Development of an evaluation framework for African-European hospital patient safety partnerships.

PubMed

Rutter, Paul; Syed, Shamsuzzoha B; Storr, Julie; Hightower, Joyce D; Bagheri-Nejad, Sepideh; Kelley, Edward; Pittet, Didier

2014-04-01

Patient safety is recognised as a significant healthcare problem worldwide, and healthcare-associated infections are an important aspect. African Partnerships for Patient Safety is a WHO programme that pairs hospitals in Africa with hospitals in Europe with the objective to work together to improve patient safety. To describe the development of an evaluation framework for hospital-to-hospital partnerships participating in the programme. The framework was structured around the programme's three core objectives: facilitate strong interhospital partnerships, improve in-hospital patient safety and spread best practices nationally. Africa-based clinicians, their European partners and experts in patient safety were closely involved in developing the evaluation framework in an iterative process. The process defined six domains of partnership strength, each with measurable subdomains. We developed a questionnaire to measure these subdomains. Participants selected six indicators of hospital patient safety improvement from a short-list of 22 based on their relevance, sensitivity to intervention and measurement feasibility. Participants proposed 20 measures of spread, which were refined into a two-part conceptual framework, and a data capture tool created. Taking a highly participatory approach that closely involved its end users, we developed an evaluation framework and tools to measure partnership strength, patient safety improvements and the spread of best practice.

Risk analysis based CWR track buckling safety evaluations

DOT National Transportation Integrated Search

2001-01-01

As part of the Federal Railroad Administrations (FRA) track systems research program, the US DOTS Volpe Center is conducting analytic and experimental investigations to evaluate track lateral strength and stability limits for improved safety an...

Reporting of meta-analyses of randomized controlled trials with a focus on drug safety: an empirical assessment.

PubMed

Hammad, Tarek A; Neyarapally, George A; Pinheiro, Simone P; Iyasu, Solomon; Rochester, George; Dal Pan, Gerald

2013-01-01

Due to the sparse nature of serious drug-related adverse events (AEs), meta-analyses combining data from several randomized controlled trials (RCTs) to evaluate drug safety issues are increasingly being conducted and published, influencing clinical and regulatory decision making. Evaluation of meta-analyses involves the assessment of both the individual constituent trials and the approaches used to combine them. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting framework is designed to enhance the reporting of systematic reviews and meta-analyses. However, PRISMA may not cover all critical elements useful in the evaluation of meta-analyses with a focus on drug safety particularly in the regulatory-public health setting. This work was conducted to (1) evaluate the adherence of a sample of published drug safety-focused meta-analyses to the PRISMA reporting framework, (2) identify gaps in this framework based on key aspects pertinent to drug safety, and (3) stimulate the development and validation of a more comprehensive reporting tool that incorporates elements unique to drug safety evaluation. We selected a sample of meta-analyses of RCTs based on review of abstracts from high-impact journals as well as top medical specialty journals between 2009 and 2011. We developed a preliminary reporting framework based on PRISMA with specific additional reporting elements critical for the evaluation of drug safety meta-analyses of RCTs. The reporting of pertinent elements in each meta-analysis was reviewed independently by two authors; discrepancies in the independent evaluations were resolved through discussions between the two authors. A total of 27 meta-analyses, 12 from highest impact journals, 13 from specialty medical journals, and 2 from Cochrane reviews, were identified and evaluated. The great majority (>85%) of PRISMA elements were addressed in more than half of the meta-analyses reviewed. However, the majority of meta-analyses (>60%) did not address most (>80%) of the additional reporting elements critical for the evaluation of drug safety. Some of these elements were not addressed in any of the reviewed meta-analyses. This review included a sample of meta-analyses, with a focus on drug safety, recently published in high-impact journals; therefore, we may have underestimated the extent of the reporting problem across all meta-analyses of drug safety. Furthermore, temporal trends in reporting could not be evaluated in this review because of the short time interval selected. While the majority of PRISMA elements were addressed by most studies reviewed, the majority of studies did not address most of the additional safety-related elements. These findings highlight the need for the development and validation of a drug safety reporting framework and the importance of the current initiative by the Council for International Organizations of Medical Sciences (CIOMS) to create a guidance document for drug safety information synthesis/meta-analysis, which may improve reporting, conduct, and evaluation of meta-analyses of drug safety and inform clinical and regulatory decision making.

Federal Motor Carrier Safety Administration’s Advanced System Testing Utilizing a Data Acquisition System on the Highways (FAST DASH) Safety Technology Evaluation Project #2: Driver Monitoring Final Report.

DOT National Transportation Integrated Search

2016-12-01

An independent evaluation of a non-video-based onboard monitoring system (OBMS) was conducted. The objective was to determine if the OBMS system performed reliably, improved driving safety and performance, and improved fuel efficiency in a commercial...

Federal Motor Carrier Safety Administration’s advanced system testing utilizing a data acquisition system on the highways (FAST DASH) safety technology evaluation project #2 : driver monitoring, final report.

DOT National Transportation Integrated Search

2016-11-01

An independent evaluation of a non-video-based onboard monitoring system (OBMS) was conducted. The objective was to determine if the OBMS system performed reliably, improved driving safety and performance, and improved fuel efficiency in a commercial...

Risk analysis based CWR track buckling safety evaluations

DOT National Transportation Integrated Search

1999-12-01

As part of the Federal Railroad Administration's (FRA) track systems research program, the US DOT'S Volpe Center is conducting analytic and experimental investigations to evaluate track lateral strength and stability limits for improved safety and pe...

[Explore method about post-marketing safety re-evaluation of Chinese patent medicines based on HIS database in real world].

PubMed

Yang, Wei; Xie, Yanming; Zhuang, Yan

2011-10-01

There are many kinds of Chinese traditional patent medicine used in clinical practice and many adverse events have been reported by clinical professionals. Chinese patent medicine's safety problems are the most concerned by patients and physicians. At present, many researchers have studied re-evaluation methods about post marketing Chinese medicine safety inside and outside China. However, it is rare that using data from hospital information system (HIS) to re-evaluating post marketing Chinese traditional patent medicine safety problems. HIS database in real world is a good resource with rich information to research medicine safety. This study planed to analyze HIS data selected from ten top general hospitals in Beijing, formed a large HIS database in real world with a capacity of 1 000 000 cases in total after a series of data cleaning and integrating procedures. This study could be a new project that using information to evaluate traditional Chinese medicine safety based on HIS database. A clear protocol has been completed as for the first step for the whole study. The protocol is as follows. First of all, separate each of the Chinese traditional patent medicines existing in the total HIS database as a single database. Secondly, select some related laboratory tests indexes as the safety evaluating outcomes, such as routine blood, routine urine, feces routine, conventional coagulation, liver function, kidney function and other tests. Thirdly, use the data mining method to analyze those selected safety outcomes which had abnormal change before and after using Chinese patent medicines. Finally, judge the relationship between those abnormal changing and Chinese patent medicine. We hope this method could imply useful information to Chinese medicine researchers interested in safety evaluation of traditional Chinese medicine.

Internet-Based Training to Improve Preschool Playground Safety: Evaluation of the Stamp-in-Safety Programme

ERIC Educational Resources Information Center

Schwebel, David C.; Pennefather, Jordan; Marquez, Brion; Marquez, Jessie

2015-01-01

Objective: Playground injuries result in over 200,000 US pediatric emergency department visits annually. One strategy to reduce injuries is improved adult supervision. The Stamp-in-Safety programme, which involves supervisors stamping rewards for children playing safely, has been demonstrated in preliminary classroom-based work to reduce child…

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.

2006 NASA Range Safety Annual Report

NASA Technical Reports Server (NTRS)

TenHaken, Ron; Daniels, B.; Becker, M.; Barnes, Zack; Donovan, Shawn; Manley, Brenda

2007-01-01

Throughout 2006, Range Safety was involved in a number of exciting and challenging activities and events, from developing, implementing, and supporting Range Safety policies and procedures-such as the Space Shuttle Launch and Landing Plans, the Range Safety Variance Process, and the Expendable Launch Vehicle Safety Program procedures-to evaluating new technologies. Range Safety training development is almost complete with the last course scheduled to go on line in mid-2007. Range Safety representatives took part in a number of panels and councils, including the newly formed Launch Constellation Range Safety Panel, the Range Commanders Council and its subgroups, the Space Shuttle Range Safety Panel, and the unmanned aircraft systems working group. Space based range safety demonstration and certification (formerly STARS) and the autonomous flight safety system were successfully tested. The enhanced flight termination system will be tested in early 2007 and the joint advanced range safety system mission analysis software tool is nearing operational status. New technologies being evaluated included a processor for real-time compensation in long range imaging, automated range surveillance using radio interferometry, and a space based range command and telemetry processor. Next year holds great promise as we continue ensuring safety while pursuing our quest beyond the Moon to Mars.

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.

Embedding technology into inter-professional best practices in home safety evaluation.

PubMed

Burns, Suzanne Perea; Pickens, Noralyn Davel

2017-08-01

To explore inter-professional home evaluators' perspectives and needs for building useful and acceptable decision-support tools for the field of home modifications. Twenty semi-structured interviews were conducted with a range of home modification professionals from different regions of the United States. The interview transcripts were analyzed with a qualitative, descriptive, perspective approach. Technology supports current best practice and has potential to inform decision making through features that could enhance home evaluation processes, quality, efficiency and inter-professional communication. Technological advances with app design have created numerous opportunities for the field of home modifications. Integrating technology and inter-professional best practices will improve home safety evaluation and intervention development to meet client-centred and societal needs. Implications for rehabilitation Understanding home evaluators technology needs for home safety evaluations contributes to the development of app-based assessments. Integrating inter-professional perspectives of best practice and technological needs in an app for home assessments improves processes. Novice and expert home evaluators would benefit from decision support systems embedded in app-based assessments. Adoption of app-based assessment would improve efficiency while remaining client-centred.

Drug safety data mining with a tree-based scan statistic.

PubMed

Kulldorff, Martin; Dashevsky, Inna; Avery, Taliser R; Chan, Arnold K; Davis, Robert L; Graham, David; Platt, Richard; Andrade, Susan E; Boudreau, Denise; Gunter, Margaret J; Herrinton, Lisa J; Pawloski, Pamala A; Raebel, Marsha A; Roblin, Douglas; Brown, Jeffrey S

2013-05-01

In post-marketing drug safety surveillance, data mining can potentially detect rare but serious adverse events. Assessing an entire collection of drug-event pairs is traditionally performed on a predefined level of granularity. It is unknown a priori whether a drug causes a very specific or a set of related adverse events, such as mitral valve disorders, all valve disorders, or different types of heart disease. This methodological paper evaluates the tree-based scan statistic data mining method to enhance drug safety surveillance. We use a three-million-member electronic health records database from the HMO Research Network. Using the tree-based scan statistic, we assess the safety of selected antifungal and diabetes drugs, simultaneously evaluating overlapping diagnosis groups at different granularity levels, adjusting for multiple testing. Expected and observed adverse event counts were adjusted for age, sex, and health plan, producing a log likelihood ratio test statistic. Out of 732 evaluated disease groupings, 24 were statistically significant, divided among 10 non-overlapping disease categories. Five of the 10 signals are known adverse effects, four are likely due to confounding by indication, while one may warrant further investigation. The tree-based scan statistic can be successfully applied as a data mining tool in drug safety surveillance using observational data. The total number of statistical signals was modest and does not imply a causal relationship. Rather, data mining results should be used to generate candidate drug-event pairs for rigorous epidemiological studies to evaluate the individual and comparative safety profiles of drugs. Copyright © 2013 John Wiley & Sons, Ltd.

Mine safety assessment using gray relational analysis and bow tie model

PubMed Central

2018-01-01

Mine safety assessment is a precondition for ensuring orderly and safety in production. The main purpose of this study was to prevent mine accidents more effectively by proposing a composite risk analysis model. First, the weights of the assessment indicators were determined by the revised integrated weight method, in which the objective weights were determined by a variation coefficient method and the subjective weights determined by the Delphi method. A new formula was then adopted to calculate the integrated weights based on the subjective and objective weights. Second, after the assessment indicator weights were determined, gray relational analysis was used to evaluate the safety of mine enterprises. Mine enterprise safety was ranked according to the gray relational degree, and weak links of mine safety practices identified based on gray relational analysis. Third, to validate the revised integrated weight method adopted in the process of gray relational analysis, the fuzzy evaluation method was used to the safety assessment of mine enterprises. Fourth, for first time, bow tie model was adopted to identify the causes and consequences of weak links and allow corresponding safety measures to be taken to guarantee the mine’s safe production. A case study of mine safety assessment was presented to demonstrate the effectiveness and rationality of the proposed composite risk analysis model, which can be applied to other related industries for safety evaluation. PMID:29561875

Safety evaluation for packaging for the transport of K Basin sludge samples in the PAS-1 cask

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

SMITH, R.J.

1998-11-17

This safety evaluation for packaging authorizes the shipment of up to two 4-L sludge samples to and from the 325 Lab or 222-S Lab for characterization. The safety of this shipment is based on the current U.S. Department of Energy Certification of Compliance (CoC) for the PAS-1 cask, USA/9184/B(U) (DOE).

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.

Evaluation of the US Department of Energy's occupational safety and health program for its government-owned contractor-operated facilities

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

Not Available

The purpose of this report is to present to Secretary of Energy James Watkins the findings and recommendations of the Occupational Safety and Health Administration's (OSHA) evaluation of the Department of Energy's (DOE) programs for worker safety and health at DOE's government-owned contractor-operated (GOCO) nuclear facilities. The OSHA evaluation is based on an intensive and comprehensive review and analysis of DOE's worker safety and health programs including: written programs; safety and health inspection programs; and the adequacy of resource, training, and management controls. The evaluation began on April 10, 1990 and involved over three staff years before its conclusion. Themore » evaluation was initiated by former Secretary of Labor Elizabeth Dole in response to Secretary of Energy James Watkins' request that OSHA assist him in determining the actions needed to assure that DOE has an exemplary safety and health program in place at its GOCOs. 6 figs.« less

Evaluation of a community based childhood injury prevention program.

PubMed Central

Bablouzian, L.; Freedman, E. S.; Wolski, K. E.; Fried, L. E.

1997-01-01

OBJECTIVES: This pilot study evaluates the effectiveness of a community based childhood injury prevention program on the reduction of home hazards. METHODS: High risk pregnant women, who were enrolled in a home visiting program that augments existing health and human services, received initial home safety assessments. Clients received education about injury prevention practices, in addition to receiving selected home safety supplies. Fourteen questions from the initial assessment tool were repeated upon discharge from the program. Matched analyses were conducted to evaluate differences from initial assessment to discharge. RESULTS: A significantly larger proportion of homes were assessed as safe at discharge, compared with the initial assessment, for the following hazards: children riding unbuckled in all auto travel, Massachusetts Poison Center sticker on the telephone, outlet plugs in all unused electrical outlets, safety latches on cabinets and drawers, and syrup of ipecac in the home. CONCLUSIONS: A community based childhood injury prevention program providing education and safety supplies to clients significantly reduced four home hazards for which safety supplies were provided. Education and promotion of the proper use of child restraint systems in automobiles significantly reduced a fifth hazard, children riding unbuckled in auto travel. This program appears to reduce the prevalence of home hazards and, therefore, to increase home safety. PMID:9113841

Effectiveness evaluation of simulative workshops for newly licensed drivers.

PubMed

Rosenbloom, Tova; Eldror, Ehud

2014-02-01

The current study set to examine the effects of simulator use in driving instruction on newly licensed drivers, comparing the road safety knowledge and reported intended behavior, as well as the actual driving performance of new drivers. Participants consisted of 280 newly licensed driver, of which 140 whose drivers license training included additional simulator-based lessons, and 140 drivers whose training precluded simulator-based lessons. All drivers answered questionnaires pertaining to their intended safe driving behaviors (according to Ajzen's (2000) theory of planned behavior), and to their traffic safety knowledge. Of the initial sample, 40 drivers received actual driving performance evaluation by an expert driving instructor, as well as by in-vehicle data recorders (IVDRs). We assumed that safer drivers report safer driving intentions, demonstrate greater traffic safety knowledge, evaluated as safer drivers by the driving instructor, and display lower and stable driving parameters on the IVDRs. We hypothesized that theoretical driving studies combined with practical training on simulators will elevate the safety level of novices driving. Hierarchical regression analyses on driving intentions indicated that drivers who did not receive simulator-based lessons demonstrated safer driving intentions compared to drivers who received simulator-based lessons. This pattern possibly indicating the drivers who received simulator-based lessons felt more confident in their driving abilities compared to drivers who did not receive simulated training. No significant difference was found in traffic safety knowledge, or in the evaluation of the expert driving instructor. IDVR data comparisons indicated drivers who received simulator-based lessons braked more often and were less prone to headway events, suggesting a more responsive driving style. These findings do not point to any significant advantage or disadvantage of the current simulator-based driving training over other driving training methods. Copyright © 2013 Elsevier Ltd. All rights reserved.

Fluorescence-based bioassays for the detection and evaluation of food materials.

PubMed

Nishi, Kentaro; Isobe, Shin-Ichiro; Zhu, Yun; Kiyama, Ryoiti

2015-10-13

We summarize here the recent progress in fluorescence-based bioassays for the detection and evaluation of food materials by focusing on fluorescent dyes used in bioassays and applications of these assays for food safety, quality and efficacy. Fluorescent dyes have been used in various bioassays, such as biosensing, cell assay, energy transfer-based assay, probing, protein/immunological assay and microarray/biochip assay. Among the arrays used in microarray/biochip assay, fluorescence-based microarrays/biochips, such as antibody/protein microarrays, bead/suspension arrays, capillary/sensor arrays, DNA microarrays/polymerase chain reaction (PCR)-based arrays, glycan/lectin arrays, immunoassay/enzyme-linked immunosorbent assay (ELISA)-based arrays, microfluidic chips and tissue arrays, have been developed and used for the assessment of allergy/poisoning/toxicity, contamination and efficacy/mechanism, and quality control/safety. DNA microarray assays have been used widely for food safety and quality as well as searches for active components. DNA microarray-based gene expression profiling may be useful for such purposes due to its advantages in the evaluation of pathway-based intracellular signaling in response to food materials.

Fluorescence-Based Bioassays for the Detection and Evaluation of Food Materials

PubMed Central

Nishi, Kentaro; Isobe, Shin-Ichiro; Zhu, Yun; Kiyama, Ryoiti

2015-01-01

We summarize here the recent progress in fluorescence-based bioassays for the detection and evaluation of food materials by focusing on fluorescent dyes used in bioassays and applications of these assays for food safety, quality and efficacy. Fluorescent dyes have been used in various bioassays, such as biosensing, cell assay, energy transfer-based assay, probing, protein/immunological assay and microarray/biochip assay. Among the arrays used in microarray/biochip assay, fluorescence-based microarrays/biochips, such as antibody/protein microarrays, bead/suspension arrays, capillary/sensor arrays, DNA microarrays/polymerase chain reaction (PCR)-based arrays, glycan/lectin arrays, immunoassay/enzyme-linked immunosorbent assay (ELISA)-based arrays, microfluidic chips and tissue arrays, have been developed and used for the assessment of allergy/poisoning/toxicity, contamination and efficacy/mechanism, and quality control/safety. DNA microarray assays have been used widely for food safety and quality as well as searches for active components. DNA microarray-based gene expression profiling may be useful for such purposes due to its advantages in the evaluation of pathway-based intracellular signaling in response to food materials. PMID:26473869

Implementation of a patient safety program at a tertiary health system: A longitudinal analysis of interventions and serious safety events.

PubMed

Cropper, Douglas P; Harb, Nidal H; Said, Patricia A; Lemke, Jon H; Shammas, Nicolas W

2018-04-01

We hypothesize that implementation of a safety program based on high reliability organization principles will reduce serious safety events (SSE). The safety program focused on 7 essential elements: (a) safety rounding, (b) safety oversight teams, (c) safety huddles, (d) safety coaches, (e) good catches/safety heroes, (f) safety education, and (g) red rule. An educational curriculum was implemented focusing on changing high-risk behaviors and implementing critical safety policies. All unusual occurrences were captured in the Midas system and investigated by risk specialists, the safety officer, and the chief medical officer. A multidepartmental committee evaluated these events, and a root cause analysis (RCA) was performed. Events were tabulated and serious safety event (SSE) recorded and plotted over time. Safety success stories (SSSs) were also evaluated over time. A steady drop in SSEs was seen over 9 years. Also a rise in SSSs was evident, reflecting on staff engagement in the program. The parallel change in SSEs, SSSs, and the implementation of various safety interventions highly suggest that the program was successful in achieving its goals. A safety program based on high-reliability organization principles and made a core value of the institution can have a significant positive impact on reducing SSEs. © 2018 American Society for Healthcare Risk Management of the American Hospital Association.

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…

Behavior-based safety at Amtrak-Chicago associated with reduced injuries and costs.

DOT National Transportation Integrated Search

2007-02-01

The Federal Railroad Administration (FRA) Human Factors Research and Development (R&D) Program is sponsoring the Clear Signal for Action Program (CSA) to evaluate whether an approach that combines behavior-based safety (BBS) and continuous improvemen...

Next generation safety performance monitoring at signalized intersections using connected vehicle technology.

DOT National Transportation Integrated Search

2014-08-01

Crash-based safety evaluation is often hampered by randomness, lack of timeliness, and rarity of crash : occurrences. This is particularly the case for technology-driven safety improvement projects that are : frequently updated or replaced by newer o...

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.

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

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.

On Some Methods in Safety Evaluation in Geotechnics

NASA Astrophysics Data System (ADS)

Puła, Wojciech; Zaskórski, Łukasz

2015-06-01

The paper demonstrates how the reliability methods can be utilised in order to evaluate safety in geotechnics. Special attention is paid to the so-called reliability based design that can play a useful and complementary role to Eurocode 7. In the first part, a brief review of first- and second-order reliability methods is given. Next, two examples of reliability-based design are demonstrated. The first one is focussed on bearing capacity calculation and is dedicated to comparison with EC7 requirements. The second one analyses a rigid pile subjected to lateral load and is oriented towards working stress design method. In the second part, applications of random field to safety evaluations in geotechnics are addressed. After a short review of the theory a Random Finite Element algorithm to reliability based design of shallow strip foundation is given. Finally, two illustrative examples for cohesive and cohesionless soils are demonstrated.

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.

Food Safety Evaluation Based on Near Infrared Spectroscopy and Imaging: A Review.

PubMed

Fu, Xiaping; Ying, Yibin

2016-08-17

In recent years, due to the increasing consciousness of food safety and human health, much progress has been made in developing rapid and nondestructive techniques for the evaluation of food hazards, food authentication, and traceability. Near infrared (NIR) spectroscopy and imaging techniques have gained wide acceptance in many fields because of their advantages over other analytical techniques. Following a brief introduction of NIR spectroscopy and imaging basics, this review mainly focuses on recent NIR spectroscopy and imaging applications for food safety evaluation, including (1) chemical hazards detection; (2) microbiological hazards detection; (3) physical hazards detection; (4) new technology-induced food safety concerns; and (5) food traceability. The review shows NIR spectroscopy and imaging to be effective tools that will play indispensable roles for food safety evaluation. In addition, on-line/real-time applications of these techniques promise to be a huge growth field in the near future.

Efficacy of Web-Based Instruction to Provide Training on Federal Motor Carrier Safety Regulations

DOT National Transportation Integrated Search

2011-05-01

This report presents an evaluation of the current state-of-the-art Web-based instruction (WBI), reviews the current computer platforms of potential users of WBI, reviews the current status of WBI applications for Federal Motor Carrier Safety Administ...

Metabonomics approaches and the potential application in foodsafety evaluation.

PubMed

Kuang, Hua; Li, Zhe; Peng, Chifang; Liu, Liqiang; Xu, Liguang; Zhu, Yingyue; Wang, Libing; Xu, Chuanlai

2012-01-01

It is essential that the novel biomarkers discovered by means of advanced detection tools based on metabonomics could be used for long-term monitoring in food safety. By summarizing the common biomarkers discovery flowsheet based on metabonomics, this review evaluates the possible application of metabonomics in new biomarker discovery, especially in relation to food safety issues. Metabonomics have the advantages of decreasing detection limits and constant monitoring. Although metabonomics is still in the developmental stage, we believe that, based on its properties, such as noninvasiveness, sensitivity, and persistence, together with rigorous experimental designs, new and novel technologies, as well as increasingly accurate chemometrics and a relational database, metabonomics can demonstrate extensive application in food safety in the postgenome period.

Long-term impact of community-based information, education and communication activities on food hygiene and food safety behaviors in Vietnam: a longitudinal study.

PubMed

Takanashi, Kumiko; Quyen, Dao To; Le Hoa, Nguyen Thi; Khan, Nguyen Cong; Yasuoka, Junko; Jimba, Masamine

2013-01-01

Ingestion of contaminated water or food is a major contributor to childhood diarrhea in developing countries. In Vietnam, the use of community-based information, education and communication (IEC) activities could be a sustainable strategy to improve food hygiene and food safety behaviors. This study thus examined the long-term impact of community-based IEC activities on food hygiene and food safety behaviors. In this longitudinal study, we interviewed caregivers of children aged between six months and four years in suburban Hanoi. Baseline data were collected in January 2006 (n = 125). After conducting IEC interventions, we collected a 1(st) set of evaluation data in January 2007 (n = 132). To examine the long-term impact of the interventions, we then collected a 2(nd) set of evaluation data in January 2008 (n = 185). Changes in childhood diarrhea prevalence, IEC coverage, and food hygiene and food safety behaviors were assessed over a two-year period using bivariate and logistic regression analyses. Effective IEC channels were determined through multiple linear regression analysis. Childhood diarrhea was significantly reduced from 21.6% at baseline to 7.6% at the 1(st) post-intervention evaluation (P = 0.002), and to 5.9% at the 2(nd) evaluation. Among 17 food hygiene and food safety behaviors measured, a total of 11 behaviors were improved or maintained by the 2(nd) evaluation. Handwashing after toilet use was significantly improved at both evaluation points. Overall, 3 food safety behaviors and 7 food hygiene behaviors were found to have significantly improved at the 1(st) and at the 2(nd) evaluations, respectively. Flip chart communication administered by community groups was identified to be the most effective IEC channel for effecting behavior change (P = 0.018). Flip chart communication administered by community groups is effective for improving multiple food hygiene and food safety behaviors in sustainable ways, and should be included in water and health promotion programs.

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.

Non-Use of Motor Vehicle Safety Belts as an Issue in Civil Litigation

DOT National Transportation Integrated Search

1983-08-01

The current and potential role of the "safety belt defense" in civil litigation is studied. The paper presents an overview of the safety belt defense, including an evaluation of current precedent. Based on interviews with leading motor vehicle civil ...

The Effectiveness of a Bicycle Safety Program for Improving Safety-Related Knowledge and Behavior in Young Elementary Students

PubMed Central

Glang, Ann

2010-01-01

Objective The purpose of this study was to evaluate the “Bike Smart” program, an eHealth software program that teaches bicycle safety behaviors to young children. Methods Participants were 206 elementary students in grades kindergarten to 3. A random control design was employed to evaluate the program, with students assigned to either the treatment condition (Bike Smart) or the control condition (a video on childhood safety). Outcome measures included computer-based knowledge items (safety rules, helmet placement, hazard discrimination) and a behavioral measure of helmet placement. Results Results demonstrated that regardless of gender, cohort, and grade the participants in the treatment group showed greater gains than control participants in both the computer-presented knowledge items (p > .01) and the observational helmet measure (p > .05). Conclusions Findings suggest that the Bike Smart program can be a low cost, effective component of safety training packages that include both skills-based and experiential training. PMID:19755497

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.

Understanding the impact of area-based interventions on area safety in deprived areas: realist evaluation of a neighbour nuisance intervention in Arnhem, the Netherlands.

PubMed

Kramer, Daniëlle; Harting, Janneke; Kunst, Anton E

2016-03-31

Area-based health inequalities may partly be explained by higher levels of area disorder in deprived areas. Area disorder may cause safety concerns and hence impair health. This study assessed how, for whom and in what conditions the intervention Meeting for Care and Nuisance (MCN) had an impact on neighbour nuisance and area safety in four deprived districts in Arnhem, the Netherlands. Realist evaluation methodology was applied to uncover how, for whom, and under what conditions MCN was expected to and actually produced change. Expected change was based on action plans and scientific theories. Actual change was based on progress reports, media articles, interviews with district managers, and quantitative surveys. Three levels of impact were distinguished. At the organisational level, partly as expected, MCN's coordinated partnership strategy enabled role alignment, communication, and leadership. This resulted in a more efficient approach of nuisance households. At the level of nuisance households, as expected, MCN's joint assistance and enforcement strategy removed many of the underlying reasons for nuisance. This resulted in less neighbour nuisance. At the district level, perceptions of social control and area safety improved only in one district. Key conditions for change included a wider safety approach, dense population, and central location of the district within the city. This realist evaluation provided insight into the mechanisms by which a complex area-based intervention was able to reduce neighbour nuisance in deprived areas. Depending on wider conditions, such a reduction in neighbour nuisance may or may not lead to improved perceptions of area safety at the district level.

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 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.

Development and validation of a remote home safety protocol.

PubMed

Romero, Sergio; Lee, Mi Jung; Simic, Ivana; Levy, Charles; Sanford, Jon

2018-02-01

Environmental assessments and subsequent modifications conducted by healthcare professionals can enhance home safety and promote independent living. However, travel time, expense and the availability of qualified professionals can limit the broad application of this intervention. Remote technology has the potential to increase access to home safety evaluations. This study describes the development and validation of a remote home safety protocol that can be used by a caregiver of an elderly person to video-record their home environment for later viewing and evaluation by a trained professional. The protocol was developed based on literature reviews and evaluations from clinical and content experts. Cognitive interviews were conducted with a group of six caregivers to validate the protocol. The final protocol included step-by-step directions to record indoor and outdoor areas of the home. The validation process resulted in modifications related to safety, clarity of the protocol, readability, visual appearance, technical descriptions and usability. Our final protocol includes detailed instructions that a caregiver should be able to follow to record a home environment for subsequent evaluation by a home safety professional. Implications for Rehabilitation The results of this study have several implications for rehabilitation practice The remote home safety evaluation protocol can potentially improve access to rehabilitation services for clients in remote areas and prevent unnecessary delays for needed care. Using our protocol, a patient's caregiver can partner with therapists to quickly and efficiently evaluate a patient's home before they are released from the hospital. Caregiver narration, which reflects a caregiver's own perspective, is critical to evaluating home safety. In-home safety evaluations, currently not available to all who need them due to access barriers, can enhance a patient's independence and provide a safer home environment.

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.

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

On Building an Ontological Knowledge Base for Managing Patient Safety Events.

PubMed

Liang, Chen; Gong, Yang

2015-01-01

Over the past decade, improving healthcare quality and safety through patient safety event reporting systems has drawn much attention. Unfortunately, such systems are suffering from low data quality, inefficient data entry and ineffective information retrieval. For improving the systems, we develop a semantic web ontology based on the WHO International Classification for Patient Safety (ICPS) and AHRQ Common Formats for patient safety event reporting. The ontology holds potential in enhancing knowledge management and information retrieval, as well as providing flexible data entry and case analysis for both reporters and reviewers of patient safety events. In this paper, we detailed our efforts in data acquisition, transformation, implementation and initial evaluation of the ontology.

Systematic Analysis of Icotinib Treatment for Patients with Non-Small Cell Lung Cancer.

PubMed

Shi, Bing; Zhang, Xiu-Bing; Xu, Jian; Huang, Xin-En

2015-01-01

This analysis was conducted to evaluate the efficacy and safety of icotinib based regimens in treating patients with non-small cell lung cancer (NSCLC). Clinical studies evaluating the efficacy and safety of icotinib-based regimens with regard to response and safety for patients with NSCLC were identified using a predefined search strategy. Pooled response rates of treatment were calculated. With icotinib-based regimens, 7 clinical studies which including 5,985 Chinese patients with NSCLC were considered eligible for inclusion. The pooled analysis suggested that, in all patients, the positive reponse rate was 30.1% (1,803/5,985) with icotinib-based regimens. Mild skin itching, rashes and diarrhea were the main side effects. No grade III or IV renal or liver toxicity was observed. No treatment-related death occurred in patients treated with icotinib-based regimens. This evidence based analysis suggests that icotinib based regimens are associated with mild response rate and acceptable toxicity for treating Chinese patients with NSCLC.

A Web-based searchable system to confirm magnetic resonance compatibility of implantable medical devices in Japan: a preliminary study.

PubMed

Fujiwara, Yasuhiro; Fujioka, Hitoshi; Watanabe, Tomoko; Sekiguchi, Maiko; Murakami, Ryuji

2017-09-01

Confirmation of the magnetic resonance (MR) compatibility of implanted medical devices (IMDs) is mandatory before conducting magnetic resonance imaging (MRI) examinations. In Japan, few such confirmation methods are in use, and they are time-consuming. This study aimed to develop a Web-based searchable MR safety information system to confirm IMD compatibility and to evaluate the usefulness of the system. First, MR safety information for intravascular stents and stent grafts sold in Japan was gathered by interviewing 20 manufacturers. These IMDs were categorized based on the descriptions available on medical package inserts as: "MR Safe," "MR Conditional," "MR Unsafe," "Unknown," and "No Medical Package Insert Available". An MR safety information database for implants was created based on previously proposed item lists. Finally, a Web-based searchable system was developed using this database. A questionnaire was given to health-care personnel in Japan to evaluate the usefulness of this system. Seventy-nine datasets were collected using information provided by 12 manufacturers and by investigating the medical packaging of the IMDs. Although the datasets must be updated by collecting data from other manufacturers, this system facilitates the easy and rapid acquisition of MR safety information for IMDs, thereby improving the safety of MRI examinations.

Evaluation of protein safety in the context of agricultural biotechnology.

PubMed

Delaney, Bryan; Astwood, James D; Cunny, Helen; Conn, Robin Eichen; Herouet-Guicheney, Corinne; Macintosh, Susan; Meyer, Linda S; Privalle, Laura; Gao, Yong; Mattsson, Joel; Levine, Marci

2008-05-01

One component of the safety assessment of agricultural products produced through biotechnology is evaluation of the safety of newly expressed proteins. The ILSI International Food Biotechnology Committee has developed a scientifically based two-tiered, weight-of-evidence strategy to assess the safety of novel proteins used in the context of agricultural biotechnology. Recommendations draw upon knowledge of the biological and chemical characteristics of proteins and testing methods for evaluating potential intrinsic hazards of chemicals. Tier I (potential hazard identification) includes an assessment of the biological function or mode of action and intended application of the protein, history of safe use, comparison of the amino acid sequence of the protein to other proteins, as well as the biochemical and physico-chemical properties of the proteins. Studies outlined in Tier II (hazard characterization) are conducted when the results from Tier I are not sufficient to allow a determination of safety (reasonable certainty of no harm) on a case-by-case basis. These studies may include acute and repeated dose toxicology studies and hypothesis-based testing. The application of these guidelines is presented using examples of transgenic proteins applied for agricultural input and output traits in genetically modified crops along with recommendations for future research considerations related to protein safety assessment.

The Decision Making Trial and Evaluation Laboratory (Dematel) and Analytic Network Process (ANP) for Safety Management System Evaluation Performance

NASA Astrophysics Data System (ADS)

Rolita, Lisa; Surarso, Bayu; Gernowo, Rahmat

2018-02-01

In order to improve airport safety management system (SMS) performance, an evaluation system is required to improve on current shortcomings and maximize safety. This study suggests the integration of the DEMATEL and ANP methods in decision making processes by analyzing causal relations between the relevant criteria and taking effective analysis-based decision. The DEMATEL method builds on the ANP method in identifying the interdependencies between criteria. The input data consists of questionnaire data obtained online and then stored in an online database. Furthermore, the questionnaire data is processed using DEMATEL and ANP methods to obtain the results of determining the relationship between criteria and criteria that need to be evaluated. The study cases on this evaluation system were Adi Sutjipto International Airport, Yogyakarta (JOG); Ahmad Yani International Airport, Semarang (SRG); and Adi Sumarmo International Airport, Surakarta (SOC). The integration grades SMS performance criterion weights in a descending order as follow: safety and destination policy, safety risk management, healthcare, and safety awareness. Sturges' formula classified the results into nine grades. JOG and SMG airports were in grade 8, while SOG airport was in grade 7.

[Establish research model of post-marketing clinical safety evaluation for Chinese patent medicine].

PubMed

Zheng, Wen-ke; Liu, Zhi; Lei, Xiang; Tian, Ran; Zheng, Rui; Li, Nan; Ren, Jing-tian; Du, Xiao-xi; Shang, Hong-cai

2015-09-01

The safety of Chinese patent medicine has become a focus of social. It is necessary to carry out work on post-marketing clinical safety evaluation for Chinese patent medicine. However, there have no criterions to guide the related research, it is urgent to set up a model and method to guide the practice for related research. According to a series of clinical research, we put forward some views, which contained clear and definite the objective and content of clinical safety evaluation, the work flow should be determined, make a list of items for safety evaluation project, and put forward the three level classification of risk control. We set up a model of post-marketing clinical safety evaluation for Chinese patent medicine. Based this model, the list of items can be used for ranking medicine risks, and then take steps for different risks, aims to lower the app:ds:risksrisk level. At last, the medicine can be managed by five steps in sequence. The five steps are, collect risk signal, risk recognition, risk assessment, risk management, and aftereffect assessment. We hope to provide new ideas for the future research.

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.

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.

Implementation and evaluation of a patient safety course in a problem-based learning program.

PubMed

Eltony, Sarah Ahmed; El-Sayed, Nahla Hassan; El-Araby, Shimaa El-Sayed; Kassab, Salah Eldin

2017-01-01

Since the development of the WHO patient safety curriculum guide, there has been insufficient reporting regarding the implementation and evaluation of patient safety courses in undergraduate problem-based learning (PBL) programs. This study is designed to implement a patient safety course to undergraduate students in a PBL medical school and evaluate this course by examining its effects on students' knowledge and satisfaction. The target population included year 6 medical students (n = 71) at the Faculty of Medicine, Suez Canal University in Egypt. A 3-day course was conducted addressing three principal topics from the WHO patient safety curriculum guide. The methods of instruction included reflection on students' past experiences, PBL case discussions, and tasks with incident report cards. A pre- and post-test design was used to assess the effect of the course on students' knowledge of inpatient safety topics. Furthermore, students' perceptions of the quality of the course were assessed through a structured self-administered course evaluation questionnaire. The results of the pre- and post-test demonstrated a significant increase (P < 0.05) in the students' mean multiple choice question (MCQ) scores. The MCQ scores for "what is patient safety" topic increased by 50% (P < 0.01). Similarly, the MCQ scores for the "infection control" topic increased by 39% (P < 0.01), and scores for the "medication safety" topic increased by 45% (P < 0.01). The majority of students perceived the different aspects of the course positively, including the structure and introduction of the course (75%) and the communication skills (83.2%) and teamwork skills they had developed (94.4%). The findings of the incident report cards indicated that 46.7% of the students perceived that incidents most commonly take place in the emergency room while only 6.7% in the outpatient clinic. This patient safety education program within a PBL curriculum is positively perceived by students. Furthermore, patient safety education in clinical settings should focus on emergencies, where students perceive most errors.

Summary of Federal Aviation Administration Responses to National Transportation Safety Board Safety Recommendations.

DTIC Science & Technology

1982-01-01

A-81-154. A-81-155. Adopt procedures and directives to use the student evaluations prepared by academic personnel at the FAA controller training...density ATC facilities. This determination, which is based on academic evaluations and the performance of the trainee in the radar training facility...81-154) Adopt procedures and directives to use the student evaluations prepared by academic personnel at the FAA controller training center as a

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

Protocol for a mixed-methods study on leader-based interventions in construction contractors' safety commitments.

PubMed

Pedersen, Betina Holbaek; Dyreborg, Johnny; Kines, Pete; Mikkelsen, Kim Lyngby; Hannerz, Harald; Andersen, Dorte Raaby; Spangenberg, Søren

2010-06-01

Owing to high injury rates, safety interventions are needed in the construction industry. Evidence-based interventions tailored to this industry are, however, scarce. Leader-based safety interventions have proven more effective than worker-based interventions in other industries. To test a leader-based safety intervention for construction sites. The intervention consists of encouraging safety coordinators to provide feedback on work safety to the client and line management. The intention is to increase communication and interactions regarding safety within the line management and between the client and the senior management. It is hypothesised that this, in turn, will lead to increased communication and interaction about safety between management and coworkers as well as an increased on-site safety level. A group-randomised double-blinded case study of six Danish construction sites (three intervention sites and three control sites). The recruitment of the construction sites is performed continuously from January 2010 to June 2010. The investigation of each site lasts 20 continuous weeks. Confirmatory statistical analysis is used to test if the safety level increased, and if the probability of safety communications between management and coworkers increases as a consequence of the intervention. The data collection will be blinded. Qualitative methods are used to evaluate if communication and interactions about safety at all managerial levels, including the client, increase. (1) The proportion of safety-related communications out of all studied communications between management and coworkers. (2) The safety level index of the construction sites.

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 ...

The Voluntary Use of Physical Education Safety Guidelines in Schools

ERIC Educational Resources Information Center

Rothe, J. Peter

2009-01-01

About 25 percent of child injuries occur in schools, most of them during physical education activities. Physical education safety guidelines are one strategy to reduce the number of student injuries. However, based on the findings of a recent evaluation of provincial safety guidelines, only two-thirds of physical education teachers use the safety…

The collection of national trend data on alcohol related crashes for comparison with alcohol safety action projects results. Volume 2, ASAP control site data

DOT National Transportation Integrated Search

1977-07-01

As a result of evaluations of the Alcohol Safety Action Projects (ASAP), a requirement was generated by the National Highway Traffic Safety Administration (NHTSA) for the development of a data base of alcohol-related accidents in communities with no ...

Effect of railway safety education on the safety knowledge and behaviour intention of schoolchildren.

PubMed

Silla, Anne; Kallberg, Veli-Pekka

2016-04-01

This study was designed to evaluate whether railway safety lessons are effective in increasing schoolchildren's safety knowledge and behaviour intention. The railway safety education in schools included a 45-min lesson on safe behaviour in a railway environment directed at 8-11 year old schoolchildren. The lessons were held in four schools located near railway lines in Finland. The effectiveness of this measure was evaluated based on a short survey directed at pupils before the lesson (base level) and around 2-3 months later (post-lesson) based on three variables which are considered as strong determinants of actual behaviour: behaviour intention, estimated dangerousness of the behaviour, and level of knowledge on the legality of the behaviour. The results show that the change in the share of correct answers was positive regarding all questions except for one question in which the difference was not significant. Based on this we can reasonably assume that railway safety education in schools can have a positive effect for all the measured variables, although the effect is not necessarily large. The results indicate that these positive changes can have a positive effect on the frequency of trespassing (i.e. fewer unsafe crossings in the future). We can further assume that reduction in the frequency of trespassing would reduce the frequency of trespassing accidents. Copyright © 2015 Elsevier Ltd. All rights reserved.

Raising awareness on cyber safety: adolescents' experience of a primary healthcare professional-led, school-based, multi-center intervention.

PubMed

Tsimtsiou, Zoi; Drosos, Evangelos; Drontsos, Anastasios; Haidich, Anna-Bettina; Dantsi, Fotini; Sekeri, Zafiria; Dardavesis, Theodoros; Nanos, Panagiotis; Arvanitidou, Malamatenia

2017-09-15

Purpose Although safe Internet use is an emerging public health issue, there is a scarcity of published work describing relevant school-based interventions. The objective of this study was to explore the impact of a health professional-led, school-based intervention in raising awareness on cyber-safety in adolescents, Therefore, the aim of this study was to investigate adolescents' evaluation of this school-based intervention, 6 months after its implementation, as well as the impact of adolescents' school class and gender on their evaluation. Methods A student sample was selected using a multistage stratified random sampling technique, according to the location and school grade level (middle, high school). The students - aged from 12 to 18 years old experienced an interactive presentation in their classrooms on the amount of time spent online, the use of social networks and the available support services. An evaluation tool was completed anonymously and voluntarily 6 months after the intervention. Results Four hundred and sixty-two students (response rate 90.7%, 246 middle, 216 high school) completed the evaluation tool. Younger students, especially the ones in the first year of middle school, scored significantly higher in all six parameters used in the evaluation of this intervention compared with all the older participants: (a) they had kept the presented information on Safeline and Saferinternet websites and the helpline Ypostirizo (70.2% vs. 33.7%, p < 0.001) (b) they had already used it (32.5% vs. 12.3%, p < 0.001), (c) they had learned new information on cyber safety (66.4% vs. 34%, p < 0.001), (d) they rated the intervention as more interesting (median 8 vs. 7, p < 0.05), (e) they had reconsidered the way they use Internet (median 7 vs. 6, p < 0.05) and (f) they had changed their cyber behavior (median 7 vs. 5, p < 0.05). Conclusion The active involvement of students in a discussion on cyber-safety based on their experiences was highly evaluated. The impact of the intervention on the youngest students underlines the need for raising awareness on cyber-safety and support services, earlier in the students' life.

Research on public participant urban infrastructure safety monitoring system using smartphone

NASA Astrophysics Data System (ADS)

Zhao, Xuefeng; Wang, Niannian; Ou, Jinping; Yu, Yan; Li, Mingchu

2017-04-01

Currently more and more people concerned about the safety of major public security. Public participant urban infrastructure safety monitoring and investigation has become a trend in the era of big data. In this paper, public participant urban infrastructure safety protection system based on smart phones is proposed. The system makes it possible to public participant disaster data collection, monitoring and emergency evaluation in the field of disaster prevention and mitigation. Function of the system is to monitor the structural acceleration, angle and other vibration information, and extract structural deformation and implement disaster emergency communications based on smartphone without network. The monitoring data is uploaded to the website to create urban safety information database. Then the system supports big data analysis processing, the structure safety assessment and city safety early warning.

NASA Range Safety Annual Report 2007

NASA Technical Reports Server (NTRS)

Dumont, Alan G.

