Clinica Chimica Acta 309 Ž2001.

115–120
www.elsevier.comrlocaterclinchim

Accreditation and postgraduate training in European countries:

an FESCC survey
V. Blaton )
Department of Clinical Chemistry, AZ Sint-Jan AV, RuddershoÕe 10, 8000 Brugge, Belgium

Abstract

The mission of the Federation of European Societies of Clinical Chemistry is to support and promote clinical chemistry
and laboratory medicine in Europe, to aid communication between the International Federation of Clinical Chemistry and
Laboratory Medicine ŽIFCC. and National Scientific Societies, to develop education and quality in the discipline, and to
encourage young scientists to take an active role in these activities. One recent initiative of the Federation was a survey on
accreditation of medical laboratories and training in laboratory medicine in Europe. Among European countries, three
promote accreditation according to EN 45001, several countries apply systems based on professional and nationally defined
standards Že.g. CPA in the UK. and other countries are moving to define accreditation standards at a national level. Data on
vocational training demonstrate that this is based on a postgraduate education with duration ranging from 6 months to 11
years; in most countries the average length of university education is 5 years and that of postgraduate training is 4 years. A
great difference, moreover, exists regarding the polyvalent versus monovalent training. Taken together, these data indicate
that a great effort should be made by the Federation for promoting harmonization and coordination in Europe. q 2001
Elsevier Science B.V. All rights reserved.

Keywords: Education; Postgraduate training; Accreditation; EN 45001; Harmonization; European Union

1. Introduction Prof. Dr. H. Wisser as first chairman. The first

election of the FESCC-EB was in 1991 ŽCracow.
Federation of European Societies of Clinical
and the official formalisation of FESCC was in Nice
Chemistry ŽFESCC. is a forum of the national soci-
Ž1993.. The following National Societies are mem-
eties of Europe, which are concerned with clinical
bers: Albania, Austria, Belgium, Bulgaria, Croatia,
chemistry and laboratory medicine and which are
Czech Republic, Denmark, Finland, France, Ger-
members of the International Federation of Clinical
many, Greece, Hungary, Iceland, Ireland, Israel, Italy,
Chemistry and Laboratory Medicine ŽIFCC.. FESCC
Latvia, Lithuania, Luxembourg, Macedonia, Nether-
is the European arm of IFCC. The first ideas about
lands, Norway, Poland, Portugal, Romania, Russia,
the European organisation under the IFCC umbrella
Slovak Republic, Slovenia, Spain, Sweden, Swit-
were created in Pont a` Mousson Ž1988. and the first
zerland, Turkey, United Kingdom, Yugoslavia
Executive Board was elected in Munich Ž1990., with
ŽSerbiarMonte Negro.. The strategic plan for 1999–
2002 contains a vision and a mission statement.
)
Tel.: q32-50452640; fax: q32-50452619. FESCC should provide European leadership in clini-
E-mail address: Victor.Blaton@azbrugge.be ŽV. Blaton.. cal chemistry and clinical laboratory medicine to

