The Triangle Model for evaluating the effect of health information technology on healthcare quality and safety

PubMed Central

Kern, Lisa M; Abramson, Erika; Kaushal, Rainu

2011-01-01

With the proliferation of relatively mature health information technology (IT) systems with large numbers of users, it becomes increasingly important to evaluate the effect of these systems on the quality and safety of healthcare. Previous research on the effectiveness of health IT has had mixed results, which may be in part attributable to the evaluation frameworks used. The authors propose a model for evaluation, the Triangle Model, developed for designing studies of quality and safety outcomes of health IT. This model identifies structure-level predictors, including characteristics of: (1) the technology itself; (2) the provider using the technology; (3) the organizational setting; and (4) the patient population. In addition, the model outlines process predictors, including (1) usage of the technology, (2) organizational support for and customization of the technology, and (3) organizational policies and procedures about quality and safety. The Triangle Model specifies the variables to be measured, but is flexible enough to accommodate both qualitative and quantitative approaches to capturing them. The authors illustrate this model, which integrates perspectives from both health services research and biomedical informatics, with examples from evaluations of electronic prescribing, but it is also applicable to a variety of types of health IT systems. PMID:21857023

Full Bayesian evaluation of the safety effects of reducing the posted speed limit in urban residential area.

PubMed

Islam, Md Tazul; El-Basyouny, Karim

2015-07-01

Full Bayesian (FB) before-after evaluation is a newer approach than the empirical Bayesian (EB) evaluation in traffic safety research. While a number of earlier studies have conducted univariate and multivariate FB before-after safety evaluations and compared the results with the EB method, often contradictory conclusions have been drawn. To this end, the objectives of the current study were to (i) perform a before-after safety evaluation using both the univariate and multivariate FB methods in order to enhance our understanding of these methodologies, (ii) perform the EB evaluation and compare the results with those of the FB methods and (iii) apply the FB and EB methods to evaluate the safety effects of reducing the urban residential posted speed limit (PSL) for policy recommendation. In addition to three years of crash data for both the before and after periods, traffic volume, road geometry and other relevant data for both the treated and reference sites were collected and used. According to the model goodness-of-fit criteria, the current study found that the multivariate FB model for crash severities outperformed the univariate FB models. Moreover, in terms of statistical significance of the safety effects, the EB and FB methods led to opposite conclusions when the safety effects were relatively small with high standard deviation. Therefore, caution should be taken in drawing conclusions from the EB method. Based on the FB method, the PSL reduction was found effective in reducing crashes of all severities and thus is recommended for improving safety on urban residential collector roads. Copyright © 2015 Elsevier Ltd. All rights reserved.

The transferability of safety-driven access management models for application to other sites.

DOT National Transportation Integrated Search

2001-01-01

Several research studies have produced mathematical models that predict the safety impacts of selected access management techniques. Since new models require substantial resources to construct, this study evaluated five existing models with regard to...

Evaluating Models of Human Performance: Safety-Critical Systems Applications

NASA Technical Reports Server (NTRS)

Feary, Michael S.

2012-01-01

This presentation is part of panel discussion on Evaluating Models of Human Performance. The purpose of this panel is to discuss the increasing use of models in the world today and specifically focus on how to describe and evaluate models of human performance. My presentation will focus on discussions of generating distributions of performance, and the evaluation of different strategies for humans performing tasks with mixed initiative (Human-Automation) systems. I will also discuss issues with how to provide Human Performance modeling data to support decisions on acceptability and tradeoffs in the design of safety critical systems. I will conclude with challenges for the future.

Effect of state workplace safety laws on occupational injury rates.

PubMed

Smitha, M W; Kirk, K A; Oestenstad, K R; Brown, K C; Lee, S D

2001-12-01

The purpose of this study was to evaluate the effect of four common types of mandatory state-level workplace safety regulations on injury severity rates during the period 1992 to 1997 for the manufacturing sector. The full Poisson regression model showed safety committee regulations to have a highly significant reducing effect on injury rates, chi 2 (1, n = 3286) = 10.1774, P = 0.0014. Safety program regulations were significant at the alpha = 0.10 level, chi 2 (1, n = 3286) = 3.5676, P = 0.0589. The effect of insurance carrier loss control regulations in the full model was nonsignificant. However, insurance carrier loss control regulations were highly significant (alpha = 0.01) in the final reduced model. Targeting initiatives were nonsignificant in both the full and reduced models (alpha = 0.05). The study results are important to state and federal agencies considering adopting workplace safety regulations that are similar to the four types evaluated in this study.

The Ergonomic Program Implementation Continuum (EPIC): integration of health and safety--a process evaluation in the healthcare sector.

PubMed

Baumann, Andrea; Holness, D Linn; Norman, Patrica; Idriss-Wheeler, Dina; Boucher, Patricia

2012-07-01

This article presents a health and safety intervention model and the use of process evaluation to assess a participatory ergonomic intervention. The effectiveness of the Ergonomic Program Implementation Continuum (EPIC) was assessed at six healthcare pilot sites in Ontario, Canada. The model provided a framework to demonstrate evaluation findings. Participants reported that EPIC was thorough and identified improvements related to its use. Participants believed the program contributed to advancing an organizational culture of safety (COS). Main barriers to program uptake included resistance to change and need for adequate funding and resources. The dedication of organizational leaders and consultant coaches was identified as essential to the program's success. In terms of impact on industry, findings contribute to the evidence-based knowledge of health and safety interventions and support use of the framework for creating a robust infrastructure to advance organizational COS and link staff safety and wellness with patient safety in healthcare. Copyright © 2012 National Safety Council and Elsevier Ltd. All rights reserved.

Evaluation of the safety performance of highway alignments based on fault tree analysis and safety boundaries.

PubMed

Chen, Yikai; Wang, Kai; Xu, Chengcheng; Shi, Qin; He, Jie; Li, Peiqing; Shi, Ting

2018-05-19

To overcome the limitations of previous highway alignment safety evaluation methods, this article presents a highway alignment safety evaluation method based on fault tree analysis (FTA) and the characteristics of vehicle safety boundaries, within the framework of dynamic modeling of the driver-vehicle-road system. Approaches for categorizing the vehicle failure modes while driving on highways and the corresponding safety boundaries were comprehensively investigated based on vehicle system dynamics theory. Then, an overall crash probability model was formulated based on FTA considering the risks of 3 failure modes: losing steering capability, losing track-holding capability, and rear-end collision. The proposed method was implemented on a highway segment between Bengbu and Nanjing in China. A driver-vehicle-road multibody dynamics model was developed based on the 3D alignments of the Bengbu to Nanjing section of Ning-Luo expressway using Carsim, and the dynamics indices, such as sideslip angle and, yaw rate were obtained. Then, the average crash probability of each road section was calculated with a fixed-length method. Finally, the average crash probability was validated against the crash frequency per kilometer to demonstrate the accuracy of the proposed method. The results of the regression analysis and correlation analysis indicated good consistency between the results of the safety evaluation and the crash data and that it outperformed the safety evaluation methods used in previous studies. The proposed method has the potential to be used in practical engineering applications to identify crash-prone locations and alignment deficiencies on highways in the planning and design phases, as well as those in service.

Software for occupational health and safety risk analysis based on a fuzzy model.

PubMed

Stefanovic, Miladin; Tadic, Danijela; Djapan, Marko; Macuzic, Ivan

2012-01-01

Risk and safety management are very important issues in healthcare systems. Those are complex systems with many entities, hazards and uncertainties. In such an environment, it is very hard to introduce a system for evaluating and simulating significant hazards. In this paper, we analyzed different types of hazards in healthcare systems and we introduced a new fuzzy model for evaluating and ranking hazards. Finally, we presented a developed software solution, based on the suggested fuzzy model for evaluating and monitoring risk.

Safety Study of an Antimicrobial Peptide Lactocin 160, Produced by the Vaginal Lactobacillus rhamnosus

PubMed Central

Dover, Sara E.; Aroutcheva, Alla A.; Faro, S.; Chikindas, Michael L.

2007-01-01

Objective. To evaluate the safety of the antimicrobial peptide, lactocin 160. Methods. Lactocin 160, a product of vaginal probiotic Lactobacillus rhamnosus 160 was evaluated for toxicity and irritation. An in vitro human organotypic vaginal-ectocervical tissue model (EpiVaginal) was employed for the safety testing by determining the exposure time to reduce tissue viability to 50% (ET-50). Hemolytic activity of lactocin160 was tested using 8% of human erythrocyte suspension. Susceptibility of lactobacilli to lactocin160 was also studied. Rabbit vaginal irritation (RVI) model was used for an in vivo safety evaluation. Results. The ET-50 value was 17.5 hours for lactocin 160 (4.9 hours for nonoxynol 9, N9). Hemolytic activity of lactocin 160 was 8.2% (N9 caused total hemolysis). Lactobacilli resisted to high concentrations of peptide preparation. The RVI model revealed slight vaginal irritation. An average irritation index grade was evaluated as “none.” Conclusions. Lactocin 160 showed minimal irritation and has a good potential for intravaginal application. PMID:18273406

Effectiveness of maritime safety control in different navigation zones using a spatial sequential DEA model: Yangtze River case.

PubMed

Wu, Bing; Wang, Yang; Zhang, Jinfen; Savan, Emanuel Emil; Yan, Xinping

2015-08-01

This paper aims to analyze the effectiveness of maritime safety control from the perspective of safety level along the Yangtze River with special considerations for navigational environments. The influencing variables of maritime safety are reviewed, including ship condition, maritime regulatory system, human reliability and navigational environment. Because the former three variables are generally assumed to be of the same level of safety, this paper focuses on studying the impact of navigational environments on the level of safety in different waterways. An improved data envelopment analysis (DEA) model is proposed by treating the navigational environment factors as inputs and ship accident data as outputs. Moreover, because the traditional DEA model cannot provide an overall ranking of different decision making units (DMUs), the spatial sequential frontiers and grey relational analysis are incorporated into the DEA model to facilitate a refined assessment. Based on the empirical study results, the proposed model is able to solve the problem of information missing in the prior models and evaluate the level of safety with a better accuracy. The results of the proposed DEA model are further compared with an evidential reasoning (ER) method, which has been widely used for level of safety evaluations. A sensitivity analysis is also conducted to better understand the relationship between the variation of navigational environments and level of safety. The sensitivity analysis shows that the level of safety varies in terms of traffic flow. It indicates that appropriate traffic control measures should be adopted for different waterways to improve their safety. This paper presents a practical method of conducting maritime level of safety assessments under dynamic navigational environment. Copyright © 2015 Elsevier Ltd. All rights reserved.

[In silico, in vitro, in omic experimental models and drug safety evaluation].

PubMed

Claude, Nancy; Goldfain-Blanc, Françoise; Guillouzo, André

2009-01-01

Over the last few decades, toxicology has benefited from scientific, technical, and bioinformatic developments relating to patient safety assessment during clinical and drug marketing studies. Based on this knowledge, new in silico, in vitro, and "omic" experimental models are emerging. Although these models cannot currently replace classic safety evaluations performed on laboratory animals, they allow compounds with unacceptable toxicity to be rejected in the early stages of drug development, thereby reducing the number of laboratory animals needed. In addition, because these models are particularly adapted to mechanistic studies, they can help to improve the relevance of the data obtained, thus enabling better prevention and screening of the adverse effects that may occur in humans. Much progress remains to be done, especially in the field of validation. Nevertheless, current efforts by industrial, academic laboratories, and regulatory agencies should, in coming years, significantly improve preclinical drug safety evaluation thanks to the integration of these new methods into the drug research and development process.

A Safety Index and Method for Flightdeck Evaluation

NASA Technical Reports Server (NTRS)

Latorella, Kara A.

2000-01-01

If our goal is to improve safety through machine, interface, and training design, then we must define a metric of flightdeck safety that is usable in the design process. Current measures associated with our notions of "good" pilot performance and ultimate safety of flightdeck performance fail to provide an adequate index of safe flightdeck performance for design evaluation purposes. The goal of this research effort is to devise a safety index and method that allows us to evaluate flightdeck performance holistically and in a naturalistic experiment. This paper uses Reason's model of accident causation (1990) as a basis for measuring safety, and proposes a relational database system and method for 1) defining a safety index of flightdeck performance, and 2) evaluating the "safety" afforded by flightdeck performance for the purpose of design iteration. Methodological considerations, limitations, and benefits are discussed as well as extensions to this work.

Video Modeling to Teach Social Safety Skills to Young Adults with Intellectual Disability

ERIC Educational Resources Information Center

Spivey, Corrine E.; Mechling, Linda C.

2016-01-01

This study evaluated the effectiveness of video modeling with a constant time delay procedure to teach social safety skills to three young women with intellectual disability. A multiple probe design across three social safety skills (responding to strangers who: requested personal information; requested money; and entered the participant's…

Determining an appropriate integrated assessment model of tourism safety risk within the Changbai Mountain Scenic Area

NASA Astrophysics Data System (ADS)

Zhou, Lijun; Liu, Jisheng

2017-03-01

Tourism safety is gradually gaining more attention due to the rapid development of the tourism industry in China. Changbai Mountain is one of the most famous mountainous scenic areas in Northeast Asia. Assessment on Changbai Mountain scenic area’s tourism safety risk could do a favor in detecting influence factor of tourism safety risk and classifying tourism safety risk rank, thereby reducing and preventing associated tourism safety risks. This paper uses the Changbai Mountain scenic area as the study subject. By the means of experts scoring and analytic hierarchy process on quantified relevant evaluation indicator, the grid GIS method is used to vectorize the relevant data within a 1000m grid. It respectively analyzes main indicators associated tourism safety risk in Changbai Mountain scenic area, including hazard, exposure, vulnerability and ability to prevent and mitigate disasters. The integrated tourism safety risk model is used to comprehensively evaluate tourism safety risk in Changbai Mountain scenic area.

A bicycle safety index for evaluating urban street facilities.

PubMed

Asadi-Shekari, Zohreh; Moeinaddini, Mehdi; Zaly Shah, Muhammad

2015-01-01

The objectives of this research are to conceptualize the Bicycle Safety Index (BSI) that considers all parts of the street and to propose a universal guideline with microscale details. A point system method comparing existing safety facilities to a defined standard is proposed to estimate the BSI. Two streets in Singapore and Malaysia are chosen to examine this model. The majority of previous measurements to evaluate street conditions for cyclists usually cannot cover all parts of streets, including segments and intersections. Previous models also did not consider all safety indicators and cycling facilities at a microlevel in particular. This study introduces a new concept of a practical BSI to complete previous studies using its practical, easy-to-follow, point system-based outputs. This practical model can be used in different urban settings to estimate the level of safety for cycling and suggest some improvements based on the standards.

Improved guidelines for estimating the Highway safety manual calibration factors.

DOT National Transportation Integrated Search

2016-01-01

Crash prediction models can be used to predict the number of crashes and evaluate roadway safety. Part C of the first edition of the Highway Safety Manual (HSM) provides safety performance functions (SPFs). The HSM addendum that includes freeway and ...

Counterfactual simulations applied to SHRP2 crashes: The effect of driver behavior models on safety benefit estimations of intelligent safety systems.

PubMed

Bärgman, Jonas; Boda, Christian-Nils; Dozza, Marco

2017-05-01

As the development and deployment of in-vehicle intelligent safety systems (ISS) for crash avoidance and mitigation have rapidly increased in the last decades, the need to evaluate their prospective safety benefits before introduction has never been higher. Counterfactual simulations using relevant mathematical models (for vehicle dynamics, sensors, the environment, ISS algorithms, and models of driver behavior) have been identified as having high potential. However, although most of these models are relatively mature, models of driver behavior in the critical seconds before a crash are still relatively immature. There are also large conceptual differences between different driver models. The objective of this paper is, firstly, to demonstrate the importance of the choice of driver model when counterfactual simulations are used to evaluate two ISS: Forward collision warning (FCW), and autonomous emergency braking (AEB). Secondly, the paper demonstrates how counterfactual simulations can be used to perform sensitivity analyses on parameter settings, both for driver behavior and ISS algorithms. Finally, the paper evaluates the effect of the choice of glance distribution in the driver behavior model on the safety benefit estimation. The paper uses pre-crash kinematics and driver behavior from 34 rear-end crashes from the SHRP2 naturalistic driving study for the demonstrations. The results for FCW show a large difference in the percent of avoided crashes between conceptually different models of driver behavior, while differences were small for conceptually similar models. As expected, the choice of model of driver behavior did not affect AEB benefit much. Based on our results, researchers and others who aim to evaluate ISS with the driver in the loop through counterfactual simulations should be sure to make deliberate and well-grounded choices of driver models: the choice of model matters. Copyright © 2017 Elsevier Ltd. All rights reserved.

Implementation of non-condensable gases condensation suppression model into the WCOBRA/TRAC-TF2 LOCA safety evaluation code

DOE Office of Scientific and Technical Information (OSTI.GOV)

Liao, J.; Cao, L.; Ohkawa, K.

2012-07-01

The non-condensable gases condensation suppression model is important for a realistic LOCA safety analysis code. A condensation suppression model for direct contact condensation was previously developed by Westinghouse using first principles. The model is believed to be an accurate description of the direct contact condensation process in the presence of non-condensable gases. The Westinghouse condensation suppression model is further revised by applying a more physical model. The revised condensation suppression model is thus implemented into the WCOBRA/TRAC-TF2 LOCA safety evaluation code for both 3-D module (COBRA-TF) and 1-D module (TRAC-PF1). Parametric study using the revised Westinghouse condensation suppression model ismore » conducted. Additionally, the performance of non-condensable gases condensation suppression model is examined in the ACHILLES (ISP-25) separate effects test and LOFT L2-5 (ISP-13) integral effects test. (authors)« less

Evaluation of the CSA 2010 Operational Model Test: Full Report

DOT National Transportation Integrated Search

2011-08-01

In accordance with its primary mission to reduce crashes, injuries, and fatalities involving large trucks and buses, the Federal Motor Carrier Safety Administration (FMCSA) initiated the Comprehensive Safety Analysis 2010 (CSA 2010) Operational Model...

Modeling Techniques for Shipboard Manning: A Review and Plan for Development

DTIC Science & Technology

1993-02-01

manning levels. Once manning models have been created, experiments can be conducted to show how changes in the manning structure might affect ship safety...these predictions, users of the manning models can evaluate how changes in crew configurations, manning levels, and voyage profiles affect ship safety...mitigate emergency situations would provide crucial information on how changes in manning structure would affect overall ship safety. Like emergency

Large-scale road safety programmes in low- and middle-income countries: an opportunity to generate evidence.

PubMed

Hyder, Adnan A; Allen, Katharine A; Peters, David H; Chandran, Aruna; Bishai, David

2013-01-01

The growing burden of road traffic injuries, which kill over 1.2 million people yearly, falls mostly on low- and middle-income countries (LMICs). Despite this, evidence generation on the effectiveness of road safety interventions in LMIC settings remains scarce. This paper explores a scientific approach for evaluating road safety programmes in LMICs and introduces such a road safety multi-country initiative, the Road Safety in 10 Countries Project (RS-10). By building on existing evaluation frameworks, we develop a scientific approach for evaluating large-scale road safety programmes in LMIC settings. This also draws on '13 lessons' of large-scale programme evaluation: defining the evaluation scope; selecting study sites; maintaining objectivity; developing an impact model; utilising multiple data sources; using multiple analytic techniques; maximising external validity; ensuring an appropriate time frame; the importance of flexibility and a stepwise approach; continuous monitoring; providing feedback to implementers, policy-makers; promoting the uptake of evaluation results; and understanding evaluation costs. The use of relatively new approaches for evaluation of real-world programmes allows for the production of relevant knowledge. The RS-10 project affords an important opportunity to scientifically test these approaches for a real-world, large-scale road safety evaluation and generate new knowledge for the field of road safety.

Using Modeling and Rehearsal to Teach Fire Safety to Children with Autism

ERIC Educational Resources Information Center

Garcia, David; Dukes, Charles; Brady, Michael P.; Scott, Jack; Wilson, Cynthia L.

2016-01-01

We evaluated the efficacy of an instructional procedure to teach young children with autism to evacuate settings and notify an adult during a fire alarm. A multiple baseline design across children showed that an intervention that included modeling, rehearsal, and praise was effective in teaching fire safety skills. Safety skills generalized to…

Integration of Occupational Safety to Contractors` or Subcontractors` Performance Evaluation in Construction Projects

NASA Astrophysics Data System (ADS)

Kozlovská, Mária; Struková, Zuzana

2013-06-01

Several factors should be considered by the owner and general contractor in the process of contractors` and subcontractors` selection and evaluation. The paper reviews the recent models addressed to guide general contractors in subcontractors' selection process and in evaluation of different contractors during the execution of the project. Moreover the paper suggests the impact of different contractors' performance to the overall level of occupational health and safety culture at the sites. It deals with the factors influencing the safety performance of contractors during construction and analyses the methods for assessing the safety performance of construction contractors. The results of contractors' safety performance evaluation could be a useful tool in motivating contractors to achieve better safety outcomes or could have effect on owners` or general contractors' decision making about contractors suitability for future contracting works.

Multilevel models in the explanation of the relationship between safety climate and safe behavior.

PubMed

Cheyne, Alistair; Tomás, José M; Oliver, Amparo

2013-01-01

This study examines the relationships between components of organizational safety climate, including employee attitudes to organizational safety issues; perceptions of the physical working environment, and evaluations of worker engagement with safety issues; and relates these to self-reported levels of safety behavior. It attempts to explore the relationships between these variables in 1189 workers across 78 work groups in a large transportation organization. Evaluations of safety climate, the working environment and worker engagement, as well as safe behaviors, were collected using a self report questionnaire. The multilevel analysis showed that both levels of evaluation (the work group and the individual), and some cross-level interactions, were significant in explaining safe behaviors. Analyses revealed that a number of variables, at both levels, were associated with worker engagement and safe behaviors. The results suggest that, while individual evaluations of safety issues are important, there is also a role for the fostering of collective safety climates in encouraging safe behaviors and therefore reducing accidents.

Evaluation of surrogate measures for pedestrian safety in various road and roadside environments.

DOT National Transportation Integrated Search

2012-10-01

This report presents an investigation of pedestrian conflicts and crash count models to learn which exposure measures and roadway or roadside characteristics significantly influence pedestrian safety at road crossings. Negative binomial models were e...

Research on safety evaluation model for in-vehicle secondary task driving.

PubMed

Jin, Lisheng; Xian, Huacai; Niu, Qingning; Bie, Jing

2015-08-01

This paper presents a new method for evaluating in-vehicle secondary task driving safety. There are five in-vehicle distracter tasks: tuning the radio to a local station, touching the touch-screen telephone menu to a certain song, talking with laboratory assistant, answering a telephone via Bluetooth headset, and finding the navigation system from Ipad4 computer. Forty young drivers completed the driving experiment on a driving simulator. Measures of fixations, saccades, and blinks are collected and analyzed. Based on the measures of driver eye movements which have significant difference between the baseline and secondary task driving conditions, the evaluation index system is built. The Analytic Network Process (ANP) theory is applied for determining the importance weight of the evaluation index in a fuzzy environment. On the basis of the importance weight of the evaluation index, Fuzzy Comprehensive Evaluation (FCE) method is utilized to evaluate the secondary task driving safety. Results show that driving with secondary tasks greatly distracts the driver's attention from road and the evaluation model built in this study could estimate driving safety effectively under different driving conditions. Crown Copyright © 2014. Published by Elsevier Ltd. All rights reserved.

Evaluation of Human and Anthropomorphic Test Device Finite Element Models under Spaceflight Loading Conditions

NASA Technical Reports Server (NTRS)

Putnam, Jacob P.; Untaroiu, Costin; Somers. Jeffrey

2014-01-01

In an effort to develop occupant protection standards for future multipurpose crew vehicles, the National Aeronautics and Space Administration (NASA) has looked to evaluate the test device for human occupant restraint with the modification kit (THOR-K) anthropomorphic test device (ATD) in relevant impact test scenarios. With the allowance and support of the National Highway Traffic Safety Administration, NASA has performed a series of sled impact tests on the latest developed THOR-K ATD. These tests were performed to match test conditions from human volunteer data previously collected by the U.S. Air Force. The objective of this study was to evaluate the THOR-K finite element (FE) model and the Total HUman Model for Safety (THUMS) FE model with respect to the tests performed. These models were evaluated in spinal and frontal impacts against kinematic and kinetic data recorded in ATD and human testing. Methods: The FE simulations were developed based on recorded pretest ATD/human position and sled acceleration pulses measured during testing. Predicted responses by both human and ATD models were compared to test data recorded under the same impact conditions. The kinematic responses of the models were quantitatively evaluated using the ISO-metric curve rating system. In addition, ATD injury criteria and human stress/strain data were calculated to evaluate the risk of injury predicted by the ATD and human model, respectively. Results: Preliminary results show well-correlated response between both FE models and their physical counterparts. In addition, predicted ATD injury criteria and human model stress/strain values are shown to positively relate. Kinematic comparison between human and ATD models indicates promising biofidelic response, although a slightly stiffer response is observed within the ATD. Conclusion: As a compliment to ATD testing, numerical simulation provides efficient means to assess vehicle safety throughout the design process and further improve the design of physical ATDs. The assessment of the THOR-K and THUMS FE models in a spaceflight testing condition is an essential first step to implementing these models in the computational evaluation of spacecraft occupant safety. Promising results suggest future use of these models in the aerospace field.

Application of Model Animals in the Study of Drug Toxicology

NASA Astrophysics Data System (ADS)

Song, Yagang; Miao, Mingsan

2018-01-01

Drug safety is a key factor in drug research and development, Drug toxicology test is the main method to evaluate the safety of drugs, The body condition of an animal has important implications for the results of the study, Previous toxicological studies of drugs were carried out in normal animals in the past, There is a great deviation from the clinical practice.The purpose of this study is to investigate the necessity of model animals as a substitute for normal animals for toxicological studies, It is expected to provide exact guidance for future drug safety evaluation.

Evaluation of FY 1987 safety belt use law state enforcement grants

DOT National Transportation Integrated Search

1991-03-01

The report presents information and an evaluation of safety belt use law enforcement grants provided to 17 states through supplemental 403 grants during FY 1987. Elmira-type programs were to serve as a model in order to demonstrate that basic enforce...

Flightdeck Automation Problems (FLAP) Model for Safety Technology Portfolio Assessment

NASA Technical Reports Server (NTRS)

Ancel, Ersin; Shih, Ann T.

2014-01-01

NASA's Aviation Safety Program (AvSP) develops and advances methodologies and technologies to improve air transportation safety. The Safety Analysis and Integration Team (SAIT) conducts a safety technology portfolio assessment (PA) to analyze the program content, to examine the benefits and risks of products with respect to program goals, and to support programmatic decision making. The PA process includes systematic identification of current and future safety risks as well as tracking several quantitative and qualitative metrics to ensure the program goals are addressing prominent safety risks accurately and effectively. One of the metrics within the PA process involves using quantitative aviation safety models to gauge the impact of the safety products. This paper demonstrates the role of aviation safety modeling by providing model outputs and evaluating a sample of portfolio elements using the Flightdeck Automation Problems (FLAP) model. The model enables not only ranking of the quantitative relative risk reduction impact of all portfolio elements, but also highlighting the areas with high potential impact via sensitivity and gap analyses in support of the program office. Although the model outputs are preliminary and products are notional, the process shown in this paper is essential to a comprehensive PA of NASA's safety products in the current program and future programs/projects.

Performance Evaluation and Analysis of Rural Drinking Water Safety Project——A Case Study in Jiangsu, China

NASA Astrophysics Data System (ADS)

Du, Xiaorong

2017-04-01

Water is the basic condition for human survival and development. As China is the most populous country, rural drinking water safety problems are most conspicuous. Therefore, the Chinese government keeps increasing investment and has built a large number of rural drinking water safety projects. Scientific evaluation of project performance is of great significance to promote the sustainable operation of the project and the sustainable development of rural economy. Previous studies mainly focus on the economic benefits of the project, while ignoring the fact that the rural drinking water safety project is quasi-public goods, which has economic, social and ecological benefits. This paper establishes a comprehensive evaluation model for rural drinking water safety performance, which adapts the rules of "5E" (economy, efficiency, effectiveness, equity and environment) as the value orientation, and selects a rural drinking water safety project as object in case study at K District, which is in the north of Jiangsu Province, China. The results shows: 1) the comprehensive performance of K project is in good condition; 2) The performance of every part shows that the scores of criteria "efficiency", "environment" and "effect" are higher than the mean performance, while the "economy" is slightly lower than the mean and the "equity" is the lowest. 3) The performance of indicator layer shows that: the planned completion rate of project, the reduction rate of project cost and the penetration rate of water-use population are significantly lower than other indicators. Based on the achievements of previous studies and the characteristics of rural drinking water safety project, this study integrates the evaluation dimensions of equity and environment, which can contribute to a more comprehensive and systematic assessment of project performance and provide empirical data for performance evaluation and management of rural drinking water safety project. Key Words: Rural drinking water safety project; Performance evaluation; 5E rules; Comprehensive evaluation model

Modelling safety of multistate systems with ageing components

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kołowrocki, Krzysztof; Soszyńska-Budny, Joanna

An innovative approach to safety analysis of multistate ageing systems is presented. Basic notions of the ageing multistate systems safety analysis are introduced. The system components and the system multistate safety functions are defined. The mean values and variances of the multistate systems lifetimes in the safety state subsets and the mean values of their lifetimes in the particular safety states are defined. The multi-state system risk function and the moment of exceeding by the system the critical safety state are introduced. Applications of the proposed multistate system safety models to the evaluation and prediction of the safty characteristics ofmore » the consecutive “m out of n: F” is presented as well.« less

Meeting the customer's needs for mobility and safety during construction and maintenance operations : model work zone traffic management program and self evaluation guide

DOT National Transportation Integrated Search

1998-09-01

This model program was developed by combining traffic management concepts reported in research studies and papers with the effective techniques currently being used by States to minimize motorist delays and enhance work zone safety. This model is pre...

Influence Map Methodology for Evaluating Systemic Safety Issues

NASA Technical Reports Server (NTRS)

2008-01-01

"Raising the bar" in safety performance is a critical challenge for many organizations, including Kennedy Space Center. Contributing-factor taxonomies organize information about the reasons accidents occur and therefore are essential elements of accident investigations and safety reporting systems. Organizations must balance efforts to identify causes of specific accidents with efforts to evaluate systemic safety issues in order to become more proactive about improving safety. This project successfully addressed the following two problems: (1) methods and metrics to support the design of effective taxonomies are limited and (2) influence relationships among contributing factors are not explicitly modeled within a taxonomy.

Did you have an impact? A theory-based method for planning and evaluating knowledge-transfer and exchange activities in occupational health and safety.

PubMed

Kramer, Desré M; Wells, Richard P; Carlan, Nicolette; Aversa, Theresa; Bigelow, Philip P; Dixon, Shane M; McMillan, Keith

2013-01-01

Few evaluation tools are available to assess knowledge-transfer and exchange interventions. The objective of this paper is to develop and demonstrate a theory-based knowledge-transfer and exchange method of evaluation (KEME) that synthesizes 3 theoretical frameworks: the promoting action on research implementation of health services (PARiHS) model, the transtheoretical model of change, and a model of knowledge use. It proposes a new term, keme, to mean a unit of evidence-based transferable knowledge. The usefulness of the evaluation method is demonstrated with 4 occupational health and safety knowledge transfer and exchange (KTE) implementation case studies that are based upon the analysis of over 50 pre-existing interviews. The usefulness of the evaluation model has enabled us to better understand stakeholder feedback, frame our interpretation, and perform a more comprehensive evaluation of the knowledge use outcomes of our KTE efforts.

System modeling with the DISC framework: evidence from safety-critical domains.

PubMed

Reiman, Teemu; Pietikäinen, Elina; Oedewald, Pia; Gotcheva, Nadezhda

2012-01-01

The objective of this paper is to illustrate the development and application of the Design for Integrated Safety Culture (DISC) framework for system modeling by evaluating organizational potential for safety in nuclear and healthcare domains. The DISC framework includes criteria for good safety culture and a description of functions that the organization needs to implement in order to orient the organization toward the criteria. Three case studies will be used to illustrate the utilization of the DISC framework in practice.

Evaluating the impact of grade crossing safety factors through signal detection theory

DOT National Transportation Integrated Search

2012-10-22

The purpose of this effort was to apply signal detection theory to descriptively model the impact : of five grade crossing safety factors to understand their effect on driver decision making. The : safety factors consisted of: improving commercial mo...

Perceived organizational support for safety and employee safety voice: the mediating role of coworker support for safety.

PubMed

Tucker, Sean; Chmiel, Nik; Turner, Nick; Hershcovis, M Sandy; Stride, Chris B

2008-10-01

In the present study, we modeled 2 sources of safety support (perceived organizational support for safety and perceived coworker support for safety) as predictors of employee safety voice, that is, speaking out in an attempt to change unsafe working conditions. Drawing on social exchange and social impact theories, we hypothesized and tested a mediated model predicting employee safety voice using a cross-sectional survey of urban bus drivers (n = 213) in the United Kingdom. Hierarchical regression analysis showed that perceived coworker support for safety fully mediated the relationship between perceived organizational support for safety and employee safety voice. This study adds to the employee voice literature by evaluating the important role that coworkers can play in encouraging others to speak out about safety issues. Implications for research and practice related to change-oriented safety communication are discussed.

Insights on in vitro models for safety and toxicity assessment of cosmetic ingredients.

PubMed

Almeida, Andreia; Sarmento, Bruno; Rodrigues, Francisca

2017-03-15

According to the current European legislation, the safety assessment of each individual cosmetic ingredient of any formulation is the basis for the safety evaluation of a cosmetic product. Also, animal testing in the European Union is prohibited for cosmetic ingredients and products since 2004 and 2009, respectively. Additionally, the commercialization of any cosmetic products containing ingredients tested on animal models was forbidden in 2009. In consequence of these boundaries, the European Centre for the Validation of Alternative Methods (ECVAM) proposes a list of validated cell-based in vitro models for predicting the safety and toxicity of cosmetic ingredients. These models have been demonstrated as valuable and effective tools to overcome the limitations of animal in vivo studies. Although the use of in vitro cell-based models for the evaluation of absorption and permeability of cosmetic ingredients is widespread, a detailed study on the properties of these platforms and the in vitro-in vivo correlation compared with human data are required. Moreover, additional efforts must be taken to develop in vitro models to predict carcinogenicity, repeat dose toxicity and reproductive toxicity, for which no alternative in vitro methods are currently available. This review paper summarizes and characterizes the most relevant in vitro models validated by ECVAM employed to predict the safety and toxicology of cosmetic ingredients. Copyright © 2017 Elsevier B.V. All rights reserved.

Integrated indicator to evaluate vehicle performance across: Safety, fuel efficiency and green domains.

PubMed

Torrao, G; Fontes, T; Coelho, M; Rouphail, N

2016-07-01

In general, car manufacturers face trade-offs between safety, efficiency and environmental performance when choosing between mass, length, engine power, and fuel efficiency. Moreover, the information available to the consumers makes difficult to assess all these components at once, especially when aiming to compare vehicles across different categories and/or to compare vehicles in the same category but across different model years. The main objective of this research was to develop an integrated tool able to assess vehicle's performance simultaneously for safety and environmental domains, leading to the research output of a Safety, Fuel Efficiency and Green Emissions (SEG) indicator able to evaluate and rank vehicle's performance across those three domains. For this purpose, crash data was gathered in Porto (Portugal) for the period 2006-2010 (N=1374). The crash database was analyzed and crash severity prediction models were developed using advanced logistic regression models. Following, the methodology for the SEG indicator was established combining the vehicle's safety and the environmental evaluation into an integrated analysis. The obtained results for the SEG indicator do not show any trade-off between vehicle's safety, fuel consumption and emissions. The best performance was achieved for newer gasoline passenger vehicles (<5year) with a smaller engine size (<1400cm(3)). According to the SEG indicator, a vehicle with these characteristics can be recommended for a safety-conscious profile user, as well as for a user more interested in fuel economy and/or in green performance. On the other hand, for larger engine size vehicles (>2000cm(3)) the combined score for safety user profile was in average more satisfactory than for vehicles in the smaller engine size group (<1400cm(3)), which suggests that in general, larger vehicles may offer extra protection. The achieved results demonstrate that the developed SEG integrated methodology can be a helpful tool for consumers to evaluate their vehicle selection through different domains (safety, fuel efficiency and green emissions). Furthermore, SEG indicator allows the comparison of vehicles across different categories and vehicle model years. Hence, this research is intended to support the decision-making process for transportation policy, safety and sustainable mobility, providing insights not only to policy makers, but also for general public guidance. Copyright © 2016 Elsevier Ltd. All rights reserved.

Modeling for influenza vaccines and adjuvants profile for safety prediction system using gene expression profiling and statistical tools

PubMed Central

Sasaki, Eita; Momose, Haruka; Hiradate, Yuki; Furuhata, Keiko; Takai, Mamiko; Asanuma, Hideki; Ishii, Ken J.

2018-01-01

Historically, vaccine safety assessments have been conducted by animal testing (e.g., quality control tests and adjuvant development). However, classical evaluation methods do not provide sufficient information to make treatment decisions. We previously identified biomarker genes as novel safety markers. Here, we developed a practical safety assessment system used to evaluate the intramuscular, intraperitoneal, and nasal inoculation routes to provide robust and comprehensive safety data. Influenza vaccines were used as model vaccines. A toxicity reference vaccine (RE) and poly I:C-adjuvanted hemagglutinin split vaccine were used as toxicity controls, while a non-adjuvanted hemagglutinin split vaccine and AddaVax (squalene-based oil-in-water nano-emulsion with a formulation similar to MF59)-adjuvanted hemagglutinin split vaccine were used as safety controls. Body weight changes, number of white blood cells, and lung biomarker gene expression profiles were determined in mice. In addition, vaccines were inoculated into mice by three different administration routes. Logistic regression analyses were carried out to determine the expression changes of each biomarker. The results showed that the regression equations clearly classified each vaccine according to its toxic potential and inoculation amount by biomarker expression levels. Interestingly, lung biomarker expression was nearly equivalent for the various inoculation routes. The results of the present safety evaluation were confirmed by the approximation rate for the toxicity control. This method may contribute to toxicity evaluation such as quality control tests and adjuvant development. PMID:29408882

Performance Analysis of the IEEE 802.11p Multichannel MAC Protocol in Vehicular Ad Hoc Networks

PubMed Central

2017-01-01

Vehicular Ad Hoc Networks (VANETs) employ multichannel to provide a variety of safety and non-safety applications, based on the IEEE 802.11p and IEEE 1609.4 protocols. The safety applications require timely and reliable transmissions, while the non-safety applications require efficient and high throughput. In the IEEE 1609.4 protocol, operating interval is divided into alternating Control Channel (CCH) interval and Service Channel (SCH) interval with an identical length. During the CCH interval, nodes transmit safety-related messages and control messages, and Enhanced Distributed Channel Access (EDCA) mechanism is employed to allow four Access Categories (ACs) within a station with different priorities according to their criticality for the vehicle’s safety. During the SCH interval, the non-safety massages are transmitted. An analytical model is proposed in this paper to evaluate performance, reliability and efficiency of the IEEE 802.11p and IEEE 1609.4 protocols. The proposed model improves the existing work by taking serval aspects and the character of multichannel switching into design consideration. Extensive performance evaluations based on analysis and simulation help to validate the accuracy of the proposed model and analyze the capabilities and limitations of the IEEE 802.11p and IEEE 1609.4 protocols, and enhancement suggestions are given. PMID:29231882

Performance Analysis of the IEEE 802.11p Multichannel MAC Protocol in Vehicular Ad Hoc Networks.

PubMed

Song, Caixia

2017-12-12

Vehicular Ad Hoc Networks (VANETs) employ multichannel to provide a variety of safety and non-safety applications, based on the IEEE 802.11p and IEEE 1609.4 protocols. The safety applications require timely and reliable transmissions, while the non-safety applications require efficient and high throughput. In the IEEE 1609.4 protocol, operating interval is divided into alternating Control Channel (CCH) interval and Service Channel (SCH) interval with an identical length. During the CCH interval, nodes transmit safety-related messages and control messages, and Enhanced Distributed Channel Access (EDCA) mechanism is employed to allow four Access Categories (ACs) within a station with different priorities according to their criticality for the vehicle's safety. During the SCH interval, the non-safety massages are transmitted. An analytical model is proposed in this paper to evaluate performance, reliability and efficiency of the IEEE 802.11p and IEEE 1609.4 protocols. The proposed model improves the existing work by taking serval aspects and the character of multichannel switching into design consideration. Extensive performance evaluations based on analysis and simulation help to validate the accuracy of the proposed model and analyze the capabilities and limitations of the IEEE 802.11p and IEEE 1609.4 protocols, and enhancement suggestions are given.

Prospective safety performance evaluation on construction sites.

PubMed

Wu, Xianguo; Liu, Qian; Zhang, Limao; Skibniewski, Miroslaw J; Wang, Yanhong

2015-05-01

This paper presents a systematic Structural Equation Modeling (SEM) based approach for Prospective Safety Performance Evaluation (PSPE) on construction sites, with causal relationships and interactions between enablers and the goals of PSPE taken into account. According to a sample of 450 valid questionnaire surveys from 30 Chinese construction enterprises, a SEM model with 26 items included for PSPE in the context of Chinese construction industry is established and then verified through the goodness-of-fit test. Three typical types of construction enterprises, namely the state-owned enterprise, private enterprise and Sino-foreign joint venture, are selected as samples to measure the level of safety performance given the enterprise scale, ownership and business strategy are different. Results provide a full understanding of safety performance practice in the construction industry, and indicate that the level of overall safety performance situation on working sites is rated at least a level of III (Fair) or above. This phenomenon can be explained that the construction industry has gradually matured with the norms, and construction enterprises should improve the level of safety performance as not to be eliminated from the government-led construction industry. The differences existing in the safety performance practice regarding different construction enterprise categories are compared and analyzed according to evaluation results. This research provides insights into cause-effect relationships among safety performance factors and goals, which, in turn, can facilitate the improvement of high safety performance in the construction industry. Copyright © 2015 Elsevier Ltd. All rights reserved.

[Associations of occupational safety atmosphere and behaviors with unintentional injuries].

PubMed

Xiao, Ya-ni; Huang, Zhi-xiong; Huang, Shao-bin; Cao, Xiao-ou; Chen, Xia-ming; Liu, Xu-hua; Chen, Wei-qing

2012-07-01

To evaluate the associations of perception of safety atmosphere at workplace, occupational safety attitude and behaviors with occupational unintentional injury among manufacturing workers. A cross-sectional study was performed and a self-administered questionnaire was used to inquire socio-demographic characteristics, perceived safety atmosphere, occupational safety attitudes, occupational safety behaviors and occupational unintentional injuries among 10585 manufacturing workers selected from 46 enterprises in Guangdong. Structural equation modeling was applied to assess the relationship of the perception of safety atmosphere at workplace, occupational safety attitude, and occupational safety behaviors with occupational unintentional injury. Among 24 pathways supposed in structural equation model, 20 pathways (except for the attitude toward occupational safety, the attitude toward managers' support, the work posture and individual protection) were significantly related to the occupational unintentional injuries. The further analysis indicated that the perceived safety atmosphere might impact the occupational unintentional injuries by the attitude toward occupational safety and occupational safety behaviors. Workers' perception of safety atmosphere indirectly influenced on occupational unintentional injuries through occupational safety attitudes and occupational safety behaviors.

A System for Integrated Reliability and Safety Analyses

NASA Technical Reports Server (NTRS)

Kostiuk, Peter; Shapiro, Gerald; Hanson, Dave; Kolitz, Stephan; Leong, Frank; Rosch, Gene; Coumeri, Marc; Scheidler, Peter, Jr.; Bonesteel, Charles

1999-01-01

We present an integrated reliability and aviation safety analysis tool. The reliability models for selected infrastructure components of the air traffic control system are described. The results of this model are used to evaluate the likelihood of seeing outcomes predicted by simulations with failures injected. We discuss the design of the simulation model, and the user interface to the integrated toolset.

Safety modelling and testing of lithium-ion batteries in electrified vehicles

NASA Astrophysics Data System (ADS)

Deng, Jie; Bae, Chulheung; Marcicki, James; Masias, Alvaro; Miller, Theodore

2018-04-01

To optimize the safety of batteries, it is important to understand their behaviours when subjected to abuse conditions. Most early efforts in battery safety modelling focused on either one battery cell or a single field of interest such as mechanical or thermal failure. These efforts may not completely reflect the failure of batteries in automotive applications, where various physical processes can take place in a large number of cells simultaneously. In this Perspective, we review modelling and testing approaches for battery safety under abuse conditions. We then propose a general framework for large-scale multi-physics modelling and experimental work to address safety issues of automotive batteries in real-world applications. In particular, we consider modelling coupled mechanical, electrical, electrochemical and thermal behaviours of batteries, and explore strategies to extend simulations to the battery module and pack level. Moreover, we evaluate safety test approaches for an entire range of automotive hardware sets from cell to pack. We also discuss challenges in building this framework and directions for its future development.

The likelihood of achieving quantified road safety targets: a binary logistic regression model for possible factors.

PubMed

Sze, N N; Wong, S C; Lee, C Y

2014-12-01

In past several decades, many countries have set quantified road safety targets to motivate transport authorities to develop systematic road safety strategies and measures and facilitate the achievement of continuous road safety improvement. Studies have been conducted to evaluate the association between the setting of quantified road safety targets and road fatality reduction, in both the short and long run, by comparing road fatalities before and after the implementation of a quantified road safety target. However, not much work has been done to evaluate whether the quantified road safety targets are actually achieved. In this study, we used a binary logistic regression model to examine the factors - including vehicle ownership, fatality rate, and national income, in addition to level of ambition and duration of target - that contribute to a target's success. We analyzed 55 quantified road safety targets set by 29 countries from 1981 to 2009, and the results indicate that targets that are in progress and with lower level of ambitions had a higher likelihood of eventually being achieved. Moreover, possible interaction effects on the association between level of ambition and the likelihood of success are also revealed. Copyright © 2014 Elsevier Ltd. All rights reserved.

Regulatory Forum Opinion Piece*: Use and Utility of Animal Models of Disease for Nonclinical Safety Assessment: A Pharmaceutical Industry Survey.

PubMed

Morgan, Sherry J; Couch, Jessica; Guzzie-Peck, Peggy; Keller, Douglas A; Kemper, Ray; Otieno, Monicah A; Schulingkamp, Robert J; Jones, Thomas W

2017-04-01

An Innovation and Quality (IQ) Consortium focus group conducted a cross-company survey to evaluate current practices and perceptions around the use of animal models of disease (AMDs) in nonclinical safety assessment of molecules in clinical development. The IQ Consortium group is an organization of pharmaceutical and biotechnology companies with the mission of advancing science and technology. The survey queried the utilization of AMDs during drug discovery in which drug candidates are evaluated in efficacy models and limited short-duration non-Good Laboratory Practices (GLP) toxicology testing and during drug development in which drug candidates are evaluated in GLP toxicology studies. The survey determined that the majority of companies used AMDs during drug discovery primarily as a means for proactively assessing potential nonclinical safety issues prior to the conduct of toxicology studies, followed closely by the use of AMDs to better understand toxicities associated with exaggerated pharmacology in traditional toxicology models or to derisk issues when the target is only expressed in the disease state. In contrast, the survey results indicated that the use of AMDs in development is infrequent, being used primarily to investigate nonclinical safety issues associated with targets expressed only in disease states and/or in response to requests from global regulatory authorities.

A model study of the Haihe river passenger ferry risk based on AHP

NASA Astrophysics Data System (ADS)

Du, Jinyin; Xu, Yanming; Du, Chunzhi; Jin, Zhenhua

2017-05-01

The core function of maritime is water safety supervision, whose emphasis and difficulty is ferry. In combination with the practical situation of Haihe river passenger ferry operation management, this paper analyzes Haihe river passenger ferry risk from four aspects "human, machinery, environment and management", and establishes the ferry risk index system. By using AHP (Analytic Hierarchy Process), the ferry risk evaluation model is established. By using the ferry model, the application of Ferry Zhengyanfa7 in Tianjin Haihe river crossing is evaluated, whose safety situation is verified to be between "relatively high risk" and "high risk".

A Model Train-The-Trainer Program for HACCP-Based Food Safety Training in the Retail/Food Service Industry: An Evaluation.

ERIC Educational Resources Information Center

Martin, Kenneth E.; Knabel, Steve; Mendenhall, Von

1999-01-01

A survey showed states are adopting higher training and certification requirements for food-service workers. A train-the-trainer model was developed to prepare extension agents, health officers, and food-service managers to train others in food-safety procedures. (SK)

Promoting Fitness and Safety in Elementary Students: A Randomized Control Study of the Michigan Model for Health

ERIC Educational Resources Information Center

O'Neill, James M.; Clark, Jeffrey K.; Jones, James A.

2016-01-01

Background: In elementary grades, comprehensive health education curricula have demonstrated effectiveness in addressing singular health issues. The Michigan Model for Health (MMH) was implemented and evaluated to determine its impact on nutrition, physical fitness, and safety knowledge and skills. Methods: Schools (N = 52) were randomly assigned…

Road safety risk evaluation and target setting using data envelopment analysis and its extensions.

PubMed

Shen, Yongjun; Hermans, Elke; Brijs, Tom; Wets, Geert; Vanhoof, Koen

2012-09-01

Currently, comparison between countries in terms of their road safety performance is widely conducted in order to better understand one's own safety situation and to learn from those best-performing countries by indicating practical targets and formulating action programmes. In this respect, crash data such as the number of road fatalities and casualties are mostly investigated. However, the absolute numbers are not directly comparable between countries. Therefore, the concept of risk, which is defined as the ratio of road safety outcomes and some measure of exposure (e.g., the population size, the number of registered vehicles, or distance travelled), is often used in the context of benchmarking. Nevertheless, these risk indicators are not consistent in most cases. In other words, countries may have different evaluation results or ranking positions using different exposure information. In this study, data envelopment analysis (DEA) as a performance measurement technique is investigated to provide an overall perspective on a country's road safety situation, and further assess whether the road safety outcomes registered in a country correspond to the numbers that can be expected based on the level of exposure. In doing so, three model extensions are considered, which are the DEA based road safety model (DEA-RS), the cross-efficiency method, and the categorical DEA model. Using the measures of exposure to risk as the model's input and the number of road fatalities as output, an overall road safety efficiency score is computed for the 27 European Union (EU) countries based on the DEA-RS model, and the ranking of countries in accordance with their cross-efficiency scores is evaluated. Furthermore, after applying clustering analysis to group countries with inherent similarity in their practices, the categorical DEA-RS model is adopted to identify best-performing and underperforming countries in each cluster, as well as the reference sets or benchmarks for those underperforming ones. More importantly, the extent to which each reference set could be learned from is specified, and practical yet challenging targets are given for each underperforming country, which enables policymakers to recognize the gap with those best-performing countries and further develop their own road safety policy. Copyright © 2012 Elsevier Ltd. All rights reserved.

Safety climate and safety behaviors in the construction industry: The importance of co-workers commitment to safety.

PubMed

Schwatka, Natalie V; Rosecrance, John C

2016-06-16

There is growing empirical evidence that as safety climate improves work site safety practice improve. Safety climate is often measured by asking workers about their perceptions of management commitment to safety. However, it is less common to include perceptions of their co-workers commitment to safety. While the involvement of management in safety is essential, working with co-workers who value and prioritize safety may be just as important. To evaluate a concept of safety climate that focuses on top management, supervisors and co-workers commitment to safety, which is relatively new and untested in the United States construction industry. Survey data was collected from a cohort of 300 unionized construction workers in the United States. The significance of direct and indirect (mediation) effects among safety climate and safety behavior factors were evaluated via structural equation modeling. Results indicated that safety climate was associated with safety behaviors on the job. More specifically, perceptions of co-workers commitment to safety was a mediator between both management commitment to safety climate factors and safety behaviors. These results support workplace health and safety interventions that build and sustain safety climate and a commitment to safety amongst work teams.

Evaluation of the Efficacy of Simulation Games in Traffic Safety Education of Kindergarten Children.

ERIC Educational Resources Information Center

Renaud, Lise; Suissa, Samy

1989-01-01

Uses a post-test-only control group study to evaluate the effect of three different types of simulation games used to teach traffic safety to kindergarten students. Results suggest that games including role-playing/group dynamics and modeling/training can change attitudes and modify behavior with this age group. (FMW)

Validation of a Preclinical Spinal Safety Model: Effects of Intrathecal Morphine in the Neonatal Rat

PubMed Central

Westin, B. David; Walker, Suellen M.; Deumens, Ronald; Grafe, Marjorie; Yaksh, Tony L.

2010-01-01

Background Preclinical studies demonstrate increased neuroapoptosis after general anesthesia in early life. Neuraxial techniques may minimize potential risks, but there has been no systematic evaluation of spinal analgesic safety in developmental models. We aimed to validate a preclinical model for evaluating dose-dependent efficacy, spinal cord toxicity, and long term function following intrathecal morphine in the neonatal rat. Methods Lumbar intrathecal injections were performed in anesthetized rats aged postnatal day (P)3, 10 and 21. The relationship between injectate volume and segmental spread was assessed post mortem and by in-vivo imaging. To determine the antinociceptive dose, mechanical withdrawal thresholds were measured at baseline and 30 minutes following intrathecal morphine. To evaluate toxicity, doses up to the maximum tolerated were administered, and spinal cord histopathology, apoptosis and glial response were evaluated 1 and 7 days following P3 or P21 injection. Sensory thresholds and gait analysis were evaluated at P35. Results Intrathecal injection can be reliably performed at all postnatal ages and injectate volume influences segmental spread. Intrathecal morphine produced spinally-mediated analgesia at all ages with lower dose requirements in younger pups. High dose intrathecal morphine did not produce signs of spinal cord toxicity or alter long-term function. Conclusions The therapeutic ratio for intrathecal morphine (toxic dose / antinociceptive dose) was at least 300 at P3, and at least 20 at P21 (latter doses limited by side effects). This data provides relative efficacy and safety data for comparison with other analgesic preparations and contributes supporting evidence for the validity of this preclinical neonatal safety model. PMID:20526189

Validation of a preclinical spinal safety model: effects of intrathecal morphine in the neonatal rat.

PubMed

Westin, B David; Walker, Suellen M; Deumens, Ronald; Grafe, Marjorie; Yaksh, Tony L

2010-07-01

Preclinical studies demonstrate increased neuroapoptosis after general anesthesia in early life. Neuraxial techniques may minimize potential risks, but there has been no systematic evaluation of spinal analgesic safety in developmental models. We aimed to validate a preclinical model for evaluating dose-dependent efficacy, spinal cord toxicity, and long-term function after intrathecal morphine in the neonatal rat. Lumbar intrathecal injections were performed in anesthetized rats aged postnatal day (P) 3, 10, and 21. The relationship between injectate volume and segmental spread was assessed postmortem and by in vivo imaging. To determine the antinociceptive dose, mechanical withdrawal thresholds were measured at baseline and 30 min after intrathecal morphine. To evaluate toxicity, doses up to the maximum tolerated were administered, and spinal cord histopathology, apoptosis, and glial response were evaluated 1 and 7 days after P3 or P21 injection. Sensory thresholds and gait analysis were evaluated at P35. Intrathecal injection can be reliably performed at all postnatal ages and injectate volume influences segmental spread. Intrathecal morphine produced spinally mediated analgesia at all ages with lower dose requirements in younger pups. High-dose intrathecal morphine did not produce signs of spinal cord toxicity or alter long-term function. The therapeutic ratio for intrathecal morphine (toxic dose/antinociceptive dose) was at least 300 at P3 and at least 20 at P21 (latter doses limited by side effects). These data provide relative efficacy and safety for comparison with other analgesic preparations and contribute supporting evidence for the validity of this preclinical neonatal safety model.

Evaluation of the CSA 2010 operational model test.

DOT National Transportation Integrated Search

2011-08-01

"In accordance with its primary mission to reduce crashes, injuries, and fatalities involving large trucks and buses, the Federal Motor Carrier Safety Administration (FMCSA) initiated the Comprehensive Safety Analysis 2010 (CSA 2010) Operational Mode...

ITS logical architecture : volume 3, data dictionary.

DOT National Transportation Integrated Search

1981-01-01

The objective of the research effort was to develop an empirically and experiencially based model pedestrian safety program which cities can use as guidelines for pedestrian safety program planning, implementation, and evaluation. The basis of these ...

Bayesian-network-based safety risk assessment for steel construction projects.

PubMed

Leu, Sou-Sen; Chang, Ching-Miao

2013-05-01

There are four primary accident types at steel building construction (SC) projects: falls (tumbles), object falls, object collapse, and electrocution. Several systematic safety risk assessment approaches, such as fault tree analysis (FTA) and failure mode and effect criticality analysis (FMECA), have been used to evaluate safety risks at SC projects. However, these traditional methods ineffectively address dependencies among safety factors at various levels that fail to provide early warnings to prevent occupational accidents. To overcome the limitations of traditional approaches, this study addresses the development of a safety risk-assessment model for SC projects by establishing the Bayesian networks (BN) based on fault tree (FT) transformation. The BN-based safety risk-assessment model was validated against the safety inspection records of six SC building projects and nine projects in which site accidents occurred. The ranks of posterior probabilities from the BN model were highly consistent with the accidents that occurred at each project site. The model accurately provides site safety-management abilities by calculating the probabilities of safety risks and further analyzing the causes of accidents based on their relationships in BNs. In practice, based on the analysis of accident risks and significant safety factors, proper preventive safety management strategies can be established to reduce the occurrence of accidents on SC sites. Copyright © 2013 Elsevier Ltd. All rights reserved.

JPRS Report, Science & Technology, Japan, 4th Intelligent Robots Symposium, Volume 2

DTIC Science & Technology

1989-03-16

accidents caused by strikes by robots,5 a quantitative model for safety evaluation,6 and evaluations of actual systems7 in order to contribute to...Mobile Robot Position Referencing Using Map-Based Vision Systems.... 160 Safety Evaluation of Man-Robot System 171 Fuzzy Path Pattern of Automatic...camera are made after the robot stops to prevent damage from occurring through obstacle interference. The position of the camera is indicated on the

Pharmacology-based toxicity assessment: towards quantitative risk prediction in humans.

PubMed

Sahota, Tarjinder; Danhof, Meindert; Della Pasqua, Oscar

2016-05-01

Despite ongoing efforts to better understand the mechanisms underlying safety and toxicity, ~30% of the attrition in drug discovery and development is still due to safety concerns. Changes in current practice regarding the assessment of safety and toxicity are required to reduce late stage attrition and enable effective development of novel medicines. This review focuses on the implications of empirical evidence generation for the evaluation of safety and toxicity during drug development. A shift in paradigm is needed to (i) ensure that pharmacological concepts are incorporated into the evaluation of safety and toxicity; (ii) facilitate the integration of historical evidence and thereby the translation of findings across species as well as between in vitro and in vivo experiments and (iii) promote the use of experimental protocols tailored to address specific safety and toxicity questions. Based on historical examples, we highlight the challenges for the early characterisation of the safety profile of a new molecule and discuss how model-based methodologies can be applied for the design and analysis of experimental protocols. Issues relative to the scientific rationale are categorised and presented as a hierarchical tree describing the decision-making process. Focus is given to four different areas, namely, optimisation, translation, analytical construct and decision criteria. From a methodological perspective, the relevance of quantitative methods for estimation and extrapolation of risk from toxicology and safety pharmacology experimental protocols, such as points of departure and potency, is discussed in light of advancements in population and Bayesian modelling techniques (e.g. non-linear mixed effects modelling). Their use in the evaluation of pharmacokinetics (PK) and pharmacokinetic-pharmacodynamic relationships (PKPD) has enabled great insight into the dose rationale for medicines in humans, both in terms of efficacy and adverse events. Comparable benefits can be anticipated for the assessment of safety and toxicity profile of novel molecules. © The Author 2016. Published by Oxford University Press on behalf of the UK Environmental Mutagen Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Team Psychological Safety and Team Learning: A Cultural Perspective

ERIC Educational Resources Information Center

Cauwelier, Peter; Ribière, Vincent M.; Bennet, Alex

2016-01-01

Purpose: The purpose of this paper was to evaluate if the concept of team psychological safety, a key driver of team learning and originally studied in the West, can be applied in teams from different national cultures. The model originally validated for teams in the West is applied to teams in Thailand to evaluate its validity, and the views team…

Using modeling and rehearsal to teach fire safety to children with autism.

PubMed

Garcia, David; Dukes, Charles; Brady, Michael P; Scott, Jack; Wilson, Cynthia L

2016-09-01

We evaluated the efficacy of an instructional procedure to teach young children with autism to evacuate settings and notify an adult during a fire alarm. A multiple baseline design across children showed that an intervention that included modeling, rehearsal, and praise was effective in teaching fire safety skills. Safety skills generalized to novel settings and maintained during a 5-week follow-up in both training and generalization settings. © 2016 Society for the Experimental Analysis of Behavior.

Nuclear Data Activities in Support of the DOE Nuclear Criticality Safety Program

NASA Astrophysics Data System (ADS)

Westfall, R. M.; McKnight, R. D.

2005-05-01

The DOE Nuclear Criticality Safety Program (NCSP) provides the technical infrastructure maintenance for those technologies applied in the evaluation and performance of safe fissionable-material operations in the DOE complex. These technologies include an Analytical Methods element for neutron transport as well as the development of sensitivity/uncertainty methods, the performance of Critical Experiments, evaluation and qualification of experiments as Benchmarks, and a comprehensive Nuclear Data program coordinated by the NCSP Nuclear Data Advisory Group (NDAG). The NDAG gathers and evaluates differential and integral nuclear data, identifies deficiencies, and recommends priorities on meeting DOE criticality safety needs to the NCSP Criticality Safety Support Group (CSSG). Then the NDAG identifies the required resources and unique capabilities for meeting these needs, not only for performing measurements but also for data evaluation with nuclear model codes as well as for data processing for criticality safety applications. The NDAG coordinates effort with the leadership of the National Nuclear Data Center, the Cross Section Evaluation Working Group (CSEWG), and the Working Party on International Evaluation Cooperation (WPEC) of the OECD/NEA Nuclear Science Committee. The overall objective is to expedite the issuance of new data and methods to the DOE criticality safety user. This paper describes these activities in detail, with examples based upon special studies being performed in support of criticality safety for a variety of DOE operations.

An evaluation of two conducted electrical weapons and two probe designs using a swine comparative cardiac safety model.

PubMed

Dawes, Donald Murray; Ho, Jeffrey D; Moore, Johanna C; Miner, James R

2013-09-01

Despite human laboratory and field studies that have demonstrated a reasonable safety profile for TASER brand conducted electrical weapons (CEW), the results of some swine studies and arrest related deaths temporal to the use of the CEWs continue to raise questions regarding cardiac safety. TASER International, Inc., has released a new CEW, the TASER X2, touted to have a better safety profile than its long-standing predecessor, the TASER X26. We have developed a model to assess the relative cardiac safety of CEWs and used it to compare the TASER X2 and the TASER X26. This safety model was also used to assess the relative safety of an experimental probe design as compared to the standard steel probe. Our results suggest that the TASER X2 has an improved safety margin over the TASER X26. The new probe design also has promise for enhanced cardiac safety, although may have some disadvantages when compared to the existing design which would make field use impractical.

A Method for Evaluating the Safety Impacts of Air Traffic Automation

NASA Technical Reports Server (NTRS)

Kostiuk, Peter; Shapiro, Gerald; Hanson, Dave; Kolitz, Stephan; Leong, Frank; Rosch, Gene; Bonesteel, Charles

1998-01-01

This report describes a methodology for analyzing the safety and operational impacts of emerging air traffic technologies. The approach integrates traditional reliability models of the system infrastructure with models that analyze the environment within which the system operates, and models of how the system responds to different scenarios. Products of the analysis include safety measures such as predicted incident rates, predicted accident statistics, and false alarm rates; and operational availability data. The report demonstrates the methodology with an analysis of the operation of the Center-TRACON Automation System at Dallas-Fort Worth International Airport.

Overview of Threats and Failure Models for Safety-Relevant Computer-Based Systems

NASA Technical Reports Server (NTRS)

Torres-Pomales, Wilfredo

2015-01-01

This document presents a high-level overview of the threats to safety-relevant computer-based systems, including (1) a description of the introduction and activation of physical and logical faults; (2) the propagation of their effects; and (3) function-level and component-level error and failure mode models. These models can be used in the definition of fault hypotheses (i.e., assumptions) for threat-risk mitigation strategies. This document is a contribution to a guide currently under development that is intended to provide a general technical foundation for designers and evaluators of safety-relevant systems.

Economic evaluation in patient safety: a literature review of methods.

PubMed

de Rezende, Bruna Alves; Or, Zeynep; Com-Ruelle, Laure; Michel, Philippe

2012-06-01

Patient safety practices, targeting organisational changes for improving patient safety, are implemented worldwide but their costs are rarely evaluated. This paper provides a review of the methods used in economic evaluation of such practices. International medical and economics databases were searched for peer-reviewed publications on economic evaluations of patient safety between 2000 and 2010 in English and French. This was complemented by a manual search of the reference lists of relevant papers. Grey literature was excluded. Studies were described using a standardised template and assessed independently by two researchers according to six quality criteria. 33 articles were reviewed that were representative of different patient safety domains, data types and evaluation methods. 18 estimated the economic burden of adverse events, 3 measured the costs of patient safety practices and 12 provided complete economic evaluations. Healthcare-associated infections were the most common subject of evaluation, followed by medication-related errors and all types of adverse events. Of these, 10 were selected that had adequately fulfilled one or several key quality criteria for illustration. This review shows that full cost-benefit/utility evaluations are rarely completed as they are resource intensive and often require unavailable data; some overcome these difficulties by performing stochastic modelling and by using secondary sources. Low methodological transparency can be a problem for building evidence from available economic evaluations. Investing in the economic design and reporting of studies with more emphasis on defining study perspectives, data collection and methodological choices could be helpful for strengthening our knowledge base on practices for improving patient safety.

Overview of phase IV clinical trials for postmarket drug safety surveillance: a status report from the ClinicalTrials.gov registry.

