Kelly C. Younge

Practical implementation of failure mode and effects analysis for safety and efficiency in stereotactic radiosurgery.

PURPOSE To improve the safety and efficiency of a new stereotactic radiosurgery program with the application of failure mode and effects analysis (FMEA) performed by a multidisciplinary team of health care professionals. METHODS AND MATERIALS Representatives included physicists, therapists, dosimetrists, oncologists, and administrators. A detailed process tree was created from an initial high-level process tree to facilitate the identification of possible failure modes. Group members were asked to determine failure modes that they considered to be the highest risk before scoring failure modes. Risk priority numbers (RPNs) were determined by each group member individually and then averaged. RESULTS A total of 99 failure modes were identified. The 5 failure modes with an RPN above 150 were further analyzed to attempt to reduce these RPNs. Only 1 of the initial items that the group presumed to be high-risk (magnetic resonance imaging laterality reversed) was ranked in these top 5 items. New process controls were put in place to reduce the severity, occurrence, and detectability scores for all of the top 5 failure modes. CONCLUSIONS FMEA is a valuable team activity that can assist in the creation or restructuring of a quality assurance program with the aim of improved safety, quality, and efficiency. Performing the FMEA helped group members to see how they fit into the bigger picture of the program, and it served to reduce biases and preconceived notions about which elements of the program were the riskiest.

Improving treatment plan evaluation with automation

The goal of this work is to evaluate the effectiveness of Plan‐Checker Tool (PCT) which was created to improve first‐time plan quality, reduce patient delays, increase the efficiency of our electronic workflow, and standardize and automate the physics plan review in the treatment planning system (TPS). PCT uses an application programming interface to check and compare data from the TPS and treatment management system (TMS). PCT includes a comprehensive checklist of automated and manual checks that are documented when performed by the user as part of a plan readiness check for treatment. Prior to and during PCT development, errors identified during the physics review and causes of patient treatment start delays were tracked to prioritize which checks should be automated. Nineteen of 33 checklist items were automated, with data extracted with PCT. There was a 60% reduction in the number of patient delays in the six months after PCT release. PCT was successfully implemented for use on all external beam treatment plans in our clinic. While the number of errors found during the physics check did not decrease, automation of checks increased visibility of errors during the physics check, which led to decreased patient delays. The methods used here can be applied to any TMS and TPS that allows queries of the database. PACS number(s): 87.55.‐x, 87.55.N‐, 87.55.Qr, 87.55.tm, 89.20.BbThe goal of this work is to evaluate the effectiveness of Plan-Checker Tool (PCT) which was created to improve first-time plan quality, reduce patient delays, increase the efficiency of our electronic workflow, and standardize and automate the physics plan review in the treatment planning system (TPS). PCT uses an application programming interface to check and compare data from the TPS and treatment management system (TMS). PCT includes a comprehensive checklist of automated and manual checks that are documented when performed by the user as part of a plan readiness check for treatment. Prior to and during PCT development, errors identified during the physics review and causes of patient treatment start delays were tracked to prioritize which checks should be automated. Nineteen of 33 checklist items were automated, with data extracted with PCT. There was a 60% reduction in the number of patient delays in the six months after PCT release. PCT was successfully implemented for use on all external beam treatment plans in our clinic. While the number of errors found during the physics check did not decrease, automation of checks increased visibility of errors during the physics check, which led to decreased patient delays. The methods used here can be applied to any TMS and TPS that allows queries of the database. PACS number(s): 87.55.-x, 87.55.N-, 87.55.Qr, 87.55.tm, 89.20.Bb.

