title: Implementation of the global risk analysis in pulsed-dose rate brachytherapy: methods and results.
abstract: OBJECTIVE
  To report the application of the global risk analysis (GRA) in the pulsed-dose rate (PDR) brachytherapy workflow.
  
  
  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.
  
  
  CONCLUSIONS
  The implementation of the GRA appeared feasible, and led to implement 21 corrective actions, based on scenarios and not on incidents.
authors.affiliation: Radiation Oncology, Gustave-Roussy Cancer Campus Grand Paris, 114, rue Édouard-Vaillant, 97805 Villejuif cedex, France. Electronic address: rmazeron@gmail.com.
authors.forename: R
authors.initials: R
authors.lastname: Mazeron
authors.affiliation: Quality and risk Assessment, Gustave-Roussy Cancer Campus Grand Paris, 114, rue Édouard-Vaillant, 97805 Villejuif cedex, France.
authors.forename: N
authors.initials: N
authors.lastname: Aguini
authors.affiliation: Radiation Oncology, Gustave-Roussy Cancer Campus Grand Paris, 114, rue Édouard-Vaillant, 97805 Villejuif cedex, France.
authors.forename: E
authors.initials: E
authors.lastname: Rivin Del Campo
authors.affiliation: Medical physics, Gustave-Roussy Cancer Campus Grand Paris, 114, rue Édouard-Vaillant, 97805 Villejuif cedex, France.
authors.forename: I
authors.initials: I
authors.lastname: Dumas
authors.affiliation: Radiation Oncology, Gustave-Roussy Cancer Campus Grand Paris, 114, rue Édouard-Vaillant, 97805 Villejuif cedex, France.
authors.forename: M-C
authors.initials: MC
authors.lastname: Gensse
authors.affiliation: Radiation Oncology, Gustave-Roussy Cancer Campus Grand Paris, 114, rue Édouard-Vaillant, 97805 Villejuif cedex, France.
authors.forename: G
authors.initials: G
authors.lastname: Brusadin
authors.affiliation: Medical physics, Gustave-Roussy Cancer Campus Grand Paris, 114, rue Édouard-Vaillant, 97805 Villejuif cedex, France.
authors.forename: D
authors.initials: D
authors.lastname: Lefkopoulos
authors.affiliation: Radiation Oncology, Gustave-Roussy Cancer Campus Grand Paris, 114, rue Édouard-Vaillant, 97805 Villejuif cedex, France.
authors.forename: E
authors.initials: E
authors.lastname: Deutsch
authors.affiliation: Radiation Oncology, Gustave-Roussy Cancer Campus Grand Paris, 114, rue Édouard-Vaillant, 97805 Villejuif cedex, France.
authors.forename: C
authors.initials: C
authors.lastname: Haie-Meder
mesh_terms: D001918:Brachytherapy / Q000295:instrumentation / Q000379:methods*; D006801:Humans; D010348:Patient Care Team; D058996:Quality Improvement; D011787:Quality of Health Care; D011832:Radiation Injuries / Q000517:prevention & control; D061089:Radiotherapy, Image-Guided; D018570:Risk Assessment; D017751:Safety Management; D057188:Workflow
keywords: Analyse globale des risques; Cartographie; Curiethérapie de débit de dose pulsé; Global risk analysis; Mapping; Pulsed-dose rate brachytherapy; Risk assessment; Safety; Sécurité; Évaluation des risques