An a priori analysis of the risks on the manufacturing process of customized parenteral nutrition bags (NP) at the Rennes University Hospital

9 October 2015

L. Ruesche1, P-N. Boivin1, M-A. Lester1, S. Morille2, P. Le Corre1 1 Pharmacotechnie, Pôle Pharmacie
2 Direction Qualité et Relations Usagers
CHU de Rennes, 2 Rue Henri le Guilloux, 35000 Rennes, France

The manufacturing of customized parenteral pediatric nutrition bags is performed by the Pharmacy Department (PUI) at the Rennes University Hospital. This high-risk process requires a complete control to prevent the occurrence of serious adverse events. Following the acquisition of BAXA EM2400 automaton (Baxter Corporation), an analysis on the whole process was conducted to identify the new risks and to estimate the security barriers which need to be set up.

The analytical grid was elaborated by means of an institutional model, given by the Quality and User Relationship Direction. For each step of the process, risks and their causes were detailed, as well as barriers which now exist or have to be implemented. To calculate initial criticality (Cri), occurrence frequency and associated gravity were graded for each identified risk. The level of control was also graded, to calculate the balanced criticality (Crp).

To realize this analysis, the various actors involved in NP mixtures manufacturing were requested: pharmaceutical assistants, pharmacists and agents.

This process analysis allowed to highlight steps for which the risk level is not controlled enough (Crp score of 48 or more): prescription and its transcription by the pharmacist, decontamination of material prior to the entrance in the controlled atmosphere area (ZAC), installation and assembly on the automaton, packaging of NP bags and the final controls of the preparation.

This works allows to show that each step includes at least one event for which criticality can be at a high level. This makes it possible to bring out priority improvement axes in order to secure the manufacturing process : staff training, computerization of the prescription, more efficient analytical controls, audit of the pratices.

The imminent implementation of new monitoring indicators will allow to see the evolution of the securing of the process.

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