Accred Qual Assur (2001) 6:140146

Springer-Verlag 2001

Ulf rnemark
Nick Boley
Khalid Saeed
Petronella M. van Berkel
Rainer Schmidt
Michael Noble
Irma Mkinen
Mauri Keinnen
Adam Uldall
Heidi Steensland
Adriaan Van der Veen
Daniel W. Tholen
Manfred Golze
Jytte Molin Christensen
Paul De Bivre
Ed W.B. De Leer

Received: 8 January 2001

Accepted: 17 January 2001

REVIEW PAPER

Proficiency testing in analytical chemistry,

microbiology, and laboratory medicine
working group discussions on current status,
problems, and future directions

R. Schmidt
Bayer AG, Chemicals Business Group,
DE-51368 Leverkusen, Germany
M. Noble
CMPT, 2733 Heather Str.,
Vancouver BC Canada V5Z 1M9, Canada
I. Mkinen
Finnish Environment Institute,
Hakuuninmaantie 46,
FIN-00430 Helsinki, Finland
M. Keinnen
Labquality Oy, Ratamestarinkatu 11,
FIN-00520 Helsinki, Finland
A. Uldall
DEKS, 54 M1, Herlev University Hospital,
DK-2730 Herlev, Denmark
H. Steensland
NKK, Ullevaal University Hospital,
NO-0407, Oslo, Norway

U. rnemark ()
SP, P.O. Box 857, SE-501 15 Bors,
Sweden
e-mail: ulf.ornemark@sp.se
Tel: +46 33 165275, Fax: +46 33 123749
N. Boley
LGC, Queens Road, Teddington,
Middlesex, TW11 0LY, UK
K Saeed
Norwegian Metrology and Accreditation
Service, Fetveien 99, NO-2007 Kjeller,
Norway
P.M. van Berkel
Kiwa Research and Consultancy,
P.O. Box 1072, 3430 BB Nieuwegein,
The Netherlands

A. Van der Veen E. W.B. De Leer

NMi-VSL, Schoemakerstraat 97,
NL-2600 AR Delft, The Netherlands
D.W. Tholen
Dan Tholen Statistical Consulting,
823 Webster St., Traverse City MI 49686,
USA
M. Golze
BAM, Unter den Eichen 87,
DE-12205 Berlin, Germany
J.M. Christensen
National Environmental Research Institute,
P.O. Box 358, DK-4000 Roskilde,
Denmark
P. De Bivre
European Commission, JRC, IRMM,
Retieseweg, BE-2440, Geel Belgium

Abstract Working group (WG)

discussions on proficiency testing
(PT) held at the joint Eurachem/
EQALM workshop, Bors, Sweden,
2426 September 2000 are summarized. The discussions focused on
aspects of PT and accreditation
(WG 1), general aspects of PT in analytical chemistry (WG 2), microbiology (WG 3), and laboratory medicine (WG 4), incorporation of measurement uncertainty into PT
schemes (WG 5), international harmonization of PT schemes (WG 6),
and the role of PT in the international structure of chemical measurement (WG 7). Current status, problems and future directions are identified. Each WG contained a majority
of participants experienced in the
subject being covered by that WG,
and a few participants with different
expertise. This was done to promote
cross-fertilization of ideas between
sectors, a key objective of the workshop. The WG issues reflected the
content of the keynote lectures and
some issues were covered from different perspectives by more than one
group.
Keywords Accreditation
External quality assessment
International harmonization
Proficiency testing Uncertainty

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The most important developments in PT in the past,

