Issue n. 3/2017

In this issue:
Hot topics in Laboratory Medicine
Harmonisation in Laboratory Medicine

THE EFLM BI-MONTHLY NEWSLETTERNews from EFLM Committees
Why join the Register of European Specialists inLaboratory Medicine (EUSpLM)
News from the WG­Harmonisation of Total Testing
ProcessVacancies in EFLM functional unitsEFLM events

EFLM Connects National Societies of Clinical Chemistry
and Laboratory Medicine and Creates a Platform for all
European “Specialists in Laboratory Medicine”

Updates on EFLM Publications
Change of guard in EFLM National Societies
News from EFLM National Societies
Calendar of EFLM events and events under EFLM
auspices

HOT TOPICS IN LABORATORY MEDICINE

Harmonisation inLaboratory Medicine
by Jill Tate, Pathology Queensland, Chemical Pathology,
Royal Brisbane & Women’s Hospital, Brisbane, Australia

Clinical laboratory testing is now a global
activity with laboratories no longer working
in isolation but as regional and national
networks, and often at international levels.
Harmonisation refers to our ability toachieve the same result (within clinically
acceptable limits) and the sameinterpretation
irrespectiveofthemeasurement procedure used, the unit orreference interval applied, and when
and/or where a measurement is made. It is
often assumed by clinicians, patients andlaboratories that tests performed at
different laboratories are comparable intheir quality and interpretation. However,this may not be so in which case there is the potential for
misinterpretation of results, wrong treatments and adverse patient
outcomes.
Therefore, how can we achieve harmonisation of our testing across all
aspects of the total testing procedure (TTP) including the request, thesample, the analysis and the report (Figure)?

Forewordby Harjit Pal Bhattoa, Editor EFLM EuroLabNews

In this current issue of the EFLM EuroLabNews Jill Tate,in the regular section of Laboratory Hot Topics,
enumerates on the topic of Harmonization in Laboratory
Medicine. Gilbert Wieringa, Chair of the Profesion
Committee outlines the reasons why to join the Registerof European Specialists in Laboratory Medicine. Ferruccio
Ceriotti, Chair of the EFLM WG on Harmonisation of Total
Testing Process (WG­H) highlights their perusals for
improving the harmonisation of reference intervals usedby European laboratories. The EFLM Working Group“Accreditation and ISO/CEN standards” has advertised avacancy for 1 Full Member position. Important practicaldetails of the upcoming EuroMedLab meeting in Athens
are focused upon. Nada Majkic­Singh is extending her
invitation to attend the 13th EFLM Symposium for theBalkan Region to be held between 21­22 September inBelgrade, Serbia. MariaStella Graziani, Chair of the EFLM
Communications Committee presents the update of the
EFLM publications list. As a regular column of the
EuroLabNews, changing of the guard and otherimportant news from National Societies have once again
made this issue more colourful. Attendees may marktheir calendars to attend stimulating meeting as
mentioned in the Calendar of Events.

to be continued on page 2

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 on
the newsletter write to: news@eflm.eu
Contents may not be reproduced without the priorpermission of the Newsletter Editor.

A systematic approach to harmonisation is needed and requires:• Awareness by the Laboratory Medicine community that there is a needfor harmonised processes not only for the analytical phase but acrossall steps of the TTP (1)• Awareness that harmonisation processes are complex; hence asystematic and evidence­based approach that reflects best laboratory
practice is needed• An organisational plan or roadmap for the set­up and implementationof each harmonisation activity is a pre­requisite together with strong
leadership and working groups that are prepared to do the work
• Communication with main stakeholders, i.e. pathologists, scientists,
clinical groups, diagnostic industry, regulatory bodies, IT developers,
and consumer groups with a consensus outcome arrived at throughcooperation and discussion.
The European Federation of Clinical Chemistry and Laboratory Medicine(EFLM) has established several working groups and task and finish groups
to address a number of harmonisation projects relating to the test request
and sample. These include test requesting, guidelines and position papers,
patient preparation and sample collection, and sample handling andtransport.

