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January/February 2021 EuroLabNews: Coffee with Evgenija Homšak

January/February 2021 EuroLabNews: Coffee with Evgenija Homšak | Laboratory Medicine | Scoop.it
What is your role in EFLM? What are the activities of the functional unit in which you work? Currently, I am the chair of Profession Committee and Expert/Consultant of the WG-Congresses and Postgraduate Education, where I was a chair of this WG in the past few years. The most visible achievements that I was actively involved in and contributed in this WG were the establishment of EFLMLabX – a project of exchanging practice on LM and PGCs (Biostatistics in LM and How to write a good article). In C-P, our important activity is fighting for the (automatic) recognition and rising the power of our profession on the European level according to the new EU Directive. We struggle to establish high-quality Equivalent of Standards (EoS) of specialisation training and Common training framework according to prepared and presented Syllabus in all EU/EFLM Countries and enable our specialists' free movement (to be employed) through EU Countries. In this regard, we have established EuSpLM (previous EC4) register. Another crucial point is the established EFLM Academy, which presents an umbrella inside EFLM that offers its members several important benefits (free education possibilities). Both EuSpLM and Academy register, are continually growing and showed a remarkable increase in the past year with the possibility of "block" NSs members' enrollment.   What do you like most about EFLM? Possibility of linking people with the same profession from different parts of Europe, with different experiences and knowledge to communicate, combine and share both through the common organization. There is always the place for anyone willing to work and contribute to common goals with his/her ideas.   Could you name something great about your current job? I am happy to be the head of Laboratory for hormone and autoimmune diagnostics in Department for Laboratory Diagnostics in University Clinical Centre Maribor. I have good co-workers, many possibilities to apply new diagnostics, markers and research, and be a leader or part of several different teams on different research fields. I am also pleased to be at the challenging position of the Head of Clinical Biochemistry Department at Medical Faculty in University Maribor, where I do my best to introduce, share the knowledge and importance of LM to medical students, potential our co-health workers.   Who is your role model? What makes this person so special? There is not particularly one person. Many different persons from the past and present have inspired me with their great personality, open-minded, honest, curious, high scientific and professional skills, but with simplicity and kindness when is the question of how to approach them and how they address /treat the people.   What are the things outside of your work that you are passionate about? How do you like to spend you free time? My Family with two great kids, Music, Sports (jogging, cycling, skiing…) and travelling/searching for new natural beautiful places or interesting cities/culture are essential to my personality and fill me with energy and make me happy and complete.   How would your spouse (wife, husband) describe you? It would be best if you asked him. But I am sure that he will describe me as a perfect wife (ha-ha). You just have to catch the right moment/time But he would probably describe me as a person who like to smile, never gives up and always tries to find the positive way out and bright side of life.   What are your greatest challenges? To manage all essential things in my life, from professional to personal, within one common time and stay healthy and keep a positive approach. Professionally, to continue with curiosity and transfer it to the younger generation. How say NO to proposed task, despite it presents a challenge that I like.   Are you good in time management? I am trying to manage, and so-far it goes through. Sometimes it is not always possible to predict all things, that suddenly appear, and you should find the free place in your already busy schedule. And these "sometimes" becoming more and more the daily reality-so the challenge. But I always find the time for "off" of duties, because it is necessary for "managing" yourself on a long time for well-being.   What do you value most about your country and its culture? I find my country still like a pearl on the earth, with its pure natural beauty, safety, wellbeing. We have a cute architectural fascinating small cities, great food and wine culture, that put us on the top of the exciting world destinations. Our talented sportsmen, musicians and artists result from an excellent systematic (music) school system, which is more the exception than the typical case in many world countries. It sounds poetic, but whenever I come back from travelling from abroad I feel the same, I am proud and love my country and I am happy to live in Slovenia. Do you have a pet? (feel free to share its photo with us, if you like) Yes, we have a cat Pika, and in the next few days, we will get a new member to our family, Australian Sheppard, by name Indie . We are looking forward to having her, which will bring us a lot of joy and a different way to spend our free time!
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November/December 2020 EuroLabNews: Harmonization of antineutrophil cytoplasmic antibodies (ANCA) testing by reporting test result- specific likelihood ratios: position paper

