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Clin Chem Lab Med 2017; 55(6): 806808

Opinion Paper

Kristin M. Aakrea,*, Wytze P. Oosterhuisa, Shivani Misraa, Michel R. Langloisa,


Watine Josepha, Patrick J. Twomeya and Julian H. Bartha

Could accreditation bodies facilitate the


implementation of medical guidelines in
laboratories?
DOI 10.1515/cclm-2016-0577 Laboratory medicine is an integrated part of all clinical
Received June 30, 2016; accepted September 28, 2016; previously disciplines. This is reflected in the fact that most clinical
published online November 7, 2016 practice guidelines (CPG) include some recommendations
on the different aspects of laboratory tests. The inclusion
Abstract: Several studies have shown that recommendations
of recommendations regarding analytical performance
related to how laboratory testing should be performed and
goals in CPG can influence the analytical performance of
results interpreted are limited in medical guidelines and
CE marked assays, as evidenced by the changes in accept-
that the uptake and implementation of the recommenda-
able precision for the measurement of HbA1c and troponins
tions that are available need improvement. The EFLM/UEMS
leading to major improvement in the analytical perfor-
Working Group on Guidelines conducted a survey amongst
mance of these assays. However, CPG often include limited
the national societies for clinical chemistry in Europe regard-
or incomplete information regarding the laboratory tests
ing development of laboratory-related guidelines. The results
that are being recommended [1, 2]. This is challenging, as
showed that most countries have guidelines that are specifi-
increased knowledge about all the aspects of the recom-
cally related to laboratory testing; however, not all countries
mended laboratory tests (diagnostic value, interferences,
have a formal procedure for accepting such guidelines and
pre-analytical conditions, etc.) is likely to prevent labora-
few countries have guideline committees. Based on this, the
tory related errors and to facilitate correct use and inter-
EFLM/UEMS Working Group on Guidelines conclude that
pretation of test results. A previous study performed by
there is still room for improvement regarding these processes
the EFLM Working Group (WG) on Guidelines has shown
in Europe and raise the question if the accreditation bodies
that the involvement of laboratory specialists in the guide-
could be a facilitator for an improvement.
line development process improved the description of lab-
Keywords: accreditation; clinical chemistry; clinical oratory tests utilised in CPG [1]. There is therefore a need
practice; ISO standard; laboratory medicine; national for specific laboratory guidelines in Europe.
societies. The EFLM/UEMS WG on Guidelines undertook a short
European survey to investigate the number of available
a
The European Federation of Clinical Chemistry and Laboratory
laboratory related guidelines in Europe and the involve-
Medicine and European Union of Medical Specialists Joint Working
Group on Guidelines
ment of laboratory specialists in guideline development.
*Corresponding author: Kristin M. Aakre, Laboratory of Clinical The survey was sent to 41 National Societies for Laboratory
Biochemistry, Haukeland University Hospital, 5021 Bergen, Norway, Medicine in 40 countries, and 26 countries responded.
Phone: +47 55973188, Fax: +47 55975976, The results are shown in Table 1. Most countries
E-mail: kristin.moberg.aakre@helse-bergen.no have guidelines that are specifically related to laboratory
Wytze P. Oosterhuis: Department of Clinical Chemistry, Zuyderland
testing; however, not all countries have a procedure for
Medical Centre, Heerlen, The Netherlands
Shivani Misra: Diabetes, Endocrinology and Metabolism, St Marys accepting such guidelines. Few countries have procedures
Hospital, Imperial College London, UK for developing guidelines or guideline committees and
Michel R. Langlois: Department of Laboratory Medicine, AZ St-Jan working groups for guidelines and very few use guidelines
Hospital, Bruges, Belgium with recommendations for guideline development when
Watine Joseph: Laboratoire de Biologie Polyvalente, Hpital de la
they conduct such work.
Chartreuse, Villefranche-de-Rouergue, France
Patrick J. Twomey: Department of Clinical Chemistry, St. Vincents
Our survey has highlighted two issues. First, the lack
University Hospital, Dublin, Ireland of national professionally driven procedures to aid devel-
Julian H. Barth: Blood Sciences, Leeds General Infirmary, Leeds, UK opment of national guidelines, and second, the lack of

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Aakre etal.: Could accreditation bodies facilitate guideline implementation?807

Table 1:The results of the European survey on guideline development.

Yes, n (%) No, n (%)

Are there any guidelines developed by your society or another organisation that are aimed 17 (65) 9 (35)
specifically to the activities of the laboratory, and of laboratory professionals? (n=26)
If the answer is yes, and there are guidelines, is there a procedure to officially accept 14 (78) 4 (22)
guidelines? This could be by plenary voting, or voting within the board of the society, or other
procedure that would lead to support of your society of these guidelines? (n=18)
Does your society have a procedure to develop guidelines? This might involve a procedure to 8 (31) 18 (69)
select interesting topics, and installation of working groups to develop the guidelines. (n=26)
Does your society have (or use) a guideline for guidelines? This is a guideline with 3 (13) 20 (87)
recommendations how to develop evidence based guidelines. (n=23)
Does your society have a guidelines committee or working group? (n=26) 7 (27) 19 (73)

