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Supporting the industry by developing a design guidance for computer-based procedures for field workers - 274

The paper-based procedures currently used for nearly all activities in the commercial nuclear power industry have a long history of ensuring safe operation of the plants. However, there is potential to greatly increase efficiency and safety by improving how the human interacts with the procedures, which can be achieved through the use of computer-based procedures (CBPs). A CBP system offers a vast variety of improvements, such as context driven job aids, integrated human performance tools and dynamic step presentation. As a step toward the goal of improving procedure use performance, the U.S. Department of Energy Light Water Reactor Sustainability Program researchers, together with the nuclear industry, have been investigating the feasibility of replacing current paper-based procedures with CBPs. The main purpose of the CBP research for nuclear field workers conducted at the Idaho National Laboratory was to provide design guidance to the nuclear industry to be used by both utilities and vendors. After studying existing design guidance for CBP systems, the researchers concluded that the majority of the existing guidance is intended for control room CBP systems, and does not necessarily address the challenges of designing CBP systems for instructions carried out in the field. Further, the guidance is often presented on a high level, which leaves the designer to interpret what is meant by the guidance and how to specifically implement it. The authors developed a design guidance to provide guidance specifically tailored to instructions that are carried out in the field based. (authors)

46 INSTRUMENTATION RELATED TO NUCLEAR SCIENCE AND ↗

The Use of Laser Guidance Reduces Fluoroscopy Time for C-Arm Cone-Beam Computed Tomography-Guided Biopsies

PurposeWhen using laser guidance for cone-beam computed tomography (CBCT)-guided needle interventions, planned needle paths are visualized to the operator without the need to switch between entry- and progress-view during needle placement. The current study assesses the effect of laser guidance during CBCT-guided biopsies on fluoroscopy and procedure times.Materials and MethodsProspective data from 15 CBCT-guided biopsies of 8–65 mm thoracic and abdominal lesions assisted by a ceiling-mounted laser guidance technique were compared to retrospective data of 36 performed CBCT-guided biopsies of lesions >20 mm using the freehand technique. Fluoroscopy time, procedure time, and number of CBCT-scans were recorded. All data are presented as median (ranges).ResultsFor biopsies using the freehand technique, more fluoroscopy time was necessary to guide the needle onto the target, 165 s (83–333 s) compared to 87 s (44–190 s) for laser guidance (p < 0.001). Procedure times were shorter for freehand-guided biopsies, 24 min versus 30 min for laser guidance (p < 0.001).ConclusionThe use of laser guidance during CBCT-guided biopsies significantly reduces fluoroscopy time.

62 RADIOLOGY AND NUCLEAR MEDICINE↗

MO-DE-210-07: Investigation of Treatment Interferences of a Novel Robotic Ultrasound Radiotherapy Guidance System with Clinical VMAT Plans for Liver SBRT Patients

Purpose: To evaluate the proportion of liver SBRT cases in which robotic ultrasound image guidance concurrent with beam delivery can be deployed without interfering with clinically used VMAT beam configurations. Methods: A simulation environment incorporating LINAC, couch, planning CT, and robotic ultrasound guidance hardware was developed. Virtual placement of the robotic ultrasound hardware was guided by a target visibility map rendered on the CT surface. The map was computed on GPU by using the planning CT to simulate ultrasound propagation and attenuation along rays connecting skin surface points to a rasterized imaging target. The visibility map was validated in a prostate phantom experiment by capturing live ultrasound images of the prostate from different phantom locations. In 20 liver SBRT patients treated with VMAT, the simulation environment was used to place the robotic hardware and ultrasound probe at imaging locations indicated on the visibility map. Imaging targets were either entire PTV (range 5.9–679.5 ml) or entire GTV (range 0.9–343.4 ml). Presence or absence of mechanical collisions with LINAC, couch, and patient body as well as interferences with treated beams were recorded. Results: For PTV targets, robotic ultrasound guidance without mechanical collision was possible in 80% of the cases and guidance without beam interference was possible in 60% of the cases. For the smaller GTV targets, these proportions were 95% and 85% correspondingly. GTV size (1/20), elongated shape (1/20), and depth (1/20) were the main factors limiting the availability of non-interfering imaging positions. Conclusion: This study indicates that for VMAT liver SBRT, robotic ultrasound tracking of a relevant internal target would be possible in 85% of cases while using treatment plans currently deployed in the clinic. With beam re-planning in accordance with the presence of robotic ultrasound guidance, intra-fractional ultrasound guidance may be an option for 95% of the liver SBRT cases. This project was funded by NIH Grant R41CA174089.

