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Updated: Aug 7, 2026
Dynamic Lung Tumor Tracking for Stereotactic Ablative Body Radiation Therapy
Published on: June 7, 2015
Implementation of an FMEA-guided quality-improvement workflow is associated with improved setup accuracy in lung
Zunhao Wen1, Zhiwei Liu1, Weizhi Li1
1Department of Radiation Oncology, Ganzhou Cancer Hospital, Ganzhou, China.
Background:
Lung stereotactic body radiotherapy (SBRT) requires highly reproducible workflow execution because of steep dose gradients, respiratory motion, and narrow treatment margins. This study evaluated the workflow effectiveness and process-safety impact of an FMEA-guided quality-improvement workflow for lung SBRT.
Methods:
This single-center historical-control study included 128 patients treated with lung SBRT. Sixty-three patients treated under conventional quality-control procedures served as the control group, and 65 patients managed after implementation of an FMEA-guided quality-improvement workflow served as the FMEA-guided group. The workflow included risk identification, targeted corrective measures, respiratory coaching, dual verification, immobilization optimization, and enhanced equipment quality control. RPN changes were analyzed using the Wilcoxon signed-rank test. CBCT-derived setup deviations were assessed using patient-level median absolute couch correction values and fraction-level linear mixed-effects models. Workflow-related adverse events were compared using Fisher's exact test.
Results:
Eleven high-risk failure modes were identified. The overall median residual RPN was lower than the initial RPN [39.0 (IQR, 26.0-46.5) vs 177.5 (IQR, 165.0-209.0); p = 0.003]. The setup-error analysis included 374 CBCT registrations from 63 control patients and 388 registrations from 65 patients in the FMEA-guided group. Patient-level median absolute couch correction values were smaller in the FMEA-guided group, and fraction-level mixed-effects models confirmed significantly smaller deviations across all six translational and rotational dimensions. Workflow-related adverse events decreased from 11.11% to 3.08%, but the difference was not statistically significant (RR = 0.277, 95% CI, 0.060-1.282; p = 0.093).
Conclusion:
Implementation of an FMEA-guided quality-improvement workflow was associated with reduced residual RPN scores and smaller CBCT-derived setup deviations in lung SBRT. Workflow-related adverse events decreased numerically but did not reach statistical significance. These findings support the value of proactive, closed-loop workflow risk management, while further prospective multicenter validation is warranted.
