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Wim Huisman,
chairman EC4 WG on Accreditation
Clinical Chemical Laboratory, Medical Centre Haaglanden, The Hague,
The Netherlands
w.huisman@mchaaglanden.nl
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Introduction
The basic idea of the European Union is freedom of movement of
people, products and services. This is realised through
harmonisation of practices, for example in the field of laboratory
medicine, a patient wants to be sure that the result of a test can
be trusted and is interpreted in the right way during his stay
abroad. This has several implications for our profession. Within
EC4, the European Communion Confederation of Clinical Chemistry and
Laboratory Medicine, several working groups have contributed to the
harmonisation of the profession, laboratory and laboratory data. Of
course, international developments have been supported.
Quality and
competence
The title of the ISO 15189 standard is �Medical laboratories �
Particular requirements for quality and competence� (1). Several
aspects of this title are important. The inclusion of the term
�Competence� indicates that more than the existence of a valid
quality system is considered. �Medical laboratories� indicates as
well that it is written specifically for that field. The importance
of these aspects will be indicated in the following sections.
Quality system
The quality of the analytical work had been a major focus for a
very long time and as laboratory professionals, we have developed
reference methods, international standards, and use quality control
material to be sure about the internal variation coefficient of our
methods and participate in External quality assessment schemes to
understand the relationship between the performance of different
laboratories. Still the physicians confronted us with mistakes. The
quality approach taught us to consider the complete process. For a
medical laboratory it meant the pre-examination procedures, the
examination procedures and the post-examination procedures.
ISO 9001:2000 �Quality management systems � Requirements� (2)
describes a very general approach to quality systems. It can de
used to set up a quality system for different types of
organisations. It is applied in hotels, garages, manufacturers of
diagnostics and laboratories. It helps a lot to structure the
different aspects in an organisation. It pays specific attention to
the critical points. It makes clear that mistakes should be
examined to avoid repeating them. It helps to focus on the needs of
clients (for the medical laboratory, this includes both patients
and doctors). To ensure that a company has complied with this
standard in setting up its quality system, it must be inspected and
certified as compliant by a recognized certification body. In order
to claim that it operate a quality system in accordance with ISO
9001:2000, a company must have received certification by a third
party.
Competence in
testing
This ISO 9000 approach is very general. If a customer receives a
result from a laboratory that has tested for instance the amount of
lead in a substance and this laboratory has an ISO 9001
certificate, it indicates that a quality system exists and that the
laboratory does the testing according to written procedures but it
does not give assurance about the competence with which the tests
are performed.
To facilitate international trade it is necessary to ensure that
tests on products performed by industrial testing laboratories in
different countries are reliable and give comparable results.
It is therefore necessary to assess the competence of testing
laboratories, as well as their quality systems. The standard
ISO/IEC 17025:1999 �General requirements for quality and competence
of testing laboratories� (3) has been developed for this purpose.
This standard includes all aspects of the quality system, but adds
specific demands concerning the analysis. The results should be
traceable to international standards, external quality assessment
should be done; validation of the test system is essential. The
people who do the tests should be adequately trained. The analyses
should be performed according the best available methodology. Thus,
specific demands concerning the competence of the laboratory are
explicitly added. Again, inspection by a third party � in this case
an accreditation body � is necessary. An important difference
between this and a certification inspection is that the inspection
team should include someone with experience in the field in which
the laboratory is working. If the laboratory passes the inspection,
it can claim to be accredited according to ISO 17025. Many
accrediting bodies in Europe cooperate in the organization EA
(European Cooperation on Accreditation). They perform mutual
assessments. This gives confidence that the test results can be
used internationally. Although it is quite possible that a
laboratory with only an ISO 9000 certificate does the test as well
as the one with a 17025 accreditation, the customer cannot be
sure.
Competence in a
medical laboratory
When the discussion about introduction of quality systems in
medical laboratories started in the late nineteen-eighties, it
focussed on which aspects were specific for medical laboratories.
