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Systems‐theoretic process analysis (STPA) is a prospective safety assessment tool increasingly applied in healthcare. A problem hampering STPA proliferation is the difficulty of modeling systems for analysis by creating control structures. In this work, a method is proposed to use existing process maps—commonly available in healthcare—when creating a control structure. The proposed method entails (1) extract information from the process map, (2) determine the modeling boundary of the control structure, (3) transfer the extracted information to the control structure, (4) add additional information to complete the control structure. Two case studies were conducted: (1) ambulance patient offloading in the emergency department and (2) ischemic stroke care with intravenous thrombolysis. The amount of process map‐derived information in the control structures was quantified. On average, 68% of the information in the final control structures was derived from the process map. Additional control actions and feedback were added from nonprocess map sources for management and frontline controllers. Despite the differences between process maps and control structures, much of the information in a process map can be used when creating a control structure. The method enables the creation of a control structure from a process map to be done in a structured fashion. [ABSTRACT FROM AUTHOR]

Purpose: Advanced technologies have led to improvements in modern radiotherapy over the years. However, adoption of advanced technologies can present challenges to existing clinical operations and negatively impact safety. The purpose of this work is to perform an assessment of modern radiotherapy for the operational objectives of safety, efficiency, and financial viability. Methods: This work focuses on external beam radiotherapy (EBRT). The operational assessment included department management, treatment planning, treatment delivery, and associated workflows for three equipment configurations of Ethos, Halcyon, and TrueBeam with the ARIA information system, Eclipse treatment planning, and IDENTIFY surface guidance. Systems‐theoretic process analysis (STPA) was used to analyze the related workflows. Control actions, unsafe contexts of those control actions, and associated causal scenarios that can lead to unsafe radiation and non‐radiation physical injury (safety objective), reduced treatment capacity (efficiency objective), and costs that exceed budget (financial viability objective) were identified. Results: The number of control actions (and causal scenarios) were 18 (254), 18 (267), and 20 (267) for the equipment configurations of Halcyon, TrueBeam, and Ethos, respectively. The extent that safety, efficiency, and financial viability were impacted is similar across the different equipment configurations, but there were some noteworthy differences related to information transfer and workflow bottlenecks potentially impacting access to care. Seventy‐five percent of the scenarios across all three configurations were related to safety. Overall, 29% of the scenarios impacted more than one operational objective and 48% were related to human decisions during the process of care. Planned or unplanned process changes were responsible for 8% of the causal scenarios. Conclusions: Broad‐based clinical improvements may be realized by addressing causal scenarios that impact multiple objectives. Redesigning the roles and responsibilities of the clinical team and some aspects of the radiotherapy workflow may be helpful to fully realize the benefits of advanced technologies. Radiotherapy may benefit from additional tools to improve the consistency between decisions and actions when system or process changes occur. [ABSTRACT FROM AUTHOR]

The clinical use of surface imaging has increased dramatically, with demonstrated utility for initial patient positioning, real‐time motion monitoring, and beam gating in a variety of anatomical sites. The Therapy Physics Subcommittee and the Imaging for Treatment Verification Working Group of the American Association of Physicists in Medicine commissioned Task Group 302 to review the current clinical uses of surface imaging and emerging clinical applications. The specific charge of this task group was to provide technical guidelines for clinical indications of use for general positioning, breast deep‐inspiration breath hold treatment, and frameless stereotactic radiosurgery. Additionally, the task group was charged with providing commissioning and on‐going quality assurance (QA) requirements for surface‐guided radiation therapy (SGRT) as part of a comprehensive QA program including risk assessment. Workflow considerations for other anatomic sites and for computed tomography simulation, including motion management, are also discussed. Finally, developing clinical applications, such as stereotactic body radiotherapy (SBRT) or proton radiotherapy, are presented. The recommendations made in this report, which are summarized at the end of the report, are applicable to all video‐based SGRT systems available at the time of writing. [ABSTRACT FROM AUTHOR]

Purpose: To provide insight into the types of questions asked to medical physicists by patients during one‐on‐one physicist–patient consults at one institution. Materials and Methods: Medical physicists trained in patient communication techniques met with patients to provide an overview of the treatment planning and delivery processes, discuss the patient's treatment plan, and answer any technical questions. From August 2016 to December 2019, 152 physicist–patient consults were conducted. In the initial months of the study (August 2016—December 2017), following each physicist–patient consult, all patient questions were documented by the physicists. For the remaining time period (January 2018—December 2019), any newly encountered questions were periodically added to the list. The questions were compiled into a comprehensive list and organized into categories. Results: There were a total of 88 unique patient questions. These questions fit into four topical categories. Fifty‐four questions (61.4%) were in the "Treatment Planning and Delivery Questions" category, 15 questions (17.1%) were in the "General Radiation Questions or Concerns" category, 13 questions (14.8%) were in the "Safety and Quality Assurance Questions" category, and 6 questions (6.8%) were in the "Medical Questions" category. Overall, patients were primarily concerned about how radiation works, the treatment planning and delivery processes, and what is being done to keep them safe throughout their treatment. Conclusion: Physicist–patient consults provided an opportunity to address the technical aspects of radiation therapy with patients in greater detail. The fact that patient questions could be conveniently grouped into only four topical categories indicates that it may be straightforward for other medical physicists to prepare for effectively addressing technical questions during physicist–patient consults. [ABSTRACT FROM AUTHOR]

