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Sci-Fri AM: Quality, Safety, and Professional Issues 01: CPQR Technical Quality Control Suite Development including Quality Control Workload Results

A close partnership between the Canadian Partnership for Quality Radiotherapy (CPQR) and the Canadian Organization of Medical Physicist’s (COMP) Quality Assurance and Radiation Safety Advisory Committee (QARSAC) has resulted in the development of a suite of Technical Quality Control (TQC) Guidelines for radiation treatment equipment, that outline specific performance objectives and criteria that equipment should meet in order to assure an acceptable level of radiation treatment quality. The framework includes consolidation of existing guidelines and/or literature by expert reviewers, structured stages of public review, external field-testing and ratification by COMP. The adopted framework for the development and maintenance of the TQCs ensures the guidelines incorporate input from the medical physics community during development, measures the workload required to perform the QC tests outlined in each TQC, and remain relevant (i.e. “living documents”) through subsequent planned reviews and updates. This presentation will show the Multi-Leaf Linear Accelerator document as an example of how feedback and cross-national work to achieve a robust guidance document. During field-testing, each technology was tested at multiple centres in a variety of clinic environments. As part of the defined feedback, workload data was captured. This lead to average time associated with testing as defined in each TQC document. As a result, for a medium-sized centre comprising 6 linear accelerators and a comprehensive brachytherapy program, we evaluate the physics workload to 1.5 full-time equivalent physicist per year to complete all QC tests listed in this suite.

60 APPLIED LIFE SCIENCES↗

Sci-Fri AM: Quality, Safety, and Professional Issues 02: Recent work on TQC Suite and Data from a National survey on Community Uptake

The Canadian Partnership for Quality Radiotherapy (CPQR) and the Canadian Organization of Medical Physicist’s (COMP) Quality Assurance and Radiation Safety Advisory Committee (QARSAC) have worked together in the development of a suite of Technical Quality Control (TQC) Guidelines for radiation treatment equipment and technologies, that outline specific performance objectives and criteria that equipment should meet in order to assure an acceptable level of radiation treatment quality. Early community engagement and uptake survey data showed 70% of Canadian centers are part of this process and that the data in the guideline documents reflect, and are influencing the way Canadian radiation treatment centres run their technical quality control programs. As the TQC development framework matured as a cross-country initiative, guidance documents have been developed in many clinical technologies. Recently, there have been new TQC documents initiated for Gamma Knife and Cyberknife technologies where the entire communities within Canada are involved in the review process. At the same time, QARSAC reviewed the suite as a whole for the first time and it was found that some tests and tolerances overlapped across multiple documents as single tests could pertain to multiple quality control areas. The work to streamline the entire suite has allowed for improved usability of the suite while keeping the integrity of single quality control areas. The suite will be published by the JACMP, in the coming year.

60 APPLIED LIFE SCIENCES↗

Study of serious adverse drug reactions using FDA-approved drug labeling and MedDRA

Background Adverse Drug Reactions (ADRs) are of great public health concern. FDA-approved drug labeling summarizes ADRs of a drug product mainly in three sections, i.e., Boxed Warning (BW), Warnings and Precautions (WP), and Adverse Reactions (AR), where the severity of ADRs are intended to decrease in the order of BW > WP > AR. Several reported studies have extracted ADRs from labeling documents, but most, if not all, did not discriminate the severity of the ADRs by the different labeling sections. Such a practice could overstate or underestimate the impact of certain ADRs to the public health. In this study, we applied the Medical Dictionary for Regulatory Activities (MedDRA) to drug labeling and systematically analyzed and compared the ADRs from the three labeling sections with a specific emphasis on analyzing serious ADRs presented in BW, which is of most drug safety concern. Results This study investigated New Drug Application (NDA) labeling documents for 1164 single-ingredient drugs using Oracle Text search to extract MedDRA terms. We found that only a small portion of MedDRA Preferred Terms (PTs), 3819 out of 21,920 or 17.42%, were observed in a whole set of documents. In detail, 466/3819 (12.0%) PTs were in BW, 2023/3819 (53.0%) were in WP, and 2961/3819 (77.5%) were in AR sections. We also found a higher overlap of top 20 occurring BW PTs with WP sections compared to AR sections. Within the MedDRA System Organ Class levels, serious ADRs (sADRs) from BW were prevalent in Nervous System disorders and Vascular disorders. A Hierarchical Cluster Analysis (HCA) revealed that drugs within the same therapeutic category shared the same ADR patterns in BW (e.g., nervous system drug class is highly associated with drug abuse terms such as dependence, substance abuse, and respiratory depression). Conclusions This study demonstrated that combining MedDRA standard terminologies with data mining techniques facilitated computer-aided ADR analysis of drug labeling. We also highlighted the importance of labeling sections that differ in seriousness and application in drug safety. Using sADRs primarily related to BW sections, we illustrated a prototype approach for computer-aided ADR monitoring and studies which can be applied to other public health documents.

