Laboratory medicine is an integrated part of all clinical disciplines. This is reflected in the fact that most clinical practice guidelines (CPG) include some recommendations on the different aspects of laboratory tests. The inclusion of recommendations regarding analytical performance goals in CPG can influence the analytical performance of CE marked assays, as evidenced by the changes in acceptable precision for the measurement of HbA1c and troponins leading to major improvement in the analytical performance of these assays. However, CPG often include limited or incomplete information regarding the laboratory tests that are being recommended , . This is challenging, as increased knowledge about all the aspects of the recommended laboratory tests (diagnostic value, interferences, pre-analytical conditions, etc.) is likely to prevent laboratory related errors and to facilitate correct use and interpretation of test results. A previous study performed by the EFLM Working Group (WG) on Guidelines has shown that the involvement of laboratory specialists in the guideline development process improved the description of laboratory tests utilised in CPG . There is therefore a need for specific laboratory guidelines in Europe.
The EFLM/UEMS WG on Guidelines undertook a short European survey to investigate the number of available laboratory related guidelines in Europe and the involvement of laboratory specialists in guideline development. The survey was sent to 41 National Societies for Laboratory Medicine in 40 countries, and 26 countries responded.
The results are shown in Table 1. Most countries have guidelines that are specifically related to laboratory testing; however, not all countries have a procedure for accepting such guidelines. Few countries have procedures for developing guidelines or guideline committees and working groups for guidelines and very few use guidelines with recommendations for guideline development when they conduct such work.
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 specifically to the activities of the laboratory, and of laboratory professionals? (n=26)||17 (65)||9 (35)|
|If the answer is yes, and there are guidelines, is there a procedure to officially accept 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)||14 (78)||4 (22)|
|Does your society have a procedure to develop guidelines? This might involve a procedure to select interesting topics, and installation of working groups to develop the guidelines. (n=26)||8 (31)||18 (69)|
|Does your society have (or use) a “guideline for guidelines”? This is a guideline with recommendations how to develop evidence based guidelines. (n=23)||3 (13)||20 (87)|
|Does your society have a guidelines committee or working group? (n=26)||7 (27)||19 (73)|
Our survey has highlighted two issues. First, the lack of national professionally driven procedures to aid development of national guidelines, and second, the lack of mechanisms for recommending the adoption of guidelines that have been prepared in other countries. These issues are important, as guidelines have the potential to improve health outcomes. The actual benefit will differ between countries depending on populations, disease prevalence and laboratory resources. These latter factors will, however, not justify disregarding guidelines but might be an explanation for their selective implementation. Since the process of accreditation is increasingly undertaken in Europe, it is worth considering if the addition of a standard related to guideline uptake in the accreditation process would facilitate the implementation of medical guidelines in laboratories?
There are large differences between medical guidelines and ISO standards. The ISO standards are purely based on consensus, and despite the considerable resources required for accreditation, its effect on clinical outcomes and health-care economic benefits has not, to our knowledge, been documented. ISO 15189 essentially covers the laboratory’s management and working processes: “a medical laboratory’s fulfillment of the requirements of this International Standard means the laboratory meets both the technical competence requirements and the management system requirements that are necessary for it to consistently deliver technically valid results” . Thus, ISO standard 15189 does give specific recommendations regarding the laboratories internal procedures and documentation of these. It further states that the laboratory should “fulfill the needs of users”, but provides no specific direction regarding this be it pre-analytical (e.g. which tests should be available for given clinical situations), analytical (e.g. what the required analytical quality standards are in given clinical situations) or post-analytical (e.g. the clinical utilisation and interpretation of test results). Since the ISO 15189 document is utilised internationally, specific advice might not be expedient; however, the standard could then advise the laboratory to use local or international guidelines that may objectively define “the needs of users”. As ISO 15189 currently stands, it might be up to the laboratory itself to define if the “need of the users” is fulfilled. As a result, the ISO 15189 accreditation standards are sometimes criticised for having no clinical significance , , .
High-quality, evidence-based medical guidelines justify their recommendations either by scientific evidence or expert consensus. The EFLM/UEMS WG Guidelines believe that closer integration between ISO standards and medical guidelines might be advantageous both to facilitate laboratories engagement in clinical activities and to make the ISO standards more clinically focussed. However, it should be noted that although different medical guidelines may evaluate the same evidence base, concluding recommendations may be vastly different , . Consequently, the national professional societies or clinical laboratories may need to provide their own interpretation and choose between different sets of advice. In such cases, one should not only focus on the operational quality of the testing processes but also on medical quality (clinical added value) of the tests. The EFLM WG Test Evaluation proposed a cyclical framework for the evaluation of essential components of quality of laboratory assays such as analytical performance, clinical performance, clinical and cost-effectiveness of a biomarker to becoming a medically useful test . The EFLM WG of Guidelines has earlier proposed a checklist for laboratory test evaluation in clinical practice guidelines  that might be helpful.
Whilst medical guidelines themselves should not be included in the ISO standards, it is our recommendation that the clinical relevance of the standards would be strengthened by the inclusion of sections describing the different aspects of GL implementation by laboratories with respect to (national and international) medical guidelines providing recommendations on laboratory testing. We would also advise that countries apply a formal process for guidelines assessment prior to implementation.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
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