EC4 Strategic Plan 2005-2008

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1. Introduction
2. Strategy
3. Goals of EC4
4. Structure of EC4
5. Profession regulation (CARE for the profession)
6. Performance of the profession
7. Performance of laboratories (CARE for the laboratories)
8. Performance of laboratories (CARE for laboratory data)
9. Profiling towards European bodies and organisations
10. Promotion of EC4 activities
11. Strategic Actions related to the Strategic Plan 2002-2005

1. Introduction

The freedom of movement of people and goods within the European Union (EU) has a large impact for the member states. Particularly within health care it is important to demonstrate, or if necessary ensure, an adequate level of the quality of profession and practice, so that citizens know that health care is offered in their country at a level comparable to other countries.
The importance of recognition also applies to laboratory medicine. This was envisaged by the National Societies of Clinical Chemistry in EU countries related to the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). The common political reality led to the institution of the European Communities Confederation of Clinical Chemistry (EC4) on 27th of April 1993. On September 14th 2002, the name was changed in conformity with that of IFCC and the Federation of European Societies of Clinical Chemistry and Laboratory Medicine (FESCC) to the European Communities Confederation of Clinical Chemistry and Laboratory Medicine (EC4).
EC4 is the organization of societies for clinical chemistry and laboratory medicine in the EU and the Executive Board consists of representatives from the societies. The EC4 member societies are members of the IFCC as well of its broad European regional branch (FESCC).
To indicate its plans for the near future and to open them for discussion, the board of EC4 publishes its Strategic Plan 2005-2008. It succeeds the Strategic Plans 2002-2005 and 1999-2002 of which all of the planned actions were fulfilled. The new Plan builds on the work of the previous Strategic Plans and is more focussed on actions designed to produce direct benefit for the patient.

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2. Strategy

In European health care, patients are treated in a health care “chain”. In this chain, patients move quickly from primary health institutes to secondary and tertiary institutes, and vice versa. This situation involves many health care workers and may include several different laboratories. Diagnosis and therapy are now central to health care and medical laboratories play an essential role in this.
The broad spectrum of medical laboratory investigations makes the consultant role of the medical laboratory specialist ever more important. The quality of both professionals and laboratories, as well as continuity of laboratory data within and between laboratories is of the utmost importance.
EC4 is active in giving support to attain such quality and to ensure that laboratory medicine is practised at an adequate level throughout Europe.
In most countries this is already the case and EC4 plays a central role in co-ordinating mutual recognition on the basis of existing equivalence of standards. The Co-ordination of Automatic Recognition of Equivalence of standards (CARE) is important at three levels, CARE for the profession, CARE for quality of laboratories and CARE for laboratory data. Together, these result in proper standards of patient care.

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3. Goals of EC4

The goals of EC4 include co-operation and harmonisation in the field of laboratory medicine. The efforts are focussed on several aspects:

• Co-operation for the advancement of clinical chemistry and laboratory medicine as a science, in its fundamental aspects as well as in its application, within the European Union in particular and Europe in general.
• Co-operation to reach recognition of professional qualifications of the profession on a European level, in compliance with the principles of free movement of professionals within the EU.
• Co-operation and recognition of equivalence of standards in the field of training of specialists in clinical chemistry and laboratory medicine, irrespective of their varying academic background.
• Co-operation and recognition of equivalence of standards of accreditation and quality systems of medical laboratories
• Co-operation to introduce a common professional view in ISO and CEN deliberations
• Co-operation in defining guidelines on a European level for the performance of the profession and the laboratory management of disease.
• Co-operation in evaluating effects of EU directives on professional matters
• Co-operation in evaluating effects of EU directives related to laboratories and laboratory data
• Communicating with and informing the public on the significance of their laboratory data

In the 2005-2008 Strategic Plan the following five main issues are elaborated to reach the goals:

• Profession Regulation
• Performance of the profession
• Performance of laboratories
• Liaison with European and other bodies
• Promotion of EC4 activities
  

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4. Structure of EC4

The structure of EC4 is depicted by the following diagram:

The Executive Board is formed by the President of EC4, the Secretary, the Treasurer and two Members at Large. The officers are all elected by the General Assembly. In 2005 new officers will be elected. The President ends his second term and is not re-electable.
At meetings of the Executive Board the chairmen of the working groups are normally invited to report. The main responsibility of the Executive Board in the Strategic Plan period will be the co-ordination of the work in an enlarged European Union. On May 1st 2004 ten countries joined the European Union bringing the total number to 25 member states. In 2007 further expansion is planned.

