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Opinion Paper
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.
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.