PubMed

Zhang, Xinji; Zhang, Yuan; Ye, Xiaofei; Guo, Xiaojing; Zhang, Tianyi; He, Jia

2016-11-23

Phase IV trials are often used to investigate drug safety after approval. However, little is known about the characteristics of contemporary phase IV clinical trials and whether these studies are of sufficient quality to advance medical knowledge in pharmacovigilance. We aimed to determine the fundamental characteristics of phase IV clinical trials that evaluated drug safety using the ClinicalTrials.gov registry data. A data set of 19 359 phase IV clinical studies registered in ClinicalTrials.gov was downloaded. The characteristics of the phase IV trials focusing on safety only were compared with those evaluating both safety and efficacy. We also compared the characteristics of the phase IV trials in three major therapeutic areas (cardiovascular diseases, mental health and oncology). Multivariable logistic regression was used to evaluate factors associated with the use of blinding and randomisation. A total of 4772 phase IV trials were identified, including 330 focusing on drug safety alone and 4392 evaluating both safety and efficacy. Most of the phase IV trials evaluating drug safety (75.9%) had enrolment <300 with 96.5% <3000. Among these trials, 8.2% were terminated or withdrawn. Factors associated with the use of blinding and randomisation included the intervention model, clinical specialty and lead sponsor. Phase IV trials evaluating drug safety in the ClinicalTrials.gov registry were dominated by small trials that might not have sufficient power to detect less common adverse events. An adequate sample size should be emphasised for phase IV trials with safety surveillance as main task. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Safety evaluation of the temporary consolidant based on a zebrafish embryo model.

PubMed

Zhang, Lu; Zhang, Xiao Yan; Hu, Yulan; Zhang, Bing Jian

2018-05-07

Temporary consolidants, such as cyclododecane, menthol, coumarin, and ethyl maltol, are proved to be effective for urgent conservation in archaeological field. However, the safety of these temporary consolidants is still unknown although they are always heavily used in archaeological field. Thus reports on the toxicity of these temporary consolidants are limited. Here, a zebrafish model was used for safety evaluation of these four temporary consolidants. In the present study, four temporary consolidants, including cyclododecane, menthol, coumarin, and ethyl maltol, at different concentrations were incubated with zebrafish embryos, and their biological toxic effects were firstly evaluated. It was shown that embryo exposure to temporary consolidants resulted in an increased mortality and malformation rate, and a decreased hatching rate. The order of embryo toxicity of the four types of temporary consolidants tested was menthol > coumarin > ethyl maltol > cyclododecane. Although the embryo toxicity of cyclododecane was minimal, some studies have indicated that this temporary consolidant could be bioaccumulated. The results also suggested that the zebrafish embryos can serve as a reliable model for the evaluation of embryo toxicity of temporary consolidants, as this model could offer the possibility to perform the rapid, medium throughput, cost-effective analyses. Copyright © 2018 Elsevier Ltd. All rights reserved.

Knowledge Acquisition Methods for the IHDS Diagnostic Review Expert System

DOT National Transportation Integrated Search

1997-12-01

The Federal Highway Administration's Interactive Highway Safety Design Model (IHSDM) is a suite of CADD-compatible programs that highway designers can use to evaluate the safety effects of various design alternatives. The IHSDM will include a Policy ...

Safety impacts of red light cameras at signalized intersections based on cellular automata models.

PubMed

Chai, C; Wong, Y D; Lum, K M

2015-01-01

This study applies a simulation technique to evaluate the hypothesis that red light cameras (RLCs) exert important effects on accident risks. Conflict occurrences are generated by simulation and compared at intersections with and without RLCs to assess the impact of RLCs on several conflict types under various traffic conditions. Conflict occurrences are generated through simulating vehicular interactions based on an improved cellular automata (CA) model. The CA model is calibrated and validated against field observations at approaches with and without RLCs. Simulation experiments are conducted for RLC and non-RLC intersections with different geometric layouts and traffic demands to generate conflict occurrences that are analyzed to evaluate the hypothesis that RLCs exert important effects on road safety. The comparison of simulated conflict occurrences show favorable safety impacts of RLCs on crossing conflicts and unfavorable impacts for rear-end conflicts during red/amber phases. Corroborative results are found from broad analysis of accident occurrence. RLCs are found to have a mixed effect on accident risk at signalized intersections: crossing collisions are reduced, whereas rear-end collisions may increase. The specially developed CA model is found to be a feasible safety assessment tool.

Protecting You/Protecting Me: Evaluation of a Student-Led Alcohol Prevention and Traffic Safety Program for Elementary Students

ERIC Educational Resources Information Center

Bell, Mary Lou; Baker, Tara Kelley; Falb, Timothy; Roberts-Gray, Cindy

2005-01-01

Pre- and post-surveys of self-protective knowledge and skills in third, fourth, and fifth grade classrooms (n = 24) randomly assigned to a model program for alcohol prevention and traffic safety or to comparison group (n = 24 classrooms) were analyzed to evaluate replicability of immediate positive effects of first-year exposure and to test…

Longitudinal safety evaluation of electric vehicles with the partial wireless charging lane on freeways.

PubMed

Li, Ye; Wang, Wei; Xing, Lu; Fan, Qi; Wang, Hao

2018-02-01

As an environment friendly transportation mode, the electric vehicle (EV) has drawn an increasing amount of attention from governments, vehicle manufactories and researchers recently. One of the biggest issue impeding EV's popularization associates with the charging process. The wireless charging lane (WCL) has been proposed as a convenient charging facility for EVs. Due to the high costs, the application of WCL on the entire freeways is impractical in the near future, while the partial WCL (PWCL) may be a feasible solution. This study aims to evaluate longitudinal safety of EVs with PWCL on freeways based on simulations. The simulation experiments are firstly designed, including deployment of PWCL on freeways and distribution of state of charge (SOC) of EVs. Then, a vehicle behavior model for EVs is proposed based on the intelligent driver model (IDM). Two surrogate safety measures, derived from time-to-collision (TTC), are utilized as indicators for safety evaluations. Sensitivity analysis is also conducted for related factors. Results show that the distribution of EVs' SOC significantly affect longitudinal safety when the PWCL is utilized. The low SOC in traffic consisting of EVs has the negative effect on longitudinal safety. The randomness and incompliance of EV drivers worsens the safety performance. The sensitivity analysis indicates that the larger maximum deceleration rate results in the higher longitudinal crash risks of EVs, while the length of PWCL has no monotonous effect. Different TTC thresholds also show no impact on results. A case study shows the consistent results. Based on the findings, several suggestions are discussed for EVs' safety improvement. Results of this study provide useful information for freeway safety when EVs are applied in the future. Copyright © 2017 Elsevier Ltd. All rights reserved.

Development and weighting of a life cycle assessment screening model

NASA Astrophysics Data System (ADS)

Bates, Wayne E.; O'Shaughnessy, James; Johnson, Sharon A.; Sisson, Richard

2004-02-01

Nearly all life cycle assessment tools available today are high priced, comprehensive and quantitative models requiring a significant amount of data collection and data input. In addition, most of the available software packages require a great deal of training time to learn how to operate the model software. Even after this time investment, results are not guaranteed because of the number of estimations and assumptions often necessary to run the model. As a result, product development, design teams and environmental specialists need a simplified tool that will allow for the qualitative evaluation and "screening" of various design options. This paper presents the development and design of a generic, qualitative life cycle screening model and demonstrates its applicability and ease of use. The model uses qualitative environmental, health and safety factors, based on site or product-specific issues, to sensitize the overall results for a given set of conditions. The paper also evaluates the impact of different population input ranking values on model output. The final analysis is based on site or product-specific variables. The user can then evaluate various design changes and the apparent impact or improvement on the environment, health and safety, compliance cost and overall corporate liability. Major input parameters can be varied, and factors such as materials use, pollution prevention, waste minimization, worker safety, product life, environmental impacts, return of investment, and recycle are evaluated. The flexibility of the model format will be discussed in order to demonstrate the applicability and usefulness within nearly any industry sector. Finally, an example using audience input value scores will be compared to other population input results.

Comparison of safety effect estimates obtained from empirical Bayes before-after study, propensity scores-potential outcomes framework, and regression model with cross-sectional data.

PubMed

Wood, Jonathan S; Donnell, Eric T; Porter, Richard J

2015-02-01

A variety of different study designs and analysis methods have been used to evaluate the performance of traffic safety countermeasures. The most common study designs and methods include observational before-after studies using the empirical Bayes method and cross-sectional studies using regression models. The propensity scores-potential outcomes framework has recently been proposed as an alternative traffic safety countermeasure evaluation method to address the challenges associated with selection biases that can be part of cross-sectional studies. Crash modification factors derived from the application of all three methods have not yet been compared. This paper compares the results of retrospective, observational evaluations of a traffic safety countermeasure using both before-after and cross-sectional study designs. The paper describes the strengths and limitations of each method, focusing primarily on how each addresses site selection bias, which is a common issue in observational safety studies. The Safety Edge paving technique, which seeks to mitigate crashes related to roadway departure events, is the countermeasure used in the present study to compare the alternative evaluation methods. The results indicated that all three methods yielded results that were consistent with each other and with previous research. The empirical Bayes results had the smallest standard errors. It is concluded that the propensity scores with potential outcomes framework is a viable alternative analysis method to the empirical Bayes before-after study. It should be considered whenever a before-after study is not possible or practical. Copyright © 2014 Elsevier Ltd. All rights reserved.

Development and Evaluation of an Online, Inquiry-Based Food Safety Education Program for Secondary Teachers and Their Students

ERIC Educational Resources Information Center

Beffa-Negrini, Patricia A.; Cohen, Nancy L.; Laus, Mary Jane; McLandsborough, Lynne A.

2007-01-01

Secondary science teachers who integrate food safety (FS) into curricula can provide FS knowledge and skills to youth while reinforcing science skills and concepts. National science education standards and the Biological Science Curriculum Study 5E Inquiry-based Learning Model were used to design an online training, Food Safety FIRST. The training…

Time series trends of the safety effects of pavement resurfacing.

PubMed

Park, Juneyoung; Abdel-Aty, Mohamed; Wang, Jung-Han

2017-04-01

This study evaluated the safety performance of pavement resurfacing projects on urban arterials in Florida using the observational before and after approaches. The safety effects of pavement resurfacing were quantified in the crash modification factors (CMFs) and estimated based on different ranges of heavy vehicle traffic volume and time changes for different severity levels. In order to evaluate the variation of CMFs over time, crash modification functions (CMFunctions) were developed using nonlinear regression and time series models. The results showed that pavement resurfacing projects decrease crash frequency and are found to be more safety effective to reduce severe crashes in general. Moreover, the results of the general relationship between the safety effects and time changes indicated that the CMFs increase over time after the resurfacing treatment. It was also found that pavement resurfacing projects for the urban roadways with higher heavy vehicle volume rate are more safety effective than the roadways with lower heavy vehicle volume rate. Based on the exploration and comparison of the developed CMFucntions, the seasonal autoregressive integrated moving average (SARIMA) and exponential functional form of the nonlinear regression models can be utilized to identify the trend of CMFs over time. Copyright © 2017 Elsevier Ltd. All rights reserved.

Occupational health and safety: Designing and building with MACBETH a value risk-matrix for evaluating health and safety risks

NASA Astrophysics Data System (ADS)

Lopes, D. F.; Oliveira, M. D.; Costa, C. A. Bana e.

2015-05-01

Risk matrices (RMs) are commonly used to evaluate health and safety risks. Nonetheless, they violate some theoretical principles that compromise their feasibility and use. This study describes how multiple criteria decision analysis methods have been used to improve the design and the deployment of RMs to evaluate health and safety risks at the Occupational Health and Safety Unit (OHSU) of the Regional Health Administration of Lisbon and Tagus Valley. ‘Value risk-matrices’ (VRMs) are built with the MACBETH approach in four modelling steps: a) structuring risk impacts, involving the construction of descriptors of impact that link risk events with health impacts and are informed by scientific evidence; b) generating a value measurement scale of risk impacts, by applying the MACBETH-Choquet procedure; c) building a system for eliciting subjective probabilities that makes use of a numerical probability scale that was constructed with MACBETH qualitative judgments on likelihood; d) and defining a classification colouring scheme for the VRM. A VRM built with OHSU members was implemented in a decision support system which will be used by OHSU members to evaluate health and safety risks and to identify risk mitigation actions.

Human performance cognitive-behavioral modeling: a benefit for occupational safety.

PubMed

Gore, Brian F

2002-01-01

Human Performance Modeling (HPM) is a computer-aided job analysis software methodology used to generate predictions of complex human-automation integration and system flow patterns with the goal of improving operator and system safety. The use of HPM tools has recently been increasing due to reductions in computational cost, augmentations in the tools' fidelity, and usefulness in the generated output. An examination of an Air Man-machine Integration Design and Analysis System (Air MIDAS) model evaluating complex human-automation integration currently underway at NASA Ames Research Center will highlight the importance to occupational safety of considering both cognitive and physical aspects of performance when researching human error.

Human performance cognitive-behavioral modeling: a benefit for occupational safety

NASA Technical Reports Server (NTRS)

Gore, Brian F.

2002-01-01

Human Performance Modeling (HPM) is a computer-aided job analysis software methodology used to generate predictions of complex human-automation integration and system flow patterns with the goal of improving operator and system safety. The use of HPM tools has recently been increasing due to reductions in computational cost, augmentations in the tools' fidelity, and usefulness in the generated output. An examination of an Air Man-machine Integration Design and Analysis System (Air MIDAS) model evaluating complex human-automation integration currently underway at NASA Ames Research Center will highlight the importance to occupational safety of considering both cognitive and physical aspects of performance when researching human error.

Effects of patient safety auditing in hospital care: results of a mixed-method evaluation (part 1).

PubMed

Hanskamp-Sebregts, Mirelle; Zegers, Marieke; Westert, Gert P; Boeijen, Wilma; Teerenstra, Steven; van Gurp, Petra J; Wollersheim, Hub

2018-06-15

To evaluate the effectiveness of internal auditing in hospital care focussed on improving patient safety. A before-and-after mixed-method evaluation study was carried out in eight departments of a university medical center in the Netherlands. Internal auditing and feedback focussed on improving patient safety. The effect of internal auditing was assessed 15 months after the audit, using linear mixed models, on the patient, professional, team and departmental levels. The measurement methods were patient record review on adverse events (AEs), surveys regarding patient experiences, safety culture and team climate, analysis of administrative hospital data (standardized mortality rate, SMR) and safety walk rounds (SWRs) to observe frontline care processes on safety. The AE rate decreased from 36.1% to 31.3% and the preventable AE rate from 5.5% to 3.6%; however, the differences before and after auditing were not statistically significant. The patient-reported experience measures regarding patient safety improved slightly over time (P < 0.001). The SMR, patient safety culture and team climate remained unchanged after the internal audit. The SWRs showed that medication safety and information security were improved (P < 0.05). Internal auditing was associated with improved patient experiences and observed safety on wards. No effects were found on adverse outcomes, safety culture and team climate 15 months after the internal audit.

Generalized railway tank car safety design optimization for hazardous materials transport: addressing the trade-off between transportation efficiency and safety.

PubMed

Saat, Mohd Rapik; Barkan, Christopher P L

2011-05-15

North America railways offer safe and generally the most economical means of long distance transport of hazardous materials. Nevertheless, in the event of a train accident releases of these materials can pose substantial risk to human health, property or the environment. The majority of railway shipments of hazardous materials are in tank cars. Improving the safety design of these cars to make them more robust in accidents generally increases their weight thereby reducing their capacity and consequent transportation efficiency. This paper presents a generalized tank car safety design optimization model that addresses this tradeoff. The optimization model enables evaluation of each element of tank car safety design, independently and in combination with one another. We present the optimization model by identifying a set of Pareto-optimal solutions for a baseline tank car design in a bicriteria decision problem. This model provides a quantitative framework for a rational decision-making process involving tank car safety design enhancements to reduce the risk of transporting hazardous materials. Copyright © 2011 Elsevier B.V. All rights reserved.

Exploring the sociotechnical intersection of patient safety and electronic health record implementation

PubMed Central

Meeks, Derek W; Takian, Amirhossein; Sittig, Dean F; Singh, Hardeep; Barber, Nick

2014-01-01

Objective The intersection of electronic health records (EHR) and patient safety is complex. To examine the applicability of two previously developed conceptual models comprehensively to understand safety implications of EHR implementation in the English National Health Service (NHS). Methods We conducted a secondary analysis of interview data from a 30-month longitudinal, prospective, case study-based evaluation of EHR implementation in 12 NHS hospitals. We used a framework analysis approach to apply conceptual models developed by Sittig and Singh to understand better EHR implementation and use: an eight-dimension sociotechnical model and a three-phase patient safety model (safe technology, safe use of technology, and use of technology to improve safety). Results The intersection of patient safety and EHR implementation and use was characterized by risks involving technology (hardware and software, clinical content, and human–computer interfaces), the interaction of technology with non-technological factors, and improper or unsafe use of technology. Our data support that patient safety improvement activities as well as patient safety hazards change as an organization evolves from concerns about safe EHR functionality, ensuring safe and appropriate EHR use, to using the EHR itself to provide ongoing surveillance and monitoring of patient safety. Discussion We demonstrate the face validity of two models for understanding the sociotechnical aspects of safe EHR implementation and the complex interactions of technology within a healthcare system evolving from paper to integrated EHR. Conclusions Using sociotechnical models, including those presented in this paper, may be beneficial to help stakeholders understand, synthesize, and anticipate risks at the intersection of patient safety and health information technology. PMID:24052536

Exploring the sociotechnical intersection of patient safety and electronic health record implementation.

PubMed

Meeks, Derek W; Takian, Amirhossein; Sittig, Dean F; Singh, Hardeep; Barber, Nick

2014-02-01

The intersection of electronic health records (EHR) and patient safety is complex. To examine the applicability of two previously developed conceptual models comprehensively to understand safety implications of EHR implementation in the English National Health Service (NHS). We conducted a secondary analysis of interview data from a 30-month longitudinal, prospective, case study-based evaluation of EHR implementation in 12 NHS hospitals. We used a framework analysis approach to apply conceptual models developed by Sittig and Singh to understand better EHR implementation and use: an eight-dimension sociotechnical model and a three-phase patient safety model (safe technology, safe use of technology, and use of technology to improve safety). The intersection of patient safety and EHR implementation and use was characterized by risks involving technology (hardware and software, clinical content, and human-computer interfaces), the interaction of technology with non-technological factors, and improper or unsafe use of technology. Our data support that patient safety improvement activities as well as patient safety hazards change as an organization evolves from concerns about safe EHR functionality, ensuring safe and appropriate EHR use, to using the EHR itself to provide ongoing surveillance and monitoring of patient safety. We demonstrate the face validity of two models for understanding the sociotechnical aspects of safe EHR implementation and the complex interactions of technology within a healthcare system evolving from paper to integrated EHR. Using sociotechnical models, including those presented in this paper, may be beneficial to help stakeholders understand, synthesize, and anticipate risks at the intersection of patient safety and health information technology.

A Model-Based Approach to Support Validation of Medical Cyber-Physical Systems.

PubMed

Silva, Lenardo C; Almeida, Hyggo O; Perkusich, Angelo; Perkusich, Mirko

2015-10-30

Medical Cyber-Physical Systems (MCPS) are context-aware, life-critical systems with patient safety as the main concern, demanding rigorous processes for validation to guarantee user requirement compliance and specification-oriented correctness. In this article, we propose a model-based approach for early validation of MCPS, focusing on promoting reusability and productivity. It enables system developers to build MCPS formal models based on a library of patient and medical device models, and simulate the MCPS to identify undesirable behaviors at design time. Our approach has been applied to three different clinical scenarios to evaluate its reusability potential for different contexts. We have also validated our approach through an empirical evaluation with developers to assess productivity and reusability. Finally, our models have been formally verified considering functional and safety requirements and model coverage.

A blended supervision model in Australian general practice training.

PubMed

Ingham, Gerard; Fry, Jennifer

2016-05-01

The Royal Australian College of General Practitioners' Standards for general practice training allow different models of registrar supervision, provided these models achieve the outcomes of facilitating registrars' learning and ensuring patient safety. In this article, we describe a model of supervision called 'blended supervision', and its initial implementation and evaluation. The blended supervision model integrates offsite supervision with available local supervision resources. It is a pragmatic alternative to traditional supervision. Further evaluation of the cost-effectiveness, safety and effectiveness of this model is required, as is the recruitment and training of remote supervisors. A framework of questions was developed to outline the training practice's supervision methods and explain how blended supervision is achieving supervision and teaching outcomes. The supervision and teaching framework can be used to understand the supervision methods of all practices, not just practices using blended supervision.

A Model-Based Approach to Support Validation of Medical Cyber-Physical Systems

PubMed Central

Silva, Lenardo C.; Almeida, Hyggo O.; Perkusich, Angelo; Perkusich, Mirko

2015-01-01

Medical Cyber-Physical Systems (MCPS) are context-aware, life-critical systems with patient safety as the main concern, demanding rigorous processes for validation to guarantee user requirement compliance and specification-oriented correctness. In this article, we propose a model-based approach for early validation of MCPS, focusing on promoting reusability and productivity. It enables system developers to build MCPS formal models based on a library of patient and medical device models, and simulate the MCPS to identify undesirable behaviors at design time. Our approach has been applied to three different clinical scenarios to evaluate its reusability potential for different contexts. We have also validated our approach through an empirical evaluation with developers to assess productivity and reusability. Finally, our models have been formally verified considering functional and safety requirements and model coverage. PMID:26528982

Evaluating the effectiveness of a peer-led education intervention to improve the patient safety attitudes of junior pharmacy students: a cross-sectional study using a latent growth curve modelling approach.

PubMed

Walpola, Ramesh L; Fois, Romano A; McLachlan, Andrew J; Chen, Timothy F

2015-12-08

Despite the recognition that educating healthcare students in patient safety is essential, changing already full curricula can be challenging. Furthermore, institutions may lack the capacity and capability to deliver patient safety education, particularly from the start of professional practice studies. Using senior students as peer educators to deliver practice-based education can potentially overcome some of the contextual barriers in training junior students. Therefore, this study aimed to evaluate the effectiveness of a peer-led patient safety education programme for junior pharmacy students. A repeat cross-sectional design utilising a previously validated patient safety attitudinal survey was used to evaluate attitudes prior to, immediately after and 1 month after the delivery of a patient safety education programme. Latent growth curve (LGC) modelling was used to evaluate the change in attitudes of first-year students using second-year students as a comparator group. Undergraduate university students in Sydney, Australia. 175 first-year and 140 second-year students enrolled in the Bachelor of Pharmacy programme at the University of Sydney. An introductory patient safety programme was implemented into the first-year Bachelor of Pharmacy curriculum at the University of Sydney. The programme covered introductory patient safety topics including teamwork, communication skills, systems thinking and open disclosure. The programme consisted of 2 lectures, delivered by a senior academic, and a workshop delivered by trained final-year pharmacy students. A full LGC model was constructed including the intervention as a non-time-dependent predictor of change (χ(2) (51)=164.070, root mean square error of approximation=0.084, comparative fit index=0.913, standardised root mean square=0.056). First-year students' attitudes significantly improved as a result of the intervention, particularly in relation to internalising errors (p=0.010), questioning behaviours (p<0.001) and open disclosure (p=0.008). Peer-led education is an effective method that can be adopted to improve junior pharmacy students' attitudes towards patient safety. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Study on the evaluation method for fault displacement based on characterized source model

NASA Astrophysics Data System (ADS)

Tonagi, M.; Takahama, T.; Matsumoto, Y.; Inoue, N.; Irikura, K.; Dalguer, L. A.

2016-12-01

In IAEA Specific Safety Guide (SSG) 9 describes that probabilistic methods for evaluating fault displacement should be used if no sufficient basis is provided to decide conclusively that the fault is not capable by using the deterministic methodology. In addition, International Seismic Safety Centre compiles as ANNEX to realize seismic hazard for nuclear facilities described in SSG-9 and shows the utility of the deterministic and probabilistic evaluation methods for fault displacement. In Japan, it is required that important nuclear facilities should be established on ground where fault displacement will not arise when earthquakes occur in the future. Under these situations, based on requirements, we need develop evaluation methods for fault displacement to enhance safety in nuclear facilities. We are studying deterministic and probabilistic methods with tentative analyses using observed records such as surface fault displacement and near-fault strong ground motions of inland crustal earthquake which fault displacements arose. In this study, we introduce the concept of evaluation methods for fault displacement. After that, we show parts of tentative analysis results for deterministic method as follows: (1) For the 1999 Chi-Chi earthquake, referring slip distribution estimated by waveform inversion, we construct a characterized source model (Miyake et al., 2003, BSSA) which can explain observed near-fault broad band strong ground motions. (2) Referring a characterized source model constructed in (1), we study an evaluation method for surface fault displacement using hybrid method, which combines particle method and distinct element method. At last, we suggest one of the deterministic method to evaluate fault displacement based on characterized source model. This research was part of the 2015 research project `Development of evaluating method for fault displacement` by the Secretariat of Nuclear Regulation Authority (S/NRA), Japan.

Sophisticated Calculation of the 1oo4-architecture for Safety-related Systems Conforming to IEC61508

NASA Astrophysics Data System (ADS)

Hayek, A.; Bokhaiti, M. Al; Schwarz, M. H.; Boercsoek, J.

2012-05-01

With the publication and enforcement of the standard IEC 61508 of safety related systems, recent system architectures have been presented and evaluated. Among a number of techniques and measures to the evaluation of safety integrity level (SIL) for safety-related systems, several measures such as reliability block diagrams and Markov models are used to analyze the probability of failure on demand (PFD) and mean time to failure (MTTF) which conform to IEC 61508. The current paper deals with the quantitative analysis of the novel 1oo4-architecture (one out of four) presented in recent work. Therefore sophisticated calculations for the required parameters are introduced. The provided 1oo4-architecture represents an advanced safety architecture based on on-chip redundancy, which is 3-failure safe. This means that at least one of the four channels have to work correctly in order to trigger the safety function.

Results of a community-based survey of construction safety climate for Hispanic workers.

PubMed

Marin, Luz S; Cifuentes, Manuel; Roelofs, Cora

2015-01-01

Hispanic construction workers experience high rates of occupational injury, likely influenced by individual, organizational, and social factors. To characterize the safety climate of Hispanic construction workers using worker, contractor, and supervisor perceptions of the workplace. We developed a 40-item interviewer-assisted survey with six safety climate dimensions and administered it in Spanish and English to construction workers, contractors, and supervisors. A safety climate model, comparing responses and assessing contributing factors was created based on survey responses. While contractors and construction supervisors' (n = 128) scores were higher, all respondents shared a negative perception of safety climate. Construction workers had statistically significantly lower safety climate scores compared to supervisors and contractors (30·6 vs 46·5%, P<0·05). Safety climate scores were not associated with English language ability or years lived in the United States. We found that Hispanic construction workers in this study experienced a poor safety climate. The Hispanic construction safety climate model we propose can serve as a framework to guide organizational safety interventions and evaluate safety climate improvements.

Results of a community-based survey of construction safety climate for Hispanic workers

PubMed Central

Marin, Luz S; Cifuentes, Manuel; Roelofs, Cora

2015-01-01

Background: Hispanic construction workers experience high rates of occupational injury, likely influenced by individual, organizational, and social factors. Objectives: To characterize the safety climate of Hispanic construction workers using worker, contractor, and supervisor perceptions of the workplace. Methods: We developed a 40-item interviewer-assisted survey with six safety climate dimensions and administered it in Spanish and English to construction workers, contractors, and supervisors. A safety climate model, comparing responses and assessing contributing factors was created based on survey responses. Results: While contractors and construction supervisors’ (n = 128) scores were higher, all respondents shared a negative perception of safety climate. Construction workers had statistically significantly lower safety climate scores compared to supervisors and contractors (30.6 vs 46.5%, P<0.05). Safety climate scores were not associated with English language ability or years lived in the United States. Conclusions: We found that Hispanic construction workers in this study experienced a poor safety climate. The Hispanic construction safety climate model we propose can serve as a framework to guide organizational safety interventions and evaluate safety climate improvements. PMID:26145454

Safety self-efficacy and safety performance: potential antecedents and the moderation effect of standardization.

PubMed

Katz-Navon, Tal; Naveh, Eitan; Stern, Zvi

2007-01-01

The purpose of this paper is to suggest a new safety self-efficacy construct and to explore its antecedents and interaction with standardization to influence in-patient safety. The paper used a survey of 161 nurses using a self-administered questionnaire over a 14-day period in two large Israeli general hospitals. Nurses answered questions relating to four safety self-efficacy antecedents: enactive mastery experiences; managers as safety role models; verbal persuasion; and safety priority, that relate to the perceived level of standardization and safety self-efficacy. Confirmatory factor analysis was used to assess the scale's construct validity. Regression models were used to test hypotheses regarding the antecedents and influence of safety self-efficacy. Results indicate that: managers as safety role models; distributing safety information; and priority given to safety, contributed to safety self-efficacy. Additionally, standardization moderated the effects of safety self-efficacy and patient safety such that safety self-efficacy was positively associated with patient safety when standardization was low rather than high. Hospital managers should be aware of individual motivations as safety self-efficacy when evaluating the potential influence of standardization on patient safety. Theoretically, the study introduces a new safety self-efficacy concept, and captures its antecedents and influence on safety performance. Also, the study suggests safety self-efficacy as a boundary condition for the influence of standardization on safety performance. Implementing standardization in healthcare is problematic because not all processes can be standardized. In this case, self-efficacy plays an important role in securing patient safety. Hence, safety self-efficacy may serve as a "substitute-for-standardization," by promoting staff behaviors that affect patient safety.

Development of an automated assessment tool for MedWatch reports in the FDA adverse event reporting system.

PubMed

Han, Lichy; Ball, Robert; Pamer, Carol A; Altman, Russ B; Proestel, Scott

2017-09-01

As the US Food and Drug Administration (FDA) receives over a million adverse event reports associated with medication use every year, a system is needed to aid FDA safety evaluators in identifying reports most likely to demonstrate causal relationships to the suspect medications. We combined text mining with machine learning to construct and evaluate such a system to identify medication-related adverse event reports. FDA safety evaluators assessed 326 reports for medication-related causality. We engineered features from these reports and constructed random forest, L1 regularized logistic regression, and support vector machine models. We evaluated model accuracy and further assessed utility by generating report rankings that represented a prioritized report review process. Our random forest model showed the best performance in report ranking and accuracy, with an area under the receiver operating characteristic curve of 0.66. The generated report ordering assigns reports with a higher probability of medication-related causality a higher rank and is significantly correlated to a perfect report ordering, with a Kendall's tau of 0.24 ( P  = .002). Our models produced prioritized report orderings that enable FDA safety evaluators to focus on reports that are more likely to contain valuable medication-related adverse event information. Applying our models to all FDA adverse event reports has the potential to streamline the manual review process and greatly reduce reviewer workload. Published by Oxford University Press on behalf of the American Medical Informatics Association 2017. This work is written by US Government employees and is in the public domain in the United States.

Contribution of European research to risk analysis.

PubMed

Boenke, A

2001-12-01

The European Commission's, Quality of Life Research Programme, Key Action 1-Health, Food & Nutrition is mission-oriented and aims, amongst other things, at providing a healthy, safe and high-quality food supply leading to reinforced consumer confidence in the safety, of European food. Its objectives also include the enhancing of the competitiveness of the European food supply. Key Action 1 is currently supporting a number of different types of European collaborative projects in the area of risk analysis. The objectives of these projects range from the development and validation of prevention strategies including the reduction of consumers risks; development and validation of new modelling approaches, harmonization of risk assessment principles methodologies and terminology; standardization of methods and systems used for the safety evaluation of transgenic food; providing of tools for the evaluation of human viral contamination of shellfish and quality control; new methodologies for assessing the potential of unintended effects of genetically modified (genetically modified) foods; development of a risk assessment model for Cryptosporidium parvum related to the food and water industries, to the development of a communication platform for genetically modified organism, producers, retailers, regulatory authorities and consumer groups to improve safety assessment procedures, risk management strategies and risk communication; development and validation of new methods for safety testing of transgenic food; evaluation of the safety and efficacy of iron supplementation in pregnant women, evaluation of the potential cancer-preventing activity of pro- and pre-biotic ('synbiotic') combinations in human volunteers. An overview of these projects is presented here.

Report on SARS backfit evaluation, Catalytic, Inc. Solvent Refined Coal Pilot Plant, Wilsonville, Alabama

DOE Office of Scientific and Technical Information (OSTI.GOV)

Meyer, A.F. Jr.

1980-07-02

A site visit was made in company with the DOE-OPTA-EA Safety and Health Official for the purpose of providing that official with technical assistance in evaluating the validity of an earlier DOE-OPTA recommendation exempting this facility from the Safety and Analysis and Review backfit requirements of DOE Order 5481.1. A further purpose of the visit was to assess and evaluate the occupational safety and health program at this facility, as compared with the criteria and guidelines contained in ASFE Order 5481.1. Adequate documentation regarding compliance with codes, standards, and regulations were observed at this facility. There is in existence anmore » ongoing continuous safety analysis effort for both modifications or additions to this facility. Adequate environmental safeguards and plans and procedures were observed. The SARS backfit exemption is appropriate. The occupational safety and health program is in many ways a model for the scope of work and nature of hazards involved, and is consistent with ASFE guidelines and statutory requirements.« less

Evaluating chemical safety: ToxCast, Tipping Points and Virtual Tissues (Tamburro Symposium)

EPA Science Inventory

This presentation provides an overview of high-throughput toxicology at the NCCT using high-content imaging and computational models for analyzing chemical safety. In In particular, this work outlines the derivation of toxicological "tipping points" from in vitro concentration- a...

New geometric design consistency model based on operating speed profiles for road safety evaluation.

PubMed

Camacho-Torregrosa, Francisco J; Pérez-Zuriaga, Ana M; Campoy-Ungría, J Manuel; García-García, Alfredo

2013-12-01

To assist in the on-going effort to reduce road fatalities as much as possible, this paper presents a new methodology to evaluate road safety in both the design and redesign stages of two-lane rural highways. This methodology is based on the analysis of road geometric design consistency, a value which will be a surrogate measure of the safety level of the two-lane rural road segment. The consistency model presented in this paper is based on the consideration of continuous operating speed profiles. The models used for their construction were obtained by using an innovative GPS-data collection method that is based on continuous operating speed profiles recorded from individual drivers. This new methodology allowed the researchers to observe the actual behavior of drivers and to develop more accurate operating speed models than was previously possible with spot-speed data collection, thereby enabling a more accurate approximation to the real phenomenon and thus a better consistency measurement. Operating speed profiles were built for 33 Spanish two-lane rural road segments, and several consistency measurements based on the global and local operating speed were checked. The final consistency model takes into account not only the global dispersion of the operating speed, but also some indexes that consider both local speed decelerations and speeds over posted speeds as well. For the development of the consistency model, the crash frequency for each study site was considered, which allowed estimating the number of crashes on a road segment by means of the calculation of its geometric design consistency. Consequently, the presented consistency evaluation method is a promising innovative tool that can be used as a surrogate measure to estimate the safety of a road segment. Copyright © 2012 Elsevier Ltd. All rights reserved.

Using micro-simulation to investigate the safety impacts of transit design alternatives at signalized intersections.

PubMed

Li, Lu; Persaud, Bhagwant; Shalaby, Amer

2017-03-01

This study investigates the use of crash prediction models and micro-simulation to develop an effective surrogate safety assessment measure at the intersection level. With the use of these tools, hypothetical scenarios can be developed and explored to evaluate the safety impacts of design alternatives in a controlled environment, in which factors not directly associated with the design alternatives can be fixed. Micro-simulation models are developed, calibrated, and validated. Traffic conflicts in the micro-simulation models are estimated and linked with observed crash frequency, which greatly alleviates the lengthy time needed to collect sufficient crash data for evaluating alternatives, due to the rare and infrequent nature of crash events. A set of generalized linear models with negative binomial error structure is developed to correlate the simulated conflicts with the observed crash frequency in Toronto, Ontario, Canada. Crash prediction models are also developed for crashes of different impact types and for transit-involved crashes. The resulting statistical significance and the goodness-of-fit of the models suggest adequate predictive ability. Based on the established correlation between simulated conflicts and observed crashes, scenarios are developed in the micro-simulation models to investigate the safety effects of individual transit line elements by making hypothetical modifications to such elements and estimating changes in crash frequency from the resulting changes in conflicts. The findings imply that the existing transit signal priority schemes can have a negative effect on safety performance, and that the existing near-side stop positioning and streetcar transit type can be safer at their current state than if they were to be replaced by their respective counterparts. Copyright © 2017 Elsevier Ltd. All rights reserved.

Designing Serious Games for Safety Education: "Learn to Brace" versus Traditional Pictorials for Aircraft Passengers.

PubMed

Chittaro, Luca

2016-05-01

Serious games for safety education (SGSE) are a novel tool for preparing people to prevent and\\or handle risky situations. Although several SGSE have been developed, design and evaluation methods for SGSE need to be better grounded in and guided by safety-relevant psychological theories. In particular, this paper focuses on threat appeals and the assessment of variables, such as safety locus of control, that influence human behavior in real risky situations. It illustrates how we took into account such models in the design and evaluation of "Learn to Brace", a first-of-its-kind serious game that deals with a major problem in aviation safety, i.e. the scarce effectiveness of the safety cards used by airlines. The study considered a sample of 48 users: half of them received instructions about the brace position through the serious game, the other half through a traditional safety card pictorial. Results showed that the serious game was much more effective than the traditional instructions both in terms of learning and of changing safety-relevant perceptions, especially safety locus of control and recommendation perception.

Developing a Methodology for Eliciting Subjective Probability Estimates During Expert Evaluations of Safety Interventions: Application for Bayesian Belief Networks

NASA Technical Reports Server (NTRS)

Wiegmann, Douglas A.a

2005-01-01

The NASA Aviation Safety Program (AvSP) has defined several products that will potentially modify airline and/or ATC operations, enhance aircraft systems, and improve the identification of potential hazardous situations within the National Airspace System (NAS). Consequently, there is a need to develop methods for evaluating the potential safety benefit of each of these intervention products so that resources can be effectively invested to produce the judgments to develop Bayesian Belief Networks (BBN's) that model the potential impact that specific interventions may have. Specifically, the present report summarizes methodologies for improving the elicitation of probability estimates during expert evaluations of AvSP products for use in BBN's. The work involved joint efforts between Professor James Luxhoj from Rutgers University and researchers at the University of Illinois. The Rutgers' project to develop BBN's received funding by NASA entitled "Probabilistic Decision Support for Evaluating Technology Insertion and Assessing Aviation Safety System Risk." The proposed project was funded separately but supported the existing Rutgers' program.

Innovative neuro-fuzzy system of smart transport infrastructure for road traffic safety

NASA Astrophysics Data System (ADS)

Beinarovica, Anna; Gorobetz, Mikhail; Levchenkov, Anatoly

2017-09-01

The proposed study describes applying of neural network and fuzzy logic in transport control for safety improvement by evaluation of accidents’ risk by intelligent infrastructure devices. Risk evaluation is made by following multiple-criteria: danger, changeability and influence of changes for risk increasing. Neuro-fuzzy algorithms are described and proposed for task solution. The novelty of the proposed system is proved by deep analysis of known studies in the field. The structure of neuro-fuzzy system for risk evaluation and mathematical model is described in the paper. The simulation model of the intelligent devices for transport infrastructure is proposed to simulate different situations, assess the risks and propose the possible actions for infrastructure or vehicles to minimize the risk of possible accidents.

Risk assessment of supply chain for pharmaceutical excipients with AHP-fuzzy comprehensive evaluation.

PubMed

Li, Maozhong; Du, Yunai; Wang, Qiyue; Sun, Chunmeng; Ling, Xiang; Yu, Boyang; Tu, Jiasheng; Xiong, Yerong

2016-01-01

As the essential components in formulations, pharmaceutical excipients directly affect the safety, efficacy, and stability of drugs. Recently, safety incidents of pharmaceutical excipients posing seriously threats to the patients highlight the necessity of controlling the potential risks. Hence, it is indispensable for the industry to establish an effective risk assessment system of supply chain. In this study, an AHP-fuzzy comprehensive evaluation model was developed based on the analytic hierarchy process and fuzzy mathematical theory, which quantitatively assessed the risks of supply chain. Taking polysorbate 80 as the example for model analysis, it was concluded that polysorbate 80 for injection use is a high-risk ingredient in the supply chain compared to that for oral use to achieve safety application in clinic, thus measures should be taken to control and minimize those risks.

Risk assessment of supply chain for pharmaceutical excipients with AHP-fuzzy comprehensive evaluation.

PubMed

Li, Maozhong; Du, Yunai; Wang, Qiyue; Sun, Chunmeng; Ling, Xiang; Yu, Boyang; Tu, Jiasheng; Xiong, Yerong

2016-04-01

As the essential components in formulations, pharmaceutical excipients directly affect the safety, efficacy, and stability of drugs. Recently, safety incidents of pharmaceutical excipients posing seriously threats to the patients highlight the necessity of controlling the potential risks. Hence, it is indispensable for the industry to establish an effective risk assessment system of supply chain. In this study, an AHP-fuzzy comprehensive evaluation model was developed based on the analytic hierarchy process and fuzzy mathematical theory, which quantitatively assessed the risks of supply chain. Taking polysorbate 80 as the example for model analysis, it was concluded that polysorbate 80 for injection use is a high-risk ingredient in the supply chain compared to that for oral use to achieve safety application in clinic, thus measures should be taken to control and minimize those risks.

Evaluation of the comfort and convenience of safety belt systems in 1980 and 1981 model vehicles

DOT National Transportation Integrated Search

1981-03-01

An analysis was conducted of both user and vehicle characteristics that influence the user perceptions of safety belt system comfort and convenience. A research design was developed involving various passenger cars, vans, and pickups, and a set of dr...

Integrated optimisation technique based on computer-aided capacity and safety evaluation for managing downstream lane-drop merging area of signalised junctions

NASA Astrophysics Data System (ADS)

Chen, CHAI; Yiik Diew, WONG

2017-02-01

This study provides an integrated strategy, encompassing microscopic simulation, safety assessment, and multi-attribute decision-making, to optimize traffic performance at downstream merging area of signalized intersections. A Fuzzy Cellular Automata (FCA) model is developed to replicate microscopic movement and merging behavior. Based on simulation experiment, the proposed FCA approach is able to provide capacity and safety evaluation of different traffic scenarios. The results are then evaluated through data envelopment analysis (DEA) and analytic hierarchy process (AHP). Optimized geometric layout and control strategies are then suggested for various traffic conditions. An optimal lane-drop distance that is dependent on traffic volume and speed limit can thus be established at the downstream merging area.

Demonstration of a Safety Analysis on a Complex System

NASA Technical Reports Server (NTRS)

Leveson, Nancy; Alfaro, Liliana; Alvarado, Christine; Brown, Molly; Hunt, Earl B.; Jaffe, Matt; Joslyn, Susan; Pinnell, Denise; Reese, Jon; Samarziya, Jeffrey;

Safety Assessment of Dangerous Goods Transport Enterprise Based on the Relative Entropy Aggregation in Group Decision Making Model

PubMed Central

Wu, Jun; Li, Chengbing; Huo, Yueying

2014-01-01

Safety of dangerous goods transport is directly related to the operation safety of dangerous goods transport enterprise. Aiming at the problem of the high accident rate and large harm in dangerous goods logistics transportation, this paper took the group decision making problem based on integration and coordination thought into a multiagent multiobjective group decision making problem; a secondary decision model was established and applied to the safety assessment of dangerous goods transport enterprise. First of all, we used dynamic multivalue background and entropy theory building the first level multiobjective decision model. Secondly, experts were to empower according to the principle of clustering analysis, and combining with the relative entropy theory to establish a secondary rally optimization model based on relative entropy in group decision making, and discuss the solution of the model. Then, after investigation and analysis, we establish the dangerous goods transport enterprise safety evaluation index system. Finally, case analysis to five dangerous goods transport enterprises in the Inner Mongolia Autonomous Region validates the feasibility and effectiveness of this model for dangerous goods transport enterprise recognition, which provides vital decision making basis for recognizing the dangerous goods transport enterprises. PMID:25477954

Safety assessment of dangerous goods transport enterprise based on the relative entropy aggregation in group decision making model.

PubMed

Wu, Jun; Li, Chengbing; Huo, Yueying

2014-01-01

Safety of dangerous goods transport is directly related to the operation safety of dangerous goods transport enterprise. Aiming at the problem of the high accident rate and large harm in dangerous goods logistics transportation, this paper took the group decision making problem based on integration and coordination thought into a multiagent multiobjective group decision making problem; a secondary decision model was established and applied to the safety assessment of dangerous goods transport enterprise. First of all, we used dynamic multivalue background and entropy theory building the first level multiobjective decision model. Secondly, experts were to empower according to the principle of clustering analysis, and combining with the relative entropy theory to establish a secondary rally optimization model based on relative entropy in group decision making, and discuss the solution of the model. Then, after investigation and analysis, we establish the dangerous goods transport enterprise safety evaluation index system. Finally, case analysis to five dangerous goods transport enterprises in the Inner Mongolia Autonomous Region validates the feasibility and effectiveness of this model for dangerous goods transport enterprise recognition, which provides vital decision making basis for recognizing the dangerous goods transport enterprises.

Evaluating predictive modeling's potential to improve teleretinal screening participation in urban safety net clinics.

PubMed

Ogunyemi, Omolola; Teklehaimanot, Senait; Patty, Lauren; Moran, Erin; George, Sheba

2013-01-01

Screening guidelines for diabetic patients recommend yearly eye examinations to detect diabetic retinopathy and other forms of diabetic eye disease. However, annual screening rates for retinopathy in US urban safety net settings remain low. Using data gathered from a study of teleretinal screening in six urban safety net clinics, we assessed whether predictive modeling could be of value in identifying patients at risk of developing retinopathy. We developed and examined the accuracy of two predictive modeling approaches for diabetic retinopathy in a sample of 513 diabetic individuals, using routinely available clinical variables from retrospective medical record reviews. Bayesian networks and radial basis function (neural) networks were learned using ten-fold cross-validation. The predictive models were modestly predictive with the best model having an AUC of 0.71. Using routinely available clinical variables to predict patients at risk of developing retinopathy and to target them for annual eye screenings may be of some usefulness to safety net clinics.

Implementation evaluation of a culturally competent eye injury prevention program for citrus workers in a Florida migrant community.

PubMed

Luque, John S; Monaghan, Paul; Contreras, Ricardo B; August, Euna; Baldwin, Julie A; Bryant, Carol A; McDermott, Robert J

2007-01-01

The Partnership for Citrus Worker Health (PCWH) is a coalition that connects academic institutions, public health agencies, industry and community-based organizations for implementation of an eye safety pilot project with citrus workers using the Camp Health Aide (CHA) model. This project was an implementation evaluation of an eye safety curriculum using modeling and peer-to-peer education among Mexican migrant citrus workers in a southwest Florida community to increase positive perceptions toward the use of safety eyewear and reduce occupational eye injuries. CHAs have been employed and trained in eye safety and health during harvesting seasons since 2004. Field observations, focus group interviews, and written questionnaires assessed program implementation and initial outcomes. There was an increase in positive perceptions toward use of safety eyewear between 2004 and 2005. Evaluation of training suggested ways to improve the curriculum. The modest literacy level of the CHAs necessitated some redesign of the curriculum and its implementation (e.g., introduction of and more reliance on use of training posters). PCWH benefited by extensive documentation of the training and supervision, a pilot project that demonstrated the potential effectiveness of CHAs, and having a well-defined target population of citrus workers (n = 427). Future research can rigorously test the effectiveness of CHAs in reducing eye injuries among citrus workers.

Towards a better reliability of risk assessment: development of a qualitative & quantitative risk evaluation model (Q2REM) for different trades of construction works in Hong Kong.

PubMed

Fung, Ivan W H; Lo, Tommy Y; Tung, Karen C F

2012-09-01

Since the safety professionals are the key decision makers dealing with project safety and risk assessment in the construction industry, their perceptions of safety risk would directly affect the reliability of risk assessment. The safety professionals generally tend to heavily rely on their own past experiences to make subjective decisions on risk assessment without systematic decision making. Indeed, understanding of the underlying principles of risk assessment is significant. In this study, the qualitative analysis on the safety professionals' beliefs of risk assessment and their perceptions towards risk assessment, including their recognitions of possible accident causes, the degree of differentiations on their perceptions of risk levels of different trades of works, recognitions of the occurrence of different types of accidents, and their inter-relationships with safety performance in terms of accident rates will be explored in the Stage 1. At the second stage, the deficiencies of the current general practice for risk assessment can be sorted out firstly. Based on the findings from Stage 1 and the historical accident data from 15 large-scaled construction projects in 3-year average, a risk evaluation model prioritizing the risk levels of different trades of works and which cause different types of site accident due to various accident causes will be developed quantitatively. With the suggested systematic accident recording techniques, this model can be implemented in the construction industry at both project level and organizational level. The model (Q(2)REM) not only act as a useful supplementary guideline of risk assessment for the construction safety professionals, but also assists them to pinpoint the potential risks on site for the construction workers under respective trades of works through safety trainings and education. It, in turn, arouses their awareness on safety risk. As the Q(2)REM can clearly show the potential accident causes leading to different types of accident by trade of works, it helps the concerned safety professionals and parties to plan effective accident prevention measures with reference to the priority of the risk levels. Copyright © 2011 Elsevier Ltd. All rights reserved.

Accelerated Evaluation of Automated Vehicles Safety in Lane-Change Scenarios Based on Importance Sampling Techniques

PubMed Central

Zhao, Ding; Lam, Henry; Peng, Huei; Bao, Shan; LeBlanc, David J.; Nobukawa, Kazutoshi; Pan, Christopher S.

2016-01-01

Automated vehicles (AVs) must be thoroughly evaluated before their release and deployment. A widely used evaluation approach is the Naturalistic-Field Operational Test (N-FOT), which tests prototype vehicles directly on the public roads. Due to the low exposure to safety-critical scenarios, N-FOTs are time consuming and expensive to conduct. In this paper, we propose an accelerated evaluation approach for AVs. The results can be used to generate motions of the other primary vehicles to accelerate the verification of AVs in simulations and controlled experiments. Frontal collision due to unsafe cut-ins is the target crash type of this paper. Human-controlled vehicles making unsafe lane changes are modeled as the primary disturbance to AVs based on data collected by the University of Michigan Safety Pilot Model Deployment Program. The cut-in scenarios are generated based on skewed statistics of collected human driver behaviors, which generate risky testing scenarios while preserving the statistical information so that the safety benefits of AVs in nonaccelerated cases can be accurately estimated. The cross-entropy method is used to recursively search for the optimal skewing parameters. The frequencies of the occurrences of conflicts, crashes, and injuries are estimated for a modeled AV, and the achieved accelerated rate is around 2000 to 20 000. In other words, in the accelerated simulations, driving for 1000 miles will expose the AV with challenging scenarios that will take about 2 to 20 million miles of real-world driving to encounter. This technique thus has the potential to greatly reduce the development and validation time for AVs. PMID:27840592

Accelerated Evaluation of Automated Vehicles Safety in Lane-Change Scenarios Based on Importance Sampling Techniques.

PubMed

Zhao, Ding; Lam, Henry; Peng, Huei; Bao, Shan; LeBlanc, David J; Nobukawa, Kazutoshi; Pan, Christopher S

2017-03-01

Automated vehicles (AVs) must be thoroughly evaluated before their release and deployment. A widely used evaluation approach is the Naturalistic-Field Operational Test (N-FOT), which tests prototype vehicles directly on the public roads. Due to the low exposure to safety-critical scenarios, N-FOTs are time consuming and expensive to conduct. In this paper, we propose an accelerated evaluation approach for AVs. The results can be used to generate motions of the other primary vehicles to accelerate the verification of AVs in simulations and controlled experiments. Frontal collision due to unsafe cut-ins is the target crash type of this paper. Human-controlled vehicles making unsafe lane changes are modeled as the primary disturbance to AVs based on data collected by the University of Michigan Safety Pilot Model Deployment Program. The cut-in scenarios are generated based on skewed statistics of collected human driver behaviors, which generate risky testing scenarios while preserving the statistical information so that the safety benefits of AVs in nonaccelerated cases can be accurately estimated. The cross-entropy method is used to recursively search for the optimal skewing parameters. The frequencies of the occurrences of conflicts, crashes, and injuries are estimated for a modeled AV, and the achieved accelerated rate is around 2000 to 20 000. In other words, in the accelerated simulations, driving for 1000 miles will expose the AV with challenging scenarios that will take about 2 to 20 million miles of real-world driving to encounter. This technique thus has the potential to greatly reduce the development and validation time for AVs.

In vitro dosimetry modeling will be a critical step toward efficient assessment of engineered nanomaterials for environmental health and safety

EPA Science Inventory

Presentation Description: The development and application of engineered nanomaterials (ENM) into commercial and consumer products is far outpacing the ability of traditional approaches to evaluate the potential implications for environmental health and safety. This problem recen...

Evaluation of interactive highway safety design model crash prediction tools for two-lane rural roads on Kansas Department of Transportation projects.

DOT National Transportation Integrated Search

2014-01-01

Historically, project-level decisions for the selection of highway features to promote safety were : based on either engineering judgment or adherence to accepted national guidance. These tools have allowed : highway designers to produce facilities t...

Evaluation of interactive highway safety design model crash prediction tools for two-lane rural roads on Kansas Department of Transportation projects : [technical summary].

DOT National Transportation Integrated Search

2014-01-01

Historically, project-level decisions for the selection of highway features to promote safety were based on either engineering judgment or adherence to accepted national guidance. These tools have allowed highway designers to produce facilities that ...

Safety and reliability analysis in a polyvinyl chloride batch process using dynamic simulator-case study: Loss of containment incident.

PubMed

Rizal, Datu; Tani, Shinichi; Nishiyama, Kimitoshi; Suzuki, Kazuhiko

2006-10-11

In this paper, a novel methodology in batch plant safety and reliability analysis is proposed using a dynamic simulator. A batch process involving several safety objects (e.g. sensors, controller, valves, etc.) is activated during the operational stage. The performance of the safety objects is evaluated by the dynamic simulation and a fault propagation model is generated. By using the fault propagation model, an improved fault tree analysis (FTA) method using switching signal mode (SSM) is developed for estimating the probability of failures. The timely dependent failures can be considered as unavailability of safety objects that can cause the accidents in a plant. Finally, the rank of safety object is formulated as performance index (PI) and can be estimated using the importance measures. PI shows the prioritization of safety objects that should be investigated for safety improvement program in the plants. The output of this method can be used for optimal policy in safety object improvement and maintenance. The dynamic simulator was constructed using Visual Modeler (VM, the plant simulator, developed by Omega Simulation Corp., Japan). A case study is focused on the loss of containment (LOC) incident at polyvinyl chloride (PVC) batch process which is consumed the hazardous material, vinyl chloride monomer (VCM).

Evaluating SafeClub: can risk management training improve the safety activities of community soccer clubs?

PubMed

Abbott, K; Klarenaar, P; Donaldson, A; Sherker, S

2008-06-01

To evaluate a sports safety-focused risk-management training programme. Controlled before and after test. Four community soccer associations in Sydney, Australia. 76 clubs (32 intervention, 44 control) at baseline, and 67 clubs (27 intervention, 40 control) at post-season and 12-month follow-ups. SafeClub, a sports safety-focused risk-management training programme (3x2 hour sessions) based on adult-learning principles and injury-prevention concepts and models. Changes in mean policy, infrastructure and overall safety scores as measured using a modified version of the Sports Safety Audit Tool. There was no significant difference in the mean policy, infrastructure and overall safety scores of intervention and control clubs at baseline. Intervention clubs achieved higher post-season mean policy (11.9 intervention vs 7.5 controls), infrastructure (15.2 vs 10.3) and overall safety (27.0 vs 17.8) scores than did controls. These differences were greater at the 12-month follow-up: policy (16.4 vs 7.6); infrastructure (24.7 vs 10.7); and overall safety (41.1 vs 18.3). General linear modelling indicated that intervention clubs achieved statistically significantly higher policy (p<0.001), infrastructure (p<0.001) and overall safety (p<0.001) scores compared with control clubs at the post-season and 12-month follow-ups. There was also a significant linear interaction of time and group for all three scores: policy (p<0.001), infrastructure (p<0.001) and overall safety (p<0.001). SafeClub effectively assisted community soccer clubs to improve their sports safety activities, particularly the foundations and processes for good risk-management practice, in a sustainable way.

Laser safety eyewear.

PubMed

1993-04-01

In spite of repeated warnings about laser safety practices, as well as the availability of laser safety eyewear (LSE), eye injuries continue to occur during use of surgical lasers, as discussed in the Clinical Perspective, "Laser Energy and Its Dangers to Eyes," preceding this Evaluation. We evaluated 48 models of LSE, including goggles, spectacles, and wraps, from 11 manufacturers. The evaluated models are designed with absorptive lenses that provide protection from CO2 (carbon dioxide), Nd:YAG (neodymium:yttrium-aluminum-garnet), and 532 (frequency-doubled Nd:YAG) surgical laser wavelengths; several models provide multiwavelength protection. (Refer to ECRI's Product Comparison System report on LSE for specifications of other models.) Although most of the evaluated models can adequately protect users from laser energy--provided that the eyewear is used--many models of LSE, especially goggles, are designed with little regard for the needs of actual use (e.g., adequate labeling, no alteration of color perception, sufficient field of vision [FOV], comfort). Because these factors can discourage people from using LSE, we encourage manufacturers to develop new and improved models that will be worn. We based our ratings primarily on the laser protection provided by the optical density (OD) of the lenses; we acknowledge the contribution of Montana Laser Optics Inc., of Bozeman, Montana, in performing our OD testing. We also considered actual-use factors, such as those mentioned above, to be significant. Among the models rated Acceptable is one whose labeled OD is lower than the level we determined to be adequate for use during most laser surgery; however, this model offers protection under specific conditions of use (e.g., for use by spectators some distance from the surgical site, for use during endoscopic procedures) that should be determined by the laser safety officer (LSO). LSE that would put the wearer at risk are rated Unacceptable (e.g., some models are not properly or clearly labeled, have measured ODs that are not adequate for protection, or significantly restrict the wearer's FOV); also, LSE with side shields that do not offer adequate protection from diffuse laser energy are rated Unacceptable. Those models that offer adequate protection for surgical applications, but whose measured OD is less than their labeled OD, are rated Acceptable--Not Recommended; if the discrepancy is great, they are rated Unacceptable. Those models whose labels were removed during cleaning are rated Conditionally Acceptable.(ABSTRACT TRUNCATED AT 400 WORDS)

Safety models incorporating graph theory based transit indicators.

PubMed

Quintero, Liliana; Sayed, Tarek; Wahba, Mohamed M

2013-01-01

There is a considerable need for tools to enable the evaluation of the safety of transit networks at the planning stage. One interesting approach for the planning of public transportation systems is the study of networks. Network techniques involve the analysis of systems by viewing them as a graph composed of a set of vertices (nodes) and edges (links). Once the transport system is visualized as a graph, various network properties can be evaluated based on the relationships between the network elements. Several indicators can be calculated including connectivity, coverage, directness and complexity, among others. The main objective of this study is to investigate the relationship between network-based transit indicators and safety. The study develops macro-level collision prediction models that explicitly incorporate transit physical and operational elements and transit network indicators as explanatory variables. Several macro-level (zonal) collision prediction models were developed using a generalized linear regression technique, assuming a negative binomial error structure. The models were grouped into four main themes: transit infrastructure, transit network topology, transit route design, and transit performance and operations. The safety models showed that collisions were significantly associated with transit network properties such as: connectivity, coverage, overlapping degree and the Local Index of Transit Availability. As well, the models showed a significant relationship between collisions and some transit physical and operational attributes such as the number of routes, frequency of routes, bus density, length of bus and 3+ priority lanes. Copyright © 2012 Elsevier Ltd. All rights reserved.

A collision model for safety evaluation of autonomous intelligent cruise control.

PubMed

Touran, A; Brackstone, M A; McDonald, M

1999-09-01

This paper describes a general framework for safety evaluation of autonomous intelligent cruise control in rear-end collisions. Using data and specifications from prototype devices, two collision models are developed. One model considers a train of four cars, one of which is equipped with autonomous intelligent cruise control. This model considers the car in front and two cars following the equipped car. In the second model, none of the cars is equipped with the device. Each model can predict the possibility of rear-end collision between cars under various conditions by calculating the remaining distance between cars after the front car brakes. Comparing the two collision models allows one to evaluate the effectiveness of autonomous intelligent cruise control in preventing collisions. The models are then subjected to Monte Carlo simulation to calculate the probability of collision. Based on crash probabilities, an expected value is calculated for the number of cars involved in any collision. It is found that given the model assumptions, while equipping a car with autonomous intelligent cruise control can significantly reduce the probability of the collision with the car ahead, it may adversely affect the situation for the following cars.

The West Virginia Occupational Safety and Health Initiative: practicum training for a new marketplace.

PubMed

Meyer, J D; Becker, P E; Stockdale, T; Ducatman, A M

1999-05-01

Occupational medicine practice has experienced a shift from larger corporate medical departments to organizations providing services for a variety of industries. Specific training needs will accompany this shift in practice patterns; these may differ from those developed in the traditional industrial or corporate medical department setting. The West Virginia Occupational Health and Safety Initiative involves occupational medicine residents in consultation to a variety of small industries and businesses. It uses the expertise of occupational physicians, health and safety extension faculty, and faculty in engineering and industrial hygiene. Residents participate in multidisciplinary evaluations of worksites, and develop competencies in team-building, workplace health and safety evaluation, and occupational medical consulting. Specific competencies that address requirements for practicum training are used to measure the trainee's acquisition of knowledge and skills. Particular attention is paid to the acquisition of group problem-solving expertise, skills relevant to the current market in practice opportunities, and the specific career interests of the resident physician. Preliminary evaluation indicates the usefulness of training in evaluation of diverse industries and worksites. We offer this program as a training model that can prepare residents for the challenges of a changing marketplace for occupational health and safety services.

Assessment of Contributions to Patient Safety Knowledge by the Agency for Healthcare Research and Quality-Funded Patient Safety Projects

PubMed Central

Sorbero, Melony E S; Ricci, Karen A; Lovejoy, Susan; Haviland, Amelia M; Smith, Linda; Bradley, Lily A; Hiatt, Liisa; Farley, Donna O

2009-01-01

Objective To characterize the activities of projects funded in Agency for Healthcare Research and Quality (AHRQ)' patient safety portfolio and assess their aggregate potential to contribute to knowledge development. Data Sources Information abstracted from proposals for projects funded in AHRQ' patient safety portfolio, information on safety practices from the AHRQ Evidence Report on Patient Safety Practices, and products produced by the projects. Study Design This represented one part of the process evaluation conducted as part of a longitudinal evaluation based on the Context–Input–Process–Product model. Principal Findings The 234 projects funded through AHRQ' patient safety portfolio examined a wide variety of patient safety issues and extended their work beyond the hospital setting to less studied parts of the health care system. Many of the projects implemented and tested practices for which the patient safety evidence report identified a need for additional evidence. The funded projects also generated a substantial body of new patient safety knowledge through a growing number of journal articles and other products. Conclusions The projects funded in AHRQ' patient safety portfolio have the potential to make substantial contributions to the knowledge base on patient safety. The full value of this new knowledge remains to be confirmed through the synthesis of results. PMID:21456108

Assessment of contributions to patient safety knowledge by the Agency for Healthcare Research and Quality-funded patient safety projects.

PubMed

Sorbero, Melony E S; Ricci, Karen A; Lovejoy, Susan; Haviland, Amelia M; Smith, Linda; Bradley, Lily A; Hiatt, Liisa; Farley, Donna O

2009-04-01

To characterize the activities of projects funded in Agency for Healthcare Research and Quality (AHRQ)'s patient safety portfolio and assess their aggregate potential to contribute to knowledge development. Information abstracted from proposals for projects funded in AHRQ's patient safety portfolio, information on safety practices from the AHRQ Evidence Report on Patient Safety Practices, and products produced by the projects. This represented one part of the process evaluation conducted as part of a longitudinal evaluation based on the Context–Input–Process–Product model. The 234 projects funded through AHRQ's patient safety portfolio examined a wide variety of patient safety issues and extended their work beyond the hospital setting to less studied parts of the health care system. Many of the projects implemented and tested practices for which the patient safety evidence report identified a need for additional evidence. The funded projects also generated a substantial body of new patient safety knowledge through a growing number of journal articles and other products. The projects funded in AHRQ's patient safety portfolio have the potential to make substantial contributions to the knowledge base on patient safety. The full value of this new knowledge remains to be confirmed through the synthesis of results

Safety evaluation of driver cognitive failures and driving errors on right-turn filtering movement at signalized road intersections based on Fuzzy Cellular Automata (FCA) model.

PubMed

Chai, Chen; Wong, Yiik Diew; Wang, Xuesong

2017-07-01

This paper proposes a simulation-based approach to estimate safety impact of driver cognitive failures and driving errors. Fuzzy Logic, which involves linguistic terms and uncertainty, is incorporated with Cellular Automata model to simulate decision-making process of right-turn filtering movement at signalized intersections. Simulation experiments are conducted to estimate the relationships between cognitive failures and driving errors with safety performance. Simulation results show Different types of cognitive failures are found to have varied relationship with driving errors and safety performance. For right-turn filtering movement, cognitive failures are more likely to result in driving errors with denser conflicting traffic stream. Moreover, different driving errors are found to have different safety impacts. The study serves to provide a novel approach to linguistically assess cognitions and replicate decision-making procedures of the individual driver. Compare to crash analysis, the proposed FCA model allows quantitative estimation of particular cognitive failures, and the impact of cognitions on driving errors and safety performance. Copyright © 2017 Elsevier Ltd. All rights reserved.

Chemical plant innovative safety investments decision-support methodology.

PubMed

Reniers, G L L; Audenaert, A

2009-01-01

This article examines the extent to which investing in safety during the creation of a new chemical installation proves profitable. The authors propose a management supporting cost-benefit model that identifies and evaluates investments in safety within a chemical company. This innovative model differentiates between serious accidents and less serious accidents, thus providing an authentic image of prevention-related costs and benefits. In classic cost-benefit analyses, which do not make such differentiations, only a rudimentary image of potential profitability resulting from investments in safety is obtained. The resulting management conclusions that can be drawn from such classical analyses are of a very limited nature. The proposed model, however, is applied to a real case study and the proposed investments in safety at an appointed chemical installation are weighed against the estimated hypothetical benefits resulting from the preventive measures to be installed at the installation. In the case-study carried out in question, it would appear that the proposed prevention investments are justified. Such an economic exercise may be very important to chemical corporations trying to (further) improve their safety investments.

Promoting the safe and strategic use of technology for victims of intimate partner violence: evaluation of the technology safety project.

