Accred Qual Assur
DOI 10.1007/s00769-009-0630-8
REVIEW
Strategies to set global analytical quality specifications
in laboratory medicine: 10 years on from the Stockholm
consensus conference
Per Hyltoft Petersen • Callum G. Fraser
Received: 29 October 2009 / Accepted: 23 December 2009

Springer-Verlag 2010
Abstract The setting of analytical quality specifications
in laboratory medicine has attracted attention for many
years. Over time, many strategies were advocated and all
had advantages and disadvantages. In the final decade of
the last millennium, considerable confusion existed on
how to define analytical quality specifications correctly
and how to apply them in everyday practice. This led to
wide professional interest. In 1999, a consensus conference
sponsored by IUPAC, IFCC and WHO was held in
Stockholm on ‘‘Strategies to Set Global Analytical Quality
Specifications in Laboratory Medicine’’. The consensus set
useful and well-documented strategies for the setting of
analytical quality specifications into a hierarchy with the
best strategy at the highest level, namely, (1) Evaluation of
the effect of analytical performance on clinical outcomes in
specific clinical situations, (2) Evaluation of the effect of
analytical performance on clinical decisions in general, (3)
Published professional recommendations, (4) Performance
goals set by regulatory bodies and EQAS organisers, and
(5) Goals based on the current state of the art. Much
success has been achieved since the promulgation of the
statement with the approach being adopted by many in
P. H. Petersen (&)
Norwegian Quality Improvement of Primary Care Laboratories,
NOKLUS, Division for General Practice, University of Bergen,
Box 6165, 5892 Bergen, Norway
e-mail: Per.Petersen@isf.uib.no
C. G. Fraser
Scottish Bowel Screening Centre Laboratory, Kings Cross,
Dundee, Scotland, UK
P. H. Petersen
Flittig Lise Vej 20, 5250 Odense SV, Denmark
laboratory medicine for a very wide variety of purposes,
particularly in quality management. However, there is a
requirement for additional investigation of, inter alia,
quality specifications for examinations done on measure-
ments performed on ordinal and nominal scales, pre-
analytical factors and matrix effects, examinations done as
POCT, target values of control materials, and ways in
which analytical quality specifications can be used both to
set what is the optimum performance and as a tool for
assessment of everyday practice.
Keywords Analytical bias and imprecision

