Sample records for safety analyses based

  1. 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.

  2. 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...

  3. Assessment of the Impact of Scheduled Postmarketing Safety Summary Analyses on Regulatory Actions

    PubMed Central

    Sekine, S; Pinnow, EE; Wu, E; Kurtzig, R; Hall, M; Dal Pan, GJ

    2016-01-01

    In addition to standard postmarketing drug safety monitoring, Section 915 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) requires the US Food and Drug Administration (FDA) to conduct a summary analysis of adverse event reports to identify risks of a drug or biologic product 18 months after product approval, or after 10,000 patients have used the product, whichever is later. We assessed the extent to which these analyses identified new safety signals and resultant safety-related label changes. Among 458 newly approved products, 300 were the subjects of a scheduled analysis; a new safety signal that resulted in a safety-related label change was found for 11 of these products. Less than 2% of 713 safety-related label changes were based on the scheduled analyses. Our study suggests that the safety summary analyses provide only marginal value over other pharmacovigilance activities. PMID:26853718

  4. Analysis of adverse events as a contribution to safety culture in the context of practice development

    PubMed

    Hoffmann, Susanne; Frei, Irena Anna

    2017-01-01

    Background: Analysing adverse events is an effective patient safety measure. Aim: We show, how clinical nurse specialists have been enabled to analyse adverse events with the „Learning from Defects-Tool“ (LFD-Tool). Method: Our multi-component implementation strategy addressed both, the safety knowledge of clinical nurse specialists and their attitude towards patient safety. The culture of practice development was taken into account. Results: Clinical nurse specialists relate competency building on patient safety due to the application of the LFD-tool. Applying the tool, fosters the reflection of adverse events in care teams. Conclusion: Applying the „Learning from Defects-Tool“ promotes work-based learning. Analysing adverse events with the „Learning from Defects-Tool“ contributes to the safety culture in a hospital.

  5. Implementation of GIS-based highway safety analyses : bridging the gap

    DOT National Transportation Integrated Search

    2001-01-01

    In recent years, efforts have been made to expand the analytical features of the Highway Safety Information System (HSIS) by integrating Geographic Information System (GIS) capabilities. The original version of the GIS Safety Analysis Tools was relea...

  6. The influence of environmental conditions on safety management in hospitals: a qualitative study.

    PubMed

    Alingh, Carien W; van Wijngaarden, Jeroen D H; Huijsman, Robbert; Paauwe, Jaap

    2018-05-02

    Hospitals are confronted with increasing safety demands from a diverse set of stakeholders, including governmental organisations, professional associations, health insurance companies, patient associations and the media. However, little is known about the effects of these institutional and competitive pressures on hospital safety management. Previous research has shown that organisations generally shape their safety management approach along the lines of control- or commitment-based management. Using a heuristic framework, based on the contextually-based human resource theory, we analysed how environmental pressures affect the safety management approach used by hospitals. A qualitative study was conducted into hospital care in the Netherlands. Five hospitals were selected for participation, based on organisational characteristics as well as variation in their reputation for patient safety. We interviewed hospital managers and staff with a central role in safety management. A total of 43 semi-structured interviews were conducted with 48 respondents. The heuristic framework was used as an initial model for analysing the data, though new codes emerged from the data as well. In order to ensure safe care delivery, institutional and competitive stakeholders often impose detailed safety requirements, strong forces for compliance and growing demands for accountability. As a consequence, hospitals experience a decrease in the room to manoeuvre. Hence, organisations increasingly choose a control-based management approach to make sure that safety demands are met. In contrast, in case of more abstract safety demands and an organisational culture which favours patient safety, hospitals generally experience more leeway. This often results in a stronger focus on commitment-based management. Institutional and competitive conditions as well as strategic choices that hospitals make have resulted in various combinations of control- and commitment-based safety management. A balanced approach is required. A strong focus on control-based management generates extrinsic motivation in employees but may, at the same time, undermine or even diminish intrinsic motivation to work on patient safety. Emphasising commitment-based management may, in contrast, strengthen intrinsic motivation but increases the risk of priorities being set elsewhere. Currently, external pressures frequently lead to the adoption of control-based management. A balanced approach requires a shift towards more trust-based safety demands.

  7. 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.

  8. Integrated vehicle-based safety systems field operational test final program report.

    DOT National Transportation Integrated Search

    2011-06-01

    "This document presents results from the light-vehicle and heavy-truck field operational tests performed as part of the Integrated Vehicle-Based Safety Systems (IVBSS) program. The findings are the result of analyses performed by the University of Mi...

  9. Integrated Vehicle-Based Safety Systems Field Operational Test : Final Program Report

    DOT National Transportation Integrated Search

    2011-06-01

    This document presents results from the light-vehicle and heavy-truck field operational tests performed as part of the Integrated Vehicle-Based Safety Systems (IVBSS) program. The findings are the result of analyses performed by the University of Mic...

  10. Integrated vehicle-based safety systems : heavy-truck field operational test key findings report.

    DOT National Transportation Integrated Search

    2010-08-01

    This document presents key findings from the heavy-truck field operational test conducted as : part of the Integrated Vehicle-Based Safety Systems program. These findings are the result of : analyses performed by the University of Michigan Transporta...

  11. Integrated vehicle-based safety systems light-vehicle field operational test key findings report.

    DOT National Transportation Integrated Search

    2011-01-01

    This document presents key findings from the light-vehicle field operational test conducted as part of the Integrated Vehicle-Based Safety Systems program. These findings are the result of analyses performed by the University of Michigan Transportati...

  12. Integrated vehicle-based safety systems light-vehicle field operational test key findings report.

    DOT National Transportation Integrated Search

    2011-01-01

    "This document presents key findings from the light-vehicle field operational test conducted as part of the Integrated Vehicle-Based Safety Systems program. These findings are the result of analyses performed by the University of Michigan Transportat...

  13. Integrated vehicle-based safety systems heavy truck field operational test, methodology and results report.

    DOT National Transportation Integrated Search

    2010-12-01

    "This document presents the methodology and results from the heavy-truck field operational test conducted as part of the Integrated Vehicle-Based Safety Systems program. These findings are the result of analyses performed by the University of Michiga...

  14. Integrated vehicle-based safety systems light-vehicle field operational test, methodology and results report.

    DOT National Transportation Integrated Search

    2010-12-01

    "This document presents the methodology and results from the light-vehicle field operational test conducted as part of the Integrated Vehicle-Based Safety Systems program. These findings are the result of analyses performed by the University of Michi...

  15. Quasi-Static Probabilistic Structural Analyses Process and Criteria

    NASA Technical Reports Server (NTRS)

    Goldberg, B.; Verderaime, V.

    1999-01-01

    Current deterministic structural methods are easily applied to substructures and components, and analysts have built great design insights and confidence in them over the years. However, deterministic methods cannot support systems risk analyses, and it was recently reported that deterministic treatment of statistical data is inconsistent with error propagation laws that can result in unevenly conservative structural predictions. Assuming non-nal distributions and using statistical data formats throughout prevailing stress deterministic processes lead to a safety factor in statistical format, which integrated into the safety index, provides a safety factor and first order reliability relationship. The embedded safety factor in the safety index expression allows a historically based risk to be determined and verified over a variety of quasi-static metallic substructures consistent with the traditional safety factor methods and NASA Std. 5001 criteria.

  16. Influence of safety motivation and climate on safety behaviour and outcomes: evidence from the Saudi Arabian construction industry.

    PubMed

    Panuwatwanich, Kriengsak; Al-Haadir, Saeed; Stewart, Rodney A

    2017-03-01

    Over the last three decades, safety literature has focused on safety climate and its role in forecasting injuries and accidents. However, research findings regarding the relationships between safety climate and other key outcome constructs are somewhat inconsistent. Recent safety climate literature suggests that examining the role of safety motivation may help provide a better explanation of such relationships. The research presented in this article aimed to empirically analyse the relationships among safety motivation, safety climate, safety behaviour and safety outcomes within the context of the Saudi Arabian construction industry. A conceptual model was developed to examine the relationships among four main constructs: safety motivation, safety climate, safety behaviour and safety outcomes. Based on the survey data collected in Saudi Arabia from site engineers and project managers (n = 295), statistical analyses were carried out, including confirmatory and exploratory factor analysis, and structural equation modelling to assess the model and test the hypotheses. The main results indicated that safety motivation could positively influence safety behaviour through safety climate, which plays a mediating role for this mechanism. The results also confirmed that safety behaviour could predict safety outcomes within the context of the Saudi Arabian construction industry.

  17. A method for identifying EMI critical circuits during development of a large C3

    NASA Astrophysics Data System (ADS)

    Barr, Douglas H.

    The circuit analysis methods and process Boeing Aerospace used on a large, ground-based military command, control, and communications (C3) system are described. This analysis was designed to help identify electromagnetic interference (EMI) critical circuits. The methodology used the MIL-E-6051 equipment criticality categories as the basis for defining critical circuits, relational database technology to help sort through and account for all of the approximately 5000 system signal cables, and Macintosh Plus personal computers to predict critical circuits based on safety margin analysis. The EMI circuit analysis process systematically examined all system circuits to identify which ones were likely to be EMI critical. The process used two separate, sequential safety margin analyses to identify critical circuits (conservative safety margin analysis, and detailed safety margin analysis). These analyses used field-to-wire and wire-to-wire coupling models using both worst-case and detailed circuit parameters (physical and electrical) to predict circuit safety margins. This process identified the predicted critical circuits that could then be verified by test.

  18. Preventing Road Rage by Modelling the Car-following and the Safety Distance Model

    NASA Astrophysics Data System (ADS)

    Lan, Si; Fang, Ni; Zhao, Huanming; Ye, Shiqi

    2017-11-01

    Starting from the different behaviours of the driver’s lane change, the car-following model based on the distance and speed and the safety distance model are established in this paper, so as to analyse the impact on traffic flow and safety, helping solve the phenomenon of road anger.

  19. Internet of Things Based Combustible Ice Safety Monitoring System Framework

    NASA Astrophysics Data System (ADS)

    Sun, Enji

    2017-05-01

    As the development of human society, more energy is requires to meet the need of human daily lives. New energies play a significant role in solving the problems of serious environmental pollution and resources exhaustion in the present world. Combustible ice is essentially frozen natural gas, which can literally be lit on fire bringing a whole new meaning to fire and ice with less pollutant. This paper analysed the advantages and risks on the uses of combustible ice. By compare to other kinds of alternative energies, the advantages of the uses of combustible ice were concluded. The combustible ice basic physical characters and safety risks were analysed. The developments troubles and key utilizations of combustible ice were predicted in the end. A real-time safety monitoring system framework based on the internet of things (IOT) was built to be applied in the future mining, which provide a brand new way to monitoring the combustible ice mining safety.

  20. SLUDGE TREATMENT PROJECT KOP CONCEPTUAL DESIGN CONTROL DECISION REPORT

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

    CARRO CA

    2010-03-09

    This control decision addresses the Knock-Out Pot (KOP) Disposition KOP Processing System (KPS) conceptual design. The KPS functions to (1) retrieve KOP material from canisters, (2) remove particles less than 600 {micro}m in size and low density materials from the KOP material, (3) load the KOP material into Multi-Canister Overpack (MCO) baskets, and (4) stage the MCO baskets for subsequent loading into MCOs. Hazard and accident analyses of the KPS conceptual design have been performed to incorporate safety into the design process. The hazard analysis is documented in PRC-STP-00098, Knock-Out Pot Disposition Project Conceptual Design Hazard Analysis. The accident analysismore » is documented in PRC-STP-CN-N-00167, Knock-Out Pot Disposition Sub-Project Canister Over Lift Accident Analysis. Based on the results of these analyses, and analyses performed in support of MCO transportation and MCO processing and storage activities at the Cold Vacuum Drying Facility (CVDF) and Canister Storage Building (CSB), control decision meetings were held to determine the controls required to protect onsite and offsite receptors and facility workers. At the conceptual design stage, these controls are primarily defined by their safety functions. Safety significant structures, systems, and components (SSCs) that could provide the identified safety functions have been selected for the conceptual design. It is anticipated that some safety SSCs identified herein will be reclassified based on hazard and accident analyses performed in support of preliminary and detailed design.« less

  1. Error Generation in CATS-Based Agents

    NASA Technical Reports Server (NTRS)

    Callantine, Todd

    2003-01-01

    This research presents a methodology for generating errors from a model of nominally preferred correct operator activities, given a particular operational context, and maintaining an explicit link to the erroneous contextual information to support analyses. It uses the Crew Activity Tracking System (CATS) model as the basis for error generation. This report describes how the process works, and how it may be useful for supporting agent-based system safety analyses. The report presents results obtained by applying the error-generation process and discusses implementation issues. The research is supported by the System-Wide Accident Prevention Element of the NASA Aviation Safety Program.

  2. How might health services capture patient-reported safety concerns in a hospital setting? An exploratory pilot study of three mechanisms.

    PubMed

    O'Hara, Jane Kathryn; Armitage, Gerry; Reynolds, Caroline; Coulson, Claire; Thorp, Liz; Din, Ikhlaq; Watt, Ian; Wright, John

    2017-01-01

    Emergent evidence suggests that patients can identify and report safety issues while in hospital. However, little is known about the best method for collecting information from patients about safety concerns. This study presents an exploratory pilot of three mechanisms for collecting data on safety concerns from patients during their hospital stay. Three mechanisms for capturing safety concerns were coproduced with healthcare professionals and patients, before being tested in an exploratory trial using cluster randomisation at the ward level. Nine wards participated, with each mechanism being tested over a 3-month study period. Patients were asked to feed back safety concerns via the mechanism on their ward (interviewing at their bedside, paper-based form or patient safety 'hotline'). Safety concerns were subjected to a two-stage review process to identify those that would meet the definition of a patient safety incident. Differences between mechanisms on a range of outcomes were analysed using inferential statistics. Safety concerns were thematically analysed to develop reporting categories. 178 patients were recruited. Patients in the face-to-face interviewing condition provided significantly more safety concerns per patient (1.91) compared with the paper-based form (0.92) and the patient safety hotline (0.43). They were also significantly more likely to report one or more concerns, with 64% reporting via the face-to-face mechanism, compared with 41% via the paper-based form and 19% via the patient safety hotline. No mechanism differed significantly in the number of classified patient safety incidents or physician-rated preventability and severity. Interviewing at the patient's bedside is likely to be the most effective means of gathering safety concerns from inpatients, potentially providing an opportunity for health services to gather patient feedback about safety from their perspective. 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/.

  3. Deep Borehole Disposal Safety Analysis.

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

    Freeze, Geoffrey A.; Stein, Emily; Price, Laura L.

    This report presents a preliminary safety analysis for the deep borehole disposal (DBD) concept, using a safety case framework. A safety case is an integrated collection of qualitative and quantitative arguments, evidence, and analyses that substantiate the safety, and the level of confidence in the safety, of a geologic repository. This safety case framework for DBD follows the outline of the elements of a safety case, and identifies the types of information that will be required to satisfy these elements. At this very preliminary phase of development, the DBD safety case focuses on the generic feasibility of the DBD concept.more » It is based on potential system designs, waste forms, engineering, and geologic conditions; however, no specific site or regulatory framework exists. It will progress to a site-specific safety case as the DBD concept advances into a site-specific phase, progressing through consent-based site selection and site investigation and characterization.« less

  4. Model-Based Safety Analysis

    NASA Technical Reports Server (NTRS)

    Joshi, Anjali; Heimdahl, Mats P. E.; Miller, Steven P.; Whalen, Mike W.

    2006-01-01

    System safety analysis techniques are well established and are used extensively during the design of safety-critical systems. Despite this, most of the techniques are highly subjective and dependent on the skill of the practitioner. Since these analyses are usually based on an informal system model, it is unlikely that they will be complete, consistent, and error free. In fact, the lack of precise models of the system architecture and its failure modes often forces the safety analysts to devote much of their effort to gathering architectural details about the system behavior from several sources and embedding this information in the safety artifacts such as the fault trees. This report describes Model-Based Safety Analysis, an approach in which the system and safety engineers share a common system model created using a model-based development process. By extending the system model with a fault model as well as relevant portions of the physical system to be controlled, automated support can be provided for much of the safety analysis. We believe that by using a common model for both system and safety engineering and automating parts of the safety analysis, we can both reduce the cost and improve the quality of the safety analysis. Here we present our vision of model-based safety analysis and discuss the advantages and challenges in making this approach practical.

  5. Prediction of main factors’ values of air transportation system safety based on system dynamics

    NASA Astrophysics Data System (ADS)

    Spiridonov, A. Yu; Rezchikov, A. F.; Kushnikov, V. A.; Ivashchenko, V. A.; Bogomolov, A. S.; Filimonyuk, L. Yu; Dolinina, O. N.; Kushnikova, E. V.; Shulga, T. E.; Tverdokhlebov, V. A.; Kushnikov, O. V.; Fominykh, D. S.

    2018-05-01

    On the basis of the system-dynamic approach [1-8], a set of models has been developed that makes it possible to analyse and predict the values of the main safety indicators for the operation of aviation transport systems.

  6. Development and Validation of Career Development Guidelines by Task/Activity Analysis of Occupational Safety and Health Professions: Industrial Hygiene and Safety Professional. Final Report. Technical Report XII.

    ERIC Educational Resources Information Center

    Vernon, Ralph J.; And Others

    This report summarizes research findings which resulted in development of curricula for occupational safety and health professions based on task/activity analyses and related performance objectives. The first seven chapters focus on the seven objectives. Chapter 1, Literature Review and Selection of Employers, concerns tasks required for…

  7. Confirming criticality safety of TRU waste with neutron measurements and risk analyses

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

    Winn, W.G.; Hochel, R.D.

    1992-04-01

    The criticality safety of {sup 239}Pu in 55-gallon drums stored in TRU waste containers (culverts) is confirmed using NDA neutron measurements and risk analyses. The neutron measurements yield a {sup 239}Pu mass and k{sub eff} for a culvert, which contains up to 14 drums. Conservative probabilistic risk analyses were developed for both drums and culverts. Overall {sup 239}Pu mass estimates are less than a calculated safety limit of 2800 g per culvert. The largest measured k{sub eff} is 0.904. The largest probability for a critical drum is 6.9 {times} 10{sup {minus}8} and that for a culvert is 1.72 {times} 10{supmore » {minus}7}. All examined suspect culverts, totaling 118 in number, are appraised as safe based on these observations.« less

  8. Comparison of the occupational safety applications in marble quarries of Carrara (Italy) and Iscehisar (Turkey) by using Elmeri method.

    PubMed

    Ersoy, Metin; Yesilkaya, Liyaddin

    2016-01-01

    In this paper, a brief summary is given about marble quarries in Carrara (Italy) and Iscehisar (Turkey), the Elmeri method is introduced, work accidents that can happen in marble quarries and their causes besides work safety behaviours in fields are explained, and the Elmeri monitoring method is applied and analysed. For this reason, marble quarries are divided into seven in terms of working conditions and active six quarries both in Carrara and Iscehisar areas, and work safety behaviours are analysed. Analysis process is based on True-False method; there are 18 items in total under six main topics; three items on each topic. The safety index for each section and the main topics are also calculated. According to the calculated safety indexes, Carrara area marble quarries (65.08%) are safer than Iscehisar area marble quarries (46.01%).

  9. Perceived school safety is strongly associated with adolescent mental health problems.

    PubMed

    Nijs, Miesje M; Bun, Clothilde J E; Tempelaar, Wanda M; de Wit, Niek J; Burger, Huibert; Plevier, Carolien M; Boks, Marco P M

    2014-02-01

    School environment is an important determinant of psychosocial function and may also be related to mental health. We therefore investigated whether perceived school safety, a simple measure of this environment, is related to mental health problems. In a population-based sample of 11,130 secondary school students, we analysed the relationship of perceived school safety with mental health problems using multiple logistic regression analyses to adjust for potential confounders. Mental health problems were defined using the clinical cut-off of the self-reported Strengths and Difficulties Questionnaire. School safety showed an exposure-response relationship with mental health problems after adjustment for confounders. Odds ratios increased from 2.48 ("sometimes unsafe") to 8.05 ("very often unsafe"). The association was strongest in girls and young and middle-aged adolescents. Irrespective of the causal background of this association, school safety deserves attention either as a risk factor or as an indicator of mental health problems.

  10. Health economics and outcomes methods in risk-based decision-making for blood safety.

    PubMed

    Custer, Brian; Janssen, Mart P

    2015-08-01

    Analytical methods appropriate for health economic assessments of transfusion safety interventions have not previously been described in ways that facilitate their use. Within the context of risk-based decision-making (RBDM), health economics can be important for optimizing decisions among competing interventions. The objective of this review is to address key considerations and limitations of current methods as they apply to blood safety. Because a voluntary blood supply is an example of a public good, analyses should be conducted from the societal perspective when possible. Two primary study designs are recommended for most blood safety intervention assessments: budget impact analysis (BIA), which measures the cost to implement an intervention both to the blood operator but also in a broader context, and cost-utility analysis (CUA), which measures the ratio between costs and health gain achieved, in terms of reduced morbidity and mortality, by use of an intervention. These analyses often have important limitations because data that reflect specific aspects, for example, blood recipient population characteristics or complication rates, are not available. Sensitivity analyses play an important role. The impact of various uncertain factors can be studied conjointly in probabilistic sensitivity analyses. The use of BIA and CUA together provides a comprehensive assessment of the costs and benefits from implementing (or not) specific interventions. RBDM is multifaceted and impacts a broad spectrum of stakeholders. Gathering and analyzing health economic evidence as part of the RBDM process enhances the quality, completeness, and transparency of decision-making. © 2015 AABB.

  11. Software system safety

    NASA Technical Reports Server (NTRS)

    Uber, James G.

    1988-01-01

    Software itself is not hazardous, but since software and hardware share common interfaces there is an opportunity for software to create hazards. Further, these software systems are complex, and proven methods for the design, analysis, and measurement of software safety are not yet available. Some past software failures, future NASA software trends, software engineering methods, and tools and techniques for various software safety analyses are reviewed. Recommendations to NASA are made based on this review.

  12. Towards a Competency-based Vision for Construction Safety Education

    NASA Astrophysics Data System (ADS)

    Pedro, Akeem; Hai Chien, Pham; Park, Chan Sik

    2018-04-01

    Accidents still prevail in the construction industry, resulting in injuries and fatalities all over the world. Educational programs in construction should deliver safety knowledge and skills to students who will become responsible for ensuring safe construction work environments in the future. However, there is a gap between the competencies current pedagogical approaches target, and those required for safety in practice. This study contributes to addressing this issue in three steps. Firstly, a vision for competency-based construction safety education is conceived. Building upon this, a research scheme to achieve the vision is developed, and the first step of the scheme is initiated in this study. The critical competencies required for safety education are investigated through analyses of literature, and confirmed through surveys with construction and safety management professionals. Results from the study would be useful in establishing and orienting education programs towards current industry safety needs and requirements

  13. Urban transport safety assessment in akure based on corresponding performance indicators

    NASA Astrophysics Data System (ADS)

    Oye, Adedamola; Aderinlewo, Olufikayo; Croope, Silvana

    2013-03-01

    The level of safety of the transportation system in Akure, Nigeria was assessed by identifying the associated road safety problems and developing the corresponding safety performance indicators. These indicators were analysed with respect to accidents that occurred within the city from the year 2005 to 2009 based on the corresponding attributable risk measures. The results of the analysis showed the state of existing safety programs in Akure town. Six safety performance indicators were identified namely alcohol and drug use, excessive speeds, protection system (use of seat belts and helmets), use of day time running lights, state of vehicles (passive safety) and road condition. These indicators were used to determine the percentage of injury accidents as follows: 83.33% and 86.36% for years 2005 and 2006 respectively, 81.46% for year 2007 while years 2008 and 2009 had 82.86% and 78.12% injury accidents respectively.

  14. Safety incidents involving confused and forgetful older patients in a specialised care setting--analysis of the safety incidents reported to the HaiPro reporting system.

    PubMed

    Kinnunen-Luovi, Kaisa; Saarnio, Reetta; Isola, Arja

    2014-09-01

    To describe the safety incidents involving confused and forgetful older patients in a specialised care setting entered in the HaiPro reporting system. About 10% of patients experience a safety incident during hospitalisation, which causes or could cause them harm. The possibility of a safety incident during hospitalisation increases significantly with age. A mild or moderate memory disorder and acute confusion are often present in the safety incidents originating with an older patient. The design of the study was action research with this study using findings from one of the first-phase studies, which included qualitative and quantitative analysed data. Data were collected from the reporting system for safety incidents (HaiPro) in a university hospital in Finland. There were 672 reported safety incidents from four acute medical wards during the years 2009-2011, which were scrutinised. Seventy-five of them were linked to a confused patient and were analysed. The majority of the safety incidents analysed involved patient-related accidents. In addition to challenging behaviour, contributing factors included ward routines, shortage of nursing staff, environmental factors and staff knowledge and skills. Nurses tried to secure the patient safety in many different ways, but the modes of actions were insufficient. Nursing staff need evidence-based information on how to assess the cognitive status of a confused patient and how to encounter such patients. The number of nursing staff and ward routines should be examined critically and put in proportion to the care intensity demands caused by the patient's confused state. The findings can be used as a starting point in the prevention of safety incidents and in improving the care of older patients. © 2013 John Wiley & Sons Ltd.

  15. A root cause analysis project in a medication safety course.

    PubMed

    Schafer, Jason J

    2012-08-10

    To develop, implement, and evaluate team-based root cause analysis projects as part of a required medication safety course for second-year pharmacy students. Lectures, in-class activities, and out-of-class reading assignments were used to develop students' medication safety skills and introduce them to the culture of medication safety. Students applied these skills within teams by evaluating cases of medication errors using root cause analyses. Teams also developed error prevention strategies and formally presented their findings. Student performance was assessed using a medication errors evaluation rubric. Of the 211 students who completed the course, the majority performed well on root cause analysis assignments and rated them favorably on course evaluations. Medication error evaluation and prevention was successfully introduced in a medication safety course using team-based root cause analysis projects.

  16. Implementation of Recommendations from the One System Comparative Evaluation of the Hanford Tank Farms and Waste Treatment Plant Safety Bases

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

    Garrett, Richard L.; Niemi, Belinda J.; Paik, Ingle K.

    2013-11-07

    A Comparative Evaluation was conducted for One System Integrated Project Team to compare the safety bases for the Hanford Waste Treatment and Immobilization Plant Project (WTP) and Tank Operations Contract (TOC) (i.e., Tank Farms) by an Expert Review Team. The evaluation had an overarching purpose to facilitate effective integration between WTP and TOC safety bases. It was to provide One System management with an objective evaluation of identified differences in safety basis process requirements, guidance, direction, procedures, and products (including safety controls, key safety basis inputs and assumptions, and consequence calculation methodologies) between WTP and TOC. The evaluation identified 25more » recommendations (Opportunities for Integration). The resolution of these recommendations resulted in 16 implementation plans. The completion of these implementation plans will help ensure consistent safety bases for WTP and TOC along with consistent safety basis processes. procedures, and analyses. and should increase the likelihood of a successful startup of the WTP. This early integration will result in long-term cost savings and significant operational improvements. In addition, the implementation plans lead to the development of eight new safety analysis methodologies that can be used at other U.S. Department of Energy (US DOE) complex sites where URS Corporation is involved.« less

  17. Patient safety education to change medical students' attitudes and sense of responsibility.

    PubMed

    Roh, Hyerin; Park, Seok Ju; Kim, Taekjoong

    2015-01-01

    This study examined changes in the perceptions and attitudes as well as the sense of individual and collective responsibility in medical students after they received patient safety education. A three-day patient safety curriculum was implemented for third-year medical students shortly before entering their clerkship. Before and after training, we administered a questionnaire, which was analysed quantitatively. Additionally, we asked students to answer questions about their expected behaviours in response to two case vignettes. Their answers were analysed qualitatively. There was improvement in students' concepts of patient safety after training. Before training, they showed good comprehension of the inevitability of error, but most students blamed individuals for errors and expressed a strong sense of individual responsibility. After training, students increasingly attributed errors to system dysfunction and reported more self-confidence in speaking up about colleagues' errors. However, due to the hierarchical culture, students still described difficulties communicating with senior doctors. Patient safety education effectively shifted students' attitudes towards systems-based thinking and increased their sense of collective responsibility. Strategies for improving superior-subordinate communication within a hierarchical culture should be added to the patient safety curriculum.

  18. Near real-time vaccine safety surveillance with partially accrued data.

    PubMed

    Greene, Sharon K; Kulldorff, Martin; Yin, Ruihua; Yih, W Katherine; Lieu, Tracy A; Weintraub, Eric S; Lee, Grace M

    2011-06-01

    The Vaccine Safety Datalink (VSD) Project conducts near real-time vaccine safety surveillance using sequential analytic methods. Timely surveillance is critical in identifying potential safety problems and preventing additional exposure before most vaccines are administered. For vaccines that are administered during a short period, such as influenza vaccines, timeliness can be improved by undertaking analyses while risk windows following vaccination are ongoing and by accommodating predictable and unpredictable data accrual delays. We describe practical solutions to these challenges, which were adopted by the VSD Project during pandemic and seasonal influenza vaccine safety surveillance in 2009/2010. Adjustments were made to two sequential analytic approaches. The Poisson-based approach compared the number of pre-defined adverse events observed following vaccination with the number expected using historical data. The expected number was adjusted for the proportion of the risk window elapsed and the proportion of inpatient data estimated to have accrued. The binomial-based approach used a self-controlled design, comparing the observed numbers of events in risk versus comparison windows. Events were included in analysis only if they occurred during a week that had already passed for both windows. Analyzing data before risk windows fully elapsed improved the timeliness of safety surveillance. Adjustments for data accrual lags were tailored to each data source and avoided biasing analyses away from detecting a potential safety problem, particularly early during surveillance. The timeliness of vaccine and drug safety surveillance can be improved by properly accounting for partially elapsed windows and data accrual delays. Copyright © 2011 John Wiley & Sons, Ltd.

  19. Development and perceived effects of an educational programme on quality and safety in medication handling in residential facilities.

    PubMed

    Mygind, Anna; El-Souri, Mira; Rossing, Charlotte; Thomsen, Linda Aagaard

    2018-04-01

    To develop and test an educational programme on quality and safety in medication handling for staff in residential facilities for the disabled. The continuing pharmacy education instructional design model was used to develop the programme with 22 learning objectives on disease and medicines, quality and safety, communication and coordination. The programme was a flexible, modular seven + two days' course addressing quality and safety in medication handling, disease and medicines, and medication supervision and reconciliation. The programme was tested in five Danish municipalities. Municipalities were selected based on their application for participation; each independently selected a facility for residents with mental and intellectual disabilities, and a facility for residents with severe mental illnesses. Perceived effects were measured based on a questionnaire completed by participants before and after the programme. Effects on motivation and confidence as well as perceived effects on knowledge, skills and competences related to medication handling, patient empowerment, communication, role clarification and safety culture were analysed conducting bivariate, stratified analyses and test for independence. Of the 114 participants completing the programme, 75 participants returned both questionnaires (response rate = 66%). Motivation and confidence regarding quality and safety in medication handling significantly improved, as did perceived knowledge, skills and competences on 20 learning objectives on role clarification, safety culture, medication handling, patient empowerment and communication. The programme improved staffs' motivation and confidence and their perceived ability to handle residents' medication safely through improved role clarification, safety culture, medication handling and patient empowerment and communication skills. © 2017 Royal Pharmaceutical Society.

  20. Safety Psychology Applicating on Coal Mine Safety Management Based on Information System

    NASA Astrophysics Data System (ADS)

    Hou, Baoyue; Chen, Fei

    In recent years, with the increase of intensity of coal mining, a great number of major accidents happen frequently, the reason mostly due to human factors, but human's unsafely behavior are affected by insecurity mental control. In order to reduce accidents, and to improve safety management, with the help of application security psychology, we analyse the cause of insecurity psychological factors from human perception, from personality development, from motivation incentive, from reward and punishment mechanism, and from security aspects of mental training , and put forward countermeasures to promote coal mine safety production,and to provide information for coal mining to improve the level of safety management.

  1. Safety and Efficacy of Methotrexate in Psoriasis: A Meta-Analysis of Published Trials

    PubMed Central

    West, Jonathan; Ogston, Simon; Foerster, John

    2016-01-01

    Background Methotrexate (MTX) has been used to treat psoriasis for over half a century. Even so, clinical data characterising its efficacy and safety are sparse. Objective In order to enhance the available evidence, we conducted two meta-analyses, one for efficacy and one for safety outcomes, respectively, according to PRISMA checklist. (Data sources, study criteria, and study synthesis methods are detailed in Methods). Results In terms of efficacy, only eleven studies met criteria for study design and passed a Cochrane risk of bias analysis. Based on this limited dataset, 45.2% [95% confidence interval 34.1–60.0] of patients achieve PASI75 at primary endpoint (12 or 16 weeks, respectively, n = 705 patients across all studies), compared to a calculated PASI75 of 4.4 [3.5–5.6] for placebo, yielding a relative risk of 10.2 [95% C.I. 7.1–14.7]. For safety outcomes, we extended the meta-analysis to include studies employing the same dose range of MTX for other chronic inflammatory conditions, e.g. rheumatoid arthritis, in order not to maximise capture of relevant safety data. Based on 2763 patient safety years, adverse events (AEs) were found treatment limiting in 6.9 ± 1.4% (mean ± s.e.) of patients treated for six months, with an adverse effect profile largely in line with that encountered in clinical practice. Finally, in order to facilitate prospective clinical audit and to help generate long-term treatment outcomes under real world conditions, we also developed an easy to use documentation form to be completed by patients without requirement for additional staff time. Limitations Meta-analyses for efficacy and safety, respectively, employed non-identical selection criteria. Conclusions These meta-analyses summarise currently available evidence on MTX in psoriasis and should be of use to gauge whether local results broadly fall within outcomes. PMID:27168193

  2. 75 FR 26098 - Safety Zone; Under Water Clean Up of Copper Canyon, Lake Havasu, AZ

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-11

    ... rulemaking (NPRM) with respect to this rule because the logistical details of the event were not finalized or... Port, or his designated representative. Regulatory Analyses We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13...

  3. 76 FR 9227 - Safety Zone; Havasu Landing Regatta, Colorado River, Lake Havasu Landing, CA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-17

    ... rulemaking (NPRM) with respect to this rule because doing so would be impracticable. The logistical details... designated representative. Regulatory Analyses We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or...

  4. Classification of antecedents towards safety use of health information technology: A systematic review.

    PubMed

    Salahuddin, Lizawati; Ismail, Zuraini

    2015-11-01

    This paper provides a systematic review of safety use of health information technology (IT). The first objective is to identify the antecedents towards safety use of health IT by conducting systematic literature review (SLR). The second objective is to classify the identified antecedents based on the work system in Systems Engineering Initiative for Patient Safety (SEIPS) model and an extension of DeLone and McLean (D&M) information system (IS) success model. A systematic literature review (SLR) was conducted from peer-reviewed scholarly publications between January 2000 and July 2014. SLR was carried out and reported based on the preferred reporting items for systematic reviews and meta-analyses (PRISMA) statement. The related articles were identified by searching the articles published in Science Direct, Medline, EMBASE, and CINAHL databases. Data extracted from the resultant studies included are to be analysed based on the work system in Systems Engineering Initiative for Patient Safety (SEIPS) model, and also from the extended DeLone and McLean (D&M) information system (IS) success model. 55 articles delineated to be antecedents that influenced the safety use of health IT were included for review. Antecedents were identified and then classified into five key categories. The categories are (1) person, (2) technology, (3) tasks, (4) organization, and (5) environment. Specifically, person is attributed by competence while technology is associated to system quality, information quality, and service quality. Tasks are attributed by task-related stressor. Organisation is related to training, organisation resources, and teamwork. Lastly, environment is attributed by physical layout, and noise. This review provides evidence that the antecedents for safety use of health IT originated from both social and technical aspects. However, inappropriate health IT usage potentially increases the incidence of errors and produces new safety risks. The review cautions future implementation and adoption of health IT to carefully consider the complex interactions between social and technical elements propound in healthcare settings. Copyright © 2015. Published by Elsevier Ireland Ltd.

  5. [Assessment of the patient-safety culture in a healthcare district].

    PubMed

    Pozo Muñoz, F; Padilla Marín, V

    2013-01-01

    1) To describe the frequency of positive attitudes and behaviours, in terms of patient safety, among the healthcare providers working in a healthcare district; 2) to determine whether the level of safety-related culture differs from other studies; and 3) to analyse negatively valued dimensions, and to establish areas for their improvement. A descriptive, cross-sectional study based on the results of an evaluation of the safety-related culture was conducted on a randomly selected sample of 247 healthcare providers, by using the Spanish adaptation of the Hospital Survey on Patient Safety Culture (HSOPSC) designed by the Agency for Healthcare Research and Quality (AHRQ), as the evaluation tool. Positive and negative responses were analysed, as well as the global score. Results were compared with international and national results. A total of 176 completed survey questionnaires were analysed (response rate: 71.26%); 50% of responders described the safety climate as very good, 37% as acceptable, and 7% as excellent. Strong points were: «Teamwork within the units» (80.82%) and «Supervisor/manager expectations and actions» (80.54%). Dimensions identified for potential improvement included: «Staffing» (37.93%), «Non-punitive response to error» (41.67%), and «Frequency of event reporting» (49.05%). Strong and weak points were identified in the safety-related culture of the healthcare district studied, together with potential improvement areas. Benchmarking at the international level showed that our safety-related culture was within the average of hospitals, while at the national level, our results were above the average of hospitals. Copyright © 2013 SECA. Published by Elsevier Espana. All rights reserved.

  6. 75 FR 55975 - Safety Zone; San Diego Harbor Shark Fest Swim; San Diego Bay, San Diego, CA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-15

    ... Guard did not receive notification of the logistical details of the San Diego Bay swim in sufficient... the Captain of the Port, or designated representative. Regulatory Analyses We developed this rule... analyses based on 13 of these statutes or executive orders. Regulatory Planning and Review This rule is not...

  7. 78 FR 58878 - Safety Zone; San Diego Shark Fest Swim; San Diego Bay, San Diego, CA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-25

    ... this rule because the logistical details of the San Diego Shark Fest Swim were not finalized nor... Local Notice to Mariners and Broadcast Notice to Mariners. D. Regulatory Analyses We developed this rule... analyses based on a number of these statutes and executive orders. 1. Regulatory Planning and Review This...

  8. 10 CFR Appendix A to Part 52 - Design Certification Rule for the U.S. Advanced Boiling Water Reactor

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ....34—Separate Plant Safety Parameter Display Console; 2. Paragraph (f)(2)(viii) of 10 CFR 50.34—Post... design bases or in the safety analyses. c. A proposed departure from Tier 2 affecting resolution of an ex... if: (1) There is a substantial increase in the probability of an ex-vessel severe accident such that...

  9. 10 CFR Appendix A to Part 52 - Design Certification Rule for the U.S. Advanced Boiling Water Reactor

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ....34—Separate Plant Safety Parameter Display Console; 2. Paragraph (f)(2)(viii) of 10 CFR 50.34—Post... design bases or in the safety analyses. c. A proposed departure from Tier 2 affecting resolution of an ex... if: (1) There is a substantial increase in the probability of an ex-vessel severe accident such that...

  10. Quality and Safety Aspects of Cereals (Wheat) and Their Products.

    PubMed

    Varzakas, Theo

    2016-11-17

    Cereals and, most specifically, wheat are described in this chapter highlighting on their safety and quality aspects. Moreover, wheat quality aspects are adequately addressed since they are used to characterize dough properties and baking quality. Determination of dough properties is also mentioned and pasta quality is also described in this chapter. Chemometrics-multivariate analysis is one of the analyses carried out. Regarding production weighing/mixing of flours, kneading, extruded wheat flours, and sodium chloride are important processing steps/raw materials used in the manufacturing of pastry products. Staling of cereal-based products is also taken into account. Finally, safety aspects of cereal-based products are well documented with special emphasis on mycotoxins, acrylamide, and near infrared methodology.

  11. Aerospace Safety Advisory Panel

    NASA Technical Reports Server (NTRS)

    1989-01-01

    This report provides findings, conclusions and recommendations regarding the National Space Transportation System (NSTS), the Space Station Freedom Program (SSFP), aeronautical projects and other areas of NASA activities. The main focus of the Aerospace Safety Advisory Panel (ASAP) during 1988 has been monitoring and advising NASA and its contractors on the Space Transportation System (STS) recovery program. NASA efforts have restored the flight program with a much better management organization, safety and quality assurance organizations, and management communication system. The NASA National Space Transportation System (NSTS) organization in conjunction with its prime contractors should be encouraged to continue development and incorporation of appropriate design and operational improvements which will further reduce risk. The data from each Shuttle flight should be used to determine if affordable design and/or operational improvements could further increase safety. The review of Critical Items (CILs), Failure Mode Effects and Analyses (FMEAs) and Hazard Analyses (HAs) after the Challenger accident has given the program a massive data base with which to establish a formal program with prioritized changes.

  12. Safety climate and culture: Integrating psychological and systems perspectives.

    PubMed

    Casey, Tristan; Griffin, Mark A; Flatau Harrison, Huw; Neal, Andrew

    2017-07-01

    Safety climate research has reached a mature stage of development, with a number of meta-analyses demonstrating the link between safety climate and safety outcomes. More recently, there has been interest from systems theorists in integrating the concept of safety culture and to a lesser extent, safety climate into systems-based models of organizational safety. Such models represent a theoretical and practical development of the safety climate concept by positioning climate as part of a dynamic work system in which perceptions of safety act to constrain and shape employee behavior. We propose safety climate and safety culture constitute part of the enabling capitals through which organizations build safety capability. We discuss how organizations can deploy different configurations of enabling capital to exert control over work systems and maintain safe and productive performance. We outline 4 key strategies through which organizations to reconcile the system control problems of promotion versus prevention, and stability versus flexibility. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  13. Proposed qualification requirements for selected railroad jobs

    DOT National Transportation Integrated Search

    1975-01-01

    This report proposes minimum safety-related knowledge, performance and training requirements for the jobs of railroad engineer, conductor, brakeman and train dispatchers. Analyses performed were primarily based upon job and task analytic documentatio...

  14. Analysis of Material Handling Safety in Construction Sites and Countermeasures for Effective Enhancement

    PubMed Central

    Anil Kumar, C. N.; Sakthivel, M.; Elangovan, R. K.; Arularasu, M.

    2015-01-01

    One of many hazardous workplaces includes the construction sites as they involve several dangerous tasks. Many studies have revealed that material handling equipment is a major cause of accidents at these sites. Though safety measures are being followed and monitored continuously, accident rates are still high as either workers are unaware of hazards or the safety regulations are not being strictly followed. This paper analyses the safety management systems at construction sites through means of questionnaire surveys with employees, specifically referring to safety of material handling equipment. Based on results of the questionnaire surveys, two construction sites were selected for a safety education program targeting worker safety related to material handling equipment. Knowledge levels of the workers were gathered before and after the program and results obtained were subjected to a t-test analysis to mark significance level of the conducted safety education program. PMID:26446572

  15. Meta-analysis of surgical safety checklist effects on teamwork, communication, morbidity, mortality, and safety.

    PubMed

    Lyons, Vanessa E; Popejoy, Lori L

    2014-02-01

    The purpose of this study is to examine the effectiveness of surgical safety checklists on teamwork, communication, morbidity, mortality, and compliance with safety measures through meta-analysis. Four meta-analyses were conducted on 19 studies that met the inclusion criteria. The effect size of checklists on teamwork and communication was 1.180 (p = .003), on morbidity and mortality was 0.123 (p = .003) and 0.088 (p = .001), respectively, and on compliance with safety measures was 0.268 (p < .001). The results indicate that surgical safety checklists improve teamwork and communication, reduce morbidity and mortality, and improve compliance with safety measures. This meta-analysis is limited in its generalizability based on the limited number of studies and the inclusion of only published research. Future research is needed to examine possible moderating variables for the effects of surgical safety checklists.