Purpose/objectives: Three‐dimensional (3D) printing is recognized as an effective clinical and educational tool in procedurally intensive specialties. However, it has a nascent role in radiation oncology. The goal of this investigation is to clarify the extent to which 3D printing applications are currently being used in radiation oncology through a systematic review of the literature. Materials/methods: A search protocol was defined according to preferred reporting items for systematic reviews and meta‐analyses (PRISMA) guidelines. Included articles were evaluated using parameters of interest including: year and country of publication, experimental design, sample size for clinical studies, radiation oncology topic, reported outcomes, and implementation barriers or safety concerns. Results: One hundred and three publications from 2012 to 2019 met inclusion criteria. The most commonly described 3D printing applications included quality assurance phantoms (26%), brachytherapy applicators (20%), bolus (17%), preclinical animal irradiation (10%), compensators (7%), and immobilization devices (5%). Most studies were preclinical feasibility studies (63%), with few clinical investigations such as case reports or series (13%) or cohort studies (11%). The most common applications evaluated within clinical settings included brachytherapy applicators (44%) and bolus (28%). Sample sizes for clinical investigations were small (median 10, range 1–42). A minority of articles described basic or translational research (11%) and workflow or cost evaluation studies (3%). The number of articles increased over time (P < 0.0001). While outcomes were heterogeneous, most studies reported successful implementation of accurate and cost‐effective 3D printing methods. Conclusions: Three‐dimensional printing is rapidly growing in radiation oncology and has been implemented effectively in a diverse array of applications. Although the number of 3D printing publications has steadily risen, the majority of current reports are preclinical in nature and the few clinical studies that do exist report on small sample sizes. Further dissemination of ongoing investigations describing the clinical application of developed 3D printing technologies in larger cohorts is warranted. [ABSTRACT FROM AUTHOR]

Purpose: In this work, we investigated the effect on the workflow and setup accuracy of using surface guided radiation therapy (SGRT) for patient setup, megavoltage cone beam CT (MVCBCT) or kilovoltage cone beam CT (kVCBCT) for imaging and fixed IMRT or volumetric‐modulated arc therapy (VMAT) for treatment delivery with the Halcyon linac. Methods: We performed a retrospective investigation of 272 treatment fractions, using three different workflows. The first and second workflows used MVCBCT and fixed IMRT for imaging and treatment delivery, and the second one also used SGRT for patient setup. The third workflow used SGRT for setup, kVCBCT for imaging and VMAT for delivery. Workflows were evaluated by comparing the number of fractions requiring repeated imaging acquisitions and the time required for setup, imaging and treatment delivery. Setup position accuracy was assessed by comparing the daily kV‐ or MV‐ CBCT with the planning CT and measuring the residual rotational errors for pitch, yaw and roll angles. Results: Without the use of SGRT, the imaging fields were delivered more than once on 11.1% of the fractions, while re‐imaging was necessary in 5.5% of the fractions using SGRT. The total treatment time, including setup, imaging, and delivery, for the three workflows was 531 ± 157 s, 503 ± 130 s and 457 ± 91 s, respectively. A statistically significant difference was observed when comparing the third workflow with the first two. The total residual rotational errors were 1.96 ± 1.29°, 1.28 ± 0.67° and 1.22 ± 0.76° and statistically significant differences were observed when comparing workflows with and without SGRT. Conclusions: The use of SGRT allowed for a reduction of re‐imaging during patient setup and improved patient position accuracy by reducing residual rotational errors. A reduction in treatment time using kVCBCT with SGRT was observed. The most efficient workflow was the one including kVCBCT and SGRT for setup and VMAT for delivery. [ABSTRACT FROM AUTHOR]

Dr. Todd Pawlicki is arguing for the proposition that " I RO-APM brings more benefits than detriments to the medical physics profession i ", while Dr. Eric Ford is arguing against it. Physicists could easily be replaced with less qualified (and less expensive) staff that would be tasked with the majority of technical/routine work, leaving only a very few qualified physicists in the department for key physics-only work such as output calibrations. With these two axioms in mind, I can confidently say that the RO-APM would be I much more i of a benefit to the medical physics profession than it is a detriment - provided that physicists are willing to transform their current clinical role. The new medical physicist role will have primary responsibility for all technical decisions related to patient care in radiation oncology including the management of the patient's care path through radiation treatment. [Extracted from the article]

Purpose: The Halcyon consists of precommissioned linear accelerator and treatment planning algorithms that were designed to simplify the acceptance, commissioning, and clinical workflow for image‐guided intensity‐modulated radiotherapy. The purpose of this work was to perform a comprehensive safety assessment for the clinical use of the Halcyon. Methods: Systems‐Theoretic Process Analysis was used as the safety assessment tool. As part of the analysis, a number of control loops and control actions are created to describe system function. Safety is assessed by determining unsafe control actions and a corresponding list of causal scenarios that leads to accidents. The scope of the analysis was from the acceptance of the Halcyon to routine patient treatments. All aspects of treating patients were considered including the roles of physicians, physicists, dosimetrists, and therapists. The analysis was completed by four physicists with input from other members of the radiation therapy team. The causal scenarios were summarized using the causality categories from the consensus recommendations for incident learning database structures in radiation oncology (Med Phys, Vol. 39, No. 12, Dec 2012). Results: Twenty‐three (23) control loops containing 52 control actions were created for the clinical use of the Halcyon. One hundred forty‐four (144) unsafe control actions were identified with 385 associated causal scenarios. Twenty‐seven percent (27%) of the causal scenarios were related to equipment technical issues, while 73% of the causal scenarios were predominantly related to procedural issues, human behavior, and organizational management. Conclusions: For routine clinical use of closed or largely automated radiation therapy equipment, the majority of safety concerns is related to nontechnical issues. The Halcyon and other similar systems may present opportunities to streamline, reduce, or eliminate some traditional equipment commissioning and routine quality assurance activities in exchange for an increased focus on issues related to organizational management, procedures, and human behavior. [ABSTRACT FROM AUTHOR]

