Mauro Panteghini Who, what and when to do in validation/verification of methods.
Prof Mauro Panteghini - EFLM Madrid - President Report... · 2017-02-09 · Develop relationships...
Transcript of Prof Mauro Panteghini - EFLM Madrid - President Report... · 2017-02-09 · Develop relationships...
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9th EFLM GENERAL MEETING March 21st 2016
President’s End-of-Mandate Report
Prof Mauro Panteghini
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40 Countries are represented in EFLM
Representing 22,000 Laboratory Medicine Specialists Bielorus, Malta, Moldova are the only European
Countries that still have to join EFLM
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EFLM structure
& organization
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Task Force on Performance Specifications in Laboratory Medicine
An EFLM Task Force on Performance Specifications in Laboratory Medicine (TF-PS)
has been created to coordinate the activities of the Task & Finish Group (TFG) established as outcome of the
1st EFLM Strategic Conference
EFLM Task Force on Performance Specifications in Laboratory Medicine
TFG Allocation of
laboratory tests to different models for performance
specifications
TFG Performance specifications
for EQAS
TFG Total error
TFG Performance
specifications for the extra-analytical
phases
TFG Biological variation database
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EFLM functional units involve 118 officers representing 24 European Countries
ALBANIA LITHUANIA
AUSTRIA 1 LUXEMBOURG
BELGIUM 5 MACEDONIA 2
BOSNIA HERZEGOVINA MONTENEGRO 1
BULGARIA NETHERLANDS 15
CROATIA 4 NORWAY 7
CYPRUS POLAND 3
CZECH REPUBLIC 3 PORTUGAL 3
DENMARK 4 ROMANIA 1
ESTONIA RUSSIA
FINLAND 2 SERBIA
FRANCE 6 SLOVAK REPUBLIC 1
GERMANY 4 SLOVENIA 1
GREECE SPAIN 13
HUNGARY 2 SWEDEN 6
ICELAND SWITZERLAND 1
IRELAND TURKEY 2
ISRAEL UK 17
ITALY 14 UKRAINE
LATVIA
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EFLM Strategic Plan 2014-2015
Strategic plan
32 actions
Structure & organization
Promotion
Relationship with other
organizations
Scientific affairs
Education & training
Quality & regulation
Professional affairs
28 of 32 Aims achieved;
3 Actions are still progressing
1 Action is ongoing
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Develop relationships and collaboration with IFCC
1) New MoU finalized (renewal for 10 years: 2015-2025).
2) New agreement with IFCC for Office Staff: establishment of 1 full-time employee for EFLM.
3) New Guidelines for EuroMedLab released (sharing with IFCC the organization with active presence in COC & SPC; increasing incomes for EFLM: IFCC will share with EFLM the 20% of the general income plus the 55% of the surplus derived from the last Euromedlab Congress according to the following rates: 75% to IFCC and 25% to EFLM)
Strategic Plan 2014-2015 1. Structure & Organization
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Strengthen and formalize relationship with industrial partners
1. EFLM Corporate partners policy
2. BD Sponsorship Agreement for EFLM-BD Conferences 2017-2021
3. Abbott, BD & Roche supported Awards
4. Roche & Siemens supporting specific projects
Strategic Plan 2014-2015 1. Structure & Organization
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Standardize EFLM operating procedures
1. EFLM Procedure Manual updated and implemented
2. EFLM Meeting Guidelines updated and implemented
3. EFLM Publication Policy released and implemented
Strategic Plan 2014-2015 1. Structure & Organization
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Review activities of Committees, WG and TFG A structured review of Cs/WGs/TFGs activities and outcome evaluation
has been introduced in a dedicated EB meeting at the end of the year
Strategic Plan 2014-2015 1. Structure & Organization
C-S WG-H “Harmonisation of Total Testing Process”
C-S TFG-LTD “Laboratory Testing for Dyslipidemia”
C-S TFG-STCC “Task and Finish Group on Standardization of the colour coding for blood collection tube closures”
C-C TFG-H “History of EFLM”
C-ET WG-DE “Distance e-learning”
C-ET TFG-CPD “Continuous Professional Development”
TF TF-PS “Task Force on Performance Specifications in Laboratory Medicine”
TF TFG-DM “Allocation of laboratory tests to different models for performance specifications”
TF TFG-PSEQA “Performance specifications for EQAS”
TF TFG-TE “Total error”
TF TFG-PSEP “Performance specifications for the extra-analytical phases”
TF TFG-BVD “Biological variation database”
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Review activities of Committees, WG and TFG A structured review of Cs/WGs/TFGs activities and outcome evaluation
has been introduced in a dedicated EB meeting at the end of the year
Strategic Plan 2014-2015 1. Structure & Organization
C-S TFG-C “Critical Results”
C-P WG-CTF “Common Training Frameworks/Syllabus”
C-P WG-RPQ “Recognition of Professional Qualifications. Liaison with European entities”
C-QR WG-IVD “IVD Directive”
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Consolidate EC4 activities in the EFLM structure [progressing]