60 APPLIED LIFE SCIENCES↗

Three-dimensional Image Fusion Guidance for Transjugular Intrahepatic Portosystemic Shunt Placement

IntroductionTo assess the safety, feasibility and effectiveness of image fusion guidance with pre-procedural portal phase computed tomography with intraprocedural fluoroscopy for transjugular intrahepatic portosystemic shunt (TIPS) placement.Materials and methodsAll consecutive cirrhotic patients presenting at our interventional unit for TIPS creation from January 2015 to January 2016 were prospectively enrolled. Procedures were performed under general anesthesia in an interventional suite equipped with flat panel detector, cone-beam computed tomography (CBCT) and image fusion technique. All TIPSs were placed under image fusion guidance. After hepatic vein catheterization, an unenhanced CBCT acquisition was performed and co-registered with the pre-procedural portal phase CT images. A virtual path between hepatic vein and portal branch was made using the virtual needle path trajectory software. Subsequently, the 3D virtual path was overlaid on 2D fluoroscopy for guidance during portal branch cannulation. Safety, feasibility, effectiveness and per-procedural data were evaluated.ResultsSixteen patients (12 males; median age 56 years) were included. Procedures were technically feasible in 15 of the 16 patients (94%). One procedure was aborted due to hepatic vein catheterization failure related to severe liver distortion. No periprocedural complications occurred within 48 h of the procedure. The median dose-area product was 91 Gy cm{sup 2}, fluoroscopy time 15 min, procedure time 40 min and contrast media consumption 65 mL. Clinical benefit of the TIPS placement was observed in nine patients (56%).ConclusionThis study suggests that 3D image fusion guidance for TIPS is feasible, safe and effective. By identifying virtual needle path, CBCT enables real-time multiplanar guidance and may facilitate TIPS placement.

62 RADIOLOGY AND NUCLEAR MEDICINE↗

Enhanced Magnetic Levitation and Guidance Force in MgB{sub 2} Bulks by Synthetic Engine Oil Immersion

We have used ‘Synthetic engine oil’ as a rich easily accessible carbon source and investigated the effect of engine oil on the microstructure, critical current density (J{sub c}), vertical levitation force (F{sub z}) and guidance force (F{sub x}) properties of MgB{sub 2} superconductor. The polycrystalline disk-shaped MgB{sub 2} bulk samples have been prepared using two-step solid-state reaction process. After the first heating process, MgB{sub 2} bulk samples immersed in the engine oil for different durations (30, 120, 300 and 1440 min). XRD analysis indicated the decreasing of lattice parameters of samples and confirmed C substitution in boron sites. Vertical levitation and guidance force measurements were carried out with both Field-cooling (FC) and zero-field-cooling (ZFC) regimes at different temperatures of 20, 24 and 28 K. It was found that engine oil addition slightly increases the levitation and guidance force properties. The F{sub z} values were obtained as 11.17 and 11.58 N for pure and MgB{sub 2} sample immersed for 30 min at 20 K in ZFC regime. In addition, the MgB{sub 2} sample immersed for 300 min in engine oil showed the highest J{sub c} value of 5.3×10{sup 4} A cm{sup − 2} at 15 K and self-field and showed the highest guidance force value of 4.14 N at 20 K. These finding suggest that synthetic engine oil is a cost-effective and promising method to improve the levitation and guidance force performance as well as the critical current density of MgB{sub 2} bulk superconductor.

75 CONDENSED MATTER PHYSICS, SUPERCONDUCTIVITY AND↗

Immobilization and image-guidance methods for radiation therapy of limb extremity soft tissue sarcomas: Results of a multi-institutional survey

