Foreword Measurement Uncertainty in Medical ... - dmbj.org.rs · uncertainty that derives from the accumulated uncertainty of the corresponding traceability chain: uncertainty of

Issue n. 5/2017

EFLM Connects National Societies of Clinical Chemistryand Laboratory Medicine and Creates a Platform for allEuropean “Specialists in Laboratory Medicine”

In this issue:

In this current issue of the EFLM EuroLabNews FedericaBraga presents Measurement Uncertainty in MedicalLaboratories in the regular section of Laboratory HotTopics. Ana­Maria Simundic, EFLM EB Secretary deliversthe minutes of the Ninth EFLM General Meeting atAthens this year. Daniel Rajdl, Chair of the WG onDistance Education and e­learning, presents theforthcoming EFLM webinars. Ozkan Alatas, Chair ofCongress Organizing Committee and President ofTurkish Society of Clinical Biochemistry, invites all toparticipate in the 5th EFLM­UEMS European JointCongress in Laboratory Medicine ­ “LaboratoryMedicine at the Clinical Interface”, in Antalya, Turkey inOctober, 2018. Snežana Jovičić, from the Society ofMedical Biochemists of Serbia, covers the 13th EFLMSymposium for the Balkan Region. MariaStella Graziani,Chair of the EFLM Communications Committee,presents recent additions to the EFLM publications list.Heike Jahnke, CCLM Editor offers free access to all newCCLM articles for 3 days following publication. As aregular column of the EuroLabNews, news fromNational Societies of Italy, Spain and Kosovo give us aninsight into their activities. Attendees may mark theircalendars to attend stimulating meeting as mentionedin the Calendar of Events.

Forewordby Harjit Pal Bhattoa, Editor EFLM EuroLabNews

Hot topics in Laboratory Medicine Measurement Uncertainty in Medical Laboratories:Friend or Foe?

News from EFLM Executive Board Minutes from 9th EFLM General Meeting, Athens 2017

News from EFLM Committees EFLM webinars

EFLM events

Updates on EFLM Publications list

The EFLM Office Informs

News from EFLM National Societies

Calendar of EFLM events and events under EFLMauspices

In Laboratory Medicine a measurement is moreaccurate when it offers a smaller analytical error.An important assumption behind the uncertaintyconcept is that the bias (or systematiccomponent of the measurement error) should beappropriately eliminated. To this aim, it isessential to define a reference measurement

system describing a traceability chain, permitting a reliable transfer ofthe measurement trueness from the highest hierarchical levels of thechain to field methods. When measurement procedures operate underunbiased conditions, they produce results having an associateduncertainty that derives from the accumulated uncertainty of thecorresponding traceability chain: uncertainty of the higher­orderreference material used to transfer trueness, uncertainty of assaycalibrator, and uncertainty due to the measurement random effects (i.e.,imprecision of the measuring system and performance of individuallaboratory using it) (Figure 1).

To be continued on page 2

Measurement Uncertaintyin Medical Laboratories:Friend or Foe?

by Federica Braga, Research Centre for MetrologicalTraceability in Laboratory Medicine (CIRME), Univer­sity of Milan, Milan, Italy

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.

The measurement uncertaintyobtained by combining thoseindividual sources is calledcombined uncertainty. Bymultiplying the combineduncertainty by the so­calledcoverage factor (k), one obtains theexpanded measurementuncertainty (k = 2 is recommendedfor a 95% confidence level).

The estimation of measurementuncertainty for clinical laboratoriesis needed to obtain theaccreditation according to ISO15189:2012 standard. Althoughlaboratorians may easilyunderstand the meaning, thedetermination of measurementuncertainty in actual practice maybe difficult given that this standarddoes not clarify how it should bedetermined. In 2012, the Clinicaland Laboratory Standards Institute(CLSI) published a guideline aboutmeasurement uncertainty, wherethe two available approaches toestimate the measurementuncertainty, the so­called“bottom­up” and “top­down”approaches, were described. The“bottom­up” approach is the

model originally proposed by the‘Guide to the Expression ofUncertainty of Measurement(GUM)’, based on a comprehensivedissection of the measurement, inwhich each potential source ofuncertainty is identified, quantifiedand combined to generate acombined uncertainty of the resultusing statistical propagation rules.This model has been endorsed bymetrology institutes and suppliersof reference materials and must beused by reference measurementlaboratories to obtain accreditationaccording to ISO 17025 and ISO15195 standards for performingreference measurementprocedures. The application ofGUM in clinical laboratories is,however, not straightforward andhas encountered many practicalproblems and objections. The “top­down” approach represents analternative to the GUM model. Itestimates the measurementuncertainty of laboratory results byusing quality control data to derivethe random components ofuncertainty and certified referencematerials for bias estimation.Some experimental studies have

demonstrated that the two approaches give equivalentestimates of uncertainty, so that clinical laboratories mayuse the simpler “top­down” approach to determinemeasurement uncertainty of their methods used in dailypractice.

Once the combined uncertainty has been estimated, eachuser should compare it with the appropriate analyticalperformance specifications. The analytical goal that shouldbe considered by laboratorians to evaluate the clinicalacceptability of the measurement uncertainty for a givenmeasuring system is that related to the reproducibility (read‘imprecision’), as the correct transfer of trueness along theselected metrological traceability chain should allow theobtainment of unbiased results. To allow clinical laboratoryfulfilling the performance analytical specifications to provideclinically reliable patient results, it is necessary that thesources of uncertainties at the level of reference providersand in vitro medical diagnostics calibrators are sufficientlylimited. Particularly, it is advisable to consume no more than50% of the allowable total uncertainty budget at the levelof the commercial calibrators to leave the remaining part ofthe budget for the measuring system imprecision (includingthe lot­to­lot variation of reagents) and individual laboratoryperformance.

In the traceability era, estimating measurement uncertaintyand verifying that it fulfils the established budget at eachlevel of the selected metrological traceability chain isessential to guarantee the reliability of the laboratory resultsand to avoid that the measurement error prevails on theassociated clinical information. Ultimately, it is matter ofpatient safety. The next International Meeting (the 11th ofthe series) organized by CIRME, taking advantage from thepresence of recognized experts in the field, is expected tofurther contribute spreading knowledge about this topic.

Figure 1. Sources of combineduncertainty in traceabilityimplementation.U result, combineduncertainty of patient result;U2ref, uncertainty of thehigher­order referencematerial; U2cal, uncertainty ofassay calibrator; U2random,uncertainty due to themeasurement random effects.

The EFLM Newsletter n. 5/2017 2

11th International Scientific MeetingMeasurement Uncertainty in Medical Laboratories:

Friend or Foe?Milano, Italy

November 30th, 2017Click here to access the full programme

The conference at its 11th edition will deal with the widelydiscussed topic of the Measurement Uncertainty inLaboratory Medicine, including the definition of acceptablelimits for the combined uncertainty budget in theimplementation of metrological traceability, the role of totalerror in the uncertainty era, the information onmeasurement uncertainty to be communicated to cliniciansand how, the definition of uncertainty of referencemeasurement procedures, the value­assignment protocolfor the uncertainty of commercial calibrators, and thederivation of the uncertainty information from qualitycontrol data. Key note speakers: F. Braga (IT), F. Ceriotti (IT),A. Mosca (IT), M. Panteghini (IT), Mario Plebani (IT), W.Oosterhuis (NL), T. Orzechowski (US).

Secure your space at the next

CIRME meeting!

11th International Scientific Meeting

Uresult = (U2ref + U2

cal + U2random)

½

The EFLM Newsletter n. 5/2017 3

1. Opening and welcome

The EFLM President, Sverre Sandberg (SS), greeted the audienceand welcomed delegates to the General Meeting (GM) in Athens.SS pointed out that IFCC proposal shall not be discussed,because it will first be elaborated in more details within IFCC.Once EFLM receives a well elaborated proposal, it will bediscussed among EFLM members.SS announced a small break before the elections, to allow alldelegates who were out at other meetings, to come for voting. SS reminded all attendees that EFLM is 10 years old and that oneof the founders of EFLM was Vic Blaton, who sadly passed awayearlier this year and who had the idea that there should be oneorganization within Europe and that therefore EC4 and FESCshould be merged.SS called for one minute of silence to memorize the legacy ofVic Blaton.

2. Approval of the minutes of the previous GM

No matters arising from the minutes of the last GM in Paris, June2015. Minutes were approved.