Purpose: To assess the performance of routine cone‐beam computed tomography (CBCT) quality assurance (QA) at predicting and diagnosing clinically recognizable linac CBCT image quality issues. Methods: Monthly automated linac CBCT image quality QA data were acquired on eight Varian linacs (Varian Medical Systems, Palo Alto, CA) using the CATPHAN 500 series phantom (The Phantom Laboratory, Inc., Greenwich, NY) and Total QA software (Image Owl, Inc., Greenwich, NY) over 34 months between July 2014 and May 2017. For each linac, the following image quality metrics were acquired: geometric distortion, spatial resolution, Hounsfield Unit (HU) constancy, uniformity, and noise. Quality control (QC) limits were determined by American Association of Physicists in Medicine (AAPM) expert consensus documents Task Group (TG‐142 and TG‐179) and the manufacturer acceptance testing procedure. Clinically recognizable CBCT issues were extracted from the in‐house incident learning system (ILS) and service reports. The sensitivity and specificity of CATPHAN QA at predicting clinically recognizable image quality issues was investigated. Sensitivity was defined as the percentage of clinically recognizable CBCT image quality issues that followed a failing CATPHAN QA. Quality assurance results are categorized as failing if one or more image quality metrics are outside the QC limits. The specificity of CATPHAN QA was defined as one minus the fraction of failing CATPHAN QA results that did not have a clinically recognizable CBCT image quality issue in the subsequent month. Receiver operating characteristic (ROC) curves were generated for each image quality metric by plotting the true positive rate (TPR) against the false‐positive rate (FPR). Results: Over the study period, 18 image quality issues were discovered by clinicians while using CBCT to set up the patient and five were reported prior to x‐ray tube repair. The incidents ranged from ring artifacts to uniformity problems. The sensitivity of the TG‐142/179 limits was 17% (four of the prior monthly QC tests detected a clinically recognizable image quality issue). The area under the curve (AUC) calculated for each image quality metric ROC curve was: 0.85 for uniformity, 0.66 for spatial resolution, 0.51 for geometric distortion, 0.56 for noise, 0.73 for HU constancy, and 0.59 for contrast resolution. Conclusion: Automated monthly QA is not a good predictor of CBCT image quality issues. Of the available metrics, uniformity has the best predictive performance, but still has a high FPR and low sensitivity. The poor performance of CATPHAN QA as a predictor of image quality problems is partially due to its reliance on region‐of‐interest (ROI) based algorithms and a lack of a global algorithm such as correlation. The manner in which image quality issues occur (trending toward failure or random) is still not known and should be studied further. CBCT image quality QA should be adapted based on how CBCT is used clinically. [ABSTRACT FROM AUTHOR]

Objectives: To develop a training program designed to meet the specific needs of medical physicists as they transition into a clinical role with direct patient care responsibilities. Materials and Methods: The training program was designed in collaboration with the faculty at the UC San Diego School of Medicine and incorporates training techniques that have been shown to be effective in improving communication skills. The program emphasizes experiential, practice‐based learning over didactic presentations. Results: The training program is comprised of 5 components: 1) a 1‐day Clinician‐Patient Communication Workshop run by the UC San Diego School of Medicine, 2) Communication Strategies for Radiation Oncology, which consists of two, 2‐hour sessions designed to provide trainees with patient communication skills that are specific to patient interactions in radiation oncology, 3) Simulated Patient Interactions, in which trainees perform mock physicist‐patient consults with trained patient actors, 4) Faculty‐Observed Patient Consults, and 5) a Case‐Based Treatment Toxicity Course. A competency assessment mechanism was also developed to provide a clear set of objectives and to guide trainer feedback. [Correction added after first online publication on November 7, 2018: The phrase ", which consists of two, 2‐hour" was added above.] Conclusions: The training program that we have developed incorporates an array of established education techniques and provides a comprehensive, accessible, means of improving medical physicists' patient communication skills. [ABSTRACT FROM AUTHOR]

Derived from 2 yr of deliberations and community engagement, Medical Physics 3.0 (MP3.0) is an effort commissioned by the American Association of Physicists in Medicine (AAPM) to devise a framework of strategies by which medical physicists can maintain and improve their integral roles in, and contributions to, health care and its innovation under conditions of rapid change and uncertainty. Toward that goal, MP3.0 advocates a broadened and refreshed model of sustainable excellence by which medical physicists can and should contribute to health care. The overarching conviction of MP3.0 is that every healthcare facility can benefit from medical physics and every patient's care can be improved by a medical physicist. This large and expansive challenge necessitates a range of strategies specific to each area of medical physics: clinical practice, research, product development, and education. The present paper offers a summary of the Phase 1 deliberations of the MP3.0 initiative pertaining to strategic directions of the discipline primarily but not exclusively oriented toward the clinical practice of medical physics in the United States. [ABSTRACT FROM AUTHOR]

Purpose: Patient‐specific IMRT QA measurements are important components of processes designed to identify discrepancies between calculated and delivered radiation doses. Discrepancy tolerance limits are neither well defined nor consistently applied across centers. The AAPM TG‐218 report provides a comprehensive review aimed at improving the understanding and consistency of these processes as well as recommendations for methodologies and tolerance limits in patient‐specific IMRT QA. Methods: The performance of the dose difference/distance‐to‐agreement (DTA) and γ dose distribution comparison metrics are investigated. Measurement methods are reviewed and followed by a discussion of the pros and cons of each. Methodologies for absolute dose verification are discussed and new IMRT QA verification tools are presented. Literature on the expected or achievable agreement between measurements and calculations for different types of planning and delivery systems are reviewed and analyzed. Tests of vendor implementations of the γ verification algorithm employing benchmark cases are presented. Results: Operational shortcomings that can reduce the γ tool accuracy and subsequent effectiveness for IMRT QA are described. Practical considerations including spatial resolution, normalization, dose threshold, and data interpretation are discussed. Published data on IMRT QA and the clinical experience of the group members are used to develop guidelines and recommendations on tolerance and action limits for IMRT QA. Steps to check failed IMRT QA plans are outlined. Conclusion: Recommendations on delivery methods, data interpretation, dose normalization, the use of γ analysis routines and choice of tolerance limits for IMRT QA are made with focus on detecting differences between calculated and measured doses via the use of robust analysis methods and an in‐depth understanding of IMRT verification metrics. The recommendations are intended to improve the IMRT QA process and establish consistent, and comparable IMRT QA criteria among institutions. [ABSTRACT FROM AUTHOR]