2007-01-01

As always, Range Safety has been involved in a number of exciting and challenging activities and events. Throughout the year, we have strived to meet our goal of protecting the public, the workforce, and property during range operations. During the past year, Range Safety was involved in the development, implementation, and support of range safety policy. Range Safety training curriculum development was completed this year and several courses were presented. Tailoring exercises concerning the Constellation Program were undertaken with representatives from the Constellation Program, the 45th Space Wing, and the Launch Constellation Range Safety Panel. Range Safety actively supported the Range Commanders Council and it subgroups and remained involved in updating policy related to flight safety systems and flight safety analysis. In addition, Range Safety supported the Space Shuttle Range Safety Panel and addressed policy concerning unmanned aircraft systems. Launch operations at Kennedy Space Center, the Eastern and Western ranges, Dryden Flight Research Center, and Wallops Flight Facility were addressed. Range Safety was also involved in the evaluation of a number of research and development efforts, including the space-based range (formerly STARS), the autonomous flight safety system, the enhanced flight termination system, and the joint advanced range safety system. Flight safety system challenges were evaluated. Range Safety's role in the Space Florida Customer Assistance Service Program for the Eastern Range was covered along with our support for the Space Florida Educational Balloon Release Program. We hope you have found the web-based format both accessible and easy to use. Anyone having questions or wishing to have an article included in the 2008 Range Safety Annual Report should contact Alan Dumont, the NASA Range Safety Program Manager located at the Kennedy Space Center, or Michael Dook at NASA Headquarters.

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.

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).

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.

Recommendations for safety planning, data collection, evaluation and reporting during drug, biologic and vaccine development: a report of the safety planning, evaluation, and reporting team.

PubMed

Crowe, Brenda J; Xia, H Amy; Berlin, Jesse A; Watson, Douglas J; Shi, Hongliang; Lin, Stephen L; Kuebler, Juergen; Schriver, Robert C; Santanello, Nancy C; Rochester, George; Porter, Jane B; Oster, Manfred; Mehrotra, Devan V; Li, Zhengqing; King, Eileen C; Harpur, Ernest S; Hall, David B

2009-10-01

The Safety Planning, Evaluation and Reporting Team (SPERT) was formed in 2006 by the Pharmaceutical Research and Manufacturers of America. SPERT's goal was to propose a pharmaceutical industry standard for safety planning, data collection, evaluation, and reporting, beginning with planning first-in-human studies and continuing through the planning of the post-product-approval period. SPERT's recommendations are based on our review of relevant literature and on consensus reached in our discussions. An important recommendation is that sponsors create a Program Safety Analysis Plan early in development. We also give recommendations for the planning of repeated, cumulative meta-analyses of the safety data obtained from the studies conducted within the development program. These include clear definitions of adverse events of special interest and standardization of many aspects of data collection and study design. We describe a 3-tier system for signal detection and analysis of adverse events and highlight proposals for reducing "false positive" safety findings. We recommend that sponsors review the aggregated safety data on a regular and ongoing basis throughout the development program, rather than waiting until the time of submission. We recognize that there may be other valid approaches. The proactive approach we advocate has the potential to benefit patients and health care providers by providing more comprehensive safety information at the time of new product marketing and beyond.

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.

Study of Evaluation OSH Management System Policy Based On Safety Culture Dimensions in Construction Project

NASA Astrophysics Data System (ADS)

Latief, Yusuf; Armyn Machfudiyanto, Rossy; Arifuddin, Rosmariani; Mahendra Fira Setiawan, R.; Yogiswara, Yoko

2017-07-01

Safety Culture in the construction industry is very influential on the socio economic conditions that resulted in the country’s competitiveness. Based on the data, the accident rate of construction projects in Indonesia is very high. In the era of the Asian Economic Community (AEC) Indonesian contractor is required to improve competitiveness, one of which is the implementation of the project without zero accident. Research using primary and secondary data validated the results of the literature experts and questionnaire respondents were analyzed using methods SmartPLS, obtained pattern of relationships between dimensions of safety culture to improve the performance of Safety. The results showed that the behaviors and Cost of Safety into dimensions that significantly affect the performance of safety. an increase in visible policy-based on Regulation of Public Work and Housing No 5/PRT/M/2014 to improve to lower the accident rate.

Development and Evaluation of a Multi-Institutional Case Studies-Based Course in Food Safety

ERIC Educational Resources Information Center

Pleitner, Aaron M.; Chapin, Travis K.; Hammons, Susan R.; Stelten, Anna Van; Nightingale, Kendra K.; Wiedmann, Martin; Johnston, Lynette M.; Oliver, Haley F.

2015-01-01

Developing novel, engaging courses in food safety is necessary to train professionals in this discipline. Courses that are interactive and case-based encourage development of critical thinking skills necessary for identifying and preventing foodborne disease outbreaks. The purpose of this study was to assess the efficacy of a case study…

An evaluation of The Great Escape: can an interactive computer game improve young children's fire safety knowledge and behaviors?

PubMed

Morrongiello, Barbara A; Schwebel, David C; Bell, Melissa; Stewart, Julia; Davis, Aaron L

2012-07-01

Fire is a leading cause of unintentional injury and, although young children are at particularly increased risk, there are very few evidence-based resources available to teach them fire safety knowledge and behaviors. Using a pre-post randomized design, the current study evaluated the effectiveness of a computer game (The Great Escape) for teaching fire safety information to young children (3.5-6 years). Using behavioral enactment procedures, children's knowledge and behaviors related to fire safety were compared to a control group of children before and after receiving the intervention. The results indicated significant improvements in knowledge and fire safety behaviors in the intervention group but not the control. Using computer games can be an effective way to promote young children's understanding of safety and how to react in different hazardous situations.

Evaluation of safety ratings of roads based on frontal crashes with known crash pulse and injury outcome.

PubMed

Stigson, H

2009-06-01

The objective in this study, using data from crashed cars fitted with on-board crash pulse recorders, was to present differences in average crash severity, distribution of crash severity, and injury outcomes, based on an independent safety rating of roads, also taking road type and speed limit into consideration. Furthermore, the objective was to evaluate differences in injury risk, based on the distribution of crash severity. The investigation included both frontal two-vehicle crashes and single-vehicle crashes with known injury outcome. In total, 209 real-world crashes involving cars fitted with crash pulse recorders were included. For all crashes, average mean acceleration and change of velocity of the vehicle acceleration pulse were measured and calculated. All crash spots were classified according to an independent road safety rating program (European Road Assessment Programme Road Protection Score), where the safety quality of roads is rated in relation to posted speed limits. The crash severity and injury outcome in crashes that occurred on roads with good safety ratings were compared with crashes on roads with poor safety ratings. The data were also divided into subcategories according to posted speed limit and road type, to evaluate whether there was a difference in crash severity and injury outcome within the categories. In total, crash severity was statistically significantly lower in crashes occurring on roads with good safety ratings than in crashes occurring on roads with poor safety ratings. It was found that crash severity and injury risk were lower on roads with good safety ratings with a speed limit of above 90 km/h compared with roads with poor safety ratings, irrespective of speed limit. On the other hand, crash severity was higher on roads with good safety ratings with speed limit of 70 km/h than on roads with poor safety ratings with the same speed limit. Though it was found that a higher speed limit resulted in higher crash severity on roads with poor safety ratings, the opposite was found on roads with good safety ratings. The main reason for this was that lanes for traffic traveling in opposite directions were more often separated at higher speeds on roads with good safety ratings. On divided roads with good safety ratings, there were no crashes resulting in crash severity above the level corresponding to a 10 percent risk of sustaining serious or fatal injury. This indicates that one of the most important safety measures is divided roads.

Promoting Health and Home Safety for Children of Parents with Intellectual Disability: A Randomized Controlled Trial.

ERIC Educational Resources Information Center

Llewellyn, Gwynnyth; McConnell, David; Honey, Anne; Mayes, Rachel; Russo, Domenica

2003-01-01

This study evaluated a home-based intervention for parents with intellectual disability to promote child health and home safety in the preschool years. The intervention improved parents' ability to recognize home dangers and to handle emergencies, increased their knowledge about illness and medicines, and increased the number of safety precautions…

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.

A Pooled Analysis on Crizotinib in Treating Chinese Patients with EML4-ALK Positive Non-small-cell Lung Cancer.

PubMed

Li, Yang; Huang, Xin-En

2015-01-01

This analysis was conducted to evaluate the efficacy and safety of crizotinib based regimens in treating Chinese patients with EML4-ALK positive non-small-cell lung cancer. Clinical studies evaluating the efficacy and safety of crizotinib based regimens on response and safety for Chinese patients with EML4-ALK positive non-small-cell lung cancer were identified by using a predefined search strategy. Pooled response rate (RR) of treatment were calculated. In crizotinib based regimens, 3 clinical studies which including 128 Chinese patients with EML4-ALK positive non-small-cell lung cancer and treated with crizotinib based regimen were considered eligible for inclusion. Pooled analysis suggested that, in all patients, the pooled RR was 59.3% (76/128) in crizotinib based regimens. ALT/AST mild visual disturbances, nausea, and vomiting were the main side effects. No treatment related death occurred in these crizotinib based treatments. This pooled analysis suggests that crizotinib based regimens are associated with good response rate and accepted toxicities in treating Chinese patients with EML4-ALK positive non-small-cell lung cancer.

An evaluation of an airline cabin safety education program for elementary school children.

PubMed

Liao, Meng-Yuan

2014-04-01

The knowledge, attitude, and behavior intentions of elementary school students about airline cabin safety before and after they took a specially designed safety education course were examined. A safety education program was designed for school-age children based on the cabin safety briefings airlines given to their passengers, as well as on lessons learned from emergency evacuations. The course is presented in three modes: a lecture, a demonstration, and then a film. A two-step survey was used for this empirical study: an illustrated multiple-choice questionnaire before the program, and, upon completion, the same questionnaire to assess its effectiveness. Before the program, there were significant differences in knowledge and attitude based on school locations and the frequency that students had traveled by air. After the course, students showed significant improvement in safety knowledge, attitude, and their behavior intention toward safety. Demographic factors, such as gender and grade, also affected the effectiveness of safety education. The study also showed that having the instructor directly interact with students by lecturing is far more effective than presenting the information using only video media. A long-term evaluation, the effectiveness of the program, using TV or video accessible on the Internet to deliver a cabin safety program, and a control group to eliminate potential extraneous factors are suggested for future studies. Copyright © 2013 Elsevier Ltd. All rights reserved.

Consumer and farmer safety evaluation of application of botanical pesticides in black pepper crop protection.

PubMed

Hernández-Moreno, David; Soffers, Ans E M F; Wiratno; Falke, Hein E; Rietjens, Ivonne M C M; Murk, Albertinka J

2013-06-01

This study presents a consumer and farmer safety evaluation on the use of four botanical pesticides in pepper berry crop protection. The pesticides evaluated include preparations from clove, tuba root, sweet flag and pyrethrum. Their safety evaluation was based on their active ingredients being eugenol, rotenone, β-asarone and pyrethrins, respectively. Botanical pesticides from Acorus calamus are of possible concern because of the genotoxic and carcinogenic ingredient β-asarone although estimated margins of exposure (MOE) for consumers indicate a low priority for risk management. For the other three botanical pesticides the margin of safety (MOS) between established acute reference doses and/or acceptable daily intake values and intake estimates for the consumer, resulting from their use as a botanical pesticide are not of safety concern, with the exception for levels of rotenone upon use of tuba root extracts on stored berries. Used levels of clove and pyrethrum as botanical pesticides in pepper berry crop production is not of safety concern for consumers or farmers, whereas for use of tuba root and sweet flag some risk factors were defined requiring further evaluation and/or risk management. It seems prudent to look for alternatives for use of sweet flag extracts containing β-asarone. Copyright © 2013 Elsevier Ltd. All rights reserved.

Evaluation of estrogen receptor alpha activation by glyphosate-based herbicide constituents

EPA Science Inventory

The safety, including the endocrine disruptive capability, of glyphosate-based herbicides (GBHs) is a matter of intense debate. We evaluated the estrogenic potential of glyphosate, commercial GBHs and polyethoxylated tallowamine adjuvants present as co-formulants in GBHs. Glyph...

A strategy for systemic toxicity assessment based on non-animal approaches: The Cosmetics Europe Long Range Science Strategy programme.

PubMed

Desprez, Bertrand; Dent, Matt; Keller, Detlef; Klaric, Martina; Ouédraogo, Gladys; Cubberley, Richard; Duplan, Hélène; Eilstein, Joan; Ellison, Corie; Grégoire, Sébastien; Hewitt, Nicola J; Jacques-Jamin, Carine; Lange, Daniela; Roe, Amy; Rothe, Helga; Blaauboer, Bas J; Schepky, Andreas; Mahony, Catherine

2018-08-01

When performing safety assessment of chemicals, the evaluation of their systemic toxicity based only on non-animal approaches is a challenging objective. The Safety Evaluation Ultimately Replacing Animal Test programme (SEURAT-1) addressed this question from 2011 to 2015 and showed that further research and development of adequate tools in toxicokinetic and toxicodynamic are required for performing non-animal safety assessments. It also showed how to implement tools like thresholds of toxicological concern (TTCs) and read-across in this context. This paper shows a tiered scientific workflow and how each tier addresses the four steps of the risk assessment paradigm. Cosmetics Europe established its Long Range Science Strategy (LRSS) programme, running from 2016 to 2020, based on the outcomes of SEURAT-1 to implement this workflow. Dedicated specific projects address each step of this workflow, which is introduced here. It tackles the question of evaluating the internal dose when systemic exposure happens. The applicability of the workflow will be shown through a series of case studies, which will be published separately. Even if the LRSS puts the emphasis on safety assessment of cosmetic relevant chemicals, it remains applicable to any type of chemical. Copyright © 2018. Published by Elsevier Ltd.

Evaluation of a Drowning Prevention Program Based on Testimonial Videos: A Randomized Controlled Trial

PubMed Central

Pang, Shulan; Schwebel, David C.

2016-01-01

Objective Unintentional drowning is the most common cause of childhood death in rural China. Global intervention efforts offer mixed results regarding the efficacy of educational programs. Methods Using a randomized controlled design, we evaluated a testimonial-based intervention to reduce drowning risk among 280 3rd- and 4th-grade rural Chinese children. Children were randomly assigned to view either testimonials on drowning risk (intervention) or dog-bite risk (control). Safety knowledge and perceived vulnerability were measured by self-report questionnaires, and simulated behaviors in and near water were assessed with a culturally appropriate dollhouse task. Results Children in the intervention group had improved children’s safety knowledge and simulated behaviors but not perceived vulnerability compared with controls. Conclusions The testimonial-based intervention’s efficacy appears promising, as it improved safety knowledge and simulated risk behaviors with water among rural Chinese children. PMID:26546476

FLAMMABLE GAS TECHNICAL BASIS DOCUMENT

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

KRIPPS, L.J.

2005-02-18

This document describes the qualitative evaluation of frequency and consequences for double shell tank (DST) and single shell tank (SST) representative flammable gas accidents and associated hazardous conditions without controls. The evaluation indicated that safety-significant SSCs and/or TSRS were required to prevent or mitigate flammable gas accidents. Discussion on the resulting control decisions is included. This technical basis document was developed to support of the Tank Farms Documented Safety Analysis (DSA) and describes the risk binning process for the flammable gas representative accidents and associated represented hazardous conditions. The purpose of the risk binning process is to determine the needmore » for safety-significant structures, systems, and components (SSC) and technical safety requirement (TSR)-level controls for a given representative accident or represented hazardous condition based on an evaluation of the event frequency and consequence.« less

Selected considerations of implementation of the GNSS

NASA Astrophysics Data System (ADS)

Cwiklak, Janusz; Fellner, Andrzej; Fellner, Radoslaw; Jafernik, Henryk; Sledzinski, Janusz

2014-05-01

The article describes analysis of the safety and risk for the implementation of precise approach procedures (Localizer Performance and Vertical Guidance - LPV) with GNSS sensor at airports in Warsaw and Katowice. There were used some techniques of the identification of threats (inducing controlled flight into terrain, landing accident, mid-air collision) and evaluations methods based on Fault Tree Analysis, probability of the risk, safety risk evaluation matrix and Functional Hazard Assesment. Also safety goals were determined. Research led to determine probabilities of appearing of threats, as well as allow compare them with regard to the ILS. As a result of conducting the Preliminary System Safety Assessment (PSSA), there were defined requirements essential to reach the required level of the safety. It is worth to underline, that quantitative requirements were defined using FTA.

Corporate incentives for promoting safety belt use : rationale, guidelines, and examples

DOT National Transportation Integrated Search

1982-10-01

This manual was designed to teach the corporate executive successful strategies for implementing and evaluating a successful industry-based program to motivate employee safety belt use. A rationale is given for the general approach; and specific guid...

[Process and key points of clinical literature evaluation of post-marketing traditional Chinese medicine].

PubMed

Liu, Huan; Xie, Yanming

2011-10-01

The clinical literature evaluation of the post-marketing traditional Chinese medicine is a comprehensive evaluation by the comprehensive gain, analysis of the drug, literature of drug efficacy, safety, economy, based on the literature evidence and is part of the evaluation of evidence-based medicine. The literature evaluation in the post-marketing Chinese medicine clinical evaluation is in the foundation and the key position. Through the literature evaluation, it can fully grasp the information, grasp listed drug variety of traditional Chinese medicines second development orientation, make clear further clinical indications, perfect the medicines, etc. This paper discusses the main steps and emphasis of the clinical literature evaluation. Emphasizing security literature evaluation should attach importance to the security of a comprehensive collection drug information. Safety assessment should notice traditional Chinese medicine validity evaluation in improving syndrome, improveing the living quality of patients with special advantage. The economics literature evaluation should pay attention to reliability, sensitivity and practicability of the conclusion.

Guiding principles for the implementation of non-animal safety assessment approaches for cosmetics: skin sensitisation.

PubMed

Goebel, Carsten; Aeby, Pierre; Ade, Nadège; Alépée, Nathalie; Aptula, Aynur; Araki, Daisuke; Dufour, Eric; Gilmour, Nicola; Hibatallah, Jalila; Keller, Detlef; Kern, Petra; Kirst, Annette; Marrec-Fairley, Monique; Maxwell, Gavin; Rowland, Joanna; Safford, Bob; Schellauf, Florian; Schepky, Andreas; Seaman, Chris; Teichert, Thomas; Tessier, Nicolas; Teissier, Silvia; Weltzien, Hans Ulrich; Winkler, Petra; Scheel, Julia

2012-06-01

Characterisation of skin sensitisation potential is a key endpoint for the safety assessment of cosmetic ingredients especially when significant dermal exposure to an ingredient is expected. At present the mouse local lymph node assay (LLNA) remains the 'gold standard' test method for this purpose however non-animal test methods are under development that aim to replace the need for new animal test data. COLIPA (the European Cosmetics Association) funds an extensive programme of skin sensitisation research, method development and method evaluation and helped coordinate the early evaluation of the three test methods currently undergoing pre-validation. In May 2010, a COLIPA scientific meeting was held to analyse to what extent skin sensitisation safety assessments for cosmetic ingredients can be made in the absence of animal data. In order to propose guiding principles for the application and further development of non-animal safety assessment strategies it was evaluated how and when non-animal test methods, predictions based on physico-chemical properties (including in silico tools), threshold concepts and weight-of-evidence based hazard characterisation could be used to enable safety decisions. Generation and assessment of potency information from alternative tools which at present is predominantly derived from the LLNA is considered the future key research area. Copyright © 2012 Elsevier Inc. All rights reserved.

Process value of care safety: women's willingness to pay for perinatal services.

PubMed

Anezaki, Hisataka; Hashimoto, Hideki

2017-08-01

To evaluate the process value of care safety from the patient's view in perinatal services. Cross-sectional survey. Fifty two sites of mandated public neonatal health checkup in 6 urban cities in West Japan. Mothers who attended neonatal health checkups for their babies in 2011 (n = 1316, response rate = 27.4%). Willingness to pay (WTP) for physician-attended care compared with midwife care as the process-related value of care safety. WTP was estimated using conjoint analysis based on the participants' choice over possible alternatives that were randomly assigned from among eight scenarios considering attributes such as professional attendance, amenities, painless delivery, caesarean section rate, travel time and price. The WTP for physician-attended care over midwife care was estimated 1283 USD. Women who had experienced complications in prior deliveries had a 1.5 times larger WTP. We empirically evaluated the process value for safety practice in perinatal care that was larger than a previously reported accounting-based value. Our results indicate that measurement of process value from the patient's view is informative for the evaluation of safety care, and that it is sensitive to individual risk perception for the care process. © The Author 2017. Published by Oxford University Press in association with the International Society for Quality in Health Care.

Health Monitoring and Evaluation of Long-Span Bridges Based on Sensing and Data Analysis: A Survey

PubMed Central

Zhou, Jianting; Li, Xiaogang; Xia, Runchuan; Yang, Jun; Zhang, Hong

2017-01-01

Aimed at the health monitoring and evaluation of bridges based on sensing technology, the monitoring contents of different structural types of long-span bridges were defined. Then, the definition, classification, selection principle, and installation requirements of the sensors were summarized. The concept was proposed that new adaptable long-life sensors could be developed by new theories and new effects. The principle and methods to select controlled sections and optimize the layout design of measuring points were illustrated. The functional requirements were elaborated on about the acquisition, transmission, processing, and management of sensing information. Some advanced concepts about the method of bridge safety evaluation were demonstrated and technology bottlenecks in the current safety evaluation were also put forward. Ultimately, combined with engineering practices, an application was carried out. The results showed that new, intelligent, and reliable sensor technology would be one of the main future development directions in the long-span bridge health monitoring and evaluation field. Also, it was imperative to optimize the design of the health monitoring system and realize its standardization. Moreover, it is a heavy responsibility to explore new thoughts and new concepts regarding practical bridge safety and evaluation technology. PMID:28300785

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.

Continental United States Military Housing Inspections Southeast

DTIC Science & Technology

2015-09-24

and safety, including focus on mold, asbestos , radon, lead-based paint, drinking water quality, and pest management. We conducted this inspection in...electrical system safety inspections. In addition, we inspected to EPA standards governing safe drinking water and toxic substances, radon, asbestos , and...inspections focused on mold, asbestos , radon, lead-based paint, drinking water quality, and pest management. We evaluated the associated plans and

Sequence analysis of CVI988-based vaccine, pCVI988-699-2-RV that has undergone a reversion to virulence

USDA-ARS?s Scientific Manuscript database

In our safety evaluation of CVI988-699-2delta, a vaccine derived from a bacterial artificial chromosome (BAC)-based infectious clone of low passage CVI988, we found that the virus reverted to virulence during a safety trial using specific pathogen free (SPF) leghorn chickens. To determine changes i...

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.

Concept for a Satellite-Based Advanced Air Traffic Management System : Volume 5. System Performance.

DOT National Transportation Integrated Search

1974-02-01

The volume presents the results of the performance evaluation of the Satellite-Based Advanced Air Traffic Management System (SAATMS). The evaluation established the capacity, safety, and delay performance of the system for the Los Angeles Basin termi...

Development and Pilot Testing of a Food Safety Curriculum for Managers and Staff of Residential Childcare Institutions (RCCIs)

ERIC Educational Resources Information Center

Pivarnik, Lori F.; Patnoad, Martha S.; Nyachuba, David; McLandsborough, Lynne; Couto, Stephen; Hagan, Elsina E.; Breau, Marti

2013-01-01

Food safety training materials, targeted for residential childcare institution (RCCI) staff of facilities of 20 residents or less, were developed, piloted, and evaluated. The goal was to assist in the implementation of a Hazard Analysis Critical Control Points (HACCP)-based food safety plan as required by Food and Nutrition Service/United States…

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.

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.

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.

Applying importance-performance analysis to patient safety culture.

PubMed

Lee, Yii-Ching; Wu, Hsin-Hung; Hsieh, Wan-Lin; Weng, Shao-Jen; Hsieh, Liang-Po; Huang, Chih-Hsuan

2015-01-01

The Sexton et al.'s (2006) safety attitudes questionnaire (SAQ) has been widely used to assess staff's attitudes towards patient safety in healthcare organizations. However, to date there have been few studies that discuss the perceptions of patient safety both from hospital staff and upper management. The purpose of this paper is to improve and to develop better strategies regarding patient safety in healthcare organizations. The Chinese version of SAQ based on the Taiwan Joint Commission on Hospital Accreditation is used to evaluate the perceptions of hospital staff. The current study then lies in applying importance-performance analysis technique to identify the major strengths and weaknesses of the safety culture. The results show that teamwork climate, safety climate, job satisfaction, stress recognition and working conditions are major strengths and should be maintained in order to provide a better patient safety culture. On the contrary, perceptions of management and hospital handoffs and transitions are important weaknesses and should be improved immediately. Research limitations/implications - The research is restricted in generalizability. The assessment of hospital staff in patient safety culture is physicians and registered nurses. It would be interesting to further evaluate other staff's (e.g. technicians, pharmacists and others) opinions regarding patient safety culture in the hospital. Few studies have clearly evaluated the perceptions of healthcare organization management regarding patient safety culture. Healthcare managers enable to take more effective actions to improve the level of patient safety by investigating key characteristics (either strengths or weaknesses) that healthcare organizations should focus on.

Evaluating the effectiveness of a radiation safety training intervention for oncology nurses: a pretest-intervention-posttest study.

PubMed

Dauer, Lawrence T; Kelvin, Joanne F; Horan, Christopher L; St Germain, Jean

2006-06-08

Radiation, for either diagnosis or treatment, is used extensively in the field of oncology. An understanding of oncology radiation safety principles and how to apply them in practice is critical for nursing practice. Misconceptions about radiation are common, resulting in undue fears and concerns that may negatively impact patient care. Effectively educating nurses to help overcome these misconceptions is a challenge. Historically, radiation safety training programs for oncology nurses have been compliance-based and behavioral in philosophy. A new radiation safety training initiative was developed for Memorial Sloan-Kettering Cancer Center (MSKCC) adapting elements of current adult education theories to address common misconceptions and to enhance knowledge. A research design for evaluating the revised training program was also developed to assess whether the revised training program resulted in a measurable and/or statistically significant change in the knowledge or attitudes of nurses toward working with radiation. An evaluation research design based on a conceptual framework for measuring knowledge and attitude was developed and implemented using a pretest-intervention-posttest approach for 15% of the study population of 750 inpatient registered oncology nurses. As a result of the intervention program, there was a significant difference in nurse's cognitive knowledge as measured with the test instrument from pretest (58.9%) to posttest (71.6%). The evaluation also demonstrated that while positive nursing attitudes increased, the increase was significant for only 5 out of 9 of the areas evaluated. The training intervention was effective for increasing cognitive knowledge, but was less effective at improving overall attitudes. This evaluation provided insights into the effectiveness of training interventions on the radiation safety knowledge and attitude of oncology nurses.

Evaluating the effectiveness of a radiation safety training intervention for oncology nurses: a pretest – intervention – posttest study

PubMed Central

Dauer, Lawrence T; Kelvin, Joanne F; Horan, Christopher L; St Germain, Jean

2006-01-01

Background Radiation, for either diagnosis or treatment, is used extensively in the field of oncology. An understanding of oncology radiation safety principles and how to apply them in practice is critical for nursing practice. Misconceptions about radiation are common, resulting in undue fears and concerns that may negatively impact patient care. Effectively educating nurses to help overcome these misconceptions is a challenge. Historically, radiation safety training programs for oncology nurses have been compliance-based and behavioral in philosophy. Methods A new radiation safety training initiative was developed for Memorial Sloan-Kettering Cancer Center (MSKCC) adapting elements of current adult education theories to address common misconceptions and to enhance knowledge. A research design for evaluating the revised training program was also developed to assess whether the revised training program resulted in a measurable and/or statistically significant change in the knowledge or attitudes of nurses toward working with radiation. An evaluation research design based on a conceptual framework for measuring knowledge and attitude was developed and implemented using a pretest-intervention-posttest approach for 15% of the study population of 750 inpatient registered oncology nurses. Results As a result of the intervention program, there was a significant difference in nurse's cognitive knowledge as measured with the test instrument from pretest (58.9%) to posttest (71.6%). The evaluation also demonstrated that while positive nursing attitudes increased, the increase was significant for only 5 out of 9 of the areas evaluated. Conclusion The training intervention was effective for increasing cognitive knowledge, but was less effective at improving overall attitudes. This evaluation provided insights into the effectiveness of training interventions on the radiation safety knowledge and attitude of oncology nurses. PMID:16762060

Modeling level-of-safety for bus stops in China.

PubMed

Ye, Zhirui; Wang, Chao; Yu, Yongbo; Shi, Xiaomeng; Wang, Wei

2016-08-17

Safety performance at bus stops is generally evaluated by using historical traffic crash data or traffic conflict data. However, in China, it is quite difficult to obtain such data mainly due to the lack of traffic data management and organizational issues. In light of this, the primary objective of this study is to develop a quantitative approach to evaluate bus stop safety performance. The concept of level-of-safety for bus stops is introduced and corresponding models are proposed to quantify safety levels, which consider conflict points, traffic factors, geometric characteristics, traffic signs and markings, pavement conditions, and lighting conditions. Principal component analysis and k-means clustering methods were used to model and quantify safety levels for bus stops. A case study was conducted to show the applicability of the proposed model with data collected from 46 samples for the 7 most common types of bus stops in China, using 32 of the samples for modeling and 14 samples for illustration. Based on the case study, 6 levels of safety for bus stops were defined. Finally, a linear regression analysis between safety levels and the number of traffic conflicts showed that they had a strong relationship (R(2) value of 0.908). The results indicated that the method was well validated and could be practically used for the analysis and evaluation of bus stop safety in China. The proposed model was relatively easy to implement without the requirement of traffic crash data and/or traffic conflict data. In addition, with the proposed method, it was feasible to evaluate countermeasures to improve bus stop safety (e.g., exclusive bus lanes).

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

Evaluation of the safety benefits of legacy safe routes to school programs

DOT National Transportation Integrated Search

2008-08-01

This study first examined the feasibility of conducting a crash-based assessment of the safety effects of legacy Safe Routes to School : (SRTS) programs. These were SRTS programs operating before the passage of the Safe, Accountable, Flexible, Effici...

Development of a hazard-based method for evaluating the fire safety of passenger trains

DOT National Transportation Integrated Search

1999-01-01

The fire safety of U.S. passenger rail trains currently is addressed through small-scale flammability and smoke emission tests and performance criteria promulgated by the Federal Railroad Administration (FRA). The FRA approach relies heavily on test ...

23 CFR 1251.4 - Functions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 23 Highways 1 2010-04-01 2010-04-01 false Functions. 1251.4 Section 1251.4 Highways NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION AND FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION... Program Manual (23 CFR 1204.4, Supplement B), based on evaluation of highway accidents and safety problems...

Incorporating organisational safety culture within ergonomics practice.

PubMed

Bentley, Tim; Tappin, David

2010-10-01

This paper conceptualises organisational safety culture and considers its relevance to ergonomics practice. Issues discussed in the paper include the modest contribution that ergonomists and ergonomics as a discipline have made to this burgeoning field of study and the significance of safety culture to a systems approach. The relevance of safety culture to ergonomics work with regard to the analysis, design, implementation and evaluation process, and implications for participatory ergonomics approaches, are also discussed. A potential user-friendly, qualitative approach to assessing safety culture as part of ergonomics work is presented, based on a recently published conceptual framework that recognises the dynamic and multi-dimensional nature of safety culture. The paper concludes by considering the use of such an approach, where an understanding of different aspects of safety culture within an organisation is seen as important to the success of ergonomics projects. STATEMENT OF RELEVANCE: The relevance of safety culture to ergonomics practice is a key focus of this paper, including its relationship with the systems approach, participatory ergonomics and the ergonomics analysis, design, implementation and evaluation process. An approach to assessing safety culture as part of ergonomics work is presented.

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.

Active drug safety surveillance: a tool to improve public health.

PubMed

Platt, Richard; Madre, Leanne; Reynolds, Robert; Tilson, Hugh

2008-12-01

Ensuring that drugs have an acceptable safety profile and are used safely is a major public health priority. The Centers for Education and Research on Therapeutics (CERTs) convened experts from academia, government, and industry to assess strategies to increase the speed and predictive value of generating and evaluating safety signals, and to identify next steps to improve the US system for identifying and evaluating potential safety signals. The CERTs convened a think tank comprising representatives of the groups noted above to address these goals. Participants observed that, with the increasing availability of electronic health data, opportunities have emerged to more accurately characterize and confirm potential safety issues. The gain for public health from a highly coordinated network of population-based databases for active surveillance is great and within reach, although operational questions remain. A collaborative network must create a working definition of a safety signal, screening algorithms, and criteria and strategies to confirm or refute a signal once identified through screening. Guidelines are needed for when and how to communicate a signal exists and is being evaluated, as well as the outcome of that evaluation. A public-private partnership to create a network of government and private databases to routinely evaluate and prioritize safety questions is in the public interest. Better methods are needed, and a knowledgeable workforce is required to conduct the surveillance and understand how to interpret the results. The international community will benefit from the availability of better methods and more experts. Copyright (c) 2008 John Wiley & Sons, Ltd.

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

An innovative approach to the safety evaluation of natural products: cranberry (Vaccinium macrocarpon Aiton) leaf aqueous extract as a case study.

PubMed

Booth, Nancy L; Kruger, Claire L; Wallace Hayes, A; Clemens, Roger

2012-09-01

Assessment of safety for a food or dietary ingredient requires determination of a safe level of ingestion compared to the estimated daily intake from its proposed uses. The nature of the assessment may require the use of different approaches, determined on a case-by-case basis. Natural products are chemically complex and challenging to characterize for the purpose of carrying out a safety evaluation. For example, a botanical extract contains numerous compounds, many of which vary across batches due to changes in environmental conditions and handling. Key components integral to the safety evaluation must be identified and their variability established to assure that specifications are representative of a commercial product over time and protective of the consumer; one can then extrapolate the results of safety studies on a single batch of product to other batches that are produced under similar conditions. Safety of a well-characterized extract may be established based on the safety of its various components. When sufficient information is available from the public literature, additional toxicology testing is not necessary for a safety determination on the food or dietary ingredient. This approach is demonstrated in a case study of an aqueous extract of cranberry (Vaccinium macrocarpon Aiton) leaves. Copyright © 2012. Published by Elsevier Ltd.

Assessment of the current status of playground safety in the midwestern region of Turkey: an effort to provide a safe environment for children.

PubMed

Uskun, Ersin; Kişioğlu, Ahmet Nesimi; Altay, Tülin; Cikinlar, Rengül; Kocakaya, Asuman

2008-01-01

This study aimed to identify and evaluate the degree of conformity to the playground standards and the level of compliance with current safety specifications of the playgrounds in the midwestern region of Turkey. An observational technique was used at a total of 57 public playgrounds. A playground safety control form was prepared based on the United States National Program for Playground Safety and the Consumer Product Safety Commission security standards, since there is no national law covering playground equipment and safety in Turkey. The study evaluated the surroundings of the playground, arrangement of equipment in the playground, and characteristics of the equipment. The percentage of playgrounds surveyed with inadequate or hard surfacing was 80.7%. Fifty-two percent of the equipment was found to be inappropriate. Equipment was higher than the recommended heights. The results of our study unfortunately point out that playgrounds for children do not meet many of the safety criteria.

A Semantic Approach with Decision Support for Safety Service in Smart Home Management

PubMed Central

Huang, Xiaoci; Yi, Jianjun; Zhu, Xiaomin; Chen, Shaoli

2016-01-01

Research on smart homes (SHs) has increased significantly in recent years because of the convenience provided by having an assisted living environment. The functions of SHs as mentioned in previous studies, particularly safety services, are seldom discussed or mentioned. Thus, this study proposes a semantic approach with decision support for safety service in SH management. The focus of this contribution is to explore a context awareness and reasoning approach for risk recognition in SH that enables the proper decision support for flexible safety service provision. The framework of SH based on a wireless sensor network is described from the perspective of neighbourhood management. This approach is based on the integration of semantic knowledge in which a reasoner can make decisions about risk recognition and safety service. We present a management ontology for a SH and relevant monitoring contextual information, which considers its suitability in a pervasive computing environment and is service-oriented. We also propose a rule-based reasoning method to provide decision support through reasoning techniques and context-awareness. A system prototype is developed to evaluate the feasibility, time response and extendibility of the approach. The evaluation of our approach shows that it is more effective in daily risk event recognition. The decisions for service provision are shown to be accurate. PMID:27527170

A Semantic Approach with Decision Support for Safety Service in Smart Home Management.

PubMed

Huang, Xiaoci; Yi, Jianjun; Zhu, Xiaomin; Chen, Shaoli

2016-08-03

Research on smart homes (SHs) has increased significantly in recent years because of the convenience provided by having an assisted living environment. The functions of SHs as mentioned in previous studies, particularly safety services, are seldom discussed or mentioned. Thus, this study proposes a semantic approach with decision support for safety service in SH management. The focus of this contribution is to explore a context awareness and reasoning approach for risk recognition in SH that enables the proper decision support for flexible safety service provision. The framework of SH based on a wireless sensor network is described from the perspective of neighbourhood management. This approach is based on the integration of semantic knowledge in which a reasoner can make decisions about risk recognition and safety service. We present a management ontology for a SH and relevant monitoring contextual information, which considers its suitability in a pervasive computing environment and is service-oriented. We also propose a rule-based reasoning method to provide decision support through reasoning techniques and context-awareness. A system prototype is developed to evaluate the feasibility, time response and extendibility of the approach. The evaluation of our approach shows that it is more effective in daily risk event recognition. The decisions for service provision are shown to be accurate.

Is vehicle automation enough to prevent crashes? Role of traffic operations in automated driving environments for traffic safety.

PubMed

Jeong, Eunbi; Oh, Cheol; Lee, Seolyoung

2017-07-01

Automated driving systems (ADSs) are expected to prevent traffic accidents caused by driver carelessness on freeways. There is no doubt regarding this safety benefit if all vehicles in the transportation system were equipped with ADSs; however, it is implausible to expect that ADSs will reach 100% market penetration rate (MPR) in the near future. Therefore, the following question arises: 'Can ADSs, which consider only situations in the vicinity of an equipped vehicle, really contribute to a significant reduction in traffic accidents?' To address this issue, the interactions between equipped and unequipped vehicles must be investigated, which is the purpose of this study. This study evaluated traffic safety at different MPRs based on a proposed index to represent the overall rear-end crash risk of the traffic stream. Two approaches were evaluated for adjusting longitudinal vehicle maneuvers: vehicle safety-based maneuvering (VSM), which considers the crash risk of an equipped vehicle and its neighboring vehicles, and traffic safety-based maneuvering (TSM), which considers the overall crash risk in the traffic stream. TSM assumes that traffic operational agencies are able to monitor all the vehicles and to intervene in vehicle maneuvering. An optimization process, which attempts to obtain vehicle maneuvering control parameters to minimize the overall crash risk, is integrated into the proposed evaluation framework. The main purpose of employing the optimization process for vehicle maneuvering in this study is to identify opportunities to improve traffic safety through effective traffic management rather than developing a vehicle control algorithm that can be implemented in practice. The microscopic traffic simulator VISSIM was used to simulate the freeway traffic stream and to conduct systematic evaluations based on the proposed methodology. Both TSM and VSM achieved significant reductions in the potential for rear-end crashes. However, TSM obtained much greater reductions when the MPR was greater than 50%. This study should inspire transportation researchers and engineers to develop effective traffic operations strategies for automated driving environments. Copyright © 2017. Published by Elsevier Ltd.

Base-Level Management of Laser Radiation Protection Program

DTIC Science & Technology

1992-02-01

safety eyewear . special considerations for medical lasers and optical fibers, and summary evaluations of common Air Force laser systems... optical density of 2. Laser safety eyewear should have the optical density clearly marked for ail wavelengths for which the eyewear provides protection. c...density of protective eyewear . The optical density required for laser safety eyewear is dependent on the irradiance or radiant exposure-of the

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.

Does classroom-based Crew Resource Management training improve patient safety culture? A systematic review

PubMed Central

de Bruijne, Martine C; Zwijnenberg, Nicolien C; Jansma, Elise P; van Dyck, Cathy; Wagner, Cordula

2014-01-01

Aim: To evaluate the evidence of the effectiveness of classroom-based Crew Resource Management training on safety culture by a systematic review of literature. Methods: Studies were identified in PubMed, Cochrane Library, PsycINFO, and Educational Resources Information Center up to 19 December 2012. The Methods Guide for Comparative Effectiveness Reviews was used to assess the risk of bias in the individual studies. Results: In total, 22 manuscripts were included for review. Training settings, study designs, and evaluation methods varied widely. Most studies reporting only a selection of culture dimensions found mainly positive results, whereas studies reporting all safety culture dimensions of the particular survey found mixed results. On average, studies were at moderate risk of bias. Conclusion: Evidence of the effectiveness of Crew Resource Management training in health care on safety culture is scarce and the validity of most studies is limited. The results underline the necessity of more valid study designs, preferably using triangulation methods. PMID:26770720

Potential safety benefits of intelligent cruise control systems.

PubMed

Chira-Chavala, T; Yoo, S M

1994-04-01

Potential safety impact of a hypothetical intelligent cruise control system (ICCS) is evaluated in terms of changes in traffic accidents and some traffic operation characteristics affecting safety. The analysis of changes in traffic accidents is accomplished by in-depth examinations of police accident reports for four major counties in California. The evaluation of changes in traffic operation characteristics affecting safety is accomplished by vehicle simulation. The accident analysis reveals that the use of the hypothetical ICCS could potentially reduce traffic accidents by up to 7.5%. Preliminary vehicle simulation results based on a 10-vehicle convoy indicate that the use of the hypothetical ICCS could reduce frequencies of hard acceleration and deceleration, enhance speed harmonization among vehicles, and reduce incidence of "less-safe" headway.

Novel approaches to development, delivery and evaluation of a peer-led occupational safety training for Latino day laborers.

PubMed

De Souza, Rachael Ann; Hecker, Steven; de Castro, A B; Stern, Hilary; Hernandez, Araceli; Seixas, Noah

2012-01-01

Latino day laborers experience high rates of work-related injuries and are a hard-to-reach group for safety interventions. This study describes the creation and implementation of safety training based in empowerment theory and its evaluation to address three levels in empowerment's hierarchy of change. Pictographic pre- and post-tests were used to assess knowledge level changes. Individual and large-group interviews were conducted to address attitudes and behavior-level changes. Results indicate that day laborers learn and apply lessons from this type of safety training. Findings also offer insight into challenges that day laborers encounter when trying to work safely as well as ideas for future training interventions.

Oligonucleotide-based pharmaceuticals: Non-clinical and clinical safety signals and non-clinical testing strategies.

PubMed

Mustonen, Enni-Kaisa; Palomäki, Tiina; Pasanen, Markku

2017-11-01

Antisense oligonucleotides, short interfering RNAs (siRNAs) and aptamers are oligonucleotide-based pharmaceuticals with a promising role in targeted therapies. Currently, five oligonucleotide-based pharmaceuticals have achieved marketing authorization in Europe or USA and many more are undergoing clinical testing. However, several safety concerns have been raised in non-clinical and clinical studies. Oligonucleotides share properties with both chemical and biological pharmaceuticals and therefore they pose challenges also from the regulatory point of view. We have analyzed the safety data of oligonucleotides and evaluated the applicability of current non-clinical toxicological guidelines for assessing the safety of oligonucleotide-based pharmaceuticals. Oligonucleotide-based pharmaceuticals display a similar toxicological profile, exerting adverse effects on liver and kidney, evoking hematological alterations, as well as causing immunostimulation and prolonging the coagulation time. It is possible to extrapolate some of these effects from non-clinical studies to humans. However, evaluation strategies for genotoxicity testing of "non-natural" oligonucleotides should be revised. Additionally, the selective use of surrogates and prediction of clinical endpoints for non-clinically observed immunostimulation is complicated by its multiple potential manifestations, demanding improvements in the testing strategies. Utilizing more relevant and mechanistic-based approaches and taking better account of species differences, could possibly improve the prediction of relevant immunological/proinflammatory effects in humans. Copyright © 2017 Elsevier Inc. All rights reserved.

Evaluation of Human Reliability in Selected Activities in the Railway Industry

NASA Astrophysics Data System (ADS)

Sujová, Erika; Čierna, Helena; Molenda, Michał

2016-09-01

The article focuses on evaluation of human reliability in the human - machine system in the railway industry. Based on a survey of a train dispatcher and of selected activities, we have identified risk factors affecting the dispatcher`s work and the evaluated risk level of their influence on the reliability and safety of preformed activities. The research took place at the authors` work place between 2012-2013. A survey method was used. With its help, authors were able to identify selected work activities of train dispatcher's risk factors that affect his/her work and the evaluated seriousness of its influence on the reliability and safety of performed activities. Amongst the most important finding fall expressions of unclear and complicated internal regulations and work processes, a feeling of being overworked, fear for one's safety at small, insufficiently protected stations.

An approach to evaluating reactive airborne wind shear systems

NASA Technical Reports Server (NTRS)

Gibson, Joseph P., Jr.

1992-01-01

An approach to evaluating reactive airborne windshear detection systems was developed to support a deployment study for future FAA ground-based windshear detection systems. The deployment study methodology assesses potential future safety enhancements beyond planned capabilities. The reactive airborne systems will be an integral part of planned windshear safety enhancements. The approach to evaluating reactive airborne systems involves separate analyses for both landing and take-off scenario. The analysis estimates the probability of effective warning considering several factors including NASA energy height loss characteristics, reactive alert timing, and a probability distribution for microburst strength.

[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.

Crash Outcome Data Evaluation System (CODES) Project Safety Belt and Helmet Analyses

DOT National Transportation Integrated Search

1996-02-15

Analyses of the benefits of safety belt and helmet use were undertaken for a : Report that was sent to Congress February, 1996. NHTSA awarded grants to link : crash and injury state data and perform the analyses upon which the report was : based. The...

Food safety considerations for innovative nutrition solutions.

