Applying failure mode and effects analysis to enhance patient safety in the risk management of the radiotherapy planning process

Abstract

Background

Risk management in the radiotherapy planning workflow helps enhance patient safety. This study aimed to identify high-risk failure modes (FMs) in the radiotherapy planning process using Failure Mode and Effects Analysis (FMEA) and to enhance patient safety and improve planning quality through intervention procedure.

Methods

This retrospective analysis evaluated treatment plans developed between 2019 and 2022. Following the FMEA as detailed in the task group 100 report by the American Association of Physicists in Medicine, five physicists assigned each FM a risk priority number (RPN = O × S × D) by employing a scoring system in which the frequency of occurrence (O), severity (S), and detectability (D) of errors are rated on a scale from 1 to 10. The planning compliance rate, determined by dividing the number of plans without errors by the total number of plans and multiplying the value by 100%, was used to evaluate treatment planning quality.

Results

The FMEA results revealed nine FMs with RPNs exceeding 100, including 3 with RPNs exceeding 125 and 6 with severity (S) scores greater than 8. The critical FMs involved couch-density correction (RPN = 168), digitally reconstructed radiographs/cone beam computed tomography image transfer (RPN = 144), and handwritten isocenter shifts (RPN = 144). The baseline planning compliance rates improved from 78.3% in 2020 to 89.1% in 2021, reaching 94.3% in 2022.

Conclusion

Identifying high-risk failure modes from FMEA results and developing improvement strategies to enhance patient safety and improve the quality of radiotherapy treatment planning.