and in the next five years
In analytical chemistry, changes in equipment, training,
awareness of quality benefits, and improvement in analytical performance has resulted in more accurate measurements. The number of national and international PT
schemes has increased considerably. The quality of the
schemes is generally higher today, e.g. with improved
distribution of samples and faster information exchange
because of new information technology (IT). The revised
ISO Guide 43 [1] and the ILAC Guidelines [2] have contributed to the harmonization of PT providers. Regulations and protocol on the statistical evaluation of results
also contribute to harmonization but do not necessarily
mean striving for uniformity of the schemes. In the next
five years schemes will place more emphasis on fitness
for purpose and include consensus agreement on requirements. Training and education of providers, participants,
and authorities will improve, and schemes become more
harmonized through co-operation between providers.
Listing of available schemes [3] and of suitable software
on the Internet exemplifies how IT will continue to be
of importance. The uncertainty concept will be included
in the schemes, e.g. accompanying the assigned values,
and the participants will be asked to provide uncertainties for their own results. More and better test materials
will be available after special interlaboratory comparisons (ILCs) to assign values.
Microbiological PT schemes for food and water have
become more stable, with the most substantial change
being the inclusion of new challenges, e.g. Escherichia
coli O157:H7. In clinical microbiology the rate of
change has been greater with more attention being paid
to the influence of pre- and post-analytical work. The analytical phase stresses the importance of sample interpretation, recognizing that normal flora, and contaminants must be accounted for to create accurate and useful results. Consistent with ISO Guide 43 [1], clinical PT
recognizes the importance of having materials look and
act like real samples. As in the food sector, many clinical
programs are developing more substrate-specific materials. In the next five years all programs will continue to
develop, especially when trying to assure that samples
are homogeneous and stable before distribution. Microorganisms inherently grow at varying rates over time and
attach themselves to container surfaces, leaving clusters
that distribute unevenly. The number of targets (bacteria,
viruses, fungi, or parasites) can rapidly increase through
replication or decrease through death, creating problems
throughout the testing cycle. Quality-control (QC) assays
examining for homogeneity are destructive, meaning that
once tested the sample cannot be re-used. Specific temperature or other conditions, many of which are complex
and expensive, might be required to maintain consistency during transport. Cultured strains of organisms are of-

ten different antigenic targets from wild strains which

might not work with reagents used in many laboratories.
Organisms stabilized by lyophilization do not often revitalize uniformly and have atypical enzyme-activity profiles. Changes in equipment seem to overcome part of
these problems and some programs use alternatives to lyophilization. Many distributed organisms are potentially
pathogenic to humans and must be handled with care.
Pathogens, e.g. Escherichia coli O157 H7 or Corynebacterium diphtheriae express virulent toxins. To reduce
risk some programs use only strains that do not produce
toxins. To better assess laboratories performance, a review of statistical procedures is required. Many schemes
base evaluation on Z-score, which is intended for use
with normally distributed data. The concentrations of microorganisms in most samples are low or very low and
distribute consistently with a Poisson distribution.
PT or external quality assessment (EQA) schemes
have been organized in laboratory medicine for many decades. During the last five years IT has produced several
possibilities, but at present only a few schemes use the
latest technique. There is an increased demand for PT by
laboratories, mainly in special schemes, and more users
mean more possibilities of organizing schemes. The
schemes have improved in quality, e.g. in terms of sample materials and reports. Providers have been interested
to develop their services according to approved quality
standards. In some schemes there is growing interest in
bias and in the use of target values obtained by reference
methods. Providers have strengthened their scientific
thinking to form a more solid base for the schemes and
the information produced by them. Increased co-operation between providers and manufacturers to develop
more reliable laboratory tests has proved fruitful. Several
developments in the next five years are linked to IT. A
faster and better service requires that IT developments
are exploited in data collection and reporting. Overview
reports and more detailed data interpretation might be
needed to better serve the laboratories. The internet can
be used for virtual EQA, e.g. in schemes with pictures
and videos. Software for fast statistical treatment of data
and reporting via the internet needs to be developed. For
multinational or international services, the Eptis database
[3] might be a useful information tool, but the WG saw
no need to incorporate national schemes. Some schemes
need more and better patient-simulating test materials.
The issue of pre- and post-analytical EQA was raised to
give wider scope to the schemes, and such schemes are
needed also for educational purposes. Even if the measurement is exact, inadequate pre-analytical (e.g. sampling, transfer) or post-analytical (e.g. interpretation)
phases might render the results misleading. Focusing
more on traceability of the target values, and on uncertainty issues, and by using occasionally assigned values
obtained by reference methods, will add value to the
schemes.

