so we try to learn from each other 's national
systems, and we hope to be able to recognise the
best elements ofclinical chemistry in the separate
countries to bring them into practice in the whole
European Union.
Under the umbrella of harmonisation EC4 set
itself twomain tasks: qualityof the laboratory and
quality of the professional. These two main goals
are of course inter linked and in itself consist of a
number ofminor aspects.
For the quality of the professional the initiative
forthe European registerofCiinicalChemistrywas
taken. For the quality of the clinical chemistry
laboratory, as for other disciplines in health care,
accreditation is the recognition of the status of the
overall diagnostic process. One of the conditions
for recognition ofexcellenceofa laboratory isthat
the professional contribution is of the highest
possible, proven, leve!. So, accreditation cannot
be complete without relevant training of
professional staff and technicians. There the Eu–
ropean registration and accreditation meet at the
interest of the patients for whom we perform our
activities.
European register
The institution of the EU Register for Cl inical
Chemists is one of the best ways to regulate the
profession of clinical chemistry, since it is based
on a common EU training program. That is where
harmonisation should start. The activities EC4 has
undertaken to reach this goal in the past years, are
(l)
publication of European Syllabus for
Postgraduate Training, (2) make a proposal for a
sectorial directive for clinical chemists in the EU,
and (3) the institution of a European Register for
Clinical Chemists.
Before theEuropeanRegister itself is dealtwith,
a short explanation of the content and position of
clinical chemistry in the EU is given.
Clinical Chemistry in the EU is practised by
some 25,000 professionals and the estimated total
annual tumover is 15
*
l0
9
Euro. The background
of the professionals can be
Medical, Pharmaceutical, Science-oriented,
Veterinary, and Microbiological. For all , a
university education is the basis for postgraduate
training in clinicalchemistry. The average number
of training years is 11 (8-1 3), average years of
82
university education 5-6, average years of
postgraduate training 5 (4-6). the minimum stan–
dard is 8 years of study after entering university
('BAC
+
8' or 'Abitur
+
8 Jahre').
The most appropriate way to regulate a profes–
sion in theEUwould have been to create aSpecific
Directivededicated to that profession. ForClinical
Chemistry that was not feasible and thus the pro–
fession became subject to the so called General
Directive 89/48/EEC (and 92/51/EEC).
This Directive regulates the recognition of all
highereducation diplomas awarded oncompletion
of professional education and training of at !east
three years' duration (instead of the 8 years
vocational training necessary to obtain sufficient
knowledge in clinical chemistry). It assures
recognition of certain diplomas, but not the
actmission ofall clinical chemists to health-related
activities of the national healthcare systems.
Therefore, EC4 has taken the initiative to
regulate Clinical Chemistry in the EU based on
the harmonisarianofvocational training inClinical
Chemistry in the European Union.
That initiative has led
to
the EuropeanRegister
for Clinical Chemists. The initiative of the Euro–
pean Federation of ational Engineering As–
sociations (FEANI) has served as an mode! for
EC4. According to the European Commission this
is anexcellent example of self-regulatianby a pro–
fession at the European level.
2
The EC4 European Syllabus for Postgraduate
Training forms the basis for the European Regis–
ter.
lt
is not a training guide as such, but must be
seen as an indication of the leve] of requirements
in post-graduate training and the content of natio–
nal programs needed to obtain appropriate
knowledge and experience. It is a common mini–
mal program approved by all EU societies of
clinical chemistry and leaves undisturbed the dif–
ferent structures of medical laboratories as de–
veloped in their national environments. Some of
the core elements are: Knowledge in clinical
chemistry, hematology, blood banking, immuno–
logy, etc.: Pre-analytical conditions; Analysis and
methodological evaluation of analytical findings;
Medical interpretation of analytical findings;
Clinical training; Research and develop-ment;
Laboratory management and quality assur-ance.
Such a syIlabus is the reflectionofa profession
KliniJk Kemi
i
Nordell
-1.
1999