59 BASIC BIOLOGICAL SCIENCES↗

Templates for developing and versioning data standards and reporting formats using GitHub

This data package contains three templates that can be used for creating README files and Issue Templates, written in the markdown language, that support community-led data reporting formats. We created these templates based on the results of a systematic review (see related references) that explored how groups developing data standard documentation use the Version Control platform GitHub, to collaborate on supporting documents. Based on our review of 32 GitHub repositories, we make recommendations for the content of README Files (e.g., provide a user license, indicate how users can contribute) and so 'README_template.md' includes headings for each section. The two issue templates we include ('issue_template_for_all_other_changes.md' and 'issue_template_for_documentation_change.md') can be used in a GitHub repository to help structure user-submitted issues, or can be modified to suit the needs of data standard developers. We used these templates when establishing ESS-DIVE's community space on GitHub (https://github.com/ess-dive-community) that includes documentation for community-led data reporting formats. We also include file-level metadata 'flmd.csv' that describes the contents of each file within this data package. Lastly, the temporal range that we indicate in our metadata is the time range during which we searched for data standards documented on GitHub.

54 ENVIRONMENTAL SCIENCES↗

Data from: "A guide to using GitHub for developing and versioning data standards and reporting formats"

These data are the results of a systematic review that investigated how data standards and reporting formats are documented on the version control platform GitHub. Our systematic review identified 32 data standards in earth science, environmental science, and ecology that use GitHub for version control of data standard documents. In our analysis, we characterized the documents and content within each of the 32 GitHub repositories to identify common practices for groups that version control their documents on GitHub.In this data package, there are 8 CSV files that contain data that we characterized from each repository, according to the location within the repository. For example, in 'readme_pages.csv' we characterize the content that appears across the 32 GitHub repositories included in our systematic review. Each of the 8 CSV files has an associated data dictionary file (names appended with '_dd.csv' and here we describe each content category within CSV files.There is one file-level metadata file (flmd.csv) that provides a description of each file within the data package.

54 ENVIRONMENTAL SCIENCES↗

Genesis Data Card Schema, Template and Supporting Tools

Genesis Data Cards provide a standardized template and schema for documenting scientific datasets in support of discovery, access, interoperability, reusability, governed use, and AI usability. This release of the Genesis Data Card repository includes a versioned Markdown template, a LinkML schema with generated Pydantic and JSON artifacts, schema documentation, and example completed data cards. Validation tooling is provided to ensure that completed data cards conform to the schema prior to submission. Accompanying documentation for the structured metadata is provided as a Field Reference Guide. The schema and accompanying template provided in this repository address the call for actionable context that enables humans and AI systems to find, access, interpret, cite, and reuse data, and, when appropriate, integrate it into AI and machine learning workflows. The data card is intended to serve as a common metadata artifact intended to support standardized, cross-program dataset documentation across Department of Energy (DOE)-aligned efforts, including but not limited to Genesis Mission-related implementations, the Office of Science, National Nuclear Security Administration (NNSA), and Advanced Simulation and Computing (ASC) data governance and stewardship initiatives.