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Availability of, and need for, new PT schemes

On the question whether or not there are too many PT
schemes in some sectors across Europe, WG 2 said the
area is completely market-driven, which means that no
action is needed. WG 6 meant, however, that the demand
is not completely clear. There were some preferences in
the group for non-profit organizations to operate PT
schemes. In any case impartiality and independence is
required, e.g. separation of PT providers and decisions
on the basis of results. There are not too many schemes
or providers in laboratory medicine, but some schemes
have too few participants to be practical, reliable, and
economical (WG 4). There could be more co-operation
in material development, and merging of some small
schemes.
New schemes should be developed for analysis of
genetically modified foods, radioactive materials, contaminated soil, trace constituents in agricultural land
(<1 g kg1), and air samples from industry. In microbiology, food and water programs are driven primarily by
the recognition of new microbial targets. In the water
sector, more programs need to challenge the ability to
detect parasites, e.g. Giardia lamblia and Cryptosporidium parvum, because an increasing number of laboratories perform these assays. The revolution of microbial
detection by molecular genetic testing is increasing as a
result of direct detection by use of specific probes, or by
genetic amplification such as polymerase chain reaction;
new programs will be needed. Molecular testing PT is in
its infancy, partly because of the lack of standardization
within the field, and partly because of the considerable
research and development required to develop reliable
markers. This might prove an area of PT development
that works best through collaboration or program sharing. In laboratory medicine new schemes are expected
for, e.g., genetic tests and measurement of endocrine disrupters.

Aspects of PT and accreditation

Accreditation of PT schemes and providers
The Netherlands, Australia, Finland, Denmark, Belgium,
and USA are early adopters of accredited PT providers. These countries have gained experience on, e.g., cost
development, how practical interpretation of guidelines
was achieved, how national accreditation bodies managed technical challenges, on getting the accreditation if
you hold/do not hold an accreditation as a testing laboratory. WGs 14 were asked if PT providers/schemes
should be accredited and to identify special problems for
such an accreditation.
WGs 1 and 4 saw accreditation of PT schemes/providers as a good thing in general. Third party peer re-

view is essential but should not be mandatory. WG 1

asked if there is an alternative to accreditation, and in
what other ways can providers demonstrate their competence? Accreditation will impact on participants in several ways, including higher fees for the services which
must be paid by the customers, improved methods, more
information on uncertainty components, and more comparable reports and faster reporting. If accreditation becomes mandatory, some small providers will disappear
but the range of testing fields will increase. Confidence
in programs accepted by national accreditation bodies
will grow and these bodies are likely to push laboratories
towards accredited programs. For providers that see an
advantage of formal registration or accreditation, it presumes there are bodies and agencies available that can
perform these actions with competency and authority,
and this is not yet the case (WG 3). According to WG 4,
demands for an accreditation start to come from the laboratories and some already choose PT providers according to their accreditation status.
According to WG 6, accreditation of PT providers
will impact on the harmonization of schemes, e.g. concerning quality management systems, use of different
levels of schemes where accreditation must provide
transparency between levels, and on fitness for purpose. The group expressed different opinions whether
or not accreditation bodies should recognize providers
accredited in other countries. Those in favor stated that
conditions should be the same as for testing laboratories,
and this stimulates cross-boundary comparability. Those
against said that such recognition only is needed where
there is a harmonized approach that can lead to a multilateral recognition arrangement (MRA). WG 2 mentioned improvement of quality and credibility, the introduction of transparency, and the importance of third-party assessment as reasons for accrediting analytical chemistry schemes. On the other hand it has not yet been demonstrated that quality has improved as a result of accreditation. The WG pointed to three overriding factors:
cost/benefit analysis, risk (impact of losing accreditation), and, if accreditation becomes general, will there be
a need for special PT schemes for providers?
WG 2 mentioned that ISO Guide 43 lacks the management requirements found in ISO 9000 but is appropriate for the accreditation of PT providers that already
hold an accreditation as a testing laboratory based on
ISO/IEC 17025. The ISO 15189 for clinical laboratories
should be considered when revising the ILAC Guidelines [2]. WG 3 pointed to the importance of giving the
participants confidence. Just as PT programs recognize
the value for participating laboratories, they expect providers to apply the same discipline in the programs. The
collective community will, in time, determine which
standard or guide will form the basis for an accreditation. Are there advantages of recognizing one international standard or should regions define standards to fit

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their specific needs? Will, e.g., the ILAC Guidelines [2]

eventually meet the requirements of national regulations
such as the American Clinical Laboratory Improvement
Act (CLIA)?

ticipation, and frequent participation could justify reducing the number of on-site assessments.