3. President’s report

SS provided an overview of the recent EFLM activities, since thelast GM in Paris. SS said that EFLM is representing laboratorymedicine in Europe and that EFLM is doing what NSs wants it todo. SS called all participants to send their proposals for futureactions and activities to EFLM.Furthermore, SS pointed out that the goal of EFLM is to includerepresentatives from all EFLM NSs in different functional units.SS encouraged all NSs to engage more in the work of EFLM andinvited all countries who are not represented yet within theEFLM, to send their nominations to various WGs. SS again reminded NSs why there was a change in bylaws. Hecontinued by emphasizing that EFLM is trying to make a newimage. SS called all participants to let us know if there are somethings which we need to do better. The inclusion of EC4 into the EFLM structure was successfullymanaged and SS explained how it was done and why is itimportant. Furthermore, he gave a brief overview of the ongoingand future projects within EFLM. At the end of his presentation, SS thanked all EFLM officers whovoluntarily contribute to EFLM for their hard work.There were no comments. The report was endorsed.

4. Treasurer’s report

Huib Storm (HS), EFLM Treasurer, gave a report on the following:1. Audit2. Balance sheet 20163. Internal budget 2016Audit of the EFLM financial matters for 2016 had been done inaccordance with GAAP (General Accountant Audit principles) bythe certified auditor. The audit was successful and EFLM hasobtain a certificate proving that EFLM accounts are maintainedfully in accordance with the Belgian law and GAAP.HS presented the Balance sheet for 2016 according to BelgianGAAP and invited EFLM NSs for its approval. GM has approvedthe accounts by General Meeting (which constitutes the

discharge for EB members).HS has also presented the Internal Budget 2017 and asked forits formal approval.EFLM GM approved the Internal budget with 25/25 votes in favour.

5. Election Executive Board 2018­2019

Mauro Panteghini, the Past President (MP) has briefly explainedthe procedure of elections for the EB members. According tocurrent EFLM membership, the quorum is 21 members. Duringthe voting procedure there were 25 NSs present. Majorityrepresents 13 votes.All decisions are made by a simple voting (majority of votespresent). ­ Ana­Maria Simundic was the only candidate and was elected

by acclamation as EFLM President­elect.­ Giuseppe Lippi was the only candidate and was elected by

acclamation as EFLM Secretary­ Huib Storm was the only candidate and was elected by

acclamation for a second two­years term as EFLM Treasurer(third term)

Candidates for 2 Member­at­large positions were:• Prof. Tiago GUIMARAES (Portugal)• Prof. Grazyna SYPNIEWSKA (Poland)• Prof. Michel LANGLOIS (Belgium)• Prof. Tomas ZIMA (Czech Rep)Thus, for Member­at­large there were 4 candidates and acandidate needs more that 50% of votes. If nobody has themajority, the candidate who has the lowest number of votes isleft out and there is another round of voting, until somecandidate gets a majority of votes.As there were 4 candidates for 2 Member­at­large positions, MPinvited GM members to first vote for a first position.

1. Member­at­large position

Two candidates had the same lowest number (5) of votes(SYPNIEWSKA and LANGLOIS). MP said that according to theprocedure there should be another voting round, but he said thatNSs could also decide to exclude two last candidates with the leastnumber of votes. NSs voted for the preferred choice and 20/25 NSs were in favourof dropping last two candidates. As Tiago Guimaraes had receivedthe majority of votes, out of the two remaining candidates, he waselected for the first Member­at­large position.

2. Member­at­large position

Minutes taken by Ana­Maria Simundic, EFLM EB Secretary

Presentations and documents referred to in these minutes can be viewed and downloaded from EFLM’s website:https://www.eflm.eu/site/page/a/1058/

NEWS FROM EFLM EXECUTIVE BOARD

Ninth EFLM General MeetingMinutes

Athens (Greece) ­ 11 June 2017 14.00­17.40 Hilton Hotel – Galaxy Meeting Room

Candidate number of votes (1 round)

number of votes (2 round)

Grazyna SYPNIEWSKA 5 left out

Tiago GUIMARAES 9 14

Tomas ZIMA 6 11

Michel LANGLOIS 5 left out

Candidate number of votes

Grazyna SYPNIEWSKA 3

Tomas ZIMA 13

Michel LANGLOIS 9

As Tomas Zima had received the majority of votes, he was elected for thesecond Member­at­large position (third term).

6. Membership ­ National Societies

• Application of the Kosovan Association for Clinical Chemistry as FullIFCC Member

Kosovo has been accepted as IFCC Full Member. Therefore theirmembership is, in accordance with the EFLM bylaws, automaticallyupgraded from Affiliated to Full membership. AMS has briefly informedthe NSs about that.

• Slovak Society for Laboratory Medicine (SSLM) has requested tobecome an Provisional Member

Slovak Society for Laboratory Medicine has applied for Provisionalmembership and has submitted all necessary documents. This is a subjectto voting by the EFLM NSs. This decision has been voted for by 25/25 votes.

7. Reports from Committee chairs

Reports about the past and ongoing activities within the EFLM functionalunits were given by the Science Committee (E. Kilpatrick, C­S Chair),Profession Committee (G. Wieringa, C­P Chair), Quality & RegulationsCommittee (W. Huisman, C­Q­R Chair), Education & Training Committee(R. Lichtinghagen, C­ET Chair) and Communication Committee (M.Graziani, C­ET Chair). Power point presentations with reportscan be viewed and downloaded from EFLM’s website:https://www.eflm.eu/site/page/a/1058/.There were several questions asked from the audience.

Q: Hans Janssen (NL): asked how C­S chair is seeing the necessity tohave internationally acceptable standards and documents. How do weplan to work with the rest of the world? C­S chair replied that producing standards and recommendations isviewed as an important activity within EFLM. He stated he was due tomeet Philippe Gillery, Chair of the IFCC Scientific Division, later duringthe Athens meeting to ensure a co­ordinated approach to these activitiesand where there was any overlap that this be approached jointly. TheEFLM will hopefully also be able to ‘adapt or adopt’ some existingexcellent guidelines from its constituent national societies.

Q: Ian Young (UK): asked about the position of C­P and EFLM regardingthe Brexit? GW: replied that we should stop talking about EU and start talking aboutEurope.

Q: Ferruccio Cerriotti (IT): asked whether EFLM Syllabus is published. C­P chair replied that version 5 is almost complete and shall soon (withinnot more than 4 months) be made available to all NSs. It will besubmitted for publication by the end of 2017.

Q: Ferruccio Cerriotti (IT): reiterated the request to NSs to respond to

The EFLM Newsletter n. 5/2017 4

NEWS FROM EFLM COMMITTEES

EFLM WEBINARSby Daniel Rajdl, Chair of the EFLM WG Distance Education ande­Learning

surveys. SS added that EFLM needs feedback from itsmembers. EFLM NSs members are kindly requested torespond to various EFLM requests and share with EFLM theirviews and needs.

No further questions were raised.

8. Report from IFCC

Maurizio Ferrari (MF) has given a report about the past andongoing activities within the IFCC. Power point presentationwith this report can be viewed and downloaded from EFLM’swebsite: https://www.eflm.eu/site/page/a/1058/.He emphasised the intense activity of various IFCC units anddifficulties in managing and supervising their work. Thenumber of Task forces has increased and they are not understrict control. It was therefore decided to maintain very fewtask forces and move all other under the divisions. To achievethat, some new divisions shall be created. One new divisionshall be Emerging technology division. The chair will beSergio Bernardini. IFCC shall communicate all these changeswith its members in a timely manner.No questions were raised.

9. Date and place of the next EFLM GM

The next GM shall take place in October 2018 in Antalya. The exact time and date shall be communicated soon.GA was closed at 18:00.

Save the new GM date in your agenda: at the last EB meeting,it was decided to schedule the next GM in Mannheim,Germany on 19 June 2018 from h. 16.00 to 19.00 (instead ofAntalya) on occasion of the 2nd EFLM Strategic Conferencewhich will be held on 18 an 19 June (further information willfollow in due course).

