Scientific Committee of the EFLM Elvar Theodorsson Tasks of the - - PowerPoint PPT Presentation

Scientific Committee of the EFLM

Elvar Theodorsson

Tasks of the scientific committee

• Promotion of research that

– translates the scientific results of clinical chemistry and laboratory medicine to clinical applications and – improves patient outcomes through the appropriate use and interpretation of laboratory data in clinical practice

SC and EFLM strategic plan

No Strategic

• bjective

Activities EFLM functio nal unit(s) involve d FIRST periodic status to be sent by 5 JUNE 2014 SECOND periodic status to be sent by 15 SEPTEMBER 2014 THIRD periodic status to be sent by 6 NOVEMBER 2014

• 1. STRUCTURE AND ORGANIZATION

1 Develop relationshi ps and collaborati

• n with

IFCC Renewal of the MoU. Liaison between EFLM and IFCC functional units of mutual interest EB, C- Chairs * WG-CM: A member of the IFCC WG Standardization of TnI has liaised the survey of WG-Cm to US and Canada. * S-C Chair now has direct contact with Prof. Ian Young IFCC SD for mutual exchange of information. WG-CM has noted that IFCC has a working group on cardiac

• markers. The IFCC working

group has its primary focus on educational matters. Paul Collison is a liason between the IFCC and EFLM groups. 3 Standardiz e EFLM

• perating

procedures Apply and maintain the EFLM Procedure Manual. Implementing guidelines for EFLM meetings EB, C/WG Chairs * S-C chair and has made a particular point of studying the EFLM Rules of Procedure in general and in the number

• f more- or less delicate questions that

have needed attention * WG-CM: Done Unchanged from the June report 4 Review activities of Committee s (C), Working groups (WG) and Task and Finish Groups (TFG) Ensure existing C, WG & TFG are fit for purpose and evaluate

• utcomes by

periodical reports and at the end of the year during the last EB meeting EB, C/WG/T FG Chairs * The functions of the WG and TFG have been reviewed in this perspective. In the case of one TFG pointed out to the chair of the C-S by the EB, measures have been taken to speed up the work towards finishing the task by agreed publication(s). A separate report

• n this matter was submitted to the EB
• n June 3rd 2014.

* WG-CM: WG members are actively involved in all activities. The Science Committee chair realizes this is an important challenge for him and intends to give this work high priority duting the autumn of 2014

SC and EFLM strategic plan

No Strategic

• bjective

Activities EFLM function al unit(s) involved FIRST periodic status to be sent by 5 JUNE 2014 SECOND periodic status to be sent by 15 SEPTEMBER 2014 THIRD periodic status to be sent by 6 NOVEMBER 2014

• 1. STRUCTURE AND ORGANIZATION
• 2. EFLM PROMOTION

Participated in 7 EFLM Publications Create an EFLM Publication Policy and maintain an updated inventory of EFLM publications EB, C-C, WG-P, C/WG Chairs WG-CM: List of publications on the w ebsite. TFG-CR. Ensured that all publications issued have EFLM acknow ledged. Ensured that all publications issued have EFLM acknow ledged. Participated in initiating e-semninars arranged by the EFLM 14 Engagement

• f EFLM

w ith NSs Promote presence of EFLM representatives at NS events. Promote the inclusion of EFLM link on the w ebsite

• f EFLM members.

Promote a satisfaction survey among EFLM NSs EB, Cs, WG-P WG-CM: WG-CM members have given presentations at their national meetings. WG-TE: Tw o members of the WG-TE gave talks at the April meeting of the Australasian Association of Clinical Biochemists TFG-CR: Eva Ajzner and Rita Horvath have had each their ow n oral presentation accepted for the AACC2014 congress in Chicago this summer. Both on subjects related to critical results. Summaries of both their talks w ill appear in the June 12th edition

• f CLN Stat, w hich is AACC's new w eekly e-

new sletter. One or tw o manuscripts are being prepared and are expected to be submitted during 2014. Sverre Sandberg and Elvar Theodorsson w ill attend the semi- annual Nordic Conference in Clinical Chemistry in Gothenburg in

• September. WG-CM has proposed

symposia for AACC and EuroMedLab Paris, but they have not been accepted. How ever, Paul Collison is giving lectures at WorldLab, AACC and EuroMedLab

• Paris. WG-PRE chair (Ana-Maria

Simundic) w as invited to ECAT Symposium on Quality held on 14 May 2014 in den Hague (NL) to present a lecture: Managing the quality of preanalytical phase, on behalf of EFLM WG-PRE.