Purpose New techniques and materials have recently been developed to expedite the conventional linac acceptance testing procedure ( Med Phys. 2017;22), which use the electronic portal imaging device ( EPID) for data collection. This new procedure is designed to be more efficient and robust than the conventional approach. The purpose of this work was to perform a comparative risk assessment of the two acceptance testing procedures ( ATPs). Materials and Methods Failure Modes and Effects Analysis was used to assess risks for both ATP approaches. Five domain experts (Medical Physicists) comprised the analysis team. The risk assessment method and ranking scales were adopted from the AAPM TG-100. The number of failure pathways and associated risk priority numbers ( RPNs) for the two ATP approaches were compared. RPNs > 100 were considered high-priority failure modes. Results Fewer failure pathways were determined for the new ATP ( ATPEPID) compared to the conventional ATP ( ATPconv) resulting in a 44% difference (n = 233 vs. n = 534, respectively). There were also 35% fewer RPNs > 100 for the ATPEPID (n = 40) compared to the ATPconv (n = 114). Failure pathways and RPNs > 100 for individual ATP tests were 2.0 and 3.5 times higher, on average, for the ATPconv compared to the ATPEPID, respectively. The EPID pixel sensitivity map was identified as a high risk failure for the ATPEPID. Conclusions Potential errors due to human factors were decreased for the ATPEPID compared to ATPconv so it is possible that a largely automated linac ATP can mitigate many error occurrences. Manufacturers should be careful when designing an EPID-based ATP to address errors in the EPID pixel sensitivity map which can potentially lead to a significant impact on patients' treatment. [ABSTRACT FROM AUTHOR]

Purpose To evaluate the level of risk involved in treatment planning system ( TPS) commissioning using a manual test procedure, and to compare the associated process-based risk to that of an automated commissioning process ( ACP) by performing an in-depth failure modes and effects analysis ( FMEA). Methods The authors collaborated to determine the potential failure modes of the TPS commissioning process using (a) approaches involving manual data measurement, modeling, and validation tests and (b) an automated process utilizing application programming interface ( API) scripting, preloaded, and premodeled standard radiation beam data, digital heterogeneous phantom, and an automated commissioning test suite ( ACTS). The severity (S), occurrence (O), and detectability (D) were scored for each failure mode and the risk priority numbers ( RPN) were derived based on TG-100 scale. Failure modes were then analyzed and ranked based on RPN. The total number of failure modes, RPN scores and the top 10 failure modes with highest risk were described and cross-compared between the two approaches. RPN reduction analysis is also presented and used as another quantifiable metric to evaluate the proposed approach. Results The FMEA of a MTP resulted in 47 failure modes with an RPNave of 161 and Save of 6.7. The highest risk process of 'Measurement Equipment Selection' resulted in an RPNmax of 640. The FMEA of an ACP resulted in 36 failure modes with an RPNave of 73 and Save of 6.7. The highest risk process of ' EPID Calibration' resulted in an RPNmax of 576. Conclusions An FMEA of treatment planning commissioning tests using automation and standardization via API scripting, preloaded, and pre-modeled standard beam data, and digital phantoms suggests that errors and risks may be reduced through the use of an ACP. [ABSTRACT FROM AUTHOR]

Purpose The purpose of this study was to develop a novel process for using on-board MV and kV Electronic Portal Imaging Devices ( EPIDs) to perform linac acceptance testing ( AT) for two reasons: (a) to standardize the assessment of new equipment performance, and (b) to reduce the time to clinical use while reducing physicist workload. Methods and materials In this study, Varian TrueBeam linacs equipped with amorphous silicon-based EPID ( aS1000) were used. The conventional set of AT tests and tolerances were used as a baseline guide. A novel methodology was developed or adopted from published literature to perform as many tests as possible using the MV and kV EPIDs. The developer mode on Varian TrueBeam linacs was used to automate the process. In the EPID-based approach, most of mechanical tests were conducted by acquiring images through a custom phantom and software tools were developed for quantitative analysis to extract different performance parameters. The embedded steel-spheres in a custom phantom provided both visual and radiographic guidance for beam geometry testing. For photon beams, open field EPID images were used to extract inline/crossline profiles to verify the beam energy, flatness and symmetry. EPID images through a double wedge phantom were used for evaluating electron beam properties via diagonal profile. Testing was augmented with a commercial automated application (Machine Performance Check) which was used to perform several geometric accuracy tests such as gantry, collimator rotations, and couch rotations/translations. Results The developed process demonstrated that the tests, which required customer demonstration, were efficiently performed using EPIDs. The AT tests that were performed using EPIDs were fully automated using the developer mode on the Varian TrueBeam system, while some tests, such as the light field versus radiation field congruence, and collision interlock checks required user interaction. Conclusions On-board imagers are quite suitable for both geometric and dosimetric testing of linac system involved in AT. Electronic format of the acquired data lends itself to benchmarking, transparency, as well as longitudinal use of AT data. While the tests were performed on a specific model of a linear accelerator, the proposed approach can be extended to other linacs. [ABSTRACT FROM AUTHOR]

