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The objective is to use cost-benefit analyses to identify, for a given project, optimal sets of software assurance activities. Towards this end we have incorporated cost-benefit calculations into a risk management framework.
The objective is to use cost-benefit analyses to identify, for a given project, optimal sets of software assurance activities.
This is a software-specific quality assurance plan (SQAP) for the X-Ray ToolKit (XTK) software that aligns with Sandia policy IT008, the SSQAP policy SS-R89727, and requirements related to DOE O 414.1D, Quality Assurance for software development.
Purpose: Complex treatments in radiation therapy require robust verification in order to prevent errors that can adversely affect the patient. For this purpose, the authors estimate the effectiveness of detecting errors with a “defense in depth” system composed of electronic portal imaging device (EPID) based dosimetry and a software-based system composed of rules-based and Bayesian network verifications. Methods: The authors analyzed incidents with a high potential severity score, scored as a 3 or 4 on a 4 point scale, recorded in an in-house voluntary incident reporting system, collected from February 2012 to August 2014. The incidents were categorized into different failure modes. The detectability, defined as the number of incidents that are detectable divided total number of incidents, was calculated for each failure mode. Results: In total, 343 incidents were used in this study. Of the incidents 67% were related to photon external beam therapy (EBRT). The majority of the EBRT incidents were related to patient positioning and only a small number of these could be detected by EPID dosimetry when performed prior to treatment (6%). A large fraction could be detected by in vivo dosimetry performed during the first fraction (74%). Rules-based and Bayesian network verifications were found to be complimentary to EPID dosimetry, able to detect errors related to patient prescriptions and documentation, and errors unrelated to photon EBRT. Combining all of the verification steps together, 91% of all EBRT incidents could be detected. Conclusions: This study shows that the defense in depth system is potentially able to detect a large majority of incidents. The most effective EPID-based dosimetry verification is in vivo measurements during the first fraction and is complemented by rules-based and Bayesian network plan checking.
GeoSAR Geographic Synthetic Aperture Radar) is a new 3 year effort to build a unique, dual-frequency, airborne Interferometric SAR for mapping of terrain. This is being pursued via a Consortium of the Jet Propulsion Laboratory (JPL), Calgis, Inc., and the California Department of Conservation. The airborne portion of this system will operate on a Calgis Gulfstream-II aircraft outfitted with P- and X-band Interferometric SARs. The ground portions of this system will be a suite of Flight Planning Software, an IFSAR Processor and a Radar-GIS Workstation. The airborne P-band and X-band radars will be constructed by JPL with the goal of obtaining foliage penetration at the longer P-band wavelengths. The P-band and X-band radar will operate at frequencies of 350 Mhz and 9.71 Ghz with bandwidths of either 80 or 160 Mhz. The airborne radars will be complemented with airborne laser system for measuring antenna positions. Aircraft flight lines and radar operating instructions will be computed with the Flight Planning Software The ground processing will be a two-step step process. First, the raw radar data will be processed into radar images and interferometer derived Digital Elevation Models (DEMs). Second, these radar images and DEMs will be processed with a Radar GIS Workstation which performs processes such as Projection Transformations, Registration, Geometric Adjustment, Mosaicking, Merging and Database Management. JPL will construct the IFSAR Processor and Calgis, Inc. will construct the Radar GIS Workstation. The GeoSAR Project was underway in November 1996 with a goal of having the radars and laser systems fully integrated onto the Calgis Gulfstream-II aircraft in early 1999. Then, Engineering Checkout and Calibration-Characterization Flights will be conducted through November 1999. The system will be completed at the end of 1999 and ready for routine operations in the year 2000.
Background and Purpose: Precise stent deployment is important for successful treatment of intracranial aneurysms by stent-assisted coiling (SAC). We evaluated the accuracy of virtual stents generated using commercial stent planning software by comparing the length of virtual and actually deployed intracranial laser cut stents on three-dimensional digital subtraction angiography (3D-DSA) images. Methods: We retrospectively analyzed the data of 75 consecutive cases of intracranial wide-necked aneurysms treated with the SAC technique using laser cut stents. Based on 3D-DSA images acquired by C-arm CT, stent sizing and placement were intraoperatively simulated by a commercial software application. The difference in length of the stents was estimated by measuring proximal discrepancies between the end points of the virtual and actually deployed stents on fused pre-procedural and post-procedural 3D-DSA images. Discrepancies between distal stent end points were manually minimized. The Kruskal–Wallis test was applied to test whether stent location, type, and length had an effect on difference in length between virtual and real stent. Results: The median difference in length between virtual and real stents was 1.58 mm with interquartile range 1.12–2.12 mm. There was no evidence for an effect of stent location (p = 0.23), stent type (p = 0.33), or stent length (p = 0.53) on difference in length between virtual and real stents. Conclusions: Stent planning software allows 3D simulation of laser cut stents overlain on 3D-DSA images of vessels and may thus be useful for stent selection and deployment of laser cut stents during stent-assisted coiling of intracranial aneurysms.