SC and EFLM strategic plan

• 3. RELATION WITH OTHER ORGANIZATIONS

17 Establish basis for relationships with clinical

• rganisations

Identify potential partners. Exploring possibilities of cooperation and establish agreements EB, C-S, WG-G * A memodandum of understanding has been written with the European Atherosclerosis Society to produce joint guidelies on the clinical use of measurements on plasma lipids and lipoproteins. * EFLM was invided by the Swiss health authorities to participate in a working group to establish the use of biomarkers for Alzheimers disease. Patrick Bussuit was appoiinted by the EFLM for this work. * EFLM and UEMS have agreed on and signed a memorandum of understanding on co-operattion in the working group on guidelines (WG-G).

• 1. Prepare guidelines for making recommendations

for laboratory testing.

• 2. Co-operate with clinical guidelines developers (e.g.

SIGN, ADA, NICE) for the development of the laboratory part of clinical guidelines.

• 3. Develop laboratory guidelines for reflective testing.

* The president of the EFLM is working to identify a person able to formulate a project proposal to create a working group in the field of tumour markers * The EFLM Executive Board has identified the fields

• f Cardiology and Nephrology of particular

relevence for co-operation with clinical disciplines * WG-CM: Has proposed joint symposia with ESC and IFCC for AACC 2014, ESC 2014, EuroMedLab 2015, no success, however. WG-PRE Has nominated Dr. Johannes Zander for the Walter Guder Preanalytical Award WG-PRE is organizing the 3rd EFLM-BD Preanalytical Phase meeting to be held in Porto (Portugal) during 20-21 March 2015. WG-PRE is organizing the 3rd EFLM-BD Preanalytical Phase meeting to be held in Porto (Portugal) during 20-21 March 2015. WG-PLM has reached out to The European Society of Pharmacogenomics and Therapeutics (ESPT) for co-operation in applying for a Horizon 2020 grant for research in personalised laboratory medicine.

SC and EFLM strategic plan

• 4. SCIENTIFIC AFFAIRS

19 Ensure that meanigful and consequenti al scientific questions are identified as topics Fulfil established ToR and explore new potential areas (e.g. harmonization in Laboratory Medicine) C-S * A lively dialog on this important topic is taking place. * Prof. Ferruccio Ceriotti has written and submitted to the EB a proposal on "Harmonization of the total testing process". The harmonization should start from an homogeneous diagnostic approach to a disease to continue with the correct collection of the biological sample to be analysed with a standardized method, reported with the correct units, interpreted versus adequate reference intervals and /

• r decision limits. If the entire process is
• ptimally performed, the efficacy of

laboratory results on the patient’s outcome will certainly improve. The analytical part of the measurement process is properly addressed by the principles and methods of metrology. However the majority of the remainder of the total measurement process deals with opinions, attitudes and preferences of people which are more properly addressed by qualitative research methods. Elvar Theodorsson and Ana-Maria Sigmundic are working on an

• pinion paper intended to stimulate

dialog and discussion within the EFLM e.g. about the increased use

• f qualitative methodologies in
• rder to study the total testing

process 20 Ensure that C-S publications fully acknowledg e the contribution

• f EFLM in

the authorship Surveillance by the C-S Chair C-S, WGs The matter of acknowledging EFLM has been stressed within the C-S as a whole. Ensured that all publications issued have EFLM acknowledged.

Working group Cardiac markers (WG-CM)

• Results of survey 2013-2014, including US and

Canada

– Surveys 2009 and 2013 – Possibility to complement data – Manuscript will be drafted in the end of 2014

• Co-operation with IFCC – complementary

work

– The IFCC group is primarily educational – The EFLM group focuses on guidelines

Working group Cardiac markers (WG-CM)

• Co-operation with the EFLM WG Guidelines on

a joint manuscript

• Co-operation on symposia in international

congresses

• Website updates and new material

Working group Biological Variation (WG-BV)

• Identified further need for users to understand

the uncertainty in applying published estimates

• f biological variation
• Identify a minimum dataset to accompany

published figures of biological variation

• The WG-BV is establishing critical appraisal

checklists for publication of biological variation data

• Use of international coding system e.g. LOINC or

SNOMED

Working group Biological Variation (WG-BV)

1. Target - analyte and measurand, sample matrix, method characteristics. 2. Population characteristics- demographics, state of well being, physical/physiological characteristics, medication. 3. Study Characteristics- study duration and design, power of study to detect BV indices, model assumptions, statistical approach. 4. Data Characteristics- indices of biological variability, confidence intervals, tests for model assumptions 5. Publication Details- links to the original publication. 6. Data rating- new concept to be developed to indicate the quality of the BV data against a set of key criteria.

Working Group Guidelines (WG-G)

• Establishing even more extensive collaborations with

clinical disciplines

• Plans to do a survey among the European countries and

find out what guidelines there are out there, but strictly limit this to laboratory-only guidelines.

• In The Netherlands there are several guidelines that are
• fficially accepted by the national society: like one on POCT,

drawing blood, consulting, pre-analytical issues etc. We know that other countries would appreciate some support in this field (e.g. Poland with POCT GL).

• One result of this survey would be to know what is out

there, which is always a good starting point for some sort of harmonization.