Abstract: AlignRT is a surface imaging system that has been utilized for localizing and tracking patient position during radiotherapy. AlignRT has two calibration procedures that can set the system's isocenter called “Monthly Calibration” (MC) and “Isocentre Calibration” (IC). The MC utilizes a calibration plate. In addition to the calibration plate, the IC utilizes a cubic phantom that is imaged with the linac treatment beam to aid in aligning the AlignRT and treatment‐beam isocenters. This work evaluated the effects of misaligning the calibration plate during the calibration process. The plate was intentionally shifted away from isocenter ±3.0 mm in the longitudinal and lateral directions and ±1.0 mm in the longitudinal, lateral, and vertical directions. A mock stereotactic radiosurgery (SRS) treatment was used to evaluate the effects of the miscalibrations. An anthropomorphic head phantom was placed in an SRS treatment position and monitored with the AlignRT system. The AlignRT‐indicated offsets were recorded at 270°, 315°, 0°, 45°, and 90° couch angles for each intentional misalignment of the calibration plate during the MC. The IC was also performed after each miscalibration, and the measurements were repeated and compared to the previous results. With intentional longitudinal and lateral shifts of ±3.0 mm and ±1.0 mm of the calibration plate, the average indicated offsets at couch rotations of ±90° were 4.3 mm and 1.6 mm, respectively. This was in agreement with the theoretical offset of √2*(shift‐of‐the‐calibration plate). Since vertical shifts were along the rotation axis of the couch, these shifts had little effect on the offsets with changing couch angle. When the IC was applied, the indicated offsets were all within 0.5 mm for all couch angles for each of the miscalibrations. These offsets were in agreement with the known magnitude of couch walkout. The IC method effectively removes the potential miscalibration artifacts of the MC method due to misalignments of the calibration plate. [ABSTRACT FROM AUTHOR]

Purpose: In surface image guided radiosurgery, action limits are created to determine at what point intrafractional motion exhibited by the patient is large enough to warrant intervention. Action limit values remain constant across patients despite the fact that patient motion affects the target coverage of brain metastases differently depending on the planning technique and other treatment plan-specific factors. The purpose of this work was twofold. The first purpose was to characterize the sensitivity of single-met per iso and multimet per iso treatment plans to uncorrected patient motion. The second purpose was to describe a method to prospectively determine treatment plan-specific action limits considering this sensitivity. Methods: In their surface image guided radiosurgery technique, patient positioning is achieved with a thermoplastic mask that does not cover the patient's face. The patient's exposed face is imaged by a stereoscopic photogrammetry system. It is then compared to a reference surface and monitored throughout treatment. Seventy-two brain metastases (representing 29 patients) were used for this study. Twenty-five mets were treated individually ("single-met per iso plans"), and 47 were treated in a plan simultaneously with at least one other met ("multimet per iso plans"). For each met, the proportion of the gross tumor volume that remained within the 100% prescription isodose line was estimated under the influence of combinations of translations and rotations (0.0-3.0 mm and 0.0-3.0, respectively). The target volume and the prescription dose-volume were considered concentric spheres that each encompassed a volume determined from the treatment plan. Plan-specific contour plots and DVHs were created to illustrate the sensitivity of a specific lesion to uncorrected patient motion. Results: Both single-met per iso and multimet per iso plans exhibited compromised target coverage under translations and rotations, though multimet per iso plans were considerably more sensitive to these transformations (2.3% and 39.8%, respectively). Plan-specific contour plots and DVHs were used to illustrate how size, distance from isocenter, and planning technique affect a particular met's sensitivity to motion. Conclusions: Stereotactic radiosurgery treatment plans that treat multiple brain metastases using a common isocenter are particularly susceptible to compromised target coverage as a result of uncorrected patient motion. The use of such a planning technique along with other treatment plan-specific factors should influence patient motion management. A graphical representation of the effect of translations and rotations on any particular plan can be generated to inform clinicians of the appropriate action limit when monitoring intrafractional motion. [ABSTRACT FROM AUTHOR]

Purpose: Both humans and software are notoriously challenging to account for in traditional hazard analysis models. The purpose of this work is to investigate and demonstrate the application of a new, extended accident causality model, called systems theoretic accident model and processes (STAMP), to radiation oncology. Specifically, a hazard analysis technique based on STAMP, system-theoretic process analysis (STPA), is used to perform a hazard analysis. Methods: The STPA procedure starts with the definition of high-level accidents for radiation oncology at the medical center and the hazards leading to those accidents. From there, the hierarchical safety control structure of the radiation oncology clinic is modeled, i.e., the controls that are used to prevent accidents and provide effective treatment. Using STPA, unsafe control actions (behaviors) are identified that can lead to the hazards as well as causal scenarios that can lead to the identified unsafe control. This information can be used to eliminate or mitigate potential hazards. The STPA procedure is demonstrated on a new online adaptive cranial radiosurgery procedure that omits the CT simulation step and uses CBCT for localization, planning, and surface imaging system during treatment. Results: The STPA procedure generated a comprehensive set of causal scenarios that are traced back to system hazards and accidents. Ten control loops were created for the new SRS procedure, which covered the areas of hospital and department management, treatment design and delivery, and vendor service. Eighty three unsafe control actions were identified as well as 472 causal scenarios that could lead to those unsafe control actions. Conclusions: STPA provides a method for understanding the role of management decisions and hospital operations on system safety and generating process design requirements to prevent hazards and accidents. The interaction of people, hardware, and software is highlighted. The method of STPA produces results that can be used to improve safety and prevent accidents and warrants further investigation. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this study was 2-fold. One purpose was to develop an automated, streamlined quality assurance (QA) program for use by multiple centers. The second purpose was to evaluate machine performance over time for multiple centers using linear accelerator (Linac) log files and electronic portal images. The authors sought to evaluate variations in Linac performance to establish as a reference for other centers. Methods: The authors developed analytical software tools for a QA program using both log files and electronic portal imaging device (EPID) measurements. The first tool is a general analysis tool which can read and visually represent data in the log file. This tool, which can be used to automatically analyze patient treatment or QA log files, examines the files for Linac deviations which exceed thresholds. The second set of tools consists of a test suite of QA fields, a standard phantom, and software to collect information from the log files on deviations from the expected values. The test suite was designed to focus on the mechanical tests of the Linac to include jaw, MLC, and collimator positions during static, IMRT, and volumetric modulated arc therapy delivery. A consortium of eight institutions delivered the test suite at monthly or weekly intervals on each Linac using a standard phantom. The behavior of various components was analyzed for eight TrueBeam Linacs. Results: For the EPID and trajectory log file analysis, all observed deviations which exceeded established thresholds for Linac behavior resulted in a beam hold off. In the absence of an interlocktriggering event, the maximum observed log file deviations between the expected and actual component positions (such as MLC leaves) varied from less than 1% to 26% of published tolerance thresholds. The maximum and standard deviations of the variations due to gantry sag, collimator angle, jaw position, and MLC positions are presented. Gantry sag among Linacs was 0.336±0.072 mm. The standard deviation in MLC position, as determined by EPID measurements, across the consortium was 0.33 mm for IMRT fields. With respect to the log files, the deviations between expected and actual positions for parameters were small (<0.12 mm) for all Linacs. Considering both log files and EPID measurements, all parameters were well within published tolerance values. Variations in collimator angle, MLC position, and gantry sag were also evaluated for all Linacs. Conclusions: The performance of the TrueBeam Linac model was shown to be consistent based on automated analysis of trajectory log files and EPID images acquired during delivery of a standardized test suite. The results can be compared directly to tolerance thresholds. In addition, sharing of results from standard tests across institutions can facilitate the identification of QA process and Linac changes. These reference values are presented along with the standard deviation for common tests so that the test suite can be used by other centers to evaluate their Linac performance against those in this consortium. [ABSTRACT FROM AUTHOR]