The EFLM WG “Distance Education and e­Learning” incollaboration with the EFLM WG “Congress and Post­Graduate Education” are pleased to inform about next EFLMwebinars. The attendance to EFLM webinars is free of charge.For those not able to attend, the recording of all EFLMwebinars is available on at the new EFLM e­learning platformhttps://elearning.eflm.eu

October 18, 2017 at h. 18.00 CET (new final scheduled date compared to the first one announced)

HEPATIC FIBROSIS ASSESSMENT USING MULTIPARAMETRICBIOMARKER TESTS

Speaker: Ralf Lichtinghagen (DE)Moderator: Merve Sibel Gungoren (TR)

Abstract: The stage of fibrosis is the most important singlepredictor of significant morbidity and mortality in chronicliver disease. The mechanisms leading to fibrosis andeventually cirrhosis are thought to be similar, irrespective of

The EFLM Newsletter n. 5/2017 5

the underlying etiology. At cellular level, hepatic stellate cells(HSC) undergo a phenotypic switch usually addressed astransactivation. Activated HSC are regarded as the main sourceof extracellular matrix (ECM) in the fibrotic liver. Additional celltypes namely fibroblasts and myofibroblasts may alsocontribute to ECM deposition. Despite the similarities inpathophysiology at cellular level, morphogenesis and histologicappearance of the fibrotic liver may differ according to theetiology. Liver biopsy remains the gold standard to evaluateliver fibrosis. Not least, one has to keep in mind that liver biopsyprovides additional information like histological grading andetiology that may be overlooked when surrogate markers areused. Ideally, those tests should answer two questions. 1) Whatis the stage of fibrotic organ damage (i.e. the amount ofdeposited ECM and the disturbed balance of hepaticmicroarchitecture)? 2) What is the net balance between ECMdeposition and degradation (i.e. the dynamics of ECMturnover)? The former serves to evaluate the prognosis andindicate therapy, while the latter might be used to control theefficacy of treatment with regard to disease progression. Manydifferent parameters including standard clinical chemistry andparameters of matrix metabolism have been evaluated. In thelast decade, markers were assembled to multiparametric scores.Here, we can distinguish scores assembled of standard clinicalchemistry markers (e.g. aspartate aminotransferase­to­plateletratio index, FibroTest, Forns’ index) from scores using circulatingmarkers of hepatic matrix metabolism like hyaluronic acid (HA),tissue inhibitor of metalloproteinases­1 (TIMP­1), matrixmetalloproteinase­2, propeptide of type III procollagen (PIIINP).In the webinar we will learn further details about the relevantcomplex scores, the clinical evaluation and current practicalguidelines.About the speaker: Prof. Dr. Ralf Lichtinghagen obtained hisdoctorate at Ruhr University Bochum in the field ofNeurobiochemistry in 1989. At the beginning of the 1990s heundertook further training at Hannover Medical University(Institute of Clinical Chemistry) to qualify as a EuropeanSpecialist in Laboratory Medicine. He carried out differentresearch projects on the pathophysiology of the extracellularmatrix in chronic liver disease and acquired his authorization toteach Clinical Chemistry at the university in 2001. Today his mainareas of research are molecular diagnostics and newbiomarkers. In addition to his responsibilities in patient care andresearch he gives lectures in Clinical Chemistry / LaboratoryDiagnostics and is the academic head of the Medical LaboratoryAssistants School. Prof. Lichtinghagen is a chair of EFLMEducation and Training Committee since 2016.

November 7, 2017 at h. 18.00 CET

THE DEVELOPMENT OF GUIDELINES AND RECOMMENDATIONS FORPERIPHERAL BLOOD FILM REVIEW INTERNATIONALLY

Speaker: Anna Merino (ES)Moderator: to be defined

Abstract: not yet available.About the speaker: Anna Merino González MD, PhD is a Seniorconsultant of cytology unit of Hemotherapy­HemostasisDepartment in Hospital Clinic of Barcelona. Her main researchinterests are: morphology and identification of hematopoieticprogenitor cells using flow cytometry, external quality programsin peripheral blood smear and automatic classification ofabnormal peripheral blood cells. She has written 2monographies and more than 80 articles in scientific journalswith H­index 17. She is also a corresponding member of EFLMWorking Group Distant Education and e­Learning.

November 14, 2017 at h. 18.00 CET

HARMONIZATION OF PREANALYTICAL PHASE IN EUROPE

Speaker: Ana­Maria Simundic (HR)Moderator: João Tiago Guimarães (PT)

Abstract: European National Societies, members of EFLM, haveagreed in Porto, during the 3rd EFLM­BD European PreanalyticalPhase Conference that harmonization of preanalytical practicesand policies is necessary and possible in each and every countryin Europe as well as internationally, at the European level. TheWorking group for Preanalytical phase (WG­PRE) of theEuropean Federation for Clinical Chemistry and LaboratoryMedicine (EFLM), has taken the leading role in this process. Theaim of this e­seminar is to present past, ongoing and future WG­PRE activities and various projects which aim is to improve thequality of preanalytical phase in Europe as well as to promotewide harmonization of preanalytical practices, patient safetyimprovement and reduction of unnecessary waste andhealthcare expenses.About the speaker: Since 2011, Prof. Simundic is the Chair ofthe EFLM working group for Preanalytical phase (WG­PRE), since2011 and also serves as EFLM (European Federation of ClinicalChemistry and Laboratory Medicine) Executive Board Secretary.Moreover, Prof. Simundic is the President of the Croatian Societyof Medical Biochemsitry and Laboratory Medicine and theEditor­in­chief of the Scientific Journal Biochemia Medica, whichis the official Journal of Croatian society. During her career, shehas published over 100 scientific papers and several bookchapters and has been invited as a guest speaker at numerousinternational meetings and conferences. She was awarded withthe: Best Young Scientist award in 2000, Best Research award for2011 by the Croatian Society of Medical Biochemistry andLaboratory Medicine, “Per Hyltoft Petersen Award” in 2012, bythe Slovak Society of Laboratory Medicine, Honorarymembership of the Hungarian Society for Laboratory Medicinein 2012. Currently, Prof. Simundic serves as the Head of theDepartment for Medical Laboratory Diagnostics of the ClinicalHospital Sveti Duh and teaches Clinical Chemistry at theUniversity of Pharmacy and Medical Biochemistry in Zagreb.

December 19, 2017 at h. 18.00 CET

LABORATORY HEMOSTASIS

Speaker: Giuseppe Lippi (IT)Moderator: to be defined

Abstract: Hemostasis is a complicated mechanism finalized topreventing unjustified bleeding during vascular injury, orunwarranted thrombosis when the vessels are substantiallyintact. Hemostasis is typically classified in two essential steps.The first event is an endothelial injury, which activates primaryhemostasis and is then followed by activation of secondaryhemostasis. Specifically, primary hemostasis develops withrecruitment of a many platelets being at site of vascular injury.Platelets are subjected to a sequential process of activation,adhesion and aggregation. This initial hemostatic plug ishowever unstable, since it is vulnerable to fast dissolution withinin the local blood, especially in arteries. To prevent dissolution,additional fundamental mechanisms of secondary hemostasis(also known as blood coagulation) are activated, with the aim tostabilize the initial plot by large fibrin deposition.The diagnostics of bleeding disorders of primary and secondaryhemostasis remains a challenge for laboratory professionals,especially those lacking experience background, experience andskill on this topic. Bleeding is essentially due to many acquiredor congenital conditions, impairing either primary or secondaryhemostasis. A universal consensus on the diagnostics ofbleeding diseases remains an unmet target, so that the aim of

this Webinar is providing practical guidance for laboratory professionalswho are less familiar with this important area of in vitro diagnostic testing.A practical strategy for diagnosing bleeding disorders of primary andsecondary hemostasis is necessarily based on a multifaceted andmultistep strategy, entailing accurate personal and family historycollection, interpretation results of the so­called first­line hemostasistests, then followed by interpretation (when necessary) of second­ andthird­line test to identify the both nature and severity of bleeding disease.The observation of profound hemorrhages rather than muco­cutaneousbleeding suggests a disorder of secondary hemostasis. Although positivefamily history can be frequently seen in patients with congenital disorders,the absence of clinically significant symptoms in relatives cannot beconsidered always suggestive of acquired disorders. The next phase isbased on performance of the so­called first­line coagulation tests, mainlyrepresented by activated partial thromboplastin time (APTT), prothrombintime (PT) and fibrinogen, especially when the family history is notindicative of specific factor deficiencies. The observation of abnormalresults of these tests and the combination of results can help drivingperformance of the so­called second­line tests, which especially entailclotting factor assays. The so­called third­line tests (especially entailingimmunologic tests of coagulation factors and molecular biology) are thenuseful to make a final diagnosis and/or for detecting the specific natureof the protein deficiency.About the speaker: Giuseppe Lippi was born in Padova (Italy) on October4th, 1967. He has taken the degree in Medicine in 1986 and thespecialization in Clinical Biochemistry and Laboratory Medicine in 1992.He currently serves as Full Professor of Clinical Biochemistry andMolecular Biology at the University of Verona (Italy) and Director of theClinical Chemistry and Haematology laboratories of the UniversityHospital of Verona (Italy). He has published more than 1400 articles inpeer­reviewed journals, his total Impact Factor is over 5300 and the HirschIndex (H­index) is 72. He has participated to more than 500 national andinternational congresses and has given more than 250 lectures to nationaland international meetings. In 2017 he has been appointed as Secretaryof European Federation of Clinical Chemistry and Laboratory Medicine(EFLM). He has been awarded with the 2014 Management Sciences andPatient Safety Division Award of the American Association for ClinicalChemistry (AACC) for outstanding contributions in the field of patientsafety in the clinical laboratory/healthcare industry, and with the 2015Outstanding Speaker Award by the AACC. He has also received researchgrants from the European Community and from the Regional Heath CareService. Giuseppe Lippi is Editor in Chief of “Annals of TranslationalMedicine” and “Journal of Laboratory and Precision Medicine” and alsoserves as Associate Editor of the journals “Clinical Chemistry andLaboratory Medicine”, “Seminars in Thrombosis and Hemostasis” and“Diagnosis”, is the National Representative of the Italian Society of ClinicalBiochemistry and Laboratory Medicine (SIBioC) and member of theEuropean Federation of Laboratory Medicine (EFLM) Working Group onPreanalytical Variability (WG­PA). The main fields of research include pre­analytical variability, analytical and clinical validation of biomarkers,