Harmonisation of the different aspects of analysis includes:
promoting development of traceable assays, development ofcommutable secondary reference materials, harmonisation of
measurement values for methods where no suitable referencematerial or reference measurement procedure is available,
and harmonised mass spectrometry methodology. Key
organisations involved in this analytical work are theInternational Federation of Clinical Chemistry and Laboratory
Medicine (IFCC), the International Consortium for
Harmonization of Clinical Laboratory Results (ICHCLR),
national measurement institutes, expert specialist laboratorygroups and external quality assurance (EQA) groups.
Post analysis there are a range of harmonisation activities thatare being addressed including: standardisation of reporting
units, terminology, calculated parameters and reportformatting, harmonised approaches to validation of thequality of biological variation data, harmonised reference
intervals, and harmonised processes for management andcommunication of critical laboratory results and ofinterpretative result commenting. Working groups andcommittees led by IFCC, EFLM and many national clinicalchemistry societies including those in Australasia, Asia,
Canada, Scandinavia, Turkey, and the UK have begun toaddress these issues (2).
Efforts are also being made to harmonise activities outside
the domain of the laboratory and include the establishmentof laboratory relationships with clinicians and patient­focusedgroups, and education of the public via the internet andaccessing Lab Tests Online.
Guidance about quality indicators to be used to assess thestatus of pre­ and post­analytical tasks in the laboratory is
being promoted across the global Laboratory Medicine
community with EFLM, IFCC, and the Institute of Medicine
jointly working to decrease laboratory errors. At the national
level surveillance of the implementation of one or more
harmonisation activities across a country is best undertaken
through the national EQA provider. In Australia, for example,
the Royal College of Pathologists of Australasia Quality
Assurance Programs surveys the uptake of common reference
intervals, calculations, test profiles, interpretative commenting
and report formatting.
Harmonised test results will ensure that clinical guidelinesthat call for the use of laboratory tests and decision limits canbe universally implemented. By doing this there is lessconfusion among clinicians and patients, thereby minimising
misinterpretation of test results. Harmonised laboratory
practices should be based on hard evidence that has beensystematically compiled and agreed to. The implementationof harmonised practices requires support of laboratories by
the national Laboratory Medicine profession and, importantly,
there must be close interaction between the laboratory andthe clinician at the local level. Although harmonisation is apragmatic process that aims to reduce the unnecessary
variation in laboratory test practices, it still allows forinnovation through discussion and the input of new ideas. I
encourage you as a Laboratory Medicine professional to be
involved.
References

FIGURE.
Laboratory total testing procedure that enables harmonisation

The EFLM Newsletter n. 3/2017

1. Plebani M. Harmonization in laboratory medicine: thecomplete picture. Clin Chem Lab Med 2013;51:741­51.
2. Tate JR, Myers GL. Harmonization of clinical laboratory
test results. EJIFCC 2016;27:5­14.

2

NEWS FROM EFLM COMMITTEES

Why join the Register of European Specialists in Laboratory
Medicine (EUSpLM)
by Gilbert Wieringa, Chair of the EFLM Profession Committee

The Register is the database of Specialists in Laboratory Medicine
across the European Union. It identifies individuals able to meet
Equivalence of Standards in education and training as follows:
•
•
•
•
•

Minimum 9 years (ideally 10) years academic (4/5 years) andspecialist (5 years) training;
Education and training to standards set in the EC4/EFLM
syllabus (ref to 2012 syllabus);
A Master’s degree in Medicine, Pharmacy or Science;
An EFLM Profession Committee recognised ‘Equivalence ofStandards’ exit qualification;
Evidence of participation in continuous professional
development (CPD).

•

•

•

Holders of the title EUSpLM are widely recognised as
individuals with high levels of knowledge, skills andcompetence who have met ‘Equivalence of Standards’ with
their colleagues across the European Union.
A ‘Specialists’ register can help catalyse harmonisation oflaboratory medicine practice across Europe in turn leading tobetter patient outcomes and enhanced patient safety
Achieving recognition raises the profile of the contribution oflaboratory medicine to better health and best care and, inparticular, the role and contribution of its specialist
practitioners.

How to join

Through the standards it sets and the code of conduct it expects
from its registrants the Register has identified a cohort of nearly
3000 individuals with unique knowledge, skills and competencies
for leading/delivering high quality laboratory medicine services.
First established in 1997 by the European Communities
Confederation of Clinical Chemistry and Laboratory Medicine (EC4),
the merger of EC4 with FESCC culminated in 2016 with the transferof the Register to EFLM.

Individuals able to meet the Equivalence of Standards of their EU
member state are invited to submit applications to EFLM via
https://register.eflm.eu. The site provides a step by step guide on
how to upload qualifications, evidence of experience andparticipation in CPD in support of applications. Auto­registration
is now also possible and encouraged via national societies’
databases. Please contact the EFLM office (silvia.cattaneo@eflm.eu)
for further information on setting up this process.

Why join?

Want to know more?