  16. Evaluating a Website to Teach Children Safety with Dogs: A Randomized Controlled Trial

    PubMed Central

    Schwebel, David C.; Li, Peng; McClure, Leslie A.; Severson, Joan

    2016-01-01

    Dog bites represent a significant threat to child health. Theory-driven interventions scalable for broad dissemination are sparse. A website was developed to teach children dog safety via increased knowledge, improved cognitive skills in relevant domains, and increased perception of vulnerability to bites. A randomized controlled trial was conducted with 69 children aged 4–5 randomly assigned to use the dog safety website or a control transportation safety website for ~3 weeks. Assessment of dog safety knowledge and behavior plus skill in three relevant cognitive constructs (impulse control, noticing details, and perspective-taking) was conducted both at baseline and following website use. The dog safety website incorporated interactive games, instructional videos including testimonials, a motivational rewards system, and messaging to parents concerning child lessons. Our results showed that about two-thirds of the intervention sample was not adherent to website use at home, so both intent-to-treat and per-protocol analyses were conducted. Intent-to-treat analyses yielded mostly null results. Per-protocol analyses suggested children compliant to the intervention protocol scored higher on knowledge and recognition of safe behavior with dogs following the intervention compared to the control group. Adherent children also had improved scores post-intervention on the cognitive skill of noticing details compared to the control group. We concluded that young children’s immature cognition can lead to dog bites. Interactive eHealth training on websites shows potential to teach children relevant cognitive and safety skills to reduce risk. Compliance to website use is a challenge, and some relevant cognitive skills (e.g., noticing details) may be more amenable to computer-based training than others (e.g., impulse control). PMID:27918466

  17. Evaluating a Website to Teach Children Safety with Dogs: A Randomized Controlled Trial.

    PubMed

    Schwebel, David C; Li, Peng; McClure, Leslie A; Severson, Joan

    2016-12-02

    Dog bites represent a significant threat to child health. Theory-driven interventions scalable for broad dissemination are sparse. A website was developed to teach children dog safety via increased knowledge, improved cognitive skills in relevant domains, and increased perception of vulnerability to bites. A randomized controlled trial was conducted with 69 children aged 4-5 randomly assigned to use the dog safety website or a control transportation safety website for ~3 weeks. Assessment of dog safety knowledge and behavior plus skill in three relevant cognitive constructs (impulse control, noticing details, and perspective-taking) was conducted both at baseline and following website use. The dog safety website incorporated interactive games, instructional videos including testimonials, a motivational rewards system, and messaging to parents concerning child lessons. Our results showed that about two-thirds of the intervention sample was not adherent to website use at home, so both intent-to-treat and per-protocol analyses were conducted. Intent-to-treat analyses yielded mostly null results. Per-protocol analyses suggested children compliant to the intervention protocol scored higher on knowledge and recognition of safe behavior with dogs following the intervention compared to the control group. Adherent children also had improved scores post-intervention on the cognitive skill of noticing details compared to the control group. We concluded that young children's immature cognition can lead to dog bites. Interactive eHealth training on websites shows potential to teach children relevant cognitive and safety skills to reduce risk. Compliance to website use is a challenge, and some relevant cognitive skills (e.g., noticing details) may be more amenable to computer-based training than others (e.g., impulse control).

  18. An Operational Safety and Certification Assessment of a TASAR EFB Application

    NASA Technical Reports Server (NTRS)

    Koczo, Stefan; Wing, David

    2013-01-01

    This paper presents an overview of a Traffic Aware Strategic Aircrew Requests (TASAR) Electronic Flight Bag application intended to inform the pilot of trajectory improvement opportunities while en route that result in operational benefits. The results of safety analyses and a detailed review of Federal Aviation Administration (FAA) regulatory documents that establish certification and operational approval requirements are presented for TASAR. The safety analyses indicate that TASAR has a likely Failure Effects Classification of “No Effect,” and at most, is no worse than “Minor Effect.” Based on this safety assessment and the detailed review of FAA regulatory documents that determine certification and operational approval requirements, this study concludes that TASAR can be implemented in the flight deck as a Type B software application hosted on a Class 2 Portable Electronic Device (PED) Electronic Flight Bag (EFB). This implementation approach would provide a relatively low-cost path to certification and operational approval for both retrofit and forward fit implementation, while at the same time facilitating the business case for early ADS-B IN equipage. A preliminary review by FAA certification and operational approvers of the analyses presented here confirmed that the conclusions are appropriate and that TASAR will be considered a Type B application.

  19. Impact of Venetoclax Exposure on Clinical Efficacy and Safety in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia.

    PubMed

    Freise, Kevin J; Jones, Aksana K; Eckert, Doerthe; Mensing, Sven; Wong, Shekman L; Humerickhouse, Rod A; Awni, Walid M; Salem, Ahmed Hamed

    2017-05-01

    Venetoclax is a selective, potent, first-in-class B-cell lymphoma-2 inhibitor that restores apoptosis in cancer cells and has demonstrated efficacy in a variety of hematological malignancies. The objective of this research was to characterize the relationship between venetoclax exposures and efficacy and safety in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). A total of 272 and 338 patients from four clinical studies were pooled for the exposure-efficacy and exposure-safety analyses, respectively. Demographics, baseline disease characteristics, and select co-medications were evaluated for their impact on efficacy (lymphocytes, tumor size, objective response [OR]) and safety (neutropenia and infection). Higher venetoclax concentrations led to a more rapid decrease in lymphocyte counts and tumor size, which translated into patients more rapidly achieving OR. The 17p deletion somatic mutation was not identified, in any of the analyses, to affect the responsiveness of patients to venetoclax. Model-based simulations of lymphocyte counts and tumor size estimated an OR rate (ORR) of 84.8 % (95 % confidence interval 81.5-88.0 %) at a venetoclax dosage of 400 mg daily, with minimal increase in ORR at higher doses. The safety analyses of the adverse events (grade 3 or higher) of neutropenia and infection indicated that higher average venetoclax concentrations were not associated with an increase in adverse events. The exposure-response analyses indicated that a venetoclax dosage regimen of 400 mg daily results in a high (>80 %) probability of achieving OR in R/R CLL/SLL patients, with minimal probability of increasing neutropenia or infection with higher exposures.

  20. Operational and safety-based analyses of varied toll lanes.

    DOT National Transportation Integrated Search

    2016-02-01

    Over the past decades, fatal crashes and severe injuries have been observed to : increase in highway facilities. This has created a big concern among different : transportation agencies and other organizations such as State Departments of : Transport...

  1. Supporting calculations and assumptions for use in WESF safetyanalysis

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

    Hey, B.E.

    This document provides a single location for calculations and assumptions used in support of Waste Encapsulation and Storage Facility (WESF) safety analyses. It also provides the technical details and bases necessary to justify the contained results.

  2. Under the radar: community safety nets for AIDS-affected households in sub-Saharan Africa.

    PubMed

    Foster, G

    2007-01-01

    Safety nets are mechanisms to mitigate the effects of poverty on vulnerable households during times of stress. In sub-Saharan Africa, extended families, together with communities, are the most effective responses enabling access to support for households facing crises. This paper reviews literature on informal social security systems in sub-Saharan Africa, analyses changes taking place in their functioning as a result of HIV/AIDS and describes community safety net components including economic associations, cooperatives, loan providers, philanthropic groups and HIV/AIDS initiatives. Community safety nets target households in greatest need, respond rapidly to crises, are cost efficient, based on local needs and available resources, involve the specialized knowledge of community members and provide financial and psycho-social support. Their main limitations are lack of material resources and reliance on unpaid labour of women. Changes have taken place in safety net mechanisms because of HIV/AIDS, suggesting the resilience of communities rather than their impending collapse. Studies are lacking that assess the value of informal community-level transfers, describe how safety nets assist the poor or analyse modifications in response to HIV/AIDS. The role of community safety nets remains largely invisible under the radar of governments, non-governmental organizations and international bodies. External support can strengthen this system of informal social security that provides poor HIV/AIDS-affected households with significant support.

  3. 77 FR 45282 - NRC Position on the Relationship Between General Design Criteria and Technical Specification...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-31

    ..., are described in the final safety analysis report (FSAR). The staff safety evaluation documents the acceptability of these analyses, and it is the combination of the FSAR analyses and the staff safety evaluation... analysis, maintain their capability to perform their safety functions. Technical Specification Operability...

  4. Improving patient safety in Libya: insights from a British health system perspective.

    PubMed

    Elmontsri, Mustafa; Almashrafi, Ahmed; Dubois, Elizabeth; Banarsee, Ricky; Majeed, Azeem

    2018-04-16

    Purpose Patient safety programmes aim to make healthcare safe for both patients and health professionals. The purpose of this paper is to explore the UK's patient safety improvement programmes over the past 15 years and explore what lessons can be learnt to improve Libyan healthcare patient safety. Design/methodology/approach Publications focusing on UK patient safety were searched in academic databases and content analysed. Findings Several initiatives have been undertaken over the past 15 years to improve British healthcare patient safety. Many stakeholders are involved, including regulatory and professional bodies, educational providers and non-governmental organisations. Lessons can be learnt from the British journey. Practical implications Developing a national patient safety strategy for Libya, which reflects context and needs is paramount. Above all, Libyan patient safety programmes should reference internationally approved guidelines, evidence, policy and learning from Britain's unique experience. Originality/value This review examines patient safety improvement strategies adopted in Britain to help developing country managers to progress local strategies based on lessons learnt from Britain's unique experience.

  5. The Relationship Among School Safety, School Liking, and Students' Self-Esteem: Based on a Multilevel Mediation Model.

    PubMed

    Zhang, Xinghui; Xuan, Xin; Chen, Fumei; Zhang, Cai; Luo, Yuhan; Wang, Yun

    2016-03-01

    Perceptions of school safety have an important effect on students' development. Based on the model of "context-process-outcomes," we examined school safety as a context variable to explore how school safety at the school level affected students' self-esteem. We used hierarchical linear modeling to examine the link between school safety at the school level and students' self-esteem, including school liking as a mediator. The data were from the National Children's Study of China (NCSC), in which 6618 fourth- to fifth-grade students in 79 schools were recruited from 100 counties in 31 provinces in China. Multilevel mediation analyses showed that the positive relationship between school safety at the school level and self-esteem was partially mediated by school liking, controlling for demographics at both student and school levels. Furthermore, a sex difference existed in the multilevel mediation model. For boys, school liking fully mediated the relationship between school safety at the school level and self-esteem. However, school liking partially mediated the relationship between school safety at the school level and self-esteem among girls. School safety should receive increasing attention from policymakers because of its impact on students' self-esteem. © 2016, American School Health Association.

  6. Demonstrating the Safety and Reliability of a New System or Spacecraft: Incorporating Analyses and Reviews of the Design and Processing in Determining the Number of Tests to be Conducted

    NASA Technical Reports Server (NTRS)

    Vesely, William E.; Colon, Alfredo E.

    2010-01-01

    Design Safety/Reliability is associated with the probability of no failure-causing faults existing in a design. Confidence in the non-existence of failure-causing faults is increased by performing tests with no failure. Reliability-Growth testing requirements are based on initial assurance and fault detection probability. Using binomial tables generally gives too many required tests compared to reliability-growth requirements. Reliability-Growth testing requirements are based on reliability principles and factors and should be used.

  7. Extended time-to-collision measures for road traffic safety assessment.

    PubMed

    Minderhoud, M M; Bovy, P H

    2001-01-01

    This article describes two new safety indicators based on the time-to-collision notion suitable for comparative road traffic safety analyses. Such safety indicators can be applied in the comparison of a do-nothing case with an adapted situation, e.g. the introduction of intelligent driver support systems. In contrast to the classical time-to-collision value, measured at a cross section, the improved safety indicators use vehicle trajectories collected over a specific time horizon for a certain roadway segment to calculate the overall safety indicator value. Vehicle-specific indicator values as well as safety-critical probabilities can easily be determined from the developed safety measures. Application of the derived safety indicators is demonstrated for the assessment of the potential safety impacts of driver support systems from which it appears that some Autonomous Intelligent Cruise Control (AICC) designs are more safety-critical than the reference case without these systems. It is suggested that the indicator threshold value to be applied in the safety assessment has to be adapted when advanced AICC-systems with safe characteristics are introduced.

  8. Scientific Approach for Optimising Performance, Health and Safety in High-Altitude Observatories

    NASA Astrophysics Data System (ADS)

    Böcker, Michael; Vogy, Joachim; Nolle-Gösser, Tanja

    2008-09-01

    The ESO coordinated study “Optimising Performance, Health and Safety in High-Altitude Observatories” is based on a psychological approach using a questionnaire for data collection and assessment of high-altitude effects. During 2007 and 2008, data from 28 staff and visitors involved in APEX and ALMA were collected and analysed and the first results of the study are summarised. While there is a lot of information about biomedical changes at high altitude, relatively few studies have focussed on psychological changes, for example with respect to performance of mental tasks, safety consciousness and emotions. Both, biomedical and psychological changes are relevant factors in occupational safety and health. The results of the questionnaire on safety, health and performance issues demonstrate that the working conditions at high altitude are less detrimental than expected.

  9. Models Extracted from Text for System-Software Safety Analyses

    NASA Technical Reports Server (NTRS)

    Malin, Jane T.

    2010-01-01

    This presentation describes extraction and integration of requirements information and safety information in visualizations to support early review of completeness, correctness, and consistency of lengthy and diverse system safety analyses. Software tools have been developed and extended to perform the following tasks: 1) extract model parts and safety information from text in interface requirements documents, failure modes and effects analyses and hazard reports; 2) map and integrate the information to develop system architecture models and visualizations for safety analysts; and 3) provide model output to support virtual system integration testing. This presentation illustrates the methods and products with a rocket motor initiation case.

  10. Lunar mission safety and rescue: Executive summary

    NASA Technical Reports Server (NTRS)

    1971-01-01

    An executive summary is presented of the escape/rescue and the hazards analyses for manned missions and operations in the 1980 time frame. The method of approach, basic data generated, and significant results are outlined, and highlights of the two analyses are given. Areas in which research or technical development efforts could improve mission safety, and specific suggestions for additional effort studies on safety analyses are listed.

  11. Effects on Task Performance and Psychophysiological Measures of Performance During Normobaric Hypoxia Exposure

    NASA Technical Reports Server (NTRS)

    Stephens, Chad; Kennedy, Kellie; Napoli, Nicholas; Demas, Matthew; Barnes, Laura; Crook, Brenda; Williams, Ralph; Last, Mary Carolyn; Schutte, Paul

    2017-01-01

    Human-autonomous systems have the potential to mitigate pilot cognitive impairment and improve aviation safety. A research team at NASA Langley conducted an experiment to study the impact of mild normobaric hypoxia induction on aircraft pilot performance and psychophysiological state. A within-subjects design involved non-hypoxic and hypoxic exposures while performing three 10-minute tasks. Results indicated the effect of 15,000 feet simulated altitude did not induce significant performance decrement but did produce increase in perceived workload. Analyses of psychophysiological responses evince the potential of biomarkers for hypoxia onset. This study represents on-going work at NASA intending to add to the current knowledge of psychophysiologically-based input to automation to increase aviation safety. Analyses involving coupling across physiological systems and wavelet transforms of cortical activity revealed patterns that can discern between the simulated altitude conditions. Specifically, multivariate entropy of ECG/Respiration components were found to be significant predictors (p< 0.02) of hypoxia. Furthermore, in EEG, there was a significant decrease in mid-level beta (15.19-18.37Hz) during the hypoxic condition in thirteen of sixteen sites across the scalp. Task performance was not appreciably impacted by the effect of 15,000 feet simulated altitude. Analyses of psychophysiological responses evince the potential of biomarkers for mild hypoxia onset.The potential for identifying shifts in underlying cortical and physiological systems could serve as a means to identify the onset of deteriorated cognitive state. Enabling such assessment in future flightdecks could permit increasingly autonomous systems-supported operations. Augmenting human operator through assessment of cognitive impairment has the potential to further improve operator performance and mitigate human error in safety critical contexts. This study represents ongoing work at NASA intending to add to the current knowledge of psychophysiologically-based input to automation to increase aviation safety.

  12. A systemic analysis of South Korea Sewol ferry accident - Striking a balance between learning and accountability.

    PubMed

    Kee, Dohyung; Jun, Gyuchan Thomas; Waterson, Patrick; Haslam, Roger

    2017-03-01

    The South Korea Sewol ferry accident in April 2014 claimed the lives of over 300 passengers and led to criminal charges of 399 personnel concerned including imprisonment of 154 of them as of Oct 2014. Blame and punishment culture can be prevalent in a more hierarchical society like South Korea as shown in the aftermath of this disaster. This study aims to analyse the South Korea ferry accident using Rasmussen's risk management framework and the associated AcciMap technique and to propose recommendations drawn from an AcciMap-based focus group with systems safety experts. The data for the accident analysis were collected mainly from an interim investigation report by the Board of Audit and Inspection of Korea and major South Korean and foreign newspapers. The analysis showed that the accident was attributed to many contributing factors arising from front-line operators, management, regulators and government. It also showed how the multiple factors including economic, social and political pressures and individual workload contributed to the accident and how they affected each other. This AcciMap was presented to 27 safety researchers and experts at 'the legacy of Jens Rasmussen' symposium adjunct to ODAM2014. Their recommendations were captured through a focus group. The four main recommendations include forgive (no blame and punishment on individuals), analyse (socio-technical system-based), learn (from why things do not go wrong) and change (bottom-up safety culture and safety system management). The findings offer important insights into how this type of accident should be understood, analysed and the subsequent response. Copyright © 2016 Elsevier Ltd. All rights reserved.

  13. 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.

  14. Collapse Mechanisms Of Masonry Structures

    NASA Astrophysics Data System (ADS)

    Zuccaro, G.; Rauci, M.

    2008-07-01

    The paper outlines a possible approach to typology recognition, safety check analyses and/or damage measuring taking advantage by a multimedia tool (MEDEA), tracing a guided procedure useful for seismic safety check evaluation and post event macroseismic assessment. A list of the possible collapse mechanisms observed in the post event surveys on masonry structures and a complete abacus of the damages are provided in MEDEA. In this tool a possible combination between a set of damage typologies and each collapse mechanism is supplied in order to improve the homogeneity of the damages interpretation. On the other hand recent researches of one of the author have selected a number of possible typological vulnerability factors of masonry buildings, these are listed in the paper and combined with potential collapse mechanisms to be activated under seismic excitation. The procedure takes place from simple structural behavior models, derived from the Umbria-Marche earthquake observations, and tested after the San Giuliano di Puglia event; it provides the basis either for safety check analyses of the existing buildings or for post-event structural safety assessment and economic damage evaluation. In the paper taking advantage of MEDEA mechanisms analysis, mainly developed for the post event safety check surveyors training, a simple logic path is traced in order to approach the evaluation of the masonry building safety check. The procedure starts from the identification of the typological vulnerability factors to derive the potential collapse mechanisms and their collapse multipliers and finally addresses the simplest and cheapest strengthening techniques to reduce the original vulnerability. The procedure has been introduced in the Guide Lines of the Regione Campania for the professionals in charge of the safety check analyses and the buildings strengthening in application of the national mitigation campaign introduced by the Ordinance of the Central Government n. 3362/03. The main cases of out of plane mechanisms are analyzed and a possible innovative theory for masonry building vulnerability assessment, based on limit state analyses, is outlined. The paper report the first step of a research granted by the Department of the Civil Protection to Reluis within the research program of Line 10.

  15. Collapse Mechanisms Of Masonry Structures

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

    Zuccaro, G.; Rauci, M.

    2008-07-08

    The paper outlines a possible approach to typology recognition, safety check analyses and/or damage measuring taking advantage by a multimedia tool (MEDEA), tracing a guided procedure useful for seismic safety check evaluation and post event macroseismic assessment. A list of the possible collapse mechanisms observed in the post event surveys on masonry structures and a complete abacus of the damages are provided in MEDEA. In this tool a possible combination between a set of damage typologies and each collapse mechanism is supplied in order to improve the homogeneity of the damages interpretation. On the other hand recent researches of onemore » of the author have selected a number of possible typological vulnerability factors of masonry buildings, these are listed in the paper and combined with potential collapse mechanisms to be activated under seismic excitation. The procedure takes place from simple structural behavior models, derived from the Umbria-Marche earthquake observations, and tested after the San Giuliano di Puglia event; it provides the basis either for safety check analyses of the existing buildings or for post-event structural safety assessment and economic damage evaluation. In the paper taking advantage of MEDEA mechanisms analysis, mainly developed for the post event safety check surveyors training, a simple logic path is traced in order to approach the evaluation of the masonry building safety check. The procedure starts from the identification of the typological vulnerability factors to derive the potential collapse mechanisms and their collapse multipliers and finally addresses the simplest and cheapest strengthening techniques to reduce the original vulnerability. The procedure has been introduced in the Guide Lines of the Regione Campania for the professionals in charge of the safety check analyses and the buildings strengthening in application of the national mitigation campaign introduced by the Ordinance of the Central Government n. 3362/03. The main cases of out of plane mechanisms are analyzed and a possible innovative theory for masonry building vulnerability assessment, based on limit state analyses, is outlined. The paper report the first step of a research granted by the Department of the Civil Protection to Reluis within the research program of Line 10.« less

  16. 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

  17. Exploring the application of latent class cluster analysis for investigating pedestrian crash injury severities in Switzerland.

    PubMed

    Sasidharan, Lekshmi; Wu, Kun-Feng; Menendez, Monica

    2015-12-01

    One of the major challenges in traffic safety analyses is the heterogeneous nature of safety data, due to the sundry factors involved in it. This heterogeneity often leads to difficulties in interpreting results and conclusions due to unrevealed relationships. Understanding the underlying relationship between injury severities and influential factors is critical for the selection of appropriate safety countermeasures. A method commonly employed to address systematic heterogeneity is to focus on any subgroup of data based on the research purpose. However, this need not ensure homogeneity in the data. In this paper, latent class cluster analysis is applied to identify homogenous subgroups for a specific crash type-pedestrian crashes. The manuscript employs data from police reported pedestrian (2009-2012) crashes in Switzerland. The analyses demonstrate that dividing pedestrian severity data into seven clusters helps in reducing the systematic heterogeneity of the data and to understand the hidden relationships between crash severity levels and socio-demographic, environmental, vehicle, temporal, traffic factors, and main reason for the crash. The pedestrian crash injury severity models were developed for the whole data and individual clusters, and were compared using receiver operating characteristics curve, for which results favored clustering. Overall, the study suggests that latent class clustered regression approach is suitable for reducing heterogeneity and revealing important hidden relationships in traffic safety analyses. Copyright © 2015 Elsevier Ltd. All rights reserved.

  18. [Nutritional composition of infant milk formulas. Level of compliance in their manufacture and adequacy of nutritional needs].

    PubMed

    Jardí Piñana, C; Aranda Pons, N; Bedmar Carretero, C; Arija Val, V

    2015-12-01

    A high percentage of infants are fed with infant formulas. The aim of this study was to assess compliance with the Technical and Safety Regulations in the manufacture of Spanish infant formulas, analyse their adequacy to the recommendations of nutritional composition and the Dietary References Intakes for infants. A total of 31 infant formulas were analysed, of which 18 were infant formulas, 10 follow-on formulas, and 3 growing-up milks. The European Technical and Safety Regulations, the Spanish Dietary Reference Intakes and the Institute of Medicine of the United States and Canada, were used for the assessment of compliance and adequacy. The energy and macronutrient content of analysed infant formulas is placed in the middle of the range indicated in the Technical and Safety Regulations, and meets the recommended amounts. However, most micronutrients such as phosphorus, calcium, retinol, vitamin D, E, C, B6, B12, thiamin, riboflavin, and folate are at the lower limit of the Technical and Safety Regulations. However, the recommended consumption of infant formulas exceeded the Dietary References Intakes for vitamin E, C, retinol, vitamin B and folate, and vitamin B12 for follow-on formulas. Infant formulas are within the reference values of the European Technical and Safety Regulations in energy and macronutrients, but we believe that the level of micronutrients should be reviewed, based on current scientific data on infant requirements and possible adverse effects. Copyright © 2014 Asociación Española de Pediatría. Published by Elsevier España, S.L.U. All rights reserved.

  19. Patient safety issues in office-based surgery and anaesthesia in Switzerland: a qualitative study.

    PubMed

    McLennan, Stuart; Schwappach, David; Harder, Yves; Staender, Sven; Elger, Bernice

    2017-08-01

    To identify the spectrum of patient safety issues in office-based surgery and anaesthesia in Switzerland. Purposive sample of 23 experts in surgery and anaesthesia and quality and regulation in Switzerland. Data were collected via individual qualitative interviews using a researcher-developed semi-structured interview guide between March 2016 and September 2016. Interviews were transcribed and analysed using conventional content analysis. Issues were categorised under the headings "structure", "process", and "outcome". Experts identified two key overarching patient safety and regulatory issues in relation to office-based surgery and anaesthesia in Switzerland. First, experts repeatedly raised the current lack of data and transparency of the setting. It is unknown how many surgeons are operating in offices, how many and what types of operations are being done, and what the outcomes are. Secondly, experts also noted the limited oversight and regulation of the setting. While some standards exists, most experts felt that more minimal safety standards are needed regarding the requirements that must be met to do office-based surgery and what can and cannot be done in the office-based setting are needed, but they advocated a self-regulatory approach. There is a lack of empirical data regarding the quantity and quality office-based surgery and anaesthesia in Switzerland. Further research is needed to address these research gaps and inform health policy in relation to patient safety in office-based surgery and anaesthesia in Switzerland. Copyright © 2017. Published by Elsevier GmbH.

  20. Restaurant manager and worker food safety certification and knowledge.

    PubMed

    Brown, Laura G; Le, Brenda; Wong, Melissa R; Reimann, David; Nicholas, David; Faw, Brenda; Davis, Ernestine; Selman, Carol A

    2014-11-01

    Over half of foodborne illness outbreaks occur in restaurants. To combat these outbreaks, many public health agencies require food safety certification for restaurant managers, and sometimes workers. Certification entails passing a food safety knowledge examination, which is typically preceded by food safety training. Current certification efforts are based on the assumption that certification leads to greater food safety knowledge. The Centers for Disease Control and Prevention conducted this study to examine the relationship between food safety knowledge and certification. We also examined the relationships between food safety knowledge and restaurant, manager, and worker characteristics. We interviewed managers (N=387) and workers (N=365) about their characteristics and assessed their food safety knowledge. Analyses showed that certified managers and workers had greater food safety knowledge than noncertified managers and workers. Additionally, managers and workers whose primary language was English had greater food safety knowledge than those whose primary language was not English. Other factors associated with greater food safety knowledge included working in a chain restaurant, working in a larger restaurant, having more experience, and having more duties. These findings indicate that certification improves food safety knowledge, and that complex relationships exist among restaurant, manager, and worker characteristics and food safety knowledge.

  1. Restaurant Manager and Worker Food Safety Certification and Knowledge

    PubMed Central

    Brown, Laura G.; Le, Brenda; Wong, Melissa R.; Reimann, David; Nicholas, David; Faw, Brenda; Davis, Ernestine; Selman, Carol A.

    2017-01-01

    Over half of foodborne illness outbreaks occur in restaurants. To combat these outbreaks, many public health agencies require food safety certification for restaurant managers, and sometimes workers. Certification entails passing a food safety knowledge examination, which is typically preceded by food safety training. Current certification efforts are based on the assumption that certification leads to greater food safety knowledge. The Centers for Disease Control and Prevention conducted this study to examine the relationship between food safety knowledge and certification. We also examined the relationships between food safety knowledge and restaurant, manager, and worker characteristics. We interviewed managers (N = 387) and workers (N = 365) about their characteristics and assessed their food safety knowledge. Analyses showed that certified managers and workers had greater food safety knowledge than noncertified managers and workers. Additionally, managers and workers whose primary language was English had greater food safety knowledge than those whose primary language was not English. Other factors associated with greater food safety knowledge included working in a chain restaurant, working in a larger restaurant, having more experience, and having more duties. These findings indicate that certification improves food safety knowledge, and that complex relationships exist among restaurant, manager, and worker characteristics and food safety knowledge. PMID:25361386

  2. 14 CFR 415.204-415.400 - [Reserved

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... Subsystem Design Information 10.4Flight Safety System Analyses 10.5Flight Termination System Environmental... Analysis 4.1.1Flight Safety Sub-Analyses, Methods, and Assumptions 4.1.2Sample Calculation and Products 4.1.3 Launch Specific Updates and Final Flight Safety Analysis Data 4.2Radionuclide Data (where...

  3. 14 CFR 415.204-415.400 - [Reserved

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... Subsystem Design Information 10.4Flight Safety System Analyses 10.5Flight Termination System Environmental... Analysis 4.1.1Flight Safety Sub-Analyses, Methods, and Assumptions 4.1.2Sample Calculation and Products 4.1.3 Launch Specific Updates and Final Flight Safety Analysis Data 4.2Radionuclide Data (where...

  4. 14 CFR 415.204-415.400 - [Reserved

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Subsystem Design Information 10.4Flight Safety System Analyses 10.5Flight Termination System Environmental... Analysis 4.1.1Flight Safety Sub-Analyses, Methods, and Assumptions 4.1.2Sample Calculation and Products 4.1.3 Launch Specific Updates and Final Flight Safety Analysis Data 4.2Radionuclide Data (where...

  5. Can Disproportionality Analysis of Post-marketing Case Reports be Used for Comparison of Drug Safety Profiles?

    PubMed

    Michel, Christiane; Scosyrev, Emil; Petrin, Michael; Schmouder, Robert

    2017-05-01

    Clinical trials usually do not have the power to detect rare adverse drug reactions. Spontaneous adverse reaction reports as for example available in post-marketing safety databases such as the FDA Adverse Event Reporting System (FAERS) are therefore a valuable source of information to detect new safety signals early. To screen such large data-volumes for safety signals, data-mining algorithms based on the concept of disproportionality have been developed. Because disproportionality analysis is based on spontaneous reports submitted for a large number of drugs and adverse event types, one might consider using these data to compare safety profiles across drugs. In fact, recent publications have promoted this practice, claiming to provide guidance on treatment decisions to healthcare decision makers. In this article we investigate the validity of this approach. We argue that disproportionality cannot be used for comparative drug safety analysis beyond basic hypothesis generation because measures of disproportionality are: (1) missing the incidence denominators, (2) subject to severe reporting bias, and (3) not adjusted for confounding. Hypotheses generated by disproportionality analyses must be investigated by more robust methods before they can be allowed to influence clinical decisions.

  6. Self-focused attention and safety behaviors across group therapies for social anxiety disorder.

    PubMed

    Desnoyers, Amanda J; Kocovski, Nancy L; Fleming, Jan E; Antony, Martin M

    2017-07-01

    Self-focused attention (SFA) and safety behaviors are two variables implicated in the maintenance of social anxiety disorder (SAD). The present study examined SFA and safety behaviors across two therapies for SAD, cognitive behavioral group therapy (CBGT) and mindfulness and acceptance-based group therapy (MAGT). Participants with symptoms meeting criteria for SAD (N = 137) were randomly assigned to the 12-week-treatment groups (n = 53 for each condition) or a waitlist control (n = 31). Variables were assessed at baseline, midtreatment, posttreatment, and a 3-month follow-up. Both treatment conditions reported significantly lower SFA and safety behaviors compared to control, but did not differ from one another at posttreatment. Mediation analyses supported the following models: (1) safety behaviors mediating the relationship between SFA and social anxiety, and (2) SFA mediating the relationship between safety behaviors and social anxiety. These models were supported for both treatment groups. Both treatments may have the potential to reduce the SFA and safety behaviors that serve to maintain SAD.

  7. Using game technologies to improve the safety of construction plant operations.

    PubMed

    Guo, Hongling; Li, Heng; Chan, Greg; Skitmore, Martin

    2012-09-01

    Many accidents occur world-wide in the use of construction plant and equipment, and safety training is considered by many to be one of the best approaches to their prevention. However, current safety training methods/tools are unable to provide trainees with the hands-on practice needed. Game technology-based safety training platforms have the potential to overcome this problem in a virtual environment. One such platform is described in this paper - its characteristics are analysed and its possible contribution to safety training identified. This is developed and tested by means of a case study involving three major pieces of construction plant, which successfully demonstrates that the platform can improve the process and performance of the safety training involved in their operation. This research not only presents a new and useful solution to the safety training of construction operations, but illustrates the potential use of advanced technologies in solving construction industry problems in general. Copyright © 2011 Elsevier Ltd. All rights reserved.

  8. Recognising safety critical events: can automatic video processing improve naturalistic data analyses?

    PubMed

    Dozza, Marco; González, Nieves Pañeda

    2013-11-01

    New trends in research on traffic accidents include Naturalistic Driving Studies (NDS). NDS are based on large scale data collection of driver, vehicle, and environment information in real world. NDS data sets have proven to be extremely valuable for the analysis of safety critical events such as crashes and near crashes. However, finding safety critical events in NDS data is often difficult and time consuming. Safety critical events are currently identified using kinematic triggers, for instance searching for deceleration below a certain threshold signifying harsh braking. Due to the low sensitivity and specificity of this filtering procedure, manual review of video data is currently necessary to decide whether the events identified by the triggers are actually safety critical. Such reviewing procedure is based on subjective decisions, is expensive and time consuming, and often tedious for the analysts. Furthermore, since NDS data is exponentially growing over time, this reviewing procedure may not be viable anymore in the very near future. This study tested the hypothesis that automatic processing of driver video information could increase the correct classification of safety critical events from kinematic triggers in naturalistic driving data. Review of about 400 video sequences recorded from the events, collected by 100 Volvo cars in the euroFOT project, suggested that drivers' individual reaction may be the key to recognize safety critical events. In fact, whether an event is safety critical or not often depends on the individual driver. A few algorithms, able to automatically classify driver reaction from video data, have been compared. The results presented in this paper show that the state of the art subjective review procedures to identify safety critical events from NDS can benefit from automated objective video processing. In addition, this paper discusses the major challenges in making such video analysis viable for future NDS and new potential applications for NDS video processing. As new NDS such as SHRP2 are now providing the equivalent of five years of one vehicle data each day, the development of new methods, such as the one proposed in this paper, seems necessary to guarantee that these data can actually be analysed. Copyright © 2013 Elsevier Ltd. All rights reserved.

  9. Semi-Markov Approach to the Shipping Safety Modelling

    NASA Astrophysics Data System (ADS)

    Guze, Sambor; Smolarek, Leszek

    2012-02-01

    In the paper the navigational safety model of a ship on the open area has been studied under conditions of incomplete information. Moreover the structure of semi-Markov processes is used to analyse the stochastic ship safety according to the subjective acceptance of risk by the navigator. In addition, the navigator’s behaviour can be analysed by using the numerical simulation to estimate the probability of collision in the safety model.

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

    Hurt, Christopher J.; Freels, James D.; Hobbs, Randy W.

    There has been a considerable effort over the previous few years to demonstrate and optimize the production of plutonium-238 ( 238Pu) at the High Flux Isotope Reactor (HFIR). This effort has involved resources from multiple divisions and facilities at the Oak Ridge National Laboratory (ORNL) to demonstrate the fabrication, irradiation, and chemical processing of targets containing neptunium-237 ( 237Np) dioxide (NpO 2)/aluminum (Al) cermet pellets. A critical preliminary step to irradiation at the HFIR is to demonstrate the safety of the target under irradiation via documented experiment safety analyses. The steady-state thermal safety analyses of the target are simulated inmore » a finite element model with the COMSOL Multiphysics code that determines, among other crucial parameters, the limiting maximum temperature in the target. Safety analysis efforts for this model discussed in the present report include: (1) initial modeling of single and reduced-length pellet capsules in order to generate an experimental knowledge base that incorporate initial non-linear contact heat transfer and fission gas equations, (2) modeling efforts for prototypical designs of partially loaded and fully loaded targets using limited available knowledge of fabrication and irradiation characteristics, and (3) the most recent and comprehensive modeling effort of a fully coupled thermo-mechanical approach over the entire fully loaded target domain incorporating burn-up dependent irradiation behavior and measured target and pellet properties, hereafter referred to as the production model. These models are used to conservatively determine several important steady-state parameters including target stresses and temperatures, the limiting condition of which is the maximum temperature with respect to the melting point. The single pellet model results provide a basis for the safety of the irradiations, followed by parametric analyses in the initial prototypical designs that were necessary due to the limiting fabrication and irradiation data available. The calculated parameters in the final production target model are the most accurate and comprehensive, while still conservative. Over 210 permutations in irradiation time and position were evaluated, and are supported by the most recent inputs and highest fidelity methodology. The results of these analyses show that the models presented in this report provide a robust and reliable basis for previous, current and future experiment safety analyses. In addition, they reveal an evolving knowledge of the steady-state behavior of the NpO 2/Al pellets under irradiation for a variety of target encapsulations and potential conditions.« less

  11. 77 FR 66486 - Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-05

    .... The analyses for LSCS, Unit 2, Cycle 15 have concluded that a two-loop MCPR SL of >= 1.14, based on... safety. The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the... has provided its analysis of the issue of no significant hazards consideration, which is presented...

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

    Brunett, A. J.; Fei, T.; Strons, P. S.

    The Transient Reactor Test Facility (TREAT), located at Idaho National Laboratory (INL), is a test facility designed to evaluate the performance of reactor fuels and materials under transient accident conditions. The facility, an air-cooled, graphite-moderated reactor designed to utilize fuel containing high-enriched uranium (HEU), has been in non-operational standby status since 1994. Currently, in support of the missions of the Department of Energy (DOE) National Nuclear Security Administration (NNSA) Material Management and Minimization (M3) Reactor Conversion Program, a new core design is being developed for TREAT that will utilize low-enriched uranium (LEU). The primary objective of this conversion effort ismore » to design an LEU core that is capable of meeting the performance characteristics of the existing HEU core. Minimal, if any, changes are anticipated for the supporting systems (e.g. reactor trip system, filtration/cooling system, etc.); therefore, the LEU core must also be able to function with the existing supporting systems, and must also satisfy acceptable safety limits. In support of the LEU conversion effort, a range of ancillary safety analyses are required to evaluate the LEU core operation relative to that of the existing facility. These analyses cover neutronics, shielding, and thermal hydraulic topics that have been identified as having the potential to have reduced safety margins due to conversion to LEU fuel, or are required to support the required safety analyses documentation. The majority of these ancillary tasks have been identified in [1] and [2]. The purpose of this report is to document the ancillary safety analyses that have been performed at Argonne National Laboratory during the early stages of the LEU design effort, and to describe ongoing and anticipated analyses. For all analyses presented in this report, methodologies are utilized that are consistent with, or improved from, those used in analyses for the HEU Final Safety Analysis Report (FSAR) [3]. Depending on the availability of historical data derived from HEU TREAT operation, results calculated for the LEU core are compared to measurements obtained from HEU TREAT operation. While all analyses in this report are largely considered complete and have been reviewed for technical content, it is important to note that all topics will be revisited once the LEU design approaches its final stages of maturity. For most safety significant issues, it is expected that the analyses presented here will be bounding, but additional calculations will be performed as necessary to support safety analyses and safety documentation. It should also be noted that these analyses were completed as the LEU design evolved, and therefore utilized different LEU reference designs. Preliminary shielding, neutronic, and thermal hydraulic analyses have been completed and have generally demonstrated that the various LEU core designs will satisfy existing safety limits and standards also satisfied by the existing HEU core. These analyses include the assessment of the dose rate in the hodoscope room, near a loaded fuel transfer cask, above the fuel storage area, and near the HEPA filters. The potential change in the concentration of tramp uranium and change in neutron flux reaching instrumentation has also been assessed. Safety-significant thermal hydraulic items addressed in this report include thermally-induced mechanical distortion of the grid plate, and heating in the radial reflector.« less

  13. The influence of HOPE VI neighborhood revitalization on neighborhood-based physical activity: A mixed-methods approach.

    PubMed

    Dulin-Keita, Akilah; Clay, Olivio; Whittaker, Shannon; Hannon, Lonnie; Adams, Ingrid K; Rogers, Michelle; Gans, Kim

    2015-08-01

    This study uses a mixed methods approach to 1) identify surrounding residents' perceived expectations for Housing Opportunities for People Everywhere (HOPE VI) policy on physical activity outcomes and to 2) quantitatively examine the odds of neighborhood-based physical activity pre-/post-HOPE VI in a low socioeconomic status, predominantly African American community in Birmingham, Alabama. To address aim one, we used group concept mapping which is a structured approach for data collection and analyses that produces pictures/maps of ideas. Fifty-eight residents developed statements about potential influences of HOPE VI on neighborhood-based physical activity. In the quantitative study, we examined whether these potential influences increased the odds of neighborhood walking/jogging. We computed block entry logistic regression models with a larger cohort of residents at baseline (n = 184) and six-months (n = 142, 77% retention; n = 120 for all informative variables). We examined perceived neighborhood disorder (perceived neighborhood disorder scale), walkability and aesthetics (Neighborhood Environment Walkability Scale) and HOPE VI-related community safety and safety for physical activity as predictors. During concept mapping, residents generated statements that clustered into three distinct concepts, "Increased Leisure Physical Activity," "Safe Play Areas," and "Generating Health Promoting Resources." The quantitative analyses indicated that changes in neighborhood walkability increased the odds of neighborhood-based physical activity (p = 0.04). When HOPE VI-related safety for physical activity was entered into the model, it was associated with increased odds of physical activity (p = 0.04). Walkability was no longer statistically significant. These results suggest that housing policies that create walkable neighborhoods and that improve perceptions of safety for physical activity may increase neighborhood-based physical activity. However, the longer term impacts of neighborhood-level policies on physical activity require more longitudinal evidence to determine whether increased participation in physical activity is sustained. Copyright © 2015 Elsevier Ltd. All rights reserved.

  14. The psychometric properties of the 'Hospital Survey on Patient Safety Culture' in Dutch hospitals.

    PubMed

    Smits, Marleen; Christiaans-Dingelhoff, Ingrid; Wagner, Cordula; Wal, Gerrit van der; Groenewegen, Peter P

    2008-11-07

    In many different countries the Hospital Survey on Patient Safety Culture (HSOPS) is used to assess the safety culture in hospitals. Accordingly, the questionnaire has been translated into Dutch for application in the Netherlands. The aim of this study was to examine the underlying dimensions and psychometric properties of the questionnaire in Dutch hospital settings, and to compare these results with the original questionnaire used in USA hospital settings. The HSOPS was completed by 583 staff members of four general hospitals, three teaching hospitals, and one university hospital in the Netherlands. Confirmatory factor analyses were performed to examine the applicability of the factor structure of the American questionnaire to the Dutch data. Explorative factor analyses were performed to examine whether another composition of items and factors would fit the data better. Supplementary psychometric analyses were performed, including internal consistency and construct validity. The confirmatory factor analyses were based on the 12-factor model of the original questionnaire and resulted in a few low reliability scores. 11 Factors were drawn with explorative factor analyses, with acceptable reliability scores and a good construct validity. Two items were removed from the questionnaire. The composition of the factors was very similar to that of the original questionnaire. A few items moved to another factor and two factors turned out to combine into a six-item dimension. All other dimensions consisted of two to five items. The Dutch translation of the HSOPS consists of 11 factors with acceptable reliability and good construct validity. and is similar to the original HSOPS factor structure.

  15. Analyses of track shift under high-speed vehicle-track interaction : safety of high speed ground transportation systems

    DOT National Transportation Integrated Search

    1997-06-01

    This report describes analysis tools to predict shift under high-speed vehicle- : track interaction. The analysis approach is based on two fundamental models : developed (as part of this research); the first model computes the track lateral : residua...

  16. Assessment and evaluations of I-80 truck loads and their load effects : final report.

    DOT National Transportation Integrated Search

    2016-12-01

    The research objective is to examine the safety of Wyoming bridges on the I-80 corridor considering the actual truck traffic on the : interstate based upon weigh in motion (WIM) data. This was accomplished by performing statistical analyses to determ...

  17. Comparison of Traditional and Trial-Based Methodologies for Conducting Functional Analyses

    ERIC Educational Resources Information Center

    LaRue, Robert H.; Lenard, Karen; Weiss, Mary Jane; Bamond, Meredith; Palmieri, Mark; Kelley, Michael E.

    2010-01-01

    Functional analysis represents a sophisticated and empirically supported functional assessment procedure. While these procedures have garnered considerable empirical support, they are often underused in clinical practice. Safety risks resulting from the evocation of maladaptive behavior and the length of time required to conduct functional…

  18. Post Hoc Analyses of the Effect of Crisaborole Topical Ointment, 2% on Atopic Dermatitis: Associated Pruritus from Phase 1 and 2 Clinical Studies.