Purpose: Surface image guided, Linac-based radiosurgery (SIG-RS) is a modern approach for delivering radiosurgery that utilizes optical stereoscopic imaging to monitor the surface of the patient during treatment in lieu of using a head frame for patient immobilization. Considering the novelty of the SIG-RS approach and the severity of errors associated with delivery of large doses per fraction, a risk assessment should be conducted to identify potential hazards, determine their causes, and formulate mitigation strategies. The purpose of this work is to investigate SIG-RS using the combined application of failure modes and effects analysis (FMEA) and fault tree analysis (FTA), report on the effort required to complete the analysis, and evaluate the use of FTA in conjunction with FMEA. Methods: A multidisciplinary team was assembled to conduct the FMEA on the SIG-RS process. A process map detailing the steps of the SIG-RS was created to guide the FMEA. Failure modes were determined for each step in the SIG-RS process, and risk priority numbers (RPNs) were estimated for each failure mode to facilitate risk stratification. The failure modes were ranked by RPN, and FTA was used to determine the root factors contributing to the riskiest failure modes. Using the FTA, mitigation strategies were formulated to address the root factors and reduce the risk of the process. The RPNs were re-estimated based on the mitigation strategies to determine the margin of risk reduction. Results: The FMEA and FTAs for the top two failure modes required an effort of 36 person-hours (30 person-hours for the FMEA and 6 person-hours for two FTAs). The SIG-RS process consisted of 13 major subprocesses and 91 steps, which amounted to 167 failure modes. Of the 91 steps, 16 were directly related to surface imaging. Twenty-five failure modes resulted in a RPN of 100 or greater. Only one of these top 25 failure modes was specific to surface imaging. The riskiest surface imaging failure mode had an overall RPN-rank of eighth. Mitigation strategies for the top failure mode decreased the RPN from 288 to 72. Conclusions: Based on the FMEA performed in this work, the use of surface imaging for monitoring intrafraction position in Linac-based stereotactic radiosurgery (SRS) did not greatly increase the risk of the Linac-based SRS process. In some cases, SIG helped to reduce the risk of Linac-based RS. The FMEA was augmented by the use of FTA since it divided the failure modes into their fundamental components, which simplified the task of developing mitigation strategies. [ABSTRACT FROM AUTHOR]