The EC4 Register plays a central role in many of the EC4 activities. The increasing number of applicants to the Register requires a more professional organisation. A legal body (Foundation) for EC4 was established in September 2002.
A bank account was opened and internet banking is currently in use. The Treasurer of the Executive Board should set up a debiting and accounting system and should see to external control of the EC4 accounts.
The web site is under the responsibility of the Web master. Both web site and Register database have been completely revised. The RC secretary manages the daily operation of the Register. The secretary of the Executive Board manages the secretariat of EC4. The Web master manages the maintenance of the web site.

The Registration Commission deals with all matters concerning the maintenance of the Register. The Registration Commission is composed of representatives from the National Clinical Chemistry and Laboratory Medicine Registration Committees. The chair is elected at the General Assembly. In 2005 the chair ends her first term and is re-electable.
The working group Profession deals with the promotion of the Register and the contacts with the European Commission. It also monitors EU directives and draft directives on issues important for profession or laboratories.
The working group ISO CEN co-ordinates the efforts to influence ISO and CEN with respect to issues pertaining to laboratory medicine.
The working group on Accreditation co-ordinates the efforts for harmonisation of accreditation and quality systems. It defines Essential Criteria to achieve such harmonisation.
The working group on Competence to be a Consultant defines guidelines for duties and competences of consultant clinical biochemists.
The working group on Number of Consultant Clinical Biochemists defines Essential Criteria for the appropriate number of professionals in various categories of medical laboratories.
The working group on Guidelines for Investigation of Disease issues European Guidelines for laboratory investigation of disease in specific fields of laboratory medicine based on peer reviewed evidence.The working group functions as a steering group, initiating project groups of multi-disciplinary membership on various topics.
The working group Vision defines the important areas where our profession and EC4 should focus on in the future.
The project group EQUAL has initiated a project on quality assessment in DNA-analysis in routine clinical chemistry laboratories.
The working groups will be encouraged to proceed with their work. Young colleagues should be interested to participate.

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5. Profession Regulation (CARE for the profession)

EC4 Register

Background
The installation of the EC4 Register of European Specialists in Clinical Chemistry and Laboratory Medicine is a major step forward to the attainment of the first level, Recognition of Equivalence of Standards of the profession.
Individual medical laboratory specialists should and do apply for registration. In most EU countries National Registers of medical laboratory specialists exist. In some countries several registers exist, depending on the academic background of the medical laboratory specialist.
Such National Registers may apply for EC4RC Recognition of Equivalence of Standards. In some EU countries no national register exist and EC4 encourages and helps these countries to set up such a Register. Colleagues from all relevant academic background, scientific as well as medicine, pharmacy, veterinary, and other, if registered in their National Register can and do apply for registration in the EC4 register.
The name ‘Clinical Chemist’ causes confusion and inhibits some colleagues from applying. Therefore the name was changed into European Specialist in Clinical Chemistry and Laboratory Medicine in 2002, keeping, however, the existing abbreviation EurClinChem.

