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The European Register for Specialists in Laboratory Medicine:
Code of Conduct


This article was published in: Clin Chem Lab Med 2009;47(3):372-375

Version 2/ 2008
Approved by the EC4 Register Commission
and by the EFLM Executive Board in Paris on 6 November 2008

Abstract

In 1997, the European Communities Confederation of Clinical Chemistry and Laboratory Medicine (EC4) set up a Register for European Specialists in Laboratory Medicine. The operation of the Register is undertaken by a Register Commission (EC4RC). During the last 10 years more than 2000 specialists in laboratory medicine have joined the Register. In 2007 EC4 merged with the Federation of European Societies of Clinical Chemistry and Laboratory Medicine (FESCC) to form the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM). A Code of Conduct was adopted in 2003 and a revised and updated version, taking account particularly of the guidelines of the Conseil Européen des Professions Libérales (CEPLIS) of which EFLM is a member, is presented in this article.

The revised version was approved by the EC4 Register Commission and by the EFLM Executive Board in Paris on 6 November 2008.


Introduction

Following the expansion of the European Union to 27 countries, and thus the decreased geographical differences between the two organisations, the European Communities Confederation of Clinical Chemistry and Laboratory Medicine (EC4) merged with the Federation of European Societies of Clinical Chemistry and Laboratory Medicine (FESCC) in 2007 to form the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM). EFLM is now the European branch of IFCC. EC4 remains as a sub-section of EFLM with responsibility for the operation of the EC4 Register of Specialists in Laboratory Medicine.

One of the primary goals of EC4 and EFLM is to stimulate the professional development of the Specialist in Laboratory Medicine and the maintenance of his* professional activities at a very high level (1,2). To further this aim, in 1998 EC4 set up the European registration system, in which Specialists in Clinical Chemistry and Laboratory Medicine of all countries affiliated to EC4 can be registered (3-5). One of the conditions for registration is that the Specialist in Laboratory Medicine undertakes to comply with the EC4 Code of Conduct (5). This Code of Conduct is additional to and does not replace any Code of Conduct to which the registrant might be subject to in his own country.

The original Code of Conduct was adopted in 2003 (6) and this has now been revised and updated taking account of general changes in the field, and particularly of the statement on common values adopted in 2007 by CEPLIS (Conseil Européen des Professions Libérales, European Council of the Liberal Professions) (7), of which EFLM is a member.

EC4/EFLM Code of Conduct

General principles

EFLM is the European professional organisation representing Specialists in Laboratory Medicine, a profession determined by its high level of professional qualifications. The relevant national professional society in each of the EU Member States is represented within EFLM.

In all their work, Specialists in Laboratory Medicine shall conduct themselves in a manner that does not bring into disrepute the discipline and the profession of Clinical Chemistry and Laboratory Medicine. They shall value integrity, impartiality and respect for persons and evidence and shall seek to establish the highest standards of quality and ethics in their work. Because of their concern for valid evidence, they shall ensure that research is carried out in keeping with the highest standards of scientific integrity. Taking account of their obligations under the law, they shall hold the interest and welfare of patients and those in receipt of their services to be paramount at all times and ensure that the interests of participants in research are safeguarded.

All registrants, having signed an application form, agree to abide by this Code of Conduct. They are also obliged to comply with the Codes of Conduct of their appropriate national registration body and national societies, where appropriate.

Key principles

1. Quality and excellence

The Specialist in Laboratory Medicine shall put his* knowledge and ability concerning laboratory diagnostics (including the indication for analyses, the reliability of the results, the interpretation of results and scientific research) at the service of diagnosis, therapy and prevention of human and animal diseases. At all times he shall act in the best interests of patients, subject to any over-riding legal requirements, with the highest standards of competency and integrity.


2. Continuous professional development

In order to optimally fulfil his duties and in accordance with what is regarded as good practice in his profession and having regard to the laws of the country in which he is working, the Specialist in Laboratory Medicine shall:

  1. maintain and develop his competence at the highest level of quality by following all relevant (scientific and practical) developments concerning health care in general and Clinical Chemistry and Laboratory Medicine in particular, by participating in relevant training courses and other appropriate continuous professional development programmes throughout his working life, and by practising his profession on a regular basis;

  2. accept assignments only within his area of competence; beyond this limit, he will seek the collaboration of appropriate experts;

  3. keep up-to-date with statutory codes of practice which affect his work.
    The Specialist in Laboratory Medicine will display his commitment to the profession of Clinical Chemistry and Laboratory Medicine by taking part in the activities of its scientific societies, notably those which promote the profession, and contribute to continuing training of their members.


3. Compliance with codes of ethics and conduct

The Specialist in Laboratory Medicine shall comply not only with the provisions of this Code of Conduct but also with legislation and with any codes of practice and standards relating to his professional work which are applicable in the country in which he is working.