PubMed

Finn, Jerry; Atkinson, Teresa

2009-11-01

The Technology Safety Project of the Washington State Coalition Against Domestic Violence was designed to increase awareness and knowledge of technology safety issues for domestic violence victims, survivors, and advocacy staff. The project used a "train-the-trainer" model and provided computer and Internet resources to domestic violence service providers to (a) increase safe computer and Internet access for domestic violence survivors in Washington, (b) reduce the risk posed by abusers by educating survivors about technology safety and privacy, and (c) increase the ability of survivors to help themselves and their children through information technology. Evaluation of the project suggests that the program is needed, useful, and effective. Consumer satisfaction was high, and there was perceived improvement in computer confidence and knowledge of computer safety. Areas for future program development and further research are discussed.

[Study on building index system of risk assessment of post-marketing Chinese patent medicine based on AHP-fuzzy neural network].

PubMed

Li, Yuanyuan; Xie, Yanming; Fu, Yingkun

2011-10-01

Currently massive researches have been launched about the safety, efficiency and economy of post-marketing Chinese patent medicine (CPM) proprietary Chinese medicine, but it was lack of a comprehensive interpretation. Establishing the risk evaluation index system and risk assessment model of CPM is the key to solve drug safety problems and protect people's health. The clinical risk factors of CPM exist similarities with the Western medicine, can draw lessons from foreign experience, but also have itself multi-factor multivariate multi-level complex features. Drug safety risk assessment for the uncertainty and complexity, using analytic hierarchy process (AHP) to empower the index weights, AHP-based fuzzy neural network to build post-marketing CPM risk evaluation index system and risk assessment model and constantly improving the application of traditional Chinese medicine characteristic is accord with the road and feasible beneficial exploration.

Automated Analysis of Stateflow Models

NASA Technical Reports Server (NTRS)

Bourbouh, Hamza; Garoche, Pierre-Loic; Garion, Christophe; Gurfinkel, Arie; Kahsaia, Temesghen; Thirioux, Xavier

2017-01-01

Stateflow is a widely used modeling framework for embedded and cyber physical systems where control software interacts with physical processes. In this work, we present a framework a fully automated safety verification technique for Stateflow models. Our approach is two-folded: (i) we faithfully compile Stateflow models into hierarchical state machines, and (ii) we use automated logic-based verification engine to decide the validity of safety properties. The starting point of our approach is a denotational semantics of State flow. We propose a compilation process using continuation-passing style (CPS) denotational semantics. Our compilation technique preserves the structural and modal behavior of the system. The overall approach is implemented as an open source toolbox that can be integrated into the existing Mathworks Simulink Stateflow modeling framework. We present preliminary experimental evaluations that illustrate the effectiveness of our approach in code generation and safety verification of industrial scale Stateflow models.

Improving the health and safety of 911 emergency call centre agents: an evaluability assessment of a knowledge transfer strategy.

PubMed

Dagenais, Christian; Plouffe, Laurence; Gagné, Charles; Toulouse, Georges; Breault, Andrée-Anne; Dupont, Didier

2017-03-01

A knowledge transfer (KT) strategy was implemented by the IRSST, an occupational health and safety research institute established in Québec (Canada), to improve the prevention of psychological and musculoskeletal problems among 911 emergency call centre agents. An evaluability assessment was conducted in which each aspect of the KT approach was documented systematically to determine whether the strategy had the potential to be evaluated in terms of its impact on the targeted population. A review of the literature on KT in occupational health and safety and on the evaluation of such KT programmes, along with the development of a logic model based on documentary analysis and semi-structured interviews with key stakeholders, indicated that the KT strategy was likely to have had a positive impact in the 911 emergency call centre sector. Implications for future research are discussed.

Comparative Studies of Collaborative Team Depression Care Adoption in Safety Net Clinics

ERIC Educational Resources Information Center

Ell, Kathleen; Wu, Shinyi; Guterman, Jeffrey; Schulman, Sandra-Gross; Sklaroff, Laura; Lee, Pey-Jiuan

2018-01-01

Purpose: To evaluate three approaches adopting collaborative depression care model in Los Angeles County safety net clinics with predominantly Latino type 2 diabetes patients. Methods: Pre-post differences in treatment rates and symptom reductions were compared between baseline, 6-month, and 12-month follow-ups for each approach: (a) Multifaceted…

Improvements in safety testing of lithium cells

NASA Astrophysics Data System (ADS)

Stinebring, R. C.; Krehl, P.

1985-07-01

A systematic approach was developed for evaluating the basic safety parameters of high power lithium soluble cathode cells. This approach consists of performing a series of tests on each cell model during the design, prototype and production phases. Abusive testing is performed in a facility where maximum protection is given to test personnel.

Improvements in safety testing of lithium cells

NASA Technical Reports Server (NTRS)

Stinebring, R. C.; Krehl, P.

1985-01-01

A systematic approach was developed for evaluating the basic safety parameters of high power lithium soluble cathode cells. This approach consists of performing a series of tests on each cell model during the design, prototype and production phases. Abusive testing is performed in a facility where maximum protection is given to test personnel.

Structural equation model to investigate the dimensions influencing safety culture improvement in construction sector: A case in Indonesia

NASA Astrophysics Data System (ADS)

Machfudiyanto, Rossy Armyn; Latief, Yusuf; Yogiswara, Yoko; Setiawan, R. Mahendra Fitra

2017-06-01

In facing the ASEAN Economic Community, the level of prevailing working accidents becomes one of the competitiveness factors among the companies. A construction industry is one of the industries prone to high level of accidents. Improving the safety record will not be completely effective unless the occupational safety and healthy culture is enhanced. The aim of this research was to develop a model and to conduct empirical investigation on the relationships among the dimensions of construction occupational safety culture. This research used the structural equation model as a means to examine the hypothesis of positive relationships between dimensions and objectives. The method used in this research was questionnaire survey which was distributed to the respondents from construction companies in a state-owned enterprise in Indonesia. Moreover, there were dimensions of occupational safety culture that was established, such as leadership, behavior, value, strategy, policy, process, employee, safety cost, and contract system. The results of this study indicated that all dimensions were significant and inter-related in forming the safety culture. The result of R2 yielded the safety performance was 54%, which means it was in low category and evaluation of policies on construction companies was required in addressing the issue of working accidents.

Evaluating the road safety effects of a fuel cost increase measure by means of zonal crash prediction modeling.

PubMed

Pirdavani, Ali; Brijs, Tom; Bellemans, Tom; Kochan, Bruno; Wets, Geert

2013-01-01

Travel demand management (TDM) consists of a variety of policy measures that affect the transportation system's effectiveness by changing travel behavior. The primary objective to implement such TDM strategies is not to improve traffic safety, although their impact on traffic safety should not be neglected. The main purpose of this study is to evaluate the traffic safety impact of conducting a fuel-cost increase scenario (i.e. increasing the fuel price by 20%) in Flanders, Belgium. Since TDM strategies are usually conducted at an aggregate level, crash prediction models (CPMs) should also be developed at a geographically aggregated level. Therefore zonal crash prediction models (ZCPMs) are considered to present the association between observed crashes in each zone and a set of predictor variables. To this end, an activity-based transportation model framework is applied to produce exposure metrics which will be used in prediction models. This allows us to conduct a more detailed and reliable assessment while TDM strategies are inherently modeled in the activity-based models unlike traditional models in which the impact of TDM strategies are assumed. The crash data used in this study consist of fatal and injury crashes observed between 2004 and 2007. The network and socio-demographic variables are also collected from other sources. In this study, different ZCPMs are developed to predict the number of injury crashes (NOCs) (disaggregated by different severity levels and crash types) for both the null and the fuel-cost increase scenario. The results show a considerable traffic safety benefit of conducting the fuel-cost increase scenario apart from its impact on the reduction of the total vehicle kilometers traveled (VKT). A 20% increase in fuel price is predicted to reduce the annual VKT by 5.02 billion (11.57% of the total annual VKT in Flanders), which causes the total NOCs to decline by 2.83%. Copyright © 2012 Elsevier Ltd. All rights reserved.

Multiple attribute decision making model and application to food safety risk evaluation.

PubMed

Ma, Lihua; Chen, Hong; Yan, Huizhe; Yang, Lifeng; Wu, Lifeng

2017-01-01

Decision making for supermarket food purchase decisions are characterized by network relationships. This paper analyzed factors that influence supermarket food selection and proposes a supplier evaluation index system based on the whole process of food production. The author established the intuitive interval value fuzzy set evaluation model based on characteristics of the network relationship among decision makers, and validated for a multiple attribute decision making case study. Thus, the proposed model provides a reliable, accurate method for multiple attribute decision making.

Evaluating predictive modeling’s potential to improve teleretinal screening participation in urban safety net clinics

PubMed Central

Ogunyemi, Omolola; Teklehaimanot, Senait; Patty, Lauren; Moran, Erin; George, Sheba

2013-01-01

Introduction Screening guidelines for diabetic patients recommend yearly eye examinations to detect diabetic retinopathy and other forms of diabetic eye disease. However, annual screening rates for retinopathy in US urban safety net settings remain low. Methods Using data gathered from a study of teleretinal screening in six urban safety net clinics, we assessed whether predictive modeling could be of value in identifying patients at risk of developing retinopathy. We developed and examined the accuracy of two predictive modeling approaches for diabetic retinopathy in a sample of 513 diabetic individuals, using routinely available clinical variables from retrospective medical record reviews. Bayesian networks and radial basis function (neural) networks were learned using ten-fold cross-validation. Results The predictive models were modestly predictive with the best model having an AUC of 0.71. Discussion Using routinely available clinical variables to predict patients at risk of developing retinopathy and to target them for annual eye screenings may be of some usefulness to safety net clinics. PMID:23920536

A Quality Model to Select Patients in Cupping Therapy Clinics: A New Tool for Ensuring Safety in Clinical Practice.

PubMed

Aboushanab, Tamer; AlSanad, Saud

2018-06-08

Cupping therapy is a popular treatment in various countries and regions, including Saudi Arabia. Cupping therapy is regulated in Saudi Arabia by the National Center for Complementary and Alternative Medicine (NCCAM), Ministry of Health. The authors recommend that this quality model for selecting patients in cupping clinics - first version (QMSPCC-1) - be used routinely as part of clinical practice and quality management in cupping clinics. The aim of the quality model is to ensure the safety of patients and to introduce and facilitate quality and auditing processes in cupping therapy clinics. Clinical evaluation of this tool is recommended. Continued development, re-evaluation and reassessment of this tool are important. Copyright © 2018. Published by Elsevier B.V.

[Definition of "Safety and Hygiene Packages" as a management model for the Hospital Hygiene Service (HHS)].

PubMed

Raponi, Matteo; Damiani, Gianfranco; Vincenti, Sara; Wachocka, Malgorzata; Boninti, Federica; Bruno, Stefania; Quaranta, Gianluigi; Moscato, Umberto; Boccia, Stefania; Ficarra, Maria Giovanna; Specchia, Maria Lucia; Posteraro, Brunella; Berloco, Filippo; Celani, Fabrizio; Ricciardi, Walter; Laurenti, Patrizia

2014-01-01

The purpose of this research is to identify and formalize the Hospital Hygiene Service activities and products, evaluating them in a cost accounting management view. The ultimate aim, is to evaluate the financial adverse events prevention impact, in an Hospital Hygiene Service management. A three step methodology based on affinity grouping activities, was employed. This methodology led us to identify 4 action areas, with 23 related productive processes, and 86 available safety packages. Owing to this new methodology, we was able to implement a systematic evaluation of the furnished services.

Evaluating the effectiveness of Behavior-Based Safety education methods for commercial vehicle drivers.

PubMed

Wang, Xuesong; Xing, Yilun; Luo, Lian; Yu, Rongjie

2018-08-01

Risky driving behavior is one of the main causes of commercial vehicle related crashes. In order to achieve safer vehicle operation, safety education for drivers is often provided. However, the education programs vary in quality and may not always be successful in reducing crash rates. Behavior-Based Safety (BBS) education is a popular approach found effective by numerous studies, but even this approach varies as to the combination of frequency, mode and content used by different education providers. This study therefore evaluates and compares the effectiveness of BBS education methods. Thirty-five drivers in Shanghai, China, were coached with one of three different BBS education methods for 13 weeks following a 13-week baseline phase with no education. A random-effects negative binomial (NB) model was built and calibrated to investigate the relationship between BBS education and the driver at-fault safety-related event rate. Based on the results of the random-effects NB model, event modification factors (EMF) were calculated to evaluate and compare the effectiveness of the methods. Results show that (1) BBS education was confirmed to be effective in safety-related event reduction; (2) the most effective method among the three applied monthly face-to-face coaching, including feedback with video and statistical data, and training on strategies to avoid driver-specific unsafe behaviors; (3) weekly telephone coaching using statistics and strategies was rated by drivers as the most convenient delivery mode, and was also significantly effective. Copyright © 2018 Elsevier Ltd. All rights reserved.

Increasing the number of trained health and safety professionals in agricultural medicine: evaluation of the "building capacity" program, 2007-2013.

PubMed

Rudolphi, Josie M; Donham, Kelley J

2015-01-01

ABSTRACT The University of Iowa began training health care professionals to care for farmers' occupational health needs since 1974. In order to geographically expand this training to practicing health and safety professionals, the "Building Capacity: A National Resource of Agricultural Medicine Professionals" program was developed and launched in 2006. The model began in 1987 as a program of Iowa's Center for Agricultural Safety and Health. In 2006, with funding from the National Institute for Occupational Safety and Health (NIOSH), Great Plains Center for Agricultural Health (GPCAH), the program was expanded beyond the Iowa borders. The principal component of the program, the 40-hour course, Agricultural Medicine: Occupational and Environmental Health for Rural Health Professionals-the Core Course (AMCC) is now being offered to health and safety professionals in nine states in the United States, in Australia, and a modified version presented in Turkey. An initial paper evaluated the first phase of the program, years 2007-2010. This paper compares the first phase (2007-2010) with the second phase (2011-2013), which has involved over 500 health and safety professionals. This paper also describes evaluation of the course and changes resulting from the evaluation. Finally, this paper describes best practices for operating this program and makes recommendations for future courses, as well as other trainings within the field.

I-81 ITS program evaluation framework

DOT National Transportation Integrated Search

2003-07-01

This document presents the evaluation framework for the I-81 ITS Model Safety Corridor Program. The objectives of the framework are threefold: 1) serve as input into the development of infrastructure in the I-81 Corridor to generate baseline data for...

Evaluation of countermeasures for red light running by traffic simulator-based surrogate safety measures.

PubMed

Lee, Changju; So, Jaehyun Jason; Ma, Jiaqi

2018-01-02

The conflicts among motorists entering a signalized intersection with the red light indication have become a national safety issue. Because of its sensitivity, efforts have been made to investigate the possible causes and effectiveness of countermeasures using comparison sites and/or before-and-after studies. Nevertheless, these approaches are ineffective when comparison sites cannot be found, or crash data sets are not readily available or not reliable for statistical analysis. Considering the random nature of red light running (RLR) crashes, an inventive approach regardless of data availability is necessary to evaluate the effectiveness of each countermeasure face to face. The aims of this research are to (1) review erstwhile literature related to red light running and traffic safety models; (2) propose a practical methodology for evaluation of RLR countermeasures with a microscopic traffic simulation model and surrogate safety assessment model (SSAM); (3) apply the proposed methodology to actual signalized intersection in Virginia, with the most prevalent scenarios-increasing the yellow signal interval duration, installing an advance warning sign, and an RLR camera; and (4) analyze the relative effectiveness by RLR frequency and the number of conflicts (rear-end and crossing). All scenarios show a reduction in RLR frequency (-7.8, -45.5, and -52.4%, respectively), but only increasing the yellow signal interval duration results in a reduced total number of conflicts (-11.3%; a surrogate safety measure of possible RLR-related crashes). An RLR camera makes the greatest reduction (-60.9%) in crossing conflicts (a surrogate safety measure of possible angle crashes), whereas increasing the yellow signal interval duration results in only a 12.8% reduction of rear-end conflicts (a surrogate safety measure of possible rear-end crash). Although increasing the yellow signal interval duration is advantageous because this reduces the total conflicts (a possibility of total RLR-related crashes), each countermeasure shows different effects by RLR-related conflict types that can be referred to when making a decision. Given that each intersection has different RLR crash issues, evaluated countermeasures are directly applicable to enhance the cost and time effectiveness, according to the situation of the target intersection. In addition, the proposed methodology is replicable at any site that has a dearth of crash data and/or comparison sites in order to test any other countermeasures (both engineering and enforcement countermeasures) for RLR crashes.

Method for selection of optimal road safety composite index with examples from DEA and TOPSIS method.

PubMed

Rosić, Miroslav; Pešić, Dalibor; Kukić, Dragoslav; Antić, Boris; Božović, Milan

2017-01-01

Concept of composite road safety index is a popular and relatively new concept among road safety experts around the world. As there is a constant need for comparison among different units (countries, municipalities, roads, etc.) there is need to choose an adequate method which will make comparison fair to all compared units. Usually comparisons using one specific indicator (parameter which describes safety or unsafety) can end up with totally different ranking of compared units which is quite complicated for decision maker to determine "real best performers". Need for composite road safety index is becoming dominant since road safety presents a complex system where more and more indicators are constantly being developed to describe it. Among wide variety of models and developed composite indexes, a decision maker can come to even bigger dilemma than choosing one adequate risk measure. As DEA and TOPSIS are well-known mathematical models and have recently been increasingly used for risk evaluation in road safety, we used efficiencies (composite indexes) obtained by different models, based on DEA and TOPSIS, to present PROMETHEE-RS model for selection of optimal method for composite index. Method for selection of optimal composite index is based on three parameters (average correlation, average rank variation and average cluster variation) inserted into a PROMETHEE MCDM method in order to choose the optimal one. The model is tested by comparing 27 police departments in Serbia. Copyright © 2016 Elsevier Ltd. All rights reserved.

"Failure-to-Identify" Hunting Incidents: A Resilience Engineering Approach.

PubMed

Bridges, Karl E; Corballis, Paul M; Hollnagel, Erik

2018-03-01

Objective The objective was to develop an understanding, using the Functional Resonance Analysis Method (FRAM), of the factors that could cause a deer hunter to misidentify their intended target. Background Hunting is a popular activity in many communities. However, hunters vary considerably based on training, experience, and expertise. Surprisingly, safety in hunting has not received much attention, especially failure-to-identify hunting incidents. These are incidents in which the hunter, after spotting and targeting their quarry, discharge their firearm only to discover they have been spotting and targeting another human, an inanimate object, or flora by mistake. The hunter must consider environment, target, time of day, weather, and many other factors-continuously evaluating whether the hunt should continue. To understand how these factors can relate to one another is fundamental to begin to understand how incidents happen. Method Workshops with highly experienced and active hunters led to the development of a FRAM model detailing the functions of a "Hunting FRAM." The model was evaluated for correctness based on confidential and anonymous near-miss event submissions by hunters. Results A FRAM model presenting the functions of a hunt was produced, evaluated, and accepted. Using the model, potential sources of incidents or other unintended outcomes were identified, which in turn helped to improve the model. Conclusion Utilizing principles of understanding and visualization tools of the FRAM, the findings create a foundation for safety improvements potentially through training or safety messages based on an increased understanding of the complexity of hunting.

A Model-Based Product Evaluation Protocol for Comparison of Safety-Engineered Protection Mechanisms of Winged Blood Collection Needles.

PubMed

Haupt, C; Spaeth, J; Ahne, T; Goebel, U; Steinmann, D

2016-05-01

To evaluate differences in product characteristics and user preferences of safety-engineered protection mechanisms of winged blood collection needles. Randomized model-based simulation study. University medical center. A total of 33 third-year medical students. Venipuncture was performed using winged blood collection needles with 4 different safety mechanisms: (a) Venofix Safety, (b) BD Vacutainer Push Button, (c) Safety-Multifly, and (d) Surshield Surflo. Each needle type was used in 3 consecutive tries: there was an uninstructed first handling, then instructions were given according to the operating manual; subsequently, a first trial and second trial were conducted. Study end points included successful activation, activation time, single-handed activation, correct activation, possible risk of needlestick injury, possibility of deactivation, and preferred safety mechanism. The overall successful activation rate during the second trial was equal for all 4 devices (94%-100%). Median activation time was (a) 7 s, (b) 2 s, (c) 9 s, and (d) 7 s. Single-handed activation during the second trial was (a) 18%, (b) 82%, (c) 15%, and (d) 45%. Correct activation during the second trial was (a) 3%, (b) 64%, (c) 15%, and (d) 39%. Possible risk of needlestick injury during the second trial was highest with (d). Possibility of deactivation was (a) 0%, (b) 12%, (c) 9%, and (d) 18%. Individual preferences for each system were (a) 11, (b) 17, (c) 5, and (d) 0. The main reason for preference was the comprehensive safety mechanism. Significant differences exist between safety mechanisms of winged blood collection needles.

Gating the holes in the Swiss cheese (part I): Expanding professor Reason's model for patient safety.

PubMed

Seshia, Shashi S; Bryan Young, G; Makhinson, Michael; Smith, Preston A; Stobart, Kent; Croskerry, Pat

2018-02-01

Although patient safety has improved steadily, harm remains a substantial global challenge. Additionally, safety needs to be ensured not only in hospitals but also across the continuum of care. Better understanding of the complex cognitive factors influencing health care-related decisions and organizational cultures could lead to more rational approaches, and thereby to further improvement. A model integrating the concepts underlying Reason's Swiss cheese theory and the cognitive-affective biases plus cascade could advance the understanding of cognitive-affective processes that underlie decisions and organizational cultures across the continuum of care. Thematic analysis, qualitative information from several sources being used to support argumentation. Complex covert cognitive phenomena underlie decisions influencing health care. In the integrated model, the Swiss cheese slices represent dynamic cognitive-affective (mental) gates: Reason's successive layers of defence. Like firewalls and antivirus programs, cognitive-affective gates normally allow the passage of rational decisions but block or counter unsounds ones. Gates can be breached (ie, holes created) at one or more levels of organizations, teams, and individuals, by (1) any element of cognitive-affective biases plus (conflicts of interest and cognitive biases being the best studied) and (2) other potential error-provoking factors. Conversely, flawed decisions can be blocked and consequences minimized; for example, by addressing cognitive biases plus and error-provoking factors, and being constantly mindful. Informed shared decision making is a neglected but critical layer of defence (cognitive-affective gate). The integrated model can be custom tailored to specific situations, and the underlying principles applied to all methods for improving safety. The model may also provide a framework for developing and evaluating strategies to optimize organizational cultures and decisions. The concept is abstract, the model is virtual, and the best supportive evidence is qualitative and indirect. The proposed model may help enhance rational decision making across the continuum of care, thereby improving patient safety globally. © 2017 The Authors. Journal of Evaluation in Clinical Practice published by John Wiley & Sons, Ltd.

Negative Stress Margins - Are They Real?

NASA Technical Reports Server (NTRS)

Raju, Ivatury S.; Lee, Darlene S.; Mohaghegh, Michael

2011-01-01

Advances in modeling and simulation, new finite element software, modeling engines and powerful computers are providing opportunities to interrogate designs in a very different manner and in a more detailed approach than ever before. Margins of safety are also often evaluated using local stresses for various design concepts and design parameters quickly once analysis models are defined and developed. This paper suggests that not all the negative margins of safety evaluated are real. The structural areas where negative margins are frequently encountered are often near stress concentrations, point loads and load discontinuities, near locations of stress singularities, in areas having large gradients but with insufficient mesh density, in areas with modeling issues and modeling errors, and in areas with connections and interfaces, in two-dimensional (2D) and three-dimensional (3D) transitions, bolts and bolt modeling, and boundary conditions. Now, more than ever, structural analysts need to examine and interrogate their analysis results and perform basic sanity checks to determine if these negative margins are real.

Quality Attribute Techniques Framework

NASA Astrophysics Data System (ADS)

Chiam, Yin Kia; Zhu, Liming; Staples, Mark

The quality of software is achieved during its development. Development teams use various techniques to investigate, evaluate and control potential quality problems in their systems. These “Quality Attribute Techniques” target specific product qualities such as safety or security. This paper proposes a framework to capture important characteristics of these techniques. The framework is intended to support process tailoring, by facilitating the selection of techniques for inclusion into process models that target specific product qualities. We use risk management as a theory to accommodate techniques for many product qualities and lifecycle phases. Safety techniques have motivated the framework, and safety and performance techniques have been used to evaluate the framework. The evaluation demonstrates the ability of quality risk management to cover the development lifecycle and to accommodate two different product qualities. We identify advantages and limitations of the framework, and discuss future research on the framework.

The Evaluation of Land Ecological Safety of Chengchao Iron Mine Based on PSR and MEM

NASA Astrophysics Data System (ADS)

Jin, Xiangdong; Chen, Yong

2018-01-01

Land ecological security is of vital importance to local security and sustainable development of mining activities. The study has analyzed the potential causal chains between the land ecological security of Iron Mine mining environment, mine resource and the social-economic background. On the base of Pressure-State-Response model, the paper set up a matter element evaluation model of land ecological security, and applies it in Chengchao iron mine. The evaluation result proves to be effective in land ecological evaluation.

The Relationship Between the Learning and Patient Safety Climates of Clinical Departments and Residents' Patient Safety Behaviors.

PubMed

Silkens, Milou E W M; Arah, Onyebuchi A; Wagner, Cordula; Scherpbier, Albert J J A; Heineman, Maas Jan; Lombarts, Kiki M J M H

2018-05-15

Improving residents' patient safety behavior should be a priority in graduate medical education to ensure the safety of current and future patients. Supportive learning and patient safety climates may foster this behavior. This study examined the extent to which residents' self-reported patient safety behavior can be explained by the learning climate and patient safety climate of their clinical departments. The authors collected learning climate data from clinical departments in the Netherlands that used the web-based Dutch Residency Educational Climate Test between September 2015 and October 2016. They also gathered data on those departments' patient safety climate and on residents' self-reported patient safety behavior. They used generalized linear mixed models and multivariate general linear models to test for associations in the data. In total, 1,006 residents evaluated 143 departments in 31 teaching hospitals. Departments' patient safety climate was associated with residents' overall self-reported patient safety behavior (regression coefficient (b) = 0.33; 95% confidence interval (CI) = 0.14 - 0.52). Departments' learning climate was not associated with residents' patient safety behavior (b = 0.01; 95% CI = -0.17 - 0.19), although it was with their patient safety climate (b = 0.73; 95% CI = 0.69 - 0.77). Departments should focus on establishing a supportive patient safety climate to improve residents' patient safety behavior. Building a supportive learning climate might help to improve the patient safety climate and, in turn, residents' patient safety behavior.

Fire Accident Testing Evaluation (FATE)

NASA Technical Reports Server (NTRS)

Ross, H. D.; Mell, W.; Pettegrew, R.; Hicks, M.; Urban, D.

2001-01-01

By performing parametric experiments both in normal gravity and reduced gravity on the KC-135 aircraft, as well as developing and analyzing related modeling, generality of the interpretation of the experimental findings will be pursued along with direct recommendations for fire safety practices and policies for fire safety on spacecraft and in Martian habitats. This is the principal value of the research.

Using Space Syntax to Assess Safety in Public Areas - Case Study of Tarbiat Pedestrian Area, Tabriz-Iran

NASA Astrophysics Data System (ADS)

Cihangir Çamur, Kübra; Roshani, Mehdi; Pirouzi, Sania

2017-10-01

In studying the urban complex issues, simulation and modelling of public space use considerably helps in determining and measuring factors such as urban safety. Depth map software for determining parameters of the spatial layout techniques; and Statistical Package for Social Sciences (SPSS) software for analysing and evaluating the views of the pedestrians on public safety were used in this study. Connectivity, integration, and depth of the area in the Tarbiat city blocks were measured using the Space Syntax Method, and these parameters are presented as graphical and mathematical data. The combination of the results obtained from the questionnaire and statistical analysis with the results of spatial arrangement technique represents the appropriate and inappropriate spaces for pedestrians. This method provides a useful and effective instrument for decision makers, planners, urban designers and programmers in order to evaluate public spaces in the city. Prior to physical modification of urban public spaces, space syntax simulates the pedestrian safety to be used as an analytical tool by the city management. Finally, regarding the modelled parameters and identification of different characteristics of the case, this study represents the strategies and policies in order to increase the safety of the pedestrians of Tarbiat in Tabriz.

Development of a new generation of high-resolution anatomical models for medical device evaluation: the Virtual Population 3.0

NASA Astrophysics Data System (ADS)

Gosselin, Marie-Christine; Neufeld, Esra; Moser, Heidi; Huber, Eveline; Farcito, Silvia; Gerber, Livia; Jedensjö, Maria; Hilber, Isabel; Di Gennaro, Fabienne; Lloyd, Bryn; Cherubini, Emilio; Szczerba, Dominik; Kainz, Wolfgang; Kuster, Niels

2014-09-01

The Virtual Family computational whole-body anatomical human models were originally developed for electromagnetic (EM) exposure evaluations, in particular to study how absorption of radiofrequency radiation from external sources depends on anatomy. However, the models immediately garnered much broader interest and are now applied by over 300 research groups, many from medical applications research fields. In a first step, the Virtual Family was expanded to the Virtual Population to provide considerably broader population coverage with the inclusion of models of both sexes ranging in age from 5 to 84 years old. Although these models have proven to be invaluable for EM dosimetry, it became evident that significantly enhanced models are needed for reliable effectiveness and safety evaluations of diagnostic and therapeutic applications, including medical implants safety. This paper describes the research and development performed to obtain anatomical models that meet the requirements necessary for medical implant safety assessment applications. These include implementation of quality control procedures, re-segmentation at higher resolution, more-consistent tissue assignments, enhanced surface processing and numerous anatomical refinements. Several tools were developed to enhance the functionality of the models, including discretization tools, posing tools to expand the posture space covered, and multiple morphing tools, e.g., to develop pathological models or variations of existing ones. A comprehensive tissue properties database was compiled to complement the library of models. The results are a set of anatomically independent, accurate, and detailed models with smooth, yet feature-rich and topologically conforming surfaces. The models are therefore suited for the creation of unstructured meshes, and the possible applications of the models are extended to a wider range of solvers and physics. The impact of these improvements is shown for the MRI exposure of an adult woman with an orthopedic spinal implant. Future developments include the functionalization of the models for specific physical and physiological modeling tasks.

The role of Aboriginal family workers in delivering a child safety focused home visiting program for Aboriginal families in an urban region of NSW.

PubMed

Clapham, Kathleen; Bennett-Brook, Keziah; Hunter, Kate

2018-05-09

Aboriginal Australian children experience higher rates of injury than other Australian children. However few culturally acceptable programs have been developed or evaluated. The Illawarra Aboriginal Medical Service (IAMS) developed the Safe Homes Safe Kids program as an injury prevention program targeting disadvantaged Aboriginal families with children aged 0-5 in an urban region of NSW. Delivered by Aboriginal Family Workers the program aims to reduce childhood injury by raising awareness of safety in the home. A program evaluation was conducted to determine the effectiveness of the home visiting model as an injury prevention program. This paper reports on the qualitative interviews which explored the ways in which clients, IAMS staff, and external service providers experienced the program and assessed its delivery by the Aboriginal Family Workers. A qualitative program evaluation was conducted between January 2014 and June 2015. We report here on the semi-structured interviews undertaken with 34 individuals. The results show increased client engagement in the program; improved child safety knowledge and skills; increased access to services; improved attitudes to home and community safety; and changes in the home safety environment. Safe Homes Safe Kids provides a culturally appropriate child safety program delivered by Aboriginal Family Workers to vulnerable families. Clients, IAMS staff, and external service were satisfied with the family workers' delivery of the program and the holistic model of service provision. SO WHAT?: This promising program could be replicated in other Aboriginal health services to address unintentional injury to vulnerable Aboriginal children. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Overcoming the organization-practice barrier in sports injury prevention: A nonhierarchical organizational model.

PubMed

Dahlström, Ö; Jacobsson, J; Timpka, T

2015-08-01

The organization of sports at the national level has seldom been included in scientific discussions of sports injury prevention. The aim of this study was to develop a model for organization of sports that supports prevention of overuse injuries. The quality function deployment technique was applied in seminars over a two-season period to develop a national organizational structure for athletics in Sweden that facilitates prevention of overuse injuries. Three central features of the resulting model for organization of sports at the national level are (a) diminishment of the organizational hierarchy: participatory safety policy design is introduced through annual meetings where actors from different sectors of the sporting community discuss training, injury prevention, and sports safety policy; (b) introduction of a safety surveillance system: a ubiquitous system for routine collection of injury and illness data; and (c) an open forum for discussion of safety issues: maintenance of a safety forum for participants from different sectors of the sport. A nonhierarchical model for organization of sports at the national level - facilitated by modern information technology - adapted for the prevention of overuse injuries has been developed. Further research is warranted to evaluate the new organizational model in prospective effectiveness studies. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Predicting motor vehicle collisions using Bayesian neural network models: an empirical analysis.

PubMed

Xie, Yuanchang; Lord, Dominique; Zhang, Yunlong

2007-09-01

Statistical models have frequently been used in highway safety studies. They can be utilized for various purposes, including establishing relationships between variables, screening covariates and predicting values. Generalized linear models (GLM) and hierarchical Bayes models (HBM) have been the most common types of model favored by transportation safety analysts. Over the last few years, researchers have proposed the back-propagation neural network (BPNN) model for modeling the phenomenon under study. Compared to GLMs and HBMs, BPNNs have received much less attention in highway safety modeling. The reasons are attributed to the complexity for estimating this kind of model as well as the problem related to "over-fitting" the data. To circumvent the latter problem, some statisticians have proposed the use of Bayesian neural network (BNN) models. These models have been shown to perform better than BPNN models while at the same time reducing the difficulty associated with over-fitting the data. The objective of this study is to evaluate the application of BNN models for predicting motor vehicle crashes. To accomplish this objective, a series of models was estimated using data collected on rural frontage roads in Texas. Three types of models were compared: BPNN, BNN and the negative binomial (NB) regression models. The results of this study show that in general both types of neural network models perform better than the NB regression model in terms of data prediction. Although the BPNN model can occasionally provide better or approximately equivalent prediction performance compared to the BNN model, in most cases its prediction performance is worse than the BNN model. In addition, the data fitting performance of the BPNN model is consistently worse than the BNN model, which suggests that the BNN model has better generalization abilities than the BPNN model and can effectively alleviate the over-fitting problem without significantly compromising the nonlinear approximation ability. The results also show that BNNs could be used for other useful analyses in highway safety, including the development of accident modification factors and for improving the prediction capabilities for evaluating different highway design alternatives.

Gear Spline Coupling Program

DOE Office of Scientific and Technical Information (OSTI.GOV)

Guo, Yi; Errichello, Robert

2013-08-29

An analytical model is developed to evaluate the design of a spline coupling. For a given torque and shaft misalignment, the model calculates the number of teeth in contact, tooth loads, stiffnesses, stresses, and safety factors. The analytic model provides essential spline coupling design and modeling information and could be easily integrated into gearbox design and simulation tools.

77 FR 4586 - Notice of Opportunity for Public Comment on the Proposed Models for Plant-Specific Adoption of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-30

... Comment on the Proposed Models for Plant-Specific Adoption of Technical Specifications Task Force Traveler... on the proposed model safety evaluation (SE) for plant- specific adoption of Technical Specifications... System (ADAMS) under Accession Number ML103360003; the model application is available in ADAMS under...

Design, development, and evaluation of truck and bus driver wellness programs

DOT National Transportation Integrated Search

2000-06-01

In May 1997, the Federal Motor Carrier Safety Administration (FMCSA) began a research project to design, develop, and evaluate a model truck and bus driver wellness program. This wellness program was developed to provide a resource for addressing tru...

Loss of Coolant Accident (LOCA) / Emergency Core Coolant System (ECCS Evaluation of Risk-Informed Margins Management Strategies for a Representative Pressurized Water Reactor (PWR)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Szilard, Ronaldo Henriques

A Risk Informed Safety Margin Characterization (RISMC) toolkit and methodology are proposed for investigating nuclear power plant core, fuels design and safety analysis, including postulated Loss-of-Coolant Accident (LOCA) analysis. This toolkit, under an integrated evaluation model framework, is name LOCA toolkit for the US (LOTUS). This demonstration includes coupled analysis of core design, fuel design, thermal hydraulics and systems analysis, using advanced risk analysis tools and methods to investigate a wide range of results.

A theory-driven, longitudinal evaluation of the impact of team training on safety culture in 24 hospitals.

PubMed

Jones, Katherine J; Skinner, Anne M; High, Robin; Reiter-Palmon, Roni

2013-05-01

Effective teamwork facilitates collective learning, which is integral to safety culture. There are no rigorous evaluations of the impact of team training on the four components of safety culture-reporting, just, flexible and learning cultures. We evaluated the impact of a year-long team training programme on safety culture in 24 hospitals using two theoretical frameworks. We used two quasi-experimental designs: a cross-sectional comparison of hospital survey on patient safety culture (HSOPS) results from an intervention group of 24 hospitals to a static group of 13 hospitals and a pre-post comparison of HSOPS results within intervention hospitals. Dependent variables were HSOPS items representing the four components of safety culture; independent variables were derived from items added to the HSOPS that measured the extent of team training, learning and transfer. We used a generalised linear mixed model approach to account for the correlated nature of the data. 59% of 2137 respondents from the intervention group reported receiving team training. Intervention group HSOPS scores were significantly higher than static group scores in three dimensions assessing the flexible and learning components of safety culture. The distribution of the adoption of team behaviours (transfer) varied in the intervention group from 2.8% to 31.0%. Adoption of team behaviours was significantly associated with odds of an individual reacting more positively at reassessment than baseline to nine items reflecting all four components of safety culture. Team training can result in transformational change in safety culture when the work environment supports the transfer of learning to new behaviour.

Analysis of dynamical response of air blast loaded safety device

NASA Astrophysics Data System (ADS)

Tropkin, S. N.; Tlyasheva, R. R.; Bayazitov, M. I.; Kuzeev, I. R.

2018-03-01

Equipment of many oil and gas processing plants in the Russian Federation is considerably worn-out. This causes the decrease of reliability and durability of equipment and rises the accident rate. An air explosion is the one of the most dangerous cases for plants in oil and gas industry, usually caused by uncontrolled emission and inflammation of oil products. Air explosion can lead to significant danger for life and health of plant staff, so it necessitates safety device usage. A new type of a safety device is designed. Numerical simulation is necessary to analyse design parameters and performance of the safety device, subjected to air blast loading. Coupled fluid-structure interaction analysis is performed to determine strength of the protective device and its performance. The coupled Euler-Lagrange method, allowable in Abaqus by SIMULIA, is selected as the most appropriate analysis tool to study blast wave interaction with the safety device. Absorption factors of blast wave are evaluated for the safety device. This factors allow one to assess efficiency of the safety device, and its main structural component – dampener. Usage of CEL allowed one to model fast and accurately the dampener behaviour, and to develop the parametric model to determine safety device sizes.

Integrating Safety and Mission Assurance into Systems Engineering Modeling Practices

NASA Technical Reports Server (NTRS)

Beckman, Sean; Darpel, Scott

2015-01-01

During the early development of products, flight, or experimental hardware, emphasis is often given to the identification of technical requirements, utilizing such tools as use case and activity diagrams. Designers and project teams focus on understanding physical and performance demands and challenges. It is typically only later, during the evaluation of preliminary designs that a first pass, if performed, is made to determine the process, safety, and mission quality assurance requirements. Evaluation early in the life cycle, though, can yield requirements that force a fundamental change in design. This paper discusses an alternate paradigm for using the concepts of use case or activity diagrams to identify safety hazard and mission quality assurance risks and concerns using the same systems engineering modeling tools being used to identify technical requirements. It contains two examples of how this process might be used in the development of a space flight experiment, and the design of a Human Powered Pizza Delivery Vehicle, along with the potential benefits to decrease development time, and provide stronger budget estimates.

Preclinical immunogenicity and safety of a Group A streptococcal M protein-based vaccine candidate.

PubMed

Batzloff, Michael R; Fane, Anne; Gorton, Davina; Pandey, Manisha; Rivera-Hernandez, Tania; Calcutt, Ainslie; Yeung, Grace; Hartas, Jon; Johnson, Linda; Rush, Catherine M; McCarthy, James; Ketheesan, Natkunam; Good, Michael F

2016-12-01

Streptococcus pyogenes (group A streptococcus, GAS) causes a wide range of clinical manifestations ranging from mild self-limiting pyoderma to invasive diseases such as sepsis. Also of concern are the post-infectious immune-mediated diseases including rheumatic heart disease. The development of a vaccine against GAS would have a large health impact on populations at risk of these diseases. However, there is a lack of suitable models for the safety evaluation of vaccines with respect to post-infectious complications. We have utilized the Lewis Rat model for cardiac valvulitis to evaluate the safety of the J8-DT vaccine formulation in parallel with a rabbit toxicology study. These studies demonstrated that the vaccine did not induce abnormal pathology. We also show that in mice the vaccine is highly immunogenic but that 3 doses are required to induce protection from a GAS skin challenge even though 2 doses are sufficient to induce a high antibody titer.

Preclinical immunogenicity and safety of a Group A streptococcal M protein-based vaccine candidate

PubMed Central

Batzloff, Michael R.; Fane, Anne; Gorton, Davina; Pandey, Manisha; Rivera-Hernandez, Tania; Calcutt, Ainslie; Yeung, Grace; Hartas, Jon; Johnson, Linda; Rush, Catherine M.; McCarthy, James; Ketheesan, Natkunam; Good, Michael F.

2016-01-01

ABSTRACT Streptococcus pyogenes (group A streptococcus, GAS) causes a wide range of clinical manifestations ranging from mild self-limiting pyoderma to invasive diseases such as sepsis. Also of concern are the post-infectious immune-mediated diseases including rheumatic heart disease. The development of a vaccine against GAS would have a large health impact on populations at risk of these diseases. However, there is a lack of suitable models for the safety evaluation of vaccines with respect to post-infectious complications. We have utilized the Lewis Rat model for cardiac valvulitis to evaluate the safety of the J8-DT vaccine formulation in parallel with a rabbit toxicology study. These studies demonstrated that the vaccine did not induce abnormal pathology. We also show that in mice the vaccine is highly immunogenic but that 3 doses are required to induce protection from a GAS skin challenge even though 2 doses are sufficient to induce a high antibody titer. PMID:27541593

The Microphysiology Systems Database for Analyzing and Modeling Compound Interactions with Human and Animal Organ Models

PubMed Central

Vernetti, Lawrence; Bergenthal, Luke; Shun, Tong Ying; Taylor, D. Lansing

2016-01-01

Abstract Microfluidic human organ models, microphysiology systems (MPS), are currently being developed as predictive models of drug safety and efficacy in humans. To design and validate MPS as predictive of human safety liabilities requires safety data for a reference set of compounds, combined with in vitro data from the human organ models. To address this need, we have developed an internet database, the MPS database (MPS-Db), as a powerful platform for experimental design, data management, and analysis, and to combine experimental data with reference data, to enable computational modeling. The present study demonstrates the capability of the MPS-Db in early safety testing using a human liver MPS to relate the effects of tolcapone and entacapone in the in vitro model to human in vivo effects. These two compounds were chosen to be evaluated as a representative pair of marketed drugs because they are structurally similar, have the same target, and were found safe or had an acceptable risk in preclinical and clinical trials, yet tolcapone induced unacceptable levels of hepatotoxicity while entacapone was found to be safe. Results demonstrate the utility of the MPS-Db as an essential resource for relating in vitro organ model data to the multiple biochemical, preclinical, and clinical data sources on in vivo drug effects. PMID:28781990

Safety in the Chemical Laboratory: Laboratory Air Quality: Part I. A Concentration Model.

ERIC Educational Resources Information Center

Butcher, Samuel S.; And Others

1985-01-01

Offers a simple model for estimating vapor concentrations in instructional laboratories. Three methods are described for measuring ventilation rates, and the results of measurements in six laboratories are presented. The model should provide a simple screening tool for evaluating worst-case personal exposures. (JN)

Preclinical evaluation of implantable cardioverter-defibrillator developed for magnetic resonance imaging use.

PubMed

Gold, Michael R; Kanal, Emanuel; Schwitter, Juerg; Sommer, Torsten; Yoon, Hyun; Ellingson, Michael; Landborg, Lynn; Bratten, Tara

2015-03-01

Many patients with an implantable cardioverter-defibrillator (ICD) have indications for magnetic resonance imaging (MRI). However, MRI is generally contraindicated in ICD patients because of potential risks from hazardous interactions between the MRI and ICD system. The purpose of this study was to use preclinical computer modeling, animal studies, and bench and scanner testing to demonstrate the safety of an ICD system developed for 1.5-T whole-body MRI. MRI hazards were assessed and mitigated using multiple approaches: design decisions to increase safety and reliability, modeling and simulation to quantify clinical MRI exposure levels, animal studies to quantify the physiologic effects of MRI exposure, and bench testing to evaluate safety margin. Modeling estimated the incidence of a chronic change in pacing capture threshold >0.5 V and 1.0 V to be less than 1 in 160,000 and less than 1 in 1,000,000 cases, respectively. Modeling also estimated the incidence of unintended cardiac stimulation to occur in less than 1 in 1,000,000 cases. Animal studies demonstrated no delay in ventricular fibrillation detection and no reduction in ventricular fibrillation amplitude at clinical MRI exposure levels, even with multiple exposures. Bench and scanner testing demonstrated performance and safety against all other MRI-induced hazards. A preclinical strategy that includes comprehensive computer modeling, animal studies, and bench and scanner testing predicts that an ICD system developed for the magnetic resonance environment is safe and poses very low risks when exposed to 1.5-T normal operating mode whole-body MRI. Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Application of Poisson random effect models for highway network screening.

PubMed

Jiang, Ximiao; Abdel-Aty, Mohamed; Alamili, Samer

2014-02-01

In recent years, Bayesian random effect models that account for the temporal and spatial correlations of crash data became popular in traffic safety research. This study employs random effect Poisson Log-Normal models for crash risk hotspot identification. Both the temporal and spatial correlations of crash data were considered. Potential for Safety Improvement (PSI) were adopted as a measure of the crash risk. Using the fatal and injury crashes that occurred on urban 4-lane divided arterials from 2006 to 2009 in the Central Florida area, the random effect approaches were compared to the traditional Empirical Bayesian (EB) method and the conventional Bayesian Poisson Log-Normal model. A series of method examination tests were conducted to evaluate the performance of different approaches. These tests include the previously developed site consistence test, method consistence test, total rank difference test, and the modified total score test, as well as the newly proposed total safety performance measure difference test. Results show that the Bayesian Poisson model accounting for both temporal and spatial random effects (PTSRE) outperforms the model that with only temporal random effect, and both are superior to the conventional Poisson Log-Normal model (PLN) and the EB model in the fitting of crash data. Additionally, the method evaluation tests indicate that the PTSRE model is significantly superior to the PLN model and the EB model in consistently identifying hotspots during successive time periods. The results suggest that the PTSRE model is a superior alternative for road site crash risk hotspot identification. Copyright © 2013 Elsevier Ltd. All rights reserved.

Linking Environmental Sustainability, Health, and Safety Data in Health Care: A Research Roadmap.

PubMed

Kaplan, Susan B; Forst, Linda

2017-08-01

Limited but growing evidence demonstrates that environmental sustainability in the health-care sector can improve worker and patient health and safety. Yet these connections are not appreciated or understood by decision makers in health-care organizations or oversight agencies. Several studies demonstrate improvements in quality of care, staff satisfaction, and work productivity related to environmental improvements in the health-care sector. A pilot study conducted by the authors found that already-collected data could be used to evaluate impacts of environmental sustainability initiatives on worker and patient health and safety, yet few hospitals do so. Future research should include a policy analysis of laws that could drive efforts to integrate these areas, elucidation of organizational models that promote sharing of environmental and health and safety data, and development of tools and methods to enable systematic linkage and evaluation of these data to expand the evidence base and improve the hospital environment.

The role of flight planning in aircrew decision performance

NASA Technical Reports Server (NTRS)

Pepitone, Dave; King, Teresa; Murphy, Miles

1989-01-01

The role of flight planning in increasing the safety and decision-making performance of the air transport crews was investigated in a study that involved 48 rated airline crewmembers on a B720 simulator with a model-board-based visual scene and motion cues with three degrees of freedom. The safety performance of the crews was evaluated using videotaped replays of the flight. Based on these evaluations, the crews could be divided into high- and low-safety groups. It was found that, while collecting information before flights, the high-safety crews were more concerned with information about alternative airports, especially the fuel required to get there, and were characterized by making rapid and appropriate decisions during the emergency part of the flight scenario, allowing these crews to make an early diversion to other airports. These results suggest that contingency planning that takes into account alternative courses of action enhances rapid and accurate decision-making under time pressure.

[Trial of "Huber Plus" in outpatients with chemotherapy by blood port system].

PubMed

Matsumura, Natsuko; Tazumi, Keiko; Kouji, Keiko; Kondo, Motoi; Mizuki, Masao

2008-03-01

We evaluated the advantages and disadvantages of Huber Plus through three outpatients treated with central venous (CV) port chemotherapy (FOLFOX). One of the three outpatients first received chemotherapy with safety huber (Huber Plus) in this study, and the huber needle was changed from non-safety to a safety huber (Huber Plus) in two of the three outpatients. All three outpatients were taught about needle removal methods and port care. In patients? education, 1) we used a skin model and training CV port, and 2) dressing materials were used as film dressing plus three-point fixation by Fixomull stretch. As a result, the safety system assured zero incidents. Moreover, the evaluation revealed that operability and pain of Huber Plus were not clinical problems. We suggest that Huber Plus is applicable in outpatient chemotherapy and that our care plan with patients? education might become a standard treatment.

Associations between attending physician workload, teaching effectiveness, and patient safety.

PubMed

Wingo, Majken T; Halvorsen, Andrew J; Beckman, Thomas J; Johnson, Matthew G; Reed, Darcy A

2016-03-01

Prior studies suggest that high workload among attending physicians may be associated with reduced teaching effectiveness and poor patient outcomes, but these relationships have not been investigated using objective measures of workload and safety. To examine associations between attending workload, teaching effectiveness, and patient safety, hypothesizing that higher workload would be associated with lower teaching effectiveness and negative patient outcomes. We conducted a retrospective study of 69,386 teaching evaluation items submitted by 543 internal medicine residents for 107 attending physicians who supervised inpatient teaching services from July 2, 2005 to July 1, 2011. Attending workload measures included hospital service census, patient length of stay, daily admissions, daily discharges, and concurrent outpatient duties. Teaching effectiveness was measured using residents' evaluations of attendings. Patient outcomes considered were applicable patient safety indicators (PSIs), intensive care unit transfers, cardiopulmonary resuscitation/rapid response team calls, and patient deaths. Mixed linear models and generalized linear regression models were used for statistical analysis. Workload measures of midnight census and daily discharges were associated with lower teaching evaluation scores (both β = -0.026, P < 0.0001). The number of daily admissions was associated with higher teaching scores (β = 0.021, P = 0.001) and increased PSIs (odds ratio = 1.81, P = 0.0001). Several measures of attending physician workload were associated with slightly lower teaching effectiveness, and patient safety may be compromised when teams are managing new admissions. Ongoing efforts by residency programs to optimize the learning environment should include strategies to manage the workload of supervising attendings. © 2016 Society of Hospital Medicine.

Investigating different approaches to develop informative priors in hierarchical Bayesian safety performance functions.

PubMed

Yu, Rongjie; Abdel-Aty, Mohamed

2013-07-01

The Bayesian inference method has been frequently adopted to develop safety performance functions. One advantage of the Bayesian inference is that prior information for the independent variables can be included in the inference procedures. However, there are few studies that discussed how to formulate informative priors for the independent variables and evaluated the effects of incorporating informative priors in developing safety performance functions. This paper addresses this deficiency by introducing four approaches of developing informative priors for the independent variables based on historical data and expert experience. Merits of these informative priors have been tested along with two types of Bayesian hierarchical models (Poisson-gamma and Poisson-lognormal models). Deviance information criterion (DIC), R-square values, and coefficients of variance for the estimations were utilized as evaluation measures to select the best model(s). Comparison across the models indicated that the Poisson-gamma model is superior with a better model fit and it is much more robust with the informative priors. Moreover, the two-stage Bayesian updating informative priors provided the best goodness-of-fit and coefficient estimation accuracies. Furthermore, informative priors for the inverse dispersion parameter have also been introduced and tested. Different types of informative priors' effects on the model estimations and goodness-of-fit have been compared and concluded. Finally, based on the results, recommendations for future research topics and study applications have been made. Copyright © 2013 Elsevier Ltd. All rights reserved.

Training and action for patient safety: embedding interprofessional education for patient safety within an improvement methodology.

PubMed

Slater, Beverley L; Lawton, Rebecca; Armitage, Gerry; Bibby, John; Wright, John

2012-01-01

Despite an explosion of interest in improving safety and reducing error in health care, one important aspect of patient safety that has received little attention is a systematic approach to education and training for the whole health care workforce. This article describes an evaluation of an innovative multiprofessional, team-based training program that embeds patient safety within quality improvement methods. Kirkpatrick's "levels of evaluation" model was adopted to evaluate the program in health organizations across one city in the north of England. Questionnaires were used to assess reaction of participants to the program (Level 1). Improvements in patient safety knowledge and patient safety culture (Level 2) were assessed using a 12-item multiple-choice questionnaire and a culture questionnaire. Interviews and project-specific quantitative measurements were used to assess changes in professional practice and patient outcomes (Levels 3 and 4). All aspects of the program were positively received by participants. Few participants completed the MCQ at both time points, but those who did showed improvement in knowledge. There were some small but significant improvements in patient safety culture. Interviews revealed a number of additional benefits beyond the specific problems addressed. Most importantly, 8 of the 11 teams showed improvements in patient safety practices and/or outcomes. This program is an example of interprofessional education in practice and demonstrates that team-based learning using quality improvement methods is feasible and can be effective in improving patient safety, but requires time and space for participants. Alignment with continuing education arrangements could support mainstream adoption of this approach within organizations. Copyright © 2012 The Alliance for Continuing Education in the Health Professions, the Society for Academic Continuing Medical Education, and the Council on CME, Association for Hospital Medical Education.

Evaluating Intra-Articular Drug Delivery for the Treatment of Osteoarthritis in a Rat Model

PubMed Central

Allen, Kyle D.; Adams, Samuel B.

2010-01-01

Osteoarthritis (OA) is a degenerative joint disease that can result in joint pain, loss of joint function, and deleterious effects on activity levels and lifestyle habits. Current therapies for OA are largely aimed at symptomatic relief and may have limited effects on the underlying cascade of joint degradation. Local drug delivery strategies may provide for the development of more successful OA treatment outcomes that have potential to reduce local joint inflammation, reduce joint destruction, offer pain relief, and restore patient activity levels and joint function. As increasing interest turns toward intra-articular drug delivery routes, parallel interest has emerged in evaluating drug biodistribution, safety, and efficacy in preclinical models. Rodent models provide major advantages for the development of drug delivery strategies, chiefly because of lower cost, successful replication of human OA-like characteristics, rapid disease development, and small joint volumes that enable use of lower total drug amounts during protocol development. These models, however, also offer the potential to investigate the therapeutic effects of local drug therapy on animal behavior, including pain sensitivity thresholds and locomotion characteristics. Herein, we describe a translational paradigm for the evaluation of an intra-articular drug delivery strategy in a rat OA model. This model, a rat interleukin-1β overexpression model, offers the ability to evaluate anti-interleukin-1 therapeutics for drug biodistribution, activity, and safety as well as the therapeutic relief of disease symptoms. Once the action against interleukin-1 is confirmed in vivo, the newly developed anti-inflammatory drug can be evaluated for evidence of disease-modifying effects in more complex preclinical models. PMID:19943805

A Heckman selection model for the safety analysis of signalized intersections

PubMed Central

Wong, S. C.; Zhu, Feng; Pei, Xin; Huang, Helai; Liu, Youjun

2017-01-01

Purpose The objective of this paper is to provide a new method for estimating crash rate and severity simultaneously. Methods This study explores a Heckman selection model of the crash rate and severity simultaneously at different levels and a two-step procedure is used to investigate the crash rate and severity levels. The first step uses a probit regression model to determine the sample selection process, and the second step develops a multiple regression model to simultaneously evaluate the crash rate and severity for slight injury/kill or serious injury (KSI), respectively. The model uses 555 observations from 262 signalized intersections in the Hong Kong metropolitan area, integrated with information on the traffic flow, geometric road design, road environment, traffic control and any crashes that occurred during two years. Results The results of the proposed two-step Heckman selection model illustrate the necessity of different crash rates for different crash severity levels. Conclusions A comparison with the existing approaches suggests that the Heckman selection model offers an efficient and convenient alternative method for evaluating the safety performance at signalized intersections. PMID:28732050

Predicting the effectiveness of road safety campaigns through alternative research designs.

PubMed

Adamos, Giannis; Nathanail, Eftihia

2016-12-01

A large number of road safety communication campaigns have been designed and implemented in the recent years; however their explicit impact on driving behavior and road accident rates has been estimated in a rather low proportion. Based on the findings of the evaluation of three road safety communication campaigns addressing the issues of drinking and driving, seat belt usage, and driving fatigue, this paper applies different types of research designs (i.e., experimental, quasi-experimental, and non-experimental designs), when estimating the effectiveness of road safety campaigns, implements a cross-design assessment, and conducts a cross-campaign evaluation. An integrated evaluation plan was developed, taking into account the structure of evaluation questions, the definition of measurable variables, the separation of the target audience into intervention (exposed to the campaign) and control (not exposed to the campaign) groups, the selection of alternative research designs, and the appropriate data collection methods and techniques. Evaluating the implementation of different research designs in estimating the effectiveness of road safety campaigns, results showed that the separate pre-post samples design demonstrated better predictability than other designs, especially in data obtained from the intervention group after the realization of the campaign. The more constructs that were added to the independent variables, the higher the values of the predictability were. The construct that most affects behavior is intention, whereas the rest of the constructs have a lower impact on behavior. This is particularly significant in the Health Belief Model (HBM). On the other hand, behavioral beliefs, normative beliefs, and descriptive norms, are significant parameters for predicting intention according to the Theory of Planned Behavior (TPB). The theoretical and applied implications of alternative research designs and their applicability in the evaluation of road safety campaigns are provided by this study. Copyright © 2016 Elsevier Ltd and National Safety Council. All rights reserved.

Randomized Clinical Trial of the Innovative Bilayered Wound Dressing Made of Silk and Gelatin: Safety and Efficacy Tests Using a Split-Thickness Skin Graft Model

PubMed Central

Hasatsri, Sukhontha; Angspatt, Apichai

2015-01-01

We developed the novel silk fibroin-based bilayered wound dressing for the treatment of partial thickness wounds. And it showed relevant characteristics and accelerated the healing of full-thickness wounds in a rat model. This study is the clinical evaluation of the bilayered wound dressing to confirm its safety and efficacy for the treatment of split-thickness skin donor sites. The safety test was performed using a patch model and no evidence of marked and severe cutaneous reactions was found. The efficacy test of the bilayered wound dressing was conducted on 23 patients with 30 split-thickness skin graft donor sites to evaluate healing time, pain score, skin barrier function, and systemic reaction in comparison to Bactigras. We found that the healing time of donor site wounds treated with the bilayered wound dressing (11 ± 6 days) was significantly faster than those treated with Bactigras (14 ± 6 days) (p = 10−6). The wound sites treated with the bilayered wound dressing showed significantly less pain and more rapid skin functional barrier recovery than those treated with Bactigras (p = 10−5). Therefore, these results confirmed the clinical safety and efficacy of the bilayered wound dressing for the treatment of split-thickness skin graft donor sites. PMID:26221170

[Comprehensive evaluation of protective measures in electric welding].

PubMed

Ye, K; Zhao, Z

1995-03-01

Protective effects of safety masks, eyewear, work clothes, gloves, periodically physical examination system, and ventilation and barriers at workplace, were evaluated by one-way analysis for handtorch welding, carbon dioxide gas-protective welding, and argon-arc welding operations, etc. in township and village enterprises and state-owned enterprises by interviewing managers in the departments of technology and work safety and field investigating. Based on the results of one-way analysis of protective measures, comprehensive evaluations of various enterprises were made with a fussy mathematical model. Both enterprises in township and village level and of state-owned were graded as A on a basis of the evaluation, which will be helpful to the better management of occupational health in the future.

Effects of safety behaviour on the maintenance of anxiety and negative belief social anxiety disorder.

PubMed

Okajima, Isa; Kanai, Yoshihiro; Chen, Junwen; Sakano, Yuji

2009-01-01

Safety behaviour plays an important role in the maintenance of social anxiety disorder (SAD). SAD patients engage in various safety behaviours in social situations in order to decrease the risk of negative evaluations from others. The present study examined the effect of safety behaviour on the maintenance of anxiety and negative belief in SAD by using Structural Equation Modelling (SEM). Participants were a healthy group (442) and a SAD group (46) who met the SAD criteria for DSM-IV and who had high scores of SAD symptoms. In the assumed maintenance model, independence variables were safety and avoidance behaviour and dependence variables were anxiety and negative belief. This result showed that the SAD group significantly has more high scores than the healthy group in all scales of anxiety, negative belief and avoidance behaviour, expect for safety behaviour. The result of the multiple-group procedure indicated that safety behaviour contributes more strongly to anxiety and negative belief in the SAD group than in the healthy group. It is speculated that the SAD group have a stronger link between safety behaviour and negative belief than the healthy group, whereas frequency of the use of safety behaviour is equivalent between two groups. These results support the findings of previous studies.

Evaluation of the commercial vehicle information systems and networks (CVISN) model deployment initiative. Volume I, Final report

DOT National Transportation Integrated Search

2002-03-01

The Commercial Vehicle Information Systems and Networks Model Deployment Initiative (CVISN MDI) is funded by the Intelligent Transportation Systems Joint Program Office (ITS JPO) and managed by the Federal Motor Carrier Safety Administration (FMCSA),...

Evaluation of the commercial vehicle information systems and networks (CVISN) model deployment initiative. Volume II, Appendices

DOT National Transportation Integrated Search

2002-03-01

The Commercial Vehicle Information Systems and Networks Model Deployment Initiative (CVISN MDI) is funded by the Intelligent Transportation Systems Joint Program Office (ITS JPO) and managed by the Federal Motor Carrier Safety Administration (FMCSA),...

Biocompatibility and intradiscal application of a thermoreversible celecoxib-loaded poly-N-isopropylacrylamide MgFe-layered double hydroxide hydrogel in a canine model.

PubMed

Willems, Nicole; Yang, Hsiao-Yin; Langelaan, Marloes L P; Tellegen, Anna R; Grinwis, Guy C M; Kranenburg, Hendrik-Jan C; Riemers, Frank M; Plomp, Saskia G M; Craenmehr, Eric G M; Dhert, Wouter J A; Papen-Botterhuis, Nicole E; Meij, Björn P; Creemers, Laura B; Tryfonidou, Marianna A

2015-08-20

Chronic low back pain due to intervertebral disc (IVD) degeneration is associated with increased levels of inflammatory mediators. Current medical treatment consists of oral anti-inflammatory drugs to alleviate pain. In this study, the efficacy and safety of a novel thermoreversible poly-N-isopropylacrylamide MgFe-layered double hydroxide (pNIPAAM MgFe-LDH) hydrogel was evaluated for intradiscal controlled delivery of the selective cyclooxygenase (COX) 2 inhibitor and anti-inflammatory drug celecoxib (CXB). Degradation, release behavior, and the ability of a CXB-loaded pNIPAAM MgFe-LDH hydrogel to suppress prostaglandin E2 (PGE2) levels in a controlled manner in the presence of a proinflammatory stimulus (TNF-α) were evaluated in vitro. Biocompatibility was evaluated histologically after subcutaneous injection in mice. Safety of intradiscal application of the loaded and unloaded hydrogels was studied in a canine model of spontaneous mild IVD degeneration by histological, biomolecular, and biochemical evaluation. After the hydrogel was shown to be biocompatible and safe, an in vivo dose-response study was performed in order to determine safety and efficacy of the pNIPAAM MgFe-LDH hydrogel for intradiscal controlled delivery of CXB. CXB release correlated to hydrogel degradation in vitro. Furthermore, controlled release from CXB-loaded hydrogels was demonstrated to suppress PGE2 levels in the presence of TNF-α. The hydrogel was shown to exhibit a good biocompatibility upon subcutaneous injection in mice. Upon intradiscal injection in a canine model, the hydrogel exhibited excellent biocompatibility based on histological evaluation of the treated IVDs. Gene expression and biochemical analyses supported the finding that no substantial negative effects of the hydrogel were observed. Safety of application was further confirmed by the absence of clinical symptoms, IVD herniation or progression of degeneration. Controlled release of CXB resulted in a nonsignificant maximal inhibition (approximately 35 %) of PGE2 levels in the mildly degenerated canine IVDs. In conclusion, this study showed biocompatibility and safe intradiscal application of an MgFe LDH-pNIPAAM hydrogel. Controlled release of CXB resulted in only limited inhibition of PGE2 in this model with mild IVD degeneration, and further studies should concentrate on application of controlled release from this type of hydrogel in animal models with more severe IVD degeneration.

Efficacy and safety of damage control in experimental animal models of injury: protocol for a systematic review and meta-analysis

PubMed Central

2014-01-01

Background Although abbreviated surgery with planned reoperation (damage control surgery) is now widely used to manage major trauma patients, the procedure and its component interventions have not been evaluated in randomized controlled trials (RCTs). While some have suggested the need for such trials, they are unlikely to be conducted because of patient safety concerns. As animal studies may overcome several of the limitations of existing observational damage control studies, the primary objective of this study is to evaluate the efficacy and safety of damage control versus definitive surgery in experimental animal models of injury. Methods/design We will search electronic databases (Medline, Embase, PubMed, Web of Science, Scopus, and the Cochrane Library), conference abstracts, personal files, and bibliographies of included articles. We will include RCTs and prospective cohort studies that utilized an animal model of injury and compared damage control surgery (or specific damage control interventions or adjuncts) to definitive surgery (or specific definitive surgical interventions). Two investigators will independently evaluate the internal and external/construct validity of individual studies. The primary outcome will be all-cause mortality. Secondary outcomes will include blood loss amounts; blood pressures and heart rates; urinary outputs; core body temperatures; arterial lactate, pH, and base deficit/excess values; prothrombin and partial thromboplastin times; international normalized ratios; and thromboelastography (TEG) results/activated clotting times. We will calculate summary relative risks (RRs) of mortality and mean differences (for continuous outcomes) using DerSimonian and Laird random effects models. Heterogeneity will be explored using subgroup meta-analysis and meta-regression. We will assess for publication bias using funnel plots and Begg’s and Egger’s tests. When evidence of publication bias exists, we will use the Duval and Tweedie trim and fill method to estimate the potential influence of this bias on pooled summary estimates. Discussion This study will evaluate the efficacy and safety of damage control in experimental animal models of injury. Study results will be used to guide future clinical evaluations of damage control surgery, determine which animal study outcomes may potentially be generalizable to the clinical setting, and to provide guidelines to strengthen the conduct and relevance of future pre-clinical studies. PMID:25416175

The role of quantitative safety evaluation in regulatory decision making of drugs.