Analytical goals
Analytical requirements

Laboratory medicine
Matrix effects
Point-of-care-testing
Introduction
Over the last decade, since the landmark international
consensus conference on ‘‘Strategies to Set Global Ana-
lytical Quality Specifications in Laboratory Medicine’’
held in Stockholm [1], there has been wide introduction of
national accreditation in laboratory medicine, generally
based on ISO 15189 [2]. The basis for all such accredita-
tion is a robust quality management system that sets
standards for each and every aspect of the organisation,
management and delivery of a quality laboratory medicine
service. However, before a decision can be made on
whether or otherwise a quality service is being delivered, it
is obligatory for the standards to be precisely defined.
While it is widely stated that current methodology and
technology allow the delivery of laboratory data that are of
more than sufficient quality to meet clinical needs, there is
considerable evidence that this is not the case [3]. It is
therefore vital that objectively set numerical quality
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specifications for the reliability performance characteristics
of examinations in laboratory medicine are laid down so
that satisfactory methodology can be adopted and applied.
It is pointless undertaking quality control, assessment and
assurance unless the quality required has been defined
a priori. In this paper, the background to the 1999 con-
sensus conference, the results of the conference that did so
much to publicise objective approaches to the setting of
analytical quality specifications, and the achievements or
otherwise are discussed and ways forward suggested.
Background
The setting of numerical analytical quality specifications,
also termed analytical goals, quality goals and analytical
performance goals, has been a subject of interest for a
considerable time. The concepts promulgated in the early
years has been discussed in detail previously [4, 5] and will
be simply summarised here.
The first attempt to delineate analytical quality specifi-
cations was that of Tonks [6] who suggested that the
allowable limits of error (ALE), often taken as twice the
analytical co-efficient of variation (CV), although clearly
more relevant to total laboratory error (imprecision plus
bias), could be calculated from the following formula:
ALE ¼ 2CV ¼ 0:25ðul  ll)=l
where l is the mean of the reference interval and ul is the
upper reference limit and ll is the lower reference limit of
the 0.95 reference interval. By multiplying CV by 100, the
coefficient of variation is transformed to percentage.
However, it should be noted that this quality specifica-
tion was advocated for analysis of performance in external
quality assessment schemes, not for judgement of indi-
vidual laboratory performance. Moreover, while similar
ideas were expressed by others [4, 5] and these clearly were
useful at the time, it became obvious that, since the ref-
erence interval is influenced by imprecision and bias, the
specifications derived was not independent of existing
performance and, in consequence, the approach became
considered outmoded.
This was followed by the publication of ‘‘medically
significant CV’’ by Barnett [7]. Analytical quality specifi-
cations were said to be derived from the opinions of
clinicians and laboratory specialists. These were sub-
jective. Similar work was done by others [4, 5], and this
included analysis of responses to clinical vignettes where a
change in results was used to derive a numerical quality
specification based on the median difference reported.
However, these studies were seriously flawed in that
the changes documented were considered to be due to
analytical imprecision alone, whereas they are due to
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Accred Qual Assur
pre-analytical and within-subject biological variation as
well: additionally, the probability with which clinical
decisions are made is not always based on the medians and
at P \ 0.05 as assumed by all those adopting this strategy.
Much information is available on the analytical ‘‘state of
the art’’ attained in laboratory medicine. These data were
used to set quality specifications in a variety of strategies
[4, 5] but are clearly less than ideal since the state of the art
represents what is achievable with the methodology and
technology used to derive the data and thus may not be
related to the quality that is actually required to facilitate
optimum clinical decision-making.
The concept that quality specifications could be derived
from numerical data on components of biological variation
was elaborated some 40 years ago [8, 9]. This idea was
adopted by the College of American Pathologists who
documented that, for group screening, the analytical CV
(CVA) should be less than half of the within-subject (CVI)
plus between subject (CVG) biological variation, that is,
CVA \ 0.5 (CV2I ? CV2G)0.5 and, for diagnosis and moni-
toring treatment, CVA \ 0.5 CVI. This approach has been
considerably refined since this original publication as is
described below.
After the publication of these original strategies for the
setting of analytical quality specifications, based on refer-
ence values, the opinions of clinicians and the components
of biological variation and, as methodology and technology
advanced and significant interest in quality management
developed, there was further more detailed work in the
setting of objective quality specifications for analytical
reliability performance characteristics.
Gowans et al. [10] explored the setting of quality
specifications for bias and suggested that, in order to be
able to use common reference intervals across geography,
the bias (B) had to be less than one-quarter of the group
biological variation, that is,

0:5
jBj\0:25 CV 2I þ CV 2G :
In addition, a group from the Nordic countries undertook a
series of detailed analyses of the effect of analytical
performance (imprecision and bias) on clinical outcomes in
very specific clinical situations and showed that it was more
than possible to set quality specifications whose achievement
would ensure optimal delivery of patient care [11, 12]. This
approach has been followed by some others since and an
excellent recent example is provided by Boyd and Bruns [13]
who derived quality specifications for glucose meters based
on simulation modeling of errors in insulin dose.
The idea that the opinions of users (both clinicians and
patients) of laboratory data can be used to derive objective
quality specifications through analysis of the numerical
changes that stimulate action was further explored in the
Accred Qual Assur

well designed and executed model studies of Sandberg and A real problem
colleagues [14, 15]. The group was convinced that quality
specifications derived from analysis of the effects of per- In spite of all the work done on approaches to setting
formance in specific and well-defined medical strategies analytical quality specifications for reliability performance
revealed the ideal basis for setting quality specifications. characteristics and the guidelines from international expert
Such conditions, however, are difficult to define and need groups, some very real problems remained near the end of
individual, and often complicated, models for evaluation of the last millennium.
the specifications; however, these may not be relevant for These included the following:
use of the same quantity in other clinical settings.
• there were, vide supra, many published recommenda-
Therefore, strategies based on formulae derived using
tions dating from 1963 onwards and it might be difficult
the components of biological variation were generally seen
for some professionals in laboratory medicine, unfa-
as the best for practical purposes and have been discussed
miliar with the details of these, to select the most
at many conferences, congresses and courses. In addition, a
appropriate,
number of professional groups including the EGE-Lab, the
• there continued to be further new recommendations
European Group for the Evaluation of Analytical Systems
published over time, again possibly causing difficulties
in Laboratory Medicine [16], and a number of the Working
in selection of the most appropriate strategy,
Groups of the European EQAS Organisers Groups [17, 18]
• data from examinations in laboratory medicine are used
supported the concepts.
in many different clinical situations, including diagnosis,
However, it was realised that there were some defi-
monitoring, screening, research, development, teaching
ciencies with the approaches, in particular that the
and training, and it might be that a single set of quality
biological variation for certain quantities was very small
specifications would be inappropriate for all of these,
and the quality specifications could not be met with
• some strongly advocated the hypothesis that neither
available methodology and technology; in addition, some
patients nor clinicians were harmed by current analyt-
quantities had large biological variation which led to
ical performance, so there was no reason to impose
quality specifications that were very easily attained. In
more stringent quality specifications, and
consequence, it was advocated [19] that a tiered approach
• it was not obvious that manufacturers of analytical
could be used to generate quality specifications for
systems and reagent kit sets used objective quality
imprecision, bias and total allowable error (TEa), that is,
specifications in development or marketing.
desirable quality specifications:
CV A \0:5 CV I :

