Guide to the European Register of Specialists in Laboratory Medicine

The European Register for Specialists in Clinical Chemistry and Laboratory Medicine:
Guide to the Register, Version 3 – 2010
Clinical Chemistry and Laboratory Medicine 2010;48(7):999-1008

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3rd revision: approved at the EC4 Register Commission meeting in Paris, on 5 November 2009.

Contents

I. Introduction

1.0 Clinical Chemistry and Laboratory Medicine
2.0 EC4 and EFLM
2.1 Objectives

II. The EC4 register

3.0 Premise
4.0 Professional training
5.0 Minimum standards
5.1 Minimum standards to enter speciality training
5.2 Minimum standards for registration as a European Specialist in Laboratory Medicine
5.3 Evolution of Clinical Chemistry
6.0 Title
7.0 Competencies
8.0 National registers
9.0 Code of Conduct

III. Operation of the Register

10.0 EC4/EFLM bodies
10.1 The EC4 Register Commission, EC4RC
10.2 The National Clinical Chemistry Register Committees, NCCRCs
10.3 The EC4 Committee of Appeal, EC4CA
10.4 Custody of the EC4 Register

IV. Procedures

11.0 Application
11.1 Validation of applications
11.1.1 EU citizens trained within the EU
11.1.2 EU citizens trained outside the EU
11.1.3 Non-EU citizens
11.2 Registration as a European Specialist in Laboratory Medicine
11.3 Certificates
11.4 Renewal of registration
11.5 Finances

V. Points of contention

12.0 Cases of Doubt

Application Form


I. Introduction

1.0 Clinical Chemistry and Laboratory Medicine

The name Clinical Chemistry will be used throughout this document, according to the definition of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). The speciality is defined as follows:

"Clinical Chemistry and Laboratory Medicine is the application of chemical, molecular and cellular concepts and techniques to the understanding and evaluation of human health and disease. At the core of the discipline is the provision of results of measurements and observations to the cause of disease, the maintenance of health and the conversion of these data into specific and general patient- and disease-related information at the laboratory-clinician interface. The discipline is committed to deepening understanding of health and disease through fundamental and applied research" (1).

In addition it is stated that:

"Clinical Chemistry is the largest subdiscipline of Laboratory Medicine which is a multidisciplinary medical and scientific speciality with several interacting subdisciplines such as haematology, immunology, clinical biochemistry, and others. Through these activities clinical chemists influence the practice of medicine for the benefit of the public" (2).

In many countries the practice of Clinical Chemistry includes components of microbiology, haematology, molecular biology and immunology as well as traditional clinical biochemistry. Clinical Chemists are responsible for comprehensive laboratory services including, for example, provision of clinical interpretation and advice, management, quality assurance and informatics. They frequently conduct research in laboratory medicine. For these reasons their professional education needs to include scientific, analytical, clinical, research skills and management training combined with informatics.

Where "analysis" is referred to, the complete analytical process, including pre- and post-analytical phases, is included.

In different member states of the European Union (EU) the designation for Clinical Chemistry appears either by speciality designation of Clinical Chemistry or associated with, or included in, other specialities under a broader designation.

The designations for the speciality in the member states of the EU are:

Austria

Medizinische Chemie, Laboratoriumsdiagnostik

Belgium

Biologie Clinique/Klinische Biologie

Bulgaria

Clinical Laboratory

Czech Republic

Klinická Biochemie

Cyprus

Laboratory Medicine/Clinical Chemistry

Denmark

Klinisk Biokemi

Estonia

Laboratory Medicine

Finland

Kliininen Kemia

France

Biologie Médical

Germany

Klinische Chemie, Laboratoriumsmedizin

Greece

Klinikè Chimeia – Klinikè Biochimeia

Hungary

Orvosi Laboratoriumi Diagnosztika (Medical Laboratory Diagnostics/Laboratory Medicine)

Ireland

Clinical Biochemistry

Italy

Patologia Clinica/Laboratory Medicine

Latvia

Laboratorâ Medicina

Lithuania

Laboratorine Medicina/Medicinos Biologija

Luxembourg

Biologie Clinique/Biochemie

Malta

Patol ija Kimika (Chemical Pathology)

Netherlands

Klinische Chemie en Laboratorium Geneeskunde

Poland

Diagnostyka Laboratoryjna

Portugal

Analises Clinicas/Patologia Clinica

Romania

Laboratory Medicine

Slovakia

Klinická Biochémia

Slovenia

Medicinska Biokemija

Spain

Bioquímica Clínica – monovalent Análisis Clínicos - polyvalent

Sweden

Klinisk Kemi

United Kingdom

Clinical Biochemistry/Chemical Pathology

Thus Clinical Chemists are medical laboratory specialists having knowledge of, expertise in, and responsibility for, a broad spectrum of diagnostic laboratory investigations.

