Statistical Sampling Plans for Prior Measurement Verification and Determination of the SNM Content of Inventories

Current regulations require that prior information on the Special Nuclear Material (SNM) content o f a population o f containers be verified and that periodic measurements o f the SNM inventory of a facility be performed. This report develops and describes statistical sampling plans for accomplishing these tasks and compares results obtained by sampling to those obtained by the current practice o f performing a census (100% sampling

Experimental and Sampling Design for the INL-2 Sample Collection Operational Test

This report describes the experimental and sampling design developed to assess sampling approaches and methods for detecting contamination in a building and clearing the building for use after decontamination. An Idaho National Laboratory (INL) building will be contaminated with BG (Bacillus globigii, renamed Bacillus atrophaeus), a simulant for Bacillus anthracis (BA). The contamination, sampling, decontamination, and re-sampling will occur per the experimental and sampling design. This INL-2 Sample Collection Operational Test is being planned by the Validated Sampling Plan Working Group (VSPWG). The primary objectives are: 1) Evaluate judgmental and probabilistic sampling for characterization as well as probabilistic and combined (judgment and probabilistic) sampling approaches for clearance, 2) Conduct these evaluations for gradient contamination (from low or moderate down to absent or undetectable) for different initial concentrations of the contaminant, 3) Explore judgment composite sampling approaches to reduce sample numbers, 4) Collect baseline data to serve as an indication of the actual levels of contamination in the tests. A combined judgmental and random (CJR) approach uses Bayesian methodology to combine judgmental and probabilistic samples to make clearance statements of the form "X% confidence that at least Y% of an area does not contain detectable contamination” (X%/Y% clearance statements). The INL-2 experimental design has five test events, which 1) vary the floor of the INL building on which the contaminant will be released, 2) provide for varying the amount of contaminant released to obtain desired concentration gradients, and 3) investigate overt as well as covert release of contaminants. Desirable contaminant gradients would have moderate to low concentrations of contaminant in rooms near the release point, with concentrations down to zero in other rooms. Such gradients would provide a range of contamination levels to challenge the sampling, sample extraction, and analytical methods to be used in the INL-2 study. For each of the five test events, the specified floor of the INL building will be contaminated with BG using a point-release device located in the room specified in the experimental design. Then quality control (QC), reference material coupon (RMC), judgmental, and probabilistic samples will be collected according to the sampling plan for each test event. Judgmental samples will be selected based on professional judgment and prior information. Probabilistic samples were selected with a random aspect and in sufficient numbers to provide desired confidence for detecting contamination or clearing uncontaminated (or decontaminated) areas. Following sample collection for a given test event, the INL building will be decontaminated. For possibly contaminated areas, the numbers of probabilistic samples were chosen to provide 95% confidence of detecting contaminated areas of specified sizes. For rooms that may be uncontaminated following a contamination event, or for whole floors after decontamination, the numbers of judgmental and probabilistic samples were chosen using the CJR approach. The numbers of samples were chosen to support making X%/Y% clearance statements with X = 95% or 99% and Y = 96% or 97%. The experimental and sampling design also provides for making X%/Y% clearance statements using only probabilistic samples. For each test event, the numbers of characterization and clearance samples were selected within limits based on operational considerations while still maintaining high confidence for detection and clearance aspects. The sampling design for all five test events contains 2085 samples, with 1142 after contamination and 943 after decontamination. These numbers include QC, RMC, judgmental, and probabilistic samples. The experimental and sampling design specified in this report provides a good statistical foundation for achieving the objectives of the INL-2 study

Experimental Design for a Sponge-Wipe Study to Relate the Recovery Efficiency and False Negative Rate to the Concentration of a Bacillus anthracis Surrogate for Six Surface Materials