ANSYS Inc. develops and markets engineering simulation software and services used in the aerospace, automotive, manufacturing, electronics, biomedical, energy, defense, and many other industries. ANSYS is dedicated to engineering simulation and is the world’s leading software provider. ANSYS was founded in 1970 and is headquartered in Canonsburg, Pennsylvania. ANSYS provides an engineering analysis tool combining structural, thermal, computational fluid dynamics, acoustic, and electromagnetic simulation capabilities. ANSYS has two main programs, which use the same solvers: (1) Mechanical APDL (ANSYS Design Parametric Language), a Fortran-based coding platform, and (2) ANSYS Workbench, which uses a graphical user interface to aid in finite element analysis implementation. This plan covers both APDL and Workbench. The ANSYS computer program is a large-scale, multipurpose finite element program that can be used to solve several classes of engineering analyses. The analysis capabilities of ANSYS include the ability to solve static and dynamic structural analyses, steady-state and transient heat transfer problems, mode-frequency and buckling eigenvalue problems, static or time-varying magnetic analyses, and various types of field and coupled-field applications. The program contains many special features that allow nonlinearities or secondary effects such as plasticity, large strain, hyperelasticity, creep, swelling, large deflections, contact, stress stiffening, temperature dependency, material anisotropy, and radiation to be included in the solution. As ANSYS has been developed, other special capabilities such as substructuring, submodeling, random vibration, kinetostatics, kinetodynamics, free convection fluid analysis, acoustics, magnetics, piezoelectrics, coupled-field analysis, and design optimization have been added to the program. These capabilities contribute further to making ANSYS a multipurpose analysis tool for varied engineering disciplines. The ANSYS program has been in commercial use for over 50 years and has been used extensively in the aerospace, automotive, construction, electronic, energy services, manufacturing, nuclear, plastics, oil, and steel industries. Additionally, many consulting firms and hundreds of universities have used ANSYS for analysis, research, and educational purposes. ANSYS is recognized worldwide as one of the most widely used and capable programs of its type. Ansys design analysis software is the first created within a quality system with ISO 9001 certification, the internationally accepted quality standard. Product development, testing, maintenance and support processes also meet the United States Nuclear Regulatory Commission's quality requirements, as they have for nearly four decades. The Quality Assurance Service Agreement is suitable for the customers working in the nuclear industry who need to meet specific federal regulations including 10CRF50 Appendix B and provisions of 10CFR21. ANSYS has retained its original International Organization for Standardization (ISO) 9001 accreditation certificate since1995-05-04, It’s current certificate is valid until 2027-05-29.
Purpose: To present a novel multi-criteria optimization (MCO) solution approach that generates well-dispersed representation of the Pareto front for radiation treatment planning. Methods: Different algorithms have been proposed and implemented in commercial planning software to generate MCO plans for external-beam radiation therapy. These algorithms consider convex optimization problems. We propose a grid-based algorithm to generate well-dispersed treatment plans over Pareto front. Our method is able to handle nonconvexity in the problem to deal with dose-volume objectives/constraints, biological objectives, such as equivalent uniform dose (EUD), tumor control probability (TCP), normal tissue complication probability (NTCP), etc. In addition, our algorithm is able to provide single MCO plan when clinicians are targeting narrow bounds of objectives for patients. In this situation, usually none of the generated plans were within the bounds and a solution is difficult to identify via manual navigation. We use the subproblem formulation utilized in the grid-based algorithm to obtain a plan within the specified bounds. The subproblem aims to generate a solution that maps into the rectangle defined by the bounds. If such a solution does not exist, it generates the solution closest to the rectangle. We tested our method with 10 locally advanced head and neck cancer cases. Results: 8 objectives were used including 3 different objectives for primary target volume, high-risk and low-risk target volumes, and 5 objectives for each of the organs-at-risk (OARs) (two parotids, spinal cord, brain stem and oral cavity). Given tight bounds, uniform dose was achieved for all targets while as much as 26% improvement was achieved in OAR sparing comparing to clinical plans without MCO and previously proposed MCO method. Conclusion: Our method is able to obtain well-dispersed treatment plans to attain better approximation for convex and nonconvex Pareto fronts. Single treatment plan can be achieved when given bounds on the objectives.