4. Honesty and integrity

The professional integrity and intellectual honesty of the Specialist in Laboratory Medicine shall be the guarantee of his impartiality of analysis, judgment and consequent decisions.
The Specialist in Laboratory Medicine shall at all times avoid deceit in professional and scientific respect, such as fraud, plagiarism, concealment, improper omission of information, and expressing incorrect or misleading opinions in both clinical work and in research.

The Specialist in Laboratory Medicine will not accept any obligation that brings him into conflict with his professional independence. In particular he undertakes:

  1. not to solicit for, or accept, gifts, pecuniary advantages or benefits from the medical product or diagnostics industry, unless they are of low monetary value and relevant to the practice of Clinical Chemistry and Laboratory Medicine;

  2. not to solicit for, or accept, hospitality at sales promotions, symposia or congresses and the like unless this hospitality is reasonable in level and secondary to the main purpose of the meeting and does not extend to persons other than health professional;

  3. not to accept financial support from the industry, directly or indirectly, other than for events for purely professional and scientific purposes; such gifts must always be reasonable in level and remain subordinate to the main scientific objective of the event and must not be extended to persons other than health professionals.


5. Relationship with others

The Specialist in Laboratory Medicine shall at all times act with courtesy, honest and integrity in his relationships with patients and others, including professional colleagues, and must not engage in any activity or behaviour which would bring the profession into disrepute or undermine public confidence in the profession.
He must work constructively within a team, and communicate and co-operate with other health professionals and others caring for patients.
He must not abuse his professional position to establish improper relationships with patients, to persuade patients to give or lend money or benefits, to recommend treatments or investigations which are not in the patient's best interests, or to withhold investigations or treatments.
He must report concerns to employers or regulatory bodies where he believes a colleague's health, conduct or performance is a threat to a patient.


6. Independence and impartiality

The Specialist in Laboratory Medicine must exercise his professional judgment within the framework of his responsibilities impartially and objectively, after taking into account all relevant circumstances, in the best interests of his patient without pressure from external sources or conflicts of interest. He will ensure that the interests of participants in research are safeguarded and are paramount.
The Specialist in Laboratory Medicine will serve the individual patient to the best of his ability and provide the general public with such information, within in his field of competence, to enable a proper understanding of health care matters of public interest.


8. Confidentiality

Without prejudice to legislation on privacy applicable in the country where he is working, the Specialist in Laboratory Medicine will consider himself bound to respect the confidentiality of information obtained by him in his professional work. The Specialist in Laboratory Medicine will be on his guard against misuse of such information. He will ensure that information about a patient or other individual is not disclosed to others except in specified circumstances, such as to other health professionals involved in the care of the patient, and, where possible, with the informed consent of the patient.


9. Conflict with moral and ethical beliefs

The Specialist in Laboratory Medicine is not obliged to offer to provide a professional service in ways which conflict with his own moral or religious beliefs, but must respect the moral, religious and cultural beliefs of individual patients. He has an obligation to provide information on where the service requested can most conveniently be obtained from a professional colleague, or details of the institution or professional organisation from which that information can be obtained. If he has agreed to provide a service, he must set aside any personal religious, cultural, philosophical or other convictions. He must ensure equitable access to his services to all who are entitled to use them.


10. Delegation and supervision

As head and/or member of the team operating in the Clinical Chemistry and Laboratory Medicine laboratory, the Specialist in Laboratory Medicine will, given the specific circumstances of the situation concerned:

  1. obtain a clear definition of the services required of him and/or his team;

  2. ensure that all activities in the laboratory are organised and executed as accurately and as quickly as possible;

  3. protect the safety and well-being of his colleagues and be conscious of nature and the environment;

  4. show respect for superiors, colleagues and subordinates by taking due account of their requirements and aspirations, provided they conform to the laws and ethics of their profession;

  5. strive for a high level of technical achievement which will also contribute to and promote a healthy and agreeable environment for his colleagues;

  6. ensure that any member of support staff to whom a task is delegated has the knowledge, skills and competencies necessary to undertake that task effectively and efficiently, and that appropriate supervision is in place;

  7. retain responsibility for the task delegated, except when the delegatee is at the same level of professional qualification.


11. Professional indemnity insurance

The Specialist in Laboratory Medicine should have in place a form of insurance in respect of potential liabilities to patients and, where applicable, to third parties arising out of his professional work. This should be at a level sufficient to ensure that a justified complainant would be adequately compensated. Such insurance may be provided through a national arrangement for services provided by the state, by an employer, through membership of a professional association or by the individual practitioner. Exceptionally, and by formal prior arrangement, the risk may be borne by the recipient of the service, in Member States where legislation permits such an arrangement. The patient should be made aware of these arrangements.


12. Advertising

Specialists in Laboratory Medicine practise in both the public and private health sectors and the relative distribution between the two varies considerably between the Member States. In Member States where advertising of a Specialist's services is permitted, any such advertising must be accurate, honest, legal, decent and proportionate, and must focus solely on the professional services offered. It must also conform to any national or EU legislation and guidelines in this area.

