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Article ID
1301200105
Author, A. Kallner, J. Waldenstrom
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In 1992 the first clinical chemistry laboratory was
accredited in Sweden to take a holistic view on quality and not
only focus on the quality of measurements and observations in the
laboratory. About 80 % of the Swedish clinical chemistry
laboratories have since been accredited as well as many other
laboratories in laboratory medicine. Accreditation was performed
according to the ISO Guide 25 'General requirements for the
competence of calibration and testing laboratories' and the EN
45001 'General criteria for the operation of testing laboratories'.
In the following years accreditation of medical laboratories was
introduced in many countries. The ISO Guide 25 and EN 45001 deal
mainly with analytical quality and organisation of the laboratory
and it was soon realized that none of the available standards was
entirely suitable for medical laboratories. Therefore, a number of
application notes were published e.g. in the Scandinavian
countries, Holland and Switzerland. The European Confederation of
Laboratory Medicine (ECLM) produced an application document to ISO
Guide 25 that was recognised by EA (European Accreditation) and
widely used. The European Communities Confederation of Clinical
Chemistry (EC4) has published "Essential Criteria for Quality
Systems in Laboratory Medicine" (2). The Project Group Good Medical
Laboratory Services of the ECLM proposed a model for the future
development of the concept of total quality management (ref)
focusing more on patient outcome.
The IFCC in its policy statement on clinical
laboratory accreditation states 'Adherence to high standards, such
as those related to timeliness of test results, laboratory trueness
and precision, clinical relevance of tests performed,
qualifications and training of personnel, and prevention of errors,
is an ethical responsibility of all clinical laboratory staff' (1).
To meet this statement, the previously available standards need to
be substituted by something new.
The new ISO Standard 17025 that substitutes the ISO
Guide 25 is still cantered on analytical performance in addition to
complying with the ISO 9000 series for quality systems. The ISO TC
212, therefore proposed to write an accreditation standard
specially for medical laboratories. This has become the ISO/FDIS
15189. This standard will, when it is finally released, take us a
good step nearer total quality management of medical
laboratories.
A working group of the Swedish Society for Clinical
Chemistry has worked out a protocol for a medical audit of
accredited medical laboratories. The proposed protocol is now
studied by the various sub-specialties of laboratory medicine. We
believe it would be of interest to invite the international
community to comment on the protocol at an early stage and to
initiate a presentation and discussion of what is happening in
other countries in this Journal.
Is your laboratory accredited? In that case, which
Standard do you use? (ISO guide 25/ EN45001, ISO 17025, ISO 15189
or a national standard). Do you have peer visits or other forms of
medical audits? If you want to participate in a discussion about
these topics do so by emailing the IFCC webmaster at webmaster@ifcc.orgThis protocol is planned to fill the gap between EN
45001/ISO 17025 and the forthcoming ISO 15189.
1. The executive shall be sufficiently
competent to make all necessary decisions. The competence can be
divided between several persons. In that case there shall be a
clear description of who is responsible for what. A physician,
specialist in the field of the laboratory, shall be medically
responsible.
2. Physicians, working in the
laboratory and not under training, shall be specialists in the
appropriate field.
3. Continued education shall meet the
needs of all staff within their field of responsibility.
Note:Funds should be budgeted for internal
and external education and the plan for education and training
reviewed annually.
The laboratory shall have access to an adequate
reference library and electronic or other sufficient library
service.
Note:It is assumed that the personnel have
received the necessary education to use the library and other
library or electronic information services.
1. The selection of analytes shall be a
joint concern for the laboratory and its customers and regularly
reviewed to meet the needs of health care.
Note 1: Consequences of prospective changes
should be discussed. Economic reasons alone should, as far as
possible, not influence the selection of investigations.
Note 2: Attention should be paid to the need
for and to the laboratory's ability to provide interpretation and
evaluation of the results.
2. There shall be established routines
for how to accomplish changes in the selection of analytes and how
to distribute new information about important changes in the
services of the laboratory.
Note 1:Information about new analytes and
their use could be; change of reference intervals, upgrading of
patient instructions, deletion of old and introduction of new
methods.
Note 2: Analytical work can be decentralized
to hospital units as well as primary care units. Transferability of
results should be the leading principle in the choice of
measurement procedures.