    PubMed

    Draelos, Zoe Diana; Stein Gold, Linda F; Murrell, Dedee F; Hughes, Matilda H; Zane, Lee T

    2016-02-01

    Two post hoc analyses assessed the antipruritic activity of crisaborole topical ointment, 2% (crisaborole; Anacor Pharmaceuticals, Inc., Palo Alto, CA), a first-in-class boron-based phosphodiesterase-4 inhibitor in development for treatment of mild to moderate atopic dermatitis (AD). Two pooled analyses included data from 4 studies evaluating crisaborole in AD (study 1, phase 1b, systemic exposure, safety, and pharmacokinetics [PK] under maximal-use conditions in children and adolescents; study 2, phase 2a, safety and PK in adolescents; study 3, phase 2a, efficacy and safety in adults; study 4, phase 2, efficacy and safety in adolescents). Pooled data from studies 1 and 2 included whole body assessments; studies 3 and 4 included target lesion assessments. Pruritus severity was evaluated using a 4-point rating scale (0=none to 3=severe). Efficacy assessments included percent change from baseline in pruritus severity scores at days 8 (first pooled assessment), 15, 22, and 29 (whole body assessments) or days 15 (first pooled assessment), 22, and 29 (target lesions). Paired t-tests comparing change from baseline against zero were used to calculate P values. Categorical shifts in pruritus severity were also assessed (no to mild pruritus, 0-1.5; moderate to severe pruritus, 2-3). In the pooled analysis of studies 1 and 2 (N=57), the percent change from baseline in pruritus severity scores were 63.0% and 64.9% at days 8 and 29, respectively (P<0.001 for each). Similar results were observed in the pooled analysis of studies 3 and 4 (N=67). In both analyses, most patients had mild to no pruritus from the first time point assessed through the remainder of treatment. Treatment with crisaborole topical ointment, 2% resulted in statistically significant reductions in pruritus severity at the first time point evaluated in both analyses. These findings provide preliminary evidence of the antipruritic activity of crisaborole topical ointment, 2%.

  19. PRIORITIZING FUTURE RESEACH ON OFF-LABEL PRESCRIBING: RESULTS OF A QUANTITATIVE EVALUATION

    PubMed Central

    Walton, Surrey M.; Schumock, Glen T.; Lee, Ky-Van; Alexander, G. Caleb; Meltzer, David; Stafford, Randall S.

    2015-01-01

    Background Drug use for indications not approved by the Food and Drug Administration exceeds 20% of prescribing. Available compendia indicate that a minority of off-label uses are well supported by evidence. Policy makers, however, lack information to identify where systematic reviews of the evidence or other research would be most valuable. Methods We developed a quantitative model for prioritizing individual drugs for future research on off-label uses. The base model incorporated three key factors, 1) the volume of off-label use with inadequate evidence, 2) safety, and 3) cost and market considerations. Nationally representative prescribing data were used to estimate the number of off-label drug uses by indication from 1/2005 through 6/2007 in the United States, and these indications were then categorized according to the adequacy of scientific support. Black box warnings and safety alerts were used to quantify drug safety. Drug cost, date of market entry, and marketing expenditures were used to quantify cost and market considerations. Each drug was assigned a relative value for each factor, and the factors were then weighted in the final model to produce a priority score. Sensitivity analyses were conducted by varying the weightings and model parameters. Results Drugs that were consistently ranked highly in both our base model and sensitivity analyses included quetiapine, warfarin, escitalopram, risperidone, montelukast, bupropion, sertraline, venlafaxine, celecoxib, lisinopril, duloxetine, trazodone, olanzapine, and epoetin alfa. Conclusion Future research into off-label drug use should focus on drugs used frequently with inadequate supporting evidence, particularly if further concerns are raised by known safety issues, high drug cost, recent market entry, and extensive marketing. Based on quantitative measures of these factors, we have prioritized drugs where targeted research and policy activities have high potential value. PMID:19025425

  20. Safety Considerations in the Use of Ketorolac for Postoperative Pain.

    PubMed

    Maslin, Benjamin; Lipana, Lawrence; Roth, Brandon; Kodumudi, Gopal; Vadivelu, Nalini

    2017-01-01

    Ketorolac use has significantly expanded for postoperative pain management since it first became available in the United States, primarily due to well established effects on patient pain scores and its ability to reduce perioperative opioid requirements. As an inhibitor of cyclooxygenase, ketorolac use has raised clinical concern including particular controversy regarding its potential effects on bone healing, postoperative kidney function and perioperative bleeding. To review the supporting data from clinical studies addressing the safety of ketorolac use for postoperative pain. This review highlights the most up-to-date research from clinical trials as well as from retrospective studies and meta-analyses regarding the effects of perioperative use of ketorolac on bone healing, kidney function and blood loss. Based on the most up-to-date literature, ketorolac in normal doses has been demonstrated to be safe with respect to bone healing. In patients with normal kidney function, numerous studies have established the safety of Ketorolac; however other studies have raised safety concerns in patients with comorbid kidney, heart and liver disease. While there is evidence that ketorolac may cause prolonged bleeding time and may be associated with increased postoperative blood loss after tonsillectomy, large scale prospective randomized controlled trials and subsequent meta-analyses have failed to establish an association of ketorolac use and perioperative blood loss. Perioperative administration of ketorolac has been demonstrated to be safe and effective in healthy patients and is particularly beneficial as an opioid-sparing agent in vulnerable patient groups. However, in certain surgical and medical contexts, proper patient selection based on the multidisciplinary collaboration between perioperative clinician specialists will optimize patient safety and pain management outcomes. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  1. 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.

  2. Fault Detection and Safety in Closed-Loop Artificial Pancreas Systems

    PubMed Central

    2014-01-01

    Continuous subcutaneous insulin infusion pumps and continuous glucose monitors enable individuals with type 1 diabetes to achieve tighter blood glucose control and are critical components in a closed-loop artificial pancreas. Insulin infusion sets can fail and continuous glucose monitor sensor signals can suffer from a variety of anomalies, including signal dropout and pressure-induced sensor attenuations. In addition to hardware-based failures, software and human-induced errors can cause safety-related problems. Techniques for fault detection, safety analyses, and remote monitoring techniques that have been applied in other industries and applications, such as chemical process plants and commercial aircraft, are discussed and placed in the context of a closed-loop artificial pancreas. PMID:25049365

  3. Car manufacturers and global road safety: a word frequency analysis of road safety documents.

    PubMed

    Roberts, I; Wentz, R; Edwards, P

    2006-10-01

    The World Bank believes that the car manufacturers can make a valuable contribution to road safety in poor countries and has established the Global Road Safety Partnership (GRSP) for this purpose. However, some commentators are sceptical. The authors examined road safety policy documents to assess the extent of any bias. Word frequency analyses of road safety policy documents from the World Health Organization (WHO) and the GRSP. The relative occurrence of key road safety terms was quantified by calculating a word prevalence ratio with 95% confidence intervals. Terms for which there was a fourfold difference in prevalence between the documents were tabulated. Compared to WHO's World report on road traffic injury prevention, the GRSP road safety documents were substantially less likely to use the words speed, speed limits, child restraint, pedestrian, public transport, walking, and cycling, but substantially more likely to use the words school, campaign, driver training, and billboard. There are important differences in emphasis in road safety policy documents prepared by WHO and the GRSP. Vigilance is needed to ensure that the road safety interventions that the car industry supports are based on sound evidence of effectiveness.

  4. Patient safety climate profiles across time: Strength and level of safety climate associated with a quality improvement program in Switzerland-A cross-sectional survey study.

    PubMed

    Mascherek, Anna C; Schwappach, David L B

    2017-01-01

    Safety Climate has been acknowledged as an unspecific factor influencing patient safety. However, studies rarely provide in-depth analysis of climate data. As a helpful approach, the concept of "climate strength" has been proposed. In the present study we tested the hypotheses that even if safety climate remains stable on mean-level across time, differences might be evident in strength or shape. The data of two hospitals participating in a large national quality improvement program were analysed for differences in climate profiles at two measurement occasions. We analysed differences on mean-level, differences in percent problematic response, agreement within groups, and frequency histograms in two large hospitals in Switzerland at two measurement occasions (2013 and 2015) applying the Safety Climate Survey. In total, survey responses of 1193 individuals were included in the analyses. Overall, small but significant differences on mean-level of safety climate emerged for some subgroups. Also, although agreement was strong at both time-points within groups, tendencies of divergence or consensus were present in both hospitals. Depending on subgroup and analyses chosen, differences were more or less pronounced. The present study illustrated that taking several measures into account and describing safety climate from different perspectives is necessary in order to fully understand differences and trends within groups and to develop interventions addressing the needs of different groups more precisely.

  5. 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

  6. 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.

  7. Phase II : operational and safety-based analyses of varied toll lane configurations.

    DOT National Transportation Integrated Search

    2016-08-01

    The Puerto Rico Dynamic Toll Lane (DTL) is a 6.44 mi (10.4 km) reversible facility within a stretch of freeway PR-22 that operates a congestion pricing system; the first of its kind in the Commonwealth of Puerto Rico. This managed lane system is shar...

  8. On the safety assessment of human exposure in the proximity of cellular communications base-station antennas at 900, 1800 and 2170 MHz.

    PubMed

    Martínez-Búrdalo, M; Martín, A; Anguiano, M; Villar, R

    2005-09-07

    In this work, the procedures for safety assessment in the close proximity of cellular communications base-station antennas at three different frequencies (900, 1800 and 2170 MHz) are analysed. For each operating frequency, we have obtained and compared the distances to the antenna from the exposure places where electromagnetic fields are below reference levels and the distances where the specific absorption rate (SAR) values in an exposed person are below the basic restrictions, according to the European safety guidelines. A high-resolution human body model has been located, in front of each base-station antenna as a worst case, at different distances, to compute whole body averaged SAR and maximum 10 g averaged SAR inside the exposed body. The finite-difference time-domain method has been used for both electromagnetic fields and SAR calculations. This paper shows that, for antenna-body distances in the near zone of the antenna, the fact that averaged field values be below the reference levels could, at certain frequencies, not guarantee guidelines compliance based on basic restrictions.

  9. 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.

  10. 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

  11. Population-based cohort study on comparative effectiveness and safety of biologics in inflammatory bowel disease

    PubMed Central

    Trotta, Francesco; Cascini, Silvia; Agabiti, Nera; Kohn, Anna; Gasbarrini, Antonio; Davoli, Marina; Addis, Antonio

    2018-01-01

    Background The comparison of effectiveness and safety of anti-tumor necrosis factor-alpha agents for the treatment of inflammatory bowel disease (IBD) is relevant for clinical practice and stakeholders. Objective The objective of this study was to compare the risk of abdominal surgery, steroid utilization, and hospitalization for infection in Crohn’s disease (CD) or ulcerative colitis (UC) patients newly treated with infliximab (IFX) or adalimumab (ADA). Methods A retrospective population-based cohort study was performed using health information systems data from Lazio region, Italy. Patients with CD or UC diagnosis were enrolled at first prescription of IFX or ADA during 2008–2014 (index date). Only new drug users were followed for 2 years from the index date. IFX versus ADA adjusted hazard ratios were calculated applying “intention-to-treat” approach, controlling for several characteristics and stratifying the analysis on steroid use according to previous drug utilization. Sensitivity analyses were performed according to “as-treated” approach, adjusting for propensity score, censoring at switching or discontinuation, and evaluating different lengths of follow-up periods. Results We enrolled 1,432 IBD patients (42% and 83% exposed to IFX for CD and UC, respectively). In both diseases, treatment effects did not differ in any outcome considered, and sensitivity analyses confirmed the results from the main analysis. Conclusion In our population-based cohort study, effectiveness and safety data in new users of ADA or IFX with CD or UC were comparable for the outcomes we tested. PMID:29440933

  12. The use of whole food animal studies in the safety assessment of genetically modified crops: limitations and recommendations.

    PubMed

    Bartholomaeus, Andrew; Parrott, Wayne; Bondy, Genevieve; Walker, Kate

    2013-11-01

    There is disagreement internationally across major regulatory jurisdictions on the relevance and utility of whole food (WF) toxicity studies on GM crops, with no harmonization of data or regulatory requirements. The scientific value, and therefore animal ethics, of WF studies on GM crops is a matter addressable from the wealth of data available on commercialized GM crops and WF studies on irradiated foods. We reviewed available GM crop WF studies and considered the extent to which they add to the information from agronomic and compositional analyses. No WF toxicity study was identified that convincingly demonstrated toxicological concern or that called into question the adequacy, sufficiency, and reliability of safety assessments based on crop molecular characterization, transgene source, agronomic characteristics, and/or compositional analysis of the GM crop and its near-isogenic line. Predictions of safety based on crop genetics and compositional analyses have provided complete concordance with the results of well-conducted animal testing. However, this concordance is primarily due to the improbability of de novo generation of toxic substances in crop plants using genetic engineering practices and due to the weakness of WF toxicity studies in general. Thus, based on the comparative robustness and reliability of compositional and agronomic considerations and on the absence of any scientific basis for a significant potential for de novo generation of toxicologically significant compositional alterations as a sole result of transgene insertion, the conclusion of this review is that WF animal toxicity studies are unnecessary and scientifically unjustifiable.

  13. Risk management systems for health care and safety development on transplantation: a review and a proposal.

    PubMed

    Pretagostini, R; Gabbrielli, F; Fiaschetti, P; Oliveti, A; Cenci, S; Peritore, D; Stabile, D

    2010-05-01

    Starting from the report on medical errors published in 1999 by the US Institute of Medicine, a number of different approaches to risk management have been developed for maximum risk reduction in health care activities. The health care authorities in many countries have focused attention on patient safety, employing action research programs that are based on quite different principles. We performed a systematic Medline research of the literature since 1999. The following key words were used, also combining boolean operators and medical subheading terms: "adverse event," "risk management," "error," and "governance." Studies published in the last 5 years were particularly classified in various groups: risk management in health care systems; safety in specific hospital activities; and health care institutions' official documents. Methods of action researches have been analysed and their characteristics compared. Their suitability for safety development in donation, retrieval, and transplantation processes were discussed in the reality of the Italian transplant network. Some action researches and studies were dedicated to entire national healthcare systems, whereas others focused on specific risks. Many research programs have undergone critical review in the literature. Retrospective analysis has centered on so-called sentinel events to particularly analyze only a minor portion of the organizational phenomena, which can be the origin of an adverse event, an incident, or an error. Sentinel events give useful information if they are studied in highly engineered and standardized organizations like laboratories or tissue establishments, but they show several limits in the analysis of organ donation, retrieval, and transplantation processes, which are characterized by prevailing human factors, with high intrinsic risk and variability. Thus, they are poorly effective to deliver sure elements to base safety management improvement programs, especially regarding multidisciplinary systems with high complexity. In organ transplantation, the possibility to increase safety seems greater using proactive research, mainly centred on organizational processes together with retrospective analyses but not limited to sentinel event reports. Copyright (c) 2010. Published by Elsevier Inc.

  14. Good practices on cost - effective road infrastructure safety investments.

    PubMed

    Yannis, George; Papadimitriou, Eleonora; Evgenikos, Petros; Dragomanovits, Anastasios

    2016-12-01

    The paper presents the findings of a research project aiming to quantify and subsequently classify several infrastructure-related road safety measures, based on the international experience attained through extensive and selected literature review and additionally on a full consultation process including questionnaire surveys addressed to experts and relevant workshops. Initially, a review of selected research reports was carried out and an exhaustive list of road safety infrastructure investments covering all types of infrastructure was compiled. Individual investments were classified according to the infrastructure investment area and the type of investment and were thereafter analysed on the basis of key safety components. These investments were subsequently ranked in relation to their safety effects and implementation costs and on the basis of this ranking, a set of five most promising investments was selected for an in-depth analysis. The results suggest that the overall cost effectiveness of a road safety infrastructure investment is not always in direct correlation with the safety effect and is recommended that cost-benefit ratios and safety effects are always examined in conjunction with each other in order to identify the optimum solution for a specific road safety problem in specific conditions and with specific objectives.

  15. The effect of governance mechanisms on food safety in the supply chain: Evidence from the Lebanese dairy sector.

    PubMed

    Abebe, Gumataw K; Chalak, Ali; Abiad, Mohamad G

    2017-07-01

    Food safety is a key public health issue worldwide. This study aims to characterise existing governance mechanisms - governance structures (GSs) and food safety management systems (FSMSs) - and analyse the alignment thereof in detecting food safety hazards, based on empirical evidence from Lebanon. Firm-to-firm and public baseline are the dominant FSMSs applied in a large-scale, while chain-wide FSMSs are observed only in a small-scale. Most transactions involving farmers are relational and market-based in contrast to (large-scale) processors, which opt for hierarchical GSs. Large-scale processors use a combination of FSMSs and GSs to minimise food safety hazards albeit potential increase in coordination costs; this is an important feature of modern food supply chains. The econometric analysis reveals contract period, on-farm inspection and experience having significant effects in minimising food safety hazards. However, the potential to implement farm-level FSMS is influenced by formality of the contract, herd size, trading partner choice, and experience. Public baseline FSMSs appear effective in controlling food safety hazards; however, this may not be viable due to the scarcity of public resources. We suggest public policies to focus on long-lasting governance mechanisms by introducing incentive schemes and farm-level FSMSs by providing loans and education to farmers. © 2016 Society of Chemical Industry. © 2016 Society of Chemical Industry.

  16. Key performance outcomes of patient safety curricula: root cause analysis, failure mode and effects analysis, and structured communications skills.

    PubMed

    Fassett, William E

    2011-10-10

    As colleges and schools of pharmacy develop core courses related to patient safety, course-level outcomes will need to include both knowledge and performance measures. Three key performance outcomes for patient safety coursework, measured at the course level, are the ability to perform root cause analyses and healthcare failure mode effects analyses, and the ability to generate effective safety communications using structured formats such as the Situation-Background-Assessment-Recommendation (SBAR) situational briefing model. Each of these skills is widely used in patient safety work and competence in their use is essential for a pharmacist's ability to contribute as a member of a patient safety team.

  17. Patient safety climate profiles across time: Strength and level of safety climate associated with a quality improvement program in Switzerland—A cross-sectional survey study

    PubMed Central

    Mascherek, Anna C.

    2017-01-01

    Safety Climate has been acknowledged as an unspecific factor influencing patient safety. However, studies rarely provide in-depth analysis of climate data. As a helpful approach, the concept of “climate strength” has been proposed. In the present study we tested the hypotheses that even if safety climate remains stable on mean-level across time, differences might be evident in strength or shape. The data of two hospitals participating in a large national quality improvement program were analysed for differences in climate profiles at two measurement occasions. We analysed differences on mean-level, differences in percent problematic response, agreement within groups, and frequency histograms in two large hospitals in Switzerland at two measurement occasions (2013 and 2015) applying the Safety Climate Survey. In total, survey responses of 1193 individuals were included in the analyses. Overall, small but significant differences on mean-level of safety climate emerged for some subgroups. Also, although agreement was strong at both time-points within groups, tendencies of divergence or consensus were present in both hospitals. Depending on subgroup and analyses chosen, differences were more or less pronounced. The present study illustrated that taking several measures into account and describing safety climate from different perspectives is necessary in order to fully understand differences and trends within groups and to develop interventions addressing the needs of different groups more precisely. PMID:28753633

  18. 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.

  19. The risk of elevated prolactin levels in pediatric patients exposed to antipsychotics for the treatment of schizophrenia and schizophrenia spectrum disorders: protocol for a systematic review and meta-analysis

    PubMed Central

    2014-01-01

    Background Antipsychotic medications, particularly second-generation antipsychotics, are increasingly being used to alleviate the symptoms of schizophrenia and other severe mental disorders in the pediatric population. While evidence-based approaches examining efficacy and safety outcomes have been reported, no review has evaluated prolactin-based adverse events for antipsychotic treatments in schizophrenia and schizophrenia spectrum disorders. Methods/design Searches involving MEDLINE, EMBASE, CENTRAL, PsycINFO, and clinical trial registries (ClinicalTrials.gov, Drug Industry Document Archive [DIDA], International Clinical Trials Registry Platform [ICTRP]) will be used to identify relevant studies. Two reviewers will independently screen abstracts and relevant full-text articles of the papers identified by the initial search according to the prospectively defined eligibility criteria. Data extraction will be conducted in duplicate independently. Pairwise random effects meta-analyses and network meta-analyses will be conducted on individual drug and class effects where appropriate. Discussion This systematic review will evaluate prolactin-based adverse events of first- and second-generation antipsychotics in the pediatric population with schizophrenia and schizophrenia spectrum disorders. It will also seek to strengthen the evidence base of the safety of antipsychotics by incorporating both randomized controlled trials and observational studies. Systematic review registration PROSPERO CRD42014009506 PMID:25312992

  20. Effect of the mileage of a passenger car on changes in its body geometry

    NASA Astrophysics Data System (ADS)

    Gonera, Jarosław; Napiórkowski, Jerzy

    2018-04-01

    This study analyses the effect of the mileage of a passenger car on changes in its body geometry in regards to its safety. Ninety-six passenger cars used in similar environmental conditions were examined. The required position of twelve base points was compared to their actual position. Those were the points responsible for the active and passive safety of a car on the left and right side of the floor panel. The geometry of the floor panel was measured with a GYSMETER device manufactured by GYS and Allvis Light software. Increasing mileage was found to result in increasing changes in the floor panel geometry, which take place mainly on the right side of a car and at points affecting passive safety.

  1. Lunar mission safety and rescue: Technical summary

    NASA Technical Reports Server (NTRS)

    1971-01-01

    A technical summary is presented of the escape/rescue and the hazards analyses for manned missions and operations in the 1980 time frame. Hazards are interpreted as hazards to man, not to equipment, program schedule, or program objectives. Hazards in 39 individual areas are analyzed, and corrective measures are recommended. Over 200 safety guidelines are proposed, based on significant hazards. Escape and rescue situtations and requirements are identified and analyzed, and escape/survival/rescue concepts are defined to cope with each escape/rescue situation. Areas in which research or technical development efforts could improve mission safety are identified. It is concluded that the primary emphasis should be on survival and escape provisions, with rescue required only where self-help cannot bring the endangered crewmen to a safe haven.

  2. Intensive care nurses' perceptions of simulation-based team training for building patient safety in intensive care: a descriptive qualitative study.

    PubMed

    Ballangrud, Randi; Hall-Lord, Marie Louise; Persenius, Mona; Hedelin, Birgitta

    2014-08-01

    To describe intensive care nurses' perceptions of simulation-based team training for building patient safety in intensive care. Failures in team processes are found to be contributory factors to incidents in an intensive care environment. Simulation-based training is recommended as a method to make health-care personnel aware of the importance of team working and to improve their competencies. The study uses a qualitative descriptive design. Individual qualitative interviews were conducted with 18 intensive care nurses from May to December 2009, all of which had attended a simulation-based team training programme. The interviews were analysed by qualitative content analysis. One main category emerged to illuminate the intensive care nurse perception: "training increases awareness of clinical practice and acknowledges the importance of structured work in teams". Three generic categories were found: "realistic training contributes to safe care", "reflection and openness motivates learning" and "finding a common understanding of team performance". Simulation-based team training makes intensive care nurses more prepared to care for severely ill patients. Team training creates a common understanding of how to work in teams with regard to patient safety. Copyright © 2014 Elsevier Ltd. All rights reserved.

  3. 47 CFR 12.3 - 911 and E911 analyses and reports.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... wireless 911 rules set forth in § 20.18 of this chapter; and interconnected Voice over Internet Protocol... Public Safety and Homeland Security Bureau (PSHSB) has the delegated authority to implement and activate... generation Internet Protocol-based E911 platform. (b) These reports are due 120 days from the date that the...

  4. 77 FR 62473 - Safety Zone, Seafair Blue Angels Air Show Performance, Seattle, WA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-15

    ....1319 has been determined to be inadequate to accommodate the anticipated flight pattern of the Blue.... [Datum: NAD 1983]'' However, the participating aircraft have a flight pattern that will extend past the... summarize our analyses based on a number of these statutes or executive orders. 1. Regulatory Planning and...

  5. Using computer graphics to enhance astronaut and systems safety

    NASA Technical Reports Server (NTRS)

    Brown, J. W.

    1985-01-01

    Computer graphics is being employed at the NASA Johnson Space Center as a tool to perform rapid, efficient and economical analyses for man-machine integration, flight operations development and systems engineering. The Operator Station Design System (OSDS), a computer-based facility featuring a highly flexible and versatile interactive software package, PLAID, is described. This unique evaluation tool, with its expanding data base of Space Shuttle elements, various payloads, experiments, crew equipment and man models, supports a multitude of technical evaluations, including spacecraft and workstation layout, definition of astronaut visual access, flight techniques development, cargo integration and crew training. As OSDS is being applied to the Space Shuttle, Orbiter payloads (including the European Space Agency's Spacelab) and future space vehicles and stations, astronaut and systems safety are being enhanced. Typical OSDS examples are presented. By performing physical and operational evaluations during early conceptual phases. supporting systems verification for flight readiness, and applying its capabilities to real-time mission support, the OSDS provides the wherewithal to satisfy a growing need of the current and future space programs for efficient, economical analyses.

  6. Diffusion of robotics into clinical practice in the United States: process, patient safety, learning curves, and the public health.

    PubMed

    Mirheydar, Hossein S; Parsons, J Kellogg

    2013-06-01

    Robotic technology disseminated into urological practice without robust comparative effectiveness data. To review the diffusion of robotic surgery into urological practice. We performed a comprehensive literature review focusing on diffusion patterns, patient safety, learning curves, and comparative costs for robotic radical prostatectomy, partial nephrectomy, and radical cystectomy. Robotic urologic surgery diffused in patterns typical of novel technology spreading among practicing surgeons. Robust evidence-based data comparing outcomes of robotic to open surgery were sparse. Although initial Level 3 evidence for robotic prostatectomy observed complication outcomes similar to open prostatectomy, subsequent population-based Level 2 evidence noted an increased prevalence of adverse patient safety events and genitourinary complications among robotic patients during the early years of diffusion. Level 2 evidence indicated comparable to improved patient safety outcomes for robotic compared to open partial nephrectomy and cystectomy. Learning curve recommendations for robotic urologic surgery have drawn exclusively on Level 4 evidence and subjective, non-validated metrics. The minimum number of cases required to achieve competency for robotic prostatectomy has increased to unrealistically high levels. Most comparative cost-analyses have demonstrated that robotic surgery is significantly more expensive than open or laparoscopic surgery. Evidence-based data are limited but suggest an increased prevalence of adverse patient safety events for robotic prostatectomy early in the national diffusion period. Learning curves for robotic urologic surgery are subjective and based on non-validated metrics. The urological community should develop rigorous, evidence-based processes by which future technological innovations may diffuse in an organized and safe manner.

  7. Impact of participation in the California Healthcare-Associated Infection Prevention Initiative on adoption and implementation of evidence-based practices for patient safety and health care-associated infection rates in a cohort of acute care general hospitals.

    PubMed

    Halpin, Helen Ann; McMenamin, Sara B; Simon, Lisa Payne; Jacobsen, Diane; Vanneman, Megan; Shortell, Stephen; Milstein, Arnold

    2013-04-01

    In 2008, hospitals were selected to participate in the California Healthcare-Associated Infection Prevention Initiative (CHAIPI). This research evaluates the impact of CHAIPI on hospital adoption and implementation of evidence-based patient safety practices and reduction of health care-associated infection (HAI) rates. Statewide computer-assisted telephone surveys of California's general acute care hospitals were conducted in 2008 and 2010 (response rates, 80% and 76%, respectively). Difference-in-difference analyses were used to compare changes in process and HAI rate outcomes in CHAIPI hospitals (n = 34) and non-CHAIPI hospitals (n = 149) that responded to both waves of the survey. Compared with non-CHAIPI hospitals, CHAIPI hospitals demonstrated greater improvements between 2008 and 2010 in adoption (P = .021) and implementation (P = .012) of written evidence-based practices for overall patient safety and prevention of HAIs and in assessing their compliance (P = .033) with these practices. However, there were no significant differences in the changes in HAI rates between CHAIPI and non-CHAIPI hospitals over this time period. Participation in the CHAIPI collaborative was associated with significant improvements in evidence-based patient safety practices in hospitals. However, determining how evidence-based practices translate into changes in HAI rates may take more time. Our results suggest that all hospitals be offered the opportunity to participate in an active learning collaborative to improve patient safety. Copyright © 2013 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Mosby, Inc. All rights reserved.

  8. 14 CFR 414.11 - Application.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... the safety element for which the safety approval is sought. (ii) Engineering design and analyses that... TRANSPORTATION LICENSING SAFETY APPROVALS Application Procedures § 414.11 Application. (a) The application must...) Safety element (i.e., launch vehicle, reentry vehicle, safety system, process, service, or any identified...

  9. 14 CFR 414.11 - Application.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... the safety element for which the safety approval is sought. (ii) Engineering design and analyses that... TRANSPORTATION LICENSING SAFETY APPROVALS Application Procedures § 414.11 Application. (a) The application must...) Safety element (i.e., launch vehicle, reentry vehicle, safety system, process, service, or any identified...

  10. 14 CFR 414.11 - Application.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... the safety element for which the safety approval is sought. (ii) Engineering design and analyses that... TRANSPORTATION LICENSING SAFETY APPROVALS Application Procedures § 414.11 Application. (a) The application must...) Safety element (i.e., launch vehicle, reentry vehicle, safety system, process, service, or any identified...

  11. Impacts of Bicycle Infrastructure in Mid-Sized Cities (IBIMS): protocol for a natural experiment study in three Canadian cities

    PubMed Central

    Winters, Meghan; Branion-Calles, Michael; Therrien, Suzanne; Fuller, Daniel; Gauvin, Lise; Whitehurst, David G T; Nelson, Trisalyn

    2018-01-01

    Introduction Bicycling is promoted as a transportation and population health strategy globally. Yet bicycling has low uptake in North America (1%–2% of trips) compared with European bicycling cities (15%–40% of trips) and shows marked sex and age trends. Safety concerns due to collisions with motor vehicles are primary barriers. To attract the broader population to bicycling, many cities are making investments in bicycle infrastructure. These interventions hold promise for improving population health given the potential for increased physical activity and improved safety, but such outcomes have been largely unstudied. In 2016, the City of Victoria, Canada, committed to build a connected network of infrastructure that separates bicycles from motor vehicles, designed to attract people of ‘all ages and abilities’ to bicycling. This natural experiment study examines the impacts of the City of Victoria’s investment in a bicycle network on active travel and safety outcomes. The specific objectives are to (1) estimate changes in active travel, perceived safety and bicycle safety incidents; (2) analyse spatial inequities in access to bicycle infrastructure and safety incidents; and (3) assess health-related economic benefits. Methods and analysis The study is in three Canadian cities (intervention: Victoria; comparison: Kelowna, Halifax). We will administer population-based surveys in 2016, 2018 and 2021 (1000 people/city). The primary outcome is the proportion of people reporting bicycling. Secondary outcomes are perceived safety and bicycle safety incidents. Spatial analyses will compare the distribution of bicycle infrastructure and bicycle safety incidents across neighbourhoods and across time. We will also calculate the economic benefits of bicycling using WHO’s Health Economic Assessment Tool. Ethics and dissemination This study received approval from the Simon Fraser University Office of Research Ethics (study no. 2016s0401). Findings will be disseminated via a website, presentations to stakeholders, at academic conferences and through peer-reviewed journal articles. PMID:29358440

  12. Roadway safety design workbook.

    DOT National Transportation Integrated Search

    2009-07-01

    Highway safety is an ongoing concern to the Texas Department of Transportation (TxDOT). As part of its : proactive commitment to improving highway safety, TxDOT is moving toward including quantitative safety : analyses earlier in the project developm...

  13. Highway safety design workshops.

    DOT National Transportation Integrated Search

    2010-11-01

    Highway safety is an ongoing concern for the Texas Department of Transportation (TxDOT). As part of its : proactive commitment to improving highway safety, TxDOT is moving toward including quantitative safety : analyses earlier in the project develop...

  14. Benefits, safety, and prescription of exercise in persons with multiple sclerosis.

    PubMed

    Motl, Robert W

    2014-12-01

    Exercise represents a behavioral approach for the restoration of function and management of symptoms among persons with multiple sclerosis (MS). The current paper provides a review on the topic of exercise in MS and is separated into four sections. The first section defines exercise and related constructs. The second section summarizes evidence for the benefits of exercise in MS based on literature reviews and meta-analyses. The third section focuses on the safety of exercise in MS based on the reporting of relapses and other adverse events, and the last section describes guidelines for exercise. The paper concludes with a discussion of major limitations with the existing body of research and highlights some of the pressing areas for future research on exercise in MS.

  15. 14 CFR Appendix B to Part 415 - Safety Review Document Outline

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ....0Flight Safety (§ 415.115) 4.1Initial Flight Safety Analysis 4.1.1Flight Safety Sub-Analyses, Methods, and... Analysis Data 4.2Radionuclide Data (where applicable) 4.3Flight Safety Plan 4.3.1Flight Safety Personnel 4... Safety (§ 415.117) 5.1Ground Safety Analysis Report 5.2Ground Safety Plan 6.0Launch Plans (§ 415.119 and...

  16. 14 CFR Appendix B to Part 415 - Safety Review Document Outline

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ....0Flight Safety (§ 415.115) 4.1Initial Flight Safety Analysis 4.1.1Flight Safety Sub-Analyses, Methods, and... Analysis Data 4.2Radionuclide Data (where applicable) 4.3Flight Safety Plan 4.3.1Flight Safety Personnel 4... Safety (§ 415.117) 5.1Ground Safety Analysis Report 5.2Ground Safety Plan 6.0Launch Plans (§ 415.119 and...

  17. A systematic review of patient safety in mental health: a protocol based on the inpatient setting.

    PubMed

    D'Lima, Danielle; Archer, Stephanie; Thibaut, Bethan Ines; Ramtale, Sonny Christian; Dewa, Lindsay H; Darzi, Ara

    2016-11-29

    Despite the growing international interest in patient safety as a discipline, there has been a lack of exploration of its application to mental health. It cannot be assumed that findings based upon physical health in acute care hospitals can be applied to mental health patients, disorders and settings. To the authors' knowledge, there has only been one review of the literature that focuses on patient safety research in mental health settings, conducted in Canada in 2008. We have identified a need to update this review and develop the methodology in order to strengthen the findings and disseminate internationally for advancement in the field. This systematic review will explore the existing research base on patient safety in mental health within the inpatient setting. To conduct this systematic review, a thorough search across multiple databases will be undertaken, based upon four search facets ("mental health", "patient safety", "research" and "inpatient setting"). The search strategy has been developed based upon the Canadian review accompanied with input from the National Reporting and Learning System (NRLS) taxonomy of patient safety incidents and the Diagnostic and Statistical Manual of Mental Disorders (fifth edition). The screening process will involve perspectives from at least two researchers at all stages with a third researcher invited to review when discrepancies require resolution. Initial inclusion and exclusion criteria have been developed and will be refined iteratively throughout the process. Quality assessment and data extraction of included articles will be conducted by at least two researchers. A data extraction form will be developed, piloted and iterated as necessary in accordance with the research question. Extracted information will be analysed thematically. We believe that this systematic review will make a significant contribution to the advancement of patient safety in mental health inpatient settings. The findings will enable the development and implementation of interventions to improve the quality of care experienced by patients and support the identification of future research priorities. PROSPERO CRD42016034057.

  18. The Safety Culture Enactment Questionnaire (SCEQ): Theoretical model and empirical validation.

    PubMed

    de Castro, Borja López; Gracia, Francisco J; Tomás, Inés; Peiró, José M

    2017-06-01

    This paper presents the Safety Culture Enactment Questionnaire (SCEQ), designed to assess the degree to which safety is an enacted value in the day-to-day running of nuclear power plants (NPPs). The SCEQ is based on a theoretical safety culture model that is manifested in three fundamental components of the functioning and operation of any organization: strategic decisions, human resources practices, and daily activities and behaviors. The extent to which the importance of safety is enacted in each of these three components provides information about the pervasiveness of the safety culture in the NPP. To validate the SCEQ and the model on which it is based, two separate studies were carried out with data collection in 2008 and 2014, respectively. In Study 1, the SCEQ was administered to the employees of two Spanish NPPs (N=533) belonging to the same company. Participants in Study 2 included 598 employees from the same NPPs, who completed the SCEQ and other questionnaires measuring different safety outcomes (safety climate, safety satisfaction, job satisfaction and risky behaviors). Study 1 comprised item formulation and examination of the factorial structure and reliability of the SCEQ. Study 2 tested internal consistency and provided evidence of factorial validity, validity based on relationships with other variables, and discriminant validity between the SCEQ and safety climate. Exploratory Factor Analysis (EFA) carried out in Study 1 revealed a three-factor solution corresponding to the three components of the theoretical model. Reliability analyses showed strong internal consistency for the three scales of the SCEQ, and each of the 21 items on the questionnaire contributed to the homogeneity of its theoretically developed scale. Confirmatory Factor Analysis (CFA) carried out in Study 2 supported the internal structure of the SCEQ; internal consistency of the scales was also supported. Furthermore, the three scales of the SCEQ showed the expected correlation patterns with the measured safety outcomes. Finally, results provided evidence of discriminant validity between the SCEQ and safety climate. We conclude that the SCEQ is a valid, reliable instrument supported by a theoretical framework, and it is useful to measure the enactment of safety culture in NPPs. Copyright © 2017 Elsevier Ltd. All rights reserved.

  19. Computational modelling of ovine critical-sized tibial defects with implanted scaffolds and prediction of the safety of fixator removal.

    PubMed

    Doyle, Heather; Lohfeld, Stefan; Dürselen, Lutz; McHugh, Peter

    2015-04-01

    Computational model geometries of tibial defects with two types of implanted tissue engineering scaffolds, β-tricalcium phosphate (β-TCP) and poly-ε-caprolactone (PCL)/β-TCP, are constructed from µ-CT scan images of the real in vivo defects. Simulations of each defect under four-point bending and under simulated in vivo axial compressive loading are performed. The mechanical stability of each defect is analysed using stress distribution analysis. The results of this analysis highlights the influence of callus volume, and both scaffold volume and stiffness, on the load-bearing abilities of these defects. Clinically-used image-based methods to predict the safety of removing external fixation are evaluated for each defect. Comparison of these measures with the results of computational analyses indicates that care must be taken in the interpretation of these measures. Copyright © 2015 Elsevier Ltd. All rights reserved.

  20. Critical incident reporting and learning.

    PubMed

    Mahajan, R P

    2010-07-01

    The success of incident reporting in improving safety, although obvious in aviation and other high-risk industries, is yet to be seen in health-care systems. An incident reporting system which would improve patient safety would allow front-end clinicians to have easy access for reporting an incident with an understanding that their report will be handled in a non-punitive manner, and that it will lead to enhanced learning regarding the causation of the incident and systemic changes which will prevent it from recurring. At present, significant problems remain with local and national incident reporting systems. These include fear of punitive action, poor safety culture in an organization, lack of understanding among clinicians about what should be reported, lack of awareness of how the reported incidents will be analysed, and how will the reports ultimately lead to changes which will improve patient safety. In particular, lack of systematic analysis of the reports and feedback directly to the clinicians are seen as major barriers to clinical engagement. In this review, robust systematic methodology of analysing incidents is discussed. This methodology is based on human factors model, and the learning paradigm which emphasizes significant shift from traditional judicial approach to understanding how 'latent errors' may play a role in a chain of events which can set up an 'active error' to occur. Feedback directly to the clinicians is extremely important for keeping them 'in the loop' for their continued engagement, and it should target different levels of analyses. In addition to high-level information on the types of incidents, the feedback should incorporate results of the analyses of active and latent factors. Finally, it should inform what actions, and at what level/stage, have been taken in response to the reported incidents. For this, local and national systems will be required to work in close cooperation, so that the lessons can be learnt and actions taken within an organization, and across organizations. In the UK, a recently introduced speciality-specific incident reporting system for anaesthesia aims to incorporate the elements of successful reporting system, as presented in this review, to achieve enhanced clinical engagement and improved patient safety.

  1. 14 CFR 414.11 - Application.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ...) Safety element (i.e., launch vehicle, reentry vehicle, safety system, process, service, or any identified... operating limits for which the safety approval is sought. (3) The following as applicable: (i) Information... the safety element for which the safety approval is sought. (ii) Engineering design and analyses that...

  2. 14 CFR 414.11 - Application.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ...) Safety element (i.e., launch vehicle, reentry vehicle, safety system, process, service, or any identified... operating limits for which the safety approval is sought. (3) The following as applicable: (i) Information... the safety element for which the safety approval is sought. (ii) Engineering design and analyses that...

  3. Inherent Safety Characteristics of Advanced Fast Reactors

    NASA Astrophysics Data System (ADS)

    Bochkarev, A. S.; Korsun, A. S.; Kharitonov, V. S.; Alekseev, P. N.

    2017-01-01

    The study presents SFR transient performance for ULOF events initiated by pump trip and pump seizure with simultaneous failure of all shutdown systems in both cases. The most severe cases leading to the pin cladding rupture and possible sodium boiling are demonstrated. The impact of various features on SFR inherent safety performance for ULOF events was analysed. The decrease in hydraulic resistance of primary loop and increase in primary pump coast down time were investigated. Performing analysis resulted in a set of recommendations to varying parameters for the purpose of enhancing the inherent safety performance of SFR. In order to prevent the safety barrier rupture for ULOF events the set of thermal hydraulic criteria defining the ULOF transient processes dynamics and requirements to these criteria were recommended based on achieved results: primary sodium flow dip under the natural circulation asymptotic level and natural circulation rise time.

  4. Development of safety performance monitoring procedures.

    DOT National Transportation Integrated Search

    2010-02-01

    Highway safety is an ongoing concern to the Texas Department of Transportation (TxDOT). As part of its : proactive commitment to improving highway safety, TxDOT is moving toward including quantitative safety : analyses earlier in the project developm...

  5. Stability Assessment as a Criterion of Stabilization of the Movement Trajectory of Mobile Crane Working Elements

    NASA Astrophysics Data System (ADS)

    Kacalak, W.; Budniak, Z.; Majewski, M.

    2018-02-01

    The article presents a stability assessment method of the mobile crane handling system based on the safety indicator values that were accepted as the trajectory optimization criterion. With the use of the mathematical model built and the model built in the integrated CAD/CAE environment, analyses were conducted of the displacements of the mass centre of the crane system, reactions of the outrigger system, stabilizing and overturning torques that act on the crane as well as the safety indicator values for the given movement trajectories of the crane working elements.

  6. More explicit communication after classroom-based crew resource management training: results of a pragmatic trial.

    PubMed

    Verbeek-van Noord, Inge; de Bruijne, Martine C; Twisk, Jos W R; van Dyck, Cathy; Wagner, Cordula

    2015-02-01

    Aviation-based crew resource management trainings to optimize non-technical skills among professionals are often suggested for health care as a way to increase patient safety. Our aim was to evaluate the effect of a 2-day classroom-based crew resource management (CRM) training at emergency departments (EDs) on explicit professional oral communication (EPOC; non-technical skills). A pragmatic controlled before-after trial was conducted. Four EDs of general teaching hospitals were recruited (two intervention and two control departments). ED nurses and ED doctors were observed on their non-technical skills by means of a validated observation tool (EPOC). Our main outcome measure was the amount of EPOC observed per interaction in 30 minutes direct observations. Three outcome measures from EPOC were analysed: human interaction, anticipation on environment and an overall EPOC score. Linear and logistic mixed model analyses were performed. Models were corrected for the outcome measurement at baseline, days between training and observation, patient safety culture and error management culture at baseline. A statistically significant increase after the training was found on human interaction (β=0.27, 95% CI 0.08-0.49) and the overall EPOC score (β=0.25, 95% CI 0.06-0.43), but not for anticipation on environment (OR=1.19, 95% CI .45-3.15). This means that approximately 25% more explicit communication was shown after CRM training. We found an increase in the use of CRM skills after classroom-based crew resource management training. This study adds to the body of evidence that CRM trainings have the potential to increase patient safety by reducing communication flaws, which play an important role in health care-related adverse events. © 2014 John Wiley & Sons, Ltd.