The result from any assurance measurement needs to be checked against some limits for acceptability. There are two types of limits; those that define clinical acceptability (action limits) and those that are meant to serve as a warning that the measurement is close to the action limits (tolerance limits). Currently, there is no standard procedure to set these limits. In this work, we propose an operational procedure to set tolerance limits and action limits. The approach to establish the limits is based on techniques of quality engineering using control charts and a process capability index. The method is different for tolerance limits and action limits with action limits being categorized into those that are specified and unspecified. The procedure is to first ensure process control using the I-MR control charts. Then, the tolerance limits are set equal to the control chart limits on the I chart. Action limits are determined using the Cpm process capability index with the requirements that the process must be in-control. The limits from the proposed procedure are compared to an existing or conventional method. Four examples are investigated: two of volumetric modulated arc therapy (VMAT) point dose quality assurance (QA) and two of routine linear accelerator output QA. The tolerance limits range from about 6% larger to 9% smaller than conventional action limits for VMAT QA cases. For the linac output QA, tolerance limits are about 60% smaller than conventional action limits. The operational procedure describe in this work is based on established quality management tools and will provide a systematic guide to set up tolerance and action limits for different equipment and processes. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this work is threefold: (1) to explore biological consequences of the multileaf collimator (MLC) calibration errors in intensity modulated radiotherapy (IMRT) of prostate and head and neck cancers, (2) to determine levels of planning target volume (PTV) and normal tissue under- or overdose flagged with clinically used QA action limits, and (3) to provide biologically based input for MLC QA and IMRT QA action limits. Methods: Ten consecutive prostate IMRT cases and ten consecutive head and neck IMRT cases were used. Systematic MLC offsets (i.e., calibration error) were introduced for each control point of the plan separately for X1 and X2 leaf banks. Offsets were from - 2 to 2 mm with a 0.5 mm increment. The modified files were imported into the planning system for forward dose recalculation. The original plan served as the reference. The generalized equivalent uniform dose (gEUD) was used as the biological index for the targets, rectum, parotid glands, brainstem, and spinal cord. Each plan was recalculated on a CT scan of a 27 cm diameter cylindrical phantom with a contoured 0.6 cc ion chamber. Dose to ion chamber and 3D gamma analysis were compared to the reference plan. QA pass criteria: (1) at least 95% of voxels with a dose cutoff of 50% of maximum dose have to pass at 3 mm/3% and (2) dose to chamber within 2% of the reference dose. Results: For prostate cases, differences in PTV and rectum gEUD greater than 2% were identified. However, a larger proportion of plans leading to greater than 2% difference in prostate PTV gEUD passed the ion chamber QA but not 3D gamma QA. A similar trend was found for the rectum gEUD. For head and neck IMRT, the QA pass criteria flagged plans leading to greater than 4% differences in PTV gEUD and greater than 5% differences in the maximum dose to brainstem. If pass criteria were relaxed to 90% for gamma and 3% for ion chamber QA, plans leading to a 5% difference in PTV gEUD and a 5%-8% difference in brainstem maximum dose would likely pass IMRT QA. A larger proportion of head and neck plans with greater than 2% PTV gEUD difference passed 3D gamma QA compared to ion chamber QA. Conclusions: For low modulation plans, there is a better chance to catch MLC calibration errors with 3D gamma QA rather than ion chamber QA. Conversely, for high modulation plans, there is a better chance to catch MLC calibration errors with ion chamber QA rather than with 3D gamma QA. Ion chamber and 3D gamma analysis IMRT QA can detect greater than 2% change in gEUD for PTVs and critical structures for low modulation treatment plans. For high modulation treatment plans, ion chamber and 3D gamma analysis can detect greater than 2% change in gEUD for PTVs and a 5% change in critical structure gEUD since either QA methods passes the QA criteria. For gEUD changes less than those listed above, either QA method has the same proportion of passing rate. [ABSTRACT FROM AUTHOR]

Purpose: To assess the temporal and spatial accuracy of the GateCT™ system (VisionRT, London, UK), a recently released respiratory tracking system for 4DCT, under both ideal and nonideal respiratory conditions. Methods: Three experiments were performed by benchmarking and comparing its results with the ground-truth input data and those generated by the widely used Varian RPM™ system (Real-time Position Management, Varian, Palo Alto, CA). The first experiment used 10 sinusoidal breathing patterns (constant amplitude and frequency using sin6ωt), 10 'consistent' patient breathing patterns, and 10 'sporadic' patient breathing patterns. Motion was simulated with the quasar™ Programmable Respiratory Motion Platform (MODUS, London, Canada) as the surrogate. The GateCT™ and RPM™ systems were used to track the breathing patterns. The data from both systems were then analyzed in the Fourier domain, to evaluate temporal/phase accuracy, using the Pearson's correlation coefficient (PCC). The analysis correlated the ground-truth input data against the GateCT™ and RPM™ tracking results, respectively. The second experiment used 10 ideal sinusoidal breathing patterns, five of period 2.0 s, and five of period 5.0 s, with varying abdominal amplitudes found in clinical cases (peak-to-peak range: 1.67-10 mm) to test the sensitivity of the system to reconstruct various range of motion. And, the third experiment used 12 consecutive clinical patients to track the abdominal motion simultaneously by the GateCT™ and RPM™ systems. The baseline of the tracking results from both the two systems was analyzed via the mean-position-estimate (MPE) calculations. All experiments were tracked for at least 120 s. Results: In the first experiment, the average PCC values (±SD) of all thirty breathing patterns were 0.9995 ± 0.00035 and 0.9994 ± 0.00041 for the GateCT™ and the RPM™ system, respectively. These nearly identical results demonstrated similar temporal/phase tracking accuracy for the two systems. The results in the second experiment, however, revealed a pattern for the GateCT™ system in which the uncertainty of its mean-position tracking increased as the amplitude of the breathing pattern decreased. For example, a non-negligible baseline drift of up to 29.3% with respect to the peak-to-peak amplitude of 1.67-mm was observed. On the contrary, the RPM™ system displayed a more consistent recording of amplitudes over time with the greatest drift being <7.7%. The third experiment confirmed these findings in the clinical setting. Consistent decrease in PCC values due to the increase in artificial amplitude drifts, as the breathing amplitude decreased, was found. The lowest PCC value was 0.7239 for a patient with 1.57-mm peak-to-peak amplitude. Conclusions: The GateCT™ system revealed its consistency in temporal/phase tracking but had limitations in accurately tracking the absolute abdominal positions, thus suggesting its appropriateness for phase-sorting of 4DCT rather than amplitude-sorting. In contrast, the RPM™ system demonstrated stable respiratory signal tracking in all ranges and accurately both in phase and amplitude, and is a robust system to use for both phase-sorting and amplitude-sorting techniques. The impact of the observed mean-position drift in the GateCT™ system on the resulting 4DCT image quality, in amplitude-sorting, needs further investigation. [ABSTRACT FROM AUTHOR]

