The profession of laboratory medicine differs between countries within the European Union (EU) in many respects. The objective of professional organizations of the promotion of mutual recognition of specialists within the EU is closely related to the free movement of people. This policy translates to equivalence of standards and harmonization of the training curriculum. The aim of the present study is the description of the organization and practice of laboratory medicine within the countries that constitute the EU. A questionnaire covering many aspects of the profession was sent to delegates of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and Union Européenne de Médecins Spécialistes (UEMS) of the 28 EU countries. Results were sent to the delegates for confirmation. Many differences between countries were identified: predominantly medical or scientific professionals; a broad or limited professional field of interest; inclusion of patient treatment; formal or absent recognition; a regulated or absent formal training program; general or minor application of a quality system based on ISO Norms. The harmonization of the postgraduate training of both clinical chemists and of laboratory physicians has been a goal for many years. Differences in the organization of the laboratory professions still exist in the respective countries which all have a long historical development with their own rationality. It is an important challenge to harmonize our profession, and difficult choices will need to be made. Recent developments with respect to the directive on Recognition of Professional Qualifications call for new initiatives to harmonize laboratory medicine both across national borders, and across the borders of scientific and medical professions.

Laboratory medicine's practitioners across the European community include medical, scientific and pharmacy trained specialists whose contributions to health and healthcare is in the application of diagnostic tests for screening and early detection of disease, differential diagnosis, monitoring, management and treatment of patients, and their prognostic assessment. In submitting a revised common syllabus for post-graduate education and training across the 27 member states an expectation is set for harmonised, high quality, safe practice. In this regard an extended 'Core knowledge, skills and competencies' division embracing all laboratory medicine disciplines is described. For the first time the syllabus identifies the competencies required to meet clinical leadership demands for defining, directing and assuring the efficiency and effectiveness of laboratory services as well as expectations in translating knowledge and skills into ability to practice. In a 'Specialist knowledge' division, the expectations from the individual disciplines of Clinical Chemistry/Immunology, Haematology/Blood Transfusion, Microbiology/ Virology, Genetics and In Vitro Fertilisation are described. Beyond providing a common platform of knowledge, skills and competency, the syllabus supports the aims of the European Commission in providing safeguards to increasing professional mobility across European borders at a time when demand for highly qualified professionals is increasing and the labour force is declining. It continues to act as a guide for the formulation of national programmes supplemented by the needs of individual country priorities.

We need a common name to have a clear identity which best describes the scope of the work we carry out for the patients. A clear and easily understood name which reflects the level of education and training of a specialist in the medical laboratory, and hence eligibility to be on the EC4 Register, is therefore needed, whatever academic background and whether polyvalent or sub-specialised.

In 1997, the European Communities Confederation of Clinical Chemistry and Laboratory Medicine (EC4) set up a Register for European Specialists in Clinical Chemistry and Laboratory Medicine. The operation of the Register is undertaken by a Register Commission (EC4RC). During the last 10 years, more than 2000 specialists in Clinical Chemistry and 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 (EFCC). 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 EFCC is a member, is presented in this article. The revised version was approved by the EC4 Register Commission and by the EFCC Executive Board in Paris on 6 November, 2008.

In 1997, the European Communities Confederation of Clinical Chemistry and Laboratory Medicine (EC4) set up a Register for European Specialists in Clinical Chemistry and Laboratory Medicine. The operation of the Register is undertaken by a Register Commission (EC4RC). During the last 12 years, more than 2200 specialists in Clinical Chemistry and Laboratory Medicine have joined the Register. In 2007, EC4 merged with the Forum of European Societies of Clinical Chemistry and Laboratory Medicine (FESCC) to form the European Federation of Clinical Chemistry and Laboratory Medicine (EFCC). Two previous Guides to the Register have been published, one in 1997 and another in 2003. The third version of the Guide is presented in this article and is based on the experience gained and development of the profession since the last revision. Registration is valid for 5 years and the procedure and criteria for re-registration are presented as an Appendix at the end of the article.