PubMed

Chakravarty, Aloka G; Izem, Rima; Keeton, Stephine; Kim, Clara Y; Levenson, Mark S; Soukup, Mat

2016-01-01

Evaluation of safety is a critical component of drug review at the US Food and Drug Administration (FDA). Statisticians are playing an increasingly visible role in quantitative safety evaluation and regulatory decision-making. This article reviews the history and the recent events relating to quantitative drug safety evaluation at the FDA. The article then focuses on five active areas of quantitative drug safety evaluation and the role Division of Biometrics VII (DBVII) plays in these areas, namely meta-analysis for safety evaluation, large safety outcome trials, post-marketing requirements (PMRs), the Sentinel Initiative, and the evaluation of risk from extended/long-acting opioids. This article will focus chiefly on developments related to quantitative drug safety evaluation and not on the many additional developments in drug safety in general.

Road Risk Modeling and Cloud-Aided Safety-Based Route Planning.

PubMed

Li, Zhaojian; Kolmanovsky, Ilya; Atkins, Ella; Lu, Jianbo; Filev, Dimitar P; Michelini, John

2016-11-01

This paper presents a safety-based route planner that exploits vehicle-to-cloud-to-vehicle (V2C2V) connectivity. Time and road risk index (RRI) are considered as metrics to be balanced based on user preference. To evaluate road segment risk, a road and accident database from the highway safety information system is mined with a hybrid neural network model to predict RRI. Real-time factors such as time of day, day of the week, and weather are included as correction factors to the static RRI prediction. With real-time RRI and expected travel time, route planning is formulated as a multiobjective network flow problem and further reduced to a mixed-integer programming problem. A V2C2V implementation of our safety-based route planning approach is proposed to facilitate access to real-time information and computing resources. A real-world case study, route planning through the city of Columbus, Ohio, is presented. Several scenarios illustrate how the "best" route can be adjusted to favor time versus safety metrics.

Safety evaluation model of urban cross-river tunnel based on driving simulation.

PubMed

Ma, Yingqi; Lu, Linjun; Lu, Jian John

2017-09-01

Currently, Shanghai urban cross-river tunnels have three principal characteristics: increased traffic, a high accident rate and rapidly developing construction. Because of their complex geographic and hydrological characteristics, the alignment conditions in urban cross-river tunnels are more complicated than in highway tunnels, so a safety evaluation of urban cross-river tunnels is necessary to suggest follow-up construction and changes in operational management. A driving risk index (DRI) for urban cross-river tunnels was proposed in this study. An index system was also constructed, combining eight factors derived from the output of a driving simulator regarding three aspects of risk due to following, lateral accidents and driver workload. Analytic hierarchy process methods and expert marking and normalization processing were applied to construct a mathematical model for the DRI. The driving simulator was used to simulate 12 Shanghai urban cross-river tunnels and a relationship was obtained between the DRI for the tunnels and the corresponding accident rate (AR) via a regression analysis. The regression analysis results showed that the relationship between the DRI and the AR mapped to an exponential function with a high degree of fit. In the absence of detailed accident data, a safety evaluation model based on factors derived from a driving simulation can effectively assess the driving risk in urban cross-river tunnels constructed or in design.

Emergy assessment of three home courtyard agriculture production systems in Tibet Autonomous Region, China*

PubMed Central

Guan, Fa-chun; Sha, Zhi-peng; Zhang, Yu-yang; Wang, Jun-feng; Wang, Chao

2016-01-01

Home courtyard agriculture is an important model of agricultural production on the Tibetan plateau. Because of the sensitive and fragile plateau environment, it needs to have optimal performance characteristics, including high sustainability, low environmental pressure, and high economic benefit. Emergy analysis is a promising tool for evaluation of the environmental-economic performance of these production systems. In this study, emergy analysis was used to evaluate three courtyard agricultural production models: Raising Geese in Corn Fields (RGICF), Conventional Corn Planting (CCP), and Pea-Wheat Rotation (PWR). The results showed that the RGICF model produced greater economic benefits, and had higher sustainability, lower environmental pressure, and higher product safety than the CCP and PWR models. The emergy yield ratio (EYR) and emergy self-support ratio (ESR) of RGICF were 0.66 and 0.11, respectively, lower than those of the CCP production model, and 0.99 and 0.08, respectively, lower than those of the PWR production model. The impact of RGICF (1.45) on the environment was lower than that of CCP (2.26) and PWR (2.46). The emergy sustainable indices (ESIs) of RGICF were 1.07 and 1.02 times higher than those of CCP and PWR, respectively. With regard to the emergy index of product safety (EIPS), RGICF had a higher safety index than those of CCP and PWR. Overall, our results suggest that the RGICF model is advantageous and provides higher environmental benefits than the CCP and PWR systems. PMID:27487808

Emergy assessment of three home courtyard agriculture production systems in Tibet Autonomous Region, China.

PubMed

Guan, Fa-Chun; Sha, Zhi-Peng; Zhang, Yu-Yang; Wang, Jun-Feng; Wang, Chao

2016-08-01

Home courtyard agriculture is an important model of agricultural production on the Tibetan plateau. Because of the sensitive and fragile plateau environment, it needs to have optimal performance characteristics, including high sustainability, low environmental pressure, and high economic benefit. Emergy analysis is a promising tool for evaluation of the environmental-economic performance of these production systems. In this study, emergy analysis was used to evaluate three courtyard agricultural production models: Raising Geese in Corn Fields (RGICF), Conventional Corn Planting (CCP), and Pea-Wheat Rotation (PWR). The results showed that the RGICF model produced greater economic benefits, and had higher sustainability, lower environmental pressure, and higher product safety than the CCP and PWR models. The emergy yield ratio (EYR) and emergy self-support ratio (ESR) of RGICF were 0.66 and 0.11, respectively, lower than those of the CCP production model, and 0.99 and 0.08, respectively, lower than those of the PWR production model. The impact of RGICF (1.45) on the environment was lower than that of CCP (2.26) and PWR (2.46). The emergy sustainable indices (ESIs) of RGICF were 1.07 and 1.02 times higher than those of CCP and PWR, respectively. With regard to the emergy index of product safety (EIPS), RGICF had a higher safety index than those of CCP and PWR. Overall, our results suggest that the RGICF model is advantageous and provides higher environmental benefits than the CCP and PWR systems.

A Roadmap for the Development of Alternative (Non-Animal) Methods for Systemic Toxicity Testing

EPA Science Inventory

Systemic toxicity testing forms the cornerstone for the safety evaluation of substances. Pressures to move from traditional animal models to novel technologies arise from various concerns, including: the need to evaluate large numbers of previously untested chemicals and new prod...

Crime Prevention Through Environmental Design (CPTED) Characteristics Associated With Violence and Safety in Middle Schools.

PubMed

Vagi, Kevin J; Stevens, Mark R; Simon, Thomas R; Basile, Kathleen C; Carter, Sherry P; Carter, Stanley L

2018-04-01

This study used a new Crime Prevention Through Environmental Design (CPTED) assessment tool to test the associations between physical attributes of schools and violence-related behaviors and perceptions of students. Data were collected from 4717 students from 50 middle schools. Student perceptions of risk and safety, and violence were assessed. Evaluators used the CPTED School Assessment (CSA) to quantify how well the physical elements of each school correspond to ideal CPTED principles. Generalized linear mixed models were used to adjust for school- and student-level characteristics. Higher CSA scores were generally associated with higher perceptions of safety and lower levels of violence perpetration and perceived risk in unadjusted models. Higher CSA scores were also associated with lower odds of missing school because of safety concerns in most adjusted models, with significant adjusted odds ratios (AORs) ranging from 0.32 to 0.63. CSA scores for parking and bus loading areas also remained associated with higher perceived safety (AORs = 1.28 and 1.32, respectively) and lower perceived risk (AORs = 0.73 and 0.66, respectively) in adjusted models. The CSA is useful for assessing school environments that are associated with violence-related behaviors and perceptions. The CSA might help guide school environmental modifications to reduce violence. © 2018, American School Health Association.

Multi-approach model for improving agrochemical safety among rice farmers in Pathumthani, Thailand

PubMed Central

Raksanam, Buppha; Taneepanichskul, Surasak; Siriwong, Wattasit; Robson, Mark

2012-01-01

The large-scale use of agrochemicals has raised environmental and human health concerns. A comprehensive intervention strategy for improving agrochemical safety among rice farmers in Thailand is lacking. The objective of this study is to develop a model in order to improve farmers’ health and prevent them from being exposed to agrochemical hazards, in addition to evaluating the effectiveness of the intervention in terms of agrochemical safety. This study was conducted between October 2009 and January 2011. It measures changes in the mean scores of agrochemical knowledge, health beliefs, agrochemical use behaviors, and in-home pesticide safety. Knowledge of agrochemical use constitutes a basic knowledge of agrochemicals and agrochemical safety behaviors. Health beliefs constitute perceived susceptibility, severity, benefits, and barriers to using agrochemicals. Agrochemical use behaviors include self-care practices in terms of personal health at specific times including before spraying, while spraying, during storage, transportation, waste management, and health risk management. Fifty rice farmers from Khlong Seven Community (study group) and 51 rice farmers from Bueng Ka Sam community (control group) were randomly recruited with support from community leaders. The participants were involved in a combination of home visits (ie, pesticide safety assessments at home) and community participatory activities regarding agrochemical safety. This study reveals that health risk behaviors regarding agrochemical exposure in the study area are mainly caused by lack of attention to safety precautions and the use of faulty protective gear. After 6 months, the intervention program showed significant improvements in the overall scores on knowledge, beliefs, behaviors, and home pesticide safety in the study group (P < 0.05). Therefore, this intervention model is effective in improving agrochemical safety behaviors among Khlong Seven Community rice farmers. These findings demonstrate that a multi-approach model for improving agrochemical safety behaviors can lead to sustainable prevention of agrochemical hazards for farmers. PMID:22956888

Risk Assessment in Underground Coalmines Using Fuzzy Logic in the Presence of Uncertainty

NASA Astrophysics Data System (ADS)

Tripathy, Debi Prasad; Ala, Charan Kumar

2018-04-01

Fatal accidents are occurring every year as regular events in Indian coal mining industry. To increase the safety conditions, it has become a prerequisite to performing a risk assessment of various operations in mines. However, due to uncertain accident data, it is hard to conduct a risk assessment in mines. The object of this study is to present a method to assess safety risks in underground coalmines. The assessment of safety risks is based on the fuzzy reasoning approach. Mamdani fuzzy logic model is developed in the fuzzy logic toolbox of MATLAB. A case study is used to demonstrate the applicability of the developed model. The summary of risk evaluation in case study mine indicated that mine fire has the highest risk level among all the hazard factors. This study could help the mine management to prepare safety measures based on the risk rankings obtained.

Developing and Evaluating the Impact of an Extension-Based Train-the-Trainer Model for Effectively Disseminating Food Safety Education to Middle School Students

ERIC Educational Resources Information Center

Richards, Jennifer; Pratt, Carrie; Skolits, Gary J.; Burney, Janie

2012-01-01

Adolescents are an understudied, but meaningful, population when it comes to food safety education. With the proliferation of pathogenic microbes and changes in eating habits of Americans, today's youth are more at risk of contracting a foodborne illness than previous generations. Hands On: Real World Lessons for Middle School Classrooms provides…

External validity of a generic safety climate scale for lone workers across different industries and companies.

PubMed

Lee, Jin; Huang, Yueng-hsiang; Robertson, Michelle M; Murphy, Lauren A; Garabet, Angela; Chang, Wen-Ruey

2014-02-01

The goal of this study was to examine the external validity of a 12-item generic safety climate scale for lone workers in order to evaluate the appropriateness of generalized use of the scale in the measurement of safety climate across various lone work settings. External validity evidence was established by investigating the measurement equivalence (ME) across different industries and companies. Confirmatory factor analysis (CFA)-based and item response theory (IRT)-based perspectives were adopted to examine the ME of the generic safety climate scale for lone workers across 11 companies from the trucking, electrical utility, and cable television industries. Fairly strong evidence of ME was observed for both organization- and group-level generic safety climate sub-scales. Although significant invariance was observed in the item intercepts across the different lone work settings, absolute model fit indices remained satisfactory in the most robust step of CFA-based ME testing. IRT-based ME testing identified only one differentially functioning item from the organization-level generic safety climate sub-scale, but its impact was minimal and strong ME was supported. The generic safety climate scale for lone workers reported good external validity and supported the presence of a common feature of safety climate among lone workers. The scale can be used as an effective safety evaluation tool in various lone work situations. Copyright © 2013 Elsevier Ltd. All rights reserved.

Application of a model for delivering occupational safety and health to smaller businesses: Case studies from the US

PubMed Central

Cunningham, Thomas R.; Sinclair, Raymond

2015-01-01

Smaller firms are the majority in every industry in the US, and they endure a greater burden of occupational injuries, illnesses, and fatalities than larger firms. Smaller firms often lack the necessary resources for effective occupational safety and health activities, and many require external assistance with safety and health programming. Based on previous work by researchers in Europe and New Zealand, NIOSH researchers developed for occupational safety and health intervention in small businesses. This model was evaluated with several intermediary organizations. Four case studies which describe efforts to reach small businesses with occupational safety and health assistance include the following: trenching safety training for construction, basic compliance and hazard recognition for general industry, expanded safety and health training for restaurants, and fall prevention and respirator training for boat repair contractors. Successful efforts included participation by the initiator among the intermediaries’ planning activities, alignment of small business needs with intermediary offerings, continued monitoring of intermediary activities by the initiator, and strong leadership for occupational safety and health among intermediaries. Common challenges were a lack of resources among intermediaries, lack of opportunities for in-person meetings between intermediaries and the initiator, and balancing the exchanges in the initiator–intermediary–small business relationships. The model offers some encouragement that initiator organizations can contribute to sustainable OSH assistance for small firms, but they must depend on intermediaries who have compatible interests in smaller businesses and they must work to understand the small business social system. PMID:26300585

Application of a model for delivering occupational safety and health to smaller businesses: Case studies from the US.

PubMed

Cunningham, Thomas R; Sinclair, Raymond

2015-01-01

Smaller firms are the majority in every industry in the US, and they endure a greater burden of occupational injuries, illnesses, and fatalities than larger firms. Smaller firms often lack the necessary resources for effective occupational safety and health activities, and many require external assistance with safety and health programming. Based on previous work by researchers in Europe and New Zealand, NIOSH researchers developed for occupational safety and health intervention in small businesses. This model was evaluated with several intermediary organizations. Four case studies which describe efforts to reach small businesses with occupational safety and health assistance include the following: trenching safety training for construction, basic compliance and hazard recognition for general industry, expanded safety and health training for restaurants, and fall prevention and respirator training for boat repair contractors. Successful efforts included participation by the initiator among the intermediaries' planning activities, alignment of small business needs with intermediary offerings, continued monitoring of intermediary activities by the initiator, and strong leadership for occupational safety and health among intermediaries. Common challenges were a lack of resources among intermediaries, lack of opportunities for in-person meetings between intermediaries and the initiator, and balancing the exchanges in the initiator-intermediary-small business relationships. The model offers some encouragement that initiator organizations can contribute to sustainable OSH assistance for small firms, but they must depend on intermediaries who have compatible interests in smaller businesses and they must work to understand the small business social system.

Evaluation of Mid-Size Male Hybrid III Models for use in Spaceflight Occupant Protection Analysis

NASA Technical Reports Server (NTRS)

Putnam, J.; Somers, J.; Wells, J.; Newby, N.; Currie-Gregg, N.; Lawrence, C.

2016-01-01

Introduction: In an effort to improve occupant safety during dynamic phases of spaceflight, the National Aeronautics and Space Administration (NASA) has worked to develop occupant protection standards for future crewed spacecraft. One key aspect of these standards is the identification of injury mechanisms through anthropometric test devices (ATDs). Within this analysis, both physical and computational ATD evaluations are required to reasonably encompass the vast range of loading conditions any spaceflight crew may encounter. In this study the accuracy of publically available mid-size male HIII ATD finite element (FE) models are evaluated within applicable loading conditions against extensive sled testing performed on their physical counterparts. Methods: A series of sled tests were performed at the Wright Patterson Air force Base (WPAFB) employing variations of magnitude, duration, and impact direction to encompass the dynamic loading range for expected spaceflight. FE simulations were developed to the specifications of the test setup and driven using measured acceleration profiles. Both fast and detailed FE models of the mid-size male HIII were ran to quantify differences in their accuracy and thus assess the applicability of each within this field. Results: Preliminary results identify the dependence of model accuracy on loading direction, magnitude, and rate. Additionally the accuracy of individual response metrics are shown to vary across each model within evaluated test conditions. Causes for model inaccuracy are identified based on the observed relationships. Discussion: Computational modeling provides an essential component to ATD injury metric evaluation used to ensure the safety of future spaceflight occupants. The assessment of current ATD models lays the groundwork for how these models can be used appropriately in the future. Identification of limitations and possible paths for improvement aid in the development of these effective analysis tools.

Evaluation of Mid-Size Male Hybrid III Models for use in Spaceflight Occupant Protection Analysis

NASA Technical Reports Server (NTRS)

Putnam, Jacob B.; Sommers, Jeffrey T.; Wells, Jessica A.; Newby, Nathaniel J.; Currie-Gregg, Nancy J.; Lawrence, Chuck

2016-01-01

In an effort to improve occupant safety during dynamic phases of spaceflight, the National Aeronautics and Space Administration (NASA) has worked to develop occupant protection standards for future crewed spacecraft. One key aspect of these standards is the identification of injury mechanisms through anthropometric test devices (ATDs). Within this analysis, both physical and computational ATD evaluations are required to reasonably encompass the vast range of loading conditions any spaceflight crew may encounter. In this study the accuracy of publically available mid-size male HIII ATD finite element (FE) models are evaluated within applicable loading conditions against extensive sled testing performed on their physical counterparts. Methods: A series of sled tests were performed at the Wright Patterson Air force Base (WPAFB) employing variations of magnitude, duration, and impact direction to encompass the dynamic loading range for expected spaceflight. FE simulations were developed to the specifications of the test setup and driven using measured acceleration profiles. Both fast and detailed FE models of the mid-size male HIII were ran to quantify differences in their accuracy and thus assess the applicability of each within this field. Results: Preliminary results identify the dependence of model accuracy on loading direction, magnitude, and rate. Additionally the accuracy of individual response metrics are shown to vary across each model within evaluated test conditions. Causes for model inaccuracy are identified based on the observed relationships. Discussion: Computational modeling provides an essential component to ATD injury metric evaluation used to ensure the safety of future spaceflight occupants. The assessment of current ATD models lays the groundwork for how these models can be used appropriately in the future. Identification of limitations and possible paths for improvement aid in the development of these effective analysis tools.

High Reliability Organizations--Medication Safety.

PubMed

Yip, Luke; Farmer, Brenna

2015-06-01

High reliability organizations (HROs), such as the aviation industry, successfully engage in high-risk endeavors and have low incidence of adverse events. HROs have a preoccupation with failure and errors. They analyze each event to effect system wide change in an attempt to mitigate the occurrence of similar errors. The healthcare industry can adapt HRO practices, specifically with regard to teamwork and communication. Crew resource management concepts can be adapted to healthcare with the use of certain tools such as checklists and the sterile cockpit to reduce medication errors. HROs also use The Swiss Cheese Model to evaluate risk and look for vulnerabilities in multiple protective barriers, instead of focusing on one failure. This model can be used in medication safety to evaluate medication management in addition to using the teamwork and communication tools of HROs.

A Risk Assessment Model for Reduced Aircraft Separation: A Quantitative Method to Evaluate the Safety of Free Flight

NASA Technical Reports Server (NTRS)

Cassell, Rick; Smith, Alex; Connors, Mary; Wojciech, Jack; Rosekind, Mark R. (Technical Monitor)

1996-01-01

As new technologies and procedures are introduced into the National Airspace System, whether they are intended to improve efficiency, capacity, or safety level, the quantification of potential changes in safety levels is of vital concern. Applications of technology can improve safety levels and allow the reduction of separation standards. An excellent example is the Precision Runway Monitor (PRM). By taking advantage of the surveillance and display advances of PRM, airports can run instrument parallel approaches to runways separated by 3400 feet with the same level of safety as parallel approaches to runways separated by 4300 feet using the standard technology. Despite a wealth of information from flight operations and testing programs, there is no readily quantifiable relationship between numerical safety levels and the separation standards that apply to aircraft on final approach. This paper presents a modeling approach to quantify the risk associated with reducing separation on final approach. Reducing aircraft separation, both laterally and longitudinally, has been the goal of several aviation R&D programs over the past several years. Many of these programs have focused on technological solutions to improve navigation accuracy, surveillance accuracy, aircraft situational awareness, controller situational awareness, and other technical and operational factors that are vital to maintaining flight safety. The risk assessment model relates different types of potential aircraft accidents and incidents and their contribution to overall accident risk. The framework links accident risks to a hierarchy of failsafe mechanisms characterized by procedures and interventions. The model will be used to assess the overall level of safety associated with reducing separation standards and the introduction of new technology and procedures, as envisaged under the Free Flight concept. The model framework can be applied to various aircraft scenarios, including parallel and in-trail approaches. This research was performed under contract to NASA and in cooperation with the FAA's Safety Division (ASY).

Relating crash frequency and severity: evaluating the effectiveness of shoulder rumble strips on reducing fatal and major injury crashes.

PubMed

Wu, Kun-Feng; Donnell, Eric T; Aguero-Valverde, Jonathan

2014-06-01

To approach the goal of "Toward Zero Deaths," there is a need to develop an analysis paradigm to better understand the effects of a countermeasure on reducing the number of severe crashes. One of the goals in traffic safety research is to search for an effective treatment to reduce fatal and major injury crashes, referred to as severe crashes. To achieve this goal, the selection of promising countermeasures is of utmost importance, and relies on the effectiveness of candidate countermeasures in reducing severe crashes. Although it is important to precisely evaluate the effectiveness of candidate countermeasures in reducing the number of severe crashes at a site, the current state-of-the-practice often leads to biased estimates. While there have been a few advanced statistical models developed to mitigate the problem in practice, these models are computationally difficult to estimate because severe crashes are dispersed spatially and temporally, and cannot be integrated into the Highway Safety Manual framework, which develops a series of safety performance functions and crash modification factors to predict the number of crashes. Crash severity outcomes are generally integrated into the Highway Safety Manual using deterministic distributions rather than statistical models. Accounting for the variability in crash severity as a function geometric design, traffic flow, and other roadway and roadside features is afforded by estimating statistical models. Therefore, there is a need to develop a new analysis paradigm to resolve the limitations in the current Highway Safety Manual methods. We propose an approach which decomposes the severe crash frequency into a function of the change in the total number of crashes and the probability of a crash becoming a severe crash before and after a countermeasure is implemented. We tested this approach by evaluating the effectiveness of shoulder rumble strips on reducing the number of severe crashes. A total of 310 segments that have had shoulder rumble strips installed during 2002-2009 are included in the analysis. It was found that shoulder rumble strips reduce the total number of crashes, but have no statistically significant effect on reducing the probability of a severe crash outcome. Copyright © 2014 Elsevier Ltd. All rights reserved.

Probabilistic design of fibre concrete structures

NASA Astrophysics Data System (ADS)

Pukl, R.; Novák, D.; Sajdlová, T.; Lehký, D.; Červenka, J.; Červenka, V.

2017-09-01

Advanced computer simulation is recently well-established methodology for evaluation of resistance of concrete engineering structures. The nonlinear finite element analysis enables to realistically predict structural damage, peak load, failure, post-peak response, development of cracks in concrete, yielding of reinforcement, concrete crushing or shear failure. The nonlinear material models can cover various types of concrete and reinforced concrete: ordinary concrete, plain or reinforced, without or with prestressing, fibre concrete, (ultra) high performance concrete, lightweight concrete, etc. Advanced material models taking into account fibre concrete properties such as shape of tensile softening branch, high toughness and ductility are described in the paper. Since the variability of the fibre concrete material properties is rather high, the probabilistic analysis seems to be the most appropriate format for structural design and evaluation of structural performance, reliability and safety. The presented combination of the nonlinear analysis with advanced probabilistic methods allows evaluation of structural safety characterized by failure probability or by reliability index respectively. Authors offer a methodology and computer tools for realistic safety assessment of concrete structures; the utilized approach is based on randomization of the nonlinear finite element analysis of the structural model. Uncertainty of the material properties or their randomness obtained from material tests are accounted in the random distribution. Furthermore, degradation of the reinforced concrete materials such as carbonation of concrete, corrosion of reinforcement, etc. can be accounted in order to analyze life-cycle structural performance and to enable prediction of the structural reliability and safety in time development. The results can serve as a rational basis for design of fibre concrete engineering structures based on advanced nonlinear computer analysis. The presented methodology is illustrated on results from two probabilistic studies with different types of concrete structures related to practical applications and made from various materials (with the parameters obtained from real material tests).

[Ideas and methods on efficient screening of traditional medicines for anti-osteoporosis activity based on M-Act/Tox integrated evaluation using zebrafish].

PubMed

Wang, Mo; Ling, Jie; Chen, Ying; Song, Jie; Sun, E; Shi, Zi-Qi; Feng, Liang; Jia, Xiao-Bin; Wei, Ying-Jie

2017-11-01

The increasingly apparent liver injury problems of bone strengthening Chinese medicines have brought challenges for clinical application, and it is necessary to consider both effectiveness and safety in screening anti-osteoporosis Chinese medicines. Metabolic transformation is closely related to drug efficacy and toxicity, so it is significant to comprehensively consider metabolism-action/toxicity(M-Act/Tox) for screening anti-osteoporosis Chinese medicines. The current evaluation models and the number of compounds(including metabolites) severely restrict efficient screening in vivo. By referring to previous relevant research and domestic and abroad literature, zebrafish M-Act/Tox integrative method was put forward for efficiently screening anti-osteoporosis herb medicines, which has organically integrated zebrafish metabolism model, osteoporosis model and toxicity evaluation method. This method can break through the bottleneck and blind spots that trace compositions can't achieve efficient and integrated in vivo evaluation, and realize both efficient and comprehensive screening on anti-osteoporosis traditional medicines based on in vivo process taking both safety and effectiveness into account, which is significant to accelerate discovery of effective and safe innovative traditional Chinese medicines for osteoporosis. Copyright© by the Chinese Pharmaceutical Association.

Water safety in the bush: strategies for addressing training needs in remote areas.

PubMed

Beattie, N; Shaw, P; Larson, A

2008-01-01

This article describes a unique, remote, water safety-training program delivered to 11 remote Australian communities during 2006-2007. The program, known as 'Water Safety in the Bush', was developed by Combined Universities Centre for Rural Health in Geraldton Western Australia in consultation with the Commonwealth Government Department of Health and Ageing, and the Royal Life Saving Society of Australia. Drowning and near drowning are major causes of childhood death and injury in rural and remote Australia, making improved water safety awareness and skills a public health priority. Water Safety in the Bush employed a flexible, community development model to meet the special requirements of remote and isolated communities. The model had three elements: coordination by a local organisation; a water safety instruction program based on a Royal Life Saving Society of Australia curriculum adapted to meet local priorities; and strategies for sustainability. In the delivery of the program a total of 873 children and 219 adults received swimming and water safety instruction; 47 adults and older children received first-aid training; and 38 community members became AUSTAWIM (the Australian Council for the Teaching of Swimming and Water Safety) accredited instructors. Project evaluation showed parents and community organisations were very satisfied with the program which met a real need. Parents and instructors gave evidence of children's increased skills in water safety, swimming ability, life-saving and water confidence. Training programs with greater contact hours showed greater skill gains. Sustainability strategies included accreditation of local AUSTSWIM instructors, the erection of water safety signs, sourcing of continuing funding, and the introduction of water safety theory into the school curriculum. Flexibility was the major success factor. Within the parameters of minimum guidelines, communities were encouraged to choose the timing, venue and delivery mode of the training to ensure the program was best suited to the local community. Community ownership was achieved by requiring that local organisations design and implement the projects. Designing programs that addressed local constraints ensured high participation rates. A number of challenges were also identified. Not all community organisations had the capacity to take on the coordinating role, and struggled to effectively deliver a sustainable program. Other models may be needed for these communities. Accessing appropriately qualified water safety instructors in local areas also proved difficult at several of the sites. Further, designing standardised outcome evaluation strategies that could be implemented across all participating sites was problematic. Remote and isolated communities have a pressing need to gain the knowledge and skills necessary for water safety and survival. Standard training programs, which in the case of swimming and water safety instruction are generally run in two-week blocks, are often not feasible. Models for delivering training, which give resources and power to local organisations to find innovative ways to meet their priorities, build capacity and ensure high participation rates.

Evaluation of the impacts of cooperative adaptive cruise control on reducing rear-end collision risks on freeways.

PubMed

Li, Ye; Wang, Hao; Wang, Wei; Xing, Lu; Liu, Shanwen; Wei, Xueyan

2017-01-01

Although plenty of studies have been conducted recently about the impacts of cooperative adaptive cruise control (CACC) system on traffic efficiency, there are few researches analyzing the safety effects of this advanced driving-assistant system. Thus, the primary objective of this study is to evaluate the impacts of the CACC system on reducing rear-end collision risks on freeways. The CACC model is firstly developed, which is based on the Intelligent Driver Model (IDM). Then, two surrogated safety measures, derived from the time-to-collision (TTC), denoting time exposed time-to-collision (TET) and time integrated time-to-collision (TIT), are introduced for quantifying the collision risks. And the safety effects are analyzed both theoretically and experimentally, by the linear stability analysis and simulations. The theoretical and simulation results conformably indicate that the CACC system brings dramatic benefits for reducing rear-end collision risks (TET and TIT are reduced more than 90%, respectively), when the desired time headway and time delay are set properly. The sensitivity analysis indicates there are few differences among different values of the threshold of TTC and the length of a CACC platoon. The results also show that the safety improvements weaken with the decrease of the penetration rates of CACC on the market and the increase of time delay between platoons. We also evaluate the traffic efficiency of the CACC system with different desired time headway. Copyright © 2016 Elsevier Ltd. All rights reserved.

77 FR 21595 - Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-10

... must be one which, if proven, would entitle the requestor/petitioner to relief. A requestor/ petitioner..., and fire modeling calculations, have been performed to demonstrate that the performance-based... may include engineering evaluations, probabilistic safety assessments, and fire modeling calculations...

29 CFR 1960.80 - Secretary's evaluations of agency occupational safety and health programs.

Code of Federal Regulations, 2013 CFR

2013-07-01

... EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs § 1960.80 Secretary's evaluations of agency occupational safety and health... evaluating an agency's occupational safety and health program. To accomplish this, the Secretary shall...

29 CFR 1960.80 - Secretary's evaluations of agency occupational safety and health programs.

Code of Federal Regulations, 2011 CFR

2011-07-01

... EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs § 1960.80 Secretary's evaluations of agency occupational safety and health... evaluating an agency's occupational safety and health program. To accomplish this, the Secretary shall...

29 CFR 1960.80 - Secretary's evaluations of agency occupational safety and health programs.

Code of Federal Regulations, 2012 CFR

2012-07-01

... EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs § 1960.80 Secretary's evaluations of agency occupational safety and health... evaluating an agency's occupational safety and health program. To accomplish this, the Secretary shall...

29 CFR 1960.80 - Secretary's evaluations of agency occupational safety and health programs.

Code of Federal Regulations, 2014 CFR

2014-07-01

... EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs § 1960.80 Secretary's evaluations of agency occupational safety and health... evaluating an agency's occupational safety and health program. To accomplish this, the Secretary shall...

29 CFR 1960.80 - Secretary's evaluations of agency occupational safety and health programs.

Code of Federal Regulations, 2010 CFR

2010-07-01

... EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs § 1960.80 Secretary's evaluations of agency occupational safety and health... evaluating an agency's occupational safety and health program. To accomplish this, the Secretary shall...

NASA Aviation Safety Reporting System (ASRS)

NASA Technical Reports Server (NTRS)

Connell, Linda

2011-01-01

The NASA Aviation Safety Reporting System (ASRS) collects, analyzes, and distributes de-identified safety information provided through confidentially submitted reports from frontline aviation personnel. Since its inception in 1976, the ASRS has collected over 900,000 reports and has never breached the identity of the people sharing their information about events or safety issues. From this volume of data, the ASRS has released over 5,500 aviation safety alerts concerning potential hazards and safety concerns. The ASRS processes these reports, evaluates the information, and provides de-identified report information through the online ASRS Database at http://asrs.arc.nasa.gov. The NASA ASRS is also a founding member of the International Confidential Aviation Safety Systems (ICASS) group which is a collection of other national aviation reporting systems throughout the world. The ASRS model has also been replicated for application to improving safety in railroad, medical, fire fighting, and other domains. This presentation \\vill discuss confidential, voluntary, and non-punitive reporting systems and their advantages in providing information for safety improvements.

NASA Aviation Safety Reporting System (ASRS)

NASA Technical Reports Server (NTRS)

Connell, Linda J.

2017-01-01

The NASA Aviation Safety Reporting System (ASRS) collects, analyzes, and distributes de-identified safety information provided through confidentially submitted reports from frontline aviation personnel. Since its inception in 1976, the ASRS has collected over 1.4 million reports and has never breached the identity of the people sharing their information about events or safety issues. From this volume of data, the ASRS has released over 6,000 aviation safety alerts concerning potential hazards and safety concerns. The ASRS processes these reports, evaluates the information, and provides selected de-identified report information through the online ASRS Database at http:asrs.arc.nasa.gov. The NASA ASRS is also a founding member of the International Confidential Aviation Safety Systems (ICASS) group which is a collection of other national aviation reporting systems throughout the world. The ASRS model has also been replicated for application to improving safety in railroad, medical, fire fighting, and other domains. This presentation will discuss confidential, voluntary, and non-punitive reporting systems and their advantages in providing information for safety improvements.

[HERA-QUEST: HTA evaluation of generic pharmaceutical products to improve quality, economic efficiency, patient safety and transparency in drug product changes in hospitals].

PubMed

Gyalrong-Steur, Miriam; Kellermann, Anita; Bernard, Rudolf; Berndt, Georg; Bindemann, Meike; Nusser-Rothermundt, Elfriede; Amann, Steffen; Brakebusch, Myga; Brüggmann, Jörg; Tydecks, Eva; Müller, Markus; Dörje, Frank; Kochs, Eberhard; Riedel, Rainer

2017-04-01

In view of the rising cost pressure and an increasing number of drug shortages, switches between generic drug preparations have become a daily routine in hospitals. To ensure consistently high treatment quality and best possible patient safety, the equivalence of the new and the previous drug preparation must be ensured before any change in the purchase of pharmaceutical products takes place. So far, no easily usable, transparent and standardized instrument for this kind of comparison between generic drug products has been available. A group of pharmaceutical experts has developed the drug HTA (health technology assessment) model "HERA" (HTA Evaluation of geneRic phArmaceutical products) through a multi-step process. The instrument is designed to perform both a qualitative and economic comparison of equivalent drug preparations ("aut idem" substitution) before switching products. The economic evaluation does not only consider unit prices and consumption quantity, but also the processing costs associated with a product change process. The qualitative comparison is based on the evaluation of 34 quality criteria belonging to six evaluation fields (e.g., approval status, practical handling, packaging design). The objective evaluation of the quality criteria is complemented by an assessment of special features of the individual hospital for complex drug switches, including the feedback of the physicians utilizing the drug preparation. Thus potentially problematic switches of pharmaceutical products can be avoided at the best possible rate, contributing to the improvement of patient safety. The novel drug HTA model HERA is a tool used in clinical practice that can add to an increase in quality, therapeutic safety and transparency of drug use while simultaneously contributing to the economic optimization of drug procurement in hospitals. Combining these two is essential for hospitals facing the tension between rising cost pressure and at the same time increasing demands on quality and transparency, triggered by, amongst others, current legislation (Hospital Structures Act, anti-corruption legislation). Copyright © 2017. Published by Elsevier GmbH.

Accounting for heterogeneity among treatment sites and time trends in developing crash modification functions.

PubMed

Sacchi, Emanuele; Sayed, Tarek

2014-11-01

Collision modification factors (CMFs) are commonly used to quantify the impact of safety countermeasures. The CMFs obtained from observational before-after (BA) studies are usually estimated by averaging the safety impact (i.e., index of effectiveness) for a group of treatment sites. The heterogeneity among the treatment locations, in terms of their characteristics, and the effect of this heterogeneity on safety treatment effectiveness are usually ignored. This is in contrast to treatment evaluations in other fields like medical statistics where variations in the magnitude (or in the direction) of response to the same treatment given to different patients are considered. This paper introduces an approach for estimating a CMFunction from BA safety studies that account for variable treatment location characteristics (heterogeneity). The treatment sites heterogeneity was incorporated into the CMFunction using fixed-effects and random-effects regression models. In addition to heterogeneity, the paper also advocates the use of CMFunctions with a time variable to acknowledge that the safety treatment (intervention) effects do not occur instantaneously but are spread over future time. This is achieved using non-linear intervention (Koyck) models, developed within a hierarchical full Bayes (FB) context. To demonstrate the approach, a case study is presented to evaluate the safety effectiveness of the "Signal Head Upgrade Program" recently implemented in the city of Surrey (British Columbia, Canada), where signal visibility was improved at several urban signalized intersections. The results demonstrated the importance of considering treatment sites heterogeneity and time trends when developing CMFunctions. Copyright © 2014 Elsevier Ltd. All rights reserved.

Generic Sensor Failure Modeling for Cooperative Systems.

PubMed

Jäger, Georg; Zug, Sebastian; Casimiro, António

2018-03-20

The advent of cooperative systems entails a dynamic composition of their components. As this contrasts current, statically composed systems, new approaches for maintaining their safety are required. In that endeavor, we propose an integration step that evaluates the failure model of shared information in relation to an application's fault tolerance and thereby promises maintainability of such system's safety. However, it also poses new requirements on failure models, which are not fulfilled by state-of-the-art approaches. Consequently, this work presents a mathematically defined generic failure model as well as a processing chain for automatically extracting such failure models from empirical data. By examining data of an Sharp GP2D12 distance sensor, we show that the generic failure model not only fulfills the predefined requirements, but also models failure characteristics appropriately when compared to traditional techniques.

Generic Sensor Failure Modeling for Cooperative Systems

PubMed Central

Jäger, Georg; Zug, Sebastian

2018-01-01

The advent of cooperative systems entails a dynamic composition of their components. As this contrasts current, statically composed systems, new approaches for maintaining their safety are required. In that endeavor, we propose an integration step that evaluates the failure model of shared information in relation to an application’s fault tolerance and thereby promises maintainability of such system’s safety. However, it also poses new requirements on failure models, which are not fulfilled by state-of-the-art approaches. Consequently, this work presents a mathematically defined generic failure model as well as a processing chain for automatically extracting such failure models from empirical data. By examining data of an Sharp GP2D12 distance sensor, we show that the generic failure model not only fulfills the predefined requirements, but also models failure characteristics appropriately when compared to traditional techniques. PMID:29558435

Systematic drug safety evaluation based on public genomic expression (Connectivity Map) data: Myocardial and infectious adverse reactions as application cases

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wang, Kejian, E-mail: kejian.wang.bio@gmail.com; Weng, Zuquan; Sun, Liya

Adverse drug reaction (ADR) is of great importance to both regulatory agencies and the pharmaceutical industry. Various techniques, such as quantitative structure–activity relationship (QSAR) and animal toxicology, are widely used to identify potential risks during the preclinical stage of drug development. Despite these efforts, drugs with safety liabilities can still pass through safety checkpoints and enter the market. This situation raises the concern that conventional chemical structure analysis and phenotypic screening are not sufficient to avoid all clinical adverse events. Genomic expression data following in vitro drug treatments characterize drug actions and thus have become widely used in drug repositioning. Inmore » the present study, we explored prediction of ADRs based on the drug-induced gene-expression profiles from cultured human cells in the Connectivity Map (CMap) database. The results showed that drugs inducing comparable ADRs generally lead to similar CMap expression profiles. Based on such ADR-gene expression association, we established prediction models for various ADRs, including severe myocardial and infectious events. Drugs with FDA boxed warnings of safety liability were effectively identified. We therefore suggest that drug-induced gene expression change, in combination with effective computational methods, may provide a new dimension of information to facilitate systematic drug safety evaluation. - Highlights: • Drugs causing common toxicity lead to similar in vitro gene expression changes. • We built a model to predict drug toxicity with drug-specific expression profiles. • Drugs with FDA black box warnings were effectively identified by our model. • In vitro assay can detect severe toxicity in the early stage of drug development.« less

A full Bayes before-after study accounting for temporal and spatial effects: Evaluating the safety impact of new signal installations.

PubMed

Sacchi, Emanuele; Sayed, Tarek; El-Basyouny, Karim

2016-09-01

Recently, important advances in road safety statistics have been brought about by methods able to address issues other than the choice of the best error structure for modeling crash data. In particular, accounting for spatial and temporal interdependence, i.e., the notion that the collision occurrence of a site or unit times depend on those of others, has become an important issue that needs further research. Overall, autoregressive models can be used for this purpose as they can specify that the output variable depends on its own previous values and on a stochastic term. Spatial effects have been investigated and applied mostly in the context of developing safety performance functions (SPFs) to relate crash occurrence to highway characteristics. Hence, there is a need for studies that attempt to estimate the effectiveness of safety countermeasures by including the spatial interdependence of road sites within the context of an observational before-after (BA) study. Moreover, the combination of temporal dynamics and spatial effects on crash frequency has not been explored in depth for SPF development. Therefore, the main goal of this research was to carry out a BA study accounting for spatial effects and temporal dynamics in evaluating the effectiveness of a road safety treatment. The countermeasure analyzed was the installation of traffic signals at unsignalized urban/suburban intersections in British Columbia (Canada). The full Bayes approach was selected as the statistical framework to develop the models. The results demonstrated that zone variation was a major component of total crash variability and that spatial effects were alleviated by clustering intersections together. Finally, the methodology used also allowed estimation of the treatment's effectiveness in the form of crash modification factors and functions with time trends. Copyright © 2016 Elsevier Ltd. All rights reserved.

Evaluation of the efficacy of simulation games in traffic safety education of kindergarten children.

PubMed Central

Renaud, L; Suissa, S

1989-01-01

Using a simulation game designed to teach children to obey certain traffic safety rules, an experimental study was conducted with 136 five-year-old children in four Quebec schools. Within each classroom, subjects were randomly divided into four groups: three intervention groups and one control group. Each of the experimental groups was subjected to a different intervention with outcome measured using three instruments related to attitudes, behavior, and transfer of learning of pedestrian traffic safety. Results suggest that simulation games including role-playing/group dynamics and modeling/training can change attitudes and modify behavior in the area of pedestrian traffic safety in children of this age. PMID:2916716

Evaluation of the efficacy of simulation games in traffic safety education of kindergarten children.

PubMed

Renaud, L; Suissa, S

1989-03-01

Using a simulation game designed to teach children to obey certain traffic safety rules, an experimental study was conducted with 136 five-year-old children in four Quebec schools. Within each classroom, subjects were randomly divided into four groups: three intervention groups and one control group. Each of the experimental groups was subjected to a different intervention with outcome measured using three instruments related to attitudes, behavior, and transfer of learning of pedestrian traffic safety. Results suggest that simulation games including role-playing/group dynamics and modeling/training can change attitudes and modify behavior in the area of pedestrian traffic safety in children of this age.

Estimation of the upper bound of predictive performance for alternative models that use in vivo reference data (OpenTox USA 2017)

EPA Science Inventory

The number of chemicals with limited toxicological information for chemical safety decision-making has accelerated alternative model development, which often are evaluated via referencing animal toxicology studies. In vivo studies are generally considered the standard for hazard ...

MaSTiS, microorganism and solute transport in streams, model documentation and user manual

USDA-ARS?s Scientific Manuscript database

In-stream fate and transport of solutes and microorganisms need to be understood to evaluate suitability of waters for agricultural, recreational, and household uses and eventually minimize surface water contamination. Concerns over safety of this water resulted in development of predictive models f...

Evaluation of Patient Safety Indicators in Semnan City Hospitals by Using the Patient Safety Friendly Hospital Initiative (PSFHI).

PubMed

Babamohamadi, Hassan; Nemati, Roghayeh Khabiri; Nobahar, Monir; Keighobady, Seifullah; Ghazavi, Soheila; Izadi-Sabet, Farideh; Najafpour, Zhila

2016-08-01

Nowadays, patient safety issue is among one of the main concerns of the hospital policy worldwide. This study aimed to evaluate the patient safety status in hospitals affiliated to Semnan city, using the WHO model for Patient Safety Friendly Hospital Initiatives (PSFHI) in summer 2014. That was a cross sectional descriptive study that addressed patient safety , which explained the current status of safety in the Semnan hospitals using by instrument of Patient safety friendly initiative standards (PSFHI). Data was collected from 5 hospitals in Semnan city during four weeks in May 2014. The finding of 5 areas examined showed that some components in critical standards had disadvantages. Critical standards of hospitals including areas of leadership and administration, patient and public involvement and safe evidence-based clinical practice, safe environment with and lifetime education in a safe and secure environment were analyzed. The domain of patient and public involvement obtained the lowest mean score and the domain of safe environment obtained the highest mean score in the surveyed hospitals. All the surveyed hospitals had a poor condition regarding standards based on patient safety. Further, the identified weak points are almost the same in the hospitals. Therefore, In order to achieve a good level of all aspects of the protocol, the goals should be considered in the level of strategic planning at hospitals. An effective execution of patient safety creatively may depend on the legal infrastructure and enforcement of standards by hospital management, organizational liability to expectation of patients, safety culture in hospitals.

Novel strategies in immunotherapy for allergic diseases.

PubMed

Rajakulendran, Mohana; Tham, Elizabeth Huiwen; Soh, Jian Yi; Van Bever, H P

2018-04-01

Conventional immunotherapy (IT) for optimal control of respiratory and food allergies has been fraught with concerns of efficacy, safety, and tolerability. The development of adjuvants to conventional IT has potentially increased the effectiveness and safety of allergen IT, which may translate into improved clinical outcomes and sustained unresponsiveness even after cessation of therapy. Novel strategies incorporating the successful use of adjuvants such as allergoids, immunostimulatory DNA sequences, monoclonal antibodies, carriers, recombinant proteins, and probiotics have now been described in clinical and murine studies. Future approaches may include fungal compounds, parasitic molecules, vitamin D, and traditional Chinese herbs. More robust comparative clinical trials are needed to evaluate the safety, clinical efficacy, and cost effectiveness of various adjuvants in order to determine ideal candidates in disease-specific and allergen-specific models. Other suggested approaches to further optimize outcomes of IT include early introduction of IT during an optimal window period. Alternative routes of administration of IT to optimize delivery and yet minimize potential side effects require further evaluation for safety and efficacy before they can be recommended.

SRTC criticality safety technical review: Nuclear Criticality Safety Evaluation 93-04 enriched uranium receipt

DOE Office of Scientific and Technical Information (OSTI.GOV)

Rathbun, R.

Review of NMP-NCS-930087, {open_quotes}Nuclear Criticality Safety Evaluation 93-04 Enriched Uranium Receipt (U), July 30, 1993, {close_quotes} was requested of SRTC (Savannah River Technology Center) Applied Physics Group. The NCSE is a criticality assessment to determine the mass limit for Engineered Low Level Trench (ELLT) waste uranium burial. The intent is to bury uranium in pits that would be separated by a specified amount of undisturbed soil. The scope of the technical review, documented in this report, consisted of (1) an independent check of the methods and models employed, (2) independent HRXN/KENO-V.a calculations of alternate configurations, (3) application of ANSI/ANS 8.1,more » and (4) verification of WSRC Nuclear Criticality Safety Manual procedures. The NCSE under review concludes that a 500 gram limit per burial position is acceptable to ensure the burial site remains in a critically safe configuration for all normal and single credible abnormal conditions. This reviewer agrees with that conclusion.« less

Monopolar radiofrequency treatment of the eyelids: a safety evaluation.

PubMed

Biesman, Brian S; Pope, Karl

2007-07-01

Monopolar radiofrequency (RF) energy has been used to successfully accomplish noninvasive skin tightening of the face, abdomen, and extremities. Owing to concerns about injury to the eye itself, monopolar RF treatment of the eyelids has not been feasible. The objective was to evaluate the safety of a novel 0.25-cm(2)"shallow" treatment tip for noninvasive tightening of eyelid skin. This was a tripartite study that began with an animal model to evaluate soft tissue effects and temperature change at the ocular surface. Findings were then extrapolated to ex vivo evaluation of human eyelids and ultimately to an in vivo human eyelid safety study. The animal studies demonstrated that the 0.25-cm(2) treatment tip could be used safely on eyelids in conjunction with appropriate ocular protection. The ex vivo human eyelid studies confirmed that, at typical treatment settings, the shallow treatment tip did not produce frank eyelid injury. The in vivo human studies confirmed that, at the tested settings, the novel treatment tip did not injure the eyelids or eyes. If used properly, the 0.25-cm(2) treatment tip can be safely used on human eyelids.

[Preclinical evaluation of the safety of biotechnology products: specific aspects].

PubMed

Descotes, Jacques; Ravel, Guillaume; Vial, Thierry

2003-01-01

Biotechnology-derived products represent a class of increasingly numerous drugs. One of their major characteristics is extreme diversity, which requires specific approaches for the preclinical evaluation of their safety. The selection of relevant animal species is not easy, as most of these products are human-specific. Thus, only one species will often be used, i.e. primates. As most of these products are large molecules, they can be directly immunogenic. When they are human-specific, no animal model is available to predict the risk. Many biotechnology-derived products have an expected influence on the immune system. This must be taken into account in the preclinical strategy of immunotoxicity evaluation that is now required for every new drug. As conventional toxicity testing is generally limited, safety pharmacology studies should include more than the core battery of assays required by current guidelines in order to complement missing data as much as possible. Because of these particularities, a comprehensive investigation of metabolism and pharmacokinetics is not usually needed. Some products can cross-react with cellular components not intended as therapeutic targets. It is, therefore, essential to rule out the risk of possible cross-reactions that can result in adverse effects. Finally, viral safety is a crucial component of the preclinical safety evaluation of these products. Overall, biotechnology-derived products raise specific issues because of their innovative and original characteristics, and it is difficult to address all these issues if not by using a case-by-case approach.

Development and evaluation of a finite element model of the THOR for occupant protection of spaceflight crewmembers.

PubMed

Putnam, Jacob B; Somers, Jeffrey T; Wells, Jessica A; Perry, Chris E; Untaroiu, Costin D

2015-09-01

New vehicles are currently being developed to transport humans to space. During the landing phases, crewmembers may be exposed to spinal and frontal loading. To reduce the risk of injuries during these common impact scenarios, the National Aeronautics and Space Administration (NASA) is developing new safety standards for spaceflight. The Test Device for Human Occupant Restraint (THOR) advanced multi-directional anthropomorphic test device (ATD), with the National Highway Traffic Safety Administration modification kit, has been chosen to evaluate occupant spacecraft safety because of its improved biofidelity. NASA tested the THOR ATD at Wright-Patterson Air Force Base (WPAFB) in various impact configurations, including frontal and spinal loading. A computational finite element model (FEM) of the THOR to match these latest modifications was developed in LS-DYNA software. The main goal of this study was to calibrate and validate the THOR FEM for use in future spacecraft safety studies. An optimization-based method was developed to calibrate the material models of the lumbar joints and pelvic flesh. Compression test data were used to calibrate the quasi-static material properties of the pelvic flesh, while whole body THOR ATD kinematic and kinetic responses under spinal and frontal loading conditions were used for dynamic calibration. The performance of the calibrated THOR FEM was evaluated by simulating separate THOR ATD tests with different crash pulses along both spinal and frontal directions. The model response was compared with test data by calculating its correlation score using the CORrelation and Analysis rating system. The biofidelity of the THOR FEM was then evaluated against tests recorded on human volunteers under 3 different frontal and spinal impact pulses. The calibrated THOR FEM responded with high similarity to the THOR ATD in all validation tests. The THOR FEM showed good biofidelity relative to human-volunteer data under spinal loading, but limited biofidelity under frontal loading. This may suggest a need for further improvements in both the THOR ATD and FEM. Overall, results presented in this study provide confidence in the THOR FEM for use in predicting THOR ATD responses for conditions, such as those observed in spacecraft landing, and for use in evaluating THOR ATD biofidelity. Copyright © 2015 Elsevier Ltd. All rights reserved.

Use of the FDA nozzle model to illustrate validation techniques in computational fluid dynamics (CFD) simulations

PubMed Central

Hariharan, Prasanna; D’Souza, Gavin A.; Horner, Marc; Morrison, Tina M.; Malinauskas, Richard A.; Myers, Matthew R.

2017-01-01

A “credible” computational fluid dynamics (CFD) model has the potential to provide a meaningful evaluation of safety in medical devices. One major challenge in establishing “model credibility” is to determine the required degree of similarity between the model and experimental results for the model to be considered sufficiently validated. This study proposes a “threshold-based” validation approach that provides a well-defined acceptance criteria, which is a function of how close the simulation and experimental results are to the safety threshold, for establishing the model validity. The validation criteria developed following the threshold approach is not only a function of Comparison Error, E (which is the difference between experiments and simulations) but also takes in to account the risk to patient safety because of E. The method is applicable for scenarios in which a safety threshold can be clearly defined (e.g., the viscous shear-stress threshold for hemolysis in blood contacting devices). The applicability of the new validation approach was tested on the FDA nozzle geometry. The context of use (COU) was to evaluate if the instantaneous viscous shear stress in the nozzle geometry at Reynolds numbers (Re) of 3500 and 6500 was below the commonly accepted threshold for hemolysis. The CFD results (“S”) of velocity and viscous shear stress were compared with inter-laboratory experimental measurements (“D”). The uncertainties in the CFD and experimental results due to input parameter uncertainties were quantified following the ASME V&V 20 standard. The CFD models for both Re = 3500 and 6500 could not be sufficiently validated by performing a direct comparison between CFD and experimental results using the Student’s t-test. However, following the threshold-based approach, a Student’s t-test comparing |S-D| and |Threshold-S| showed that relative to the threshold, the CFD and experimental datasets for Re = 3500 were statistically similar and the model could be considered sufficiently validated for the COU. However, for Re = 6500, at certain locations where the shear stress is close the hemolysis threshold, the CFD model could not be considered sufficiently validated for the COU. Our analysis showed that the model could be sufficiently validated either by reducing the uncertainties in experiments, simulations, and the threshold or by increasing the sample size for the experiments and simulations. The threshold approach can be applied to all types of computational models and provides an objective way of determining model credibility and for evaluating medical devices. PMID:28594889

Use of the FDA nozzle model to illustrate validation techniques in computational fluid dynamics (CFD) simulations.

PubMed

Hariharan, Prasanna; D'Souza, Gavin A; Horner, Marc; Morrison, Tina M; Malinauskas, Richard A; Myers, Matthew R

2017-01-01

A "credible" computational fluid dynamics (CFD) model has the potential to provide a meaningful evaluation of safety in medical devices. One major challenge in establishing "model credibility" is to determine the required degree of similarity between the model and experimental results for the model to be considered sufficiently validated. This study proposes a "threshold-based" validation approach that provides a well-defined acceptance criteria, which is a function of how close the simulation and experimental results are to the safety threshold, for establishing the model validity. The validation criteria developed following the threshold approach is not only a function of Comparison Error, E (which is the difference between experiments and simulations) but also takes in to account the risk to patient safety because of E. The method is applicable for scenarios in which a safety threshold can be clearly defined (e.g., the viscous shear-stress threshold for hemolysis in blood contacting devices). The applicability of the new validation approach was tested on the FDA nozzle geometry. The context of use (COU) was to evaluate if the instantaneous viscous shear stress in the nozzle geometry at Reynolds numbers (Re) of 3500 and 6500 was below the commonly accepted threshold for hemolysis. The CFD results ("S") of velocity and viscous shear stress were compared with inter-laboratory experimental measurements ("D"). The uncertainties in the CFD and experimental results due to input parameter uncertainties were quantified following the ASME V&V 20 standard. The CFD models for both Re = 3500 and 6500 could not be sufficiently validated by performing a direct comparison between CFD and experimental results using the Student's t-test. However, following the threshold-based approach, a Student's t-test comparing |S-D| and |Threshold-S| showed that relative to the threshold, the CFD and experimental datasets for Re = 3500 were statistically similar and the model could be considered sufficiently validated for the COU. However, for Re = 6500, at certain locations where the shear stress is close the hemolysis threshold, the CFD model could not be considered sufficiently validated for the COU. Our analysis showed that the model could be sufficiently validated either by reducing the uncertainties in experiments, simulations, and the threshold or by increasing the sample size for the experiments and simulations. The threshold approach can be applied to all types of computational models and provides an objective way of determining model credibility and for evaluating medical devices.

The Evaluation Of Therapeutic Efficacy and Safety Profile of Simvastatin Prodrug Micelles in a Closed Fracture Mouse Model

PubMed Central

Zhang, Yijia; Jia, Zhenshan; Yuan, Hongjiang; Dusad, Anand; Ren, Ke; Wei, Xin; Fehringer, Edward V.; Purdue, P. Edward; Daluiski, Aaron; Goldring, Steven R.; Wang, Dong

2016-01-01

Purpose To evaluate the therapeutic efficiency of a micellar prodrug formulation of simvastatin (SIM/SIM-mPEG) and explore its safety in a closed femoral fracture mouse model. Methods The amphiphilic macromolecular prodrug of simvastatin (SIM-mPEG) was synthesized and formulated together with free simvastatin into micelles. It was also labeled with a near infrared dye for in vivo imaging purpose. A closed femoral fracture mouse model was established using a three-point bending device. The mice with established closed femoral fracture were treated with SIM/SIM-mPEG micelle, using free simvastatin and saline as controls. The therapeutic efficacy of the micelles was evaluated using a high-resolution micro-CT. Serum biochemistry and histology analyses were performed to explore the potential toxicity of the micelle formulation. Results Near Infrared Fluorescence (NIRF) imaging confirmed the passive targeting of SIM/SIM-mPEG micelles to the bone lesion of the mice with closed femoral fracture. The micelle was found to promote fracture healing with an excellent safety profile. In addition, the accelerated healing of the femoral fracture also helped to prevent disuse-associated same-side tibia bone loss accompanying the femur fracture. Conclusion SIM/SIM-mPEG micelle was found to be an effective and safe treatment for closed femoral fracture repair in mice. The evidence obtained in this study suggests that it may have the potential to be translated into a novel therapy for clinical management of skeletal fractures and non-union. PMID:27164897

Evaluating the effectiveness of active vehicle safety systems.

PubMed

Jeong, Eunbi; Oh, Cheol

2017-03-01

Advanced vehicle safety systems have been widely introduced in transportation systems and are expected to enhance traffic safety. However, these technologies mainly focus on assisting individual vehicles that are equipped with them, and less effort has been made to identify the effect of vehicular technologies on the traffic stream. This study proposed a methodology to assess the effectiveness of active vehicle safety systems (AVSSs), which represent a promising technology to prevent traffic crashes and mitigate injury severity. The proposed AVSS consists of longitudinal and lateral vehicle control systems, which corresponds to the Level 2 vehicle automation presented by the National Highway Safety Administration (NHTSA). The effectiveness evaluation for the proposed technology was conducted in terms of crash potential reduction and congestion mitigation. A microscopic traffic simulator, VISSIM, was used to simulate freeway traffic stream and collect vehicle-maneuvering data. In addition, an external application program interface, VISSIM's COM-interface, was used to implement the AVSS. A surrogate safety assessment model (SSAM) was used to derive indirect safety measures to evaluate the effectiveness of the AVSS. A 16.7-km freeway stretch between the Nakdong and Seonsan interchanges on Korean freeway 45 was selected for the simulation experiments to evaluate the effectiveness of AVSS. A total of five simulation runs for each evaluation scenario were conducted. For the non-incident conditions, the rear-end and lane-change conflicts were reduced by 78.8% and 17.3%, respectively, under the level of service (LOS) D traffic conditions. In addition, the average delay was reduced by 55.5%. However, the system's effectiveness was weakened in the LOS A-C categories. Under incident traffic conditions, the number of rear-end conflicts was reduced by approximately 9.7%. Vehicle delays were reduced by approximately 43.9% with 100% of market penetration rate (MPR). These results imply that from the perspective of traffic operations and control to address the safety and congestion issues of a traffic stream, smarter management strategies that consider both traffic conditions and MPR are required to fully exploit the effectiveness of the AVSS in the field. Copyright © 2017 Elsevier Ltd. All rights reserved.

Quality management, a directive approach to patient safety.

PubMed

Ayuso-Murillo, Diego; de Andrés-Gimeno, Begoña; Noriega-Matanza, Concha; López-Suárez, Rafael Jesús; Herrera-Peco, Ivan

Nowadays the implementation of effective quality management systems and external evaluation in healthcare is a necessity to ensure not only transparency in activities related to health but also access to health and patient safety. The key to correctly implementing a quality management system is support from the managers of health facilities, since it is managers who design and communicate to health professionals the strategies of action involved in quality management systems. This article focuses on nursing managers' approach to quality management through the implementation of cycles of continuous improvement, participation of improvement groups, monitoring systems and external evaluation quality models (EFQM, ISO). The implementation of a quality management system will enable preventable adverse effects to be minimized or eliminated, and promote patient safety and safe practice by health professionals. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

Criticality Safety Evaluation Report CSER-96-019 for Spent Nuclear Fuel (SNF) Processing and Storage Facilities Multi Canister Overpack (MCO)

DOE Office of Scientific and Technical Information (OSTI.GOV)

KESSLER, S.F.

This criticality evaluation is for Spent N Reactor fuel unloaded from the existing canisters in both KE and KW Basins, and loaded into multiple canister overpack (MCO) containers with specially built baskets containing a maximum of either 54 Mark IV or 48 Mark IA fuel assemblies. The criticality evaluations include loading baskets into the cask-MCO, operation at the Cold Vacuum Drying Facility,a nd storage in the Canister Storage Building. Many conservatisms have been built into this analysis, the primary one being the selection of the K{sub eff} = 0.95 criticality safety limit. This revision incorporates the analyses for the sampling/weldmore » station in the Canister Storage Building and additional analysis of the MCO during the draining at CVDF. Additional discussion of the scrap basket model was added to show why the addition of copper divider plates was not included in the models.« less

Evaluating the safety impact of adaptive cruise control in traffic oscillations on freeways.

PubMed

Li, Ye; Li, Zhibin; Wang, Hao; Wang, Wei; Xing, Lu

2017-07-01

Adaptive cruise control (ACC) has been considered one of the critical components of automated driving. ACC adjusts vehicle speeds automatically by measuring the status of the ego-vehicle and leading vehicle. Current commercial ACCs are designed to be comfortable and convenient driving systems. Little attention is paid to the safety impacts of ACC, especially in traffic oscillations when crash risks are the highest. The primary objective of this study was to evaluate the impacts of ACC parameter settings on rear-end collisions on freeways. First, the occurrence of a rear-end collision in a stop-and-go wave was analyzed. A car-following model in an integrated ACC was developed for a simulation analysis. The time-to-collision based factors were calculated as surrogate safety measures of the collision risk. We also evaluated different market penetration rates considering that the application of ACC will be a gradual process. The results showed that the safety impacts of ACC were largely affected by the parameters. Smaller time delays and larger time gaps improved safety performance, but inappropriate parameter settings increased the collision risks and caused traffic disturbances. A higher reduction of the collision risk was achieved as the ACC vehicle penetration rate increased, especially in the initial stage with penetration rates of less than 30%. This study also showed that in the initial stage, the combination of ACC and a variable speed limit achieved better safety improvements on congested freeways than each single technique. Copyright © 2017 Elsevier Ltd. All rights reserved.

Teams communicating through STEPPS.

PubMed

Stead, Karen; Kumar, Saravana; Schultz, Timothy J; Tiver, Sue; Pirone, Christy J; Adams, Robert J; Wareham, Conrad A

2009-06-01

To evaluate the effectiveness of the implementation of a TeamSTEPPS (Team Strategies and Tools to Enhance Performance and Patient Safety) program at an Australian mental health facility. TeamSTEPPS is an evidence-based teamwork training system developed in the United States. Five health care sites in South Australia implemented TeamSTEPPS using a train-the-trainer model over an 8-month intervention period commencing January 2008 and concluding September 2008. A team of senior clinical staff was formed at each site to drive the improvement process. Independent researchers used direct observation and questionnaire surveys to evaluate the effectiveness of the implementation in three outcome areas: observed team behaviours; staff attitudes and opinions; and clinical performance and outcome. The results reported here focus on one site, an inpatient mental health facility. Team knowledge, skills and attitudes; patient safety culture; incident reporting rates; seclusion rates; observation for the frequency of use of TeamSTEPPS tools. Outcomes included restructuring of multidisciplinary meetings and the introduction of structured communication tools. The evaluation of patient safety culture and of staff knowledge, skills and attitudes (KSA) to teamwork and communication indicated a significant improvement in two dimensions of patient safety culture (frequency of event reporting, and organisational learning) and a 6.8% increase in the total KSA score. Clinical outcomes included reduced rates of seclusion. TeamSTEPPS implementation had a substantial impact on patient safety culture, teamwork and communication at an Australian mental health facility. It encouraged a culture of learning from patient safety incidents and making continuous improvements.

[Legislation and inspection for the health and safety of workers. Efficacy and limits].

PubMed

Tozzi, G A

2009-01-01

To provide information regarding Occupational Health and Safety (OHS) Inspections in Europe. The dynamics that are transforming regulatory subsystems and complementary inspection services are described. Simplification initiatives, the limits and difficulties of applying the different models of Health and Safety Management Systems are discussed. Examples are given on how to evaluate legislation and technical standards during planning and enforcement. Different approaches for studying characteristics, methodologies and efficacy in practice of OHS Inspection are provided. Targeted inspections need to respond to the needs of enterprises and workers. Impartiality must be guaranteed and workers' participation should be facilitated.

Healthy Choices for Every Body Adult Curriculum Improves Participants' Food Resource Management Skills and Food Safety Practices.