2.0 EC4 and EFLM

Until 2007 the European Communities Confederation of Clinical Chemistry and Laboratory Medicine (3) was the organisation linking all national IFCC-recognised clinical chemistry societies within the different member states of the European Union. It was founded in 1973 and its constitution formalised in 1993. The Articles of Association were drawn up in Amsterdam in September 2002. The Forum of European Societies of Clinical Chemistry and Laboratory Medicine (FESCC) was the European section of the IFCC and was composed of the IFCC-recognised clinical chemistry societies from the whole of Europe, as defined by the World Health Organisation. With the expansion of the European Union from 15 to 25 member states in 2004, and to 27 in 2007, the geographical differences between EC4 and FESCC diminished and the two organisations merged in 2007 forming the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) (4) which is now the European Regional Organisation of the IFCC. The EC4 Register Commission (EC4RC) remains a sub-section of EFLM with responsibility for the European Register of Specialists in Clinical Chemistry and Laboratory Medicine. EC4 is established as a Foundation under Netherlands law and the EC4 Foundation Board and the Professional Committee oversee the EC4 Register Commission under the direction of the Executive Board of EFLM.

2.1 Objectives

The present objectives of EC4 Register Commission are:

(a) to promote the advancement of Clinical Chemistry within the EU to the European Commission, European citizens and the medical profession, and to do all such things as may in the opinion of the Foundation Board of EC4 spread or increase the knowledge and standing of Clinical Chemistry within the EU, in cooperation with EFLM and IFCC;

(b) to promote the regulation of the profession of Clinical Chemistry in the EU by maintaining a register and by furthering the establishment of a "Common Platform" within the framework of the EU system of Directives regarding professional recognition, describing the discipline and the standards of education, training and experience required to achieve "Registered Clinical Chemist" status;

(c) to coordinate the automatic and mutual recognition of European Specialists in Laboratory Medicine on the basis of equivalence of standards and to promote the recognition of, and to protect, the "European Specialist in Clinical Chemistry" title;

(d) to cooperate with any examining body in a clinical or basic science subject in promoting suitable qualifying examinations for members of the profession of Clinical Chemistry;

(e) to foster high standards of continuous professional development and education, and to introduce related requirements for re-registration in the Register.

II. The EC4 Register

3.0 Premise

In each member state, laboratory medicine is organised within its own national health care system. The EC4RC respects these different structures and has created a Register based on a Syllabus (5) for postgraduate training in order to:

(a) guarantee that the minimum requirements for the education and training of the individual clinical chemist have been fulfilled for the benefit of the individual patient and of health care in general;

(b) facilitate the comparability of professional training of clinical chemists within the EU by establishing a framework of mutual recognition of qualifications, and facilitate the free movement of practitioners in order to provide clinical chemists who wish to practise outside their country with a guarantee of ability;

(c) encourage continuous improvement in the quality of Clinical Chemistry and its practitioners by setting, monitoring and reviewing standards for the definition and practice of Clinical Chemistry in the EU;

(d) provide a source of information about the different systems of education and training in the member states.

4.0 Professional training

EC4RC has judged the respective values of the education and professional training systems in the EU and has developed a Syllabus comprising all the subjects necessary to achieve a high level of professional competence.

The European Syllabus for postgraduate training in Clinical Chemistry (5) describes the minimum scientific and professional knowledge, recognising the responsibility of each member state for organising laboratory medicine within its own health care system. Thus, although significant differences exist in the practice of Clinical Chemistry across the EU, a large number of core elements can be discerned. These are considered to be the minimum scientific requirements for those who want to be registered as a specialist. The attainment of these competences is the threshold which opens the right to registration. Since in most cases the professional activities include management responsibilities, it is important that the subject of laboratory organisation and management are included in the training period.
The specialist who is registered on the basis of the above standards not only fulfils the professional objectives of the EC4RC but is also competent to be the head of a laboratory, one of the conditions necessary for its accreditation under ISO 15189 (6).