PubMed

Byrd-Bredbenner, Carol; Cohn, Marjorie Nolan; Farber, Jeffrey M; Harris, Linda J; Roberts, Tanya; Salin, Victoria; Singh, Manpreet; Jaferi, Azra; Sperber, William H

2015-07-01

Failure to secure safe and affordable food to the growing global population leads far too often to disastrous consequences. Among specialists and other individuals, food scientists have a key responsibility to improve and use science-based tools to address risk and advise food handlers and manufacturers with best-practice recommendations. With collaboration from production agriculture, food processors, state and federal agencies, and consumers, it is critical to implement science-based strategies that address food safety and that have been evaluated for effectiveness in controlling and/or eliminating hazards. It is an open question whether future food safety concerns will shift in priority given the imperatives to supply sufficient food. This report brings together leading food safety experts to address these issues with a focus on three areas: economic, social, and policy aspects of food safety; production and postharvest technology for safe food; and innovative public communication for food safety and nutrition. © 2015 New York Academy of Sciences.

An impact evaluation of underage drinking prevention projects

DOT National Transportation Integrated Search

2004-03-01

This report presents the results of an impact evaluation of four community-based underage drinking prevention projects stimulated by technical assistance coordinated by the National Association of Governor's Highway Safety Representatives (now called...

Monitoring biomedical literature for post-market safety purposes by analyzing networks of text-based coded information.

PubMed

Botsis, Taxiarchis; Foster, Matthew; Kreimeyer, Kory; Pandey, Abhishek; Forshee, Richard

2017-01-01

Literature review is critical but time-consuming in the post-market surveillance of medical products. We focused on the safety signal of intussusception after the vaccination of infants with the Rotashield Vaccine in 1999 and retrieved all PubMed abstracts for rotavirus vaccines published after January 1, 1998. We used the Event-based Text-mining of Health Electronic Records system, the MetaMap tool, and the National Center for Biomedical Ontologies Annotator to process the abstracts and generate coded terms stamped with the date of publication. Data were analyzed in the Pattern-based and Advanced Network Analyzer for Clinical Evaluation and Assessment to evaluate the intussusception-related findings before and after the release of the new rotavirus vaccines in 2006. The tight connection of intussusception with the historical signal in the first period and the absence of any safety concern for the new vaccines in the second period were verified. We demonstrated the feasibility for semi-automated solutions that may assist medical reviewers in monitoring biomedical literature.

Evaluation of a Drowning Prevention Program Based on Testimonial Videos: A Randomized Controlled Trial.

PubMed

Shen, Jiabin; Pang, Shulan; Schwebel, David C

2016-06-01

Unintentional drowning is the most common cause of childhood death in rural China. Global intervention efforts offer mixed results regarding the efficacy of educational programs. Using a randomized controlled design, we evaluated a testimonial-based intervention to reduce drowning risk among 280 3rd- and 4th-grade rural Chinese children. Children were randomly assigned to view either testimonials on drowning risk (intervention) or dog-bite risk (control). Safety knowledge and perceived vulnerability were measured by self-report questionnaires, and simulated behaviors in and near water were assessed with a culturally appropriate dollhouse task. Children in the intervention group had improved children's safety knowledge and simulated behaviors but not perceived vulnerability compared with controls. The testimonial-based intervention's efficacy appears promising, as it improved safety knowledge and simulated risk behaviors with water among rural Chinese children. © The Author 2015. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

The role of evidence, standards and education in rock fishing safety in New South Wales, Australia.

PubMed

Mitchell, Rebecca J; Ware, Lauren; Bambach, Mike R

2014-12-01

To examine rock fishing-related fatalities and hospitalisations, identify initiatives aimed at improving safety and survey key rock fishing stakeholders about the strengths and limitations of each initiative. This research obtained information from mortality and hospitalisation statistics, the published literature and key stakeholders for opinions on the strengths, limitations and improvements for rock fishing safety initiatives. Injury patterns involving rock fishers have largely remained unchanged over time. The literature revealed that many rock fishing safety initiatives focused on awareness raising and engineering initiatives, but ignored the development of guidelines and the use of enforcement strategies. There had been limited evaluations conducted of any of the initiatives reviewed. It is likely that a combination of evidence-based, standard-focused and education initiatives would be useful in improving rock fishing safety in NSW, provided that the impact of these initiatives were routinely evaluated. Information from this research will be used to inform preventive strategies aimed at improving rock fishing safety through better coordination of the role of evidence in informing standards and practices and the continued evaluation of these initiatives. © 2014 Public Health Association of Australia.

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 ...

Setting Priorities for NIOSH Research

ERIC Educational Resources Information Center

Gallagher, Richard E.

1975-01-01

The National Institute for Occupational Safety and Health (NIOSH) is attempting to develop total programs of occupational safety and health protection. It has established research criteria and a priority system for evaluating the order of investigating suspect substances or agents based upon the expected gain of the health benefit. (Author/MW)

30 CFR 6.1 - Purpose and effective date.

Code of Federal Regulations, 2013 CFR

2013-07-01

... APPROVAL OF MINING PRODUCTS TESTING AND EVALUATION BY INDEPENDENT LABORATORIES AND NON-MSHA PRODUCT SAFETY... based on non-MSHA product safety standards once MSHA has determined that the non-MSHA standards are equivalent to MSHA's applicable product approval requirements or can be modified to provide at least the same...

30 CFR 6.1 - Purpose and effective date.

Code of Federal Regulations, 2012 CFR

2012-07-01

... APPROVAL OF MINING PRODUCTS TESTING AND EVALUATION BY INDEPENDENT LABORATORIES AND NON-MSHA PRODUCT SAFETY... based on non-MSHA product safety standards once MSHA has determined that the non-MSHA standards are equivalent to MSHA's applicable product approval requirements or can be modified to provide at least the same...

30 CFR 6.1 - Purpose and effective date.

Code of Federal Regulations, 2011 CFR

2011-07-01

... APPROVAL OF MINING PRODUCTS TESTING AND EVALUATION BY INDEPENDENT LABORATORIES AND NON-MSHA PRODUCT SAFETY... based on non-MSHA product safety standards once MSHA has determined that the non-MSHA standards are equivalent to MSHA's applicable product approval requirements or can be modified to provide at least the same...

30 CFR 6.1 - Purpose and effective date.

Code of Federal Regulations, 2010 CFR

2010-07-01

... APPROVAL OF MINING PRODUCTS TESTING AND EVALUATION BY INDEPENDENT LABORATORIES AND NON-MSHA PRODUCT SAFETY... based on non-MSHA product safety standards once MSHA has determined that the non-MSHA standards are equivalent to MSHA's applicable product approval requirements or can be modified to provide at least the same...

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.

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.

An update on safety and immunogenicity of vaccines containing emulsion-based adjuvants.

PubMed

Fox, Christopher B; Haensler, Jean

2013-07-01

With the exception of alum, emulsion-based vaccine adjuvants have been administered to far more people than any other adjuvant, especially since the 2009 H1N1 influenza pandemic. The number of clinical safety and immunogenicity evaluations of vaccines containing emulsion adjuvants has correspondingly mushroomed. In this review, the authors introduce emulsion adjuvant composition and history before detailing the most recent findings from clinical and postmarketing data regarding the effects of emulsion adjuvants on vaccine immunogenicity and safety, with emphasis on the most widely distributed emulsion adjuvants, MF59® and AS03. The authors also present a summary of other emulsion adjuvants in clinical development and indicate promising avenues for future emulsion-based adjuvant development. Overall, emulsion adjuvants have demonstrated potent adjuvant activity across a number of disease indications along with acceptable safety profiles.

Impact of IgG Fc-Oligosaccharides on Recombinant Monoclonal Antibody Structure, Stability, Safety, and Efficacy.

PubMed

Liu, Hongcheng; Nowak, Christine; Andrien, Bruce; Shao, Mei; Ponniah, Gomathinayagam; Neill, Alyssa

2017-09-01

Glycosylation of the conserved asparagine residue in the CH2 domain is the most common posttranslational modification of recombinant monoclonal antibodies. Ideally, a consistent oligosaccharide profile should be maintained from early clinical material to commercial material for the development of recombinant monoclonal therapeutics, though variation in the profile is a typical result of process changes. The risk of oligosaccharide variation posed to further development is required to be thoroughly evaluated based on its impact on antibody structure, stability, efficacy and safety. The variation should be controlled within a range so that there is no detrimental impact on safety and efficacy and thus allowing the use of early phase safety and efficacy data to support project advancement to later phase. This review article focuses on the current scientific understanding of the commonly observed oligosaccharides found in recombinant monoclonal antibodies and their impact on structure, stability and biological functions, which are the basis to evaluate safety and efficacy. It also provides a brief discussion on critical quality attribute (CQA) assessment with regard to oligosaccharides based on the mechanism of action (MOA). © 2017 American Institute of Chemical Engineers Biotechnol. Prog., 33:1173-1181, 2017. © 2017 American Institute of Chemical Engineers.

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.

Safety and privacy outcomes from a moderated online social therapy for young people with first-episode psychosis.

PubMed

Gleeson, John F; Lederman, Reeva; Wadley, Greg; Bendall, Sarah; McGorry, Patrick D; Alvarez-Jimenez, Mario

2014-04-01

Internet-based treatments for early psychosis offer considerable promise, but safety and security need to be established. This study pilot tested Horyzons, a novel online treatment application that integrates purpose-built moderated social networking with psychoeducation for recovery from early psychosis. Safety, privacy, and security were evaluated during a one-month single-group trial with 20 young consumers recovering from early psychosis who were recruited in Melbourne, Australia. Known clinical risk factors informed the safety protocol. Safety, privacy, and security were evaluated with respect to relapse and self-harm, users' perceptions of safety and privacy, and activity using Horyzons. No clinical or security problems with use of Horyzons were noted. Participants described feeling safe and trusting Horyzons. Private moderated online social networking combined with psychoeducation was a safe and secure therapeutic environment for consumers recovering from a first episode of psychosis. Testing the intervention in a randomized controlled trial is warranted.

Safety analysis and review system (SARS) assessment report

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

Browne, E.T.

1981-03-01

Under DOE Order 5481.1, Safety Analysis and Review System for DOE Operations, safety analyses are required for DOE projects in order to ensure that: (1) potential hazards are systematically identified; (2) potential impacts are analyzed; (3) reasonable measures have been taken to eliminate, control, or mitigate the hazards; and (4) there is documented management authorization of the DOE operation based on an objective assessment of the adequacy of the safety analysis. This report is intended to provide the DOE Office of Plans and Technology Assessment (OPTA) with an independent evaluation of the adequacy of the ongoing safety analysis effort. Asmore » part of this effort, a number of site visits and interviews were conducted, and FE SARS documents were reviewed. The latter included SARS Implementation Plans for a number of FE field offices, as well as safety analysis reports completed for certain FE operations. This report summarizes SARS related efforts at the DOE field offices visited and evaluates the extent to which they fulfill the requirements of DOE 5481.1.« less

[Side effects of biologic therapies in psoriasis].

PubMed

Altenburg, A; Augustin, M; Zouboulis, C C

2018-04-01

The introduction of biologics has revolutionized the treatment of moderate to severe plaque psoriasis. Due to the continuous expansion of biological therapies for psoriasis, it is particularly important to acknowledge efficacy and safety of the compounds not only in clinical trials but also in long-term registry-based observational studies. Typical side effects and significant risks of antipsoriatic biologic therapies considering psoriatic control groups are presented. A selective literature search was conducted in PubMed and long-term safety studies of the psoriasis registries PsoBest, PSOLAR and BADBIR were evaluated. To assess the long-term safety of biologics, the evaluation of the course of large patient cohorts in long-term registries is of particular medical importance. Newer biologic drugs seem to exhibit a better safety profile than older ones.

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.

Evidence-Based and Value-Based Decision Making About Healthcare Design: An Economic Evaluation of the Safety and Quality Outcomes.

PubMed

Zadeh, Rana; Sadatsafavi, Hessam; Xue, Ryan

2015-01-01

This study describes a vision and framework that can facilitate the implementation of evidence-based design (EBD), scientific knowledge base into the process of the design, construction, and operation of healthcare facilities and clarify the related safety and quality outcomes for the stakeholders. The proposed framework pairs EBD with value-driven decision making and aims to improve communication among stakeholders by providing a common analytical language. Recent EBD research indicates that the design and operation of healthcare facilities contribute to an organization's operational success by improving safety, quality, and efficiency. However, because little information is available about the financial returns of evidence-based investments, such investments are readily eliminated during the capital-investment decision-making process. To model the proposed framework, we used engineering economy tools to evaluate the return on investments in six successful cases, identified by a literature review, in which facility design and operation interventions resulted in reductions in hospital-acquired infections, patient falls, staff injuries, and patient anxiety. In the evidence-based cases, calculated net present values, internal rates of return, and payback periods indicated that the long-term benefits of interventions substantially outweighed the intervention costs. This article explained a framework to develop a research-based and value-based communication language on specific interventions along the planning, design and construction, operation, and evaluation stages. Evidence-based and value-based design frameworks can be applied to communicate the life-cycle costs and savings of EBD interventions to stakeholders, thereby contributing to more informed decision makings and the optimization of healthcare infrastructures. © The Author(s) 2015.

Interrelation Between Safety Factors and Reliability

NASA Technical Reports Server (NTRS)

Elishakoff, Isaac; Chamis, Christos C. (Technical Monitor)

2001-01-01

An evaluation was performed to establish relationships between safety factors and reliability relationships. Results obtained show that the use of the safety factor is not contradictory to the employment of the probabilistic methods. In many cases the safety factors can be directly expressed by the required reliability levels. However, there is a major difference that must be emphasized: whereas the safety factors are allocated in an ad hoc manner, the probabilistic approach offers a unified mathematical framework. The establishment of the interrelation between the concepts opens an avenue to specify safety factors based on reliability. In cases where there are several forms of failure, then the allocation of safety factors should he based on having the same reliability associated with each failure mode. This immediately suggests that by the probabilistic methods the existing over-design or under-design can be eliminated. The report includes three parts: Part 1-Random Actual Stress and Deterministic Yield Stress; Part 2-Deterministic Actual Stress and Random Yield Stress; Part 3-Both Actual Stress and Yield Stress Are Random.

Ensuring Patient Safety in Care Transitions: An Empirical Evaluation of a Handoff Intervention Tool

PubMed Central

Abraham, Joanna; Kannampallil, Thomas; Patel, Bela; Almoosa, Khalid; Patel, Vimla L.

2012-01-01

Successful handoffs ensure smooth, efficient and safe patient care transitions. Tools and systems designed for standardization of clinician handoffs often focuses on ensuring the communication activity during transitions, with limited support for preparatory activities such as information seeking and organization. We designed and evaluated a Handoff Intervention Tool (HAND-IT) based on a checklist-inspired, body system format allowing structured information organization, and a problem-case narrative format allowing temporal description of patient care events. Based on a pre-post prospective study using a multi-method analysis we evaluated the effectiveness of HAND-IT as a documentation tool. We found that the use of HAND-IT led to fewer transition breakdowns, greater tool resilience, and likely led to better learning outcomes for less-experienced clinicians when compared to the current tool. We discuss the implications of our results for improving patient safety with a continuity of care-based approach. PMID:23304268

Automated enforcement : a compendium of worldwide evaluations of results.

DOT National Transportation Integrated Search

2007-07-01

This compendium details automated enforcement systems (AES) implemented around the world and characterizes the safety impacts of such deployments, based on available scientific evaluations of the outcome measures. A systematic literature search was c...

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.

Using hazard maps to identify and eliminate workplace hazards: a union-led health and safety training program.

PubMed

Anderson, Joe; Collins, Michele; Devlin, John; Renner, Paul

2012-01-01

The Institute for Sustainable Work and Environment and the Utility Workers Union of America worked with a professional evaluator to design, implement, and evaluate the results of a union-led system of safety-based hazard identification program that trained workers to use hazard maps to identify workplace hazards and target them for elimination. The evaluation documented program implementation and impact using data collected from both qualitative interviews and an on-line survey from worker trainers, plant managers, and health and safety staff. Managers and workers reported that not only were many dangerous hazards eliminated as a result of hazard mapping, some of which were long-standing, difficult-to-resolve issues, but the evaluation also documented improved communication between union members and management that both workers and managers agreed resulted in better, more sustainable hazard elimination.

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

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.

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.

[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.

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.

Applications of near-infrared spectroscopy in food safety evaluation and control: a review of recent research advances.

PubMed

Qu, Jia-Huan; Liu, Dan; Cheng, Jun-Hu; Sun, Da-Wen; Ma, Ji; Pu, Hongbin; Zeng, Xin-An

2015-01-01

Food safety is a critical public concern, and has drawn great attention in society. Consequently, developments of rapid, robust, and accurate methods and techniques for food safety evaluation and control are required. As a nondestructive and convenient tool, near-infrared spectroscopy (NIRS) has been widely shown to be a promising technique for food safety inspection and control due to its huge advantages of speed, noninvasive measurement, ease of use, and minimal sample preparation requirement. This review presents the fundamentals of NIRS and focuses on recent advances in its applications, during the last 10 years of food safety control, in meat, fish and fishery products, edible oils, milk and dairy products, grains and grain products, fruits and vegetables, and others. Based upon these applications, it can be demonstrated that NIRS, combined with chemometric methods, is a powerful tool for food safety surveillance and for the elimination of the occurrence of food safety problems. Some disadvantages that need to be solved or investigated with regard to the further development of NIRS are also discussed.

Environmental Assessment: Base Realignment and Closure (BRAC) 2005 Mission Realignments to Vandenberg AFB

DTIC Science & Technology

2007-02-01

Utilities (3.11), and Health and Safety (3.12). The following areas of environmental consequences evaluated in the EA were determined to have the... Safety requires a walk- through survey prior to construction. Prior to the commencement of construction activities on the electrical substation site...an unexploded ordnance survey shall be conducted by 30th Space Wing Safety . Should any unexploded ordnances be identified as a result of the survey

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.

Improving the governance of patient safety in emergency care: a systematic review of interventions

PubMed Central

Hesselink, Gijs; Berben, Sivera; Beune, Thimpe

2016-01-01

Objectives To systematically review interventions that aim to improve the governance of patient safety within emergency care on effectiveness, reliability, validity and feasibility. Design A systematic review of the literature. Methods PubMed, EMBASE, Cumulative Index to Nursing and Allied Health Literature, the Cochrane Database of Systematic Reviews and PsychInfo were searched for studies published between January 1990 and July 2014. We included studies evaluating interventions relevant for higher management to oversee and manage patient safety, in prehospital emergency medical service (EMS) organisations and hospital-based emergency departments (EDs). Two reviewers independently selected candidate studies, extracted data and assessed study quality. Studies were categorised according to study quality, setting, sample, intervention characteristics and findings. Results Of the 18 included studies, 13 (72%) were non-experimental. Nine studies (50%) reported data on the reliability and/or validity of the intervention. Eight studies (44%) reported on the feasibility of the intervention. Only 4 studies (22%) reported statistically significant effects. The use of a simulation-based training programme and well-designed incident reporting systems led to a statistically significant improvement of safety knowledge and attitudes by ED staff and an increase of incident reports within EDs, respectively. Conclusions Characteristics of the interventions included in this review (eg, anonymous incident reporting and validation of incident reports by an independent party) could provide useful input for the design of an effective tool to govern patient safety in EMS organisations and EDs. However, executives cannot rely on a robust set of evidence-based and feasible tools to govern patient safety within their emergency care organisation and in the chain of emergency care. Established strategies from other high-risk sectors need to be evaluated in emergency care settings, using an experimental design with valid outcome measures to strengthen the evidence base. PMID:26826151

[Safety monitoring of cell-based medicinal products (CBMPs)].

PubMed

Funk, Markus B; Frech, Marion; Spranger, Robert; Keller-Stanislawski, Brigitte

2015-11-01

Cell-based medicinal products (CBMPs), a category of advanced-therapy medicinal products (ATMPs), are authorised for the European market by the European Commission by means of the centralized marketing authorisation. By conforming to the German Medicinal Products Act (Sec. 4b AMG), national authorisation can be granted by the Paul-Ehrlich-Institut in Germany exclusively for ATMPs not based on a routine manufacturing procedure. In both procedures, quality, efficacy, and safety are evaluated and the risk-benefit balance is assessed. For the centralised procedure, mainly controlled clinical trial data must be submitted, whereas the requirements for national procedures could be modified corresponding to the stage of development of the ATMP. After marketing authorization, the marketing authorization/license holder is obligated to report all serious adverse reactions to the competent authority and to provide periodic safety update reports. If necessary, post-authorization safety studies could be imposed. On the basis of these regulatory measures, the safety of advanced therapies can be monitored and improved.

Toxicologic Pathology Forum Opinion Paper: Considerations for Toxicologic Pathologists Evaluating the Safety of Biomaterials and Finished Medical Devices.

PubMed

Gad, Shayne C; Schuh, JoAnn C L

2018-06-01

Safety ("biocompatibility") assessment of medical devices has evolved along a different path than that of drugs, being historically governed more by the considerations and needs of engineers rather than chemists and biologists. As a result, the involvement of veterinary pathologists has been much more limited-almost entirely to evaluating tissue responses in tissues in direct contact with implanted devices. As devices have become more complex in composition, structure, placement, and use, concerns as to adverse systemic responses in patients have called for more comprehensive and thoughtful evaluations of effects throughout the body. Further complexities arise from the increasing marriage of devices and drug/biologic therapeutics to achieve either better dose control and, specifically, in delivery to target organs/tissues or better tolerance of the body to medical devices (i.e., minimization of the foreign body response). The challenge to pathologists is to integrate in new technologies (such as in vivo imaging and immunology) and ways of viewing interactions with patient bodies. To fail to do so will allow the methods and standards for medical device safety evaluation to be based on chemical analysis and then the limited details inherent in literature-based risk assessments.

Evaluating the Performance of the NASA LaRC CMF Motion Base Safety Devices

NASA Technical Reports Server (NTRS)

Gupton, Lawrence E.; Bryant, Richard B., Jr.; Carrelli, David J.

2006-01-01

This paper describes the initial measured performance results of the previously documented NASA Langley Research Center (LaRC) Cockpit Motion Facility (CMF) motion base hardware safety devices. These safety systems are required to prevent excessive accelerations that could injure personnel and damage simulator cockpits or the motion base structure. Excessive accelerations may be caused by erroneous commands or hardware failures driving an actuator to the end of its travel at high velocity, stepping a servo valve, or instantly reversing servo direction. Such commands may result from single order failures of electrical or hydraulic components within the control system itself, or from aggressive or improper cueing commands from the host simulation computer. The safety systems must mitigate these high acceleration events while minimizing the negative performance impacts. The system accomplishes this by controlling the rate of change of valve signals to limit excessive commanded accelerations. It also aids hydraulic cushion performance by limiting valve command authority as the actuator approaches its end of travel. The design takes advantage of inherent motion base hydraulic characteristics to implement all safety features using hardware only solutions.

[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.

A probabilistic bridge safety evaluation against floods.

PubMed

Liao, Kuo-Wei; Muto, Yasunori; Chen, Wei-Lun; Wu, Bang-Ho

2016-01-01

To further capture the influences of uncertain factors on river bridge safety evaluation, a probabilistic approach is adopted. Because this is a systematic and nonlinear problem, MPP-based reliability analyses are not suitable. A sampling approach such as a Monte Carlo simulation (MCS) or importance sampling is often adopted. To enhance the efficiency of the sampling approach, this study utilizes Bayesian least squares support vector machines to construct a response surface followed by an MCS, providing a more precise safety index. Although there are several factors impacting the flood-resistant reliability of a bridge, previous experiences and studies show that the reliability of the bridge itself plays a key role. Thus, the goal of this study is to analyze the system reliability of a selected bridge that includes five limit states. The random variables considered here include the water surface elevation, water velocity, local scour depth, soil property and wind load. Because the first three variables are deeply affected by river hydraulics, a probabilistic HEC-RAS-based simulation is performed to capture the uncertainties in those random variables. The accuracy and variation of our solutions are confirmed by a direct MCS to ensure the applicability of the proposed approach. The results of a numerical example indicate that the proposed approach can efficiently provide an accurate bridge safety evaluation and maintain satisfactory variation.

[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.

Development and evaluation of a university campus-based food safety media campaign for young adults.

PubMed

Abbot, Jaclyn Maurer; Policastro, Peggy; Bruhn, Christine; Schaffner, Donald W; Byrd-Bredbenner, Carol

2012-06-01

Food safety information campaigns are more likely to be most effective if the messages are tailored to the needs of a specific audience. Designing effective campaigns involves careful study of the target population and working with them using a community-based participatory research model. Thus, the development of the campaign materials for a university campus-based food safety media campaign for young adults followed intense efforts of working with the target audience to gather the baseline data needed to characterize this audience, to identify the most salient messages for college students, and to create materials and events that would resonate with them. This campaign was implemented and evaluated on eight university campuses in the United States. The results indicate that the campaign significantly increased self-ratings of food safety knowledge and skill, actual food safety knowledge, food safety self-efficacy, stage of change for safe food handling, and reported hand washing behaviors of a geographically and racially diverse group of college students. The positive study outcomes support the value of engaging in these research and development efforts and reflect the usefulness of the audience-specific materials and activities developed for the campaign. The findings also demonstrate the versatility and utility of the materials on different campuses. Developing health media campaigns specifically for unique populations is key to ensuring health messages reach the target audience and, even more importantly, appeal to them. The detailed overview of the development of a food safety media campaign aimed at young adults presented in this article illustrates how health professionals can work with their target population to develop a focused, effective health promotion campaign.

Criticality Safety Evaluation for Small Sample Preparation and Non-Destructive Assay (NDA) Operations in Wing 7 Basement of the CMR Facility

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

Kunkle, Paige Elizabeth; Zhang, Ning

Nuclear Criticality Safety (NCS) has reviewed the fissionable material small sample preparation and NDA operations in Wing 7 Basement of the CMR Facility. This is a Level-1 evaluation conducted in accordance with NCS-AP-004 [Reference 1], formerly NCS-GUIDE-01, and the guidance set forth on use of the Standard Criticality Safety Requirements (SCSRs) [Reference 2]. As stated in Reference 2, the criticality safety evaluation consists of both the SCSR CSED and the SCSR Application CSED. The SCSR CSED is a Level-3 CSED [Reference 3]. This Level-1 CSED is the SCSR Application CSED. This SCSR Application (Level-1) evaluation does not derive controls, itmore » simply applies controls derived from the SCSR CSED (Level-3) for the application of operations conducted here. The controls derived in the SCSR CSED (Level-3) were evaluated via the process described in Section 6.6.5 of SD-130 (also reproduced in Section 4.3.5 of NCS-AP-004 [Reference 1]) and were determined to not meet the requirements for consideration of elevation into the safety basis documentation for CMR. According to the guidance set forth on use of the SCSRs [Reference 2], the SCSR CSED (Level-3) is also applicable to the CMR Facility because the process and the normal and credible abnormal conditions in question are bounded by those that are described in the SCSR CSED. The controls derived in the SCSR CSED include allowances for solid materials and solution operations. Based on the operations conducted at this location, there are less-than-accountable (LTA) amounts of 233U. Based on the evaluation documented herein, the normal and credible abnormal conditions that might arise during the execution of this process will remain subcritical with the following recommended controls.« less

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)

A Real-time Evaluation of Human-based Approaches to Safety Testing: What We Can Do Now (TDS)

EPA Science Inventory

Despite ever-increasing efforts in early safety assessment in all industries, there are still many chemicals that prove toxic in humans. While greater use of human in vitro test methods may serve to reduce this problem, the formal validation process applied to such tests represen...

Pedestrian safety engineering and intelligent transportation system-based countermeasures program for reduced pedestrian fatalities, injuries, conflicts and other surrogate measures : Miami-Dade site.

DOT National Transportation Integrated Search

2008-08-25

This report presents the methods and key findings from the Miami-Dade comprehensive pedestrian safety planning and engineering project. It is one of three such projects in the nation funded by the Federal Highway Administration (FHWA) to evaluate: In...

10 CFR 52.157 - Contents of applications; technical information in final safety analysis report.

Code of Federal Regulations, 2010 CFR

2010-01-01

... analysis of the structures, systems, and components of the reactor to be manufactured, with emphasis upon... assumed for this evaluation should be based upon a major accident, hypothesized for purposes of site... structures, systems, and components with the objective of assessing the risk to public health and safety...

How Can We Improve School Safety Research?

ERIC Educational Resources Information Center

Astor, Ron Avi; Guerra, Nancy; Van Acker, Richard

2010-01-01

The authors of this article consider how education researchers can improve school violence and school safety research by (a) examining gaps in theoretical, conceptual, and basic research on the phenomena of school violence; (b) reviewing key issues in the design and evaluation of evidence-based practices to prevent school violence; and (c)…

Study on development and application of platform with students' safety based on SOA

NASA Astrophysics Data System (ADS)

Jiang, Derong

2011-10-01

Students' safety management is a very important work, which is responsible for the entire school student security problems, student safety primarily prevent, only advance predict various of the imminent problems, to better protect their safety. The system mainly used on the development request the student safety management, safety evaluation, safety education, and etc, which are for daily management work completed for students in the security digital management. Development of the system can reduce the safety management for department working pressure, meanwhile, can reduce the labor force to use, accelerate query speed, strengthens the management, as well as the national various departments about the information step, making each management standardized. Therefore, developing a set of suitability and the populace, compatibly good system is very necessary.

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.

Promoting a Culture of Safety as a Patient Safety Strategy

PubMed Central

Weaver, Sallie J.; Lubomksi, Lisa H.; Wilson, Renee F.; Pfoh, Elizabeth R.; Martinez, Kathryn A.; Dy, Sydney M.

2015-01-01

Developing a culture of safety is a core element of many efforts to improve patient safety and care quality. This systematic review identifies and assesses interventions used to promote safety culture or climate in acute care settings. The authors searched MEDLINE, CINAHL, PsycINFO, Cochrane, and EMBASE to identify relevant English-language studies published from January 2000 to October 2012. They selected studies that targeted health care workers practicing in inpatient settings and included data about change in patient safety culture or climate after a targeted intervention. Two raters independently screened 3679 abstracts (which yielded 33 eligible studies in 35 articles), extracted study data, and rated study quality and strength of evidence. Eight studies included executive walk rounds or interdisciplinary rounds; 8 evaluated multicomponent, unit-based interventions; and 20 included team training or communication initiatives. Twenty-nine studies reported some improvement in safety culture or patient outcomes, but measured outcomes were highly heterogeneous. Strength of evidence was low, and most studies were pre–post evaluations of low to moderate quality. Within these limits, evidence suggests that interventions can improve perceptions of safety culture and potentially reduce patient harm. PMID:23460092

What do we need to know prior to thinking about incorporating an epigenetic evaluation into safety assessments

EPA Science Inventory

The Ineternation Life Sciences Institute, Health and Environmental Sciences Institute sponsored a workgroup entitled "state of the science: evaluating epigenetic changes" hosted by NIEHS. The goal was to evaluate and enhance the scientific knowledge base regarding epigenetics an...

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 incentive and penalty provisions in Indian construction projects and their impact on safety performance.

PubMed

Hasan, Abid; Jha, Kumar Neeraj

2013-01-01

Safety incentive and penalty (I/P) provisions in construction contracts are one of the most common forms of I/P. Contradictory opinions on the effectiveness of these provisions have been expressed in the literature. Statistics on safety provisions were collected from 32 construction projects, which include both types of contracts - those with safety I/P provisions and those without them. Although inclusion of safety I/P provisions in contracts helps in improving the overall safety performance in construction projects, further scope for improvement still exists. Literature review and structured personal interviews, coupled with a survey based on preliminary questionnaire, revealed that successful formulation and implementation of such provisions are dependent on 25 attributes which need the attention of both clients and contractors. A questionnaire-based survey was conducted to evaluate these attributes. The six factors extracted by carrying out factor analysis are: incentive distribution method, proper labour training, special attention to risky situations, role of safety committee and sub-contractors, specialised works and safety equipments, and right form of I/P. If taken care of, these attributes have the potential to improve the safety performance in construction projects. The results would be useful to clients and contractors in implementing the safety I/P provisions and thereby improving safety performance.

Safety evaluation methodology for advanced coal extraction systems

NASA Technical Reports Server (NTRS)

Zimmerman, W. F.

1981-01-01

Qualitative and quantitative evaluation methods for coal extraction systems were developed. The analysis examines the soundness of the design, whether or not the major hazards have been eliminated or reduced, and how the reduction would be accomplished. The quantitative methodology establishes the approximate impact of hazards on injury levels. The results are weighted by peculiar geological elements, specialized safety training, peculiar mine environmental aspects, and reductions in labor force. The outcome is compared with injury level requirements based on similar, safer industries to get a measure of the new system's success in reducing injuries. This approach provides a more detailed and comprehensive analysis of hazards and their effects than existing safety analyses.

Pushing and pulling: an assessment tool for occupational health and safety practitioners.

PubMed

Lind, Carl Mikael

2018-03-01

A tool has been developed for supporting practitioners when assessing manual pushing and pulling operations based on an initiative by two global companies in the manufacturing industry. The aim of the tool is to support occupational health and safety practitioners in risk assessment and risk management of pushing and pulling operations in the manufacturing and logistics industries. The tool is based on a nine-multiplier equation that includes a wide range of factors affecting an operator's health risk and capacity in pushing and pulling. These multipliers are based on psychophysical, physiological and biomechanical studies in combination with judgments from an expert group consisting of senior researchers and ergonomists. In order to consider usability, more than 50 occupational health and safety practitioners (e.g., ergonomists, managers, safety representatives and production personnel) participated in the development of the tool. An evaluation by 22 ergonomists supports that the push/pull tool is user friendly in general.

Economic evaluation of occupational health and safety programmes in health care.

PubMed

Guzman, J; Tompa, E; Koehoorn, M; de Boer, H; Macdonald, S; Alamgir, H

2015-10-01

Evidence-based resource allocation in the public health care sector requires reliable economic evaluations that are different from those needed in the commercial sector. To describe a framework for conducting economic evaluations of occupational health and safety (OHS) programmes in health care developed with sector stakeholders. To define key resources and outcomes to be considered in economic evaluations of OHS programmes and to integrate these into a comprehensive framework. Participatory action research supported by mixed qualitative and quantitative methods, including a multi-stakeholder working group, 25 key informant interviews, a 41-member Delphi panel and structured nominal group discussions. We found three resources had top priority: OHS staff time, training the workers and programme planning, promotion and evaluation. Similarly, five outcomes had top priority: number of injuries, safety climate, job satisfaction, quality of care and work days lost. The resulting framework was built around seven principles of good practice that stakeholders can use to assist them in conducting economic evaluations of OHS programmes. Use of a framework resulting from this participatory action research approach may increase the quality of economic evaluations of OHS programmes and facilitate programme comparisons for evidence-based resource allocation decisions. The principles may be applicable to other service sectors funded from general taxes and more broadly to economic evaluations of OHS programmes in general. © The Author 2015. Published by Oxford University Press on behalf of the Society of Occupational Medicine. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Safety and usability evaluation of a web-based insulin self-titration system for patients with type 2 diabetes mellitus.

PubMed

Simon, Airin C R; Holleman, Frits; Gude, Wouter T; Hoekstra, Joost B L; Peute, Linda W; Jaspers, Monique W M; Peek, Niels

2013-09-01

The rising incidence of type 2 diabetes mellitus (T2DM) induces severe challenges for the health care system. Our research group developed a web-based system named PANDIT that provides T2DM patients with insulin dosing advice using state of the art clinical decision support technology. The PANDIT interface resembles a glucose diary and provides advice through pop-up messages. Diabetes nurses (DNs) also have access to the system, allowing them to intervene when needed. The objective of this study was to establish whether T2DM patients can safely use PANDIT at home. To this end, we assessed whether patients experience usability problems with a high risk of compromising patient safety when interacting with the system, and whether PANDIT's insulin dosing advice are clinically safe. The study population consisted of patients with T2DM (aged 18-80) who used a once daily basal insulin as well as DNs from a university hospital. The usability evaluation consisted of think-aloud sessions with four patients and three DNs. Video data, audio data and verbal utterances were analyzed for usability problems encountered during PANDIT interactions. Usability problems were rated by a physician and a usability expert according to their potential impact on patient safety. The usability evaluation was followed by an implementation with a duration of four weeks. This implementation took place at the patients' homes with ten patients to evaluate clinical safety of PANDIT advice. PANDIT advice were systematically compared with DN advice. Deviating advice were evaluated with respect to patient safety by a panel of experienced physicians, which specialized in diabetes care. We detected seventeen unique usability problems, none of which was judged to have a high risk of compromising patient safety. Most usability problems concerned the lay-out of the diary, which did not clearly indicate which data entry fields had to be entered in order to obtain an advice. 27 out of 74 (36.5%) PANDIT advice differed from those provided by DNs. However, only one of these (1.4%) was considered unsafe by the panel. T2DM patients with no prior experience with the web-based self-management system were capable of consulting the system without encountering significant usability problems. Furthermore, the large majority of PANDIT advice were considered clinically safe according to the expert panel. One advice was considered unsafe. This could however easily be corrected by implementing a small modification to the system's knowledge base. Copyright © 2013 Elsevier B.V. All rights reserved.

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.

Drivers' safety needs, behavioural adaptations and acceptance of new driving support systems.

PubMed

Saad, Farida; Van Elslande, Pierre

2012-01-01

The aim of this paper is to discuss the contribution of two complementary approaches for designing and evaluating new driver support systems likely to improve the operation and safety of the road traffic system. The first approach is based on detailed analyses of traffic crashes so as to estimate drivers' needs for assistance and the situational constraints that safety functions should address to be efficient. The second approach is based on in depth-analyses of behavioral adaptations induced by the usage of new driver support systems in regular driving situations and on drivers' acceptance of the assistance provided by the systems.

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.

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

Personal digital assistant-based drug information sources: potential to improve medication safety.

PubMed

Galt, Kimberly A; Rule, Ann M; Houghton, Bruce; Young, Daniel O; Remington, Gina

2005-04-01

This study compared the potential for personal digital assistant (PDA)-based drug information sources to minimize potential medication errors dependent on accurate and complete drug information at the point of care. A quality and safety framework for drug information resources was developed to evaluate 11 PDA-based drug information sources. Three drug information sources met the criteria of the framework: Eprocrates Rx Pro, Lexi-Drugs, and mobileMICROMEDEX. Medication error types related to drug information at the point of care were then determined. Forty-seven questions were developed to test the potential of the sources to prevent these error types. Pharmacists and physician experts from Creighton University created these questions based on the most common types of questions asked by primary care providers. Three physicians evaluated the drug information sources, rating the source for each question: 1=no information available, 2=some information available, or 3 = adequate amount of information available. The mean ratings for the drug information sources were: 2.0 (Eprocrates Rx Pro), 2.5 (Lexi-Drugs), and 2.03 (mobileMICROMEDEX). Lexi-Drugs was significantly better (mobileMICROMEDEX t test; P=0.05; Eprocrates Rx Pro t test; P=0.01). Lexi-Drugs was found to be the most specific and complete PDA resource available to optimize medication safety by reducing potential errors associated with drug information. No resource was sufficient to address the patient safety information needs for all cases.

Selecting an Architecture for a Safety-Critical Distributed Computer System with Power, Weight and Cost Considerations

NASA Technical Reports Server (NTRS)

Torres-Pomales, Wilfredo

2014-01-01

This report presents an example of the application of multi-criteria decision analysis to the selection of an architecture for a safety-critical distributed computer system. The design problem includes constraints on minimum system availability and integrity, and the decision is based on the optimal balance of power, weight and cost. The analysis process includes the generation of alternative architectures, evaluation of individual decision criteria, and the selection of an alternative based on overall value. In this example presented here, iterative application of the quantitative evaluation process made it possible to deliberately generate an alternative architecture that is superior to all others regardless of the relative importance of cost.

Evaluation and Customization of WHO Safety Checklist for Patient Safety in Otorhinolaryngology.

PubMed

Dabholkar, Yogesh; Velankar, Haritosh; Suryanarayan, Sneha; Dabholkar, Twinkle Y; Saberwal, Akanksha A; Verma, Bhavika

2018-03-01

The WHO has designed a safe surgery checklist to enhance communication and awareness of patient safety during surgery and to minimise complications. WHO recommends that the check-list be evaluated and customised by end users as a tool to promote safe surgery. The aim of present study was to evaluate the impact of WHO safety checklist on patient safety awareness in otorhinolaryngology and to customise it for the speciality. A prospective structured questionnaire based study was done in ENT operating room for duration of 1 month each for cases, before and after implementation of safe surgery checklist. The feedback from respondents (surgeons, nurses and anaesthetists) was used to arrive at a customised checklist for otolaryngology as per WHO guidelines. The checklist significantly improved team member's awareness of patient's identity (from 17 to 86%) and each other's identity and roles (from 46 to 94%) and improved team communication (from 73 to 92%) in operation theatre. There was a significant improvement in preoperative check of equipment and critical events were discussed more frequently. The checklist could be effectively customised to suit otolaryngology needs as per WHO guidelines. The modified checklist needs to be validated by otolaryngology associations. We conclude from our study that the WHO Surgical safety check-list has a favourable impact on patient safety awareness, team-work and communication of operating team and can be customised for otolaryngology setting.

Evaluation of the intelligent cruise control system. Volume 2, Appendices

DOT National Transportation Integrated Search

1999-10-01

The Intelligent Cruise Control (ICC) system evaluation was sponsored by the National Highway Traffic Safety Administration (NHTSA) and based on an ICC Field Operational Test (FOT) conducted under a cooperative agreement between the NHTSA and the Univ...

Progressive Care Nurses Improving Patient Safety by Limiting Interruptions During Medication Administration.

PubMed

Flynn, Fran; Evanish, Julie Q; Fernald, Josephine M; Hutchinson, Dawn E; Lefaiver, Cheryl

2016-08-01

Because of the high frequency of interruptions during medication administration, the effectiveness of strategies to limit interruptions during medication administration has been evaluated in numerous quality improvement initiatives in an effort to reduce medication administration errors. To evaluate the effectiveness of evidence-based strategies to limit interruptions during scheduled, peak medication administration times in 3 progressive cardiac care units (PCCUs). A secondary aim of the project was to evaluate the impact of limiting interruptions on medication errors. The percentages of interruptions and medication errors before and after implementation of evidence-based strategies to limit interruptions were measured by using direct observations of nurses on 2 PCCUs. Nurses in a third PCCU served as a comparison group. Interruptions (P < .001) and medication errors (P = .02) decreased significantly in 1 PCCU after implementation of evidence-based strategies to limit interruptions. Avoidable interruptions decreased 83% in PCCU1 and 53% in PCCU2 after implementation of the evidence-based strategies. Implementation of evidence-based strategies to limit interruptions in PCCUs decreases avoidable interruptions and promotes patient safety. ©2016 American Association of Critical-Care Nurses.

The impacts of using community health volunteers to coach medication safety behaviors among rural elders with chronic illnesses.

PubMed

Wang, Chi-Jane; Fetzer, Susan J; Yang, Yi-Ching; Wang, Jing-Jy

2013-01-01

It is a challenge for rural health professionals to promote medication safety among older adults taking multiple medications. A volunteer coaching program to promote medication safety among rural elders with chronic illnesses was designed and evaluated. A community-based interventional study randomly assigned 62 rural elders with at least two chronic illnesses to routine care plus volunteer coaching or routine care alone. The volunteer coaching group received a medication safety program, including a coach and reminders by well-trained volunteers, as well as three home visits and five telephone calls over a two-month period. All the subjects received routine medication safety instructions for their chronic illnesses. The program was evaluated using pre- and post-tests of knowledge, attitude and behaviors with regard to medication safety. Results show the volunteer coaching group improved their knowledge of medication safety, but there was no change in attitude after the two-month study period. Moreover, the group demonstrated three improved medication safety behaviors compared to the routine care group. The volunteer coaching program and instructions with pictorial aids can provide a reference for community health professionals who wish to improve the medication safety of chronically ill elders. Copyright © 2013 Mosby, Inc. All rights reserved.

Vessel traffic safety in busy waterways: A case study of accidents in western shenzhen port.

PubMed

Mou, J M; Chen, P F; He, Y X; Yip, Tsz Leung; Li, W H; Tang, J; Zhang, H Z

2016-08-03

Throughout the world, busy waterways near large ports witness heavy vessel traffic in recent decades. The waterways are characterized by high risk in terms of loss of life, property, and pollution to environment. To facilitate maritime safety management with satisfactory efficiency and efficacy, the authors propose a framework of safety indexes to evaluate the risk level in busy waterways according to the accident severity, fatality rate and special indicators of maritime transportation. The safety indexes consist of Safety Evaluation Index (SEI) and Safety Warning Index (SWI), and are derived from the proposed risk criteria of Chinese vessel traffic. As a case study, data on vessel traffic accidents reported in the Western Shenzhen Port, South China from 1995 to 2015 are analyzed. The actual risk level of this area during the period is calculated under the framework. The implementation of the safety indexes indicate that the risk criteria and safety indexes are practicable and effective for the vessel traffic management. The methodology based on long-term accident data can significantly support the risk analysis in the macroscopic perspective for busy ports and waterways, such that SWI can act as threshold to trigger actions, while SEI can act as an indicator to measure safety status. Copyright © 2016 Elsevier Ltd. All rights reserved.

Safety evaluation of cosmetics in the EU. Reality and challenges for the toxicologist.

PubMed

Pauwels, Marleen; Rogiers, Vera

2004-06-15

Council Directive 76/768/EEC, its seven amendments and 30 adaptations to technical progress form the basis of the cosmetic EU legislation today. There are actually four key principles for safety in the cosmetic legislation. (i) The full responsibility for the safety of cosmetics for human health is placed on the manufacturer, first importer in the EU or marketer. (ii) The safety evaluation of finished products is based on safety of individual ingredients, more specifically on their chemical structure, toxicological profile and their level of exposure. (iii) A compilation of information on each cosmetic product (dossier) must be kept readily available for inspection by the competent authorities of the Member State concerned. This information source, usually called a technical information file (TIF) or product information file/requirements (PIF(R)), contains, as the most important part, the safety assessment of the product undersigned by a competent safety assessor. (iv) The use of validated replacement alternative methods instead of animal testing forms the 4th key principle for safety of cosmetic products on the EU market. The 7th amendment imposes strict deadlines for the abolition of animal in vivo studies on cosmetic ingredients. These legal requirements induce a number of important challenges for the cosmetic industry and more specifically for the toxicologist involved as safety assessor.