Education and training related to PT

Use of PT schemes by accreditation bodies,
regulators, and customers
The WGs were asked specifically to discuss if accreditation bodies, regulators and customers use PT schemes
consistently and appropriately. The EA/Eurolab/Eurachem working group on PT focuses on this issue and is
preparing guidelines on how PT schemes should be used
for accreditation purposes [4]. WG 1 thought that, in
general, accreditation bodies apply approximately the
same procedures and review results with more or less the
same frequency. According to WGs 24, however, the
perception of PT scheme information varies, and accredited bodies, regulators, and customers use PT inconsistently both between and within different countries. Programs that develop and distribute client satisfaction surveys often receive positive feedback. It is recognized
that although receiving positive information is comforting, opportunities for improvement often come from the
more critical comments. In microbiology, regulators, e.g.
health authorities and insurance companies in some
countries, require participation and successful performance in PT schemes before they award a license to perform tests. In some countries reimbursement is conditional on participation and acceptable performance in
schemes. There might occasionally be misuse of PT by
administrators and regulators. The use of PT information
by participants and other laboratories varies a lot and includes advertising (not allowed in all countries), obtaining knowledge about what kind of instrument to buy,
identifying non-obvious trends in the measurements,
complementing internal QC, obtaining information about
uncertainty, and education.
Contacts between accreditation bodies and PT providers should be close and schemes need not necessarily be
independent of the former. In fact, 2% of accreditation
bodies organize PT schemes and WG 1 stated that this
can be allowed if they are as impartial as possible, use
transparent processes, and preferably are regularly and
independently assessed/reviewed. The frequency of participation in PT varies considerably. An annual summary
of overall Z-scores or En-numbers as proposed by WG 6
is, therefore, not possible in all sectors. Also single ILCs
(frequency once or <once/year) are valuable to accreditation bodies. A higher frequency is preferable whenever
possible and practical, because it enables participants to
observe changes in procedure/improvement quickly (educational and quality-improvement reasons) but frequency must be balanced with other QA measures. Some accreditation bodies request a minimum frequency for par-

Technical assessors
Technical assessors (TAs) must understand how PT is organized and what its critical points are (WG 1). They
should be experienced in recognizing the limitations in a
specific field and be aware of matrix effects in applicable
sectors. TAs should have special training in interpretation
of PT results, and of remedial/corrective actions, if they are
to be able to judge the effectiveness of actions taken by
laboratories. Simplification of reporting to make schemes
easier to understand for assessor and participant was considered very important. Current training of the individual
assessors could be improved in some countries and is particularly important where providers are accredited.
PT schemes: policemen or teachers?
Part of the duality of PT schemes as an external quality
assessment tool is associated with its role as policemen
or teachers (WG 3). Accreditation bodies find the information critical as a mechanism for monitoring laboratory
proficiency, and as such information derived from
scheme will inevitably have an element of police function. For many small or intermediate laboratories, however, PT samples often afford the most consistent and
available access to materials of known composition, and
provide an opportunity for self-examination and protocol
review. In some programs performance reports are accompanied by an analysis of results, and recommendations for improving performance are made. For many
programs this teacher function is at least as important
as the monitoring component and providers should promote this. Whereas schemes like to see themselves as
providing this two-tiered service, the reality is that many
clients perceive only the police function. WG 2 said the
policemanteacher issue depends on the purpose of the
scheme. Schemes may emphasize educational aspects
hence a teaching role, but real life often contains an authority-driven element, e.g. EC directives. In such circumstances, or when money or health aspects are involved, the policeman is more visible with an obvious
risk of loss of impartiality and independence if this role
dominates. Participating in schemes for educational purposes, and in other schemes, is also a matter of cost for
the laboratory. The two roles can however be combined.
Laboratories should benefit from participation in PT
through added value, and scheme providers should keep
track with analytical and legislative development. WG 4
stressed that PT/EQA schemes in laboratory medicine