Radiation therapy for limb-extremity soft tissue sarcoma (STS) requires accurate, reproducible dose delivery. However, patient positioning is challenging and there is a lack of existing guidelines to assist institutional standardization. Therefore, we conducted a multi-institutional international survey of STS immobilization, image guidance methods, and treatment protocols to investigate current practice. Seventy-three UK radiotherapy centers and 15 hospitals in 7 other countries completed a questionnaire on STS immobilization and image-guidance procedures. Specifically, the survey collated information on the current usage of immobilization equipment, including custom devices, patient setup tolerances, the use of written protocols, the modality and frequency of image guidance, the method of treatment, allocated treatment times, and the application of surgical clips. Multiple combinations of immobilization devices were reported. In the UK, 12%, 40%, 30%, 12%, and 5% use 1, 2, 3, 4, and 5 types of device for lower limb STS. Vacuum bag plus either foot or ankle support was most common (66%). Of 15 international centers, 27%, 60%, 7%, 0%, 7% use 1, 2, 3, 4, 5 devices, with vacuum bags (73%) and thermoplastic (47%) predominant, similar to UK values of 77% and 52%. For image guidance, in the UK, 37% use kV planar, 34% use MV planar, and 16% use cone-beam CT for the first 3 fractions and then weekly. Internationally, daily imaging was more prevalent with 33% using kV planar, 7% MV planar, and 40% cone-beam CT daily. Custom devices plus combinations of devices, along with 5- and 10-mm set-up tolerances, were most commonly reported. Less than half of centers have written treatment protocols. Conventional treatment is most common in the UK, with only 42% using conformal techniques. Treatment is allocated between 10 and 30 minutes. Twenty-six percent of UK centers and 53% of international centers use surgical clips. Across treatment centers, there is no consistent approach to STS immobilization, image-guidance methods, or treatment protocols assessed by this survey. A wide variety of immobilization devices and configurations are utilized, and the frequency and modality of imaging are similarly diverse. In the absence of guidelines, the creation of an online repository of example immobilization techniques could enable centers to compare a diversity of cases. The availability of a forum for viewing and discussing a range of cases could potentially lead to improved patient setup and reduce the time taken to devise an individual immobilization strategy.

62 RADIOLOGY AND NUCLEAR MEDICINE↗

NETL CO2U LCA Guidance Document

The NETL CO2U LCA Guidance Document is part of the NETL CO2U LCA Guidance Toolkit for Carbon Utilization funding recipients to meet their LCA requirements. The toolkit includes the following files: NETL CO2U LCA Guidance Document, NETL CO2U openLCA LCI Database, NETL CO2U openLCA Results Contribution Tool, NETL CO2U LCA Documentation Spreadsheet, and NETL CO2U LCA Report Template. The NETL CO2U LCA Guidance Document provides guidance to funding recipients on what shall, should, and may be included in their LCA, along with helpful information on completing their LCA.

Source record↗

Spin-stabilized orbital rocket guidance

Technologies for guidance of a spin-stabilized orbital rocket are described herein. The spin-stabilized rocket includes a guidance controller. The guidance controller computes parameters of a burn of a second-stage engine of the rocket to reach a desired nominal orbit subsequent to burnout of the first stage of the rocket. The guidance controller computes the burn parameters of the second-stage engine based upon one or more desired orbit parameters and a current position and velocity of the rocket. The computation of the burn parameters is based upon a simulated point-mass model of the motion of the rocket. The guidance controller then controls the rocket to initiate a second-stage burn having the computed burn parameters.

Gilkey, Jeffrey C.↗

The utility of ultrasound guidance in transjugular liver biopsy: our experience

Purpose: To demonstrate the utility of ultrasound (US) guidance in improving the safety and efficacy of transjugular liver biopsy (TJLB) by analyzing all the TJLBs performed by us in the last 4 years. Materials and methods: Forty-seven patients who underwent TJLB in the last 4 years in our two centers were retrospectively analyzed. US guidance was used for all but for one patient during the two crucial steps of the procedure—for internal jugular vein (IJV) access and during the parenchymal biopsy. Biopsies were obtained under real-time sonographic guidance from the right lobe after confirming an adequate room for needle throw without breaching the liver capsule or any major hilar structures. Post-procedure complications, tissue yield, and histopathological adequacy of samples were analyzed. Results: Overall technical success rate was 100%. No major complications were found where ultrasound-assisted TJLB (uTJLB) was performed. One patient who underwent non-US guided TJLB had an event of a capsular breach and intra-peritoneal hemorrhage requiring coil embolization. Samples were of adequate dimension. Histopathological positivity was 100%. The overall complication rate for uTJLB was 4.7% which was due to minor complications in two patients. Conclusions: Addition of US unit to the angiographic suite is effortless and Interventional Radiologists being already skilled in US can easily implement this simple yet valuable modification to conventional TJLB procedures. Our experience on uTJLB further emphasizes the role of US guidance in improving the procedural success rate, safety profile, and efficacy in the histopathological outcome of TJLB in all patients irrespective of age and disease burden.

