WHO European Guidance on Standards for Infectious Disease Laboratories

Good quality laboratory results are required to support diagnosis of disease, to monitor the effectiveness of treatment and to support the safe use of blood. In addition, the results are used for epidemiological purposes and to provide early warning of the outbreak of disease, not only at a national level but also in the context of the International Health Regulation 2005 (IHR). All laboratory activities are subject to errors and the purpose of quality monitoring and the introduction of standards is to reduce errors to a minimum and reduce the impact that such errors have on the variability of test results. The effect should be increasing confidence shown by users of the service in the reliability of the results.

WHO has published this guidance for developing standards that are intended to prompt discussion and policy decisions on how basic standards for all laboratories receiving biological samples from patients may be introduced and implemented. It is intended to be an opportunity for introducing standards in those countries that have yet to do so. If adopted they could be used to support the introduction of accreditation or licensing systems with which all practising medical laboratories must comply.

One of the objectives is that for any individual result it should be possible to establish all activities and products or materials that will have influenced the result (traceability). If successfully implemented by countries, WHO could be assured that data from compliant laboratories meet minimum quality standards and trust the results used in the context of IHR.