Two concerns were raised by the Government Accountability Office following the 2001 building contaminations via letters containing Bacillus anthracis (BA). These included the: 1) lack of validated sampling methods, and 2) need to use statistical sampling to quantify the confidence of no contamination when all samples have negative results. Critical to addressing these concerns is quantifying the false negative rate (FNR). The FNR may depend on the 1) method of contaminant deposition, 2) surface concentration of the contaminant, 3) surface material being sampled, 4) sample collection method, 5) sample storage/transportation conditions, 6) sample processing method, and 7) sample analytical method. A review of the literature found 17 laboratory studies that focused on swab, wipe, or vacuum samples collected from a variety of surface materials contaminated by BA or a surrogate, and used culture methods to determine the surface contaminant concentration. These studies quantified performance of the sampling and analysis methods in terms of recovery efficiency (RE) and not FNR (which left a major gap in available information). Quantifying the FNR under a variety of conditions is a key aspect of validating sample and analysis methods, and also for calculating the confidence in characterization or clearance decisions based on a statistical sampling plan. A laboratory study was planned to partially fill the gap in FNR results. This report documents the experimental design developed by Pacific Northwest National Laboratory and Sandia National Laboratories (SNL) for a sponge-wipe method. The testing was performed by SNL and is now completed. The study investigated the effects on key response variables from six surface materials contaminated with eight surface concentrations of a BA surrogate (Bacillus atrophaeus). The key response variables include measures of the contamination on test coupons of surface materials tested, contamination recovered from coupons by sponge-wipe samples, RE, and FNR. The experimental design involves 16 test runs, performed in two blocks of eight runs. Three surface materials (stainless steel, vinyl tile, and ceramic tile) were tested in the first block, while three other surface materials (plastic, painted wood paneling, and faux leather) were tested in the second block. The eight surface concentrations of the surrogate were randomly assigned to test runs within each block. Some of the concentrations were very low and presented challenges for deposition, sampling, and analysis. However, such tests are needed to investigate RE and FNR over the full range of concentrations of interest. In each run, there were 10 test coupons of each of the three surface materials. A positive control sample was generated at the same time as each test sample. The positive control results will be used to 1) calculate RE values for the wipe sampling and analysis method, and 2) fit RE- and FNR-concentration equations, for each of the six surface materials. Data analyses will support 1) estimating the FNR for each combination of contaminant concentration and surface material, 2) estimating the surface concentrations and their uncertainties of the contaminant for each combination of concentration and surface material, 3) estimating RE (%) and their uncertainties for each combination of contaminant concentration and surface material, 4) fitting FNR-concentration and RE-concentration equations for each of the six surface materials, 5) assessing goodness-of-fit of the equations, and 6) quantifying the uncertainty in FNR and RE predictions made with the fitted equations

Final Report - ILAW PCT, VHT, Viscosity, and Electrical Conductivity Model Development, VSL-07R1230-1

This report describes the results of work and testing specified by the Test Specifications (24590-LAW-TSP-RT-01-013 Rev.1 and 24590-WTP-TSP-RT-02-001 Rev.0), Test Plans (VSL-02T4800-1 Rev.1 & TP-RPP-WTP-179 Rev.1), and Text Exception (24590-WTP-TEF-RT-03-040). The work and any associated testing followed established quality assurance requirements and conducted as authorized. The descriptions provided in this test report are an accurate account of both the conduct of the work and the data collected. Results required by the Test Plans are reported. Also reported are any unusual or anomalous occurrences that are different from the starting hypotheses. The test results and this report have been reviewed and verified

First-order model for durability of Hanford waste glasses as a function of composition

Two standard chemical durability tests, the static leach test MCC-1 and product consistency test PCT, were conducted on simulated borosilicate glasses that encompass the expected range of compositions to be produced in the Hanford Waste Vitrification Plant (HWVP). A first-order empirical model was fitted to the data from each test method. The results indicate that glass durability is increased by addition of Al{sub 2}O{sub 3}, moderately increased by addition of ZrO{sub 2} and SiO{sub 2}, and decreased by addition of Li{sub 2}O, Na{sub 2}O, B{sub 2}O{sub 3}, and MgO. Addition of Fe{sub 2}O{sub 3} and CaO produce an indifferent or reducing effect on durability according to the test method. This behavior and a statistically significant lack of fit are attributed to the effects of multiple chemical reactions occurring during glass-water interaction. Liquid-liquid immiscibility is suspected to be responsible for extremely low durability of some glasses

Calculating Confidence, Uncertainty, and Numbers of Samples When Using Statistical Sampling Approaches to Characterize and Clear Contaminated Areas

