A failure modes and effects analysis study for gynecologic high-dose-rate brachytherapy.

PURPOSE: To improve the quality of our gynecologic brachytherapy practice and reduce reportable events, we performed a process analysis after the failure modes and effects analysis (FMEA). METHODS AND MATERIALS: The FMEA included a multidisciplinary team specifically targeting the tandem and ring brachytherapy procedure. The treatment process was divided into six subprocesses and failure modes (FMs). A scoring guideline was developed based on published FMEA studies and assigned through team consensus. FMs were ranked according to overall and severity scores. FM ranking >5% of the highest risk priority number (RPN) score was selected for in-depth analysis. The efficiency of each existing quality assurance to detect each FM was analyzed. RESULTS: We identified 170 FMs, and 99 were scored. RPN scores ranged from 1 to 192. Of the 13 highest-ranking FMs with RPN scores >80, half had severity scores of 8 or 9, with no mode having severity of 10. Of these FM, the originating process steps were simulation (5), treatment planning (5), treatment delivery (2), and insertion (1). Our high-ranking FM focused on communication and the potential for applicator movement. Evaluation of the efficiency and the comprehensiveness of our quality assurance program showed coverage of all but three of the top 49 FMs ranked by RPN. CONCLUSIONS: This is the first reported FMEA process for a comprehensive gynecologic brachytherapy procedure overview. We were able to identify FMs that could potentially and severely impact the patient's treatment. We continue to adjust our quality assurance program based on the results of our FMEA analysis.

Evaluation of the efficiency and effectiveness of independent dose calculation followed by machine log file analysis against conventional measurement based IMRT QA.

Experimental methods are commonly used for patient-specific IMRT delivery verification. There are a variety of IMRT QA techniques which have been proposed and clinically used with a common understanding that not one single method can detect all possible errors. The aim of this work was to compare the efficiency and effectiveness of independent dose calculation followed by machine log file analysis to conventional measurement-based methods in detecting errors in IMRT delivery. Sixteen IMRT treatment plans (5 head-and-neck, 3 rectum, 3 breast, and 5 prostate plans) created with a commercial treatment planning system (TPS) were recalculated on a QA phantom. All treatment plans underwent ion chamber (IC) and 2D diode array measurements. The same set of plans was also recomputed with another commercial treatment planning system and the two sets of calculations were compared. The deviations between dosimetric measurements and independent dose calculation were evaluated. The comparisons included evaluations of DVHs and point doses calculated by the two TPS systems. Machine log files were captured during pretreatment composite point dose measurements and analyzed to verify data transfer and performance of the delivery machine. Average deviation between IC measurements and point dose calculations with the two TPSs for head-and-neck plans were 1.2 ± 1.3% and 1.4 ± 1.6%, respectively. For 2D diode array measurements, the mean gamma value with 3% dose difference and 3 mm distance-to-agreement was within 1.5% for 13 of 16 plans. The mean 3D dose differences calculated from two TPSs were within 3% for head-and-neck cases and within 2% for other plans. The machine log file analysis showed that the gantry angle, jaw position, collimator angle, and MUs were consistent as planned, and maximal MLC position error was less than 0.5 mm. The independent dose calculation followed by the machine log analysis takes an average 47 ± 6 minutes, while the experimental approach (using IC and 2D diode array measurements) takes an average about 2 hours in our clinic. Independent dose calculation followed by machine log file analysis can be a reliable tool to verify IMRT treatments. Additionally, independent dose calculations have the potential to identify several problems (heterogeneity calculations, data corruptions, system failures) with the primary TPS, which generally are not identifiable with a measurement-based approach. Additionally, machine log file analysis can identify many problems (gantry, collimator, jaw setting) which also may not be detected with a measurement-based approach. Machine log file analysis could also detect performance problems for individual MLC leaves which could be masked in the analysis of a measured fluence.