  7. Commentary: Status of road safety in Asia.

    PubMed

    Wismans, Jac; Skogsmo, Ingrid; Nilsson-Ehle, Anna; Lie, Anders; Thynell, Marie; Lindberg, Gunnar

    2016-01-01

    The objective of this article is to assess the status of road safety in Asia and present accident and injury prevention strategies based on global road safety improvement experiences and discuss the way forward by indicating opportunities and countermeasures that could be implemented to achieve a new level of safety in Asia. This study provides a review and analyses of data in the literature, including from the World Health Organization (WHO) and World Bank, and a review of lessons learned from best practices in high-income countries. In addition, an estimation of costs due to road transport injuries in Asia and review of future trends in road transport is provided. Data on the global and Asian road safety problem and status of prevention strategies in Asia as well as recommendations for future actions are discussed. The total number of deaths due to road accidents in the 24 Asian countries, encompassing 56% of the total world population, is 750,000 per year (statistics 2010). The total number of injuries is more than 50 million, of which 12% are hospital admissions. The loss to the economy in the 24 Asian countries is estimated to around US$800 billion or 3.6% of the gross domestic product (GDP). This article clearly shows that road safety is causing large problems and high costs in Asia, with an enormous impact on the well-being of people, economy, and productivity. In many Asian low- and middle-income countries, the yearly number of fatalities and injuries is increasing. Vulnerable road users (pedestrians, cyclists, and motorcyclists combined) are particularly at risk. Road safety in Asia should be given rightful attention, including taking powerful, effective actions. This review stresses the need for reliable accident data, because there is considerable underreporting in the official statistics. Reliable accident data are imperative to determine evidence-based intervention strategies and monitor the success of these interventions and analyses. On the other hand, lack of good high-quality accident data should not be an excuse to postpone interventions. There are many opportunities for evidence-based transport safety improvements, including measures concerning the 5 key risk factors: speed, drunk driving, not wearing motorcycle helmets, not wearing seat belts, and not using child restraints in cars, as specified in the Decade of Action for Road Safety 2011-2020. In this commentary, a number of additional measures are proposed that are not covered in the Decade of Action Plan. These new measures include separate roads or lanes for pedestrians and cyclists; helmet wearing for e-bike riders; special attention to elderly persons in public transportation; introduction of emerging collision avoidance technologies, in particular automatic emergency braking (AEB) and alcohol locks; improved truck safety focusing on the other road user (including blind spot detection technology; underride protection at the front, rear, and side; and energy-absorbing fronts); and improvements in motorcycle safety concerning protective clothing, requirements for advanced braking systems, improved visibility of motorcycles by using daytime running lights, and better guardrails.

  8. Cryptographically supported NFC tags in medication for better inpatient safety.

    PubMed

    Özcanhan, Mehmet Hilal; Dalkılıç, Gökhan; Utku, Semih

    2014-08-01

    Reliable sources report that errors in drug administration are increasing the number of harmed or killed inpatients, during healthcare. This development is in contradiction to patient safety norms. A correctly designed hospital-wide ubiquitous system, using advanced inpatient identification and matching techniques, should provide correct medicine and dosage at the right time. Researchers are still making grouping proof protocol proposals based on the EPC Global Class 1 Generation 2 ver. 1.2 standard tags, for drug administration. Analyses show that such protocols make medication unsecure and hence fail to guarantee inpatient safety. Thus, the original goal of patient safety still remains. In this paper, a very recent proposal (EKATE) upgraded by a cryptographic function is shown to fall short of expectations. Then, an alternative proposal IMS-NFC which uses a more suitable and newer technology; namely Near Field Communication (NFC), is described. The proposed protocol has the additional support of stronger security primitives and it is compliant to ISO communication and security standards. Unlike previous works, the proposal is a complete ubiquitous system that guarantees full patient safety; and it is based on off-the-shelf, new technology products available in every corner of the world. To prove the claims the performance, cost, security and scope of IMS-NFC are compared with previous proposals. Evaluation shows that the proposed system has stronger security, increased patient safety and equal efficiency, at little extra cost.

  9. The use of whole food animal studies in the safety assessment of genetically modified crops: Limitations and recommendations

    PubMed Central

    Bartholomaeus, Andrew; Parrott, Wayne; Bondy, Genevieve

    2013-01-01

    There is disagreement internationally across major regulatory jurisdictions on the relevance and utility of whole food (WF) toxicity studies on GM crops, with no harmonization of data or regulatory requirements. The scientific value, and therefore animal ethics, of WF studies on GM crops is a matter addressable from the wealth of data available on commercialized GM crops and WF studies on irradiated foods. We reviewed available GM crop WF studies and considered the extent to which they add to the information from agronomic and compositional analyses. No WF toxicity study was identified that convincingly demonstrated toxicological concern or that called into question the adequacy, sufficiency, and reliability of safety assessments based on crop molecular characterization, transgene source, agronomic characteristics, and/or compositional analysis of the GM crop and its near-isogenic line. Predictions of safety based on crop genetics and compositional analyses have provided complete concordance with the results of well-conducted animal testing. However, this concordance is primarily due to the improbability of de novo generation of toxic substances in crop plants using genetic engineering practices and due to the weakness of WF toxicity studies in general. Thus, based on the comparative robustness and reliability of compositional and agronomic considerations and on the absence of any scientific basis for a significant potential for de novo generation of toxicologically significant compositional alterations as a sole result of transgene insertion, the conclusion of this review is that WF animal toxicity studies are unnecessary and scientifically unjustifiable. PMID:24164514

  10. The FAA's Approach to Quality Assurance in the Flight Safety Analysis of Launch and Reentry Vehicles

    NASA Astrophysics Data System (ADS)

    Murray, Daniel P.; Weil, Andre

    2010-09-01

    The U.S. Federal Aviation Administration(FAA) Office of Commercial Space Transportation’s safety mission is to ensure protection of the public, property, and the national security and foreign policy interests of the United States during commercial launch and reentry activities. As part of this mission, the FAA issues licenses to the operators of launch and reentry vehicles who successfully demonstrate compliance with FAA regulations. To meet these regulations, vehicle operators submit an application that contains, among other things, flight safety analyses of their proposed missions. In the process of evaluating these submitted analyses, the FAA often conducts its own independent analyses, using input data from the submitted license application. These analyses are conducted according to approved procedures using industry developed tools. To assist in achieving the highest levels of quality in these independent analyses, the FAA has developed a quality assurance program that consists of multiple levels of review. These reviews rely on the work of multiple teams, as well as additional, independently performed work of support contractors. This paper describes the FAA’s quality assurance process for flight safety analyses. Members of the commercial space industry may find that elements of this process can be easily applied to their own analyses, improving the quality of the material they submit to the FAA in their license applications.

  11. 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.

  12. Safety climate in OHSAS 18001-certified organisations: antecedents and consequences of safety behaviour.

    PubMed

    Fernández-Muñiz, Beatriz; Montes-Peón, José Manuel; Vázquez-Ordás, Camilo José

    2012-03-01

    The occupational health and safety standard OHSAS 18001 has gained considerable acceptance worldwide, and firms from diverse sectors and of varying sizes have implemented it. Despite this, very few studies have analysed safety management or the safety climate in OHSAS 18001-certified organisations. The current work aims to analyse the safety climate in these organisations, identify its dimensions, and propose and test a structural equation model that will help determine the antecedents and consequences of employees' safety behaviour. For this purpose, the authors carry out an empirical study using a sample of 131 OHSAS 18001-certified organisations located in Spain. The results show that management's commitment, and particularly communication, have an effect on safety behaviour and on safety performance, employee satisfaction, and firm competitiveness. These findings are particularly important for management since they provide evidence about the factors that should be encouraged to reduce risks and improve performance in this type of organisation. Copyright © 2011 Elsevier Ltd. All rights reserved.

  13. Patient-reported safety incidents in older patients with long-term conditions: a large cross-sectional study

    PubMed Central

    Panagioti, Maria; Blakeman, Thomas; Hann, Mark; Bower, Peter

    2017-01-01

    Background Increasing evidence suggests that patient safety is a serious concern for older patients with long-term conditions. Despite this, there is a lack of research on safety incidents encountered by this patient group. In this study, we sought to examine patient reports of safety incidents and factors associated with reports of safety incidents in older patients with long-term conditions. Methods The baseline cross-sectional data from a longitudinal cohort study were analysed. Older patients (n=3378 aged 65 years and over) with a long-term condition registered in general practices were included in the study. The main outcome was patient-reported safety incidents including availability and appropriateness of medical tests and prescription of wrong types or doses of medication. Binary univariate and multivariate logistic regression analyses were undertaken to examine factors associated with patient-reported safety incidents. Results Safety incidents were reported by 11% of the patients. Four factors were significantly associated with patient-reported safety incidents in multivariate analyses. The experience of multiple long-term conditions (OR=1.09, 95% CI 1.05 to 1.13), a probable diagnosis of depression (OR=1.36, 95% CI 1.06 to 1.74) and greater relational continuity of care (OR=1.28, 95% CI 1.08 to 1.52) were associated with increased odds for patient-reported safety incidents. Perceived greater support and involvement in self-management was associated with lower odds for patient-reported safety incidents (OR=0.95, 95% CI 0.93 to 0.97). Conclusions We found that older patients with multimorbidity and depression are more likely to report experiences of patient safety incidents. Improving perceived support and involvement of patients in their care may help prevent patient-reported safety incidents. PMID:28559454

  14. Labor unions and safety climate: perceived union safety values and retail employee safety outcomes.

    PubMed

    Sinclair, Robert R; Martin, James E; Sears, Lindsay E

    2010-09-01

    Although trade unions have long been recognized as a critical advocate for employee safety and health, safety climate research has not paid much attention to the role unions play in workplace safety. We proposed a multiple constituency model of workplace safety which focused on three central safety stakeholders: top management, ones' immediate supervisor, and the labor union. Safety climate research focuses on management and supervisors as key stakeholders, but has not considered whether employee perceptions about the priority their union places on safety contributes contribute to safety outcomes. We addressed this gap in the literature by investigating unionized retail employee (N=535) perceptions about the extent to which their top management, immediate supervisors, and union valued safety. Confirmatory factor analyses demonstrated that perceived union safety values could be distinguished from measures of safety training, workplace hazards, top management safety values, and supervisor values. Structural equation analyses indicated that union safety values influenced safety outcomes through its association with higher safety motivation, showing a similar effect as that of supervisor safety values. These findings highlight the need for further attention to union-focused measures related to workplace safety as well as further study of retail employees in general. We discuss the practical implications of our findings and identify several directions for future safety research. 2009 Elsevier Ltd. All rights reserved.

  15. 14 CFR Appendix B of Part 415 - Safety Review Document Outline

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Performed by Certified Personnel 4.0Flight Safety (§ 415.115) 4.1Initial Flight Safety Analysis 4.1.1Flight Safety Sub-Analyses, Methods, and Assumptions 4.1.2Sample Calculation and Products 4.1.3 Launch Specific Updates and Final Flight Safety Analysis Data 4.2Radionuclide Data (where applicable) 4.3Flight Safety...

  16. 14 CFR Appendix B of Part 415 - Safety Review Document Outline

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... Performed by Certified Personnel 4.0Flight Safety (§ 415.115) 4.1Initial Flight Safety Analysis 4.1.1Flight Safety Sub-Analyses, Methods, and Assumptions 4.1.2Sample Calculation and Products 4.1.3 Launch Specific Updates and Final Flight Safety Analysis Data 4.2Radionuclide Data (where applicable) 4.3Flight Safety...

  17. 14 CFR Appendix B of Part 415 - Safety Review Document Outline

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... Performed by Certified Personnel 4.0Flight Safety (§ 415.115) 4.1Initial Flight Safety Analysis 4.1.1Flight Safety Sub-Analyses, Methods, and Assumptions 4.1.2Sample Calculation and Products 4.1.3 Launch Specific Updates and Final Flight Safety Analysis Data 4.2Radionuclide Data (where applicable) 4.3Flight Safety...

  18. Calibration factors handbook : safety prediction models calibrated with Texas highway system.

    DOT National Transportation Integrated Search

    2009-10-01

    Highway safety is an ongoing concern to the Texas Department of Transportation (TxDOT). As part of its : proactive commitment to improving highway safety, TxDOT is moving toward including quantitative safety : analyses earlier in the project developm...

  19. A framework for the development of patient safety education and training guidelines.

    PubMed

    Zikos, Dimitrios; Diomidous, Marianna; Mantas, John

    2010-01-01

    Patient Safety (PS) is a major concern that involves a wide range of roles in healthcare, including those who are directly and indirectly involved, and patients as well. In order to succeed into developing a safety culture among healthcare providers, carers and patients, there should be given great attention into building appropriate education and training tools, especially addressing those who plan patient safety activities. The framework described in this policy paper is based on the results of the European Network for Patient Safety (EUNetPaS) project and analyses the principles and elements of the guidance that should be provided to those who design and implement Patient Safety Education and training activities. The main principles that it should be based on and the core teaching objectives-expected outcomes are addressed. Once the main context and considerations are properly set, the guidance should define the general schema of the content that should be included in the Education and Training activities, as well as how these activities would be delivered. It is also important that the different roles of the recipients are clearly distinguished and linked to their role-specific methods, proper delivery platforms and success stories. Setting these principles into practice when planning and implementing interventions, primarily aims to enlighten and support those who are enrolled to design and implement Patient Safety education and training teaching activities. This is achieved by providing them with a framework to build upon, succeeding to build a collaborative, safety conscious and competent environment, in terms of PS. A guidelines web platform has been developed to support this process.

  20. Exploration of Heterogeneity in Distributed Research Network Drug Safety Analyses

    ERIC Educational Resources Information Center

    Hansen, Richard A.; Zeng, Peng; Ryan, Patrick; Gao, Juan; Sonawane, Kalyani; Teeter, Benjamin; Westrich, Kimberly; Dubois, Robert W.

    2014-01-01

    Distributed data networks representing large diverse populations are an expanding focus of drug safety research. However, interpreting results is difficult when treatment effect estimates vary across datasets (i.e., heterogeneity). In a previous study, risk estimates were generated for selected drugs and potential adverse outcomes. Analyses were…

  1. Development of cost estimation tools for total occupational safety and health activities and occupational health services: cost estimation from a corporate perspective.

    PubMed

    Nagata, Tomohisa; Mori, Koji; Aratake, Yutaka; Ide, Hiroshi; Ishida, Hiromi; Nobori, Junichiro; Kojima, Reiko; Odagami, Kiminori; Kato, Anna; Tsutsumi, Akizumi; Matsuda, Shinya

    2014-01-01

    The aim of the present study was to develop standardized cost estimation tools that provide information to employers about occupational safety and health (OSH) activities for effective and efficient decision making in Japanese companies. We interviewed OSH staff members including full-time professional occupational physicians to list all OSH activities. Using activity-based costing, cost data were obtained from retrospective analyses of occupational safety and health costs over a 1-year period in three manufacturing workplaces and were obtained from retrospective analyses of occupational health services costs in four manufacturing workplaces. We verified the tools additionally in four workplaces including service businesses. We created the OSH and occupational health standardized cost estimation tools. OSH costs consisted of personnel costs, expenses, outsourcing costs and investments for 15 OSH activities. The tools provided accurate, relevant information on OSH activities and occupational health services. The standardized information obtained from our OSH and occupational health cost estimation tools can be used to manage OSH costs, make comparisons of OSH costs between companies and organizations and help occupational health physicians and employers to determine the best course of action.

  2. Construction safety monitoring based on the project's characteristic with fuzzy logic approach

    NASA Astrophysics Data System (ADS)

    Winanda, Lila Ayu Ratna; Adi, Trijoko Wahyu; Anwar, Nadjadji; Wahyuni, Febriana Santi

    2017-11-01

    Construction workers accident is the highest number compared with other industries and falls are the main cause of fatal and serious injuries in high rise projects. Generally, construction workers accidents are caused by unsafe act and unsafe condition that can occur separately or together, thus a safety monitoring system based on influencing factors is needed to achieve zero accident in construction industry. The dynamic characteristic in construction causes high mobility for workers while doing the task, so it requires a continuously monitoring system to detect unsafe condition and to protect workers from potential hazards. In accordance with the unique nature of project, fuzzy logic approach is one of the appropriate methods for workers safety monitoring on site. In this study, the focus of discussion is based on the characteristic of construction projects in analyzing "potential hazard" and the "protection planning" to be used in accident prevention. The data have been collected from literature review, expert opinion and institution of safety and health. This data used to determine hazard identification. Then, an application model is created using Delphi programming. The process in fuzzy is divided into fuzzification, inference and defuzzification, according to the data collection. Then, the input and final output data are given back to the expert for assessment as a validation of application model. The result of the study showed that the potential hazard of construction workers accident could be analysed based on characteristic of project and protection system on site and fuzzy logic approach can be used for construction workers accident analysis. Based on case study and the feedback assessment from expert, it showed that the application model can be used as one of the safety monitoring tools.

  3. Application of LogitBoost Classifier for Traceability Using SNP Chip Data

    PubMed Central

    Kang, Hyunsung; Cho, Seoae; Kim, Heebal; Seo, Kang-Seok

    2015-01-01

    Consumer attention to food safety has increased rapidly due to animal-related diseases; therefore, it is important to identify their places of origin (POO) for safety purposes. However, only a few studies have addressed this issue and focused on machine learning-based approaches. In the present study, classification analyses were performed using a customized SNP chip for POO prediction. To accomplish this, 4,122 pigs originating from 104 farms were genotyped using the SNP chip. Several factors were considered to establish the best prediction model based on these data. We also assessed the applicability of the suggested model using a kinship coefficient-filtering approach. Our results showed that the LogitBoost-based prediction model outperformed other classifiers in terms of classification performance under most conditions. Specifically, a greater level of accuracy was observed when a higher kinship-based cutoff was employed. These results demonstrated the applicability of a machine learning-based approach using SNP chip data for practical traceability. PMID:26436917

  4. Application of LogitBoost Classifier for Traceability Using SNP Chip Data.

    PubMed

    Kim, Kwondo; Seo, Minseok; Kang, Hyunsung; Cho, Seoae; Kim, Heebal; Seo, Kang-Seok

    2015-01-01

    Consumer attention to food safety has increased rapidly due to animal-related diseases; therefore, it is important to identify their places of origin (POO) for safety purposes. However, only a few studies have addressed this issue and focused on machine learning-based approaches. In the present study, classification analyses were performed using a customized SNP chip for POO prediction. To accomplish this, 4,122 pigs originating from 104 farms were genotyped using the SNP chip. Several factors were considered to establish the best prediction model based on these data. We also assessed the applicability of the suggested model using a kinship coefficient-filtering approach. Our results showed that the LogitBoost-based prediction model outperformed other classifiers in terms of classification performance under most conditions. Specifically, a greater level of accuracy was observed when a higher kinship-based cutoff was employed. These results demonstrated the applicability of a machine learning-based approach using SNP chip data for practical traceability.

  5. Field safety notices released by manufacturers in cases of failure of products for infection testing: analysis of cases reported to the BfArM between 2005 and 2007

    PubMed Central

    2010-01-01

    The European Directive 98/79/EC for in vitro diagnostic medical devices (IVD) regulates marketing and post marketing surveillance of IVD in the European Economic Area. Manufacturers have to inform the responsible Competent Authorities (CA) about incidents and field safety corrective actions (FSCA) related to IVD. In Germany, the Federal Institute for Drugs and Medical Devices (BfArM) is the responsible CA for most IVD, only few IVD as specified in Annex II of the Directive are under the responsibility of the Paul Ehrlich Institute (PEI). In case of a FSCA manufacturers have to inform customers by means of a Field Safety Notice (FSN) which should be sent to BfArM prior to release and is published on the BfArM home-page. Between beginning of 2005 and end of 2007 the BfArM received a total of 1025 reports regarding IVD. From these, 38 related to tests, reagents, calibrators, and control materials for infection testing, 13 related to analysers and general consumables (n = 8 and n = 5, respectively) based on culture techniques, and 7 related to analysers and general consumables (n = 5 and n = 2, respectively) based on molecular biological methods. FSCA were performed in Germany in 32 (84.2%) of all notifications related to tests reagents, calibrators, and control materials as well as in 13 (100%) and 7 (100%) of notifications related to analysers and consumables based on culture techniques and molecular biological methods, respectively. A number of relevant deficiencies regarding the quality of the FSN were separately demonstrated for FSN in German and English language. In brief, manufacturers often sent their FSN to the BfArM with delay. Additionally, a subset of FSN provided insufficient information on the product related risks or the measures to be performed by the customer to mitigate product related risks. Furthermore, customer confirmation forms often were missing in the FSN sent to the BfArM. Our data suggest that for IVD for infection testing FSCA and FSN are frequently performed. For better vigilance performance, manufacturers could shorten the time until release and improve the contents of FSN to ensure the safety of IVD in cases of product related corrective actions. PMID:21147647

  6. Field safety notices released by manufacturers in cases of failure of products for infection testing: analysis of cases reported to the BfArM between 2005 and 2007.

    PubMed

    Siekmeier, R; Lisson, K; Wetzel, D

    2010-11-04

    The European Directive 98/79/EC for in vitro diagnostic medical devices (IVD) regulates marketing and post marketing surveillance of IVD in the European Economic Area. Manufacturers have to inform the responsible Competent Authorities (CA) about incidents and field safety corrective actions (FSCA) related to IVD. In Germany, the Federal Institute for Drugs and Medical Devices (BfArM) is the responsible CA for most IVD, only few IVD as specified in Annex II of the Directive are under the responsibility of the Paul Ehrlich Institute (PEI). In case of a FSCA manufacturers have to inform customers by means of a Field Safety Notice (FSN) which should be sent to BfArM prior to release and is published on the BfArM homepage. Between beginning of 2005 and end of 2007 the BfArM received a total of 1025 reports regarding IVD. From these, 38 related to tests, reagents, calibrators, and control materials for infection testing, 13 related to analysers and general consumables (n = 8 and n = 5, respectively) based on culture techniques, and 7 related to analysers and general consumables (n = 5 and n = 2, respectively) based on molecular biological methods. FSCA were performed in Germany in 32 (84.2%) of all notifications related to tests reagents, calibrators, and control materials as well as in 13 (100%) and 7 (100%) of notifications related to analysers and consumables based on culture techniques and molecular biological methods, respectively. A number of relevant deficiencies regarding the quality of the FSN were separately demonstrated for FSN in German and English language. In brief, manufacturers often sent their FSN to the BfArM with delay. Additionally, a subset of FSN provided insufficient information on the product related risks or the measures to be performed by the customer to mitigate product related risks. Furthermore, customer confirmation forms often were missing in the FSN sent to the BfArM. Our data suggest that for IVD for infection testing FSCA and FSN are frequently performed. For better vigilance performance, manufacturers could shorten the time until release and improve the contents of FSN to ensure the safety of IVD in cases of product related corrective actions.

  7. Composition, labelling, and safety of food supplements based on bee products in the legislative framework of the European Union - Croatian experiences.

    PubMed

    Vujić, Mario; Pollak, Lea

    2015-12-01

    The European Union market is overflown by food supplements and an increasing number of consumers prefer those where bee products play an important part in their composition. This paper deals with complex European Union legislation concerning food supplements based on bee products, placing a special emphasis on their composition, labelling, and safety. Correct labelling of food supplements also represents a great challenge since, in spite of legal regulations in force, there are still open issues regarding the statements on the amount of propolis, which is not clearly defined by the legal framework. One of the key issues are the labels containing health claims from the EU positive list approved by the European Food Safety Authority. Emphasis will also be placed on informing consumers about food, as statements which imply the healing properties of food supplements and their capacity to cure diseases are forbidden. One of the key elements of product safety is HACCP based on the EU Regulations EC 178/02 and 852/2004. Health safety analyses of food supplements with bee products used as raw materials, which are standardised by legal regulations will also be discussed. In the future, attention should also be paid to establishing the European Union "nutrivigilance" system. Croatian experiences in addressing challenges faced by producers, supervisory entities, and regulatory and inspection bodies may serve as an example to countries aspiring to become part of the large European family.

  8. Integrating evidence-based practices for increasing cancer screenings in safety net health systems: a multiple case study using the Consolidated Framework for Implementation Research.

    PubMed

    Liang, Shuting; Kegler, Michelle C; Cotter, Megan; Emily, Phillips; Beasley, Derrick; Hermstad, April; Morton, Rentonia; Martinez, Jeremy; Riehman, Kara

    2016-08-02

    Implementing evidence-based practices (EBPs) to increase cancer screenings in safety net primary care systems has great potential for reducing cancer disparities. Yet there is a gap in understanding the factors and mechanisms that influence EBP implementation within these high-priority systems. Guided by the Consolidated Framework for Implementation Research (CFIR), our study aims to fill this gap with a multiple case study of health care safety net systems that were funded by an American Cancer Society (ACS) grants program to increase breast and colorectal cancer screening rates. The initiative funded 68 safety net systems to increase cancer screening through implementation of evidence-based provider and client-oriented strategies. Data are from a mixed-methods evaluation with nine purposively selected safety net systems. Fifty-two interviews were conducted with project leaders, implementers, and ACS staff. Funded safety net systems were categorized into high-, medium-, and low-performing cases based on the level of EBP implementation. Within- and cross-case analyses were performed to identify CFIR constructs that influenced level of EBP implementation. Of 39 CFIR constructs examined, six distinguished levels of implementation. Two constructs were from the intervention characteristics domain: adaptability and trialability. Three were from the inner setting domain: leadership engagement, tension for change, and access to information and knowledge. Engaging formally appointed internal implementation leaders, from the process domain, also distinguished level of implementation. No constructs from the outer setting or individual characteristics domain differentiated systems by level of implementation. Our study identified a number of influential CFIR constructs and illustrated how they impacted EBP implementation across a variety of safety net systems. Findings may inform future dissemination efforts of EBPs for increasing cancer screening in similar settings. Moreover, our analytic approach is similar to previous case studies using CFIR and hence could facilitate comparisons across studies.

  9. An evidence-based review of pregabalin for the treatment of fibromyalgia.

    PubMed

    Arnold, Lesley M; Choy, Ernest; Clauw, Daniel J; Oka, Hiroshi; Whalen, Ed; Semel, David; Pauer, Lynne; Knapp, Lloyd

    2018-04-16

    Pregabalin, an α2-δ agonist, is approved for the treatment of fibromyalgia (FM) in the United States, Japan, and 37 other countries. The purpose of this article was to provide an in-depth, evidence-based summary of pregabalin for FM as demonstrated in randomized, placebo-controlled clinical studies, including open-label extensions, meta-analyses, combination studies and post-hoc analyses of clinical study data. PubMed was searched using the term "pregabalin AND fibromyalgia" and the Cochrane Library with the term "pregabalin". Both searches were conducted on 2 March 2017 with no other date limits set. Eleven randomized, double-blind, placebo-controlled clinical studies were identified including parallel group, two-way crossover and randomized withdrawal designs. One was a neuroimaging study. Five open-label extensions were also identified. Evidence of efficacy was demonstrated across the studies identified with significant and clinically relevant improvements in pain, sleep quality and patient status. The safety and tolerability profile of pregabalin is consistent across all the studies identified, including in adolescents, with dizziness and somnolence the most common adverse events reported. These efficacy and safety data are supported by meta-analyses (13 studies). Pregabalin in combination with other pharmacotherapies (7 studies) is also efficacious. Post-hoc analyses have demonstrated the onset of pregabalin efficacy as early as 1-2 days after starting treatment, examined the effect of pregabalin on other aspects of sleep beyond quality, and shown it is effective irrespective of the presence of a wide variety of patient demographic and clinical characteristics. Pregabalin is a treatment option for FM; its clinical utility has been comprehensively demonstrated.

  10. 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

  11. Relational approach in managing construction project safety: a social capital perspective.

    PubMed

    Koh, Tas Yong; Rowlinson, Steve

    2012-09-01

    Existing initiatives in the management of construction project safety are largely based on normative compliance and error prevention, a risk management approach. Although advantageous, these approaches are not wholly successful in further lowering accident rates. A major limitation lies with the approaches' lack of emphasis on the social and team processes inherent in construction project settings. We advance the enquiry by invoking the concept of social capital and project organisational processes, and their impacts on project safety performance. Because social capital is a primordial concept and affects project participants' interactions, its impact on project safety performance is hypothesised to be indirect, i.e. the impact of social capital on safety performance is mediated by organisational processes in adaptation and cooperation. A questionnaire survey was conducted within Hong Kong construction industry to test the hypotheses. 376 usable responses were received and used for analyses. The results reveal that, while the structural dimension is not significant, the mediational thesis is generally supported with the cognitive and relational dimensions affecting project participants' adaptation and cooperation, and the latter two processes affect safety performance. However, the cognitive dimension also directly affects safety performance. The implications of these results for project safety management are discussed. Copyright © 2011 Elsevier Ltd. All rights reserved.

  12. High-Explosives Applications Facility (HEAF)

    NASA Astrophysics Data System (ADS)

    Morse, J. L.; Weingart, R. C.

    1989-03-01

    This Safety Analysis Report (SAR) reviews the safety and environmental aspects of the High Explosives Applications Facility (HEAF). Topics covered include the site selected for the HEAF, safety design criteria, operations planned within the facility, and the safety and environmental analyses performed on this project to date. Provided in the Summary section is a review of hazards and the analyses, conclusions, and operating limits developed in this SAR. Appendices provide supporting documents relating to this SAR. This SAR is required by the LLNL Health and Safety Manual and DOE Order 5481.1B(2) to document the safety analysis efforts. The SAR was assembled by the Hazards Control Department, B-Division, and HEAF project personnel. This document was reviewed by B Division, the Chemistry Department, the Hazards Control Department, the Laboratory Associate Director for Administration and Operations, and the Associate Directors ultimately responsible for HEAF operations.

  13. ANITA Air Monitoring on the International Space Station: Results Compared to Other Measurements

    NASA Technical Reports Server (NTRS)

    Honne, A.; Schumann-Olsen, H.; Kaspersen, K.; Limero, T.; Macatangay, A.; Mosebach, H.; Kampf, D.; Mudgett, P. D.; James, J. T.; Tan, G.; hide

    2009-01-01

    ANITA (Analysing Interferometer for Ambient Air) is a flight experiment precursor for a permanent continuous air quality monitoring system on the ISS (International Space Station). For the safety of the crew, ANITA can detect and quantify quasi-online and simultaneously 33 gas compounds in the air with ppm or sub-ppm detection limits. The autonomous measurement system is based on FTIR (Fourier Transform Infra-Red spectroscopy). The system represents a versatile air quality monitor, allowing for the first time the detection and monitoring of trace gas dynamics in a spacecraft atmosphere. ANITA operated on the ISS from September 2007 to August 2008. This paper summarizes the results of ANITA s air analyses with emphasis on comparisons to other measurements. The main basis of comparison is NASA s set of grab samples taken onboard the ISS and analysed on ground applying various GC-based (Gas Chromatography) systems.

  14. The Traditional Chinese Medicine and Relevant Treatment for the Efficacy and Safety of Atopic Dermatitis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Shi, Zhao-feng; Song, Tie-bing; Xie, Juan; Yan, Yi-quan

    2017-01-01

    Background Atopic dermatitis (AD) has become a common skin disease that requires systematic and comprehensive treatment to achieve adequate clinical control. Traditional Chinese medicines and related treatments have shown clinical effects for AD in many studies. But the systematic reviews and meta-analyses for them are lacking. Objective The systematic review and meta-analysis based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement were conducted to evaluate the efficacy and safety of traditional Chinese medicines and related treatments for AD treatment. Methods Randomized controlled trials (RCTs) were searched based on standardized searching rules in eight medical databases from the inception up to December 2016 and a total of 24 articles with 1,618 patients were enrolled in this meta-analysis. Results The results revealed that traditional Chinese medicines and related treatments did not show statistical differences in clinical effectiveness, SCORAD amelioration, and SSRI amelioration for AD treatment compared with control group. However, EASI amelioration of traditional Chinese medicines and related treatments for AD was superior to control group. Conclusion We need to make conclusion cautiously for the efficacy and safety of traditional Chinese medicine and related treatment on AD therapy. More standard, multicenter, double-blind randomized controlled trials (RCTs) of traditional Chinese medicine and related treatment for AD were required to be conducted for more clinical evidences providing in the future. PMID:28713436

  15. 77 FR 60479 - Burnup Credit in the Criticality Safety Analyses of Pressurized Water Reactor Spent Fuel in...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-03

    ... Pressurized Water Reactor Spent Fuel in Transportation and Storage Casks AGENCY: Nuclear Regulatory Commission... 3, entitled, ``Burnup Credit in the Criticality Safety Analyses of PWR [Pressurized Water Reactor... water reactor spent nuclear fuel (SNF) in transportation packages and storage casks. SFST-ISG-8...

  16. Comparative analysis based on factor analysis of integrate production capacity of foodstuff in main foodstuff provinces

    NASA Astrophysics Data System (ADS)

    Zhang, Dehua; Zhou, Huiqiu

    2011-10-01

    Under great background of financial crisis, large fluctuation on international foodstuff price and frequent happening of natural disasters, each nation attaches importance to foodstuff safety problem increasingly. As a Great Power of population, China pays more attention to foodstuff safety problem definitely. Large foodstuff provinces play a major role on ensuring it. The paper arrives at the conclusion that each province has advantages and disadvantages in different factors through factor analyses on influencing factors of integrated production capacity of foodstuff in each province. Then we arrange the factor score, analyze the result of each large foodstuff province and ultimately give out feasible suggestions.

  17. Sample Return Primer and Handbook

    NASA Technical Reports Server (NTRS)

    Barrow, Kirk; Cheuvront, Allan; Faris, Grant; Hirst, Edward; Mainland, Nora; McGee, Michael; Szalai, Christine; Vellinga, Joseph; Wahl, Thomas; Williams, Kenneth; hide

    2007-01-01

    This three-part Sample Return Primer and Handbook provides a road map for conducting the terminal phase of a sample return mission. The main chapters describe element-by-element analyses and trade studies, as well as required operations plans, procedures, contingencies, interfaces, and corresponding documentation. Based on the experiences of the lead Stardust engineers, the topics include systems engineering (in particular range safety compliance), mission design and navigation, spacecraft hardware and entry, descent, and landing certification, flight and recovery operations, mission assurance and system safety, test and training, and the very important interactions with external support organizations (non-NASA tracking assets, landing site support, and science curation).

  18. Electrostatic forces for personnel restraints

    NASA Technical Reports Server (NTRS)

    Ashby, N.; Ciciora, J.; Gardner, R.; Porter, K.

    1977-01-01

    The feasibility of utilizing electrostatic forces for personnel retention devices on exterior spacecraft surfaces was analyzed. The investigation covered: (1) determination of the state of the art; (2) analysis of potential adhesion surfaces; (3) safety considerations for personnel; (4) electromagnetic force field determination and its effect on spacecraft instrumentation; and (5) proposed advances to current technology based on documentation review, analyses, and experimental test data.

  19. What Happened, and Why: Toward an Understanding of Human Error Based on Automated Analyses of Incident Reports. Volume 2

    NASA Technical Reports Server (NTRS)

    Ferryman, Thomas A.; Posse, Christian; Rosenthal, Loren J.; Srivastava, Ashok N.; Statler, Irving C.

    2006-01-01

    The objective of the Aviation System Monitoring and Modeling project of NASA's Aviation Safety and Security Program was to develop technologies to enable proactive management of safety risk, which entails identifying the precursor events and conditions that foreshadow most accidents. Information about what happened can be extracted from quantitative data sources, but the experiential account of the incident reporter is the best available source of information about why an incident happened. In Volume I, the concept of the Scenario was introduced as a pragmatic guide for identifying similarities of what happened based on the objective parameters that define the Context and the Outcome of a Scenario. In this Volume II, that study continues into the analyses of the free narratives to gain understanding as to why the incident occurred from the reporter s perspective. While this is just the first experiment, the results of our approach are encouraging and indicate that it will be possible to design an automated analysis process guided by the structure of the Scenario that can achieve the level of consistency and reliability of human analysis of narrative reports.

  20. Analysis For Monitoring the Earth Science Afternoon Constellation

    NASA Technical Reports Server (NTRS)

    Demarest, Peter; Richon, Karen V.; Wright, Frank

    2005-01-01

    The Earth Science Afternoon Constellation consists of Aqua, Aura, PARASOL, CALIPSO, Cloudsat, and the Orbiting Carbon Observatory (OCO). The coordination of flight dynamics activities between these missions is critical to the safety and success of the Afternoon Constellation. This coordination is based on two main concepts, the control box and the zone-of-exclusion. This paper describes how these two concepts are implemented in the Constellation Coordination System (CCS). The CCS is a collection of tools that enables the collection and distribution of flight dynamics products among the missions, allows cross-mission analyses to be performed through a web-based interface, performs automated analyses to monitor the overall constellation, and notifies the missions of changes in the status of the other missions.

  1. Software-Based Safety Systems in Space - Learning from other Domains

    NASA Astrophysics Data System (ADS)

    Klicker, M.; Putzer, H.

    2012-01-01

    Increasing complexity and new emerging capabilities for manned and unmanned missions have been the hallmark of the past decades of space exploration. One of the drivers in this process was the ever increasing use of software and software-intensive systems to implement system functions necessary to the capabilities needed. The course of technological evolution suggests that this development will continue well into the future with a number of challenges for the safety community some of which shall be discussed in this paper. The current state of the art reveals a number of problems with developing and assessing safety critical software which explains the reluctance of the space community to rely on software-based safety measures to mitigate hazards. Among others, usually lack of trustworthy evidence of software integrity in all foreseeable situations and the difficulties to integrate software in the traditional safety analysis framework are cited. Experience from other domains and recent developments in modern software development methodologies and verification techniques are analysed for the suitability for space systems and an avionics architectural framework (see STANAG 4626) for the implementation of safety critical software is proposed. This is shown to create among other features the possibility of numerous degradation modes enhancing overall system safety and interoperability of computerized space systems. It also potentially simplifies international cooperation on a technical level by introducing a higher degree of compatibility. As software safety cannot be tested or argued into a system in hindsight, the development process and especially the architecture chosen are essential to establish safety properties for the software used to implement safety functions. The core of the safety argument revolves around the separation of different functions and software modules from each other by minimal coupling of functions and credible separation mechanisms in the architecture combined with rigorous development methodologies for the software itself.

  2. 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.

  3. 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.

  4. [Optimal versus maximal safety of the blood transfusion chain in The Netherlands; results of a conference. College for Blood Transfusion of the Dutch Red Cross].

    PubMed

    van der Poel, C L; de Boer, J E; Reesink, H W; Sibinga, C T

    1998-02-07

    An invitational conference was held on September 11, 1996 by the Medical Advisory Commission to the Blood Transfusion Council of the Netherlands Red Cross, addressing the issues of 'maximal' versus 'optimal' safety measures for the blood supply. Invited were blood transfusion specialists, clinicians, representatives of patient interest groups, the Ministry and Inspectorate of Health and members of parliament. Transfusion experts and clinicians were found to advocate an optimal course, following strategies of evidence-based medicine, cost-benefit analyses and medical technology assessment. Patient groups depending on blood products, such as haemophilia patients would rather opt for maximal safety. Insurance companies would choose likewise, to exclude any risk if possible. Health care juridical advisers would advise to choose for optimal safety, but to reserve funds covering the differences with 'maximal safety' in case of litigation. Politicians and the general public would sooner choose for maximal rather than optimal security. The overall impression persists that however small the statistical risk may be, in the eyes of many it is unacceptable. This view is very stubborn.

  5. Factors impacting perceived safety among staff working on mental health wards.

    PubMed

    Haines, Alina; Brown, Andrew; McCabe, Rhiannah; Rogerson, Michelle; Whittington, Richard

    2017-09-01

    Safety at work is a core issue for mental health staff working on in-patient units. At present, there is a limited theoretical base regarding which factors may affect staff perceptions of safety. This study attempted to identify which factors affect perceived staff safety working on in-patient mental health wards. A cross-sectional design was employed across 101 forensic and non-forensic mental health wards, over seven National Health Service trusts nationally. Measures included an online staff survey, Ward Features Checklist and recorded incident data. Data were analysed using categorical principal components analysis and ordinal regression. Perceptions of staff safety were increased by ward brightness, higher number of patient beds, lower staff to patient ratios, less dayroom space and more urban views. The findings from this study do not represent common-sense assumptions. Results are discussed in the context of the literature and may have implications for current initiatives aimed at managing in-patient violence and aggression. None. © The Royal College of Psychiatrists 2017. This is an open access article distributed under the terms of the Creative Commons Attribution (CC BY) license.

  6. The driver, the road, the rules … and the rest? A systems-based approach to young driver road safety.

    PubMed

    Scott-Parker, B; Goode, N; Salmon, P

    2015-01-01

    The persistent overrepresentation of young drivers in road crashes is universally recognised. A multitude of factors influencing their behaviour and safety have been identified through methods including crash analyses, simulated and naturalistic driving studies, and self-report measures. Across the globe numerous, diverse, countermeasures have been implemented; the design of the vast majority of these has been informed by a driver-centric approach. An alternative approach gaining popularity in transport safety is the systems approach which considers not only the characteristics of the individual, but also the decisions and actions of other actors within the road transport system, along with the interactions amongst them. This paper argues that for substantial improvements to be made in young driver road safety, what has been learnt from driver-centric research needs to be integrated into a systems approach, thus providing a holistic appraisal of the young driver road safety problem. Only then will more effective opportunities and avenues for intervention be realised. Copyright © 2014 Elsevier Ltd. All rights reserved.

  7. Partnering With a Medical Malpractice Insurer to Improve Patient Safety and Decrease Risk.

    PubMed

    Keohane, Carol A; Dwyer, Kathy; Boulanger, Jason; Zigmont, Katherine; Babayan, Astrid; Cushing, Elizabeth; Walsh, Brian

    Implementing evolving science into clinical practice remains challenging. Assimilating new scientific evidence into clinical protocols and best practice recommendations, in a timely manner, can be difficult. In this article, we examine the value of partnering with a captive medical malpractice insurance company and its Patient Safety Organization to use data and convening opportunities to build upon the principles of implementation science and foster efficient and widespread adoption of the most current evidence-based interventions. Analyses of medical malpractice and root-cause analysis data set the context for this partnership and acted as a catalyst for creating best practice guidelines for adopting therapeutic hypothermia in the treatment of neonatal encephalopathy. What follows is a powerful example of successfully leveraging the collective wisdom of healthcare providers across specialties and institutional lines to move patient safety forward while managing risk.

  8. Impacts of Bicycle Infrastructure in Mid-Sized Cities (IBIMS): protocol for a natural experiment study in three Canadian cities.

    PubMed

    Winters, Meghan; Branion-Calles, Michael; Therrien, Suzanne; Fuller, Daniel; Gauvin, Lise; Whitehurst, David G T; Nelson, Trisalyn

    2018-01-21

    Bicycling is promoted as a transportation and population health strategy globally. Yet bicycling has low uptake in North America (1%-2% of trips) compared with European bicycling cities (15%-40% of trips) and shows marked sex and age trends. Safety concerns due to collisions with motor vehicles are primary barriers.To attract the broader population to bicycling, many cities are making investments in bicycle infrastructure. These interventions hold promise for improving population health given the potential for increased physical activity and improved safety, but such outcomes have been largely unstudied. In 2016, the City of Victoria, Canada, committed to build a connected network of infrastructure that separates bicycles from motor vehicles, designed to attract people of 'all ages and abilities' to bicycling.This natural experiment study examines the impacts of the City of Victoria's investment in a bicycle network on active travel and safety outcomes. The specific objectives are to (1) estimate changes in active travel, perceived safety and bicycle safety incidents; (2) analyse spatial inequities in access to bicycle infrastructure and safety incidents; and (3) assess health-related economic benefits. The study is in three Canadian cities (intervention: Victoria; comparison: Kelowna, Halifax). We will administer population-based surveys in 2016, 2018 and 2021 (1000 people/city). The primary outcome is the proportion of people reporting bicycling. Secondary outcomes are perceived safety and bicycle safety incidents. Spatial analyses will compare the distribution of bicycle infrastructure and bicycle safety incidents across neighbourhoods and across time. We will also calculate the economic benefits of bicycling using WHO's Health Economic Assessment Tool. This study received approval from the Simon Fraser University Office of Research Ethics (study no. 2016s0401). Findings will be disseminated via a website, presentations to stakeholders, at academic conferences and through peer-reviewed journal articles. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  9. What Happened, and Why: Toward an Understanding of Human Error Based on Automated Analyses of Incident Reports. Volume 1

    NASA Technical Reports Server (NTRS)

    Maille, Nicolas P.; Statler, Irving C.; Ferryman, Thomas A.; Rosenthal, Loren; Shafto, Michael G.; Statler, Irving C.