1. Decentralization of
investigations to units within the hospital or to primary care
units shall meet the needs of the health care as far as is
technically and practically possible. Routines and arguments for
decentralization shall be documented.
2. The laboratory shall have a quality
system to guarantee consistency and transferability of
results.
1. The laboratory shall provide
clinically relevant quality specifications for each investigation.
(3).
Note: The analytical goals shall be suitable
for the purpose of the investigation and may be different depending
on the intended use, e.g. screening, emergency, monitoring.
2. The laboratory shall state the
clinical performance, e.g. patient outcome or usefulness of offered
investigations.
Note:The performance can be given as
diagnostic specificity, sensitivity or ROC diagrams for different
purposes.
3. Reference intervals, therapeutic
intervals and clinical decision levels shall be traceable to an
authoritative source.
Note:The basis for this information may be
scientific literature or suitable local or regional studies
1. On call responsibilities shall be as
extensive as required by the health care system.
Note 1:The extent of on call service varies
between different specialties within laboratory medicine.
Note 2:On call service can be organised on a
local or on a regional basis.
2. The laboratory shall give
consultative service to the extent required by the health care
system.
Note 1:The laboratory should actively seek
contact with its customers e.g. through participation in clinical
rounds or through the organisation and participation in conferences
etc.
Note 2:The laboratory should participate in
establishing diagnostic and therapeutic programs. This could be
done through defining diagnostic strategies based on, or including
results of laboratory measurements.
3. The laboratory shall be able to
suggest appropriate investigations on the basis of available
information (reflex testing).
Note:There should be established ways to
referral laboratories.
1. Requests shall include specific
questions and anamnesis information to allow informed Notes of the
results Note if requested.
2. The report forms (paper or
electronic) shall allow for comments.
3. Routines shall be described to
assure a safe transfer of results. Special attention should be
given to routines using telephone, fax and other electronic
means.
4. The laboratory shall state the
turn-around-time for measurements including those that are not
carried out frequently or on a regular basis.
5. The laboratory shall specify the
maximum "turn-around-time" for acute analyses.
Note:The laboratory should have routines that
make it possible to register the time the sample arrived and the
time when the final report was issued.
1. The laboratory shall have documented
rules for which information and how this information is assessable
for its customers.
Note:It might be critical how information is
made available and distributed within the health care system, e.g.
between clinics and different levels of the heath care system as
well as over time.
1. The laboratory shall participate in
purchasing of all equipment that the laboratory will eventually be
responsible for.
Note:This includes installation and
validation of all equipment and training of the staff to carry out
measurement procedures within its field.
2. Maintenance and control of all
equipment used for diagnostic purposes but not accredited shall
follow the same rules as accredited equipment.
1. The laboratory shall issue and
update information to clinical staff and patients to ensure
adequate sampling and sample treatment outside the
laboratory.
Note:This information can also contain
information about the clinical performance and indications for
specific investigations.
2. The laboratory shall inform its
customers about essential changes in its operations, technical and
organisational.
Note:This will create a heavy administrative
burden and an appropriate information system should be in place to
meet the needs.
3. A dedicated body shall regularly
review the service and take new initiatives to promote a smooth
collaboration between the laboratory and its users.
1. The laboratory shall specify its
willingness and ability (personal and physical) to participate in
health care related research.
2. The laboratory shall inform about
its research profile, and scientific publications when
applicable.
3. The laboratory shall describe
routines for handling of research samples.
4. The laboratory shall describe
resources for developmental work i.e. method and instrument
validation.
1. The laboratory shall actively, e.g.
through the use of questionnaires, explore the degree of customer
satisfaction.
Note:Questionnaires should be performed
repeatedly and be aimed at specific groups or routines.
2. The laboratory shall react quickly
and adequately on information obtained from customers Actions taken
shall be followed up, documented and presented at the internal
revision of the laboratory.
Note:Incidence reports and other incoming
complaints should be taken into account when deciding the need and
type of action.
1. The laboratory shall have a
documented policy for ethical aspects of sampling, sample handling
and storage, investigations, results of investigations and the care
of patients. The policy shall be endorsed on the highest available
level. (4)
2. Information about the ethical rules
and policy shall be distributed to patients, laboratory staff,
clinical staff and other relevant parties.
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