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have focused mainly on educational partnership between

laboratories and providers. The sector is aiming at quality improvements, not only QC.
Ranking of participants in PT is not recommended for
several reasons [5]. Terms such as pass and fail
should, according to WG 1, be outlawed in most PT
schemes, but some kind of presentation of results was
considered necessary and should be done by the PT provider. Failure to meet requirements in single rounds of
PT schemes must not automatically lead to suspension of
accreditation (or some other punishment). Such decisions should be taken by organizations other than the accreditation body, e.g. a government institution according
to standards set by them; participants should know this
beforehand. The general findings from schemes should
still be a basis for the teaching role of PT.
What can each discipline learn from the other two?
It is often stated that EQA is different from PT in that
the former stresses more the educational role. WG 2
concluded that the analytical sector could focus more
on schemes driven by fitness for purpose rather than
the need for excellence, and supporting continuous quality
improvement is of prime importance in PT. Microbiology
programs in different disciplines could currently learn more
from each other than from analytical or clinical chemistry.
Examples of cross-discipline improvements include creation of substrate-specific materials. Learning about the
complexities of submitting organisms in different matrixes
can be extremely valuable to other disciplines. Assessment
of samples containing microbes is dramatically different
from chemical composition, because the tendency to see
more explicitly the impact of Poisson distribution.

PT schemes as a help in the harmonization

and development of methods
There are real advantages in harmonization and PT
schemes should, e.g., be used to help the harmonization
and development of methods (WGs 24). In microbiology, especially in the heavily standardized areas of food
and water analysis, harmonization of assays already exists. Samples are produced to be processed using closely
defined procedures. In other schemes, mainly those
linked to clinical microbiology procedures, the degree of
standardization and harmonization is very low. Harmonization needs to take into account, e.g., organisms, reagents, and materials in common use in different regions,
available personnel, existing work patterns and conditions, and importantly, regional differences in client expectations. Some small programs perceive themselves as
direct-service oriented, their primary role being to provide samples, analyze, and report results. These pro-

grams do not have regular access to the staff or equipment which would enable their involvement in the research and development of new procedures. For other
programs research and development is an inherent component of daily activity and some have already a national
or international scope that includes developing and harmonizing methods. This value-added role of PT might
require significant resources, but in the long run it can
have considerable benefits in shared trade and intellectual activities. Topics, e.g. microorganism stabilization,
creation of simulated sample materials, development of
statistical techniques, and the development and harmonization of standards for microbiological PT can be subject
to cross-discipline collaborations. International ILCs can
be based on sharing of test materials. In the medical field
there is some co-operation with manufacturers, but more
help from them is needed to solve, e.g., problems resulting from the test samples. It is an opportunity and an
added value to provide method comparisons driven by
participants and the infrastructure of schemes.
Several WGs said that results from the same PT/EQA
scheme could also be used to draw conclusions about the
properties of the test material and/or the participants
methods. The reason for this question is the widespread
confusion about terminology and objectives of different
ILCs. It is understandable that providers wish to extract
as much information as possible from the results. However, a PT/EQA scheme focuses on the quality of the
laboratories routine work. There are normally no restrictions on methods used, and laboratories, although working in the same sector, might use methods with different
metrological properties and have different experience in
the use of the methods. An ILC with the objective of assessing the trueness and/or precision of a method (e.g.
according to ISO 5725) should involve only laboratories
with significant experience in the use of that method.
The procedure might be far from routine and special requests might be made relating to the number of measurements to be made and how to evaluate laboratory performance. Also in the third common ILC, where property
values of a test material or a candidate reference material
are established, laboratories work under more rigorous
conditions than in PT/EQA. In addition, the low frequency of PT in some sectors, the numerous ways of investigating and reporting the reliability of the measurement
results, and the actual spread of participants results often precludes all serious use of the results for purposes
other than to assess routine work.