•

As part of EFLM’s symposium at EuromedLab2017 on‘Harmonisation of Laboratory Medicine’ practice on 12th June from
0900 ­1200 Gilbert Wieringa, Chair of EFLM’s Profession
Committee will present ‘Harmonising the recognition of specialists
in laboratory medicine across Europe’. Further backgroundinformation, slides from talks, and a webinar presentation can befound on the EFLM website at www.eflm.eu.

The Register supports the case for recognition of Specialists inLaboratory Medicine under EU Commission Directive
2013/55/EU – the Recognition of Professional Qualifications.
Achieving recognition extends opportunities for specialists topractice in other EU countries without having ‘compensation
measures’ imposed e.g. re­taking of local professional
examinations which can delay and detract the individual fromprofessional migration.

NEWS FROM EFLM WORKING GROUPSEFLM WG on Harmonisation of Total Testing Process (WG­H)
by Ferruccio Ceriotti, Chair of the WG

The WG­H started a campaign to improve the harmonisation ofreference intervals used by European laboratories and launcheda Survey among the EFLM National Societies members to gather
more information. The survey closed on May 31st and the results
will be reported soon using the EFLM communication channels.
For more complete information, please find below the
introduction to the Survey clearly stating the scope of the Survey
and of the WG:
Survey EFLM WG­H on Reference Intervals
The European Federation of Clinical Chemistry and Laboratory
Medicine (EFLM) has created the Working Group on

Harmonization in Total Testing Process, with the aim to promoteand spread the harmonization activities carried out, or currently
ongoing, in the different national societies of Europe. Following
the survey on Harmonisation activities, the WG­H intends to starta campaign for improving the harmonisation of reference
intervals used by European laboratories.
To set a background from which to start we prepared a shortquestionnaire focusing on the reference intervals used for themost commonly performed tests. The aim of the survey is tounderstand what the origin of the reference intervals presently
in use are and if the partitioning criteria for the use of reference
intervals are the same all over Europe.

VACANCIES IN EFLM FUNCTIONAL UNITSEFLM Working Group “Accreditation and
ISO/CEN standards” – deadline to send
nominations: 30 June 2017
The aim of the EFLM Working Group on Accreditation and
ISO/CEN standards is to represent EFLM and the interest ofEuropean laboratories in EA, ISO TC212 and CEN TC140 & EU
regulatory frameworks and to harmonize accreditation in Europe.
A vacancy arose and we are calling nominations for 1 Full
Member position.
The terms of reference for each WG are available at www.eflm.eu.
The term of office will be for 2 years ending on 31 December
2018. The position could be renewable for other two more terms
if the work for the Group is deemed essential at that time. The

The EFLM Newsletter n. 3/2017

work is mainly conducted by e­mail and teleconferencing, the WG
usually meets once per year.
Procedure for applications: each EFLM National Society Member
in good standing with the membership fee can submit one
nomination using the form circulated to the National Society’s
representatives to be sent back to silvia.cattaneo@eflm.eu. A
brief plan of the applicant’s contribution to the aims andobjectives of the relevant Working Group has to be included in
the form. Together with the application, a short CV should also
be submitted underlining the qualifications and prior experienceand publications in the relevant area. Candidates have to be
officially recommended by their National Society through aformal letter of support. Applicants who are not selected as full
members may be eligible for corresponding membership.

3

DOWNLOAD THE APP!
USING THE EUROMEDLAB APP YOU CAN DISPLAY
THE FOLLOWING:• SCIENTIFIC PROGRAMME WITH SPEAKERS’
PRESENTATIONSONLY FEW DAYS TOEUROMEDLAB 2017 IN ATHENSEuroMedLab Athens 2017: Special Event for Young Scientists!
Tuesday June 13 evening ­ Starting at 20.00
An interesting event jointly organized by the IFCC Task Force of Young
Scientists TF­YS) and the International Society of Enzymology (ISE) which
combines a scientific presentation by Dr. Nader Rifai, Editor in Chief of“Clinical Chemistry”, entitled “Communication of Scientific
Information” and a musical performance of the well­known Mikis
Theodorakis Orchestra.
A Get Together Dinner kindly offered by the GSCC­CB and overlooking
the Acropolis and the Parthenon awaits for you. The evening will continue
in a friendly musical atmosphere.
The event is free for the first 100 Young Scientists
registered to the Congress who confirm the participation
via web at the following link http://www.ifcc.org/task­
force­young­scientists­web­pages/ (registrations’ open:
May 20).
This event is also open to all other delegates but they need to purchasea ticket (Eur 80 per person) by writing to Amanda Goddard(amanda.goddard@sinaihealthsystem.ca). Space is limited and tickets will
be sold on a first­come first­served basis.