Review of quality assessment tools for the evaluation of pharmacoepidemiological safety studies

PubMed Central

Neyarapally, George A; Hammad, Tarek A; Pinheiro, Simone P; Iyasu, Solomon

2012-01-01

Objectives Pharmacoepidemiological studies are an important hypothesis-testing tool in the evaluation of postmarketing drug safety. Despite the potential to produce robust value-added data, interpretation of findings can be hindered due to well-recognised methodological limitations of these studies. Therefore, assessment of their quality is essential to evaluating their credibility. The objective of this review was to evaluate the suitability and relevance of available tools for the assessment of pharmacoepidemiological safety studies. Design We created an a priori assessment framework consisting of reporting elements (REs) and quality assessment attributes (QAAs). A comprehensive literature search identified distinct assessment tools and the prespecified elements and attributes were evaluated. Primary and secondary outcome measures The primary outcome measure was the percentage representation of each domain, RE and QAA for the quality assessment tools. Results A total of 61 tools were reviewed. Most tools were not designed to evaluate pharmacoepidemiological safety studies. More than 50% of the reviewed tools considered REs under the research aims, analytical approach, outcome definition and ascertainment, study population and exposure definition and ascertainment domains. REs under the discussion and interpretation, results and study team domains were considered in less than 40% of the tools. Except for the data source domain, quality attributes were considered in less than 50% of the tools. Conclusions Many tools failed to include critical assessment elements relevant to observational pharmacoepidemiological safety studies and did not distinguish between REs and QAAs. Further, there is a lack of considerations on the relative weights of different domains and elements. The development of a quality assessment tool would facilitate consistent, objective and evidence-based assessments of pharmacoepidemiological safety studies. PMID:23015600

Featured Article: Evaluating Smartphone-Based Virtual Reality to Improve Chinese Schoolchildren's Pedestrian Safety: A Nonrandomized Trial.

PubMed

Schwebel, David C; Wu, Yue; Li, Peng; Severson, Joan; He, Yefei; Xiang, Henry; Hu, Guoqing

2018-06-01

This nonrandomized trial evaluated whether classroom-based training in a smartphone-based virtual reality (VR) pedestrian environment (a) teaches schoolchildren to cross streets safely, and (b) increases their self-efficacy for street-crossing. Fifty-six children, aged 8-10 years, attending primary school in Changsha, China participated. Baseline pedestrian safety assessment occurred in the VR environment and through unobtrusive observation of a subsample crossing a street for 11 days outside school. Self-efficacy was assessed through both self-report and observation. Following baseline, children engaged in the VR for 12 days in their classrooms, honing complex cognitive-perceptual skills required to engage safely in traffic. Follow-up assessment replicated baseline. Probability of crash in the VR decreased posttraining (0.40 vs. 0.09), and observational data found the odds of looking at oncoming traffic while crossing the first lane of traffic increased (odds ratio [OR] = 2.4). Self-efficacy increases occurred in self-report (proportional OR = 4.7 crossing busy streets) and observation of following crossing-guard signals (OR = 0.2, first lane). Pedestrian safety training via smartphone-based VR provides children the repeated practice needed to learn the complex skills required to cross streets safely, and also helps them improve self-efficacy to cross streets. Given rapid motorization and global smartphone penetration, plus epidemiological findings that about 75,000 children die annually worldwide in pedestrian crashes, smartphone-based VR could supplement existing policy and prevention efforts to improve global child pedestrian safety.

Validation of tungsten cross sections in the neutron energy region up to 100 keV

NASA Astrophysics Data System (ADS)

Pigni, Marco T.; Žerovnik, Gašper; Leal, Luiz. C.; Trkov, Andrej

2017-09-01

Following a series of recent cross section evaluations on tungsten isotopes performed at Oak Ridge National Laboratory (ORNL), this paper presents the validation work carried out to test the performance of the evaluated cross sections based on lead-slowing-down (LSD) benchmarks conducted in Grenoble. ORNL completed the resonance parameter evaluation of four tungsten isotopes - 182,183,184,186W - in August 2014 and submitted it as an ENDF-compatible file to be part of the next release of the ENDF/B-VIII.0 nuclear data library. The evaluations were performed with support from the US Nuclear Criticality Safety Program in an effort to provide improved tungsten cross section and covariance data for criticality safety sensitivity analyses. The validation analysis based on the LSD benchmarks showed an improved agreement with the experimental response when the ORNL tungsten evaluations were included in the ENDF/B-VII.1 library. Comparison with the results obtained with the JEFF-3.2 nuclear data library are also discussed.

Towards Measurement of Confidence in Safety Cases

NASA Technical Reports Server (NTRS)

Denney, Ewen; Paim Ganesh J.; Habli, Ibrahim

2011-01-01

Arguments in safety cases are predominantly qualitative. This is partly attributed to the lack of sufficient design and operational data necessary to measure the achievement of high-dependability targets, particularly for safety-critical functions implemented in software. The subjective nature of many forms of evidence, such as expert judgment and process maturity, also contributes to the overwhelming dependence on qualitative arguments. However, where data for quantitative measurements is systematically collected, quantitative arguments provide far more benefits over qualitative arguments, in assessing confidence in the safety case. In this paper, we propose a basis for developing and evaluating integrated qualitative and quantitative safety arguments based on the Goal Structuring Notation (GSN) and Bayesian Networks (BN). The approach we propose identifies structures within GSN-based arguments where uncertainties can be quantified. BN are then used to provide a means to reason about confidence in a probabilistic way. We illustrate our approach using a fragment of a safety case for an unmanned aerial system and conclude with some preliminary observations

'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.

Autonomous Flight Safety System September 27, 2005, Aircraft Test

NASA Technical Reports Server (NTRS)

Simpson, James C.

2005-01-01

This report describes the first aircraft test of the Autonomous Flight Safety System (AFSS). The test was conducted on September 27, 2005, near Kennedy Space Center (KSC) using a privately-owned single-engine plane and evaluated the performance of several basic flight safety rules using real-time data onboard a moving aerial vehicle. This test follows the first road test of AFSS conducted in February 2005 at KSC. AFSS is a joint KSC and Wallops Flight Facility (WEF) project that is in its third phase of development. AFSS is an independent subsystem intended for use with Expendable Launch Vehicles that uses tracking data from redundant onboard sensors to autonomously make flight termination decisions using software-based rules implemented on redundant flight processors. The goals of this project are to increase capabilities by allowing launches from locations that do not have or cannot afford extensive ground-based range safety assets, to decrease range costs, and to decrease reaction time for special situations. The mission rules are configured for each operation by the responsible Range Safety authorities and can be loosely categorized in four major categories: Parameter Threshold Violations, Physical Boundary Violations present position and instantaneous impact point (TIP), Gate Rules static and dynamic, and a Green-Time Rule. Examples of each of these rules were evaluated during this aircraft test.

Introduction of structural health and safety monitoring warning systems for Shenzhen-Hong Kong Western Corridor Shenzhen Bay Bridge

NASA Astrophysics Data System (ADS)

Li, N.; Zhang, X. Y.; Zhou, X. T.; Leng, J.; Liang, Z.; Zheng, C.; Sun, X. F.

2008-03-01

Though the brief introduction of the completed structural health and safety monitoring warning systems for Shenzhen-Hongkong western corridor Shenzhen bay highway bridge (SZBHMS), the self-developed system frame, hardware and software scheme of this practical research project are systematically discussed in this paper. The data acquisition and transmission hardware and the basic software based on the NI (National Instruments) Company virtual instruments technology were selected in this system, which adopted GPS time service receiver technology and so on. The objectives are to establish the structural safety monitoring and status evaluation system to monitor the structural responses and working conditions in real time and to analyze the structural working statue using information obtained from the measured data. It will be also provided the scientific decision-making bases for the bridge management and maintenance. Potential technical approaches to the structural safety warning systems, status identification and evaluation method are presented. The result indicated that the performance of the system has achieved the desired objectives, ensure the longterm high reliability, real time concurrence and advanced technology of SZBHMS. The innovate achievement which is the first time to implement in domestic, provide the reference for long-span bridge structural health and safety monitoring warning systems design.

Effectiveness of the IMPACT:Ability Program to Improve Safety and Self-Advocacy Skills in High School Students with Disabilities

ERIC Educational Resources Information Center

Dryden, Eileen M.; Desmarais, Jeffery; Arsenault, Lisa

2014-01-01

Background: Individuals with disabilities experience higher rates of abuse than the nondisabled. Few evidence-based prevention interventions have been published despite a need for such work. This study evaluated IMPACT:Ability, a safety and self-advocacy training for individuals with cognitive and/or physical disabilities. Methods: A…

Quantitative assessment of building fire risk to life safety.

PubMed

Guanquan, Chu; Jinhua, Sun

2008-06-01

This article presents a quantitative risk assessment framework for evaluating fire risk to life safety. Fire risk is divided into two parts: probability and corresponding consequence of every fire scenario. The time-dependent event tree technique is used to analyze probable fire scenarios based on the effect of fire protection systems on fire spread and smoke movement. To obtain the variation of occurrence probability with time, Markov chain is combined with a time-dependent event tree for stochastic analysis on the occurrence probability of fire scenarios. To obtain consequences of every fire scenario, some uncertainties are considered in the risk analysis process. When calculating the onset time to untenable conditions, a range of fires are designed based on different fire growth rates, after which uncertainty of onset time to untenable conditions can be characterized by probability distribution. When calculating occupant evacuation time, occupant premovement time is considered as a probability distribution. Consequences of a fire scenario can be evaluated according to probability distribution of evacuation time and onset time of untenable conditions. Then, fire risk to life safety can be evaluated based on occurrence probability and consequences of every fire scenario. To express the risk assessment method in detail, a commercial building is presented as a case study. A discussion compares the assessment result of the case study with fire statistics.

The Interagency Nuclear Safety Review Panel's Galileo safety evaluation report

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

Nelson, R.C.; Gray, L.B.; Huff, D.A.

The safety evaluation report (SER) for Galileo was prepared by the Interagency Nuclear Safety Review Panel (INSRP) coordinators in accordance with Presidential directive/National Security Council memorandum 25. The INSRP consists of three coordinators appointed by their respective agencies, the Department of Defense, the Department of Energy (DOE), and the National Aeronautics and Space Administration (NASA). These individuals are independent of the program being evaluated and depend on independent experts drawn from the national technical community to serve on the five INSRP subpanels. The Galileo SER is based on input provided by the NASA Galileo Program Office, review and assessment ofmore » the final safety analysis report prepared by the Office of Special Applications of the DOE under a memorandum of understanding between NASA and the DOE, as well as other related data and analyses. The SER was prepared for use by the agencies and the Office of Science and Technology Policy, Executive Office of the Present for use in their launch decision-making process. Although more than 20 nuclear-powered space missions have been previously reviewed via the INSRP process, the Galileo review constituted the first review of a nuclear power source associated with launch aboard the Space Transportation System.« less

The role of safety behaviors in exposure-based treatment for panic disorder and agoraphobia: associations to symptom severity, treatment course, and outcome.

PubMed

Helbig-Lang, Sylvia; Richter, Jan; Lang, Thomas; Gerlach, Alexander L; Fehm, Lydia; Alpers, Georg W; Ströhle, Andreas; Kircher, Tilo; Deckert, Jürgen; Gloster, Andrew T; Wittchen, Hans-Ulrich

2014-12-01

The potentially detrimental effects of safety behaviors during exposure therapy are still subject to debate. Empirical findings are inconsistent, and few studies have investigated effects of idiosyncratic safety behavior manifestations during exposure or in everyday life. These limitations might be due to a lack of appropriate measures that address individual safety behaviors. We examined psychometric properties and predictive value of the Texas Safety Maneuver Scale (TSMS), a questionnaire specifically targeting safety behaviors in panic disorder and agoraphobia. Effects of safety behavior use, both during everyday life and during therapy, were examined using data from a multicenter RCT of N=268 patients that aimed at evaluating efficacy and mechanisms of action of two variants of an exposure-based therapy. The TSMS total score demonstrated good internal consistency (α=0.89), and it showed significant correlations with selected measures of baseline anxiety and impairment. The proposed factor structure could not be replicated. Frequent safety behavior use at baseline was associated with actual safety behavior during exposure exercises. Pronounced in-situ safety behavior, but not baseline safety behavior was associated to detrimental treatment outcome. The results underline the relevance of a rigorous safety behavior assessment in therapy. The actual relationship between safety behavior use and treatment outcome is yet to determine. Copyright © 2014 Elsevier Ltd. All rights reserved.

Safety assessment in plant layout design using indexing approach: implementing inherent safety perspective. Part 1 - guideword applicability and method description.

PubMed

Tugnoli, Alessandro; Khan, Faisal; Amyotte, Paul; Cozzani, Valerio

2008-12-15

Layout planning plays a key role in the inherent safety performance of process plants since this design feature controls the possibility of accidental chain-events and the magnitude of possible consequences. A lack of suitable methods to promote the effective implementation of inherent safety in layout design calls for the development of new techniques and methods. In the present paper, a safety assessment approach suitable for layout design in the critical early phase is proposed. The concept of inherent safety is implemented within this safety assessment; the approach is based on an integrated assessment of inherent safety guideword applicability within the constraints typically present in layout design. Application of these guidewords is evaluated along with unit hazards and control devices to quantitatively map the safety performance of different layout options. Moreover, the economic aspects related to safety and inherent safety are evaluated by the method. Specific sub-indices are developed within the integrated safety assessment system to analyze and quantify the hazard related to domino effects. The proposed approach is quick in application, auditable and shares a common framework applicable in other phases of the design lifecycle (e.g. process design). The present work is divided in two parts: Part 1 (current paper) presents the application of inherent safety guidelines in layout design and the index method for safety assessment; Part 2 (accompanying paper) describes the domino hazard sub-index and demonstrates the proposed approach with a case study, thus evidencing the introduction of inherent safety features in layout design.

Towards an International Classification for Patient Safety: the conceptual framework.

PubMed

Sherman, Heather; Castro, Gerard; Fletcher, Martin; Hatlie, Martin; Hibbert, Peter; Jakob, Robert; Koss, Richard; Lewalle, Pierre; Loeb, Jerod; Perneger, Thomas; Runciman, William; Thomson, Richard; Van Der Schaaf, Tjerk; Virtanen, Martti

2009-02-01

Global advances in patient safety have been hampered by the lack of a uniform classification of patient safety concepts. This is a significant barrier to developing strategies to reduce risk, performing evidence-based research and evaluating existing healthcare policies relevant to patient safety. Since 2005, the World Health Organization's World Alliance for Patient Safety has undertaken the Project to Develop an International Classification for Patient Safety (ICPS) to devise a classification which transforms patient safety information collected from disparate systems into a common format to facilitate aggregation, analysis and learning across disciplines, borders and time. A drafting group, comprised of experts from the fields of patient safety, classification theory, health informatics, consumer/patient advocacy, law and medicine, identified and defined key patient safety concepts and developed an internationally agreed conceptual framework for the ICPS based upon existing patient safety classifications. The conceptual framework was iteratively improved through technical expert meetings and a two-stage web-based modified Delphi survey of over 250 international experts. This work culminated in a conceptual framework consisting of ten high level classes: incident type, patient outcomes, patient characteristics, incident characteristics, contributing factors/hazards, organizational outcomes, detection, mitigating factors, ameliorating actions and actions taken to reduce risk. While the framework for the ICPS is in place, several challenges remain. Concepts need to be defined, guidance for using the classification needs to be provided, and further real-world testing needs to occur to progressively refine the ICPS to ensure it is fit for purpose.

Towards an International Classification for Patient Safety: the conceptual framework

PubMed Central

Sherman, Heather; Castro, Gerard; Fletcher, Martin; Hatlie, Martin; Hibbert, Peter; Jakob, Robert; Koss, Richard; Lewalle, Pierre; Loeb, Jerod; Perneger, Thomas; Runciman, William; Thomson, Richard; Van Der Schaaf, Tjerk; Virtanen, Martti

2009-01-01

Global advances in patient safety have been hampered by the lack of a uniform classification of patient safety concepts. This is a significant barrier to developing strategies to reduce risk, performing evidence-based research and evaluating existing healthcare policies relevant to patient safety. Since 2005, the World Health Organization's World Alliance for Patient Safety has undertaken the Project to Develop an International Classification for Patient Safety (ICPS) to devise a classification which transforms patient safety information collected from disparate systems into a common format to facilitate aggregation, analysis and learning across disciplines, borders and time. A drafting group, comprised of experts from the fields of patient safety, classification theory, health informatics, consumer/patient advocacy, law and medicine, identified and defined key patient safety concepts and developed an internationally agreed conceptual framework for the ICPS based upon existing patient safety classifications. The conceptual framework was iteratively improved through technical expert meetings and a two-stage web-based modified Delphi survey of over 250 international experts. This work culminated in a conceptual framework consisting of ten high level classes: incident type, patient outcomes, patient characteristics, incident characteristics, contributing factors/hazards, organizational outcomes, detection, mitigating factors, ameliorating actions and actions taken to reduce risk. While the framework for the ICPS is in place, several challenges remain. Concepts need to be defined, guidance for using the classification needs to be provided, and further real-world testing needs to occur to progressively refine the ICPS to ensure it is fit for purpose. PMID:19147595

Assessment of the impact of dipped guideways on urban rail transit systems: Ventilation and safety requirements

NASA Technical Reports Server (NTRS)

1982-01-01

The ventilation and fire safety requirements for subway tunnels with dipped profiles between stations as compared to subway tunnels with level profiles were evaluated. This evaluation is based upon computer simulations of a train fire emergency condition. Each of the tunnel configurations evaluated was developed from characteristics that are representative of modern transit systems. The results of the study indicate that: (1) The level tunnel system required about 10% more station cooling than dipped tunnel systems in order to meet design requirements; and (2) The emergency ventilation requirements are greater with dipped tunnel systems than with level tunnel systems.

Performance-based brake testers : round robin study

DOT National Transportation Integrated Search

2000-11-01

In the early 1990s, the Federal Motor Carrier Safety Administration initiated research to evaluate various types of performance-based brake testing technologies for application to commercial vehicle inspections. The purpose of the research was to det...

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.

Plant-based insect repellents: a review of their efficacy, development and testing

PubMed Central

2011-01-01

Plant-based repellents have been used for generations in traditional practice as a personal protection measure against host-seeking mosquitoes. Knowledge on traditional repellent plants obtained through ethnobotanical studies is a valuable resource for the development of new natural products. Recently, commercial repellent products containing plant-based ingredients have gained increasing popularity among consumers, as these are commonly perceived as “safe” in comparison to long-established synthetic repellents although this is sometimes a misconception. To date insufficient studies have followed standard WHO Pesticide Evaluation Scheme guidelines for repellent testing. There is a need for further standardized studies in order to better evaluate repellent compounds and develop new products that offer high repellency as well as good consumer safety. This paper presents a summary of recent information on testing, efficacy and safety of plant-based repellents as well as promising new developments in the field. PMID:21411012

CBP for Field Workers – Results and Insights from Three Usability and Interface Design Evaluations

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

Oxstrand, Johanna Helene; Le Blanc, Katya Lee; Bly, Aaron Douglas

2015-09-01

Nearly all activities that involve human interaction with the systems in a nuclear power plant are guided by procedures. Even though the paper-based procedures (PBPs) currently used by industry have a demonstrated history of ensuring safety, improving procedure use could yield significant savings in increased efficiency as well as improved nuclear safety through human performance gains. The nuclear industry is constantly trying to find ways to decrease the human error rate, especially the human errors associated with procedure use. As a step toward the goal of improving procedure use and adherence, researchers in the Light-Water Reactor Sustainability (LWRS) Program, togethermore » with the nuclear industry, have been investigating the possibility and feasibility of replacing the current paper-based procedure process with a computer-based procedure (CBP) system. This report describes a field evaluation of new design concepts of a prototype computer-based procedure system.« less

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.

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.

Strategies to reduce safety violations for working from heights in construction companies: study protocol for a randomized controlled trial.

PubMed

van der Molen, Henk F; Frings-Dresen, Monique H W

2014-05-31

Safety measures should be applied to reduce work-related fatal and non-fatal fall injuries. However, according to the labor inspectorate, more than 80% of Dutch construction sites violate safety regulations for working from heights. To increase compliance with safety regulations, employers and workers have to select, implement and monitor safety measures. To facilitate this behavioral change, stimulating knowledge awareness and personalized feedback are frequently advocated behavior change techniques. For this study, two behavior change strategies have been developed in addition to the announcement of safety inspections by the labor inspectorate. These strategies consist of 1) face-to-face contacts with safety consultants and 2) direct mail with access to internet facilities. The objective of this study is to evaluate the effectiveness of these two strategies on the safety violations for working from heights, the process and the cost measures. This study is a block randomized intervention trial in 27 cities to establish the effects of the face-to-face guidance strategy (N = 9), a direct mailing strategy (N = 9) and a control condition of no guidance (N = 9) on safety violations to record by labor inspectors after three months. A process evaluation for both strategies will be performed to determine program implementation (reach, dose delivered and dose received), satisfaction, knowledge and perceived safety behavior. A cost analysis will be performed to establish the financial costs for both strategies. The present study is in accordance with the CONSORT statement. This study increases insight into performing practice-based randomized controlled trials. The outcome will help to evaluate the effect of two guidance strategies on safety violations. If these strategies are effective, implementation of these strategies through the national institute of safety and health or labor inspectorate can take place to guide construction companies in complying with safety regulations. NTR 4298 on 29-nov-2013.

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...

Canadian Association of Gastroenterology consensus guidelines on safety and quality indicators in endoscopy

PubMed Central

Armstrong, David; Barkun, Alan; Bridges, Ron; Carter, Rose; de Gara, Chris; Dubé, Catherine; Enns, Robert; Hollingworth, Roger; MacIntosh, Donald; Borgaonkar, Mark; Forget, Sylviane; Leontiadis, Grigorios; Meddings, Jonathan; Cotton, Peter; Kuipers, Ernst J; Valori, Roland

2012-01-01

BACKGROUND: Increasing use of gastrointestinal endoscopy, particularly for colorectal cancer screening, and increasing emphasis on health care quality, highlight the need for clearly defined, evidence-based processes to support quality improvement in endoscopy. OBJECTIVE: To identify processes and indicators of quality and safety relevant to high-quality endoscopy service delivery. METHODS: A multidisciplinary group of 35 voting participants developed recommendation statements and performance indicators. Systematic literature searches generated 50 initial statements that were revised iteratively following a modified Delphi approach using a web-based evaluation and voting tool. Statement development and evidence evaluation followed the AGREE (Appraisal of Guidelines, REsearch and Evaluation) and GRADE (Grading of Recommendations, Assessment, Development and Evaluation) guidelines. At the consensus conference, participants voted anonymously on all statements using a 6-point scale. Subsequent web-based voting evaluated recommendations for specific, individual quality indicators, safety indicators and mandatory endoscopy reporting fields. Consensus was defined a priori as agreement by 80% of participants. RESULTS: Consensus was reached on 23 recommendation statements addressing the following: ethics (statement 1: agreement 100%), facility standards and policies (statements 2 to 9: 90% to 100%), quality assurance (statements 10 to 13: 94% to 100%), training, education, competency and privileges (statements 14 to 19: 97% to 100%), endoscopy reporting standards (statements 20 and 21: 97% to 100%) and patient perceptions (statements 22 and 23: 100%). Additionally, 18 quality indicators (agreement 83% to 100%), 20 safety indicators (agreement 77% to 100%) and 23 recommended endoscopy-reporting elements (agreement 91% to 100%) were identified. DISCUSSION: The consensus process identified a clear need for high-quality clinical and outcomes research to support quality improvement in the delivery of endoscopy services. CONCLUSIONS: The guidelines support quality improvement in endoscopy by providing explicit recommendations on systematic monitoring, assessment and modification of endoscopy service delivery to yield benefits for all patients affected by the practice of gastrointestinal endoscopy. PMID:22308578

Considerations for the nonclinical safety evaluation of antibody drug conjugates for oncology.

PubMed

Roberts, Stanley A; Andrews, Paul A; Blanset, Diann; Flagella, Kelly M; Gorovits, Boris; Lynch, Carmel M; Martin, Pauline L; Kramer-Stickland, Kimberly; Thibault, Stephane; Warner, Garvin

2013-12-01

Antibody drug conjugates (ADCs) include monoclonal antibodies that are linked to cytotoxic small molecules. A number of these agents are currently being developed as anti-cancer agents designed to improve the therapeutic index of the cytotoxin (i.e., cytotoxic small molecule or cytotoxic agent) by specifically delivering it to tumor cells. This paper presents primary considerations for the nonclinical safety evaluation of ADCs and includes strategies for the evaluation of the entire ADC or the various individual components (i.e., antibody, linker or the cytotoxin). Considerations are presented on how to design a nonclinical safety assessment program to identify the on- and off-target toxicities to enable first-in-human (FIH) studies. Specific discussions are also included that provide details as to the need and how to conduct the studies for evaluating ADCs in genetic toxicology, tissue cross-reactivity, safety pharmacology, carcinogenicity, developmental and reproductive toxicology, biotransformation, toxicokinetic monitoring, bioanalytical assays, immunogenicity testing, test article stability and the selection of the FIH dose. Given the complexity of these molecules and our evolving understanding of their properties, there is no single all-encompassing nonclinical strategy. Instead, each ADC should be evaluated on a case-by-case scientifically-based approach that is consistent with ICH and animal research guidelines. Copyright © 2013 Elsevier Inc. All rights reserved.

Safety of Pseudomonas chlororaphis as a gene source for genetically modified crops.

PubMed

Anderson, Jennifer A; Staley, Jamie; Challender, Mary; Heuton, Jamie

2018-02-01

Genetically modified crops undergo extensive evaluation to characterize their food, feed and environmental safety prior to commercial introduction, using a well-established, science-based assessment framework. One component of the safety assessment includes an evaluation of each introduced trait, including its source organism, for potential adverse pathogenic, toxic and allergenic effects. Several Pseudomonas species have a history of safe use in agriculture and certain species represent a source of genes with insecticidal properties. The ipd072Aa gene from P. chlororaphis encodes the IPD072Aa protein, which confers protection against certain coleopteran pests when expressed in maize plants. P. chlororaphis is ubiquitous in the environment, lacks known toxic or allergenic properties, and has a history of safe use in agriculture and in food and feed crops. This information supports, in part, the safety assessment of potential traits, such as IPD072Aa, that are derived from this source organism.

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.

Science, safety, and trust: the case of transgenic food.

PubMed

Martinelli, Lucia; Karbarz, Małgorzata; Siipi, Helena

2013-02-01

Genetically modified (GM) food is discussed as an example of the controversial relation between the intrinsic uncertainty of the scientific approach and the demand of citizen-consumers to use products of science innovation that are known to be safe. On the whole, peer-reviewed studies on GM food safety do not note significant health risks, with a few exceptions, like the most renowned "Pusztai affair" and the recent "Seralini case." These latter studies have been disregarded by the scientific community, based on incorrect experimental designs and statistic analysis. Such contradictory results show the complexity of risk evaluation, and raise concerns in the citizen-consumers against the GM food. A thoughtful consideration by scientific community and decision makers of the moral values that are present in risk evaluation and risk management should be the most trustable answer to citizen-consumers to their claim for clear and definitive answers concerning safety/un-safety of GM food.

Addendum to NuMI shielding assessment

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

Vaziri, Kamran; /Fermilab

2007-10-01

The original safety assessment and the Safety Envelope for the NuMI beam line corresponds to 400 kW of beam power. The Main Injector is currently capable of and approved for producing 500 kW of beam power2. However, operation of the NuMI beam line at 400 kW of power brings up the possibility of an occasional excursion above 400 kW due to better than usual tuning in one of the machines upstream of the NuMI beam line. An excursion above the DOE approved Safety Envelope will constitute a safety violation. The purpose of this addendum is to evaluate the radiological issuesmore » and modifications required to operate the NuMI beam line at 500 kW. This upgrade will allow 400 kW operations with a reasonable safety margin. Configuration of the NuMI beam line, boundaries, safety system and the methodologies used for the calculations are as described in the original NuMI SAD. While most of the calculations presented in the original shielding assessment were based on Monte Carlo simulations, which were based on the design geometries, most of the results presented in this addendum are based on the measurements conducted by the AD ES&H radiation safety group.« less

Assessing the 'system' in safe systems-based road designs: using cognitive work analysis to evaluate intersection designs.

PubMed

Cornelissen, M; Salmon, P M; Stanton, N A; McClure, R

2015-01-01

While a safe systems approach has long been acknowledged as the underlying philosophy of contemporary road safety strategies, systemic applications are sparse. This article argues that systems-based methods from the discipline of Ergonomics have a key role to play in road transport design and evaluation. To demonstrate, the Cognitive Work Analysis framework was used to evaluate two road designs - a traditional Melbourne intersection and a cut-through design for future intersections based on road safety safe systems principles. The results demonstrate that, although the cut-through intersection appears different in layout from the traditional intersection, system constraints are not markedly different. Furthermore, the analyses demonstrated that redistribution of constraints in the cut-through intersection resulted in emergent behaviour, which was not anticipated and could prove problematic. Further, based on the lack of understanding of emergent behaviour, similar design induced problems are apparent across both intersections. Specifically, incompatibilities between infrastructure, vehicles and different road users were not dealt with by the proposed design changes. The importance of applying systems methods in the design and evaluation of road transport systems is discussed. Copyright © 2013 Elsevier Ltd. All rights reserved.

Efficacy and safety of ethynodiol diacetate, 1 mg, with ethinyl estradiol, 35 micrograms, with an emphasis on contraceptive efficacy. A phase IV trial.

PubMed

Friedman, A J; Wheeler, J

1991-04-01

A phase IV trial evaluated the efficacy and safety of a monophasic oral contraceptive formulation, ethynodiol diacetate, 1 mg, plus ethinyl estradiol, 35 micrograms (EDA 1 mg with EE 35 micrograms) (Demulen 1/35). Nine hundred eighty-three community-based obstetrician-gynecologists treated a total of 7,759 patients with EDA 1 mg with EE 35 micrograms for one to eight months. Clinical evaluation forms on 6,382 patients were amenable to analysis for safety (including breakthrough bleeding, ovarian cyst formation and complexion changes); 5,412 patients were evaluable for efficacy (prevention of pregnancy), with a total of 21,440 cycles recorded. The study results were interpreted in terms of the impact on clinical management of oral contraceptive users and the methods, strengths and weaknesses of phase IV trials, particularly as they relate to confirmation of the results reported here.

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.

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.

An evaluation of thirteen local selective enforcement projects designed to reduce drunken driving in Virginia.

DOT National Transportation Integrated Search

1985-01-01

In accordance with federal requirements, the effectiveness of thirteen locally based DUI selective enforcement projects funded with grants from the National Highway Traffic Safety Administration was evaluated. The grants were awarded in the FY 1982 g...

Creating the Web-based Intensive Care Unit Safety Reporting System

PubMed Central

Holzmueller, Christine G.; Pronovost, Peter J.; Dickman, Fern; Thompson, David A.; Wu, Albert W.; Lubomski, Lisa H.; Fahey, Maureen; Steinwachs, Donald M.; Engineer, Lilly; Jaffrey, Ali; Morlock, Laura L.; Dorman, Todd

2005-01-01

In an effort to improve patient safety, researchers at the Johns Hopkins University designed and implemented a comprehensive Web-based Intensive Care Unit Safety Reporting System (ICUSRS). The ICUSRS collects data about adverse events and near misses from all staff in the ICU. This report reflects data on 854 reports from 18 diverse ICUs across the United States. Reporting is voluntary, and data collected is confidential, with patient, provider, and reporter information deidentified. Preliminary data include system factors reported, degree of patient harm, reporting times, and evaluations of the system. Qualitative and quantitative data are reported back to the ICU site study teams and frontline staff through monthly reports, case discussions, and a quarterly newsletter. PMID:15561794

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 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

Evaluation of liquefaction potential for building code

NASA Astrophysics Data System (ADS)

Nunziata, C.; De Nisco, G.; Panza, G. F.

2008-07-01

The standard approach for the evaluation of the liquefaction susceptibility is based on the estimation of a safety factor between the cyclic shear resistance to liquefaction and the earthquake induced shear stress. Recently, an updated procedure based on shear-wave velocities (Vs) has been proposed which could be more easily applied. These methods have been applied at La Plaja beach of Catania, that experienced liquefaction because of the 1693 earthquake. The detailed geotechnical and Vs information and the realistic ground motion computed for the 1693 event let us compare the two approaches. The successful application of the Vs procedure, slightly modified to fit historical and safety factor information, even if additional field performances are needed, encourages the development of a guide for liquefaction potential analysis, based on well defined Vs profiles to be included in the italian seismic code.

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.

Safety Evaluation of a Novel Strain of Bacteroides fragilis.

PubMed

Wang, Ye; Deng, Huimin; Li, Zhengchao; Tan, Yafang; Han, Yanping; Wang, Xiaoyi; Du, Zongmin; Liu, Yangyang; Yang, Ruifu; Bai, Yang; Bi, Yujing; Zhi, Fachao

2017-01-01

Commensal non-toxigenic Bacteroides fragilis confers powerful health benefits to the host, and has recently been identified as a promising probiotic candidate. We previously isolated B. fragilis strain ZY-312 and identified it as a novel strain based on 16S rRNA sequencing and morphological analyses. We also determined that ZY-312 displayed desirable probiotic properties, including tolerance to simulated digestive fluid, adherence, and in vitro safety. In this study, we aim to investigate whether ZY-312 meets the safety criteria required for probiotic bacteria through comprehensive and systematic evaluation. Consequently, the fatty acid profile, metabolite production, and biochemical activity of strain ZY-312 were found to closely resemble descriptions of B. fragilis in Bergey's manual. Taxonomic identification of strain ZY-312 based on whole genome sequencing indicated that ZY-312 and ATCC 25285 showed 99.99% similarity. The 33 putative virulence-associated factors identified in ZY-312 mainly encoded structural proteins and proteins with physiological activity, while the lack of bft indicated that ZY-312 was non-toxigenic. In vivo safety was proven in both normal and immune-deficient mice. The 11 identified antibiotic resistance genes were located on the chromosome rather than on a plasmid, ruling out the risk of plasmid-mediated transfer of antibiotic resistance. In vitro , ZY-312 showed resistance to cefepime, kanamycin, and streptomycin. Finally, and notably, ZY-312 exhibited high genetic stability after 100 passages in vitro . This study supplements the foundation work on the safety evaluation of ZY-312, and contributes to the development of the first probiotic representative from the dominant Bacteroidetes phylum.

Safety Evaluation of a Novel Strain of Bacteroides fragilis

PubMed Central

Deng, Huimin; Li, Zhengchao; Tan, Yafang; Han, Yanping; Wang, Xiaoyi; Du, Zongmin; Liu, Yangyang; Yang, Ruifu; Bai, Yang; Bi, Yujing; Zhi, Fachao

2017-01-01

Commensal non-toxigenic Bacteroides fragilis confers powerful health benefits to the host, and has recently been identified as a promising probiotic candidate. We previously isolated B. fragilis strain ZY-312 and identified it as a novel strain based on 16S rRNA sequencing and morphological analyses. We also determined that ZY-312 displayed desirable probiotic properties, including tolerance to simulated digestive fluid, adherence, and in vitro safety. In this study, we aim to investigate whether ZY-312 meets the safety criteria required for probiotic bacteria through comprehensive and systematic evaluation. Consequently, the fatty acid profile, metabolite production, and biochemical activity of strain ZY-312 were found to closely resemble descriptions of B. fragilis in Bergey’s manual. Taxonomic identification of strain ZY-312 based on whole genome sequencing indicated that ZY-312 and ATCC 25285 showed 99.99% similarity. The 33 putative virulence-associated factors identified in ZY-312 mainly encoded structural proteins and proteins with physiological activity, while the lack of bft indicated that ZY-312 was non-toxigenic. In vivo safety was proven in both normal and immune-deficient mice. The 11 identified antibiotic resistance genes were located on the chromosome rather than on a plasmid, ruling out the risk of plasmid-mediated transfer of antibiotic resistance. In vitro, ZY-312 showed resistance to cefepime, kanamycin, and streptomycin. Finally, and notably, ZY-312 exhibited high genetic stability after 100 passages in vitro. This study supplements the foundation work on the safety evaluation of ZY-312, and contributes to the development of the first probiotic representative from the dominant Bacteroidetes phylum. PMID:28367145

Protecting You/Protecting Me: Effects of an Alcohol Prevention and Vehicle Safety Program on Elementary Students

ERIC Educational Resources Information Center

Bell, Mary Lou; Kelley-Baker, Tara; Rider, Raamses; Ringwalt, Christopher

2005-01-01

This paper describes an evaluation of Protecting You/Protecting Me (PY/PM), a classroom-based, alcohol-use prevention and vehicle safety program for elementary students in first through fifth grades developed by Mothers Against Drunk Driving. PY/PM lessons and activities focus on teaching children about (1) their brains (why their brain is…

Inspection Score and Grading System for Food Services in Brazil: The Results of a Food Safety Strategy to Reduce the Risk of Foodborne Diseases during the 2014 FIFA World Cup.

PubMed

da Cunha, Diogo T; Saccol, Ana L de Freitas; Tondo, Eduardo C; de Oliveira, Ana B A; Ginani, Veronica C; Araújo, Carolina V; Lima, Thalita A S; de Castro, Angela K F; Stedefeldt, Elke

2016-01-01

In 2014, Brazil hosted one of the most popular sport competitions in the world, the FIFA World Cup. Concerned about the intense migration of tourists, the Brazilian government decided to deploy a food safety strategy based on inspection scores and a grading system applied to food services. The present study aimed to evaluate the results of the food safety strategy deployed during the 2014 FIFA World Cup in Brazil. To assess food safety, an evaluation instrument was applied twice in 1927 food service establishments from 26 cities before the start of the competition. This instrument generated a food safety score for each establishment that ranged from 0.0 (no flaws observed) to 2565.95, with four possible grades: A (0.0-13.2); B (13.3-502.6); C (502.7-1152.2); and pending (more than 1152.3). Each food service received a stamp with the grade of the second evaluation. After the end of the World Cup, a study was conducted with different groups of the public to evaluate the acceptance of the strategy. To this end, 221 consumers, 998 food service owners or managers, 150 health surveillance auditors, and 27 health surveillance coordinators were enrolled. These participants completed a survey with positive and negative responses about the inspection score system through a 5-point Likert scale. A reduction in violation scores from 393.1 to 224.4 (p < 0.001) was observed between the first and second evaluation cycles. Of the food services evaluated, 38.7% received the A stamp, 41.4% the B stamp, and 13.9% the C stamp. All positive responses on "system reliability" presented a mean of 4.0 or more, indicating that the public believed this strategy is reliable for communicating risks and promoting food safety. The strategy showed positive results regarding food safety and public acceptance. The deployed strategy promoted improvements in the food safety of food services. The implementation of a permanent policy may be well accepted by the public and may greatly contribute to a reduction in foodborne diseases (FBDs).

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.

Steps to Ensure a Successful Implementation of Occupational Health and Safety Interventions at an Organizational Level

PubMed Central

Herrera-Sánchez, Isabel M.; León-Pérez, José M.; León-Rubio, José M.

2017-01-01

There is increasing meta-analytic evidence that addresses the positive impact of evidence-based occupational health and safety interventions on employee health and well-being. However, such evidence is less clear when interventions are approached at an organizational level and are aimed at changing organizational policies and processes. Given that occupational health and safety interventions are usually tailored to specific organizational contexts, generalizing and transferring such interventions to other organizations is a complex endeavor. In response, several authors have argued that an evaluation of the implementation process is crucial for assessing the intervention’s effectiveness and for understanding how and why the intervention has been (un)successful. Thus, this paper focuses on the implementation process and attempts to move this field forward by identifying the main factors that contribute toward ensuring a greater success of occupational health and safety interventions conducted at the organizational level. In doing so, we propose some steps that can guide a successful implementation. These implementation steps are illustrated using examples of evidence-based best practices reported in the literature that have described and systematically evaluated the implementation process behind their interventions during the last decade. PMID:29375413

Organs-on-a-chip: Current applications and consideration points for in vitro ADME-Tox studies.

PubMed

Ishida, Seiichi

2018-02-01

Assay systems using in vitro cultured cells are increasingly applied for evaluation of the efficacy, safety, and toxicity of drug candidates. In vitro cell-based assays have two main applications in the drug discovery process: searching for a compound that is effective against the target disease (seed investigation) and confirmation of safety during use of the identified compounds (safety assessment). Currently available in vitro cell-based assays have been designed to evaluate the efficacy and toxicity in single organs, but the in vivo pharmacokinetics and pharmacodynamics of the administered drug candidates have not been considered. Thus, an evaluation system that interconnects cell culture units, one of which has appropriate drug metabolism activities and the other assesses the efficacy and toxicity of compounds, is needed. Accordingly, the in vitro ADME-Tox culture system known as organs-on-a-chip has been proposed. In this review, after introducing the organs-on-a-chip system, the evaluation of enterohepatic circulation and the gut-liver axis relationship will be presented as an example of the application of the organs-on-a-chip system for ADME studies based on inter-organ network. Additionally, the functions required for the organs-on-a-chip system and the necessity of standardization of cells mounted on the chip system will be discussed. Copyright © 2018 The Japanese Society for the Study of Xenobiotics. Published by Elsevier Ltd. All rights reserved.

[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.

Determining Safety Inspection Thresholds for Employee Incentives Programs on Construction Sites

PubMed Central

Sparer, Emily; Dennerlein, Jack

2017-01-01

The goal of this project was to evaluate approaches of determining the numerical value of a safety inspection score that would activate a reward in an employee safety incentive program. Safety inspections are a reflection of the physical working conditions at a construction site and provide a safety score that can be used in incentive programs to reward workers. Yet it is unclear what level of safety should be used when implementing this kind of program. This study explored five ways of grouping safety inspection data collected during 19 months at Harvard University-owned construction projects. Each approach grouped the data by one of the following: owner, general contractor, project, trade, or subcontractor. The median value for each grouping provided the threshold score. These five approaches were then applied to data from a completed project in order to calculate the frequency and distribution of rewards in a monthly safety incentive program. The application of each approach was evaluated qualitatively for consistency, competitiveness, attainability, and fairness. The owner-specific approach resulted in a threshold score of 96.3% and met all of the qualitative evaluation goals. It had the most competitive reward distribution (only 1/3 of the project duration) yet it was also attainable. By treating all workers equally and maintaining the same value throughout the project duration, this approach was fair and consistent. The owner-based approach for threshold determination can be used by owners or general contractors when creating leading indicator incentives programs and by researchers in future studies on incentive program effectiveness. PMID:28638178

Monitoring road safety development at regional level: A case study in the ASEAN region.

PubMed

Chen, Faan; Wang, Jianjun; Wu, Jiaorong; Chen, Xiaohong; Zegras, P Christopher

2017-09-01

Persistent monitoring of progress, evaluating the results of interventions and recalibrating to achieve continuous improvement over time is widely recognized as being crucial towards the successful development of road safety. In the ASEAN (Association of Southeast Asian Nations) region there is a lack of well-resourced teams that contain multidisciplinary safety professionals, and specialists in individual countries, who are able to carry out this work effectively. In this context, not only must the monitoring framework be effective, it must also be easy to use and adapt. This paper provides a case study that can be easily reproduced; based on an updated and refined Road Safety Development Index (RSDI), by means of the RSR (Rank-sum ratio)-based model, for monitoring/reporting road safety development at regional level. The case study was focused on the road safety achievements in eleven Southeast Asian countries; identifying the areas of poor performance, potential problems and delays. These countries are finally grouped into several classes based on an overview of their progress and achievements regarding to road safety. The results allow the policymakers to better understand their own road safety progress toward their desired impact; more importantly, these results enable necessary interventions to be made in a quick and timely manner. Keeping action plans on schedule if things are not progressing as desired. This would avoid 'reinventing the wheel' and trial and error approaches to road safety, making the implementation of action plans more effective. Copyright © 2017 Elsevier Ltd. All rights reserved.

A trigger-based design for evaluating the safety of in utero antiretroviral exposure in uninfected children of human immunodeficiency virus-infected mothers.

PubMed

Williams, Paige L; Seage, George R; Van Dyke, Russell B; Siberry, George K; Griner, Raymond; Tassiopoulos, Katherine; Yildirim, Cenk; Read, Jennifer S; Huo, Yanling; Hazra, Rohan; Jacobson, Denise L; Mofenson, Lynne M; Rich, Kenneth

2012-05-01

The Pediatric HIV/AIDS Cohort Study's Surveillance Monitoring of ART Toxicities Study is a prospective cohort study conducted at 22 US sites between 2007 and 2011 that was designed to evaluate the safety of in utero antiretroviral drug exposure in children not infected with human immunodeficiency virus who were born to mothers who were infected. This ongoing study uses a "trigger-based" design; that is, initial assessments are conducted on all children, and only those meeting certain thresholds or "triggers" undergo more intensive evaluations to determine whether they have had an adverse event (AE). The authors present the estimated rates of AEs for each domain of interest in the Surveillance Monitoring of ART Toxicities Study. They also evaluated the efficiency of this trigger-based design for estimating AE rates and for testing associations between in utero exposures to antiretroviral drugs and AEs. The authors demonstrate that estimated AE rates from the trigger-based design are unbiased after correction for the sensitivity of the trigger for identifying AEs. Even without correcting for bias based on trigger sensitivity, the trigger approach is generally more efficient for estimating AE rates than is evaluating a random sample of the same size. Minor losses in efficiency when comparing AE rates between persons exposed and unexposed in utero to particular antiretroviral drugs or drug classes were observed under most scenarios.

Consensus categorization of cheese based on water activity and pH-A rational approach to systemizing cheese diversity.