BACKGROUND:Using a questionnaire, the EC4 (European Communities Confederation of Clinical Chemistry and Laboratory Medicine) has collated an inventory of the accreditation procedures for medical laboratories in the EU.RESULTS AND DISCUSSION:Accreditation of medical laboratories in the countries of the EU is mostly carried out in cooperation with national accreditation bodies. These national accreditation bodies work together in a regional cooperation, the European Cooperation for Accreditation (EA). Professionals are trained to become assessors and play a prominent role in the accreditation process. The extent of the training is diverse, but assessors are kept informed and up-to-date by annual meetings. The frequency of assessments and surveillance visits differs from country to country and ranges from 1 to 4 years. More harmonisation is needed in this respect, based on a frequency that can be pragmatically handled by laboratory professionals. In the majority of EA bodies, accreditation is carried out on a test-by-test basis. Many professionals would prefer accreditation of the entire service provided within the actual field of testing (i.e., haematology, immunology, etc.), with accreditation granted if the majority of tests offered within a service field fulfil the requirements of the ISO 15189 standard. The scope of accreditation is a major point of discussions between the EC4 Working Group on Accreditation and representatives of accreditation bodies in the EA Medical Laboratory Committee.

V. Conclusion Nous, Biologistes, devons continuer à être très vigilants sur les modalités d’utilisation de la norme ISO/EN 15189 par les organismes accréditeurs. Ce n’est que par un dialogue constructif que nous arriverons à nous faire entendre. C’est la voie qu’ont choisie les membres d’EC4 en faisant remonter nos inquiétudes au plus haut niveau de l’ILLAC. Rejoignez-nous en vous inscrivant sur le site: www.ec-4.org La Norme a été rédigée par des Biologistes pour des Biologistes: votre démarche qualité une fois installée au laboratoire, il est facile de suivre pas à pas, avec des principes simples, les prescriptions de la Norme.

Nous devons nous préparer à l’application des directives et des normes européennes: une directive doit être transposée en droit national dans les deux ans qui suivent sa parution au JO européen. L’harmonisation de la qualité des professionnels et des structures est en voie de réalisation grâce à la norme ISO/EN 15189. Cette norme estla norme d’accréditation des laboratoires de biologie médicale (polyvalents ou spécialisés), reconnue maintenant dans le monde entier; la qualité concerne notre profession dans sa globalité (phase pré-analytique, analytique et post-analytique, et management global). L’harmonisation doit être un facteur de progrès pour tous, EC4 continue à effectuer un énorme travail auprès des instances européennes. Il est capital que les biologistes s’inscrivent.

Toute activité humaine est génératrice d’un risque (risque pour l’homme et pour l’environnement) dont il est illusoire de penser qu’il est possible de le réduire à zéro. En revanche, il est possible de diminuer, de minimiser ce risque. Il n’existe pas, pour cela, de solution univoque, du fait de la diversité des laboratoires selon leur importance, leur implantation, leur recrutement et leur spécialisation éventuelle. Il est donc nécessaire, pour chacun, d’instaurer sa propre démarche de prévention; cet article a été rédigé pour aider les directeurs de laboratoire à mettre en place une démarche efficace et pérenne.

L'application des recommandations du GBEA dans les Laboratoires d'Analyses de Biologie medicale a permis de familiariser l'ensemble des professionnels a la notion d'assurance qualite. Simultanement, dans tous les pays, des demarches du meme type se sont developpees, sans neanmoins relever d'une reglementation, comme c'est le cas en France. L'harmonisation indispensable des pratiques a rendu ineluctable la preparation d'un referentiel commun et consensuel definissant les exigences de qualite en matiere de bonnes pratiques de ce domaine. La norme ISO/EN 15 189 (actuellement au stade FDIS, etape ultime avant publication) a ete ainsi preparee au sein de l'ISO et du CEN en tenant compte des specificites de l'analyse en biologie et du contexte dans lequel elle est prescrite en concertation avec les autres specialites medicales dans le cadre de la prise en charge des patients et de l'ethique. Dans son introduction, la norme ISO/EN 15 189 precise qu'il appartient aux responsables des laboratoires desireux de faire accrediter leur structure de choisir un organisme accrediteur susceptible d'utiliser une norme qui tient compte de la specificite des Laboratoires de Biologie medicale. Avant sa parution, cette norme est deja reconnue par les organismes d'accreditation europeens.