5.0 Minimum standards

The education in all the EU countries is based on a broadly identical scheme. It comprises a university education, followed by speciality training in Clinical Chemistry. The standards stipulated below are the minimum required for admission to the Register.

5.1 Minimum standards to enter speciality training

The minimum standard to enter speciality training is a university degree in medicine, chemistry, biochemistry, pharmacy, or another relevant basic science subject, which allows entry to postgraduate speciality training.

5.2 Minimum standards for registration as a European Specialist in Laboratory Medicine

The minimum standard for registration as a European Specialist in Laboratory Medicine is a total of 9 years university and postgraduate study. A minimum of 4 years postgraduate study after gaining a university degree must be spent on specialist training in a laboratory in a medical environment approved and supervised by the national body functioning for that purpose within the health care system of the member state.

5.3 Evolution of Clinical Chemistry

In a number of countries within the EU there is an increasing trend for Clinical Chemistry to encompass several disciplines. As a result the professional training can be multidisciplinary (i.e. Clinical Chemistry and for example Haematology, Immunology etc.) as well as in a single discipline (eg. Clinical Biochemistry). Training could be multidisciplinary initially, followed by specialisation, provided the basic training includes clinical chemistry in accordance with the Syllabus sections 1: i-viii, A:1-24 (5). In all cases the conditions as specified in Section 5.2 apply.

6.0 Title

Registration as a "European Specialist in Laboratory Medicine" gives the right to be called European Specialist in Laboratory Medicine in the language of the member state and to use the professional title European Specialist in Laboratory Medicine, abbreviated EuSpLM (invariable in all member states) with the national title, if lawful.

7.0 Competencies

Clinical Chemists having obtained registration in the EC4 European Register for Specialists in Laboratory Medicine should be aware of their professional responsibilities and should have achieved competence in the following:

(a) understanding of the registrant's responsibility in the practice of his/her profession to the well-being and personal safety of his patients, colleagues, co-workers, the community, and the environment;

(b) thorough knowledge of all aspects of clinical laboratory sciences relevant to the discipline practised as specified in the Syllabus (Section 4.0);

(c) ability to obtain, explore, and employ knowledge and methods of investigation in the interest of health care and mankind;

(d) broad knowledge of, and insight into, biochemical processes in human health and disease on a general and patient-specific level;

(e) ability to work in a multidisciplinary environment and function as a consulting advisor to his/her clinical colleagues and liaise with them in the choice of tests and the interpretation of laboratory results;

(f) ability to safeguard and protect the public against misuse of medical laboratory investigations;

(g) knowledge of the principles of management leading to satisfactory direction, supervision, and organisation of a laboratory department in a public or private hospital or in any other health care environment resulting in the provision of a competent service as laid down in a laboratory quality manual, based on good laboratory services as defined in EN-ISO document 15189 and the EC4 Essential Criteria (6-9);

(h) ability to assess conflicting and various technical, financial, and human considerations (e.g. care, quality, safety, cost, and time scales) both in the short and long term, and to find the optimal solution in relation to patient care;

(i) ability to apply current techniques in human resources;

(j) ability to communicate orally and in writing, including the production of clear, cogent reports and publications in refereed international scientific journals;

(k) knowledge of, and insight into, the use of technology and analytical techniques relevant to the field of specialisation, an active appreciation of developments, and an attitude of innovation and creativity in their implementation in the profession of Clinical Chemistry;

(l) ability to take responsibility for the data and information produced, including knowledge of the influence of variation (biological as well as analytical) on interpretation of data;

(m) appreciation of developments both in science and technology and also in the understanding of disease in order to ensure the appropriate use of laboratory investigations and to optimise the advice provided on those investigations (see also ref. 5);

(n) ability to conduct research, either basic or applied, in order to further knowledge in the field of Clinical Chemistry and Laboratory Medicine.

8.0 National registers

The EC4RC acknowledges the national registers as they function in the member states provided that they are in accordance with the minimum standards and are based on the curriculum, so that it is possible for candidates to develop towards professional competence as described in Section 4. Applicants should both conform to the EC4RC-approved national equivalence of standards for registration and be a member of their national register, where one exists. In those member states where Clinical Chemistry training is not presently organised according to the defined requirements, the EC4RC (Section 10.1) and the National Registration Committees (Section 10.2) need to ensure that standards required for each national register meet the minimum standards required for the EC4 Register.