PubMed

Trmčić, A; Ralyea, R; Meunier-Goddik, L; Donnelly, C; Glass, K; D'Amico, D; Meredith, E; Kehler, M; Tranchina, N; McCue, C; Wiedmann, M

2017-01-01

Development of science-based interventions in raw milk cheese production is challenging due to the large diversity of production procedures and final products. Without an agreed upon categorization scheme, science-based food safety evaluations and validation of preventive controls would have to be completed separately on each individual cheese product, which is not feasible considering the large diversity of products and the typically small scale of production. Thus, a need exists to systematically group raw milk cheeses into logically agreed upon categories to be used for food safety evaluations. This paper proposes and outlines one such categorization scheme that provides for 30 general categories of cheese. As a base for this systematization and categorization of raw milk cheese, we used Table B of the US Food and Drug Administration's 2013 Food Code, which represents the interaction of pH and water activity for control of vegetative cells and spores in non-heat-treated food. Building on this table, we defined a set of more granular pH and water activity categories to better represent the pH and water activity range of different raw milk cheeses. The resulting categorization scheme was effectively validated using pH and water activity values determined for 273 different cheese samples collected in the marketplace throughout New York State, indicating the distribution of commercially available cheeses among the categories proposed here. This consensus categorization of cheese provides a foundation for a feasible approach to developing science-based solutions to assure compliance of the cheese processors with food safety regulations, such as those required by the US Food Safety Modernization Act. The key purpose of the cheese categorization proposed here is to facilitate product assessment for food safety risks and provide scientifically validated guidance on effective interventions for general cheese categories. Once preventive controls for a given category have been defined, these categories would represent safe havens for cheesemakers, which would allow cheesemakers to safely and legally produce raw milk cheeses that meet appropriate science-based safety requirements (e.g., risk to human health equivalent to pasteurized milk cheeses). Copyright © 2017 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

The development and psychometric evaluation of a safety climate measure for primary care.

PubMed

de Wet, C; Spence, W; Mash, R; Johnson, P; Bowie, P

2010-12-01

Building a safety culture is an important part of improving patient care. Measuring perceptions of safety climate among healthcare teams and organisations is a key element of this process. Existing measurement instruments are largely developed for secondary care settings in North America and many lack adequate psychometric testing. Our aim was to develop and test an instrument to measure perceptions of safety climate among primary care teams in National Health Service for Scotland. Questionnaire development was facilitated through a steering group, literature review, semistructured interviews with primary care team members, a modified Delphi and completion of a content validity index by experts. A cross-sectional postal survey utilising the questionnaire was undertaken in a random sample of west of Scotland general practices to facilitate psychometric evaluation. Statistical methods, including exploratory and confirmatory factor analysis, and Cronbach and Raykov reliability coefficients were conducted. Of the 667 primary care team members based in 49 general practices surveyed, 563 returned completed questionnaires (84.4%). Psychometric evaluation resulted in the development of a 30-item questionnaire with five safety climate factors: leadership, teamwork, communication, workload and safety systems. Retained items have strong factor loadings to only one factor. Reliability coefficients was satisfactory (α = 0.94 and ρ = 0.93). This study is the first stage in the development of an appropriately valid and reliable safety climate measure for primary care. Measuring safety climate perceptions has the potential to help primary care organisations and teams focus attention on safety-related issues and target improvement through educational interventions. Further research is required to explore acceptability and feasibility issues for primary care teams and the potential for organisational benchmarking.

Applying health education theory to patient safety programs: three case studies.

PubMed

Gilkey, Melissa B; Earp, Jo Anne L; French, Elizabeth A

2008-04-01

Program planning for patient safety is challenging because intervention-oriented surveillance data are not yet widely available to those working in this nascent field. Even so, health educators are uniquely positioned to contribute to patient safety intervention efforts because their theoretical training provides them with a guide for designing and implementing prevention programs. This article demonstrates the utility of applying health education concepts from three prominent patient safety campaigns, including the concepts of risk perception, community participation, and social marketing. The application of these theoretical concepts to patient safety programs suggests that health educators possess a knowledge base and skill set highly relevant to patient safety and that their perspective should be increasingly brought to bear on the design and evaluation of interventions that aim to protect patients from preventable medical error.

Integrated vehicle-based safety systems : heavy-truck field operational test independent evaluation.

DOT National Transportation Integrated Search

2011-05-01

This report presents results from the independent evaluation of a field operational test using a fleet of heavy trucks outfitted with a prototype integrated crash warning system. This effort was conducted as part of the U.S. DOT?s Integrated Vehicle-...

Test and evaluation of vehicle platooning proof-of-concept based on cooperative adaptive cruise control

DOT National Transportation Integrated Search

2017-04-01

This report presents a high-level test and evaluation framework for cooperative driving automation systems that have the potential to significantly improve mobility and enhance traffic flow stability with better safety. It focuses on the test and eva...

Evaluation of Adaptive Signal Control Technology—Volume 2 : Comparison of Base Condition to the First Year After Implementation

DOT National Transportation Integrated Search

2018-05-01

Field evaluation of adaptive signal control technologies (ASCT) is very important in understanding the systems contribution to safety and operational efficiency. Data were collected at six intersections along the Neil Street corridor in Champaign,...

Safety Assessment of Multi Purpose Small Payload Rack(MSPR)

NASA Astrophysics Data System (ADS)

Mizutani, Yoshinobu; Takada, Satomi; Murata, Kosei; Ozawa, Daisaku; Kobayashi, Ryoji; Nakamura, Yasuhiro

2010-09-01

We are reporting summary of preliminary safety assessment for Multi Purpose Small Payload Rack(MSPR), which is one of the micro gravity experiment facilities that are being developed for the 2nd phase JEM utilization(JEM: Japanese Experiment Module) that will be launched on H-II Transfer Vehicle(HTV) 2nd flight in 2011. MSPR is used for multi-purpose micro-g experiment providing experimental spaces and work stations. MSPR has three experimental spaces; first, there is a space called Work Volume(WV) with capacity volume of approximately 350 litters, in which multiple resources including electricity, communication, and moving image functions can be used. Within this space, installation of devices can be done by simple, prompt attachment by Velcro and pins with high degree of flexibility. Second, there is Small Experiment Area(SEA), with capacity volume of approximately 70 litters, in which electricity, communication, and moving image functions can also be used in the same way as WV. These spaces protect experiment devices and specimens from contingent loads by the crewmembers. Third, there is Work Bench with area of 0.5 square meters, on which can be used for maintenance, inspection and data operations of installed devices, etc. This bench can be stored in the rack during contingency. Chamber for Combustion Experiment(CCE) that is planned to be installed in WV is a pressure-resistant experimental container that can be used to seal hazardous materials from combustion experiments. This CCE has double sealing design in chamber itself, which resist gas leakage under normal the temperature and pressure. Electricity, communication, moving image function can be used in the same way as WV. JAXA Phase 2 Safety Review Panel(SRP) has been held in April, 2010. For safety analysis of MSPR, hazards were identified based on Fault Tree Analysis methodology and then these hazards were classified into either eight ISS standard-type hazards or eight unique-type hazards that requires special controls based on ISS common safety assessment methodology. Safety evaluation results are reported in the Safety Assessment Report(SAR) 1). Regarding structural failure, unique hazards are especially evaluated considering not only the tolerance for launch load but also load by crewmembers or orbital loads. Regarding electrical shock, electricity design up to secondary power is evaluated in unique hazard from a view point of Electrical design suitable for high voltage(32VDC or more) circuit. Regarding rupture/leakage of pressure system, hazards of fuel supply line, waste line for combustion gas, and pressure system including CCE are evaluated. Also evaluation for contamination due to hazardous gas leakage from CCE is conducted. External propagation of fire from CCE is also evaluated. In this report, we will show the overview of the result of safety assessment and future plan toward critical design phase activity.

Reliability-based evaluation of bridge components for consistent safety margins.

DOT National Transportation Integrated Search

2010-10-01

The Load and Resistant Factor Design (LRFD) approach is based on the concept of structural reliability. The approach is more : rational than the former design approaches such as Load Factor Design or Allowable Stress Design. The LRFD Specification fo...

Volunteer driven home safety intervention results in significant reduction in pediatric injuries: A model for community based injury reduction.

PubMed

Falcone, Richard A; Edmunds, Patrick; Lee, Emily; Gardner, Dawne; Price, Kimberly; Gittelman, Michael; Pomerantz, Wendy; Besl, John; Madhavan, Gowri; Phelan, Kieran J

2016-07-01

Home based injuries account for a significant number of injuries to children between 1 and 5years old. Evidence-based safety interventions delivered in the home with installation of safety equipment have been demonstrated to reduce injury rates. The aim of this study was to evaluate the impact of a community based volunteer implemented home safety intervention. In partnership with a community with high injury rates for children between 1 and 5years old, a home safety bundle was developed and implemented by volunteers. The safety bundle included installing evidence based safety equipment. Monthly community emergency room attended injury rates as well as emergency room attended injuries occurring in intervention and nonintervention homes was tracked throughout the study. Between May 2012 and May 2014 a total of 207 homes with children 1-5years old received the home safety bundle. The baseline monthly emergency room attended injury rate for children aged 1-5years within our target community was 11.3/1000 and that within our county was 8.7/1000. Following the intervention current rates are now 10.3/1000 and 9.2/1000 respectively. Within intervention homes the injury rate decreased to 4.2/1000 while the rate in the homes not receiving the intervention experienced an increase in injury rate to 12/1000 (p<0.05). When observed vs. expected injuries were examined the intervention group demonstrated 59% fewer injuries while the nonintervention group demonstrated a 6% increase (p<0.05). Children in homes that received a volunteer-provided, free home safety bundle experienced 59% fewer injuries than would have been expected. By partnering with community leaders and organizing volunteers, proven home safety interventions were successfully provided to 207 homes during a two-year period, and a decline in community injury rates for children younger than 5years was observed compared to county wide injury rates. Copyright © 2016 Elsevier Inc. All rights reserved.

Evaluation of Portable Multi-Gas Analyzers for use by Safety Personnel

NASA Technical Reports Server (NTRS)

Lueck, D. E.; Meneghelli, B. J.; Bardel, D. N.

1998-01-01

During confined space entry operations as well as Shuttle-safing operations, United Space Alliance (USA)/National Aeronautics and Space Administration (NASA) safety personnel use a variety of portable instrumentation to monitor for hazardous levels of compounds such as nitrogen dioxide (N%), monomethylhydrazine (NMM), FREON 21, ammonia (NH3), oxygen (O2), and combustibles (as hydrogen (H2)). Except for O2 and H2, each compound is monitored using a single analyzer. In many cases these analyzers are 5 to 10 years old and require frequent maintenance. In addition, they are cumbersome to carry and tend to make the job of personnel monitoring physically taxing. As part of an effort to upgrade the sensor technology background information was requested from a total of 27 manufacturers of portable multi-gas instruments. A set of criteria was established to determine which vendors would be selected for laboratory evaluation. These criteria were based on requests made by USA/NASA Safety personnel in order to meet requirements within their respective areas for confined-space and Shuttle-safing operations. Each of the 27 manufacturers of multi-gas analyzers was sent a copy of the criteria and asked to fill in the appropriate information pertaining to their instrumentation. Based on the results of the sensor criteria worksheets, a total of 9 vendors out of 27 surveyed manufacturers were chosen for evaluation. Each vendor included in the final evaluation process was requested to configure each of two analyzers with NO2, NH3, O2, and combustible sensors. A set of lab tests was designed in order to determine which of the multi-gas instruments under evaluation was best suited for use in both shuttle and confined space operations. These tests included linearity/repeatability, zero/span drift response/recovery, humidity, interference, and maintenance. At the conclusion of lab testing three vendors were selected for additional field testing. Based on the results of both the lab and field evaluations a single vendor was recommended for use by NASA/IJSA Safety personnel. Vendor selection criteria, as well as the results from both laboratory and field testing of the multi-gas analyzers, are presented as part of this paper.

Manned space flight nuclear system safety. Volume 1: base nuclear system safety

NASA Technical Reports Server (NTRS)

1972-01-01

The mission and terrestrial nuclear safety aspects of future long duration manned space missions in low earth orbit are discussed. Nuclear hazards of a typical low earth orbit Space Base mission (from natural sources and on-board nuclear hardware) have been identified and evaluated. Some of the principal nuclear safety design and procedural considerations involved in launch, orbital, and end of mission operations are presented. Areas of investigation include radiation interactions with the crew, subsystems, facilities, experiments, film, interfacing vehicles, nuclear hardware and the terrestrial populace. Results of the analysis indicate: (1) the natural space environment can be the dominant radiation source in a low earth orbit where reactors are effectively shielded, (2) with implementation of safety guidelines the reactor can present a low risk to the crew, support personnel, the terrestrial populace, flight hardware and the mission, (3) ten year missions are feasible without exceeding integrated radiation limits assigned to flight hardware, and (4) crew stay-times up to one year are feasible without storm shelter provisions.

3S (Safeguards, Security, Safety) based pyroprocessing facility safety evaluation plan

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

Ku, J.H.; Choung, W.M.; You, G.S.

The big advantage of pyroprocessing for the management of spent fuels against the conventional reprocessing technologies lies in its proliferation resistance since the pure plutonium cannot be separated from the spent fuel. The extracted materials can be directly used as metal fuel in a fast reactor, and pyroprocessing reduces drastically the volume and heat load of the spent fuel. KAERI has implemented the SBD (Safeguards-By-Design) concept in nuclear fuel cycle facilities. The goal of SBD is to integrate international safeguards into the entire facility design process since the very beginning of the design phase. This paper presents a safety evaluationmore » plan using a conceptual design of a reference pyroprocessing facility, in which 3S (Safeguards, Security, Safety)-By-Design (3SBD) concept is integrated from early conceptual design phase. The purpose of this paper is to establish an advanced pyroprocessing hot cell facility design concept based on 3SBD for the successful realization of pyroprocessing technology with enhanced safety and proliferation resistance.« less

Safety from Crime and Physical Activity among Older Adults: A Population-Based Study in Brazil

PubMed Central

Weber Corseuil, Maruí; Hallal, Pedro Curi; Xavier Corseuil, Herton; Jayce Ceola Schneider, Ione; d'Orsi, Eleonora

2012-01-01

Objective. To evaluate the association between safety from crime and physical activity among older adults. Methods. A population-based survey including 1,656 older adults (60+ years) took place in Florianopolis, Brazil, in 2009-2010. Commuting and leisure time physical activity were assessed through the long version of the International Physical Activity Questionnaire. Perception of safety from crime was assessed using the Neighbourhood Environment Walkability Scale. Results. Perceiving the neighbourhood as safe during the day was related to a 25% increased likelihood of being active in leisure time (95% CI 1.02–1.53); general perception of safety was also associated with a 25% increase in the likelihood of being active in leisure time (95% CI 1.01–1.54). Street lighting was related to higher levels of commuting physical activity (prevalence ratio: 1.89; 95% CI 1.28–2.80). Conclusions. Safety investments are essential for promoting physical activity among older adults in Brazil. PMID:22291723

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.

Evaluation and Countermeasures on sustainable development of nickel resources in China

NASA Astrophysics Data System (ADS)

Lin, Zhifeng

2017-08-01

Nickel is an important strategic resource in China. With the gradual reduction of nickel re-sources and the increasing competition of the global mineral resources market, the safety of nickel resources in China has been seriously threatened. Therefore, it is very important to evaluate the sustainable develop-ment of nickel resources in China and put forward the corresponding countermeasures. In this paper, the concept and research situation of sustainable development are analyzed. Based on the specific development of nickel resources in China, this paper uses AHP to evaluate the safety of nickel resources in china. Finally, it puts forward the concrete measures to implement the sustainable development strategy of nickel resources in China.

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.

Causal Relationship Analysis of the Patient Safety Culture Based on Safety Attitudes Questionnaire in Taiwan.

PubMed

Lee, Yii-Ching; Zeng, Pei-Shan; Huang, Chih-Hsuan; Wu, Hsin-Hung

2018-01-01

This study uses the decision-making trial and evaluation laboratory method to identify critical dimensions of the safety attitudes questionnaire in Taiwan in order to improve the patient safety culture from experts' viewpoints. Teamwork climate, stress recognition, and perceptions of management are three causal dimensions, while safety climate, job satisfaction, and working conditions are receiving dimensions. In practice, improvements on effect-based dimensions might receive little effects when a great amount of efforts have been invested. In contrast, improving a causal dimension not only improves itself but also results in better performance of other dimension(s) directly affected by this particular dimension. Teamwork climate and perceptions of management are found to be the most critical dimensions because they are both causal dimensions and have significant influences on four dimensions apiece. It is worth to note that job satisfaction is the only dimension affected by the other dimensions. In order to effectively enhance the patient safety culture for healthcare organizations, teamwork climate, and perceptions of management should be closely monitored.

Causal Relationship Analysis of the Patient Safety Culture Based on Safety Attitudes Questionnaire in Taiwan

PubMed Central

Zeng, Pei-Shan; Huang, Chih-Hsuan

2018-01-01

This study uses the decision-making trial and evaluation laboratory method to identify critical dimensions of the safety attitudes questionnaire in Taiwan in order to improve the patient safety culture from experts' viewpoints. Teamwork climate, stress recognition, and perceptions of management are three causal dimensions, while safety climate, job satisfaction, and working conditions are receiving dimensions. In practice, improvements on effect-based dimensions might receive little effects when a great amount of efforts have been invested. In contrast, improving a causal dimension not only improves itself but also results in better performance of other dimension(s) directly affected by this particular dimension. Teamwork climate and perceptions of management are found to be the most critical dimensions because they are both causal dimensions and have significant influences on four dimensions apiece. It is worth to note that job satisfaction is the only dimension affected by the other dimensions. In order to effectively enhance the patient safety culture for healthcare organizations, teamwork climate, and perceptions of management should be closely monitored. PMID:29686825

Flammable gas technical basis document

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

CARRO, C.A.

2003-03-22

This document qualitatively evaluates the frequency and consequences of DST and SST representative flammable gas accidents and associated represented hazardous conditions without controls. Based on the evaluation, it was determined that safety-significant SSCs and/or TSRs were required to prevent or mitigate flammable gas accidents. Controls were selected and the accidents re-evaluated taking credit for the controls.

Use of Pictorial Evaluations to Measure Knowledge Gained by Hispanic Landscape Workers Receiving Safety Training

ERIC Educational Resources Information Center

Bauske, Ellen M.; Fuhrman, Nicholas E.; Martinez-Espinoza, Alfredo D.; Orellana, Rolando

2013-01-01

Landscape work is dangerous. In the Southeast, Hispanic workers predominate in landscape industries. The incidence of functional illiteracy in this group of workers is high. A pictorial knowledge-based evaluation instrument was developed to measure the effectiveness of the trainings. No reading skills were required to take the evaluation. The…

ARAMIS project: a more explicit demonstration of risk control through the use of bow-tie diagrams and the evaluation of safety barrier performance.

PubMed

de Dianous, Valérie; Fiévez, Cécile

2006-03-31

Over the last two decades a growing interest for risk analysis has been noted in the industries. The ARAMIS project has defined a methodology for risk assessment. This methodology has been built to help the industrialist to demonstrate that they have a sufficient risk control on their site. Risk analysis consists first in the identification of all the major accidents, assuming that safety functions in place are inefficient. This step of identification of the major accidents uses bow-tie diagrams. Secondly, the safety barriers really implemented on the site are taken into account. The barriers are identified on the bow-ties. An evaluation of their performance (response time, efficiency, and level of confidence) is performed to validate that they are relevant for the expected safety function. At last, the evaluation of their probability of failure enables to assess the frequency of occurrence of the accident. The demonstration of the risk control based on a couple gravity/frequency of occurrence is also possible for all the accident scenarios. During the risk analysis, a practical tool called risk graph is used to assess if the number and the reliability of the safety functions for a given cause are sufficient to reach a good risk control.

Accident analysis and control options in support of the sludge water system safety analysis

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

HEY, B.E.

A hazards analysis was initiated for the SWS in July 2001 (SNF-8626, K Basin Sludge and Water System Preliminary Hazard Analysis) and updated in December 2001 (SNF-10020 Rev. 0, Hazard Evaluation for KE Sludge and Water System - Project A16) based on conceptual design information for the Sludge Retrieval System (SRS) and 60% design information for the cask and container. SNF-10020 was again revised in September 2002 to incorporate new hazards identified from final design information and from a What-if/Checklist evaluation of operational steps. The process hazards, controls, and qualitative consequence and frequency estimates taken from these efforts have beenmore » incorporated into Revision 5 of HNF-3960, K Basins Hazards Analysis. The hazards identification process documented in the above referenced reports utilized standard industrial safety techniques (AIChE 1992, Guidelines for Hazard Evaluation Procedures) to systematically guide several interdisciplinary teams through the system using a pre-established set of process parameters (e.g., flow, temperature, pressure) and guide words (e.g., high, low, more, less). The teams generally included representation from the U.S. Department of Energy (DOE), K Basins Nuclear Safety, T Plant Nuclear Safety, K Basin Industrial Safety, fire protection, project engineering, operations, and facility engineering.« less

Effects of a team-based assessment and intervention on patient safety culture in general practice: an open randomised controlled trial.

PubMed

Hoffmann, B; Müller, V; Rochon, J; Gondan, M; Müller, B; Albay, Z; Weppler, K; Leifermann, M; Mießner, C; Güthlin, C; Parker, D; Hofinger, G; Gerlach, F M

2014-01-01

The measurement of safety culture in healthcare is generally regarded as a first step towards improvement. Based on a self-assessment of safety culture, the Frankfurt Patient Safety Matrix (FraTrix) aims to enable healthcare teams to improve safety culture in their organisations. In this study we assessed the effects of FraTrix on safety culture in general practice. We conducted an open randomised controlled trial in 60 general practices. FraTrix was applied over a period of 9 months during three facilitated team sessions in intervention practices. At baseline and after 12 months, scores were allocated for safety culture as expressed in practice structure and processes (indicators), in safety climate and in patient safety incident reporting. The primary outcome was the indicator error management. During the team sessions, practice teams reflected on their safety culture and decided on about 10 actions per practice to improve it. After 12 months, no significant differences were found between intervention and control groups in terms of error management (competing probability=0.48, 95% CI 0.34 to 0.63, p=0.823), 11 further patient safety culture indicators and safety climate scales. Intervention practices showed better reporting of patient safety incidents, reflected in a higher number of incident reports (mean (SD) 4.85 (4.94) vs 3.10 (5.42), p=0.045) and incident reports of higher quality (scoring 2.27 (1.93) vs 1.49 (1.67), p=0.038) than control practices. Applied as a team-based instrument to assess safety culture, FraTrix did not lead to measurable improvements in error management. Comparable studies with more positive results had less robust study designs. In future research, validated combined methods to measure safety culture will be required. In addition, more attention should be paid to evaluation of process parameters. Implemented actions and incident reporting may be more appropriate target endpoints. German Clinical Trials Register (Deutsches Register Klinischer Studien, DRKS) No. DRKS00000145.

Evaluation of Brazed Joints Using Failure Assessment Diagram

NASA Technical Reports Server (NTRS)

Flom, Yury

2012-01-01

Fitness-for service approach was used to perform structural analysis of the brazed joints consisting of several base metal / filler metal combinations. Failure Assessment Diagrams (FADs) based on tensile and shear stress ratios were constructed and experimentally validated. It was shown that such FADs can provide a conservative estimate of safe combinations of stresses in the brazed joints. Based on this approach, Margins of Safety (MS) of the brazed joints subjected to multi-axial loading conditions can be evaluated..

Contributions and challenges for worldwide vaccine safety: The Global Advisory Committee on Vaccine Safety at 15 years.

PubMed

Asturias, Edwin J; Wharton, Melinda; Pless, Robert; MacDonald, Noni E; Chen, Robert T; Andrews, Nicholas; Salisbury, David; Dodoo, Alexander N; Hartigan-Go, Kenneth; Zuber, Patrick L F

2016-06-17

In 1999, the Global Advisory Committee on Vaccine Safety (GACVS) was established by the World Health Organization (WHO) to provide independent scientific advice on issues relating to the safety of vaccines and immunization. Fifteen years onward, we conducted a multi-faceted review to evaluate the impact, reach and challenges facing GACVS, including the role GACVS plays in informing global, regional and WHO member state vaccine policy. The methods included measures of organizational structure, citation impact, themes approached, and a discussion by previous and current members to evaluate past, present and future challenges. Given the increasing range of data sources and the deployment of many new vaccines, the Committee is facing the complex task of identifying the best available evidence for recommendations on vaccine safety. To help meet the increased demand for public transparency in decision making, GACVS-structured methodology for evidence-based decisions is evolving. GACVS also promotes best practices and capacity building for timely and accurate risk assessment; risk communications; outreach to help countries maintain and, if needed, rebuild public trust in vaccines; and advocacy for bridging the major gaps in vaccine safety capacity globally. Copyright © 2016 Elsevier Ltd. All rights reserved.

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…

An Evaluation of the Added Value of Co-Design in the Development of an Educational Game for Road Safety

ERIC Educational Resources Information Center

All, Anissa; Van Looy, Jan; Castellar, Elena Patricia Nuñez

2013-01-01

This study explores the added value of co-design in addition to other innovation research methods in the process of developing a serious game design document for a road safety game. The sessions aimed at exploring 4 aspects of a location-based game experience: themes, game mechanics, mobile phone applications and locations for mini-games. In…

[Evidence-based Chinese medicine：theory and practice].

PubMed

Zhang, Jun-Hua; Li, You-Ping; Zhang, Bo-Li

2018-01-01

The introduction and popularization of evidence-based medicine has opened up a new research field of clinical efficacy evaluation of traditional Chinese medicine(TCM), produced new research ideas and methods, and promoted the progress of clinical research of TCM. After about 20 years assiduous study and earnest practice, the evidence based evaluation method and technique, which conforms to the characteristics of TCM theory and practice, has been developing continuously. Evidence-based Chinese medicine (EBCM) has gradually formed and become an important branch of evidence-based medicine. The basic concept of evidence-based Chinese medicine: EBCM is an applied discipline, following the theory and methodology of evidence-based medicine, to collect, evaluate, produce, transform the evidence of effectiveness, safety and economy of TCM, to reveal the feature and regular pattern of TCM taking effect, and to guide the development of clinical guidelines, clinical pathways and health decisions. The effects and achievements of EBCM development: secondary studies mainly based on systematic review/Meta-analysis were extensively carried out; clinical efficacy studies mainly relying on randomized controlled trials grew rapidly; clinical safety evaluations based on real world study have been conducted; methodological researches mainly focused on study quality control deepened gradually; internationalization researches mainly on report specifications have got some breakthroughs; standardization researches based on treatment specification were strengthened gradually; the research team and talents with the characteristics of inter-disciplinary have been steadily increased. A number of high-quality research findings have been published at international well-known journals; the clinical efficacy and safety evidence of TCM has been increased; the level of clinical rational use of TCM has been improved; a large number of Chinese patent medicines with big market have been cultured. The future missions of EBCM mainly consist of four categories (scientific research, methodology and standard, platform construction and personnel training) with nine tasks. ①Carry out systematic reviews to systematically collect clinical trial reports of TCM and establish database of clinical evidence of TCM; ②Carry out evidence transformation research to lay the foundation for the development of clinical diagnosis and treatment guidelines, clinical pathways of TCM, and for the screening of basic drug list and medical insurance list, and for the policy-making relevant to TCM; ③Conduct researches to evaluate the advantages and effective regular patterns of TCM and form the evidence chain of TCM efficacy; ④Carry out researches for the safety evaluation of TCM, and provide evidence supporting the rational and safe use of TCM in clinical practice; ⑤Conduct researches on methodology of EBCM and provide method for developing high quality evidence; ⑥Carry out researches to develop standards and norms of TCM, and to form methods, standards, specifications and technical systems; ⑦Establish data management platform for evidence-based evaluation of TCM, and promote data sharing; ⑧Build international academic exchange platform to promote international cooperation and mutual recognition of EBCM research; ⑨Carry out education and popularization activities of evidence-based evaluation methods, and train undergraduate students, graduate students, clinical healthcare providers and practitioners of TCM. The development of EBCM, as it was, not only promoted the transformation of clinical research and decision-making mode of TCM, contributed to the modernization and internationalization of TCM, but also enriched the connotation of Evidence-based Medicine. Copyright© by the Chinese Pharmaceutical Association.

Intentions and knowledge shaping local safety policy: A comparison of two Swedish cities.

PubMed

Hanberger, Anders; Lundström, Ulf; Mårald, Gunilla

2015-12-01

This article explores how intentions and knowledge shape two Swedish cities' local safety policy (LSP). The applied framework is derived from the integration of governance and implementation research and the theory of knowledge and its use. The study shows that LSPs are shaped by a mix of intentions and different kinds of knowledge, and intentions and knowledge interplay and intertwine in many ways. Key-persons construct LSPs when they work out solutions to urgent safety problems and take departure in the local context, its pre-conditions, and their experience-based and professional knowledge. The state governs LSP softly through management by objectives in the background, but more often key-actor intentions and commitments, local safety problems, and events initiated and influenced LSPs. The article contributes to a better understanding of conditions for LSPs in multi-level governance. The article can be used to improve governance, identify implementation problems and knowledge needs that will improve LSPs and the overall safety situation in the community. The study has implications for how LSPs should be evaluated; many different evaluation criteria can be appropriate, such as relevance, legitimacy, achievement of key actors' objectives, sustainability of policy solutions, and creation of a local safety culture. Copyright © 2015 Elsevier Ltd and National Safety Council. All rights reserved.

Integrated risk assessment and screening analysis of drinking water safety of a conventional water supply system.

PubMed

Sun, F; Chen, J; Tong, Q; Zeng, S

2007-01-01

Management of drinking water safety is changing towards an integrated risk assessment and risk management approach that includes all processes in a water supply system from catchment to consumers. However, given the large number of water supply systems in China and the cost of implementing such a risk assessment procedure, there is a necessity to first conduct a strategic screening analysis at a national level. An integrated methodology of risk assessment and screening analysis is thus proposed to evaluate drinking water safety of a conventional water supply system. The violation probability, indicating drinking water safety, is estimated at different locations of a water supply system in terms of permanganate index, ammonia nitrogen, turbidity, residual chlorine and trihalomethanes. Critical parameters with respect to drinking water safety are then identified, based on which an index system is developed to prioritize conventional water supply systems in implementing a detailed risk assessment procedure. The evaluation results are represented as graphic check matrices for the concerned hazards in drinking water, from which the vulnerability of a conventional water supply system is characterized.

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.

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".

[Preliminary safety and stability assessment of orthodontic miniscrew implantation guided by surgical template based on cone-beam CT images].

PubMed

Qiu, L L; Li, S; Bai, Y X

2016-06-01

To develop surgical templates for orthodontic miniscrew implantation based on cone-beam CT(CBCT)three-dimensional(3D)images and to evaluate the safety and stability of implantation guided by the templates. DICOM data obtained in patients who had CBCT scans taken were processed using Mimics software, and 3D images of teeth and maxillary bone were acquired. Meanwhile, 3D images of miniscrews were acquired using Solidworks software and processed with Mimics software. Virtual position of miniscrews was determined based on 3D images of teeth, bone, and miniscrews. 3D virtual templates were designed according to the virtual implantation plans. STL files were output and the real templates were fabricated with stereolithographic appliance(SLA). Postoperative CBCT scans were used to evaluate the implantation safety and the stability of miniscrews were investigated. All the templates were positioned accurately and kept stable throughout the implantation process. No root damage was found. The deviations were(1.73±0.65)mm at the corona, and(1.28±0.82)mm at the apex, respectively. The stability of miniscrews was fairly well. Surgical templates for miniscrew implantation could be acquired based on 3D CBCT images and fabricated with SLA. Implantation guided by these templates was safe and stable.

Note on evaluating safety performance of road infrastructure to motivate safety competition.

PubMed

Han, Sangjin

2016-01-01

Road infrastructures are usually developed and maintained by governments or public sectors. There is no competitor in the market of their jurisdiction. This monopolic feature discourages road authorities from improving the level of safety with proactive motivation. This study suggests how to apply a principle of competition for roads, in particular by means of performance evaluation. It first discusses why road infrastructure has been slow in safety oriented development and management in respect of its business model. Then it suggests some practical ways of how to promote road safety between road authorities, particularly by evaluating safety performance of road infrastructure. These are summarized as decision of safety performance indicators, classification of spatial boundaries, data collection, evaluation, and reporting. Some consideration points are also discussed to make safety performance evaluation on road infrastructure lead to better road safety management.

[Safety assessment of foods derived from genetically modified plants].

PubMed

Pöting, A; Schauzu, M

2010-06-01

The placing of genetically modified plants and derived food on the market falls under Regulation (EC) No. 1829/2003. According to this regulation, applicants need to perform a safety assessment according to the Guidance Document of the Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA), which is based on internationally agreed recommendations. This article gives an overview of the underlying legislation as well as the strategy and scientific criteria for the safety assessment, which should generally be based on the concept of substantial equivalence and carried out in relation to an unmodified conventional counterpart. Besides the intended genetic modification, potential unintended changes also have to be assessed with regard to potential adverse effects for the consumer. All genetically modified plants and derived food products, which have been evaluated by EFSA so far, were considered to be as safe as products derived from the respective conventional plants.

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.

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...

[Patient safety in education and training of healthcare professionals in Germany].

PubMed

Hoffmann, Barbara; Siebert, H; Euteneier, A

2015-01-01

In order to improve patient safety, healthcare professionals who care for patients directly or indirectly are required to possess specific knowledge and skills. Patient safety education is not or only poorly represented in education and examination regulations of healthcare professionals in Germany; therefore, it is only practiced rarely and on a voluntary basis. Meanwhile, several training curricula and concepts have been developed in the past 10 years internationally and recently in Germany, too. Based on these concepts the German Coalition for Patient Safety developed a catalogue of core competencies required for safety in patient care. This catalogue will serve as an important orientation when patient safety is to be implemented as a subject of professional education in Germany in the future. Moreover, teaching staff has to be trained and educational and training activities have to be evaluated. Patient safety education and training for (undergraduate) healthcare professional will require capital investment.

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…

[Design requirements for clinical trials on re-evaluation of safety and efficacy of post-marketed Chinese herbs].

PubMed

Xie, Yanming; Wei, Xu

2011-10-01

Re-evaluation of post-marketed based on pharmacoepidemiology is to study and collect clinical medicine safety in large population under practical applications for a long time. It is necessary to conduct re-evaluation of clinical effectiveness because of particularity of traditional Chinese medicine (TCM). Right before carrying out clinical trials on re-evaluation of post-marketed TCM, we should determine the objective of the study and progress it in the assessment mode of combination of disease and syndrome. Specical population, involving children and seniors who were excluded in pre-marketed clinical trial, were brought into drug monitoring. Sample size needs to comply with statistical requirement. We commonly use cohort study, case-control study, nested case-control, pragmatic randomized controlled trials.

Recommendations for safety testing with the in vivo comet assay.

PubMed

Vasquez, Marie Z

2012-08-30

While the in vivo comet assay increases its role in regulatory safety testing, deliberations about the interpretation of comet data continue. Concerns can arise regarding comet assay publications with limited data from non-blind testing of positive control compounds and using protocols (e.g. dose concentrations, sample times, and tissues) known to give an expected effect. There may be a tendency towards bias when the validation or interpretation of comet assay data is based on results generated by widely accepted but non-validated assays. The greatest advantages of the comet assay are its sensitivity and its ability to detect genotoxicity in tissues and at sample times that could not previously be evaluated. Guidelines for its use and interpretation in safety testing should take these factors into account. Guidelines should be derived from objective review of data generated by blind testing of unknown compounds dosed at non-toxic concentrations and evaluated in a true safety-testing environment, where the experimental design and conclusions must be defensible. However, positive in vivo comet findings with such compounds are rarely submitted to regulatory agencies and this data is typically unavailable for publication due to its proprietary nature. To enhance the development of guidelines for safety testing with the comet assay, and with the permission of several sponsors, this paper presents and discusses relevant data from multiple GLP comet studies conducted blind, with unknown pharmaceuticals and consumer products. Based on these data and the lessons we have learned through the course of conducting these studies, I suggest significant adjustments to the current conventions, and I provide recommendations for interpreting in vivo comet assay results in situations where risk must be evaluated in the absence of carcinogenicity or clinical data. Copyright © 2012 Elsevier B.V. All rights reserved.

Report of the oversight assessment of the operational readiness review of the Savannah River Site Defense Waste Processing Facility Cold Chemical Runs

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

Lee, B.

1993-03-01

This report presents the results of an oversight assessment (OA) conducted by the US Department of Energy's (DOE) Office of Environment, Safety and Health (EH) of the operational readiness review (ORR) activities for the Cold Chemical Runs (CCRs) at the Defense Waste Processing Facility (DWPF) located at Savannah River Site (SRS). The EH OA of this facility took place concurrently with an ORR performed by the DOE Office of Environmental Restoration and Waste Management (EM). The EM ORR was conducted from September 28, 1992, through October 9, 1992, although portions of the EM ORR were extended beyond this period. Themore » EH OA evaluated the comprehensiveness and effectiveness of the EM ORR. The EH OA was designed to ascertain whether the EM ORR was thorough and demonstrated sufficient inquisitiveness to verify that the implementation of programs and procedures is adequate to assure the protection of worker safety and health. The EH OA was carried out in accordance with the protocol and procedures of the EH Program for Oversight Assessment of Operational Readiness Evaluations for Startups and Restarts,'' dated September 15, 1992. Based on its OA and verification of the resolution of EH OA findings, the EH OA Team believes that the startup of the CCRs may be safely begun, pending satisfactory completion and verification of the prestart findings identified by the EM ORR. The EH OA was based primarily on an evaluation of the comprehensiveness and effectiveness of the EM ORR and addressed the following areas: industrial safety, industrial hygiene, and respiratory protection; fire protection; and chemical safety. The EH OA conducted independent vertical-slice'' reviews to confirm EM ORR results in the areas of confined-space entry, respiratory protection, fire protection, and chemical safety.« less

The effects of crew resource management on teamwork and safety climate at Veterans Health Administration facilities.

PubMed

Schwartz, Miriam E; Welsh, Deborah E; Paull, Douglas E; Knowles, Regina S; DeLeeuw, Lori D; Hemphill, Robin R; Essen, Keith E; Sculli, Gary L

2017-11-09

Communication failure is a significant source of adverse events in health care and a leading root cause of sentinel events reported to the Joint Commission. The Veterans Health Administration National Center for Patient Safety established Clinical Team Training (CTT) as a comprehensive program to enhance patient safety and to improve communication and teamwork among health care professionals. CTT is based on techniques used in aviation's Crew Resource Management (CRM) training. The aviation industry has reached a significant safety record in large part related to the culture change generated by CRM and sustained by its recurrent implementation. This article focuses on the improvement of communication, teamwork, and patient safety by utilizing a standardized, CRM-based, interprofessional, immersive training in diverse clinical areas. The Teamwork and Safety Climate Questionnaire was used to evaluate safety climate before and after CTT. The scores for all of the 27 questions on the questionnaire showed an increase from baseline to 12 months, and 11 of those increases were statistically significant. A recurrent training is recommended to maintain the positive outcomes. CTT enhances patient safety and reduces risk of patient harm by improving teamwork and facilitating clear, concise, specific and timely communication among health care professionals. © 2017 American Society for Healthcare Risk Management of the American Hospital Association.

Evaluation of the safety benefits of the risk awareness and perception training program for novice teen drivers.

DOT National Transportation Integrated Search

2016-01-01

This project evaluated the impact of the PC-based Risk Awareness and Perception Training (RAPT) program on young driver crashes and traffic violations. Young drivers 16 to 18 years of age were recruited immediately after they passed the on-road drivi...

Using Theory to Guide Practice in Children's Pedestrian Safety Education

ERIC Educational Resources Information Center

Cross, Donna; Hall, Margaret; Howat, Peter

2003-01-01

Few pedestrian injury prevention programs appear to articulate the theory upon which their design and evaluation are based. This article describes how theory was used to plan, develop, implement, and evaluate the educational component of a comprehensive child pedestrian intervention. Organizational and planning theories were used to guide the…

Cooking Healthy, Eating Smart: A Strategically Timed Formative Evaluation of a Community-Based Nutrition and Food Safety Program for Rural Older Adults

ERIC Educational Resources Information Center

Fraser, Angela; Chao, Morgan G.; Amella, Elaine J.; Mueller, Martina

2016-01-01

The use of focus groups to formatively evaluate community-based curricula after development and before pilot testing is not highlighted in the literature. In the study discussed in this article, research with four focus groups, composed of 46 women aged 65 years and older and belonging to eight South Carolina Family and Community Leaders clubs,…

Fighting Crime by Fighting Misconceptions and Blind Spots in Policy Theories: An Evidence-Based Evaluation of Interventions and Assumed Causal Mechanisms

ERIC Educational Resources Information Center

van Noije, Lonneke; Wittebrood, Karin

2010-01-01

How effective are policy interventions to fight crime and how valid is the policy theory that underlies them? This is the twofold research question addressed in this article, which presents an evidence-based evaluation of Dutch social safety policy. By bridging the gap between actual effects and assumed effects, this study seeks to make fuller use…

Generation of clinical-grade human induced pluripotent stem cells in Xeno-free conditions.

PubMed

Wang, Juan; Hao, Jie; Bai, Donghui; Gu, Qi; Han, Weifang; Wang, Lei; Tan, Yuanqing; Li, Xia; Xue, Ke; Han, Pencheng; Liu, Zhengxin; Jia, Yundan; Wu, Jun; Liu, Lei; Wang, Liu; Li, Wei; Liu, Zhonghua; Zhou, Qi

2015-11-12

Human induced pluripotent stem cells (hiPSCs) are considered as one of the most promising seed cell sources in regenerative medicine. Now hiPSC-based clinical trials are underway. To ensure clinical safety, cells used in clinical trials or therapies should be generated under GMP conditions, and with Xeno-free culture media to avoid possible side effects like immune rejection that induced by the Xeno reagents. However, up to now there are no reports for hiPSC lines developed completely under GMP conditions using Xeno-free reagents. Clinical-grade human foreskin fibroblast (HFF) cells used as feeder cells and parental cells of the clinical-grade hiPSCs were isolated from human foreskin tissues and cultured in Xeno-free media. Clinical-grade hiPSCs were derived by integration-free Sendai virus-based reprogramming kit in Xeno-free pluriton™ reprogramming medium or X medium. Neural cells and cardiomyocytes differentiation were conducted following a series of spatial and temporal specific signals induction according to the corresponding lineage development signals. Biological safety evaluation of the clinical-grade HFF cells and hiPSCs were conducted following the guidance of the "Pharmacopoeia of the People's Republic of China, Edition 2010, Volume III". We have successfully derived several integration-free clinical-grade hiPSC lines under GMP-controlled conditions and with Xeno-free reagents culture media in line with the current guidance of international and national evaluation criteria. As for the source of hiPSCs and feeder cells, biological safety evaluation of the HFF cells have been strictly reviewed by the National Institutes for Food and Drug Control (NIFDC). The hiPSC lines are pluripotent and have passed the safety evaluation. Moreover, one of the randomly selected hiPSC lines was capable of differentiating into functional neural cells and cardiomyocytes in Xeno-free culture media. The clinical-grade hiPSC lines therefore could be valuable sources for future hiPSC-based clinical trials or therapies and for drug screening.

Container-content compatibility studies: a pharmaceutical team's integrated approach.

PubMed

Laschi, Alda; Sehnal, Natacha; Alarcon, Antoine; Barcelo, Beatrice; Caire-Maurisier, François; Delaire, Myriam; Feuilloley, Marc; Genot, Stéphanie; Lacaze, Catherine; Pisarik, Luc; Smati, Christophe

2009-01-01

Container-content compatibility studies are required as part of the submission of a new product market authorization file or for a change relating to the primary product-contact packaging. Many regulatory publications and guidances are available in the USA, Europe, and Japan. However these publications and guidances are not sufficiently precise enough to allow for consistent interpretation and implementation of the technical requirements. A working group has been formed by the French Society of Pharmaceutical Science and Technology (SFSTP) in order to propose guidance for container-content interaction studies that meet both European and US requirements, and allows consistent and standardized information to be presented by the industry to the regulators. When a pharmaceutical drug product remains in prolonged contact with a material, the two critical points to consider are the drug product's quality and safety. A pharmaceutical evaluation of the container-content relationship should be done based on the knowledge of the contact material (e.g., type, physicochemical properties), its manufacturing processes (e.g., the type of sterilization that could potentially alter the interactions), and the formulation components involved in contact with this material (e.g., physicochemical properties, pharmaceutical presentation, route of administration). Quality is evaluated using the stability study performed on the product. Safety is partially evaluated with the stability study and is analyzed in conjunction with toxicity testing, specifically with cytotoxicity testing. The toxicity aspect is the key point of the container-content compatibility study and of patient safety. Migration tests are conducted when an interaction is suspected, or found based on previous results, to identify the component responsible for this interaction and to help select a new material if needed. Therefore, such tests are perhaps not the best ones to use for the purpose of safety evaluation. Consequently, a decision tree based mainly on the toxicity aspect is proposed in order to support the pharmaceutical companies' container-content interaction approach and filing.

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.

Evaluation of Geometric Design Needs of Freeway Systems Based on Traffic and Geometric Data

DOT National Transportation Integrated Search

2013-10-20

In Las Vegas, Nevada, the increased traffic competes for the limited spaces available in the freeway system and thus reduces safety performance. This study identified geometric design issues on freeway systems in Las Vegas, Nevada, based on available...

Development and evaluation of a web-based software for crash data collection, processing and analysis.