SafetyNet: Streamlining and Automating QA in radiotherapy

Proper quality assurance (QA) of the radiotherapy process can be time‐consuming and expensive. Many QA efforts, such as data export and import, are inefficient when done by humans. Additionally, humans can be unreliable, lose attention, and fail to complete critical steps that are required for smooth operations. In our group we have sought to break down the QA tasks into separate steps and to automate those steps that are better done by software running autonomously or at the instigation of a human. A team of medical physicists and software engineers worked together to identify opportunities to streamline and automate QA. Development efforts follow a formal cycle of writing software requirements, developing software, testing and commissioning. The clinical release process is separated into clinical evaluation testing, training, and finally clinical release. We have improved six processes related to QA and safety. Steps that were previously performed by humans have been automated or streamlined to increase first‐time quality, reduce time spent by humans doing low‐level tasks, and expedite QA tests. Much of the gains were had by automating data transfer, implementing computer‐based checking and automation of systems with an event‐driven framework. These coordinated efforts by software engineers and clinical physicists have resulted in speed improvements in expediting patient‐sensitive QA tests. PACS number(s): 87.55.Ne, 87.55.Qr, 87.55.tg, 87.55.tmProper quality assurance (QA) of the radiotherapy process can be time-consuming and expensive. Many QA efforts, such as data export and import, are inefficient when done by humans. Additionally, humans can be unreliable, lose attention, and fail to complete critical steps that are required for smooth operations. In our group we have sought to break down the QA tasks into separate steps and to automate those steps that are better done by software running autonomously or at the instigation of a human. A team of medical physicists and software engineers worked together to identify opportunities to streamline and automate QA. Development efforts follow a formal cycle of writing software requirements, developing software, testing and commissioning. The clinical release process is separated into clinical evaluation testing, training, and finally clinical release. We have improved six processes related to QA and safety. Steps that were previously performed by humans have been automated or streamlined to increase first-time quality, reduce time spent by humans doing low-level tasks, and expedite QA tests. Much of the gains were had by automating data transfer, implementing computer-based checking and automation of systems with an event-driven framework. These coordinated efforts by software engineers and clinical physicists have resulted in speed improvements in expediting patient-sensitive QA tests. PACS number(s): 87.55.Ne, 87.55.Qr, 87.55.tg, 87.55.tm.

An analysis of knowledge-based planning for stereotactic body radiation therapy of the spine

PURPOSE Planning for spine stereotactic body radiation therapy (SBRT) is time consuming, and differences in planner experience and technique result in discrepancies in plan quality between facilities. Here, knowledge-based planning is analyzed to determine if it may be effective in improving the quality and efficiency of spine SBRT planning. MATERIALS AND METHODS Thirty-eight spine SBRT cases were collected from the University of Michigan database and inverse planned to deliver 3 10-Gy fractions to the planning target volume (PTV). These plans were used to train a knowledge-based model (model A) using RapidPlan (Varian Medical Systems). The model was evaluated for outliers and validated in 10 independent cases. Each of these cases was manually planned to compare the quality of the model-generated plans with the manual plans. To further test the robustness of the software, 2 additional models (models B and C) were created with intentional outliers resulting from inconsistent contouring. RESULTS Using models A, B, and C, all 10 generated plans met all dose objectives for modeled organs at risk (OARs) (spinal cord, cord planning risk volume, and esophagus) without user intervention. The target coverage and OAR dose sparing was improved or equivalent to manual planning by an expert dosimetrist; however, manually created plans typically required 1 to 1.5 hours to produce and model-generated plans required only 10 to 15 minutes with minimal human intervention to meet all dose objectives. CONCLUSIONS The clinical quality of plans produced by RapidPlan were found to improve on or be similar to the manually created plans in terms of normal tissue objectives and PTV dose coverage and could be produced in a fraction of the time. RapidPlan is a robust technique that can improve planning efficiency in spine SBRT while maintaining or potentially improving plan quality and standardization across planners and centers.

An integrated multidisciplinary algorithm for the management of spinal metastases: an International Spine Oncology Consortium report

Spinal metastases are becoming increasingly common because patients with metastatic disease are living longer. The close proximity of the spinal cord to the vertebral column limits many conventional therapeutic options that can otherwise be used to treat cancer. In response to this problem, an innovative multidisciplinary approach has been developed for the management of spinal metastases, leveraging the capabilities of image-guided stereotactic radiosurgery, separation surgery, vertebroplasty, and minimally invasive local ablative approaches. In this Review, we discuss the variables that should be considered during the management of these patients and review the role of each discipline and their respective management options to provide optimal care. This work is synthesised into a practical algorithm to aid clinicians in the management of patients with spinal metastasis.