Different approaches were followed in different countries. To help
in harmonisation in setting up of quality system and in the process
of accreditation, a Working Group on Accreditation was set up
within EC4. In a survey held within Europe in the field of clinical
chemistry, it was quite clear that there was a requirement to
include pre- and post-examination aspects, and to make evident that
a medical laboratory gives information and not just figures (4).
The Essential Criteria (5) and Additional Essential Criteria (6)
that were published by this Working Group contained all these
items. The ISO Working Group that produced ISO 15189 included
workers in the field of laboratory medicine, several of whom were
members of the EC4 WG on Accreditation. It had input from different
parts of the world and a major impact from the EC4 Essential
Criteria. The utmost importance of this ISO 15189 is that it really
covers all aspects of the work in a medical laboratory. It should
mean that a medical laboratory which has been accredited according
to ISO15189 by a competent accreditation body pays attention to all
these different aspects. Its customers can be confident that the
laboratory provides not only accurate test results, but also a good
medical laboratory service.
In the ISO15189 all aspects of the generic ISO9001 are covered
and the vast majority of the more specific ISO17025. It adds
aspects specific for a medical laboratory, such as:
- working in a medical surrounding
- consultation function
- headed by a professional
- role of diagnostic manufacturer
Working in a medical
surrounding
In a hospital environment, we have to deliver valid information
about the patients during 24 hours every day of the year. Many of
the results have to be available within a very short time, from
minutes to an hour at the most for our stat samples. Our big volume
test results are expected within a couple of hours. Only for a
small volume of the tests we can take more time. To achieve this,
we must not only have reliable apparatus, but also well trained
technicians. They must not only be aware of analytics, but also of
the clinical implications of the results. A laboratory professional
must be available for consultation during the time tests are
performed
The laboratory not only provides tests, but also service. This
can involve the organisation of point of care testing. It can
involve satellite laboratories for instance near intensive care.
The laboratory professional should be responsible for the quality
of the laboratory tests done in the hospital.
The taking of the samples from a patient is often critical, as
is the transport. The medical laboratory should provide
instructions that are critical. It should be rather stringent in
the process of identification of the sample to a specific patient
and refuse to give results if uncertainty exists.
When a test result has to be revised after it was available to a
physician treating a patient, the doctor should be informed.
Consultation
function
The medical laboratory professional should give advice
concerning the tests which are adequate for certain categories and
for individual patients, in consultation with the specialist who
treats that specific patient. This is part of the pre-examination
aspects of a laboratory, which certainly are not restricted to
technical aspects of phlebotomy, transportation and
refrigeration.
The medical laboratory professional takes care that the analysis
is done according to the state of the art, with the clinically
required precision and accuracy. He is aware of drug interactions
and other interfering factors. This is part of his role in the
analytical process.
The medical laboratory professional discusses the results with
the clinicians and is involved in discussion of patient cases and
in the education of the clinicians concerning new developments in
laboratory medicine. He is a member of the medical staff of the
hospital. In the management review, which is part of the quality
system, the adequacy of the test repertoire and delivered service
in connection with patient care is an important aspect.
This is part of his role in the post examination aspects.
In the ISO 15189 these tasks of the medical laboratory
professional are mentioned specifically. It means that during an
accreditation the laboratory can show that these requirements are
fulfilled. The professional should not only have been trained
adequately to become registered for instance as a clinical
biochemist, but he should also have taken part in post academic
training to keep his registration. To make movement of
professionals easier in the European Union, EC4 has set up a
register of European Specialists in Clinical Chemistry and
Laboratory Medicine.
Headed by a
professional
ISO 15189 mentions that the responsibility of the laboratory
director should include professional, scientific, consultative or
advisory, organisational, administrative and educational matters.
He (or she) should have the appropriate training and background to
be able to discharge his/her responsibilities in specified items
concerning all these aspects. This means that the professional
responsibility of a medical laboratory can only be taken by a
registered medical laboratory professional.