diagnostics of the acute coronary syndrome, metabolism oflipoproteins and relevant assay methods, frailty, diagnosisand management of disorders of hemostasis..

January 23, 2018 at h. 18.00 CET (preliminary date)

FAECAL HAEMOGLOBIN: NEWER APPROACHES TO SCREENING ANDDIAGNOSIS OF COLORECTAL DISEASE

Speaker: Callum G. Fraser (UK)Moderator: Sally C Benton (UK)

Abstract: not yet available.About the speaker: Prof. Fraser graduated BSc and PhDfrom the University of Aberdeen. After a year of postdoctoralwork in the National Research Council of Canada in Ottawa,he returned to the University of Aberdeen as Lecturer inChemical Pathology. From 1975, he was Chief ClinicalBiochemist at the then new Flinders Medical Centre in SouthAustralia and Honorary Senior Lecturer in ClinicalBiochemistry in the Flinders University of South Australia,later Associate Professor. He returned to Scotland in 1983and was Director of Biochemical Medicine, NHS Tayside, andHonorary Senior Lecturer in the Universities of Dundee andSt Andrews. He is currently Consultant to the ScottishColorectal Cancer Screening Research Unit; HonoraryProfessor, Centre for Research into Cancer Prevention andScreening, University of Dundee, and Honorary ConsultantClinical Biochemist, NHS Tayside. He has published over 300papers, 11 book chapters and two monographs,*Interpretation of Clinical Chemistry Laboratory Data” andthe best­selling “Biological Variation: From Principles toPractice”: both books have been translated into Spanish andthe second into Japanese, Russian and Italian also. He hasserved on many regional, national and internationalprofessional bodies. Over the last 15 years, he has beenheavily involved in the setting up of the UK Colorectal CancerScreening Pilot, the development and roll­out of the ScottishBowel Screening Programme and the assessment of newerfaecal tests. He is a founding Member of the Expert WorkingGroup on Faecal Immunochemical Tests for Screening of theColorectal Cancer Screening Committee, World EndoscopyOrganization. He has been honoured by the FoundationAward and Honorary Membership of the Association forClinical Biochemistry and Laboratory Medicine. In 2017, hewas awarded with the EFLM­Roche Scientific Award forLaboratory Medicine.

March 6, 2018 at h. 18.00 CET(new final scheduled date compared to the first one announced)

RELIABLE ESTIMATES OF BIOLOGICAL VARIATION – THE WAYFORWARD

Speaker: Aasne Karine Aarsand (NO)Moderator: Bill Bartlett (UK)

Abstract: Biological variation (BV) data has many appliancesin the daily laboratory life, being used both when evaluatingthe diagnosis and monitoring of disease and for settinganalytical performance specifications. Thus, the quality of ourwork directly depends on the reliability of the BV estimatesused as basis for these processes. Widely varying BVestimates are available for different measurands, and it islikely that this may be caused by differences in study designand statistical handling. Addressing this issue, the EFLMestablished in 2014 an EFLM Task and Finish Group (TFG) for

The EFLM Newsletter n. 5/2017 6

Upcoming event: 5th EFLM­UEMS European Joint Congress in Laboratory Medicine “Laboratory Medicine at the Clinical Interface”, October 10­13, 2018

The EFLM Newsletter n. 5/2017 7

by Ozkan Alatas, Chair of Congress Organizing Committee and President of Turkish Society of Clinical Biochemistry

EFLM EVENTS

the Biological Variation Database. The TFG is made up bymembers from the EFLM Working Group on Biological Variation,the Analytical Quality Commission of the Spanish Society ofClinical Chemistry and experts in the area. The TFG hasdeveloped a critical appraisal list for evaluation of studies on BVand this will be used as basis for the setup of a database withmeasures of BV, the derived performance specifications and theevidence behind it.About the speaker: Aasne K. Aarsand, M.D. Ph.D., is a consultantin medical biochemistry at the Norwegian Porphyria Centre(NAPOS) and the Laboratory of Clinical Biochemistry, HaukelandUniversity Hospital and at the Norwegian Quality Improvementof Laboratory Examinations (NOKLUS), Haraldsplass DeaconessHospital, Bergen, Norway. She received her Ph.D. in porphyriadiagnostics from the University of Bergen in 2012. Her researchinterests include the evidence­based use of diagnostic markers,in particular in the porphyrias, biological variation andharmonisation of the total testing process. She is Chair of theBiological Variation Working Group and a member of the Taskand Finish Group for the Biological Variation Database in theEuropean Federation of Clinical Chemistry and LaboratoryMedicine. She is also manager of the European Porphyria Registryand part of the Steering Committee of the European PorphyriaNetwork (EPNET).

March 27, 2018 at h. 14.00 CET (preliminary date)

M­PROTEIN DIAGNOSTICS OF MULTIPLE MYELOMA PATIENTS TREATEDWITH BIOLOGICS

Speaker: Hans Jacobs (NL)Moderator: Jillian Tate (AU)

Abstract: Treatment of multiple myeloma (MM) has substantiallychanged with the recent introduction of therapeutic monoclonalantibodies (mAb) which have further improved the rates anddepth of clinical response. mAb therapy in MM patients has

introduced new challenges in how therapy responses can bedefined. On the one hand, recently approved mAb interfere withroutine M­protein diagnostics. On the other hand, given the highrates of complete responses, new response categories need tobe defined to measure minimal residual disease. As a reactionto these challenges research has focused on adaptations ofconventional M­protein diagnostics to mitigate interference andon the introduction of novel methods that enable theidentification of minimal residual disease. The aim of this e­seminar is to discuss how mAb therapy has changed both thetherapeutic as well as the diagnostic landscape of MM.About the speaker: Dr. J.F.M. (Hans) Jacobs. M.D., Ph.D. worksas Laboratory Specialist Medical Immunology at the RadboudUniversity Medical Centre, Nijmegen, The Netherlands. He isspecialized in onco­immunology, monitoring cancer­immunotherapy trials, and biomarker development for IVDapplications. As head of the national reference centre for M­protein diagnostics at the Radboudumc, dr. Jacobs coordinatesthe Dutch External Quality Assessment program for M­proteindiagnostics since 2012. He is national board member the SKMLsection Humoral Immunology and National board memberKalibration­2000. Within the IFCC framework, dr. Jacobs isinvolved in the harmonization and standardization of M­proteindiagnostics. Dr. Jacobs is co­author of more than 60 internationalarticles and book­chapters. Since 2016 he is member of theeditorial board of ‘Clinical Chemistry and Laboratory Medicine’.Dr. Jacobs teaches immunology courses at the Radboudumc andthe University of Twente.Dr. Jacobs is awarded with: (2017) KWF Young Investigator Grant(Dutch Cancer Society); (2016) Young Investigator Award DutchSociety of Clinical Chemistry; (2016) Research GrantRadboudumc Oncology Foundation; (2013) Kalibration­2000Grant, (2012) Noyons Grant; (2012) ZonMW Veni Grant (TheNetherlands Organisation for Scientific Research)

Secure your place and make your registration now athttps://elearning.eflm.eu

The Joint EFLM and UEMS­LM/MB European Joint Congress inLaboratory Medicine was initiated in October 2010 in Lisbon.Since then, this biannual event gained great attention. 5th EFLM­UEMS European Joint Congress in Laboratory Medicine will beheld in Antalya, Turkey, on October 10­13, 2018 at Titanic BeachLara Hotel by Turkish Society of Clinical Biochemistry. Owing to the theme of “Laboratory Medicine at the ClinicalInterface”, invited speakers are experts from laboratory medicineand clinical medicine as well. Building on the success of previouscongresses, 5th EFLM­UEMS European Joint Congress inLaboratory Medicine will include plenary sessions, symposiums,oral and poster presentations.The Joint Congress will provide an ideal forum to stimulateintense discussions in laboratory medicine as well as to establishcollaborations which is very important for young professionalsin the field.Antalya, the beautiful city on the Mediterranean coast of Turkey,is well known not only with its natural and cultural beauties butalso historical places especially ruins of antic cities. The congressvenue promises the participants take a break from the intensivescientific program and enjoy Turkish cuisine and social program

in the autumn days. Pre and post­congress tours will make yourvisit unforgettable.Only through your kind participation, we may enjoy a fruitfulcongress feast. We are expecting your valuable contributions tothe 5th EFLM­UEMS European Joint Congress in LaboratoryMedicine.