0009-8981r01r$ - see front matter q 2001 Elsevier Science B.V. All rights reserved.
PII: S 0 0 0 9 - 8 9 8 1 Ž 0 1 . 0 0 5 0 7 - 1
116 V. Blatonr Clinica Chimica Acta 309 (2001) 115–120
national societies, which are full members of the
IFCC, to the diagnostic industry and to governmental
and nongovernmental organisations in order to serve
the public interest in health care. The mission of
FESCC is to support and promote clinical chemistry
and laboratory medicine in Europe, to aid communi-
cation between IFCC and the National Societies of
Clinical Chemistry and Laboratory Medicine, to pro-
mote education and quality in clinical chemistry, and
to encourage young European scientists to take an
active part in the above described activities.
Main FESCC activities are the organization of the
European congresses of clinical chemistry and the
support to specialised symposia. Special attention is
given on education, accreditation and development
of the discipline. In particular, in the last 2 years
FESCC supported the subregional congresses, Alps-
Adria, in the Balkan and Baltic countries.
FESCC launched a survey in July 1998 to gather
information on postgraduate education and on ac-
creditation in clinical chemistry and laboratory
medicine w1x.
2. Education and accreditation in laboratory
medicine
The European countries, members of the Euro-
pean Union, have realised with success AEuropean
Register for Clinical Chemists,B based on standards
of equivalence for education training and experience
as defined by the European Communities Confedera-
tion of Clinical Chemistry ŽEC4.. Many other Euro-
pean countries would like to adapt their systems of
professional education to this model.
At the present time, there is no detailed knowl-
edge of professional education of specialists in clini-
cal chemistry in the non-EC4 European countries.
According to World Health Organization ŽWHO.,
Europe is composed of 35 countries, all countries of
the European continent plus Israel and Turkey.
FESCC, the Federation of European Societies of
Clinical Chemistry, is the European Task Force of
IFCC and covers Europe as defined by WHO. Among
these 35 national societies, 15 belong to the Euro-
pean community ŽEC. and 20 belong to countries,
which are not yet members of EU. This means that
there are 35 different systems; EC4 however set up
an expert panel of clinical chemists in order to
establish common EU standards in the field of edu-
cation and accreditation in laboratory medicine w2x.
As harmonisation of quality assessment and ac-
creditation procedures are listed among the main
goals of FESCC, according to its 1999–2000 strate-
gic plan, it is acceptable that many other countries
are willing to adapt their system of professional
education to the FESCC EC4 model w3x. By example
on this basis, it might be interesting to implement a
parallel register for European Clinical Chemists be-
longing to non-EC members.
3. Method of survey
The questionnaire on accreditation was sent in
July 1998 to the 35 presidents of the FESCC mem-
ber societies for clinical chemistry, biochemistry and
for laboratory medicine. The questionnaire included
seven questions addressing the following items: type
and total number of clinical laboratories Žuniversity,
non-university hospital, private, physician’s office.,
date of first accredited laboratory, norms used for
accreditation of clinical laboratories, name status
Žpublic, private, private nonprofit., procedure for
renewal of accreditation and certification, approxi-
mate costs of accreditation audits or accreditation
renewal audits. The questionnaire on education was
sent in addition to the former questionnaire to the 20
presidents of the FESCC member societies for clini-
cal chemistry or biochemistry, which do not belong
to EC4. It included 11 questions, which are pre-
sented in Section 4 w1x. The most important questions
are: which graduate training can lead to a postgradu-
ate training in clinical chemistry? Is training in clini-
cal chemistry a postgraduate training? Does training
in clinical chemistry Žclinical biology. match the
European syllabus? The results of these surveys were
also presented as a poster at the Florence World Lab
IFCC meeting in June 1999 w4x.
4. Results and discussion
By August 1999, 14 out of 15 EC4 FESCC
societies Ž93%. had responded and data from 11
countries were available on accreditation. Eight of
 V. Blatonr Clinica Chimica Acta 309 (2001) 115–120 117

