Mitigation of Intensity Modulated Radiation Therapy and Stereotactic Body Radiation Therapy Treatment Planning Errors on the Novel RefleXion X1 System Using Failure Mode and Effect Analysis Within Six Sigma Framework

Abstract

PurposeApply the Six Sigma methodology and Failure Mode and Effect Analysis (FMEA) to mitigate errors in IMRT/SBRT treatment planning with the first clinical installation of RefleXion X1.MethodsThe Six Sigma approach consisted of five phases, Define-Measure-Analyze- Improve-Control. The Define-Measure-Analyze phases consisted of process mapping and an FMEA of IMRT/SBRT treatment planning on the X1. The multidisciplinary team out-lined the workflow process and identified/ranked the failure modes associated with the plan check items using AAPM TG-100 recommendations. Items with the highest average risk priority numbers (RPN) and Severity ≥7 were prioritized for automation using the Eclipse Scripting API (ESAPI). The Improve phase consisted of developing ESAPI scripts prior to the clinical launch of X1 to improve efficiency and safety. In the Control phase, the FMEA ranking was re-evaluated one-year post-clinical launch.ResultsOverall, 100 plan check items were identified where the RPN values ranged from 10.2—429.0. Fifty of these items (50%) were suitable for automation within ESAPI. Of the 10 highest-risk items, eight were suitable for automation. Based on the results of the FMEA, two scripts were developed: Planning Assistant used by the planner during preparation for planning and the Automated Plan Check used by the planner and the plan checker during plan preparation for treatment. After 12 months of clinical use of the X1 and developed scripts, only three errors were reported. The average RPN pre-scripts was 138.0 compared to average post-scripts RPN of 47.8 (p<0.05) signifying a safer process.ConclusionsImplementing new technology into the clinic can be an error-prone process where the likelihood of errors increases with increasing pressure to implement the technology quickly. To limit errors in clinical implementation of the novel RefleXion X1 system, the Six Sigma methodology was utilized to identify failure modes, establish quality control checks, and re-evaluate these checks one-year post-clinical implementation.

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