Purpose: To improve the quality and safety of our tandem and ring brachytherapy practice and procedure, we performed a treatment process analysis following the failure modes and effects analysis (FMEA) method. Methods: The FMEA analysis was performed by a multi‐disciplinary team. The treatment process was divided into six sub‐processes and a flowchart was created for each. For each action point within a sub‐process, failure modes (FM) were collected. A scoring guideline was developed based on published FMEA studies and adapted for brachytherapy at UC Davis. Scores were assigned through team consensus. FM were ranked according to overall score as well as severity score alone. FM ranking above 5% of the highest risk priority number (RPN) score, representing half the FM, were selected for in‐depth analysis. The efficiency of each existing QA process to detect FM and the number of QA tests in place for each FM were analyzed. Results: 96 FM were scored for severity, occurrence and detectability. RPN scores ranged from 1 to 192. Of the 12 highest ranking FM with RPN scores > 80, half had severity scores of 8 or 9, with no mode having severity of 10. Of the top 48 FM, the originating process steps were insertion (10%), simulation (33%), planning (29%) and delivery (25%). Checklist efficiency and comprehensiveness including physician, nurse and physics checks, ranged from 25% to 79% in preventing the top 48 FM ranked by RPN. Physics machine QA was inefficient in detecting the top ranked FM (<5%), but was very efficient to catch FM with severity >7 (15%). Conclusion: This is the first reported FMEA process in gynecologic brachytherapy. We were able to identify failure modes that could potentially and severely impact the patient's treatment. We continue to adjust our QA program based on the results of our FMEA analysis.
ASJC Scopus subject areas
- Radiology Nuclear Medicine and imaging