PubMed

Montella, Alfonso; Chiaradonna, Salvatore; Criscuolo, Giorgio; De Martino, Salvatore

2017-02-05

First step of the development of an effective safety management system is to create reliable crash databases since the quality of decision making in road safety depends on the quality of the data on which decisions are based. Improving crash data is a worldwide priority, as highlighted in the Global Plan for the Decade of Action for Road Safety adopted by the United Nations, which recognizes that the overall goal of the plan will be attained improving the quality of data collection at the national, regional and global levels. Crash databases provide the basic information for effective highway safety efforts at any level of government, but lack of uniformity among countries and among the different jurisdictions in the same country is observed. Several existing databases show significant drawbacks which hinder their effective use for safety analysis and improvement. Furthermore, modern technologies offer great potential for significant improvements of existing methods and procedures for crash data collection, processing and analysis. To address these issues, in this paper we present the development and evaluation of a web-based platform-independent software for crash data collection, processing and analysis. The software is designed for mobile and desktop electronic devices and enables a guided and automated drafting of the crash report, assisting police officers both on-site and in the office. The software development was based both on the detailed critical review of existing Australasian, EU, and U.S. crash databases and software as well as on the continuous consultation with the stakeholders. The evaluation was carried out comparing the completeness, timeliness, and accuracy of crash data before and after the use of the software in the city of Vico Equense, in south of Italy showing significant advantages. The amount of collected information increased from 82 variables to 268 variables, i.e., a 227% increase. The time saving was more than one hour per crash, i.e., a 36% reduction. The on-site data collection did not produce time saving, however this is a temporary weakness that will be annihilated very soon in the future after officers are more acquainted with the software. The phase of evaluation, processing and analysis carried out in the office was dramatically shortened, i.e., a 69% reduction. Another benefit was the standardization which allowed fast and consistent data analysis and evaluation. Even if all these benefits are remarkable, the most valuable benefit of the new procedure was the reduction of the police officers mistakes during the manual operations of survey and data evaluation. Because of these benefits, the satisfaction questionnaires administrated to the police officers after the testing phase showed very good acceptance of the procedure. Copyright © 2017 Elsevier Ltd. All rights reserved.

Operating manual-based usability evaluation of medical devices: an effective patient safety screening method.

PubMed

Turley, James P; Johnson, Todd R; Smith, Danielle Paige; Zhang, Jaijie; Brixey, Juliana J

2006-04-01

Use of medical devices often directly contributes to medical errors. Because it is difficult or impossible to change the design of existing devices, the best opportunity for improving medical device safety is during the purchasing process. However, most hospital personnel are not familiar with the usability evaluation methods designed to identify aspects of a user interface that do not support intuitive and safe use. A review of medical device operating manuals is proposed as a more practical method of usability evaluation. Operating manuals for five volumetric infusion pumps from three manufacturers were selected for this study (January-April 2003). Each manual's safety message content was evaluated to determine whether the message indicated a device design characteristic that violated known usability principles (heuristics) or indicated a violation of an affordance of the device. "Minimize memory load," with 65 violations, was the heuristic violated most frequently across pumps. Variations between pumps, including the frequency and severity of violations for each, were noted. Results suggest that manual review can provide a proxy for heuristic evaluation of the actual medical device. This method, intended to be a component of prepurchasing evaluation, can complement more formal usability evaluation methods and be used to select a subset of devices for more extensive and formal testing.

Safety evaluation of some wild plants in the New Nordic Diet.

PubMed

Mithril, Charlotte; Dragsted, Lars Ove

2012-12-01

One of the dietary components in the New Nordic Diet, is plants from the wild countryside. However, these may have a high content of bioactive components, some of which could be toxic in larger quantities. The objective of this paper is to outline a strategy for safety evaluation of wild plants not covered in current food compositional databases and to apply the method for selected plants used in the New Nordic Diet recipes. Four examples of typical wild edible plants were evaluated (stinging nettle, sorrel, chickweed and common lambsquarters), and based on substantial equivalence with known food plants the majority of the bioactive components reported were within the range experienced when eating or drinking typical food stuffs. For most compounds the hazards could be evaluated as minor. The only precaution found was for common lambsquarters because of its presumed high level of oxalic acid. It is concluded that a substance-by-substance evaluation of intake by equivalence to common foods is a useful and efficient strategy to evaluate the safety of newly introduced wild edible plants. Further evaluation and better compositional analyses are warranted before a daily consumption of significant amounts of wild edible plants can be generally regarded as safe. Copyright © 2012 Elsevier Ltd. All rights reserved.

Usability Methods for Ensuring Health Information Technology Safety: Evidence-Based Approaches. Contribution of the IMIA Working Group Health Informatics for Patient Safety.

PubMed

Borycki, E; Kushniruk, A; Nohr, C; Takeda, H; Kuwata, S; Carvalho, C; Bainbridge, M; Kannry, J

2013-01-01

Issues related to lack of system usability and potential safety hazards continue to be reported in the health information technology (HIT) literature. Usability engineering methods are increasingly used to ensure improved system usability and they are also beginning to be applied more widely for ensuring the safety of HIT applications. These methods are being used in the design and implementation of many HIT systems. In this paper we describe evidence-based approaches to applying usability engineering methods. A multi-phased approach to ensuring system usability and safety in healthcare is described. Usability inspection methods are first described including the development of evidence-based safety heuristics for HIT. Laboratory-based usability testing is then conducted under artificial conditions to test if a system has any base level usability problems that need to be corrected. Usability problems that are detected are corrected and then a new phase is initiated where the system is tested under more realistic conditions using clinical simulations. This phase may involve testing the system with simulated patients. Finally, an additional phase may be conducted, involving a naturalistic study of system use under real-world clinical conditions. The methods described have been employed in the analysis of the usability and safety of a wide range of HIT applications, including electronic health record systems, decision support systems and consumer health applications. It has been found that at least usability inspection and usability testing should be applied prior to the widespread release of HIT. However, wherever possible, additional layers of testing involving clinical simulations and a naturalistic evaluation will likely detect usability and safety issues that may not otherwise be detected prior to widespread system release. The framework presented in the paper can be applied in order to develop more usable and safer HIT, based on multiple layers of evidence.

Method of Evaluating the Life Cycle Cost of Small Earth Dams Considering the Risk of Heavy Rainfall and Selection Method of the Optimum Countermeasure

NASA Astrophysics Data System (ADS)

Hori, Toshikazu; Mohri, Yoshiyuki; Matsushima, Kenichi; Ariyoshi, Mitsuru

In recent years the increase in the number of heavy rainfall occurrences such as through unpredictable cloudbursts have resulted in the safety of the embankments of small earth dams needing to be improved. However, the severe financial condition of the government and local autonomous bodies necessitate the cost of improving them to be reduced. This study concerns the development of a method of evaluating the life cycle cost of small earth dams considered to pose a risk and in order to improve the safety of the downstream areas of small earth dams at minimal cost. Use of a safety evaluation method that is based on a combination of runoff analysis, saturated and unsaturated seepage analysis, and slope stability analysis enables the probability of a dam breach and its life cycle cost with the risk of heavy rainfall taken into account to be calculated. Moreover, use of the life cycle cost evaluation method will lead to the development of a technique for selecting the method of the optimal improvement or countermeasures against heavy rainfall.

Flammable Gas Technical Basis Document

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

CARRO, C.A.

2003-07-30

This document qualitatively evaluates the frequency and consequences of DST and SST representative flammable gas accidents and associated represented hazardous conditions without controls. Based on the evaluation, it was determined that safety-significant SSCs and/or TSRs were required to prevent or mitigate flammable gas accidents. Controls were selected and the accidents re-evaluated taking credit for the controls. Revision 1 incorporates comments received from ORP.

New evaluation of thermal neutron scattering libraries for light and heavy water

NASA Astrophysics Data System (ADS)

Marquez Damian, Jose Ignacio; Granada, Jose Rolando; Cantargi, Florencia; Roubtsov, Danila

2017-09-01

In order to improve the design and safety of thermal nuclear reactors and for verification of criticality safety conditions on systems with significant amount of fissile materials and water, it is necessary to perform high-precision neutron transport calculations and estimate uncertainties of the results. These calculations are based on neutron interaction data distributed in evaluated nuclear data libraries. To improve the evaluations of thermal scattering sub-libraries, we developed a set of thermal neutron scattering cross sections (scattering kernels) for hydrogen bound in light water, and deuterium and oxygen bound in heavy water, in the ENDF-6 format from room temperature up to the critical temperatures of molecular liquids. The new evaluations were generated and processable with NJOY99 and also with NJOY-2012 with minor modifications (updates), and with the new version of NJOY-2016. The new TSL libraries are based on molecular dynamics simulations with GROMACS and recent experimental data, and result in an improvement of the calculation of single neutron scattering quantities. In this work, we discuss the importance of taking into account self-diffusion in liquids to accurately describe the neutron scattering at low neutron energies (quasi-elastic peak problem). To improve modeling of heavy water, it is important to take into account temperature-dependent static structure factors and apply Sköld approximation to the coherent inelastic components of the scattering matrix. The usage of the new set of scattering matrices and cross-sections improves the calculation of thermal critical systems moderated and/or reflected with light/heavy water obtained from the International Criticality Safety Benchmark Evaluation Project (ICSBEP) handbook. For example, the use of the new thermal scattering library for heavy water, combined with the ROSFOND-2010 evaluation of the cross sections for deuterium, results in an improvement of the C/E ratio in 48 out of 65 international benchmark cases calculated with the Monte Carlo code MCNP5, in comparison with the existing library based on the ENDF/B-VII.0 evaluation.

Knowledge, attitudes and practices of food handlers in food safety: An integrative review.

PubMed

Zanin, Laís Mariano; da Cunha, Diogo Thimoteo; de Rosso, Veridiana Vera; Capriles, Vanessa Dias; Stedefeldt, Elke

2017-10-01

This study presents an overview of the relationship between knowledge, attitudes and practices (KAP) of food handlers with training in food safety, in addition to proposing reflections on the training of food handlers, considering its responsibility for food safety and health of consumers. The review was based on the integrative method. The descriptors used were: (food handler), (knowledge, attitudes and practice) and (training). Six databases were searched, 253 articles were consulted and 36 original articles were included. Fifty per cent of the articles pointed that there was no proper translation of knowledge into attitudes/practices or attitudes into practices after training. Knowledge, attitudes and practices of food handlers are important for identifying how efficient training in food safety is allowing prioritize actions in planning training. The evaluation of KAP is the first step to understand the food handler's point of view. After this evaluation other diagnostic strategies become necessary to enhance this understanding. Copyright © 2017. Published by Elsevier Ltd.

Accelerating clinical development of HIV vaccine strategies: methodological challenges and considerations in constructing an optimised multi-arm phase I/II trial design.

PubMed

Richert, Laura; Doussau, Adélaïde; Lelièvre, Jean-Daniel; Arnold, Vincent; Rieux, Véronique; Bouakane, Amel; Lévy, Yves; Chêne, Geneviève; Thiébaut, Rodolphe

2014-02-26

Many candidate vaccine strategies against human immunodeficiency virus (HIV) infection are under study, but their clinical development is lengthy and iterative. To accelerate HIV vaccine development optimised trial designs are needed. We propose a randomised multi-arm phase I/II design for early stage development of several vaccine strategies, aiming at rapidly discarding those that are unsafe or non-immunogenic. We explored early stage designs to evaluate both the safety and the immunogenicity of four heterologous prime-boost HIV vaccine strategies in parallel. One of the vaccines used as a prime and boost in the different strategies (vaccine 1) has yet to be tested in humans, thus requiring a phase I safety evaluation. However, its toxicity risk is considered minimal based on data from similar vaccines. We newly adapted a randomised phase II trial by integrating an early safety decision rule, emulating that of a phase I study. We evaluated the operating characteristics of the proposed design in simulation studies with either a fixed-sample frequentist or a continuous Bayesian safety decision rule and projected timelines for the trial. We propose a randomised four-arm phase I/II design with two independent binary endpoints for safety and immunogenicity. Immunogenicity evaluation at trial end is based on a single-stage Fleming design per arm, comparing the observed proportion of responders in an immunogenicity screening assay to an unacceptably low proportion, without direct comparisons between arms. Randomisation limits heterogeneity in volunteer characteristics between arms. To avoid exposure of additional participants to an unsafe vaccine during the vaccine boost phase, an early safety decision rule is imposed on the arm starting with vaccine 1 injections. In simulations of the design with either decision rule, the risks of erroneous conclusions were controlled <15%. Flexibility in trial conduct is greater with the continuous Bayesian rule. A 12-month gain in timelines is expected by this optimised design. Other existing designs such as bivariate or seamless phase I/II designs did not offer a clear-cut alternative. By combining phase I and phase II evaluations in a multi-arm trial, the proposed optimised design allows for accelerating early stage clinical development of HIV vaccine strategies.

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.

The impact of red light cameras on safety in Arizona.

PubMed

Shin, Kangwon; Washington, Simon

2007-11-01

Red light cameras (RLCs) have been used in a number of US cities to yield a demonstrable reduction in red light violations; however, evaluating their impact on safety (crashes) has been relatively more difficult. Accurately estimating the safety impacts of RLCs is challenging for several reasons. First, many safety related factors are uncontrolled and/or confounded during the periods of observation. Second, "spillover" effects caused by drivers reacting to non-RLC equipped intersections and approaches can make the selection of comparison sites difficult. Third, sites selected for RLC installation may not be selected randomly, and as a result may suffer from the regression to the mean bias. Finally, crash severity and resulting costs need to be considered in order to fully understand the safety impacts of RLCs. Recognizing these challenges, a study was conducted to estimate the safety impacts of RLCs on traffic crashes at signalized intersections in the cities of Phoenix and Scottsdale, Arizona. Twenty-four RLC equipped intersections in both cities are examined in detail and conclusions are drawn. Four different evaluation methodologies were employed to cope with the technical challenges described in this paper and to assess the sensitivity of results based on analytical assumptions. The evaluation results indicated that both Phoenix and Scottsdale are operating cost-effective installations of RLCs: however, the variability in RLC effectiveness within jurisdictions is larger in Phoenix. Consistent with findings in other regions, angle and left-turn crashes are reduced in general, while rear-end crashes tend to increase as a result of RLCs.

Current concepts in simulation-based trauma education.

PubMed

Cherry, Robert A; Ali, Jameel

2008-11-01

The use of simulation-based technology in trauma education has focused on providing a safe and effective alternative to the more traditional methods that are used to teach technical skills and critical concepts in trauma resuscitation. Trauma team training using simulation-based technology is also being used to develop skills in leadership, team-information sharing, communication, and decision-making. The integration of simulators into medical student curriculum, residency training, and continuing medical education has been strongly recommended by the American College of Surgeons as an innovative means of enhancing patient safety, reducing medical errors, and performing a systematic evaluation of various competencies. Advanced human patient simulators are increasingly being used in trauma as an evaluation tool to assess clinical performance and to teach and reinforce essential knowledge, skills, and abilities. A number of specialty simulators in trauma and critical care have also been designed to meet these educational objectives. Ongoing educational research is still needed to validate long-term retention of knowledge and skills, provide reliable methods to evaluate teaching effectiveness and performance, and to demonstrate improvement in patient safety and overall quality of care.

Methods and strategies for future reactor safety goals

NASA Astrophysics Data System (ADS)

Arndt, Steven Andrew

There have been significant discussions over the past few years by the United States Nuclear Regulatory Commission (NRC), the Advisory Committee on Reactor Safeguards (ACRS), and others as to the adequacy of the NRC safety goals for use with the next generation of nuclear power reactors to be built in the United States. The NRC, in its safety goals policy statement, has provided general qualitative safety goals and basic quantitative health objectives (QHOs) for nuclear reactors in the United States. Risk metrics such as core damage frequency (CDF) and large early release frequency (LERF) have been used as surrogates for the QHOs. In its review of the new plant licensing policy the ACRS has looked at the safety goals, as has the NRC. A number of issues have been raised including what the Commission had in mind when it drafted the safety goals and QHOs, how risk from multiple reactors at a site should be combined for evaluation, how the combination of a new and old reactor at the same site should be evaluated, what the criteria for evaluating new reactors should be, and whether new reactors should be required to be safer than current generation reactors. As part of the development and application of the NRC safety goal policy statement the Commissioners laid out the expectations for the safety of a nuclear power plant but did not address the risk associated with current multi-unit sites, potential modular reactor sites, and hybrid sites that could contain current generation reactors, new passive reactors, and/or modular reactors. The NRC safety goals and the QHOs refer to a "nuclear power plant," but do not discuss whether a "plant" refers to only a single unit or all of the units on a site. There has been much discussion on this issue recently due to the development of modular reactors. Additionally, the risk of multiple reactor accidents on the same site has been largely ignored in the probabilistic risk assessments (PRAs) done to date, and in most risk-informed analyses and discussions. This dissertation examines potential approaches to updating the safety goals that include the establishment of new quantitative safety goal associated with the comparative risk of generating electricity by viable competing technologies and modifications of the goals to account for multi-plant reactor sites, and issues associated with the use of safety goals in both initial licensing and operational decision making. This research develops a new quantitative health objective that uses a comparable benefit risk metric based on the life-cycle risk of the construction, operation and decommissioning of a comparable non-nuclear electric generation facility, as well as the risks associated with mining and transportation. This dissertation also evaluates the effects of using various methods for aggregating site risk as a safety metric, as opposed to using single plant safety goals. Additionally, a number of important assumptions inherent in the current safety goals, including the effect of other potential negative societal effects such as the generation of greenhouse gases (e.g., carbon dioxide) have on the risk of electric power production and their effects on the setting of safety goals, is explored. Finally, the role risk perception should play in establishing safety goals has been explored. To complete this evaluation, a new method to analytically compare alternative technologies of generating electricity was developed, including development of a new way to evaluate risk perception, and a new method was developed for evaluating the risk at multiple units on a single site. To test these modifications to the safety goals a number of possible reactor designs and configurations were evaluated using these new proposed safety goals to determine the goals' usefulness and utility. The results of the analysis showed that the modifications provide measures that more closely evaluate the potential risk to the public from the operation of nuclear power plants than the current safety goals, while still providing a straight-forward process for assessment of reactor design and operation.

Utilization of cone-beam CT for offline evaluation of target volume coverage during prostate image-guided radiotherapy based on bony anatomy alignment.

PubMed

Paluska, Petr; Hanus, Josef; Sefrova, Jana; Rouskova, Lucie; Grepl, Jakub; Jansa, Jan; Kasaova, Linda; Hodek, Miroslav; Zouhar, Milan; Vosmik, Milan; Petera, Jiri

2012-01-01

To assess target volume coverage during prostate image-guided radiotherapy based on bony anatomy alignment and to assess possibility of safety margin reduction. Implementation of IGRT should influence safety margins. Utilization of cone-beam CT provides current 3D anatomic information directly in irradiation position. Such information enables reconstruction of the actual dose distribution. Seventeen prostate patients were treated with daily bony anatomy image-guidance. Cone-beam CT (CBCT) scans were acquired once a week immediately after bony anatomy alignment. After the prostate, seminal vesicles, rectum and bladder were contoured, the delivered dose distribution was reconstructed. Target dose coverage was evaluated by the proportion of the CTV encompassed by the 95% isodose. Original plans employed a 1 cm safety margin. Alternative plans assuming a smaller 7 mm margin between CTV and PTV were evaluated in the same way. Rectal and bladder volumes were compared with the initial ones. Rectal and bladder volumes irradiated with doses higher than 75 Gy, 70 Gy, 60 Gy, 50 Gy and 40 Gy were analyzed. In 12% of reconstructed plans the prostate coverage was not sufficient. The prostate underdosage was observed in 5 patients. Coverage of seminal vesicles was not satisfactory in 3% of plans. Most of the target underdosage corresponded to excessive rectal or bladder filling. Evaluation of alternative plans assuming a smaller 7 mm margin revealed 22% and 11% of plans where prostate and seminal vesicles coverage, respectively, was compromised. These were distributed over 8 and 7 patients, respectively. Sufficient dose coverage of target volumes was not achieved for all patients. Reducing of safety margin is not acceptable. Initial rectal and bladder volumes cannot be considered representative for subsequent treatment.

A novel framework to evaluate pedestrian safety at non-signalized locations.

PubMed

Fu, Ting; Miranda-Moreno, Luis; Saunier, Nicolas

2018-02-01

This paper proposes a new framework to evaluate pedestrian safety at non-signalized crosswalk locations. In the proposed framework, the yielding maneuver of a driver in response to a pedestrian is split into the reaction and braking time. Hence, the relationship of the distance required for a yielding maneuver and the approaching vehicle speed depends on the reaction time of the driver and deceleration rate that the vehicle can achieve. The proposed framework is represented in the distance-velocity (DV) diagram and referred as the DV model. The interactions between approaching vehicles and pedestrians showing the intention to cross are divided in three categories: i) situations where the vehicle cannot make a complete stop, ii) situations where the vehicle's ability to stop depends on the driver reaction time, and iii) situations where the vehicle can make a complete stop. Based on these classifications, non-yielding maneuvers are classified as "non-infraction non-yielding" maneuvers, "uncertain non-yielding" maneuvers and "non-yielding" violations, respectively. From the pedestrian perspective, crossing decisions are classified as dangerous crossings, risky crossings and safe crossings accordingly. The yielding compliance and yielding rate, as measures of the yielding behavior, are redefined based on these categories. Time to crossing and deceleration rate required for the vehicle to stop are used to measure the probability of collision. Finally, the framework is demonstrated through a case study in evaluating pedestrian safety at three different types of non-signalized crossings: a painted crosswalk, an unprotected crosswalk, and a crosswalk controlled by stop signs. Results from the case study suggest that the proposed framework works well in describing pedestrian-vehicle interactions which helps in evaluating pedestrian safety at non-signalized crosswalk locations. Copyright © 2017 Elsevier Ltd. All rights reserved.

Measuring Health Information Dissemination and Identifying Target Interest Communities on Twitter: Methods Development and Case Study of the @SafetyMD Network.

PubMed

Kandadai, Venk; Yang, Haodong; Jiang, Ling; Yang, Christopher C; Fleisher, Linda; Winston, Flaura Koplin

2016-05-05

Little is known about the ability of individual stakeholder groups to achieve health information dissemination goals through Twitter. This study aimed to develop and apply methods for the systematic evaluation and optimization of health information dissemination by stakeholders through Twitter. Tweet content from 1790 followers of @SafetyMD (July-November 2012) was examined. User emphasis, a new indicator of Twitter information dissemination, was defined and applied to retweets across two levels of retweeters originating from @SafetyMD. User interest clusters were identified based on principal component analysis (PCA) and hierarchical cluster analysis (HCA) of a random sample of 170 followers. User emphasis of keywords remained across levels but decreased by 9.5 percentage points. PCA and HCA identified 12 statistically unique clusters of followers within the @SafetyMD Twitter network. This study is one of the first to develop methods for use by stakeholders to evaluate and optimize their use of Twitter to disseminate health information. Our new methods provide preliminary evidence that individual stakeholders can evaluate the effectiveness of health information dissemination and create content-specific clusters for more specific targeted messaging.

A toxicity-based method for evaluating safety of reclaimed water for environmental reuses.

PubMed

Xu, Jianying; Zhao, Chuntao; Wei, Dongbin; Du, Yuguo

2014-10-01

A large quantity of toxic chemical pollutants possibly remains in reclaimed water due to the limited removal efficiency in traditional reclamation processes. It is not enough to guarantee the safety of reclaimed water using conventional water quality criteria. An integrated assessment method based on toxicity test is necessary to vividly depict the safety of reclaimed water for reuse. A toxicity test battery consisting of lethality, genotoxicity and endocrine disrupting effect was designed to screen the multiple biological effects of residual toxic chemicals in reclaimed water. The toxicity results of reclaimed water were converted into the equivalent concentrations of the corresponding positive reference substances (EQC). Simultaneously, the predicted no-effect concentration (PNEC) of each positive reference substance was obtained by analyzing the species sensitivity distribution (SSD) of toxicity data. An index "toxicity score" was proposed and valued as 1, 2, 3, or 4 depending on the ratio of the corresponding EQC to PNEC. For vividly ranking the safety of reclaimed water, an integrated assessment index "toxicity rank" was proposed, which was classified into A, B, C, or D rank with A being the safest. The proposed method was proved to be effective in evaluating reclaimed water samples in case studies. Copyright © 2014. Published by Elsevier B.V.

Key Performance Indicators in the Evaluation of the Quality of Radiation Safety Programs.

PubMed

Schultz, Cheryl Culver; Shaffer, Sheila; Fink-Bennett, Darlene; Winokur, Kay

2016-08-01

Beaumont is a multiple hospital health care system with a centralized radiation safety department. The health system operates under a broad scope Nuclear Regulatory Commission license but also maintains several other limited use NRC licenses in off-site facilities and clinics. The hospital-based program is expansive including diagnostic radiology and nuclear medicine (molecular imaging), interventional radiology, a comprehensive cardiovascular program, multiple forms of radiation therapy (low dose rate brachytherapy, high dose rate brachytherapy, external beam radiotherapy, and gamma knife), and the Research Institute (including basic bench top, human and animal). Each year, in the annual report, data is analyzed and then tracked and trended. While any summary report will, by nature, include items such as the number of pieces of equipment, inspections performed, staff monitored and educated and other similar parameters, not all include an objective review of the quality and effectiveness of the program. Through objective numerical data Beaumont adopted seven key performance indicators. The assertion made is that key performance indicators can be used to establish benchmarks for evaluation and comparison of the effectiveness and quality of radiation safety programs. Based on over a decade of data collection, and adoption of key performance indicators, this paper demonstrates one way to establish objective benchmarking for radiation safety programs in the health care environment.

Taking up national safety alerts to improve patient safety in hospitals: The perspective of healthcare quality and risk managers.

PubMed

Pfeiffer, Yvonne; Schwappach, David

2016-01-01

National safety alert systems publish relevant information to improve patient safety in hospitals. However, the information has to be transformed into local action to have an effect on patient safety. We studied three research questions: How do Swiss healthcare quality and risk managers (qm/rm(1)) see their own role in learning from safety alerts issued by the Swiss national voluntary reporting and analysis system? What are their attitudes towards and evaluations of the alerts, and which types of improvement actions were fostered by the safety alerts? A survey was developed and applied to Swiss healthcare risk and quality managers, with a response rate of 39 % (n=116). Descriptive statistics are presented. The qm/rm disseminate and communicate with a broad variety of professional groups about the alerts. While most respondents felt that they should know the alerts and their contents, only a part of them felt responsible for driving organizational change based on the recommendations. However, most respondents used safety alerts to back up their own patient safety goals. The alerts were evaluated positively on various dimensions such as usefulness and were considered as standards of good practice by the majority of the respondents. A range of organizational responses was applied, with disseminating information being the most common. An active role is related to using safety alerts for backing up own patient safety goals. To support an active role of qm/rm in their hospital's learning from safety alerts, appropriate organizational structures should be developed. Furthermore, they could be given special information or training to act as an information hub on the issues discussed in the alerts. Copyright © 2016. Published by Elsevier GmbH.

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.

Investigation of safety analysis methods using computer vision techniques

NASA Astrophysics Data System (ADS)

Shirazi, Mohammad Shokrolah; Morris, Brendan Tran

2017-09-01

This work investigates safety analysis methods using computer vision techniques. The vision-based tracking system is developed to provide the trajectory of road users including vehicles and pedestrians. Safety analysis methods are developed to estimate time to collision (TTC) and postencroachment time (PET) that are two important safety measurements. Corresponding algorithms are presented and their advantages and drawbacks are shown through their success in capturing the conflict events in real time. The performance of the tracking system is evaluated first, and probability density estimation of TTC and PET are shown for 1-h monitoring of a Las Vegas intersection. Finally, an idea of an intersection safety map is introduced, and TTC values of two different intersections are estimated for 1 day from 8:00 a.m. to 6:00 p.m.

The role of safety signals in fear extinction: An analogue study.

PubMed

Restrepo-Castro, Juan C; Castro-Camacho, Leonidas; Javier Labrador, Francisco

2017-12-01

Safety signals are conditioned inhibitory stimuli that indicate the absence of unconditioned stimuli. It is not clear whether the presence of safety signals is detrimental or beneficial in extinction-based interventions. The purpose of this study was to evaluate the effect of safety signals on autonomic and expectancy fear-related responses. Following the conditional discrimination paradigm (AX +, BX-), undergraduate students (N = 48) underwent an aversive conditioning procedure, while safety signals were experimentally created. Participants were randomly assigned to one of two conditions during extinction: presence or absence of safety signals. Significant reductions of fear-related responses were found in both groups. Expectancy measures showed that the presence of safety signals did not interfere with reduction of fear related responses at follow-up. The analogue nature of the study affects its ecological validity. There are some methodological issues. Safety signals did not interfere with extinction learning. Attention may be a mechanism associated with the maintenance of fear responses. Copyright © 2017 Elsevier Ltd. All rights reserved.

Newspaper content analysis in evaluation of a community-based participatory project to increase physical activity.

PubMed

Granner, Michelle L; Sharpe, Patricia A; Burroughs, Ericka L; Fields, Regina; Hallenbeck, Joyce

2010-08-01

This study conducted a newspaper content analysis as part of an evaluation of a community-based participatory research project focused on increasing physical activity through policy and environmental changes, which included activities related to media advocacy and media-based community education. Daily papers (May 2003 to December 2005) from both the intervention and comparison counties were reviewed for topics related to physical activity and an active living environment (e.g. safety, policy, urban design, transportation and recreational resources). A total of 2681 articles from 1764 newspapers were analyzed. The intervention county had a greater proportion of articles on the selected topics. Specifically, the intervention county had a greater proportion of articles in topics related to safety, policy and community initiatives, as well as in sidewalks and recreational facilities; both priority areas for the intervention. Prominence of the articles was assessed using a composite index score. Generally, prominence of the topics analyzed was low. Articles in the sidewalks and recreational facilities topic category in the intervention county had higher prominence scores on average than the comparison county. The study demonstrates that media content analysis can be a valuable component in evaluating community-based interventions.

Reliability of digital reactor protection system based on extenics.

PubMed

Zhao, Jing; He, Ya-Nan; Gu, Peng-Fei; Chen, Wei-Hua; Gao, Feng

2016-01-01

After the Fukushima nuclear accident, safety of nuclear power plants (NPPs) is widespread concerned. The reliability of reactor protection system (RPS) is directly related to the safety of NPPs, however, it is difficult to accurately evaluate the reliability of digital RPS. The method is based on estimating probability has some uncertainties, which can not reflect the reliability status of RPS dynamically and support the maintenance and troubleshooting. In this paper, the reliability quantitative analysis method based on extenics is proposed for the digital RPS (safety-critical), by which the relationship between the reliability and response time of RPS is constructed. The reliability of the RPS for CPR1000 NPP is modeled and analyzed by the proposed method as an example. The results show that the proposed method is capable to estimate the RPS reliability effectively and provide support to maintenance and troubleshooting of digital RPS system.

Pre-surgery briefings and safety climate in the operating theatre.

PubMed

Allard, Jon; Bleakley, Alan; Hobbs, Adrian; Coombes, Lee

2011-08-01

In 2008, the WHO produced a surgical safety checklist against a background of a poor patient safety record in operating theatres. Formal team briefings are now standard practice in high-risk settings such as the aviation industry and improve safety, but are resisted in surgery. Research evidence is needed to persuade the surgical workforce to adopt safety procedures such as briefings. To investigate whether exposure to pre-surgery briefings is related to perception of safety climate. Three Safety Attitude Questionnaires, completed by operating theatre staff in 2003, 2004 and 2006, were used to evaluate the effects of an educational intervention introducing pre-surgery briefings. Individual practitioners who agree with the statement 'briefings are common in the operating theatre' also report a better 'safety climate' in operating theatres. The study reports a powerful link between briefing practices and attitudes towards safety. Findings build on previous work by reporting on the relationship between briefings and safety climate within a 4-year period. Briefings, however, remain difficult to establish in local contexts without appropriate team-based patient safety education. Success in establishing a safety culture, with associated practices, may depend on first establishing unidirectional, positive change in attitudes to create a safety climate.

Evaluating imbalances of adverse events during biosimilar development

PubMed Central

Vana, Alicia M.; Freyman, Amy W.; Reich, Steven D.; Yin, Donghua; Li, Ruifeng; Anderson, Scott; Jacobs, Ira A.; Zacharchuk, Charles M.; Ewesuedo, Reginald

2016-01-01

ABSTRACT Biosimilars are designed to be highly similar to approved or licensed (reference) biologics and are evaluated based on the totality of evidence from extensive analytical, nonclinical and clinical studies. As part of the stepwise approach recommended by regulatory agencies, the first step in the clinical evaluation of biosimilarity is to conduct a pharmacokinetics similarity study in which the potential biosimilar is compared with the reference product. In the context of biosimilar development, a pharmacokinetics similarity study is not necessarily designed for a comparative assessment of safety. Development of PF-05280014, a potential biosimilar to trastuzumab, illustrates how a numerical imbalance in an adverse event in a small pharmacokinetics study can raise questions on safety that may require additional clinical trials. PMID:27050730

[Study toward practical use of oligonucleotide therapeutics].

PubMed

Inoue, Takao; Yoshida, Tokuyuki

2014-01-01

Over the past decade, oligonucleotide-based therapeutics such as antisense oligonucleotides and small interfering RNAs (siRNAs) have been developed extensively. For example, mipomersen (Kynamro; ISIS Pharmaceuticals), which is a second-generation antisense oligonucleotide administered by subcutaneous injection, has recently been approved by the FDA for the treatment of homozygous familial hypercholesterolemia. On the other hands, methods for the evaluation of quality, efficacy and safety of oligonucleotide therapeutics have not been fully discussed. Furthermore, the regulatory guidance specific for oligonucleotide therapeutics has not been established yet. Under these circumstances, we started to collaborate with Osaka University and PMDA to discuss regulatory science focused on oligonucleotide therapeutics. Through the collaboration, we would like to propose the possible design of quality evaluation and preclinical safety-evaluation of oligonucleotide therapeutics.

The Collision Auto Repair Safety Study (CARSS): a health and safety intervention.

PubMed

Parker, David L; Bejan, Anca; Brosseau, Lisa M; Skan, Maryellen; Xi, Min

2015-01-01

Collision repair employs approximately 205,500 people in 33,400 shops. Workers are exposed to a diverse array of chemical, physical, and ergonomic hazards. CARSS was based on a random and purposeful sample. Baseline and one baseline and one-year evaluations consisted of 92 questions addressing issues, such as Right-to-Know, fire protection, painting-related hazards, ergonomics, electrical safety, and personal protective equipment. Owners received a report and selected at least 30% of items found deficient for remediation. In-person and web-based services were provided. Forty-nine shops were evaluated at baseline and 45 at follow-up. At baseline, 54% of items were present. This improved to 71% at follow-up (P < 0.0001). Respiratory protection improved 37% (P < 0.0001) and Right-to-Know training increased 30% (P < 0.0001). Owners completed 61% of items they selected for remediation. Small businesses' interventions should address the lack of personnel and administrative infrastructure. Tailored information regarding hazards and easy-to-use training and administrative programs overcome many barriers to improvement. © 2014 Wiley Periodicals, Inc.

Regulatory science based approach in development of novel medical devices.

PubMed

Sakuma, Ichiro

2015-08-01

For development rational evaluation method for medical devices' safety and efficacy, regulatory science studies are important. Studies on regulatory affairs related to a medical device under development should be conducted as well as its technological development. Clinical performance of a medical device is influenced by performance of the device, medical doctors' skill, pathological condition of a patient, and so on. Thus it is sometimes difficult to demonstrate superiority of the device in terms of clinical outcome although its efficacy as a medical device is accepted. Setting of appropriate end points is required to evaluate a medical device appropriately. Risk assessment and risk management are the basis of medical device safety assurance. In case of medical device software, there are difficulties in identifying the risk due to its complexity of user environment and different design and manufacturing procedure compared with conventional hardware based medical devices. Recent technological advancement such as information and communication technologies (ICT) for medical devices and wireless network has raised new issue on risk management: cybersecurity. We have to watch closely the progress of safety standard development.

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.

Curriculum and Evaluation Guide for Safety Education Programs. Research and Evaluation Report Series No. 40.00.

ERIC Educational Resources Information Center

Lowry, Carlee S.

Designed to assist Bureau of Indian Affairs school officials in the identification of safety education program needs, this evaluation guide focuses upon the basic operational components in a safety education program. The means for establishing an evaluation design for safety education are presented via a flexible model appropriate for most…

Defining the taxonomic domain of applicability for mammalian-based high-throughput screening assays

EPA Science Inventory

Cell-based high throughput screening (HTS) technologies are becoming mainstream in chemical safety evaluations. The US Environmental Protection Agency (EPA) Toxicity Forecaster (ToxCastTM) and the multi-agency Tox21 Programs have been at the forefront in advancing this science, m...

Application of the threshold of toxicological concern approach for the safety evaluation of calendula flower (Calendula officinalis) petals and extracts used in cosmetic and personal care products.

PubMed

Re, T A; Mooney, D; Antignac, E; Dufour, E; Bark, I; Srinivasan, V; Nohynek, G

2009-06-01

Calendula flower (Calendula officinalis) (CF) has been used in herbal medicine because of its anti-inflammatory activity. CF and C. officinalis extracts (CFE) are used as skin conditioning agents in cosmetics. Although data on dermal irritation and sensitization of CF and CFE's are available, the risk of subchronic systemic toxicity following dermal application has not been evaluated. The threshold of toxicological concern (TTC) is a pragmatic, risk assessment based approach that has gained regulatory acceptance for food and has been recently adapted to address cosmetic ingredient safety. The purpose of this paper is to determine if the safe use of CF and CFE can be established based upon the TTC class for each of its known constituents. For each constituent, the concentration in the plant, the molecular weight, and the estimated skin penetration potential were used to calculate a maximal daily systemic exposure which was then compared to its corresponding TTC class value. Since the composition of plant extracts are variable, back calculation was used to determine the maximum acceptable concentration of a given constituent in an extract of CF. This paper demonstrates the utility and practical application of the TTC concept when used as a tool in the safety evaluation of botanical extracts.

Simulator training to minimize ionizing radiation exposure in the catheterization laboratory.

PubMed

Katz, Aric; Shtub, Avraham; Solomonica, Amir; Poliakov, Adva; Roguin, Ariel

2017-03-01

To learn about radiation and how to lower it. Patients and operators are routinely exposed to high doses of ionizing radiation during catheterization procedures. This increased exposure to ionizing radiation is partially due to a lack of awareness to the effects of ionizing radiation, and lack of knowledge on the distribution and behavior of scattered radiation. A simulator, which incorporates data on scattered ionizing radiation, was built based on multiple phantom measurements and used for teaching radiation safety. The validity of the simulator was confirmed in three catheterization laboratories and tested by 20 interventional cardiologists. All evaluators were tested by an objective knowledge examination before, immediately following, and 12 weeks after simulator-based learning and training. A subjective Likert questionnaire on satisfaction with simulation-based learning and training was also completed. The 20 evaluators learned and retained the knowledge that they gained from using the simulator: the average scores of the knowledge examination pre-simulator training was 54 ± 15% (mean ± standard deviation), and this score significantly increased after training to 94 ± 10% (p < 0.001). The evaluators also reported high levels of satisfaction following simulation-based learning and training according to the results of the subjective Likert questionnaire. Simulators can be used to train cardiology staff and fellows and to further educate experienced personnel on radiation safety. As a result of simulator training, the operator gains knowledge, which can then be applied in the catheterization laboratory in order to reduce radiation doses to the patient and to the operator, thereby improving the safety of the intervention.

Regulatory Science in Practice (Pharmaceuticals and Medical Devices Agency).

PubMed

Hojo, Taisuke

2017-01-01

Review, safety, and relief services of the Pharmaceuticals and Medical Devices Agency are primarily focused on scientifically evaluating pharmaceuticals, medical devices, and cellular and tissue-based products referring to their quality, efficacy, and safety, which requires a variety of scientific knowledge and methods. Pharmaceutical regulation should be established based on the most advanced scientific expertise at all times. In order to evaluate products that use cutting-edge technology such as induced pluripotent stem cells and information and communication technology adequately, since fiscal year 2012 the Science Committee has been established as a platform to exchange opinions among members from top-ranking domestic and international academia and to enhance personnel exchanges through the Initiative to Facilitate Development of Innovative Drugs. In addition, the Regulatory Science Center will be established in 2018 to increase the integrity of our services for product reviews and safety measures. In particular, requiring electronic data submissions for clinical trial applications followed by an advanced approach to analysis should not only enhance the quality of reviews of individual products but should also support the development of pharmaceuticals and medical devices by providing pharmaceutical affairs consultations on research and development strategies with various guidelines based on new insights resulting from product-bridging data analysis. Moreover, a database including electronic health records with comprehensive medical information collected mainly from 10 cooperating medical institutions will be developed with the aim of developing safety measures in a more timely manner using methods of pharmacoepidemiological analysis.

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.

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

[Monitoring evaluation system for high-specialty hospitals].

PubMed

Fajardo Dolci, Germán; Aguirre Gas, Héctor G; Robledo Galván, Héctor

2011-01-01

Hospital evaluation is a fundamental process to identify medical units' objective compliance, to analyze efficiency of resource use and allocation, institutional values and mission alignment, patient safety and quality standards, contributions to research and medical education, and the degree of coordination among medical units and the health system as a whole. We propose an evaluation system for highly specialized regional hospitals through the monitoring of performance indicators. The following are established as base thematic elements in the construction of indicators: safe facilities and equipment, financial situation, human resources management, policy management, organizational climate, clinical activity, quality and patient safety, continuity of care, patients' and providers' rights and obligations, teaching, research, social responsibility, coordination mechanisms. Monitoring refers to the planned and systematic evaluation of valid and reliable indicators, aimed at identifying problems and opportunity areas. Moreover, evaluation is a powerful tool to strengthen decision-making and accountability in medical units.

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.

Advances in Liposuction: Five Key Principles with Emphasis on Patient Safety and Outcomes

PubMed Central

Tabbal, Geo N.; Ahmad, Jamil; Lista, Frank

2013-01-01

Summary: Since Illouz’s presentation of a technique for lipoplasty at the 1982 Annual Meeting of the American Society of Plastic and Reconstructive Surgeons, liposuction has become one of the most commonly performed aesthetic surgery procedures. The evolution of liposuction has seen refinements in technique and improvement of patient safety-related standards of care. Based on long-term experience with body contouring surgery, 5 principles of advanced liposuction are presented: preoperative evaluation and planning, intraoperative monitoring—safety measures, the role of wetting solutions and fluid resuscitation, circumferential contouring and complication prevention, and outcomes measurement. PMID:25289270

Safe Use of Hydrogen and Hydrogen Systems

NASA Technical Reports Server (NTRS)

Maes, Miguel

2006-01-01

This is a viewgraph presentation that is a course for teaching the safe use of hydrogen. The objectives of the course are 1. To familiarize the student with H2 safety properties 2. To enable the identification, evaluations and addressing of H2 system hazards 3. To teach: a. Safe practices for, b. Design, c. Materials selection, d. H2 system operation, e. Physical principles and empirical observations on which these safe practices are based, f. How to respond to emergency situations involving H2, g How to visualize safety concepts through in-class exercises, h. Identify numerous parameters important to H2 safety.

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.

NASA Safety Manual. Volume 3: System Safety

NASA Technical Reports Server (NTRS)

1970-01-01

This Volume 3 of the NASA Safety Manual sets forth the basic elements and techniques for managing a system safety program and the technical methods recommended for use in developing a risk evaluation program that is oriented to the identification of hazards in aerospace hardware systems and the development of residual risk management information for the program manager that is based on the hazards identified. The methods and techniques described in this volume are in consonance with the requirements set forth in NHB 1700.1 (VI), Chapter 3. This volume and future volumes of the NASA Safety Manual shall not be rewritten, reprinted, or reproduced in any manner. Installation implementing procedures, if necessary, shall be inserted as page supplements in accordance with the provisions of Appendix A. No portion of this volume or future volumes of the NASA Safety Manual shall be invoked in contracts.

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.

Safety Testing of Ammonium Nitrate Based Mixtures

NASA Astrophysics Data System (ADS)

Phillips, Jason; Lappo, Karmen; Phelan, James; Peterson, Nathan; Gilbert, Don

2013-06-01

Ammonium nitrate (AN)/ammonium nitrate based explosives have a lengthy documented history of use by adversaries in acts of terror. While historical research has been conducted on AN-based explosive mixtures, it has primarily focused on detonation performance while varying the oxygen balance between the oxidizer and fuel components. Similarly, historical safety data on these materials is often lacking in pertinent details such as specific fuel type, particle size parameters, oxidizer form, etc. A variety of AN-based fuel-oxidizer mixtures were tested for small-scale sensitivity in preparation for large-scale testing. Current efforts focus on maintaining a zero oxygen-balance (a stoichiometric ratio for active chemical participants) while varying factors such as charge geometry, oxidizer form, particle size, and inert diluent ratios. Small-scale safety testing was conducted on various mixtures and fuels. It was found that ESD sensitivity is significantly affected by particle size, while this is less so for impact and friction. Thermal testing is in progress to evaluate hazards that may be experienced during large-scale testing.

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...

Applications of hyperspectral imaging in chicken meat safety and quality detection and evaluation: a review.

PubMed

Xiong, Zhenjie; Xie, Anguo; Sun, Da-Wen; Zeng, Xin-An; Liu, Dan

2015-01-01

Currently, the issue of food safety and quality is a great public concern. In order to satisfy the demands of consumers and obtain superior food qualities, non-destructive and fast methods are required for quality evaluation. As one of these methods, hyperspectral imaging (HSI) technique has emerged as a smart and promising analytical tool for quality evaluation purposes and has attracted much interest in non-destructive analysis of different food products. With the main advantage of combining both spectroscopy technique and imaging technique, HSI technique shows a convinced attitude to detect and evaluate chicken meat quality objectively. Moreover, developing a quality evaluation system based on HSI technology would bring economic benefits to the chicken meat industry. Therefore, in recent years, many studies have been conducted on using HSI technology for the safety and quality detection and evaluation of chicken meat. The aim of this review is thus to give a detailed overview about HSI and focus on the recently developed methods exerted in HSI technology developed for microbiological spoilage detection and quality classification of chicken meat. Moreover, the usefulness of HSI technique for detecting fecal contamination and bone fragments of chicken carcasses are presented. Finally, some viewpoints on its future research and applicability in the modern poultry industry are proposed.