November/December 2020 EuroLabNews: Harmonization of antineutrophil cytoplasmic antibodies (ANCA) testing by reporting test result- specific likelihood ratios: position paper | Laboratory Medicine | Scoop.it
Bossuyt X, Damoiseaux J, Rasmussen N, van Paassen P, Hellmich B, Baslund B, Blockmans D, Vermeersch P, Lopez-Hoyos M, Vercammen M, Barret E, Hammar F, Leinfelder U, Mahler M, Olschowka N, Roggenbuck D, Schlumberger W, Walker R, Rönnelid J, Cohen Tervaert J-W, Csernok E, Fierz W for (i) the European Federation of Laboratory Medicine (EFLM) Task and Finish Group “Autoimmunity Testing,” (ii) the European Autoimmune Standardization Initiative (EASI) and the (iii) European Consensus Finding Study Group on autoantibodies (ECFSG) Clin Chem Lab Med 2020; Available from: https://doi.org/10.1515/cclm-2020-1178 Reported by Lejla Alić, member of the EFLM WG-Promotion & Publications Recently, many high-quality immunoassays for proteinase-3 and myeloperoxidase antineutrophil cytoplasmic antibodies (ANCA) have . Although reference materials and standards are available for measurements, studies have shown that the harmonization of ANCA test results reporting is an open question. In this position paper authors propose harmonization of reporting test results of ANCA immunoassays using test-results specific likelihood ratios (LR). ight different immunoassays using 924 disease controls (suspected for ANCA-associated vasculitis) and 251 diagnostic samples (confirmed ANCA-associated vasculitis, AAV). The test results-specific LRs were estimated using derivative of the receiver operating characteristics (ROC) curve and by Bezier curves. Authors propose reporting of the test results as LR of 0.1, 1, 10, and 30a
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BioMed Alliance - EFLM becomes the 33rd member of the BioMed Alliance

BioMed Alliance - EFLM becomes the 33rd member of the BioMed Alliance | Laboratory Medicine | Scoop.it
The European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) has now officially joined the BioMed Alliance. It is the 33rd organisation to join the BioMed Alliance, bringing important expertise related to the fields of clinical chemistry and laboratory medicine. We would like to warmly welcome them to our growing organisation. EFLM connects National Societies of Clinical Chemistry and Laboratory Medicine and creates a platform for all European “Specialists in Laboratory Medicine”. EFLM provides European leadership in Clinical Chemistry and Laboratory Medicine to national professional societies, the diagnostic industry and to governmental and non-governmental organisations in order to serve the public interest in health care. EFLM represents the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) in Europe.
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Course: EFLM Academy: presentation and benefits

Course: EFLM Academy: presentation and benefits | Laboratory Medicine | Scoop.it
Speaker: Ana-Maria Simundic (HR) Moderator: Sverre Sandberg (NO) Webinar manager: Daniel Rajdl (CZ) Date: 14th November 2019 at 18:00 CET Abstract The aims of EFLM Academy are: To provide a web domain comprising an information and communication platform; To support education, training and continuous professional development of laboratory medicine practitioners; and To raise the profile of EFLM. EFLM Academy will be officially launched on January 1st  2020. Who can be a member of EFLM Academy? All members of the EFLM National Societies are eligible for membership in the EFLM Academy. Beside Members who also meet the requirements for “European Specialists in Laboratory Medicine” will, by joining the EFLM Academy, automatically be enrolled into the EFLM Register (without any additional cost). What are the benefits of EFLM Academy members? Free on-line subscription to CCLM, the official EFLM journal; Unlimited access to all documents (laboratory standards) of the CLSI (Clinical and Laboratory Standards Institute) database; Regular e-mail notifications of all EFLM activities, programmes and opportunities; Eligibility to apply for EFLM travel grants* Reduced registration fee to all EFLM conferences and courses** Free access to EFLM webinars* How can I become a member of the EFLM Academy? National Societies are encouraged to establish automatic block enrolment of all its members into the EFLM Academy. Besides, individual members of the EFLM National Societies can apply directly through on-line subscription service in the EFLM website. The annual fee is 15 EUR to receive the benefits listed above. *   Please note that starting with January 1st, those who are not members of the EFLM Academy will not have the access to EFLM webinars and will not have the opportunity to apply for EFLM Travel grants.  ** This applies to: EFLM Preanalytical conferences, EFLM Strategic Conferences, CELME Symposium, but does not apply to congresses/conferences organized in collaboration with other organizations, such as EuroMedLab. About the speaker and moderator                 EFLM President-Elect                                          Past president EFLM
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Validation and verification of examination procedures in medical laboratories: opinion of the EFLM Working Group Accreditation and ISO/CEN standards (WG-A/ISO) on dealing with ISO 15189:2012 demand...