Failure mode and effects analysis in a dual-product microsphere brachytherapy environment

PURPOSE We performed a failure mode and effects analysis (FMEA) during the addition of a new microspheres product into our existing microsphere brachytherapy program to identify areas for safety improvements. METHODS AND MATERIALS A diverse group of team members from the microsphere program participated in the project to create a process map, identify and score failure modes, and discuss programmatic changes to address the highest ranking items. We developed custom severity ranking scales for staff- and institution-related failure modes to encompass possible risks that may exist outside of patient-based effects. RESULTS Between both types of microsphere products, 173 failure mode/effect pairs were identified: 90 for patients, 35 for staff, and 48 for the institution. The SIR-Spheres program was ranked separately from the TheraSphere program because of significant differences in workflow during dose calculation, preparation, and delivery. High-ranking failure modes in each category were addressed with programmatic changes. CONCLUSIONS The FMEA aided in identifying potential risk factors in our microsphere program and allowed a theoretically safer and more efficient design of the workflow and quality assurance for both our new SIR-Spheres program and our existing TheraSphere program. As new guidelines are made available, and our experience with the SIR-Spheres program increases, we will update the FMEA as an efficient starting point for future improvements.

Predicting deliverability of volumetric-modulated arc therapy (VMAT) plans using aperture complexity analysis

The purpose of this study was to evaluate the ability of an aperture complexity metric for volumetric‐modulated arc therapy (VMAT) plans to predict plan delivery accuracy. We developed a complexity analysis tool as a plug‐in script to Varians Eclipse treatment planning system. This script reports the modulation of plans, arcs, and individual control points for VMAT plans using a previously developed complexity metric. The calculated complexities are compared to that of 649 VMAT plans previously treated at our institution from 2013 to mid‐2015. We used the VMAT quality assurance (QA) results from the 649 treated plans, plus 62 plans that failed pretreatment QA, to validate the ability of the complexity metric to predict plan deliverability. We used a receiver operating characteristic (ROC) analysis to determine an appropriate complexity threshold value above which a plan should be considered for reoptimization before it moves further through our planning workflow. The average complexity metric for the 649 treated plans analyzed with the script was 0.132 mm−1 with a standard deviation of 0.036 mm−1. We found that when using a threshold complexity value of 0.180 mm−1, the true positive rate for correctly identifying plans that failed QA was 44%, and the false‐positive rate was 7%. Used clinically with this threshold, the script can identify overly modulated plans and thus prevent a significant portion of QA failures. Reducing VMAT plan complexity has a number of important clinical benefits, including improving plan deliverability and reducing treatment time. Use of the complexity metric during both the planning and QA processes can reduce the number of QA failures and improve the quality of VMAT plans used for treatment. PACS number(s): 87.55.de, 87.55.Qr, 87.56.jkThe purpose of this study was to evaluate the ability of an aperture complexity metric for volumetric-modulated arc therapy (VMAT) plans to predict plan delivery accuracy. We developed a complexity analysis tool as a plug-in script to Varians Eclipse treatment planning system. This script reports the modulation of plans, arcs, and individual control points for VMAT plans using a previously developed complexity metric. The calculated complexities are compared to that of 649 VMAT plans previously treated at our institution from 2013 to mid-2015. We used the VMAT quality assurance (QA) results from the 649 treated plans, plus 62 plans that failed pretreatment QA, to validate the ability of the complexity metric to predict plan deliverability. We used a receiver operating characteristic (ROC) analysis to determine an appropriate complexity threshold value above which a plan should be considered for reoptimization before it moves further through our planning workflow. The average complexity metric for the 649 treated plans analyzed with the script was 0.132 mm-1 with a standard deviation of 0.036 mm-1. We found that when using a threshold complexity value of 0.180 mm-1, the true positive rate for correctly identifying plans that failed QA was 44%, and the false-positive rate was 7%. Used clinically with this threshold, the script can identify overly modulated plans and thus prevent a significant portion of QA failures. Reducing VMAT plan complexity has a number of important clinical benefits, including improving plan deliverability and reducing treatment time. Use of the complexity metric during both the planning and QA processes can reduce the number of QA failures and improve the quality of VMAT plans used for treatment. PACS number(s): 87.55.de, 87.55.Qr, 87.56.jk.