We have employed a frameless localization system for intracranial radiosurgery, utilizing a custom biteblock with fiducial markers and an infra-red camera for set-up and monitoring patient position. For multiple brain metastases or large irregular lesions, we use a single-isocenter intensity-modulated approach. We report our quality assurance measurements and our experience using Intensity Modulated Radiosurgery (IMRS) to treat such intracranial lesions. A phantom with integrated targets and fiducial markers was utilized to test the positional accuracy of the system. The frameless localization system was used for patient setup and target localization as well as for motion monitoring during treatment. Inverse optimization planning gave satisfactory dose coverage and critical organ sparing. Patient setup was guided by the infrared camera through fine adjustment in three translational and three rotational degrees for isocenter localization and verified by orthogonal kilovoltage (kV) images, taken before treatment to ensure the accuracy of treatment. The relative localization of the camera based system was verified to be highly accurate along three translational directions of couch motion and couch rotation. After verification, we began treating patients with this technique. About 8–12 properly selected fixed beams with a single isocenter were sufficient to achieve good dose coverage and organ sparing. Portal dosimetry with an Electronic Portal Imaging Device (EPID) and kV images provided excellent quality assurance for the IMRS plan and patient setup. The treatment time was less than 60 min to deliver doses of 16–20 Gy in a single fraction. The camera-based system was verified for positional accuracy and was deemed sufficiently accurate for stereotactic treatments. Single isocenter IMRS treatment of multiple brain metastases or large irregular lesions can be done within an acceptable treatment time and gives the benefits of dose-conformity and organ-sparing, easy plan QA, and patient setup verification. [ABSTRACT FROM AUTHOR]

A modern approach to quality was developed in the United States at Bell Telephone Laboratories during the first part of the 20th century. Over the years, those quality techniques have been adopted and extended by almost every industry. Medicine in general and radiation oncology in particular have been slow to adopt modern quality techniques. This work contains a brief description of the history of research on quality that led to the development of organization-wide quality programs such as Six Sigma. The aim is to discuss the current approach to quality in radiation oncology as well as where quality should be in the future. A strategy is suggested with the goal to provide a threshold improvement in quality over the next 10 years. [ABSTRACT FROM AUTHOR]

Background. Our aim was to correlate patterns of failure with target volume delineations in patients with head and neck squamous cell carcinoma (HNSCC) treated with intensity-modulated radiation therapy (IMRT) and to report subjective xerostomia outcomes after IMRT as compared with conventional radiation therapy (CRT). Methods. Between January 2000 and April 2005, 69 patients with newly diagnosed nonmetastatic HNSCC underwent curative parotid-sparing IMRT at Stanford University. Sites included were oropharynx (n = 39), oral cavity (n = 8), larynx (n = 8), hypopharynx (n = 8), and unknown primary (n = 6). Forty-six patients received definitive IMRT (66 Gy, 2.2 Gy/fraction), and 23 patients received postoperative IMRT (60.2 Gy, 2.15 Gy/fraction). Fifty-one patients also received concomitant chemotherapy. Posttreatment salivary gland function was evaluated by a validated xerostomia questionnaire in 29 IMRT and 75 matched CRT patients >6 months after completing radiation treatment. Results. At a median follow-up of 25 months for living patients (range, 10–60), 7 locoregional failures were observed, 5 in the gross target or high-risk postoperative volume, 1 in the clinical target volume, and 1 at the junction of the IMRT and supraclavicular fields. The 2-year Kaplan–Meier estimates for locoregional control and overall survival were 92% and 74% for definitive IMRT and 87% and 87% for postoperative IMRT patients, respectively. The mean total xerostomia questionnaire score was significantly better for IMRT than for CRT patients (p = .006). Conclusions. The predominant pattern of failure in IMRT-treated patients is in the gross tumor volume. Parotid sparing with IMRT resulted in less subjective xerostomia and may improve quality of life in irradiated HNSCC patients. © 2006 Wiley Periodicals, Inc. Head Neck, 2007 [ABSTRACT FROM AUTHOR]

Purpose: All forms of past and current high-dose-rate brachytherapy utilize immobile applicators during treatment delivery. The only moving part is the source itself. This paradigm misses an important degree of freedom that, if explored, can in some instances produce previously unachievable dose conformality; that is, the dynamic motion of the applicator itself during treatment delivery. Monte Carlo and treatment planning simulations were used to illustrate the potential benefits of moving applicators for rectal cancer applications in particular. This concept is termed dynamic modulated brachytherapy (DMBT). Methods: The DMBT system uses a high-density, 18.0 g/cm3, 45 mm long tungsten alloy shield, cylindrical in shape, with a small window on one side to encapsulate a 192Ir source, to create collimation that results in a highly directional beam profile. This shield can be dynamically translated and rotated, using an attached robotic arm, during treatment to create a volumetric modulated arc therapy-type delivery, but from inside the rectal cavity. Monte Carlo simulations and planning optimization algorithms were developed inhouse to evaluate the effectiveness of this new approach using 36 clinical treatment plans comprised of 13 patients each treated using the intracavitary mold applicator (ICMA, Nucletron, The Netherlands) to quantify the potential clinical benefit. The prescription dose was 10 Gy/fx and the group had an average clinical target volume of 9.0 ± 3.5 cm3. Ideal phantom geometries were used to evaluate the impact of various shield dimensions and designs on the resulting plan quality. Results: Simulations of ideal phantom geometries found that shields as small as 10 mm in diameter can produce high quality plans. For the clinical patient cases, compared to the ICMA, for equal prescription tumor coverage, the DMBT plans provided >30% decrease in D5 (high dose volume) resulting in a ∼40% decrease in dose heterogeneity index. In addition, mean dose and D98 showed a reduction (typically 40%-60%) on all critical structures evaluated. However, for a 10 Gy prescribed dose there was an increase in total treatment time on average from 7.6 to 20.8 min for a source with an air-kerma strength of 40.25 kU (10 Ci). Conclusions: Dosimetric properties of a novel DMBT system have been described and evaluated. Comparison with the ICMA commercial applicator has shown it to be a prospective step forward in high-dose-rate brachytherapy 192Ir technology. Dynamic motion of an applicator during treatment, for any applicator and site in general, can provide additional degrees of freedom that, if properly considered, can potentially increase the plan quality significantly. [ABSTRACT FROM AUTHOR]