Purpose: The Utrecht MRI-linac (MRL) design enables new MR-guided radiotherapy (RT) approaches. This is a feasibility study for a single-fraction high dose (boost) to individual lymph nodes (LNs) in breast-cancer patients, after breast-conserving surgery (BCS) and hypofractionated whole-breast irradiation (WBI) with conventional axillary RT (AxRT). Methods: After written informed consent, 5 breast-cancer patients (cT1-3N0) were enrolled (NL500460.041.14 trial) and underwent 1.5T MRI in supine RT position, after BCS. Axillary levels, based on ESTRO guidelines, and organs-at-risk (OARs) – including lungs, chest wall, plexus and neurovascular bundle (NVB) – were delineated. Pseudo-CT scans (pCTs) were generated by HU bulk-assignment of water, lung, and air. With Monaco treatment-planning software (TPS Elekta), VMAT plans were generated for simultaneous WBI and AxRT, prescribing 16×2.66=42.56Gy (V95%>99% V107%<2cc). Two scenarios were considered: AxRT of levels I–II; AxRT of levels I–IV, depending on boost location. Per patient, 4 LNs with varying axillary locations were selected, delineated, and expanded to PTV with 2-mm margin. Using dedicated MRL TPS, accounting for magnetic-field effects, an IMRT 1×8.5Gy boost was simulated for each LN, to achieve a total target dose of 66Gy EQD2 (α/β=3.5Gy). WBI/ART doses and boost doses were added, and evaluated in EQD2. Results: For all scenarios, 1×8.5Gy boosts could be simulated within clinical constraints for a 66Gy total dose, in addition to WBI/AxRT. LN target coverage was excellent (V95%>95%, mean >8.5Gy). Additional dose to OARs was limited. Conclusion: Our study explored the concept of LN boosting using on-line MRI guidance. It is feasible to boost individual axillary LNs – with 2-mm margin – with an additional 1×8.5Gy, in all axillary levels, within clinical constraints. This may lead to more personalized RT approaches for patients with involved LNs and may reduce RT-induced toxicity, or the need for axillary surgery. Other LN boost strategies, including dose escalation, are under investigation.
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This document describes the software development practice areas and processes which contribute to the ability of SWiFT software developers to provide quality software. These processes are designed to satisfy the requirements set forth by the Sandia Software Quality Assurance Program (SSQAP). APPROVALS SWiFT Software Quality Assurance Plan (SAND2016-0765) approved by: Department Manager SWiFT Site Lead Dave Minster (6121) Date Jonathan White (6121) Date SWiFT Controls Engineer Jonathan Berg (6121) Date CHANGE HISTORY Issue Date Originator(s) Description A 2016/01/27 Jon Berg (06121) Initial release of the SWiFT Software Quality Assurance Plan
Purpose: This work investigates the impact of low and high dose rate on IMRT through Dynalogs by evaluating Gamma Index and Dose Volume Histogram. Methods: The Eclipse™ treatment planning software was used to generate plans on prostate and head and neck sites. A range of dose rates 300 MU/min and 600 MU/min were applied to each plan in order to investigate their effect on the beam ON time, efficiency and accuracy. Each plan had distinct monitor units per fraction, delivery time, mean dose rate and leaf speed. The DVH data was used in the assessment of the conformity and plan quality.The treatments were delivered on Varian™ Clinac 2100C accelerator equipped with 120 leaf millennium MLC. Dynalogs of each plan were analyzed by MATLAB™ program. Fluence measurements were performed using the Sun Nuclear™ 2D diode array and results were assessed, based on Gamma analysis of dose fluence maps, beam delivery statistics and Dynalogs data. Results: Minor differences found by adjusted R-squared analysis of DVH’s for all the plans with different dose rates. It has been also found that more and larger fields have greater time reduction at high dose rate and there was a sharp decrease in number of control points observed in dynalog files by switching dose rate from 300 MU/min to 600 MU/min. Gamma Analysis of all plans passes the confidence limit of ≥95% with greater number of passing points in 300 MU/min dose rate plans. Conclusion: The dynalog files are compatible tool for software based IMRT QA. It can work perfectly parallel to measurement based QA setup and stand-by procedure for pre and post delivery of treatment plan.