• POSTERS• GENERAL INFORMATION• SPONSORS AND EXHIBITORS• PUSH NOTIFICATIONS WITH THE LATEST NEWS• BREAKING NEWS• ASK QUESTIONS TO THE PRESENTERS AND CHAIRSDURING SCIENTIFIC SESSIONS• PARTICIPATE TO SURVEYS POSTED BY THE SPEAKERS• RATE THE SCIENTIFIC SESSIONSSCAN THE CODE TO GET IT ON YOUR MOBILE PHONE
EuroMedLab Athens 2017: Free shuttle service airport /Megaron Convention Center / airport
From Saturday June 10 to Thursday June 15
A free shared shuttle service, kindly offered by Mindray, isoffered to you from and between Athens airport (arrival hall
B – Door 5) and the Megaron Convention Centre (mainentrance) and back:
SATURDAY 10 JUNE ­ 8am­8pm ­ every 1 hour from the airport
to the Megaron directly
SUNDAY 11 JUNE ­ 8am­8pm ­ every 1 hour between 8am­
12am and every 1/2 hour between 12am – 8pm, fromairport to the Megaron directly
MONDAY 12 JUNE ­ 10am­6pm ­ every 1 hour from Megaron
to the airport and from the Megaron back to the airport
TUESDAY 13 JUNE ­ 10am­6pm ­ every 1 hour from Megaron
to the airport and from the Megaron back to the airport
WEDNESDAY 14 JUNE ­ 10am­6pm ­ every 1 hour from
Megaron to the airport and from the Megaron back to
the airport
THURSDAY 15 JUNE ­ 8am­15pm ­ every 1/2 hour from
Megaron to the airport directly

VENUE OF THE EVENT: GAZARTE, 32­34 VOUTADON STR.­ GAZI, KERAMEIKOS STATION.
EuroMedLab Athens 2017: Opening Ceremony
Sunday June 11 at the Herodes Atticus Theatre
20.15 ­ 20.30 Arrival of Delegates
20.30 ­ 21.00 Welcome addresses ­ Announcement of Awards
21.00 ­ 21.30 Opening Lecture David Epstein:… and mark in your agenda also the other events addressed to Young
Scientists:
� “MEET THE EXPERTS” SESSIONS: six interactive sessions (on Monday,
Tuesday and Wednesday) have been organized by the Scientific
Congress Committee in collaboration with the Young Scientists
Division of IFCC covering subjects of general interest. An interesting
opportunity to join a small group of interested colleagues for an
intense and interactive discussions. Sessions are open to all delegatesbut require a free pre­registration as the seats’ availability is limited
for practical reasons. For more details visit www.athens2017.org anddownload the scientific programme.
� OPEN MEETING & QUIZ OF THE IFCC TASK FORCE FOR YOUNG SCIENTISTS:
Tuesday June 13 from h. 9.00 to 12.30 at the Hilton Hotel (Meeting
room: Santorini 4­5­6) ­ Young Scientists like surprises ­ Prizes for
Quiz winners;
ALL DELEGATES ARE INVITED! To confirm the presence please contact:
guilaineboursier@yahoo.fr“The Original Olympic spirit: the evolution of athletes andthe tiny margins between good and great”

21.30 ­ 21.40 Intermission
21.40 ­ 22.00 Cultural Event "Facades" by Andonis Foniadakis
A ballet specially created for EuroMedLab Athens 2017
Welcome Party
22.00

IN ORDER TO ASSIST TO THE OPENING CEREMONY PEOPLE MUST BE
REGISTERED TO THE CONGRESS AND SHOW AT THE ENTRANCE A VALIDEUROMEDLAB BADGE OR THE PRINTOUT OF THE INVITATION RECEIVED BY
E­MAIL FROM THE CONGRESS SECRETARIAT.

SUNDAY JUNE 11
Athens, Hilton Hotel
Room: Galaxy
h. 14.00-17.40

WE LOOK FORWARD TO MEETING YOU!

The EFLM Newsletter n. 3/2017

4

EFLM EVENTS

Welcome to the 13th EFLM
Symposium for Balkan Region
by Nada Majkić­Singh, President of the Symposium

The Society of Medical Biochemists of Serbia has the pleasure toorganize the 13th EFLM Symposium for Balkan Region under
the title “Laboratory Medicine Management: Leadership Skills
for Effective Laboratory”. European Federation for Clinical
Chemistry and Laboratory Medicine (EFLM) appointed Belgrade(Serbia) and the Society of Medical Biochemists of Serbia as theorganizer of educational symposia for clinical chemists in the
Balkan region and as a result of these decision twelve symposia
have been organized thus far very successfully. The 13th EFLM
Symposium for Balkan Region is organized under the Auspicesof the International Federation of Clinical Chemistry (IFCC),
Ministry of Education, Science and Technological Developmentof Serbia and Ministry of Health of Serbia.

