Klinisk Biokemi i Norden Nr 4, vol. 11, 1999 - page 13

of which the contents are changing continuously.
Therefore, it should never bemade to last for ever
and it needs regularly updating. The next syIlabus
update will be published in due course.
A guide to the EC4 Register has been publis–
hed, leading to the title of European Clinical
Chemist (EurClinChem)
3 · •
A European Register has actvantages for the
individual professional, the profession, and the
patient. The individual professional can proveto
be a qualified clinical chemist, may use the title
EurCiinChem, is recognized at least by all clinical
chemistry societies, allover the European Union
even where under local law no protection exists,
and free movement within the EU is facilitated.
For the profession ofclinical chemistry the adv–
antages of a European Register are: the profile of
clinical chemjstry is raisedwithin theEU, and com–
mon high standards of education, training,
experience, and compliance with continuing
professional development are instituted. Moreover,
comparability ofprofessional training, andofcon–
tent and practiceofclinical chemistry is facilitated,
and mobility is improved.
The Register is beneficial to the patient (and
employer) since it guarantees adequate profes–
sianal training, and assures adherence to the Code
ofConduct added to the Register.
The EuropeanRegister is kept byEC4Register
Commission (EC4RC), advised by the National
Clinical Chemistry Register Committees
(NCCRC). Another important task for the CCRC
is to guarantee the equality of the vocational
training at a national leve!.
Aclinical cherrust wishing to register, sends an
application with personal details and a curriculum
vitae to the NCCRC. This committee keeps the
national register andassesses the suitability of the
candidate.After recommendation the final decision
is at the EC4RC. The Registration in the EC4 Re–
gister thus assures professional training according
to the standards and the connected competencies,
grants the title EurC!inChem, and guarantees that
the registered professional adheres to the Code of
Conduct.
Application is open for EU citizens trained
within EU, EU citizens trained outside EU, and
non-EU citizens trained within the EU. Non-EU
citizens not trained in an EU country are not
Klinisk Kemi
i
Nordeli
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/999
eligible for registration.
The present status of the Register is that it was
launched after the publication of the documents
mentioned in references 3 and 4. Also, an infor–
mation leaflet has become available.
The first certificates to European Clinical
Chemists were granred in Helsinki on October
3rct
1998. A few days later three Italian colleagues
followed and increasing amounts of applications
are coming in now. By now 104 certificates have
been awarded.
Formore in formation the EC4 website may be
consulted.
5
Accreditation of laboratories
There is increasing awareness in medical
laboratories for the need of total qua!ity manage–
ment. After a Iong history of the use of interna!
quality control and externa! quality assessment
schemes, there is now the requirement for control
of the complete laboratory process. An important
too] to achieve such controlisa total quality ma–
nagement system.
But as far as accreditation of laboratories is
concerned, the situation is different fromthat con–
cerning vocational training. No EC4 accrediting
body exists, and EC4 does not wish to fulfill that
role. It only has tried to describe the guidelines
(Essential Criteria) which itjudges appropriate for
establishing the quality of laboratory service.
Thereby EC4 focuses on medical laboratories in
general because in most EU countries clinical
chemistry is a polyvalent discipline. With the
Essential Criteria EC4 tries to influence interna–
tional standardisation organisations like CEN and
ISO in the development of documents concerning
quality of medical laboratories. It is hoped that
accrediting bodies in the EU will proceed along
these Iines when judging quality systems present
in a laboratory. In these the whole process from
pre-analysis to interpretation has to be included.
That means that EC4 is strongly of the opinion
that medicallaboratory accreditation must be ser–
vice rather than test based.
A quality system requires a quality manual to
be compiled describing the organization of the
Jaboratory including functionality and the re–
sponsibilities of staff.Operatingproeectureswould
describe pre-analytical, analytical and post-
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