Constitution of a national group of external quality assesment for the hospitals control laboratories

C. Merienne (Lyon - France)

The technical performances of the analytical methods used by our quality control laboratories can be assessed by three parameters: repeatability, trueness bias and the stability of the measure. These parameters can be evaluated through a well-conducted validation protocol during the method development. The bias of laboratory and the stability of the measure can be reevaluated periodically using reference standards. However, when they exist, these reference standards rarely correspond in form and composition to the hospital-compounded medicines. Therefore, external quality assessment by interlaboratory comparison can be an efficient tool for performance management. We present here the constitution of a working group whose aim is to allow inter-laboratories comparison for hospital pharmacies.
Formed in 2020 during the COVID19 sanitary crisis, this group of external quality assessment is currently comprised of about ten quality control laboratories. It offers to perform campaigns of inter-laboratory comparisons of quantitative analysis methods used for quality control of pharmaceuticals preparations. The quality control campaign are currently performed twice a year, coordinated by one or two volunteer laboratories. During each campaign, the blinded centers received 5 samples of a quality control preparation to be analysed. Two meeting are organized for each campaign: one for the compound and preparation selection, the other for the restitution of the results. A full detailed report, including statistical analysis results and control charts, is presented for each participant.
The inter-laboratory comparison allows us to compare our results, but more importantly it offers a periodic evaluation, independent and objective about the quality of our daily measures. The analysis of the results allows feedback for technical ameliorations. Finally, the meetings offer a convenient way to share information between laboratories.
There are three mains limits to the deployment of the external quality assessment in our hospital quality controls laboratories. The first one is linked to the heterogeneity of our preparation, which does not enable easy selection of the analytical method to compare. The second limit is related to the differences in equipment in our laboratories, which must be taken into account when selecting the preparation and interpreting the results obtained by different analytical processes. Finally, despite the number of laboratories participating today being is high, it is still insufficient to reach a statistical significant threshold (N > 30). Thereby, the recruitment for the next campaign of inter-laboratory comparison is opened.
The fourth campaign will focus on the quantitative measures of spironolactone in liquid suspension and in solid oral form. It will take place between the 17th and the 29th of October 2022, and will be coordinated by the Clermont-Ferrand and Bordeaux university hospitals. To take part in this campaign, you can contact: ; and

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