Validation and verification of examination procedures in medical laboratories: opinion of the EFLM Working Group Accreditation and ISO/CEN standards (WG-A/ISO) on dealing with ISO 15189:2012 demand... | Laboratory Medicine | Scoop.it
AbstractThis paper reflects the opinion of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN standards (WG-A/ISO). It aims to provide guidance for drawing up local/national documents about validation and verification of laboratory...
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November/December 2020 EuroLabNews: Season's Greeting from the EFLM President

November/December 2020 EuroLabNews: Season's Greeting from the EFLM President | Laboratory Medicine | Scoop.it
Dear colleagues and friends of Laboratory Medicine, unfortunately, this year has been unexpectedly challenging for all of us, both professionally and personally. The COVID-19 pandemic has impacted all aspects of activities around the world. It has been overwhelmingly demanding for healthcare systems in general and has put Laboratory Medicine on the first line of the fight against the pandemic. Besides many repercussions, the pandemic has accelerated the digitalization processes and has caused that most of the events have moved to on-line platforms or have been cancelled or postponed, waiting for better times. It was not different in EFLM. The EFLM Executive Board (EB) has decided to cancel the 3rd EFLM Strategic Conference 2020 and all EFLM short postgraduate courses planned for 2020, as well as all visits of the Executive Board members to National society meetings. The 6th EFLM Conference on Preanalytical Phase has been postponed to 2022 and EuroMedLab Congress has also been postponed from May 2021 to November 2021. Despite many difficulties we have faced, I dare to say that 2020 was fruitful for EFLM. We have undoubtedly expanded, improved and promoted many of our activities. Maybe the most important EFLM project in 2020 was a launch of the EFLM Academy in January 2020. Today, along EFLM National Societies’ members, Academy is open to all individuals (even non-European) interested in Laboratory Medicine, as well as to representatives from In Vitro Diagnostic (IVD) companies. The Academy has so far gained an impressive number of more than 4350 members, and besides other benefits has offered five successful and highly attended webinars, organized via EFLM e-learning platform. EFLM webinars have been a great opportunity for our colleagues to learn about COVID-19 biology and diagnostics, communication, leadership, management, POCT and Urinalysis. For 2021, EFLM continues with this form of education and here I wish to announce three exciting upcoming webinars which will cover very important topics for our everyday work: the verification of quantitative and qualitative methods as well as verification of the indirect methods reference intervals. With pleasure I also wish to note that one new full member (The Laboratory Medicine Association of Georgia) and three new affiliate members (The Academy of Clinical Science and Lab Medicine, Ireland, Serbian Society for Clinical Laboratory Medicine, Serbia and The Order of Biochemists, Biologists and Chemists in the Romanian Health System, Romania) have joined EFLM in 2020. Welcome on board! The numerous EFLM's working groups and task forces have been very successful in publishing the results of their studies (14 publications in high impact journals). Furthermore, EFLM has been increasingly active in virtual space and social networks, gaining an exponentially growing number of followers and members. Collaboration with other biomedical societies and organizations has been set as one of the main goals of EFLM. EFLM has been accepted to the Biomedical Alliance in Europe, an organization representing 33 leading biomedical societies in Europe and more than 400,000 researchers and health professionals. As its member, EFLM has taken part in a critical initiative initiated during the peak phase of spring COVID-19 pandemic with the aim to persuade the decision-makers in Europe to support the uninterrupted functioning of all medical and research societies throughout Europe. Furthermore, EFLM focuses on taking an active role in regulation- and policy-making in Europe. Therefore, we have founded a new Task Force on European Regulatory Affairs, which will have an important role during meetings and consultations of the European Commission (EC) regarding interpretation and operationalization of the IVD Regulations. To encourage and expand the professional and scientific development and exchanges of our colleagues from EFLM National Societies coming from lower income countries, according to UN and World bank classification criteria, the EB has decided to launch an EFLM bursary programme. The new bursary programme is dedicated to the memory of the first president of EFLM prof. Vic Blaton. Although the programme is designed with a wide range of opportunities for our colleagues, due to COVID-19-related uncertainty we are at the moment able to offer only the EFLM Academy memberships. One of the key aims of EFLM is to attract young colleagues, who definitely are the future of EFLM. We hope they will be encouraged by these exciting opportunities to join the EFLM and get involved in many of its activities. I would like to share my appreciation and gratitude for witnessing the optimism and devotion of all our committees' and working groups' members and colleagues from national societies. They have shown the will and readiness to adjust and overcome challenges and obstacles set before all of us in these difficult times. I take the opportunity to also welcome a number of new enthusiastic colleagues who have recently joined various Committees, Working groups and Task forces in EFLM. Thanks to all of you, EFLM is rapidly moving forward! I wish to express my sincere thanks and appreciation to all of them. Thank you all very much! Finally, with hopes that we will overcome this ongoing crisis together, I send you my best wishes for forthcoming holidays and a happy and successful start in 2021. Please keep yourself and your loved ones safe and healthy.   Ana-Maria Šimundić, EFLM President
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A modern and pragmatic definition of Laboratory Medicine : Clinical Chemistry and Laboratory Medicine (CCLM)