62 RADIOLOGY AND NUCLEAR MEDICINE↗

Fusion Guidance in Endovascular Peripheral Artery Interventions: A Feasibility Study

PurposeThis study was designed to evaluate the feasibility of endovascular guidance by means of live fluoroscopy fusion with magnetic resonance angiography (MRA) and computed tomography angiography (CTA).MethodsFusion guidance was evaluated in 20 endovascular peripheral artery interventions in 17 patients. Fifteen patients had received preinterventional diagnostic MRA and two patients had undergone CTA. Time for fluoroscopy with MRA/CTA coregistration was recorded. Feasibility of fusion guidance was evaluated according to the following criteria: for every procedure the executing interventional radiologists recorded whether 3D road-mapping provided added value (yes vs. no) and whether PTA and/or stenting could be performed relying on the fusion road-map without need for diagnostic contrast-enhanced angiogram series (CEAS) (yes vs. no). Precision of the fusion road-map was evaluated by recording maximum differences between the position of the vasculature on the virtual CTA/MRA images and conventional angiography.ResultsAverage time needed for image coregistration was 5 ± 2 min. Three-dimensional road-map added value was experienced in 15 procedures in 12 patients. In half of the patients (8/17), intervention was performed relying on the fusion road-map only, without diagnostic CEAS. In two patients, MRA roadmap showed a false-positive lesion. Excluding three patients with inordinate movements, mean difference in position of vasculature on angiography and MRA/CTA road-map was 1.86 ± 0.95 mm, implying that approximately 95 % of differences were between 0 and 3.72 mm (2 ± 1.96 standard deviation).ConclusionsFluoroscopy with MRA/CTA fusion guidance for peripheral artery interventions is feasible. By reducing the number of CEAS, this technology may contribute to enhance procedural safety.

62 RADIOLOGY AND NUCLEAR MEDICINE↗

Pediatric Percutaneous Osteoid Osteoma Ablation: Cone-Beam CT with Fluoroscopic Overlay Versus Conventional CT Guidance

PurposeTo compare technical success, clinical success, complications, radiation dose, and total room utilization time for osteoid osteoma thermal (radiofrequency or microwave) ablation using cone-beam computed tomography (CBCT) with two-axis fluoroscopic navigational overlay versus conventional computed tomography (CT) guidance.Materials and MethodsA retrospective review was performed to identify all osteoid osteoma ablations performed over a 5.5-year period at a single tertiary care pediatric hospital. Twenty-five ablations (15 radiofrequency and 10 microwave) in 23 patients undergoing fluoroscopic CBCT-guided osteoid osteoma ablation were compared to 35 ablations (35 radiofrequency) in 32 patients undergoing ablation via conventional CT guidance. Dose area product and dose length product were recorded for CBCT and conventional CT, respectively, and converted to effective doses. Technical success, clinical success (cessation of pain and medication use 1 month after ablation), complications, radiation dose, and total room utilization time were compared.ResultsAll procedures were technically successful. Twenty-two of 25 (88.0%) CBCT and 31 of 35 (88.6%) conventional CT-guided ablations achieved immediate clinical success. There were two minor complications in each group and no major complications. Mean effective radiation dose was significantly lower for CBCT compared to CT guidance (0.12 vs. 0.39 mSv, p = 0.02). Mean total room utilization time for CBCT was longer (133.5 vs. 97.5 min, p = 0.0001).ConclusionsFluoroscopic CBCT guidance for percutaneous osteoid osteoma ablation yields similar technical and clinical success, reduced radiation dose, and increased total room utilization time compared to conventional CT guidance.

62 RADIOLOGY AND NUCLEAR MEDICINE↗

C-Arm Cone Beam CT for Intraprocedural Image Fusion and 3D Guidance in Portal Vein Embolization (PVE)