0:5 A potential solution
jBj\0:25 CV 2I þ CV 2G

0:5
TEa\1:65  0:5 CV I : þ 0:25 CV 2I þ CV 2G In 1999, the Information for Authors of Clinical Chemistry
optimum quality specifications: was modified to state: ‘‘Analytical quality. Results obtained
for the performance characteristics should be compared
CV A \0:25 CV I :

0:5 objectively to well-documented quality specifications, e.g.,
jBj\0:125 CV 2I þ CV 2G published data on the state of the art, performance required

0:5 by regulatory bodies such as CLIA ‘88, or recommenda-
TEa\1:65  0:25 CV I : þ 0:125 CV 2I þ CV 2G
tions documented by expert professional groups’’.
minimum quality specifications: An Editorial [23] supporting this statement and giving
CV A \0:75 CV I : potential authors detailed advice on how to fulfil this

0:5 requirement was then published. This proposed that, at least
jBj\0:375 CV 2I þ CV 2G

0:5 for data reported on ratio (and difference) scales, an approach
TEa\1:65  0:75 CV I : þ 0:375 CV 2I þ CV 2G should be adopted that, like the types of evidence and grading
of recommendations used in clinical practice guidelines,
It should be noted that this approach is facilitated by
placed available and useful strategies in a hierarchy of
easy access to a data base on biological variation, regularly
objectivity, the best being first and the worst being last. The
updated by Ricos et al. [20]. Moreover, the applicability of
hierarchy suggested the following acceptable strategies:
such data is supported by the fact that, in chronic but stable
disease, the components of biological variation are not • assessment of the effect of analytical performance on
much different to those in health [21], which often can be clinical decision-making—quality specifications in spe-
considered as constant over time and geography [22]. cific clinical situations followed by

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 Accred Qual Assur

• general quality specifications based on medical needs, 1. Evaluation of the effect of analytical performance on
including, strategies based on biological variation, clinical outcomes in specific clinical situations
• professional recommendations and guidelines from 2. Evaluation of the effect of analytical performance on
national or international expert groups followed by clinical decisions in general
guidelines from expert individuals or institutional
a. Data based on the components of biological
groups,
variation
• quality specifications laid down by regulation or by
b. Data based on analysis of clinicians’ opinions
EQAS organisers—quality specifications laid down by
regulation followed by quality specifications laid down 3. Published professional recommendations
by EQAS organisers, and finally,
a. From national and international expert bodies
• published data on the state of the art from external
b. From expert local groups or individuals
quality assessment and proficiency testing schemes and
then from published methodology. 4. Performance goals set by
Around the same time, a Working Group of ISO TC 212 a. Regulatory bodies
undertook the task of preparing a Standard or Guide on how b. Organisers of External Quality Assessment (EQA)
to define and apply quality specifications. Eventually, in schemes
2001, TC 212/SC/WG 3 published ISO/TR 15196, a Tech-
5. Goals based on the current state of the art
nical Report (type 2) entitled ‘‘Determination of analytical
performance goals for laboratory procedures based on a. As demonstrated by data from EQA or Proficiency
medical requirements’’. This was not an ISO International Testing Schemes
Standard and was distributed for review and comment: it b. As found in current publications on methodology.
was noted that it was subject to change without notice and
When available, and when appropriate for the intended
may not be referred to as an International Standard. It is
purpose, models higher in the hierarchy are to be pre-
much regretted that this work does not appear to have been
ferred to those at lower levels. The concept of such a
progressed, since it supported the concepts in the Editorial in
hierarchy is described in a recent Clinical Chemistry
Clinical Chemistry and, indeed, expanded these somewhat
Editorial in which the relative merits of the above models
and generally concurred with the consensus statement
are discussed [23]. This hierarchy has also been proposed
reached at the consensus conference next described.
by the ISO/TC 212/WG3 subgroup on ‘‘performance
Goals Based on Medical Needs’’ as the basis for the
Strategies to set global analytical quality specifications ongoing ISO/CD 15196. The following matters were also
in laboratory medicine discussed and agreed:
• The above hierarchy includes currently available
The question of, and difficulties in, setting analytical
models; however, new useful concepts will undoubtedly
quality specifications in laboratory medicine was attracting
evolve. Implementation of any of the models should use
very wide international interest and, as a result, the
well-defined and described procedures.
Stockholm Consensus Conference on Quality Specifica-
• To facilitate the future debate on the setting on
tions in Laboratory Medicine, was organised in 1999. This
analytical quality specifications, there is a need for
was supported by the Clinical Chemistry Section of the
agreement on concepts, definitions and terms.
International Union of Pure and Applied Chemistry (IU-
• There is a need for continuous improvement in the
PAC), the International Federation of Clinical Chemistry
exchange of information on quality issues between
and Laboratory Medicine (IFCC) and the World Health
clinical laboratory professionals and the diagnostics
Organization (WHO). Professionals who had published in
industry, and between clinical laboratory services and
the field were invited to present their views and others
the users of the laboratory service.
involved in this facet of laboratory medicine also partici-
pated. The papers and the consensus statement were
published in a Special issue of the Scandinavian Journal of
Clinical and Laboratory Medicine [1]. Successes
The majority of the consensus statement is reproduced
here. This approach was very well received by professionals in
The main outcome of the conference was agreement that laboratory medicine at the time and, since its promulgation,
the following hierarchy of models should be used to set has been cited on many occasions and very widely applied,
analytical quality specifications. particularly in method selection and assessment,