data card↗

Hanford External Dosimetry Technical Basis Manual PNL-MA-842

The Hanford External Dosimetry Technical Basis Manual PNL-MA-842 documents the design and implementation of the external dosimetry system used at the U.S. Department of Energy (DOE) Hanford site. The manual describes the dosimeter design, processing protocols, dose calculation methodology, radiation fields encountered, dosimeter response characteristics, limitations of dosimeter design under field conditions, and makes recommendations for effective use of the dosimeters in the field. The manual describes the technical basis for the dosimetry system in a manner intended to help ensure defensibility of the dose of record at Hanford and to demonstrate compliance with requirements of 10 CFR 835, the DOE Laboratory Accreditation Program, the DOE Richland Operations Office, DOE Office of River Protection, DOE Pacific Northwest Office of Science, and Hanford’s DOE contractors. The dosimetry system is operated by the Pacific Northwest National Laboratory (PNNL) Hanford External Dosimetry Program which provides dosimetry services to PNNL and all Hanford contractors. The primary users of this manual are DOE and DOE contractors at Hanford using the dosimetry services of PNNL. Development and maintenance of this manual is funded directly by DOE and DOE contractors. Its contents have been reviewed and approved by DOE and DOE contractors at Hanford through the Hanford Personnel Dosimetry Advisory Committee which is chartered and chaired by DOE-RL and serves as means of coordinating dosimetry practices across contractors at Hanford. This manual was established in 1996. Since its inception, it has been revised many times and maintained by PNNL as a controlled document with controlled distribution. The first revision to be released through PNNL’s Electronic Records & Information Capture Architecture database was designated Revision 0. Revision numbers that are whole numbers reflect major revisions typically involving significant changes to all chapters in the document. Revision numbers that include a decimal fraction reflect minor revisions, usually restricted to selected chapters or selected pages in the document. Maintenance and distribution of controlled hard copies of the manual by PNNL was discontinued beginning with Revision 0.2.

61 RADIATION PROTECTION AND DOSIMETRY↗

Strategy for the Identification of an INL Comprehensive Utility Corridor

This report documents the strategy developed to identify a comprehensive utility corridor (CUC) on the Idaho National Laboratory (INL) Site. The strategy established the process for which the Campus Development Office will evaluate land management issues. It is a process that uses geographical information system geospatial technology to layer critical INL mission information in a way that thorough evaluations can be conducted and strategies developed. The objective of the CUC Project was to develop a process that could be implemented to identify potential utility corridor options for consideration. The process had to take into account all the missions occurring on the INL and other land-related issues. The process for developing a CUC strategy consists of the following four basic elements using geographical information system capabilities: 1. Development of an INL base layer map; this base layer map geospatially references all stationary geographical features on INL and sitewide information. 2. Development of current and future mission land-use need maps; this involved working with each directorate to identify current mission land use needs and future land use needs that project 30 years into the future. 3. Development of restricted and potential constraint maps; this included geospatially mapping areas such as wells, contaminated areas, firing ranges, cultural areas, ecological areas, hunting areas, easement, and grazing areas. 4. Development of state highway and power line rights of way map; this included geospatially mapping rights-of-way along existing state highways and power lines running through the INL that support INL operations. It was determined after completing and evaluating the geospatial information that the area with the least impact to INL missions was around the perimeter of the INL Site. Option 1, in this document, identifies this perimeter; however, it does not mean the entire perimeter is viable. Many places along the perimeter corridor cannot be used or are not economically viable. Specific detailed studies will need to be conducted on a case-by-case basis to clearly identify which sections along the perimeter can and cannot be used. Option 2, in this document, identifies areas along existing highways that could be a viable option. However, discussions would have to take place with the State of Idaho to use their easement as part of the corridor and mission impact would need to be evaluated if a specific request was made to the Department of Energy, Idaho Operations Office. Option 3, in this document, is a combination of Options 1 and 2. This option provides the most flexibility to minimize impacts to INL missions. As with the other two options, discussions and agreements with the State of Idaho would be needed and any specific route would need to be thoroughly evaluated for impact, implementation, and operability beyond just a strategy.

