Objectives: As a result of an adverse event detected at the Radiotherapy Treatment Unit, a safety improvement project was undertaken to analyze and eliminate risks and thus increase patient safety. Material and method: Failure Mode and Effects Analysis (FMEA), an analytical tool used in many US hospitals, was applied. As required by FMEA, risks of potential failure modes were quantified on a scale of 1 to 1000, using the Risk Priority Number (RPN). In the first improvement phase, an RPN value greater than 100 was considered to be the limit above which corrective actions should be taken. Several potential failure modes were detected in existing treatment protocols and all the causes of potential failure modes were eliminated through corrective actions that included redefinition of treatment protocols, the creation of new records for existing controls and the addition of new controls, checklists, and internal audits, among other measures. Subsequently, a quality management system based on ISO9001 was introduced. Process indicators were defined to measure treatment quality, and the results were analyzed on a monthly basis with top management participation. Results: A total of 100 improvement actions were taken. The RPN values calculated after the implementation of the actions were significantly lower, increasing patient safety. The actions taken ensure the maintenance of the achieved safety levels. Conclusions: The experience shows that the risks present in all steps taken can be objectively identified. Through improved procedures, the limited resources available can be allocated to those processes or activities that pose maximum risk.
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