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.

Failure mode and effect analysis for delivery of lung stereotactic body radiation therapy.

PURPOSE: To improve the quality and safety of our practice of stereotactic body radiation therapy (SBRT), we analyzed the process following the failure mode and effects analysis (FMEA) method. METHODS: The FMEA was performed by a multidisciplinary team. For each step in the SBRT delivery process, a potential failure occurrence was derived and three factors were assessed: the probability of each occurrence, the severity if the event occurs, and the probability of detection by the treatment team. A rank of 1 to 10 was assigned to each factor, and then the multiplied ranks yielded the relative risks (risk priority numbers). The failure modes with the highest risk priority numbers were then considered to implement process improvement measures. RESULTS: A total of 28 occurrences were derived, of which nine events scored with significantly high risk priority numbers. The risk priority numbers of the highest ranked events ranged from 20 to 80. These included transcription errors of the stereotactic coordinates and machine failures. CONCLUSION: Several areas of our SBRT delivery were reconsidered in terms of process improvement, and safety measures, including treatment checklists and a surgical time-out, were added for our practice of gantry-based image-guided SBRT. This study serves as a guide for other users of SBRT to perform FMEA of their own practice.

Commissioning experience with cone-beam computed tomography for image-guided radiation therapy.

This paper reports on the commissioning of an Elekta cone-beam computed tomography (CT) system at one of the first U.S. sites to install a "regular," off-the-shelf Elekta Synergy (Elekta, Stockholm, Sweden) accelerator system. We present the quality assurance (QA) procedure as a guide for other users. The commissioning had six elements: (1) system safety, (2) geometric accuracy (agreement of megavoltage and kilovoltage beam isocenters), (3) image quality, (4) registration and correction accuracy, (5) dose to patient and dosimetric stability, and (6) QA procedures. The system passed the safety tests, and agreement of the isocenters was found to be within 1 mm. Using a precisely moved skull phantom, the reconstruction and alignment algorithm was found to be accurate within 1 mm and 1 degree in each dimension. Of 12 measurement points spanning a 9x9x15-cm volume in a Rando phantom (The Phantom Laboratory, Salem, NY), the average agreement in the x, y, and z coordinates was 0.10 mm, -0.12 mm, and 0.22 mm [standard deviations (SDs): 0.21 mm, 0.55 mm, 0.21 mm; largest deviations: 0.6 mm, 1.0 mm, 0.5 mm] respectively. The larger deviation for the y component can be partly attributed to the CT slice thickness of 1 mm in that direction. Dose to the patient depends on the machine settings and patient geometry. To monitor dose consistency, air kerma (output) and half-value layer (beam quality) are measured for a typical clinical setting. Air kerma was 6.3 cGy (120 kVp, 40 mA, 40 ms per frame, 360-degree scan, S20 field of view); half value layer was 7.1 mm aluminum (120 kV, 40 mA). We suggest performing items 1, 2, and 3 monthly, and 4 and 5 annually. In addition, we devised a daily QA procedure to verify agreement of the megavoltage and kilovoltage isocenters using a simple phantom containing three small steel balls. The frequency of all checks will be reevaluated based on data collected during about 1 year.

Introducing new technologies into the clinic.

Introducing new technologies into radiation oncology clinical practices poses very specific logistical dilemmas. How do we determine that a new technology's dose distribution is better than the 'standard' and what are the methods that can be applied to easily compare the 'new' with the 'old'? We consider how the benchmark dose-volume histogram (DVH) can serve as a conceptual model to approach these issues. Comparing dosimetric differences using benchmark DVHs helps a 'global' comparison of the area under the curve that is intuitive, relatively efficient and easily implemented. These concepts, applied in prostate cancer in this communication, have wider applications in other disease sites and in the introduction of technologies beyond intensity-modulated radiation therapy.