstplenary was given by Prof. Dr. Aytekin Oğuz (the Founding and thecurrent President of the Metabolic Syndrome Association) who with hishumorous and vibrant speech, clarified the recent clinical approach tothe problem.The second plenary titled “The tests used in the diagnosis and follow­up of insulin resistance” was given by Assoc. Prof. Dr. Özlem Gülbaharwho compared the up­to date analyses commonly required in themedical biochemistry laboratories for metabolic syndrome and insulinresistance cases. Her informative and awareness rising talk on thenecessity of questioning the reliability of the insulin level measurementmethods in particular led to a fruitful discussion among the participants. During the Public Conference within the symposium, the dietician TaylanKümeli who has given conferences on diet on many internationalplatforms gave tips on diet in order to maintain a healthy life againstinsulin resistance and metabolic syndrome. Kümeli also answered anumber of questions from the audience and established an importantand warm interaction in terms of public health. An encouraging surprise of the public conference was the energetic andthe moving performance of the Ege University Medical Doctors Zumbagroup who performed to emphasize the preventive importance of activelife against insulin resistance. The performance was welcomedimmensely by the audience and attracted great attention.All the papers selected by the Symposium Scientific Program Committeeto be presented as a poster or oral presentation in the symposium willbe published in the special supplement of Turkish Journal ofBiochemistry indexed within the scope of SCI­Expanded. Doğan Yücel, the head of Turkish Biochemical Society; Dildar Konukoğlu,The Head of the Association for Clinical Biochemistry Specialists andBekir Keskinkılıç, as the Deputy Head of Turkey Public Health Institutionin the Ministry of Health as well as Prof. Oğuz participated in the last

BULGARIAN SOCIETY CLINICAL LABORATORY

Prof. Dobrin A. Svinarov (Dept of Clinical Laboratory &Clinical Immunology, Alexander University Hospital, Facultyof Medicine at the Medical University of Sofia) is the newPresident of the Bulgarian Society Clinical Laboratoryreplacing Prof. Kamen Tzatchev. Prof. Svinarov will act alsoas EFLM National Representative. A warm welcome to Prof.Svinarov and a thanks to Prof. Tzatchev for his collaborationand support to EFLM activities during these past years..

DANISH SOCIETY OF CLINICAL CHEMISTRY

Dr. Lise Bathum (Dept. of Clinical Biochemistry, Amager andHvidovre Hospital) is the new President of the DanishSociety of Clinical Chemistry replacing Dr. Henrik L.Jorgensen while Dr. Malene Bjerregaard Pass (Dept. ofClinical Biochemistry, Sjællands Universitetshospital,Roskilde) is the new EFLM National Representative replacingDr. Peter H. Nissen. A warm welcome to Dr. Bathun and Dr.Bjerregaard Pass and a thanks to Dr. Jorgensen and Dr.Nissen for their collaboration in these past years.

NETHERLANDS SOCIETY FOR CLINICAL CHEMISTRY AND LABORATORYMEDICINE

Dr. Claudia Pronk­Admiraal (Atalmedial, Amsterdam) is thenew EFLM National Representative for the NetherlandsSociety for Clinical Chemistry and Laboratory Medicinereplacing Dr. J.W. Hans Janssen. A warm welcome to Dr.Pronk­Admiraal and thanks to Dr. Janssen for hiscollaboration and support to EFLM activities during thesepast years.

The EFLM Newsletter n. 6/2017 8

panel titled “The approach of the stakeholders towards insulinresistance”.As a gratifying outcome of the Insulin Resistance Symposium,all presentations, discussions, opinions and suggestions weretaken into consideration for creating a health strategy andpolicy against insulin resistance and related health problemsin Turkey.

Figure 1Group Photo: Insulin Resistance Symposium in İzmir­Turkey on March 22, 2017.

Figure 2Ege University Medical Doctors Zumba Group.