This report discusses the methodology, formulas, and inputs needed to make characterization and clearance decisions for Bacillus anthracis-contaminated and uncontaminated (or decontaminated) areas using a statistical sampling approach. Specifically, the report includes the methods and formulas for calculating the • number of samples required to achieve a specified confidence in characterization and clearance decisions • confidence in making characterization and clearance decisions for a specified number of samples for two common statistically based environmental sampling approaches. In particular, the report addresses an issue raised by the Government Accountability Office by providing methods and formulas to calculate the confidence that a decision area is uncontaminated (or successfully decontaminated) if all samples collected according to a statistical sampling approach have negative results. Key to addressing this topic is the probability that an individual sample result is a false negative, which is commonly referred to as the false negative rate (FNR). The two statistical sampling approaches currently discussed in this report are 1) hotspot sampling to detect small isolated contaminated locations during the characterization phase, and 2) combined judgment and random (CJR) sampling during the clearance phase. Typically if contamination is widely distributed in a decision area, it will be detectable via judgment sampling during the characterization phrase. Hotspot sampling is appropriate for characterization situations where contamination is not widely distributed and may not be detected by judgment sampling. CJR sampling is appropriate during the clearance phase when it is desired to augment judgment samples with statistical (random) samples. The hotspot and CJR statistical sampling approaches are discussed in the report for four situations: 1. qualitative data (detect and non-detect) when the FNR = 0 or when using statistical sampling methods that account for FNR > 0 2. qualitative data when the FNR > 0 but statistical sampling methods are used that assume the FNR = 0 3. quantitative data (e.g., contaminant concentrations expressed as CFU/cm2) when the FNR = 0 or when using statistical sampling methods that account for FNR > 0 4. quantitative data when the FNR > 0 but statistical sampling methods are used that assume the FNR = 0. For Situation 2, the hotspot sampling approach provides for stating with Z% confidence that a hotspot of specified shape and size with detectable contamination will be found. Also for Situation 2, the CJR approach provides for stating with X% confidence that at least Y% of the decision area does not contain detectable contamination. Forms of these statements for the other three situations are discussed in Section 2.2. Statistical methods that account for FNR > 0 currently only exist for the hotspot sampling approach with qualitative data (or quantitative data converted to qualitative data). This report documents the current status of methods and formulas for the hotspot and CJR sampling approaches. Limitations of these methods are identified. Extensions of the methods that are applicable when FNR = 0 to account for FNR > 0, or to address other limitations, will be documented in future revisions of this report if future funding supports the development of such extensions. For quantitative data, this report also presents statistical methods and formulas for 1. quantifying the uncertainty in measured sample results 2. estimating the true surface concentration corresponding to a surface sample 3. quantifying the uncertainty of the estimate of the true surface concentration. All of the methods and formulas discussed in the report were applied to example situations to illustrate application of the methods and interpretation of the results

EVALUATION OF CONCRETE PROPERTY DATA AT ELEVATED TEMPERATURES FOR USE IN THE SAFE-CRACK COMPUTER CODE

Design and analysis of Hanford double-shell waste storage tanks has made use of the finite element computer code SAFE-CRACK as a check of the concrete portion of the tank design after cmpletion of design. Rockwell Hanford Operations, the site contractor responsible for operation of the tanks, has requested Battelle Pacific Northwest Laboratory (PNL) to evaluate the use of the Hanford concrete property data at elevated temperatures by the SAFE-CRACK code. The purpose of this investigation is to evaluate the proper use of the mathematical expressions in SAFE-CRACK to best define the physical concrete properties extrapolated from the documented concrete property data when subjected to elevated temperatures and cyclic temperature variations

