Implementation of the global risk analysis in pulsed-dose rate brachytherapy: methods and results.

PURPOSE: To report the application of the global risk analysis (GRA) in the pulsed-dose rate (PDR) brachytherapy workflow. MATERIAL AND METHODS: Analyses were led by a multidisciplinary working group established within the unit with the guidance of a quality engineer. First, a mapping of hazardous situations was developed as a result of interactions between the patient workflow for a treatment using PDR brachytherapy split into 51 sub-phases with a comprehensive list of the hazards that he/she faces (44). Interactions, when relevant, were sorted by level of priority: to be treated immediately, secondarily (the group is not entitled to treat the situation), or later (safe situation). Secondly, for each high priority dangerous situation, scenarios were developed to anticipate their potential consequences. Criticality was assessed, using likelihood and severity scales and a matrix, which allocated risks into categories: acceptable (C1), tolerable under control (C2) and unacceptable (C3). Then, corrective actions were proposed and planned when relevant, after assessment of their feasibility with a scale of effort. Finally, the criticality of the scenarios was reevaluated, taking into account the implementation of these actions, leading to a residual risk mapping, which could trigger additional proposals of actions. RESULTS: Two thousand one hundred and eighty-four potential interactions between the list of hazards and the workflow were analyzed. Mapping of dangerous situations identified 213 relevant interactions, from which 61 were considered with high priority. One hundred and twenty-six scenarios were generated: 68 with a low criticality (74.3%), 58 with an intermediate score (25.7%). No scenario with the highest criticality was individualized. Twenty-one corrective actions were planned. Mapping of residual risk resulted in the disappearance of most C2 risks, leaving 5 C2 scenarios (4%), for which four monitoring indicators were implemented in addition to the corrected actions decided on. CONCLUSION: The implementation of the GRA appeared feasible, and led to implement 21 corrective actions, based on scenarios and not on incidents.

[Risk analysis in radiation therapy: state of the art]. / Analyse des risques en radiothérapie: état des lieux.

Five radiotherapy accidents, from which two serial, occurred in France from 2003 to 2007, led the authorities to establish a roadmap for securing radiotherapy. By analogy with industrial processes, a technical decision form the French Nuclear Safety Authority in 2008 requires radiotherapy professionals to conduct analyzes of risks to patients. The process of risk analysis had been tested in three pilot centers, before the occurrence of accidents, with the creation of cells feedback. The regulation now requires all radiotherapy services to have similar structures to collect precursor events, incidents and accidents, to perform analyzes following rigorous methods and to initiate corrective actions. At the same time, it is also required to conduct analyzes a priori, less intuitive, and usually require the help of a quality engineer, with the aim of reducing risk. The progressive implementation of these devices is part of an overall policy to improve the quality of radiotherapy. Since 2007, no radiotherapy accident was reported.