99 GENERAL AND MISCELLANEOUS↗

High Temperature Gas-Cooled Reactors Lessons Learned Applicable to the Next Generation Nuclear Plant

The purpose of this report is to identify possible issues highlighted by these lessons learned that could apply to the NGNP in reducing technical risks commensurate with the current phase of design. Some of the lessons learned have been applied to the NGNP and documented in the Preconceptual Design Report. These are addressed in the background section of this document and include, for example, the decision to use TRISO fuel rather than BISO fuel used in the Peach Bottom reactor; the use of a reactor pressure vessel rather than prestressed concrete found in Fort St. Vrain; and the use of helium as a primary coolant rather than CO2. Other lessons learned, 68 in total, are documented in Sections 2 through 6 and will be applied, as appropriate, in advancing phases of design. The lessons learned are derived from both negative and positive outcomes from prior HTGR experiences. Lessons learned are grouped according to the plant, areas, systems, subsystems, and components defined in the NGNP Preconceptual Design Report, and subsequent NGNP project documents.

21 SPECIFIC NUCLEAR REACTORS AND ASSOCIATED PLANTS↗

Establishment of a Rating Program for Pre- and Post-Fabricated Windows

This document was prepared to support the Smart Buildings-Material Testing and Rating Centres (SB-2) activity of the Asia-Pacific Economic Cooperation (APEC) Energy Smart Communities Initiative (ESCI). The ESCI was put forward by APEC Leaders at the 2010 meeting in Japan. APEC is the premier forum for facilitating economic growth, cooperation, trade and investment in the Asia-Pacific region. This document addresses the testing and certification of building products and equipment to support building energy codes, focusing specifically on energy-efficient factory-built windows. It sets forth a proposed structure for an APEC economy to establish a testing, rating, certification, and labeling program for efficient factory-built windows. In the context of this document, efficient windows would be windows made with insulating glass (IG) and an efficient frame assembly. The minimum efficiency metric (or thermal performance) for these windows is not quantified in this document and would generally be established by a governmental agency.

32 ENERGY CONSERVATION, CONSUMPTION, AND UTILIZATI↗

Fiscalini Farms Biomass Energy Project

In this final report describes and documents research that was conducted by the Ecological Engineering Research Program (EERP) at the University of the Pacific (Stockton, CA) under subcontract to Fiscalini Farms LP for work under the Assistance Agreement DE-EE0001895 'Measurement and Evaluation of a Dairy Anaerobic Digestion/Power Generation System' from the United States Department of Energy, National Energy Technology Laboratory. Fiscalini Farms is operating a 710 kW biomass-energy power plant that uses bio-methane, generated from plant biomass, cheese whey, and cattle manure via mesophilic anaerobic digestion, to produce electricity using an internal combustion engine. The primary objectives of the project were to document baseline conditions for the anaerobic digester and the combined heat and power (CHP) system used for the dairy-based biomass-energy production. The baseline condition of the plant was evaluated in the context of regulatory and economic constraints. In this final report, the operation of the plant between start-up in 2009 and operation in 2010 are documented and an interpretation of the technical data is provided. An economic analysis of the biomass energy system was previously completed (Appendix A) and the results from that study are discussed briefly in this report. Results from the start-up and first year of operation indicate that mesophilic anaerobic digestion of agricultural biomass, combined with an internal combustion engine, is a reliable source of alternative electrical production. A major advantage of biomass energy facilities located on dairy farms appears to be their inherent stability and ability to produce a consistent, 24 hour supply of electricity. However, technical analysis indicated that the Fiscalini Farms system was operating below capacity and that economic sustainability would be improved by increasing loading of feedstocks to the digester. Additional operational modifications, such as increased utilization of waste heat and better documentation of potential of carbon credits, would also improve the economic outlook. Analysis of baseline operational conditions indicated that a reduction in methane emissions and other greenhouse gas savings resulted from implementation of the project. The project results indicate that using anaerobic digestion to produce bio-methane from agricultural biomass is a promising source of electricity, but that significant challenges need to be addressed before dairy-based biomass energy production can be fully integrated into an alternative energy economy. The biomass energy facility was found to be operating undercapacity. Economic analysis indicated a positive economic sustainability, even at the reduced power production levels demonstrated during the baseline period. However, increasing methane generation capacity (via the importation of biomass codigestate) will be critical for increasing electricity output and improving the long-term economic sustainability of the operation. Dairy-based biomass energy plants are operating under strict environmental regulations applicable to both power-production and confined animal facilities and novel approached are being applied to maintain minimal environmental impacts. The use of selective catalytic reduction (SCR) for nitrous oxide control and a biological hydrogen sulfide control system were tested at this facility. Results from this study suggest that biomass energy systems can be compliant with reasonable scientifically based air and water pollution control regulations. The most significant challenge for the development of biomass energy as a viable component of power production on a regional scale is likely to be the availability of energy-rich organic feedstocks. Additionally, there needs to be further development of regional expertise in digester and power plant operations. At the Fiscalini facility, power production was limited by the availability of biomass for methane generation, not the designed system capacity. During the baseline study period, feedstocks included manure, sudan grass silage, and refused-feed. The ability of the dairy to produce silage in excess of on-site feed requirements limited power production. The availability of biomass energy crops and alternative feedstocks, such as agricultural and food wastes, will be a major determinant to the economic and environmental sustainability of biomass based electricity production.

