Activities ofCEN and ISO
EC4 considers it also one of its tasks to monitor
the activities of the different standardizing bodies
that might influence the practice of clinical
chemistry.
Themain ones are: ISO!fC 212Working group
l and CENTC 140.The former is cancerned with
accreditation and the latter with In Vitro Diagnos–
tics.
It is advised
to
every national clinical chemistry
society to follow these activities and to find out
which committees are involved in these matters
on a national leve!.
Future strategy
EC4 is actively busy perforrning all the tasks it
has set for itself, but future goals are also amatter
of discussion. The strategy document has been
prepared.
The key words for future activities of EC4will
remain clinical chemistry in its broadest sense,
European Union and harmonisation.
Within these boundaries the work on the regis–
ter and the accreditation will continue, and EC4
will follow the activities of CEN and ISO to see
what the consequences for our profession they
might have.
In relation to these key items four aspects may
be discerned: profession (contents of clinical
chemistry), performance of the profession,
performance of laboratories, profiling of clinical
chemistry.
The profession now has an established register
and re-registration will be an issue for the future.
Also the European Syllabus which will always
form the basis of the register should be updated
regularly, which is essential in a dynamic profes–
sion as ours.
The performance of the profession will profit
most from strategies for interpretation of test
results, diagnostic strategies, and clinical decision
making and evidence based laboratory medicine.
The performance of laboratories can be based
on the essential criteria that the EC4 Working
Group on accreditation has published. Harmo–
nisation of national systems for accreditation of
medical laboratories will lead to general EV
qualifications for heads of clinical chemistry
laboratories, advised requirements for their orga-
Klinisk Kemi
i
Norde'1 4,
1999
nisation and quality assessment schemes, and the
leve! on which they perform their services.
Profiling of clinical chemistry in the EV will
be necessary once EC4 has results of its activities
to show.
And last, but not !east, the extension of the Eu–
ropean Unionwill force EC4 to orient itself to the
practice ofel inical chemistry outside the EV. EC4
realizes that its activities may influence the posi–
tion of professionals in other, non-EV, countries.
Therefore, a good cooperation with FESCC will
remain essential.
References
l. Sanders GTB, KellyAM, Breuer J,Mocarelli P.
The role of European Communities Confederation of
Clinical Chemistry (EC4) in the harmonisation ofClinical
Chemistry in the European Union (Letter to the Editor).
Eur JClin ChemClin Biochem 1995; 33:947-948.
2. Document 94/C 268/72 of the European Commis–
sion,March 1994.
3. 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.
4. Sanders GT, Kelly AM, Breuer J, Kohse KP,
Mocarelli P, Sachs C. European Communities Con–
federation ofClinical ChemistryGuide to the EC4 Regis–
ter: European Clinical Chemist. Eur
J
Clin Chem Clin
Biochem 1997;35:797-803.
5. EC4 website:
.
6. Jansen RTP,BiatonV,BurnettD,Queralt6,Huisman
W. Quality and accreditation systems in clinical
biochemistry in theEuropeanUnion.Eur JClinChemClin
Biochem 1995; 33:393-398.
7. EC4Working Group on Harmonisation ofQualily
Systems andAccreditation: Jansen RTP(chairman), Biaton
V, Burnett D,HuismanW,Queralto JM,Zerah S,Allmann
B. Essential Criteria for Qualily Systems of Clinical
BiochemistryLaboratories in the EU.
Published in: Burnett D. Understanding Accreditation in
LaboratoryMedicine. London:ACBVenturePublications,
1996: Appendix 5.
8. Jansen RTP, Biaton V, Burnett D, Huisman W,
Queralt6 JM, Zerah S, Allmann B. Essential criteria for
quality systems in medical laboratories. Eur
J
Clin Chem
Clin Biochem 1997; 35:121-122.
9. Jansen RTP, Biaton V, Burnett D, Huisman W,
Queralt6JM,Zerah
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AllmannB. EuropeanConfe-deration
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of medical laboratories. Eur
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JO.
Jansen RTP, Biaton V, Burnett D, Huisman W,
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