Table 1
Accreditation in EC4 FESCC members
Country Type of lab Total number Total number of Standards
of labs accredited labs
Ž1. Austria Priv. 105 5 ISO 9002
Phys. 2328 0
Un.H. 3 Ž3 PU. 1
NUn.H. 258 Ž232 PU. 3
Ž2. Belgium Priv. 245 13 EN 45001
Phys. – –
Un.H. 7 Ž4PU. 2 ŽPU.
NUn.H. 155 Ž80 PU. 0
Ž3. Denmark Priv. 3 2 EN 45001; ISO 9002
Phys. – –
Un.H. 10 Ž10 PU. 1
NUn.H. 75 Ž75 PU. 0
Ž4. Finland Priv. 4 2 EN 45001; ISOrIEC Guide 25
Phys. 55 0
Un.H. 5 Ž5 PU. 5 Ž10 labs.
NUn.H. 160 Ž110 PU. 1 Žprivate.
Ž5. France Priv. NA 8 EN 45001
Phys. NA
Un.H. NA 1
NUn.H. NA
Ž6. Germany Priv. NA 16 EN 45001
Phys. NA 0
Un.H. NA 4
NUn.H. NA 0
Ž7. Italy Priv. 4000 16 Ž1. ISO 9002; Ž2. CPA, UK
Phys. – –
Un.H. Ž50 PU. 3 Ž2 PU.
NUn.H. 2500 Ž1300 PU. 10 Ž10 PU.
Ž8. Luxembourg Priv. 7 – NA
Phys. NA –
Un.H. NA –
NUn.H. 12 Ž10 PU. All
Ž9. The Netherlands Priv. 0 0 CCKL code of practice based
Phys. 20 a 5 on ISO 9002 and EN 45001
Un.H. 40 b Ž40 PU. 2
NUn.H. 300 Ž300 PU. 18
Ž10. Spain Priv. 1000 5–10 ISO 9002
Phys. 0 0
Un.H. 100 Ž80 PU. 1–2 ŽPU.
NUn.H. 600 Ž500 PU. 0
Ž11. Sweden Priv. 5 5 EN 45001; ISOrIEC Guide 25
Phys. – –
Un.H. 8 Ž8 PU. 8 Ž35 labs.
NUn.H. 95 60 labs
Ž12. UK Priv. 131 50 Own norm based on the Australian
Phys. NA NA model; moving towards ISO 15189
Un.H. 327 200
NUn.H. 738 408

Abbreviations: Priv.: Private laboratories; Phys.: Physician’s office laboratory; Un.H.: University Hospital; NUn.H.: Non-University
Hospital; PU: Public; EA: European Accreditation; NA: not available; Prim.HCC: Primary Health Care Center.
a
For a whole region or primary care physicians.
b
Eight universities with five laboratories each.
118 V. Blatonr Clinica Chimica Acta 309 (2001) 115–120