03 NATURAL GAS↗

Sandia National Laboratories environmental fluid dynamics code: pH effects user manual

This document describes the implementation level changes in the source code and input files of Sandia National Laboratories Environmental Fluid Dynamics Code (SNL-EFDC) that are necessary for including pH effects into algae-growth dynamics. The document also gives a brief introduction to how pH effects are modeled into the algae-growth model. The document assumes that the reader is aware of the existing algae-growth model in SNL-EFDC. The existing model is described by James, Jarardhanam and more theoretical considerations behind modeling pH effects are presented therein. This document should be used in conjunction with the original EFDC manual and the original water-quality manual.

22 GENERAL STUDIES OF NUCLEAR REACTORS↗

Ground Control Annual Plan for the Waste Isolation Pilot Plant (Rev. 9)

This Ground Control Annual Plan (GCAP) is a guidance document for short- and long-term planning for the Washington TRU Solutions LLC (WTS) underground ground control operations. Because ground conditions are dynamic, the data collected for the plan and the evaluation of these data are most useful when used or considered immediately after collection. Use of the data becomes more difficult and less certain with time. This plan is updated annually, and each successive document supersedes the previous document. The data, evaluations, and support plans may be updated more frequently. This document is not intended to be used as a final plan for construction. Detailed plans and work instructions are developed specifically for that purpose.

12 MANAGEMENT OF RADIOACTIVE AND NON-RADIOACTIVE W↗

Ground Control Annual Plan for the Waste Isolation Pilot Plant (Rev. 10)

This Ground Control Annual Plan (GCAP) is a guidance document for short- and long-term planning for the Washington TRU Solutions LLC (WTS) underground ground control operations. Because ground conditions are dynamic, the data collected for the plan and the evaluation of these data are most useful when used or considered immediately after collection. Use of the data becomes more difficult and less certain with time. This plan is updated annually, and each successive document supersedes the previous document. The data, evaluations, and support plans may be updated more frequently. This document is not intended to be used as a final plan for construction. Detailed plans and work instructions are developed specifically for that purpose.