    2006-01-01

    The objective of the Aviation System Monitoring and Modeling (ASMM) project of NASA s Aviation Safety and Security Program was to develop technologies that will enable proactive management of safety risk, which entails identifying the precursor events and conditions that foreshadow most accidents. This presents a particular challenge in the aviation system where people are key components and human error is frequently cited as a major contributing factor or cause of incidents and accidents. In the aviation "world", information about what happened can be extracted from quantitative data sources, but the experiential account of the incident reporter is the best available source of information about why an incident happened. This report describes a conceptual model and an approach to automated analyses of textual data sources for the subjective perspective of the reporter of the incident to aid in understanding why an incident occurred. It explores a first-generation process for routinely searching large databases of textual reports of aviation incident or accidents, and reliably analyzing them for causal factors of human behavior (the why of an incident). We have defined a generic structure of information that is postulated to be a sound basis for defining similarities between aviation incidents. Based on this structure, we have introduced the simplifying structure, which we call the Scenario as a pragmatic guide for identifying similarities of what happened based on the objective parameters that define the Context and the Outcome of a Scenario. We believe that it will be possible to design an automated analysis process guided by the structure of the Scenario that will aid aviation-safety experts to understand the systemic issues that are conducive to human error.

  10. Healthcare professional and patient codesign and validation of a mechanism for service users to feedback patient safety experiences following a care transfer: a qualitative study

    PubMed Central

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

    2016-01-01

    Objective To develop and validate a mechanism for patients to provide feedback on safety experiences following a care transfer between organisations. Design Qualitative study using participatory methods (codesign workshops) and cognitive interviews. Workshop data were analysed concurrently with participants, and cognitive interviews were thematically analysed using a deductive approach based on the developed feedback mechanism. Participants Expert patients (n=5) and healthcare professionals (n=11) were recruited purposively to develop the feedback mechanism in 2 workshops. Workshop 1 explored principles underpinning safety feedback mechanisms, and workshop 2 included the practical development of the feedback mechanism. Final design and content of the feedback mechanism (a safety survey) were verified by workshop participants, and cognitive interviews (n=28) were conducted with patients. Results Workshop participants identified that safety feedback mechanisms should be patient-centred, short and concise with clear signposting on how to complete, with an option to be anonymous and balanced between positive (safe) and negative (unsafe) experiences. The agreed feedback mechanism consisted of a survey split across 3 stages of the care transfer: departure, journey and arrival. Care across organisational boundaries was recognised as being complex, with healthcare professionals acknowledging the difficulty implementing changes that impact other organisations. Cognitive interview participants agreed the content of the survey was relevant but identified barriers to completion relating to the survey formatting and understanding of a care transfer. Conclusions Participatory, codesign principles helped overcome differences in understandings of safety in the complex setting of care transfers when developing a safety survey. Practical barriers to the survey's usability and acceptability to patients were identified, resulting in a modified survey design. Further research is required to determine the usability and acceptability of the survey to patients and healthcare professionals, as well as identifying how governance structures should accommodate patient feedback when relating to multiple health or social care providers. PMID:27406641

  11. eLearning techniques supporting problem based learning in clinical simulation.

    PubMed

    Docherty, Charles; Hoy, Derek; Topp, Helena; Trinder, Kathryn

    2005-08-01

    This paper details the results of the first phase of a project using eLearning to support students' learning within a simulated environment. The locus was a purpose built clinical simulation laboratory (CSL) where the School's philosophy of problem based learning (PBL) was challenged through lecturers using traditional teaching methods. a student-centred, problem based approach to the acquisition of clinical skills that used high quality learning objects embedded within web pages, substituting for lecturers providing instruction and demonstration. This encouraged student nurses to explore, analyse and make decisions within the safety of a clinical simulation. Learning was facilitated through network communications and reflection on video performances of self and others. Evaluations were positive, students demonstrating increased satisfaction with PBL, improved performance in exams, and increased self-efficacy in the performance of nursing activities. These results indicate that eLearning techniques can help students acquire clinical skills in the safety of a simulated environment within the context of a problem based learning curriculum.

  12. Data from the US and UK cystic fibrosis registries support disease modification by CFTR modulation with ivacaftor.

    PubMed

    Bessonova, Leona; Volkova, Nataliya; Higgins, Mark; Bengtsson, Leif; Tian, Simon; Simard, Christopher; Konstan, Michael W; Sawicki, Gregory S; Sewall, Ase; Nyangoma, Stephen; Elbert, Alexander; Marshall, Bruce C; Bilton, Diana

    2018-05-10

    Ivacaftor is the first cystic fibrosis transmembrane conductance regulator (CFTR) modulator demonstrating clinical benefit in patients with cystic fibrosis (CF). As ivacaftor is intended for chronic, lifelong use, understanding long-term effects is important for patients and healthcare providers. This ongoing, observational, postapproval safety study evaluates clinical outcomes and disease progression in ivacaftor-treated patients using data from the US and the UK CF registries following commercial availability. Annual analyses compare ivacaftor-treated and untreated matched comparator patients for: risks of death, transplantation, hospitalisation, pulmonary exacerbation; prevalence of CF-related complications and microorganisms and lung function changes in a subset of patients who initiated ivacaftor in the first year of commercial availability. Results from the 2014 analyses (2 and 3 years following commercial availability in the UK and USA, respectively) are presented here. Analyses included 1256 ivacaftor-treated and 6200 comparator patients from the USA and 411 ivacaftor-treated and 2069 comparator patients from the UK. No new safety concerns were identified based on the evaluation of clinical outcomes included in the analyses. As part of safety evaluations, ivacaftor-treated US patients were observed to have significantly lower risks of death (0.6% vs 1.6%, p=0.0110), transplantation (0.2% vs 1.1%, p=0.0017), hospitalisation (27.5% vs 43.1%, p<0.0001) and pulmonary exacerbation (27.8% vs 43.3%, p<0.0001) relative to comparators; trends were similar in the UK. In both registries, ivacaftor-treated patients had a lower prevalence of CF-related complications and select microorganisms and had better preserved lung function. While general limitations of observational research apply, analyses revealed favourable results for clinically important outcomes among ivacaftor-treated patients, adding to the growing body of literature supporting disease modification by CFTR modulation with ivacaftor. EUPAS4270. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  13. Using US EPA’s Chemical Safety for Sustainability’s Comptox Chemistry Dashboard and Tools for Bioactivity, Chemical and Toxicokinetic Modeling Analyses (Course at 2017 ISES Annual Meeting)

    EPA Science Inventory

    Title: Using US EPA’s Chemical Safety for Sustainability’s Comptox Chemistry Dashboard and Tools for Bioactivity, Chemical and Toxicokinetic Modeling Analyses • Class format: half-day (4 hours) • Course leader(s): Barbara A. Wetmore and Antony J. Williams,...

  14. Safety profile of levetiracetam.

    PubMed

    Arroyo, Santiago; Crawford, Pamela

    2003-05-01

    A good balance between safety and tolerability is necessary for an antiepileptic drug (AED) to be successful in the management of patients with epilepsy. Levetiracetam is one of the new generation of AEDs licensed as an add-on therapy for the treatment of patients with partial-onset seizures. Leveti-racetam's mechanisms of action are not fully understood. Controlled clinical trials, open-label studies, and postmarketing surveillance indicate that leveti-racetam has a favorable safety profile characterized by little effect on vital signs or clinical laboratory values, reported adverse events that are mild to moderate, and no known drug-drug interactions. The tolerability of levetiracetam may extend to both pediatric and elderly patients based on analyses of small numbers of patients. Tolerability is maintained over the long term. Levetirac-etam does not appear to have a different safety profile in learning-disabled patients. Levetiracetam appears to have a good balance between tolerability and efficacy in the treatment of a wide variety of patients with partial epilepsy.

  15. Patient safety and patient assessment in pre-hospital care: a study protocol.

    PubMed

    Hagiwara, Magnus Andersson; Nilsson, Lena; Strömsöe, Anneli; Axelsson, Christer; Kängström, Anna; Herlitz, Johan

    2016-02-12

    Patient safety issues in pre-hospital care are poorly investigated. The aim of the planned study is to survey patient safety problems in pre-hospital care in Sweden. The study is a retro-perspective structured medical record review based on the use of 11 screening criteria. Two instruments for structured medical record review are used: a trigger tool instrument designed for pre-hospital care and a newly development instrument designed to compare the pre-hospital assessment with the final hospital assessment. Three different ambulance organisations are participating in the study. Every month, one rater in each organisation randomly collects 30 medical records for review. With guidance from the review instrument, he/she independently reviews the record. Every month, the review team meet for a discussion of problematic reviews. The results will be analysed with descriptive statistics and logistic regression. The findings will make an important contribution to knowledge about patient safety issues in pre-hospital care.

  16. Factors influencing workers to follow food safety management systems in meat plants in Ontario, Canada.

    PubMed

    Ball, Brita; Wilcock, Anne; Aung, May

    2009-06-01

    Small and medium sized food businesses have been slow to adopt food safety management systems (FSMSs) such as good manufacturing practices and Hazard Analysis Critical Control Point (HACCP). This study identifies factors influencing workers in their implementation of food safety practices in small and medium meat processing establishments in Ontario, Canada. A qualitative approach was used to explore in-plant factors that influence the implementation of FSMSs. Thirteen in-depth interviews in five meat plants and two focus group interviews were conducted. These generated 219 pages of verbatim transcripts which were analysed using NVivo 7 software. Main themes identified in the data related to production systems, organisational characteristics and employee characteristics. A socio-psychological model based on the theory of planned behaviour is proposed to describe how these themes and underlying sub-themes relate to FSMS implementation. Addressing the various factors that influence production workers is expected to enhance FSMS implementation and increase food safety.

  17. The influence of authentic leadership on safety climate in nursing.

    PubMed

    Dirik, Hasan Fehmi; Seren Intepeler, Seyda

    2017-07-01

    This study analysed nurses' perceptions of authentic leadership and safety climate and examined the contribution of authentic leadership to the safety climate. It has been suggested and emphasised that authentic leadership should be used as a guidance to ensure quality care and the safety of patients and health-care personnel. This predictive study was conducted with 350 nurses in three Turkish hospitals. The data were collected using the Authentic Leadership Questionnaire and the Safety Climate Survey and analysed using hierarchical regression analysis. The mean authentic leadership perception and the safety climate scores of the nurses were 2.92 and 3.50, respectively. The percentage of problematic responses was found to be less than 10% for only four safety climate items. Hierarchical regression analysis revealed that authentic leadership significantly predicted the safety climate. Procedural and political improvements are required in terms of the safety climate in institutions, where the study was conducted, and authentic leadership increases positive perceptions of safety climate. Exhibiting the characteristics of authentic leadership, or improving them and reflecting them on to personnel can enhance the safety climate. Planning information sharing meetings to raise the personnel's awareness of safety climate and systemic improvements can contribute to creating safe care climates. © 2017 John Wiley & Sons Ltd.

  18. Bounding criticality safety analyses for shipments of unconfigured spent nuclear fuel

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

    Lichtenwalter, J.J.; Parks, C.V.

    1998-06-01

    In November 1996, a request was made to the US Department of Energy for a waiver for three shipments of spent nuclear fuel (SNF) from Oak Ridge National Laboratory (ORNL) to the Savannah River Site (SRS) in the US NRC certified BMI-1 cask (CoC 5957). Although the post-irradiation fissile mass (based on chemical assays) in each shipment was less than 800 g, a criticality safety analysis was needed because the pre-irradiation mass exceeded 800 g, the fissile material limit in the CoC. The analyses were performed on SNF consisting of aluminum-clad U{sub 3}O{sub 8}, UAl{sub x}, and U{sub 3}Si{sub 2}more » plates, fragments and pieces that had been irradiated at ORNL during the Reduced Enrichment Research and Test Reactor Program of the 1980s. The highlights of the approach used to analyze this unique SNF and the benefits of the waiver are presented in this paper.« less

  19. Ares I-X Range Safety Analyses Overview

    NASA Technical Reports Server (NTRS)

    Starr, Brett R.; Gowan, John W., Jr.; Thompson, Brian G.; Tarpley, Ashley W.

    2011-01-01

    Ares I-X was the first test flight of NASA's Constellation Program's Ares I Crew Launch Vehicle designed to provide manned access to low Earth orbit. As a one-time test flight, the Air Force's 45th Space Wing required a series of Range Safety analysis data products to be developed for the specified launch date and mission trajectory prior to granting flight approval on the Eastern Range. The range safety data package is required to ensure that the public, launch area, and launch complex personnel and resources are provided with an acceptable level of safety and that all aspects of prelaunch and launch operations adhere to applicable public laws. The analysis data products, defined in the Air Force Space Command Manual 91-710, Volume 2, consisted of a nominal trajectory, three sigma trajectory envelopes, stage impact footprints, acoustic intensity contours, trajectory turn angles resulting from potential vehicle malfunctions (including flight software failures), characterization of potential debris, and debris impact footprints. These data products were developed under the auspices of the Constellation's Program Launch Constellation Range Safety Panel and its Range Safety Trajectory Working Group with the intent of beginning the framework for the operational vehicle data products and providing programmatic review and oversight. A multi-center NASA team in conjunction with the 45th Space Wing, collaborated within the Trajectory Working Group forum to define the data product development processes, performed the analyses necessary to generate the data products, and performed independent verification and validation of the data products. This paper outlines the Range Safety data requirements and provides an overview of the processes established to develop both the data products and the individual analyses used to develop the data products, and it summarizes the results of the analyses required for the Ares I-X launch.

  20. Preliminary Results Obtained in Integrated Safety Analysis of NASA Aviation Safety Program Technologies

    NASA Technical Reports Server (NTRS)

    Reveley, Mary S.

    2003-01-01

    The goal of the NASA Aviation Safety Program (AvSP) is to develop and demonstrate technologies that contribute to a reduction in the aviation fatal accident rate by a factor of 5 by the year 2007 and by a factor of 10 by the year 2022. Integrated safety analysis of day-to-day operations and risks within those operations will provide an understanding of the Aviation Safety Program portfolio. Safety benefits analyses are currently being conducted. Preliminary results for the Synthetic Vision Systems (SVS) and Weather Accident Prevention (WxAP) projects of the AvSP have been completed by the Logistics Management Institute under a contract with the NASA Glenn Research Center. These analyses include both a reliability analysis and a computer simulation model. The integrated safety analysis method comprises two principal components: a reliability model and a simulation model. In the reliability model, the results indicate how different technologies and systems will perform in normal, degraded, and failed modes of operation. In the simulation, an operational scenario is modeled. The primary purpose of the SVS project is to improve safety by providing visual-flightlike situation awareness during instrument conditions. The current analyses are an estimate of the benefits of SVS in avoiding controlled flight into terrain. The scenario modeled has an aircraft flying directly toward a terrain feature. When the flight crew determines that the aircraft is headed toward an obstruction, the aircraft executes a level turn at speed. The simulation is ended when the aircraft completes the turn.

  1. Crash data analyses for vehicle-to-infrastructure communications for safety applications.

    DOT National Transportation Integrated Search

    2012-11-01

    This report presents the potential safety benefits of wireless communication between the roadway infrastructure and vehicles, : (i.e., vehicle-to-infrastructure (V2I) safety). Specifically, it identifies the magnitude, characteristics, and cost of cr...

  2. Bricks-and-mortar and patient safety culture.

    PubMed

    Brandis, Susan; Schleimer, Stephanie; Rice, John

    2017-06-19

    Purpose Building a new hospital requires a major investment in capital infrastructure. The purpose of this paper is to investigate the impact of bricks-and-mortar on patient safety culture before and two years after the move of a large tertiary hospital to a greenfield site. The difference in patient safety perceptions between clinical and non-clinical staff is also explored. Design/methodology/approach This research uses data collected from the same workforce across two time periods (2013 and 2015) in a large Australian healthcare service. Validated surveys of patient safety culture ( n=306 and 246) were analysed using descriptive and inferential statistics. Findings Using two-way analysis of variance, the authors found that perceived patient safety culture remains unchanged for staff despite a major relocation and upgrade of services and different perceptions of patient safety culture between staff groups remains the same throughout change. Practical implications A dramatic change in physical context, such as moving an entire hospital, made no measurable impact on perceived patient safety culture by major groups of staff. Improving patient safety culture requires more than investment in buildings and infrastructure. Understanding differences in professional perspectives of patient safety culture may inform organisational management approaches, and enhance the targeting of specific strategies. Originality/value The authors believe this to be the first empirically based paper that investigates the impact of a large investment into hospital capital and a subsequent relocation of services on clinical and non-clinical staff perceptions of patient safety culture.

  3. Commonalities and Differences in Functional Safety Systems Between ISS Payloads and Industrial Applications

    NASA Astrophysics Data System (ADS)

    Malyshev, Mikhail; Kreimer, Johannes

    2013-09-01

    Safety analyses for electrical, electronic and/or programmable electronic (E/E/EP) safety-related systems used in payload applications on-board the International Space Station (ISS) are often based on failure modes, effects and criticality analysis (FMECA). For industrial applications of E/E/EP safety-related systems, comparable strategies exist and are defined in the IEC-61508 standard. This standard defines some quantitative criteria based on potential failure modes (for example, Safe Failure Fraction). These criteria can be calculated for an E/E/EP system or components to assess their compliance to requirements of a particular Safety Integrity Level (SIL). The standard defines several SILs depending on how much risk has to be mitigated by a safety-critical system. When a FMECA is available for an ISS payload or its subsystem, it may be possible to calculate the same or similar parameters as defined in the 61508 standard. One example of a payload that has a dedicated functional safety subsystem is the Electromagnetic Levitator (EML). This payload for the ISS is planned to be operated on-board starting 2014. The EML is a high-temperature materials processing facility. The dedicated subsystem "Hazard Control Electronics" (HCE) is implemented to ensure compliance to failure tolerance in limiting samples processing parameters to maintain generation of the potentially toxic by-products to safe limits in line with the requirements applied to the payloads by the ISS Program. The objective of this paper is to assess the implementation of the HCE in the EML against criteria for functional safety systems in the IEC-61508 standard and to evaluate commonalities and differences with respect to safety requirements levied on ISS Payloads. An attempt is made to assess a possibility of using commercially available components and systems certified for compliance to industrial functional safety standards in ISS payloads.

  4. The Financial Effect of Value-Based Purchasing and the Hospital Readmissions Reduction Program on Safety-Net Hospitals in 2014: A Cohort Study.

    PubMed

    Gilman, Matlin; Hockenberry, Jason M; Adams, E Kathleen; Milstein, Arnold S; Wilson, Ira B; Becker, Edmund R

    2015-09-15

    Medicare's value-based purchasing (VBP) and the Hospital Readmissions Reduction Program (HRRP) could disproportionately affect safety-net hospitals. To determine whether safety-net hospitals incur larger financial penalties than other hospitals under VBP and HRRP. Cross-sectional analysis. United States in 2014. 3022 acute care hospitals participating in VBP and the HRRP. Safety-net hospitals were defined as being in the top quartile of the Medicare disproportionate share hospital (DSH) patient percentage and Medicare uncompensated care (UCC) payments per bed. The differences in penalties in both total dollars and dollars per bed between safety-net hospitals and other hospitals were estimated with the use of bivariate and graphical regression methods. Safety-net hospitals in the top quartile of each measure were more likely to be penalized under VBP than other hospitals (62.9% vs. 51.0% under the DSH definition and 60.3% vs. 51.5% under the UCC per-bed definition). This was also the case under the HRRP (80.8% vs. 69.0% and 81.9% vs. 68.7%, respectively). Safety-net hospitals also had larger payment penalties ($115 900 vs. $66 600 and $150 100 vs. $54 900, respectively). On a per-bed basis, this translated to $436 versus $332 and $491 versus $314, respectively. Sensitivity analysis setting the cutoff at the top decile rather than the top quartile decile led to similar conclusions with somewhat larger differences between safety-net and other hospitals. The quadratic fit of the data indicated that the larger effect of these penalties is in the middle of the distribution of the DSH and UCC measures. Only 2 measures of safety-net status were included in the analyses. Safety-net hospitals were disproportionately likely to be affected under VBP and the HRRP, but most incurred relatively small payment penalties in 2014. Patient-Centered Outcomes Research Institute.

  5. Preventing construction worker injury incidents through the management of personal stress and organizational stressors.

    PubMed

    Leung, Mei-yung; Chan, Isabelle Yee Shan; Yu, Jingyu

    2012-09-01

    Construction workers (CWs) are positioned at the lowest level of an organization and thus have limited control over their work. For this reason, they are often deprived of their due rewards and training or sometimes are even compelled to focus on production at the expense of their own safety. These organizational stressors not only cause the CWs stress but also impair their safety behaviors. The impairment of safety behaviors is the major cause of CW injury incidents. Hence, to prevent injury incidents and enhance safety behaviors of CWs, the current study aimed to identify the impact of various organizational stressors and stress on CW safety behaviors and injury incidents. To achieve this aim, we surveyed 395 CWs. Using factor analysis, we identified five organizational stressors (unfair reward and treatment, inappropriate safety equipment, provision of training, lack of goal setting, and poor physical environment), two types of stress (emotional and physical), and safety behaviors. The results of correlation and regression analyses revealed the following: (1) injury incidents were minimized by safety behaviors but escalated by a lack of goal setting, (2) safety behaviors were maximized by moderate levels of emotional stress (i.e., an inverted U-shape relationship between these two variables) and increased in line with physical stress and inappropriate safety equipment, (3) emotional stress was positively predicted by the provision of training and inappropriate safety equipment, and (4) physical stress was predicted only by inappropriate safety equipment. Based on these results, we suggest various recommendations to construction stakeholders on how to prevent CW injury incidents. Copyright © 2011 Elsevier Ltd. All rights reserved.

  6. Extended Nuclear Deterrence for Europe Without Forward-based Weapons

    DTIC Science & Technology

    2012-02-15

    financial costs of nuclear burden sharing, bolsters safety and security and further reduces proliferation risks. 22 Bibliography Bildt, Carl and... Sagan , Scott D. and Waltz, Kenneth N. The Spread of Nuclear Weapons: A Debate Renewed. W. W. Norton and Company New York, NY and London...Point. Center for International Relations, Reports and Analyses. Konrad-Adenauer Foundation, Warsaw, 2011, 2. 30 Bildt, Carl and Sikorski, Radek

  7. [Analysis and modelling of safety culture in a Mexican hospital by Markov chains].

    PubMed

    Velázquez-Martínez, J D; Cruz-Suárez, H; Santos-Reyes, J

    2016-01-01

    The objective of this study was to analyse and model the safety culture with Markov chains, as well as predicting and/or prioritizing over time the evolutionary behaviour of the safety culture of the health's staff in one Mexican hospital. The Markov chain theory has been employed in the analysis, and the input data has been obtained from a previous study based on the Safety Attitude Questionnaire (CAS-MX-II), by considering the following 6 dimensions: safety climate, teamwork, job satisfaction, recognition of stress, perception of management, and work environment. The results highlighted the predictions and/or prioritisation of the approximate time for the possible integration into the evolutionary behaviour of the safety culture as regards the "slightly agree" (Likert scale) for: safety climate (in 12 years; 24.13%); teamwork (8 years; 34.61%); job satisfaction (11 years; 52.41%); recognition of the level of stress (8 years; 19.35%); and perception of the direction (22 years; 27.87%). The work environment dimension was unable to determine the behaviour of staff information, i.e. no information cultural roots were obtained. In general, it has been shown that there are weaknesses in the safety culture of the hospital, which is an opportunity to suggest changes to the mandatory policies in order to strengthen it. Copyright © 2016 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

  8. Use of empirical and full Bayes before-after approaches to estimate the safety effects of roadside barriers with different crash conditions.

    PubMed

    Park, Juneyoung; Abdel-Aty, Mohamed; Lee, Jaeyoung

    2016-09-01

    Although many researchers have estimated the crash modification factors (CMFs) for specific treatments (or countermeasures), there is a lack of prior studies that have explored the variation of CMFs. Thus, the main objectives of this study are: (a) to estimate CMFs for the installation of different types of roadside barriers, and (b) to determine the changes of safety effects for different crash types, severities, and conditions. Two observational before-after analyses (i.e. empirical Bayes (EB) and full Bayes (FB) approaches) were utilized in this study to estimate CMFs. To consider the variation of safety effects based on different vehicle, driver, weather, and time of day information, the crashes were categorized based on vehicle size (passenger and heavy), driver age (young, middle, and old), weather condition (normal and rain), and time difference (day time and night time). The results show that the addition of roadside barriers is safety effective in reducing severe crashes for all types and run-off roadway (ROR) crashes. On the other hand, it was found that roadside barriers tend to increase all types of crashes for all severities. The results indicate that the treatment might increase the total number of crashes but it might be helpful in reducing injury and severe crashes. In this study, the variation of CMFs was determined for ROR crashes based on the different vehicle, driver, weather, and time information. Based on the findings from this study, the variation of CMFs can enhance the reliability of CMFs for different roadway conditions in decision making process. Also, it can be recommended to identify the safety effects of specific treatments for different crash types and severity levels with consideration of the different vehicle, driver, weather, and time of day information. Copyright © 2016 Elsevier Ltd and National Safety Council. All rights reserved.

  9. KENO-VI Primer: A Primer for Criticality Calculations with SCALE/KENO-VI Using GeeWiz

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

    Bowman, Stephen M

    2008-09-01

    The SCALE (Standardized Computer Analyses for Licensing Evaluation) computer software system developed at Oak Ridge National Laboratory is widely used and accepted around the world for criticality safety analyses. The well-known KENO-VI three-dimensional Monte Carlo criticality computer code is one of the primary criticality safety analysis tools in SCALE. The KENO-VI primer is designed to help a new user understand and use the SCALE/KENO-VI Monte Carlo code for nuclear criticality safety analyses. It assumes that the user has a college education in a technical field. There is no assumption of familiarity with Monte Carlo codes in general or with SCALE/KENO-VImore » in particular. The primer is designed to teach by example, with each example illustrating two or three features of SCALE/KENO-VI that are useful in criticality analyses. The primer is based on SCALE 6, which includes the Graphically Enhanced Editing Wizard (GeeWiz) Windows user interface. Each example uses GeeWiz to provide the framework for preparing input data and viewing output results. Starting with a Quickstart section, the primer gives an overview of the basic requirements for SCALE/KENO-VI input and allows the user to quickly run a simple criticality problem with SCALE/KENO-VI. The sections that follow Quickstart include a list of basic objectives at the beginning that identifies the goal of the section and the individual SCALE/KENO-VI features that are covered in detail in the sample problems in that section. Upon completion of the primer, a new user should be comfortable using GeeWiz to set up criticality problems in SCALE/KENO-VI. The primer provides a starting point for the criticality safety analyst who uses SCALE/KENO-VI. Complete descriptions are provided in the SCALE/KENO-VI manual. Although the primer is self-contained, it is intended as a companion volume to the SCALE/KENO-VI documentation. (The SCALE manual is provided on the SCALE installation DVD.) The primer provides specific examples of using SCALE/KENO-VI for criticality analyses; the SCALE/KENO-VI manual provides information on the use of SCALE/KENO-VI and all its modules. The primer also contains an appendix with sample input files.« less

  10. An analysis of electronic health record-related patient safety incidents.

    PubMed

    Palojoki, Sari; Mäkelä, Matti; Lehtonen, Lasse; Saranto, Kaija

    2017-06-01

    The aim of this study was to analyse electronic health record-related patient safety incidents in the patient safety incident reporting database in fully digital hospitals in Finland. We compare Finnish data to similar international data and discuss their content with regard to the literature. We analysed the types of electronic health record-related patient safety incidents that occurred at 23 hospitals during a 2-year period. A procedure of taxonomy mapping served to allow comparisons. This study represents a rare examination of patient safety risks in a fully digital environment. The proportion of electronic health record-related incidents was markedly higher in our study than in previous studies with similar data. Human-computer interaction problems were the most frequently reported. The results show the possibility of error arising from the complex interaction between clinicians and computers.

  11. Using a High-Resolution Ensemble Modeling Method to Inform Risk-Based Decision-Making at Taylor Park Dam, Colorado

    NASA Astrophysics Data System (ADS)

    Mueller, M.; Mahoney, K. M.; Holman, K. D.

    2015-12-01

    The Bureau of Reclamation (Reclamation) is responsible for the safety of Taylor Park Dam, located in central Colorado at an elevation of 9300 feet. A key aspect of dam safety is anticipating extreme precipitation, runoff and the associated inflow of water to the reservoir within a probabilistic framework for risk analyses. The Cooperative Institute for Research in Environmental Sciences (CIRES) has partnered with Reclamation to improve understanding and estimation of precipitation in the western United States, including the Taylor Park watershed. A significant challenge is that Taylor Park Dam is located in a relatively data-sparse region, surrounded by mountains exceeding 12,000 feet. To better estimate heavy precipitation events in this basin, a high-resolution modeling approach is used. The Weather Research and Forecasting (WRF) model is employed to simulate events that have produced observed peaks in streamflow at the location of interest. Importantly, an ensemble of model simulations are run on each event so that uncertainty bounds (i.e., forecast error) may be provided such that the model outputs may be more effectively used in Reclamation's risk assessment framework. Model estimates of precipitation (and the uncertainty thereof) are then used in rainfall runoff models to determine the probability of inflows to the reservoir for use in Reclamation's dam safety risk analyses.

  12. Analysis of longitudinal laboratory data in the presence of common selection mechanisms: a view toward greater emphasis on pre-marketing pharmaceutical safety.

    PubMed

    Schildcrout, Jonathan S; Jenkins, Cathy A; Ostroff, Jack H; Gillen, Daniel L; Harrell, Frank E; Trost, Donald C

    2008-05-30

    Pharmaceutical safety has received substantial attention in the recent past; however, longitudinal clinical laboratory data routinely collected during clinical trials to derive safety profiles are often used ineffectively. For example, these data are frequently summarized by comparing proportions (between treatment arms) of participants who cross pre-specified threshold values at some time during follow-up. This research is intended, in part, to encourage more effective utilization of these data by avoiding unnecessary dichotomization of continuous data, acknowledging and making use of the longitudinal follow-up, and combining data from multiple clinical trials. However, appropriate analyses require careful consideration of a number of challenges (e.g. selection, comparability of study populations, etc.). We discuss estimation strategies based on estimating equations and maximum likelihood for analyses in the presence of three response history-dependent selection mechanisms: dropout, follow-up frequency, and treatment discontinuation. In addition, because clinical trials' participants usually represent non-random samples from target populations, we describe two sensitivity analysis approaches. All discussions are motivated by an analysis that aims to characterize the dynamic relationship between concentrations of a liver enzyme (alanine aminotransferase) and three distinct doses (no drug, low dose, and high dose) of an nk-1 antagonist across four Phase II clinical trials.

  13. [Costs of serious adverse events in a community teaching hospital, in Mexico].

    PubMed

    Gutiérrez-Mendoza, Luis Meave; Torres-Montes, Abraham; Soria-Orozco, Manuel; Padrón-Salas, Aldanely; Ramírez-Hernández, María Elizabeth

    2015-01-01

    Serious adverse events during hospital care are a worldwide reality and threaten the safety of the hospitalised patient. To identify serious adverse events related to healthcare and direct hospital costs in a Teaching Hospital in México. A study was conducted in a 250-bed Teaching Hospital in San Luis Potosi, Mexico. Data were obtained from the Quality and Patient Safety Department based on 2012 incidents report. Every event was reviewed and analysed by an expert team using the "fish bone" tool. The costs were calculated since the event took place until discharge or death of the patient. A total of 34 serious adverse events were identified. The average cost was $117,440.89 Mexican pesos (approx. €7,000). The great majority (82.35%) were largely preventable and related to the process of care. Undergraduate medical staff were involved in 58.82%, and 14.7% of patients had suffered adverse events in other hospitals. Serious adverse events in a Teaching Hospital setting need to be analysed to learn and deploy interventions to prevent and improve patient safety. The direct costs of these events are similar to those reported in developed countries. Copyright © 2015 Academia Mexicana de Cirugía A.C. Published by Masson Doyma México S.A. All rights reserved.

  14. Concept analysis of safety climate in healthcare providers.

    PubMed

    Lin, Ying-Siou; Lin, Yen-Chun; Lou, Meei-Fang

    2017-06-01

    To report an analysis of the concept of safety climate in healthcare providers. Compliance with safe work practices is essential to patient safety and care outcomes. Analysing the concept of safety climate from the perspective of healthcare providers could improve understanding of the correlations between safety climate and healthcare provider compliance with safe work practices, thus enhancing quality of patient care. Concept analysis. The electronic databases of CINAHL, MEDLINE, PubMed and Web of Science were searched for literature published between 1995-2015. Searches used the keywords 'safety climate' or 'safety culture' with 'hospital' or 'healthcare'. The concept analysis method of Walker and Avant analysed safety climate from the perspective of healthcare providers. Three attributes defined how healthcare providers define safety climate: (1) creation of safe working environment by senior management in healthcare organisations; (2) shared perception of healthcare providers about safety of their work environment; and (3) the effective dissemination of safety information. Antecedents included the characteristics of healthcare providers and healthcare organisations as a whole, and the types of work in which they are engaged. Consequences consisted of safety performance and safety outcomes. Most studies developed and assessed the survey tools of safety climate or safety culture, with a minority consisting of interventional measures for improving safety climate. More prospective studies are needed to create interventional measures for improving safety climate of healthcare providers. This study is provided as a reference for use in developing multidimensional safety climate assessment tools and interventional measures. The values healthcare teams emphasise with regard to safety can serve to improve safety performance. Having an understanding of the concept of and interventional measures for safety climate allows healthcare providers to ensure the safety of their operations and their patients. © 2016 John Wiley & Sons Ltd.

  15. Traceability of Software Safety Requirements in Legacy Safety Critical Systems

    NASA Technical Reports Server (NTRS)

    Hill, Janice L.

    2007-01-01

    How can traceability of software safety requirements be created for legacy safety critical systems? Requirements in safety standards are imposed most times during contract negotiations. On the other hand, there are instances where safety standards are levied on legacy safety critical systems, some of which may be considered for reuse for new applications. Safety standards often specify that software development documentation include process-oriented and technical safety requirements, and also require that system and software safety analyses are performed supporting technical safety requirements implementation. So what can be done if the requisite documents for establishing and maintaining safety requirements traceability are not available?

  16. Evidence based vaccinology.

    PubMed

    Nalin, David R

    2002-02-22

    Evidence based vaccinology (EBV) is the identification and use of the best evidence in making and implementing decisions during all of the stages of the life of a vaccine, including pre-licensure vaccine development and post-licensure manufacture and research, and utilization of the vaccine for disease control. Vaccines, unlike most pharmaceuticals, are in a continuous process of development both before and after licensure. Changes in biologics manufacturing technology and changes that vaccines induce in population and disease biology lead to periodic review of regimens (and sometimes dosage) based on changing immunologic data or public perceptions relevant to vaccine safety and effectiveness. EBV includes the use of evidence based medicine (EBM) both in clinical trials and in national disease containment programs. The rationale for EBV is that the highest evidentiary standards are required to maintain a rigorous scientific basis of vaccine quality control in manufacture and to ensure valid determination of vaccine efficacy, field effectiveness and safety profiles (including post-licensure safety monitoring), cost-benefit analyses, and risk:benefit ratios. EBV is increasingly based on statistically validated, clearly defined laboratory, manufacturing, clinical and epidemiological research methods and procedures, codified as good laboratory practices (GLP), good manufacturing practices (GMP), good clinical research practices (GCRP) and in clinical and public health practice (good vaccination practices, GVP). Implementation demands many data-driven decisions made by a spectrum of specialists pre- and post-licensure, and is essential to maintaining public confidence in vaccines.

  17. General aviation crash safety program at Langley Research Center

    NASA Technical Reports Server (NTRS)

    Thomson, R. G.

    1976-01-01

    The purpose of the crash safety program is to support development of the technology to define and demonstrate new structural concepts for improved crash safety and occupant survivability in general aviation aircraft. The program involves three basic areas of research: full-scale crash simulation testing, nonlinear structural analyses necessary to predict failure modes and collapse mechanisms of the vehicle, and evaluation of energy absorption concepts for specific component design. Both analytical and experimental methods are being used to develop expertise in these areas. Analyses include both simplified procedures for estimating energy absorption capabilities and more complex computer programs for analysis of general airframe response. Full-scale tests of typical structures as well as tests on structural components are being used to verify the analyses and to demonstrate improved design concepts.

  18. Developing a patient-led electronic feedback system for quality and safety within Renal PatientView.

    PubMed

    Giles, Sally J; Reynolds, Caroline; Heyhoe, Jane; Armitage, Gerry

    2017-03-01

    It is increasingly acknowledged that patients can provide direct feedback about the quality and safety of their care through patient reporting systems. The aim of this study was to explore the feasibility of patients, healthcare professionals and researchers working in partnership to develop a patient-led quality and safety feedback system within an existing electronic health record (EHR), known as Renal PatientView (RPV). Phase 1 (inception) involved focus groups (n = 9) and phase 2 (requirements) involved cognitive walkthroughs (n = 34) and 1:1 qualitative interviews (n = 34) with patients and healthcare professionals. A Joint Services Expert Panel (JSP) was convened to review the findings from phase 1 and agree the core principles and components of the system prototype. Phase 1 data were analysed using a thematic approach. Data from phase 1 were used to inform the design of the initial system prototype. Phase 2 data were analysed using the components of heuristic evaluation, resulting in a list of core principles and components for the final system prototype. Phase 1 identified four main barriers and facilitators to patients feeding back on quality and safety concerns. In phase 2, the JSP agreed that the system should be based on seven core principles and components. Stakeholders were able to work together to identify core principles and components for an electronic patient quality and safety feedback system in renal services. Tensions arose due to competing priorities, particularly around anonymity and feedback. Careful consideration should be given to the feasibility of integrating a novel element with differing priorities into an established system with existing functions and objectives. © 2016 European Dialysis and Transplant Nurses Association/European Renal Care Association.

  19. Cumulative and episodic vaccine aluminum exposure in a population-based cohort of young children.

    PubMed

    Glanz, Jason M; Newcomer, Sophia R; Daley, Matthew F; McClure, David L; Baxter, Roger P; Jackson, Michael L; Naleway, Allison L; Lugg, Marlene M; DeStefano, Frank

    2015-11-27

    In addition to antigens, vaccines contain small amounts of preservatives, adjuvants, and residual substances from the manufacturing process. Some parents have concerns about the safety of these ingredients, yet no large epidemiological studies have specifically examined associations between health outcomes and vaccine ingredients, other than thimerosal. This study examined the extent to which the Vaccine Safety Datalink (VSD) could be used to study vaccine ingredient safety in children. Children born 2004-2011 were identified in VSD data. Using immunization records, two cohorts were identified: children who were up-to-date and children who were undervaccinated before age 2 years. A database was also created linking vaccine type and manufacturer with ingredient amounts documented in vaccine package inserts. Thirty-four ingredients in two or more infant vaccines were identified. However, only amounts (in mg) for aluminum were consistently documented and commonly contained in infant vaccines. Analyses compared vaccine aluminum exposure across cohorts and determined the statistical power for studying associations between aluminum exposure and hypothetical vaccine adverse events. Among 408,608 children, mean cumulative vaccine aluminum exposure increased from 1.11 to 4.00 mg between ages 92-730 days. Up-to-date children were exposed to 11-26% more aluminum from vaccines than undervaccinated children. Power analyses demonstrated that safety studies of aluminum could detect relative risks ranging from 1.1 to 5.8 for a range of adverse event incidence. The safety of vaccine aluminum exposure can be feasibly studied in the VSD. However, possible biological mechanisms and confounding variables would need to be considered before conducting any studies. Copyright © 2015 Elsevier Ltd. All rights reserved.

  20. Advances on the Failure Analysis of the Dam-Foundation Interface of Concrete Dams.

    PubMed

    Altarejos-García, Luis; Escuder-Bueno, Ignacio; Morales-Torres, Adrián

    2015-12-02

    Failure analysis of the dam-foundation interface in concrete dams is characterized by complexity, uncertainties on models and parameters, and a strong non-linear softening behavior. In practice, these uncertainties are dealt with a well-structured mixture of experience, best practices and prudent, conservative design approaches based on the safety factor concept. Yet, a sound, deep knowledge of some aspects of this failure mode remain unveiled, as they have been offset in practical applications by the use of this conservative approach. In this paper we show a strategy to analyse this failure mode under a reliability-based approach. The proposed methodology of analysis integrates epistemic uncertainty on spatial variability of strength parameters and data from dam monitoring. The purpose is to produce meaningful and useful information regarding the probability of occurrence of this failure mode that can be incorporated in risk-informed dam safety reviews. In addition, relationships between probability of failure and factors of safety are obtained. This research is supported by a more than a decade of intensive professional practice on real world cases and its final purpose is to bring some clarity, guidance and to contribute to the improvement of current knowledge and best practices on such an important dam safety concern.

  1. Advances on the Failure Analysis of the Dam—Foundation Interface of Concrete Dams

    PubMed Central

    Altarejos-García, Luis; Escuder-Bueno, Ignacio; Morales-Torres, Adrián

    2015-01-01

    Failure analysis of the dam-foundation interface in concrete dams is characterized by complexity, uncertainties on models and parameters, and a strong non-linear softening behavior. In practice, these uncertainties are dealt with a well-structured mixture of experience, best practices and prudent, conservative design approaches based on the safety factor concept. Yet, a sound, deep knowledge of some aspects of this failure mode remain unveiled, as they have been offset in practical applications by the use of this conservative approach. In this paper we show a strategy to analyse this failure mode under a reliability-based approach. The proposed methodology of analysis integrates epistemic uncertainty on spatial variability of strength parameters and data from dam monitoring. The purpose is to produce meaningful and useful information regarding the probability of occurrence of this failure mode that can be incorporated in risk-informed dam safety reviews. In addition, relationships between probability of failure and factors of safety are obtained. This research is supported by a more than a decade of intensive professional practice on real world cases and its final purpose is to bring some clarity, guidance and to contribute to the improvement of current knowledge and best practices on such an important dam safety concern. PMID:28793709

  2. 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.

  3. Finite element analysis of container ship's cargo hold using ANSYS and POSEIDON software

    NASA Astrophysics Data System (ADS)

    Tanny, Tania Tamiz; Akter, Naznin; Amin, Osman Md.

    2017-12-01

    Nowadays ship structural analysis has become an integral part of the preliminary ship design providing further support for the development and detail design of ship structures. Structural analyses of container ship's cargo holds are carried out for the balancing of their safety and capacity, as those ships are exposed to the high risk of structural damage during voyage. Two different design methodologies have been considered for the structural analysis of a container ship's cargo hold. One is rule-based methodology and the other is a more conventional software based analyses. The rule based analysis is done by DNV-GL's software POSEIDON and the conventional package based analysis is done by ANSYS structural module. Both methods have been applied to analyze some of the mechanical properties of the model such as total deformation, stress-strain distribution, Von Mises stress, Fatigue etc., following different design bases and approaches, to indicate some guidance's for further improvements in ship structural design.

  4. Study design and analysis of automobile bumper for pedestrian safety

    NASA Astrophysics Data System (ADS)

    Kulkarni, Akash; Vora, Rushabh; Ravi, K.

    2017-11-01

    This paper aims to design and analyse the bumper beam structure, in order to ensure the protection of the pedestrians along with the occupants inside the vehicle. The concern shown towards the pedestrian safety is because, each year about 2,70,000 pedestrians are killed in road accidents that accounts to 22% of the total deaths. From the literature review, it was inferred that the mounting position of bumper and material selection play a crucial role in maximising the pedestrian safety. Hence in this paper, the effects of bumper mounting position and the bumper beam material have been studied, with reference to an explicit dynamic collision involving with a dummy human lower leg set-up. The acceptance of a particular mounting position/material was based on the fact that the maximum stress and deformation induced were less than the yield limits of the human leg form structure (representing the skin, femur and tibia).

