Implementation of a quality management system in a central sterilization unit: experience in the Hospital Tahar Sfar, Mandia, Tunisia

In Tunisia, Hospital sterilization guidelines recommend the establishment of a quality assurance system. The purpose of this study is to give an overview of the situation in a sterilization unit in order to assess the adherence to good practice criteria and to identify opportunities for improvement. We conducted a prospective study in the sterilization unit of the Hospital Tahar Sfar, Mandia in 2019. Two internal audits were conducted under the same conditions and were carried out one year apart. The first audit identified failures and malfunctions and the outlining of an action plan. The impact of the measures undertaken was tested using a second audit. Data collection was carried out by direct observation of the existing resources and practices. Compliance rate was calculated taking into account compliant criteria and applicable criteria. The results of the first audit revealed a compliance rate of around 28.1%. The analysis used to observe deviations made it possible to identify 5 axes of improvement, in particular the implementation of a system of documentation and a quality management system. In total, we prepared 14 documents related to the managerial processes, 26 to the operational processes and 41 to the support processes. The actions put in place enabled to achieve a compliance rate of 60.4%. The approach taken to upgrade sterilization processes made it possible to standardize them while ensuring traceability.