have commenced and will be progressing in the future. 1. EFLM EB ratification of integration road map
2. Started discussion with the EC4 Foundation Board
Strategic Plan 2014-2015 1. Structure & Organization
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Ensure the financial position of EFLM
EFLM own capital
Strategic Plan 2014-2015 1. Structure & Organization
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EFLM Publications
Strategic Plan 2014-2015 2. EFLM Promotion
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Improve EFLM communication
Strategic Plan 2014-2015 2. EFLM Promotion
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Implementation of the relationship with CCLM
Strategic Plan 2014-2015 2. EFLM Promotion
Clinical Chemistry and Laboratory Medicine (CCLM): the official journal of EFLM
A new agreement on mutual co-operation has been signed between
EFLM and CCLM for the duration of 5 years (2014-2018)
Many opportunities for EFLM National Societies have been included in the
contract
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Promote the profession increasing awareness of the importance of clinical laboratories
Strategic Plan 2014-2015 2. EFLM Promotion
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Renewal of EFLM awards and identification of new ones
1) Existing Awards continue: a) EFLM-Abbott Award for Excellence in Outcomes
Research in Laboratory Medicine
b) EFLM-Roche Scientific Award for Laboratory Medicine
2) Established the new EFLM Walter-Guder Pre-analytical award (sponsored by BD)
Strategic Plan 2014-2015 2. EFLM Promotion
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Promote active participation of young scientists (YS) to EFLM activities
1. To improve YS (<35) engagement, EFLM reserves a full member position to YS in each WG. Invitation through NSs and then competition and selection. 12 YS members are currently active in EFLM WGs (one is chairing a WG).
2. A number of bursary programs to attend the main EFLM events are available (an important part of the EFLM budget is allocated to this).
Strategic Plan 2014-2015 2. EFLM Promotion
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Map the EFLM history [progressing]
TFG-History has a new chair, who prepared the structure of a
specific brochure on the topic.
With the assistance of EFLM office, the activity is now well under way and will continue during the rest of 2016.
Strategic Plan 2014-2015 2. EFLM Promotion
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Engagement of EFLM with NSs
• EFLM EB members present at 9 NS meetings (2014 and 2015).
• 29/40 NSs put the EFLM logo/link in their websites. A new specific section to host news from the NSs has been included in the EFLM website.
Strategic Plan 2014-2015 2. EFLM Promotion
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Engagement with NSs: Visited Countries
Strategic Plan 2014-2015 2. EFLM Promotion
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Promote the agreement with CCLM among the NSs
Strategic Plan 2014-2015 2. EFLM Promotion
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Promote the agreement with CCLM among the NSs
Strategic Plan 2014-2015 2. EFLM Promotion
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Work with the other IFCC Regional organizations
Establish basis for relationships with clinical organizations
Strategic Plan 2014-2015 3. Relation with other organizations
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AACB (Australasian Association of Clinical Biochemists)
AACC (American Association of Clinical Chemistry)
CEN (European Committee for Standardization)
CEPLIS (European Council of the Liberal Professions)
CLSI (Clinical Laboratory Standards Insitute)
EA (European co-operation for Accreditation)
EAPM (European Alliance for Personalised Medicine)
EAS (European Atherosclerosis Society)
EASL (European Association for the Study of Liver)
EC (European Commission)
EDMA (European Diagnostic Manufacturers Association)
EPMA (European Ass. for Predictive, Preventive & Personalized Medicine)
EQALM (External Quality Assurance Programmes in Lab Med)
ESPT (European Society for Pharmacogenomics and Theranostics)
EUCOMED (Medical Devices Industry)
IFCC (International Federation of Clinical Chemistry and Lab Med)
IRMM (Institute for Reference materials & Measurements)
ISO (International Organization for Standardization)
UEMS (European Union of Medical Specialists)
Strategic Plan 2014-2015 3. Relation with other organizations
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Consolidate partnership with UEMS 1. 3rd joint EFLM-UEMS “EuroLabFocus”
(Liverpool 2014)
2. Venues for the 4th (Warsaw 2016) and 5th (Antalya 2018) joint EFLM-UEMS Congresses defined.
3. Signed a MoU on co-operation in the WG-Guidelines.
Strategic Plan 2014-2015 3. Relation with other organizations
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Ensure that scientific questions are identified as topics
1. 1st EFLM Strategic Conference on Performance Specifications in Laboratory Medicine was organized and a specific Task Force was created, including 5 TFGs.