Experimental Design for the INL Sample Collection Operational Test

This document describes the test events and numbers of samples comprising the experimental design that was developed for the contamination, decontamination, and sampling of a building at the Idaho National Laboratory (INL). This study is referred to as the INL Sample Collection Operational Test. Specific objectives were developed to guide the construction of the experimental design. The main objective is to assess the relative abilities of judgmental and probabilistic sampling strategies to detect contamination in individual rooms or on a whole floor of the INL building. A second objective is to assess the use of probabilistic and Bayesian (judgmental + probabilistic) sampling strategies to make clearance statements of the form “X% confidence that at least Y% of a room (or floor of the building) is not contaminated. The experimental design described in this report includes five test events. The test events (i) vary the floor of the building on which the contaminant will be released, (ii) provide for varying or adjusting the concentration of contaminant released to obtain the ideal concentration gradient across a floor of the building, and (iii) investigate overt as well as covert release of contaminants. The ideal contaminant gradient would have high concentrations of contaminant in rooms near the release point, with concentrations decreasing to zero in rooms at the opposite end of the building floor. For each of the five test events, the specified floor of the INL building will be contaminated with BG, a stand-in for Bacillus anthracis. The BG contaminant will be disseminated from a point-release device located in the room specified in the experimental design for each test event. Then judgmental and probabilistic samples will be collected according to the pre-specified sampling plan. Judgmental samples will be selected based on professional judgment and prior information. Probabilistic samples will be selected in sufficient numbers to provide desired confidence for detecting contamination or clearing uncontaminated (or decontaminated) areas. Following sample collection for a given test event, the INL building will be decontaminated using Cl2O gas. For possibly contaminated areas (individual rooms or the whole floor of a building), the numbers of probabilistic samples were chosen to provide 95% confidence of detecting contaminated areas of specified sizes. The numbers of judgmental samples were chosen based on guidance from experts in judgmental sampling. For rooms that may be uncontaminated following a contamination event, or for whole floors after decontamination, the numbers of judgmental and probabilistic samples were chosen using a Bayesian approach that provides for combining judgmental and probabilistic samples to make a clearance statement of the form “95% confidence that at least 99% of the room (or floor) is not contaminated”. The experimental design also provides for making 95%/Y% clearance statements using only probabilistic samples, where Y < 99. For each test event, the numbers of samples were selected for a minimal plan (containing fewer samples) and a preferred plan (containing more samples). The preferred plan is recommended over the minimal plan. The preferred plan specifies a total of 1452 samples, 912 after contamination and 540 after decontamination. The minimal plan specifies a total of 1119 samples, 744 after contamination and 375 after decontamination. If the advantages of the “after decontamination” portion of the preferred plan are judged to be small compared to the “after decontamination” portion of the minimal plan, it is an option to combine the “after contamination” portion of the preferred plan (912 samples) with the “after decontamination” portion of the minimal plan (375 samples). This hybrid plan would involve a total of 1287 samples

Bayesian D-Optimal Choice Designs for Mixtures

__Abstract__ \n \nConsumer products and services can often be described as mixtures of ingredients. Examples are the mixture of ingredients in a cocktail and the mixture of different components of waiting time (e.g., in-vehicle and out-of-vehicle travel time) in a transportation setting. Choice experiments may help to determine how the respondents\' choice of a product or service is affected by the combination of ingredients. In such studies, individuals are confronted with sets of hypothetical products or services and they are asked to choose the most preferred product or service from each set. \n \nHowever, there are no studies on the optimal design of choice experiments involving mixtures. We propose a method for generating an optimal design for such choice experiments. To this end, we first introduce mixture models in the choice context and next present an algorithm to construct optimal experimental designs, assuming the multinomial logit model is used to analyze the choice data. To overcome the problem that the optimal designs depend on the unknown parameter values, we adopt a Bayesian D-optimal design approach. We also consider locally D-optimal designs and compare the performance of the resulting designs to those produced by a utility-neutral (UN) approach in which designs are based on the assumption that individuals are indifferent between all choice alternatives. We demonstrate that our designs are quite different and in general perform better than the UN designs

COVID-19 in cancer patients: clinical characteristics and outcome—an analysis of the LEOSS registry

Introduction Since the early SARS-CoV-2 pandemic, cancer patients have been assumed to be at higher risk for severe COVID-19. Here, we present an analysis of cancer patients from the LEOSS (Lean European Open Survey on SARS-CoV-2 Infected Patients) registry to determine whether cancer patients are at higher risk. Patients and methods We retrospectively analyzed a cohort of 435 cancer patients and 2636 non-cancer patients with confirmed SARS-CoV-2 infection, enrolled between March 16 and August 31, 2020. Data on socio-demographics, comorbidities, cancer-related features and infection course were collected. Age-, sex- and comorbidity-adjusted analysis was performed. Primary endpoint was COVID-19-related mortality. Results In total, 435 cancer patients were included in our analysis. Commonest age category was 76–85 years (36.5%), and 40.5% were female. Solid tumors were seen in 59% and lymphoma and leukemia in 17.5% and 11% of patients. Of these, 54% had an active malignancy, and 22% had recently received anti-cancer treatments. At detection of SARS-CoV-2, the majority (62.5%) presented with mild symptoms. Progression to severe COVID-19 was seen in 55% and ICU admission in 27.5%. COVID-19-related mortality rate was 22.5%. Male sex, advanced age, and active malignancy were associated with higher death rates. Comparing cancer and non-cancer patients, age distribution and comorbidity differed significantly, as did mortality (14% vs 22.5%, p value < 0.001). After adjustments for other risk factors, mortality was comparable. Conclusion Comparing cancer and non-cancer patients, outcome of COVID-19 was comparable after adjusting for age, sex, and comorbidity. However, our results emphasize that cancer patients as a group are at higher risk due to advanced age and pre-existing conditions