Promotion of information from PT schemes

There are many ways in which information derived
from PT schemes can and should be shared (WG 3).
Collective information on laboratory group performance for individual tests or groups of tests illustrates

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the general state of laboratory QC. It can also be instructive within teaching facilities, provide insight
within planning institutions, provide guidance for policy development, and be useful in research and development. Specific individual information can also provide
assistance and guidance while working through problems related to equipment, personnel, or protocol
changes. Recognizing these possibilities, the risks for
considerable harm also exist. Some schemes are commercial, and value-added programs developed within
these could be an advantage in the market place. The
limits that define the scope of conflicts of interest,
whether in a commercial or non-commercial context,
must be carefully drawn. Information collected from
PT providers must be handled with full confidentiality.
Any information that might directly or indirectly indicate the performance of a single laboratory must not be
shared, except with accrediting bodies when and as required. Information generated with the understanding
of voluntary participation cannot breach confidentiality,
including that with accrediting bodies. The ethics of
sharing information without the informed agreement
or understanding of participants should be resolved
through international debate.
The benefits of participation in PT for accredited and
non-accredited laboratories can be promoted by focusing
on education issues, e.g. by providing more easily understandable reports, on-going education, informative
and educational scheme designs, and explaining how
schemes may be part of a formal demonstration that laboratories tests are done properly. With emphasis on external QC and demonstrating improvements, and ensuring that laboratories not experience too much pressure,
participation will be experienced as a quality partnership
and an effective management tool. WG 6 mentioned that
there is no direct information on PT data from accreditation bodies or PT providers to laboratories customers,
and that these also need to be educated.

Metrological aspects of PT
Incorporating participants uncertainty statements
into PT schemes
With the requirements of ISO/IEC 17025 [6], there has
been renewed interest in estimating measurement uncertainty; this will lead to PT providers receiving uncertainty statements with the test results. Accreditation bodies
should encourage and assess the use of measurement uncertainty in PT schemes, to an extent relevant to the particular testing field. Some fields might already use allowances for uncertainty in the acceptance criteria, perhaps by having wider intervals than purely fitness for
purpose. Z-score limits of 3 are often quite wide relative to desired goal for accuracy. In certain fields of test-

ing uncertainty is not established or reported and they

will continue using existing approaches. In this case
there is no need for the provider to act. In fields where
uncertainty estimates are, or are becoming, established it
is necessary for schemes to begin incorporating them.
ISO Guide 431 [1] also requires consideration of the
uncertainty of the assigned value when reviewing data.
As a result, schemes in the testing area are likely to follow those in calibration, where coordinators are obliged
to gather information about uncertainty.
Measurement uncertainty is currently poorly understood by laboratories. Although many laboratories have
evaluated uncertainty for years, most do not know how to
report it, or report it differently from recommended procedures. There would be a necessary learning period before participants uncertainty statements can be properly
assessed and used by PT providers to evaluate laboratory
performance. There was concern that requesting this information now would generate much confusion and compromise the utility of current programs. But, because laboratories are required to estimate uncertainty, and because
PT schemes are an important tool for assisting improvement of the quality of these statements, providers should
offer a means of assessing the laboratories statements,
and prepare to incorporate them into the reports and, perhaps, their evaluations. Initially it is more important to
assist the laboratories with the fine-tuning of this part of
their activities, rather than to make rigid judgements on
suitability and validity. The first step would simply be to
gather statements and report them back to participants
with some kind of evaluation and/or educational material.
This would alert laboratories with highly inconsistent
statements. Later, comparison of uncertainty statements
with fitness for purpose criteria or with those of other
participants can be made. This could lead to broader understanding of appropriate estimates; this in turn leads to
goals for uncertainty, and then evaluations.
New statistical tools are necessary to include uncertainty
in the evaluation of participants results. These could be
similar to the En-number, or have a new form. A dialogue
with ISO TC 69 on ISO 13528 [7] was proposed. When
there is better agreement on uncertainty calculations and on
how accreditors want to see this applied, more detailed procedures can be developed. Evaluation could be based on
target values for uncertainties (TVUs). These are fixed criteria (expressed as expanded uncertainties) that are to be
met by the participants, and would be determined by a combination of consensus and research. TVUs are useful in legislation, as in the example of the EU directive on drinking
water [8], and schemes could benefit from this concept.
Assigned values and uncertainties of test materials for PT
Assigned values, i.e. the values serving as references in
the evaluation of the participants performance, are com-