Role of diagnostic
industry
ISO 15189 has a specific section (5.3) about laboratory
equipment. It pays attention to the role these manufacturers play
in providing instruction and in general as a partner in the process
of providing relevant patients� results. In this aspect the
introduction in Europe of CE marking for in vitro devices is
relevant. It should give confidence that the results can be related
to internationally accepted standards (traceability). It makes
certain that relevant information about interactions is supplied
and that a post marketing surveillance program is set up. One of
the aims of EC4 is to stimulate work in this field of harmonisation
of laboratory data. They will cooperate with industry in these
matters.
Setting up the
quality system
Setting up a quality system in line with the ISO 15189 is a task
which all medical laboratories in the enlarged Europe should try to
accomplish. It is quite an effort, but worthwhile. It is a process
which will take a couple of years. It has to be set up carefully.
One of the medical laboratory professionals should be made
responsible. Many people in the laboratory should be involved in
preparing standard operating procedures, which are really used and
kept up to date. One of the laboratory staff should be designated
as Quality Manager and given enough time to fulfil this task. A
Quality Manual should be set up and all documentation should be
taken care of. In ISO 15189 all these aspects are mentioned. The
problem with its structure is that it is based on that of the old
ISO 9001:1994. Many items which are certainly connected are worded
under different paragraphs. For that reason, reading of the
Essential Criteria will help to make it more understandable. Even
more important is to realise that this whole effort is part of a
continuous improvement process. The real meaning of a quality
system is working on improvement by using the input of the
customers, in our case the physicians and patients. This make
internal audit and the management review part of the mainstay of
the quality system.
Accreditation
To make it clear to the customer that a laboratory has an
adequate quality system and the competence to give reliable results
and interpretation of their meaning for treatment of patients, an
accreditation system has to be set up. It is quite clear that it
can only be done when medical laboratory specialists are deeply
involved in this process. For a medical laboratory the
accreditation should be for a specific group of tests and not for
specific tests in themselves. The frequency of the inspections
should be in line with what gives added value. At this moment the
EC4 Working Group on Accreditation is planning to produce a paper
on essential criteria for assessments and assessors. This of course
in line with the guidelines produced by EA and ILAC (International
Laboratory Accreditation Cooperation), but with specific attention
to items specific for the medical laboratories. In these aspects
close contact exists between members of this working group and of
EA.
Multilateral
Agreement
Many medical laboratories in countries in Europe are working on
setting up a quality system according to ISO 15189. They should
include specific items required by law in such a country to make it
possible to use one system instead of several. Some countries like
United Kingdom have already such a system. The systems used in
several countries need not to be identical as long as they contain
all specific aspects of the ISO15189. Contacts between different
countries and members of the working group exist.
It is important that the accrediting bodies use comparable
guidelines during inspection. They should come to a form of mutual
assessment and eventual recognition. For medical laboratory tests
the same situation should exist as for testing laboratories in
general, that results of accredited laboratories are recognised in
all countries, in the enlarged Europe. This means a multilateral
agreement under which each accrediting body agrees to recognise
accreditation according to ISO 15189 by the other bodies.
Conclusion
ISO15189 is the standard all medical laboratories in Europe
should use to set up their quality system and use for
accreditation. It contains all aspects of importance to give
confidence to our patients and medical doctors that we deliver good
service.
In the end it should be possible that the doctor in Prague can
use with confidence a result of a patient from a laboratory in
Madrid.
References
- ISO 15189:2003 Medical laboratories-Particular requirements for
quality and competence
- ISO 9001:2000 Quality management systems-requirements
- ISO/IEC 17025:1999 General requirements for the competence of
testing and calibration laboratories
- Jansen RTP, Blaton V, Burnett D, et al Quality and
accreditation systems in clinical biochemistry in the European
Union. Eur J Clin Chem Clin Biochem 1995;33:393-398
- Jansen RTP, Blaton V, Burnett D, et al. Essential Criteria for
quality systems in medical laboratories. Eur J Clin Chem Clin
Biochem 1997;35:121-132
- Jansen RTP, Blaton V, Burnett D, et al. Additional essential
criteria for quality system of medical laboratories. Clin Chem Lab
Med 1998;38:249-252
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