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Accred Qual Assur
international, national and regional external quality
assessment scheme performance evaluation and other fac-
ets of quality management.
Moreover, it is pleasing to note that the majority of the
international and national professional bodies that develop
evidence-based guidelines, including IFCC and CLSI
(Clinical and Laboratory Standards Institute), now gener-
ally use the approaches based upon biological variation to
develop analytical quality specifications when these are
including in such works, the level 3 standards now being
developed using the level 2 strategy.
Interestingly, since 1999, there have been many pub-
lications on the generation of data on biological variation
for an ever expanding range of quantities of interest in
laboratory medicine [20]. Almost without exception,
these describe the setting of analytical quality specifica-
tions using the data generated as well as other
applications.
The rationale behind the need for analytical quality
specifications, the advantages and disadvantages of the
strategies in the hierarchy and ways in which these can be
applied in everyday practice have been detailed in a
monograph [22] and will not be addressed further.
However, two outstanding projects with publications
must attract particular attention. First a project on estab-
lishing common reference intervals for 25 common clinical
chemical quantities in a homogeneous Nordic population
across country borders where all elements of quality were
considered, including traceability of calibration standards
and external control of measurements according to quality
specifications for bias based on specifications for common
reference intervals, beside painstaking description of the
reference individuals [24]. Second, a report from the
National Institute of Standards and Technology (NIST) on
consequences of poor calibration and thereby analytical
bias on serum calcium, related to the increase in number of
extra laboratory examinations and other investigations
performed on patients or extra costs in USD for increasing
bias [25].
However, although these outcomes are very positive,
this does not mean that the consensus cannot be improved
upon with the passage of time and a number of issues
remain that require exploration by professionals in labo-
ratory medicine.
Examinations reported on ordinal and nominal scales
The vast majority of investigations on analytical quality
specifications have been concerned with quantitative
measurements on components measured in blood, serum or
plasma using ratio or difference scales and use those
derived from data on biological variation. These models
are usually based on parametric statistics with estimated
Gaussian or log-Gaussian distributions as described by
Ricos et al. [20]. These assumptions and models can easily
be extrapolated to quantitative quality specifications for
acceptable bias or acceptable imprecision. However, many
quantities in other matrices, including urine, are measured
on an ordinal scale where the result has an uncertainty: not
as a quantitative distribution, but simply as a dichotomy of
positive or negative results which can have large concen-
tration intervals in which both positive and negative results
can be correct. Here, the uncertainty is in a form where it
can be acceptable with, for example, 20% positive and 80%
negative results for a certain control material. How can
reliable quality specifications be outlined for this type of
examination?
Measurements performed on ordinal scales were dis-
cussed by Kouri et al. during the Stockholm Conference
[26]. They generally investigated dichotomously report-
able examinations (positive/negative, present/absent,
detected/not detected) and introduced quality specifica-
tions in the form of detection limit, defined as the
concentration for which the percentage of positive results
should be below a certain value, and confirmation limit,
defined as the concentration for which the percentage of
negative results should be below a certain value: the ratio
between these values should be 5. These proposals have
now been published in European Urinalysis Guidelines
[27]. Here, the group also investigated the more detailed
possible ordinal scale approach (negative, 1?, 2?, etc.),
but did not distinguish this from what are usually
described as semi-quantitative examinations, which actu-
ally have an underlying ratio scale which makes it
possible to standardise and control the examination. Later,
improved models described the characteristics of dichot-
omous tests [28] and semi-quantitative tests [29] which
made it relatively easy to describe performance variables
for, for example, different reagent kit sets whereby con-
trol of the different tests according to defined analytical
quality specifications could be derived. But the problem
remains as to how specifications for allowable deviations
of the results of examinations made on ordinal scales
should be defined?
Pre-analytical factors and matrix effects
Guder described the many pre-analytical factors which can
increase the variability of measurement results or change
the concentration or activity of a quantity, ranging from the
‘‘pre-analytical time’’, which is important when fast
delivery of results is needed to ‘‘influence of interfering
factors’’, which can be divided into in vivo and in vitro
influences [30]. Both can be reduced by painstaking
123