On behalf of the Society of Medical Biochemists of Serbia andthe European Federation of Clinical Chemistry and Laboratory
Medicine (EFLM), we would like to welcome all our distinguishedlecturers and thank them for their participation in the 13th EFLM
Symposium for Balkan Region. Their presence gives very highrecognition and prestige to this Meeting, which will influence thedevelopment of clinical chemistry and laboratory medicine in the
Balkan region.
3th EFLM Symposium for Balkan Region
Laboratory Medicine Management:
Leadership Skills for Effective Laboratory
Under

The Society of Medical Biochemists of Serbia as a member of the
IFCC and EFLM greatly appreciates the role it has in thecontinuing development of our discipline according to the IFCC
and EFLM mission and the Strategic Plan. The 13th EFLM
Symposium for Balkan Region is organized on September 21st and22nd, with participation of the European and domestic specialists
in field of: Type of Medical Laboratory and Strategy, Laboratory
Medicine Planning and Organization, Medical Laboratory
Accreditation and Competence and Laboratory Medicine
Environmental Health and Safety. These topics will be presented
by European lecturers (Paul Collinson, Ivan Brandslund, Mario
Plebani, Per E. Jørgensen, Sverre Sandberg, Bernard Gouget,
Matthias Nauck, Herbert Stekel, Tomas Zima and Ciprian­Valentin
Mihali) and from Serbia (Nada Majkić­Singh, Vera Lukić, Snežana
Jovičić, Nataša Bogavac­Stanojević, Svetlana Ignjatović, ZoricaŠumarac, Jelena Kotur­Stevuljić and Verica Milatović).

Auspices

Hyatt Regency Beograd, Belgrade, Serbia
September 21 and 22, 2017www.dmbj.org.rs

Update of the EFLM publication listby MariaStella Graziani, Chair of the EFLM Communications Committee

Improving quality in the preanalytical phase throughinnovation, on behalf of the European Federation for Clinical
Chemistry and Laboratory Medicine (EFLM) Working Groupfor Preanalytical Phase (WG­PRE)

Lippi G, Baird GS, Banfi G, Bölenius K, Cadamuro J, Church S, etal. Clin Chem Lab Med 2017; 55:489–500
Despite the many advances made for achieving a high degree of
quality and safety in the analytical part of diagnostic testing, many
hurdles in the total testing process remain, especially in thepreanalytical phase ranging from test ordering to obtaining andmanaging the biological specimens. In keeping with these issues,the European Federation of Clinical Chemistry and Laboratory

Medicine (EFLM) has established a specific Working Group for the
Preanalytical Phase (WG­PRE), the aims of which are mainly aimed
at mitigating the vulnerability of many preanalytical activities,
releasing official documents, guidelines and recommendations, aswell as providing continuous education for laboratory
professionals and other healthcare operators.
This collective article follows the previous three opinion papers
that were published by the EFLM WGPRE on the same topic, andbrings together the summaries of the presentations given at the
4th EFLM­BD meeting “Improving quality in the preanalytical phasethrough innovation” in Amsterdam, 24–25 March, 2017.
The full list of the EFLM publications is available on www.eflm.eu
under EFLM Publications, where you can download the full papers.

Change of the Guard in EFLM National Societies
NETHERLANDS SOCIETY FOR CLINICAL CHEMISTRY AND LABORATORYMEDICINE
Dr. M.G.L.M. (Marc) Elisen (MC Groep MC Zuiderzee, KLC,
Lelystad) is the new President of the Netherlands Society for
Clinical Chemistry and Laboratory Medicine replacing Dr. Claudia
Pronk­Admiraal. A warm welcome to Dr. Elisen and a thanks to
Dr. Pronk­Admiraal for her collaboration and support to EFLM
activities during these past years.
SWEDISH SOCIETY FOR CLINICAL CHEMISTRY
Prof. Lars Breimer (Laboratory Medicine, USÖ, Örebro) is the new
President of the Swedish Society for Clinical Chemistry replacing
Dr. Maria Berggren Söderlund. A warm welcome to Prof. Breimer
The EFLM Newsletter n. 3/2017

