Laboratory medicine in the European Union

Definition of the specialty

Many different names are used for the specialty field at a national level (Table 1), which is reflected in the EC directives [1, 2]. The words used in different combinations are: clinical, medical, laboratory, (bio)chemistry and diagnostic. Together these words accurately define the profession of clinical chemistry and laboratory medicine. At the European level, the EFCC (now named EFLM) in 2010 has adopted the name of the profession “specialist in laboratory medicine”, after consultation of and voting by the National Societies [3].

Professional societies

The EFLM member societies are listed in Table 1 [4, 5]. Except for Cyprus and (until recently) Croatia, all these professional societies are mixed, with members of both scientific and medical background. About half of the countries reported a separate professional organization exclusively for members of medical background (Cyprus, Czech Republic, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Portugal, Slovakia, Spain and UK).

Number and background of specialists (Table 2)

The academic training before specialization varies between EU countries. All countries have specialists of both medical and scientific background, with medical laboratory professionals being officially recognized as medical specialists. The Netherlands is an exception, where the training of medical specialists was stopped in 2001. In Croatia the medical specialty of laboratory medicine was recently started upon entering the EU. The proportion of medical doctors varies between countries, with at the low end Croatia (0%) and the Netherlands (8.1%), and at the high end Greece (92%) and Austria, that does not have laboratory specialists with a scientific background. The total number of laboratory specialists in the EU is (with background): 14,800 (physicians), 11,300 (pharmacists), and 10,200 (scientists). Medical specialists in laboratory medicine thus comprise around 40% of more than 30,000 practicing laboratory professionals in the EU.

In five countries pharmacists constitute a high proportion of the laboratory professionals: France (73%), Spain (61%), Portugal (57%), Slovenia (50%) and Belgium (45%). Except for Slovenia, these countries have a training that is almost exclusively restricted to medical doctors and pharmacists. In France both groups have an equal legal position. All other counties, however, have few pharmacists in clinical chemistry. The mean proportion of pharmacists in these 19 countries is 2.1% (range 0%–9.5%). Their training and position is in most cases equal to scientists but not to medical doctors.

The total number of laboratory specialists differs considerably between the EU countries. Expressed as the number of laboratory specialists per inhabitant, Greece has the highest number with 346 per million, followed by Cyprus with almost 200 per million. At the low end are Ireland and the UK with 4.2 and 11.6 per million, respectively. The countries are different with regard to the number of fields of interest that are part of the laboratory medicine specialty. If we take into account six specialized fields [biochemistry, hematology, endocrinology, immunology, transfusion medicine (serology) and microbiology], there is only a weak correlation between the number of laboratory specialists, and the number of specialized fields of the profession.

Academically trained laboratory professionals (Master’s degree) without specialist training do exist in some countries. In the UK these are named “biomedical scientist”. In Croatia, more than half of the people who have studied clinical chemistry find work in the laboratory without further post-academic specialization (280 vs. 249 specialists).

By exception, in some countries technologists have university level training. In Sweden technicians working in the laboratory have a 3-year university degree to become a “licensed practitioner of medicine”. They do not have the level of training to carry out the same responsibilities as a clinical chemist, and are not accepted in the EC4 Register [6].

Fields of interest and responsibilities in clinical chemistry/laboratory medicine (Table 3)

Laboratory medicine does include different fields in different countries. “Laboratoriumsmedizin” in Germany and Austria includes biochemistry, endocrinology, microbiology and hematology and transfusion medicine. This form of general laboratory medicine (however with a special position of transfusion medicine) is practiced in other countries like France and Spain (análisis clinicos). Hematology is only practiced by physicians in Spain, as the specialty includes clinical practice and blood transfusion. However, clinical biochemistry in the UK does not include hematology and microbiology. In most cases, however, the medical laboratory profession in this country (chemical pathology) includes the treatment of outpatients (lipid clinics, metabolic disorders etc.).

Laboratory medicine is sometimes called “polyvalent” or “general” if it includes a broad field of interests, and “monovalent” if it includes only one field of interest (e.g., microbiology, transfusion medicine). We arbitrarily define laboratory medicine here as polyvalent or general, if it includes at least biochemistry, hematology and microbiology. According to that definition, 60% (15/25) of the countries included in this study are polyvalent (Table 3). This corresponds to 83% of all laboratory specialists in the EU working in countries with a polyvalent or general type of laboratory medicine.