9.0 Code of Conduct

The EC4RC has developed a Code of Conduct (10) which all applicants to the Register must agree to abide by. This Code of Conduct does not over-ride any codes of practice in place with national registers or national societies.

III. Operation of the Register

10.0 EC4/EFLM bodies

The EC4 Foundation Board and the EC4 Register Commission (Section 10.1) are responsible for the Register and for modification of the standards in the light of changing technology and other developments, under the supervision of the EFLM Board and its Professional Committee. Standards are accordingly reviewed at regular intervals of not more than five years.

The EC4 Register is maintained by the EC4RC (Section 10.1) and is administered by the EC4 Secretariat which keeps records of the registrations. Whenever possible, the EC4RC will seek the advice of the National Clinical Chemistry Register Committees (NCCRCs) (Section 10.2), in making its decisions.

10.1 The EC4 Register Commission, EC4RC

The Register Commission is composed of one representative from each member state, preferably a member of the National Clinical Chemistry Register Committee (NCCRC), and members of the Board of EFLM. National Representatives should be mandated members of the national society recognised by the IFCC but they need not be officers of that society. The representatives should be registered European Clinical Chemists, if possible. If more than one NCCRC exists in a member state, e.g. for different academic origins, the National Representative should be a joint representative.
The Chairman and Secretary of the EC4RC are appointed by the EFLM Board and the Chairman is in this capacity a co-opted member of the EFLM Board. The term of office for both the Chairman and the Secretary is three years with a maximum of two terms.

The EFLM Board appoints two of its members to represent the Board on the EC4RC.

The EC4RC decides on minimum requirements for registration and re-registration.

The EC4RC decides on the granting of Equivalence of Standards of the national training programme to National Registers, including the level of admission to the programme.

The EC4RC decides on the eligibility of candidates for registration and re-registration.

The EC4RC provides its members annually with statistical information about the number of new registrations from the different member states.

10.2 The National Clinical Chemistry Register Committees, NCCRCs

The National Clinical Chemistry Register Committees, NCCRCs, are national bodies composed of representatives from the national clinical chemistry societies and the government, or any other body recognised for the purpose in that member state. It is the responsibility of these Committees to keep EC4RC well informed on the national education structure.

The NCCRC assesses whether applicants from that member state meet the equivalence of standards. It may or may not be the responsible body for national registration. Applicants approved by their NCCRC may then apply to EC4RC to be recognised as European Specialists.

Applications for the EC4 Register are sent to the NCCRC. The NCCRC checks whether the applicant fulfils the national requirements. The NCCRC sends the application accompanied by its advice to the EC4RC Secretariat.

The NCCRC is responsible for checking that the application fee to the Register is paid according to agreed procedure(s), prior to forwarding the application.

10.3 The EC4 Committee of Appeal, EC4CA

The EC4 Committee of Appeal, EC4CA, is a European body composed of five independent experts from representative member states. Committee members are proposed by the NCCRCs and appointed by the EFLM Board. Their term of office is a maximum of five years. EC4CA elects a chairman responsible to the EC4RC and individual applicants. EC4CA acts on behalf of the EFLM Board in adjudicating on applicants who appeal against a decision of EC4RC not to grant registration. The EC4CA also advises the EC4RC on equivalence when applicants have not followed standard education or training programmes.

10.4 Custody of the European Register

The European Register is kept by the EC4RC. The computer database is maintained by a commercial company under contract to EFLM.

Application Form

IV. Procedures

11.0 Application

Application is open only to individuals who have the required qualifications, i.e. they must have trained and/or be registered in an EU country. Application for registration is made on-line on the EC4 Register website (11) followed by a paper copy of the application form and relevant documents being sent to the NCCRC.

11.1 Validation of applications

11.1.1 EU citizens trained within the EU

As a general rule, an EU citizen who has professional registration as a clinical chemist in an EU country is automatically eligible for registration by EC4RC, if the national register and training programme have been granted equivalence of standards. It is the responsibility of the NCCRC of the country of registration to check the validity of his/her university education (as specified in 5.1) and professional training. Consequently the minimum EC4 requirements have then been fulfilled (Sections 5.2 and 5.3).
An EU citizen who is not residing and registered in an EU country but was trained within the EU can apply for EC4 registration via the NCCRC of the country in which they were trained. It is the responsibility of the NCCRC to check the validity of his/her university education and professional training (see previous paragraph).