The software quality assurance (SQA) function for the Guidance and Control Software (GCS) project which is part of a software error studies research program is described. The SQA plan outlines all of the procedures, controls, and audits to be carried out by the SQA organization to ensure adherence to the policies, procedures, and standards for the GCS project.
The Cardinal Software Quality Assurance (SQA) Program aims to provide the controls and processes necessary to enable continuous, high-quality software development while meeting user and program sponsor requirements. This SQA Plan (SQAP) delineates the SQA Program framework for Cardinal by describing the Program activities, organization, and documentation, and by clearly defining the interconnection of all Program items. It should be noted that this SQAP is aligned with the current version of the Argonne Quality Assurance Program Plan, which was designed to align with DOE O 414.1D. This SQAP is also aligned with the revision 10 of the SQAP for MOOSE and MOOSE-based applications.
Purpose: To test the feasibility of using 3D-printed patient-specific phantoms for intensity-modulated radiation therapy (IMRT) quality assurance (QA). Methods: We created a patient-specific whole-head phantom using a 3D printer. The printer data file was created from high-resolution DICOM computed tomography (CT) images of 3-year old child treated at our institution for medulloblastoma. A custom-modified extruder system was used to create tissue-equivalent materials. For the printing process, the Hounsfield Units from the CT images were converted to proportional volumetric densities. A 5-field IMRT plan was created from the patient CT and delivered to the 3D- phantom. Dose was measured by an ion chamber placed through the eye. The ion chamber was placed at the posterior edge of the planning target volume in a high dose gradient region. CT scans of the patient and 3D-phantom were fused by using commercial treatment planning software (TPS). The patient’s plan was calculated on the phantom CT images. The ion chamber’s active volume was delineated in the TPS; dose per field and total dose were obtained. Measured and calculated doses were compared. Results: The 3D-phantom dimensions and tissue densities were in good agreement with the patient. However, because of a printing error, there was a large discrepancy in the density in the frontal cortex. The calculated and measured treatment plan doses were 1.74 Gy and 1.72 Gy, respectively. For individual fields, the absolute dose difference between measured and calculated values was on average 3.50%. Conclusion: This study demonstrated the feasibility of using 3D-printed patient-specific phantoms for IMRT QA. Such phantoms would be particularly advantageous for complex IMRT treatment plans featuring high dose gradients and/or for anatomical sites with high variation in tissue densities. Our preliminary findings are promising. We anticipate that, once the printing process is further refined, the agreement between measured and calculated doses will improve.
The development of automatic guidance is discussed for helicopter Nap-of-the-Earth (NOE) and near-NOE flight. It deals with algorithm refinements relating to automated real-time flight path planning and to mission planning. With regard to path planning, it relates rotorcraft trajectory characteristics to the NOE computation scheme and addresses real-time computing issues and both ride quality issues and pilot-vehicle interfaces. The automated mission planning algorithm refinements include route optimization, automatic waypoint generation, interactive applications, and provisions for integrating the results into the real-time path planning software. A microcomputer based mission planning workstation was developed and is described. Further, the application of Defense Mapping Agency (DMA) digital terrain to both the mission planning workstation and to automatic guidance is both discussed and illustrated.
The Guidance and Control Software (GCS) project was the last in a series of software reliability studies conducted at Langley Research Center between 1977 and 1994. The technical results of the GCS project were recorded after the experiment was completed. Some of the support documentation produced as part of the experiment, however, is serving an unexpected role far beyond its original project context. Some of the software used as part of the GCS project was developed to conform to the RTCA/DO-178B software standard, "Software Considerations in Airborne Systems and Equipment Certification," used in the civil aviation industry. That standard requires extensive documentation throughout the software development life cycle, including plans, software requirements, design and source code, verification cases and results, and configuration management and quality control data. The project documentation that includes this information is open for public scrutiny without the legal or safety implications associated with comparable data from an avionics manufacturer. This public availability has afforded an opportunity to use the GCS project documents for DO-178B training. This report provides a brief overview of the GCS project, describes the 4-volume set of documents and the role they are playing in training, and includes the development documents from the GCS project. Volume 2 contains three appendices: A. Guidance and Control Software Development Specification; B. Design Description for the Pluto Implementation of the Guidance and Control Software; and C. Source Code for the Pluto Implementation of the Guidance and Control Software