Check out the congress website for more information:http://eflm­uems­antalya2018.org/

The EFLM Newsletter n. 5/2017 8

Thirteen years ago, EuropeanFederation for Clinical Chemistry(EFLM) appointed Belgrade and theSociety of Medical Biochemists ofSerbia as the organizer ofeducational symposia for clinicalchemists and laboratory medicineprofessionals of the Balkan region.These annual symposia have beenorganized with great success in thetwelve previous years, alwayscovering the topics of the greatestcurrent interest in the field ofclinical chemistry and laboratorymedicine. In this manner, this years’EFLM Symposium for BalkanRegion entitled “LaboratoryMedicine Management: LeadershipSkills for Effective Laboratory”successfully fulfilled highexpectations set thirteen years ago.The 13th EFLM Symposium forBalkan Region was held on 21 and22 September, and organizedunder the auspices of theInternational Federation of ClinicalChemistry and LaboratoryMedicine (IFCC), Balkan ClinicalLaboratory Federation (BCLF),Ministry of Education, Science andTechnological Development ofSerbia and Ministry of Health ofSerbia.

During the two­day Symposium,eminent foreign and local expertsintroduced participants to thelatest developments in themanagement in laboratorymedicine, leadership skills oflaboratory medicine professionals,laboratory medicine planning,organization and strategy, medicallaboratory accreditation andcompetence, and laboratorymedicine environmental health andsafety. Also, the optimization of thepost­analytical phase, economy of

consolidation and decentralizationof medical laboratories, how to uselaboratory information system andmanage laboratory data, and alsohow to implement economicevaluation of laboratory testingwere elaborated. Experiencesregarding accreditation processand total quality managementwere discussed, with the accent onthe balance between theaccreditation process and patientsafety, possible errors and risks insample collection, and how toregister frequent pre­analyticalincidents, and efficiently manageunexpected events and accidents.Special attention was given tolaboratory reports form, itscategorization and actions, as wellas to the use of statistics inlaboratory practice.

The 13th EFLM Symposium forBalkan Region opened prof. SverreSandberg, the EFLM President, withthe reminder of the role andcurrent developments in the EFLM.The welcoming word of theSymposium President prof. NadaMajkić­Singh followed, when theparticipants were introduced with

13th EFLM Symposium for Balkan RegionLaboratory Medicine

Management: LeadershipSkills for Effective Laboratory

the Society of Medical Biochemists of Serbia’s activities and thecontents of the previous symposia. The first session of theSymposium was dealing with types of medical laboratories andstrategy. In the first part, the word was about the role oflaboratory medicine in the evolution of medical practice. Prof.Paul Collinson (St George’s Medical School, London, UK) wasthe first speaker, and his inspiring talk was dedicated tolaboratory medicine faced with the evolution of medicalpractice. Since laboratory medicine is an integral part of medicalpractice, medical practice usually lead laboratory medicine, butequally laboratory medicine can be the standard setter andinnovate and develop to support or extend clinical medicalpractice. Prof. Collinson presented examples for the initiative oflaboratory medicine in treatment monitoring, in theintroduction of new tests, in responsiveness to new treatmentstrategies which utilize testing in novel ways, and in its responseto the appearance of new diseases. Prof. Ivan Brandslund(Health Science Faculty, University of Southern Denmark,Hospital Lillebaelt, and Vejle County Hospital, Denmark)followed with his lecture that elaborated principles of leadershipin clinical laboratories, based on the European Foundation forQuality Management Excellence model mixed with a personalexperience of what is necessary and helpful.

In the second part of the first session, the issues in leadershipand management in clinical biochemistry were discussed. DrPer Jorgensen (Copenhagen University Hospital –Rigshospitalet, Denmark) analyzed the influence of the rapidscientific and technological advancements that increase thediagnostic possibilities and change the interfaces among thevarious specialties of laboratory medicine, the increase of thedemands for laboratory tests with demographic changes witha growing elderly population, the increased complexity of thehealth care systems and the more well­informed patients thatcall for improved clinical pathways, the change of the modernEuropean countries from “production societies” towardsknowledge and innovation societies” that increases the needfor integration of research into daily clinical work, as well as theneed for a quicker integration of new knowledge into clinicalpractice. The lecture about the optimization of the post­analytical phase of prof. Sverre Sandberg (University of Bergen,Norway) followed. Prof. Sandberg elaborated this topic fromthe main features of post analytical phase ­ verification ofresults, reflex/reflective testing, report forms, reference limits,reference change values, how to comment test results andreport critical results, to the post­post analytical phase, whichis usually outside the direct influence of laboratory health

EFLM EVENTS

by Dr Snežana Jovičić, Society of Medical Biochemists of Serbia

SVERRE SANDBERG, EFLM PRESIDENTADDRESSES TO THE SYMPOSIUM PARTICIPANTS

SYMPOSIUM LECTURERS: SVERRE SANDBERG, NADA MAJKIĆ­SINGH,BERNARD GOUGET, SNEŽNA JOVIČIĆ, VERA LUKIĆ, NATAŠA BOGAVAC­STANOJEVIĆ, PAUL COLINSON, IVAN BRANDLUND

The EFLM Newsletter n. 5/2017 9

persons. The focus was on how laboratory professionals shouldwork with the post­analytical phases to secure a sensible use oflaboratory and clinical resources.

The second session was dedicated to laboratory medicineplanning and organisation. The evolution of the medicallaboratories in France in the light of economics, managerial andarchitectural challenges were analyzed by prof. Bernard Gouget(Counsellor for Public Health at the Fédération Hospitalière deFrance). The role of laboratory information system (LIS) inlaboratory medicine through an experience and practicalexamples was presented by dr Vera Lukić (Laboratory Departmentat the Railway Healthcare Institute, Belgrade, Serbia), whoevaluated advantages of using LIS, and discussed furtherpossibilities in its use. Laboratory data management and the widerange of possibilities of using the large amount of informationproduced by laboratory information systems, the use of queriesperformed into the laboratory and clinical databases, and theappropriate analytical approeach were presented by dr SnežanaJovičić (Center for Medical Biochemistry, Clinical Center of Serbia,Faculty of Pharmacy, University of Belgrade, Serbia). Prof. NatašaBogavac­Stanojević (Faculty of Pharmacy, University of Belgrade,Serbia) discussed the implementation of economic evaluation oflaboratory testing. The most appropriate tool for quantitativeassessment of the economic value of laboratory testing are cost–effectiveness (CEA) and cost–utility (CUA) analysis. However,recently emerged the multicriteria decision analysis which allowscomparison of diagnostic strategies in terms of benefits,opportunities, costs and risks. All analysis are constructed toidentify laboratory test that produce the greatest healthcarebenefit with the resources available.