All applications must be accompanied by a statement from the NCCRC of the country of registration and/or training supporting the applicant and stating that the applicant has the necessary qualifications for registration as a European Clinical Chemist. If the education and training are assessed as adequate it would be assumed that the applicant has achieved competence as defined in Section 7.0.

11.1.2 EU citizens trained outside the EU

EU citizens trained outside the EU and registered in an EU country can be considered for EU registration only if they have undergone a university education and professional training which meet the EC4 criteria. It is for the NCCRC of the country of registration to provide the EC4RC with the evidence that the candidate meets the Equivalence of Standards. The final decision is with the EC4RC. The EC4RC does not give general decisions on the equivalence of diplomas or degrees accepted in EU member states.

11.1.3 Non-EU citizens

Non-EU citizens may be eligible for registration only if the education and training of the applicant has taken place in an EU country according to the predefined conditions. The NCCRC of the country of training and, when different, of the country of registration, must support the application.

Non-EU citizens not trained or registered in an EU country are not eligible for registration.

11.2 Registration as a European Specialist in Laboratory Medicine

The EC4 RC decides on the basis of Sections 11.0 and 11.1 the eligibility of applicants for registration. Successful applicants are then included in the Register.
Persons registered as European Specialists in Laboratory Medicine must abide by the EC4/EFLM Code of Conduct (10).

Any application not approved will be returned to the NCCRC and reasons for rejection will be given. Such applicants have the right to appeal the decision and they can submit their case to the EC4 Committee of Appeal within a defined time period.

11.3 Certificates

Registration as a European Specialist Laboratory Medicine is attested by a certificate which is prepared by the Secretariat and signed by the Chairman of the EC4RC and an EFLM Board member.

11.4 Renewal of registration

Continuing registration as a European Specialist in Laboratory Medicine is dependent on the registrant remaining in practice and observing the EC4/EFLM Code of Conduct (10).

Registration should be renewed every five years through the relevant NCCRC.

11.5 Finances

EFLM/EC4RC and each individual national Clinical Chemistry society bear the costs of the administrative work involved in operating the Register and are entitled to recover these costs by charging a fee to applicants. EFLM and EC4RC are non-profit making bodies.

V. Points of Contention

12.0 Cases of doubt

All cases of doubt or difficulty, relating to the decision on individual applications, are referred to the EC4 Committee of Appeal (see 10.3) for decision. An individual may subsequently appeal in writing against this decision to the EFLM Board, whose decision is final and without appeal.

Application Form

References

International Federation of Clinical Chemistry and Laboratory Medicine

Handbook 2006

http://www.ifcc.org

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The role of European Communities Confederation of Clinical Chemistry (EC4) in the Harmonisation of of Clinical Chemistry in the European Union

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European Federation of Clinical Chemistry and Laboratory Medicine

http://www.efcclm.eu

Zérah S, McMurray J, Bousquet B, Baum H, Beastall G, Blaton V et al

EC4 European Syllabus for Post-Graduate Training in Clinical Chemistry and Laboratory Medicine: Version 3-2005

Clin Chem Lab Med 2006; 44:110-120

ISO 15189:2007

Medical laboratories – Particular requirements for quality and competence

International Organization for Standardisation, 2007

Jansen RTP, Blaton V, Burnett D, Huisman W, Queraltó JM, Zérah S, et al

Essential criteria for quality systems in medical laboratories

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Jansen RTP, Blaton V, Burnett D, Huisman W, Queralto J, Zérah S et al

Additional essential criteria for quality systems of medical laboratories

Clin Chem Lab Med 1998; 36:249-252

Jansen RTP, Kenny D, Blaton V, Burnett D, Huisman W, Plebani M et al

Usefulness of EC4 Essential Criteria for Quality Systems of Medical Laboratories as Guideline to the ISO 15189 and ISO 17025 documents

Clin Chem Lab Med 2000; 38:1057-1064

McMurray J, Zérah S, Hallworth M, Koeller U, Blaton V, Tzatchev K et al

The European Register of Specialists in Clinical Chemistry and Laboratory Medicine: Code of Conduct, Version 2-2008

Clin Chem Lab Med 2009; 47(3):372-375

EC4 Register

  http://www.ec4register.eu

Corresponding author: Janet McMurray, EC4 Register Commission, c/o Association for Clinical Biochemistry and Laboratory Medicine, 130-132 Tooley Street, London SE1 2TU, United Kingdom
Phone: +44-20-7403-8001 Fax: +44-20-7403-8006, E-mail: enquiries@ACB.org.uk