PubMed

Adedokun, Omolola A; Plonski, Paula; Jenkins-Howard, Brooke; Cotterill, Debra B; Vail, Ann

2018-06-01

To evaluate the impact of the University of Kentucky's Healthy Choices for Every Body (HCEB) adult nutrition education curriculum on participants' food resource management (FRM) skills and food safety practices. A quasi-experimental design was employed using propensity score matching to pair 8 intervention counties with 8 comparison counties. Independent-samples t tests and ANCOVA models compared gains in FRM skills and food safety practices between the intervention and comparison groups (n = 413 and 113, respectively). Propensity score matching analysis showed a statistical balance and similarities between the comparison and intervention groups. Food resource management and food safety gain scores were statistically significantly higher for the intervention group (P < .001), with large effect sizes (d = 0.9) for both variables. The group differences persisted even after controlling for race and age in the ANCOVA models. The HCEB curriculum was effective in improving the FRM skills and food safety practices of participants. Copyright © 2018 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

VIPER: Chronic Pain after Amputation: Inflammatory Mechanisms, Novel Analgesic Pathways, and Improved Patient Safety

DTIC Science & Technology

2017-10-01

Through analysis of data obtained in the Molecular Signatures of Chronic Pain Subtypes study termed Veterans Integrated Pain Evaluation Research...immune cells (macrophages) to chronic pain while also evaluating novel analgesics in relevant animal models. The current proposal also attempts to...analysis of data obtained in the Molecular Signatures of Chronic Pain Subtypes study termed Veterans Integrated Pain Evaluation Research (VIPER

Evaluation of critical nuclear power plant electrical cable response to severe thermal fire conditions

NASA Astrophysics Data System (ADS)

Taylor, Gabriel James

The failure of electrical cables exposed to severe thermal fire conditions are a safety concern for operating commercial nuclear power plants (NPPs). The Nuclear Regulatory Commission (NRC) has promoted the use of risk-informed and performance-based methods for fire protection which resulted in a need to develop realistic methods to quantify the risk of fire to NPP safety. Recent electrical cable testing has been conducted to provide empirical data on the failure modes and likelihood of fire-induced damage. This thesis evaluated numerous aspects of the data. Circuit characteristics affecting fire-induced electrical cable failure modes have been evaluated. In addition, thermal failure temperatures corresponding to cable functional failures have been evaluated to develop realistic single point thermal failure thresholds and probability distributions for specific cable insulation types. Finally, the data was used to evaluate the prediction capabilities of a one-dimension conductive heat transfer model used to predict cable failure.

A literature review of safety culture.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Cole, Kerstan Suzanne; Stevens-Adams, Susan Marie; Wenner, Caren A.

2013-03-01

Workplace safety has been historically neglected by organizations in order to enhance profitability. Over the past 30 years, safety concerns and attention to safety have increased due to a series of disastrous events occurring across many different industries (e.g., Chernobyl, Upper Big-Branch Mine, Davis-Besse etc.). Many organizations have focused on promoting a healthy safety culture as a way to understand past incidents, and to prevent future disasters. There is an extensive academic literature devoted to safety culture, and the Department of Energy has also published a significant number of documents related to safety culture. The purpose of the current endeavormore » was to conduct a review of the safety culture literature in order to understand definitions, methodologies, models, and successful interventions for improving safety culture. After reviewing the literature, we observed four emerging themes. First, it was apparent that although safety culture is a valuable construct, it has some inherent weaknesses. For example, there is no common definition of safety culture and no standard way for assessing the construct. Second, it is apparent that researchers know how to measure particular components of safety culture, with specific focus on individual and organizational factors. Such existing methodologies can be leveraged for future assessments. Third, based on the published literature, the relationship between safety culture and performance is tenuous at best. There are few empirical studies that examine the relationship between safety culture and safety performance metrics. Further, most of these studies do not include a description of the implementation of interventions to improve safety culture, or do not measure the effect of these interventions on safety culture or performance. Fourth, safety culture is best viewed as a dynamic, multi-faceted overall system composed of individual, engineered and organizational models. By addressing all three components of safety culture, organizations have a better chance of understanding, evaluating, and making positive changes towards safety within their own organization.« less

Aviation Safety: Modeling and Analyzing Complex Interactions between Humans and Automated Systems

NASA Technical Reports Server (NTRS)

Rungta, Neha; Brat, Guillaume; Clancey, William J.; Linde, Charlotte; Raimondi, Franco; Seah, Chin; Shafto, Michael

2013-01-01

The on-going transformation from the current US Air Traffic System (ATS) to the Next Generation Air Traffic System (NextGen) will force the introduction of new automated systems and most likely will cause automation to migrate from ground to air. This will yield new function allocations between humans and automation and therefore change the roles and responsibilities in the ATS. Yet, safety in NextGen is required to be at least as good as in the current system. We therefore need techniques to evaluate the safety of the interactions between humans and automation. We think that current human factor studies and simulation-based techniques will fall short in front of the ATS complexity, and that we need to add more automated techniques to simulations, such as model checking, which offers exhaustive coverage of the non-deterministic behaviors in nominal and off-nominal scenarios. In this work, we present a verification approach based both on simulations and on model checking for evaluating the roles and responsibilities of humans and automation. Models are created using Brahms (a multi-agent framework) and we show that the traditional Brahms simulations can be integrated with automated exploration techniques based on model checking, thus offering a complete exploration of the behavioral space of the scenario. Our formal analysis supports the notion of beliefs and probabilities to reason about human behavior. We demonstrate the technique with the Ueberligen accident since it exemplifies authority problems when receiving conflicting advices from human and automated systems.

Evaluating the urate-lowering effects of different microbial fermented extracts in hyperuricemic models accompanied with a safety study.

PubMed

Chen, Rong-Jane; Chen, Mei-Huei; Chen, Yen-Lin; Hsiao, Ching-Mao; Chen, Hsiu-Min; Chen, Siao-Jhen; Wu, Ming-Der; Yech, Yi-Jen; Yuan, Gwo-Fang; Wang, Ying-Jan

2017-07-01

Uric acid (UA) is an end product of purine metabolism by the enzyme xanthine oxidase (XOD). Hyperuricemia is characterized by the accumulation of serum UA and is an important risk factor for gout and many chronic disorders. XOD inhibitors or uricase (catalyzes UA to the more soluble end product) can prevent these chronic diseases. However, currently available hypouricemic agents induce severe side effects. Therefore, we developed new microbial fermented extracts (MFEs) with substantial XOD inhibition activity from Lactobacillus (MFE-21) and Acetobacter (MFE-25), and MFE-120 with high uricase activity from Aspergillus. The urate-lowering effects and safety of these MFEs were evaluated. Our results showed that MFE-25 exerts superior urate-lowering effects in the therapeutic model. In the preventive model, both MFE-120 and MFE-25 significantly reduced UA. The results of the safety study showed that no organ toxicity and no treatment-related adverse effects were observed in mice treated with high doses of MFEs. Taken together, the results showed the effectiveness of MFEs in reducing hyperuricemia without systemic toxicity in mice at high doses, suggesting that they are safe for use in the treatment and prevention of hyperuricemia. Copyright © 2016. Published by Elsevier B.V.

Quantitative analysis of pedestrian safety at uncontrolled multi-lane mid-block crosswalks in China.

PubMed

Zhang, Cunbao; Zhou, Bin; Chen, Guojun; Chen, Feng

2017-11-01

A lot of pedestrian-vehicle crashes at mid-block crosswalks severely threaten pedestrian's safety around the world. The situations are even worse in China due to low yielding rate of vehicles at crosswalks. In order to quantitatively analyze pedestrian's safety at multi-lane mid-block crosswalks, the number of pedestrian-vehicle conflicts was utilized to evaluate pedestrian's accident risk. Five mid-block crosswalks (Wuhan, China) were videoed to collect data of traffic situation and pedestrian-vehicle conflicts, and the quantity and spatial distribution of pedestrian-vehicle conflicts at multi-lane mid-block crosswalk were analyzed according to lane-based post-encroachment time(LPET). Statistical results indicate that conflicts are mainly concentrated in lane3 and lane6. Percentage of conflict of each lane numbered from 1 to 6 respectively are 4.1%, 13.1%, 19.8%, 8.4%, 19.0%, 28.1%. Conflict rate under different crossing strategies are also counted. Moreover, an order probit (OP) model of pedestrian-vehicle conflict analysis (PVCA) was built to find out the contributions corresponding to those factors (such as traffic volume, vehicle speed, pedestrian crossing behavior, pedestrian refuge, etc.) to pedestrian-vehicle conflicts. The results show that: pedestrian refuge have positive effects on pedestrian safety; on the other hand, high vehicle speed, high traffic volume, rolling gap crossing pattern, and larger pedestrian platoon have negative effects on pedestrian safety. Based on our field observation and PVCA model, the number of conflicts will rise by 2% while the traffic volume increases 200 pcu/h; similarly, if the vehicle speed increases 5km/h, the number of conflicts will rise by 12% accordingly. The research results could be used to evaluate pedestrian safety at multi-lane mid-block crosswalks, and useful to improve pedestrian safety by means of pedestrian safety education, pedestrian refuge setting, vehicle speed limiting, and so on. Copyright © 2017 Elsevier Ltd. All rights reserved.

Healthcare system intervention for prevention of birth injuries - process evaluation of self-assessment, peer review, feedback and agreement for change.

PubMed

Nyström, Monica E; Westerlund, Anna; Höög, Elisabet; Millde-Luthander, Charlotte; Högberg, Ulf; Grunewald, Charlotta

2012-08-24

Patient safety is fundamental in high quality healthcare systems but despite an excellent record of perinatal care in Sweden some children still suffer from substandard care and unnecessary birth injuries. Sustainable patient safety improvements assume changes in key actors' mental models, norms and culture as well as in the tools, design and organisation of work. Interventions positively affecting team mental models on safety issues are a first step to enhancing change. Our purpose was to study a national intervention programme for the prevention of birth injuries with the aim to elucidate how the main interventions of self-assessment, peer review, feedback and written agreement for change affected the teams and their mental model of patient safety, and thereby their readiness for change. Knowledge of relevant considerations before implementing this type of patient safety intervention series could thereby be increased. Eighty participants in twenty-seven maternity units were interviewed after the first intervention sequence of the programme. A content analysis using a priori coding was performed in order to relate results to the anticipated outcomes of three basic interventions: self-assessment, peer review and written feedback, and agreement for change. The self-assessment procedure was valuable and served as a useful tool for elucidating strengths and weaknesses and identifying areas for improvement for a safer delivery in maternity units. The peer-review intervention was appreciated, despite it being of less value when considering the contribution to explicit outcome effects (i.e. new input to team mental models and new suggestions for actions). The feedback report and the mutual agreement on measures for improvements reached when signing the contract seemed exert positive pressures for change. Our findings are in line with several studies stressing the importance of self-evaluation by encouraging a thorough review of objectives, practices and outcomes for the continuous improvement of an organisation. Even though effects of the peer review were limited, feedback from peers, or other change agents involved, and the support that a clear and well-structured action plan can provide are considered to be two important complements to future self-assessment procedures related to patient safety improvement.

Escalator design features evaluation

NASA Technical Reports Server (NTRS)

Zimmerman, W. F.; Deshpande, G. K.

1982-01-01

Escalators are available with design features such as dual speed (90 and 120 fpm), mat operation and flat steps. These design features were evaluated based on the impact of each on capital and operating costs, traffic flow, and safety. A human factors engineering model was developed to analyze the need for flat steps at various speeds. Mat operation of escalators was found to be cost effective in terms of energy savings. Dual speed operation of escalators with the higher speed used during peak hours allows for efficient operation. A minimum number of flat steps required as a function of escalator speed was developed to ensure safety for the elderly.

The FITS model office ergonomics program: a model for best practice.

PubMed

Chim, Justine M Y

2014-01-01

An effective office ergonomics program can predict positive results in reducing musculoskeletal injury rates, enhancing productivity, and improving staff well-being and job satisfaction. Its objective is to provide a systematic solution to manage the potential risk of musculoskeletal disorders among computer users in an office setting. A FITS Model office ergonomics program is developed. The FITS Model Office Ergonomics Program has been developed which draws on the legislative requirements for promoting the health and safety of workers using computers for extended periods as well as previous research findings. The Model is developed according to the practical industrial knowledge in ergonomics, occupational health and safety management, and human resources management in Hong Kong and overseas. This paper proposes a comprehensive office ergonomics program, the FITS Model, which considers (1) Furniture Evaluation and Selection; (2) Individual Workstation Assessment; (3) Training and Education; (4) Stretching Exercises and Rest Break as elements of an effective program. An experienced ergonomics practitioner should be included in the program design and implementation. Through the FITS Model Office Ergonomics Program, the risk of musculoskeletal disorders among computer users can be eliminated or minimized, and workplace health and safety and employees' wellness enhanced.

Evaluation of biotechnology-derived novel proteins for the risk of food-allergic potential: advances in the development of animal models and future challenges.

PubMed

Ahuja, Varun; Quatchadze, Maria; Ahuja, Vaishali; Stelter, Daniela; Albrecht, Achim; Stahlmann, Ralf

2010-12-01

Increasing concern from the public about the safety of genetically modified food has made critical to have suitable methods for recognizing associated potential hazards. Hierarchical approaches to allergenicity determination were proposed, and these include evaluation of the structural and sequence homology and serological identity of novel proteins with existing allergens, measuring the resistance to proteolytic digestion and assessment of sensitizing potential using animal models. Allergic individuals have a predisposed (i.e. atopic) genetic background, and a close resemblance to this setup is therefore desirable in animal models, which is possible by using a strain of an animal species that is prone for allergic disorders. So far, none of the animal model has been validated for the purpose of hazard identification in the context of safety assessment. However, the available knowledge suggests that the judicious use of an appropriate animal model could provide important information about the allergic potential of novel proteins. This paper provides an up-to-date review of the progress made in the field of development of in vivo models in this direction and the further goals that have to be achieved.

Probabilistic modeling approach for evaluating the compliance of ready-to-eat foods with new European Union safety criteria for Listeria monocytogenes.

PubMed

Koutsoumanis, Konstantinos; Angelidis, Apostolos S

2007-08-01

Among the new microbiological criteria that have been incorporated in EU Regulation 2073/2005, of particular interest are those concerning Listeria monocytogenes in ready-to eat (RTE) foods, because for certain food categories, they no longer require zero tolerance but rather specify a maximum allowable concentration of 100 CFU/g or ml. This study presents a probabilistic modeling approach for evaluating the compliance of RTE sliced meat products with the new safety criteria for L. monocytogenes. The approach was based on the combined use of (i) growth/no growth boundary models, (ii) kinetic growth models, (iii) product characteristics data (pH, a(w), shelf life) collected from 160 meat products from the Hellenic retail market, and (iv) storage temperature data recorded from 50 retail stores in Greece. This study shows that probabilistic analysis of the above components using Monte Carlo simulation, which takes into account the variability of factors affecting microbial growth, can lead to a realistic estimation of the behavior of L. monocytogenes throughout the food supply chain, and the quantitative output generated can be further used by food managers as a decision-making tool regarding the design or modification of a product's formulation or its "use-by" date in order to ensure its compliance with the new safety criteria. The study also argues that compliance of RTE foods with the new safety criteria should not be considered a parameter with a discrete and binary outcome because it depends on factors such as product characteristics, storage temperature, and initial contamination level, which display considerable variability even among different packages of the same RTE product. Rather, compliance should be expressed and therefore regulated in a more probabilistic fashion.

Dynamic bridge substructure evaluation and monitoring

DOT National Transportation Integrated Search

2005-09-01

This research project was funded to investigate the possibility that, by measuring and modeling the dynamic response characteristics of a bridge substructure, it might be possible to determine the condition and safety of the substructure and identify...

76 FR 8316 - Special Conditions: Gulfstream Model GVI Airplane; Interaction of Systems and Structures

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-14

... considered in isolation but should be included in the overall safety evaluation of the airplane. These... forced structural vibrations (oscillatory failures) must not produce loads that could result in...

Validation of the train energy and dynamics simulator (TEDS).

DOT National Transportation Integrated Search

2015-01-01

FRA has developed Train Energy and Dynamics Simulator (TEDS) based upon a longitudinal train dynamics and operations : simulation model which allows users to conduct safety and risk evaluations, incident investigations, studies of train operations, :...

Mouse Models Applied to the Research of Pharmacological Treatments in Asthma.

PubMed

Marqués-García, Fernando; Marcos-Vadillo, Elena

2016-01-01

Models developed for the study of asthma mechanisms can be used to investigate new compounds with pharmacological activity against this disease. The increasing number of compounds requires a preclinical evaluation before starting the application in humans. Preclinical evaluation in animal models reduces the number of clinical trials positively impacting in the cost and in safety. In this chapter, three protocols for the study of drugs are shown: a model to investigate corticoids as a classical treatment of asthma; a protocol to test the effects of retinoic acid (RA) on asthma; and a mouse model to test new therapies in asthma as monoclonal antibodies.

Estimation of the chemical-induced eye injury using a weight-of-evidence (WoE) battery of 21 artificial neural network (ANN) c-QSAR models (QSAR-21): part I: irritation potential.

PubMed

Verma, Rajeshwar P; Matthews, Edwin J

2015-03-01

Evaluation of potential chemical-induced eye injury through irritation and corrosion is required to ensure occupational and consumer safety for industrial, household and cosmetic ingredient chemicals. The historical method for evaluating eye irritant and corrosion potential of chemicals is the rabbit Draize test. However, the Draize test is controversial and its use is diminishing - the EU 7th Amendment to the Cosmetic Directive (76/768/EEC) and recast Regulation now bans marketing of new cosmetics having animal testing of their ingredients and requires non-animal alternative tests for safety assessments. Thus, in silico and/or in vitro tests are advocated. QSAR models for eye irritation have been reported for several small (congeneric) data sets; however, large global models have not been described. This report describes FDA/CFSAN's development of 21 ANN c-QSAR models (QSAR-21) to predict eye irritation using the ADMET Predictor program and a diverse training data set of 2928 chemicals. The 21 models had external (20% test set) and internal validation and average training/verification/test set statistics were: 88/88/85(%) sensitivity and 82/82/82(%) specificity, respectively. The new method utilized multiple artificial neural network (ANN) molecular descriptor selection functionalities to maximize the applicability domain of the battery. The eye irritation models will be used to provide information to fill the critical data gaps for the safety assessment of cosmetic ingredient chemicals. Copyright © 2014 Elsevier Inc. All rights reserved.

Evaluation of odometry algorithm performances using a railway vehicle dynamic model

NASA Astrophysics Data System (ADS)

Allotta, B.; Pugi, L.; Ridolfi, A.; Malvezzi, M.; Vettori, G.; Rindi, A.

2012-05-01

In modern railway Automatic Train Protection and Automatic Train Control systems, odometry is a safety relevant on-board subsystem which estimates the instantaneous speed and the travelled distance of the train; a high reliability of the odometry estimate is fundamental, since an error on the train position may lead to a potentially dangerous overestimation of the distance available for braking. To improve the odometry estimate accuracy, data fusion of different inputs coming from a redundant sensor layout may be used. Simplified two-dimensional models of railway vehicles have been usually used for Hardware in the Loop test rig testing of conventional odometry algorithms and of on-board safety relevant subsystems (like the Wheel Slide Protection braking system) in which the train speed is estimated from the measures of the wheel angular speed. Two-dimensional models are not suitable to develop solutions like the inertial type localisation algorithms (using 3D accelerometers and 3D gyroscopes) and the introduction of Global Positioning System (or similar) or the magnetometer. In order to test these algorithms correctly and increase odometry performances, a three-dimensional multibody model of a railway vehicle has been developed, using Matlab-Simulink™, including an efficient contact model which can simulate degraded adhesion conditions (the development and prototyping of odometry algorithms involve the simulation of realistic environmental conditions). In this paper, the authors show how a 3D railway vehicle model, able to simulate the complex interactions arising between different on-board subsystems, can be useful to evaluate the odometry algorithm and safety relevant to on-board subsystem performances.

76 FR 19510 - Notice of Availability (NOA) of the Models For Plant-Specific Adoption of Technical...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-07

...-Specific Adoption of Technical Specifications Task Force (TSTF) Traveler TSTF- 422, Revision 2, ``Change In... model safety evaluation (SE) for plant-specific adoption of TSTF Traveler TSTF-422, Revision 2, ``Change..., Revision 2, is available in the Agencywide Documents Access and Management System (ADAMS) under Accession...

21 CFR 315.6 - Evaluation of safety.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Evaluation of safety. 315.6 Section 315.6 Food and... USE DIAGNOSTIC RADIOPHARMACEUTICALS § 315.6 Evaluation of safety. (a) Factors considered in the safety...)(1) To establish the safety of a diagnostic radiopharmaceutical, FDA may require, among other...

Promoting young children's interpersonal safety knowledge, intentions, confidence, and protective behavior skills: Outcomes of a randomized controlled trial.

PubMed

White, Codi; Shanley, Dianne C; Zimmer-Gembeck, Melanie J; Walsh, Kerryann; Hawkins, Russell; Lines, Katrina; Webb, Haley

2018-06-11

Promoting young children's interpersonal safety knowledge, intentions confidence and skills is the goal of many child maltreatment prevention programs; however, evaluation of their effectiveness has been limited. In this study, a randomized controlled trial was conducted examining the effectiveness of the Australian protective behaviors program, Learn to be safe with Emmy and friends™ compared to a waitlist condition. In total, 611 Australian children in Grade 1 (5-7 years; 50% male) participated, with assessments at Pre-intervention, Post-intervention and a 6-month follow-up. This study also included a novel assessment of interpersonal safety skills through the Observed Protective Behaviors Test (OPBT). Analyses showed participating in Learn to be safe with Emmy and friends™ was effective post-program in improving interpersonal safety knowledge (child and parent-rated) and parent-rated interpersonal safety skills. These benefits were retained at the 6-month follow-up, with participating children also reporting increased disclosure confidence. However, Learn to be safe with Emmy and friends™ participation did not significantly impact children's disclosure intentions, safety identification skills, or interpersonal safety skills as measured by the OPBT. Future research may seek to evaluate the effect of further parent and teacher integration into training methods and increased use of behavioral rehearsal and modelling to more effectively target specific disclosure intentions and skills. Copyright © 2018 Elsevier Ltd. All rights reserved.

Scheme for the selection of measurement uncertainty models in blood establishments' screening immunoassays.

PubMed

Pereira, Paulo; Westgard, James O; Encarnação, Pedro; Seghatchian, Jerard; de Sousa, Gracinda

2015-02-01

Blood establishments routinely perform screening immunoassays to assess safety of the blood components. As with any other screening test, results have an inherent uncertainty. In blood establishments the major concern is the chance of false negatives, due to its possible impact on patients' health. This article briefly reviews GUM and diagnostic accuracy models for screening immunoassays, recommending a scheme to support the screening laboratories' staffs on the selection of a model considering the intended use of the screening results (i.e., post-transfusion safety). The discussion is grounded on a "risk-based thinking", risk being considered from the blood donor selection to the screening immunoassays. A combination of GUM and diagnostic accuracy models to evaluate measurement uncertainty in blood establishments is recommended. Copyright © 2014 Elsevier Ltd. All rights reserved.

Developing Methodologies for Evaluating the Earthquake Safety of Existing Buildings.

ERIC Educational Resources Information Center

Bresler, B.; And Others

This report contains four papers written during an investigation of methods for evaluating the safety of existing school buildings under Research Applied to National Needs (RANN) grants. In "Evaluation of Earthquake Safety of Existing Buildings," by B. Bresler, preliminary ideas on the evaluation of the earthquake safety of existing…

An Educational Intervention to Enhance Nurse Leaders' Perceptions of Patient Safety Culture

PubMed Central

Ginsburg, Liane; Norton, Peter G; Casebeer, Ann; Lewis, Steven

2005-01-01

Objective To design a training intervention and then test its effect on nurse leaders' perceptions of patient safety culture. Study Setting Three hundred and fifty-six nurses in clinical leadership roles (nurse managers and educators/CNSs) in two Canadian multi-site teaching hospitals (study and control). Study Design A prospective evaluation of a patient safety training intervention using a quasi-experimental untreated control group design with pretest and posttest. Nurses in clinical leadership roles in the study group were invited to participate in two patient safety workshops over a 6-month period. Individuals in the study and control groups completed surveys measuring patient safety culture and leadership for improvement prior to training and 4 months following the second workshop. Extraction Methods Individual nurse clinical leaders were the unit of analysis. Exploratory factor analysis of the safety culture items was conducted; repeated-measures analysis of variance and paired t-tests were used to evaluate the effect of the training intervention on perceived safety culture (three factors). Hierarchical regression analyses looked at the influence of demographics, leadership for improvement, and the training intervention on nurse leaders' perceptions of safety culture. Principal Findings A statistically significant improvement in one of three safety culture measures was shown for the study group (p<.001) and a significant decline was seen on one of the safety culture measures for the control group (p<.05). Leadership support for improvement was found to explain significant amounts of variance in all three patient safety culture measures; workshop attendance explained significant amounts of variance in one of the three safety culture measures. The total R2 for the three full hierarchical regression models ranged from 0.338 and 0.554. Conclusions Sensitively delivered training initiatives for nurse leaders can help to foster a safety culture. Organizational leadership support for improvement is, however, also critical for fostering a culture of safety. Together, training interventions and leadership support may have the most significant impact on patient safety culture. PMID:16033489

A cross-comparison of different techniques for modeling macro-level cyclist crashes.

PubMed

Guo, Yanyong; Osama, Ahmed; Sayed, Tarek

2018-04-01

Despite the recognized benefits of cycling as a sustainable mode of transportation, cyclists are considered vulnerable road users and there are concerns about their safety. Therefore, it is essential to investigate the factors affecting cyclist safety. The goal of this study is to evaluate and compare different approaches of modeling macro-level cyclist safety as well as investigating factors that contribute to cyclist crashes using a comprehensive list of covariates. Data from 134 traffic analysis zones (TAZs) in the City of Vancouver were used to develop macro-level crash models (CM) incorporating variables related to actual traffic exposure, socio-economics, land use, built environment, and bike network. Four types of CMs were developed under a full Bayesian framework: Poisson lognormal model (PLN), random intercepts PLN model (RIPLN), random parameters PLN model (RPPLN), and spatial PLN model (SPLN). The SPLN model had the best goodness of fit, and the results highlighted the significant effects of spatial correlation. The models showed that the cyclist crashes were positively associated with bike and vehicle exposure measures, households, commercial area density, and signal density. On the other hand, negative associations were found between cyclist crashes and some bike network indicators such as average edge length, average zonal slope, and off-street bike links. Copyright © 2018 Elsevier Ltd. All rights reserved.

Comparison of AIHA ISO 9001-based occupational health and safety management system guidance document with a manufacturer's occupational health and safety assessment instrument.

PubMed

Dyjack, D T; Levine, S P; Holtshouser, J L; Schork, M A

1998-06-01

Numerous manufacturing and service organizations have integrated or are considering integration of their respective occupational health and safety management and audit systems into the International Organization for Standardization-based (ISO) audit-driven Quality Management Systems (ISO 9000) or Environmental Management Systems (ISO 14000) models. Companies considering one of these options will likely need to identify and evaluate several key factors before embarking on such efforts. The purpose of this article is to identify and address the key factors through a case study approach. Qualitative and quantitative comparisons of the key features of the American Industrial Hygiene Association ISO-9001 harmonized Occupational Health and Safety Management System with The Goodyear Tire & Rubber Co. management and audit system were conducted. The comparisons showed that the two management systems and their respective audit protocols, although structured differently, were not substantially statistically dissimilar in content. The authors recommend that future studies continue to evaluate the advantages and disadvantages of various audit protocols. Ideally, these studies would identify those audit outcome measures that can be reliably correlated with health and safety performance.

MODEL 9977 B(M)F-96 SAFETY ANALYSIS REPORT FOR PACKAGING

DOE Office of Scientific and Technical Information (OSTI.GOV)

Abramczyk, G; Paul Blanton, P; Kurt Eberl, K

2006-05-18

This Safety Analysis Report for Packaging (SARP) documents the analysis and testing performed on and for the 9977 Shipping Package, referred to as the General Purpose Fissile Package (GPFP). The performance evaluation presented in this SARP documents the compliance of the 9977 package with the regulatory safety requirements for Type B packages. Per 10 CFR 71.59, for the 9977 packages evaluated in this SARP, the value of ''N'' is 50, and the Transport Index based on nuclear criticality control is 1.0. The 9977 package is designed with a high degree of single containment. The 9977 complies with 10 CFR 71more » (2002), Department of Energy (DOE) Order 460.1B, DOE Order 460.2, and 10 CFR 20 (2003) for As Low As Reasonably Achievable (ALARA) principles. The 9977 also satisfies the requirements of the Regulations for the Safe Transport of Radioactive Material--1996 Edition (Revised)--Requirements. IAEA Safety Standards, Safety Series No. TS-R-1 (ST-1, Rev.), International Atomic Energy Agency, Vienna, Austria (2000). The 9977 package is designed, analyzed and fabricated in accordance with Section III of the American Society of Mechanical Engineers (ASME) Boiler and Pressure Vessel (B&PV) Code, 1992 edition.« less

Preclinical in vivo long-term evaluation of the novel Mitra-Spacer technology: experimental validation in the ovine model.

PubMed

Peppas, Athanasios; Furer, Ariel; Wilson, Jon; Yi, GengHua; Cheng, Yanping; Van Wygerden, Karl; Seguin, Christopher; Shibuya, Masahiko; Kaluza, Grzegorz L; Granada, Juan F

2017-06-20

The Mitra-Spacer (Cardiosolutions, Bridgewater, MA, USA) is designed to treat mitral regurgitation by introducing a dynamic spacer that constantly adapts to the changing haemodynamic conditions during the cardiac cycle. We aimed to evaluate the performance and safety of this device in the chronic ovine model. Eight sheep were enrolled in this study. Through a left thoracotomy, the Mitra-Spacer was inserted via the transapical approach and advanced into the left atrium (LA) under imaging guidance. Device performance and safety were evaluated up to 90 days using fluoroscopy, echocardiography and histopathology. The volume within the balloon spacer shifted during the cardiac cycle in all cases. Seven animals survived up to 90 days for terminal imaging and tissue harvest. Echocardiography showed no change in left ventricle (LV) ejection fraction from baseline to 90 days. There were no observations of changes in LV diastolic function, pulmonary vein inflow, or tricuspid valve function. Histological analysis demonstrated no significant injury to the mitral apparatus. In the healthy ovine model, Mitra-Spacer implantation was feasible and safe. At 90 days, no evidence of structural damage to the mitral apparatus or deterioration of cardiac performance was demonstrated.

Safety evaluation of joint and conventional lane merge configurations for freeway work zones.

PubMed

Ishak, Sherif; Qi, Yan; Rayaprolu, Pradeep

2012-01-01

Inefficient operation of traffic in work zone areas not only leads to an increase in travel time delays, queue length, and fuel consumption but also increases the number of forced merges and roadway accidents. This study evaluated the safety performance of work zones with a conventional lane merge (CLM) configuration in Louisiana. Analysis of variance (ANOVA) was used to compare the crash rates for accidents involving fatalities, injuries, and property damage only (PDO) in each of the following 4 areas: (1) advance warning area, (2) transition area, (3) work area, and (4) termination area. The analysis showed that the advance warning area had higher fatality, injury, and PDO crash rates when compared to the transition area, work area, and termination area. This finding confirmed the need to make improvements in the advance warning area where merging maneuvers take place. Therefore, a new lane merge configuration, called joint lane merge (JLM), was proposed and its safety performance was examined and compared to the conventional lane merge configuration using a microscopic simulation model (VISSIM), which was calibrated with real-world data from an existing work zone on I-55 and used to simulate a total of 25 different scenarios with different levels of demand and traffic composition. Safety performance was evaluated using 2 surrogate measures: uncomfortable decelerations and speed variance. Statistical analysis was conducted to determine whether the differences in safety performance between both configurations were significant. The safety analysis indicated that JLM outperformed CLM in most cases with low to moderate flow rates and that the percentage of trucks did not have a significant impact on the safety performance of either configuration. Though the safety analysis did not clearly indicate which lane merge configuration is safer for the overall work zone area, it was able to identify the possibly associated safety changes within the work zone area under different traffic conditions. Copyright © 2012 Taylor & Francis Group, LLC

Evaluating the impact of bike network indicators on cyclist safety using macro-level collision prediction models.

PubMed

Osama, Ahmed; Sayed, Tarek

2016-12-01

Many cities worldwide are recognizing the important role that cycling plays in creating green and livable communities. However, vulnerable road users such as cyclists are usually subjected to an elevated level of injury risk which discourages many road users to cycle. This paper studies cyclist-vehicle collisions at 134 traffic analysis zones in the city of Vancouver to assess the impact of bike network structure on cyclist safety. Several network indicators were developed using Graph theory and their effect on cyclist safety was investigated. The indicators included measures of connectivity, directness, and topography of the bike network. The study developed several macro-level (zonal) collision prediction models that explicitly incorporated bike network indicators as explanatory variables. As well, the models incorporated the actual cyclist exposure (bike kilometers travelled) as opposed to relying on proxies such as population or bike network length. The macro-level collision prediction models were developed using generalized linear regression and full Bayesian techniques, with and without spatial effects. The models showed that cyclist collisions were positively associated with bike and vehicle exposure. The exponents of the exposure variables were less than one which supports the "safety in numbers" hypothesis. Moreover, the models showed positive associations between cyclist collisions and the bike network connectivity and linearity indicators. In contrast, negative associations were found between cyclist collisions and the bike network continuity and topography indicators. The spatial effects were statistically significant in all of the developed models. Copyright © 2016 Elsevier Ltd. All rights reserved.

West Virginia’s impaired driving high-visibility enforcement campaign, 2003-2005

DOT National Transportation Integrated Search

2007-08-01

In 2002, West Virginia became a Strategic Evaluation State for the National Highway Traffic Safety Administration's Impaired Driving High-Visibility Enforcement campaign. The State implemented NHTSA's model publicity and enforcement program in target...

One model for the evaluation of ASAP rehabilitation effort

DOT National Transportation Integrated Search

1974-10-01

The relative effectiveness of Alcohol Safety Action Projects (ASAP) modalities was inferred from recidivism defined as re-arrest for Drinking While Intoxicated (DWI) after entry into a rehabilitation modality. The first phase of the investigation emp...

Genetic modification of hematopoietic cells using retroviral and lentiviral vectors: safety considerations for vector design and delivery into target cells.

PubMed

Dropulic, Boro

2005-07-01

The recent development of leukemia in three patients following retroviral vector gene transfer in hematopoietic stem cells, resulting in the death of one patient, has raised safety concerns for the use of integrating gene transfer vectors for human gene therapy. This review discusses these serious adverse events from the perspective of whether restrictions on vector design and vector-modified target cells are warranted at this time. A case is made against presently establishing specific restrictions for vector design and transduced cells; rather, their safety should be ascertained by empiric evaluation in appropriate preclinical models on a case-by-case basis. Such preclinical data, coupled with proper informed patient consent and a risk-benefit ratio analysis, provide the best available prospective evaluation of gene transfer vectors prior to their translation into the clinic.

Prediction based active ramp metering control strategy with mobility and safety assessment

NASA Astrophysics Data System (ADS)

Fang, Jie; Tu, Lili

2018-04-01

Ramp metering is one of the most direct and efficient motorway traffic flow management measures so as to improve traffic conditions. However, owing to short of traffic conditions prediction, in earlier studies, the impact on traffic flow dynamics of the applied RM control was not quantitatively evaluated. In this study, a RM control algorithm adopting Model Predictive Control (MPC) framework to predict and assess future traffic conditions, which taking both the current traffic conditions and the RM-controlled future traffic states into consideration, was presented. The designed RM control algorithm targets at optimizing the network mobility and safety performance. The designed algorithm is evaluated in a field-data-based simulation. Through comparing the presented algorithm controlled scenario with the uncontrolled scenario, it was proved that the proposed RM control algorithm can effectively relieve the congestion of traffic network with no significant compromises in safety aspect.

Applicability and feasibility of systematic review for performing evidence-based risk assessment in food and feed safety.

PubMed

Aiassa, E; Higgins, J P T; Frampton, G K; Greiner, M; Afonso, A; Amzal, B; Deeks, J; Dorne, J-L; Glanville, J; Lövei, G L; Nienstedt, K; O'connor, A M; Pullin, A S; Rajić, A; Verloo, D

2015-01-01

Food and feed safety risk assessment uses multi-parameter models to evaluate the likelihood of adverse events associated with exposure to hazards in human health, plant health, animal health, animal welfare, and the environment. Systematic review and meta-analysis are established methods for answering questions in health care, and can be implemented to minimize biases in food and feed safety risk assessment. However, no methodological frameworks exist for refining risk assessment multi-parameter models into questions suitable for systematic review, and use of meta-analysis to estimate all parameters required by a risk model may not be always feasible. This paper describes novel approaches for determining question suitability and for prioritizing questions for systematic review in this area. Risk assessment questions that aim to estimate a parameter are likely to be suitable for systematic review. Such questions can be structured by their "key elements" [e.g., for intervention questions, the population(s), intervention(s), comparator(s), and outcome(s)]. Prioritization of questions to be addressed by systematic review relies on the likely impact and related uncertainty of individual parameters in the risk model. This approach to planning and prioritizing systematic review seems to have useful implications for producing evidence-based food and feed safety risk assessment.

Applying Qualitative Hazard Analysis to Support Quantitative Safety Analysis for Proposed Reduced Wake Separation Conops

NASA Technical Reports Server (NTRS)

Shortle, John F.; Allocco, Michael

2005-01-01

This paper describes a scenario-driven hazard analysis process to identify, eliminate, and control safety-related risks. Within this process, we develop selective criteria to determine the applicability of applying engineering modeling to hypothesized hazard scenarios. This provides a basis for evaluating and prioritizing the scenarios as candidates for further quantitative analysis. We have applied this methodology to proposed concepts of operations for reduced wake separation for closely spaced parallel runways. For arrivals, the process identified 43 core hazard scenarios. Of these, we classified 12 as appropriate for further quantitative modeling, 24 that should be mitigated through controls, recommendations, and / or procedures (that is, scenarios not appropriate for quantitative modeling), and 7 that have the lowest priority for further analysis.

RF safety assessment of a bilateral four-channel transmit/receive 7 Tesla breast coil: SAR versus tissue temperature limits.

PubMed

Fiedler, Thomas M; Ladd, Mark E; Bitz, Andreas K

2017-01-01

The purpose of this work was to perform an RF safety evaluation for a bilateral four-channel transmit/receive breast coil and to determine the maximum permissible input power for which RF exposure of the subject stays within recommended limits. The safety evaluation was done based on SAR as well as on temperature simulations. In comparison to SAR, temperature is more directly correlated with tissue damage, which allows a more precise safety assessment. The temperature simulations were performed by applying three different blood perfusion models as well as two different ambient temperatures. The goal was to evaluate whether the SAR and temperature distributions correlate inside the human body and whether SAR or temperature is more conservative with respect to the limits specified by the IEC. A simulation model was constructed including coil housing and MR environment. Lumped elements and feed networks were modeled by a network co-simulation. The model was validated by comparison of S-parameters and B 1 + maps obtained in an anatomical phantom. Three numerical body models were generated based on 3 Tesla MRI images to conform to the coil housing. SAR calculations were performed and the maximal permissible input power was calculated based on IEC guidelines. Temperature simulations were performed based on the Pennes bioheat equation with the power absorption from the RF simulations as heat source. The blood perfusion was modeled as constant to reflect impaired patients as well as with a linear and exponential temperature-dependent increase to reflect two possible models for healthy subjects. Two ambient temperatures were considered to account for cooling effects from the environment. The simulation model was validated with a mean deviation of 3% between measurement and simulation results. The highest 10 g-averaged SAR was found in lung and muscle tissue on the right side of the upper torso. The maximum permissible input power was calculated to be 17 W. The temperature simulations showed that temperature maximums do not correlate well with the position of the SAR maximums in all considered cases. The body models with an exponential blood perfusion increase did not exceed the temperature limit when an RF power according to the SAR limit was applied; in this case, a higher input power level by up to 73% would be allowed. The models with a constant or linear perfusion exceeded the limit for the local temperature when the local SAR limit was adhered to and would require a decrease in the input power level by up to 62%. The maximum permissible input power was determined based on SAR simulations with three newly generated body models and compared with results from temperature simulations. While SAR calculations are state-of-the-art and well defined as they are based on more or less well-known material parameters, temperature simulations depend strongly on additional material, environmental and physiological parameters. The simulations demonstrated that more consideration needs be made by the MR community in defining the parameters for temperature simulations in order to apply temperature limits instead of SAR limits in the context of MR RF safety evaluations. © 2016 American Association of Physicists in Medicine.

The Aviation System Monitoring and Modeling (ASMM) Project: A Documentation of its History and Accomplishments: 1999-2005

NASA Technical Reports Server (NTRS)

Statler, Irving C. (Editor)

2007-01-01

The Aviation System Monitoring and Modeling (ASMM) Project was one of the projects within NASA s Aviation Safety Program from 1999 through 2005. The objective of the ASMM Project was to develop the technologies to enable the aviation industry to undertake a proactive approach to the management of its system-wide safety risks. The ASMM Project entailed four interdependent elements: (1) Data Analysis Tools Development - develop tools to convert numerical and textual data into information; (2) Intramural Monitoring - test and evaluate the data analysis tools in operational environments; (3) Extramural Monitoring - gain insight into the aviation system performance by surveying its front-line operators; and (4) Modeling and Simulations - provide reliable predictions of the system-wide hazards, their causal factors, and their operational risks that may result from the introduction of new technologies, new procedures, or new operational concepts. This report is a documentation of the history of this highly successful project and of its many accomplishments and contributions to improved safety of the aviation system.

A fully Bayesian before-after analysis of permeable friction course (PFC) pavement wet weather safety.

PubMed

Buddhavarapu, Prasad; Smit, Andre F; Prozzi, Jorge A

2015-07-01

Permeable friction course (PFC), a porous hot-mix asphalt, is typically applied to improve wet weather safety on high-speed roadways in Texas. In order to warrant expensive PFC construction, a statistical evaluation of its safety benefits is essential. Generally, the literature on the effectiveness of porous mixes in reducing wet-weather crashes is limited and often inconclusive. In this study, the safety effectiveness of PFC was evaluated using a fully Bayesian before-after safety analysis. First, two groups of road segments overlaid with PFC and non-PFC material were identified across Texas; the non-PFC or reference road segments selected were similar to their PFC counterparts in terms of site specific features. Second, a negative binomial data generating process was assumed to model the underlying distribution of crash counts of PFC and reference road segments to perform Bayesian inference on the safety effectiveness. A data-augmentation based computationally efficient algorithm was employed for a fully Bayesian estimation. The statistical analysis shows that PFC is not effective in reducing wet weather crashes. It should be noted that the findings of this study are in agreement with the existing literature, although these studies were not based on a fully Bayesian statistical analysis. Our study suggests that the safety effectiveness of PFC road surfaces, or any other safety infrastructure, largely relies on its interrelationship with the road user. The results suggest that the safety infrastructure must be properly used to reap the benefits of the substantial investments. Copyright © 2015 Elsevier Ltd. All rights reserved.

Achieving a climate for patient safety by focusing on relationships.

PubMed

Manojlovich, Milisa; Kerr, Mickey; Davies, Barbara; Squires, Janet; Mallick, Ranjeeta; Rodger, Ginette L

2014-12-01

Despite many initiatives, advances in patient safety remain uneven in part because poor relationships among health professionals have not been addressed. The purpose of this study was to determine whether relationships between health professionals contributed to a patient safety climate, after implementation of an intervention to improve inter-professional collaboration. This was a secondary analysis of data collected to evaluate the Interprofessional Model of Patient Care (IPMPC) at The Ottawa Hospital in Ontario, Canada, which consists of five sites. A series of generalized estimating equation models were generated, accounting for the clustering of responses by site. Thirteen health professionals including physicians, nurses, physiotherapists and others (n = 1896) completed anonymous surveys about 1 year after the IPMPC was introduced. The IPMPC was implemented to improve interdisciplinary collaboration. Reliable instruments were used to measure collaboration, respect, inter-professional conflict and patient safety climate. Collaboration (β = 0.13; P = 0.002) and respect (β = 1.07; P = 0.03) were significant independent predictors of patient safety climate. Conflict was an independent and significant inverse predictor of patient safety climate (β = -0.29; P = 0.03), but did not moderate linkages between collaboration and patient safety climate or between respect and patient safety climate. Through the IPMPC, all health professionals learned how to collaborate and build a patient safety climate, even in the presence of inter-professional conflict. Efforts by others to foster better work relationships may yield similar improvements in patient safety climate. © The Author 2014. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

Possible overexposure of pregnant women to emissions from a walk through metal detector.

PubMed

Wu, Dagang; Qiang, Rui; Chen, Ji; Seidman, Seth; Witters, Donald; Kainz, Wolfgang

2007-10-07

This paper presents a systematic procedure to evaluate the induced current densities and electric fields due to walk-through metal detector (WTMD) exposure. This procedure is then used to assess the exposure of nine pregnant women models exposed to one WTMD model. First, we measured the magnetic field generated by the WTMD, then we extracted the equivalent current source to represent the WTMD emissions and finally we calculated the induced current densities and electric fields using the impedance method. The WTMD emissions and the induced fields in the pregnant women and fetus models are then compared to the ICNIRP Guidelines and the IEEE C95.6 exposure safety standard. The results prove the consistency between maximum permissible exposure (MPE) levels and basic restrictions for the ICNIRP Guidelines and IEEE C95.6. We also found that this particular WTMD complies with the ICNIRP basic restrictions for month 1-5 models, but leads to both fetus and pregnant women overexposure for month 6-9 models. The IEEE C95.6 restrictions (MPEs and basic restrictions) are not exceeded. The fetus overexposure of this particular WTMD calls for carefully conducted safety evaluations of security systems before they are deployed.

Possible overexposure of pregnant women to emissions from a walk through metal detector

NASA Astrophysics Data System (ADS)

Wu, Dagang; Qiang, Rui; Chen, Ji; Seidman, Seth; Witters, Donald; Kainz, Wolfgang

2007-09-01

This paper presents a systematic procedure to evaluate the induced current densities and electric fields due to walk-through metal detector (WTMD) exposure. This procedure is then used to assess the exposure of nine pregnant women models exposed to one WTMD model. First, we measured the magnetic field generated by the WTMD, then we extracted the equivalent current source to represent the WTMD emissions and finally we calculated the induced current densities and electric fields using the impedance method. The WTMD emissions and the induced fields in the pregnant women and fetus models are then compared to the ICNIRP Guidelines and the IEEE C95.6 exposure safety standard. The results prove the consistency between maximum permissible exposure (MPE) levels and basic restrictions for the ICNIRP Guidelines and IEEE C95.6. We also found that this particular WTMD complies with the ICNIRP basic restrictions for month 1-5 models, but leads to both fetus and pregnant women overexposure for month 6-9 models. The IEEE C95.6 restrictions (MPEs and basic restrictions) are not exceeded. The fetus overexposure of this particular WTMD calls for carefully conducted safety evaluations of security systems before they are deployed.

Automation for System Safety Analysis

NASA Technical Reports Server (NTRS)

Malin, Jane T.; Fleming, Land; Throop, David; Thronesbery, Carroll; Flores, Joshua; Bennett, Ted; Wennberg, Paul

2009-01-01

This presentation describes work to integrate a set of tools to support early model-based analysis of failures and hazards due to system-software interactions. The tools perform and assist analysts in the following tasks: 1) extract model parts from text for architecture and safety/hazard models; 2) combine the parts with library information to develop the models for visualization and analysis; 3) perform graph analysis and simulation to identify and evaluate possible paths from hazard sources to vulnerable entities and functions, in nominal and anomalous system-software configurations and scenarios; and 4) identify resulting candidate scenarios for software integration testing. There has been significant technical progress in model extraction from Orion program text sources, architecture model derivation (components and connections) and documentation of extraction sources. Models have been derived from Internal Interface Requirements Documents (IIRDs) and FMEA documents. Linguistic text processing is used to extract model parts and relationships, and the Aerospace Ontology also aids automated model development from the extracted information. Visualizations of these models assist analysts in requirements overview and in checking consistency and completeness.

Patient Reporting of Safety experiences in Organisational Care Transfers (PRoSOCT): a feasibility study of a patient reporting tool as a proactive approach to identifying latent conditions within healthcare systems

PubMed Central

Scott, Jason; Waring, Justin; Heavey, Emily; Dawson, Pamela

2014-01-01

Background It is increasingly recognised that patients can play a role in reporting safety incidents. Studies have tended to focus on patients within hospital settings, and on the reporting of patient safety incidents as defined within a medical model of safety. This study aims to determine the feasibility of collecting and using patient experiences of safety as a proactive approach to identifying latent conditions of safety as patients undergo organisational care transfers. Methods and analysis The study comprises three components: (1) patients’ experiences of safety relating to a care transfer, (2) patients’ receptiveness to reporting experiences of safety, (3) quality improvement using patient experiences of safety. (1) A safety survey and evaluation form will be distributed to patients discharged from 15 wards across four clinical areas (cardiac, care of older people, orthopaedics and stroke) over 1 year. Healthcare professionals involved in the care transfer will be provided with a regular summary of patient feedback. (2) Patients (n=36) who return an evaluation form will be sampled representatively based on the four clinical areas and interviewed about their experiences of healthcare and safety and completing the survey. (3) Healthcare professionals (n=75) will be invited to participate in semistructured interviews and focus groups to discuss their experiences with and perceptions of receiving and using patient feedback. Data analysis will explore the relationship between patient experiences of safety and other indicators and measures of quality and safety. Interview and focus group data will be thematically analysed and triangulated with all other data sources using a convergence coding matrix. Ethics and dissemination The study has been granted National Health Service (NHS) Research Ethics Committee approval. Patient experiences of safety will be disseminated to healthcare teams for the purpose of organisational development and quality improvement. Results will be disseminated to study participants as well as through peer-reviewed outputs. PMID:24833698

The Analysis of the Contribution of Human Factors to the In-Flight Loss of Control Accidents

NASA Technical Reports Server (NTRS)

Ancel, Ersin; Shih, Ann T.

2012-01-01

In-flight loss of control (LOC) is currently the leading cause of fatal accidents based on various commercial aircraft accident statistics. As the Next Generation Air Transportation System (NextGen) emerges, new contributing factors leading to LOC are anticipated. The NASA Aviation Safety Program (AvSP), along with other aviation agencies and communities are actively developing safety products to mitigate the LOC risk. This paper discusses the approach used to construct a generic integrated LOC accident framework (LOCAF) model based on a detailed review of LOC accidents over the past two decades. The LOCAF model is comprised of causal factors from the domain of human factors, aircraft system component failures, and atmospheric environment. The multiple interdependent causal factors are expressed in an Object-Oriented Bayesian belief network. In addition to predicting the likelihood of LOC accident occurrence, the system-level integrated LOCAF model is able to evaluate the impact of new safety technology products developed in AvSP. This provides valuable information to decision makers in strategizing NASA's aviation safety technology portfolio. The focus of this paper is on the analysis of human causal factors in the model, including the contributions from flight crew and maintenance workers. The Human Factors Analysis and Classification System (HFACS) taxonomy was used to develop human related causal factors. The preliminary results from the baseline LOCAF model are also presented.

Comparison between monitored and modeled pore water pressure and safety factor in a slope susceptible to shallow landslides

NASA Astrophysics Data System (ADS)

Bordoni, Massimiliano; Meisina, Claudia; Zizioli, Davide; Valentino, Roberto; Bittelli, Marco; Chersich, Silvia

2014-05-01

Shallow landslides can be defined as slope movements affecting superficial deposits of small thicknesses which are usually triggered due to extreme rainfall events, also very concentrated in time. Shallow landslides are hazardous phenomena: in particular, if they happen close to urbanized areas they could cause significant damages to cultivations, structures, infrastructures and, sometimes, human losses. The triggering mechanism of rainfall-induced shallow landslides is strictly linked with the hydrological and mechanical responses of usually unsaturated soils to rainfall events. For this reason, it is fundamental knowing the intrinsic hydro-mechanical properties of the soils in order to assess both susceptibility and hazard of shallow landslide and to develop early-warning systems at large scale. The hydrological data collected by a 20 months monitoring on a slope susceptible to shallow landslides in an area of the North -Eastern Oltrepo Pavese (Northern Apennines, Italy) were used to identify the hydrological behaviors of the investigated soils towards rainfall events. Field conditions under different rainfall trends have also been modeled by using both hydrological and physically-based stability models for the evaluation of the slope safety factor . The main objectives of this research are: (a) to compare the field measured pore water pressures at different depths with results of hydrological models, in order to evaluate the efficiency of the tested models and to determine how precipitations affect pore pressure development; (b) to compare the time trends of the safety factor that have been obtained by applying different stability models; (c) to evaluate, through a sensitivity analysis, the effects of soil hydrological properties on modeling pore water pressure and safety factor. The test site slope where field measurements were acquired is representative of other sites in Northern Apennines affected by shallow landslides and is characterized by medium-high topographic gradient (ranging from 22 to 35°). The bedrock is made up of gravel, sand and poorly cemented conglomerates; superficial soils, derived by the weathered bedrock, are prevalently clayey-sandy silts and clayey-silty sands with different amounts of pebbles and carbonate concretions. A geotechnical, mechanical, pedological and mineralogical characterization of superficial deposits was performed. Laboratory reconstruction of hysteretic soil water characteristic curves was also carried out to determine the main soil hydrological properties. The experimental station consists in a pluviometer, a thermo-hygrometer, a barometer, an anemometer and a net radiometer. Six TDR probes equipped with a multiplexer are installed at 0.2, 0.4, 0.6, 1, 1.2, 1.4 m from ground level to measure volumetric water content; to measure pore water pressure, three tensiometers and three heat dissipation sensors are installed at 0.2, 0.6, 1.2 m from ground level. The data are collected by a CR1000 datalogger (Campbell Sci. Inc.) each 10 minutes. In this work the results of the comparison between monitored and modeled pore water pressures and the safety factor in different conditions are analyzed in order to understand the hydro-mechanical properties that could predispose the triggering mechanism of shallow instabilities and the processes that have to be taken into account in the evaluation of shallow landslides susceptibility.

Human Milk Management Redesign: Improving Quality and Safety and Reducing Neonatal Intensive Care Unit Nurse Stress.

PubMed

Settle, Margaret Doyle; Coakley, Amanda Bulette; Annese, Christine Donahue

2017-02-01

Human milk provides superior nutritional value for infants in the neonatal intensive care unit and is the enteral feeding of choice. Our hospital used the system engineering initiative for patient safety model to evaluate the human milk management system in our neonatal intensive care unit. Nurses described the previous process in a negative way, fraught with opportunities for error, increased stress for nurses, and the need to be away from the bedside and their patients. The redesigned process improved the quality and safety of human milk management and created time for the nurses to spend with their patients.

Patient safety, quality of care, and knowledge translation in the intensive care unit.

PubMed

Needham, Dale M

2010-07-01

A large gap exists between the completion of clinical research demonstrating the benefit of new treatment interventions and improved patient outcomes resulting from implementation of these interventions as part of routine clinical practice. This gap clearly affects patient safety and quality of care. Knowledge translation is important for addressing this gap, but evaluation of the most appropriate and effective knowledge translation methods is still ongoing. Through describing one model for knowledge translation and an example of its implementation, insights can be gained into systematic methods for advancing the implementation of evidence-based interventions to improve safety, quality, and patient outcomes.

Post-approval safety issues with innovative drugs: a European cohort study.

PubMed

Mol, Peter G M; Arnardottir, Arna H; Motola, Domenico; Vrijlandt, Patrick J; Duijnhoven, Ruben G; Haaijer-Ruskamp, Flora M; de Graeff, Pieter A; Denig, Petra; Straus, Sabine M J M

2013-11-01

At time of approval, knowledge of the full benefit risk of any drug is limited, in particular with regards to safety. Post-approval surveillance of potential drug safety concerns is recognized as an important task of regulatory agencies. For innovative, often first-in-class drugs, safety knowledge at time of approval is often even less extensive and these may require tighter scrutiny post approval. We evaluated whether more post-approval serious safety issues were identified for drugs with a higher level of innovation. A cohort study was performed that included all new active substances approved under the European Centralized Procedure and for which serious safety issues were identified post-approval from 1 January 1999 to 1 January 2012. Serious safety issues were defined as issues requiring a Direct Healthcare Professional Communication to alert individual healthcare professionals of a new serious safety issue, or a safety-related drug withdrawal. Data were retrieved from publicly available websites of the Dutch Medicines Evaluation Board and the European Medicines Agency. The level of innovation was scored using a validated algorithm, grading drugs as important (A), moderate (B) or modest (C) innovations or as pharmacological or technological (pharm/tech) innovations. The data were analyzed using appropriate descriptive statistics and Kaplan-Meier analysis, with a Mantel-Cox log-rank test, and Cox-regression models correcting for follow-up duration, to identify a possible trend in serious safety issues with an increasing level of innovation. In Europe, 279 new drugs were approved between 1999 and 2011. Fifty-nine (21 %) were graded as important, 63 (23 %) moderate, or 34 (12 %) modest innovations and 123 (44 %) as non-innovative (pharm/tech), while 15 (25 %), 13 (21 %), 8 (24 %) and 17 (14 %) had post-approval safety issues, respectively (p = 0.06, linear-by-linear test). Five drugs were withdrawn from the market. The Kaplan-Meier-derived probability for having a first serious safety issue was statistically significant, log-rank (Mantel-Cox) p = 0.036. In the final adjusted Cox proportional hazard model there was no statistically significant difference in occurrence of a first serious safety issue for important, moderate and modest innovations versus non-innovative drugs; hazard ratios 1.76 (95 % CI 0.82-3.77), 1.61 (95 % CI 0.76-3.41)], and 1.25 (95 % CI 0.51-3.06), respectively. A higher level of innovation was not clearly related to an increased risk of serious safety issues identified after approval.

Modeling the safety impacts of driving hours and rest breaks on truck drivers considering time-dependent covariates.

PubMed

Chen, Chen; Xie, Yuanchang

2014-12-01

Driving hours and rest breaks are closely related to driver fatigue, which is a major contributor to truck crashes. This study investigates the effects of driving hours and rest breaks on commercial truck driver safety. A discrete-time logistic regression model is used to evaluate the crash odds ratios of driving hours and rest breaks. Driving time is divided into 11 one hour intervals. These intervals and rest breaks are modeled as dummy variables. In addition, a Cox proportional hazards regression model with time-dependent covariates is used to assess the transient effects of rest breaks, which consists of a fixed effect and a variable effect. Data collected from two national truckload carriers in 2009 and 2010 are used. The discrete-time logistic regression result indicates that only the crash odds ratio of the 11th driving hour is statistically significant. Taking one, two, and three rest breaks can reduce drivers' crash odds by 68%, 83%, and 85%, respectively, compared to drivers who did not take any rest breaks. The Cox regression result shows clear transient effects for rest breaks. It also suggests that drivers may need some time to adjust themselves to normal driving tasks after a rest break. Overall, the third rest break's safety benefit is very limited based on the results of both models. The findings of this research can help policy makers better understand the impact of driving time and rest breaks and develop more effective rules to improve commercial truck safety. Copyright © 2014 National Safety Council and Elsevier Ltd. All rights reserved.

Feasibility and Safety of RNA-transfected CD20-specific Chimeric Antigen Receptor T Cells in Dogs with Spontaneous B Cell Lymphoma.

PubMed

Panjwani, M Kazim; Smith, Jenessa B; Schutsky, Keith; Gnanandarajah, Josephine; O'Connor, Colleen M; Powell, Daniel J; Mason, Nicola J

2016-09-01

Preclinical murine models of chimeric antigen receptor (CAR) T cell therapy are widely applied, but are greatly limited by their inability to model the complex human tumor microenvironment and adequately predict safety and efficacy in patients. We therefore sought to develop a system that would enable us to evaluate CAR T cell therapies in dogs with spontaneous cancers. We developed an expansion methodology that yields large numbers of canine T cells from normal or lymphoma-diseased dogs. mRNA electroporation was utilized to express a first-generation canine CD20-specific CAR in expanded T cells. The canine CD20 (cCD20) CAR expression was efficient and transient, and electroporated T cells exhibited antigen-specific interferon-gamma (IFN-γ) secretion and lysed cCD20+ targets. In a first-in-canine study, autologous cCD20-ζ CAR T cells were administered to a dog with relapsed B cell lymphoma. Treatment was well tolerated and led to a modest, but transient, antitumor activity, suggesting that stable CAR expression will be necessary for durable clinical remissions. Our study establishes the methodologies necessary to evaluate CAR T cell therapy in dogs with spontaneous malignancies and lays the foundation for use of outbred canine cancer patients to evaluate the safety and efficacy of next-generation CAR therapies and their optimization prior to translation into humans.

Skin and Eye Irritation Assessment of Oil Palm ( Elaeis guineensis) Leaf Extract for Topical Application.

PubMed

Yusof, Nor Zuliana; Abd Gani, Siti Salwa; Azizul Hasan, Zafarizal Aldrin; Idris, Zainab

2018-01-01

Many types of phytochemicals have been found to be present in oil palm leaf and could potentially be used as functional ingredients for skincare product. However, as of today, there is no published report on hazard identification and safety assessment of oil palm ( Elaeis guineensis) leaf extract (OPLE), particularly on skin and eye irritation. In this study, potential hazard of OPLE on skin and eye irritation was evaluated as an initial step to the safety assessment of OPLE. In vitro cell viability study of OPLE on normal human dermal fibroblasts showed that OPLE was nontoxic to the cells with percentage viability more than 90% after 24 and 48 hours of incubation. Skin irritation potential of OPLE was evaluated using in vitro SkinEthic reconstructed human epidermis (RHE) model (Organization for Economic Cooperation and Development [OECD] Test Guideline 439, 2015), while eye irritation potential was evaluated using in vitro SkinEthic Human corneal epithelium (HCE) model (OECD test guideline 492, 2017). Hazard identification results showed that OPLE at 1%, 5%, and 10% (wt/wt) was classified as nonirritant to the skin and eye where mean tissue viabilities of SkinEthic RHE and SkinEthic HCE were more than 50% and 60%, respectively. Therefore, we recommend a further safety assessment, such as human patch testing, to confirm the nonirritant of OPLE.

Feasibility and Safety of RNA-transfected CD20-specific Chimeric Antigen Receptor T Cells in Dogs with Spontaneous B Cell Lymphoma

PubMed Central

Panjwani, M Kazim; Smith, Jenessa B; Schutsky, Keith; Gnanandarajah, Josephine; O'Connor, Colleen M; Powell, Daniel J; Mason, Nicola J

2016-01-01

Preclinical murine models of chimeric antigen receptor (CAR) T cell therapy are widely applied, but are greatly limited by their inability to model the complex human tumor microenvironment and adequately predict safety and efficacy in patients. We therefore sought to develop a system that would enable us to evaluate CAR T cell therapies in dogs with spontaneous cancers. We developed an expansion methodology that yields large numbers of canine T cells from normal or lymphoma-diseased dogs. mRNA electroporation was utilized to express a first-generation canine CD20-specific CAR in expanded T cells. The canine CD20 (cCD20) CAR expression was efficient and transient, and electroporated T cells exhibited antigen-specific interferon-gamma (IFN-γ) secretion and lysed cCD20+ targets. In a first-in-canine study, autologous cCD20-ζ CAR T cells were administered to a dog with relapsed B cell lymphoma. Treatment was well tolerated and led to a modest, but transient, antitumor activity, suggesting that stable CAR expression will be necessary for durable clinical remissions. Our study establishes the methodologies necessary to evaluate CAR T cell therapy in dogs with spontaneous malignancies and lays the foundation for use of outbred canine cancer patients to evaluate the safety and efficacy of next-generation CAR therapies and their optimization prior to translation into humans. PMID:27401141

Utilising the Hand Model to promote a culturally safe environment for international nursing students.

PubMed

Mackay, Bev; Harding, Thomas; Jurlina, Lou; Scobie, Norma; Khan, Ruelle

2011-04-01

The rising number of international students studying outside their own country poses challenges for nursing education. Numbers are predicted to grow and economic factors are placing increasing pressure on tertiary institutions to accept these students. In adapting to a foreign learning environment international students must not only adapt to the academic culture but also to the socio-cultural context. The most significant acculturation issues for students are English as a second language, differences in education pedagogy and social integration and connectedness. Students studying in New Zealand need to work with Maori, the indigenous people, and assimilate and practice the unique aspects of cultural safety, which has evolved in nursing as part of the response to the principles underpinning the Treaty of Waitangi. The Hand Model offers the potential to support international students in a culturally safe manner across all aspects of acculturation including those aspects of cultural safety unique to New Zealand. The model was originally developed by Lou Jurlina, a nursing teacher, to assist her to teach cultural safety and support her students in practising cultural safety in nursing. The thumb, represents 'awareness', with the other four digits signifying 'connection" 'communication', 'negotiation' and 'advocacy' respectively. Each digit is connected to the palm where the ultimate evaluation of the Hand Model in promoting cultural safety culminates in the clasping and shaking of hands: the moment of shared meaning. It promotes a sense of self worth and identity in students and a safe environment in which they can learn.

Unmanned aircraft system sense and avoid integrity and continuity

NASA Astrophysics Data System (ADS)

Jamoom, Michael B.

This thesis describes new methods to guarantee safety of sense and avoid (SAA) functions for Unmanned Aircraft Systems (UAS) by evaluating integrity and continuity risks. Previous SAA efforts focused on relative safety metrics, such as risk ratios, comparing the risk of using an SAA system versus not using it. The methods in this thesis evaluate integrity and continuity risks as absolute measures of safety, as is the established practice in commercial aircraft terminal area navigation applications. The main contribution of this thesis is a derivation of a new method, based on a standard intruder relative constant velocity assumption, that uses hazard state estimates and estimate error covariances to establish (1) the integrity risk of the SAA system not detecting imminent loss of '"well clear," which is the time and distance required to maintain safe separation from intruder aircraft, and (2) the probability of false alert, the continuity risk. Another contribution is applying these integrity and continuity risk evaluation methods to set quantifiable and certifiable safety requirements on sensors. A sensitivity analysis uses this methodology to evaluate the impact of sensor errors on integrity and continuity risks. The penultimate contribution is an integrity and continuity risk evaluation where the estimation model is refined to address realistic intruder relative linear accelerations, which goes beyond the current constant velocity standard. The final contribution is an integrity and continuity risk evaluation addressing multiple intruders. This evaluation is a new innovation-based method to determine the risk of mis-associating intruder measurements. A mis-association occurs when the SAA system incorrectly associates a measurement to the wrong intruder, causing large errors in the estimated intruder trajectories. The new methods described in this thesis can help ensure safe encounters between aircraft and enable SAA sensor certification for UAS integration into the National Airspace System.