Sanctions

Should a Specialist in Laboratory Medicine not keep to a part of this Code of Conduct, his national regulatory body (where applicable) and his national society will be responsible for determining culpability and sanctions. However, if a registrant is subject to disciplinary sanction (eg. suspension, removal) from their national register, EC4 will apply the same sanction to the individual in relation to the EC4 Register.

Transparency

The national professional societies are listed, with links, on the EC4 Register website (8) where there are also links to this Code of Conduct and other documents. There are also links to the documents from the website of the European Economic and Social Committee/Single Market Observatory Self- and Co-regulation database (9). Public access to the names held by the national regulatory bodies is available in some countries. At present public access to the names of registrants on the EC4 Register is not available but may be in the future. However this will require consent from each individual.

*Throughout this document he/his are taken for he/she and his/her respectively

By the EC4 Register Commission

Gerard Sanders

Department of Clinical Chemistry, Academic Medical Center, Amsterdam, The Netherlands

Matthias Opp

Laboratoire National de Sante, Luxembourg

Janet McMurray

Department of Clinical Biochemistry, Hope Hospital, Salford, United Kingdom

Ursula Koeller

Institute for Medical and Chemical Laboratory Diagnostics, Hospital Lainz, Vienna, Austria

Vic Blaton

Department of Clinical Chemistry, AZ Sint Jan Hospitaal, Brugge, Belgium

Erik Lund

Department of Clinical Chemistry, Vejle County Hospital, Vejle, Denmark

Aimo Harmoinen

TAYS, Laboratoriokeskus, Tampere, Finnland

Simone Zerah

Laboratoire d ’Analyses de Biologie Medicale, Bagnolet, Paris, France

Hannsjoerg Baum

Institut für Klinische Chemie und Pathobiochemie, Klinikum rechts der Isar, Munich, Germany

Demetrios Rizos

Hormone Laboratory, ‘‘Aretaieion’’ University Hospital, Athens, Greece

Desmond Kenny

Department of Clinical Biochemistry, Our Lady ’s Hospital for Sick Children, Dublin, Ireland

Mario Pazzagli

Department for Clinical Pathophysiology, University of Florence, Florence, Italy

Hans Hoffman

Department of Clinical Chemistry, Catharina Hospital, Eindhoven, The Netherlandsv

Henrique Reguengo

Servigo de Quimica Clinca, Hospital Geral de Santo Antonio, Porto, Portugal

JoseM.Queralto

Servicio de Bioquimica, Hospital de la Santa Creui Sant Pau, Barcelona, Sain

Hans Wallinder

Department of Clinical Chemistry, Medilab AB, Ta ¨by, Sweden

Rob Jansen

Director SKML, UMC St. Radboud, Nijmegen, The Netherlands

Michael Hallworth

Department of Clinical Chemistry, RoyalShrewsbury Hospital, Shrewsbury, United Kingdom

Peter Schuff-Werner

Institute for Clinical Chemistry and Pathobiochemistry, University of Rostock, Rostock, Germany

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, begin_of_the_skype_highlighting Fax: +44-20-7403-8006, E-mail: enquiries@ACB.org.uk

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Sanders GTB, Kelly AM, Breuer J, Mocarelli P.

The role of European Communities Confederation of Clinical Chemistry (EC4) in the harmonisation of clinical chemistry in the European Union (letter)
Eur J Clin Chem Clin Biochem 1995;33:947-948.

Sanders GT, Jansen RT, Beastall G,
Gurr E, Kenny D, Kohse KP et al.

Recent activities of EC4 in the harmonisation of clinical chemistry in the European Union.
Clin Chem Lab Med 1999;37:477–480.

Sanders GT, Kelly AM, Breuer J,
Kohse KP, Mocarelli P, Sachs C.

The European Register for clinical chemists.
Eur J Clin Chem Clin Biochem 1997;35:795-796.

Sanders GT, Kelly AM, Breuer J,
Kohse KP, Mocarelli P, Sachs C.

European Communities Confederation of Clinical Chemistry
Guide to the EC4 Register: European Clinical Chemist
Eur J Clin Chem Clin Biochem 1997;35:797-803.

Gurr E, Koeller U, Blaton V, Lund E, Harmoinen S et al.

The European Register for Specialists in Clinical Chemistry and Laboratory Medicine: Guide to the Version 2-2003 and Procedure for Re-registration.
Chem Lab Med 2003;41:238-247.

Sanders G, Opp M, McMurray J, Koeller U, Blaton V, Lund E et al.

The European Register for Specialists in Clinical Chemistry and Laboratory Medicine: Code of Conduct. Clin Chem Lab Med 2004; 42: 563-565.

 

Conseil Européen des Professions Libérales. Common Values of the Liberal Professions in the European Union; 2007.

 

European Economic and Social Committee, Single Market Observatory Self- and Co-regulation Database.