A modern and pragmatic definition of Laboratory Medicine : Clinical Chemistry and Laboratory Medicine (CCLM) | Laboratory Medicine | Scoop.it
Herein we propose a modern and pragmatic definition of Laboratory Medicine. Laboratory Medicine may henceforth be defined as “a clinical science and discipline, devoted to the quantitative measurement, or qualitative assessment, of any substance which can be assayed in any type of biological fluid of any animal species, thus including humans, for either medical or research purposes. The results of these measurements are translated into actionable information for improving the care and/or maintaining the wellness of both a single individual and an entire population”. This definition implicitly encompasses the use of a vast array of analytical methods, especially including – though not essentially limited to – colorimetric, enzymatic, turbidimetric, electrochemical, immunochemical, separation, nuclear magnetic resonance, cytochemical, clotting, molecular, cytogenetic and flow cytometry techniques [1]. These tests can be used for the screening, diagnosis, staging, prognostication and therapeutic monitoring of a kaleidoscope of pathological conditions, as well as for establishing health, fitness and predisposition towards certain activities and behaviors. Whilst we favorably acknowledge that this advocated definition may stimulate additional and constructive debate on this matter, we also hope that it may be seen as a good starting point for widespread discussion and/or endorsement. We further refer to the EFLM document “Syllabus for postgraduate education and training for Specialists in Laboratory Medicine” for garnering specific indications on the skills, knowledge and competence of specialists in Laboratory Medicine [1]. Reference 1. Jassam N, Lake J, Dabrowska M, Queralto J, Rizos D, Lichtinghagen R, et al. The European Federation of Clinical Chemistry and Laboratory Medicine syllabus for postgraduate education and training for Specialists in Laboratory Medicine: version 5 – 2018. Clin Chem Lab Med 2018;56:1846–63.  CrossrefWeb of SciencePubMedGoogle Scholar About the article Corresponding author: Prof. Giuseppe Lippi, Associate Editor of Diagnosis, Section of Clinical Biochemistry, Department of Neuroscience, Biomedicine and Movement, University Hospital of Verona, Piazzale L.A. Scuro, 10, 37134 Verona, Italy, Phone: 0039-045-8122970, Fax: 0039-045-8124308 Published Online: 2020-02-18 Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission. Research funding: None declared. Employment or leadership: None declared. Honorarium: None declared. Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), 20200114, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2020-0114. Export Citation ©2020 Walter de Gruyter GmbH, Berlin/Boston.
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Validation and verification of examination procedures in medical laboratories: opinion of the EFLM Working Group Accreditation and ISO/CEN standards (WG-A/ISO) on dealing with ISO 15189:2012 demand...