and a thanks to Dr. Berggren Söderlund for her collaboration andsupport during her presidency.
THE ASSOCIATION FOR CLINICAL BIOCHEMISTRY & LABORATORY MEDICINE
Prof. Ian Young (School of Medicine, Dentistry and Biomedical
Sciences, Centre for Public Health, Institute for Global Food
Security, Queen’s University, Belfast) is the new President of the
Association for Clinical Biochemistry & Laboratory Medicine
replacing Dr. Gwyn McCreanor. Prof. Young will also act as EFLM
National Representative. A warm welcome to Prof. Young and a
big thanks to Dr. Gwyn McCreanor for her collaboration andalways prompt support to EFLM activities as National
Representative and ACB President during these past years.
5News about
EFLM National Societies
MERGE OF LABORATORY MEDICINE’S NATIONAL SOCIETIES IN UKRAINEThe EFLM Full Member “Ukrainian Society of Clinical Laboratory
Diagnostics (USCLD)” merged with the EFLM Affiliate Member“Association of Clinical Chemistry & Laboratory Medicine of Ukraine(ACCLMU)” which now will represent the Full Member for Ukraine.
Congratulations to the National Societies Presidents of USCLD and
ACCLMU on this important step.
NEWS FROM EFLM NATIONAL SOCIETIESFrom SFBC ­ French Society of Clinical Biology

What‘s going on aboutaccreditation of the French
Medical Labs?
by Bernard Gouget, Counselor for Public Health FHF,
President­Human Healthcare Committee­COFRAC,
Chair­IFCC­Nominations Committee, General Secretaryof the International Francophone Federation of Clinical
Biology and Laboratory Medicine (FIFBCML), Member­
SFBC­International Relations Committee

In France, the medical biology tests are carried out in a medical laboratory
located on one or more sites situated either in the same Health territory
or in three connecting health territories. The “Health territory” is definedas the relevant area for management of care aiming to propose a moreglobal approach of the health system and of the assessment of care needs
based on the principles of accessibility, proximity and continuity of care.
The medical laboratory is operated by a private structure or within a publichealth facility.
The majority of private laboratories are operated in the form of Liberal
Societies (SELs), but also may constitute own­name business or
professional civil societies (SCPs), cooperative societies, non­profit
organizations or health cooperation groups. The « company » that
operates a private medical biology laboratory is registered with the
National Order of medical doctors and / or pharmacists (section G). The
Regional Health Agencies approved the opening of a medical laboratory
and they are responsible for regulating the provision of public and private
laboratory medicine in the regions where they operate, in order toguarantee that local laboratory medicine is sustained.
By law, for the public sector, there is only one medical laboratory byhospital or for a group of hospitals collecting all disciplines. At the general
hospital, still the laboratory is mainly called “multidisciplinary laboratory”
as a part of the “medico­technique pole”. At the University Hospital, thisis a ”pole” gathering all the disciplines with common utilization of thetechnical platforms. The territory is the favored level of healthmanagement, and according to the law on the modernization of theFrench healthcare system last January 26, 2016, the Regional Hospital
The EFLM Newsletter n. 3/2017

Group is mandatory for all public institutions. It is obligatory
to establish a shared medical project to implement
incremental managerial strategies. The Hospitals
participating in the territorial grouping organize jointly theactivities of diagnostic and medical biology. The medical
biologists have to contribute to the shared medical project
to define their territorial strategy. The hospital participatingin the group may constitute an inter­establishment medical
biology pole with several accreditations, or to establish aunique medical laboratory with one accreditation.
As regard to the competition between the private the public
sectors and the commercial labs, what we are witnessing is a
powerful trend towards concentration of medical labs in theprivate and public sectors and the establishment of a market“cartels” rather than of a genuinely competitive market. In
this context, accreditation is a differentiating factor.
The accreditation of the French medical labs is mandatory
since 2010 by order and by law since May 30 2013. The
accreditation process is under the responsibility of the
Healthcare section of the Comité francois d’accréditation(COFRAC). This section is totally dedicated to humanhealthcare issues with two instances composed byrepresentatives from the Ministry of Health, its permanent
offices in regions, the High Authority of Health, medical
biologists and pathologists, patients, prescribers, accredited
medical laboratories. The section committee participates inthe elaboration of the strategy for accreditation of medicallaboratories as well as in preparing the documents useful toevaluate and accreditate. The commission for accreditation
studies evaluation reports and looks at the candidatures oftechnical assessors and experts
The current agenda for accreditation is formed by: 1) 50% of
medical biology tests by volume with at least one test in eachof the three lines (biochemistry­genetic; immunology­
hematology­reproductive biology; microbiology) which haveto be accredited by December 31, 2017, and 2) by 100% of
tests have to be accredited by November 1, 2020. Facingthese challenges and having in mind the medicalization of
the profession, the COFRAC team optimized their working
methods to improve its efficiency, particularly regarding
assessment scheduling and reviewing rules for assessment
reports.
In 2016, there were 1034 assessments performed: 29% were
initial assessments and 32% were assessments with a scope
extension. In April, there are 945 multisites medical labs (314public, 631 private ) with approximatively 3400 sites in total.
COFRAC assessed a total of 100% of the medical labs at least
once, and 81% (769) of the medical labs are complying with
50% of the tests accredited. In addition, 11 hospital medicallabs are accredited for POCT according to the standard NF
EN ISO 22870. as well as 15 Pathology labs with NF EN ISO
15189. The accreditation remains reliant on the availabilityof the technical assessors whose numbers (384) are still low
to ensure under optimum conditions compliance with theagenda. The Healthcare section is continuing with its activity
encouraging medical biologists to become technicalassessors agreeing to carry out more assessments.
Quality and promotion of accreditation are the core concernsof the Medical Biologist community. They have shown strong
commitment to the accreditation project and havegenerously contributed with their professional timetable andresources to do this work. This was reflected in the important
overall growth of the Cofrac’s Healthcare section’ activity. To
achieve the challenge of 100%, there is a strong need to havea coordinated strategy and to adopt a more proactive
approach to respond to the changing of the international
laboratory medicine landscape.
6News SIBioC ­ Italian Society of Clinical Chemistry and Laboratory Medicine