Feasibility of an Online and Mobile Videogame Curriculum for Teaching Children Safe and Healthy Cellphone and Internet Behaviors.

PubMed

Hswen, Yulin; Rubenzahl, Lauren; Bickham, David S

2014-08-01

Increased prevalence and penetration of cellphone and mobile Internet use have raised significant concerns about children's health and safety by offering new spaces for cyberbullying, harassment, and sexual misconduct. "Cyberhero Mobile Safety" is a videogame-based education program designed using tenets of the capacity model with the goal of instilling the knowledge and skills necessary to safely and productively navigate the mobile online environment. This study evaluates its usability, appeal, and perceived impact and usefulness. Six educational videogames were part of a program delivered to 3rd-6th grade students (n=108) across six public schools in Upstate New York. Videogame play was electronically captured to evaluate usability. Likeability, acceptability, and perceived usefulness of videogame content were evaluated through postgame questionnaires. Videogame usability criteria were achieved on 82.7 percent of the students' gameplays. On a scale from 1 (low) to 5 (high), mean ratings were 4.09 (standard deviation [SD]=1.28) for likeability, 3.54 (SD=1.61) for acceptability, and 4.16 (SD=1.33) for perceived message usefulness. The "Cyberhero Mobile Safety" program is a feasible and potentially effective platform for delivering information about safe and healthy cellphone and Internet use to children. Results support the use of the capacity model to design educational videogames because games that aligned with theory principles were reported as having the most impact and being the most useful at shifting children's online behaviors. Future research should directly test the individual components of the capacity model to inform educational game design.

Performance of a semi-automated approach for risk estimation using a common data model for longitudinal healthcare databases.

PubMed

Van Le, Hoa; Beach, Kathleen J; Powell, Gregory; Pattishall, Ed; Ryan, Patrick; Mera, Robertino M

2013-02-01

Different structures and coding schemes may limit rapid evaluation of a large pool of potential drug safety signals using multiple longitudinal healthcare databases. To overcome this restriction, a semi-automated approach utilising common data model (CDM) and robust pharmacoepidemiologic methods was developed; however, its performance needed to be evaluated. Twenty-three established drug-safety associations from publications were reproduced in a healthcare claims database and four of these were also repeated in electronic health records. Concordance and discrepancy of pairwise estimates were assessed between the results derived from the publication and results from this approach. For all 27 pairs, an observed agreement between the published results and the results from the semi-automated approach was greater than 85% and Kappa coefficient was 0.61, 95% CI: 0.19-1.00. Ln(IRR) differed by less than 50% for 13/27 pairs, and the IRR varied less than 2-fold for 19/27 pairs. Reproducibility based on the intra-class correlation coefficient was 0.54. Most covariates (>90%) in the publications were available for inclusion in the models. Once the study populations and inclusion/exclusion criteria were obtained from the literature, the analysis was able to be completed in 2-8 h. The semi-automated methodology using a CDM produced consistent risk estimates compared to the published findings for most selected drug-outcome associations, regardless of original study designs, databases, medications and outcomes. Further assessment of this approach is useful to understand its roles, strengths and limitations in rapidly evaluating safety signals.

The role of theory in research to develop and evaluate the implementation of patient safety practices.

PubMed

Foy, Robbie; Ovretveit, John; Shekelle, Paul G; Pronovost, Peter J; Taylor, Stephanie L; Dy, Sydney; Hempel, Susanne; McDonald, Kathryn M; Rubenstein, Lisa V; Wachter, Robert M

2011-05-01

Theories provide a way of understanding and predicting the effects of patient safety practices (PSPs), interventions intended to prevent or mitigate harm caused by healthcare or risks of such harm. Yet most published evaluations make little or no explicit reference to theory, thereby hindering efforts to generalise findings from one context to another. Theories from a wide range of disciplines are potentially relevant to research on PSPs. Theory can be used in research to explain clinical and organisational behaviour, to guide the development and selection of PSPs, and in evaluating their implementation and mechanisms of action. One key recommendation from an expert consensus process is that researchers should describe the theoretical basis for chosen intervention components or provide an explicit logic model for 'why this PSP should work.' Future theory-driven evaluations would enhance generalisability and help build a cumulative understanding of the nature of change.

Leading clinical handover improvement: a change strategy to implement best practices in the acute care setting.

PubMed

Clarke, Christina M; Persaud, Drepaul David

2011-03-01

Many contemporary acute care facilities lack safe and effective clinical handover practices resulting in patient transitions that are vulnerable to discontinuities in care, medical errors, and adverse patient safety events. This article is intended to supplement existing handover improvement literature by providing practical guidance for leaders and managers who are seeking to improve the safety and the effectiveness of clinical handovers in the acute care setting. A 4-stage change model has been applied to guide the application of strategies for handover improvement. Change management and quality improvement principles, as well as concepts drawn from safety science and high-reliability organizations, were applied to inform strategies. A model for handover improvement respecting handover complexity is presented. Strategies targeted to stages of change include the following: 1. Enhancing awareness of handover problems and opportunities with the support of strategic directions, accountability, end user involvement, and problem complexity recognition. 2. Identifying solutions by applying and adapting best practices in local contexts. 3. Implementing locally adapted best practices supported by communication, documentation, and training. 4. Institutionalizing practice changes through integration, monitoring, and active dissemination. Finally, continued evaluation at every stage is essential. Although gaps in handover process and function knowledge remain, efforts to improve handover safety and effectiveness are still possible. Continued evaluation is critical in building this understanding and to ensure that practice changes lead to improvements in patient safety, organizational effectiveness, and patient and provider satisfaction. Through handover knowledge building, fundamental changes in handover policies and practices may be possible.

Meta-analysis of food safety training on hand hygiene knowledge and attitudes among food handlers.

PubMed

Soon, Jan Mei; Baines, Richard; Seaman, Phillip

2012-04-01

Research has shown that traditional food safety training programs and strategies to promote hand hygiene increases knowledge of the subject. However, very few studies have been conducted to evaluate the impact of food safety training on food handlers' attitudes about good hand hygiene practices. The objective of this meta-analytical study was to assess the extent to which food safety training or intervention strategies increased knowledge of and attitudes about hand hygiene. A systematic review of food safety training articles was conducted. Additional studies were identified from abstracts from food safety conferences and food science education conferences. Search terms included combinations of "food safety," "food hygiene," "training," "education," "hand washing," "hand hygiene," "knowledge," "attitudes," "practices," "behavior," and "food handlers." Only before- and after-training approaches and cohort studies with training (intervention group) and without training (control group) in hand hygiene knowledge and including attitudes in food handlers were evaluated. All pooled analyses were based on a random effects model. Meta-analysis values for nine food safety training and intervention studies on hand hygiene knowledge among food handlers were significantly higher than those of the control (without training), with an effect size (Hedges' g) of 1.284 (95% confidence interval [CI] ∼ 0.830 to 1.738). Meta-analysis of five food safety training and intervention studies in which hand hygiene attitudes and self-reported practices were monitored produced a summary effect size of 0.683 (95% CI ∼ 0.523 to 0.843). Food safety training increased knowledge and improved attitudes about hand hygiene practices. Refresher training and long-term reinforcement of good food handling behaviors may also be beneficial for sustaining good hand washing practices.

Evaluation of aviation-based safety team training in a hospital in The Netherlands.

PubMed

De Korne, Dirk F; Van Wijngaarden, Jeroen D H; Van Dyck, Cathy; Hiddema, U Francis; Klazinga, Niek S

2014-01-01

The purpose of this paper is to evaluate the implementation of a broad-scale team resource management (TRM) program on safety culture in a Dutch eye hospital, detailing the program's content and procedures. Aviation-based TRM training is recognized as a useful approach to increase patient safety, but little is known about how it affects safety culture. Pre- and post-assessments of the hospitals' safety culture was based on interviews with ophthalmologists, anesthesiologists, residents, nurses, and support staff. Interim observations were made at training sessions and in daily hospital practice. The program consisted of safety audits of processes and (team) activities, interactive classroom training sessions by aviation experts, a flight simulator session, and video recording of team activities with subsequent feedback. Medical professionals considered aviation experts inspiring role models and respected their non-hierarchical external perspective and focus on medical-technical issues. The post-assessment showed that ophthalmologists and other hospital staff had become increasingly aware of safety issues. The multidisciplinary approach promoted social (team) orientation that replaced the former functionally-oriented culture. The number of reported near-incidents greatly increased; the number of wrong-side surgeries stabilized to a minimum after an initial substantial reduction. The study was observational and the hospital's variety of efforts to improve safety culture prevented us from establishing a causal relation between improvement and any one specific intervention. Aviation-based TRM training can be a useful to stimulate safety culture in hospitals. Safety and quality improvements are not single treatment interventions but complex socio-technical interventions. A multidisciplinary system approach and focus on "team" instead of "profession" seems both necessary and difficult in hospital care.

Factors associated with self-reported inattentive driving at highway-rail grade crossings.

PubMed

Zhao, Shanshan; Khattak, Aemal J

2017-12-01

This research identified factors associated with inattentive driving at Highway-Rail Grade Crossings (HRGCs) by investigating drivers' self-reported inattentive driving experiences and factors pertaining to their socioeconomic, personality, attitudinal, and other characteristics. A random selection of 2500 households in Nebraska received a survey questionnaire designed for licensed motor vehicle drivers; respondents returned 980 questionnaires. Factor analysis identified latent variables evaluating drivers' patience and inclination to wait for trains, attitudes toward new technology, law enforcement or education regarding HRGC safety, and the propensity to commit serious traffic violations at HRGCs. The investigation utilized a structural equation model for analysis. This model indicated that drivers with a higher risk of inattentive driving at HRGCs were: female, younger in age, from households with higher incomes, with shorter tenure (in years) in their current city of residence, more frequently used HRGCs, received less information on safety at HRGCs, had less patience to wait for trains to pass and had less interest in safety improvement technology, law enforcement or safety education at HRGCs. These research findings provide useful information for future research and to policy makers for improving public safety. Additionally, the results are useful for safety educational program providers for targeted program delivery to drivers that are more vulnerable to distracted driving at HRGCs. Copyright © 2017 Elsevier Ltd. All rights reserved.

Akkermansia muciniphila: a novel functional microbe with probiotic properties.

PubMed

Gómez-Gallego, C; Pohl, S; Salminen, S; De Vos, W M; Kneifel, W

2016-09-01

Akkermansia muciniphila is an intestinal anaerobe which has been proposed as a new functional microbe with probiotic properties. However, the species is not included in the European Union qualified presumption of safety (QPS) list and has not yet been assessed. Moreover, products containing A. muciniphila are not on the market and are thus controlled by the Novel Foods Regulation, which requires extensive safety assessment. This review addresses the safety aspects of the use of A. muciniphila based on published information on its functions in humans and predictions based on its activity in model animals. Further, comprehensive studies related to A. muciniphila and its safety properties have gradually appeared and are summarised here. Many of the criteria required for novel food safety assessment in Europe can thus be fulfilled. However, studies focusing on the toxicological properties of A. muciniphila, including long-term and reproduction studies, have not so far been reported and are discussed in the light of the observation that most, if not all, healthy subjects are known to carry this intestinal anaerobe. As this also applies to other beneficial bacteria found in the human intestinal tract, the A. muciniphila case can be seen as a model for the comprehensive safety evaluations required by the European authorities.

Comparative evaluation of different medication safety measures for the emergency department: physicians' usage and acceptance of training, poster, checklist and computerized decision support.

PubMed

Sedlmayr, Brita; Patapovas, Andrius; Kirchner, Melanie; Sonst, Anja; Müller, Fabian; Pfistermeister, Barbara; Plank-Kiegele, Bettina; Vogler, Renate; Criegee-Rieck, Manfred; Prokosch, Hans-Ulrich; Dormann, Harald; Maas, Renke; Bürkle, Thomas

2013-07-29

Although usage and acceptance are important factors for a successful implementation of clinical decision support systems for medication, most studies only concentrate on their design and outcome. Our objective was to comparatively investigate a set of traditional medication safety measures such as medication safety training for physicians, paper-based posters and checklists concerning potential medication problems versus the additional benefit of a computer-assisted medication check. We concentrated on usage, acceptance and suitability of such interventions in a busy emergency department (ED) of a 749 bed acute tertiary care hospital. A retrospective, qualitative evaluation study was conducted using a field observation and a questionnaire-based survey. Six physicians were observed while treating 20 patient cases; the questionnaire, based on the Technology Acceptance Model 2 (TAM2), has been answered by nine ED physicians. During field observations, we did not observe direct use of any of the implemented interventions for medication safety (paper-based and electronic). Questionnaire results indicated that the electronic medication safety check was the most frequently used intervention, followed by checklist and posters. However, despite their positive attitude, physicians most often stated that they use the interventions in only up to ten percent for subjectively "critical" orders. Main reasons behind the low usage were deficits in ease-of-use and fit to the workflow. The intention to use the interventions was rather high after overcoming these barriers. Methodologically, the study contributes to Technology Acceptance Model (TAM) research in an ED setting and confirms TAM2 as a helpful diagnostic tool in identifying barriers for a successful implementation of medication safety interventions. In our case, identified barriers explaining the low utilization of the implemented medication safety interventions - despite their positive reception - include deficits in accessibility, briefing for the physicians about the interventions, ease-of-use and compatibility to the working environment.

Comparative evaluation of different medication safety measures for the emergency department: physicians’ usage and acceptance of training, poster, checklist and computerized decision support

PubMed Central

2013-01-01

Background Although usage and acceptance are important factors for a successful implementation of clinical decision support systems for medication, most studies only concentrate on their design and outcome. Our objective was to comparatively investigate a set of traditional medication safety measures such as medication safety training for physicians, paper-based posters and checklists concerning potential medication problems versus the additional benefit of a computer-assisted medication check. We concentrated on usage, acceptance and suitability of such interventions in a busy emergency department (ED) of a 749 bed acute tertiary care hospital. Methods A retrospective, qualitative evaluation study was conducted using a field observation and a questionnaire-based survey. Six physicians were observed while treating 20 patient cases; the questionnaire, based on the Technology Acceptance Model 2 (TAM2), has been answered by nine ED physicians. Results During field observations, we did not observe direct use of any of the implemented interventions for medication safety (paper-based and electronic). Questionnaire results indicated that the electronic medication safety check was the most frequently used intervention, followed by checklist and posters. However, despite their positive attitude, physicians most often stated that they use the interventions in only up to ten percent for subjectively “critical” orders. Main reasons behind the low usage were deficits in ease-of-use and fit to the workflow. The intention to use the interventions was rather high after overcoming these barriers. Conclusions Methodologically, the study contributes to Technology Acceptance Model (TAM) research in an ED setting and confirms TAM2 as a helpful diagnostic tool in identifying barriers for a successful implementation of medication safety interventions. In our case, identified barriers explaining the low utilization of the implemented medication safety interventions - despite their positive reception - include deficits in accessibility, briefing for the physicians about the interventions, ease-of-use and compatibility to the working environment. PMID:23890121

Flooding Capability for River-based Scenarios

DOE Office of Scientific and Technical Information (OSTI.GOV)

Smith, Curtis L.; Prescott, Steven; Ryan, Emerald

2015-10-01

This report describes the initial investigation into modeling and simulation tools for application of riverine flooding representation as part of the Risk-Informed Safety Margin Characterization (RISMC) Pathway external hazards evaluations. The report provides examples of different flooding conditions and scenarios that could impact river and watershed systems. Both 2D and 3D modeling approaches are described.

Evaluation of Force Transfer Around Openings - Experimental and Analytical Studies

Treesearch

Borjen Yeh; Tom Skaggs; Frank Lam; Minghao Li; Douglas Rammer; James Wacker

2011-01-01

Wood structural panel (WSP) sheathed shear walls and diaphragms are the primary lateral-load-resistingelements in wood-frame construction. The historical performance of light-frame structures in North America is very good due, in part, to model building codes that are designed to safeguard life safety. These model building codes have spawned continual improvement and...

A PROBABILISTIC ARSENIC EXPOSURE ASSESSMENT FOR CHILDREN WHO CONTACT CAA - TREATED PLAYSETS AND DECKS: PART 1. MODEL METHODOLOGY, VARIABILITY RESULTS, AND MODEL EVALUATION

EPA Science Inventory

Concerns have been raised regarding the safety of young children who may contact arsenic residues while playing on and around chromated copper arsenate (CCA)-treated wood playsets and decks. Although CCA registrants voluntarily canceled the production of treated wood for residen...

Novel strategies in immunotherapy for allergic diseases

PubMed Central

Tham, Elizabeth Huiwen; Soh, Jian Yi; Van Bever, HP

2018-01-01

Conventional immunotherapy (IT) for optimal control of respiratory and food allergies has been fraught with concerns of efficacy, safety, and tolerability. The development of adjuvants to conventional IT has potentially increased the effectiveness and safety of allergen IT, which may translate into improved clinical outcomes and sustained unresponsiveness even after cessation of therapy. Novel strategies incorporating the successful use of adjuvants such as allergoids, immunostimulatory DNA sequences, monoclonal antibodies, carriers, recombinant proteins, and probiotics have now been described in clinical and murine studies. Future approaches may include fungal compounds, parasitic molecules, vitamin D, and traditional Chinese herbs. More robust comparative clinical trials are needed to evaluate the safety, clinical efficacy, and cost effectiveness of various adjuvants in order to determine ideal candidates in disease-specific and allergen-specific models. Other suggested approaches to further optimize outcomes of IT include early introduction of IT during an optimal window period. Alternative routes of administration of IT to optimize delivery and yet minimize potential side effects require further evaluation for safety and efficacy before they can be recommended. PMID:29732290

Real-Time Safety Risk Assessment Based on a Real-Time Location System for Hydropower Construction Sites

PubMed Central

Fan, Qixiang; Qiang, Maoshan

2014-01-01

The concern for workers' safety in construction industry is reflected in many studies focusing on static safety risk identification and assessment. However, studies on real-time safety risk assessment aimed at reducing uncertainty and supporting quick response are rare. A method for real-time safety risk assessment (RTSRA) to implement a dynamic evaluation of worker safety states on construction site has been proposed in this paper. The method provides construction managers who are in charge of safety with more abundant information to reduce the uncertainty of the site. A quantitative calculation formula, integrating the influence of static and dynamic hazards and that of safety supervisors, is established to link the safety risk of workers with the locations of on-site assets. By employing the hidden Markov model (HMM), the RTSRA provides a mechanism for processing location data provided by the real-time location system (RTLS) and analyzing the probability distributions of different states in terms of false positives and negatives. Simulation analysis demonstrated the logic of the proposed method and how it works. Application case shows that the proposed RTSRA is both feasible and effective in managing construction project safety concerns. PMID:25114958

Real-time safety risk assessment based on a real-time location system for hydropower construction sites.

PubMed

Jiang, Hanchen; Lin, Peng; Fan, Qixiang; Qiang, Maoshan

2014-01-01

The concern for workers' safety in construction industry is reflected in many studies focusing on static safety risk identification and assessment. However, studies on real-time safety risk assessment aimed at reducing uncertainty and supporting quick response are rare. A method for real-time safety risk assessment (RTSRA) to implement a dynamic evaluation of worker safety states on construction site has been proposed in this paper. The method provides construction managers who are in charge of safety with more abundant information to reduce the uncertainty of the site. A quantitative calculation formula, integrating the influence of static and dynamic hazards and that of safety supervisors, is established to link the safety risk of workers with the locations of on-site assets. By employing the hidden Markov model (HMM), the RTSRA provides a mechanism for processing location data provided by the real-time location system (RTLS) and analyzing the probability distributions of different states in terms of false positives and negatives. Simulation analysis demonstrated the logic of the proposed method and how it works. Application case shows that the proposed RTSRA is both feasible and effective in managing construction project safety concerns.

Considering new methodologies in strategies for safety assessment of foods and food ingredients.

PubMed

Blaauboer, Bas J; Boobis, Alan R; Bradford, Bobbie; Cockburn, Andrew; Constable, Anne; Daneshian, Mardas; Edwards, Gareth; Garthoff, Jossie A; Jeffery, Brett; Krul, Cyrille; Schuermans, Jeroen

2016-05-01

Toxicology and safety assessment are changing and require new strategies for evaluating risk that are less depending on apical toxicity endpoints in animal models and relying more on knowledge of the mechanism of toxicity. This manuscript describes a number of developments that could contribute to this change and implement this in a stepwise roadmap that can be applied for the evaluation of food and food ingredients. The roadmap was evaluated in four case studies by using literature and existing data. This preliminary evaluation was shown to be useful. However, this experience should be extended by including examples where experimental work needs to be included. To further implement these new insights in toxicology and safety assessment for the area of food and food ingredients, the recommendation is that stakeholders take action in addressing gaps in our knowledge, e.g. with regard to the applicability of the roadmap for mixtures and food matrices. Further development of the threshold of toxicological concern is needed, as well as cooperation with other sectors where similar schemes are under development. Moreover, a more comprehensive evaluation of the roadmap, also including the identification of the need for in vitro experimental work is recommended. Copyright © 2016 ILSI Europe. Published by Elsevier Ltd.. All rights reserved.

A high-fidelity Monte Carlo evaluation of CANDU-6 safety parameters

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kim, Y.; Hartanto, D.

2012-07-01

Important safety parameters such as the fuel temperature coefficient (FTC) and the power coefficient of reactivity (PCR) of the CANDU-6 (CANada Deuterium Uranium) reactor have been evaluated by using a modified MCNPX code. For accurate analysis of the parameters, the DBRC (Doppler Broadening Rejection Correction) scheme was implemented in MCNPX in order to account for the thermal motion of the heavy uranium nucleus in the neutron-U scattering reactions. In this work, a standard fuel lattice has been modeled and the fuel is depleted by using the MCNPX and the FTC value is evaluated for several burnup points including the mid-burnupmore » representing a near-equilibrium core. The Doppler effect has been evaluated by using several cross section libraries such as ENDF/B-VI, ENDF/B-VII, JEFF, JENDLE. The PCR value is also evaluated at mid-burnup conditions to characterize safety features of equilibrium CANDU-6 reactor. To improve the reliability of the Monte Carlo calculations, huge number of neutron histories are considered in this work and the standard deviation of the k-inf values is only 0.5{approx}1 pcm. It has been found that the FTC is significantly enhanced by accounting for the Doppler broadening of scattering resonance and the PCR are clearly improved. (authors)« less

Prevention through Design Adoption Readiness Model (PtD ARM): An integrated conceptual model.

PubMed

Weidman, Justin; Dickerson, Deborah E; Koebel, Charles T

2015-01-01

Prevention through Design (PtD), eliminating hazards at the design-stage of tools and systems, is the optimal method of mitigating occupational health and safety risks. A recent National Institute of Safety and Health initiative has established a goal to increase adoption of PtD innovation in industry. The construction industry has traditionally lagged behind other sectors in the adoption of innovation, in general; and of safety and health prevention innovation, in particular. Therefore, as a first step toward improving adoption trends in this sector, a conceptual model was developed to describe the parameters and causal relationships that influence and predict construction stakeholder "adoption readiness" for PtD technology innovation. This model was built upon three well-established theoretical frameworks: the Health Belief Model, the Diffusion of Innovation Model, and the Technology Acceptance Model. Earp and Ennett's model development methodology was employed to build a depiction of the key constructs and directionality and magnitude of relationships among them. Key constructs were identified from the literature associated with the three theoretical frameworks, with special emphasis given to studies related to construction or OHS technology adoption. A conceptual model is presented. Recommendations for future research are described and include confirmatory structural equation modeling of model parameters and relationships, additional descriptive investigation of barriers to adoption in some trade sectors, and design and evaluation of an intervention strategy.

Signal detection of adverse events with imperfect confirmation rates in vaccine safety studies using self-controlled case series design.

PubMed

Xu, Stanley; Newcomer, Sophia; Nelson, Jennifer; Qian, Lei; McClure, David; Pan, Yi; Zeng, Chan; Glanz, Jason

2014-05-01

The Vaccine Safety Datalink project captures electronic health record data including vaccinations and medically attended adverse events on 8.8 million enrollees annually from participating managed care organizations in the United States. While the automated vaccination data are generally of high quality, a presumptive adverse event based on diagnosis codes in automated health care data may not be true (misclassification). Consequently, analyses using automated health care data can generate false positive results, where an association between the vaccine and outcome is incorrectly identified, as well as false negative findings, where a true association or signal is missed. We developed novel conditional Poisson regression models and fixed effects models that accommodate misclassification of adverse event outcome for self-controlled case series design. We conducted simulation studies to evaluate their performance in signal detection in vaccine safety hypotheses generating (screening) studies. We also reanalyzed four previously identified signals in a recent vaccine safety study using the newly proposed models. Our simulation studies demonstrated that (i) outcome misclassification resulted in both false positive and false negative signals in screening studies; (ii) the newly proposed models reduced both the rates of false positive and false negative signals. In reanalyses of four previously identified signals using the novel statistical models, the incidence rate ratio estimates and statistical significances were similar to those using conventional models and including only medical record review confirmed cases. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

New Challenges for Intervertebral Disc Treatment Using Regenerative Medicine

PubMed Central

Masuda, Koichi

2010-01-01

The development of tissue engineering therapies for the intervertebral disc is challenging due to ambiguities of disease and pain mechanisms in patients, and lack of consensus on preclinical models for safety and efficacy testing. Although the issues associated with model selection for studying orthopedic diseases or treatments have been discussed often, the multifaceted challenges associated with developing intervertebral disc tissue engineering therapies require special discussion. This review covers topics relevant to the clinical translation of tissue-engineered technologies: (1) the unmet clinical need, (2) appropriate models for safety and efficacy testing, (3) the need for standardized model systems, and (4) the translational pathways leading to a clinical trial. For preclinical evaluation of new therapies, we recommend establishing biologic plausibility of efficacy and safety using models of increasing complexity, starting with cell culture, small animals (rats and rabbits), and then large animals (goat and minipig) that more closely mimic nutritional, biomechanical, and surgical realities of human application. The use of standardized and reproducible experimental procedures and outcome measures is critical for judging relative efficacy. Finally, success will hinge on carefully designed clinical trials with well-defined patient selection criteria, gold-standard controls, and objective outcome metrics to assess performance in the early postoperative period. PMID:19903086

Do HMO and its for-profit expansion jeopardize the survival of hospital safety net services?

PubMed

Shen, Yu-Chu

2009-03-01

This study examines the effect of health maintenance organizations (HMOs) and for-profit HMO share on the survival of safety net services in hospitals between 1990 and 2004. The primary data sources are the American Hospital Association Annual Surveys, the Medicare hospital cost reports, and the HMO enrollment and ownership data from Interstudy. I analyze the risks of shutting down each safety net service separately using the proportional hazard models. I find that the risks of shutting down hospital safety net services do not vary by different levels of overall HMO penetration. However, conditional on the overall HMO penetration level, increasing for-profit presence of HMO does increase the risks of shutting down several safety net services. Policies evaluating the for-profit expansion or ownership conversion of health plans should take this potential adverse effect into consideration.

Safety evaluation of lane and shoulder width combinations on rural, two-lane, undivided roads

DOT National Transportation Integrated Search

2009-06-01

The Federal Highway Administration (FHWA) organized a pooled fund study of 26 States to evaluate low-cost safety strategies as part of its strategic highway safety effort. The goal of this study is to evaluate the safety effectiveness of various lane...

Modeling work zone crash frequency by quantifying measurement errors in work zone length.

PubMed

Yang, Hong; Ozbay, Kaan; Ozturk, Ozgur; Yildirimoglu, Mehmet

2013-06-01

Work zones are temporary traffic control zones that can potentially cause safety problems. Maintaining safety, while implementing necessary changes on roadways, is an important challenge traffic engineers and researchers have to confront. In this study, the risk factors in work zone safety evaluation were identified through the estimation of a crash frequency (CF) model. Measurement errors in explanatory variables of a CF model can lead to unreliable estimates of certain parameters. Among these, work zone length raises a major concern in this analysis because it may change as the construction schedule progresses generally without being properly documented. This paper proposes an improved modeling and estimation approach that involves the use of a measurement error (ME) model integrated with the traditional negative binomial (NB) model. The proposed approach was compared with the traditional NB approach. Both models were estimated using a large dataset that consists of 60 work zones in New Jersey. Results showed that the proposed improved approach outperformed the traditional approach in terms of goodness-of-fit statistics. Moreover it is shown that the use of the traditional NB approach in this context can lead to the overestimation of the effect of work zone length on the crash occurrence. Copyright © 2013 Elsevier Ltd. All rights reserved.

Food safety behaviors observed in celebrity chefs across a variety of programs.

PubMed

Maughan, Curtis; Chambers, Edgar; Godwin, Sandria

2017-03-01

Consumers obtain information about foodborne illness prevention from many sources, including television media. The purpose of this study was to evaluate a variety of cooking shows with celebrity chefs to understand their modeling of food safety behaviors. Cooking shows (100 episodes) were watched from 24 celebrity chefs preparing meat dishes. A tabulation of food safety behaviors was made for each show using a checklist. Proper modeling of food safety behaviors was limited, with many incidences of errors. For example, although all chefs washed their hands at the beginning of cooking at least one dish, 88% did not wash (or were not shown washing) their hands after handling uncooked meat. This was compounded with many chefs who added food with their hands (79%) or ate while cooking (50%). Other poor behaviors included not using a thermometer (75%), using the same cutting board to prepare ready-to-eat items and uncooked meat (25%), and other hygiene issues such as touching hair (21%) or licking fingers (21%). This study suggests that there is a need for improvement in demonstrated and communicated food safety behaviors among professional chefs. It also suggests that public health professionals must work to mitigate the impact of poorly modeled behaviors. © The Author 2016. Published by Oxford University Press on behalf of Faculty of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Promoting Fitness and Safety in Elementary Students: A Randomized Control Study of the Michigan Model for Health.

PubMed

O'Neill, James M; Clark, Jeffrey K; Jones, James A

2016-07-01

In elementary grades, comprehensive health education curricula have demonstrated effectiveness in addressing singular health issues. The Michigan Model for Health (MMH) was implemented and evaluated to determine its impact on nutrition, physical fitness, and safety knowledge and skills. Schools (N = 52) were randomly assigned to intervention and control conditions. Participants received MMH with 24 lessons in grade 4 and 28 more lessons in grade 5 including material focusing on nutrition, physical fitness, and safety attitudes and skills. The 40-minute lessons were taught by the classroom teacher who received curriculum training and provided feedback on implementation fidelity. Self-report survey data were collected from the fourth-grade students (N = 1983) prior to the intervention, immediately after the intervention, and 6 weeks after the intervention, with the same data collection schedule repeated in fifth grade. Analysis of the scales was conducted using a mixed-model approach. Students who received the curriculum had better nutrition, physical activity, and safety skills than the control-group students. Intervention students also reported higher consumption of fruits; however, no difference was reported for other types of food consumption. The effectiveness of the MMH in promoting fitness and safety supports the call for integrated strategies that begin in elementary grades, target multiple risk behaviors, and result in practical and financial benefits to schools. © 2016, American School Health Association.

Preventing back injuries in hospital settings: the effects of video modeling on safe patient lifting by nurses.

PubMed

Nielsen, Don; Sigurdsson, Sigurdur O; Austin, John

2009-01-01

This study evaluated video scoring and feedback about scoring as a safety intervention among 6 nursing staff. The dependent variable was safety behavior on one-person transfers. Following baseline, 5 nursing staff participated in an information phase. A video scoring phase was then introduced for all 6. A feedback phase was added for 2 participants. All participants experienced treatment withdrawal. Information resulted in improvements for all 5 participants who received it. Further improvements were observed during video scoring for the 5 participants who improved following information. No improvements were observed for the participant who received only video scoring. Safety feedback further improved safety for the 2 participants who received it. However, participants' behavior returned to video scoring levels during withdrawal.

PREVENTING BACK INJURIES IN HOSPITAL SETTINGS: THE EFFECTS OF VIDEO MODELING ON SAFE PATIENT LIFTING BY NURSES

PubMed Central

Nielsen, Don; Sigurdsson, Sigurdur O; Austin, John

2009-01-01

This study evaluated video scoring and feedback about scoring as a safety intervention among 6 nursing staff. The dependent variable was safety behavior on one-person transfers. Following baseline, 5 nursing staff participated in an information phase. A video scoring phase was then introduced for all 6. A feedback phase was added for 2 participants. All participants experienced treatment withdrawal. Information resulted in improvements for all 5 participants who received it. Further improvements were observed during video scoring for the 5 participants who improved following information. No improvements were observed for the participant who received only video scoring. Safety feedback further improved safety for the 2 participants who received it. However, participants' behavior returned to video scoring levels during withdrawal. PMID:20190918

Systematic strategies for the third industrial accident prevention plan in Korea.

PubMed

Kang, Young-sig; Yang, Sung-hwan; Kim, Tae-gu; Kim, Day-sung

2012-01-01

To minimize industrial accidents, it's critical to evaluate a firm's priorities for prevention factors and strategies since such evaluation provides decisive information for preventing industrial accidents and maintaining safety management. Therefore, this paper proposes the evaluation of priorities through statistical testing of prevention factors with a cause analysis in a cause and effect model. A priority matrix criterion is proposed to apply the ranking and for the objectivity of questionnaire results. This paper used regression method (RA), exponential smoothing method (ESM), double exponential smoothing method (DESM), autoregressive integrated moving average (ARIMA) model and proposed analytical function method (PAFM) to analyze trends of accident data that will lead to an accurate prediction. This paper standardized the questionnaire results of workers and managers in manufacturing and construction companies with less than 300 employees, located in the central Korean metropolitan areas where fatal accidents have occurred. Finally, a strategy was provided to construct safety management for the third industrial accident prevention plan and a forecasting method for occupational accident rates and fatality rates for occupational accidents per 10,000 people.

Using Quasi-Horizontal Alignment in the absence of the actual alignment.

PubMed

Banihashemi, Mohamadreza

2016-10-01

Horizontal alignment is a major roadway characteristic used in safety and operational evaluations of many facility types. The Highway Safety Manual (HSM) uses this characteristic in crash prediction models for rural two-lane highways, freeway segments, and freeway ramps/C-D roads. Traffic simulation models use this characteristic in their processes on almost all types of facilities. However, a good portion of roadway databases do not include horizontal alignment data; instead, many contain point coordinate data along the roadways. SHRP 2 Roadway Information Database (RID) is a good example of this type of data. Only about 5% of this geodatabase contains alignment information and for the rest, point data can easily be produced. Even though the point data can be used to extract actual horizontal alignment data but, extracting horizontal alignment is a cumbersome and costly process, especially for a database of miles and miles of highways. This research introduces a so called "Quasi-Horizontal Alignment" that can be produced easily and automatically from point coordinate data and can be used in the safety and operational evaluations of highways. SHRP 2 RID for rural two-lane highways in Washington State is used in this study. This paper presents a process through which Quasi-Horizontal Alignments are produced from point coordinates along highways by using spreadsheet software such as MS EXCEL. It is shown that the safety and operational evaluations of the highways with Quasi-Horizontal Alignments are almost identical to the ones with the actual alignments. In the absence of actual alignment the Quasi-Horizontal Alignment can easily be produced from any type of databases that contain highway coordinates such geodatabases and digital maps. Copyright © 2016 Elsevier Ltd. All rights reserved.

Longitudinal safety evaluation of connected vehicles' platooning on expressways.

PubMed

Rahman, Md Sharikur; Abdel-Aty, Mohamed

2018-08-01

Connected vehicles (CV) technology has recently drawn an increasing attention from governments, vehicle manufacturers, and researchers. One of the biggest issues facing CVs popularization associates it with the market penetration rate (MPR). The full market penetration of CVs might not be accomplished recently. Therefore, traffic flow will likely be composed of a mixture of conventional vehicles and CVs. In this context, the study of CV MPR is worthwhile in the CV transition period. The overarching goal of this study was to evaluate longitudinal safety of CV platoons by comparing the implementation of managed-lane CV platoons and all lanes CV platoons (with same MPR) over non-CV scenario. This study applied the CV concept on a congested expressway (SR408) in Florida to improve traffic safety. The Intelligent Driver Model (IDM) along with the platooning concept were used to regulate the driving behavior of CV platoons with an assumption that the CVs would follow this behavior in real-world. A high-level control algorithm of CVs in a managed-lane was proposed in order to form platoons with three joining strategies: rear join, front join, and cut-in joint. Five surrogate safety measures, standard deviation of speed, time exposed time-to-collision (TET), time integrated time-to-collision (TIT), time exposed rear-end crash risk index (TERCRI), and sideswipe crash risk (SSCR) were utilized as indicators for safety evaluation. The results showed that both CV approaches (i.e., managed-lane CV platoons, and all lanes CV platoons) significantly improved the longitudinal safety in the studied expressway compared to the non-CV scenario. In terms of surrogate safety measures, the managed-lane CV platoons significantly outperformed all lanes CV platoons with the same MPR. Different time-to-collision (TTC) thresholds were also tested and showed similar results on traffic safety. Results of this study provide useful insight for the management of CV MPR as managed-lane CV platoons. Copyright © 2017 Elsevier Ltd. All rights reserved.

Toward an understanding of the impact of production pressure on safety performance in construction operations.

PubMed

Han, Sanguk; Saba, Farzaneh; Lee, Sanghyun; Mohamed, Yasser; Peña-Mora, Feniosky

2014-07-01

It is not unusual to observe that actual schedule and quality performances are different from planned performances (e.g., schedule delay and rework) during a construction project. Such differences often result in production pressure (e.g., being pressed to work faster). Previous studies demonstrated that such production pressure negatively affects safety performance. However, the process by which production pressure influences safety performance, and to what extent, has not been fully investigated. As a result, the impact of production pressure has not been incorporated much into safety management in practice. In an effort to address this issue, this paper examines how production pressure relates to safety performance over time by identifying their feedback processes. A conceptual causal loop diagram is created to identify the relationship between schedule and quality performances (e.g., schedule delays and rework) and the components related to a safety program (e.g., workers' perceptions of safety, safety training, safety supervision, and crew size). A case study is then experimentally undertaken to investigate this relationship with accident occurrence with the use of data collected from a construction site; the case study is used to build a System Dynamics (SD) model. The SD model, then, is validated through inequality statistics analysis. Sensitivity analysis and statistical screening techniques further permit an evaluation of the impact of the managerial components on accident occurrence. The results of the case study indicate that schedule delays and rework are the critical factors affecting accident occurrence for the monitored project. Copyright © 2013 Elsevier Ltd. All rights reserved.

Associations of Neighborhood Crime and Safety and With Changes in Body Mass Index and Waist Circumference: The Multi-Ethnic Study of Atherosclerosis.

PubMed

Powell-Wiley, Tiffany M; Moore, Kari; Allen, Norrina; Block, Richard; Evenson, Kelly R; Mujahid, Mahasin; Diez Roux, Ana V

2017-08-01

Using data from the Multi-Ethnic Study of Atherosclerosis (MESA), we evaluated associations of neighborhood crime and safety with changes in adiposity (body mass index (BMI) and waist circumference). MESA is a longitudinal study of cardiovascular disease among adults aged 45-84 years at baseline in 2000-2002, from 6 US sites, with follow-up for MESA participants until 2012. Data for this study were limited to Chicago, Illinois, participants in the MESA Neighborhood Ancillary Study, for whom police-recorded crime data were available, and who had complete baseline data (n = 673). We estimated associations of individual-level safety, aggregated neighborhood-level safety, and police-recorded crime with baseline levels and trajectories of BMI and waist circumference over time using linear mixed modeling with random effects. We also estimated how changes in these factors related to changes in BMI and waist circumference using econometric fixed-effects models. At baseline, greater individual-level safety was associated with more adiposity. Increasing individual- and neighborhood-level safety over time were associated with decreasing BMI over the 10-year period, with a more pronounced effect observed in women for individual-level safety and men for neighborhood-level safety. Police-recorded crime was not associated with adiposity. Neighborhood-level safety likely influences adiposity change and subsequent cardiovascular risk in multiethnic populations. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health 2017. This work is written by (a) US Government employee(s) and is in the public domain in the US.

Farmworkers at the border: a bilingual initiative for occupational health and safety.

PubMed

Acosta, Martha Soledad Vela; Sechrest, Lee; Chen, Mei-Kuang

2009-01-01

Bilingual and bicultural occupational health and safety interventions for Hispanic farmworkers are extremely rare and, because of language barriers and cultural differences, issues important to their health and safety on the job remain unaddressed. We designed, conducted, and assessed the first bilingual occupational health and safety education program for farmworkers attending High School Equivalency Programs (HEPs). We took an interdisciplinary participatory approach by integrating educators and researchers with a community advisory board to guide development, evaluation, and implementation of Work Safely-Trabaje con Cuidado Curriculum (Curriculum), a bilingual occupational health and safety curriculum. We created a quasi-experimental design using mixed-method evaluation (quantitative and qualitative elements) via pre- and posttest comparisons, follow-up surveys, and focus groups assessing the Curriculum effect on knowledge, safety risk perception (SRP), and safety behavior. Focus groups and follow-up surveys reflected success and acceptance of the Curriculum among participating farmworkers under the study's logic model. Completion of the Curriculum resulted in statistically significant improvements in the combined score of knowledge and SRP at the posttest (p = 0.001) and follow-up survey (p = 0.02) in the intervention group. After completing this study, the Curriculum was permanently adopted by the two high school equivalency sites involved. The participatory approach resulted in integration of community and applied research partnership. The potential to expand use of this Curriculum by other HEP sites can further assess effectiveness and external validity among underserved minority groups.

29 CFR 1960.11 - Evaluation of occupational safety and health performance.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 29 Labor 9 2012-07-01 2012-07-01 false Evaluation of occupational safety and health performance. 1960.11 Section 1960.11 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... AND HEALTH PROGRAMS AND RELATED MATTERS Administration § 1960.11 Evaluation of occupational safety and...

29 CFR 1960.79 - Self-evaluations of occupational safety and health programs.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 29 Labor 9 2012-07-01 2012-07-01 false Self-evaluations of occupational safety and health programs. 1960.79 Section 1960.79 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs...

29 CFR 1960.79 - Self-evaluations of occupational safety and health programs.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 29 Labor 9 2014-07-01 2014-07-01 false Self-evaluations of occupational safety and health programs. 1960.79 Section 1960.79 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs...

29 CFR 1960.79 - Self-evaluations of occupational safety and health programs.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 29 Labor 9 2013-07-01 2013-07-01 false Self-evaluations of occupational safety and health programs. 1960.79 Section 1960.79 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs...

29 CFR 1960.11 - Evaluation of occupational safety and health performance.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 29 Labor 9 2013-07-01 2013-07-01 false Evaluation of occupational safety and health performance. 1960.11 Section 1960.11 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... AND HEALTH PROGRAMS AND RELATED MATTERS Administration § 1960.11 Evaluation of occupational safety and...

29 CFR 1960.11 - Evaluation of occupational safety and health performance.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 29 Labor 9 2014-07-01 2014-07-01 false Evaluation of occupational safety and health performance. 1960.11 Section 1960.11 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... AND HEALTH PROGRAMS AND RELATED MATTERS Administration § 1960.11 Evaluation of occupational safety and...

29 CFR 1960.79 - Self-evaluations of occupational safety and health programs.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 29 Labor 9 2011-07-01 2011-07-01 false Self-evaluations of occupational safety and health programs. 1960.79 Section 1960.79 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs...

29 CFR 1960.11 - Evaluation of occupational safety and health performance.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 29 Labor 9 2011-07-01 2011-07-01 false Evaluation of occupational safety and health performance. 1960.11 Section 1960.11 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... AND HEALTH PROGRAMS AND RELATED MATTERS Administration § 1960.11 Evaluation of occupational safety and...

76 FR 454 - Hazardous Materials Transportation: Revisions of Special Permits Procedures

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-05

... the agency to evaluate the applicant's fitness and the safety impact of operations that would be... applicant granted a special permit undergoes a safety fitness evaluation, further assuring the safety of... operations to enable the agency to evaluate the applicant's fitness and the safety impact of operations that...

21 CFR 315.6 - Evaluation of safety.

Code of Federal Regulations, 2011 CFR

2011-04-01

... information, the following types of data: (i) Pharmacology data, (ii) Toxicology data, (iii) Clinical adverse... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Evaluation of safety. 315.6 Section 315.6 Food and... USE DIAGNOSTIC RADIOPHARMACEUTICALS § 315.6 Evaluation of safety. (a) Factors considered in the safety...

29 CFR 1960.79 - Self-evaluations of occupational safety and health programs.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 9 2010-07-01 2010-07-01 false Self-evaluations of occupational safety and health programs. 1960.79 Section 1960.79 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs...

29 CFR 1960.11 - Evaluation of occupational safety and health performance.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 9 2010-07-01 2010-07-01 false Evaluation of occupational safety and health performance. 1960.11 Section 1960.11 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... AND HEALTH PROGRAMS AND RELATED MATTERS Administration § 1960.11 Evaluation of occupational safety and...

Quantitative systems toxicology

PubMed Central

Bloomingdale, Peter; Housand, Conrad; Apgar, Joshua F.; Millard, Bjorn L.; Mager, Donald E.; Burke, John M.; Shah, Dhaval K.

2017-01-01

The overarching goal of modern drug development is to optimize therapeutic benefits while minimizing adverse effects. However, inadequate efficacy and safety concerns remain to be the major causes of drug attrition in clinical development. For the past 80 years, toxicity testing has consisted of evaluating the adverse effects of drugs in animals to predict human health risks. The U.S. Environmental Protection Agency recognized the need to develop innovative toxicity testing strategies and asked the National Research Council to develop a long-range vision and strategy for toxicity testing in the 21st century. The vision aims to reduce the use of animals and drug development costs through the integration of computational modeling and in vitro experimental methods that evaluates the perturbation of toxicity-related pathways. Towards this vision, collaborative quantitative systems pharmacology and toxicology modeling endeavors (QSP/QST) have been initiated amongst numerous organizations worldwide. In this article, we discuss how quantitative structure-activity relationship (QSAR), network-based, and pharmacokinetic/pharmacodynamic modeling approaches can be integrated into the framework of QST models. Additionally, we review the application of QST models to predict cardiotoxicity and hepatotoxicity of drugs throughout their development. Cell and organ specific QST models are likely to become an essential component of modern toxicity testing, and provides a solid foundation towards determining individualized therapeutic windows to improve patient safety. PMID:29308440

Quality of traffic flow on urban arterial streets and its relationship with safety.

PubMed

Dixit, Vinayak V; Pande, Anurag; Abdel-Aty, Mohamed; Das, Abhishek; Radwan, Essam

2011-09-01

The two-fluid model for vehicular traffic flow explains the traffic on arterials as a mix of stopped and running vehicles. It describes the relationship between the vehicles' running speed and the fraction of running vehicles. The two parameters of the model essentially represent 'free flow' travel time and level of interaction among vehicles, and may be used to evaluate urban roadway networks and urban corridors with partially limited access. These parameters are influenced by not only the roadway characteristics but also by behavioral aspects of driver population, e.g., aggressiveness. Two-fluid models are estimated for eight arterial corridors in Orlando, FL for this study. The parameters of the two-fluid model were used to evaluate corridor level operations and the correlations of these parameters' with rates of crashes having different types/severity. Significant correlations were found between two-fluid parameters and rear-end and angle crash rates. Rate of severe crashes was also found to be significantly correlated with the model parameter signifying inter-vehicle interactions. While there is need for further analysis, the findings suggest that the two-fluid model parameters may have potential as surrogate measures for traffic safety on urban arterial streets. Copyright © 2011 Elsevier Ltd. All rights reserved.

Serious injuries: an additional indicator to fatalities for road safety benchmarking.

PubMed

Shen, Yongjun; Hermans, Elke; Bao, Qiong; Brijs, Tom; Wets, Geert

2015-01-01

Almost all of the current road safety benchmarking studies focus entirely on fatalities, which, however, represent only one measure of the magnitude of the road safety problem. The main objective of this article was to investigate the possibility of including the number of serious injuries in addition to the number of fatalities for road safety benchmarking and to further illuminate its impact on the countries' rankings. We introduced the technique of data envelopment analysis (DEA) to the road safety domain and developed a DEA-based road safety model (DEA-RS) in this study. Moreover, we outlined different types of possible weight restrictions and adopted 2 of them to indicate the relationship between road fatalities and serious injuries for the sake of rational benchmarking. One was a relative weight restriction based on the information of their shadow price, and the other was a virtual weight restriction using a priori knowledge about the importance level of these 2 aspects. By computing the most optimal road safety risk scores of 10 European countries based on the different models, we found that United Kingdom was the only best-performing country no matter which model was utilized. However, countries such as The Netherlands, Sweden, and Switzerland were no longer best-performing when the serious injuries were integrated. On the contrary, Spain, which ranked almost at the bottom among all of the countries when only the number of road fatalities was considered, became a relatively well-performing country when integrating its number of serious injuries in the evaluation. In general, no matter whether the country's road safety ranking was improved or deteriorated, most of the countries achieved a higher risk score when the number of serious injuries was included, which implied that compared to the road fatalities, more policy attention has to be paid to improve the situation of serious injuries in most countries. Given the importance of considering the serious injuries in addition to the fatalities for international benchmarking of road safety, the proposed model (i.e., the DEA-RS model with weight restrictions) turned out to be effective in deriving reasonable results. We are thereby also inspired to apply this kind of model to a more complete road safety benchmarking practice in the future when the data on, for example, the number of slight injuries, the degree of property damage, and the number of crashes are ready (i.e., comparable) to use.

Occupational hazard evaluation model underground coal mine based on unascertained measurement theory

NASA Astrophysics Data System (ADS)

Deng, Quanlong; Jiang, Zhongan; Sun, Yaru; Peng, Ya

2017-05-01

In order to study how to comprehensively evaluate the influence of several occupational hazard on miners’ physical and mental health, based on unascertained measurement theory, occupational hazard evaluation indicator system was established to make quantitative and qualitative analysis. Determining every indicator weight by information entropy and estimating the occupational hazard level by credible degree recognition criteria, the evaluation model was programmed by Visual Basic, applying the evaluation model to occupational hazard comprehensive evaluation of six posts under a coal mine, and the occupational hazard degree was graded, the evaluation results are consistent with actual situation. The results show that dust and noise is most obvious among the coal mine occupational hazard factors. Excavation face support workers are most affected, secondly, heading machine drivers, coal cutter drivers, coalface move support workers, the occupational hazard degree of these four types workers is II mild level. The occupational hazard degree of ventilation workers and safety inspection workers is I level. The evaluation model could evaluate underground coal mine objectively and accurately, and can be employed to the actual engineering.

Modeling and Evaluating Pilot Performance in NextGen: Review of and Recommendations Regarding Pilot Modeling Efforts, Architectures, and Validation Studies

NASA Technical Reports Server (NTRS)

Wickens, Christopher; Sebok, Angelia; Keller, John; Peters, Steve; Small, Ronald; Hutchins, Shaun; Algarin, Liana; Gore, Brian Francis; Hooey, Becky Lee; Foyle, David C.

2013-01-01

NextGen operations are associated with a variety of changes to the national airspace system (NAS) including changes to the allocation of roles and responsibilities among operators and automation, the use of new technologies and automation, additional information presented on the flight deck, and the entire concept of operations (ConOps). In the transition to NextGen airspace, aviation and air operations designers need to consider the implications of design or system changes on human performance and the potential for error. To ensure continued safety of the NAS, it will be necessary for researchers to evaluate design concepts and potential NextGen scenarios well before implementation. One approach for such evaluations is through human performance modeling. Human performance models (HPMs) provide effective tools for predicting and evaluating operator performance in systems. HPMs offer significant advantages over empirical, human-in-the-loop testing in that (1) they allow detailed analyses of systems that have not yet been built, (2) they offer great flexibility for extensive data collection, (3) they do not require experimental participants, and thus can offer cost and time savings. HPMs differ in their ability to predict performance and safety with NextGen procedures, equipment and ConOps. Models also vary in terms of how they approach human performance (e.g., some focus on cognitive processing, others focus on discrete tasks performed by a human, while others consider perceptual processes), and in terms of their associated validation efforts. The objectives of this research effort were to support the Federal Aviation Administration (FAA) in identifying HPMs that are appropriate for predicting pilot performance in NextGen operations, to provide guidance on how to evaluate the quality of different models, and to identify gaps in pilot performance modeling research, that could guide future research opportunities. This research effort is intended to help the FAA evaluate pilot modeling efforts and select the appropriate tools for future modeling efforts to predict pilot performance in NextGen operations.

Current Topics in Postnatal Behavioral Testing.

PubMed

Henck, Judith W; Elayan, Ikram; Vorhees, Charles; Fisher, J Edward; Morford, LaRonda L

2016-09-01

The study of developmental neurotoxicity (DNT) continues to be an important component of safety evaluation of candidate therapeutic agents and of industrial and environmental chemicals. Developmental neurotoxicity is considered to be an adverse change in the central and/or peripheral nervous system during development of an organism and has been primarily evaluated by studying functional outcomes, such as changes in behavior, neuropathology, neurochemistry, and/or neurophysiology. Neurobehavioral evaluations are a component of a wide range of toxicology studies in laboratory animal models, whereas neurochemistry and neurophysiology are less commonly employed. Although the primary focus of this article is on neurobehavioral evaluation in pre- and postnatal development and juvenile toxicology studies used in pharmaceutical development, concepts may also apply to adult nonclinical safety studies and Environmental Protection Agency/chemical assessments. This article summarizes the proceedings of a symposium held during the 2015 American College of Toxicology annual meeting and includes a discussion of the current status of DNT testing as well as potential issues and recommendations. Topics include the regulatory context for DNT testing; study design and interpretation; behavioral test selection, including a comparison of core learning and memory systems; age of testing; repeated testing of the same animals; use of alternative animal models; impact of findings; and extrapolation of animal results to humans. Integration of the regulatory experience and scientific concepts presented during this symposium, as well as from subsequent discussion and input, provides a synopsis of the current state of DNT testing in safety assessment, as well as a potential roadmap for future advancement. © The Author(s) 2016.

Evaluating and Predicting Patient Safety for Medical Devices With Integral Information Technology

DTIC Science & Technology

2005-01-01

have the potential to become solid tools for manufacturers, purchasers, and consumers to evaluate patient safety issues in various health related...323 Evaluating and Predicting Patient Safety for Medical Devices with Integral Information Technology Jiajie Zhang, Vimla L. Patel, Todd R...errors are due to inappropriate designs for user interactions, rather than mechanical failures. Evaluating and predicting patient safety in medical

Multi-level Bayesian safety analysis with unprocessed Automatic Vehicle Identification data for an urban expressway.

PubMed

Shi, Qi; Abdel-Aty, Mohamed; Yu, Rongjie

2016-03-01

In traffic safety studies, crash frequency modeling of total crashes is the cornerstone before proceeding to more detailed safety evaluation. The relationship between crash occurrence and factors such as traffic flow and roadway geometric characteristics has been extensively explored for a better understanding of crash mechanisms. In this study, a multi-level Bayesian framework has been developed in an effort to identify the crash contributing factors on an urban expressway in the Central Florida area. Two types of traffic data from the Automatic Vehicle Identification system, which are the processed data capped at speed limit and the unprocessed data retaining the original speed were incorporated in the analysis along with road geometric information. The model framework was proposed to account for the hierarchical data structure and the heterogeneity among the traffic and roadway geometric data. Multi-level and random parameters models were constructed and compared with the Negative Binomial model under the Bayesian inference framework. Results showed that the unprocessed traffic data was superior. Both multi-level models and random parameters models outperformed the Negative Binomial model and the models with random parameters achieved the best model fitting. The contributing factors identified imply that on the urban expressway lower speed and higher speed variation could significantly increase the crash likelihood. Other geometric factors were significant including auxiliary lanes and horizontal curvature. Copyright © 2015 Elsevier Ltd. All rights reserved.

Safety risk assessment using analytic hierarchy process (AHP) during planning and budgeting of construction projects.

PubMed

Aminbakhsh, Saman; Gunduz, Murat; Sonmez, Rifat

2013-09-01

The inherent and unique risks on construction projects quite often present key challenges to contractors. Health and safety risks are among the most significant risks in construction projects since the construction industry is characterized by a relatively high injury and death rate compared to other industries. In construction project management, safety risk assessment is an important step toward identifying potential hazards and evaluating the risks associated with the hazards. Adequate prioritization of safety risks during risk assessment is crucial for planning, budgeting, and management of safety related risks. In this paper, a safety risk assessment framework is presented based on the theory of cost of safety (COS) model and the analytic hierarchy process (AHP). The main contribution of the proposed framework is that it presents a robust method for prioritization of safety risks in construction projects to create a rational budget and to set realistic goals without compromising safety. The framework provides a decision tool for the decision makers to determine the adequate accident/injury prevention investments while considering the funding limits. The proposed safety risk framework is illustrated using a real-life construction project and the advantages and limitations of the framework are discussed. Copyright © 2013 National Safety Council and Elsevier Ltd. All rights reserved.

Use and misuse of motor-vehicle crash death rates in assessing highway-safety performance.

PubMed

O'Neill, Brian; Kyrychenko, Sergey Y

2006-12-01

The objectives of the article are to assess the extent to which comparisons of motor-vehicle crash death rates can be used to determine the effectiveness of highway-safety policies over time in a country or to compare policy effectiveness across countries. Motor-vehicle crash death rates per mile traveled in the 50 U.S. states from 1980 to 2003 are used to show the influence on these rates of factors independent of highway-safety interventions. Multiple regression models relating state death rates to various measures related to urbanization and demographics are used. The analyses demonstrate strong relationships between state death rates and urbanization and demographics. Almost 60% of the variability among the state death rates can be explained by the independent variables in the multiple regression models. When the death rates for passenger vehicle occupants (i.e., excluding motorcycle, pedestrian, and other deaths) are used in the regression models, almost 70% of the variability in the rates can be explained by urbanization and demographics. The analyses presented in the article demonstrate that motor-vehicle crash death rates are strongly influenced by factors unrelated to highway-safety countermeasures. Overall death rates should not be used as a basis for judging the effectiveness (or ineffectiveness) of specific highway-safety countermeasures or to assess overall highway-safety policies, especially across jurisdictions. There can be no substitute for the use of carefully designed scientific evaluations of highway-safety interventions that use outcome measures directly related to the intervention; e.g., motorcyclist deaths should be used to assess the effectiveness of motorcycle helmet laws. While this may seem obvious, there are numerous examples in the literature of death rates from all crashes being used to assess the effectiveness of interventions aimed at specific subsets of crashes.

Healthcare system intervention for prevention of birth injuries – process evaluation of self-assessment, peer review, feedback and agreement for change

PubMed Central

2012-01-01

Background Patient safety is fundamental in high quality healthcare systems but despite an excellent record of perinatal care in Sweden some children still suffer from substandard care and unnecessary birth injuries. Sustainable patient safety improvements assume changes in key actors’ mental models, norms and culture as well as in the tools, design and organisation of work. Interventions positively affecting team mental models on safety issues are a first step to enhancing change. Our purpose was to study a national intervention programme for the prevention of birth injuries with the aim to elucidate how the main interventions of self-assessment, peer review, feedback and written agreement for change affected the teams and their mental model of patient safety, and thereby their readiness for change. Knowledge of relevant considerations before implementing this type of patient safety intervention series could thereby be increased. Methods Eighty participants in twenty-seven maternity units were interviewed after the first intervention sequence of the programme. A content analysis using a priori coding was performed in order to relate results to the anticipated outcomes of three basic interventions: self-assessment, peer review and written feedback, and agreement for change. Results The self-assessment procedure was valuable and served as a useful tool for elucidating strengths and weaknesses and identifying areas for improvement for a safer delivery in maternity units. The peer-review intervention was appreciated, despite it being of less value when considering the contribution to explicit outcome effects (i.e. new input to team mental models and new suggestions for actions). The feedback report and the mutual agreement on measures for improvements reached when signing the contract seemed exert positive pressures for change. Conclusions Our findings are in line with several studies stressing the importance of self-evaluation by encouraging a thorough review of objectives, practices and outcomes for the continuous improvement of an organisation. Even though effects of the peer review were limited, feedback from peers, or other change agents involved, and the support that a clear and well-structured action plan can provide are considered to be two important complements to future self-assessment procedures related to patient safety improvement. PMID:22920327

Performability evaluation of the SIFT computer

NASA Technical Reports Server (NTRS)

Meyer, J. F.; Furchtgott, D. G.; Wu, L. T.

1979-01-01

Performability modeling and evaluation techniques are applied to the SIFT computer as it might operate in the computational evironment of an air transport mission. User-visible performance of the total system (SIFT plus its environment) is modeled as a random variable taking values in a set of levels of accomplishment. These levels are defined in terms of four attributes of total system behavior: safety, no change in mission profile, no operational penalties, and no economic process whose states describe the internal structure of SIFT as well as relavant conditions of the environment. Base model state trajectories are related to accomplishment levels via a capability function which is formulated in terms of a 3-level model hierarchy. Performability evaluation algorithms are then applied to determine the performability of the total system for various choices of computer and environment parameter values. Numerical results of those evaluations are presented and, in conclusion, some implications of this effort are discussed.

Using logic models in a community-based agricultural injury prevention project.

PubMed

Helitzer, Deborah; Willging, Cathleen; Hathorn, Gary; Benally, Jeannie

2009-01-01

The National Institute for Occupational Safety and Health has long promoted the logic model as a useful tool in an evaluator's portfolio. Because a logic model supports a systematic approach to designing interventions, it is equally useful for program planners. Undertaken with community stakeholders, a logic model process articulates the underlying foundations of a particular programmatic effort and enhances program design and evaluation. Most often presented as sequenced diagrams or flow charts, logic models demonstrate relationships among the following components: statement of a problem, various causal and mitigating factors related to that problem, available resources to address the problem, theoretical foundations of the selected intervention, intervention goals and planned activities, and anticipated short- and long-term outcomes. This article describes a case example of how a logic model process was used to help community stakeholders on the Navajo Nation conceive, design, implement, and evaluate agricultural injury prevention projects.

A participatory model for improving occupational health and safety: improving informal sector working conditions in Thailand.

PubMed

Manothum, Aniruth; Rukijkanpanich, Jittra; Thawesaengskulthai, Damrong; Thampitakkul, Boonwa; Chaikittiporn, Chalermchai; Arphorn, Sara

2009-01-01

The purpose of this study was to evaluate the implementation of an Occupational Health and Safety Management Model for informal sector workers in Thailand. The studied model was characterized by participatory approaches to preliminary assessment, observation of informal business practices, group discussion and participation, and the use of environmental measurements and samples. This model consisted of four processes: capacity building, risk analysis, problem solving, and monitoring and control. The participants consisted of four local labor groups from different regions, including wood carving, hand-weaving, artificial flower making, and batik processing workers. The results demonstrated that, as a result of applying the model, the working conditions of the informal sector workers had improved to meet necessary standards. This model encouraged the use of local networks, which led to cooperation within the groups to create appropriate technologies to solve their problems. The authors suggest that this model could effectively be applied elsewhere to improve informal sector working conditions on a broader scale.

Use of car crashes resulting in fatal and serious injuries to analyze a safe road transport system model and to identify system weaknesses.

PubMed

Stigson, Helena; Hill, Julian

2009-10-01

The objective of this study was to evaluate a model for a safe road transport system, based on some safety performance indicators regarding the road user, the vehicle, and the road, by using crashes with fatally and seriously injured car occupants. The study also aimed to evaluate whether the model could be used to identify system weaknesses and components (road user, vehicles, and road) where improvements would yield the highest potential for further reductions in serious injuries. Real-life car crashes with serious injury outcomes (Maximum Abbreviated Injury Scale 2+) were classified according to the vehicle's safety rating by Euro NCAP (European New Car Assessment Programme) and whether the vehicle was fitted with ESC (Electronic Stability Control). For each crash, the road was also classified according to EuroRAP (European Road Assessment Programme) criteria, and human behavior in terms of speeding, seat belt use, and driving under the influence of alcohol/drugs. Each crash was compared and classified according to the model criteria. Crashes where the safety criteria were not met in more than one of the 3 components were reclassified to identify whether all the components were correlated to the injury outcome. In-depth crash injury data collected by the UK On The Spot (OTS) accident investigation project was used in this study. All crashes in the OTS database occurring between 2000 and 2005 with a car occupant with injury rated MAIS2+ were included, for a total of 101 crashes with 120 occupants. It was possible to classify 90 percent of the crashes according to the model. Eighty-six percent of the occupants were injured when more than one of the 3 components were noncompliant with the safety criteria. These cases were reclassified to identify whether all of the components were correlated to the injury outcome. In 39 of the total 108 cases, at least two components were still seen to interact. The remaining cases were only related to one of the safety criteria, namely, the road user (26), the vehicle (19), and the road (24). The criteria for the road and the vehicle did not address multiple event crashes, rear-end crashes, hitting stationary/parked vehicles, or trailers. The model for a safe road transport system was found useful to classify fatal and serious road vehicle crashes. It was possible to classify 90 percent of the crashes according to the safety road transport model. For all these cases it was possible to identify weaknesses and parts of the road transport system with the highest potential to prevent fatal and serious injuries. Injury outcomes were mostly related to an interaction between the 3 components: the road, the vehicle, and the road user.

'It's a cultural expectation...' The pressure on medical trainees to work independently in clinical practice.

PubMed

Kennedy, Tara J T; Regehr, Glenn; Baker, G Ross; Lingard, Lorelei A

2009-07-01

Medical trainees demonstrate a reluctance to ask for help unless they believe it is absolutely necessary, a situation which could impact on the safety of patients. This study aimed to develop a theoretical exploration of the pressure on medical trainees to be independent and to generate theory-based approaches to the implications for patient safety of this pressure towards independent working. In Phase 1, 88 teaching team members from internal and emergency medicine were observed during clinical activities (216 hours), and 65 participants completed brief interviews. In Phase 2, 36 in-depth interviews were conducted using video vignettes. Data collection and analysis employed grounded theory methodology. Participants conceived that the pressure towards independence in clinical work originated in trainees' desire to lay claim to the identity of a doctor (as a member of a group of autonomous high achievers), and in organisational issues such as heavy workloads and constant evaluations. The identity and organisational issues related to the pressure towards independence were explored through the lenses of established theories from education and psychology. Consideration of Lave and Wenger's situated learning theory suggests that giving attention to the 'independent doctor' ideal, through measures such as involving trainees when their supervisors ask for help, could impact the safety of teaching team practice. Amalberti et al.'s migration model explains how pressures to maximise productivity and individual gain may cause teaching teams to migrate beyond the boundaries of safe practice and suggests that managing triggers (such as workload and high-stakes evaluations) for violations of safe practice might improve safety. Implementation and evaluation of these theory-based approaches to the safety of teaching team practice would contribute to a better understanding of the links between trainee independence and patient safety.