Validation and verification of examination procedures in medical laboratories: opinion of the EFLM Working Group Accreditation and ISO/CEN standards (WG-A/ISO) on dealing with ISO 15189:2012 demand... | Laboratory Medicine | Scoop.it
AbstractThis paper reflects the opinion of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN standards (WG-A/ISO). It aims to provide guidance for drawing up local/national documents about validation and verification of laboratory...
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EFLM Letter 2019

EFLM letter

Equivalence of standards survey

Gilbert C FAURE's insight:

With the extension of EFLM’s Register of Specialists in Laboratory Medicine from EU Member States to Europe in 2018 and the launch
of the EFLM Academy in January 2020 (see adjoining article - News flash: Specialists in Laboratory Medicine launch the EFLM Academy!)
this survey was carried out to determine ‘status quo’ and state of readiness to meet EFLM’s Equivalence of Standards for specialist
practice. Highlights from the survey include:
● Responses were received from 27 national societies. For a further three societies (Ireland, North Macedonia, Ukraine)
communication is ongoing about either readiness to meet Equivalence and/or establishing auto-registration. (The EFLM Office
eflm@eflm.eu will still welcome survey responses from Albania, Austria, Bulgaria, France, Iceland, Kosovo, Montenegro, Latvia,
Luxembourg, Norway and Switzerland).
● Equivalence applications were submitted at the same time by six national societies (Russia, Turkey, Israel, Lithuania, BosniaHerzegovina, Slovakia), three of which were immediately approved, further information (e.g. level of exit qualification/ evidence
of licence to practice at specialist level) is being sought from the others.
● Amongst EU Member States 27 have previously/recently had Equivalence recognized for medical staff, 21 for non-medical staff
(i.e., scientists/pharmacists). Amongst non- EU Member States, it is a pleasure to report that Equivalence has been recognized for
Serbia, Israel, Bosnia Herzegovina and North Macedonia over 2018/2019.
A national society’s Equivalence of Standards is recognized when there is evidence of:
● Minimum 9 years (ideally 10) years academic (4/5 years) and specialist (4/5 years) training;
● Education and training to standards set in the EFLM syllabus;
● A Master’s degree (or equivalent) in Medicine, Pharmacy or Science;
● An exit qualification (postgraduate certificate) which meets the EFLM “Equivalence of Standards” as indicated below in the
curriculum requirements;
● Evidence of participation in continuous professional development (CPD).
Whilst registrants will automatically be offered the benefits of EFLM Academy membership, the importance of supporting the EFLM
Register is also to add weight to the case for recognition of specialist practice under EU Directive 2013/55/EU (The recognition of
Professional Qualifications) – see EFLM’s web page about the Register.
For national societies who have yet to submit evidence of Equivalence for medical, scientific or pharmacy trained specialist

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EFLM live Webinar: Unmet clinical needs assessment for biomarker evaluation - a practical toolbox for Laboratory Medicine | Actualidad | Sociedad Española de Medicina de Laboratorio

EFLM live Webinar: Unmet clinical needs assessment for biomarker evaluation - a practical toolbox for Laboratory Medicine | Actualidad | Sociedad Española de Medicina de Laboratorio | Laboratory Medicine | Scoop.it
SIGUIENTE 16/04/2019 Para poder asistir a los Webinars organizados por el Distance Education and e-learning WG de la EFLM solo tiene que estar registrado/a en su plataforma gratuita de e-learning. 23rd April at 18:00 CET Speaker: Phillip Monagan There is a major opportunity here for laboratory professionals to play a key role in the development and implementation of clinical care pathways for new and existing laboratory tests. Stakeholder involvement; working together to overcome the conventional silos across disciplines is paramount to drive the adoption of innovative tests with robust implementation planning, so that test results are available and acted upon in an appropriate and timely manner, with a strong link to clinical intervention and outcomes. To realise the value of laboratory medicine in this context, the EFLM Working Group for Test Evaluation (WG-TE) has developed a ‘practical toolbox’ providing a Test Evaluation Framework and Interactive Unmet Clinical Needs Checklist (hosted on the EFLM eLearning platform) to assist laboratories and other key stakeholders in clinical translational research, to undertake clinical needs assessment and clinical care pathway development. Si no está registrado en la Plataforma gratuita de e-learning de la EFLM, hágalo fácilmente para poder inscribirse a éste u otros Webinars programados. Una vez registrado/a, también podrá acceder a Webinars anteriores. Se puede inscribir a este webinar a través del siguiente enlace:
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