Operation
To set up the register, EC4 installed a register commission (EC4RC) in 1997. The Register was opened in 1998. Each society was invited to send one delegate from the National Clinical Chemistry Registration Commission (NCCRC) to EC4RC. A board was elected and the structures for the operation of the register were developed. The operation of the register is based on the European Syllabus (defining the necessary items of postgraduate education), the Guide to the Register (giving the basic education and the rules for entering the register), and the Code of Conduct (defining the criteria of behaviour of professionals in our discipline).
The EC4 Register is based on the Recognition of Equivalence of Standards to national registers by the EC4 Registration Committee and the EC4 Board. A major task for the EC4RC will be the co-operation with and inclusion of the new countries.
During the Strategic Plan period the recognition of equivalence of standards of the national registers should be renewed for all countries, both old and new EU member states. The criteria which are used for recognition should be revised. Terms of reference should be defined as well as the final attainment level. The way training sites are inspected should be part of the criteria for recognition. Checklists for assessors and procedures for assessment or inspection should be defined. Criteria for training of assessors should be made.
National Register committees are keeping the national registers and are asked to keep EC4RC well informed about the national education and training structure. If more than one national register exists, e.g. for different academic backgrounds, EC4RC expects a joint representative from that country. Following the guide to the register, EC4RC acknowledges those national registers that meet the requirements of the Syllabus and other criteria.
Individual applications have to be voted by both NCCRC and EC4RC.
If there is no national post graduate education and no national register organised, EC4RC encourages and assists the national society to set up such register. Applications from such member state are considered on an individual basis.
A third revision of the Syllabus will be prepared.
The minimum number of years of training and experience was recently extended from eight years to nine, i.e. four or five years academic plus four or five years postgraduate specialist training, in total nine years.
A new Code of Conduct was published in 2004. Consent to the Code should be part of the criteria used by the national registers and by the EC4RC. The Code will play an important role in new EU directives relating to the common values of regulated professions, like the proposed directive on Recognition of Professional Qualifications and the proposed directive on Services.
The EC4RC should contribute actively in co-operation with the working group on Profession to achieve that the EC4 Register becomes a Common Platform within the framework of the EU Directive on Recognition of Professional Qualifications.

Re-registration
Re-registration is becoming an issue in many countries. Initial registration as European Specialist in Clinical Chemistry and Laboratory Medicine is granted for five years. The first applicants should re-register starting from 2005. The system for re-registration should be further developed, starting by using existing national systems. Continuous professional development will be part of the criteria for re-registration. Further guidelines for terms for such systems will be issued.

Common Platform

The free exchange of goods and services and the freedom of movement within the European Union include the free exchange of professionals between all member states. To make sure that the competence of all specialists in clinical chemistry and laboratory medicine fulfils a common minimum standard EC4 agreed to promote recognition of the profession by establishing a European register. The main goal is to achieve recognition of the EC4 Register as a so-called Common Platform by the European Commission and the EU Member States within the framework of the EU Draft Directive on Recognition of Professional Qualifications.
EC4 is active to convince the Commission of the necessity to recognise a system of Common Platforms governed by the professions under the supervision of a General European Board of National Co-ordinators. The EC4 Register should become such a Common Platform. The European Parliament and the European Commission have voted in favour on the draft directive in second reading. National politicians should now be motivated to vote in favour. The position of specialists in clinical chemistry and laboratory medicine and how clinical chemistry and laboratory medicine is organized in Europe should be explained as well as the necessity of a Common Platform.
The co-operation with CEPLIS and the European Economic and Social Committee to achieve a Common Platform will be extended.

Register -status and web site

The EC4 Register plays a central role in many of the EC4 activities. An increased number of European Specialists in Clinical Chemistry and Laboratory Medicine will facilitate the work. Therefore the number of registered colleagues should be increased. A system should be considered of opting out from automatic registration in the EC4 register once a person is (re-) registered in national register that has equivalence of standards. Facilities should be added to the web site for individuals to review their personal record and notify the RC secretariat of any changes needed. The database of registered professionals should be accessible to the public. Facilities should be added for re-registration. Also a database should be installed detailing the recognition of equivalence of standards of national registers.

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6. Performance of the profession

Competence to be a Consultant

A working group was installed to define guidelines concerning duties and competences of heads of clinical chemistry laboratories and senior consultants. In addition Essential Criteria concerning interpretation skills, contacts with clinicians and the effective and efficient use of laboratory tests and service in quantity and quality will be defined as well as competences in relation to academic background.

Patient information

There is a definite need for information among patients and the public in general. Sites like Lab Tests Online (UK and The Netherlands) are gaining increasing interest. Developments like the patient questions platform in the Netherlands are frequently used media. A working group should be installed to provide guidelines and help for national organisations to set up web sites in the native language like Lab Tests Online and Information and questions for the public.