Assuring safety without animal testing: Unilever's ongoing research programme to deliver novel ways to assure consumer safety.

PubMed

Westmoreland, Carl; Carmichael, Paul; Dent, Matt; Fentem, Julia; MacKay, Cameron; Maxwell, Gavin; Pease, Camilla; Reynolds, Fiona

2010-01-01

Assuring consumer safety without the generation of new animal data is currently a considerable challenge. However, through the application of new technologies and the further development of risk-based approaches for safety assessment, we remain confident it is ultimately achievable. For many complex, multi-organ consumer safety endpoints, the development, evaluation and application of new, non-animal approaches is hampered by a lack of biological understanding of the underlying mechanistic processes involved. The enormity of this scientific challenge should not be underestimated. To tackle this challenge a substantial research programme was initiated by Unilever in 2004 to critically evaluate the feasibility of a new conceptual approach based upon the following key components: 1.Developing new, exposure-driven risk assessment approaches. 2.Developing new biological (in vitro) and computer-based (in silico) predictive models. 3.Evaluating the applicability of new technologies for generating data (e.g. "omics", informatics) and for integrating new types of data (e.g. systems approaches) for risk-based safety assessment. Our research efforts are focussed in the priority areas of skin allergy, cancer and general toxicity (including inhaled toxicity). In all of these areas, a long-term investment is essential to increase the scientific understanding of the underlying biology and molecular mechanisms that we believe will ultimately form a sound basis for novel risk assessment approaches. Our research programme in these priority areas consists of in-house research as well as Unilever-sponsored academic research, involvement in EU-funded projects (e.g. Sens-it-iv, Carcinogenomics), participation in cross-industry collaborative research (e.g. Colipa, EPAA) and ongoing involvement with other scientific initiatives on non-animal approaches to risk assessment (e.g. UK NC3Rs, US "Human Toxicology Project" consortium).

Accelerated vehicle-to-infrastructure (V2I) safety applications : concept of operations document.

DOT National Transportation Integrated Search

2001-12-01

This document summarizes lessons learned through the evaluation of four sites selected in 1996 to serve as national models for deploying and operating intelligent transportation systems (ITS) in metropolitan areas. One of the goals of the Metropolita...

76 FR 41041 - Special Conditions: Gulfstream Aerospace LP (GALP) Model G250 Airplane, Interaction of Systems...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-13

... performance. They cannot be considered in isolation but should be included in the overall safety evaluation of.... 25.629(b)(2) are maintained. (4) Failures of the system that result in forced structural vibrations...

Generating Phenotypical Erroneous Human Behavior to Evaluate Human-automation Interaction Using Model Checking

PubMed Central

Bolton, Matthew L.; Bass, Ellen J.; Siminiceanu, Radu I.

2012-01-01

Breakdowns in complex systems often occur as a result of system elements interacting in unanticipated ways. In systems with human operators, human-automation interaction associated with both normative and erroneous human behavior can contribute to such failures. Model-driven design and analysis techniques provide engineers with formal methods tools and techniques capable of evaluating how human behavior can contribute to system failures. This paper presents a novel method for automatically generating task analytic models encompassing both normative and erroneous human behavior from normative task models. The generated erroneous behavior is capable of replicating Hollnagel’s zero-order phenotypes of erroneous action for omissions, jumps, repetitions, and intrusions. Multiple phenotypical acts can occur in sequence, thus allowing for the generation of higher order phenotypes. The task behavior model pattern capable of generating erroneous behavior can be integrated into a formal system model so that system safety properties can be formally verified with a model checker. This allows analysts to prove that a human-automation interactive system (as represented by the model) will or will not satisfy safety properties with both normative and generated erroneous human behavior. We present benchmarks related to the size of the statespace and verification time of models to show how the erroneous human behavior generation process scales. We demonstrate the method with a case study: the operation of a radiation therapy machine. A potential problem resulting from a generated erroneous human action is discovered. A design intervention is presented which prevents this problem from occurring. We discuss how our method could be used to evaluate larger applications and recommend future paths of development. PMID:23105914

Analysis of vehicle's safety envelope under car-following model

NASA Astrophysics Data System (ADS)

Tang, Tie-Qiao; Zhang, Jian; Chen, Liang; Shang, Hua-Yan

2017-05-01

In this paper, we propose an improved car-following model to explore the impacts of vehicle's two safety distances (i.e., the front safety distance and back safety distance) on the traffic safety during the starting process. The numerical results show that our model is prominently safer than the FVD (full velocity difference) model, i.e., our model is better than the FVD model from the perspective of the traffic safety, which shows that each driver should consider his two safety distances during his driving process.

Intersection crash prediction modeling with macro-level data from various geographic units.

PubMed

Lee, Jaeyoung; Abdel-Aty, Mohamed; Cai, Qing

2017-05-01

There have been great efforts to develop traffic crash prediction models for various types of facilities. The crash models have played a key role to identify crash hotspots and evaluate safety countermeasures. In recent, many macro-level crash prediction models have been developed to incorporate highway safety considerations in the long-term transportation planning process. Although the numerous macro-level studies have found that a variety of demographic and socioeconomic zonal characteristics have substantial effects on traffic safety, few studies have attempted to coalesce micro-level with macro-level data from existing geographic units for estimating crash models. In this study, the authors have developed a series of intersection crash models for total, severe, pedestrian, and bicycle crashes with macro-level data for seven spatial units. The study revealed that the total, severe, and bicycle crash models with ZIP-code tabulation area data performs the best, and the pedestrian crash models with census tract-based data outperforms the competing models. Furthermore, it was uncovered that intersection crash models can be drastically improved by only including random-effects for macro-level entities. Besides, the intersection crash models are even further enhanced by including other macro-level variables. Lastly, the pedestrian and bicycle crash modeling results imply that several macro-level variables (e.g., population density, proportions of specific age group, commuters who walk, or commuters using bicycle, etc.) can be a good surrogate exposure for those crashes. Copyright © 2017 Elsevier Ltd. All rights reserved.

Program evaluation of FHWA pedestrian and bicycle safety activities.

DOT National Transportation Integrated Search

2011-03-01

"Introduction : FHWAs Office of Highway Safety (HSA) initiated a program evaluation by Booz Allen Hamilton to assess the overall effectiveness of the Agencys Pedestrian and Bicycle Safety Program. The evaluation covers pedestrian and bicycle sa...

Extreme Environments Development of Decision Processes and Training Programs for Medical Policy Formulation

NASA Technical Reports Server (NTRS)

Stough, Roger

2004-01-01

The purpose of this workshop was to survey existing health and safety policies as well as processes and practices for various extreme environments; to identify strengths and shortcomings of these processes; and to recommend parameters for inclusion in a generic approach to policy formulation, applicable to the broadest categories of extreme environments. It was anticipated that two additional workshops would follow. The November 7, 2003 workshop would be devoted to the evaluation of different model(s) and a concluding expert evaluation of the usefulness of the model using a policy formulation example. The final workshop was planned for March 2004.

The breakdown of coordinated decision making in distributed systems.

PubMed

Bearman, Christopher; Paletz, Susannah B F; Orasanu, Judith; Thomas, Matthew J W

2010-04-01

This article aims to explore the nature and resolution of breakdowns in coordinated decision making in distributed safety-critical systems. In safety-critical domains, people with different roles and responsibilities often must work together to make coordinated decisions while geographically distributed. Although there is likely to be a large degree of overlap in the shared mental models of these people on the basis of procedures and experience, subtle differences may exist. Study 1 involves using Aviation Safety Reporting System reports to explore the ways in which coordinated decision making breaks down between pilots and air traffic controllers and the way in which the breakdowns are resolved. Study 2 replicates and extends those findings with the use of transcripts from the Apollo 13 National Aeronautics and Space Administration space mission. Across both studies, breakdowns were caused in part by different types of lower-level breakdowns (or disconnects), which are labeled as operational, informational, or evaluative. Evaluative disconnects were found to be significantly harder to resolve than other types of disconnects. Considering breakdowns according to the type of disconnect involved appears to capture useful information that should assist accident and incident investigators. The current trend in aviation of shifting responsibilities and providing increasingly more information to pilots may have a hidden cost of increasing evaluative disconnects. The proposed taxonomy facilitates the investigation of breakdowns in coordinated decision making and draws attention to the importance of considering subtle differences between participants' mental models when considering complex distributed systems.

Evaluation of safety effect of turbo-roundabout lane dividers using floating car data and video observation.

PubMed

Kieć, Mariusz; Ambros, Jiří; Bąk, Radosław; Gogolín, Ondřej

2018-06-01

Roundabouts are one of the safest types of intersections. However, the needs to meet the requirements of operation, capacity, traffic organization and surrounding development lead to a variety of design solutions. One of such alternatives are turbo-roundabouts, which simplify drivers' decision making, limit lane changing in the roundabout, and induce low driving speed thanks to raised lane dividers. However, in spite of their generally positive reception, the safety impact of turbo-roundabouts has not been sufficiently studied. Given the low number of existing turbo-roundabouts and the statistical rarity of accident occurrence, the prevalent previously conducted studies applied only simple before-after designs or relied on traffic conflicts in micro-simulations. Nevertheless, the presence of raised lane dividers is acknowledged as an important feature of well performing and safe turbo-roundabouts. Following the previous Polish studies, the primary objective of the present study was assessment of influence of presence of lane dividers on road safety and developing a reliable and valid surrogate safety measure based on field data, which will circumvent the limitations of accident data or micro-simulations. The secondary objective was using the developed surrogate safety measure to assess and compare the safety levels of Polish turbo-roundabout samples with and without raised lane dividers. The surrogate safety measure was based on speed and lane behaviour. Speed was obtained from video observations and floating car data, which enabled the construction of representative speed profiles. Lane behaviour data was gathered from video observations. The collection of the data allowed for a relative validation of the method by comparing the safety performance of turbo-roundabouts with and without raised lane dividers. In the end, the surrogate measure was applied for evaluation of safety levels and enhancement of the existing safety performance functions, which combine traffic volumes, and speeds as a function of radii). The final models may help quantify the safety impact of different turbo-roundabout solutions. Copyright © 2018 Elsevier Ltd. All rights reserved.

Implications of human tissue studies for radiation protection.

PubMed

Kathren, R L

1988-08-01

Through radiochemical analysis of voluntary tissue donations, the U.S. Transuranium and Uranium Registries (USTR) are gaining improved understanding of the distribution and biokinetics of actinide elements in occupationally exposed persons. Evaluation of the first two whole-body contributions to the USTR revealed an inverse proportionality between actinide concentration and bone ash. The analysis of a whole body with significant 241Am deposition indicated a significantly shorter half-time in liver and a greater fraction resident in the skeleton than predicted by existing models. Other studies with tissues obtained at autopsy suggest that existing biokinetic models for 238Pu and 241Am and the currently accepted models and limits on intake, which use these models as their basis, may be inaccurately implying that revisions of existing safety standards may be necessary. Other studies of the registries are designed to evaluate in-vivo estimates of actinide deposition with those derived from postmortem tissue analysis, to compare results of animal experiments with human data, and to review histopathologic slides for tissue changes that might be attributable to exposure to transuranic elements. The implications of these recent findings and other work of the registries is discussed from the standpoint of this potential effect on biokinetic modeling, internal dose assessment, and safety standards and operational health physics practices.

Long-Term Structural Health Monitoring System for a High-Speed Railway Bridge Structure.

PubMed

Ding, You-Liang; Wang, Gao-Xin; Sun, Peng; Wu, Lai-Yi; Yue, Qing

2015-01-01

Nanjing Dashengguan Bridge, which serves as the shared corridor crossing Yangtze River for both Beijing-Shanghai high-speed railway and Shanghai-Wuhan-Chengdu railway, is the first 6-track high-speed railway bridge with the longest span throughout the world. In order to ensure safety and detect the performance deterioration during the long-time service of the bridge, a Structural Health Monitoring (SHM) system has been implemented on this bridge by the application of modern techniques in sensing, testing, computing, and network communication. The SHM system includes various sensors as well as corresponding data acquisition and transmission equipment for automatic data collection. Furthermore, an evaluation system of structural safety has been developed for the real-time condition assessment of this bridge. The mathematical correlation models describing the overall structural behavior of the bridge can be obtained with the support of the health monitoring system, which includes cross-correlation models for accelerations, correlation models between temperature and static strains of steel truss arch, and correlation models between temperature and longitudinal displacements of piers. Some evaluation results using the mean value control chart based on mathematical correlation models are presented in this paper to show the effectiveness of this SHM system in detecting the bridge's abnormal behaviors under the varying environmental conditions such as high-speed trains and environmental temperature.

Implications of human tissue studies for radiation protection

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kathren, R.L.

1988-08-01

Through radiochemical analysis of voluntary tissue donations, the U.S. Transuranium and Uranium Registries (USTR) are gaining improved understanding of the distribution and biokinetics of actinide elements in occupationally exposed persons. Evaluation of the first two whole-body contributions to the USTR revealed an inverse proportionality between actinide concentration and bone ash. The analysis of a whole body with significant /sup 241/Am deposition indicated a significantly shorter half-time in liver and a greater fraction resident in the skeleton than predicted by existing models. Other studies with tissues obtained at autopsy suggest that existing biokinetic models for /sup 238/Pu and /sup 241/Am andmore » the currently accepted models and limits on intake, which use these models as their basis, may be inaccurately implying that revisions of existing safety standards may be necessary. Other studies of the registries are designed to evaluate in-vivo estimates of actinide deposition with those derived from postmortem tissue analysis, to compare results of animal experiments with human data, and to review histopathologic slides for tissue changes that might be attributable to exposure to transuranic elements. The implications of these recent findings and other work of the registries is discussed from the standpoint of this potential effect on biokinetic modeling, internal dose assessment, and safety standards and operational health physics practices.« less

A Bayesian procedure for evaluating the frequency of calibration factor updates in highway safety manual (HSM) applications.

PubMed

Saha, Dibakar; Alluri, Priyanka; Gan, Albert

2017-01-01

The Highway Safety Manual (HSM) presents statistical models to quantitatively estimate an agency's safety performance. The models were developed using data from only a few U.S. states. To account for the effects of the local attributes and temporal factors on crash occurrence, agencies are required to calibrate the HSM-default models for crash predictions. The manual suggests updating calibration factors every two to three years, or preferably on an annual basis. Given that the calibration process involves substantial time, effort, and resources, a comprehensive analysis of the required calibration factor update frequency is valuable to the agencies. Accordingly, the objective of this study is to evaluate the HSM's recommendation and determine the required frequency of calibration factor updates. A robust Bayesian estimation procedure is used to assess the variation between calibration factors computed annually, biennially, and triennially using data collected from over 2400 miles of segments and over 700 intersections on urban and suburban facilities in Florida. Bayesian model yields a posterior distribution of the model parameters that give credible information to infer whether the difference between calibration factors computed at specified intervals is credibly different from the null value which represents unaltered calibration factors between the comparison years or in other words, zero difference. The concept of the null value is extended to include the range of values that are practically equivalent to zero. Bayesian inference shows that calibration factors based on total crash frequency are required to be updated every two years in cases where the variations between calibration factors are not greater than 0.01. When the variations are between 0.01 and 0.05, calibration factors based on total crash frequency could be updated every three years. Copyright © 2016 Elsevier Ltd. All rights reserved.

A Monte-Carlo simulation analysis for evaluating the severity distribution functions (SDFs) calibration methodology and determining the minimum sample-size requirements.

PubMed

Shirazi, Mohammadali; Reddy Geedipally, Srinivas; Lord, Dominique

2017-01-01

Severity distribution functions (SDFs) are used in highway safety to estimate the severity of crashes and conduct different types of safety evaluations and analyses. Developing a new SDF is a difficult task and demands significant time and resources. To simplify the process, the Highway Safety Manual (HSM) has started to document SDF models for different types of facilities. As such, SDF models have recently been introduced for freeway and ramps in HSM addendum. However, since these functions or models are fitted and validated using data from a few selected number of states, they are required to be calibrated to the local conditions when applied to a new jurisdiction. The HSM provides a methodology to calibrate the models through a scalar calibration factor. However, the proposed methodology to calibrate SDFs was never validated through research. Furthermore, there are no concrete guidelines to select a reliable sample size. Using extensive simulation, this paper documents an analysis that examined the bias between the 'true' and 'estimated' calibration factors. It was indicated that as the value of the true calibration factor deviates further away from '1', more bias is observed between the 'true' and 'estimated' calibration factors. In addition, simulation studies were performed to determine the calibration sample size for various conditions. It was found that, as the average of the coefficient of variation (CV) of the 'KAB' and 'C' crashes increases, the analyst needs to collect a larger sample size to calibrate SDF models. Taking this observation into account, sample-size guidelines are proposed based on the average CV of crash severities that are used for the calibration process. Copyright © 2016 Elsevier Ltd. All rights reserved.

Alternative models in developmental toxicology.

PubMed

Lee, Hyung-yul; Inselman, Amy L; Kanungo, Jyotshnabala; Hansen, Deborah K

2012-02-01

In light of various pressures, toxicologists have been searching for alternative methods for safety testing of chemicals. According to a recent policy in the European Union (Regulation, Evaluation Authorisation and Restriction of Chemicals, REACH), it has been estimated that over the next twelve to fifteen years, approximately 30,000 chemicals may need to be tested for safety, and under current guidelines such testing would require the use of approximately 7.2 million laboratory animals [ Hofer et al. 2004 ]. It has also been estimated that over 80% of all animals used for safety testing under REACH legislation would be used for examining reproductive and developmental toxicity [Hofer et al., 2004]. In addition to REACH initiatives, it has been estimated that out of 5,000 to 10,000 new drug entities that a pharmaceutical company may start with, only one is finally approved by the Food and Drug Administration at a cost of over one billion dollars [ Garg et al. 2011 ]. A large portion of this cost is due to animal testing. Therefore, both the pharmaceutical and chemical industries are interested in using alternative models and in vitro tests for safety testing. This review will examine the current state of three alternative models - whole embryo culture (WEC), the mouse embryonic stem cell test (mEST), and zebrafish. Each of these alternatives will be reviewed, and advantages and disadvantages of each model will be discussed. These models were chosen because they are the models most commonly used and would appear to have the greatest potential for future applications in developmental toxicity screening and testing.

The effectiveness of insurer-supported safety and health engineering controls in reducing workers' compensation claims and costs.

PubMed

Wurzelbacher, Steven J; Bertke, Stephen J; Lampl, Michael P; Bushnell, P Timothy; Meyers, Alysha R; Robins, David C; Al-Tarawneh, Ibraheem S

2014-12-01

This study evaluated the effectiveness of a program in which a workers' compensation (WC) insurer provided matching funds to insured employers to implement safety/health engineering controls. Pre- and post-intervention WC metrics were compiled for the employees designated as affected by the interventions within 468 employers for interventions occurring from 2003 to 2009. Poisson, two-part, and linear regression models with repeated measures were used to evaluate differences in pre- and post-data, controlling for time trends independent of the interventions. For affected employees, total WC claim frequency rates (both medical-only and lost-time claims) decreased 66%, lost-time WC claim frequency rates decreased 78%, WC paid cost per employee decreased 81%, and WC geometric mean paid claim cost decreased 30% post-intervention. Reductions varied by employer size, specific industry, and intervention type. The insurer-supported safety/health engineering control program was effective in reducing WC claims and costs for affected employees. © 2014 Wiley Periodicals, Inc.

Preclinical imaging methods for assessing the safety and efficacy of regenerative medicine therapies

NASA Astrophysics Data System (ADS)

Scarfe, Lauren; Brillant, Nathalie; Kumar, J. Dinesh; Ali, Noura; Alrumayh, Ahmed; Amali, Mohammed; Barbellion, Stephane; Jones, Vendula; Niemeijer, Marije; Potdevin, Sophie; Roussignol, Gautier; Vaganov, Anatoly; Barbaric, Ivana; Barrow, Michael; Burton, Neal C.; Connell, John; Dazzi, Francesco; Edsbagge, Josefina; French, Neil S.; Holder, Julie; Hutchinson, Claire; Jones, David R.; Kalber, Tammy; Lovatt, Cerys; Lythgoe, Mark F.; Patel, Sara; Patrick, P. Stephen; Piner, Jacqueline; Reinhardt, Jens; Ricci, Emanuelle; Sidaway, James; Stacey, Glyn N.; Starkey Lewis, Philip J.; Sullivan, Gareth; Taylor, Arthur; Wilm, Bettina; Poptani, Harish; Murray, Patricia; Goldring, Chris E. P.; Park, B. Kevin

2017-10-01

Regenerative medicine therapies hold enormous potential for a variety of currently incurable conditions with high unmet clinical need. Most progress in this field to date has been achieved with cell-based regenerative medicine therapies, with over a thousand clinical trials performed up to 2015. However, lack of adequate safety and efficacy data is currently limiting wider uptake of these therapies. To facilitate clinical translation, non-invasive in vivo imaging technologies that enable careful evaluation and characterisation of the administered cells and their effects on host tissues are critically required to evaluate their safety and efficacy in relevant preclinical models. This article reviews the most common imaging technologies available and how they can be applied to regenerative medicine research. We cover details of how each technology works, which cell labels are most appropriate for different applications, and the value of multi-modal imaging approaches to gain a comprehensive understanding of the responses to cell therapy in vivo.

Hazard avoidance via descent images for safe landing

NASA Astrophysics Data System (ADS)

Yan, Ruicheng; Cao, Zhiguo; Zhu, Lei; Fang, Zhiwen

2013-10-01

In planetary or lunar landing missions, hazard avoidance is critical for landing safety. Therefore, it is very important to correctly detect hazards and effectively find a safe landing area during the last stage of descent. In this paper, we propose a passive sensing based HDA (hazard detection and avoidance) approach via descent images to lower the landing risk. In hazard detection stage, a statistical probability model on the basis of the hazard similarity is adopted to evaluate the image and detect hazardous areas, so that a binary hazard image can be generated. Afterwards, a safety coefficient, which jointly utilized the proportion of hazards in the local region and the inside hazard distribution, is proposed to find potential regions with less hazards in the binary hazard image. By using the safety coefficient in a coarse-to-fine procedure and combining it with the local ISD (intensity standard deviation) measure, the safe landing area is determined. The algorithm is evaluated and verified with many simulated descent downward looking images rendered from lunar orbital satellite images.

The Effectiveness of Insurer-Supported Safety and Health Engineering Controls in Reducing Workers’ Compensation Claims and Costs

PubMed Central

Wurzelbacher, Steven J.; Bertke, Stephen J.; Lampl, Michael P.; Bushnell, P. Timothy; Meyers, Alysha R.; Robins, David C.; Al-Tarawneh, Ibraheem S.

2015-01-01

Background This study evaluated the effectiveness of a program in which a workers’ compensation (WC) insurer provided matching funds to insured employers to implement safety/health engineering controls. Methods Pre- and post-intervention WC metrics were compiled for the employees designated as affected by the interventions within 468 employers for interventions occurring from 2003 to 2009. Poisson, two-part, and linear regression models with repeated measures were used to evaluate differences in pre- and post-data, controlling for time trends independent of the interventions. Results For affected employees, total WC claim frequency rates (both medical-only and lost-time claims) decreased 66%, lost-time WC claim frequency rates decreased 78%, WC paid cost per employee decreased 81%, and WC geometric mean paid claim cost decreased 30% post-intervention. Reductions varied by employer size, specific industry, and intervention type. Conclusions The insurer-supported safety/health engineering control program was effective in reducing WC claims and costs for affected employees. PMID:25223846

Information Extraction for System-Software Safety Analysis: Calendar Year 2008 Year-End Report

NASA Technical Reports Server (NTRS)

Malin, Jane T.

2009-01-01

This annual report describes work to integrate a set of tools to support early model-based analysis of failures and hazards due to system-software interactions. The tools perform and assist analysts in the following tasks: 1) extract model parts from text for architecture and safety/hazard models; 2) combine the parts with library information to develop the models for visualization and analysis; 3) perform graph analysis and simulation to identify and evaluate possible paths from hazard sources to vulnerable entities and functions, in nominal and anomalous system-software configurations and scenarios; and 4) identify resulting candidate scenarios for software integration testing. There has been significant technical progress in model extraction from Orion program text sources, architecture model derivation (components and connections) and documentation of extraction sources. Models have been derived from Internal Interface Requirements Documents (IIRDs) and FMEA documents. Linguistic text processing is used to extract model parts and relationships, and the Aerospace Ontology also aids automated model development from the extracted information. Visualizations of these models assist analysts in requirements overview and in checking consistency and completeness.

Reporting of methodological features in observational studies of pre-harvest food safety.

PubMed

Sargeant, Jan M; O'Connor, Annette M; Renter, David G; Kelton, David F; Snedeker, Kate; Wisener, Lee V; Leonard, Erin K; Guthrie, Alessia D; Faires, Meredith

2011-02-01

Observational studies in pre-harvest food safety may be useful for identifying risk factors and for evaluating potential mitigation strategies to reduce foodborne pathogens. However, there are no structured reporting guidelines for these types of study designs in livestock species. Our objective was to evaluate the reporting of observational studies in the pre-harvest food safety literature using guidelines modified from the human healthcare literature. We identified 100 pre-harvest food safety studies published between 1999 and 2009. Each study was evaluated independently by two reviewers using a structured checklist. Of the 38 studies that explicitly stated the observational study design, 27 were described as cross-sectional studies, eight as case-control studies, and three as cohort studies. Study features reported in over 75% of the selected studies included: description of the geographic location of the studies, definitions and sources of data for outcomes, organizational level and source of data for independent variables, description of statistical methods and results, number of herds enrolled in the study and included in the analysis, and sources of study funding. However, other features were not consistently reported, including details related to eligibility criteria for groups (such as barn, room, or pen) and individuals, numbers of groups and individuals included in various stages of the study, identification of primary outcomes, the distinction between putative risk factors and confounding variables, the identification of a primary exposure variable, the referent level for evaluation of categorical variable associations, methods of controlling confounding variables and missing variables, model fit, details of subset analysis, demographic information at the sampling unit level, and generalizability of the study results. Improvement in reporting of observational studies of pre-harvest food safety will aid research readers and reviewers in interpreting and evaluating the results of such studies. Copyright © 2010 Elsevier B.V. All rights reserved.

Gating the holes in the Swiss cheese (part I): Expanding professor Reason's model for patient safety

PubMed Central

Bryan Young, G.; Makhinson, Michael; Smith, Preston A.; Stobart, Kent; Croskerry, Pat

2017-01-01

Abstract Introduction Although patient safety has improved steadily, harm remains a substantial global challenge. Additionally, safety needs to be ensured not only in hospitals but also across the continuum of care. Better understanding of the complex cognitive factors influencing health care–related decisions and organizational cultures could lead to more rational approaches, and thereby to further improvement. Hypothesis A model integrating the concepts underlying Reason's Swiss cheese theory and the cognitive‐affective biases plus cascade could advance the understanding of cognitive‐affective processes that underlie decisions and organizational cultures across the continuum of care. Methods Thematic analysis, qualitative information from several sources being used to support argumentation. Discussion Complex covert cognitive phenomena underlie decisions influencing health care. In the integrated model, the Swiss cheese slices represent dynamic cognitive‐affective (mental) gates: Reason's successive layers of defence. Like firewalls and antivirus programs, cognitive‐affective gates normally allow the passage of rational decisions but block or counter unsounds ones. Gates can be breached (ie, holes created) at one or more levels of organizations, teams, and individuals, by (1) any element of cognitive‐affective biases plus (conflicts of interest and cognitive biases being the best studied) and (2) other potential error‐provoking factors. Conversely, flawed decisions can be blocked and consequences minimized; for example, by addressing cognitive biases plus and error‐provoking factors, and being constantly mindful. Informed shared decision making is a neglected but critical layer of defence (cognitive‐affective gate). The integrated model can be custom tailored to specific situations, and the underlying principles applied to all methods for improving safety. The model may also provide a framework for developing and evaluating strategies to optimize organizational cultures and decisions. Limitations The concept is abstract, the model is virtual, and the best supportive evidence is qualitative and indirect. Conclusions The proposed model may help enhance rational decision making across the continuum of care, thereby improving patient safety globally. PMID:29168290

[Safety culture: definition, models and design].

PubMed

Pfaff, Holger; Hammer, Antje; Ernstmann, Nicole; Kowalski, Christoph; Ommen, Oliver

2009-01-01

Safety culture is a multi-dimensional phenomenon. Safety culture of a healthcare organization is high if it has a common stock in knowledge, values and symbols in regard to patients' safety. The article intends to define safety culture in the first step and, in the second step, demonstrate the effects of safety culture. We present the model of safety behaviour and show how safety culture can affect behaviour and produce safe behaviour. In the third step we will look at the causes of safety culture and present the safety-culture-model. The main hypothesis of this model is that the safety culture of a healthcare organization strongly depends on its communication culture and its social capital. Finally, we will investigate how the safety culture of a healthcare organization can be improved. Based on the safety culture model six measures to improve safety culture will be presented.

Safety reliability evaluation when vehicles turn right from urban major roads onto minor ones based on driver's visual perception.

PubMed

Yu, Bo; Chen, Yuren; Wang, Ruiyun; Dong, Yongjie

2016-10-01

Turning right has a significant impact on urban road traffic safety. Driving into the curve inappropriately or with improper turning speed often leads to a series of potential accidents and hidden dangers. For a long time, the design speed at intersections has been used to determine the physical radius of curbs and channelization, and drivers are expected to drive in accordance with the design speed. However, a large number of real vehicle tests show that for the road without an exclusive right-turn lane, there is not a good correlation between the physical radius of curbs and the turning right speeds. In this paper, shape parameters of the driver's visual lane model are put forward and they have relatively high correlations with right-turn speeds. Hence, an evaluation method about safety reliability of turning right from urban major roads onto minor ones based on driver's visual perception is proposed. For existing roads, the evaluation object could be real driving videos; for those under construction roads, the evaluation object could be visual scenes obtained from a driving simulation device. Findings in this research will make a contribution to the optimization of right-turn design at intersections and lead to the development of auxiliary driving technology. Copyright © 2015 Elsevier Ltd. All rights reserved.

Immunogenicity and safety of xenogeneic vascular endothelial growth factor receptor-2 DNA vaccination in mice and dogs

PubMed Central

Denies, Sofie; Cicchelero, Laetitia; Polis, Ingeborgh; Sanders, Niek N.

2016-01-01

Vascular endothelial growth factor receptor-2 (VEGFR-2) is an attractive target in oncology due to its crucial role in angiogenesis. In this study a DNA vaccine coding for human VEGFR-2 was evaluated in healthy mice and dogs, administered by intradermal injection and electroporation. In mice, three doses and vaccination schedules were evaluated. Cellular immune responses were measured by intracellular IFN-gamma staining and a cytotoxicity assay and antibodies by ELISA. Safety was assessed by measuring regulatory T cells and myeloid derived suppressor cells and a wound healing assay. The vaccine was subsequently evaluated in dogs, which were vaccinated three times with 100μg. Cellular immune responses were measured by intracellular IFN-gamma staining and antibodies by a flow cytometric assay. In mice, maximal cellular responses were observed after two vaccinations with 5μg. Humoral responses continued to increase with higher dose and number of vaccinations. No abnormalities in the measured safety parameters were observed. The vaccine was also capable of eliciting a cellular and humoral immune response in dogs. No adverse effects were observed, but tolerability of the electroporation was poor. This study will facilitate the evaluation of the vaccine in tumor bearing animals, ranging from rodent models to dogs with spontaneous tumors. PMID:26871296

Safety evaluation of tangeretin and the effect of using emulsion-based delivery system: Oral acute and 28-day sub-acute toxicity study using mice.

PubMed

Ting, Yuwen; Chiou, Yi-Shiou; Jiang, Yike; Pan, Min-Hsiung; Lin, Zhengyu; Huang, Qingrong

2015-08-01

Polymethoxyflavones, found widely in the peel of citrus fruits, is an emerging group of bioactive compounds with wide arrays of disease prevention functionalities. To understand the potential oral toxicity, tangeretin, being one of the most abundant polymethoxyflavones from natural sources, was used as model compound for the safety evaluation. Acute oral toxicity study was conducted using both male and female mice giving 1000, 2000, or 3000mg/kgbody weight (bw) of tangeretin in oil suspension from single gavage administration. No evidence of death was observed during 14-day post-administration period. Alterations of the hepatic cell and clinical chemistry profile increased dose dependently and exhibited distinct injury recovery pattern among different sexes. To determine the potential safety concern related to emulsification, the sub-acute toxicity of tangeretin in emulsion was evaluated and compared with un-processed oil suspension when conducting the sub-acute toxicity study over 28days. In the sub-acute study, emulsion system did not induce a significant increase of toxicity response. However, the daily low-dose application of tangeretin showed U-shaped dose-response pattern in regard to hepatic alteration. The result from this study can serve as a good safety reference for future application of polymethoxyflavone as a functional ingredient in food. Copyright © 2015 Elsevier Ltd. All rights reserved.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hurt, Christopher J.; Freels, James D.; Hobbs, Randy W.

There has been a considerable effort over the previous few years to demonstrate and optimize the production of plutonium-238 ( 238Pu) at the High Flux Isotope Reactor (HFIR). This effort has involved resources from multiple divisions and facilities at the Oak Ridge National Laboratory (ORNL) to demonstrate the fabrication, irradiation, and chemical processing of targets containing neptunium-237 ( 237Np) dioxide (NpO 2)/aluminum (Al) cermet pellets. A critical preliminary step to irradiation at the HFIR is to demonstrate the safety of the target under irradiation via documented experiment safety analyses. The steady-state thermal safety analyses of the target are simulated inmore » a finite element model with the COMSOL Multiphysics code that determines, among other crucial parameters, the limiting maximum temperature in the target. Safety analysis efforts for this model discussed in the present report include: (1) initial modeling of single and reduced-length pellet capsules in order to generate an experimental knowledge base that incorporate initial non-linear contact heat transfer and fission gas equations, (2) modeling efforts for prototypical designs of partially loaded and fully loaded targets using limited available knowledge of fabrication and irradiation characteristics, and (3) the most recent and comprehensive modeling effort of a fully coupled thermo-mechanical approach over the entire fully loaded target domain incorporating burn-up dependent irradiation behavior and measured target and pellet properties, hereafter referred to as the production model. These models are used to conservatively determine several important steady-state parameters including target stresses and temperatures, the limiting condition of which is the maximum temperature with respect to the melting point. The single pellet model results provide a basis for the safety of the irradiations, followed by parametric analyses in the initial prototypical designs that were necessary due to the limiting fabrication and irradiation data available. The calculated parameters in the final production target model are the most accurate and comprehensive, while still conservative. Over 210 permutations in irradiation time and position were evaluated, and are supported by the most recent inputs and highest fidelity methodology. The results of these analyses show that the models presented in this report provide a robust and reliable basis for previous, current and future experiment safety analyses. In addition, they reveal an evolving knowledge of the steady-state behavior of the NpO 2/Al pellets under irradiation for a variety of target encapsulations and potential conditions.« less

Safety evaluation of centerline plus shoulder rumble strips.

DOT National Transportation Integrated Search

2015-06-01

The Federal Highway Administration organized a pooled fund study of 38 States to evaluate low-cost safety strategies as part of its strategic highway safety effort. One of the strategies selected for evaluation was the combined application of centerl...

Safety evaluation of wet reflective pavement markers.

DOT National Transportation Integrated Search

2015-09-01

The Federal Highway Administration organized a pooled fund study of 38 States to evaluate low-cost safety : strategies as part of its strategic highway safety effort. One of the strategies selected for evaluation was the : application of wet-reflecti...

Safety evaluation of wet-reflective pavement markings.

DOT National Transportation Integrated Search

2015-09-01

The Federal Highway Administration organized a pooled fund study of 38 States to evaluate low-cost safety strategies as part of its strategic highway safety effort. One of the strategies selected for evaluation was the application of wet-reflective p...

Safety evaluation of intersection conflict warning system.

DOT National Transportation Integrated Search

2016-06-01

FHWA organized a pooled fund study of 40 States to evaluate low-cost safety strategies as part of its strategic highway safety effort. One of the strategies selected for evaluation was intersection conflict warning systems (ICWSs). This strategy is i...

Development of a Novel Quantitative Adverse Outcome Pathway Predictive Model for Lung Cancer

EPA Science Inventory

Traditional methods for carcinogenicity testing are resource-intensive, retrospective, and time consuming. An increasing testing burden has generated interest in the adverse outcome pathway (AOP) concept as a tool to evaluate chemical safety in a more efficient, rapid and effecti...

78 FR 65156 - Special Conditions: Bombardier Inc., Models BD-500-1A10 and BD-500-1A11 Series Airplanes...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-31

... isolation but should be included in the overall safety evaluation of the airplane. These criteria may in... structural vibrations (e.g., oscillatory failures) must not produce loads that could result in detrimental...

Pharmacokinetics and Preliminary Safety of Pod-Intravaginal Rings Delivering the Monoclonal Antibody VRC01-N for HIV Prophylaxis in a Macaque Model.

PubMed

Zhao, Chunxia; Gunawardana, Manjula; Villinger, Francois; Baum, Marc M; Remedios-Chan, Mariana; Moench, Thomas R; Zeitlin, Larry; Whaley, Kevin J; Bohorov, Ognian; Smith, Thomas J; Anderson, Deborah J; Moss, John A

2017-07-01

The broadly neutralizing antibody (bNAb) VRC01, capable of neutralizing 91% of known human immunodeficiency virus type 1 (HIV-1) isolates in vitro , is a promising candidate microbicide for preventing sexual HIV infection when administered topically to the vagina; however, accessibility to antibody-based prophylactic treatment by target populations in sub-Saharan Africa and other underdeveloped regions may be limited by the high cost of conventionally produced antibodies and the limited capacity to manufacture such antibodies. Intravaginal rings of the pod design (pod-IVRs) delivering Nicotiana -manufactured VRC01 (VRC01-N) over a range of release rates have been developed. The pharmacokinetics and preliminary safety of VRC01-N pod-IVRs were evaluated in a rhesus macaque model. The devices sustained VRC01-N release for up to 21 days at controlled rates, with mean steady-state VRC01-N levels in vaginal fluids in the range of 10 2 to 10 3 μg g -1 being correlated with in vitro release rates. No adverse safety indications were observed. These findings indicate that pod-IVRs are promising devices for the delivery of the candidate topical microbicide VRC01-N against HIV-1 infection and merit further preclinical evaluation. Copyright © 2017 American Society for Microbiology.

Proposal of a risk-factor-based analytical approach for integrating occupational health and safety into project risk evaluation.

PubMed

Badri, Adel; Nadeau, Sylvie; Gbodossou, André

2012-09-01

Excluding occupational health and safety (OHS) from project management is no longer acceptable. Numerous industrial accidents have exposed the ineffectiveness of conventional risk evaluation methods as well as negligence of risk factors having major impact on the health and safety of workers and nearby residents. Lack of reliable and complete evaluations from the beginning of a project generates bad decisions that could end up threatening the very existence of an organization. This article supports a systematic approach to the evaluation of OHS risks and proposes a new procedure based on the number of risk factors identified and their relative significance. A new concept called risk factor concentration along with weighting of risk factor categories as contributors to undesirable events are used in the analytical hierarchy process multi-criteria comparison model with Expert Choice(©) software. A case study is used to illustrate the various steps of the risk evaluation approach and the quick and simple integration of OHS at an early stage of a project. The approach allows continual reassessment of criteria over the course of the project or when new data are acquired. It was thus possible to differentiate the OHS risks from the risk of drop in quality in the case of the factory expansion project. Copyright © 2011 Elsevier Ltd. All rights reserved.

Safety evaluation of increasing retroreflectivity of STOP signs

DOT National Transportation Integrated Search

2008-03-01

The Federal Highway Administration (FHWA) organized 26 States : to participate in the FHWA Low-Cost Safety Improvements Pooled : Fund Study to evaluate low-cost safety strategies as part of its : strategic highway safety plan support effort. The purp...

Safety evaluation of advance street name signs

DOT National Transportation Integrated Search

2009-06-01

The Federal Highway Administration (FHWA) organized a pooled fund study of 26 States to evaluate low-cost safety strategies as part of its strategic highway safety effort. The objective of the pooled fund study was to estimate the safety effectivenes...

A New Flow-Diverter (the FloWise): In-Vivo Evaluation in an Elastase-Induced Rabbit Aneurysm Model.

PubMed

Kim, Byung Moon; Kim, Dong Joon; Kim, Dong Ik

2016-01-01

We aimed to evaluate the efficacy and safety of a newly developed, partially retrievable flow-diverter (the FloWise) in an elastase-induced rabbit aneurysm model. We developed a partially retrievable flow diverter composed of 48 strands of Nitinol and platinum wire. The FloWise is compatible with any microcatheter of 0.027-inch inner diameter, and is retrievable up to 70% deployment. The efficacy and safety of the FloWise were evaluated in the elastase-induced rabbit aneurysm model. The rate of technical success (full coverage of aneurysm neck) and assessment of aneurysm occlusion and stent patency was conducted by angiograms and histologic examinations at the 1-month, 3-month, and 6-month follow-up. The patency of small arterial branches (intercostal or lumbar arteries) covered by the FloWise were also assessed in the 5 subjects. We attempted FloWise insertion in a total of 32 aneurysm models. FloWise placement was successful in 31 subjects (96.9%). Two stents (6.2%) were occluded at the 3-month follow-up, but there was no evidence of in-stent stenosis in other subjects. All stented aneurysms showed progressive occlusion: grade I (complete aneurysm occlusion) in 44.4% and grade II (aneurysm occlusion > 90%) in 55.6% at 1 month; grade I in 90% and II in 10% at 3 months; and grade I in 90% and II in 10% at 6 months. All small arterial branches covered by the FloWise remained patent. A newly developed, partially retrievable flow-diverter seems to be a safe and effective tool of aneurysm occlusion, as evaluated in the rabbit aneurysm model.

Reliability and safety of functional capacity evaluation in patients with whiplash associated disorders.

PubMed

Trippolini, M A; Reneman, M F; Jansen, B; Dijkstra, P U; Geertzen, J H B

2013-09-01

Whiplash-associated disorders (WAD) are a burden for both individuals and society. It is recommended to evaluate patients with WAD at risk of chronification to enhance rehabilitation and promote an early return to work. In patients with low back pain (LBP), functional capacity evaluation (FCE) contributes to clinical decisions regarding fitness-for-work. FCE should have demonstrated sufficient clinimetric properties. Reliability and safety of FCE for patients with WAD is unknown. Thirty-two participants (11 females and 21 males; mean age 39.6 years) with WAD (Grade I or II) were included. The FCE consisted of 12 tests, including material handling, hand grip strength, repetitive arm movements, static arm activities, walking speed, and a 3 min step test. Overall the FCE duration was 60 min. The test-retest interval was 7 days. Interclass correlations (model 1) (ICCs) and limits of agreement (LoA) were calculated. Safety was assessed by a Pain Response Questionnaire, observation criteria and heart rate monitoring. ICCs ranged between 0.57 (3 min step test) and 0.96 (short two-handed carry). LoA relative to mean performance ranged between 15 % (50 m walking test) and 57 % (lifting waist to overhead). Pain reactions after WAD FCE decreased within days. Observations and heart rate measurements fell within the safety criteria. The reliability of the WAD FCE was moderate in two tests, good in five tests and excellent in five tests. Safety-criteria were fulfilled. Interpretation at the patient level should be performed with care because LoA were substantial.

An Economic Evaluation of Food Safety Education Interventions: Estimates and Critical Data Gaps.

PubMed

Zan, Hua; Lambea, Maria; McDowell, Joyce; Scharff, Robert L

2017-08-01

The economic evaluation of food safety interventions is an important tool that practitioners and policy makers use to assess the efficacy of their efforts. These evaluations are built on models that are dependent on accurate estimation of numerous input variables. In many cases, however, there is no data available to determine input values and expert opinion is used to generate estimates. This study uses a benefit-cost analysis of the food safety component of the adult Expanded Food and Nutrition Education Program (EFNEP) in Ohio as a vehicle for demonstrating how results based on variable values that are not objectively determined may be sensitive to alternative assumptions. In particular, the focus here is on how reported behavioral change is translated into economic benefits. Current gaps in the literature make it impossible to know with certainty how many people are protected by the education (what are the spillover effects?), the length of time education remains effective, and the level of risk reduction from change in behavior. Based on EFNEP survey data, food safety education led 37.4% of participants to improve their food safety behaviors. Under reasonable default assumptions, benefits from this improvement significantly outweigh costs, yielding a benefit-cost ratio of between 6.2 and 10.0. Incorporation of a sensitivity analysis using alternative estimates yields a greater range of estimates (0.2 to 56.3), which highlights the importance of future research aimed at filling these research gaps. Nevertheless, most reasonable assumptions lead to estimates of benefits that justify their costs.

[Agricultural biotechnology safety assessment].

PubMed

McClain, Scott; Jones, Wendelyn; He, Xiaoyun; Ladics, Gregory; Bartholomaeus, Andrew; Raybould, Alan; Lutter, Petra; Xu, Haibin; Wang, Xue

2015-01-01

Genetically modified (GM) crops were first introduced to farmers in 1995 with the intent to provide better crop yield and meet the increasing demand for food and feed. GM crops have evolved to include a thorough safety evaluation for their use in human food and animal feed. Safety considerations begin at the level of DNA whereby the inserted GM DNA is evaluated for its content, position and stability once placed into the crop genome. The safety of the proteins coded by the inserted DNA and potential effects on the crop are considered, and the purpose is to ensure that the transgenic novel proteins are safe from a toxicity, allergy, and environmental perspective. In addition, the grain that provides the processed food or animal feed is also tested to evaluate its nutritional content and identify unintended effects to the plant composition when warranted. To provide a platform for the safety assessment, the GM crop is compared to non-GM comparators in what is typically referred to as composition equivalence testing. New technologies, such as mass spectrometry and well-designed antibody-based methods, allow better analytical measurements of crop composition, including endogenous allergens. Many of the analytical methods and their intended uses are based on regulatory guidance documents, some of which are outlined in globally recognized documents such as Codex Alimentarius. In certain cases, animal models are recommended by some regulatory agencies in specific countries, but there is typically no hypothesis or justification of their use in testing the safety of GM crops. The quality and standardization of testing methods can be supported, in some cases, by employing good laboratory practices (GLP) and is recognized in China as important to ensure quality data. Although the number of recommended, in some cases, required methods for safety testing are increasing in some regulatory agencies, it should be noted that GM crops registered to date have been shown to be comparable to their nontransgenic counterparts and safe . The crops upon which GM development are based are generally considered safe.

The Role of Interpersonal Relations in Healthcare Team Communication and Patient Safety: A Proposed Model of Interpersonal Process in Teamwork.

PubMed

Lee, Charlotte Tsz-Sum; Doran, Diane Marie

2017-06-01

Patient safety is compromised by medical errors and adverse events related to miscommunications among healthcare providers. Communication among healthcare providers is affected by human factors, such as interpersonal relations. Yet, discussions of interpersonal relations and communication are lacking in healthcare team literature. This paper proposes a theoretical framework that explains how interpersonal relations among healthcare team members affect communication and team performance, such as patient safety. We synthesized studies from health and social science disciplines to construct a theoretical framework that explicates the links among these constructs. From our synthesis, we identified two relevant theories: framework on interpersonal processes based on social relation model and the theory of relational coordination. The former involves three steps: perception, evaluation, and feedback; and the latter captures relational communicative behavior. We propose that manifestations of provider relations are embedded in the third step of the framework on interpersonal processes: feedback. Thus, varying team-member relationships lead to varying collaborative behavior, which affects patient-safety outcomes via a change in team communication. The proposed framework offers new perspectives for understanding how workplace relations affect healthcare team performance. The framework can be used by nurses, administrators, and educators to improve patient safety, team communication, or to resolve conflicts.

Improvements and applications of COBRA-TF for stand-alone and coupled LWR safety analyses

DOE Office of Scientific and Technical Information (OSTI.GOV)

Avramova, M.; Cuervo, D.; Ivanov, K.

2006-07-01

The advanced thermal-hydraulic subchannel code COBRA-TF has been recently improved and applied for stand-alone and coupled LWR core calculations at the Pennsylvania State Univ. in cooperation with AREVA NP GmbH (Germany)) and the Technical Univ. of Madrid. To enable COBRA-TF for academic and industrial applications including safety margins evaluations and LWR core design analyses, the code programming, numerics, and basic models were revised and substantially improved. The code has undergone through an extensive validation, verification, and qualification program. (authors)

Safety evaluation of STOP AHEAD pavement markings

DOT National Transportation Integrated Search

2007-12-01

The Federal Highway Administration (FHWA) organized a Pooled Fund Study of 26 States to evaluate low-cost safety strategies as part of its strategic highway safety effort. One of the strategies chosen to be evaluated for this study was STOP AHEAD pav...

Safety evaluation of STOP AHEAD pavement markings

DOT National Transportation Integrated Search

2008-03-01

The Federal Highway Administration (FHWA) organized a Pooled Fund Study of 26 States to evaluate low-cost safety strategies as part of its strategic highway safety effort. One of the strategies chosen to be evaluated for this study was STOP AHEAD pav...

Safety evaluation of wet-reflective pavement markings : tech brief.

DOT National Transportation Integrated Search

2015-12-01

The Federal Highway Administration (FHWA) organized : 38 States for the FHWA Evaluation of Low-Cost Safety : Improvements Pooled Fund Study as part of its strategic : highway safety plan support effort. The purpose of the : study is to evaluate the s...

A Family-Centered Rounds Checklist, Family Engagement, and Patient Safety: A Randomized Trial

PubMed Central

Jacobsohn, Gwen C.; Rajamanickam, Victoria P.; Carayon, Pascale; Kelly, Michelle M.; Wetterneck, Tosha B.; Rathouz, Paul J.; Brown, Roger L.

2017-01-01

BACKGROUND AND OBJECTIVES: Family-centered rounds (FCRs) have become standard of care, despite the limited evaluation of FCRs’ benefits or interventions to support high-quality FCR delivery. This work examines the impact of the FCR checklist intervention, a checklist and associated provider training, on performance of FCR elements, family engagement, and patient safety. METHODS: This cluster randomized trial involved 298 families. Two hospital services were randomized to use the checklist; 2 others delivered usual care. We evaluated the performance of 8 FCR checklist elements and family engagement from 673 pre- and postintervention FCR videos and assessed the safety climate with the Children’s Hospital Safety Climate Questionnaire. Random effects regression models were used to assess intervention impact. RESULTS: The intervention significantly increased the number of FCR checklist elements performed (β = 1.2, P < .001). Intervention rounds were significantly more likely to include asking the family (odds ratio [OR] = 2.43, P < .05) or health care team (OR = 4.28, P = .002) for questions and reading back orders (OR = 12.43, P < .001). Intervention families’ engagement and reports of safety climate were no different from usual care. However, performance of specific checklist elements was associated with changes in these outcomes. For example, order read-back was associated with significantly more family engagement. Asking families for questions was associated with significantly better ratings of staff’s communication openness and safety of handoffs and transitions. CONCLUSIONS: The performance of FCR checklist elements was enhanced by checklist implementation and associated with changes in family engagement and more positive perceptions of safety climate. Implementing the checklist improves delivery of FCRs, impacting quality and safety of care. PMID:28557720

A Spanish-language patient safety questionnaire to measure medical and nursing students' attitudes and knowledge.

PubMed

Mira, José J; Navarro, Isabel M; Guilabert, Mercedes; Poblete, Rodrigo; Franco, Astolfo L; Jiménez, Pilar; Aquino, Margarita; Fernández-Trujillo, Francisco J; Lorenzo, Susana; Vitaller, Julián; de Valle, Yohana Díaz; Aibar, Carlos; Aranaz, Jesús M; De Pedro, José A

2015-08-01

To design and validate a questionnaire for assessing attitudes and knowledge about patient safety using a sample of medical and nursing students undergoing clinical training in Spain and four countries in Latin America. In this cross-sectional study, a literature review was carried out and total of 786 medical and nursing students were surveyed at eight universities from five countries (Chile, Colombia, El Salvador, Guatemala, and Spain) to develop and refine a Spanish-language questionnaire on knowledge and attitudes about patient safety. The scope of the questionnaire was based on five dimensions (factors) presented in studies related to patient safety culture found in PubMed and Scopus. Based on the five factors, 25 reactive items were developed. Composite reliability indexes and Cronbach's alpha statistics were estimated for each factor, and confirmatory factor analysis was conducted to assess validity. After a pilot test, the questionnaire was refined using confirmatory models, maximum-likelihood estimation, and the variance-covariance matrix (as input). Multiple linear regression models were used to confirm external validity, considering variables related to patient safety culture as dependent variables and the five factors as independent variables. The final instrument was a structured five-point Likert self-administered survey (the "Latino Student Patient Safety Questionnaire") consisting of 21 items grouped into five factors. Compound reliability indexes (Cronbach's alpha statistic) calculated for the five factors were about 0.7 or higher. The results of the multiple linear regression analyses indicated good model fit (goodness-of-fit index: 0.9). Item-total correlations were higher than 0.3 in all cases. The convergent-discriminant validity was adequate. The questionnaire designed and validated in this study assesses nursing and medical students' attitudes and knowledge about patient safety. This instrument could be used to indirectly evaluate whether or not students in health disciplines are acquiring and thus likely to put into practice the professional skills currently considered most appropriate for patient safety.

A Baseline Patient Model to Support Testing of Medical Cyber-Physical Systems.

PubMed

Silva, Lenardo C; Perkusich, Mirko; Almeida, Hyggo O; Perkusich, Angelo; Lima, Mateus A M; Gorgônio, Kyller C

2015-01-01

Medical Cyber-Physical Systems (MCPS) are currently a trending topic of research. The main challenges are related to the integration and interoperability of connected medical devices, patient safety, physiologic closed-loop control, and the verification and validation of these systems. In this paper, we focus on patient safety and MCPS validation. We present a formal patient model to be used in health care systems validation without jeopardizing the patient's health. To determine the basic patient conditions, our model considers the four main vital signs: heart rate, respiratory rate, blood pressure and body temperature. To generate the vital signs we used regression models based on statistical analysis of a clinical database. Our solution should be used as a starting point for a behavioral patient model and adapted to specific clinical scenarios. We present the modeling process of the baseline patient model and show its evaluation. The conception process may be used to build different patient models. The results show the feasibility of the proposed model as an alternative to the immediate need for clinical trials to test these medical systems.

Model-Based Safety Analysis

NASA Technical Reports Server (NTRS)

Joshi, Anjali; Heimdahl, Mats P. E.; Miller, Steven P.; Whalen, Mike W.

2006-01-01

System safety analysis techniques are well established and are used extensively during the design of safety-critical systems. Despite this, most of the techniques are highly subjective and dependent on the skill of the practitioner. Since these analyses are usually based on an informal system model, it is unlikely that they will be complete, consistent, and error free. In fact, the lack of precise models of the system architecture and its failure modes often forces the safety analysts to devote much of their effort to gathering architectural details about the system behavior from several sources and embedding this information in the safety artifacts such as the fault trees. This report describes Model-Based Safety Analysis, an approach in which the system and safety engineers share a common system model created using a model-based development process. By extending the system model with a fault model as well as relevant portions of the physical system to be controlled, automated support can be provided for much of the safety analysis. We believe that by using a common model for both system and safety engineering and automating parts of the safety analysis, we can both reduce the cost and improve the quality of the safety analysis. Here we present our vision of model-based safety analysis and discuss the advantages and challenges in making this approach practical.

Translating New Science Into the Drug Review Process

PubMed Central

Rouse, Rodney; Kruhlak, Naomi; Weaver, James; Burkhart, Keith; Patel, Vikram; Strauss, David G.

2017-01-01

In 2011, the US Food and drug Administration (FDA) developed a strategic plan for regulatory science that focuses on developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. In line with this, the Division of Applied Regulatory Science was created to move new science into the Center for Drug Evaluation and Research (CDER) review process and close the gap between scientific innovation and drug review. The Division, located in the Office of Clinical Pharmacology, is unique in that it performs mission-critical applied research and review across the translational research spectrum including in vitro and in vivo laboratory research, in silico computational modeling and informatics, and integrated clinical research covering clinical pharmacology, experimental medicine, and postmarket analyses. The Division collaborates with Offices throughout CDER, across the FDA, other government agencies, academia, and industry. The Division is able to rapidly form interdisciplinary teams of pharmacologists, biologists, chemists, computational scientists, and clinicians to respond to challenging regulatory questions for specific review issues and for longer-range projects requiring the development of predictive models, tools, and biomarkers to speed the development and regulatory evaluation of safe and effective drugs. This article reviews the Division’s recent work and future directions, highlighting development and validation of biomarkers; novel humanized animal models; translational predictive safety combining in vitro, in silico, and in vivo clinical biomarkers; chemical and biomedical informatics tools for safety predictions; novel approaches to speed the development of complex generic drugs, biosimilars, and antibiotics; and precision medicine. PMID:29568713

Evaluation of radiological dispersion/consequence codes supporting DOE nuclear facility SARs

DOE Office of Scientific and Technical Information (OSTI.GOV)

O`Kula, K.R.; Paik, I.K.; Chung, D.Y.

1996-12-31

Since the early 1990s, the authorization basis documentation of many U.S. Department of Energy (DOE) nuclear facilities has been upgraded to comply with DOE orders and standards. In this process, many safety analyses have been revised. Unfortunately, there has been nonuniform application of software, and the most appropriate computer and engineering methodologies often are not applied. A DOE Accident Phenomenology and Consequence (APAC) Methodology Evaluation Program was originated at the request of DOE Defense Programs to evaluate the safety analysis methodologies used in nuclear facility authorization basis documentation and to define future cost-effective support and development initiatives. Six areas, includingmore » source term development (fire, spills, and explosion analysis), in-facility transport, and dispersion/ consequence analysis (chemical and radiological) are contained in the APAC program. The evaluation process, codes considered, key results, and recommendations for future model and software development of the Radiological Dispersion/Consequence Working Group are summarized in this paper.« less

A Web-based Alternative Non-animal Method Database for Safety Cosmetic Evaluations

PubMed Central

Kim, Seung Won; Kim, Bae-Hwan

2016-01-01

Animal testing was used traditionally in the cosmetics industry to confirm product safety, but has begun to be banned; alternative methods to replace animal experiments are either in development, or are being validated, worldwide. Research data related to test substances are critical for developing novel alternative tests. Moreover, safety information on cosmetic materials has neither been collected in a database nor shared among researchers. Therefore, it is imperative to build and share a database of safety information on toxicological mechanisms and pathways collected through in vivo, in vitro, and in silico methods. We developed the CAMSEC database (named after the research team; the Consortium of Alternative Methods for Safety Evaluation of Cosmetics) to fulfill this purpose. On the same website, our aim is to provide updates on current alternative research methods in Korea. The database will not be used directly to conduct safety evaluations, but researchers or regulatory individuals can use it to facilitate their work in formulating safety evaluations for cosmetic materials. We hope this database will help establish new alternative research methods to conduct efficient safety evaluations of cosmetic materials. PMID:27437094

A Web-based Alternative Non-animal Method Database for Safety Cosmetic Evaluations.

PubMed

Kim, Seung Won; Kim, Bae-Hwan

2016-07-01

Animal testing was used traditionally in the cosmetics industry to confirm product safety, but has begun to be banned; alternative methods to replace animal experiments are either in development, or are being validated, worldwide. Research data related to test substances are critical for developing novel alternative tests. Moreover, safety information on cosmetic materials has neither been collected in a database nor shared among researchers. Therefore, it is imperative to build and share a database of safety information on toxicological mechanisms and pathways collected through in vivo, in vitro, and in silico methods. We developed the CAMSEC database (named after the research team; the Consortium of Alternative Methods for Safety Evaluation of Cosmetics) to fulfill this purpose. On the same website, our aim is to provide updates on current alternative research methods in Korea. The database will not be used directly to conduct safety evaluations, but researchers or regulatory individuals can use it to facilitate their work in formulating safety evaluations for cosmetic materials. We hope this database will help establish new alternative research methods to conduct efficient safety evaluations of cosmetic materials.

Atmospheric effects on laser eye safety and damage to instrumentation

NASA Astrophysics Data System (ADS)

Zilberman, Arkadi; Kopeika, Natan S.

2017-10-01

Electro-optical sensors as well as unprotected human eyes are extremely sensitive to laser radiation and can be permanently damaged from direct or reflected beams. Laser detector/eye hazard depends on the interaction between the laser beam and the media in which it traverses. The environmental conditions including terrain features, atmospheric particulate and water content, and turbulence, may alter the laser's effect on the detector/eye. It is possible to estimate the performance of an electro-optical system as long as the atmospheric propagation of the laser beam can be adequately modeled. More recent experiments and modeling of atmospheric optics phenomena such as inner scale effect, aperture averaging, atmospheric attenuation in NIR-SWIR, and Cn2 modeling justify an update of previous eye/detector safety modeling. In the present work, the influence of the atmospheric channel on laser safety for personnel and instrumentation is shown on the basis of theoretical and experimental data of laser irradiance statistics for different atmospheric conditions. A method for evaluating the probability of damage and hazard distances associated with the use of laser systems in a turbulent atmosphere operating in the visible and NIR-SWIR portions of the electromagnetic spectrum is presented. It can be used as a performance prediction model for directed energy engagement of ground-based or air-based systems.

Narrative review of the UK Patient Safety Research Portfolio.

PubMed

Waring, Justin; Rowley, Emma; Dingwall, Robert; Palmer, Cecily; Murcott, Toby

2010-01-01

The UK Patient Safety Research Portfolio (PSRP) commissioned 38 studies investigating the threats to patient safety in various clinical settings and evaluating safety-related service interventions. This paper reviews 27 of these studies, drawing out emergent and cross-cutting themes in terms of theory, research methods and thematic findings. Given the diversity of PSRP studies, the paper takes a narrative approach that allows for qualitative description, interpretation and synthesis of the studies and their findings. The theoretical review shows the majority of PSRP studies draw upon a patient safety 'orthodoxy', developed from the concepts and models associated with the human factors approach. The methodological review shows that a diverse range of research designs and techniques have been utilized. Although many follow in the 'scientific' tradition, interpretative, mixed and innovative methods have been integral to research. The thematic review of findings highlights significant contributions to knowledge in the areas of 'people', 'organizations', and 'technology'. As well as identifying the various sources of risk in the organization and delivery of patient care, the studies also evaluate and make recommendations about service change and improvement. The PSRP has provided the foundations for significant theoretical, methodological and empirical advances in the area of patient safety. The findings and recommendations make important contributions to policy formulation and implementation as well as professional and managerial practice. Through this body of research the PSRP has supported the formation and growth of a thriving research community across academic, policy and professional communities.

Structural Evaluation of the RSRM Nozzle Replacement Adhesive

NASA Technical Reports Server (NTRS)

Batista-Rodriguez, A.; McLennan, M. L.; Palumbos, A. V.; Richardson, D. E.

1999-01-01

This paper describes the structural performance evaluation of a replacement adhesive for the Reusable Solid Rocket Motor (RSRM) nozzle utilizing finite element analysis. Due to material obsolescence and industrial safety issues, the two current structural adhesives, EA 913 and EA 946 are to be replaced with a new adhesive. TIGA 321. The structural evaluation in support of the adhesive replacement effort includes residual stress, transportation, and flight analyses. Factors of safety are calculated using the stress response from each analysis. The factors of safety are used as the limiting criteria to compare the replacement adhesive against the current adhesives. Included in this paper are the analytical approach, assumptions and modeling techniques as well as the results of the evaluation. An important factor to the evaluation is the similarity in constitutive material properties (elastic modulus and Poisson's ratio) between TIGA 321 and EA 913. This similarity leads to equivalent material response from the two adhesives. However, TIGA 321 surpasses EA 913's performance due to higher material capabilities. Conversely, the change in stress response from EA 946 to TIGA 321 is more apparent: this is primarily attributed to the difference in the modulii of the two adhesives, which differ by two orders of magnitude. The results of the bondline evaluation indicate that the replacement adhesive provides superior performance than the current adhesives with only minor exceptions. Furthermore, TIGA 321 causes only a minor chance in the response of the phenolic and metal components.

Model-based analysis of thromboxane B{sub 2} and prostaglandin E{sub 2} as biomarkers in the safety evaluation of naproxen

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sahota, Tarjinder; Sanderson, Ian; Danhof, Meindert

The assessment of safety in traditional toxicology protocols relies on evidence arising from observed adverse events (AEs) in animals and on establishing their correlation with different measures of drug exposure (e.g., C{sub max} and AUC). Such correlations, however, ignore the role of biomarkers, which can provide further insight into the underlying pharmacological mechanisms. Here we use naproxen as a paradigm drug to explore the feasibility of a biomarker-guided approach for the prediction of AEs in humans. A standard toxicology protocol was set up for the evaluation of effects of naproxen in rat, in which four doses were tested (7.5, 15,more » 40 and 80 mg/kg). In addition to sparse blood sampling for the assessment of exposure, thromboxane B{sub 2} and prostaglandin E{sub 2} were also collected in satellite groups. Nonlinear mixed effects modelling was used to evaluate the predictive performance of the approach. A one-compartmental model with first order absorption was found to best describe the pharmacokinetics of naproxen. A nonlinear relationship between dose and bioavailability was observed which leads to a less than proportional increase in naproxen concentrations with increasing doses. The pharmacodynamics of TXB{sub 2} and PGE{sub 2} was described by direct inhibition models with maximum pharmacological effects achieved at doses > 7.5 mg/kg. The predicted PKPD relationship in humans was within 10-fold of the values previously published. Moreover, our results indicate that biomarkers can be used to assess interspecies differences in PKPD and extrapolated data from animals to humans. Biomarker sampling should be used systematically in general toxicity studies. - Highlights: • Prediction of a drug's safety profile from preclinical protocols remains challenging. • Pharmacokinetic measures of safe exposure (e.g., AUC) ignore the role of biomarkers. • PKPD relationships enable the evaluation of adverse events in a mechanistic manner. • Major differences exist between rats and humans in the effects of naproxen on TXB{sub 2}. • A biomarker-guided approach may facilitate the prediction of adverse events in humans.« less

Safety climate and attitude as evaluation measures of organizational safety.

PubMed

Isla Díaz, R; Díaz Cabrera, D

1997-09-01

The main aim of this research is to develop a set of evaluation measures for safety attitudes and safety climate. Specifically it is intended: (a) to test the instruments; (b) to identify the essential dimensions of the safety climate in the airport ground handling companies; (c) to assess the quality of the differences in the safety climate for each company and its relation to the accident rate; (d) to analyse the relationship between attitudes and safety climate; and (e) to evaluate the influences of situational and personal factors on both safety climate and attitude. The study sample consisted of 166 subjects from three airport companies. Specifically, this research was centered on ground handling departments. The factor analysis of the safety climate instrument resulted in six factors which explained 69.8% of the total variance. We found significant differences in safety attitudes and climate in relation to type of enterprise.