In memory of Prof. Carlo Franzini (1934­2017)by Mauro Panteghini and Ferruccio Ceriotti

With great sadness, we announce to our professional communitythat prof Carlo Franzini is not with us anymore. This touching event
is an invaluable loss for the Laboratory Medicine worldwide.
Carlo Franzini graduated in Medicine at the University of Pisa in
1958 and became professor of Clinical Biochemistry at the
University of Milano in 1995. He worked in many clinicallaboratories in the North of Italy and, at the end of his career, he
was Director of the Clinical Laboratory of the Luigi Sacco Hospitalin Milano.
Carlo Franzini was among the founders of SIBioC. In 1969, heattended, together with valuable Italian colleagues, Giulio Vanzetti
and Giovanni Ceriotti, a meeting with the IFCC President Martin
Rubin, from which the Italian Society started its journey.
Carlo Franzini has been a very active member of SIBioC; he was
SIBioC President twice (1983 and 1999) and he was a member of
the SIBioC Executive Board for many years. He was Editor of the
SIBioC scientific journal “Biochimica Clinica” for 15 years (1991­
2006). He was also committed in the promotion of Laboratory
Medicine internationally, working in the Scientific Division andPublication Division of IFCC in 1988­1992 and 1993­1997,
respectively. In Europe, he was Secretary of FESCC between 1996
and 1999, before the merging of FESCC and EC4 in EFLM. Finally,
Carlo Franzini was President of the EuroMedLab Congress held in
Milano in 1989.
Culture and education are the two words that can label his figure;he was a precursor in many fields of our profession. We canmention here biological variability and commutability; Carlo
Franzini was a real expert in these areas of our discipline in times
when these concepts were just at their dawn. We would like toremind him to international colleagues with a picture taken at the
EuroMedLab Congress in Milano in 2013, when Carlo Franzini wasawarded from SIBioC with a career prize.

Prof M. Panteghini awards Prof C. Franzini at
the EuroMedlab Congress, Milano (Italy) 2013.

Lab Tests Online Italy (labtestsonline.it)
by Giuseppe Lippi, Section of Clinical Biochemistry, University of Verona, Verona, Italy

In 2001, the American Association of Clinical
Chemistry (AACC) launched a website named“Labtestsonline” (LTO), designed to help
patients
andthegeneralpublicunderstanding the significance of mostlaboratory tests. The site included also alippidiagnostic tests. The content of thewebsite, even if very detailed, was and is easy
to read and understand. Despite people cannow easily find information about their healthand clinical tests on Web platforms, thecontent of LTO is certified by experts in laboratory medicine.
Moreover, year after year, laboratory testing has become more andmore complex, so that LTO may also serve as an easy and quickreference tool for medical professionals. In 2016 LTO USA recorded
nearly 3 million visits and over 5 million pages visited.
In 2004, the European Association of Diagnostic Manufacturers(EDMA) started a project based on translation of the site content
into the languages of many European and non­European
countries. Beside Italy, since 2004 many countries have decided tojoin the project: Australia, Brazil, Chine, Czech Republic, France,
Germany, Greece, Hungary, Korea, Poland, Portugal, Romania,
Spain, United Kingdom, Turkey along with many others. The
project was carried out through the National Societies of Clinical
Biochemistry and, in Italy, the Italian Society of Clinical
Biochemistry and Laboratory Medicine (SIBioC) was charged withthis task. At the beginning, many SIBioC members contributed, on
a voluntary basis, to translating and reviewing of tests. Later on,
due to the growing number of tests to be translated, SIBioC andAssodiagnostici (the Italian branch of EDMA) financed a grant fora young post­graduate student in charge of the translations. The
articles, before publication in the website, are reviewed always andcarefully reviewed by senior Clinical Biochemists. The website
undergoes regular updates and now includes more than 300 tests
and over 100 clinical conditions. Beside translation of tests and

