Lombet, LouiseDuvivier, FranceSoumoy, LauraJoris, EmilieEmilieJoris2025-05-142025-05-142025-05-142024https://hdl.handle.net/2078.2/41074Background: By 2026, all hospitals in Belgium will be required by law to comply with PIC's 010-04 standards, so that controlled atmosphere areas maintain sterility for patient safety. The presence of microbes, whether pathogenic or not, represents significant risks to the sterility medical preparations. Objectives: The aim of this study was to design a strategy for implementing microbiological controls at Namur’s CHU UCL. It involved i) the analysis of financial and operational options to engage stakeholders, ii) the evaluation of PIC’s standards' financial impacts on CHU UCL Namur pharmacies and iii) the development of clear procedures and training tools. Methodology: The study used three risk assessment methods: FMECA, spaghetti diagrams and Ishikawa diagrams to identify points at risk of contamination and weaknesses in the circuit. A financial analysis considered criteria such as the comparison of culture media suppliers, the evaluation of incubation scenarios, and the determination of microbiological controls required in each controlled-atmosphere zone. Results: The analysis identified a total of 50 risks : 8 are considered high risks and 32 moderate risks. Sampling points for microbiological testing were strategically determined based on Ishikawa and spaghetti diagrams and considering airflow dynamics. Following an in-depth financial analysis, the ‘Incubation by each pharmacy’ approach was chosen, although it requires around 1 additional FTEs, all functions combined. The estimated annual costs associated with this strategy were €150 725 for the institution. Conclusion: Complying with PIC's standards represents a significant challenge for Belgian hospitals as the deadline approaches. The results obtained in this study can be transposed to other Belgian hospitals. However, these results are the expression of arbitrary thinking, which have not yet been applied in practice, and that adaptations will have to be made for each establishment. Following this work, a trend analysis could be carried out and monitoring frequencies adapted according to the results obtained.contrôles microbiologiqueZACPIC'stext::thesis::master thesisthesis:45877