Evaluation of the National Archives program to convert nitrate aerial photographs of the United States to a stable-base safety film.

USGS Publications Warehouse

Williams, R.S.; Lyons, T.R.; Ferrigno, J.G.; Quinn, M.C.

1984-01-01

Discusses the programme on reproducing the 1930's and early 1940's nitrate aerial photographs of large areas of the US onto stable-base safety film, and the proceedings of a February 1981 meeting at the National Archives and Records Service, General Services Administration, which discussed the programme and inspected the results of the new full-size (1:1), roll-to-roll conversions. The latter process was found to be acceptable to all current and envisaged future users of this photography.-R.House

A systems-based food safety evaluation: an experimental approach.

PubMed

Higgins, Charles L; Hartfield, Barry S

2004-11-01

Food establishments are complex systems with inputs, subsystems, underlying forces that affect the system, outputs, and feedback. Building on past exploration of the hazard analysis critical control point concept and Ludwig von Bertalanffy General Systems Theory, the National Park Service (NPS) is attempting to translate these ideas into a realistic field assessment of food service establishments and to use information gathered by these methods in efforts to improve food safety. Over the course of the last two years, an experimental systems-based methodology has been drafted, developed, and tested by the NPS Public Health Program. This methodology is described in this paper.

Transportation communications interoperability : phase 2, resource evaluation.

DOT National Transportation Integrated Search

2006-12-01

Based on the Arizona Department of Transportations (ADOT) previous SPR-561 Needs Assessment study, this : report continues the efforts to enhance radio interoperability between Department of Public Safety (DPS) Highway : Patrol officers and ...

Use of the false discovery rate for evaluating clinical safety data.

PubMed

Mehrotra, Devan V; Heyse, Joseph F

2004-06-01

Clinical adverse experience (AE) data are routinely evaluated using between group P values for every AE encountered within each of several body systems. If the P values are reported and interpreted without multiplicity considerations, there is a potential for an excess of false positive findings. Procedures based on confidence interval estimates of treatment effects have the same potential for false positive findings as P value methods. Excess false positive findings can needlessly complicate the safety profile of a safe drug or vaccine. Accordingly, we propose a novel method for addressing multiplicity in the evaluation of adverse experience data arising in clinical trial settings. The method involves a two-step application of adjusted P values based on the Benjamini and Hochberg false discovery rate (FDR). Data from three moderate to large vaccine trials are used to illustrate our proposed 'Double FDR' approach, and to reinforce the potential impact of failing to account for multiplicity. This work was in collaboration with the late Professor John W. Tukey who coined the term 'Double FDR'.

The history of anaesthetic equipment evaluation in the United Kingdom: lessons for developing future strategy.

PubMed

Wilkes, A R; Pandit, J J; O'Sullivan, E

2011-12-01

Recent guidance published by the Association of Anaesthetists of Great Britain and Ireland encourages the purchase of equipment based on evidence of safety and performance. For many years, evidence of the safety and performance of anaesthetic equipment was published by various government departments and agencies. However, these schemes were gradually eroded over time such that many devices entered the market with little or no clinical evidence of their efficacy. This recently led to the Difficult Airway Society's issuing guidance to its members on how best to select new airway devices; guidance that was based on the available evidence. This article provides a short history of the evaluation of anaesthetic equipment in the United Kingdom. © 2011 The Authors. Anaesthesia © 2011 The Association of Anaesthetists of Great Britain and Ireland.

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.

"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 preschool program for safety and injury prevention delivered by home visitors

PubMed Central

Johnston, B; Britt, J; D'Ambrosio, L; Mueller, B; Rivara, F

2000-01-01

Objective—To evaluate the feasibility, acceptability, and effectiveness of an injury prevention program delivered by school based home visitors to the families of low income children attending preschool enrichment programs in Washington State. Study sample—The families of children attending preschool Head Start programs in two regions were eligible. A total of 213 families (77.8% of those eligible) from intervention sites, and 149 families (71.9% of those eligible) from concurrent comparison sites, agreed to participate and completed the trial. Intervention—Trained school personnel conducted home safety inspections as part of a planned home visit. Intervention families were offered educational materials as well as smoke detectors, batteries, ipecac, and age appropriate car safety restraints based on results of the home inspection. Evaluation methods—At a repeat home visit three months later, the proportion of families with a positive change in injury prevention knowledge or behavior among those in the intervention group was compared with the proportion in the comparison group. Smoke detector presence and function were observed. Results—Among families without a working smoke detector at baseline, the intervention was associated with an increased probability of having a working detector at follow up (relative risk (RR) 3.3, 95% confidence interval (CI) 1.3 to 8.6). Intervention families were also more likely to report the presence of ipecac in the home (RR 4.7, 95% CI 3.0 to 7.3) at follow up and to have obtained an age appropriate booster seat (RR 4.1, 95% CI 1.9 to 8.8). The program was acceptable to client families and to the home visitors who conducted the intervention. Conclusions—Among the families of low income children enrolled in preschool enrichment programs, home safety inspections and the distribution of safety supplies by school based home visitors appears to improve knowledge and behavior related to poisoning, smoke detector installation, and car safety seat use over three months of follow up. PMID:11144634

Quantification of the trade-off between force attenuation and balance impairment in the design of compliant safety floors.

PubMed

Glinka, Michal N; Cheema, Kim P; Robinovitch, Stephen N; Laing, Andrew C

2013-10-01

Safety floors (also known as compliant floors) may reduce the risk of fall-related injuries by attenuating impact force during falls, but are only practical if they do not negatively affect balance and mobility. In this study, we evaluated seven safety surfaces based on their ability to attenuate peak femoral neck force during simulated hip impacts, and their influence on center of pressure (COP) sway during quiet and tandem stance. Overall, we found that some safety floors can attenuate up to 33.7% of the peak femoral impact force without influencing balance. More specifically, during simulated hip impacts, force attenuation for the safety floors ranged from 18.4 (SD 4.3)% to 47.2 (3.1)%, with each floor significantly reducing peak force compared with a rigid surface. For quiet stance, only COP root mean square was affected by flooring (and increased for only two safety floors). During tandem stance, COP root mean square and mean velocity increased in the medial-lateral direction for three of the seven floors. Based on the substantial force attenuation with no concomitant effects on balance for some floors, these results support the development of clinical trials to assess the effectiveness of safety floors at reducing fall-related injuries in high-risk settings.

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.

Driving and dementia: Efficient approach to driving safety concerns in family practice.

PubMed

Lee, Linda; Molnar, Frank

2017-01-01

To provide primary care physicians with an approach to driving safety concerns when older persons present with memory difficulties. The approach is based on an accredited memory clinic training program developed by the Centre for Family Medicine Primary Care Collaborative Memory Clinic. One of the most challenging aspects of dementia care is the assessment of driving safety. Drivers with dementia are at higher risk of motor vehicle collisions, yet many drivers with mild dementia might be safely able to continue driving for several years. Because safe driving is dependent on multiple cognitive and functional skills, clinicians should carefully consider many factors when determining if cognitive concerns affect driving safety. Specific findings on corroborated history and office-based cognitive testing might aid in the physician's decisions to refer for comprehensive on-road driving evaluation and whether to notify transportation authorities in accordance with provincial reporting requirements. Sensitive communication and a person-centred approach are essential. Primary care physicians must consider many factors when determining if cognitive concerns might affect driving safety in older drivers. Copyright© the College of Family Physicians of Canada.

Evaluation and review of the safety management system implementation in the Royal Thai Air Force

NASA Astrophysics Data System (ADS)

Chaiwan, Sakkarin

This study was designed to determine situation and effectiveness of the safety management system currently implemented in the Royal Thai Air Force. Reviewing the ICAO's SMS and the RTAF's SMS was conducted to identify similarities and differences between the two safety management systems. Later, the researcher acquired safety statistics from the RTAF Safety Center to investigate effectiveness of its safety system. The researcher also collected data to identify other factors affecting effectiveness of the safety system during conducting in-depth interviews. Findings and Conclusions: The study shows that the Royal Thai Air Force has never applied the International Civil Aviation Organization's Safety management System to its safety system. However, the RTAF's SMS and the ICAO's SMS have been developed based on the same concepts. These concepts are from Richard H. Woods's book, Aviation safety programs: A management handbook. However, the effectiveness of the Royal Thai Air Force's safety system is in good stance. An accident rate has been decreasing regularly but there are no known factors to describe the increasing rate, according to the participants' opinion. The participants have informed that there are many issues to be resolved to improve the RTAF's safety system. Those issues are cooperation among safety center's staffs, attitude toward safety of the RTAF senior commanders, and safety standards.

Line-scan hyperspectral imaging platform for agro-food safety and quality evaluation: System enhancement and characterization

USDA-ARS?s Scientific Manuscript database

Line-scan-based hyperspectral imaging techniques have often served as a research tool to develop rapid multispectral methods based on only a few spectral bands for rapid online applications. With continuing technological advances and greater accessibility to and availability of optoelectronic imagin...

Techniques to evaluate the importance of common cause degradation on reliability and safety of nuclear weapons.

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

Darby, John L.

2011-05-01

As the nuclear weapon stockpile ages, there is increased concern about common degradation ultimately leading to common cause failure of multiple weapons that could significantly impact reliability or safety. Current acceptable limits for the reliability and safety of a weapon are based on upper limits on the probability of failure of an individual item, assuming that failures among items are independent. We expanded the current acceptable limits to apply to situations with common cause failure. Then, we developed a simple screening process to quickly assess the importance of observed common degradation for both reliability and safety to determine if furthermore » action is necessary. The screening process conservatively assumes that common degradation is common cause failure. For a population with between 100 and 5000 items we applied the screening process and conclude the following. In general, for a reliability requirement specified in the Military Characteristics (MCs) for a specific weapon system, common degradation is of concern if more than 100(1-x)% of the weapons are susceptible to common degradation, where x is the required reliability expressed as a fraction. Common degradation is of concern for the safety of a weapon subsystem if more than 0.1% of the population is susceptible to common degradation. Common degradation is of concern for the safety of a weapon component or overall weapon system if two or more components/weapons in the population are susceptible to degradation. Finally, we developed a technique for detailed evaluation of common degradation leading to common cause failure for situations that are determined to be of concern using the screening process. The detailed evaluation requires that best estimates of common cause and independent failure probabilities be produced. Using these techniques, observed common degradation can be evaluated for effects on reliability and safety.« less

Evaluation of the neighborhood environment walkability scale in Nigeria.

PubMed

Oyeyemi, Adewale L; Sallis, James F; Deforche, Benedicte; Oyeyemi, Adetoyeje Y; De Bourdeaudhuij, Ilse; Van Dyck, Delfien

2013-03-21

The development of reliable and culturally sensitive measures of attributes of the built and social environment is necessary for accurate analysis of environmental correlates of physical activity in low-income countries, that can inform international evidence-based policies and interventions in the worldwide prevention of physical inactivity epidemics. This study systematically adapted the Neighborhood Environment Walkability Scale (NEWS) for Nigeria and evaluated aspects of reliability and validity of the adapted version among Nigerian adults. The adaptation of the NEWS was conducted by African and international experts, and final items were selected for NEWS-Nigeria after a cross-validation of the confirmatory factor analysis structure of the original NEWS. Participants (N = 386; female = 47.2%) from two cities in Nigeria completed the adapted NEWS surveys regarding perceived residential density, land use mix - diversity, land use mix - access, street connectivity, infrastructure and safety for walking and cycling, aesthetics, traffic safety, and safety from crime. Self-reported activity for leisure, walking for different purposes, and overall physical activity were assessed with the validated International Physical Activity Questionnaire (long version). The adapted NEWS subscales had moderate to high test-retest reliability (ICC range 0.59 -0.91). Construct validity was good, with residents of high-walkable neighborhoods reporting significantly higher residential density, more land use mix diversity, higher street connectivity, more traffic safety and more safety from crime, but lower infrastructure and safety for walking/cycling and aesthetics than residents of low-walkable neighborhoods. Concurrent validity correlations were low to moderate (r = 0.10 -0.31) with residential density, land use mix diversity, and traffic safety significantly associated with most physical activity outcomes. The NEWS-Nigeria demonstrated acceptable measurement properties among Nigerian adults and may be useful for evaluation of the built environment in Nigeria. Further adaptation and evaluation in other African countries is needed to create a version that could be used throughout the African region.

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.

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...

Range safety signal propagation through the SRM exhaust plume of the space shuttle

NASA Technical Reports Server (NTRS)

Boynton, F. P.; Davies, A. R.; Rajasekhar, P. S.; Thompson, J. A.

1977-01-01

Theoretical predictions of plume interference for the space shuttle range safety system by solid rocket booster exhaust plumes are reported. The signal propagation was calculated using a split operator technique based upon the Fresnel-Kirchoff integral, using fast Fourier transforms to evaluate the convolution and treating the plume as a series of absorbing and phase-changing screens. Talanov's lens transformation was applied to reduce aliasing problems caused by ray divergence.

Is the large simple trial design used for comparative, post-approval safety research? A review of a clinical trials registry and the published literature.

PubMed

Reynolds, Robert F; Lem, Joanna A; Gatto, Nicolle M; Eng, Sybil M

2011-10-01

Post-approval, observational drug safety studies face well known difficulties in controlling for confounding, particularly confounding by indication for drug use. A study design that addresses confounding by indication is the large simple trial (LST). LSTs are characterized by large sample sizes, often in the thousands; broad entry criteria consistent with the approved medication label; randomization based on equipoise, i.e. neither physician nor patient believes that one treatment option is superior; minimal, streamlined data collection requirements; objectively-measured endpoints (e.g. death, hospitalization); and follow-up that minimizes interventions or interference with normal clinical practice. In theory then, the LST is a preferred study design for drug and vaccine safety research because it controls for biases inherent to observational research while still providing results that are generalizable to 'real-world' use. To evaluate whether LSTs are used for comparative safety evaluation and if the design is, in fact, advantageous compared with other designs, we conducted a review of the published literature (1949 through 31 December 2010) and the ClinicalTrials.gov registry (2000 through 31 December 2010). Thirteen ongoing or completed safety LSTs were identified. The design has rarely been used in comparative drug safety research, which is due to the operational, financial and scientific hurdles of implementing the design. The studies that have been completed addressed important clinical questions and, in some cases, led to re-evaluation of medical practice. We conclude the design has demonstrated utility for comparative safety research of medicines and vaccines if the necessary scientific and operational conditions for its use are met.

A new method for the assessment of patient safety competencies during a medical school clerkship using an objective structured clinical examination

PubMed Central

Daud-Gallotti, Renata Mahfuz; Morinaga, Christian Valle; Arlindo-Rodrigues, Marcelo; Velasco, Irineu Tadeu; Arruda Martins, Milton; Tiberio, Iolanda Calvo

2011-01-01

INTRODUCTION: Patient safety is seldom assessed using objective evaluations during undergraduate medical education. OBJECTIVE: To evaluate the performance of fifth-year medical students using an objective structured clinical examination focused on patient safety after implementation of an interactive program based on adverse events recognition and disclosure. METHODS: In 2007, a patient safety program was implemented in the internal medicine clerkship of our hospital. The program focused on human error theory, epidemiology of incidents, adverse events, and disclosure. Upon completion of the program, students completed an objective structured clinical examination with five stations and standardized patients. One station focused on patient safety issues, including medical error recognition/disclosure, the patient-physician relationship and humanism issues. A standardized checklist was completed by each standardized patient to assess the performance of each student. The student's global performance at each station and performance in the domains of medical error, the patient-physician relationship and humanism were determined. The correlations between the student performances in these three domains were calculated. RESULTS: A total of 95 students participated in the objective structured clinical examination. The mean global score at the patient safety station was 87.59±1.24 points. Students' performance in the medical error domain was significantly lower than their performance on patient-physician relationship and humanistic issues. Less than 60% of students (n = 54) offered the simulated patient an apology after a medical error occurred. A significant correlation was found between scores obtained in the medical error domains and scores related to both the patient-physician relationship and humanistic domains. CONCLUSIONS: An objective structured clinical examination is a useful tool to evaluate patient safety competencies during the medical student clerkship. PMID:21876976

The Efficacy and Safety of Icotinib in Patients with Advanced Non-Small Cell Lung Cancer Previously Treated with Chemotherapy: A Single-Arm, Multi-Center, Prospective Study.

PubMed

Hu, Xingsheng; Zhang, Li; Shi, Yuankai; Zhou, Caicun; Liu, Xiaoqing; Wang, Dong; Song, Yong; Li, Qiang; Feng, Jifeng; Qin, Shukui; Xv, Nong; Zhou, Jianying; Zhang, Li; Hu, Chunhong; Zhang, Shucai; Luo, Rongcheng; Wang, Jie; Tan, Fenlai; Wang, Yinxiang; Ding, Lieming; Sun, Yan

2015-01-01

Icotinib is a small molecule targeting epidermal growth factor receptor tyrosine kinase, which shows non-inferior efficacy and better safety comparing to gefitinib in previous phase III trial. The present study was designed to further evaluate the efficacy and safety of icotinib in patients with advanced non-small-cell lung cancer (NSCLC) previously treated with platinum-based chemotherapy. Patients with NSCLC progressing after one or two lines of chemotherapy were enrolled to receive oral icotinib (125 mg tablet, three times per day). The primary endpoint was progression-free survival. The secondary endpoints included overall survival, objective response rate, time to progression, quality of life and safety. From March 16, 2010 to October 9, 2011, 128 patients from 15 centers nationwide were enrolled, in which 124 patients were available for efficacy evaluation and 127 patients were evaluable for safety. The median progression-free survival and time to progression were 5.0 months (95%CI 2.9-6.6 m) and 5.4 months (95%CI 3.1-7.9 m), respectively. The objective response rate and disease control rate were 25.8% and 67.7% respectively. Median overall survival exceeded 17.6 months (95%CI 14.2 m-NA) according to censored data. Further follow-up of overall survival is ongoing. The most frequent treatment-related adverse events were rash (26%, 33/127), diarrhea (12.6%, 16/127) and elevation of transaminase (15.7%, 20/127). In general, this study showed similar efficacy and numerically better safety when compared with that in ICOGEN trial, further confirming the efficacy and safety of icotinib in treating patients with advanced NSCLC previously treated with chemotherapy. ClinicalTrials.gov NCT02486354.

Assessment of safety culture among job positions in high-rise construction: a hybrid fuzzy multi criteria decision-making (FMCDM) approach.

PubMed

Ardeshir, A; Mohajeri, M

2018-06-01

The construction industry is known as one of the most dangerous industries, which not only requires sound operation of executive laws and regulations, but also necessitates the safety culture of all workers at workshops. Therefore, the aim of this research is to identify the factors of safety culture and ranking occupations in jobsites based on those factors in order to proactively improve the safety culture of construction projects and subsequently promote safety conditions and worksites. In this study, safety culture criteria are weighted by a combination of Fuzzy Decision Trail and Evaluation Laboratory and Fuzzy ANP methods. Next, different job positions in high-rise projects are ranked using the Fuzzy Technique for Order of Preference by Similarity to Ideal Solution method. Findings demonstrated that the project manager, site superintendent and supervisor occupations had the highest and labourers had the lowest level of safety culture in the high-rise construction industry. Furthermore, factors such as safety supervision and training must be considered more seriously in order to create a positive safety culture among workers.

A randomized, multicenter, double-blind, vehicle-controlled study evaluating the efficacy and safety of luliconazole cream 1% once daily for 7 days in patients aged ≥ 12 years with tinea cruris.

PubMed

Jones, Terry M; Jarratt, Michael T; Mendez-Moguel, Ines; Paz, Nelly; Grekin, Steven K; Cognata Smith, Christina; Kaur, Mandeep

2014-01-01

Tinea cruris, a pruritic superficial fungal infection of the groin, is the second most common clinical presentation for dermatophytosis. This phase 3 study evaluated the safety and efficacy of topical luliconazole cream 1% in patients with tinea cruris. 483 patients were enrolled and 256 male and female patients aged ≥12 years with clinically evident tinea cruris and eligible for modified intent-to-treat analysis were randomized 2:1 to receive luliconazole cream 1% (n=165) or vehicle (n=91) once daily for 7 days. Efficacy was evaluated at baseline and at days 7, 14, 21, and 28 based on mycology (potassium hydroxide, fungal culture) and clinical signs (erythema, scaling, pruritus). The primary outcome was complete clearance at day 28 (21 days posttreatment). Safety evaluations included adverse events and laboratory assessments. Complete clearance was obtained in 21.2% (35/165) of patients treated with luliconazole cream 1% compared with 4.4% (4/91) treated with vehicle (P<0.001). The safety profile of luliconazole cream 1% was similar to vehicle. The study was conducted under controlled conditions in a relatively small population. Luliconazole cream 1% applied once daily for 7 days is more effective than vehicle and well tolerated in patients with tinea cruris.

Expert opinions on the acceptance of alternative methods in food safety evaluations: Formulating recommendations to increase acceptance of non-animal methods for kinetics.

PubMed

Punt, Ans; Bouwmeester, Hans; Schiffelers, Marie-Jeanne W A; Peijnenburg, Ad A C M

2018-02-01

Inclusion of alternative methods that replace, reduce, or refine (3R) animal testing within regulatory safety evaluations of chemicals generally faces many hurdles. The goal of the current work is to i) collect responses from key stakeholders involved in food safety evaluations on what they consider the most relevant factors that influence the acceptance and use of 3R methods and to ii) use these responses to formulate activities needed to increase the acceptance and use of 3R methods, particularly for kinetics. The stakeholders were contacted by e-mail for their opinions, asking the respondents to write down three barriers and/or drivers and scoring these by distributing 5 points over the three factors. The main barriers that obtained the highest aggregated scores were i) uncertain predictability 3R methods/lack of validation, ii) insufficient guidance regulators/industry and iii) insufficient harmonization of legislation. The major driver identified was the possibility of 3R methods to provide more mechanistic information. Based on the results, recommendations are given to enhance the acceptance and application of 3R toxicokinetic methods in food safety evaluations. These include steering of regulatory data requirements as well as creating (funding) opportunities for development and validation of alternative methods for kinetics and development of guidances. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Online continuing education course enhances nutrition and health professionals' knowledge of food safety issues of high-risk populations.

PubMed

Wallner, Stephanie; Kendall, Patricia; Hillers, Virginia; Bradshaw, Eva; Medeiros, Lydia C

2007-08-01

To develop and evaluate the efficacy of an online continuing education course for professionals who provide food safety information to high-risk populations. A 2-credit graduate-level class was converted into six web-based modules (overview of foodborne illness, immunology, pregnancy, human immunodeficiency virus, cancer and transplants, and lifecycle) and offered to nutrition and health professionals. Participants had 8 weeks to complete the modules, pre and post questionnaires, and course evaluation. Those who successfully completed the protocol received six continuing education units from one of three professional associations. Change in knowledge was measured using pre and post questionnaires. Course efficacy was evaluated using a post-course questionnaire. A convenience sample of 140 registered dietitians/dietetic technicians registered, nurses, and extension educators were recruited through professional conferences and electronic mailing lists to take the course. Analysis of variance was used to evaluate differences in knowledge scores for all groups across five main effects (attempt, module, profession, age, and education). Course evaluation responses were used to assess course effectiveness. For each module, knowledge scores increased significantly (P<0.001) from pre to post questionnaire. Overall, knowledge scores increased from 67.3% before the modules to 91.9% afterwards. Course evaluation responses were favorable, and participants indicated that course objectives were met. Online continuing education courses, such as "Food Safety Issues for High Risk Populations," seem to be a convenient, effective option for dietetics professionals, nurses, and extension educators seeking knowledge about food safety issues of high-risk populations. Online learning is a promising delivery approach for the continuing education of health professionals.

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

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

Advanced biosensing methodologies developed for evaluating performance quality and safety of emerging biophotonics technologies and medical devices (Conference Presentation)

NASA Astrophysics Data System (ADS)

Ilev, Ilko K.; Walker, Bennett; Calhoun, William; Hassan, Moinuddin

2016-03-01

Biophotonics is an emerging field in modern biomedical technology that has opened up new horizons for transfer of state-of-the-art techniques from the areas of lasers, fiber optics and biomedical optics to the life sciences and medicine. This field continues to vastly expand with advanced developments across the entire spectrum of biomedical applications ranging from fundamental "bench" laboratory studies to clinical patient "bedside" diagnostics and therapeutics. However, in order to translate these technologies to clinical device applications, the scientific and industrial community, and FDA are facing the requirement for a thorough evaluation and review of laser radiation safety and efficacy concerns. In many cases, however, the review process is complicated due the lack of effective means and standard test methods to precisely analyze safety and effectiveness of some of the newly developed biophotonics techniques and devices. There is, therefore, an immediate public health need for new test protocols, guidance documents and standard test methods to precisely evaluate fundamental characteristics, performance quality and safety of these technologies and devices. Here, we will overview our recent developments of novel test methodologies for safety and efficacy evaluation of some emerging biophotonics technologies and medical devices. These methodologies are based on integrating the advanced features of state-of-the-art optical sensor technologies and approaches such as high-resolution fiber-optic sensing, confocal and optical coherence tomography imaging, and infrared spectroscopy. The presentation will also illustrate some methodologies developed and implemented for testing intraocular lens implants, biochemical contaminations of medical devices, ultrahigh-resolution nanoscopy, and femtosecond laser therapeutics.

Cornell Alliance for Science Evaluation of Consensus on Genetically Modified Food Safety: Weaknesses in Study Design

PubMed Central

Antoniou, Michael N.; Robinson, Claire J.

2017-01-01

Cornell Alliance for Science has launched an initiative in which “citizen scientists” are called upon to evaluate studies on health risks of genetically modified (GM) crops and foods. The purpose is to establish whether the consensus on GM food safety claimed by the American Association for the Advancement of Science (AAAS) is supported by a review of the scientific literature. The Alliance’s citizen scientists are examining more than 12,000 publication abstracts to quantify how far the scientific literature supports the AAAS’s statement. We identify a number of fundamental weaknesses in the Alliance’s study design, including evaluation is based only on information provided in the publication abstract; there is a lack of clarity as to what material is included in the 12,000 study abstracts to be reviewed, since the number of appropriately designed investigations addressing GM food safety are few; there is uncertainty as to whether studies of toxic effects arising from GM crop-associated pesticides will be included; there is a lack of clarity regarding whether divergent yet equally valid interpretations of the same study will be taken into account; and there is no definition of the cutoff point for consensus or non-consensus on GM food safety. In addition, vital industry proprietary biosafety data on GM crops and associated pesticides are not publicly available and is thus cannot inform this project. Based on these weaknesses in the study design, we believe it is questionable as to whether any objective or meaningful conclusion can be drawn from the Alliance’s initiative. PMID:28447029

Cornell Alliance for Science Evaluation of Consensus on Genetically Modified Food Safety: Weaknesses in Study Design.

PubMed

Antoniou, Michael N; Robinson, Claire J

2017-01-01

Cornell Alliance for Science has launched an initiative in which "citizen scientists" are called upon to evaluate studies on health risks of genetically modified (GM) crops and foods. The purpose is to establish whether the consensus on GM food safety claimed by the American Association for the Advancement of Science (AAAS) is supported by a review of the scientific literature. The Alliance's citizen scientists are examining more than 12,000 publication abstracts to quantify how far the scientific literature supports the AAAS's statement. We identify a number of fundamental weaknesses in the Alliance's study design, including evaluation is based only on information provided in the publication abstract; there is a lack of clarity as to what material is included in the 12,000 study abstracts to be reviewed, since the number of appropriately designed investigations addressing GM food safety are few; there is uncertainty as to whether studies of toxic effects arising from GM crop-associated pesticides will be included; there is a lack of clarity regarding whether divergent yet equally valid interpretations of the same study will be taken into account; and there is no definition of the cutoff point for consensus or non-consensus on GM food safety. In addition, vital industry proprietary biosafety data on GM crops and associated pesticides are not publicly available and is thus cannot inform this project. Based on these weaknesses in the study design, we believe it is questionable as to whether any objective or meaningful conclusion can be drawn from the Alliance's initiative.

Criticality safety evaluation for the Advanced Test Reactor enhanced low enriched uranium fuel elements

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

Montierth, Leland M.

2016-07-19

The Global Threat Reduction Initiative (GTRI) convert program is developing a high uranium density fuel based on a low enriched uranium (LEU) uranium-molybdenum alloy. Testing of prototypic GTRI fuel elements is necessary to demonstrate integrated fuel performance behavior and scale-up of fabrication techniques. GTRI Enhanced LEU Fuel (ELF) elements based on the ATR-Standard Size elements (all plates fueled) are to be fabricated for testing in the Advanced Test Reactor (ATR). While a specific ELF element design will eventually be provided for detailed analyses and in-core testing, this criticality safety evaluation (CSE) is intended to evaluate a hypothetical ELF element designmore » for criticality safety purposes. Existing criticality analyses have analyzed Standard (HEU) ATR elements from which controls have been derived. This CSE documents analysis that determines the reactivity of the hypothetical ELF fuel elements relative to HEU ATR elements and whether the existing HEU ATR element controls bound the ELF element. The initial calculations presented in this CSE analyzed the original ELF design, now referred to as Mod 0.1. In addition, as part of a fuel meat thickness optimization effort for reactor performance, other designs have been evaluated. As of early 2014 the most current conceptual designs are Mk1A and Mk1B, that were previously referred to as conceptual designs Mod 0.10 and Mod 0.11, respectively. Revision 1 evaluates the reactivity of the ATR HEU Mark IV elements for a comparison with the Mark VII elements.« less

Safety I-II, resilience and antifragility engineering: a debate explained through an accident occurring on a mobile elevating work platform.

PubMed

Martinetti, Alberto; Chatzimichailidou, Maria Mikela; Maida, Luisa; van Dongen, Leo

2018-04-24

Occupational health and safety (OHS) represents an important field of exploration for the research community: in spite of the growth of technological innovations, the increasing complexity of systems involves critical issues in terms of degradation of the safety levels. In such a situation, new safety management approaches are now mandatory in order to face the safety implications of the current technological evolutions. Along these lines, performing risk-based analysis alone seems not to be enough anymore. The evaluation of robustness, antifragility and resilience of a socio-technical system is now indispensable in order to face unforeseen events. This article will briefly introduce the topics of Safety I and Safety II, resilience engineering and antifragility engineering, explaining correlations, overlapping aspects and synergies. Secondly, the article will discuss the applications of those paradigms to a real accident, highlighting how they can challenge, stimulate and inspire research for improving OHS conditions.

Middle East food safety perspectives.

PubMed

Idriss, Atef W; El-Habbab, Mohammad S

2014-08-01

Food safety and quality assurance are increasingly a major issue with the globalisation of agricultural trade, on the one hand, and intensification of agriculture, on the other. Consumer protection has become a priority in policy-making amongst the large economies of the Middle East and North Africa (MENA) countries following a number of food safety incidents. To enhance food safety, it is necessary to establish markets underpinned by knowledge and resources, including analysis of international rejections of food products from MENA countries, international laboratory accreditation, improved reporting systems and traceability, continued development and validation of analytical methods, and more work on correlating sensory evaluation with analytical results. MENA countries should develop a national strategy for food safety based on a holistic approach that extends from farm-to-fork and involves all the relevant stakeholders. Accordingly, food safety should be a regional programme, raising awareness among policy- and decision-makers of the importance of food safety and quality for consumer protection, food trade and economic development. © 2014 Society of Chemical Industry.

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 Effects of Safety Information on Aeronautical Decision Making

NASA Technical Reports Server (NTRS)

Lee, Jang R.; Fanjoy, Richard O.; Dillman, Brian G.

2005-01-01

The importance of aeronautical decision making (ADM) has been considered one of the most critical issues of flight education for future professional pilots. Researchers have suggested that a safety information system based on information from incidents and near misses is an important tool to improve the intelligence and readiness of pilots. This paper describes a study that examines the effect of safety information on aeronautical decision making for students in a collegiate flight program. Data was collected from study participants who were exposed to periodic information about local aircraft malfunctions. Participants were then evaluated using a flight simulator profile and a pen and pencil test of situational judgment. Findings suggest that regular access to the described safety information program significantly improves decision making of student pilots.

A PC-based simulation of the National Transonic Facitity's safety microprocessor

NASA Technical Reports Server (NTRS)

Thibodeaux, J. J.; Kilgore, W. A.; Balakrishna, S.

1993-01-01

A brief study was undertaken to demonstrate the feasibility of using a state-of-the-art off-the-shelf high speed personal computer for simulating a microprocessor presently used for wind tunnel safety purposes at Langley Research Center's National Transonic Facility (NTF). Currently, there is no active display of tunnel alarm/alert safety information provided to the tunnel operators, but rather such information is periodically recorded on a process monitoring computer printout. This does not provide on-line situational information nor permit rapid identification of safety operational violations which are able to halt tunnel operations. It was therefore decided to simulate the existing algorithms and briefly evaluate a real-time display which could provide both position and trouble shooting information.

Safety evaluation of right-turn smart channels using automated traffic conflict analysis.

PubMed

Autey, Jarvis; Sayed, Tarek; Zaki, Mohamed H

2012-03-01

This paper presents the results of a before-after (BA) safety evaluation of a newly proposed design for channelized right-turn lanes. The new design, termed "Smart Channels", decreases the angle of the channelized right turn to approximately 70°. The implementation of these modified right-turn channels is usually advocated to allow for safer pedestrian crossing. However, the benefits also extend to vehicle-vehicle interactions since the new approach angle affords drivers a better view of the traffic stream they are to merge with. The evaluation is conducted using a video-based automated traffic conflict analysis. There are several advantages that support the adoption of traffic conflict techniques in BA safety studies. Traffic conflicts are more frequent than road collisions and are of marginal social cost, they provide insight into the failure mechanism that leads to road collisions, and BA studies based on traffic conflicts can be conducted over shorter periods. As well, the use of automated conflict analysis overcomes the reliability and repeatability problems usually associated with manual conflict observations. Data for three treatment intersections and one control intersection in Penticton, British Columbia, are used in this study. The results of the evaluation show that the implementation of the right-turn treatment has resulted in a considerable reduction in the severity and frequency of merging, rear-end, and total conflicts. The total average hourly conflict was reduced by about 51% while the average conflict severity was reduced by 41%. Copyright © 2011 Elsevier Ltd. All rights reserved.

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, :...

78 FR 47010 - Proposed Safety Evaluation for Plant-Specific

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-02

... to the existing SR on the reactor core isolation cooling system to maintain consistency within the... TS Bases are revised to reflect the change to the SRs. The proposed change captures the on-going...

A Trigger-based Design for Evaluating the Safety of In Utero Antiretroviral Exposure in Uninfected Children of Human Immunodeficiency Virus-Infected Mothers

PubMed Central

Williams, Paige L.; Seage, George R.; Van Dyke, Russell B.; Siberry, George K.; Griner, Raymond; Tassiopoulos, Katherine; Yildirim, Cenk; Read, Jennifer S.; Huo, Yanling; Hazra, Rohan; Jacobson, Denise L.; Mofenson, Lynne M.; Rich, Kenneth

2012-01-01

The Pediatric HIV/AIDS Cohort Study’s Surveillance Monitoring of ART Toxicities Study is a prospective cohort study conducted at 22 US sites between 2007 and 2011 that was designed to evaluate the safety of in utero antiretroviral drug exposure in children not infected with human immunodeficiency virus who were born to mothers who were infected. This ongoing study uses a “trigger-based” design; that is, initial assessments are conducted on all children, and only those meeting certain thresholds or “triggers” undergo more intensive evaluations to determine whether they have had an adverse event (AE). The authors present the estimated rates of AEs for each domain of interest in the Surveillance Monitoring of ART Toxicities Study. They also evaluated the efficiency of this trigger-based design for estimating AE rates and for testing associations between in utero exposures to antiretroviral drugs and AEs. The authors demonstrate that estimated AE rates from the trigger-based design are unbiased after correction for the sensitivity of the trigger for identifying AEs. Even without correcting for bias based on trigger sensitivity, the trigger approach is generally more efficient for estimating AE rates than is evaluating a random sample of the same size. Minor losses in efficiency when comparing AE rates between persons exposed and unexposed in utero to particular antiretroviral drugs or drug classes were observed under most scenarios. PMID:22491086

Efficacy and Safety of Remifentanil as an Alternative Labor Analgesic

PubMed Central

Devabhakthuni, Sandeep

2013-01-01

The objective of this review was to evaluate the clinical efficacy and safety of remifentanil in the management of labor pain. Although neuraxial analgesia is the best option during labor, alternative analgesic options are needed for patients with contraindications. Using a systematic literature search, clinical outcomes of remifentanil for labor pain have been summarized. Also, comparisons of remifentanil to other options including meperidine, epidural analgesia, fentanyl, and nitrous oxide are provided. Based on the literature review, remifentanil is associated with high overall maternal satisfaction and favorable side-effect profile. However, due to the low reporting of adverse events, large, randomized controlled trials are needed to evaluate maternal and neonatal safety adequately and determine the optimal dosing needed to provide effective analgesia. While remifentanil is a feasible alternative for patients who cannot or do not want to receive epidural analgesia, administration should be monitored closely for potential adverse effects. PMID:24665213

Health, safety, and environmental management system operation in contracting companies: A case study.

PubMed

Nassiri, Parvin; Yarahmadi, Rasoul; Gholami, Pari Shafaei; Hamidi, Abdolamir; Mirkazemi, Roksana

2016-05-03

Systematic and cooperative interactions among parent industry and contractors are necessary for a successful health, safety, and environmental management system (HSE-MS). This study was conducted to evaluate the HSE-MS performance in contracting companies in one of the petrochemical industries in Iran during 2013. Managers of parent and contracting companies participated in this study. The data collection forms included 7 elements of an integrated HSE-MS (leadership and commitment; policy and strategic objectives; organization, resources, and documentation; evaluation and risk management; planning; implementation and monitoring; auditing and reviewing). The results showed that mean percentage of the total scores in seven elements of HSE-MS was 85.7% and 87.0% based on self-report and report of parent company, respectively. In conclusion, this study showed that HSE-MS was desirably functioning; however, improvement to ensure health and safety of workers is still required.

Protocol for a multicentre, multistage, prospective study in China using system-based approaches for consistent improvement in surgical safety.

PubMed

Yu, Xiaochu; Jiang, Jingmei; Liu, Changwei; Shen, Keng; Wang, Zixing; Han, Wei; Liu, Xingrong; Lin, Guole; Zhang, Ye; Zhang, Ying; Ma, Yufen; Bo, Haixin; Zhao, Yupei

2017-06-15

Surgical safety has emerged as a crucial global health issue in the past two decades. Although several safety-enhancing tools are available, the pace of large-scale improvement remains slow, especially in developing countries such as China. The present project (Modern Surgery and Anesthesia Safety Management System Construction and Promotion) aims to develop and validate system-based integrated approaches for reducing perioperative deaths and complications using a multicentre, multistage design. The project involves collection of clinical and outcome information for 1 20 000 surgical inpatients at four regionally representative academic/teaching general hospitals in China during three sequential stages: preparation and development, effectiveness validation and improvement of implementation for promotion. These big data will provide the evidence base for the formulation, validation and improvement processes of a system-based stratified safety intervention package covering the entire surgical pathway. Attention will be directed to managing inherent patient risks and regulating medical safety behaviour. Information technology will facilitate data collection and intervention implementation, provide supervision mechanisms and guarantee transfer of key patient safety messages between departments and personnel. Changes in rates of deaths, surgical complications during hospitalisation, length of stay, system adoption and implementation rates will be analysed to evaluate effectiveness and efficiency. This study was approved by the institutional review boards of Peking Union Medical College Hospital, First Hospital of China Medical University, Qinghai Provincial People's Hospital, Xiangya Hospital Central South University and the Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences. Study findings will be disseminated via peer-reviewed journals, conference presentations and patent papers. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Protocol for a multicentre, multistage, prospective study in China using system-based approaches for consistent improvement in surgical safety

PubMed Central

Yu, Xiaochu; Jiang, Jingmei; Liu, Changwei; Shen, Keng; Wang, Zixing; Han, Wei; Liu, Xingrong; Lin, Guole; Zhang, Ye; Zhang, Ying; Ma, Yufen; Bo, Haixin; Zhao, Yupei

2017-01-01

Introduction Surgical safety has emerged as a crucial global health issue in the past two decades. Although several safety-enhancing tools are available, the pace of large-scale improvement remains slow, especially in developing countries such as China. The present project (Modern Surgery and Anesthesia Safety Management System Construction and Promotion) aims to develop and validate system-based integrated approaches for reducing perioperative deaths and complications using a multicentre, multistage design. Methods and analysis The project involves collection of clinical and outcome information for 1 20 000 surgical inpatients at four regionally representative academic/teaching general hospitals in China during three sequential stages: preparation and development, effectiveness validation and improvement of implementation for promotion. These big data will provide the evidence base for the formulation, validation and improvement processes of a system-based stratified safety intervention package covering the entire surgical pathway. Attention will be directed to managing inherent patient risks and regulating medical safety behaviour. Information technology will facilitate data collection and intervention implementation, provide supervision mechanisms and guarantee transfer of key patient safety messages between departments and personnel. Changes in rates of deaths, surgical complications during hospitalisation, length of stay, system adoption and implementation rates will be analysed to evaluate effectiveness and efficiency. Ethics and dissemination This study was approved by the institutional review boards of Peking Union Medical College Hospital, First Hospital of China Medical University, Qinghai Provincial People’s Hospital, Xiangya Hospital Central South University and the Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences. Study findings will be disseminated via peer-reviewed journals, conference presentations and patent papers. PMID:28619774

Addressing safety liabilities of TfR bispecific antibodies that cross the blood-brain barrier.

PubMed

Couch, Jessica A; Yu, Y Joy; Zhang, Yin; Tarrant, Jacqueline M; Fuji, Reina N; Meilandt, William J; Solanoy, Hilda; Tong, Raymond K; Hoyte, Kwame; Luk, Wilman; Lu, Yanmei; Gadkar, Kapil; Prabhu, Saileta; Ordonia, Benjamin A; Nguyen, Quyen; Lin, Yuwen; Lin, Zhonghua; Balazs, Mercedesz; Scearce-Levie, Kimberly; Ernst, James A; Dennis, Mark S; Watts, Ryan J

2013-05-01

Bispecific antibodies using the transferrin receptor (TfR) have shown promise for boosting antibody uptake in brain. Nevertheless, there are limited data on the therapeutic properties including safety liabilities that will enable successful development of TfR-based therapeutics. We evaluate TfR/BACE1 bispecific antibody variants in mouse and show that reducing TfR binding affinity improves not only brain uptake but also peripheral exposure and the safety profile of these antibodies. We identify and seek to address liabilities of targeting TfR with antibodies, namely, acute clinical signs and decreased circulating reticulocytes observed after dosing. By eliminating Fc effector function, we ameliorated the acute clinical signs and partially rescued a reduction in reticulocytes. Furthermore, we show that complement mediates a residual decrease in reticulocytes observed after Fc effector function is eliminated. These data raise important safety concerns and potential mitigation strategies for the development of TfR-based therapies that are designed to cross the blood-brain barrier.

Atezolizumab in Platinum-treated Locally Advanced or Metastatic Urothelial Carcinoma: Outcomes by Prior Number of Regimens.

PubMed

Perez-Gracia, Jose Luis; Loriot, Yohann; Rosenberg, Jonathan E; Powles, Thomas; Necchi, Andrea; Hussain, Syed A; Morales-Barrera, Rafael; Retz, Margitta M; Niegisch, Günter; Durán, Ignacio; Théodore, Christine; Grande, Enrique; Shen, Xiaodong; Wang, Jingjing; Nelson, Betty; Derleth, Christina L; van der Heijden, Michiel S

2017-12-19

Patients with metastatic urothelial carcinoma (mUC) who progress after platinum-based chemotherapy have had few treatment options and uniformly poor outcomes. Atezolizumab (anti-programmed death-ligand 1) was approved in the USA for cisplatin-ineligible and platinum-treated mUC based on IMvigor210, a phase 2, single-arm, two-cohort study. To evaluate the efficacy and safety of atezolizumab by the number of prior lines of systemic therapy in patients with pretreated mUC. IMvigor210 enrolled 315 patients with mUC with progression during or following platinum-based therapy at 70 international sites between May 2014 and November 2014. Key inclusion criteria included age ≥18 yr, creatinine clearance ≥30ml/min, and Eastern Cooperative Oncology Group performance status 0-1, with no limit on prior lines of treatment. Patients in this cohort received atezolizumab 1200mg intravenously every 3 wk until loss of clinical benefit. Centrally assessed Response Evaluation Criteria In Solid Tumors v1.1 objective response rate (ORR), median duration of response, overall survival (OS), and adverse events were evaluated by prior treatment. Potential differences between subgroups were evaluated using log-rank (for OS) and chi-square (for ORR and adverse events frequencies) testing. Three hundred and ten patients were efficacy and safety evaluable (median follow-up, 21 mo). Objective responses and prolonged OS occurred across all prespecified subgroups; median duration of response was not reached in most subgroups. In patients without prior systemic mUC therapy (first-line subgroup), ORR was 25% (95% confidence interval: 14-38), and median OS was 9.6 mo (95% confidence interval: 5.9-15.8). No significant differences in efficacy or toxicity by therapy line were observed. Atezolizumab demonstrated comparable efficacy and safety in previously treated patients with mUC across all lines of therapy evaluated. We investigated effects of previous treatment in patients with metastatic urothelial carcinoma that progressed after platinum-based therapy. Atezolizumab was active and tolerable no matter how many treatment regimens patients had received. ClinicalTrials.gov, NCT02108652. Copyright © 2017. Published by Elsevier B.V.

[Concept analysis of a participatory approach to occupational safety and health].

