Mitigation of IMRT/SBRT Treatment Planning Errors on the First Biology-Guided Radiotherapy System Using FMEA within Six Sigma Framework

Abstract

Utilize the Six Sigma methodology and Failure Mode and Effect Analysis (FMEA) to prevent and mitigate errors in IMRT/SBRT treatment planning with the first clinical installation of biology-guided radiotherapy (BgRT) system. The 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 the IMRT/SBRT treatment planning process on the BgRT system. The multidisciplinary team outlined the workflow process and identified 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 treatment planning system scripting API (ESAPI). The Improve phase consisted of developing ESAPI scripts prior to the launch of the BgRT system to improve efficiency and safety. In the Control phase, the FMEA ranking was re-evaluated 1-year post-clinical launch. Overall, 100 plan check items were identified where the RPN values ranged from 10.2 to 429.0. Fifty of these items (50%) were suitable for automation within ESAPI. Of the 10 highest-risk items (Table 1), 8 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. At 1-year post-clinical launch, the scripts were used for 80 patients successfully treated in 1747 fractions. During this period only 3 errors were reported: omitted bolus during treatment, nomenclature error in the BgRT system plan prescription, and dose tracking plan not approved following physics plan check. The average RPN pre-scripts was 138.0 compared to the average post-scripts RPN of 47.8 (p < 0.05) signifying a safer process. Implementing 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 the clinical implementation of the first BgRT system, the Six Sigma methodology was utilized to identify failure modes, establish quality control checks, and re-evaluate these checks 1-year post-clinical launch.