The third session was dedicated to the medical laboratoryaccreditation and competence. In this session, total qualitymanagement and accreditation were discussed. First, prof.Matthias Nauck (University of Greifswald, Germany) presented thebenefits and experiences with the EFQM (European Foundation forQuality Management) Excellence Model for Medical Laboratory. Prof. Mario Plebani (School of Medicine, University of Padova,Italy) followed with his talk about the ISO 15189 accreditation inthe sense of navigation between quality management and patientsafety, and its last version oriented on process approach withdetailed division with clearly defined requirements. Prof. Plebanielaborated the benefits of accreditation are standardization of allprocesses, responsibility of each member of team, personal policy,demonstrability of results, systematic evaluation of suppliers,better communication with partners. The accreditation oflaboratories improves facilitation of accurate and rapiddiagnostics, efficiency of treatment and reduction of errors in thelaboratory process. This system of standard procedures has theaim to improve the quality and patient safety, through theverification of examination procedures for imprecision, truenessand diagnostic accuracy, and for estimating measurementuncertainty. Also, the role of quality indicators (QIs) as afundamental requirements of the ISO 15189 was discussed. Prof. Tomáš Zima (First Faculty of Medicine, Charles University andGeneral University Hospital Prague, Czech Republic) continuedwith the lecture about accreditation system, process and benefitsfor laboratories. He stressed that the benefits of accreditation arestandardization of all processes, responsibility of each member ofteam, personal policy, demonstrability of results, systematicevaluation of suppliers, and better communication with partners.The accreditation of labs improves facilitation of accurate andrapid diagnostics, efficiency of treatment and reduction of errorsin the laboratory process.

The last, fourth session in its first part was dealing with thelaboratory medicine environmental health and safety. Prof.Svetlana Ignjatović (Faculty of Pharmacy, University of Belgrade;Centre for Medical Biochemistry, Clinical Centre of Serbia) focusedon the form of laboratory reports, its categorization and actions.Dr Herbert Stekel (General Hospital Linz, Austria) made a review

of possible errors and risks in sample collection, like the correctidentification of the patient, the time of sampling, the samplevolume, the use of additives, and – last but not least –the time oftransportation and the information given to the laboratory. DrZorica Šumarac (Centre for Medical Biochemistry, Clinical Centreof Serbia) presented experience with forming the register offrequent pre­analytical incidents, and efficient management ofunexpected events and accidents. This part of the fourth sessionended with the review of efficient management of unexpectedevents and accidents within laboratory medicine by prof, DuškoMirković (Faculty of Pharmacy, University of Belgrade; Centre forMedical Biochemistry, Clinical Centre of Serbia). In the secondpart, dr Ciprian­Valentin Mihali (“Vasile Goldis” Western Universityof Arad, Romania) presented his work on nanoparticles and otherpollutants emitted by apartment heating appliances fuelled, as animportant public health issue. The Symposium was closed with thetalk of prof. dr Jelena Kotur­Stevuljević (Faculty of Pharmacy,University of Belgrade, Serbia) on the use of statistics in laboratorypractice and its connection to university teaching.

The special lecture was preparedby the students of medicalbiochemistry of the Faculty ofPharmacy, University ofBelgrade, organized in the Teamof Medical BiochemistryStudents, Belgrade PharmacyStudents’ Association. Theirrepresentatives, Ana Đorđevićand Tamara Stamenić,presented their view onlaboratory medicinemanagement and leadership foreffective laboratory, in anoriginal and refreshing way.

The central event of the 13th

EFLM Symposium for Balkan Region was the presentation of theHonorary Diploma of the Society of Medical Biochemists of Serbia,as the highest recognition presented to foreign colleagues, forpromoting Clinical Chemistry and Laboratory Medicine in Europeand globally, and for significant contribution to the work anddevelopment of the Society of Medical Biochemists of Serbia. Itwas awarded, so far, to Prof. Victor Blaton, Prof. Stojan Danev, andProf. Simone Zerah. On thisoccasion, the HonoraryDiploma was awarded tothe distinguished professorMario Plebani for his hugeactivity and greatcontribution to thedevelopment andimprovement of ClinicalChemistry and LaboratoryMedicine at the nationaland international level, aswell as for his contributionto the work anddevelopment of theSociety of MedicalBiochemists of Serbia.

The 13th EFLM Symposium for Balkan region, with over 200participants from Balkan and European countries, fulfilled the highexpectations defined during the previous ones. The presence ofdistinguished lecturers gave very high recognition and prestigeto this Meeting, which influences the development of clinicalchemistry and laboratory medicine in the Balkan region and strivesto focus on the new data in the field of laboratory medicine. Thisis the opportunity to thank them and all the participants foranother successful symposium.

ZORICA ŠUMARAC AND MARIO PLEBANI.RECEIVING SMBS HONORARY DIPLOMA

ANA ĐORĐEVIĆ AND TAMARASTAMENIĆ, PHARMACEUTICALFACULTY STUDENTS PRESENTINGLECTURE “NEXT GENERATIONLEADERS”

The EFLM Newsletter n. 5/2017 10

Three more impressive articles byEFLM Working Groups have beenmade available, attesting once moreto the engagement of EFLMfunctional units in valuable scientificactivity.

DEFINING A ROADMAP FORHARMONIZING QUALITY INDICATORS INLABORATORY MEDICINE: A CONSENSUSSTATEMENT ON BEHALF OF THE IFCCWORKING GROUP “LABORATORY ERRORAND PATIENT SAFETY” AND EFLM TASKAND FINISH GROUP “PERFORMANCESPECIFICATIONS FOR THE EXTRA­ANALYTICAL PHASES”

Sciacovelli L, Panteghini M, Lippi G,Sumarac Z, Cadamuro J, De OliveraGaloro CA, Del Pino Castro IG,Shcolnik W, Plebani M.

Clin Chem Lab Med 2017;55:1478­88

This joint paper by the IFCC WorkingGroup “Laboratory Error and PatientSafety” and EFLM Task and FinishGroup “Performance specificationsfor the extra­analytical phases”reports on the outcomes of the2016 Consensus Conference held inPadova (Italy). The aim of theConference was to achieve aconsensus for effectiveharmonization of quality indicators(QIs) that are needed to evaluate theperformances of ClinicalLaboratories and to recognize thecritical aspects where improvementactions are necessary. A generalagreement was obtained; the mainoutcomes are: i. the release of anew version of model of qualityindicators (MQI), ii. the approval ofa criterion for establishingperformance specifications and iii.the definition of the type ofinformation that should be providedwithin the report to the clinicallaboratories participating to the QIs

project.This Consensus is particularlyimportant because, despite thelarge number of papers publishedand the many presentations duringinternational scientific meetings, alarge and steady participation ofclinical laboratories to the MQIproject has been difficult to achieve.The two main strategies identifiedby the experts at the Conference arethe involvement of nationalscientific societies, accreditationbodies and EQA/PT providers ofdifferent countries, as a means fordisseminating the MQI project andpromoting the participation oflaboratories and the selection andappointment of a National Leader,who should coordinate and managethe MQI project in each country.

A SURVEY OF PATIENTS’ VIEWS FROMEIGHT EUROPEAN COUNTRIES OFINTERPRETIVE SUPPORT FROM SPECIALISTSIN LABORATORY MEDICINE

Watson ID, Oosterhuis WP,Jorgensen PE, Z. Dikmen ZG,Siodmiak J, Jovicic S, et al. on behalfof the European Federation ofClinical Chemistry and LaboratoryMedicine Working Group on PatientFocused Laboratory Medicine

Clin Chem Lab Med 2017;55:1496­500

The study was established todetermine whether patients areinterested in receiving theirlaboratory medicine results possiblywith explanatory notes. For thescope, a survey was carried out ineight European countries (CzechRepublic, Denmark, Estonia,Netherlands, Norway, Poland,Serbia, Turkey) interviewing 1084individuals. A significant proportionof subjects (65%) are interested inreceiving the laboratory results and

Update of the EFLMPublication List

by Maria Stella Graziani, Chair of the EFLM Communication Committee

a very large percentage of these (72%) are willing to obtainindividualized comment and interpretation on the reportsas well. Furthermore, a specialist in Laboratory Medicine isan acceptable professional for such a purpose for a meanpercentage of 62% of those responding positively.Considering that a previous work by the same group (ClinChem Lab Med 2015;53:1961–6) demonstrated a willingnessby Laboratory Medicine professionals to engage in suchpractice, there is an opportunity to progress such aninitiative. This is a very interesting chance to makeLaboratory Medicine directly connect with patients offeringa new paradigm for the provision of laboratory medicineactivities. This challenge needs to be addressed with activeengagement by the profession.

Interested professionals wishing to proceed are invited tovisit the Working Group on Patient Focused LaboratoryMedicine webpage at the EFLM website; they could findthere a productive advice. (https://www.eflm.eu/upload/docs/Basic%20Guidance%20for%20PFLM%202017.pdf).

THE EUBIVAS PROJECT: WITHIN AND BETWEEN­SUBJECTBIOLOGICAL VARIATION DATA FOR SERUM CREATININE USINGENZYMATIC AND ALKALINE PICRATE METHODS AND IMPLICATIONSFOR MONITORING.