12 MANAGEMENT OF RADIOACTIVE AND NON-RADIOACTIVE W↗

Polar Drive Ignition Campaign: Conceptual Design

The Laboratory for Laser Energetics (LLE) at the University of Rochester is proposing a collaborative effort with Lawrence Livermore National Laboratory (LLNL), Los Alamos National Laboratories (LANL), the Naval Research Laboratory (NRL), and General Atomics (GA) with the goal of developing a cryogenic polar drive (PD) ignition platform on the National Ignition Facility (NIF). The scope of this proposed project requires close discourse among theorists, experimentalists, and laser and system engineers. This document describes how this proposed project can be broken into a series of parallel independent activities that, if implemented, could deliver this goal in the 2017 timeframe. This Conceptual Design document is arranged into two sections: mission need and design requirements. Design requirements are divided into four subsystems: (1) A point design that details the necessary target specifications and laser pulse requirements; (2) The beam smoothing subsystem that describes the MultiFM 1D smoothing by spectral dispersion (SSD); (3) New optical elements that include continuous phase plates (CPP's) and distributed polarization rotators (DPR's); and (4) The cryogenic target handling and insertion subsystem, which includes the design, fabrication, testing, and deployment of a dedicated PD ignition target insertion cryostat (PD-ITIC). This document includes appendices covering: the primary criteria and functional requirements, the system design requirements, the work breakdown structure, the target point design, the experimental implementation plan, the theoretical unknowns and technical implementation risks, the estimated cost and schedule, the development plan for the DPR's, the development plan for MultiFM 1D SSD, and a list of acronym definitions. While work on the facility modifications required for PD ignition has been in progress for some time, some of the technical details required to define the specific modifications for a Conceptual Design Review (CDR) remain to be defined. In all cases, the facility modifications represent functional changes to existing systems or capabilities. The bulk of the scope yet to be identified is associated with the DPR's and MultiFM beam smoothing. Detailed development plans for these two subsystems are provided in Appendices H and I; additional discussion of subsystem requirements based on the physics of PD ignition is given in Section 3. Accordingly, LLE will work closely with LLNL to develop detailed conceptual designs for the PD-specific facility modifications, including assessments of the operational impact of implementation (e.g., changing optics for direct rather than indirect-drive illumination and swapping from a hohlraum-based ITIC to one that supports PD). Furthermore, the experimental implementation plan represents the current best understanding of the experimental campaigns required to achieve PD ignition. This plan will evolve based on the lessons learned from the National Ignition Campaign (NIC) and ongoing indirect-drive ignition experiments. The plan does not take the operational realities of the PD configuration into account; configuration planning for the proposed PD experiments is beyond the scope of this document.

42 ENGINEERING↗

Steady Deflagration of PBX-9501 Within a Copper Cylinder

A copper cylinder cook-off experiment has been designed to cause steady deflagration in PBX-9501 explosive material. The design is documented and preliminary copper expansion results are presented for steady deflagration with a reaction speed of 1092 +/- 24 m/s. The expansion of reaction products from the detonation of an explosive is something that is well understood, and reasonably simulated using documented equations of state (EOS) for many explosives of interest. These EOS were historically measured using a 'standard' copper cylinder test design; this design comprised an annealed, oxygen-free high conductivity (OFHC) copper tube filled with explosive material and detonated from one end. Expansion of the copper wall was measured as a function of time using either a streak camera (for classic testing), or more recently using laser velocimetry techniques. Expansion data were then used to derive the EOS in various preferred forms - which are not discussed here for the sake of brevity. When an explosive deflagrates rather than detonating, simulation becomes more difficult. Reaction products are released on a slower time scale, and the reactions are much more affected by the geometry and local temperature within the reaction environment. It is assumed that the standard, documented EOS will no longer apply. In an effort to establish a first order approximation of deflagration product behavior, a cook-off test has been designed to cause steady deflagration in PBX-9501 explosive material, and to record the copper expansion profile as a function of time during this test. The purpose of the current paper is to document the initial test design and report some preliminary results. A proposal for modification of the design is also presented.

45 MILITARY TECHNOLOGY, WEAPONRY, AND NATIONAL DEF↗

Digitization Best Practices [Poster]

This project involved performing tests and documenting results to determine best practices for digitizing older print documents. The digitization process is complicated, especially when original documents exhibit non-standard fonts and are faded. Tests focused on solutions to improve high quality scanning, increase OCR accuracy, and efficiently use embedded metadata. Results are summarized. From the test results on the right sides, we know that when we plan to digitize documents, we should balance Quantity and Quality based on our expectation, and then make final decision for the digitization process.

99 GENERAL AND MISCELLANEOUS↗

Xyce TM Parallel Electronic Simulator: Reference Guide, Version 5.3

This document is a reference guide to the Xyce Parallel Electronic Simulator, and is a companion document to the Xyce Users’ Guide. The focus of this document is (to the extent possible) exhaustively list device parameters, solver options, parser options, and other usage details of Xyce. This document is not intended to be a tutorial. Users who are new to circuit simulation are better served by the Xyce Users’ Guide.

42 ENGINEERING↗