  5. The structure and emerging trends of construction safety management research: a bibliometric review.

    PubMed

    Liang, Huakang; Zhang, Shoujian; Su, Yikun

    2018-03-29

    Recently, construction safety management (CSM) practices and systems have become important topics for stakeholders to take care of human resources. However, few studies have attempted to map the global research on CSM. A comprehensive bibliometric review was conducted in this study based on multiple methods. In total, 1172 CSM-related papers from the Web of Science Core Collection database were examined. The analyses focused on publication year, country-institute, publication source, author and research topics. The results indicated that the USA, China, Australia and the UK took leading positions in CSM research. Two branches of journals were identified, namely the branch of engineering science and that of safety science and social science. Additionally, seven themes together with 28 specific topics were detected to allow researchers to track the main structure and temporal evolution of CSM research. Finally, the main research trends and potential research directions were discussed to guide the future research.

  6. 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

  7. Communication between office-based primary care providers and nurses working within patients' homes: an analysis of process data from CAPABLE.

    PubMed

    Smith, Patrick D; Boyd, Cynthia; Bellantoni, Julia; Roth, Jill; Becker, Kathleen L; Savage, Jessica; Nkimbeng, Manka; Szanton, Sarah L

    2016-02-01

    To examine themes of communication between office-based primary care providers and nurses working in private residences; to assess which methods of communication elicit fruitful responses to nurses' concerns. Lack of effective communication between home health care nurses and primary care providers contributes to clinical errors, inefficient care delivery and decreased patient safety. Few studies have described best practices related to frequency, methods and reasons for communication between community-based nurses and primary care providers. Secondary analysis of process data from 'Community Aging in Place: Advancing Better Living for Elders (CAPABLE)'. Independent reviewers analysed nurse documentation of communication (phone calls, letters and client coaching) initiated for 70 patients and analysed 45 letters to primary care providers to identify common concerns and recommendations raised by CAPABLE nurses. Primary care providers responded to 86% of phone calls, 56% of letters and 50% of client coaching efforts. Primary care providers addressed 86% of concerns communicated by phone, 34% of concerns communicated by letter and 41% of client-raised concerns. Nurses' letters addressed five key concerns: medication safety, pain, change in activities of daily living, fall safety and mental health. In letters, CAPABLE nurses recommended 58 interventions: medication change; referral to a specialist; patient education; and further diagnostic evaluation. Effective communication between home-based nurses and primary care providers enhances care coordination and improves outcomes for home-dwelling elders. Various methods of contact show promise for addressing specific communication needs. Nurses practicing within patients' homes can improve care coordination by using phone calls to address minor matters and written letters for detailed communication. Future research should explore implementation of Situation, Background, Assessment and Recommendation in home care to promote safe and efficient communication. Nurses should empower patients to address concerns directly with providers through use of devices including health passports. © 2016 The Authors. Journal of Clinical Nursing published by John Wiley & Sons Ltd.

  8. Implementing Software Safety in the NASA Environment

    NASA Technical Reports Server (NTRS)

    Wetherholt, Martha S.; Radley, Charles F.

    1994-01-01

    Until recently, NASA did not consider allowing computers total control of flight systems. Human operators, via hardware, have constituted the ultimate safety control. In an attempt to reduce costs, NASA has come to rely more and more heavily on computers and software to control space missions. (For example. software is now planned to control most of the operational functions of the International Space Station.) Thus the need for systematic software safety programs has become crucial for mission success. Concurrent engineering principles dictate that safety should be designed into software up front, not tested into the software after the fact. 'Cost of Quality' studies have statistics and metrics to prove the value of building quality and safety into the development cycle. Unfortunately, most software engineers are not familiar with designing for safety, and most safety engineers are not software experts. Software written to specifications which have not been safety analyzed is a major source of computer related accidents. Safer software is achieved step by step throughout the system and software life cycle. It is a process that includes requirements definition, hazard analyses, formal software inspections, safety analyses, testing, and maintenance. The greatest emphasis is placed on clearly and completely defining system and software requirements, including safety and reliability requirements. Unfortunately, development and review of requirements are the weakest link in the process. While some of the more academic methods, e.g. mathematical models, may help bring about safer software, this paper proposes the use of currently approved software methodologies, and sound software and assurance practices to show how, to a large degree, safety can be designed into software from the start. NASA's approach today is to first conduct a preliminary system hazard analysis (PHA) during the concept and planning phase of a project. This determines the overall hazard potential of the system to be built. Shortly thereafter, as the system requirements are being defined, the second iteration of hazard analyses takes place, the systems hazard analysis (SHA). During the systems requirements phase, decisions are made as to what functions of the system will be the responsibility of software. This is the most critical time to affect the safety of the software. From this point, software safety analyses as well as software engineering practices are the main focus for assuring safe software. While many of the steps proposed in this paper seem like just sound engineering practices, they are the best technical and most cost effective means to assure safe software within a safe system.

  9. IT-CARES: an interactive tool for case-crossover analyses of electronic medical records for patient safety.

    PubMed

    Caron, Alexandre; Chazard, Emmanuel; Muller, Joris; Perichon, Renaud; Ferret, Laurie; Koutkias, Vassilis; Beuscart, Régis; Beuscart, Jean-Baptiste; Ficheur, Grégoire

    2017-03-01

    The significant risk of adverse events following medical procedures supports a clinical epidemiological approach based on the analyses of collections of electronic medical records. Data analytical tools might help clinical epidemiologists develop more appropriate case-crossover designs for monitoring patient safety. To develop and assess the methodological quality of an interactive tool for use by clinical epidemiologists to systematically design case-crossover analyses of large electronic medical records databases. We developed IT-CARES, an analytical tool implementing case-crossover design, to explore the association between exposures and outcomes. The exposures and outcomes are defined by clinical epidemiologists via lists of codes entered via a user interface screen. We tested IT-CARES on data from the French national inpatient stay database, which documents diagnoses and medical procedures for 170 million inpatient stays between 2007 and 2013. We compared the results of our analysis with reference data from the literature on thromboembolic risk after delivery and bleeding risk after total hip replacement. IT-CARES provides a user interface with 3 columns: (i) the outcome criteria in the left-hand column, (ii) the exposure criteria in the right-hand column, and (iii) the estimated risk (odds ratios, presented in both graphical and tabular formats) in the middle column. The estimated odds ratios were consistent with the reference literature data. IT-CARES may enhance patient safety by facilitating clinical epidemiological studies of adverse events following medical procedures. The tool's usability must be evaluated and improved in further research. © The Author 2016. Published by Oxford University Press on behalf of the American Medical Informatics Association.

  10. [Infection control and safety culture in German hospitals].

    PubMed

    Hansen, Sonja; Schwab, Frank; Gropmann, Alexander; Behnke, Michael; Gastmeier, Petra

    2016-07-01

    Healthcare-associated infections (HAI) are the most frequent adverse events in the healthcare setting and their prevention is an important contribution to patient safety in hospitals. To analyse to what extent safety cultural aspects with relevance to infection control are implemented in German hospitals. Safety cultural aspects of infection control were surveyed with an online questionnaire; data were analysed descriptively. Data from 543 hospitals with a median of [IQR] 275 [157; 453] beds were analysed. Almost all hospitals (96.6 %) had internal guidelines for infection control (IC) in place; 82 % defined IC objectives, most often regarding hand hygiene (HH) (93 %) and multidrug resistant organisms (72 %) and less frequently for antibiotic stewardship (48 %) or prevention of specific HAI. In 94 % of hospitals, a reporting system for adverse events was in place, which was also used to report low compliance with HH, outbreaks and Clostridium difficile-associated infections. Members of the IC team were most often seen to hold daily responsibility for IC in the hospital, but rarely other hospital staff (94 versus 19 %). Safety cultural aspects are not fully implemented in German hospitals. IC should be more strongly implemented in healthcare workers' daily routine and more visibly supported by hospital management.

  11. The PANGAEA study design - a prospective, multicenter, non-interventional, long-term study on fingolimod for the treatment of multiple sclerosis in daily practice.

    PubMed

    Ziemssen, Tjalf; Kern, Raimar; Cornelissen, Christian

    2015-06-18

    Fingolimod (Gilenya) is an oral medication for patients with highly active relapsing-remitting Multiple Sclerosis (RRMS). Clinical trials and post-marketing experience on more than 114,000 patients have established a detailed safety profile. Total patient exposure now exceeds 195,000 patient-years as stated in the last financial report (Dec 2014) of the Novartis Pharma AG, Basel, Switzerland. However, less is known about the safety of long-term fingolimod use in daily practice. Here, we describe the study design of PANGAEA (Post-Authorization Non-interventional German sAfety of GilEnyA in RRMS patients), a prospective, multicenter, non-interventional, long-term study to collect safety, efficacy, and pharmacoeconomic data on RRMS patients treated with fingolimod (0.5 mg/daily) under real-world conditions in Germany. PANGAEA is striving to assess a real-world safety and efficacy profile of fingolimod, based on data from 4,000 RRMS patients, obtained during a 60-month observational phase. A pharmacoeconomic sub-study of 800 RRMS patients further collects patient-reported outcome measures of disability, quality of life, compliance, treatment satisfaction, and usage of resources during a 24-month observational phase. Descriptive statistical analyses of the safety set as well as of stratified subgroups such as patients with concomitant diabetes mellitus and pretreated patients (e.g., natalizumab) will be conducted. PANGAEA seeks to confirm the current safety profile of fingolimod obtained in phase I-III clinical trials. The study design presented here will additionally provide guidance on the therapeutic use of fingolimod in clinical practice and possibly assists physicians in making evidence-based decisions.

  12. Body mass index, safety hazards, and neighborhood attractiveness.

    PubMed

    Lovasi, Gina S; Bader, Michael D M; Quinn, James; Neckerman, Kathryn; Weiss, Christopher; Rundle, Andrew

    2012-10-01

    Neighborhood attractiveness and safety may encourage physical activity and help individuals maintain a healthy weight. However, these neighborhood characteristics may not be equally relevant to health across all settings and population subgroups. To evaluate whether potentially attractive neighborhood features are associated with lower BMI, whether safety hazards are associated with higher BMI, and whether environment-environment interactions are present such that associations for a particular characteristic are stronger in an otherwise supportive environment. Survey data and measured height and weight were collected from a convenience sample of 13,102 adult New York City (NYC) residents in 2000-2002; data analyses were completed 2008-2012. Built-environment measures based on municipal GIS data sources were constructed within 1-km network buffers to assess walkable urban form (density, land-use mix, transit access); attractiveness (sidewalk cafés, landmark buildings, street trees, street cleanliness); and safety (homicide rate, pedestrian-auto collision and fatality rate). Generalized linear models with cluster-robust SEs controlled for individual and area-based sociodemographic characteristics. The presence of sidewalk cafés, density of landmark buildings, and density of street trees were associated with lower BMI, whereas the proportion of streets rated as clean was associated with higher BMI. Interactions were observed for sidewalk cafés with neighborhood poverty, for street-tree density with walkability, and for street cleanliness with safety. Safety hazard indicators were not independently associated with BMI. Potentially attractive community and natural features were associated with lower BMI among adults in NYC, and there was some evidence of effect modification. Copyright © 2012 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

  13. Mechanics-Based Definition of Safety Factors Against Flow Failure in Unsaturated Shallow Slopes

    NASA Astrophysics Data System (ADS)

    Buscarnera, G.; Lizarraga-Barrera, J.

    2014-12-01

    Physical models for landslide forecasting rely on the combination of hydrologic models for water infiltration and stability criteria based on infinite slope mechanics. Such concepts can be used to derive safety factors for shallow landsliding, in which the mobilization of the soil cover is associated with the attainment of critical values of pore water pressures expressed as a function of the frictional strength. While such models capture the role of important geomorphic features and geotechnical properties, their performance depends on the validity of the postulate of frictional failure. As a result, the safety factors do not to consider a broader range of solid-fluid interactions promoting different slope failure mechanisms, such as flow slides. This work combines principles of soil stability, unsaturated soil mechanics and plasticity theory to derive an alternative set of safety factors. While frictional slips are included in the study as a particular case, the proposed analytical methodology can also be applied to cases in which an increase in degree of saturation promotes liquefaction instabilities, i.e. possible transitions from solid- to fluid-like response. The study shows that the incorporation of principles of unsaturated soil mechanics into slope stability analyses generates suction-dependent coefficients that alter the value of the safety factors. As a result, while the proposed approach can still be combined with standard hydrologic models simulating the evolution of pore pressures in the near-surface, it can also provide a spatially distributed assessment of evolving safety conditions in landscapes susceptible to landslides of the flow type.

  14. Rationales for home safety promotion in the Iranian primary healthcare system: results from a pilot study.

    PubMed

    Mohammadi, R; Ekman, R; Svanström, L; Gooya, M M

    2006-01-01

    To analyse the prerequisites for a nationwide primary healthcare (PHC) home safety promotion programme in Iran. Injury is a major public health problem throughout the world, currently accounting for one-seventh of all premature deaths and disabilities. Within 20 years, it is estimated that the proportion will increase to one-fifth. The present healthcare system in Iran was started in 1979, with a major focus on easy access to services and prevention. The system is based on the 'health house', which is run by community health workers. A survey shows that 36% of injuries occur in the home environment. A pilot phase of the Home Safety Promotion Programme was initiated in 1994, and included safety checking at home for fences, kitchens, drugs and poisons, heaters, electricity, and stairs and ladders. The pilot study covered 478,551 households out of the 12 million (approximately) in Iran. Sixty-nine supervisors were involved individually, assembled into eight focus groups. Household safety increased by 10-20% over the 4 years of the study. The frequency of home visits changed from annual to seasonal, since all participants agreed that there were seasonal differences in safety problems. The supervisors showed a high level of knowledge of injury as a public health problem, and also positive attitudes towards doing something about safety on the basis of a PHC scheme. The role of a surveillance system was highlighted, and it was suggested that such a system should be added to the programme. Based on our preliminary findings, there were reasons to obtain a policy decision concerning a national programme for safety promotion before extending the pilot scheme to the whole country. A national safety programme was decided upon following completion of the pilot study. It includes a home-related-injury surveillance system that is mandatory in rural areas and voluntary in some cities.

  15. Technical Guidance from the International Safety Framework for Nuclear Power Source Applications in Outer Space for Design and Development Phases

    NASA Astrophysics Data System (ADS)

    Summerer, Leopold

    2014-08-01

    In 2009, the International Safety Framework for Nuclear Power Source Applications in Outer Space [1] has been adopted, following a multi-year process that involved all major space faring nations in the frame of the International Atomic Energy Agency and the UN Committee on the Peaceful Uses of Outer Space. The safety framework reflects an international consensus on best practices. After the older 1992 Principles Relevant to the Use of Nuclear Power Sources in Outer Space, it is the second document at UN level dedicated entirely to space nuclear power sources.This paper analyses aspects of the safety framework relevant for the design and development phases of space nuclear power sources. While early publications have started analysing the legal aspects of the safety framework, its technical guidance has not yet been subject to scholarly articles. The present paper therefore focuses on the technical guidance provided in the safety framework, in an attempt to assist engineers and practitioners to benefit from these.

  16. Applying interprofessional Team-Based Learning in patient safety: a pilot evaluation study.

    PubMed

    Lochner, Lukas; Girardi, Sandra; Pavcovich, Alessandra; Meier, Horand; Mantovan, Franco; Ausserhofer, Dietmar

    2018-03-27

    Interprofessional education (IPE) interventions are not always successful in achieving learning outcomes. Team-Based Learning (TBL) would appear to be a suitable pedagogical method for IPE, as it focuses on team performance; however, little is known about interprofessional TBL as an instructional framework for patient safety. In this pilot-study, we aimed to (1) describe participants' reactions to TBL, (2) observe their achievement with respect to interprofessional education learning objectives, and (3) document their attitudinal shifts with regard to patient safety behaviours. We developed and implemented a three-day course for pre-qualifying, non-medical healthcare students to give instruction on non-technical skills related to 'learning from errors'. The course consisted of three sequential modules: 'Recognizing Errors', 'Analysing Errors', and 'Reporting Errors'. The evaluation took place within a quasi-experimental pre-test-post-test study design. Participants completed self-assessments through valid and reliable instruments such as the Mennenga's TBL Student Assessment Instrument and the University of the West of England's Interprofessional Questionnaire. The mean scores of the individual readiness assurance tests were compared with the scores of the group readiness assurance test in order to explore if students learned from each other during group discussions. Data was analysed using descriptive (i.e. mean, standard deviation), parametric (i.e. paired t-test), and non-parametric (i.e. Wilcoxon signed-rank test) methods. Thirty-nine students from five different bachelor's programs attended the course. The participants positively rated TBL as an instructional approach. All teams outperformed the mean score of their individual members during the readiness assurance process. We observed significant improvements in 'communication and teamwork' and 'interprofessional learning' but not in 'interprofessional interaction' and 'interprofessional relationships.' Findings on safety attitudes and behaviours were mixed. TBL was well received by the students. Our first findings indicate that interprofessional TBL seems to be a promising pedagogical method to achieve patient safety learning objectives. It is crucial to develop relevant clinical cases that involve all professions. Further research with larger sample sizes (e.g. including medical students) and more rigorous study designs (e.g. pre-test post-test with a control group) is needed to confirm our preliminary findings.

  17. Savannah River Site generic data base development

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

    Blanton, C.H.; Eide, S.A.

    This report describes the results of a project to improve the generic component failure data base for the Savannah River Site (SRS). A representative list of components and failure modes for SRS risk models was generated by reviewing existing safety analyses and component failure data bases and from suggestions from SRS safety analysts. Then sources of data or failure rate estimates were identified and reviewed for applicability. A major source of information was the Nuclear Computerized Library for Assessing Reactor Reliability, or NUCLARR. This source includes an extensive collection of failure data and failure rate estimates for commercial nuclear powermore » plants. A recent Idaho National Engineering Laboratory report on failure data from the Idaho Chemical Processing Plant was also reviewed. From these and other recent sources, failure data and failure rate estimates were collected for the components and failure modes of interest. This information was aggregated to obtain a recommended generic failure rate distribution (mean and error factor) for each component failure mode.« less

  18. Damage Tolerance Analysis of a Pressurized Liquid Oxygen Tank

    NASA Technical Reports Server (NTRS)

    Forth, Scott C.; Harvin, Stephen F.; Gregory, Peyton B.; Mason, Brian H.; Thompson, Joe E.; Hoffman, Eric K.

    2006-01-01

    A damage tolerance assessment was conducted of an 8,000 gallon pressurized Liquid Oxygen (LOX) tank. The LOX tank is constructed of a stainless steel pressure vessel enclosed by a thermal-insulating vacuum jacket. The vessel is pressurized to 2,250 psi with gaseous nitrogen resulting in both thermal and pressure stresses on the tank wall. Finite element analyses were performed on the tank to characterize the stresses from operation. Engineering material data was found from both the construction of the tank and the technical literature. An initial damage state was assumed based on records of a nondestructive inspection performed on the tank. The damage tolerance analyses were conducted using the NASGRO computer code. This paper contains the assumptions, and justifications, made for the input parameters to the damage tolerance analyses and the results of the damage tolerance analyses with a discussion on the operational safety of the LOX tank.

  19. Shuttle data book: SRM fragment velocity model. Presented to the SRB Fragment Model Review Panel

    NASA Technical Reports Server (NTRS)

    1989-01-01

    This study was undertaken to determine the velocity of fragments generated by the range safety destruction (RSD) or random failure of a Space Transportation System (STS) Solid Rocket Motor (SRM). The specific requirement was to provide a fragment model for use in those Galileo and Ulysses RTG safety analyses concerned with possible fragment impact on the spacecraft radioisotope thermoelectric generators (RTGS). Good agreement was obtained between predictions and observations for fragment velocity, velocity distributions, azimuths, and rotation rates. Based on this agreement with the entire data base, the model was used to predict the probable fragment environments which would occur in the event of an STS-SRM RSD or randon failure at 10, 74, 84 and 110 seconds. The results of these predictions are the basis of the fragment environments presented in the Shuttle Data Book (NSTS-08116). The information presented here is in viewgraph form.

  20. Thermal hydraulic feasibility assessment of the hot conditioning system and process

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

    Heard, F.J.

    1996-10-10

    The Spent Nuclear Fuel Project was established to develop engineered solutions for the expedited removal, stabilization, and storage of spent nuclear fuel from the K Basins at the U.S. Department of Energy`s Hanford Site in Richland, Washington. A series of analyses have been completed investigating the thermal-hydraulic performance and feasibility of the proposed Hot Conditioning System and process for the Spent Nuclear Fuel Project. The analyses were performed using a series of thermal-hydraulic models that could respond to all process and safety-related issues that may arise pertaining to the Hot Conditioning System. The subject efforts focus on independently investigating, quantifying,more » and establishing the governing heat production and removal mechanisms, flow distributions within the multi-canister overpack, and performing process simulations for various purge gases under consideration for the Hot Conditioning System, as well as obtaining preliminary results for comparison with and verification of other analyses, and providing technology- based recommendations for consideration and incorporation into the Hot Conditioning System design bases.« less

  1. Creating a culture of safety by coaching clinicians to competence.

    PubMed

    Duff, Beverley

    2013-10-01

    Contemporary discussions of nursing knowledge, skill, patient safety and the associated ongoing education are usually combined with the term competence. Ensuring patient safety is considered a fundamental tenet of clinical competence together with the ability to problem solve, think critically and anticipate variables which may impact on patient care outcomes. Nurses are ideally positioned to identify, analyse and act on deteriorating patients, near-misses and potential adverse events. The absence of competency may lead to errors resulting in serious consequences for the patient. Gaining and maintaining competence are especially important in a climate of rapid evidence availability and regular changes in procedures, systems and products. Quality and safety issues predominate highlighting a clear need for closer inter-professional collaboration between education and clinical units. Educators and coaches are ideally placed to role model positive leadership and resilience to develop capability and competence. With contemporary guidance and support from educators and coaches, nurses can participate in life-long learning to create and enhance a culture of safety. The added challenge for nurse educators is to modernise, rationalise and integrate education delivery systems to improve clinical learning. Investing in evidence-based, contemporary education assists in building a capable, resilient and competent workforce focused on patient safety. Crown Copyright © 2012. Published by Elsevier Ltd. All rights reserved.

  2. Driving behaviours, traffic risk and road safety: comparative study between Malaysia and Singapore.

    PubMed

    Khan, Saif ur Rehman; Khalifah, Zainab Binti; Munir, Yasin; Islam, Talat; Nazir, Tahira; Khan, Hashim

    2015-01-01

    The present study aims to investigate differences in road safety attitude, driver behaviour and traffic risk perception between Malaysia and Singapore. A questionnaire-based survey was conducted among a sample of Singaporean (n = 187) and Malaysian (n = 313) road users. The data was analysed using confirmatory factor analysis and structural equation modelling applied to measure comparative fit indices of Malaysian and Singaporean respondents. The results show that the perceived traffic risk of Malaysian respondents is higher than Singaporean counterparts. Moreover, the structural equation modelling has confirmed perceived traffic risk performing the role of full mediation between perceived driving skills and perceived road safety for both the countries, while perceived traffic skills was found to perform the role of partial mediation between aggression and anxiety, on one hand, and road safety, on the other hand, in Malaysia and Singapore. In addition, in both countries, a weak correlation between perceived driving skills, aggression and anxiety with perceived road safety was found, while a strong correlation exists with traffic risk perception. The findings of this study have been discussed in terms of theoretical, practical and conceptual implications for both scholars and policy-makers to better understand the young drivers' attitude and behaviour relationship towards road safety measures with a view to future research.

  3. 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

  4. The work environment and empowerment as predictors of patient safety culture in Turkey.

    PubMed

    Dirik, Hasan Fehmi; Intepeler, Seyda Seren

    2017-05-01

    As scant research based information is available regarding the work environment, empowerment and patient safety culture, this study from a developing country (Turkey) in which health care institutions are in a state of transition, aimed to investigate further the relationships between these three variables. A cross-sectional descriptive design was employed. The sample comprised 274 nurse participants working in a university hospital located in Izmir (Turkey). In data evaluation, descriptive statistics and hierarchical regression analyses were applied. The work environment and structural empowerment were related to the patient safety culture and explained 55% of the variance in patient safety culture perceptions. 'Support for optimal patient care', 'nurse/physician relationships' and 'staff involvement in organisational affairs' were the significant predictors. An enhancement of the work environment and providing access to empowerment structures may help health care organisations improve the patient safety culture. In light of the findings, the following actions can be recommended to inform health care leaders: providing necessary resources for nursing practise, encouraging nurses' participation in decision-making, strengthening communication within the team and giving nurses the opportunities to cope with challenging work problems to learn and grow. © 2017 John Wiley & Sons Ltd.

  5. Factors impacting perceived safety among staff working on mental health wards

    PubMed Central

    Brown, Andrew; McCabe, Rhiannah; Rogerson, Michelle; Whittington, Richard

    2017-01-01

    Background Safety at work is a core issue for mental health staff working on in-patient units. At present, there is a limited theoretical base regarding which factors may affect staff perceptions of safety. Aims This study attempted to identify which factors affect perceived staff safety working on in-patient mental health wards. Method A cross-sectional design was employed across 101 forensic and non-forensic mental health wards, over seven National Health Service trusts nationally. Measures included an online staff survey, Ward Features Checklist and recorded incident data. Data were analysed using categorical principal components analysis and ordinal regression. Results Perceptions of staff safety were increased by ward brightness, higher number of patient beds, lower staff to patient ratios, less dayroom space and more urban views. Conclusions The findings from this study do not represent common-sense assumptions. Results are discussed in the context of the literature and may have implications for current initiatives aimed at managing in-patient violence and aggression. Declaration of interest None. Copyright and usage © The Royal College of Psychiatrists 2017. This is an open access article distributed under the terms of the Creative Commons Attribution (CC BY) license. PMID:28904814

  6. Management capacity to promote nurse workplace health and safety.

    PubMed

    Fang, Yaxuan; McDonald, Tracey

    2018-04-01

    To investigate regarding workplace health and safety factors, and to identify strategies to preserve and promote a healthy nursing workplace. Data collected using the Delphi technique with input from 41 key informants across four participant categories drawn from a Chinese university and four hospitals were thematically analysed. Most respondents agreed on the importance of nurses' health and safety, and that nurse managers should act to protect nurses, but not enough on workplace safety. Hospital policies, staff disempowerment, workload and workplace conflicts are major obstacles. The reality of Chinese nurses' workplaces is that health and safety risks abound and relate to socio-cultural expectations of women. Self-management of risks is neccessary, gaps exist in understanding of workplace risks among different nursing groups and their perceptions of the professional status, and the value of nurses' contribution to ongoing risks in the hospital workplace. The Chinese hospital system must make these changes to produce a safer working environment for nurses. This research, based in China, presents an instructive tale for all countries that need support on the types and amounts of management for nurses working at the clinical interface, and on the consequences of management neglect of relevant policies and procedures. © 2017 John Wiley & Sons Ltd.

  7. 49 CFR 192.713 - Transmission lines: Permanent field repair of imperfections and damages.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY TRANSPORTATION OF NATURAL AND OTHER GAS BY PIPELINE: MINIMUM FEDERAL SAFETY STANDARDS...; or (2) Repaired by a method that reliable engineering tests and analyses show can permanently restore...

  8. 49 CFR 192.713 - Transmission lines: Permanent field repair of imperfections and damages.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY TRANSPORTATION OF NATURAL AND OTHER GAS BY PIPELINE: MINIMUM FEDERAL SAFETY STANDARDS...; or (2) Repaired by a method that reliable engineering tests and analyses show can permanently restore...

  9. 49 CFR 192.713 - Transmission lines: Permanent field repair of imperfections and damages.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY TRANSPORTATION OF NATURAL AND OTHER GAS BY PIPELINE: MINIMUM FEDERAL SAFETY STANDARDS...; or (2) Repaired by a method that reliable engineering tests and analyses show can permanently restore...

  10. 49 CFR 192.713 - Transmission lines: Permanent field repair of imperfections and damages.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY TRANSPORTATION OF NATURAL AND OTHER GAS BY PIPELINE: MINIMUM FEDERAL SAFETY STANDARDS...; or (2) Repaired by a method that reliable engineering tests and analyses show can permanently restore...

  11. 49 CFR 192.713 - Transmission lines: Permanent field repair of imperfections and damages.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY TRANSPORTATION OF NATURAL AND OTHER GAS BY PIPELINE: MINIMUM FEDERAL SAFETY STANDARDS...; or (2) Repaired by a method that reliable engineering tests and analyses show can permanently restore...

  12. Development of a large truck safety data needs study plan. Vol. 1, Summary

    DOT National Transportation Integrated Search

    1986-02-01

    This report discusses the results of a study to determine the data needs necessary to address truck safety issues and to develop a data collection and analysis plan. Priority truck safety issues that are amenable to truck accident data analyses were ...

  13. [The role of safety climate and the relationship with job satisfaction: an exploratory study across three different occupational contexts.

    PubMed

    Emanuel, Federica; Colombo, Lara; Cortese, Claudio G; Ghislieri, Chiara

    2017-12-01

    This study examined the role of the "safety climate", or the organization's attention to health and safety of workers, and of job demand and resources in relation with job satisfaction. Wellbeing at work is a topic of growing interest, in line with the legislation and the programs on health and safety of workers and management and the evaluation of psychosocial risks. Several studies show that organizational actions concerning health and safety can be an indicator of the attention to employees' wellbeing, even if studies about the relationship between safety climate and some psychosocial outcomes are scant. The study analysed the relationship between job demand, job resources, safety climate and job satisfaction in three different occupational contexts (public authority, N = 224; social care organization, N = 115; pharmaceutical company, N = 127); workers were divided into groups based on the risk level appeared in the objective assessment of work-related stress, in order to identify differences. The self-report questionnaire gathered information about: job satisfaction, work efforts, supervisors' support, colleagues support, safety climate (α between .72 and .93). Data analysis provided: Cronbach α, analysis of variance, correlations, stepwise multiple regressions. The results showed that job satisfaction (R2 between .23 and .88) had a negative relationship with efforts and a positive relationship with job resources and safety climate. It emerges the importance of safety climate: to support and promote wellbeing at work, organizations could endorse training and information programs on health and safety for all workers and management, not only for professional groups with high-risk level. Future studies could explore the relation between safety climate and other outcomes, such as emotional exhaustion or objective indicators of organizational health (e.g. absenteeism, accidents, etc.). Copyright© by Aracne Editrice, Roma, Italy.

  14. Patient safety climate in general public hospitals in China: differences associated with department and job type based on a cross-sectional survey.

    PubMed

    Zhou, Ping; Bai, Fei; Tang, Hui-Qin; Bai, Jie; Li, Min-Qi; Xue, Di

    2018-04-17

    This study analysed differences in the perceived patient safety climate among different working departments and job types in public general hospitals in China. Cross-sectional survey. Eighteen tertiary hospitals and 36 secondary hospitals from 10 areas in Shanghai, Hubei Province and Gansu Province, China. Overall, 4753 staff, including physicians, nurses, medical technicians and managers, were recruited from March to June 2015. The Patient Safety Climate in Healthcare Organisations (PSCHO) tool and the percentages of 'problematic responses' (PPRs) were used as outcome measures. Multivariable two-level random intercept models were applied in the analysis. A total of 4121 valid questionnaires were collected. Perceptions regarding the patient safety climate varied among departments and job types. Physicians responded with relatively more negative evaluations of 'organisational resources for safety', 'unit recognition and support for safety efforts', 'psychological safety', 'problem responsiveness' and overall safety climate. Paediatrics departments, intensive care units, emergency departments and clinical auxiliary departments require more attention. The PPRs for 'fear of blame and punishment' were universally significantly high, and the PPRs for 'fear of shame' and 'provision of safe care' were remarkably high, especially in some departments. Departmental differences across all dimensions and the overall safety climate primarily depended on job type. The differences suggest that strategies and measures for improving the patient safety climate should be tailored by working department and job type. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  15. Creating an Oversight Infrastructure for Electronic Health Record-Related Patient Safety Hazards

    PubMed Central

    Singh, Hardeep; Classen, David C.; Sittig, Dean F.

    2013-01-01

    Electronic health records (EHRs) have potential quality and safety benefits. However, reports of EHR-related safety hazards are now emerging. The Office of the National Coordinator (ONC) for Health Information Technology (HIT) recently sponsored an Institute of Medicine committee to evaluate how HIT use affects patient safety. In this paper, we propose the creation of a national EHR oversight program to provide dedicated surveillance of EHR-related safety hazards and to promote learning from identified errors, close calls, and adverse events. The program calls for data gathering, investigation/analysis and regulatory components. The first two functions will depend on institution-level EHR safety committees that will investigate all known EHR-related adverse events and near-misses and report them nationally using standardized methods. These committees should also perform routine safety self-assessments to proactively identify new risks. Nationally, we propose the long-term creation of a centralized, non-partisan board with an appropriate legal and regulatory infrastructure to ensure the safety of EHRs. We discuss the rationale of the proposed oversight program and its potential organizational components and functions. These include mechanisms for robust data collection and analyses of all safety concerns using multiple methods that extend beyond reporting; multidisciplinary investigation of selected high-risk safety events; and enhanced coordination with other national agencies in order to facilitate broad dissemination of hazards information. Implementation of this proposed infrastructure can facilitate identification of EHR-related adverse events and errors and potentially create a safer and more effective EHR-based health care delivery system. PMID:22080284

  16. Diagnosing turbulence for research aircraft safety using open source toolkits

    NASA Astrophysics Data System (ADS)

    Lang, T. J.; Guy, N.

    Open source software toolkits have been developed and applied to diagnose in-cloud turbulence in the vicinity of Earth science research aircraft, via analysis of ground-based Doppler radar data. Based on multiple retrospective analyses, these toolkits show promise for detecting significant turbulence well prior to cloud penetrations by research aircraft. A pilot study demonstrated the ability to provide mission scientists turbulence estimates in near real time during an actual field campaign, and thus these toolkits are recommended for usage in future cloud-penetrating aircraft field campaigns.

  17. Development of biosensors based on the one-dimensional semiconductor nanomaterials.

    PubMed

    Yan, Shancheng; Shi, Yi; Xiao, Zhongdang; Zhou, Minmin; Yan, Wenfu; Shen, Haoliang; Hu, Dong

    2012-09-01

    Biosensors are becoming increasingly important due to their applications in biological and chemical analyses, food safety industry, biomedical diagnostics, clinical detection, and environmental monitoring. Recent years, nanostructured semiconductor materials have been used to fabricate biosensors owing to their biocompatibility, low toxicity, high electron mobility, and easy fabrication. In the present study, we focus on recent various biosensors based on the one-dimensional semiconductor nanomaterials such as electrochemical biosensor, field-effect transistors biosensor, and label-free optical biosensor. In particular, the development of the electrochemical biosensor is discussed detailedly.

  18. Selecting Strategies to Reduce High-Risk Unsafe Work Behaviors Using the Safety Behavior Sampling Technique and Bayesian Network Analysis.

    PubMed

    Ghasemi, Fakhradin; Kalatpour, Omid; Moghimbeigi, Abbas; Mohammadfam, Iraj

    2017-03-04

    High-risk unsafe behaviors (HRUBs) have been known as the main cause of occupational accidents. Considering the financial and societal costs of accidents and the limitations of available resources, there is an urgent need for managing unsafe behaviors at workplaces. The aim of the present study was to find strategies for decreasing the rate of HRUBs using an integrated approach of safety behavior sampling technique and Bayesian networks analysis. A cross-sectional study. The Bayesian network was constructed using a focus group approach. The required data was collected using the safety behavior sampling, and the parameters of the network were estimated using Expectation-Maximization algorithm. Using sensitivity analysis and belief updating, it was determined that which factors had the highest influences on unsafe behavior. Based on BN analyses, safety training was the most important factor influencing employees' behavior at the workplace. High quality safety training courses can reduce the rate of HRUBs about 10%. Moreover, the rate of HRUBs increased by decreasing the age of employees. The rate of HRUBs was higher in the afternoon and last days of a week. Among the investigated variables, training was the most important factor affecting safety behavior of employees. By holding high quality safety training courses, companies would be able to reduce the rate of HRUBs significantly.

  19. Participation of Women and Sex Analyses in Late-Phase Clinical Trials of New Molecular Entity Drugs and Biologics Approved by the FDA in 2007–2009

    PubMed Central

    Poon, Rita; Khanijow, Keshav; Umarjee, Sphoorti; Yu, Monica; Zhang, Lei; Parekh, Ameeta

    2013-01-01

    Abstract Background Biological sex differences may contribute to differential treatment outcomes for therapeutic products. This study tracks women's participation in late-phase clinical trials (LPCTs), where efficacy and safety of drugs and biologics are evaluated, of new molecular entity (NME) drugs and biologics approved by the U.S. Food and Drug Administration (FDA) in 2007–2009. Furthermore, presentations of sex-based analyses were assessed from the FDA reviews. Methods New drug applications (NDAs) and biologics license applications (BLAs) were accessed from the U.S. FDA database and evaluated for women's participation in LPCTs. Sex-based analyses for efficacy and safety contained in FDA reviews were surveyed. Ratios for women's LPCT participation (PROPORTION OF STUDY SUBJECTS) to their proportion in the disease population were calculated for each approved therapeutic product and grouped into therapeutic categories. Results Sex-specific (n=5) and pediatric (n=3) drug applications were excluded. Women's participation in LPCTs was 39%, 48%, and 42% in NDAs (n=50) and 49%, 62%, and 58% in BLAs (n=11) for 2007, 2008, and 2009, respectively. Sixty-four percent of NDAs and 91% of BLAs had participation to proportion ratios of ≥0.80. Seventy-four percent of NDA reviews and 64% of BLA reviews included safety and efficacy sex analysis. Ninety-six percent of NDA reviews and 100% of BLA reviews included efficacy sex analysis. Conclusion Women's participation in LPCTs averaged 43% for NDAs and 57% for BLAs in 2007–2009 and varied widely by indication. As a comparison, the 2001 U.S. Government Accountability Office (GAO) reported 52% of women's participation for drug clinical trials in1998–2000 and an FDA study reported 45% for BLAs approved from 1995 to 1999. This study showed that sex-analysis of both safety and efficacy in NDA has increased to 74% since the GAO report of 72%, while those for BLAs increased to 64% from 37% reported for therapeutic biologics approved in 1995–1999. Knowledge of disease prevalence and participation in clinical trials provides an understanding of recruitment and retention patterns of patients in these trials. PMID:23768021

  20. Financing intersectoral health promotion programmes: some reasons why collaborators are collaborating as indicated by cost-effectiveness analyses.

    PubMed

    Johansson, Pia; Tillgren, Per

    2011-03-01

    Intersectoral collaboration is an important part of many health promotion programmes. The reasons for the local organisations to collaborate, i.e. to finance programmes, are presumably based on benefits they derive from the collaboration. The aim of this study is to discuss whether subsector financial analyses based on data from cost-effectiveness analyses reflect incentives of collaborating organisations in two intersectoral health promotion programmes. Within economics, financial incentives are important reasons for actions. The financial incentives of collaborators are exemplified with two subsector financial analyses containing avoided disease-related costs as estimated in two cost-effectiveness analyses, on an elderly safety promotion programme (Safe Seniors in Sundbyberg) and on a diabetes prevention programme (Stockholm Diabetes Prevention Program, SDPP) from Stockholm, Sweden. The subsector financial analyses indicate that there are financial incentives for the key local community organisation, i.e. the local authority, to collaborate in one of the programmes but not the other. There are no financial benefits for other important community organisations, such as non-governmental organisations. The reasons for collaborating organisations to collaborate within intersectoral health promotion programmes extend beyond financial benefits from averted disease. Thus, the reported subsector financial analyses are only partial reflections of the incentives of collaborators, but they might be used as a starting point for discussions on cost sharing among potential intersectoral collaborators.

  1. Safety effects of unsignalized superstreets in North Carolina.

    PubMed

    Ott, Sarah E; Haley, Rebecca L; Hummer, Joseph E; Foyle, Robert S; Cunningham, Christopher M

    2012-03-01

    Arterials across the United States are experiencing far too many collisions. Agencies tasked with improving these arterials have few available effective solutions. Superstreets, called restricted crossing u-turns by the Federal Highway Administration (FHWA), are part of a menu of unconventional arterial intersection designs that may provide a promising solution. Up to this point, there is little valid information available on the safety effects of superstreets, as study results have been from basic analyses that only account for traffic volume changes. The purpose of this research was to determine the safety effects of the unsignalized superstreet countermeasure on existing arterials in North Carolina. The safety study involved traffic flow adjustment, comparison-group, and Empirical Bayes analyses of 13 unsignalized superstreet intersections in North Carolina. The superstreets have been installed in the last few years across the state as opportunities presented themselves, but not necessarily at the most hazardous sites. The unsignalized superstreet countermeasure showed a significant reduction in total, angle and right turn, and left turn collisions in all analyses. Analyses also showed a significant reduction in fatal and injury collisions. The authors recommend that future analysts use a crash modification factor of 46 percent when considering the conversion of a typical unsignalized arterial intersection into a superstreet. Copyright © 2011 Elsevier Ltd. All rights reserved.

  2. Qualitative evaluation of the Safety and Improvement in Primary Care (SIPC) pilot collaborative in Scotland: perceptions and experiences of participating care teams.

    PubMed

    Bowie, Paul; Halley, Lyn; Blamey, Avril; Gillies, Jill; Houston, Neil

    2016-01-29

    To explore general practitioner (GP) team perceptions and experiences of participating in a large-scale safety and improvement pilot programme to develop and test a range of interventions that were largely new to this setting. Qualitative study using semistructured interviews. Data were analysed thematically. Purposive sample of multiprofessional study participants from 11 GP teams based in 3 Scottish National Health Service (NHS) Boards. 27 participants were interviewed. 3 themes were generated: (1) programme experiences and benefits, for example, a majority of participants referred to gaining new theoretical and experiential safety knowledge (such as how unreliable evidence-based care can be) and skills (such as how to search electronic records for undetected risks) related to the programme interventions; (2) improvements to patient care systems, for example, improvements in care systems reliability using care bundles were reported by many, but this was an evolving process strongly dependent on closer working arrangements between clinical and administrative staff; (3) the utility of the programme improvement interventions, for example, mixed views and experiences of participating in the safety climate survey and meeting to reflect on the feedback report provided were apparent. Initial theories on the utilisation and potential impact of some interventions were refined based on evidence. The pilot was positively received with many practices reporting improvements in safety systems, team working and communications with colleagues and patients. Barriers and facilitators were identified related to how interventions were used as the programme evolved, while other challenges around spreading implementation beyond this pilot were highlighted. 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/

  3. Qualitative evaluation of the Safety and Improvement in Primary Care (SIPC) pilot collaborative in Scotland: perceptions and experiences of participating care teams

    PubMed Central

    Bowie, Paul; Halley, Lyn; Blamey, Avril; Gillies, Jill; Houston, Neil

    2016-01-01

    Objectives To explore general practitioner (GP) team perceptions and experiences of participating in a large-scale safety and improvement pilot programme to develop and test a range of interventions that were largely new to this setting. Design Qualitative study using semistructured interviews. Data were analysed thematically. Subjects and setting Purposive sample of multiprofessional study participants from 11 GP teams based in 3 Scottish National Health Service (NHS) Boards. Results 27 participants were interviewed. 3 themes were generated: (1) programme experiences and benefits, for example, a majority of participants referred to gaining new theoretical and experiential safety knowledge (such as how unreliable evidence-based care can be) and skills (such as how to search electronic records for undetected risks) related to the programme interventions; (2) improvements to patient care systems, for example, improvements in care systems reliability using care bundles were reported by many, but this was an evolving process strongly dependent on closer working arrangements between clinical and administrative staff; (3) the utility of the programme improvement interventions, for example, mixed views and experiences of participating in the safety climate survey and meeting to reflect on the feedback report provided were apparent. Initial theories on the utilisation and potential impact of some interventions were refined based on evidence. Conclusions The pilot was positively received with many practices reporting improvements in safety systems, team working and communications with colleagues and patients. Barriers and facilitators were identified related to how interventions were used as the programme evolved, while other challenges around spreading implementation beyond this pilot were highlighted. PMID:26826149

  4. Effectiveness of web-based tailored advice on parents' child safety behaviors: randomized controlled trial.

    PubMed

    van Beelen, Mirjam Elisabeth Johanna; Beirens, Tinneke Monique Jozef; den Hertog, Paul; van Beeck, Eduard Ferdinand; Raat, Hein

    2014-01-24

    Injuries at home are a major cause of death, disability, and loss of quality of life among young children. Despite current safety education, required safety behavior of parents is often lacking. To prevent various childhood disorders, the application of Web-based tools has increased the effectiveness of health promotion efforts. Therefore, an intervention with Web-based, tailored, safety advice combined with personal counseling (E-Health4Uth home safety) was developed and applied. To evaluate the effect of E-Health4Uth home safety on parents' safety behaviors with regard to the prevention of falls, poisoning, drowning, and burns. A randomized controlled trial was conducted (2009-2011) among parents visiting well-baby clinics in the Netherlands. Parents were randomly assigned to the intervention group (E-Health4Uth home safety intervention) or to the control condition consisting of usual care. Parents in the intervention condition completed a Web-based safety behavior assessment questionnaire; the resulting tailored safety advice was discussed with their child health care professional at a well-baby visit (age approximately 11 months). Parents in the control condition received counseling using generic safety information leaflets at this well-baby visit. Parents' child safety behaviors were derived from self-report questionnaires at baseline (age 7 months) and at follow-up (age 17 months). Each specific safety behavior was classified as safe/unsafe and a total risk score was calculated. Logistic and linear regression analyses were used to reveal differences in safety behavior between the intervention and the control condition at follow-up. A total of 1292 parents (response rate 44.79%) were analyzed. At follow-up, parents in the intervention condition (n=643) showed significantly less unsafe behavior compared to parents in the control condition (n=649): top of staircase (23.91% vs. 32.19%; OR 0.65, 95% CI 0.50-0.85); bottom of staircase (63.53% vs. 71.94%; OR 0.69, 95% CI 0.53-0.88); top and bottom of staircase (68.94% vs. 78.28%; OR 0.62, 95% CI 0.48-0.81); storage of cleaning products (30.33% vs. 39.91%; OR 0.67, 95% CI 0.53-0.85); bathing of the child (23.46% vs. 32.25%; OR 0.65, 95% CI 0.51-0.84); drinking hot fluids (34.84% vs. 41.73%; OR 0.76, 95% CI 0.61-0.96); using rear hotplates (79.34% vs. 85.27%; OR 0.67, 95% CI 0.50-0.90); and the total risk score in which a higher score indicates more unsafe behavior (mean 13.63, SD 6.12 vs. mean 15.34, SD 6.07; beta -1.59, 95% CI -2.26 to -0.93). There were no significant differences for other specific behaviors between the two study conditions. Compared to generic written materials, the E-Health4Uth home safety intervention seems more effective in promoting parents' safety behavior for safe staircases, storage of cleaning products, bathing, drinking hot fluids, and cooking. This study supports the application of Web-based, tailored, safety advice for the prevention of unintentional injuries in the youth health care setting. Nederlands Trial Register: NTR1836; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1836 (Archived by WebCite at http://www.webcitation.org/6MPIGQxpx).