CoaguChek S, lot 568
Difference (%) Difference plot
CVMatrix = 7.9 % 30
CVA = 3.1 %
CV Total2 = 0 tions should be as for examinations done in other clinical
CV Matrix2 + CV A2
CV Total = 8.5 %
-30
Bias = – 15 % 0,5 1,5 2,5 3,5 4,5
Reference method (INR units)
Fig. 1 Difference plot illustrating the percentage difference between
a POCT INR method and a reference method as function of the
reference method. There is a mean bias of -15% and the dispersion
of points is CV = 0.085 (8.5%), which compared to the imprecision
of CV = 0.31, demonstrates a variation due to matrix-effects of
CV = 0.79. (Personal communication: Esther Jensen Department of
Clinical Biochemistry, Hillerød Hospital, Hillerød, Denmark)
standardisation of preparation of the patient for sampling
and proper handling of samples from the patient, but also
the stability of the quantity, choice of anticoagulant, con-
tamination (for example. from haemolysis, icterus or lipid)
may cause additional variation in the results of examina-
tions. How are these pre-analytical factors related to the
analytical quality specifications?
Differences in methods and reagents used may cause
individual but constant differences due to matrix effects,
which are reproducible, in contrast to imprecision. In these
cases, the differences in examinations done by the different
methods or with different reagents show a larger variance
than calculated from imprecision alone. This increase in
variation is thus related to the matrixes of samples and
reagents, but it is not disclosed by the usual variables of
bias and imprecision, estimated in traditional analytical
control. An obvious example is POCT instruments for
measurements of INR, where samples examined with dif-
ferent kits with different methods demonstrate a variation
which can be 2–3 times the coefficient of variation as
estimated as imprecision alone, as illustrated in the per-
centage difference-plot for two INR-methods shown in
Fig. 1. How should the allowable size of these matrix
effects be described and/or defined?
Point-of-care-testing
For point-of-care-testing (POCT), the analytical results can
be obtained in a short time after sampling and, when
examination is performed by the patient, the result is
available almost instantly. This saves time, whereby a
change in the concentration of the quantity can be imme-
diately apparent and treatment initiated promptly, for
example a fall in plasma glucose concentration, compared
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Accred Qual Assur
to the time needed to get phlebotomy, transport the sample
to the laboratory, perform the examination, and report back
the result. Although it has been cogently argued that the
analytical quality specifications required in POCT situa-
situations and these should best be based on data on bio-
logical variation [31], the gain from speediness is obvious.
5,5 The question remains: can the requirement for low turn-
around time speed modify the analytical quality
specifications for a quantity?
Target values of control materials
According to International Vocabulary of Metrology, VIM
[32], measurements performed with analytical methods,
which in clinical chemistry usually means reagent kit sets,
should be traceable to a ‘true’ concentration value, defined
by method or international reference preparation, and for
each kit an uncertainty should be stated. This is an ideal,
which should result in examinations of the same control
sample within a narrow range around the ‘true’ value.
This, however, is not achieved in clinical chemistry,
where kits from different manufacturers reveal different
results for the same control material, which is specific for
the individual kit. Moreover, these method biases may be
persistent for years. For example, the control results for
serum TSH show permanent individual bias for the five
dominating kits on the European market over a 5- year
period from 2000 to 2005, as extracted from the results
from the external quality assessment scheme performed by
the ‘‘Deutsche Gesellschaft für Klinische Chemie’’ where
the biases are constant and cover a range of 30% [33]. In
many EQA schemes, so-called peer group target values
are calculated as the mean of control results for a single
kit, and this may simply lead to confusion, especially
when the same EQAS organiser uses two models for the
analysis of results in a single scheme. The acceptable bias
should in principle be estimated from a ‘true’ concentra-
tion but, in laboratory practice, reference intervals and
decision limits are often based on the biased standardi-
sation and, consequently, the allowable bias should be