PubMed

Yoshikawa, Etsuko

2013-01-01

The purpose of this study was to analyze a participatory approach to occupational safety and health, and to examine the possibility of applying the concept to the practice and research of occupational safety and health. According to Rodger's method, descriptive data concerning antecedents, attributes and consequences were qualitatively analyzed. A total of 39 articles were selected for analysis. Attributes with a participatory approach were: "active involvement of both workers and employers", "focusing on action-oriented low-cost and multiple area improvements based on good practices", "the process of emphasis on consensus building", and "utilization of a local network". Antecedents of the participatory approach were classified as: "existing risks at the workplace", "difficulty of occupational safety and health activities", "characteristics of the workplace and workers", and "needs for the workplace". The derived consequences were: "promoting occupational safety and health activities", "emphasis of self-management", "creation of safety and healthy workplace", and "contributing to promotion of quality of life and productivity". A participatory approach in occupational safety and health is defined as, the process of emphasis on consensus building to promote occupational safety and health activities with emphasis on self-management, which focuses on action-oriented low-cost and multiple area improvements based on good practices with active involvement of both workers and employers through utilization of local networks. We recommend that the role of the occupational health professional be clarified and an evaluation framework be established for the participatory approach to promote occupational safety and health activities by involving both workers and employers.

[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.

Study on the evaluation index of active power reserve

NASA Astrophysics Data System (ADS)

Guo, Xiaorui; Liu, Jiantao; Wang, Ke; Min, Lu

2018-01-01

Based on the role of active reserve at different time scales, divides the evaluation dimension of active reserve. Analysis the calculation principle of traditional reliability index such as probability of system safety, lack of power shortage and electricity shortage expectancy, and studies the applicability of these indicators to evaluate the reserve capacity on different dimensions. Resolves the evaluation index of active reserve capacity from the dimensions of time dimension, spatial dimension, system state, risk degree and economy, then construct evaluation index of active reserve capacity.

When paradigms collide at the road rail interface: evaluation of a sociotechnical systems theory design toolkit for cognitive work analysis.

PubMed

Read, Gemma J M; Salmon, Paul M; Lenné, Michael G

2016-09-01

The Cognitive Work Analysis Design Toolkit (CWA-DT) is a recently developed approach that provides guidance and tools to assist in applying the outputs of CWA to design processes to incorporate the values and principles of sociotechnical systems theory. In this paper, the CWA-DT is evaluated based on an application to improve safety at rail level crossings. The evaluation considered the extent to which the CWA-DT met pre-defined methodological criteria and aligned with sociotechnical values and principles. Both process and outcome measures were taken based on the ratings of workshop participants and human factors experts. Overall, workshop participants were positive about the process and indicated that it met the methodological criteria and sociotechnical values. However, expert ratings suggested that the CWA-DT achieved only limited success in producing RLX designs that fully aligned with the sociotechnical approach. Discussion about the appropriateness of the sociotechnical approach in a public safety context is provided. Practitioner Summary: Human factors and ergonomics practitioners need evidence of the effectiveness of methods. A design toolkit for cognitive work analysis, incorporating values and principles from sociotechnical systems theory, was applied to create innovative designs for rail level crossings. Evaluation results based on the application are provided and discussed.

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.

49 CFR 240.205 - Procedures for determining eligibility based on prior safety conduct.

Code of Federal Regulations, 2013 CFR

2013-10-01

... prior conduct as a railroad worker, and § 240.119 involving substance abuse disorders and alcohol/drug... professional opinion that the person has been evaluated as not currently affected by a substance abuse disorder or that the person has been evaluated as affected by an active substance abuse disorder and is...

49 CFR 240.205 - Procedures for determining eligibility based on prior safety conduct.

Code of Federal Regulations, 2011 CFR

2011-10-01

... prior conduct as a railroad worker, and § 240.119 involving substance abuse disorders and alcohol/drug... professional opinion that the person has been evaluated as not currently affected by a substance abuse disorder or that the person has been evaluated as affected by an active substance abuse disorder and is...

49 CFR 240.205 - Procedures for determining eligibility based on prior safety conduct.

Code of Federal Regulations, 2010 CFR

2010-10-01

... prior conduct as a railroad worker, and § 240.119 involving substance abuse disorders and alcohol/drug... professional opinion that the person has been evaluated as not currently affected by a substance abuse disorder or that the person has been evaluated as affected by an active substance abuse disorder and is...

49 CFR 240.205 - Procedures for determining eligibility based on prior safety conduct.

Code of Federal Regulations, 2014 CFR

2014-10-01

... prior conduct as a railroad worker, and § 240.119 involving substance abuse disorders and alcohol/drug... professional opinion that the person has been evaluated as not currently affected by a substance abuse disorder or that the person has been evaluated as affected by an active substance abuse disorder and is...

Mixed-Methods Evaluation of Real-Time Safety Reporting by Hospitalized Patients and Their Care Partners: The MySafeCare Application.

PubMed

Collins, Sarah A; Couture, Brittany; Smith, Ann DeBord; Gershanik, Esteban; Lilley, Elizabeth; Chang, Frank; Yoon, Cathy; Lipsitz, Stuart; Sheikh, Aziz; Benneyan, James; Bates, David W

2018-04-27

The aims of the study were to evaluate the amount and content of data patients and care partners reported using a real-time electronic safety tool compared with other reporting mechanisms and to understand their perspectives on safety concerns and reporting in the hospital. This study used mixed methods including 20-month preimplementation and postimplementation trial evaluating MySafeCare, a web-based application, which allows hospitalized patients/care partners to report safety concerns in real time. The study compared MySafeCare submission rates for three hospital units (oncology acute care, vascular intermediate care, medical intensive care) with submissions rates of Patient Family Relations (PFR) Department, a hospital service to address patient/family concerns. The study used triangulation of quantitative data with thematic analysis of safety concern submissions and patient/care partner interviews to understand submission content and perspectives on safety reporting. Thirty-two MySafeCare submissions were received with an average rate of 1.7 submissions per 1000 patient-days and a range of 0.3 to 4.8 submissions per 1000 patient-days across all units, indicating notable variation between units. MySafeCare submission rates were significantly higher than PFR submission rates during the postintervention period on the vascular unit (4.3 [95% confidence interval = 2.8-6.5] versus 1.5 [95% confidence interval = 0.7-3.1], Poisson) (P = 0.01). Overall trends indicated a decrease in PFR submissions after MySafeCare implementation. Triangulated data indicated patients preferred to report anonymously and did not want concerns submitted directly to their care team. MySafeCare evaluation confirmed the potential value of providing an electronic, anonymous reporting tool in the hospital to capture safety concerns in real time. Such applications should be tested further as part of patient safety programs.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

Preventing Harm in the ICU-Building a Culture of Safety and Engaging Patients and Families.

PubMed

Thornton, Kevin C; Schwarz, Jennifer J; Gross, A Kendall; Anderson, Wendy G; Liu, Kathleen D; Romig, Mark C; Schell-Chaple, Hildy; Pronovost, Peter J; Sapirstein, Adam; Gropper, Michael A; Lipshutz, Angela K M

2017-09-01

Preventing harm remains a persistent challenge in the ICU despite evidence-based practices known to reduce the prevalence of adverse events. This review seeks to describe the critical role of safety culture and patient and family engagement in successful quality improvement initiatives in the ICU. We review the evidence supporting the impact of safety culture and provide practical guidance for those wishing to implement initiatives aimed at improving safety culture and more effectively integrate patients and families in such efforts. Literature review using PubMed including evaluation of key studies assessing large-scale quality improvement efforts in the ICU, impact of safety culture on patient outcomes, methodologies for quality improvement commonly used in healthcare, and patient and family engagement. Print and web-based resources from leading patient safety organizations were also searched. Our group completed a review of original studies, review articles, book chapters, and recommendations from leading patient safety organizations. Our group determined by consensus which resources would best inform this review. A strong safety culture is associated with reduced adverse events, lower mortality rates, and lower costs. Quality improvement efforts have been shown to be more effective and sustainable when paired with a strong safety culture. Different methodologies exist for quality improvement in the ICU; a thoughtful approach to implementation that engages frontline providers and administrative leadership is essential for success. Efforts to substantively include patients and families in the processes of quality improvement work in the ICU should be expanded. Efforts to establish a culture of safety and meaningfully engage patients and families should form the foundation for all safety interventions in the ICU. This review describes an approach that integrates components of several proven quality improvement methodologies to enhance safety culture in the ICU and highlights opportunities to include patients and families.

41 CFR 102-80.120 - What analytical and empirical tools should be used to support the life safety equivalency...

Code of Federal Regulations, 2010 CFR

2010-07-01

... used to support the life safety equivalency evaluation? Analytical and empirical tools, including fire models and grading schedules such as the Fire Safety Evaluation System (Alternative Approaches to Life... empirical tools should be used to support the life safety equivalency evaluation? 102-80.120 Section 102-80...

41 CFR 102-80.120 - What analytical and empirical tools should be used to support the life safety equivalency...

Code of Federal Regulations, 2011 CFR

2011-01-01

... used to support the life safety equivalency evaluation? Analytical and empirical tools, including fire models and grading schedules such as the Fire Safety Evaluation System (Alternative Approaches to Life... empirical tools should be used to support the life safety equivalency evaluation? 102-80.120 Section 102-80...

Efficacy and safety of once-daily luliconazole 1% cream in patients ≥12 years of age with interdigital tinea pedis: a phase 3, randomized, double-blind,vehicle-controlled study.

PubMed

Jarratt, Michael; Jones, Terry; Adelglass, Jeffrey; Bucko, Alicia; Pollak, Richard; Roman-Miranda, Amaury; Olin, Jason T; Swinyer, Leonard

2014-07-01

Interdigital tinea pedis is one of the most common clinical presentations of dermatophytosis. This phase 3 study evaluated the safety and efficacy of luliconazole cream 1% in patients with tinea pedis. A total of 321 male and female patients aged ≥12 years with tinea pedis and eligible for modified intent-to-treat analysis were randomized 1:1 to receive luliconazole cream 1% (n=159) or vehicle (n=162) once daily for 14 days. Efficacy was evaluated at days 28 and 42 (i.e., days 14 and 28 posttreatment) based on clinical signs (erythema, scaling, pruritus) and mycology (KOH, fungal culture). The primary outcome was complete clearance at day 42. Safety evaluations included adverse events and laboratory assessments. Complete clearance at day 42 was achieved in 26.4% (28/106) of patients treated with luliconazole cream 1% compared with 1.9% (2/103) of patients treated with vehicle (P< 0.001). Similar safety profiles were obtained for luliconazole cream 1% and vehicle. This study was conducted in a relatively small population under controlled clinical trial conditions. Luliconazole cream 1% applied once daily for 14 days is well tolerated and more effective than vehicle in patients with tinea pedis.

Should Weights and Risk Categories Be Used for Inspection Scores To Evaluate Food Safety in Restaurants?

PubMed

da Cunha, Diogo Thimoteo; de Rosso, Veridiana Vera; Stedefeldt, Elke

2016-03-01

The objective of this study was to verify the characteristics of food safety inspections, considering risk categories and binary scores. A cross-sectional study was performed with 439 restaurants in 43 Brazilian cities. A food safety checklist with 177 items was applied to the food service establishments. These items were classified into four groups (R1 to R4) according to the main factors that can cause outbreaks involving food: R1, time and temperature aspects; R2, direct contamination; R3, water conditions and raw material; and R4, indirect contamination (i.e., structures and buildings). A score adjusted for 100 was calculated for the overall violation score and the violation score for each risk category. The average violation score (standard deviation) was 18.9% (16.0), with an amplitude of 0.0 to 76.7%. Restaurants with a low overall violation score (approximately 20%) presented a high number of violations from the R1 and R2 groups, representing the most risky violations. Practical solutions to minimize this evaluation bias were discussed. Food safety evaluation should use weighted scores and be risk-based. However, some precautions must be taken by researchers, health inspectors, and health surveillance departments to develop an adequate and reliable instrument.

Evaluation of safety and quality impact of extractable and leachable substances in therapeutic biologic protein products: a risk-based perspective.

PubMed

Markovic, Ingrid

2007-09-01

Leachables are chemical entities that migrate spontaneously from the final container closure system, packaging components and/or processing equipment under recommended conditions of product use and storage. Unlike leachables, extractables are generated under exaggerated temperature and time conditions in the presence of an appropriate solvent. Increasing evidence suggests that leachables may pose a safety risk by causing toxicity, carcinogenicity, immunogenicity and/or endocrine dysregulation. These substances may also alter product physico-chemical properties via interaction with the active pharmaceutical ingredient or the excipients in product vehicle, thereby adversely affecting the final product quality. The evaluation of leachable compounds begins with a thorough identification of extractable compounds released from the production and packaging components under exaggerated conditions. The set of observed extractables helps to identify possible targets to be monitored in a subsequent leachables study over extended time periods. Although extractables and leachables also present a challenge for the safe use of device components (e.g., metered dose inhalers, dry powder inhalers, nasal spray devices or various implants), this review focusses on a safety risk assessment for specified therapeutic biological protein products. Regulatory, safety and scientific considerations in evaluating extractables and leachables are discussed, along with strategies for the analytical identification, quantification and monitoring.

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...

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.

Methodology to assess clinical liver safety data.

PubMed

Merz, Michael; Lee, Kwan R; Kullak-Ublick, Gerd A; Brueckner, Andreas; Watkins, Paul B

2014-11-01

Analysis of liver safety data has to be multivariate by nature and needs to take into account time dependency of observations. Current standard tools for liver safety assessment such as summary tables, individual data listings, and narratives address these requirements to a limited extent only. Using graphics in the context of a systematic workflow including predefined graph templates is a valuable addition to standard instruments, helping to ensure completeness of evaluation, and supporting both hypothesis generation and testing. Employing graphical workflows interactively allows analysis in a team-based setting and facilitates identification of the most suitable graphics for publishing and regulatory reporting. Another important tool is statistical outlier detection, accounting for the fact that for assessment of Drug-Induced Liver Injury, identification and thorough evaluation of extreme values has much more relevance than measures of central tendency in the data. Taken together, systematical graphical data exploration and statistical outlier detection may have the potential to significantly improve assessment and interpretation of clinical liver safety data. A workshop was convened to discuss best practices for the assessment of drug-induced liver injury (DILI) in clinical trials.

DairyBeef: maximizing quality and profits--a consistent food safety message.

PubMed

Moore, D A; Kirk, J H; Klingborg, D J; Garry, F; Wailes, W; Dalton, J; Busboom, J; Sams, R W; Poe, M; Payne, M; Marchello, J; Looper, M; Falk, D; Wright, T

2004-01-01

To respond to meat safety and quality issues in dairy market cattle, a collaborative project team for 7 western states was established to develop educational resources providing a consistent meat safety and quality message to dairy producers, farm advisors, and veterinarians. The team produced an educational website and CD-ROM course that included videos, narrated slide sets, and on-farm tools. The objectives of this course were: 1) to help producers and their advisors understand market cattle food safety and quality issues, 2) help maintain markets for these cows, and 3) help producers identify ways to improve the quality of dairy cattle going to slaughter. DairyBeef. Maximizing Quality & Profits consists of 6 sections, including 4 core segments. Successful completion of quizzes following each core segment is required for participants to receive a certificate of completion. A formative evaluation of the program revealed the necessity for minor content and technological changes with the web-based course. All evaluators considered the materials relevant to dairy producers. After editing, course availability was enabled in February, 2003. Between February and May, 2003, 21 individuals received certificates of completion.

Home-Based Comprehensive Assessment of Rural Elderly Persons: The CARE Project

ERIC Educational Resources Information Center

Cravens, David D.; Mehr, David R.; Campbell, James D.; Armer, Jane; Kruse, Robin L.; Rubenstein, Laurence Z.

2005-01-01

Context: Home-based comprehensive geriatric assessment (CGA) has been effective in urban areas but has had little study in rural areas. CGA involves medical history taking, a physical exam, and evaluation of functional status, mental status, cognitive status, gait and balance, medications, vision, extent of social supports, and home safety. We…

Using exposure prediction tools to link exposure and dosimetry for risk-based decisions: A case study with phthalates

EPA Science Inventory

A few different exposure prediction tools were evaluated for use in the new in vitro-based safety assessment paradigm using di-2-ethylhexyl phthalate (DEHP) and dibutyl phthalate (DnBP) as case compounds. Daily intake of each phthalate was estimated using both high-throughput (HT...

An Approach for Validating Actinide and Fission Product Burnup Credit Criticality Safety Analyses--Criticality (keff) Predictions

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

Scaglione, John M; Mueller, Don; Wagner, John C

2011-01-01

One of the most significant remaining challenges associated with expanded implementation of burnup credit in the United States is the validation of depletion and criticality calculations used in the safety evaluation - in particular, the availability and use of applicable measured data to support validation, especially for fission products. Applicants and regulatory reviewers have been constrained by both a scarcity of data and a lack of clear technical basis or approach for use of the data. U.S. Nuclear Regulatory Commission (NRC) staff have noted that the rationale for restricting their Interim Staff Guidance on burnup credit (ISG-8) to actinide-only ismore » based largely on the lack of clear, definitive experiments that can be used to estimate the bias and uncertainty for computational analyses associated with using burnup credit. To address the issue of validation, the NRC initiated a project with the Oak Ridge National Laboratory to (1) develop and establish a technically sound validation approach (both depletion and criticality) for commercial spent nuclear fuel (SNF) criticality safety evaluations based on best-available data and methods and (2) apply the approach for representative SNF storage and transport configurations/conditions to demonstrate its usage and applicability, as well as to provide reference bias results. The purpose of this paper is to describe the criticality (k{sub eff}) validation approach, and resulting observations and recommendations. Validation of the isotopic composition (depletion) calculations is addressed in a companion paper at this conference. For criticality validation, the approach is to utilize (1) available laboratory critical experiment (LCE) data from the International Handbook of Evaluated Criticality Safety Benchmark Experiments and the French Haut Taux de Combustion (HTC) program to support validation of the principal actinides and (2) calculated sensitivities, nuclear data uncertainties, and the limited available fission product LCE data to predict and verify individual biases for relevant minor actinides and fission products. This paper (1) provides a detailed description of the approach and its technical bases, (2) describes the application of the approach for representative pressurized water reactor and boiling water reactor safety analysis models to demonstrate its usage and applicability, (3) provides reference bias results based on the prerelease SCALE 6.1 code package and ENDF/B-VII nuclear cross-section data, and (4) provides recommendations for application of the results and methods to other code and data packages.« less

Using heuristic evaluations to assess the safety of health information systems.

PubMed

Carvalho, Christopher J; Borycki, Elizabeth M; Kushniruk, Andre W

2009-01-01

Health information systems (HISs) are typically seen as a mechanism for reducing medical errors. There is, however, evidence to prove that technology may actually be the cause of errors. As a result, it is crucial to fully test any system prior to its implementation. At present, evidence-based evaluation heuristics do not exist for assessing aspects of interface design that lead to medical errors. A three phase study was conducted to develop evidence-based heuristics for evaluating interfaces. Phase 1 consisted of a systematic review of the literature. In Phase 2 a comprehensive list of 33 evaluation heuristics was developed based on the review that could be used to test for potential technology induced errors. Phase 3 involved applying these healthcare specific heuristics to evaluate a HIS.

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.

Development, fabrication and testing of locomotive crashworthy components : base effort.

DOT National Transportation Integrated Search

2014-12-01

The Federal Railroad Administration (FRA) and the John A. Volpe National Transportation Systems Center (Volpe Center) are continuing to evaluate new technologies for increasing the safety of passengers and operators in rail equipment. In recognition ...

Department of Defense meteorological and environmental inputs to aviation systems

NASA Technical Reports Server (NTRS)

Try, P. D.

1983-01-01

Recommendations based on need, cost, and achievement of flight safety are offered, and the re-evaluation of weather parameters needed for safe landing operations that lead to reliable and consistent automated observation capabilities are considered.

AGRI Grain Power ethanol-for-fuel project feasibility-study report. Volume III. Project environmental/health/safety/ and socioeconomic

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

Not Available

1981-04-01

The AGRI GRAIN POWER (AGP) project, hereafter referred to as the Project, was formed to evaluate the commercial viability and assess the desireability of implementing a large grain based grass-roots anhydrous ethanol fuel project to be sited near Des Moines, Iowa. This report presents the results of a Project feasibility evaluation. The Project concept is based on involving a very strong managerial, financial and technical joint venture that is extremely expert in all facets of planning and implementing a large ethanol project; on locating the ethanol project at a highly desireable site; on utilizing a proven ethanol process; and onmore » developing a Project that is well suited to market requirements, resource availability and competitive factors. This volume contains the results of the environmental, health, safety, and socio-economic studies.« less

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.

Managing health and safety risks: Implications for tailoring health and safety management system practices.

PubMed

Willmer, D R; Haas, E J

2016-01-01

As national and international health and safety management system (HSMS) standards are voluntarily accepted or regulated into practice, organizations are making an effort to modify and integrate strategic elements of a connected management system into their daily risk management practices. In high-risk industries such as mining, that effort takes on added importance. The mining industry has long recognized the importance of a more integrated approach to recognizing and responding to site-specific risks, encouraging the adoption of a risk-based management framework. Recently, the U.S. National Mining Association led the development of an industry-specific HSMS built on the strategic frameworks of ANSI: Z10, OHSAS 18001, The American Chemistry Council's Responsible Care, and ILO-OSH 2001. All of these standards provide strategic guidance and focus on how to incorporate a plan-do-check-act cycle into the identification, management and evaluation of worksite risks. This paper details an exploratory study into whether practices associated with executing a risk-based management framework are visible through the actions of an organization's site-level management of health and safety risks. The results of this study show ways that site-level leaders manage day-to-day risk at their operations that can be characterized according to practices associated with a risk-based management framework. Having tangible operational examples of day-to-day risk management can serve as a starting point for evaluating field-level risk assessment efforts and their alignment to overall company efforts at effective risk mitigation through a HSMS or other processes.

A quantitative risk-assessment system (QR-AS) evaluating operation safety of Organic Rankine Cycle using flammable mixture working fluid.

PubMed

Tian, Hua; Wang, Xueying; Shu, Gequn; Wu, Mingqiang; Yan, Nanhua; Ma, Xiaonan

2017-09-15

Mixture of hydrocarbon and carbon dioxide shows excellent cycle performance in Organic Rankine Cycle (ORC) used for engine waste heat recovery, but the unavoidable leakage in practical application is a threat for safety due to its flammability. In this work, a quantitative risk assessment system (QR-AS) is established aiming at providing a general method of risk assessment for flammable working fluid leakage. The QR-AS covers three main aspects: analysis of concentration distribution based on CFD simulations, explosive risk assessment based on the TNT equivalent method and risk mitigation based on evaluation results. A typical case of propane/carbon dioxide mixture leaking from ORC is investigated to illustrate the application of QR-AS. According to the assessment results, proper ventilation speed, safe mixture ratio and location of gas-detecting devices have been proposed to guarantee the security in case of leakage. The results revealed that this presented QR-AS was reliable for the practical application and the evaluation results could provide valuable guidance for the design of mitigation measures to improve the safe performance of ORC system. Copyright © 2017 Elsevier B.V. All rights reserved.

Hospital-Based Program to Increase Child Safety Restraint Use among Birthing Mothers in China

PubMed Central

Chen, Xiaojun; Yang, Jingzhen; Peek-Asa, Corinne; Chen, Kangwen; Liu, Xiangxiang; Li, Liping

2014-01-01

Objective To evaluate a hospital-based educational program to increase child safety restraint knowledge and use among birthing mothers. Methods A prospective experimental and control study was performed in the Obstetrics department of hospitals. A total of 216 new birthing mothers from two hospitals (114 from intervention hospital and 102 from comparison hospital) were recruited and enrolled in the study. Intervention mothers received a height chart, an 8-minute video and a folded pamphlet regarding child safety restraint use during their hospital stay after giving birth. Evaluation data on the child safety seat (CSS) awareness, attitudes, and use were collected among both groups before and after the intervention. An additional phone interview was conducted among the intervention mothers two months after discharge. Results No significant differences existed between groups when comparing demographics. Over 90% of the intervention mothers found the educational intervention to be helpful to some extent. A significantly higher percentage of mothers in the intervention than the comparison group reported that CSS are necessary and are the safest seating practice. Nearly 20% of the intervention mothers actually purchased CSS for their babies after the intervention. While in both the intervention and comparison group, over 80% of mothers identified the ages of two through five as needing CSS, fewer than 50% of both groups identified infants as needing CSS, even after the intervention. Conclusion The results indicated that child safety restraint education implemented in hospitals helps increase birthing mothers' overall knowledge and use of CSS. Further efforts are needed to address specific age-related needs to promote car seats use among infants. PMID:25133502

[Clinical application evaluation of Guidelines for Diagnosis and Treatment of Internal Diseases in Traditional Chinese Medicine].

PubMed

Han, Xue-Jie; Liu, Meng-Yu; Lian, Zhi-Hua; Wang, Li-Ying; Shi, Nan-Nan; Zhao, Jun

2017-09-01

To evaluate the applicability and clinical applications of Guidelines for Diagnosis and Treatment of Internal Diseases in Traditional Chinese Medicine, so as to provide the basis for the revision of the guidelines. This study was completed by the research and promotion base for traditional Chinese medicine(TCM) standard. The methods of applicability evaluation and application evaluation were used in the study. The questionnaires were filled out to evaluate applicability of the guideline, including doctor's familiarity with the guideline,the quality of the guideline, applicable conditions and clinical applications. The prospective case study analysis method was used to evaluate application of the guideline, including evaluation of clinical application compliance and application results(such as clinical effects, safety and economy). There were two parts in the guideline, which were TCM guideline and Western medicine guideline. The results of applicability evaluation showed that there were no obvious differences between TCM guideline and Western medicine guideline in doctor's familiarity with guideline(85.43%, 84.57%) and the use of the guideline(52.10%, 54.47%); the guidelines with good quality, and higher scores in the scope of application and the use of the term rationality(91.94%, 93.35%); the rationality scores of relevant contents in syndrome differentiation and treatment were more than 75%; the applicable conditions were better, and the safety score was the the highest. The comprehensive applicability evaluation showed that the proportion of the application of TCM guideline and Western medicine guideline were 77.73%, 75.46%, respectively. The results of application evaluation showed that there was high degree coincidence between the guideline with its clinical application; except for "other treatment" and "recuperation and prevention" in TCM, other items got high scores which were more than 90%; in the evaluation of application effects, safety of the guideline was best, economy of the guideline was better, and clincal effect was good. The comprehensive application evaluation showed that 75%~80% doctors were satisfied with the guideline. The Guidelines for Diagnosis and Treatment of Internal Diseases in Traditional Chinese Medicine has been widely used in clinical practice, which is of high quality, high degree of clinical application,good safety and economy. But there were some disadvantages of the guideline such as lack of evidence-based medicine and innovation, which is need to be improved constantly in the guideline revision. Copyright© by the Chinese Pharmaceutical Association.

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.

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...

An Approach for Validating Actinide and Fission Product Burnup Credit Criticality Safety Analyses: Criticality (k eff) Predictions

DOE PAGES

Scaglione, John M.; Mueller, Don E.; Wagner, John C.

2014-12-01

One of the most important remaining challenges associated with expanded implementation of burnup credit in the United States is the validation of depletion and criticality calculations used in the safety evaluation—in particular, the availability and use of applicable measured data to support validation, especially for fission products (FPs). Applicants and regulatory reviewers have been constrained by both a scarcity of data and a lack of clear technical basis or approach for use of the data. In this study, this paper describes a validation approach for commercial spent nuclear fuel (SNF) criticality safety (k eff) evaluations based on best-available data andmore » methods and applies the approach for representative SNF storage and transport configurations/conditions to demonstrate its usage and applicability, as well as to provide reference bias results. The criticality validation approach utilizes not only available laboratory critical experiment (LCE) data from the International Handbook of Evaluated Criticality Safety Benchmark Experiments and the French Haut Taux de Combustion program to support validation of the principal actinides but also calculated sensitivities, nuclear data uncertainties, and limited available FP LCE data to predict and verify individual biases for relevant minor actinides and FPs. The results demonstrate that (a) sufficient critical experiment data exist to adequately validate k eff calculations via conventional validation approaches for the primary actinides, (b) sensitivity-based critical experiment selection is more appropriate for generating accurate application model bias and uncertainty, and (c) calculated sensitivities and nuclear data uncertainties can be used for generating conservative estimates of bias for minor actinides and FPs. Results based on the SCALE 6.1 and the ENDF/B-VII.0 cross-section libraries indicate that a conservative estimate of the bias for the minor actinides and FPs is 1.5% of their worth within the application model. Finally, this paper provides a detailed description of the approach and its technical bases, describes the application of the approach for representative pressurized water reactor and boiling water reactor safety analysis models, and provides reference bias results based on the prerelease SCALE 6.1 code package and ENDF/B-VII nuclear cross-section data.« less

Predictors of Attitudes Toward Non-Technical Skills in Farming.

PubMed

Irwin, Amy; Poots, Jill

2018-01-01

Farming is a high-risk sector with up to 170,000 worldwide fatalities reported per year; it is therefore vital to identify methods of mitigating the dangers of this industry. Research within high-risk industries, such as aviation, shipping, and agriculture, has identified the importance of non-technical skills (NTS) in maintaining effective, safe performance and reducing error and injury. However, there is a lack of research evaluating factors that may contribute to NTS attitudes and behaviors. As a first step to address this literature gap, the current study evaluated a range of individual and environmental factors as potential predictors of attitudes toward NTS in agriculture. A sample of 170 farmers from within the United Kingdom and Ireland were surveyed using an online questionnaire. The questionnaire included measures of personality, stress, attitudes toward safety (safety climate, motivation, and risk), environmental stressors (workload, work-life imbalance), and non-technical skills (team and lone worker). Attitudes toward safety climate, compliance, and motivation showed a significant association with both team-based and lone worker NTS. Conscientiousness correlated positively with the majority of the NTS elements. Multiple regression analysis indicated neuroticism and conscientiousness demonstrated capacity to predict NTS attitudes. Concerns about costs and equipment, attitudes toward safety climate, and safety motivation were also found to be significant predictors of NTS attitudes. The results indicate the utility of individual characteristics and environmental factors when predicting farming NTS attitudes. As a result, these elements could be important when evaluating engagement with NTS and developing NTS training initiatives in agriculture.

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...

Assessment of patient safety culture in clinical laboratories in the Spanish National Health System.

PubMed

Giménez-Marín, Angeles; Rivas-Ruiz, Francisco; García-Raja, Ana M; Venta-Obaya, Rafael; Fusté-Ventosa, Margarita; Caballé-Martín, Inmaculada; Benítez-Estevez, Alfonso; Quinteiro-García, Ana I; Bedini, José Luis; León-Justel, Antonio; Torra-Puig, Montserrat

2015-01-01

There is increasing awareness of the importance of transforming organisational culture in order to raise safety standards. This paper describes the results obtained from an evaluation of patient safety culture in a sample of clinical laboratories in public hospitals in the Spanish National Health System. A descriptive cross-sectional study was conducted among health workers employed in the clinical laboratories of 27 public hospitals in 2012. The participants were recruited by the heads of service at each of the participating centers. Stratified analyses were performed to assess the mean score, standardized to a base of 100, of the six survey factors, together with the overall patient safety score. 740 completed questionnaires were received (88% of the 840 issued). The highest standardized scores were obtained in Area 1 (individual, social and cultural) with a mean value of 77 (95%CI: 76-78), and the lowest ones, in Area 3 (equipment and resources), with a mean value of 58 (95%CI: 57-59). In all areas, a greater perception of patient safety was reported by the heads of service than by other staff. We present the first multicentre study to evaluate the culture of clinical safety in public hospital laboratories in Spain. The results obtained evidence a culture in which high regard is paid to safety, probably due to the pattern of continuous quality improvement. Nevertheless, much remains to be done, as reflected by the weaknesses detected, which identify areas and strategies for improvement.

Perceptions of sexual partner safety.

PubMed

Masaro, C L; Dahinten, V S; Johnson, J; Ogilvie, G; Patrick, D M

2008-06-01

Many individuals select sexual partners based on assumed partner STI/HIV safety, yet few studies have investigated how these assumptions are formed. The objective of this research was to determine the extent to which partner safety beliefs were used to evaluate partner safety, and whether these beliefs influenced perceptions of personal STI/HIV risk. Participants (n = 317) recruited from an STI clinic completed a structured self-report questionnaire. A Partner Safety Beliefs Scale (PSBS) was developed to determine the factors that most influenced perceived partner safety. Exploratory factor analysis showed that a single factor accounted for 46% of the variance in the PSBS; with an internal consistency of 0.92. Linear regression was used to determine factors predictive of perceived personal STI/HIV risk. Participants endorsed statements indicating that knowing or trusting a sexual partner influences their beliefs about their partner's safety. Linear regression analysis indicated that education, income, number of sexual partners, and PSBS scores were significant predictors of perceived personal STI/HIV risk. The results of this study indicate that many individuals are relying on partner attributes and relationship characteristics when assessing the STI/HIV status of a sexual partner, and that this reliance is associated with a decreased perception of personal STI/HIV risk. Prevention campaigns need to acknowledge that people are likely to evaluate sexual partners whom they know and trust as safe. Dispelling erroneous beliefs about the ability to select safe partners is needed to promote safer sexual behavior.

A simple approach to industrial laser safety.

PubMed

Lewandowski, Michael A; Hinz, Michael W

2005-02-01

Industrial applications of lasers include marking, welding, cutting, and other material processing. Lasers used in these ways have significant power output but are generally designed to limit operator exposure to direct or scattered laser radiation to harmless levels in order to meet the Federal Laser Product Performance Standard (21CFR1040) for Class 1 laser products. Interesting challenges occur when companies integrate high power lasers into manufacturing or process control equipment. A significant part of the integration process is developing engineering and administrative controls to produce an acceptable level of laser safety while balancing production, maintenance, and service requirements. 3M Company uses a large number of high power lasers in numerous manufacturing processes. Whether the laser is purchased as a Class 1 laser product or whether it is purchased as a Class 4 laser and then integrated into a manufacturing application, 3M Company has developed an industrial laser safety program that maintains a high degree of laser safety while facilitating the rapid and economical integration of laser technology into the manufacturing workplace. This laser safety program is based on the requirements and recommendations contained in the American National Standard for Safe Use of Lasers, ANSI Z136.1. The fundamental components of the 3M program include hazard evaluation, engineering, administrative, and procedural controls, protective equipment, signs and labels, training, and re-evaluation upon change. This program is implemented in manufacturing facilities and has resulted in an excellent history of laser safety and an effective and efficient use of laser safety resources.

Report of the oversight assessment of the operational readiness review of the Savannah River Site Defense Waste Processing Facility Cold Chemical Runs

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

Lee, B.

1993-03-01

This report presents the results of an oversight assessment (OA) conducted by the US Department of Energy`s (DOE) Office of Environment, Safety and Health (EH) of the operational readiness review (ORR) activities for the Cold Chemical Runs (CCRs) at the Defense Waste Processing Facility (DWPF) located at Savannah River Site (SRS). The EH OA of this facility took place concurrently with an ORR performed by the DOE Office of Environmental Restoration and Waste Management (EM). The EM ORR was conducted from September 28, 1992, through October 9, 1992, although portions of the EM ORR were extended beyond this period. Themore » EH OA evaluated the comprehensiveness and effectiveness of the EM ORR. The EH OA was designed to ascertain whether the EM ORR was thorough and demonstrated sufficient inquisitiveness to verify that the implementation of programs and procedures is adequate to assure the protection of worker safety and health. The EH OA was carried out in accordance with the protocol and procedures of the ``EH Program for Oversight Assessment of Operational Readiness Evaluations for Startups and Restarts,`` dated September 15, 1992. Based on its OA and verification of the resolution of EH OA findings, the EH OA Team believes that the startup of the CCRs may be safely begun, pending satisfactory completion and verification of the prestart findings identified by the EM ORR. The EH OA was based primarily on an evaluation of the comprehensiveness and effectiveness of the EM ORR and addressed the following areas: industrial safety, industrial hygiene, and respiratory protection; fire protection; and chemical safety. The EH OA conducted independent ``vertical-slice`` reviews to confirm EM ORR results in the areas of confined-space entry, respiratory protection, fire protection, and chemical safety.« less

Reducing safety risk among underserved caregivers with an Alzheimer's home safety program.

PubMed

Levy-Storms, Lené; Cherry, Debra L; Lee, Linda J; Wolf, Sheldon M

2017-09-01

Older adults living with Alzheimer's disease (AD) experience more of the types of accidents and injuries prevalent among older adults. Relatively few studies specifically on safety risks have included older adults of color and tested interventions. This pilot study tested the feasibility and evaluability of educating Hispanic and African American caregivers of patients living with AD about reducing safety risks in their homes. This outpatient memory clinic-based intervention study included a pre-/post-test survey design with two nonequivalent groups and predominately serves Hispanic and African Americans. Of 60 eligible caregivers, 67% participated in a tailored, safety training class with an optional follow-up call. The results indicate a reduction in some safety risks compared to baseline and/or a no intervention group, respectively, including leaving patients at home alone part-time (p < .01 and p < .01), getting lost (p < .05 and p < .05), going outdoors alone less often (p < .05 and p < .01), and giving themselves medicine (p < .05 and p < .01). At post-test, 47 clinically significant instances occurred, in which caregivers who participated in the intervention self-reported patients living with AD to be 'completely safe' in one or more of the safety risk items compared to 8 instances among those who did not. This pilot pre/post design with non-equivalent groups study needs refinement in a future randomized control trial. Despite limitations, this pilot study demonstrates the first feasible and evaluable intervention with both statistically and clinically significant results that suggest potential for reducing safety risks among at-risk minority patients living with AD in future research.

Development of a software safety process and a case study of its use

NASA Technical Reports Server (NTRS)

Knight, John C.

1993-01-01

The goal of this research is to continue the development of a comprehensive approach to software safety and to evaluate the approach with a case study. The case study is a major part of the project, and it involves the analysis of a specific safety-critical system from the medical equipment domain. The particular application being used was selected because of the availability of a suitable candidate system. We consider the results to be generally applicable and in no way particularly limited by the domain. The research is concentrating on issues raised by the specification and verification phases of the software lifecycle since they are central to our previously-developed rigorous definitions of software safety. The theoretical research is based on our framework of definitions for software safety. In the area of specification, the main topics being investigated are the development of techniques for building system fault trees that correctly incorporate software issues and the development of rigorous techniques for the preparation of software safety specifications. The research results are documented. Another area of theoretical investigation is the development of verification methods tailored to the characteristics of safety requirements. Verification of the correct implementation of the safety specification is central to the goal of establishing safe software. The empirical component of this research is focusing on a case study in order to provide detailed characterizations of the issues as they appear in practice, and to provide a testbed for the evaluation of various existing and new theoretical results, tools, and techniques. The Magnetic Stereotaxis System is summarized.

Context-aware system for pre-triggering irreversible vehicle safety actuators.

PubMed

Böhmländer, Dennis; Dirndorfer, Tobias; Al-Bayatti, Ali H; Brandmeier, Thomas

2017-06-01

New vehicle safety systems have led to a steady improvement of road safety and a reduction in the risk of suffering a major injury in vehicle accidents. A huge leap forward in the development of new vehicle safety systems are actuators that have to be activated irreversibly shortly before a collision in order to mitigate accident consequences. The triggering decision has to be based on measurements of exteroceptive sensors currently used in driver assistance systems. This paper focuses on developing a novel context-aware system designed to detect potential collisions and to trigger safety actuators even before an accident occurs. In this context, the analysis examines the information that can be collected from exteroceptive sensors (pre-crash data) to predict a certain collision and its severity to decide whether a triggering is entitled or not. A five-layer context-aware architecture is presented, that is able to collect contextual information about the vehicle environment and the actual driving state using different sensors, to perform reasoning about potential collisions, and to trigger safety functions upon that information. Accident analysis is used in a data model to represent uncertain knowledge and to perform reasoning. A simulation concept based on real accident data is introduced to evaluate the presented system concept. 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.

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...

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/

Patient safety and infection control: bases for curricular integration.

PubMed

Silva, Andréa Mara Bernardes da; Bim, Lucas Lazarini; Bim, Felipe Lazarini; Sousa, Alvaro Francisco Lopes; Domingues, Pedro Castania Amadio; Nicolussi, Adriana Cristina; Andrade, Denise de

2018-05-01

To analyze curricular integration between teaching of patient safety and good infection prevention and control practices. Integrative review, designed to answer the question: "How does curricular integration of content about 'patient safety teaching' and content about 'infection prevention and control practices' occur in undergraduate courses in the health field?". The following databases were searched for primary studies: CINAHL, LILACS, ScienceDirect, Web of Science, Scopus, Europe PMC and MEDLINE. The final sample consisted of 13 studies. After content analysis, primary studies were grouped into two subject categories: "Innovative teaching practices" and "Curricular evaluation. Patient safety related to infection prevention and control practices is present in the curriculum of health undergraduate courses, but is not coordinated with other themes, is taught sporadically, and focuses mainly on hand hygiene.

Safety of oral tenofovir disoproxil fumarate-based pre-exposure prophylaxis for HIV prevention.

PubMed

Mugwanya, Kenneth K; Baeten, Jared M

2016-01-01

Tenofovir disoproxil fumarate (TDF)-based pre-exposure prophylaxis is a novel HIV prevention strategy for individuals at increased sexual risk for HIV infection. For any biomedical prevention intervention, the bar for tolerating adverse effects in healthy persons is high compared to therapeutic interventions. We provide a concise summary of the clinical safety of TDF-based pre-exposure prophylaxis with focus on TDF-related effects on tolerability, kidney function, bone density, HIV resistance, sexual and reproductive health. The evidence base for this review is derived from a literature search of both randomized and observational studies evaluating efficacy and safety of TDF-based PrEP, TDF alone or in combination with emtricitabine, identified from PUBMED and EMBASE electronic databases, clinicaltrials.gov and major HIV conferences. TDF-based pre-exposure prophylaxis is a potent intervention against HIV acquisition when taken which is generally safe and well tolerated. The risk of the small, non-progressive, and reversible decline in glomerular filtration rate and bone mineral density as well as the potential selection for drug resistance associated with PrEP are outweighed, at the population level and broadly for individuals, by PrEP's substantial reduction in the risk of HIV infection.

Information technology in pharmacovigilance: Benefits, challenges, and future directions from industry perspectives.

PubMed

Lu, Zhengwu

2009-01-01

Risk assessment during clinical product development needs to be conducted in a thorough and rigorous manner. However, it is impossible to identify all safety concerns during controlled clinical trials. Once a product is marketed, there is generally a large increase in the number of patients exposed, including those with comorbid conditions and those being treated with concomitant medications. Therefore, postmarketing safety data collection and clinical risk assessment based on observational data are critical for evaluating and characterizing a product's risk profile and for making informed decisions on risk minimization. Information science promises to deliver effective e-clinical or e-health solutions to realize several core benefits: time savings, high quality, cost reductions, and increased efficiencies with safer and more efficacious medicines. The development and use of standard-based pharmacovigilance system with integration connection to electronic medical records, electronic health records, and clinical data management system holds promise as a tool for enabling early drug safety detections, data mining, results interpretation, assisting in safety decision making, and clinical collaborations among clinical partners or different functional groups. The availability of a publicly accessible global safety database updated on a frequent basis would further enhance detection and communication about safety issues. Due to recent high-profile drug safety problems, the pharmaceutical industry is faced with greater regulatory enforcement and increased accountability demands for the protection and welfare of patients. This changing climate requires biopharmaceutical companies to take a more proactive approach in dealing with drug safety and pharmacovigilance.

Adverse outcome pathway networks II: Network analytics

EPA Science Inventory

The US EPA is developing more cost effective and efficient ways to evaluate chemical safety using high throughput and computationally based testing strategies. An important component of this approach is the ability to translate chemical effects on fundamental biological processes...

Confidential close call reporting system : preliminary evaluation findings.

DOT National Transportation Integrated Search

2008-12-01

The Federal Railroad Administration (FRA) is implementing a collaborative problem-solving approach to improving safety. The Confidential Close Call Reporting System (C3RS) is a human factors-based approach that is designed to reduce the accident rate...

Creating a Culture of Safety Around Bar-Code Medication Administration: An Evidence-Based Evaluation Framework.

PubMed

Kelly, Kandace; Harrington, Linda; Matos, Pat; Turner, Barbara; Johnson, Constance

2016-01-01

Bar-code medication administration (BCMA) effectiveness is contingent upon compliance with best-practice protocols. We developed a 4-phased BCMA evaluation program to evaluate the degree of integration of current evidence into BCMA policies, procedures, and practices; identify barriers to best-practice BCMA use; and modify BCMA practice in concert with changes to the practice environment. This program provides an infrastructure for frontline nurses to partner with hospital leaders to continually evaluate and improve BCMA using a systematic process.

Assessing the safety effects of cooperative intelligent transport systems: A bowtie analysis approach.

PubMed

Ehlers, Ute Christine; Ryeng, Eirin Olaussen; McCormack, Edward; Khan, Faisal; Ehlers, Sören

2017-02-01

The safety effects of cooperative intelligent transport systems (C-ITS) are mostly unknown and associated with uncertainties, because these systems represent emerging technology. This study proposes a bowtie analysis as a conceptual framework for evaluating the safety effect of cooperative intelligent transport systems. These seek to prevent road traffic accidents or mitigate their consequences. Under the assumption of the potential occurrence of a particular single vehicle accident, three case studies demonstrate the application of the bowtie analysis approach in road traffic safety. The approach utilizes exemplary expert estimates and knowledge from literature on the probability of the occurrence of accident risk factors and of the success of safety measures. Fuzzy set theory is applied to handle uncertainty in expert knowledge. Based on this approach, a useful tool is developed to estimate the effects of safety-related cooperative intelligent transport systems in terms of the expected change in accident occurrence and consequence probability. Copyright © 2016 Elsevier Ltd. All rights reserved.

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.

SunSmart: Evaluation of a Pilot School-Based Sun Protection Intervention in Hispanic Early Adolescents

ERIC Educational Resources Information Center

Miller, K. A.; Langholz, B. M.; Ly, T.; Harris, S. C.; Richardson, J. L.; Peng, D. H.; Cockburn, M. G.

2015-01-01

The incidence of melanoma is rising among Hispanic populations in the United States. The purpose of this study is to evaluate the impact of a pilot sun safety educational intervention conducted from 2006 to 2012 on Hispanic early adolescents in a high ultraviolet environment. Nineteen schools with high Hispanic enrollment were recruited from urban…

[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.

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...