The EFLM Newsletter n. 3/2017

conditions from the AACC site, SIBioC stimulated the chairs of its
active Working Groups to assemble brief reports aimed to describe
current news related to the topic of the Working Group. The
collection of most recent articles include the description of tumor
markers, myocardial infarction, therapeutic use of Cannabis andvaccinations. SIBioC strongly believes that these reports are ideal
tools to easily communicate with the general public anddisseminate qualified opinions of Society along with top stories,
breaking news and interesting information about Laboratory
Medicine. The number of visits to the Italian LTO website during
the last three years are shown in the Figure, which reflects thegrowing interest of the public in this project. It is the firm strategy
of SIBioC to place additional efforts for continuous improvementof the contents of the website, thus offering to the public a highly
reliable and certified means for obtaining qualified laboratory
medicine information.

7

Calendar of EFLM eventsand 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 eflm@eflm.eu
10 June 2017
Metabolic Bone Disease: The Role of the Clinical Laboratory
EuroMedLab2017 ­ Satellite Meeting
http://www.athens2017.org/
Athens, Greece

October 2017
Journées Nationales 2017 de la Société Française
de Biologie Clinique
Paris, France

10­11 June 2017Management of Inborn Errors of Metabolism: From Diagnosis to Treatment
EuroMedLab2017 ­ Satellite Meeting
http://www.athens2017.org/
Athens, Greece

19 October 2017
Hepatic fibrosis assessment using multiparametricbiomarker tests
https://www.eflm.eu/site/elearning/detail/1272
EFLM webinar, online

11­15 June 2017
EuroMedLab 2017 ­ 22nd IFCC­EFLM European Congress ofClinical Chemistry and Laboratory Medicine

20­22 October 2017
XIV International Congress of Pediatric Laboratory Medicine
http://www.icplm2017.org/
Durban, South Africa

15­16 June 2017
Under Poseidon’s Eye ­ Symposium on Diabetes
EuroMedLab2017 ­ Satellite Meeting
Sounio, Greece

26 October 2017
International Conference on Laboratory Medicine “Uncertainty, Quality,
Safety And Accreditation in Laboratory Medicine”
http://www.lccongressi.it/home_eng.htm
Padova, Italy

http://www.athens2017.org/

21­22 September 201713th EFLM Symposium for Balkan Region
Laboratory Medicine Management: Leadership skills for effective Laboratory
http://www.dmbj.org.rs
Belgrade, Serbia

26 September 2017
Reliable estimates of biological variation ­ the way forward
EFLM webinar, online

https://www.eflm.eu/site/elearning/detail/1060

http://www.sfbc.asso.fr/

14 November 2017
Harmonization of preanalytical phase in Europe
EFLM webinar, online

https://www.eflm.eu/site/elearning/detail/1266

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

5­6 October 2017­01­24
EFLM Symposium: Cutting Edge at Laboratory Medicine (CELME)
www.celme2017.cz
Prague, Czech Republic

12­15 June 2018
XXXVI Nordic Congress in Clinical Chemistry
Helsinki, Finland

4­7 October 2017
3rd International Symposium on Advances in Circulating Tumor Cells: Liquid
Biopsy in Clinical Practice ­ ACTC 2017
http://www.actc2017.org/
Rhodes, Greece

10­13 October 2018
5th EFLM­UEMS Joint Congress ­ Laboratory Medicine at theclinical interface
Antalya, Turkey

4­7 October 2017
Annual meeting of the European Society for Pharmacogenomics & Personalised
Therapy (ESPT)
www.2017ESPTcongress.eu
Catania, Italy

22­23 March 2019
5th EFLM­BD European Conference on Preanalytical Phase
Biannual Conference organized by the EFLM Working Group on "Preanalyical
Phase" in collaboration with BD
http://www.preanalytical­phase.org/
Munich, Germany

http://www.nfkk2018.fi/

19­23 May 2019
EuroMedLab 2019
23rd IFCC­EFLM European Congress of Clinical Chemistry and Laboratory Medicine
Barcelona, Spain

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