validated according to the local use. This is not an ideal
solution but, as long as kits for clinical chemistry reveal
permanent bias in their standardisation, it is important to
distinguish between ‘‘true’’ target values and peer group
means in validation in EQAS where a laboratory can have
good performance but a permanent bias due to a poor kit.
A proposal for separating kit bias from performer bias is
to present the results in an x–y plot with performer
deviation as function of kit bias, e.g. as illustrated in
Fig. 2. How can the problem be solved until kit producers
deliver error free methods?
Accred Qual Assur
8 and developing countries where the requirements could
Acceptable
Deviation from peer-group mean
7 evolve at different tempo in a two-tier coordination. Is it
6 bias
5
4
(µmol/L)
3
2
1 specifications and the level of power for obtaining the
0
-1
-2
-3
-4
-4 -3 -2 -1 0 1 2 3 4
Peer-group bias (µmol/L)
Fig. 2 Illustration of the two aspects of bias (validation of method
and validation of participant). Example on S-Transferrin. The mean
peer-group bias is shown on the abscissa with confidence interval and
the laboratory deviation from the peer group mean is shown on the
ordinate together with the dispersion of results from the same peer-
group. The example illustrates a good performer (result within
acceptable performance) using a method with bias (peer-group mean
outside the acceptable bias)
A ‘two-tier’ approach to analytical quality
specifications
A further important question to be solved is related to the
difference between desirable quality, as estimated from the
clinical or biological investigations from the highest levels
of the hierarchy agreed at the consensus conference and the
real practical world, where even the best methods and
performers sometimes are unable to attain this quality. This
question was addressed in the EGE-Lab publication on
quality specifications, where the idea was to set the spec-
ifications according to the 20% best performers until the
goal was obtained for all [16].
This idea can be elaborated if we distinguish between
the ideal—which can be called analytical performance
goals for acceptable bias, imprecision and matrix effects
based on the effect of variation of the clinical use of the
quantity or data on biological variation—and the analytical
performance requirements needed to attain either a ‘‘pass’’
in proficiency testing (PT) or ‘‘satisfactory’’ performance in
EQAS.
Such analytical performance requirements could evolve
in a stepwise manner with time as methodology and tech-
nology advanced and the analytical performance goals
became attainable, when the two-tier approach could col-
lapse to a single set of analytical quality specifications
based on a strategy high in the hierarchy, an idea advanced
some years ago [19]. This approach could also make it
possible to retain the same analytical quality specifications
which document the optimum analytical quality’ and at the
same time differentiate the requirements for rich nations
reasonable to distinguish between goals and requirements?
In all cases, performance standards should be decided
regarding internal control as well as external assessment or
proficiency testing in order to cope with analytical quality
Acceptable
performance
required quality should be defined. The quality managing
process should be performed at all levels of control in
planning, processing, control, assessment and improvement
[34] and with choice of the sigma level [35].
5 6 7 8 9 10 11 12
Conclusions
An objective assessment 10 years on from the Consensus
Conference on Strategies to Set Global Analytical Quality
Specifications in Laboratory Medicine, clearly demon-
strates that much success has been achieved with the
hierarchical approach being adopted by many in laboratory
medicine for a wide variety of purposes in laboratory
medicine, particularly in quality management. However,
the conference was not all encompassing, and there is a
need for further consideration of, and work on, inter alia,
quality specifications for examinations that generate
reports on ordinal and nominal scales, pre-analytical fac-
tors and matrix effects, examinations done as POCT, target
values of control materials and ways in which analytical
quality specifications can be used both to set not only what
is the optimum performance but also that will facilitate the
best patient care and as a tool for assessment of everyday
practice. We hope that professionals in laboratory medicine
will rise to these challenges and that this facet of the
discipline of laboratory medicine will continue to push
boundaries.
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