A risk-based approach to development of ultrasound-based high-dose-rate prostate brachytherapy quality management
Purpose: The purpose of this study was to apply a risk-based approach to the development of a quality management (QM) program for ultrasound-based high-dose-rate (HDR) prostate brachytherapy (pBT) treatment planning and delivery. Methods and Materials: A QM program was developed by a multidisciplinary team, using both an in-house risk-and-benefit balance impact template (RABBIT) tool and a failure modes and effect analysis (FMEA). FMEA scores were determined by three physicists, one radiation therapist and two radiation oncologists who were familiar with the protocol. The QM program produced by both risk-based techniques was then compared and consolidated. Results: The RABBIT tool identified 26 potential risks during the treatment planning and delivery process. During the FMEA, a total of 35 potential failure modes were identified from the seven major processes in ultrasound-based HDR pBT. For the 35 potential failure modes, risk priority number scores ranged from 14 to 267. The highest ranked failure mode was identified to be mislabeling/connection of the transfer tubes/catheters. From the risks analyses, a comprehensive QM program was developed. Conclusion: Both the RABBIT tool and process mapping and FMEA were shown to be valuable tools in developing a QM program for ultrasound-based HDR pBT treatments. A considerable number of the potential failure modes identified in both tools were related to human or procedural errors, highlighting the importance of checklists and protocols in delivering a safe and effective ultrasound-based HDR pBT treatment.