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7. Performance of laboratories (CARE for laboratories)

ISO/CEN

EC4 co-ordinates and promotes the voice of professionals in the relevant CEN and ISO committees and working groups to improve the influence of the profession on the development of standards, that influence directly our work. The chair of the WG presently is chair of ISO TC212 WG 1 and EC4 is happy to support him.
Focus will be on the revision of ISO 15189. Several EC4 publications have contributed to the development of the ISO 15189 International Standard, which defines requirements for quality and competence of medical laboratories. Now that this is a published standard, the WG will co-ordinate the input for the next version of it.
Attention will be given also to documents under development, in particular regarding POCT and Safety. The working group should also contribute in the monitoring of the implementation of the EU IVD directive.
Different interpretations in individual countries of the IVD Directive ruling on in house testing, threatens expert centres and new or commercially not interesting tests. The working group should monitor new developments in ISO and CEN which influence medical laboratories and should inform national societies on these developments.

Quality systems and Accreditation

EC4 co-ordinates activities towards the European co-operation for Accreditation (EA) and national accrediting organisations, with regard to mutual recognition of accreditation systems for medical laboratories. Several colleagues in the working group on Accreditation have a seat on the EA committee on Laboratory Medicine, including the representative from EC4/FESCC. The input from the profession in the committee will be co-ordinated in the WG. The focus of the WG will be on the use of ISO 15189 as the standard for accreditation.

The EC4 Essential Criteria are widely used as practical guidelines for implementation of quality systems in medical laboratories. The EC4 Model Quality Manual is a further tool to help individual laboratories to set up their quality system. It should, however, be issued in a much more condensed form, reducing the size and turning it into a content list document.

Criteria for inspections of medical laboratories as well as for assessors will be defined. Advice will be given on the co-ordination of exchange of accreditation inspectors between EU countries. Additional Essential Criteria should be defined regarding continuous quality improvement, systems for document control, retention time of specimens, archiving of documents, retention time of records. Guidelines on method validation should be issued, and guidelines on expressing uncertainty of measurements. The specific nature of the medical laboratory requires essential criteria for clinical audit in laboratory medicine. Also criteria for internal audit including audit checklists are needed.

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8. Performance of laboratories (CARE for laboratory data)

Guidelines for Investigation of Disease

One of the main responsibilities of our profession is to give advice on the use and interpretation of laboratory data. There exist many books and publications regarding this subject. In a unifying Europe it is important to have (European) Guidelines on the Laboratory Investigation of Disease.
The working group GID functions as a steering group. It initiates multidisciplinary project groups on specific topics including experts from the laboratory discipline as well as from the clinical side. The guidelines should be evidence based. Co-operation should be sought with existing organisations like the Guidelines International Network (GIN).
EC4 will be active in this field in co-operation with FESCC and other European organisations in laboratory medicine, and in particular also other European medical specialists’ organisations, to publish such guidelines. Guidelines were published on inherited thrombophilia. The project group on IVD effect on creatinine result interpretation was started in 2004. It will publish guidelines in the Strategic Plan period. Project groups on guidelines for cardiac disease, thyroid disease and other will be started in the Plan period.
A guideline database including primarily laboratory, or lab-related guidelines would be extremely useful. There are many guidelines, but it is quite often difficult to find special recommendations within guidelines on the use of lab tests. Such an information resource should be developed.
A main additional issue will be the development of model diagnosis related request forms, which will be developed for requesting specialists as well as general practitioners.

EQUAL

In 2004 the first meeting of the EQUAL project took place. The EQUAL project was initiated by EC4 and aims at the development of a European quality assessment scheme and training courses in DNA analysis in clinical chemistry laboratories. The project obtained a large grant from the European Commission. The project should be running in 2005 and results should be published in 2006-2007.
EC4 should consider establishment of a comparable project in the field of proteomics.

Desirable Analytical Performance

The joint FESCC/EC4/EDMA working group on desirable analytical performance should define Essential Criteria concerning clinically relevant analytical requirements, based on published work and in relation to the EU IVD directive. Another important field is unified acceptance limits for EQAS, based on the above. In a joint EU, it is important to harmonise these limits.

Calibration of data

EC4 stimulates developments for harmonisation of laboratory data. The Calibration 2000 project of The Netherlands is such a project. The materials developed in this project are commutable with patient materials and should be tested on an international base to investigate their potency as Trueness Verification Materials.
The EU IVD directive requires traceability to reference systems. Verification of such traceability requires commutable materials and international co-operation between NEQAS organizers and national societies. It is the responsibility of the medical laboratory specialist to estimate within and between laboratory variations and to decide whether correction for observed bias is needed in a particular laboratory situation. This could be done in co-operation with the industry. For such corrections commutable trueness verification materials are necessary. EC4 will continue to stimulate projects in this field.