PurposePortal vein embolization (PVE) is applied in patients with extended oncologic liver disease to induce hyperplasia of the future liver remnant and make resection feasible. Ultrasound (US) guidance is the gold standard for percutaneous portal vein access. This study evaluated feasibility and safety of C-arm cone beam computed tomography (CBCT) for needle guidance.Materials and MethodsIn 10 patients, puncture was performed under 3D needle guidance in a CBCT data set. Contrast-enhanced (CE) CBCT was generated (n = 7), or native CBCT was registered to pre-examination CE-CT via image fusion (n = 3). Technical success, number of punctures, puncture time (time between CBCT acquisition and successful portal vein access), dose parameters and safety were evaluated. For comparison, 10 patients with PVE under US guidance were analyzed retrospectively. Study and control group were matched for age, BMI, INR, platelets, portal vein anatomy.ResultsAll interventions were technically successful without intervention-related complications. In the study group, the mean number of puncture attempts was 3.1 ± 2.5. Mean puncture time was 12 min (±10). Mean total dose area product (DAP) was 288 Gy cm{sup 2} (±154). The mean relative share of CBCT-related radiation exposure was 6% (±3). Intervention times and DAP were slightly higher compared to the control group without reaching significance.ConclusionCBCT-guided PVE is feasible and safe. The relative dose of CBCT is low compared to the overall dose of the intervention. This technique may be a promising approach for difficult anatomic situations that limit the use of US for needle guidance.

62 RADIOLOGY AND NUCLEAR MEDICINE↗

Clinical Experience with Real-Time 3-D Guidance Based on C-Arm-Acquired Cone-Beam CT (CBCT) in Transjugular Intrahepatic Portosystemic Stent Shunt (TIPSS) Placement

PurposeThe aim of this study was to evaluate the feasibility of cone-beam computed tomography (CBCT)-based real-time 3-D guidance of TIPSS placement and its positioning compared to standard guiding methods.Materials and MethodsIn a prospective, randomized, consecutive study design from 2015 to 2017, we included 21 patients in the CBCT guided group and 15 patients in the ultrasound (US) guided group. The prospective groups were compared in terms of success rate of intervention, portal vein puncture/procedure time, number of puncture attempts and applied dose. We furthermore retrospectively analyzed the last 23 consecutive cases with fluoroscopic guided portal vein puncture in terms of success rate, procedure time and applied dose, as it has been the standard method before US guidance.ResultsThe median number of puncture attempts (CBCT: n = 2, US: n = 4, p = 0.249) and the mean puncture time (CBCT: 32 ± 45 min, US: 36 ± 45 min, p = 0.515) were not significantly different. There were furthermore no significant differences in the mean time needed for the total TIPSS procedure (CBCT: 115 ± 52 min, US: 112 ± 41 min, fluoroscopy: 110 ± 33 min, p = 0.996). The mean applied dose of the complete procedure also showed no statistically significant differences (CBCT: 563 ± 289 Gy·cm{sup 2}, US: 322 ± 186 Gy·cm{sup 2}, fluoroscopy: 469 ± 352 Gy·cm{sup 2}, p = 0.069). There were no image guidance related complications.ConclusionReal-time 3-D needle guidance based on CBCT is feasible for TIPSS placement. In terms of puncture attempts, duration and dose, CBCT guidance was not inferior to the control groups and may be a valuable support for interventionists in TIPSS procedures.

62 RADIOLOGY AND NUCLEAR MEDICINE↗

Renewable Energy Guidance for Industry

This document is intended to help Better Plants partners navigate the renewable energy market by providing background on renewable technologies and their benefits as well as a wide range of purchasing options available to organizations. This guidance provides helpful information on adopting renewables by highlighting tools and resources for evaluating renewable energy projects. It also provides information on how renewable energy resources are accounted for by Better Plants reporting requirements. A separate supplemental document to this guidance is available that provides more in-depth information about renewable technologies. This guidance document is applicable to Better Plants partners participating at either the program or challenge level. Although the guidance is primarily intended to assist companies participating in Better Plants, the methodologies and information within are applicable to any organization interested in exploring and adopting renewable energy.

09 BIOMASS FUELS↗

Groundwater Monitoring Guidance for Decommissioning Planning - 16228

The Electric Power Research Institute (EPRI) is preparing a document called Groundwater Monitoring Guidance for Decommissioning Planning. This guidance is the first part of a multi-year EPRI project which summarizes experiences with both operational and decommissioning groundwater protection programs and compares the two in order to identify data gaps. The EPRI guidance will show how to address these data gaps and provide recommended decommissioning preparatory actions. The second part of this project will addresses the long term stewardship of a groundwater protection program after the permanent shutdown of the plant during the SAFSTOR period and/or during the active decommissioning of the plant. This paper will discuss the content of the first EPRI guidance document that is focused on decommissioning planning. (authors)

12 MANAGEMENT OF RADIOACTIVE AND NON-RADIOACTIVE W↗

A qualitative assessment of current CCF guidance based on a review of safety system digital implementation changes with evolving technology - 148