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monly established from a consensus of participants results, or from measurements by selected laboratories outside the scheme. For a specific scheme the choice between the two approaches depends on, e.g., the number
of participants, the quality of participants results, the
traceability of assigned values (to a primary source), and
the confidence that can be put on the assigned values;
this might involve the definition of reference laboratory (also driven by participants acceptance). This means
that the assigned value (irrespective of the way it is obtained) and its uncertainty must be stated and demonstrated credible for every test item (WGs 2,5). The uncertainty of the assigned value must be small enough to
enable reliable comparison of participants results, and
small compared with the acceptance interval, so that laboratories are not graded unfairly. The information should
be available to participants requesting it, but reported only when necessary. The recommendations regarding use
of the assigned value uncertainty to determine the suitability of the test material in ISO Guide 431 should be
followed. The test samples used in PT are, by definition,
reference materials (RMs). Their homogeneity and stability must be demonstrable and adequate. These are important uncertainty components to be included in the uncertainty of the assigned value. Use of test samples as,
e.g., RMs or control samples after the end of a PT round
is possible provided they are stable, and many providers
distribute excess samples. Assigned values should not be
known beforehand by participants, because of the possibility that laboratories work towards them. This is one
reason for not using CRMs in PT. Limited availability
and costs also restrict such use. Assigned values, independent of the participants results, are not required
when the objective is only to establish degree of equivalence between participants. External (traceable) reference values (RVs) are, however, needed when conclusions about the accuracy of laboratories results are
drawn. Such RVs are also needed for long-term monitoring of results, something participants are not often interested in. In a limited number of cases the same test material can be used for comparisons of different metrological levels, e.g. routine level, for reference laboratories at

regional level, and in key comparisons between national

metrology institutes [9]. This is valuable but will be rare,
owing to cost. Overlapping of PT schemes is needed internationally for evaluation of their degree of equivalence.

International harmonization and mutual recognition

of PT schemes
Operation of PT schemes in different technical areas and
countries can be harmonized in terms of quality-management issues and data format for reporting. This does not
necessarily mean uniformity and different approaches
will still be needed in different technical areas (WG 6).
Merging of schemes in similar technical areas is possible. Networking and co-operation will provide more services to laboratories but practical problems are expected
in relation to language, to national legislation, and because some schemes might become too large. Comparisons of PT providers in similar technical areas can be
based on overlapping participation of laboratories in different schemes with feedback to providers. Data sets
could also be sent to providers for statistical analysis
(post-analytical QA), and accreditation will add complementary information. Providers have different philosophies concerning acceptance criteria but they offer an
opportunity of compare what laboratories declare and
what they are able to achieve. It is possible that laboratories join schemes where it is easier to get a satisfactory
score, but accreditation bodies should prove that laboratories meet targets, where possible, and ensure a level
playing field.
Internationally recognized PT schemes and the mutual
recognition of national schemes help to underpin international trade, particularly where large economic interests
are involved and an international benchmark is required
(WGs 2, 7). This assumes that the standards for accreditation are also recognized (WG 2). Participation in mandatory schemes specified by national Governments can,
however, restrain trade if schemes of equivalent or better
technical content and quality also exist in other countries.

References
1. ISO/IEC Guide 43 (1997), Part 1: Proficiency Testing by Interlaboratory Comparison Development and Operation
of Proficiency Testing Schemes, Part 2:
Selection and Use of Proficiency Testing
Schemes by Laboratory Accreditation
Bodies
2. ILAC-G13 (2000), Guidelines for the
Requirements for the Competence of
Providers of Proficiency Testing
Schemes

3. European Information System on Proficiency Testing Schemes (2000),

www.eptis.bam.de
4. Cortez L, (2001), Accred Qual Assur, in
press
5. Lawn RE, Thompson M, Walker RF
(1997), Proficiency Testing in Analytical Chemistry, published for the LGC
(Teddington) by the Royal Society of
Chemistry, ISBN 085404329
6. ISO/IEC Guide 17025 (1999), General
Requirements for the Competence of

Testing and Calibration Laboratories,

ISO, Geneva, Switzerland
7. Draft ISO 13528 (2000), Statistical
Methods for Use in Proficiency Testing
by Interlaboratory Comparisons
8. Council Directive 98/83/EC (1998) on
the Quality of Water Intended for Human
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