Carobene A, Marino I, Coşkun A, Serteser M, Unsal I, GuerraE, et al. on behalf of the European Biological Variation Studyof the EFLM Working Group on Biological Variation

Clin Chem 2017 (doi 10.1373/clinchem.2017.275115)

This is another important paper carried out by the EFLMWorking Group on Biological Variation reporting on thebiological variation (BV) indices for serum creatinine usingboth enzymatic and alkaline picrate measurement methodsin the frame of the EuBIVAS (European Biological VariationStudy) that was established to deliver rigorously determinedBV indices.

The study involved 91 healthy subjects from six differentEuropean Centers while the tests have been performedcentrally at the S. Raffaele Hospital in Milan (Italy). Thewithin­subject BV estimates were similar for enzymatic(4.4%) and alkaline picrate (4.7%) methods, and lower thanthe estimate presently available online (CVI=5.9%). Theanalytical variation for alkaline picrate methods indicatesthat this method fails to fulfil analytical performancespecifications for imprecision.

The BV estimates obtained in this study are widelyapplicable and they may be used to determine the analyticalperformance specifications for imprecision at internationallevels in the absence of suitable clinical outcome studies.The alkaline picrate method failed to meet thesespecifications, raising questions regarding its future use.This interesting and rigorous study apart from offeringrobust BV indices, adds another tile in the worldwide debateon the methods to be used to measure serum creatinine toobtain accurate estimates of glomerular filtration rate.

The list of the EFLM publications is available onwww.eflm.eu under EFLM Publications, where youcan download the full papers.

The EFLM Newsletter n. 5/2017 11

We are pleased to inform you that De Gruyter publisher offers limited free access for all new issuesof Clinical Chemistry and Laboratory Medicine (CCLM) published until the end of 2017. All articles ofthe issues published until December 2017 are freely available online for 3 days upon publication.Please subscribe to the eTOC alert of CCLM here: Get Your eTOC Alert. Upon receipt of the eTOCalert you have Licensed Access to the entire contents of CCLM for 3 days!

NEWS FROM EFLM NATIONAL SOCIETIES

Appropriateness of test request is a leading priority for ClinicalLaboratories, in order to regulate laboratory data generation andcontextually assuring the most favourable clinical outcomes. Therecent worldwide transition from secondary to primary care formany patients with modest or chronic clinical conditionsemphasizes a sector of human medicine where a large number oftests involve a relatively narrow testing repertoire. In this scenario and in the firm believe that educational activitiesbased on scientific evidence should be the basis of dialoguebetween clinical laboratory and stakeholders, SIBioC hasdeveloped a project to create distance learning courses, freelyavailable to primary care clinicians in Italy, with collaboration ofMedical Scientific Societies and Federations. SIBioC succeeded toinclude the activity in mandatory continuous professionaleducation for healthcare professionals in Italy.The event, after introduction, includes a number of shortpresentations (around 15 minutes each), addressing 17 differentbut commonplace clinical conditions in primary care, embracingthe domains of screening, diagnosis, prognostication andtherapeutic monitoring. The full list of topics and names ofspeakers are shown in the table below. Each presentation, given by skilled Laboratory professionals,contains indications about appropriateness of test request alongwith suggestions on the interpretation of laboratory data. The course is also available to laboratory professionals; from thiseducational activity they should gain competence for theimportant activity of counselling with requesting physicians. The indications of each presentation are evidence­based andobtained from National and International Guidelines available toparticipants as supplementary educational material. The course has been available on line from SIBioC website for 9months so far; the current number (September 2017) ofsubscribers is 527 laboratory professionals and 193 primary carephysicians.

Appropriateness in the primary care practice.

Editors: MS Graziani, M Ciaccio, B Lo Sasso

News from SIBioC, Italian Society of Clinical Chemistry and Laboratory MedicineSIBioC commitment on the appropriateness of therequestsby Giuseppe Lippi, Section of Clinical Biochemistry, University of Verona, Verona, Italy and SIBioC National Representative for EFLM and Maria StellaGraziani, Referee for the SIBioC distance education activity

by Heike Jahnke, CCLM Journal Editor

THE EFLM OFFICE INFORMS

Free access to all new issues of CCLM for3 days upon publication

Introduction S Campo

The value of Laboratory Medicine M Plebani

1. Allergy AT Scacchetti

2. Amenorrhea A Fortunato

3. Anaemia S Buoro / A Dolci

4. Anticoagulant therapy G Lippi / B Morelli

5. Autoimmunity T Trenti

6. Chronic Kidney Disease MS Graziani

7. Diabetes A Mosca

8. Dyslipidaemia MS Graziani

9. Estro/progestinic treatment B Morelli

10. Heart failure M Zaninotto

11. Hepatic genetic diseases G Castaldo

12. Hypertension D Giavarina

13. Imaging techniques and contrast media M Mussap

14. Low risk monoclonal gammopathy A Terreni

15. Osteoporosis F Pagani

16. Tumor markers M Gion

17. Thyroid M Ciaccio

The EFLM Newsletter n. 5/2017 12

the opinion of all parties consulted. Thus, through aninteractive process, a consensus on protocols or concreteinitiatives can be reached).

Equally important is the project to improve the Databaseon Biological Variation that is being carried out by arecently created workgroup made up of professionalsfrom Spain (the Commission on Analytical Quality of theSEQCML) and various representatives from the EuropeanFederation of Clinical Chemistry and Laboratory Medicine(EFLM) from Norway, the United Kingdom, Italy, Holland,Canada, Turkey, and Australia.

“We are making great progress to assure the launch andongoing updating of the database, which will have a greatimpact on the quality of clinical analysis”, stressedProfessor Sverre Sandberg, President of the EFLM andcoordinator of the group.

For Professor Sandberg, “Spanish laboratories contributegreatly to the European Scientific Society in many areas,such as monitoring methods, improvement of testrequests, and work on biological variation, in which Spainis strongly represented”.

The importance of control procedures and programsfor external quality assurance

"The end result of laboratory services depends not onlyon the analytical phase, which of course is important, butalso on all of the different parts of the "chain", from therequest for the correct tests to the report of the resultsand their interpretation by doctors", explains thepresident of the EFLM.

For her part, Dr. MªAntonia Llopis, Presidentof the Committee onExternal Quality Programsfor the SEQCML, referred tothe importance of qualityin the pre­ and post­analytic phases, as this iswhere the greatestpercentage of laboratoryerrors occur.

“Much of the pre­analytic phase takes place outside ofthe laboratory, with participation from the patientsthemselves to professionals from various areas, both inhealthcare and out, which makes control more difficult.The processes of extraction, collection of samples, andidentification have a great impact on patient safety. That´swhy it is so important to make laboratories aware of theimportance of establishing proper control procedures aswell as programs for external quality assurance”, shenoted.

Currently there are few organizations that provideprograms for external guarantee of pre­analytic quality,and the SEQCML was a pioneer in Europe in theorganization of these programs. With close to 20 years ofexperience, in 2014 it provided a new focus on thisprogram by basing it on quality indicators.

Diagnostic clinical tests for hereditary diseases

Every year there is an increase in the number of hereditarydiseases (generally mono­genic) for which the genetic

News from the Spanish Society of

Laboratory Medicine (SEQCML)Leading national and internationalprofessionals participated in the VIInternational Clinical Laboratory andQuality Symposium in Barcelona onMay 30th and 31st. The event was a

reference event in the field both for its scientific program and for theprestige of its speakers.

The field of clinical analysis is continually evolving, but it is neverthelessnecessary to continue moving forward in the standardization of theentire clinical laboratory process. It is important that laboratory resultsbe transferable between centers and countries so as to avoid confusionin their interpretation.

Similarly, despite continuing improvement in measurement proceduresand the constant reduction of imprecision in analytic methods, there arestill systematic deviations in measurement methods among the differentmanufacturers of in vitro diagnostic methods.

Therefore, the coordination and standardization of the entire analyticprocess will be the key for the future in the clinical laboratory field.

This was one of the central themes of the VI International ClinicalLaboratory and Quality Symposium that was held in Barcelona on May30­31. The event was organized by the Spanish Society ofLaboratory Medicine (SEQCML) and the Foundation for QualityControl in Clinical Laboratories (FPCQLC).

Leading national and international professionals presented theirexperiences and gave updates on the latest news on topics such asquality in the sample extraction process, stability of biological tests,analytical and extra­analytical quality specifications, standardization,consensus on critical values, programs for external quality guarantees,and risk management.