Table 2
Accreditation in non-EU FESCC member countries
Country Type of lab Total number Total number of Standards
of labs accredited labs
Ž1. Bulgaria Priv. f 30 Presently no accredited –
Phys. No laboratories
Un.H. 5 ŽPU.
NUn.H. f 250 ŽPU.
Prim.HCC
Ž2. Croatia Priv. 14 Presently no accredited ISO 9000, EN 45000, EC4,
Phys. – laboratories ECCLM
Un.H. 7
NUn.H. 57
Prim.HCC 85
Ž3. Czech Republic Priv. 120 Presently no accredited EN 45001
Phys. – laboratories
Un.H. 10 Ž10 PU.
NUn.H. 127 Ž109 PU.
Ž4. Estonia Priv. 3 3 Norms from ESLM
Phys. NA 0
Un.H. 4 Ž4 Priv.. 4
NUn.H. 70 Ž70 Priv.. 70
Ž5. Hungary Priv. 0 – National rules
Phys. 0 –
Un.H. 40 Ž40 PU. 40
NUn.H. 130 Ž130 PU. 130
Ž6. Iceland Priv. 5 0 EN 45001, ISOrEC Guide 25
Phys. 22 0
Un.H. 3 Ž3 PU. 0
NUn.H. 12 Ž12 PU. 0
Ž7. Israel Priv. 15 0 –
Phys. 300 0
Un.H. 10 Ž5 PU. 0
NUn.H. 20 Ž5 PU. 0
Ž8. Lithuania Priv. 15 3 EN 45001
Phys. NA 0
Un.H. 2 Ž2 PU. 2
NUn.H. 187 Ž185 PU. 30 %
Ž9. Macedonia Priv. 0 – –
Phys. 45 0
Un.H. 12 0
NUn.H. 55 ŽPU. 0
Ž10. Norway Priv. 3 1 EN 45001
Phys. 1800
Un.H. 6 Ž6 PU. 2 PU
NUn.H. 71 Ž70 PU. 0
Ž11. Russia Priv. NA NA AThe rules of accreditation
Phys. NA NA of clinical laboratories
Un.H. NA NA in RussiaB
NUn.H. NA NA
Ž12. Slovak Republic Priv. 5 0 In the process of defining
Phys. 0 0 accreditation
Un.H. 6 Ž6 PU. 0
NUn.H. 106 Ž106 PU. 1
 V. Blatonr Clinica Chimica Acta 309 (2001) 115–120
Table 2 Ž continued .
Country Type of lab Total number
of labs
Ž13. Switzerland Priv. 120
Phys. 7600
Un.H. 60
NUn.H. 290
Ž14. Turkey Priv. 0 Presently no accredited
Phys. 0 laboratories
Un.H. 60 Ž56 PU.
NUn.H. 150 Ž150 PU.
Ž15. Yugoslavia Priv. 20
Phys. no data
Un.H. 59 Ž59 PU.
NUn.H. 406 ŽNA.
them promote accreditation or certification according
to the EN 45001 or ISO 9002. UK is moving to-
wards the forthcoming ISO 15189. First accredita-
tions were noted for UK and Sweden Ž1992. and for
Belgium Ž1993.. Major data are summarized in Table
1. 16 out of 20 non-EU societies Ž80%. had re-
sponded to the questionnaire and data are available
from 15 countries ŽTable 2.. Three countries promote
accreditation according to EN 45001 or ISO 9002.
Four countries adopted international standards for
accreditation or registration. The number of accred-
ited labs was overall low. The same 16 countries that
responded to the questionnaire on accreditation also
responded to the questionnaire on education. Clinical
chemistry in non-EU countries is practised by 13 000
professionals with backgrounds in human or veteri-
nary medicine, pharmacy, biology, biochemistry or
chemistry. Clinical chemistry requires a postgraduate
training based on a university education, with an
average training of 9 years. The average number of
years of university education is 5 years and the
number of years of postgraduate training is 4 years.
Training and education in clinical chemistry are lim-
ited to this discipline in eight countries. In others,
training is either specialised in clinical chemistry or
multidisciplinary Žclinical chemistry, haematology,
immunology and microbiology..
The answers on the clinical chemistry curriculum
and examination were quite heterogeneous: a com-
mon trend indicated a mixed practical and theoretical
training, with a similarity in the treated topics, such
as general analytical principles and procedures, ex-
ternal and internal quality control, method compari-
119
Total number of Standards
accredited labs
7 EN45001
0
1
3
–
Presently no accredited ISO 9002; EN 45001
laboratories
son and laboratory management. Most have no an-
swer whether their training matched the European
syllabus w5x.
5. Major conclusions
The data on the total number of laboratories per
country and its distribution is quite varied and inter-
esting. Physician’s office laboratories still exist in
7r26 countries. The data provided on accreditation
show that the total number of accredited labs is low
in EU countries except for UK and Sweden and even
lower in non-EU members. Among the EU-coun-
tries, three promote accreditation according to EN
45001, several countries are in the process of defin-
ing accreditation at the national level and most apply
a system of registration based on nationally defined
standards.
The data on vocational training in non-EU coun-
tries also display a great variation. Vocational train-
ing is a postgraduate one in most countries, with
duration varying from 6 months to 6 years. The total
number of professional training years for a clinical
chemist ranges from 6.5 to 11 years. Polyvalent
versus monovalent training is different.
These results provide an interesting basis for fur-
ther evaluation, discussion and promotion of voca-
tional training in clinical chemistry and accreditation.
The heterogeneity of the data indicates that a great
effort will be needed for the FESCC organisation
before harmonisation can be reached.
120 V. Blatonr Clinica Chimica Acta 309 (2001) 115–120
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