2. 3rd EFLM-BD European Conference on Pre-analytical Phase.
3. New WG on Harmonization was established.
4. EFLM has started an initiative on the standardization of the tube cap color coding.
5. With few exception, WGs/TFGs have fulfilled their established Terms of Reference.
Strategic Plan 2014-2015 4. Scientific Affairs
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Provide governance to e-learning projects
1) WG-Distance e-Learning re-established
2) 8 e-seminars run in 2014-2015
Strategic Plan 2014-2015 5. Education & Training
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Promote educational courses
14th & 15th "Dubrovnik" post-graduate courses
EFLM Test Evaluation Course
Strategic Plan 2014-2015 5. Education & Training
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Develop CPD Scheme [progressing] Results of a survey offered elements to start with an EFLM
CPD program and EFLM crediting system First draft of the ‘Rulebook on EFLM CPD system” prepared. A TFG-CPD created with the aim to finalize the development
of an EFLM CPD system.
Strategic Plan 2014-2015 5. Education & Training
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Create the EFLM Speakers Bureau
Strategic Plan 2014-2015 5. Education & Training
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Liaise with EA, accrediting institutions and standardization bodies to ensure needs of Laboratory Medicine are met EFLM has liaison position in:
• EA (European co-operation for Accreditation)
• ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems
• ISO/TC 76 Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
• CEN/TC 140 In vitro diagnostic medical devices
Strategic Plan 2014-2015 6. Quality and Regulatory Affairs
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Promotion of the ISO 15189 accreditation using the ‘flexible scope’ approach
Disseminate information to NSs
Strategic Plan 2014-2015 6. Quality and Regulatory Affairs
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Promotion of the ISO 15189 accreditation using the ‘flexible scope’ approach
Disseminate information to NSs
Strategic Plan 2014-2015 6. Quality and Regulatory Affairs
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Harmonize training and education of the profession across Europe [ongoing]
→ Common Training Framework (CTF) & recognition of Specialists in Laboratory Medicine under EU Directive 2013/55/EU.
→ The Directive was transposed into EU member states national laws on 18th January 2016. As well as allowing free professional migration across EU borders it affords opportunities for "specialist" practice to be recognized under Common Training Frameworks. EU Member States are now supposed to work to update their national legislations to the provisions of the said Directive.
→ For Specialists in Laboratory Medicine the opportunity arises to present a CTF that has been developed by EC4 and EFLM's Profession Committee, but it needs to have the support of at least one third of EU member states.
Strategic Plan 2014-2015 7. Professional Affairs
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Increase the number of EC4 registration at the Register Commission encouraging compliant NSs to implement automatic registration for EuSpLM
UK and The Netherlands have automatic registration now
Strategic Plan 2014-2015 7. Professional Affairs
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Revise the EC4 Syllabus for post-graduate training in CCLM
version 5 of EC4 Syllabus prepared and submitted for publication soon.
Strategic Plan 2014-2015 7. Professional Affairs
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12th EFLM Symposium for Balkan Region
Harmonization of total process: influence of the extra-laboratory phases Belgrade, 26 May 2016
Forthcoming EFLM events
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Forthcoming EFLM events
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Forthcoming EFLM events
Key Features of 2½ day course: The course will be interactive and talks by keynote speakers will be followed by practical assignments.
Test evaluation – definitions and basic concepts Tools to conduct test evaluation including:
Talks to highlight the differing perspectives and experience of key stakeholders and experts in test evaluation Practical assignments to understand the use of test evaluation tools.
For information visit the course website at: www.eflm-test-evaluation-course.eu
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Forthcoming EFLM events
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Communication
Education and Training
Profession
Quality and Regulations
Science
Maria Stella Graziani, IT
Elizabeta Topic, HR
Gilbert Wieringa, UK
Wim Huisman, NL
Elvar Theodorsson, SW
EFLM Committee Chairs 2014-2015
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Past President
Vice-President
Secretary
Treasurer
Member-at-Large
Member-at-Large
Ian Watson, UK
Sverre Sandberg, NO
Ana-Maria Simundic, HR
Huibert Storm, NL
Grazyna Sypniewska, PL
Tomas Zima, CZ
EFLM Executive Board 2014-2015