Working Group Guidelines (WG-G)

• Pick the good GLs and help other countries by

making these available, or by having these accepted (in a way we have to find out) by the EFLM.

Working Group Guidelines (WG-G)

• EFLM WG-G currently has a chair, four full members +

young scientist. EFLM and U.E.M.S. share interest in this activity, and have decided to join forces in order to accomplish the proposed goals of the WG. U.E.M.S. is therefore invited to participate in the WG with two new full members appointed and financed by U.E.M.S.

• As a consequence of this memorandum of

understanding EFLM intends to reduce its number of full members to three, one of them serving as chair of the WG-G.

• The two members of UEMS will be: Pat Twomey and

Wytze Oosterhuis.

Working group Harmonisation of total Testing Process (WG-H)

• New
• Chair

– Ferruccio Ceriotti

• Proposals announced

Terms of reference WG-H

• Survey and summarize national European and

pan European harmonization initiatives.

• Promote and coordinate the diffusion of at

least two especially promising harmonization initiatives among the EFLM member societies

• Take initiatives to harmonize nomenclature,

units and reference intervals on a European level

Personalised laboratory medicine (WG-PLM)

• There are currently (Sept. 30th) 49 answers to

the questionnaire on the use of personalised medicine in European clinical laboratories

• An opinion paper from the working group has

been submitted for publication

Workgroup Preanalytical Phase (WG-PRE)

• Walter Guder Preanalytical Award
• Large observational study on phlebotomy

practices, in 12 European countries.

– Assess the current phlebotomy practices in various healthcare facilities and estimate the degree of compliance of current practices with CLSI phlebotomy guidelines

• Organizing the 3rd EFLM-BD Preanalytical Phase

meeting to be held in Porto (Portugal) during 20- 21 March 2015

Workgroup Preanalytical Phase (WG-PRE)

• EFLM Position paper related to the need to

harmonize colors of tube caps – accepted for publication in CCLM

Working group postanalytical (WG-POST)

• Prepares a scientific paper on the findings of the

European survey on the evaluation of an unexpectedly prolonged APTT results.

• Prepares a scientific paper on the findings of the

European survey on the utilization of D-dimer results in the diagnostic work-up of venous thromboembolisms by clinicians

• Members of the WG deliver oral presentations

related to post-analytical phase in different conferences.

Workgroup Guidelines (WG-GL)

• Establish even more extensive collaborations with

clinical disciplines

• A survey among the european countries and find
• ut what guidelines there are out there, but

stricktly limit this to laboratory-only guidelines

• Pick the good guidelies and help other countries

by making these available, or by having these accepted (in a way we have to find out) by the EFLM.

Working Group Test Evaluation (WG-TE)

• Preparation of final draft of the clinical needs

paper –lead author Phil Monaghan (publication activity)

• Harmonisation Symposium of AACB chaired by

Rita Horvath

– ‘How to achieve harmonisation of laboratory testing - the complete picture’ and – ‘Clinical Decision Cut-offs – EQA assessment and specifications for bias limits’.

• AACB’s POCT Scientific Education Seminar in

Sydney.

Working Group Test Evaluation (WG-TE)

• 1st EFLM Strategic meeting on the revision of

the Stockholm criteria, 24-25 November, Milan, Italy: (conference and dissemination activity)

Patient focused laboratory medicine (WG-PF)

• Evaluate and study methods for how specialists in

laboratory medicine can communicate directly with the patients;

• Evaluate and study how the laboratory can play an

active role in patients using self-monitoring for monitoring their disease.

• Carry out a survey among European countries to

evaluate what (if any) activity the EFLM member states have in the two areas above;

• Perform a study to evaluate the usefulness of a direct

report of laboratory data to the patient.

Proposal from the chair

The total testing process in clinical chemistry involves several professionals and organizations in healthcare from the clinical decision to

• rder a test through

the pre-analytical, analytical and post- analytical phases to the value of the test result in the on-going clinical decisions and healthcare process

Proposal from the chair

• Changing attitudes, knowledge and practice in the pre-and

postanalytical phases of the measurement process demands understanding of why all persons involved think and do the things they do.

• In order to address the total testing process qualitative

research methodologies may be needed to properly investigate the reasons for possible resistance to change to the recommended procedures and methods of advanced change management may be needed to accomplish the changes needed.

• Neither of these technologies are amongst tools that have

been widely applied in clinical chemistry and may even be regarded of lower scientific value.

Proposal from the chair

• A manuscript intended to stimulate a creative

brainstorming within the EFLM on how to widen the scope of research methods in the pre- and postanalytical phases of the total testing process

• Since this may be seen as a paradigm shift in the

method arsenal used within EFLM, we would especially like to involve members of the Executive Board of the EFLM in the process including co-authorship of the manuscript.

• It is evidently up to the Executive board whether the

manuscript remains an internal document within the EFLM or eventually gets published.