Responsibilities of medical and scientific laboratory specialists (Table 4)

There are differences in professional responsibilities between medical and scientific laboratory specialists in European countries. In the Netherlands, clinical chemists with a scientific background can be responsible for all aspects of clinical chemistry, including transfusion medicine. In contrast, clinical chemists in Germany cannot operate but under the responsibility of a laboratory physician or another medical doctor.

The limited responsibilities of laboratory specialists with a scientific background compared to physicians concern the responsibility for diagnosis and patient treatment advice to the clinician, or the end-responsibility of the laboratory work.

In most countries both physicians, pharmacists and laboratory specialists with scientific background can be the head of a laboratory. Sometimes this is restricted to upper grade specialists (UK: consultant level). Most countries, however, do not have different grades.

Pharmacists were reported to have less limitations with respect to responsibilities compared to physicians (not limited 11, limited 4, not applicable 10), than specialists with a scientific background (not limited 14, limited 9, not applicable 2) (Table 4).

Specialist training and registration

The EC4 curriculum [6] was used in 16 countries in the development of the local specialist training curriculum. It was reported to be background information (Finland, Lithuania), or was even identical to EC4 curriculum (France). In the UK there is a close overlap between EC4 and the national curriculum, where the UK curriculum predates that of EC4. In most countries the EC4 curriculum was used for training of scientists or pharmacists, with the exception of six countries (Bulgaria, Estonia, France, Hungary, Lithuania and Slovenia) where it was also used in training of medical specialists.

The UEMS curriculum [7] was used in less countries for the medical training: Finland, Hungary, Portugal and Slovakia. Sweden has a special position, as the UEMS curriculum was adapted based on the Swedish situation.

The duration of the training was calculated as the number of years after completion of the university training. In some countries, there is an obligatory pre-training period, before the training can be started. This period was interpreted to be part of the total specialist training period (Table 5). Some countries have an academical study in clinical chemistry (Croatia and other Balkan countries not included in the EU). Only this study allows trainees to enter the specialist training. In Croatia, about 50% of these academics choose not to do this specialization, and work in clinical laboratories with a limited responsibility.

There is no training of laboratory specialists in Cyprus. It has a system of certificates (after 1 year training) in sub-specialties hematology, biochemistry, immunology and microbiology. Diplomas from abroad are accepted after a validation procedure. Training predominantly takes place in Greece. Malta and Luxembourg do not to have specialist training.

For scientists, there is no formal training in four countries (excluding countries with only physicians and pharmacists): Austria, Estonia, Denmark and Sweden.

Re-registration is obligatory for laboratory physicians in eight countries (9/25, 36%) (Table 5). Re-registration can be linked to a financial stimulus (health insurance reimbursement), while not connected to the losing of registration (Belgium). For specialists with a scientific background, re-registration is obligatory in 11 out of 23 countries (48%). In the 14 countries with a relevant number of pharmacists, nine had a re-registration program (64%).

There was a continuous medical education (CME) program in place in 20 out of 25 countries (80%) (Table 6). In some countries the system is only for physicians (Austria, Germany).

Organization and responsibility of training

The official recognition of the profession of laboratory specialists differs between EU countries. In all countries, the medical laboratory specialty is acknowledged by law, with an official register regulated by the official medical council and/or under responsibility of the ministry of health. For professionals with a scientific background, there was not (or not yet) a register in all countries. There is a register in 16 countries, and no register in seven countries.

From the data it was not always clear, whether the organization holding the register of scientists was private, or officially recognized. In one country (France) it is not applicable, with only physicians and pharmacists admitted to the profession. Pharmacists are recognized in all countries with substantial numbers of specialists with this background training, with the exception of Denmark, where there is only a formal training for physicians.

Accreditation ISO/EN 15189

Quality is a central issue for laboratory profession, and the development of a quality system based on ISO/EN15189 has taken place in many laboratories in the EU. Also in this field there are large differences between countries. Some countries have reached an almost complete introduction of audits and accreditation: Sweden, Finland, The Netherlands, and France, where this is now compulsory by law. Other countries are still at the beginning of this development (Table 6). In some countries ISO 9000 is used – for the time – more predominantly than ISO 15189 (Austria, Italy) and can be obliged by health insurance (Italy).

Although the ISO 15189 is not compulsory by law in Germany, there is a legal regulation called “Richtlinien der Bundesärztekammer zur Qualitätssicherung laboratoriumsmedizinischer Untersuchungen (RiliBÄK)” which has adopted essential contents of ISO 15189, particularly quality management aspects and management of documents. Therefore, parts of ISO 15189 are also obligatory in Germany.