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9. Profiling towards European bodies and organisations

Co-operation with other European organisations

FESCC

In order to improve the image and functioning of laboratory medicine in Europe, co-operation between the various European umbrella organisations is important. The EC4 Executive Board will put effort in maintaining and extending such co-operation.
EC4 is an autonomous working group within FESCC. All of the EC4 work and documents are sent to and available for FESCC. The boards of FESCC and EC4 maintain a close working relationship. The future relationship of FESCC and EC4 should be considered in the light of the recent enlargement and future enlargement of the European Union. As more European countries join the EU, the two organisations should work towards becoming a single organization. However, the active nature and the productivity of EC4 should be conserved in that organization.

Other professional umbrella organisations
EC4 strives for co-operation with other European umbrella organisations in laboratory medicine, such as UEMS section Bio-pathology.
EC4 should re-consider its position regarding a European Platform of Laboratory Medicine and the co-operation with other umbrella organisations in laboratory medicine.
Professional involvement in the different EU bodies which deal with aspects of clinical chemistry and laboratory medicine is essential. The importance of clinical chemistry and laboratory medicine, in its broad definition as defined in the Guide to the European Register, and all activities performed in EC4 must be more widely known in the EU official bodies.
EC4 will seek contact with the European Commission to clarify the importance of clinical chemistry and laboratory medicine in all its aspects for the improvement of patient care in the EU. Therefore it is essential to maintain a list of all EU-bodies relevant to and dealing with the medical laboratory profession. This will facilitate the recognition of the European Register and EC4 views on accreditation. The extension of the EU is an exciting challenge for EC4. EC4 will see to a firm integration of the new countries in the EC4 work.

European Commission
The monitoring of EU draft directives and their consequences for the medical laboratory professionals and medical laboratories is an important task for EC4. EC4 will co-ordinate activities and communicate developments to the national societies. Regulations of direct importance at present are the draft directive on recognition of professional qualifications, the draft directive on services in the internal market, the directive providing an information procedure in the field of technical standards and regulations, the EU Questionnaire on the common values of the regulated professions in Europe, and the IVD directive.

ISO, CEN and EA
EC4 realises that it is difficult for national societies to keep up to date with the various international standards, draft standards and documents of ISO, CEN and other bodies. The notifying of member societies of current developments in CEN and ISO will be structured. The WG will produce simple guidance documents to assist national societies in understanding and applying ISO/CEN documents. EC4 continues to encourage the national societies to find their way to the National Accreditation Bodies and Standardisation Institutes. Within the working group on ISO/CEN a network has been established to share experience and co-ordinate influence on CEN and ISO working groups and on EU directives. With regard to accreditation EC4 will continue to influencing the European c-operation on Accreditation (EA).

EDMA
Co-operation with the industry is important in scientific matters, EU regulations and directives, accreditation, and quality requirements and assessment. EC4 should be in close contact with EDMA.

Web site
The communication of EC4 activities towards member societies, European Commission, the medical profession in Europe, the public in Europe, industry and relevant European organisations is extremely important and will be extended. The EC4 website will play an important role in the providing of information. The maintenance of the website will be professionalized.

10. Promotion of EC4 activities

EC4 maintains a web site on the Internet. The web site will contain all available information about EC4. Links are available to sites of IFCC, FESCC, national societies and other organisations relevant to EC4.
To promote the Register an EC4 Newsletter will be published regularly on the web site and if relevant in Clinical Chemistry and Laboratory Medicine (CCLM). Information will be given on numbers of registrants, political status of the Register, receipt status of the Register in EU member states, EC4RC meetings, and progress of the working groups.
National societies will be encouraged to report on EC4 in their national journals and material will be sent to facilitate this. National societies will be asked to distribute information on the European register and to stress the importance of it.
There will be continuing publicity on EC4 in CCLM. The board will co-ordinate the timing of the various publications.
A central record of existing EC4 papers and translations of these will be available.

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11. Strategic Actions related to the Strategic Plan 2005-2008

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