  5. Effectiveness of Web-Based Tailored Advice on Parents’ Child Safety Behaviors: Randomized Controlled Trial

    PubMed Central

    2014-01-01

    Background Injuries at home are a major cause of death, disability, and loss of quality of life among young children. Despite current safety education, required safety behavior of parents is often lacking. To prevent various childhood disorders, the application of Web-based tools has increased the effectiveness of health promotion efforts. Therefore, an intervention with Web-based, tailored, safety advice combined with personal counseling (E-Health4Uth home safety) was developed and applied. Objective To evaluate the effect of E-Health4Uth home safety on parents’ safety behaviors with regard to the prevention of falls, poisoning, drowning, and burns. Methods A randomized controlled trial was conducted (2009-2011) among parents visiting well-baby clinics in the Netherlands. Parents were randomly assigned to the intervention group (E-Health4Uth home safety intervention) or to the control condition consisting of usual care. Parents in the intervention condition completed a Web-based safety behavior assessment questionnaire; the resulting tailored safety advice was discussed with their child health care professional at a well-baby visit (age approximately 11 months). Parents in the control condition received counseling using generic safety information leaflets at this well-baby visit. Parents’ child safety behaviors were derived from self-report questionnaires at baseline (age 7 months) and at follow-up (age 17 months). Each specific safety behavior was classified as safe/unsafe and a total risk score was calculated. Logistic and linear regression analyses were used to reveal differences in safety behavior between the intervention and the control condition at follow-up. Results A total of 1292 parents (response rate 44.79%) were analyzed. At follow-up, parents in the intervention condition (n=643) showed significantly less unsafe behavior compared to parents in the control condition (n=649): top of staircase (23.91% vs 32.19%; OR 0.65, 95% CI 0.50-0.85); bottom of staircase (63.53% vs 71.94%; OR 0.69, 95% CI 0.53-0.88); top and bottom of staircase (68.94% vs 78.28%; OR 0.62, 95% CI 0.48-0.81); storage of cleaning products (30.33% vs 39.91%; OR 0.67, 95% CI 0.53-0.85); bathing of the child (23.46% vs 32.25%; OR 0.65, 95% CI 0.51-0.84); drinking hot fluids (34.84% vs 41.73%; OR 0.76, 95% CI 0.61-0.96); using rear hotplates (79.34% vs 85.27%; OR 0.67, 95% CI 0.50-0.90); and the total risk score in which a higher score indicates more unsafe behavior (mean 13.63, SD 6.12 vs mean 15.34, SD 6.07; beta –1.59, 95% CI –2.26 to –0.93). There were no significant differences for other specific behaviors between the two study conditions. Conclusions Compared to generic written materials, the E-Health4Uth home safety intervention seems more effective in promoting parents’ safety behavior for safe staircases, storage of cleaning products, bathing, drinking hot fluids, and cooking. This study supports the application of Web-based, tailored, safety advice for the prevention of unintentional injuries in the youth health care setting. Trial Registration Nederlands Trial Register: NTR1836; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1836 (Archived by WebCite at http://www.webcitation.org/6MPIGQxpx). PMID:24463421

  6. Work stress and patient safety: observer-rated work stressors as predictors of characteristics of safety-related events reported by young nurses.

    PubMed

    Elfering, A; Semmer, N K; Grebner, S

    This study investigates the link between workplace stress and the 'non-singularity' of patient safety-related incidents in the hospital setting. Over a period of 2 working weeks 23 young nurses from 19 hospitals in Switzerland documented 314 daily stressful events using a self-observation method (pocket diaries); 62 events were related to patient safety. Familiarity of safety-related events and probability of recurrence, as indicators of non-singularity, were the dependent variables in multilevel regression analyses. Predictor variables were both situational (self-reported situational control, safety compliance) and chronic variables (job stressors such as time pressure, or concentration demands and job control). Chronic work characteristics were rated by trained observers. The most frequent safety-related stressful events included incomplete or incorrect documentation (40.3%), medication errors (near misses 21%), delays in delivery of patient care (9.7%), and violent patients (9.7%). Familiarity of events and probability of recurrence were significantly predicted by chronic job stressors and low job control in multilevel regression analyses. Job stressors and low job control were shown to be risk factors for patient safety. The results suggest that job redesign to enhance job control and decrease job stressors may be an important intervention to increase patient safety.

  7. Reporting mortality findings in trials of rofecoxib for Alzheimer disease or cognitive impairment: a case study based on documents from rofecoxib litigation.

    PubMed

    Psaty, Bruce M; Kronmal, Richard A

    2008-04-16

    Sponsors have a marketing interest to represent their products in the best light. This approach conflicts with scientific standards that require the symmetric and comparable reporting of safety and efficacy data. Selective reporting of the results of clinical trials can misrepresent the risk-benefit profile of drugs. We summarize how the sponsor represented mortality findings associated with rofecoxib in clinical trials of patients with Alzheimer disease or cognitive impairment. We reviewed documents that became available during litigation related to rofecoxib involving Merck & Co, including internal company analyses and information provided by the sponsor to the FDA. We also evaluated information in 2 published articles that reported results of these trials. In one article (reporting results of protocol 091) published in 2004, 11 "non-drug related deaths" were reported (9 deaths among 346 rofecoxib patients and 2 deaths among 346 placebo patients). In another article (reporting results of protocol 078) published in 2005, 39 deaths were reported among patients taking study treatment or within 14 days of the last dose (24 among 725 rofecoxib patients and 15 among 732 placebo patients) and an additional 22 deaths in the off-drug period (17 in rofecoxib patients and 5 in placebo patients). However, these articles did not include analyses or statistical tests of the mortality data, and the 2 articles concluded that regarding safety, rofecoxib is "well tolerated." In contrast, in April 2001, the company's internal intention-to-treat analyses of pooled data from these 2 trials identified a significant increase in total mortality (hazard ratio [HR], 4.43; 95% CI, 1.26-15.53 for protocol 091, and HR, 2.55; 95% CI, 1.17-5.56 for protocol 078), with overall mortality of 34 deaths among 1069 rofecoxib patients and 12 deaths among 1078 placebo patients (HR, 2.99; 95% CI, 1.55-5.77). These mortality analyses were neither provided to the FDA nor made public in a timely fashion. The data submitted by the sponsor to the FDA in a Safety Update Report in July 2001 used on-treatment analysis methods and reported 29 deaths (2.7%) among 1067 rofecoxib patients and 17 deaths (1.6%) among 1075 placebo patients. This on-treatment approach to reporting minimized the appearance of any mortality risk. In December 2001, when the FDA raised safety questions about the submitted safety data, the sponsor did not bring these issues to an institutional review board for review and revealed that there was no data and safety monitoring board for the protocol 078 study. The findings from this case study suggest that additional protections for human research participants, including new approaches for the conduct, oversight, and reporting of industry-sponsored trials, are necessary.

  8. Research safety vehicle program (Phase II) specification review. Volume II. Final technical report, Jul 1975--Nov 1976

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

    Pugliese, S.M.

    1977-02-01

    In Phase I of the Research Safety Vehicle Program (RSV), preliminary design and performance specifications were developed for a mid-1980's vehicle that integrates crashworthiness and occupant safety features with material resource conservation, economy, and producibility. Phase II of the program focused on development of the total vehicle design via systems engineering and integration analyses. As part of this effort, it was necessary to continuously review the Phase I recommended performance specification in relation to ongoing design/test activities. This document contains the results of analyses of the Phase I specifications. The RSV is expected to satisfy all of the producibility andmore » safety related specifications, i.e., handling and stability systems, crashworthiness, occupant protection, pedestrian/cyclist protection, etc.« less

  9. Study on the Influence of Elevation of Tailing Dam on Stability

    NASA Astrophysics Data System (ADS)

    Wan, Shuai; Wang, Kun; Kong, Songtao; Zhao, Runan; Lan, Ying; Zhang, Run

    2017-12-01

    This paper takes Yunnan as the object of a tailing, by theoretical analysis and numerical calculation method of the effect of seismic load effect of elevation on the stability of the tailing, to analyse the stability of two point driven safety factor and liquefaction area. The Bishop method is adopted to simplify the calculation of dynamic safety factor and liquefaction area analysis using comparison method of shear stress to analyse liquefaction, so we obtained the influence of elevation on the stability of the tailing. Under the earthquake, with the elevation increased, the safety coefficient of dam body decreases, shallow tailing are susceptible to liquefy. Liquefaction area mainly concentrated in the bank below the water surface, to improve the scientific basis for the design and safety management of the tailing.

  10. Safety evaluation of right turns followed by U-turns as an alternative to direct left turns : conflict analysis, Vol. 2

    DOT National Transportation Integrated Search

    2001-10-01

    This project evaluated the safety and operational impacts of two alternative left-turn treatments from driveways/side streets. The two treatments were (1) direct left turns and (2) right turns followed by U-turns. Safety analyses of the alternatives ...

  11. Circuit board accident--organizational dimension hidden by prescribed safety.

    PubMed

    de Almeida, Ildeberto Muniz; Buoso, Eduardo; do Amaral Dias, Maria Dionísia; Vilela, Rodolfo Andrade Gouveia

    2012-01-01

    This study analyzes an accident in which two maintenance workers suffered severe burns while replacing a circuit breaker panel in a steel mill, following model of analysis and prevention of accidents (MAPA) developed with the objective of enlarging the perimeter of interventions and contributing to deconstruction of blame attribution practices. The study was based on materials produced by a health service team in an in-depth analysis of the accident. The analysis shows that decisions related to system modernization were taken without considering their implications in maintenance scheduling and creating conflicts of priorities and of interests between production and safety; and also reveals that the lack of a systemic perspective in safety management was its principal failure. To explain the accident as merely non-fulfillment of idealized formal safety rules feeds practices of blame attribution supported by alibi norms and inhibits possible prevention. In contrast, accident analyses undertaken in worker health surveillance services show potential to reveal origins of these events incubated in the history of the system ignored in practices guided by the traditional paradigm.

  12. Autonomous rehabilitation at stroke patients home for balance and gait: safety, usability and compliance of a virtual reality system.

    PubMed

    Held, Jeremia P; Ferrer, Begoña; Mainetti, Renato; Steblin, Alexander; Hertler, Benjamin; Moreno-Conde, Alberto; Dueñas, Alvaro; Pajaro, Marta; L-Parra-Calderón, Carlos; Vargiu, Eloisa; Zarco, Maria J; Barrera, Maria; Echevarria, Carmen; Jódar-Sánchez, Francisco; Luft, Andreas R; Borghese, Nunzio A

    2017-09-25

    New technologies, such as telerehabilitation and gaming devices offer the possibility for patients to train at home. This opens the challenge of safety for the patient as he is called to exercise neither with a therapist on the patients' side nor with a therapist linked remotely to supervise the sessions. To study the safety, usability and patient acceptance of an autonomous telerehabilitation system for balance and gait (the REWIRE platform) in the patients home. Cohort study. Community, in the stroke patients' home. 15 participants with first-ever stroke, with a mild to moderate residual deficit of the lower extremities. Autonomous rehabilitation based on virtual rehabilitation was provided at the participants' home for twelve weeks. The primary outcome was compliance (the ratio between days of actual and scheduled training), analysed with the two-tailed Wilcoxon Mann- Whitney test. Furthermore safety is defined by adverse events. The secondary endpoint was the acceptance of the system measured with the Technology Acceptance Model. Additionally, the cumulative duration of weekly training was analysed. During the study there were no adverse events related to the therapy. Patients performed on average 71% (range 39 to 92%) of the scheduled sessions. The Technology Acceptance Model Questionnaire showed excellent values for stroke patients after the training. The average training duration per week was 99 ±53min. Autonomous telerehabilitation for balance and gait training with the REWIRE-system is safe, feasible and can help to intensive rehabilitative therapy at home. Telerehabilitation enables safe training in home environment and supports of the standard rehabilitation therapy.

  13. Hydraulics of high-yield orchard trees: a case study of three Malus domestica cultivars.

    PubMed

    Beikircher, Barbara; De Cesare, Chiara; Mayr, Stefan

    2013-12-01

    The drought tolerance of three economically important apple cultivars, Golden Delicious, Braeburn and Red Delicious, was analysed. The work offers insights into the hydraulics of these high-yield trees and indicates a possible hydraulic limitation of carbon gain. The hydraulic safety and efficiency of branch xylem and leaves were quantified, drought tolerance of living tissues was measured and stomatal regulation, turgor-loss point and osmotic potential at full turgor were analysed. Physiological measurements were correlated with anatomical parameters, such as conduit diameter, cell-wall reinforcement, stomatal density and stomatal pore length. Hydraulic safety differed considerably between the three cultivars with Golden Delicious being significantly less vulnerable to drought-induced embolism than Braeburn and Red Delicious. In Golden Delicious, leaves were less resistant than branch xylem, while in the other cultivars leaves were more resistant than branch xylem. Hydraulic efficiency and xylem anatomical measurements indicate differences in pit properties, which may also be responsible for variations in hydraulic safety. In all three cultivars, full stomatal closure occurred at water potentials where turgor had already been lost and severe loss of hydraulic conductivity as well as damage to living cells had been induced. The consequential negative safety margins pose a risk for hydraulic failure but facilitate carbon gain, which is further improved by the observed high stomatal conductance. Maximal stomatal conductance was clearly seen to be related to stomatal density and size. Based on our results, these three high-yield Malus domestica Borkh. cultivars span a wide range of drought tolerances, appear optimized for maximal carbon gain and, thus, all perform best under well-managed growing conditions.

  14. Patient safety climate in general public hospitals in China: differences associated with department and job type based on a cross-sectional survey

    PubMed Central

    Zhou, Ping; Bai, Fei; Tang, Hui-qin; Bai, Jie; Li, Min-qi; Xue, Di

    2018-01-01

    Objective This study analysed differences in the perceived patient safety climate among different working departments and job types in public general hospitals in China. Design Cross-sectional survey. Setting Eighteen tertiary hospitals and 36 secondary hospitals from 10 areas in Shanghai, Hubei Province and Gansu Province, China. Participants Overall, 4753 staff, including physicians, nurses, medical technicians and managers, were recruited from March to June 2015. Main outcome measure The Patient Safety Climate in Healthcare Organisations (PSCHO) tool and the percentages of ‘problematic responses’ (PPRs) were used as outcome measures. Multivariable two-level random intercept models were applied in the analysis. Results A total of 4121 valid questionnaires were collected. Perceptions regarding the patient safety climate varied among departments and job types. Physicians responded with relatively more negative evaluations of ‘organisational resources for safety’, ‘unit recognition and support for safety efforts’, ‘psychological safety’, ‘problem responsiveness’ and overall safety climate. Paediatrics departments, intensive care units, emergency departments and clinical auxiliary departments require more attention. The PPRs for ‘fear of blame and punishment’ were universally significantly high, and the PPRs for ‘fear of shame’ and ‘provision of safe care’ were remarkably high, especially in some departments. Departmental differences across all dimensions and the overall safety climate primarily depended on job type. Conclusions The differences suggest that strategies and measures for improving the patient safety climate should be tailored by working department and job type. PMID:29666125

  15. Effects of patient safety culture interventions on incident reporting in general practice: a cluster randomised trial

    PubMed Central

    Verbakel, Natasha J; Langelaan, Maaike; Verheij, Theo JM; Wagner, Cordula; Zwart, Dorien LM

    2015-01-01

    Background A constructive safety culture is essential for the successful implementation of patient safety improvements. Aim To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. Design and setting A three-arm cluster randomised trial was conducted in a mixed method study, studying the effect of administering a patient safety culture questionnaire (intervention I), the questionnaire complemented with a practice-based workshop (intervention II) and no intervention (control) in 30 general practices in the Netherlands. Method The primary outcome, the number of reported incidents, was measured with a questionnaire at baseline and a year after. Analysis was performed using a negative binomial model. Secondary outcomes were quality and safety indicators and safety culture. Mixed effects linear regression was used to analyse the culture questionnaires. Results The number of incidents increased in both intervention groups, to 82 and 224 in intervention I and II respectively. Adjusted for baseline number of incidents, practice size and accreditation status, the study showed that practices that additionally participated in the workshop reported 42 (95% confidence interval [CI] = 9.81 to 177.50) times more incidents compared to the control group. Practices that only completed the questionnaire reported 5 (95% CI = 1.17 to 25.49) times more incidents. There were no statistically significant differences in staff perception of patient safety culture at follow-up between the three study groups. Conclusion Educating staff and facilitating discussion about patient safety culture in their own practice leads to increased reporting of incidents. It is beneficial to invest in a team-wise effort to improve patient safety. PMID:25918337

  16. Is the relationship between the built environment and physical activity moderated by perceptions of crime and safety?

    PubMed

    Bracy, Nicole L; Millstein, Rachel A; Carlson, Jordan A; Conway, Terry L; Sallis, James F; Saelens, Brian E; Kerr, Jacqueline; Cain, Kelli L; Frank, Lawrence D; King, Abby C

    2014-02-24

    Direct relationships between safety concerns and physical activity have been inconsistently patterned in the literature. To tease out these relationships, crime, pedestrian, and traffic safety were examined as moderators of built environment associations with physical activity. Exploratory analyses used two cross-sectional studies of 2068 adults ages 20-65 and 718 seniors ages 66+ with similar designs and measures. The studies were conducted in the Baltimore, Maryland-Washington, DC and Seattle-King County, Washington regions during 2001-2005 (adults) and 2005-2008 (seniors). Participants were recruited from areas selected to sample high- and low- income and walkability. Independent variables perceived crime, traffic, and pedestrian safety were measured using scales from validated instruments. A GIS-based walkability index was calculated for a street-network buffer around each participant's home address. Outcomes were total physical activity measured using accelerometers and transportation and leisure walking measured with validated self-reports (IPAQ-long). Mixed effects regression models were conducted separately for each sample. Of 36 interactions evaluated across both studies, only 5 were significant (p< .05). Significant interactions did not consistently support a pattern of highest physical activity when safety was rated high and environments were favorable. There was not consistent evidence that safety concerns reduced the beneficial effects of favorable environments on physical activity. Only pedestrian safety showed evidence of a consistent main effect with physical activity outcomes, possibly because pedestrian safety items (e.g., crosswalks, sidewalks) were not as subjective as those on the crime and traffic safety scales. Clear relationships between crime, pedestrian, and traffic safety with physical activity levels remain elusive. The development of more precise safety variables and the use of neighborhood-specific physical activity outcomes may help to elucidate these relationships.

  17. Is the relationship between the built environment and physical activity moderated by perceptions of crime and safety?

    PubMed Central

    2014-01-01

    Background Direct relationships between safety concerns and physical activity have been inconsistently patterned in the literature. To tease out these relationships, crime, pedestrian, and traffic safety were examined as moderators of built environment associations with physical activity. Methods Exploratory analyses used two cross-sectional studies of 2068 adults ages 20–65 and 718 seniors ages 66+ with similar designs and measures. The studies were conducted in the Baltimore, Maryland-Washington, DC and Seattle-King County, Washington regions during 2001–2005 (adults) and 2005–2008 (seniors). Participants were recruited from areas selected to sample high- and low- income and walkability. Independent variables perceived crime, traffic, and pedestrian safety were measured using scales from validated instruments. A GIS-based walkability index was calculated for a street-network buffer around each participant’s home address. Outcomes were total physical activity measured using accelerometers and transportation and leisure walking measured with validated self-reports (IPAQ-long). Mixed effects regression models were conducted separately for each sample. Results Of 36 interactions evaluated across both studies, only 5 were significant (p < .05). Significant interactions did not consistently support a pattern of highest physical activity when safety was rated high and environments were favorable. There was not consistent evidence that safety concerns reduced the beneficial effects of favorable environments on physical activity. Only pedestrian safety showed evidence of a consistent main effect with physical activity outcomes, possibly because pedestrian safety items (e.g., crosswalks, sidewalks) were not as subjective as those on the crime and traffic safety scales. Conclusions Clear relationships between crime, pedestrian, and traffic safety with physical activity levels remain elusive. The development of more precise safety variables and the use of neighborhood-specific physical activity outcomes may help to elucidate these relationships. PMID:24564971

  18. Effects of patient safety culture interventions on incident reporting in general practice: a cluster randomised trial.

    PubMed

    Verbakel, Natasha J; Langelaan, Maaike; Verheij, Theo J M; Wagner, Cordula; Zwart, Dorien L M

    2015-05-01

    A constructive safety culture is essential for the successful implementation of patient safety improvements. To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. A three-arm cluster randomised trial was conducted in a mixed method study, studying the effect of administering a patient safety culture questionnaire (intervention I), the questionnaire complemented with a practice-based workshop (intervention II) and no intervention (control) in 30 general practices in the Netherlands. The primary outcome, the number of reported incidents, was measured with a questionnaire at baseline and a year after. Analysis was performed using a negative binomial model. Secondary outcomes were quality and safety indicators and safety culture. Mixed effects linear regression was used to analyse the culture questionnaires. The number of incidents increased in both intervention groups, to 82 and 224 in intervention I and II respectively. Adjusted for baseline number of incidents, practice size and accreditation status, the study showed that practices that additionally participated in the workshop reported 42 (95% confidence interval [CI] = 9.81 to 177.50) times more incidents compared to the control group. Practices that only completed the questionnaire reported 5 (95% CI = 1.17 to 25.49) times more incidents. There were no statistically significant differences in staff perception of patient safety culture at follow-up between the three study groups. Educating staff and facilitating discussion about patient safety culture in their own practice leads to increased reporting of incidents. It is beneficial to invest in a team-wise effort to improve patient safety. © British Journal of General Practice 2015.

  19. System theory and safety models in Swedish, UK, Dutch and Australian road safety strategies.

    PubMed

    Hughes, B P; Anund, A; Falkmer, T

    2015-01-01

    Road safety strategies represent interventions on a complex social technical system level. An understanding of a theoretical basis and description is required for strategies to be structured and developed. Road safety strategies are described as systems, but have not been related to the theory, principles and basis by which systems have been developed and analysed. Recently, road safety strategies, which have been employed for many years in different countries, have moved to a 'vision zero', or 'safe system' style. The aim of this study was to analyse the successful Swedish, United Kingdom and Dutch road safety strategies against the older, and newer, Australian road safety strategies, with respect to their foundations in system theory and safety models. Analysis of the strategies against these foundations could indicate potential improvements. The content of four modern cases of road safety strategy was compared against each other, reviewed against scientific systems theory and reviewed against types of safety model. The strategies contained substantial similarities, but were different in terms of fundamental constructs and principles, with limited theoretical basis. The results indicate that the modern strategies do not include essential aspects of systems theory that describe relationships and interdependencies between key components. The description of these strategies as systems is therefore not well founded and deserves further development. Copyright © 2014 Elsevier Ltd. All rights reserved.

  20. Nurses', physicians' and radiographers' perceptions of the safety of a nurse prescribing of ionising radiation initiative: A cross-sectional survey.

    PubMed

    Hyde, Abbey; Coughlan, Barbara; Naughton, Corina; Hegarty, Josephine; Savage, Eileen; Grehan, Jennifer; Kavanagh, Eoin; Moughty, Adrian; Drennan, Jonathan

    2016-06-01

    A new initiative was introduced in Ireland following legislative changes that allowed nurses with special training to prescribe ionising radiation (X-ray) for the first time. A small number of studies on nurse prescribing of ionising radiation in other contexts have found it to be broadly as safe as ionising radiation prescribing by physicians. Sociological literature on perceptions of safety indicates that these tend to be shaped by the ideological position of the professional rather than based on objective evidence. To describe, compare and analyse perceptions of the safety of a nurse prescribing of ionising radiation initiative across three occupational groups: nursing, radiography and medicine. A cross-sectional survey design. Participants were drawn from a range of clinical settings in Ireland. Respondents were 167 health professionals comprised of 49 nurses, 91 radiographers, and 27 physicians out of a total of 300 who were invited to participate. Non-probability sampling was employed and the survey was targeted specifically at health professionals with a specific interest in, or involvement with, the development of the nurse prescribing of ionising radiation initiative in Ireland. Comparisons of perspectives on the safety of nurse prescribing of ionising radiation across the three occupational groups captured by questionnaire were analysed using the Kruskal-Wallis H test. Pairwise post hoc tests were conducted using the Mann-Whitney U test. While the majority of respondents from all three groups perceived nurse prescribing of ionising radiation to be safe, the extent to which this view was held varied. A higher proportion of nurses was found to display confidence in the safety of nurse prescribing of ionising radiation compared to physicians and radiographers with differences between nurses' perceptions and those of the other two groups being statistically significant. That an occupational patterning emerged suggests that perceptions about safety and risk of nurse prescribing of ionising radiation are socially constructed according to the vantage point of the professional and may not reflect objective measures of safety. These findings need to be considered more broadly in the context of ideological barriers to expanding the role of nurses. Copyright © 2016 Elsevier Ltd. All rights reserved.

  1. Seismic Design of a Single Bored Tunnel: Longitudinal Deformations and Seismic Joints

    NASA Astrophysics Data System (ADS)

    Oh, J.; Moon, T.

    2018-03-01

    The large diameter bored tunnel passing through rock and alluvial deposits subjected to seismic loading is analyzed for estimating longitudinal deformations and member forces on the segmental tunnel liners. The project site has challenges including high hydrostatic pressure, variable ground profile and high seismic loading. To ensure the safety of segmental tunnel liner from the seismic demands, the performance-based two-level design earthquake approach, Functional Evaluation Earthquake and Safety Evaluation Earthquake, has been adopted. The longitudinal tunnel and ground response seismic analyses are performed using a three-dimensional quasi-static linear elastic and nonlinear elastic discrete beam-spring elements to represent segmental liner and ground spring, respectively. Three components (longitudinal, transverse and vertical) of free-field ground displacement-time histories evaluated from site response analyses considering wave passage effects have been applied at the end support of the strain-compatible ground springs. The result of the longitudinal seismic analyses suggests that seismic joint for the mitigation measure requiring the design deflection capacity of 5-7.5 cm is to be furnished at the transition zone between hard and soft ground condition where the maximum member forces on the segmental liner (i.e., axial, shear forces and bending moments) are induced. The paper illustrates how detailed numerical analyses can be practically applied to evaluate the axial and curvature deformations along the tunnel alignment under difficult ground conditions and to provide the seismic joints at proper locations to effectively reduce the seismic demands below the allowable levels.

  2. A Spanish-language patient safety questionnaire to measure medical and nursing students' attitudes and knowledge.

    PubMed

    Mira, José J; Navarro, Isabel M; Guilabert, Mercedes; Poblete, Rodrigo; Franco, Astolfo L; Jiménez, Pilar; Aquino, Margarita; Fernández-Trujillo, Francisco J; Lorenzo, Susana; Vitaller, Julián; de Valle, Yohana Díaz; Aibar, Carlos; Aranaz, Jesús M; De Pedro, José A

    2015-08-01

    To design and validate a questionnaire for assessing attitudes and knowledge about patient safety using a sample of medical and nursing students undergoing clinical training in Spain and four countries in Latin America. In this cross-sectional study, a literature review was carried out and total of 786 medical and nursing students were surveyed at eight universities from five countries (Chile, Colombia, El Salvador, Guatemala, and Spain) to develop and refine a Spanish-language questionnaire on knowledge and attitudes about patient safety. The scope of the questionnaire was based on five dimensions (factors) presented in studies related to patient safety culture found in PubMed and Scopus. Based on the five factors, 25 reactive items were developed. Composite reliability indexes and Cronbach's alpha statistics were estimated for each factor, and confirmatory factor analysis was conducted to assess validity. After a pilot test, the questionnaire was refined using confirmatory models, maximum-likelihood estimation, and the variance-covariance matrix (as input). Multiple linear regression models were used to confirm external validity, considering variables related to patient safety culture as dependent variables and the five factors as independent variables. The final instrument was a structured five-point Likert self-administered survey (the "Latino Student Patient Safety Questionnaire") consisting of 21 items grouped into five factors. Compound reliability indexes (Cronbach's alpha statistic) calculated for the five factors were about 0.7 or higher. The results of the multiple linear regression analyses indicated good model fit (goodness-of-fit index: 0.9). Item-total correlations were higher than 0.3 in all cases. The convergent-discriminant validity was adequate. The questionnaire designed and validated in this study assesses nursing and medical students' attitudes and knowledge about patient safety. This instrument could be used to indirectly evaluate whether or not students in health disciplines are acquiring and thus likely to put into practice the professional skills currently considered most appropriate for patient safety.

  3. Development and validation of safety climate scales for mobile remote workers using utility/electrical workers as exemplar.

    PubMed

    Huang, Yueng-Hsiang; Zohar, Dov; Robertson, Michelle M; Garabet, Angela; Murphy, Lauren A; Lee, Jin

    2013-10-01

    The objective of this study was to develop and test the reliability and validity of a new scale designed for measuring safety climate among mobile remote workers, using utility/electrical workers as exemplar. The new scale employs perceived safety priority as the metric of safety climate and a multi-level framework, separating the measurement of organization- and group-level safety climate items into two sub-scales. The question of the emergence of shared perceptions among remote workers was also examined. For the initial survey development, several items were adopted from a generic safety climate scale and new industry-specific items were generated based on an extensive literature review, expert judgment, 15-day field observations, and 38 in-depth individual interviews with subject matter experts (i.e., utility industry electrical workers, trainers and supervisors of electrical workers). The items were revised after 45 cognitive interviews and a pre-test with 139 additional utility/electrical workers. The revised scale was subsequently implemented with a total of 2421 workers at two large US electric utility companies (1560 participants for the pilot company and 861 for the second company). Both exploratory (EFA) and confirmatory factor analyses (CFA) were adopted to finalize the items and to ensure construct validity. Reliability of the scale was tested based on Cronbach's α. Homogeneity tests examined whether utility/electrical workers' safety climate perceptions were shared within the same supervisor group. This was followed by an analysis of the criterion-related validity, which linked the safety climate scores to self-reports of safety behavior and injury outcomes (i.e., recordable incidents, missing days due to work-related injuries, vehicle accidents, and near misses). Six dimensions (Safety pro-activity, General training, Trucks and equipment, Field orientation, Financial Investment, and Schedule flexibility) with 29 items were extracted from the EFA to measure the organization-level safety climate. Three dimensions (Supervisory care, Participation encouragement, and Safety straight talk) with 19 items were extracted to measure the group-level safety climate. Acceptable ranges of internal consistency statistics for the sub-scales were observed. Whether or not to aggregate these multi-dimensions of safety climate into a single higher-order construct (overall safety climate) was discussed. CFAs confirmed the construct validity of the developed safety climate scale for utility/electrical workers. Homogeneity tests showed that utility/electrical workers' safety climate perceptions were shared within the same supervisor group. Both the organization- and group-level safety climate scores showed a statistically significant relationship with workers' self-reported safety behaviors and injury outcomes. A valid and reliable instrument to measure the essential elements of safety climate for utility/electrical workers in the remote working situation has been introduced. The scale can provide an in-depth understanding of safety climate based on its key dimensions and show where improvements can be made at both group and organization levels. As such, it may also offer a valuable starting point for future safety interventions. Copyright © 2013 Elsevier Ltd. All rights reserved.

  4. An Approach for Validating Actinide and Fission Product Burnup Credit Criticality Safety Analyses-Isotopic Composition Predictions

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

    Radulescu, Georgeta; Gauld, Ian C; Ilas, Germina

    2011-01-01

    The expanded use of burnup credit in the United States (U.S.) for storage and transport casks, particularly in the acceptance of credit for fission products, has been constrained by the availability of experimental fission product data to support code validation. The U.S. Nuclear Regulatory Commission (NRC) staff has noted that the rationale for restricting the Interim Staff Guidance on burnup credit for storage and transportation casks (ISG-8) to actinide-only is 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 themore » issues of burnup credit criticality validation, the NRC initiated a project with the Oak Ridge National Laboratory to (1) develop and establish a technically sound validation approach 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 isotopic composition (depletion) validation approach and resulting observations and recommendations. Validation of the criticality calculations is addressed in a companion paper at this conference. For isotopic composition validation, the approach is to determine burnup-dependent bias and uncertainty in the effective neutron multiplication factor (keff) due to bias and uncertainty in isotopic predictions, via comparisons of isotopic composition predictions (calculated) and measured isotopic compositions from destructive radiochemical assay utilizing as much assay data as is available, and a best-estimate Monte Carlo based method. This paper (1) provides a detailed description of the burnup credit isotopic validation 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 and uncertainty results based on a quality-assurance-controlled prerelease version of the Scale 6.1 code package and the ENDF/B-VII nuclear cross section data.« less

  5. NASA Accident Precursor Analysis Handbook, Version 1.0

    NASA Technical Reports Server (NTRS)

    Groen, Frank; Everett, Chris; Hall, Anthony; Insley, Scott

    2011-01-01

    Catastrophic accidents are usually preceded by precursory events that, although observable, are not recognized as harbingers of a tragedy until after the fact. In the nuclear industry, the Three Mile Island accident was preceded by at least two events portending the potential for severe consequences from an underappreciated causal mechanism. Anomalies whose failure mechanisms were integral to the losses of Space Transportation Systems (STS) Challenger and Columbia had been occurring within the STS fleet prior to those accidents. Both the Rogers Commission Report and the Columbia Accident Investigation Board report found that processes in place at the time did not respond to the prior anomalies in a way that shed light on their true risk implications. This includes the concern that, in the words of the NASA Aerospace Safety Advisory Panel (ASAP), "no process addresses the need to update a hazard analysis when anomalies occur" At a broader level, the ASAP noted in 2007 that NASA "could better gauge the likelihood of losses by developing leading indicators, rather than continue to depend on lagging indicators". These observations suggest a need to revalidate prior assumptions and conclusions of existing safety (and reliability) analyses, as well as to consider the potential for previously unrecognized accident scenarios, when unexpected or otherwise undesired behaviors of the system are observed. This need is also discussed in NASA's system safety handbook, which advocates a view of safety assurance as driving a program to take steps that are necessary to establish and maintain a valid and credible argument for the safety of its missions. It is the premise of this handbook that making cases for safety more experience-based allows NASA to be better informed about the safety performance of its systems, and will ultimately help it to manage safety in a more effective manner. The APA process described in this handbook provides a systematic means of analyzing candidate accident precursors by evaluating anomaly occurrences for their system safety implications and, through both analytical and deliberative methods used to project to other circumstances, identifying those that portend more serious consequences to come if effective corrective action is not taken. APA builds upon existing safety analysis processes currently in practice within NASA, leveraging their results to provide an improved understanding of overall system risk. As such, APA represents an important dimension of safety evaluation; as operational experience is acquired, precursor information is generated such that it can be fed back into system safety analyses to risk-inform safety improvements. Importantly, APA utilizes anomaly data to predict risk whereas standard reliability and PRA approaches utilize failure data which often is limited and rare.

  6. Integrating teamwork, clinician occupational well-being and patient safety - development of a conceptual framework based on a systematic review.

    PubMed

    Welp, Annalena; Manser, Tanja

    2016-07-19

    There is growing evidence that teamwork in hospitals is related to both patient outcomes and clinician occupational well-being. Furthermore, clinician well-being is associated with patient safety. Despite considerable research activity, few studies include all three concepts, and their interrelations have not yet been investigated systematically. To advance our understanding of these potentially complex interrelations we propose an integrative framework taking into account current evidence and research gaps identified in a systematic review. We conducted a literature search in six major databases (Medline, PsycArticles, PsycInfo, Psyndex, ScienceDirect, and Web of Knowledge). Inclusion criteria were: peer reviewed papers published between January 2000 and June 2015 investigating a statistical relationship between at least two of the three concepts; teamwork, patient safety, and clinician occupational well-being in hospital settings, including practicing nurses and physicians. We assessed methodological quality using a standardized rating system and qualitatively appraised and extracted relevant data, such as instruments, analyses and outcomes. The 98 studies included in this review were highly diverse regarding quality, methodology and outcomes. We found support for the existence of independent associations between teamwork, clinician occupational well-being and patient safety. However, we identified several conceptual and methodological limitations. The main barrier to advancing our understanding of the causal relationships between teamwork, clinician well-being and patient safety is the lack of an integrative, theory-based, and methodologically thorough approach investigating the three concepts simultaneously and longitudinally. Based on psychological theory and our findings, we developed an integrative framework that addresses these limitations and proposes mechanisms by which these concepts might be linked. Knowledge about the mechanisms underlying the relationships between these concepts helps to identify avenues for future research, aimed at benefiting clinicians and patients by using the synergies between teamwork, clinician occupational well-being and patient safety.

  7. Assessment of safety and efficiency of nitrogen organic fertilizers from animal-based protein hydrolysates--a laboratory multidisciplinary approach.

    PubMed

    Corte, Laura; Dell'abate, Maria Teresa; Magini, Alessandro; Migliore, Melania; Felici, Barbara; Roscini, Luca; Sardella, Roccaldo; Tancini, Brunella; Emiliani, Carla; Cardinali, Gianluigi; Benedetti, Anna

    2014-01-30

    Protein hydrolysates or hydrolysed proteins (HPs) are high-N organic fertilizers allowing the recovery of by-products (leather meal and fluid hydrolysed proteins) otherwise disposed of as polluting wastes, thus enhancing matter and energy conservation in agricultural systems while decreasing potential pollution. Chemical and biological characteristics of HPs of animal origin were analysed in this work to assess their safety, environmental sustainability and agricultural efficacy as fertilizers. Different HPs obtained by thermal, chemical and enzymatic hydrolytic processes were characterized by Fourier transform infrared spectroscopy and sodium dodecyl sulfate polyacrylamide gel electrophoresis, and their safety and efficacy were assessed through bioassays, ecotoxicological tests and soil biochemistry analyses. HPs can be discriminated according to their origin and hydrolysis system by proteomic and metabolomic methods. Three experimental systems, soil microbiota, yeast and plants, were employed to detect possible negative effects exerted by HPs. The results showed that these compounds do not significantly interfere with metabolomic activity or the reproductive system. The absence of toxic and genotoxic effects of the hydrolysates prepared by the three hydrolytic processes suggests that they do not negatively affect eukaryotic cells and soil ecosystems and that they can be used in conventional and organic farming as an important nitrogen source derived from otherwise highly polluting by-products. © 2013 Society of Chemical Industry.

  8. Hazard Analysis for the Mark III Space Suit Assembly (SSA) Used in One-g Operations

    NASA Technical Reports Server (NTRS)

    Mitchell, Kate; Ross, Amy; Blanco, Raul; Wood, Art

    2012-01-01

    This Hazard Analysis document encompasses the Mark III Space Suit Assembly (SSA) and associated ancillary equipment. It has been prepared using JSC17773, "Preparing Hazard Analyses for JSC Ground Operation", as a guide. The purpose of this document is to present the potential hazards involved in ground (23 % maximum O2, One-g) operations of the Mark III and associated ancillary support equipment system. The hazards listed in this document are specific to suit operations only; each supporting facility (Bldg. 9, etc.) is responsible for test specific Hazard Analyses. A "hazard" is defined as any condition that has the potential for harming personnel or equipment. This analysis was performed to document the safety aspects associated with manned use of the Mark III for pressurized and unpressurized ambient, ground-based, One-g human testing. The hazards identified herein represent generic hazards inherent to all standard JSC test venues for nominal ground test configurations. Non-standard test venues or test specific configurations may warrant consideration of additional hazards analysis prior to test. The cognizant suit engineer is responsible for the safety of the astronaut/test subject, space suit, and suit support personnel. The test requester, for the test supported by the suit test engineer and suited subject, is responsible for overall safety and any necessary Test Readiness Reviews (TRR).

  9. ORNL necessary and sufficient standards for environment, safety, and health. Final report of the Identification Team for other industrial, radiological, and non-radiological hazard facilities

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

    NONE

    1998-07-01

    This Necessary and Sufficient (N and S) set of standards is for Other Industrial, Radiological, and Non-Radiological Hazard Facilities at Oak Ridge National Laboratory (ORNL). These facility classifications are based on a laboratory-wide approach to classify facilities by hazard category. An analysis of the hazards associated with the facilities at ORNL was conducted in 1993. To identify standards appropriate for these Other Industrial, Radiological, and Non-Radiological Hazard Facilities, the activities conducted in these facilities were assessed, and the hazards associated with the activities were identified. A preliminary hazards list was distributed to all ORNL organizations. The hazards identified in priormore » hazard analyses are contained in the list, and a category of other was provided in each general hazard area. A workshop to assist organizations in properly completing the list was held. Completed hazard screening lists were compiled for each ORNL division, and a master list was compiled for all Other Industrial, Radiological Hazard, and Non-Radiological facilities and activities. The master list was compared against the results of prior hazard analyses by research and development and environment, safety, and health personnel to ensure completeness. This list, which served as a basis for identifying applicable environment, safety, and health standards, appears in Appendix A.« less

  10. Vehicle familiarity and safety

    DOT National Transportation Integrated Search

    1983-07-01

    A literature review and accident data analyses were conducted to examine the : relationship between vehicle familiarity and safety. The infonmation from these : diverse sources was consistent in suggesting that drivers of passenger cars and . : motor...