This paper is a summary of a study performed in support of the US Nuclear Regulatory Commission (NRC) to evaluate current policy on software common-cause failure (CCF). The study reported in this paper is one of several that contributed to the technical basis to inform NRC staff. The study first reviewed policies and assessment guidance as discussed in the Staff Requirements Memorandum to the Secretary of the Commission, Office of the NRC (SECY) 93-087, Policy, Technical, and Licensing Issues Pertaining to Evolutionary and Advanced Light Water Reactor (ALWR) Designs, and Branch Technical Position (BTP) 7-19, Guidance on Evaluation of Defense-in-Depth and Diversity in Digital Computer-Based Instrumentation and Control Systems, as well as Chapter 7, 'Instrumentation and Controls', in NUREG-0800, Standard Review Plan for Review of Safety Analysis Reports for Nuclear Power Plants. The study then examined instrumentation and controls (I and C) technology implementations in nuclear power plants in the light of current CCF guidance. The intent was to assess whether the current position on CCF remains appropriate given the evolutions in digital safety system implementations and, if gaps in the guidance were found, to provide recommendations as to how these gaps could be closed. The methodology adopted was to review the vendors' technology and software implementation processes for digital safety systems as technology evolved. The following three representative safety systems were selected to provide illustrative examples: - Eagle 21 was selected to represent vintage microprocessor-based technology used from the 1980's to mid-1990's, - TELEPERM XS (TXS) was selected to represent second generation microprocessor-based technology used from the mid-1990's to the 2000's, and - The advanced logic system (ALS) was selected to represent the latest trend of using technology based on field programmable gate arrays (FPGAs). Technology implementations were reviewed in light of the basic premise of the NRC in BTP 7-19 (Revision 6), that software-based or software-logic-based digital system development errors are a credible source of CCF and therefore are susceptible to CCF because identical copies of the software-based logic and architecture are present in redundant divisions of safety-related systems. BTP 7-19 categorizes firmware and logic developed from software-based development systems all under software. (authors)

22 GENERAL STUDIES OF NUCLEAR REACTORS↗

Commissioning Guidance for Energy Savings Performance Contracts (ESPCs)

This Commissioning Guidance for Energy Savings Performance Contracts (ESPCs) is DOE’s official guidance for ordering agencies under the current DOE ESPC IDIQ contract. This guidance document explains how commissioning of energy conservation measures (ECMs) and water conservation measures (WCMs) is incorporated into the ESPC process, roles and responsibilities in project commissioning, and key elements of commissioning. This document updates the previous version, released in 2015. This guidance can also be used as applicable in the development of ESPC ENABLE and UESC performance assurance plans.

Walker, Christine↗

Development of Criticality Safety Validation Guidance for NRC-Regulated Activities

Some guidance documents support validation of criticality safety evaluations for many system types, and some accommodate different regulators or regulatory requirements. While these reports address specific applications, no single document applies to all systems and incorporates both traditional and sensitivity/uncertainty-based validation techniques. Oak Ridge National Laboratory will develop a single reference report for the US Nuclear Regulatory Commission (NRC) that provides modern examples and suggested recommendations for a uniform approach for performing and documenting k eff calculation validations applicable to any system containing fissile material. The project will include a literature review and development of a new, comprehensive NUREG/CR document on nuclear criticality safety validation. The NUREG will address the following experiences from recent reviews: 1. Inappropriate critical experiment selection 2. Insufficient trending analysis 3. Incorrectly calculated 95/95 uncertainties 4. Failure to address how validation applies to safety analysis 5. Lack of goodness-of-fit testing in trending analyses 6. Incorrect use of commercial reactor critical data 7. Failure to meet bias determination methodology prerequisites 8. Inappropriate extrapolation of bias and uncertainty 9. Failure to identify validation analysis gaps and weaknesses 10. Inadequate validation analysis documentation the final report will provide guidance on use of trending analysis results, acceptable confidence levels for normality testing and trending analysis, management of validation analysis gaps and weaknesses, use of sensitivity and uncertainty analysis in validation analysis, and potential impact of correlations among critical experiments used in validation. It will also consolidate existing guidance documents using both traditional and sensitivity/uncertainty-based approaches. This document will support NRC-regulated activities, as well as validation used in criticality safety within other regulatory frameworks.

96 KNOWLEDGE MANAGEMENT AND PRESERVATION↗