Change of the Guard inEFLM National Societies

NEWS ABOUT NATIONAL SOCIETIES

Page 9: Happy Holiday Season

The EFLM Newsletter n. 6/2017 9

Calendar of EFLM events and events under EFLM auspices12 December 20177th International Conference on Quality of Medical LaboratoriesBrdo pri Kranju, Slovenia www.szkklm.si

May 2018The order of drawEFLM webinaronline https://elearning.eflm.eu/

19 December 2017Laboratory hemostasisEFLM webinaronline https://elearning.eflm.eu/course/info.php?id=22

9­12 May 20182nd Congress of the Romanian Association of Laboratory Medicine(RALM)Bucharest, Romania http://www.raml­conference.ro/

19­21 December 2017The First International Congress on BiomedicineTehran, Iran www.icb2017.com

23­25 May 2018XXI Serbian Congress of Medical Biochemistry and LaboratoryMedicine with international participationBelgrade, Serbia www.dmbj.org.rs

23 January 2018Faecal haemoglobin: newer approaches to screening and diagnosisof colorectal diseaseEFLM webinaron­line https://elearning.eflm.eu/course/info.php?id=30

6­8 June 2018Focus 2018 – Annual Meeting of the ACBManchester, UK www.acb.org.uk/focus

27 January 2018EFLM WG­PRE venous blood sampling projectEFLM webinaronline https://elearning.eflm.eu/enrol/index.php?id=31

10­13 June 201841st European Congress of Cytology (ECC 2018)Madrid, Spain http://www.cytology2018.com/

8­9 February 2018International Congress on Quality in Laboratory MedicineHelsinki, Finland https://www.labquality.fi/en/eqas/labquality­days­congress/

12­15 June 2018XXXVI Nordic Congress in Clinical ChemistryHelsinki, Finland http://www.nfkk2018.fi/

28 February ­ 1 March 2018EFLM­AACB Course on Test EvaluationAssessing the value of biomarkers: an interactive workshopSidney, Australia https://www.aacb.asn.au

18­19 June 20182nd EFLM Strategic ConferenceThe end of laboratory medicine as we know it? Handling disruption of laboratory medicine in digital healthMannheim, Germany www.eflm.eu

28 February ­ 2 March 20183rd Turkish in vitro Diagnostic (IVD) Symposium: “Endocrine Disordersand Metabolic Diseases; Biomarkers for Diagnosis and Treatment”Izmir, Turkey http://www.ivd2018.org

21­22 June 20187th International Symposium on Critical Care Testing and BloodGasesAntibes, France http://www.criticalcaretesting­antibes2018.eu/

March 2018How to perform tube validation?EFLM webinaronline https://elearning.eflm.eu/

September 2018Catheter collectionEFLM webinaronline https://elearning.eflm.eu/

6 March 2018Reliable estimates of biological variation – the way forwardEFLM webinaronline https://elearning.eflm.eu/course/info.php?id=12

30 September ­ 3 October 20189th Santorini Conference "Systems Medicine and PersonalisedHealth & Therapy ­ The Odyssey from Hope to Practice"Santorini, Greece www.santoriniconference.org

27 March 2018M­protein diagnostics of multiple myeloma patients treated withbiologicsEFLM webinaronline https://elearning.eflm.eu/course/info.php?id=23

10­13 October 20185th EFLM­UEMS Joint Congress Laboratory Medicine at the clinical interfaceAntalya, Turkey

15­19 April 201811th International Symposium on Pneumococci and PneumococcalDiseases (ISPPD­11)Melbourne, Australia http://isppd.kenes.com/2018

November 2018Pre­analytical mysteriesEFLM webinaronline https://elearning.eflm.eu/

20­23 April 201811th International & 16th National Congress on QualityImprovement in Clinical LaboratoriesTehran, Iran http://www.iqctehran.ir

22­23 March 20195th EFLM­BD European Conference on Preanalytical PhaseBiannual Conference organized by the EFLM Working Group on"Preanalyical Phase" in collaboration with BD Zagreb, Croatia http://www.preanalytical­phase.org/

19­23 May 2019EuroMedLab 201923rd IFCC­EFLM European Congress of Clinical Chemistry and Laboratory Medicine