mechanisms for recommending the adoption of guidelines define the needs of users. As ISO 15189 currently stands,
that have been prepared in other countries. These issues it might be up to the laboratory itself to define if the need
are important, as guidelines have the potential to improve of the users is fulfilled. As a result, the ISO 15189 accredi-
health outcomes. The actual benefit will differ between tation standards are sometimes criticised for having no
countries depending on populations, disease preva- clinical significance [46].
lence and laboratory resources. These latter factors will, High-quality, evidence-based medical guidelines
however, not justify disregarding guidelines but might be justify their recommendations either by scientific evidence
an explanation for their selective implementation. Since or expert consensus. The EFLM/UEMS WG Guidelines
the process of accreditation is increasingly undertaken believe that closer integration between ISO standards and
in Europe, it is worth considering if the addition of a medical guidelines might be advantageous both to facili-
standard related to guideline uptake in the accreditation tate laboratories engagement in clinical activities and to
process would facilitate the implementation of medical make the ISO standards more clinically focussed. However,
guidelines in laboratories? it should be noted that although different medical guide-
There are large differences between medical guide- lines may evaluate the same evidence base, concluding rec-
lines and ISO standards. The ISO standards are purely ommendations may be vastly different [7, 8]. Consequently,
based on consensus, and despite the considerable the national professional societies or clinical laboratories
resources required for accreditation, its effect on clinical may need to provide their own interpretation and choose
outcomes and health-care economic benefits has not, to between different sets of advice. In such cases, one should
our knowledge, been documented. ISO 15189 essentially not only focus on the operational quality of the testing pro-
covers the laboratorys management and working pro- cesses but also on medical quality (clinical added value) of
cesses: a medical laboratorys fulfillment of the require- the tests. The EFLM WG Test Evaluation proposed a cycli-
ments of this International Standard means the laboratory cal framework for the evaluation of essential components
meets both the technical competence requirements and of quality of laboratory assays such as analytical perfor-
the management system requirements that are necessary mance, clinical performance, clinical and cost-effectiveness
for it to consistently deliver technically valid results [3]. of a biomarker to becoming a medically useful test [9]. The
Thus, ISO standard 15189 does give specific recommenda- EFLM WG of Guidelines has earlier proposed a checklist for
tions regarding the laboratories internal procedures and laboratory test evaluation in clinical practice guidelines [1]
documentation of these. It further states that the labo- that might be helpful.
ratory should fulfill the needs of users, but provides Whilst medical guidelines themselves should not
no specific direction regarding this be it pre-analytical be included in the ISO standards, it is our recommenda-
(e.g. which tests should be available for given clinical tion that the clinical relevance of the standards would
situations), analytical (e.g. what the required analytical be strengthened by the inclusion of sections describ-
quality standards are in given clinical situations) or post- ing the different aspects of GL implementation by lab-
analytical (e.g. the clinical utilisation and interpretation oratories with respect to (national and international)
of test results). Since the ISO 15189 document is utilised medical guidelines providing recommendations on
internationally, specific advice might not be expedient; laboratory testing. We would also advise that countries
however, the standard could then advise the laboratory to apply a formal process for guidelines assessment prior to
use local or international guidelines that may objectively implementation.

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808Aakre etal.: Could accreditation bodies facilitate guideline implementation?

Author contributions: All the authors have accepted c linical practice guidelines and consensus documents needs to
responsibility for the entire content of this submitted be improved. Clin Chim Acta 2014;437:5861.
3. ISO15198. https://wwwisoorg/obp/ui/#iso:std:iso:15189:ed-
manuscript and approved submission.
3:v2:en. Accessed March 2016.
Research funding: None declared. 4. Mumford V, Forde K, Greenfield D, Hinchcliff R, Braithwaite J.
Employment or leadership: None declared. Health services accreditation: what is the evidence that the ben-
Honorarium: None declared. efits justify the costs? Int J Qual Health Care 2013;25:60620.
Competing interests: The funding organization(s) played 5. Burnett D. ISO standards for pathology a step too far? Ann Clin
Biochem 2015;52(Pt 6):7124.
no role in the study design; in the collection, analysis, and
6. Bivre PD. Does accreditation ensure competence in measure-
interpretation of data; in the writing of the report; or in the
ment? Accred Qual Assur 2011;16:12.
decision to submit the report for publication. 7. Aakre KM, Watine J, Bunting PS, Sandberg S, Oosterhuis WP.
Self-monitoring of blood glucose in patients with diabetes who
do not use insulinare guidelines evidence-based? Diabet Med
2012;29:122636.
References 8. Watine J, Friedberg B, Nagy E, Onody R, Oosterhuis W, Bunting
PS, etal. Conflict between guideline methodologic quality and
1. Aakre KM, Langlois MR, Watine J, Barth JH, Baum H, Collinson P, recommendation validity: a potential problem for practitioners.
etal. Critical review of laboratory investigations in clinical prac- Clin Chem 2006;52:6572.
tice guidelines: proposals for the description of investigation. 9. Horvath AR, Lord SJ, StJohn A, Sandberg S, Cobbaert CM,
Clin Chem Lab Med 2013;51:121726. LorenzS, etal. From biomarkers to medical tests: the
2. Aakre KM, Langlois MR, Barth JH, Misra S, Watine J, Oosterhuis changing landscape of test evaluation. Clin Chim Acta
WP. The quality of laboratory aspects of troponin testing in 2014;427:4957.

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