Improving patient safety and workflow efficiency with standardized pretreatment radiation therapist chart reviews

PURPOSE Radiation therapists play a critical role in ensuring patient safety; however, they are sometimes given insufficient time to perform quality assurance (QA) of a patients treatment chart and documentation before the start of treatment. In this work, we show the benefits of introducing a formal therapist prestart QA checklist, completed in a quiet space well in advance of treatment, into our workflow. METHODS AND MATERIALS A therapist prestart QA checklist was created by analyzing in-house variance reports and treatment unit delays over 6 months. Therapists were then given dedicated time and workspace to perform their checks within the dosimetry office of our department. The effectiveness of the checklist was quantified by recording the percentage of charts that underwent QA before treatment, the percentage of charts with errors needing intervention, and treatment unit delays during a nearly 2-year period. The frequency and types of errors found by the prestart QA were also recorded. RESULTS Through the use of therapist prestart QA, instances of treatment unit delays were reduced by up to a factor of 9 during the first year of the program. At the outset of this new initiative, nearly 40% of charts had errors requiring intervention, with the majority being scheduling related. With upstream workflow changes and automation, this was reduced over the period of a year to about 10%. CONCLUSIONS The number of treatment unit delays was dramatically reduced by using a formal therapist prestart QA checklist completed well in advance of treatment. The data collected via the checklist continue to be used for further quality improvement efforts.

Radiosurgery for Treatment of Renal Cell Metastases to Spine: A Systematic Review of the Literature

BACKGROUND The incidence of renal cell carcinoma (RCC) continues to increase, and the spine is the most common site for bony metastasis. Radiation therapy is one treatment for spinal RCC metastasis. Stereotactic body radiotherapy (SBRT) is a newer treatment that reportedly has benefits over conventional external beam radiotherapy. This study systematically reviewed the current literature on SBRT for metastatic RCC to spine. METHODS A search of PubMed, Embase, and Scopus databases was conducted in accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Clinical articles evaluating SBRT for RCC metastases were identified. After inclusion and exclusion criteria were applied, the search resulted in 9 articles. Data including pain outcomes, local control, survival outcomes, vertebral compression fracture (VCF), and toxicity were extracted and evaluated. RESULTS The studies analyzed showed an improvement in pain in 41%-95% of patients. Local control rates after SBRT ranged 71.2%-85.7% at 1 year, a significant improvement when compared with conventional external beam radiotherapy. The rate of VCF after treatment with SBRT ranged 16%-27.5%, with single-fraction therapy being a risk factor for increased incidence. Overall toxicity rates ranged 23%-38.5%, with only 3 cases of grade 3 toxicity (nausea) and no cases of radiation myelitis. CONCLUSIONS Use of SBRT for spinal metastasis from RCC resulted in significant local control and pain outcomes. There is a risk of VCF with SBRT; however, treatment seems to be well tolerated with few serious side effects. There is continued need for long-term prospective studies investigating the optimal role of SBRT in the treatment algorithm of RCC spinal metastases.

The impact of a high‐definition multileaf collimator for spine SBRT

Abstract Purpose Advanced radiotherapy delivery systems designed for high‐dose, high‐precision treatments often come equipped with high‐definition multi‐leaf collimators (HD‐MLC) aimed at more finely shaping radiation dose to the target. In this work, we study the effect of a high definition MLC on spine stereotactic body radiation therapy (SBRT) treatment plan quality and plan deliverability. Methods and Materials Seventeen spine SBRT cases were planned with VMAT using a standard definition MLC (M120), HD‐MLC, and HD‐MLC with an added objective to reduce monitor units (MU). M120 plans were converted into plans deliverable on an HD‐MLC using in‐house software. Plan quality and plan deliverability as measured by portal dosimetry were compared among the three types of plans. Results Only minor differences were noted in plan quality between the M120 and HD‐MLC plans. Plans generated with the HD‐MLC tended to have better spinal cord sparing (3% reduction in maximum cord dose). HD‐MLC plans on average had 12% more MU and 55% greater modulation complexity as defined by an in‐house metric. HD‐MLC plans also had significantly degraded deliverability. Of the VMAT arcs measured, 94% had lower gamma passing metrics when using the HD‐MLC. Conclusion Modest improvements in plan quality were noted when switching from M120 to HD‐MLC at the expense of significantly less accurate deliverability in some cases.