Among the projects presented during the symposium ­ all relevant forguaranteeing quality in clinical laboratories, some that stood out werethe project to create a database for the stability of biological tests, andthe project to establishcritical values via thetechnological toolHealth Consensus (aplatform to facilitateconsensus amonghealth professionals byallowing them toconsult online while atthe same time receivingimmediate replies with

NEWS FROM EFLM NATIONAL SOCIETIES

The EFLM Newsletter n. 5/2017 13

The Kosovo Association of Clinical Chemistry

The Kosovo Association of Clinical Chemistry (KACC) wasestablished in 2000, as a voluntary and non­profit professionalassociation that represents specialists of Clinical Chemistryin Kosovo. Today, we have more than 85 members, specialists,doctors of science, assistant professors and professors involvedin the healthcare system, research and education. Our activities are: the promotion of clinical chemistry as aprofessional scientific discipline; the exchange of scientificknowledge; supporting the development and promotion ofscientific research in relevant fields; raising the quality ofcommunication between scientists in Kosovo and abroad;raising awareness of clinical chemistry, laboratory medicine andthe advancement of young researchers; cooperation with similarforeign associations and cooperation with internationalorganizations. The board is executive component of KACC and head of theboard act the role of President of KACC as well. During year 2015, Dr. Shemsi Veseli was appointed as aPresident of the KACC. Since that period Dr. Veseli and his teamworked hard to improve and develop the function of theassociation on the international cooperation level and as aresult of this commitment KACC was accepted as a full memberof IFCC and EFLM.

Members of the Kosovo Association of Clinical Chemistry areparticipating continuously on all EFLM, IFCC and other relevantCongresses and Conferences in the field of clinical chemistryand laboratory medicine. It is important to mention that on May 2017 KACC organizedthe 4th Conference of Kosova Association of Clinical Chemistrywhich was attended by more than 400 participants from Kosovoand abroad. There were nearly 25 presentations by Kosovar andInternational authors dedicated to professionals from clinicalchemistry, laboratory medicine and various fields that share thesame interest. During this conference KACC honoured 4 seniorand founding members who have contributed in different fieldsrelated the development process of KACC. Kosovo Association of Clinical Chemistry during 2017 organizedthe cycle of 12 lectures for laboratory staff, providing a goodopportunity for supporting practical perspectives and recentscientific and technological advances in clinical chemistry andlaboratory medicine. Since every event begins with the vision, KACC next vision isorganizing symposium under the auspices of EFLM in Prishtinawhich will improve our professional work and especially thequality service to our patients.

NEWS ABOUT EFLM NATIONAL SOCIETIES

cause is known. This is why the number of requests for thesestudies increases daily, as does their variety. In addition, asmethodologies are becoming simpler, they can be done morerapidly. These advances also have their negative aspect, as theycan bring about requests for genetic studies without the use ofappropriate diagnostic criteria. Therefore, the Symposiumaddressed the External Quality Assurance Programs forhereditary diseases.

“It´s not always clear when to request a genetic study. To know ifone should be done or not, available diagnostic guidelines for

the suspected disease should be consulted, as well as recentliterature. The clinical history, a physical exam, and family historyare particularly relevant in this context. In general, the mostimportant points are the age at diagnosis, multi­focal or bilateralaffectation, and alterations that are components of a syndrome”.

“To maintain a quality standard in genetic studies, these mustbe done in reference centers that participate in the ExternalQuality Assurance Programs that exist specifically for eachdisease", concluded the president of the SEQCML Committee onExternal Quality Assurance Programs.

DR. GRAMOS BEGOLLI, DR. NORMA BUDIMA AND DR. VALDETE HAXHIBEQIRIWITH THE EFLM PRESIDENT AT THE EFLM GENERAL MEETING IN ATHENS.

The EFLM Newsletter n. 5/2017 14

Calendar of EFLM events and events under EFLM auspices

Do not miss the opportunity to have your event listed here. Apply for EFLM auspices! For more information visit: https://www.eflm.eu/site/page/a/1048/ or email [email protected]

11­14 October 201714th Annual Congress of the German Society of ClinicalChemistry and Laboratory Medicine (DGKL)Oldenburg (DE) http://en.dgkl2017.de

7 November 2017EFLM webinar: The development of guidelines andrecommendations for peripheral blood film reviewinternationallyon­line https://elearning.eflm.eu

16­18 October 201749th National Congress of S.I.Bio.C. ­ Laboratory MedicineLaboratory Medicine and Clinical Practice: from present to thefutureFlorence (IT) http://congresso.sibioc.it/2017/home

14 November 2017EFLM webinar: Harmonization of preanalytical phase inEuropeon­line https://elearning.eflm.eu

16­17 October 2017Journées Nationales 2017 de la Société Française deBiologie CliniqueParis (FR) http://www.sfbc.asso.fr/

15­17 November 2017XI National Congress of Clinical LaboratoryMalaga (SP) http://labclin2017.es

18 October 2017EFLM webinar: Hepatic fibrosis assessment usingmultiparametric biomarker testson­line https://elearning.eflm.eu

30 November 201711th International Scientific Meeting of the Centre ofMetrological Traceability in Laboratory Medicine (CIRME)“Measurement Uncertainty in Medical Laboratories: Friendor Foe?”Milan (IT) http://users.unimi.it/cirme/home/index.php?selCategoria=210

19­20 October 2017EQALM Symposium 2017Dublin (IR) www.eqalm.org

1 December 2017JBP 2017 ­ Journees de Biologie PraticienneParis (FR)

For info: mail to [email protected]

20 ­22 October 2017XIVth International Congress of Pediatric LaboratoryMedicineDurban (ZA) http://www.icplm2017.org/

4­5 December 2017JCTLM Members & Stakeholders MeetingParis (FR)

http://www.bipm.org/en/committees/jc/jctlm/workshop­2017.html

26 October 2017 International Conference on Laboratory Medicine“Uncertainty, Quality, Safety And Accreditation inLaboratory MedicinePadova (IT) http://www.lccongressi.it/home_eng.htm

12 December 20177th International Conference on Quality of MedicalLaboratoriesBrdo pri Kranju (SI) http://www.szkklm.si

The EFLM Newsletter n. 5/2017 15

1 issue per year 6 issues per year1 quarter of page 500 € 1000 €Half a page 1000 € 2000 €Full page 1500 € 3000 €

Boost your brand and increase your company’s visibility through the EFLM Newsletter!EuroLabNews is the digital bi­monthly newsletter of EFLM targeting more than 4,500 laboratory medicine professionals and is alsopublished on the EFLM website. The Newsletter features information on EFLM initiatives and activities of its functional units, newsfrom EFLM National Society members and includes a calendar of the major events in the Clinical Chemistry and Laboratory Medicinefield.

The EFLM IVD partners are offered the possibility to advertise on EuroLabNews as follows:

Those companies interested in this opportunity can contact the EFLM Office at [email protected]

19 December 2017EFLM webinar: Laboratory hemostasison­line https://elearning.eflm.eu

18­19 June 2018 2nd EFLM Strategic ConferenceThe end of laboratory medicine as we know it?Mannheim (DE) www.eflm.eu

19­21 December 2017The First International Congress on BiomedicineTehran (IR) www.icb2017.com

21­22 June 20187th International Symposium on Critical Care Testing andBlood GasesAntibes (FR) www.criticalcaretesting­antibes2018.eu/

23 January 2018EFLM webinar: Faecal haemoglobin: newer approaches toscreening and diagnosis of colorectal diseaseon­line https://elearning.eflm.eu

30 September ­ 3 October 20189th Santorini Conference “Systems Medicine and PersonalisedHealth & Therapy ­ The Odyssey from Hope to Practice”Santorini (GR) www.santoriniconference.org

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

10­13 October 20185th EFLM­UEMS Joint CongressLaboratory Medicine at the clinical interfaceAntalya (TR) http://eflm­uems­antalya2018.org

6 March 2018EFLM webinar: Reliable estimates of biological variation –the way forwardOn­line https://elearning.eflm.eu

22­23 March 20195th EFLM­BD European Conference on Preanalytical PhaseBiannual Conference organized by the EFLM WG "PreanalyicalPhase" in collaboration with BDMunich (DE) http://www.preanalytical­phase.org

12­15 June 2018XXXVI Nordic Congress in Clinical ChemistryHelsinki (FI) http://www.nfkk2018.fi/

27 March 2018EFLM webinar: M­protein diagnostics of multiplemyeloma patients treated with biologicsOn­line https://elearning.eflm.eu

19­23 May 2019EuroMedLab 201923rd IFCC­EFLM European Congress of Clinical Chemistry and Laboratory MedicineBarcelona (SP)