Findings From the National Machine Guarding Program-A Small Business Intervention: Machine Safety.

PubMed

Parker, David L; Yamin, Samuel C; Xi, Min; Brosseau, Lisa M; Gordon, Robert; Most, Ivan G; Stanley, Rodney

2016-09-01

The purpose of this nationwide intervention was to improve machine safety in small metal fabrication businesses (3 to 150 employees). The failure to implement machine safety programs related to guarding and lockout/tagout (LOTO) are frequent causes of Occupational Safety and Health Administration (OSHA) citations and may result in serious traumatic injury. Insurance safety consultants conducted a standardized evaluation of machine guarding, safety programs, and LOTO. Businesses received a baseline evaluation, two intervention visits, and a 12-month follow-up evaluation. The intervention was completed by 160 businesses. Adding a safety committee was associated with a 10% point increase in business-level machine scores (P < 0.0001) and a 33% point increase in LOTO program scores (P < 0.0001). Insurance safety consultants proved effective at disseminating a machine safety and LOTO intervention via management-employee safety committees.

Safety evaluation of flashing beacons at STOP-controlled intersections

DOT National Transportation Integrated Search

2008-03-01

The Federal Highway Administration (FHWA) organized a pooled fund study of 26 States to evaluate low-cost safety strategies as part of its strategic highway safety effort. One of the strategies chosen to be evaluated for this study was flashing beaco...

Safety evaluation of increasing retroreflectivity of STOP signs

DOT National Transportation Integrated Search

2008-03-01

The Federal Highway Administration (FHWA) organized a Pooled Fund Study of 26 States to evaluate low-cost safety strategies as part of its strategic highway safety effort. One of the strategies chosen to be evaluated for this study was STOP signs wit...

Safety evaluation of offset improvements for left-turn lanes

DOT National Transportation Integrated Search

2009-06-01

The Federal Highway Administration (FHWA) organized a pooled fund study of 26 States to evaluate low-cost safety strategies as part of its strategic highway safety effort. One of the strategies chosen to be evaluated for this study was offset improve...

Proactive assessment of accident risk to improve safety on a system of freeways.

DOT National Transportation Integrated Search

2012-05-01

This report describes the development and evaluation of real-time crash risk-assessment models for four freeway corridors: U.S. Route 101 NB (northbound) and SB (southbound) and Interstate 880 NB and SB. Crash data for these freeway segments for the ...

Human exposure modeling in a life cycle framework for chemicals and products

EPA Science Inventory

A chemical enters into commerce to serve a specific function in a product or process. This decision triggers both the manufacture of the chemical and its potential release over the life cycle of the product. Efficiently evaluating chemical safety and sustainability requires combi...

Safety evaluation of flashing beacons at stop-controlled intersections

DOT National Transportation Integrated Search

2008-03-01

The Federal Highway Administration (FHWA) organized 26 States to participate in the FHWA Low-Cost Safety Improvements Pooled Fund Study as part of its strategic highway safety plan support effort. The purpose of the study is to evaluate the safety ef...

Safety evaluation of STOP AHEAD pavement markings TechBrief

DOT National Transportation Integrated Search

2008-03-01

The Federal Highway Administration (FHWA) organized 26 States to participate in the FHWA Low-Cost Safety Improvements Pooled Fund Study as part of its strategic highway safety plan support effort. The purpose of the study is to evaluate the safety ef...

Occupational safety beliefs among Latino residential roofing workers.

PubMed

Arcury, Thomas A; Summers, Phillip; Carrillo, Lourdes; Grzywacz, Joseph G; Quandt, Sara A; Mills, Thomas H

2014-06-01

This analysis describes beliefs about work safety and personal protective equipment (PPE) among Latino roofing workers, it delineates their perceptions of work environment characteristics that affect work safety and PPE use, and it describes how they experience work injuries and the consequences of these injuries. In-depth interviews were completed with 10 current and former Latino residential roofers. Interview transcripts were subjected to systematic qualitative analysis. Participants' valued productivity over safety, and this had a negative influence on their safety behavior and reduced their PPE use. They understood that roofing was hazardous. They limited use of PPE when they felt it reduced productivity and when it was uncomfortable. Work environment characteristics that affected safety included company size, the physical demands of the job, lack of training, the need for work, general life stress, and distractions at work. An injury had to result in lost work time to be considered significant. Access to health care is limited by employers not providing Workers' compensation. Future research is needed to substantiate these descriptive results and to delineate factors that are associated with safety behavior and use of PPE. Interventions, based on a lay health educator model, are needed to improve safety in this population. Safety regulations need to be evaluated and their enforcement needs to be improved. © 2013 Wiley Periodicals, Inc.

Creating High Reliability in Health Care Organizations

PubMed Central

Pronovost, Peter J; Berenholtz, Sean M; Goeschel, Christine A; Needham, Dale M; Sexton, J Bryan; Thompson, David A; Lubomski, Lisa H; Marsteller, Jill A; Makary, Martin A; Hunt, Elizabeth

2006-01-01

Objective The objective of this paper was to present a comprehensive approach to help health care organizations reliably deliver effective interventions. Context Reliability in healthcare translates into using valid rate-based measures. Yet high reliability organizations have proven that the context in which care is delivered, called organizational culture, also has important influences on patient safety. Model for Improvement Our model to improve reliability, which also includes interventions to improve culture, focuses on valid rate-based measures. This model includes (1) identifying evidence-based interventions that improve the outcome, (2) selecting interventions with the most impact on outcomes and converting to behaviors, (3) developing measures to evaluate reliability, (4) measuring baseline performance, and (5) ensuring patients receive the evidence-based interventions. The comprehensive unit-based safety program (CUSP) is used to improve culture and guide organizations in learning from mistakes that are important, but cannot be measured as rates. Conclusions We present how this model was used in over 100 intensive care units in Michigan to improve culture and eliminate catheter-related blood stream infections—both were accomplished. Our model differs from existing models in that it incorporates efforts to improve a vital component for system redesign—culture, it targets 3 important groups—senior leaders, team leaders, and front line staff, and facilitates change management—engage, educate, execute, and evaluate for planned interventions. PMID:16898981

Evaluation of glucose controllers in virtual environment: methodology and sample application.

PubMed

Chassin, Ludovic J; Wilinska, Malgorzata E; Hovorka, Roman

2004-11-01

Adaptive systems to deliver medical treatment in humans are safety-critical systems and require particular care in both the testing and the evaluation phase, which are time-consuming, costly, and confounded by ethical issues. The objective of the present work is to develop a methodology to test glucose controllers of an artificial pancreas in a simulated (virtual) environment. A virtual environment comprising a model of the carbohydrate metabolism and models of the insulin pump and the glucose sensor is employed to simulate individual glucose excursions in subjects with type 1 diabetes. The performance of the control algorithm within the virtual environment is evaluated by considering treatment and operational scenarios. The developed methodology includes two dimensions: testing in relation to specific life style conditions, i.e. fasting, post-prandial, and life style (metabolic) disturbances; and testing in relation to various operating conditions, i.e. expected operating conditions, adverse operating conditions, and system failure. We define safety and efficacy criteria and describe the measures to be taken prior to clinical testing. The use of the methodology is exemplified by tuning and evaluating a model predictive glucose controller being developed for a wearable artificial pancreas focused on fasting conditions. Our methodology to test glucose controllers in a virtual environment is instrumental in anticipating the results of real clinical tests for different physiological conditions and for different operating conditions. The thorough testing in the virtual environment reduces costs and speeds up the development process.

The association between EMS workplace safety culture and safety outcomes.

PubMed

Weaver, Matthew D; Wang, Henry E; Fairbanks, Rollin J; Patterson, Daniel

2012-01-01

Prior studies have highlighted wide variation in emergency medical services (EMS) workplace safety culture across agencies. To determine the association between EMS workplace safety culture scores and patient or provider safety outcomes. We administered a cross-sectional survey to EMS workers affiliated with a convenience sample of agencies. We recruited these agencies from a national EMS management organization. We used the EMS Safety Attitudes Questionnaire (EMS-SAQ) to measure workplace safety culture and the EMS Safety Inventory (EMS-SI), a tool developed to capture self-reported safety outcomes from EMS workers. The EMS-SAQ provides reliable and valid measures of six domains: safety climate, teamwork climate, perceptions of management, working conditions, stress recognition, and job satisfaction. A panel of medical directors, emergency medical technicians and paramedics, and occupational epidemiologists developed the EMS-SI to measure self-reported injury, medical errors and adverse events, and safety-compromising behaviors. We used hierarchical linear models to evaluate the association between EMS-SAQ scores and EMS-SI safety outcome measures. Sixteen percent of all respondents reported experiencing an injury in the past three months, four of every 10 respondents reported an error or adverse event (AE), and 89% reported safety-compromising behaviors. Respondents reporting injury scored lower on five of the six domains of safety culture. Respondents reporting an error or AE scored lower for four of the six domains, while respondents reporting safety-compromising behavior had lower safety culture scores for five of the six domains. Individual EMS worker perceptions of workplace safety culture are associated with composite measures of patient and provider safety outcomes. This study is preliminary evidence of the association between safety culture and patient or provider safety outcomes.

The association between EMS workplace safety culture and safety outcomes

PubMed Central

Weaver, Matthew D.; Wang, Henry E.; Fairbanks, Rollin J.; Patterson, Daniel

2012-01-01

Objective Prior studies have highlighted wide variation in EMS workplace safety culture across agencies. We sought to determine the association between EMS workplace safety culture scores and patient or provider safety outcomes. Methods We administered a cross-sectional survey to EMS workers affiliated with a convenience sample of agencies. We recruited these agencies from a national EMS management organization. We used the EMS Safety Attitudes Questionnaire (EMS-SAQ) to measure workplace safety culture and the EMS Safety Inventory (EMS-SI), a tool developed to capture self-reported safety outcomes from EMS workers. The EMS-SAQ provides reliable and valid measures of six domains: safety climate, teamwork climate, perceptions of management, perceptions of working conditions, stress recognition, and job satisfaction. A panel of medical directors, paramedics, and occupational epidemiologists developed the EMS-SI to measure self-reported injury, medical errors and adverse events, and safety-compromising behaviors. We used hierarchical linear models to evaluate the association between EMS-SAQ scores and EMS-SI safety outcome measures. Results Sixteen percent of all respondents reported experiencing an injury in the past 3 months, four of every 10 respondents reported an error or adverse event (AE), and 90% reported safety-compromising behaviors. Respondents reporting injury scored lower on 5 of the 6 domains of safety culture. Respondents reporting an error or AE scored lower for 4 of the 6 domains, while respondents reporting safety-compromising behavior had lower safety culture scores for 5 of 6 domains. Conclusions Individual EMS worker perceptions of workplace safety culture are associated with composite measures of patient and provider safety outcomes. This study is preliminary evidence of the association between safety culture and patient or provider safety outcomes. PMID:21950463

Safety and health concerns in forestry operations

Treesearch

Robert B. Rummer

1997-01-01

The author discusses several safety models, including the "Three E?s": engineering, education, and enforcement; the Heinrich-Lateiner model; the organizational model; and the behavioral safety model. Rummer encourages approaching safety from a broader perspective, enabling the industry to track changes in all aspects and to keep leading the safety target....

Simulation for Prediction of Entry Article Demise (SPEAD): An Analysis Tool for Spacecraft Safety Analysis and Ascent/Reentry Risk Assessment

NASA Technical Reports Server (NTRS)

Ling, Lisa

2014-01-01

For the purpose of performing safety analysis and risk assessment for a potential off-nominal atmospheric reentry resulting in vehicle breakup, a synthesis of trajectory propagation coupled with thermal analysis and the evaluation of node failure is required to predict the sequence of events, the timeline, and the progressive demise of spacecraft components. To provide this capability, the Simulation for Prediction of Entry Article Demise (SPEAD) analysis tool was developed. The software and methodology have been validated against actual flights, telemetry data, and validated software, and safety/risk analyses were performed for various programs using SPEAD. This report discusses the capabilities, modeling, validation, and application of the SPEAD analysis tool.

Influence of parental perception of school safety and gender on children's physical activity in Mexico: A cross sectional study.

PubMed

Hutchens, Amy; Soltero, Erica G; Barquera, Simón; Lévesque, Lucie; Jauregui, Edtna; López Y Taylor, Juan; Lee, Rebecca E

2016-01-01

This cross sectional study aims to determine the effects of gender and parental perception of safety at school on children's physical activity (PA) levels. Parents of school aged Mexican children residing in Guadalajara, Mexico City, and Puerto Vallarta, completed surveys about their children's PA measures. The physical activity indicators were evaluated using linear and logistical regression models. Analysis did not indicate that gender moderated the relationship between parental perception of safety and PA measures, but significant gender issues exist with girls participating less than boys in the three measures of PA in this study (p<0.001). Results suggest the need for additional interventions promoting physical activity in girls in Mexico.

Racial/ethnic differences in obesity and comorbidities between safety-net- and non safety-net integrated health systems

PubMed Central

Balasubramanian, Bijal A.; Garcia, Michael P.; Corley, Douglas A.; Doubeni, Chyke A.; Haas, Jennifer S.; Kamineni, Aruna; Quinn, Virginia P.; Wernli, Karen; Zheng, Yingye; Skinner, Celette Sugg

2017-01-01

Abstract Previous research shows that patients in integrated health systems experience fewer racial disparities compared with more traditional healthcare systems. Little is known about patterns of racial/ethnic disparities between safety-net and non safety-net integrated health systems. We evaluated racial/ethnic differences in body mass index (BMI) and the Charlson comorbidity index from 3 non safety-net- and 1 safety-net integrated health systems in a cross-sectional study. Multinomial logistic regression modeled comorbidity and BMI on race/ethnicity and health care system type adjusting for age, sex, insurance, and zip-code-level income The study included 1.38 million patients. Higher proportions of safety-net versus non safety-net patients had comorbidity score of 3+ (11.1% vs. 5.0%) and BMI ≥35 (27.7% vs. 15.8%). In both types of systems, blacks and Hispanics were more likely than whites to have higher BMIs. Whites were more likely than blacks or Hispanics to have higher comorbidity scores in a safety net system, but less likely to have higher scores in the non safety-nets. The odds of comorbidity score 3+ and BMI 35+ in blacks relative to whites were significantly lower in safety-net than in non safety-net settings. Racial/ethnic differences were present within both safety-net and non safety-net integrated health systems, but patterns differed. Understanding patterns of racial/ethnic differences in health outcomes in safety-net and non safety-net integrated health systems is important to tailor interventions to eliminate racial/ethnic disparities in health and health care. PMID:28296752

[Design, implementation and evaluation of a management model of patient safety in hospitals in Catalonia, Spain].

PubMed

Saura, Rosa Maria; Moreno, Pilar; Vallejo, Paula; Oliva, Glòria; Alava, Fernando; Esquerra, Miquel; Davins, Josep; Vallès, Roser; Bañeres, Joaquim

2014-07-01

Since its inception in 2006, the Alliance for Patient Safety in Catalonia has played a major role in promoting and shaping a series of projects related to the strategy of the Ministry of Health, Social Services and Equality, for improving patient safety. One such project was the creation of functional units or committees of safety in hospitals in order to facilitate the management of patient safety. The strategy has been implemented in hospitals in Catalonia which were selected based on criteria of representativeness. The intervention was based on two lines of action, one to develop the model framework and the other for its development. Firstly the strategy for safety management based on EFQM (European Foundation for Quality Management) was defined with the development of standards, targets and indicators to implement security while the second part involved the introduction of tools, methodologies and knowledge to the management support of patient safety and risk prevention. The project was developed in four hospital areas considered higher risk, each assuming six goals for safety management. Some of these targets such as the security control panel or system of adverse event reporting were shared. 23 hospitals joined the project in Catalonia. Despite the different situations in each centre, high compliance was achieved in the development of the objectives. In each of the participating areas the security control panel was developed. Stable structures for safety management were established or strengthened. Training in patient safety played and important role, 1415 professionals participated. Through these kind of projects not only have been introduced programs of proven effectiveness in reducing risks, but they also provide to the facilities a work system that allows autonomy in diagnosis and analysis of the different risk situations or centre specific safety issues. Copyright © 2014. Published by Elsevier Espana.

Modeling the frequency of opposing left-turn conflicts at signalized intersections using generalized linear regression models.

PubMed

Zhang, Xin; Liu, Pan; Chen, Yuguang; Bai, Lu; Wang, Wei

2014-01-01

The primary objective of this study was to identify whether the frequency of traffic conflicts at signalized intersections can be modeled. The opposing left-turn conflicts were selected for the development of conflict predictive models. Using data collected at 30 approaches at 20 signalized intersections, the underlying distributions of the conflicts under different traffic conditions were examined. Different conflict-predictive models were developed to relate the frequency of opposing left-turn conflicts to various explanatory variables. The models considered include a linear regression model, a negative binomial model, and separate models developed for four traffic scenarios. The prediction performance of different models was compared. The frequency of traffic conflicts follows a negative binominal distribution. The linear regression model is not appropriate for the conflict frequency data. In addition, drivers behaved differently under different traffic conditions. Accordingly, the effects of conflicting traffic volumes on conflict frequency vary across different traffic conditions. The occurrences of traffic conflicts at signalized intersections can be modeled using generalized linear regression models. The use of conflict predictive models has potential to expand the uses of surrogate safety measures in safety estimation and evaluation.

Development of instruction in hospital electrical safety for medical education.

PubMed

Yoo, J H; Broderick, W A

1978-01-01

Although hospital electrical safety is receiving increased attention in the literature of engineers, it is not, at present, reflected in the curricula of medical schools. A possible reason for this omission is that biomedical and/or clinical engineers knowledgeable in electrical safety are not usually trained to teach. One remedy for this problem is to combine the knowledge of engineers with that of instructional developers to design a systematic curriculum for a course in hospital electrical safety. This paper describes such an effort at the University of Texas Health Science Center at San Antonio (UTHSCSA). A biomedical engineer and an instructional developer designed an instructional module in hospital electrical safety; the engineer taught the module, and both evaluated the results. The process and outcome of their collaboration are described. This model was effectively applied in the classroom as a four-hour segment in hospital electrical safety for first-year medical students at UTHSCSA. It is hoped that an additional benefit of this system will be that it offers an opportunity for continuing improvement in this kind of instruction at other medical schools and hospitals.

Parental physical activity, safety perceptions and children’s independent mobility

PubMed Central

2013-01-01

Background Parents are likely to be a basic influence on their children's behavior. There is an absence of information about the associations between parents' physical activity and perception of neighborhood environment with children’s independent mobility. The purpose of this study is to examine the contribution of parental physical activity and perception of neighborhood safety to children’s independent mobility. Methods In this cross-sectional study of 354 pupils and their parents, independent mobility, perceptions of neighborhood safety and physical activity were evaluated by questionnaire. Categorical principal components analyses were used to determine the underlying dimensions of both independent mobility and perceptions of neighborhood safety items. Results The strongest predictor of independent mobility was the parental perception of sidewalk and street safety (ß = 0.132). Parent’s physical activity was also a significant predictor. The final model accounted for 13.0% of the variance. Conclusions Parental perception of neighborhood safety and parents’ self reported physical activity might be associated with children’s independent mobility. Further research in this topic is needed to explore this possible association. PMID:23767778

Identifying factors affecting the safety of mid-block bicycle lanes considering mixed 2-wheeled traffic flow.

PubMed

Bai, Lu; Chan, Ching-Yao; Liu, Pan; Xu, Chengcheng

2017-10-03

Electric bikes (e-bikes) have been one of the fastest growing trip modes in Southeast Asia over the past 2 decades. The increasing popularity of e-bikes raised some safety concerns regarding urban transport systems. The primary objective of this study was to identify whether and how the generalized linear regression model (GLM) could be used to relate cyclists' safety with various contributing factors when riding in a mid-block bike lane. The types of 2-wheeled vehicles in the study included bicycle-style electric bicycles (BSEBs), scooter-style electric bicycles (SSEBs), and regular bicycles (RBs). Traffic conflict technology was applied as a surrogate measure to evaluate the safety of 2-wheeled vehicles. The safety performance model was developed by adopting a generalized linear regression model for relating the frequency of rear-end conflicts between e-bikes and regular bikes to the operating speeds of BSEBs, SSEBs, and RBs in mid-block bike lanes. The frequency of rear-end conflicts between e-bikes and bikes increased with an increase in the operating speeds of e-bikes and the volume of e-bikes and bikes and decreased with an increase in the width of bike lanes. The large speed difference between e-bikes and bikes increased the frequency of rear-end conflicts between e-bikes and bikes in mid-block bike lanes. A 1% increase in the average operating speed of e-bikes would increase the expected number of rear-end conflicts between e-bikes and bikes by 1.48%. A 1% increase in the speed difference between e-bikes and bikes would increase the expected number of rear-end conflicts between e-bikes/bikes by 0.16%. The conflict frequency in mid-block bike lanes can be modeled using generalized linear regression models. The factors that significantly affected the frequency of rear-end conflicts included the operating speeds of e-bikes, the speed difference between e-bikes and regular bikes, the volume of e-bikes, the volume of bikes, and the width of bike lanes. The safety performance model can help better understand the causes of crash occurrences in mid-block bike lanes.

An integrative model of organizational safety behavior.

PubMed

Cui, Lin; Fan, Di; Fu, Gui; Zhu, Cherrie Jiuhua

2013-06-01

This study develops an integrative model of safety management based on social cognitive theory and the total safety culture triadic framework. The purpose of the model is to reveal the causal linkages between a hazardous environment, safety climate, and individual safety behaviors. Based on primary survey data from 209 front-line workers in one of the largest state-owned coal mining corporations in China, the model is tested using structural equation modeling techniques. An employee's perception of a hazardous environment is found to have a statistically significant impact on employee safety behaviors through a psychological process mediated by the perception of management commitment to safety and individual beliefs about safety. The integrative model developed here leads to a comprehensive solution that takes into consideration the environmental, organizational and employees' psychological and behavioral aspects of safety management. Copyright © 2013 National Safety Council and Elsevier Ltd. All rights reserved.

Preclinical assessment of a new recombinant ADAMTS-13 drug product (BAX930) for the treatment of thrombotic thrombocytopenic purpura.

PubMed

Kopić, A; Benamara, K; Piskernik, C; Plaimauer, B; Horling, F; Höbarth, G; Ruthsatz, T; Dietrich, B; Muchitsch, E-M; Scheiflinger, F; Turecek, M; Höllriegl, W

2016-07-01

Essentials ADAMTS-13-deficiency is a cause of thrombotic thrombocytopenic purpura (TTP). Preclinical safety of recombinant human ADAMTS-13 (BAX930) was shown in animal models. Preclinical efficacy of BAX930 was shown in a mouse model of TTP. BAX930 showed advantageous efficacy over fresh frozen plasma, the current standard of care. Click to hear Dr Cataland and Prof. Lämmle present a seminar on Thrombotic Thrombocytopenic Purpura (TTP): new Insights in Pathogenesis and Treatment Modalities. Background Thrombotic thrombocytopenic purpura (TTP) is a rare blood disorder characterized by microthrombosis in small blood vessels of the body, resulting in a low platelet count. Baxalta has developed a new recombinant ADAMTS-13 (rADAMTS-13) product (BAX930) for on-demand and prophylactic treatment of patients with hereditary TTP (hTTP). Objectives To evaluate the pharmacokinetics, efficacy and safety of BAX930 in different species, by use of an extensive preclinical program. Methods The prophylactic and therapeutic efficacies of BAX930 were tested in a previously established TTP mouse model. Pharmacokinetics were evaluated after single intravenous bolus injection in mice and rats, and after repeated dosing in cynomolgus monkeys. Toxicity was assessed in rats and monkeys, safety pharmacology in monkeys, and local tolerance in rabbits. Results BAX930 was shown to be efficacious, as demonstrated by a stabilized platelet count in ADAMTS-13 knockout mice that were thrombocytopenic when treated. Prophylactic efficacy was dose-dependent and comparable with that achieved by treatment with fresh frozen plasma, the mainstay of hTTP treatment. Therapeutic efficacy was treatment interval-dependent. Safety pharmacology evaluation did not show any deleterious effects of BAX930 on cardiovascular and respiratory functions in monkeys. The compound's pharmacokinetics were similar and dose-proportional in mice, rats, and monkeys. BAX930 was well tolerated in rats, monkeys, and rabbits, even at the highest doses tested. Conclusions These results demonstrate that BAX930 has a favorable preclinical profile, and support the clinical development of rADAMTS-13 for the treatment of hTTP. © 2016 International Society on Thrombosis and Haemostasis.

Evaluation Of The Vehicle Radar Safety Systems Rashid Radar Safety Brake Collision Warning System, Final Report

DOT National Transportation Integrated Search

1988-02-01

THIS EVALUATION OF THE VEHICLE RADAR SAFETY SYSTEMS? ANTI-COLLISION DEVICE (HEREAFTER VRSS) WAS UNDERTAKEN BY THE OPERATOR PERFORMANCE AND SAFETY ANALYSIS DIVISION OF THE TRANSPORTATION SYSTEMS CENTER AT THE REQUEST OF THE NATIONAL HIGHWAY TRAFFIC SA...

Predicting Stress Related to Basic Needs and Safety in Darfur Refugee Camps: A Structural and Social Ecological Analysis

PubMed Central

RASMUSSEN, ANDREW; ANNAN, JEANNIE

2013-01-01

The research on the determinants of mental health among refugees has been largely limited to traumatic events, but recent work has indicated that the daily hassles of living in refugee camps also play a large role. Using hierarchical linear modelling to account for refugees nested within camp blocks, this exploratory study attempted to model stress surrounding safety and acquiring basic needs and functional impairment among refugees from Darfur living in Chad, using individual-level demographics (e.g., gender, age, presence of a debilitating injury), structural factors (e.g., distance from block to distribution centre), and social ecological variables (e.g., percentage of single women within a block). We found that stress concerning safety concerns, daily hassles, and functional impairment were associated with several individual-level demographic factors (e.g., gender), but also with interactions between block-level and individual-level factors as well (e.g., injury and distance to distribution centre). Findings are discussed in terms of monitoring and evaluation of refugee services. PMID:23626407

Predicting Stress Related to Basic Needs and Safety in Darfur Refugee Camps: A Structural and Social Ecological Analysis.

PubMed

Rasmussen, Andrew; Annan, Jeannie

2010-03-01

The research on the determinants of mental health among refugees has been largely limited to traumatic events, but recent work has indicated that the daily hassles of living in refugee camps also play a large role. Using hierarchical linear modelling to account for refugees nested within camp blocks, this exploratory study attempted to model stress surrounding safety and acquiring basic needs and functional impairment among refugees from Darfur living in Chad, using individual-level demographics (e.g., gender, age, presence of a debilitating injury), structural factors (e.g., distance from block to distribution centre), and social ecological variables (e.g., percentage of single women within a block). We found that stress concerning safety concerns, daily hassles, and functional impairment were associated with several individual-level demographic factors (e.g., gender), but also with interactions between block-level and individual-level factors as well (e.g., injury and distance to distribution centre). Findings are discussed in terms of monitoring and evaluation of refugee services.

Responding to Vaccine Safety Signals during Pandemic Influenza: A Modeling Study

PubMed Central

Maro, Judith C.; Fryback, Dennis G.; Lieu, Tracy A.; Lee, Grace M.; Martin, David B.

2014-01-01

Background Managing emerging vaccine safety signals during an influenza pandemic is challenging. Federal regulators must balance vaccine risks against benefits while maintaining public confidence in the public health system. Methods We developed a multi-criteria decision analysis model to explore regulatory decision-making in the context of emerging vaccine safety signals during a pandemic. We simulated vaccine safety surveillance system capabilities and used an age-structured compartmental model to develop potential pandemic scenarios. We used an expert-derived multi-attribute utility function to evaluate potential regulatory responses by combining four outcome measures into a single measure of interest: 1) expected vaccination benefit from averted influenza; 2) expected vaccination risk from vaccine-associated febrile seizures; 3) expected vaccination risk from vaccine-associated Guillain-Barre Syndrome; and 4) expected change in vaccine-seeking behavior in future influenza seasons. Results Over multiple scenarios, risk communication, with or without suspension of vaccination of high-risk persons, were the consistently preferred regulatory responses over no action or general suspension when safety signals were detected during a pandemic influenza. On average, the expert panel valued near-term vaccine-related outcomes relative to long-term projected outcomes by 3∶1. However, when decision-makers had minimal ability to influence near-term outcomes, the response was selected primarily by projected impacts on future vaccine-seeking behavior. Conclusions The selected regulatory response depends on how quickly a vaccine safety signal is identified relative to the peak of the pandemic and the initiation of vaccination. Our analysis suggested two areas for future investment: efforts to improve the size and timeliness of the surveillance system and behavioral research to understand changes in vaccine-seeking behavior. PMID:25536228

CRITICALITY SAFETY CONTROLS AND THE SAFETY BASIS AT PFP

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kessler, S

2009-04-21

With the implementation of DOE Order 420.1B, Facility Safety, and DOE-STD-3007-2007, 'Guidelines for Preparing Criticality Safety Evaluations at Department of Energy Non-Reactor Nuclear Facilities', a new requirement was imposed that all criticality safety controls be evaluated for inclusion in the facility Documented Safety Analysis (DSA) and that the evaluation process be documented in the site Criticality Safety Program Description Document (CSPDD). At the Hanford site in Washington State the CSPDD, HNF-31695, 'General Description of the FH Criticality Safety Program', requires each facility develop a linking document called a Criticality Control Review (CCR) to document performance of these evaluations. Chapter 5,more » Appendix 5B of HNF-7098, Criticality Safety Program, provided an example of a format for a CCR that could be used in lieu of each facility developing its own CCR. Since the Plutonium Finishing Plant (PFP) is presently undergoing Deactivation and Decommissioning (D&D), new procedures are being developed for cleanout of equipment and systems that have not been operated in years. Existing Criticality Safety Evaluations (CSE) are revised, or new ones written, to develop the controls required to support D&D activities. Other Hanford facilities, including PFP, had difficulty using the basic CCR out of HNF-7098 when first implemented. Interpretation of the new guidelines indicated that many of the controls needed to be elevated to TSR level controls. Criterion 2 of the standard, requiring that the consequence of a criticality be examined for establishing the classification of a control, was not addressed. Upon in-depth review by PFP Criticality Safety staff, it was not clear that the programmatic interpretation of criterion 8C could be applied at PFP. Therefore, the PFP Criticality Safety staff decided to write their own CCR. The PFP CCR provides additional guidance for the evaluation team to use by clarifying the evaluation criteria in DOE-STD-3007-2007. In reviewing documents used in classifying controls for Nuclear Safety, it was noted that DOE-HDBK-1188, 'Glossary of Environment, Health, and Safety Terms', defines an Administrative Control (AC) in terms that are different than typically used in Criticality Safety. As part of this CCR, a new term, Criticality Administrative Control (CAC) was defined to clarify the difference between an AC used for criticality safety and an AC used for nuclear safety. In Nuclear Safety terms, an AC is a provision relating to organization and management, procedures, recordkeeping, assessment, and reporting necessary to ensure safe operation of a facility. A CAC was defined as an administrative control derived in a criticality safety analysis that is implemented to ensure double contingency. According to criterion 2 of Section IV, 'Linkage to the Documented Safety Analysis', of DOESTD-3007-2007, the consequence of a criticality should be examined for the purposes of classifying the significance of a control or component. HNF-PRO-700, 'Safety Basis Development', provides control selection criteria based on consequence and risk that may be used in the development of a Criticality Safety Evaluation (CSE) to establish the classification of a component as a design feature, as safety class or safety significant, i.e., an Engineered Safety Feature (ESF), or as equipment important to safety; or merely provides defense-in-depth. Similar logic is applied to the CACs. Criterion 8C of DOE-STD-3007-2007, as written, added to the confusion of using the basic CCR from HNF-7098. The PFP CCR attempts to clarify this criterion by revising it to say 'Programmatic commitments or general references to control philosophy (e.g., mass control or spacing control or concentration control as an overall control strategy for the process without specific quantification of individual limits) is included in the PFP DSA'. Table 1 shows the PFP methodology for evaluating CACs. This evaluation process has been in use since February of 2008 and has proven to be simple and effective. Each control identified in the applicable new/revised CSE is evaluated via the table. The results of this evaluation are documented in tables attached to the CCR as an appendix, for each CSE, to the base document.« less

Flooding Fragility Experiments and Prediction

DOE Office of Scientific and Technical Information (OSTI.GOV)

Smith, Curtis L.; Tahhan, Antonio; Muchmore, Cody

2016-09-01

This report describes the work that has been performed on flooding fragility, both the experimental tests being carried out and the probabilistic fragility predictive models being produced in order to use the text results. Flooding experiments involving full-scale doors have commenced in the Portal Evaluation Tank. The goal of these experiments is to develop a full-scale component flooding experiment protocol and to acquire data that can be used to create Bayesian regression models representing the fragility of these components. This work is in support of the Risk-Informed Safety Margin Characterization (RISMC) Pathway external hazards evaluation research and development.

A multiscale model to evaluate the efficacy of anticancer therapies based on chimeric polypeptide nanoparticles

NASA Astrophysics Data System (ADS)

Paiva, L. R.; Martins, M. L.

2011-01-01

A multiscale model for tumor growth and its chemotherapy using conjugate nanoparticles is presented, and the corresponding therapeutic outcomes are evaluated. It is found that doxorubicin assembled into chimeric polypeptide nanoparticles cannot eradicate either vascularized primary tumors or avascular micrometastasis even administrated at loads close to their maximum tolerated doses. Furthermore, an effective and safety treatment demands for conjugate nanoparticles targeted to the malignant cells with much higher specificity and affinity than those currently observed in order to leave most of the normal tissues unaffected and to ensure a fast intracellular drug accumulation.

Utilising the Hand Model to promote a culturally safe environment for international nursing students.

PubMed

Mackay, Bev; Harding, Thomas; Jurlina, Lou; Scobie, Norma; Khan, Ruelle

2012-03-01

The rising number of international students studying outside their own country poses challenges for nursing education. Numbers are predicted to grow and economic factors are placing increasing pressure on tertiary institutions to accept these students. In adapting to a foreign learning environment international students must not only adapt to the academic culture but also to the social cultural context. The most significant acculturation issues for students are English as a second language, differences in education pedagogy and social integration and connectedness. Students studying in New Zealand need to work with Māori, the indigenous people, and assimilate and practice the unique aspects of cultural safety, which has evolved in nursing as part of the response to the principles underpinning the Treaty of Waitangi. The Hand Model offers the potential to support international nursing students in a culturally safe manner across all aspects of acculturation including those aspects of cultural safety unique to New Zealand. The model was originally developed by Lou Jurlina, a nursing teacher, to assist her to teach cultural safety and support her students in practising cultural safety in nursing. The thumb, represents 'awareness', with the other four digits signifying 'connection', 'communication', 'negotiation' and 'advocacy' respectively. Each digit is connected to the palm where the ultimate evaluation of The Hand Model in promoting cultural safety culminates in the clasping and shaking of hands: the moment of shared meaning. It promotes a sense of self worth and identity in students and a safe environment in which they can learn. Copyright © 2011 Nursing Praxis in New Zealand. Published by Elsevier Ltd.. All rights reserved.

The influence of economic incentives linked to road safety indicators on accidents: the case of toll concessions in Spain.

PubMed

Rangel, Thais; Vassallo, José Manuel; Herraiz, Israel

2013-10-01

The goal of this paper is to evaluate whether the incentives incorporated in toll highway concession contracts in order to encourage private operators to adopt measures to reduce accidents are actually effective at improving safety. To this end, we implemented negative binomial regression models using information about highway characteristics and accident data from toll highway concessions in Spain from 2007 to 2009. Our results show that even though road safety is highly influenced by variables that are not managed by the contractor, such as the annual average daily traffic (AADT), the percentage of heavy vehicles on the highway, number of lanes, number of intersections and average speed; the implementation of these incentives has a positive influence on the reduction of accidents and injuries. Consequently, this measure seems to be an effective way of improving safety performance in road networks. Copyright © 2013 Elsevier Ltd. All rights reserved.

Developing a Hierarchical Decision Model to Evaluate Nuclear Power Plant Alternative Siting Technologies

NASA Astrophysics Data System (ADS)

Lingga, Marwan Mossa

A strong trend of returning to nuclear power is evident in different places in the world. Forty-five countries are planning to add nuclear power to their grids and more than 66 nuclear power plants are under construction. Nuclear power plants that generate electricity and steam need to improve safety to become more acceptable to governments and the public. One novel practical solution to increase nuclear power plants' safety factor is to build them away from urban areas, such as offshore or underground. To date, Land-Based siting is the dominant option for siting all commercial operational nuclear power plants. However, the literature reveals several options for building nuclear power plants in safer sitings than Land-Based sitings. The alternatives are several and each has advantages and disadvantages, and it is difficult to distinguish among them and choose the best for a specific project. In this research, we recall the old idea of using the alternatives of offshore and underground sitings for new nuclear power plants and propose a tool to help in choosing the best siting technology. This research involved the development of a decision model for evaluating several potential nuclear power plant siting technologies, both those that are currently available and future ones. The decision model was developed based on the Hierarchical Decision Modeling (HDM) methodology. The model considers five major dimensions, social, technical, economic, environmental, and political (STEEP), and their related criteria and sub-criteria. The model was designed and developed by the author, and its elements' validation and evaluation were done by a large number of experts in the field of nuclear energy. The decision model was applied in evaluating five potential siting technologies and ranked the Natural Island as the best in comparison to Land-Based, Floating Plant, Artificial Island, and Semi-Embedded plant.

Evaluation of helper-dependent canine adenovirus vectors in a 3D human CNS model

PubMed Central

Simão, Daniel; Pinto, Catarina; Fernandes, Paulo; Peddie, Christopher J.; Piersanti, Stefania; Collinson, Lucy M.; Salinas, Sara; Saggio, Isabella; Schiavo, Giampietro; Kremer, Eric J.; Brito, Catarina; Alves, Paula M.

2017-01-01

Gene therapy is a promising approach with enormous potential for treatment of neurodegenerative disorders. Viral vectors derived from canine adenovirus type 2 (CAV-2) present attractive features for gene delivery strategies in the human brain, by preferentially transducing neurons, are capable of efficient axonal transport to afferent brain structures, have a 30-kb cloning capacity and have low innate and induced immunogenicity in pre-clinical tests. For clinical translation, in-depth pre-clinical evaluation of efficacy and safety in a human setting is primordial. Stem cell-derived human neural cells have a great potential as complementary tools by bridging the gap between animal models, which often diverge considerably from human phenotype, and clinical trials. Herein, we explore helper-dependent CAV-2 (hd-CAV-2) efficacy and safety for gene delivery in a human stem cell-derived 3D neural in vitro model. Assessment of hd-CAV-2 vector efficacy was performed at different multiplicities of infection, by evaluating transgene expression and impact on cell viability, ultrastructural cellular organization and neuronal gene expression. Under optimized conditions, hd-CAV-2 transduction led to stable long-term transgene expression with minimal toxicity. hd-CAV-2 preferentially transduced neurons, while human adenovirus type 5 (HAdV5) showed increased tropism towards glial cells. This work demonstrates, in a physiologically relevant 3D model, that hd-CAV-2 vectors are efficient tools for gene delivery to human neurons, with stable long-term transgene expression and minimal cytotoxicity. PMID:26181626

Evaluation of helper-dependent canine adenovirus vectors in a 3D human CNS model.

PubMed

Simão, D; Pinto, C; Fernandes, P; Peddie, C J; Piersanti, S; Collinson, L M; Salinas, S; Saggio, I; Schiavo, G; Kremer, E J; Brito, C; Alves, P M

2016-01-01

Gene therapy is a promising approach with enormous potential for treatment of neurodegenerative disorders. Viral vectors derived from canine adenovirus type 2 (CAV-2) present attractive features for gene delivery strategies in the human brain, by preferentially transducing neurons, are capable of efficient axonal transport to afferent brain structures, have a 30-kb cloning capacity and have low innate and induced immunogenicity in preclinical tests. For clinical translation, in-depth preclinical evaluation of efficacy and safety in a human setting is primordial. Stem cell-derived human neural cells have a great potential as complementary tools by bridging the gap between animal models, which often diverge considerably from human phenotype, and clinical trials. Herein, we explore helper-dependent CAV-2 (hd-CAV-2) efficacy and safety for gene delivery in a human stem cell-derived 3D neural in vitro model. Assessment of hd-CAV-2 vector efficacy was performed at different multiplicities of infection, by evaluating transgene expression and impact on cell viability, ultrastructural cellular organization and neuronal gene expression. Under optimized conditions, hd-CAV-2 transduction led to stable long-term transgene expression with minimal toxicity. hd-CAV-2 preferentially transduced neurons, whereas human adenovirus type 5 (HAdV5) showed increased tropism toward glial cells. This work demonstrates, in a physiologically relevant 3D model, that hd-CAV-2 vectors are efficient tools for gene delivery to human neurons, with stable long-term transgene expression and minimal cytotoxicity.

A Review of Numerical Simulation and Analytical Modeling for Medical Devices Safety in MRI

PubMed Central

Kabil, J.; Belguerras, L.; Trattnig, S.; Pasquier, C.; Missoffe, A.

2016-01-01

Summary Objectives To review past and present challenges and ongoing trends in numerical simulation for MRI (Magnetic Resonance Imaging) safety evaluation of medical devices. Methods A wide literature review on numerical and analytical simulation on simple or complex medical devices in MRI electromagnetic fields shows the evolutions through time and a growing concern for MRI safety over the years. Major issues and achievements are described, as well as current trends and perspectives in this research field. Results Numerical simulation of medical devices is constantly evolving, supported by calculation methods now well-established. Implants with simple geometry can often be simulated in a computational human model, but one issue remaining today is the experimental validation of these human models. A great concern is to assess RF heating on implants too complex to be traditionally simulated, like pacemaker leads. Thus, ongoing researches focus on alternative hybrids methods, both numerical and experimental, with for example a transfer function method. For the static field and gradient fields, analytical models can be used for dimensioning simple implants shapes, but limited for complex geometries that cannot be studied with simplifying assumptions. Conclusions Numerical simulation is an essential tool for MRI safety testing of medical devices. The main issues remain the accuracy of simulations compared to real life and the studies of complex devices; but as the research field is constantly evolving, some promising ideas are now under investigation to take up the challenges. PMID:27830244

[Evaluation of the sanitary-and-epidemiological safety of flocculating agents used for portable water purification].

PubMed

Zholdakova, Z I; Sinitsyna, O O; Tul'skaia, E A

2006-01-01

Polyelectrolytes used in the practice of water supply to the population were comparatively hygienically studied, by using a complex of hazard indices and a new approach to sanitary-and-epidemiological evaluation of the safety of water-soluble polymers is substantiated. The anionic and cationic flocculating agents from different chemical classes, such as Superflok A-100, Fennopol A 321E, Fennopol K 221E, Praestol 2530 TR, VPK-402, Superflok C-577, Saipan, KF-91, Ecosol-401, a low molecular-weight sodium polyacrylate were tested as model compounds. Moreover, the information already available in the scientific literature on the toxicity of synthetic polyelectrolytes was analyzed. The generalized maximum permissible concentrations were substantiated for individual chemical classes of synthetic polyelectrolytes: polyacrylamides, polyamines, polydiallyldimethylammonium chloride.

US Efforts in Support of Examinations at Fukushima Daiichi – 2016 Evaluations

DOE Office of Scientific and Technical Information (OSTI.GOV)

Amway, P.; Andrews, N.; Bixby, Willis

Although it is clear that the accident signatures from each unit at the Fukushima Daiichi Nuclear Power Station (NPS) [Daiichi] differ, much is not known about the end-state of core materials within these units. Some of this uncertainty can be attributed to a lack of information related to cooling system operation and cooling water injection. There is also uncertainty in our understanding of phenomena affecting: a) in-vessel core damage progression during severe accidents in boiling water reactors (BWRs), and b) accident progression after vessel failure (ex-vessel progression) for BWRs and Pressurized Water Reactors (PWRs). These uncertainties arise due to limitedmore » full scale prototypic data. Similar to what occurred after the accident at Three Mile Island Unit 2, these Daiichi units offer the international community a means to reduce such uncertainties by obtaining prototypic data from multiple full-scale BWR severe accidents. Information obtained from Daiichi is required to inform Decontamination and Decommissioning activities, improving the ability of the Tokyo Electric Power Company Holdings (TEPCO) to characterize potential hazards and to ensure the safety of workers involved with cleanup activities. This document reports recent results from the US Forensics Effort to use information obtained by TEPCO to enhance the safety of existing and future nuclear power plant designs. This Forensics Effort, which is sponsored by the Reactor Safety Technologies Pathway of the Department of Energy Office of Nuclear Energy Light Water Reactor (LWR) Sustainability Program, consists of a group of US experts in LWR safety and plant operations that have identified examination needs and are evaluating TEPCO information from Daiichi that address these needs. Examples presented in this report demonstrate that significant safety insights are being obtained in the areas of component performance, fission product release and transport, debris end-state location, and combustible gas generation and transport. In addition to reducing uncertainties related to severe accident modeling progression, these insights are being used to update guidance for severe accident prevention, mitigation, and emergency planning. Furthermore, reduced uncertainties in modeling the events at Daiichi will improve the realism of reactor safety evaluations and inform future D&D activities by improving the capability for characterizing potential hazards to workers involved with cleanup activities.« less

Cycling transport safety quantification

NASA Astrophysics Data System (ADS)

Drbohlav, Jiri; Kocourek, Josef

2018-05-01

Dynamic interest in cycling transport brings the necessity to design safety cycling infrastructure. In las few years, couple of norms with safety elements have been designed and suggested for the cycling infrastructure. But these were not fully examined. The main parameter of suitable and fully functional transport infrastructure is the evaluation of its safety. Common evaluation of transport infrastructure safety is based on accident statistics. These statistics are suitable for motor vehicle transport but unsuitable for the cycling transport. Cycling infrastructure evaluation of safety is suitable for the traffic conflicts monitoring. The results of this method are fast, based on real traffic situations and can be applied on any traffic situations.

Integrating Worksite Health Protection and Health Promotion: A Conceptual Model for Intervention and Research

PubMed Central

Sorensen, Glorian; McLellan, Deborah L.; Sabbath, Erika L.; Dennerlein, Jack T.; Nagler, Eve M.; Hurtado, David A.; Pronk, Nicolaas P.; Wagner, Gregory R.

2016-01-01

There is increasing recognition of the value added by integrating traditionally separate efforts to protect and promote worker safety and health. This paper presents an innovative conceptual model to guide research on determinants of worker safety and health and to inform the design, implementation and evaluation of integrated approaches to promoting and protecting worker health. This model is rooted in multiple theories and the premise that the conditions of work are important determinants of individual safety and health outcomes and behaviors, and outcomes important to enterprises such as absence and turnover. Integrated policies, programs and practices simultaneously address multiple conditions of work, including the physical work environment and the organization of work (e.g., psychosocial factors, job tasks and demands). Findings from two recent studies conducted in Boston and Minnesota (2009–2015) illustrate the application of this model to guide social epidemiological research. This paper focuses particular attention on the relationships of the conditions of work to worker health-related behaviors, musculoskeletal symptoms, and occupational injury; and to the design of integrated interventions in response to specific settings and conditions of work of small and medium size manufacturing businesses, based on a systematic assessment of priorities, needs, and resources within an organization. This model provides an organizing framework for both research and practice by specifying the causal pathways through which work may influence health outcomes, and for designing and testing interventions to improve worker safety and health that are meaningful for workers and employers, and responsive to that setting’s conditions of work. PMID:27527576

Clinical Decision Support Alert Appropriateness: A Review and Proposal for Improvement

PubMed Central

McCoy, Allison B.; Thomas, Eric J.; Krousel-Wood, Marie; Sittig, Dean F.

2014-01-01

Background Many healthcare providers are adopting clinical decision support (CDS) systems to improve patient safety and meet meaningful use requirements. Computerized alerts that prompt clinicians about drug-allergy, drug-drug, and drug-disease warnings or provide dosing guidance are most commonly implemented. Alert overrides, which occur when clinicians do not follow the guidance presented by the alert, can hinder improved patient outcomes. Methods We present a review of CDS alerts and describe a proposal to develop novel methods for evaluating and improving CDS alerts that builds upon traditional informatics approaches. Our proposal incorporates previously described models for predicting alert overrides that utilize retrospective chart review to determine which alerts are clinically relevant and which overrides are justifiable. Results Despite increasing implementations of CDS alerts, detailed evaluations rarely occur because of the extensive labor involved in manual chart reviews to determine alert and response appropriateness. Further, most studies have solely evaluated alert overrides that are appropriate or justifiable. Our proposal expands the use of web-based monitoring tools with an interactive dashboard for evaluating CDS alert and response appropriateness that incorporates the predictive models. The dashboard provides 2 views, an alert detail view and a patient detail view, to provide a full history of alerts and help put the patient's events in context. Conclusion The proposed research introduces several innovations to address the challenges and gaps in alert evaluations. This research can transform alert evaluation processes across healthcare settings, leading to improved CDS, reduced alert fatigue, and increased patient safety. PMID:24940129

Modeling of a Flooding Induced Station Blackout for a Pressurized Water Reactor Using the RISMC Toolkit

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mandelli, Diego; Prescott, Steven R; Smith, Curtis L

2011-07-01

In the Risk Informed Safety Margin Characterization (RISMC) approach we want to understand not just the frequency of an event like core damage, but how close we are (or are not) to key safety-related events and how might we increase our safety margins. The RISMC Pathway uses the probabilistic margin approach to quantify impacts to reliability and safety by coupling both probabilistic (via stochastic simulation) and mechanistic (via physics models) approaches. This coupling takes place through the interchange of physical parameters and operational or accident scenarios. In this paper we apply the RISMC approach to evaluate the impact of amore » power uprate on a pressurized water reactor (PWR) for a tsunami-induced flooding test case. This analysis is performed using the RISMC toolkit: RELAP-7 and RAVEN codes. RELAP-7 is the new generation of system analysis codes that is responsible for simulating the thermal-hydraulic dynamics of PWR and boiling water reactor systems. RAVEN has two capabilities: to act as a controller of the RELAP-7 simulation (e.g., system activation) and to perform statistical analyses (e.g., run multiple RELAP-7 simulations where sequencing/timing of events have been changed according to a set of stochastic distributions). By using the RISMC toolkit, we can evaluate how power uprate affects the system recovery measures needed to avoid core damage after the PWR lost all available AC power by a tsunami induced flooding. The simulation of the actual flooding is performed by using a smooth particle hydrodynamics code: NEUTRINO.« less

Overview of medical errors and adverse events

PubMed Central

2012-01-01

Safety is a global concept that encompasses efficiency, security of care, reactivity of caregivers, and satisfaction of patients and relatives. Patient safety has emerged as a major target for healthcare improvement. Quality assurance is a complex task, and patients in the intensive care unit (ICU) are more likely than other hospitalized patients to experience medical errors, due to the complexity of their conditions, need for urgent interventions, and considerable workload fluctuation. Medication errors are the most common medical errors and can induce adverse events. Two approaches are available for evaluating and improving quality-of-care: the room-for-improvement model, in which problems are identified, plans are made to resolve them, and the results of the plans are measured; and the monitoring model, in which quality indicators are defined as relevant to potential problems and then monitored periodically. Indicators that reflect structures, processes, or outcomes have been developed by medical societies. Surveillance of these indicators is organized at the hospital or national level. Using a combination of methods improves the results. Errors are caused by combinations of human factors and system factors, and information must be obtained on how people make errors in the ICU environment. Preventive strategies are more likely to be effective if they rely on a system-based approach, in which organizational flaws are remedied, rather than a human-based approach of encouraging people not to make errors. The development of a safety culture in the ICU is crucial to effective prevention and should occur before the evaluation of safety programs, which are more likely to be effective when they involve bundles of measures. PMID:22339769

FY16 Summary Report: Participation in the KOSINA Project

DOE Office of Scientific and Technical Information (OSTI.GOV)

Matteo, Edward N.; Hansen, Francis D.

Salt formations represent a promising host for disposal of nuclear waste in the United States and Germany. Together, these countries provided fully developed safety cases for bedded salt and domal salt, respectively. Today, Germany and the United States find themselves in similar positions with respect to salt formations serving as repositories for heat-generating nuclear waste. German research centers are evaluating bedded and pillow salt formations to contrast with their previous safety case made for the Gorleben dome. Sandia National Laboratories is collaborating on this effort as an Associate Partner, and this report summarizes that teamwork. Sandia and German research groupsmore » have a long-standing cooperative approach to repository science, engineering, operations, safety assessment, testing, modeling and other elements comprising the basis for salt disposal. Germany and the United States hold annual bilateral workshops, which cover a spectrum of issues surrounding the viability of salt formations. Notably, recent efforts include development of a database for features, events, and processes applying broadly and generically to bedded and domal salt. Another international teaming activity evaluates salt constitutive models, including hundreds of new experiments conducted on bedded salt from the Waste Isolation Pilot Plant. These extensive collaborations continue to build the scientific basis for salt disposal. Repository deliberations in the United States are revisiting bedded and domal salt for housing a nuclear waste repository. By agreeing to collaborate with German peers, our nation stands to benefit by assurance of scientific position, exchange of operational concepts, and approach to elements of the safety case, all reflecting cost and time efficiency.« less

The Sheep as a Model of Preclinical Safety and Pharmacokinetic Evaluations of Candidate Microbicides

PubMed Central

Cameron, David; Dias, Nicola; Holding, Jeremy; Muntendam, Alex; Oostebring, Freddy; Dreier, Peter; Rohan, Lisa; Nuttall, Jeremy

2015-01-01

When developing novel microbicide products for the prevention of HIV infection, the preclinical safety program must evaluate not only the active pharmaceutical ingredient but also the product itself. To that end, we applied several relatively standard toxicology study methodologies to female sheep, incorporating an assessment of the pharmacokinetics, safety, tolerability, and local toxicity of a dapivirine-containing human vaginal ring formulation (Dapivirine Vaginal Ring-004). We performed a 3-month general toxicology study, a preliminary pharmacokinetic study using drug-loaded vaginal gel, and a detailed assessment of the kinetics of dapivirine delivery to plasma, vaginal, and rectal fluid and rectal, vaginal, and cervical tissue over 28 days of exposure and 3 and 7 days after removal of the ring. The findings of the general toxicology study supported the existing data from both preclinical and clinical studies in that there were no signs of toxicity related to dapivirine. In addition, the presence of the physical dapivirine ring did not alter local or systemic toxicity or the pharmacokinetics of dapivirine. Pharmacokinetic studies indicated that the dapivirine ring produced significant vaginal tissue levels of dapivirine. However, no dapivirine was detected in cervical tissue samples using the methods described here. Plasma and vaginal fluid levels were lower than those in previous clinical studies, while there were detectable dapivirine levels in the rectal tissue and fluid. All tissue and fluid levels tailed off rapidly to undetectable levels following removal of the ring. The sheep represents a very useful model for the assessment of the safety and pharmacokinetics of microbicide drug delivery devices, such as the vaginal ring. PMID:25845860

[External therapy of plasma cell mastitis by jiuyi powder using partial least-squares discriminant analysis: a safety analysis].

PubMed

Ye, Mei-na; Yang, Ming; Cheng, Yi-qin; Wang, Bing; Zhu, Ying; Xia, Ya-ru; Meng, Tian; Chen, Hao; Chen, Li-ying; Cheng, Hong-feng

2015-04-01

To evaluate the safety and the clinical value of external use of jiuyi Powder (JP) in treating plasma cell mastitis using partial least-squares discriminant analysis (PLSDA). Totally 50 patients with plasma cell mastitis treated by external use of JP were observed and biochemical examinations of blood and urine detected before application, at day 4 after application, at day 1 and 14 after discontinuation. Blood mercury and urinary mercury were detected before application, at day 1, 4, and 7 after application, at day 1 and 14 after discontinuation. Urinary mercury was also detected at 28 after discontinuation and 3 months after discontinuation. The information of wound, days of external application and the total dosage of external application were recorded before application, at day 1, 4, and 7 after application, as well as at day 1 after discontinuation. Then a discriminant model covering potential safety factors was set up by PLSDA after screening safety indices with important effects. The applicability of the model was assessed using area under ROC curve. Potential safety factors were assessed using variable importance in the projection (VIP). Urinary β2-microglobulin (β2-MG), urinary N-acetyl-β-D-glucosaminidase (NAG), 24 h urinary protein, and urinary α1-microglobulin (α1-MG) were greatly affected by external use of JP in treating plasma cell mastitis. The accuracy rate of PLSDA discriminate model was 74. 00%. The sensitivity, specificity, and the area under ROC curve was 0. 7826, 0. 7037, and 0. 8084, respectively. Three factors with greater effect on the potential safety were screened as follows: pre-application volume of the sore cavity, days of external application, and the total dosage of external application. PLSDA method could be used in analyzing bioinformation of clinical Chinese medicine. Urinary β2-MG and urinary NAG were two main safety monitoring indices. Days of external application and the total dosage of external application were main factors influencing blood mercury and urine mercury. A safety classification simulation model of treating plasma cell mastitis by external therapy of JP was established by the two factors, which could be used to assess the safety of external application of JP to some extent.

USDA's Corner

USDA-ARS?s Scientific Manuscript database

SNARC has been working with the folks at AADAP on two studies: 1) a “near” GLP compliant Target Animal Safety study to evaluate the safety of Aquaflor® administered in feed to sunshine bass and 2) a GLP compliant Target Animal Safety study to evaluate the safety of 17a-methyltestosterone administere...

FMCSA’s advanced system testing utilizing a data acquisition system on the highways (FAST DASH) safety technology evaluation project #2 : technology brief.

DOT National Transportation Integrated Search

2016-11-01

The Federal Motor Carrier Safety Administration (FMCSA) established the FAST DASH program to perform efficient independent evaluations of promising safety technologies aimed at commercial vehicle operations. In this second FAST DASH safety technology...

Safety and operational performance evaluation of four types of exit ramps on Florida's freeways (final report).

DOT National Transportation Integrated Search

2010-12-01

This project mainly focuses on exit ramp performance analysis of safety and operations. In addition, issues of advance guide sign for exit ramp are also mentioned. : Safety analysis evaluates safety performances of different exit ramps used in Florid...

Analysis on Dangerous Source of Large Safety Accident in Storage Tank Area

NASA Astrophysics Data System (ADS)

Wang, Tong; Li, Ying; Xie, Tiansheng; Liu, Yu; Zhu, Xueyuan

2018-01-01

The difference between a large safety accident and a general accident is that the consequences of a large safety accident are particularly serious. To study the tank area which factors directly or indirectly lead to the occurrence of large-sized safety accidents. According to the three kinds of hazard source theory and the consequence cause analysis of the super safety accident, this paper analyzes the dangerous source of the super safety accident in the tank area from four aspects, such as energy source, large-sized safety accident reason, management missing, environmental impact Based on the analysis of three kinds of hazard sources and environmental analysis to derive the main risk factors and the AHP evaluation model is established, and after rigorous and scientific calculation, the weights of the related factors in four kinds of risk factors and each type of risk factors are obtained. The result of analytic hierarchy process shows that management reasons is the most important one, and then the environmental factors and the direct cause and Energy source. It should be noted that although the direct cause is relatively low overall importance, the direct cause of Failure of emergency measures and Failure of prevention and control facilities in greater weight.

Findings from the National Machine Guarding Program–A Small Business Intervention: Machine Safety

PubMed Central

Yamin, Samuel C.; Xi, Min; Brosseau, Lisa M.; Gordon, Robert; Most, Ivan G.; Stanley, Rodney

2016-01-01

Objectives The purpose of this nationwide intervention was to improve machine safety in small metal fabrication businesses (3 – 150 employees). The failure to implement machine safety programs related to guarding and lockout/tagout (LOTO) are frequent causes of OSHA citations and may result in serious traumatic injury. Methods Insurance safety consultants conducted a standardized evaluation of machine guarding, safety programs, and LOTO. Businesses received a baseline evaluation, two intervention visits and a twelve-month follow-up evaluation. Results The intervention was completed by 160 businesses. Adding a safety committee was associated with a 10-percentage point increase in business-level machine scores (p< 0.0001) and a 33-percentage point increase in LOTO program scores (p <0.0001). Conclusions Insurance safety consultants proved effective at disseminating a machine safety and LOTO intervention via management-employee safety committees. PMID:26716850

Findings From the National Machine Guarding Program–A Small Business Intervention

PubMed Central

Parker, David L.; Yamin, Samuel C.; Xi, Min; Brosseau, Lisa M.; Gordon, Robert; Most, Ivan G.; Stanley, Rodney

2016-01-01

Objectives: The purpose of this nationwide intervention was to improve machine safety in small metal fabrication businesses (3 to 150 employees). The failure to implement machine safety programs related to guarding and lockout/tagout (LOTO) are frequent causes of Occupational Safety and Health Administration (OSHA) citations and may result in serious traumatic injury. Methods: Insurance safety consultants conducted a standardized evaluation of machine guarding, safety programs, and LOTO. Businesses received a baseline evaluation, two intervention visits, and a 12-month follow-up evaluation. Results: The intervention was completed by 160 businesses. Adding a safety committee was associated with a 10% point increase in business-level machine scores (P < 0.0001) and a 33% point increase in LOTO program scores (P < 0.0001). Conclusions: Insurance safety consultants proved effective at disseminating a machine safety and LOTO intervention via management-employee safety committees. PMID:27466709

Evaluation of the Quality of Occupational Health and Safety Management Systems Based on Key Performance Indicators in Certified Organizations.

PubMed

Mohammadfam, Iraj; Kamalinia, Mojtaba; Momeni, Mansour; Golmohammadi, Rostam; Hamidi, Yadollah; Soltanian, Alireza

2017-06-01

Occupational Health and Safety Management Systems are becoming more widespread in organizations. Consequently, their effectiveness has become a core topic for researchers. This paper evaluates the performance of the Occupational Health and Safety Assessment Series 18001 specification in certified companies in Iran. The evaluation is based on a comparison of specific criteria and indictors related to occupational health and safety management practices in three certified and three noncertified companies. Findings indicate that the performance of certified companies with respect to occupational health and safety management practices is significantly better than that of noncertified companies. Occupational Health and Safety Assessment Series 18001-certified companies have a better level of occupational health and safety; this supports the argument that Occupational Health and Safety Management Systems play an important strategic role in health and safety in the workplace.

Occupational Health Training of Local Health Department Personnel: A Curriculum Model and Implications of Training.

ERIC Educational Resources Information Center

El-Ahraf, Amer; And Others

1982-01-01

Examines an industrial hygiene training program which emphasizes: (1) trends in occupational health; (2) organization and administration of occupational safety and health services; (3) methods of recognizing, evaluating, and controlling occupational hazards; and (4) application of epidemiological investigation planning, and health education to…

77 FR 58421 - Model Safety Evaluation for Plant-Specific Adoption of Technical Specifications Task Force...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-20

... Ventilation System Surveillance Requirements To Operate for 10 Hours per Month,'' Using the Consolidated Line... currently require operating the ventilation system for at least 10 continuous hours with the heaters... Technical Specifications (TSs) Task Force (TSTF) Traveler TSTF-522, Revision 0, ``Revise Ventilation System...

Implementation of Recommendations from the One System Comparative Evaluation of the Hanford Tank Farms and Waste Treatment Plant Safety Bases

DOE Office of Scientific and Technical Information (OSTI.GOV)

Garrett, Richard L.; Niemi, Belinda J.; Paik, Ingle K.

2013-11-07

A Comparative Evaluation was conducted for One System Integrated Project Team to compare the safety bases for the Hanford Waste Treatment and Immobilization Plant Project (WTP) and Tank Operations Contract (TOC) (i.e., Tank Farms) by an Expert Review Team. The evaluation had an overarching purpose to facilitate effective integration between WTP and TOC safety bases. It was to provide One System management with an objective evaluation of identified differences in safety basis process requirements, guidance, direction, procedures, and products (including safety controls, key safety basis inputs and assumptions, and consequence calculation methodologies) between WTP and TOC. The evaluation identified 25more » recommendations (Opportunities for Integration). The resolution of these recommendations resulted in 16 implementation plans. The completion of these implementation plans will help ensure consistent safety bases for WTP and TOC along with consistent safety basis processes. procedures, and analyses. and should increase the likelihood of a successful startup of the WTP. This early integration will result in long-term cost savings and significant operational improvements. In addition, the implementation plans lead to the development of eight new safety analysis methodologies that can be used at other U.S. Department of Energy (US DOE) complex sites where URS Corporation is involved.« less

Model of aircraft passenger acceptance

NASA Technical Reports Server (NTRS)

Jacobson, I. D.

1978-01-01

A technique developed to evaluate the passenger response to a transportation system environment is described. Reactions to motion, noise, temperature, seating, ventilation, sudden jolts and descents are modeled. Statistics are presented for the age, sex, occupation, and income distributions of the candidates analyzed. Values are noted for the relative importance of system variables such as time savings, on-time arrival, convenience, comfort, safety, the ability to read and write, and onboard services.

Developing tools for the safety specification in risk management plans: lessons learned from a pilot project.

PubMed

Cooper, Andrew J P; Lettis, Sally; Chapman, Charlotte L; Evans, Stephen J W; Waller, Patrick C; Shakir, Saad; Payvandi, Nassrin; Murray, Alison B

2008-05-01

Following the adoption of the ICH E2E guideline, risk management plans (RMP) defining the cumulative safety experience and identifying limitations in safety information are now required for marketing authorisation applications (MAA). A collaborative research project was conducted to gain experience with tools for presenting and evaluating data in the safety specification. This paper presents those tools found to be useful and the lessons learned from their use. Archive data from a successful MAA were utilised. Methods were assessed for demonstrating the extent of clinical safety experience, evaluating the sensitivity of the clinical trial data to detect treatment differences and identifying safety signals from adverse event and laboratory data to define the extent of safety knowledge with the drug. The extent of clinical safety experience was demonstrated by plots of patient exposure over time. Adverse event data were presented using dot plots, which display the percentages of patients with the events of interest, the odds ratio, and 95% confidence interval. Power and confidence interval plots were utilised for evaluating the sensitivity of the clinical database to detect treatment differences. Box and whisker plots were used to display laboratory data. This project enabled us to identify new evidence-based methods for presenting and evaluating clinical safety data. These methods represent an advance in the way safety data from clinical trials can be analysed and presented. This project emphasises the importance of early and comprehensive planning of the safety package, including evaluation of the use of epidemiology data.