  11. Comparing two safety culture surveys: safety attitudes questionnaire and hospital survey on patient safety.

    PubMed

    Etchegaray, Jason M; Thomas, Eric J

    2012-06-01

    To examine the reliability and predictive validity of two patient safety culture surveys-Safety Attitudes Questionnaire (SAQ) and Hospital Survey on Patient Safety Culture (HSOPS)-when administered to the same participants. Also to determine the ability to convert HSOPS scores to SAQ scores. Employees working in intensive care units in 12 hospitals within a large hospital system in the southern United States were invited to anonymously complete both safety culture surveys electronically. All safety culture dimensions from both surveys (with the exception of HSOPS's Staffing) had adequate levels of reliability. Three of HSOPS's outcomes-frequency of event reporting, overall perceptions of patient safety, and overall patient safety grade-were significantly correlated with SAQ and HSOPS dimensions of culture at the individual level, with correlations ranging from r=0.41 to 0.65 for the SAQ dimensions and from r=0.22 to 0.72 for the HSOPS dimensions. Neither the SAQ dimensions nor the HSOPS dimensions predicted the fourth HSOPS outcome-number of events reported within the last 12 months. Regression analyses indicated that HSOPS safety culture dimensions were the best predictors of frequency of event reporting and overall perceptions of patient safety while SAQ and HSOPS dimensions both predicted patient safety grade. Unit-level analyses were not conducted because indices did not indicate that aggregation was appropriate. Scores were converted between the surveys, although much variance remained unexplained. Given that the SAQ and HSOPS had similar reliability and predictive validity, investigators and quality and safety leaders should consider survey length, content, sensitivity to change and the ability to benchmark when selecting a patient safety culture survey.

  12. Addressing Uniqueness and Unison of Reliability and Safety for a Better Integration

    NASA Technical Reports Server (NTRS)

    Huang, Zhaofeng; Safie, Fayssal

    2016-01-01

    Over time, it has been observed that Safety and Reliability have not been clearly differentiated, which leads to confusion, inefficiency, and, sometimes, counter-productive practices in executing each of these two disciplines. It is imperative to address this situation to help Reliability and Safety disciplines improve their effectiveness and efficiency. The paper poses an important question to address, "Safety and Reliability - Are they unique or unisonous?" To answer the question, the paper reviewed several most commonly used analyses from each of the disciplines, namely, FMEA, reliability allocation and prediction, reliability design involvement, system safety hazard analysis, Fault Tree Analysis, and Probabilistic Risk Assessment. The paper pointed out uniqueness and unison of Safety and Reliability in their respective roles, requirements, approaches, and tools, and presented some suggestions for enhancing and improving the individual disciplines, as well as promoting the integration of the two. The paper concludes that Safety and Reliability are unique, but compensating each other in many aspects, and need to be integrated. Particularly, the individual roles of Safety and Reliability need to be differentiated, that is, Safety is to ensure and assure the product meets safety requirements, goals, or desires, and Reliability is to ensure and assure maximum achievability of intended design functions. With the integration of Safety and Reliability, personnel can be shared, tools and analyses have to be integrated, and skill sets can be possessed by the same person with the purpose of providing the best value to a product development.

  13. Safety organizing, emotional exhaustion, and turnover in hospital nursing units.

    PubMed

    Vogus, Timothy J; Cooil, Bruce; Sitterding, Mary; Everett, Linda Q

    2014-10-01

    Prior research has found that safety organizing behaviors of registered nurses (RNs) positively impact patient safety. However, little research exists on how engaging in safety organizing affects caregivers. While we know that organizational processes can have divergent effects on organizational and employee outcomes, little research exists on the effects of pursuing highly reliable performance through safety organizing on caregivers. Specifically, we examined whether, and the conditions under which, safety organizing affects RN emotional exhaustion and nursing unit turnover rates. Subjects included 1352 RNs in 50 intensive care, internal medicine, labor, and surgery nursing units in 3 Midwestern acute-care hospitals who completed questionnaires between August and December 2011 and 50 Nurse Managers from the units who completed questionnaires in December 2012. Cross-sectional analyses of RN emotional exhaustion linked to survey data on safety organizing and hospital incident reporting system data on adverse event rates for the year before survey administration. Cross-sectional analysis of unit-level RN turnover rates for the year following the administration of the survey linked to survey data on safety organizing. Multilevel regression analysis indicated that safety organizing was negatively associated with RN emotional exhaustion on units with higher rates of adverse events and positively associated with RN emotional exhaustion with lower rates of adverse events. Tobit regression analyses indicated that safety organizing was associated with lower unit level of turnover rates over time. Safety organizing is beneficial to caregivers in multiple ways, especially on nursing units with high levels of adverse events and over time.

  14. The use of collaboration to implement evidence-based safe practices.

    PubMed

    Clarke, John R

    2013-12-01

    The Pennsylvania Patient Safety Authority receives over 235,000 reports of medical error per year. Near miss and serious event reports of common and interesting problems are analysed to identify best practices for preventing harmful errors. Dissemination of this evidence-based information in the peer-reviewed Pennsylvania Patient Safety Advisory and presentations to medical staffs are not sufficient for adoption of best practices. Adoption of best practices has required working with institutions to identify local barriers to and incentives for adopting best practices and redesigning the delivery system to make desired behaviour easy and undesirable behaviour more difficult. Collaborations, where institutions can learn from the experiences of others, have show decreases in harmful events. The Pennsylvania Program to Prevent Wrong-Site Surgery is used as an example. Two collaborations to prevent wrong-site surgery have been completed, one with 30 institutions in eastern Pennsylvania and one with 19 in western Pennsylvania. The first collaboration achieved a 73% decrease in the rolling average of wrong-site events over 18 months. The second collaboration experienced no wrong-site operating room procedures over more than one year. Significance for public healthSince the Institute of Medicine's To Err is Human identified medical errors as a major cause of death, the public has been interested in the recommendations for reporting of medical errors and implementing safe systems for the delivery of healthcare. The Commonwealth of Pennsylvania has followed those recommendations and found that an essential intermediate step between analysing reports and implementing safe systems is collaborative learning among healthcare institutions. The experience in Pennsylvania should be useful to other public organizations wishing to improve safety.

  15. Evaluation of the association between Hospital Survey on Patient Safety Culture (HSOPS) measures and catheter-associated infections: results of two national collaboratives

    PubMed Central

    Meddings, Jennifer; Reichert, Heidi; Greene, M Todd; Safdar, Nasia; Krein, Sarah L; Olmsted, Russell N; Watson, Sam R; Edson, Barbara; Albert Lesher, Mariana; Saint, Sanjay

    2017-01-01

    Background The Agency for Healthcare Research and Quality (AHRQ) has funded national collaboratives using the Comprehensive Unit-based Safety Program to reduce rates of two catheter-associated infections—central-line-associated bloodstream infection (CLABSI) and catheter-associated urinary tract infection (CAUTI), using evidence-based intervention bundles to improve technical aspects of care and socioadaptive approaches to foster a culture of safety. Objective Examine the association between hospital units' results for the Hospital Survey on Patient Safety Culture (HSOPS) and catheter-associated infection rates. Methods We analysed data from two prospective cohort studies from acute-care intensive care units (ICUs) and non-ICUs participating in the AHRQ CLABSI and CAUTI collaboratives. National Healthcare Safety Network catheter-associated infections per 1000 catheter-days were collected at baseline and quarterly postimplementation. The HSOPS was collected at baseline and again 1 year later. Infection rates were modelled using multilevel negative binomial models as a function of HSOPS components over time, adjusted for hospital-level characteristics. Results 1821 units from 1079 hospitals (CLABSI) and 1576 units from 949 hospitals (CAUTI) were included. Among responding units, infection rates declined over the project periods (by 47% for CLABSI, by 23% for CAUTI, unadjusted). No significant associations were found between CLABSI or CAUTI rates and HSOPS measures at baseline or over time. Conclusions We found no association between results of the HSOPS and catheter-associated infection rates when measured at baseline and postintervention in two successful large national collaboratives focused on prevention of CLABSI and CAUTI. These results suggest that it may be possible to improve CLABSI and CAUTI rates without making significant changes in safety culture, particularly as measured by instruments like HSOPS. PMID:27222593

  16. 78 FR 51664 - Vessel Traffic Service Updates, Including Establishment of Vessel Traffic Service Requirements...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-21

    ... requirements. The changes made by this rule will align regulations with the current operating procedures of the... History V. Discussion of Comments and Changes VI. Regulatory Analyses A. Regulatory Planning and Review B... Waterways Safety System PWSA Ports and Waterways Safety Act SOLAS International Convention for the Safety of...

  17. Exploratory Analyses of the Effects of Managerial Support and Feedback Consequences on Behavioral Safety Maintenance

    ERIC Educational Resources Information Center

    Cooper, M. Dominic

    2006-01-01

    Reviews indicate management commitment is vital to maintain behavioral safety processes. Similarly, the impact of observation frequency on safety behaviors is thought to be important. An employee-driven process which encompassed behavioral observations, goal-setting, and feedback was implemented in a paper mill with 55 workgroups using a…

  18. 77 FR 30443 - Safety Zone; Alexandria Bay Chamber of Commerce, St. Lawrence River, Alexandria Bay, NY

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-23

    ...-AA00 Safety Zone; Alexandria Bay Chamber of Commerce, St. Lawrence River, Alexandria Bay, NY AGENCY... Commerce fireworks display. The safety zone established by this proposed rule is necessary to protect... spectators and vessels during the Alexandria Bay Chamber of Commerce fireworks display. Regulatory Analyses...

  19. Safety evaluation of right turns followed by U-turns as an alternative to direct left turns : crash data analysis, Vol. 1

    DOT National Transportation Integrated Search

    2001-10-01

    This project evaluated the safety and operational impacts of two alternative left-turn treatments from driveway/side streets. The two treatments were: (1) direct left turns and, (2) right turns followed by U-turns. Safety analyses of the alternatives...

  20. Patient Safety Outcomes in Small Urban and Small Rural Hospitals

    ERIC Educational Resources Information Center

    Vartak, Smruti; Ward, Marcia M.; Vaughn, Thomas E.

    2010-01-01

    Purpose: To assess patient safety outcomes in small urban and small rural hospitals and to examine the relationship of hospital and patient factors to patient safety outcomes. Methods: The Nationwide Inpatient Sample and American Hospital Association annual survey data were used for analyses. To increase comparability, the study sample was…

  1. Chemical plant innovative safety investments decision-support methodology.

    PubMed

    Reniers, G L L; Audenaert, A

    2009-01-01

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

  2. Ares I-X Upper Stage Simulator Structural Analyses Supporting the NESC Critical Initial Flaw Size Assessment

    NASA Technical Reports Server (NTRS)

    Knight, Norman F., Jr.; Phillips, Dawn R.; Raju, Ivatury S.

    2008-01-01

    The structural analyses described in the present report were performed in support of the NASA Engineering and Safety Center (NESC) Critical Initial Flaw Size (CIFS) assessment for the ARES I-X Upper Stage Simulator (USS) common shell segment. The structural analysis effort for the NESC assessment had three thrusts: shell buckling analyses, detailed stress analyses of the single-bolt joint test; and stress analyses of two-segment 10 degree-wedge models for the peak axial tensile running load. Elasto-plastic, large-deformation simulations were performed. Stress analysis results indicated that the stress levels were well below the material yield stress for the bounding axial tensile design load. This report also summarizes the analyses and results from parametric studies on modeling the shell-to-gusset weld, flange-surface mismatch, bolt preload, and washer-bearing-surface modeling. These analyses models were used to generate the stress levels specified for the fatigue crack growth assessment using the design load with a factor of safety.

  3. [Internet- and Mobile Based Psychotherapy for Depression].

    PubMed

    Sander, Lasse; Ebert, David Daniel; Baumeister, Harald

    2017-01-01

    Guided Internet- and mobile-based interventions (IMIs) are an effective and scientifically sound treatment option for depression. Meta-analyses revealed effect sizes comparable to those found for face-to-face treatment as well as pharmacotherapy. Today, most IMIs are based on cognitive behavioral therapy (CBT). While IMIs are well established in healthcare systems of many countries worldwide, Germany is still lagging behind. However, there are an increasing number of model projects trying to implement IMIs into routine healthcare for depression in Germany. Both, service providers and recipients would benefit from transparent quality assurance and data safety guidelines. © Georg Thieme Verlag KG Stuttgart · New York.

  4. Integrated Response Time Evaluation Methodology for the Nuclear Safety Instrumentation System

    NASA Astrophysics Data System (ADS)

    Lee, Chang Jae; Yun, Jae Hee

    2017-06-01

    Safety analysis for a nuclear power plant establishes not only an analytical limit (AL) in terms of a measured or calculated variable but also an analytical response time (ART) required to complete protective action after the AL is reached. If the two constraints are met, the safety limit selected to maintain the integrity of physical barriers used for preventing uncontrolled radioactivity release will not be exceeded during anticipated operational occurrences and postulated accidents. Setpoint determination methodologies have actively been developed to ensure that the protective action is initiated before the process conditions reach the AL. However, regarding the ART for a nuclear safety instrumentation system, an integrated evaluation methodology considering the whole design process has not been systematically studied. In order to assure the safety of nuclear power plants, this paper proposes a systematic and integrated response time evaluation methodology that covers safety analyses, system designs, response time analyses, and response time tests. This methodology is applied to safety instrumentation systems for the advanced power reactor 1400 and the optimized power reactor 1000 nuclear power plants in South Korea. The quantitative evaluation results are provided herein. The evaluation results using the proposed methodology demonstrate that the nuclear safety instrumentation systems fully satisfy corresponding requirements of the ART.

  5. Cyclic structural analyses of anisotropic turbine blades for reusable space propulsion systems. [ssme fuel turbopump

    NASA Technical Reports Server (NTRS)

    Manderscheid, J. M.; Kaufman, A.

    1985-01-01

    Turbine blades for reusable space propulsion systems are subject to severe thermomechanical loading cycles that result in large inelastic strains and very short lives. These components require the use of anisotropic high-temperature alloys to meet the safety and durability requirements of such systems. To assess the effects on blade life of material anisotropy, cyclic structural analyses are being performed for the first stage high-pressure fuel turbopump blade of the space shuttle main engine. The blade alloy is directionally solidified MAR-M 246 alloy. The analyses are based on a typical test stand engine cycle. Stress-strain histories at the airfoil critical location are computed using the MARC nonlinear finite-element computer code. The MARC solutions are compared to cyclic response predictions from a simplified structural analysis procedure developed at the NASA Lewis Research Center.

  6. Hydroxyeyhyl starch: Controversies revisited

    PubMed Central

    Datta, Rashmi; Nair, Rajeev; Pandey, Anil; Kumar, Nitish; Sahoo, Tapan

    2014-01-01

    Hydroxyethyl starch (HES) family has been one of the cornerstones in fluid management for over four decades. Recent evidence from clinical studies and meta-analyses has raised few concerns about the safety of these fluids, especially in certain subpopulations of patients. High-quality clinical trials and meta-analyses have emphasized nephrotoxic effects, increased risk of bleeding, and a trend toward higher mortality in these patients after the use of HES solutions. Scientific evidence was derived from international guidelines, aggregated research literature, and opinion-based evidence was obtained from surveys and other activities (e.g., internet postings). On critical analysis of the current data available, it can be summarized that further large scale trials are still indicated before HES can be discarded. PMID:25425769

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

    Dobromir Panayotov; Andrew Grief; Brad J. Merrill

    'Fusion for Energy' (F4E) develops designs and implements the European Test Blanket Systems (TBS) in ITER - Helium-Cooled Lithium-Lead (HCLL) and Helium-Cooled Pebble-Bed (HCPB). Safety demonstration is an essential element for the integration of TBS in ITER and accident analyses are one of its critical segments. A systematic approach to the accident analyses had been acquired under the F4E contract on TBS safety analyses. F4E technical requirements and AMEC and INL efforts resulted in the development of a comprehensive methodology for fusion breeding blanket accident analyses. It addresses the specificity of the breeding blankets design, materials and phenomena and atmore » the same time is consistent with the one already applied to ITER accident analyses. Methodology consists of several phases. At first the reference scenarios are selected on the base of FMEA studies. In the second place elaboration of the accident analyses specifications we use phenomena identification and ranking tables to identify the requirements to be met by the code(s) and TBS models. Thus the limitations of the codes are identified and possible solutions to be built into the models are proposed. These include among others the loose coupling of different codes or code versions in order to simulate multi-fluid flows and phenomena. The code selection and issue of the accident analyses specifications conclude this second step. Furthermore the breeding blanket and ancillary systems models are built on. In this work challenges met and solutions used in the development of both MELCOR and RELAP5 codes models of HCLL and HCPB TBSs will be shared. To continue the developed models are qualified by comparison with finite elements analyses, by code to code comparison and sensitivity studies. Finally, the qualified models are used for the execution of the accident analyses of specific scenario. When possible the methodology phases will be illustrated in the paper by limited number of tables and figures. Description of each phase and its results in detail as well the methodology applications to EU HCLL and HCPB TBSs will be published in separate papers. The developed methodology is applicable to accident analyses of other TBSs to be tested in ITER and as well to DEMO breeding blankets.« less

  8. 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

  9. 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.

  10. Sources of Safety Data and Statistical Strategies for Design and Analysis: Postmarket Surveillance.

    PubMed

    Izem, Rima; Sanchez-Kam, Matilde; Ma, Haijun; Zink, Richard; Zhao, Yueqin

    2018-03-01

    Safety data are continuously evaluated throughout the life cycle of a medical product to accurately assess and characterize the risks associated with the product. The knowledge about a medical product's safety profile continually evolves as safety data accumulate. This paper discusses data sources and analysis considerations for safety signal detection after a medical product is approved for marketing. This manuscript is the second in a series of papers from the American Statistical Association Biopharmaceutical Section Safety Working Group. We share our recommendations for the statistical and graphical methodologies necessary to appropriately analyze, report, and interpret safety outcomes, and we discuss the advantages and disadvantages of safety data obtained from passive postmarketing surveillance systems compared to other sources. Signal detection has traditionally relied on spontaneous reporting databases that have been available worldwide for decades. However, current regulatory guidelines and ease of reporting have increased the size of these databases exponentially over the last few years. With such large databases, data-mining tools using disproportionality analysis and helpful graphics are often used to detect potential signals. Although the data sources have many limitations, analyses of these data have been successful at identifying safety signals postmarketing. Experience analyzing these dynamic data is useful in understanding the potential and limitations of analyses with new data sources such as social media, claims, or electronic medical records data.

  11. Legislative history of recent primary safety belt laws

    DOT National Transportation Integrated Search

    1999-01-01

    This document summarizes the strategies that supported or opposed new legislative provisions and the barriers encountered in modifying safety belt laws prior to December 1997. This study developed legislative analyses of six jurisdictions that upgrad...

  12. Ochratoxin A in cereal-based baby foods: occurrence and safety evaluation.

    PubMed

    Beretta, B; De Domenico, R; Gaiaschi, A; Ballabio, C; Galli, C L; Gigliotti, C; Restani, P

    2002-01-01

    Ochratoxin A is a typical cereal contaminant with strong nephrotoxic activity. To estimate the quantity of ochratoxin A that can be taken in by a child in the weaning period, several samples of cereal-based baby foods were analysed. Although most samples analysed contained ochratoxin A in undetectable amounts or below the Italian legal limit of 0.5 microg kg(-1), some irregular products were found. In particular, the analyses of the 119 batches (338 samples) of baby foods considered indicated that: 20 batches (16.8%) contained detectable quantities of ochratoxin A and four of these (3.4% of the total) contained ochratoxin A above the Italian permitted value. All samples coming from agricultural practices based on integrated pest management contained undetectable amounts of ochratoxin A, while approximately 5% of batches coming from conventional and organic agricultural practices were above the legal limit. On the basis of the established provisional tolerable weekly intake (PTWI), there is no significant toxicological risk for a child who occasionally consumes a formula with ochratoxin concentration slightly above the permitted level. However, stricter controls have to be applied to reject the batches containing irregular concentrations of ochratoxin A.

  13. Intervention Effects on Safety Compliance and Citizenship Behaviors: Evidence from the Work, Family, and Health Study

    PubMed Central

    Hammer, Leslie B.; Johnson, Ryan C.; Crain, Tori L.; Bodner, Todd; Kossek, Ellen Ernst; Davis, Kelly; Kelly, Erin L.; Buxton, Orfeu M.; Karuntzos, Georgia; Chosewood, L. Casey; Berkman, Lisa

    2015-01-01

    We tested the effects of a work-family intervention on employee reports of safety compliance and organizational citizenship behaviors in 30 healthcare facilities using a group-randomized trial. Based on Conservation of Resources theory and the Work-Home Resources Model, we hypothesized that implementing a work-family intervention aimed at increasing contextual resources via supervisor support for work and family and employee control over work time would lead to improved personal resources and increased employee performance on the job in the form of self-reported safety compliance and organizational citizenship behaviors. Multilevel analyses used survey data from 1,524 employees at baseline, 6-month and 12-month post-intervention follow-ups. Significant intervention effects were observed for safety compliance at the 6-month and organizational citizenship behaviors at the 12-month follow-ups. More specifically, results demonstrate that the intervention protected against declines in employee self-reported safety compliance and organizational citizenship behaviors, compared to employees in the control facilities. The hypothesized mediators of perceptions of family supportive supervisor behaviors, control over work time, and work-family conflict (work-to-family conflict, family-to-work conflict) were not significantly improved by the intervention. However, baseline perceptions of family supportive supervisor behaviors, control over work time, and work-family climate were significant moderators of the intervention effect on the self-reported safety compliance and organizational citizenship behavior outcomes. PMID:26348479

  14. [Application of Raman Spectroscopy Technique to Agricultural Products Quality and Safety Determination].

    PubMed

    Liu, Yan-de; Jin, Tan-tan

    2015-09-01

    The quality and safety of agricultural products and people health are inseparable. Using the conventional chemical methods which have so many defects, such as sample pretreatment, complicated operation process and destroying the samples. Raman spectroscopy as a powerful tool of analysing and testing molecular structure, can implement samples quickly without damage, qualitative and quantitative detection analysis. With the continuous improvement and the scope of the application of Raman spectroscopy technology gradually widen, Raman spectroscopy technique plays an important role in agricultural products quality and safety determination, and has wide application prospects. There have been a lot of related research reports based on Raman spectroscopy detection on agricultural product quality safety at present. For the understanding of the principle of detection and the current development situation of Raman spectroscopy, as well as tracking the latest research progress both at home and abroad, the basic principles and the development of Raman spectroscopy as well as the detection device were introduced briefly. The latest research progress of quality and safety determination in fruits and vegetables, livestock and grain by Raman spectroscopy technique were reviewed deeply. Its technical problems for agricultural products quality and safety determination were pointed out. In addition, the text also briefly introduces some information of Raman spectrometer and the application for patent of the portable Raman spectrometer, prospects the future research and application.

  15. 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.

  16. Safety Guided Design Based on Stamp/STPA for Manned Vehicle in Concept Design Phase

    NASA Astrophysics Data System (ADS)

    Ujiie, Ryo; Katahira, Masafumi; Miyamoto, Yuko; Umeda, Hiroki; Leveson, Nancy; Hoshino, Nobuyuki

    2013-09-01

    In manned vehicles, such as the Soyuz and the Space Shuttle, the crew and computer system cooperate to succeed in returning to the earth. While computers increase the functionality of system, they also increase the complexity of the interaction between the controllers (human and computer) and the target dynamics. In some cases, the complexity can produce a serious accident. To prevent such losses, traditional hazard analysis such as FTA has been applied to system development, however it can be used after creating a detailed system because it focuses on detailed component failures. As a result, it's more difficult to eliminate hazard cause early in the process when it is most feasible.STAMP/STPA is a new hazard analysis that can be applied from the early development phase, with the analysis being refined as more detailed decisions are made. In essence, the analysis and design decisions are intertwined and go hand-in-hand. We have applied STAMP/STPA to a concept design of a new JAXA manned vehicle and tried safety guided design of the vehicle. As a result of this trial, it has been shown that STAMP/STPA can be accepted easily by system engineers and the design has been made more sophisticated from a safety viewpoint. The result also shows that the consequences of human errors on system safety can be analysed in the early development phase and the system designed to prevent them. Finally, the paper will discuss an effective way to harmonize this safety guided design approach with system engineering process based on the result of this experience in this project.

  17. Running to Safety: Analysis of Disaster Susceptibility of Neighborhoods and Proximity of Safety Facilities in Silay City, Philippines

    NASA Astrophysics Data System (ADS)

    Patiño, C. L.; Saripada, N. A.; Olavides, R. D.; Sinogaya, J.

    2016-06-01

    Going on foot is the most viable option when emergency responders fail to show up in disaster zones at the quickest and most reasonable time. In the Philippines, the efficacy of disaster management offices is hampered by factors such as, but not limited to, lack of equipment and personnel, distance, and/or poor road networks and traffic systems. In several instances, emergency response times exceed acceptable norms. This study explores the hazard susceptibility, particularly to fire, flood, and landslides, of neighborhoods vis-à-vis their proximity to safety facilities in Silay City, Philippines. Imbang River exposes communities in the city to flooding while the mountainous terrain makes the city landslide prone. Building extraction was done to get the possible human settlements in the city. The building structures were extracted through image processing using a ruleset-based approach in the process of segmentation and classification of LiDAR derivatives and ortho-photos. Neighborhoods were then identified whether they have low to high susceptibility to disaster risks in terms of floods and landslides based on the hazards maps obtained from the Philippines' Mines and Geosciences Bureau (MGB). Service area analyses were performed to determine the safety facilities available to different neighborhoods at varying running times. Locations which are inaccessible or are difficult to run to because of distance and corresponding hazards were determined. Recommendations are given in the form of infrastructure installation, relocation of facilities, safety equipment and vehicle procurement, and policy changes for specific areas in Silay City.

  18. Integrated therapy safety management system

    PubMed Central

    Podtschaske, Beatrice; Fuchs, Daniela; Friesdorf, Wolfgang

    2013-01-01

    Aims The aim is to demonstrate the benefit of the medico-ergonomic approach for the redesign of clinical work systems. Based on the six layer model, a concept for an ‘integrated therapy safety management’ is drafted. This concept could serve as a basis to improve resilience. Methods The concept is developed through a concept-based approach. The state of the art of safety and complexity research in human factors and ergonomics forms the basis. The findings are synthesized to a concept for ‘integrated therapy safety management’. The concept is applied by way of example for the ‘medication process’ to demonstrate its practical implementation. Results The ‘integrated therapy safety management’ is drafted in accordance with the six layer model. This model supports a detailed description of specific work tasks, the corresponding responsibilities and related workflows at different layers by using the concept of ‘bridge managers’. ‘Bridge managers’ anticipate potential errors and monitor the controlled system continuously. If disruptions or disturbances occur, they respond with corrective actions which ensure that no harm results and they initiate preventive measures for future procedures. The concept demonstrates that in a complex work system, the human factor is the key element and final authority to cope with the residual complexity. The expertise of the ‘bridge managers’ and the recursive hierarchical structure results in highly adaptive clinical work systems and increases their resilience. Conclusions The medico-ergonomic approach is a highly promising way of coping with two complexities. It offers a systematic framework for comprehensive analyses of clinical work systems and promotes interdisciplinary collaboration. PMID:24007448

  19. 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.

  20. 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

  1. Accepting managed aquifer recharge of urban storm water reuse: The role of policy-related factors

    NASA Astrophysics Data System (ADS)

    Mankad, Aditi; Walton, Andrea

    2015-12-01

    A between-groups experimental design examined public acceptance for managed aquifer recharge of storm water for indirect potable and nonpotable reuse; acceptance was based on five policy-related variables (fairness, effectiveness, trust, importance of safety assurances, and importance of communication activities). Results showed that public acceptance (N = 408) for managed aquifer recharge of storm water was higher for nonpotable applications, as was the importance of safety assurances. Analyses of variance also showed that perceptions of fairness and effectiveness were higher for a nonpotable scheme, but not trust. A three-step hierarchical regression (Step 1: age, gender, education, and income; Step 2: type of use; Step 3: fairness, effectiveness, trust, safety assurance, and communication activities) demonstrated that type of storm water use and the policy-related factors accounted for 73% of the variance in acceptance of storm water (R2 = 0.74, adjusted R2 = 0.74, F (10, 397) = 113.919, p < 0.001). Age, type of use, and three of the five policy-related factors were also significant individual predictors of acceptance. The most important predictors were perceptions of trust in water authorities, perceptions of effectiveness, and perceptions of fairness. Interestingly, while safety assurance was important in attitudinal acceptance of managed aquifer recharge based on type of use, safety assurance was not found to be significant predictor of acceptance. This research suggests that policy-makers should look to address matters of greater public importance and drive such as fairness, trust, and effectiveness of storm water programs and advocate these at the forefront of their policies, rather than solely on education campaigns.

  2. 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.

  3. Structural equation modeling of the relationships between pesticide poisoning, depressive symptoms and safety behaviors among Colorado farm residents.

    PubMed

    Beseler, Cheryl Lynn; Stallones, Lorann

    2006-01-01

    To use structural equation modeling (SEM) to test the theory that a past pesticide poisoning may act as a mediator in the relationship between depression and safety practices. Depression has been associated with pesticide poisoning and was more strongly associated with safety behaviors than workload, social support or health status of farm residents in a previously published report. A cross-sectional survey of farmers and their spouses was conducted in eight counties in northeastern Colorado. Depressive symptoms were assessed using the Center for Epidemiologic Studies-Depression (CES-D) scale. Exploratory and confirmatory factor analyses were used to identify symptoms most correlated with risk factors for depression and safety practices. SEM was used to examine theoretical causal models of the relationship between depression and poor health, financial difficulties, a history of pesticide poisoning, and safety practices. Exploratory factor analysis identified three factors in the CES-D scale. The SEM showed that poor health, financial difficulties and a history of pesticide poisoning significantly explained the depressive symptoms. Models with an excellent fit for the safety behaviors resulted when modeling the probability that the pesticide poisoning preceded depression, but no fit was possible when reversing the direction and modeling depression preceding pesticide poisoning. Specific depressive symptoms appeared to be significantly associated with primarily animal handling and farm machinery. The order of events, based on SEM results, was a pesticide poisoning preceding depressed mood in relation to safety behaviors.

  4. Microbial food safety in Ghana: a meta-analysis.

    PubMed

    Saba, Courage K S; Gonzalez-Zorn, Bruno

    2012-12-16

    Food safety is a crucial factor in the growth of developing countries worldwide. In this study, we present a meta-analysis of microbiological food safety publications from Ghana. The search words "Ghana food safety", "Ghana food research", and "Ghana food bacteria" were used to search for microbiological food safety publications with related abstracts or titles in PubMed, published between 1997 and 2009. We obtained 183 research articles, from which we excluded articles concerning ready-to-eat microbial fermented foods and waterborne microorganisms as well as articles without abstracts. The criteria used for analysis of these publications were based on an assessment of methodological soundness previously developed for use in the medical field, with some modifications incorporated. The most predominant bacteria in Ghanain foods are Enterobacter spp., Citrobacter spp., Klebsiella spp. and Escherichia spp., which were found to be present in 65%, 50%, 46% and 38% respectively, of the food samples considered in the studies analysed. The most contaminated food samples were macaroni, salad, and milk. Although the methodological quality of the articles was generally sound, most of them did not give directions for future research. Several did not state possible reasons for differences between studies. The microbiological food contamination in Ghana is alarming. However, we found that the downward trend in publications of microbial food safety articles is appalling. Hence a concerted effort in research on food safety is needed in Ghana to help curb the incidence of preventable food-borne disease.

  5. Hazard Analysis and Safety Requirements for Small Drone Operations: To What Extent Do Popular Drones Embed Safety?

    PubMed

    Plioutsias, Anastasios; Karanikas, Nektarios; Chatzimihailidou, Maria Mikela

    2018-03-01

    Currently, published risk analyses for drones refer mainly to commercial systems, use data from civil aviation, and are based on probabilistic approaches without suggesting an inclusive list of hazards and respective requirements. Within this context, this article presents: (1) a set of safety requirements generated from the application of the systems theoretic process analysis (STPA) technique on a generic small drone system; (2) a gap analysis between the set of safety requirements and the ones met by 19 popular drone models; (3) the extent of the differences between those models, their manufacturers, and the countries of origin; and (4) the association of drone prices with the extent they meet the requirements derived by STPA. The application of STPA resulted in 70 safety requirements distributed across the authority, manufacturer, end user, or drone automation levels. A gap analysis showed high dissimilarities regarding the extent to which the 19 drones meet the same safety requirements. Statistical results suggested a positive correlation between drone prices and the extent that the 19 drones studied herein met the safety requirements generated by STPA, and significant differences were identified among the manufacturers. This work complements the existing risk assessment frameworks for small drones, and contributes to the establishment of a commonly endorsed international risk analysis framework. Such a framework will support the development of a holistic and methodologically justified standardization scheme for small drone flights. © 2017 Society for Risk Analysis.

  6. 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

  7. Elaboration and Validation of the Medication Prescription Safety Checklist 1

    PubMed Central

    Pires, Aline de Oliveira Meireles; Ferreira, Maria Beatriz Guimarães; do Nascimento, Kleiton Gonçalves; Felix, Márcia Marques dos Santos; Pires, Patrícia da Silva; Barbosa, Maria Helena

    2017-01-01

    ABSTRACT Objective: to elaborate and validate a checklist to identify compliance with the recommendations for the structure of medication prescriptions, based on the Protocol of the Ministry of Health and the Brazilian Health Surveillance Agency. Method: methodological research, conducted through the validation and reliability analysis process, using a sample of 27 electronic prescriptions. Results: the analyses confirmed the content validity and reliability of the tool. The content validity, obtained by expert assessment, was considered satisfactory as it covered items that represent the compliance with the recommendations regarding the structure of the medication prescriptions. The reliability, assessed through interrater agreement, was excellent (ICC=1.00) and showed perfect agreement (K=1.00). Conclusion: the Medication Prescription Safety Checklist showed to be a valid and reliable tool for the group studied. We hope that this study can contribute to the prevention of adverse events, as well as to the improvement of care quality and safety in medication use. PMID:28793128

  8. Improving surveillance for injuries associated with potential motor vehicle safety defects

    PubMed Central

    Whitfield, R; Whitfield, A

    2004-01-01

    Objective: To improve surveillance for deaths and injuries associated with potential motor vehicle safety defects. Design: Vehicles in fatal crashes can be studied for indications of potential defects using an "early warning" surveillance statistic previously suggested for screening reports of adverse drug reactions. This statistic is illustrated with time series data for fatal, tire related and fire related crashes. Geographic analyses are used to augment the tire related statistics. Results: A statistical criterion based on the Poisson distribution that tests the likelihood of an expected number of events, given the number of events that actually occurred, is a promising method that can be readily adapted for use in injury surveillance. Conclusions: Use of the demonstrated techniques could have helped to avert a well known injury surveillance failure. This method is adaptable to aid in the direction of engineering and statistical reviews to prevent deaths and injuries associated with potential motor vehicle safety defects using available databases. PMID:15066972

  9. Preparing safety data packages for experimenters using the Get Away Special (GAS) carrier system

    NASA Technical Reports Server (NTRS)

    Kosko, Jerome

    1992-01-01

    The implementation of NSTS 1700.7B and more forceful scruntiny of data packages by the Johnson Space Flight Center (JSC) lead to the development of a classification policy for GAS/CAP payloads. The purpose of this policy is to classify experiments using the carrier system so that they receive an appropriate level of JSC review (i.e., one or multiphase reviews). This policy is based on energy containment to show inherent payload safety. It impacts the approach to performing hazard analyses and the nature of the data package. This paper endeavors to explain the impact of this policy as well as the impact of recent JSC as well as Kennedy Space Flight Center (KSC) 'interpretations' of existing requirements. The GAS canister does adequately contain most experiments when flown in the sealed configuration (however this must be shown, not merely stated). This paper also includes data package preparation guidelines for those experiments that require an opening door which often present unique safety issues.

  10. Ares I-X Range Safety Flight Envelope Analysis

    NASA Technical Reports Server (NTRS)

    Starr, Brett R.; Olds, Aaron D.; Craig, Anthony S.

    2011-01-01

    Ares I-X was the first test flight of NASA's Constellation Program's Ares I Crew Launch Vehicle designed to provide manned access to low Earth orbit. As a one-time test flight, the Air Force's 45th Space Wing required a series of Range Safety analysis data products to be developed for the specified launch date and mission trajectory prior to granting flight approval on the Eastern Range. The range safety data package is required to ensure that the public, launch area, and launch complex personnel and resources are provided with an acceptable level of safety and that all aspects of prelaunch and launch operations adhere to applicable public laws. The analysis data products, defined in the Air Force Space Command Manual 91-710, Volume 2, consisted of a nominal trajectory, three sigma trajectory envelopes, stage impact footprints, acoustic intensity contours, trajectory turn angles resulting from potential vehicle malfunctions (including flight software failures), characterization of potential debris, and debris impact footprints. These data products were developed under the auspices of the Constellation's Program Launch Constellation Range Safety Panel and its Range Safety Trajectory Working Group with the intent of beginning the framework for the operational vehicle data products and providing programmatic review and oversight. A multi-center NASA team in conjunction with the 45th Space Wing, collaborated within the Trajectory Working Group forum to define the data product development processes, performed the analyses necessary to generate the data products, and performed independent verification and validation of the data products. This paper outlines the Range Safety data requirements and provides an overview of the processes established to develop both the data products and the individual analyses used to develop the data products, and it summarizes the results of the analyses required for the Ares I-X launch.

  11. Assessing the viability of bacterial species in drinking water by combined cellular and molecular analyses.

    PubMed

    Kahlisch, Leila; Henne, Karsten; Gröbe, Lothar; Brettar, Ingrid; Höfle, Manfred G

    2012-02-01

    The question which bacterial species are present in water and if they are viable is essential for drinking water safety but also of general relevance in aquatic ecology. To approach this question we combined propidium iodide/SYTO9 staining ("live/dead staining" indicating membrane integrity), fluorescence-activated cell sorting (FACS) and community fingerprinting for the analysis of a set of tap water samples. Live/dead staining revealed that about half of the bacteria in the tap water had intact membranes. Molecular analysis using 16S rRNA and 16S rRNA gene-based single-strand conformation polymorphism (SSCP) fingerprints and sequencing of drinking water bacteria before and after FACS sorting revealed: (1) the DNA- and RNA-based overall community structure differed substantially, (2) the community retrieved from RNA and DNA reflected different bacterial species, classified as 53 phylotypes (with only two common phylotypes), (3) the percentage of phylotypes with intact membranes or damaged cells were comparable for RNA- and DNA-based analyses, and (4) the retrieved species were primarily of aquatic origin. The pronounced difference between phylotypes obtained from DNA extracts (dominated by Betaproteobacteria, Bacteroidetes, and Actinobacteria) and from RNA extracts (dominated by Alpha-, Beta-, Gammaproteobacteria, Bacteroidetes, and Cyanobacteria) demonstrate the relevance of concomitant RNA and DNA analyses for drinking water studies. Unexpected was that a comparable fraction (about 21%) of phylotypes with membrane-injured cells was observed for DNA- and RNA-based analyses, contradicting the current understanding that RNA-based analyses represent the actively growing fraction of the bacterial community. Overall, we think that this combined approach provides an interesting tool for a concomitant phylogenetic and viability analysis of bacterial species of drinking water.

  12. Seismic behavior of a low-rise horizontal cylindrical tank

    NASA Astrophysics Data System (ADS)

    Fiore, Alessandra; Rago, Carlo; Vanzi, Ivo; Greco, Rita; Briseghella, Bruno

    2018-05-01

    Cylindrical storage tanks are widely used for various types of liquids, including hazardous contents, thus requiring suitable and careful design for seismic actions. The study herein presented deals with the dynamic analysis of a ground-based horizontal cylindrical tank containing butane and with its safety verification. The analyses are based on a detailed finite element (FE) model; a simplified one-degree-of-freedom idealization is also set up and used for verification of the FE results. Particular attention is paid to sloshing and asynchronous seismic input effects. Sloshing effects are investigated according to the current literature state of the art. An efficient methodology based on an "impulsive-convective" decomposition of the container-fluid motion is adopted for the calculation of the seismic force. The effects of asynchronous ground motion are studied by suitable pseudo-static analyses. Comparison between seismic action effects, obtained with and without consideration of sloshing and asynchronous seismic input, shows a rather important influence of these conditions on the final results.

  13. Migration Experiences of Foreign Educated Nurses: A Systematic Review of the Literature.

    PubMed

    Moyce, Sally; Lash, Rebecca; de Leon Siantz, Mary Lou

    2016-03-01

    Global nurse migration has a recognized impact on host and source countries, but the lived experience of foreign educated nurses is an important aspect of the success of this migration. A systematic review of the literature was conducted to understand the lived migration and acculturation experiences of foreign educated nurses. A systematic review of the literature, based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, was conducted. Primary research articles or secondary analyses were selected based on keyword and citation-based searches (n = 44). Nurses' experiences included migration and licensing barriers, difficulty with communication, racism and discrimination, skill underutilization, acculturation, and the role of the family. Barriers encountered in host countries may impede acculturation and successful nursing practice, resulting in circular migration and poor patient safety outcomes. Social support systems and cultural orientation programs can mitigate the impacts of social isolation and racism. Addressing common barriers can help minimize deskilling and allow safe and effective transitions to host countries. © The Author(s) 2015.

  14. Seismic Safety Of Simple Masonry Buildings

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

    Guadagnuolo, Mariateresa; Faella, Giuseppe

    2008-07-08

    Several masonry buildings comply with the rules for simple buildings provided by seismic codes. For these buildings explicit safety verifications are not compulsory if specific code rules are fulfilled. In fact it is assumed that their fulfilment ensures a suitable seismic behaviour of buildings and thus adequate safety under earthquakes. Italian and European seismic codes differ in the requirements for simple masonry buildings, mostly concerning the building typology, the building geometry and the acceleration at site. Obviously, a wide percentage of buildings assumed simple by codes should satisfy the numerical safety verification, so that no confusion and uncertainty have tomore » be given rise to designers who must use the codes. This paper aims at evaluating the seismic response of some simple unreinforced masonry buildings that comply with the provisions of the new Italian seismic code. Two-story buildings, having different geometry, are analysed and results from nonlinear static analyses performed by varying the acceleration at site are presented and discussed. Indications on the congruence between code rules and results of numerical analyses performed according to the code itself are supplied and, in this context, the obtained result can provide a contribution for improving the seismic code requirements.« less

  15. Safety and capacity evaluation for interstates in Kentucky.

    DOT National Transportation Integrated Search

    2005-04-01

    This analysis and evaluation was directed toward assessing safety and capacity issues on interstates in Kentucky and, particularly, the manner in which commercial vehicle traffic affects these issues. Analyses was undertaken to show past trends and p...

  16. Medical Device Safety

    MedlinePlus

    ... Cooling and Heating Systems and HX2™ Temperature Management Systems Due to Revised Cleaning Instructions 05/07/18 More Medical Device Recalls Recent Medical Device Safety Communications FDA analyses and recommendations for patients and health care providers about ongoing ...

  17. Active SMS-based influenza vaccine safety surveillance in Australian children.

    PubMed

    Pillsbury, Alexis; Quinn, Helen; Cashman, Patrick; Leeb, Alan; Macartney, Kristine

    2017-12-18

    Australia's novel, active surveillance system, AusVaxSafety, monitors the post-market safety of vaccines in near real time. We analysed cumulative surveillance data for children aged 6 months to 4 years who received seasonal influenza vaccine in 2015 and/or 2016 to determine: adverse event following immunisation (AEFI) rates by vaccine brand, age and concomitant vaccine administration. Parent/carer reports of AEFI occurring within 3 days of their child receiving an influenza vaccine in sentinel immunisation clinics were solicited by Short Message Service (SMS) and/or email-based survey. Retrospective data from 2 years were combined to examine specific AEFI rates, particularly fever and medical attendance as a proxy for serious adverse events (SAE), with and without concomitant vaccine administration. As trivalent influenza vaccines (TIV) were funded in Australia's National Immunisation Program (NIP) in 2015 and quadrivalent (QIV) in 2016, respectively, we compared their safety profiles. 7402 children were included. Data were reported weekly through each vaccination season; no safety signals or excess of adverse events were detected. More children who received a concomitant vaccine had fever (7.5% versus 2.8%; p < .001). Meningococcal B vaccine was associated with the highest increase in AEFI rates among children receiving a specified concomitant vaccine: 30.3% reported an AEFI compared with 7.3% who received an influenza vaccine alone (p < .001). Reported fever was strongly associated with medical attendance (OR: 42.6; 95% Confidence Interval (CI): 25.6-71.0). TIV and QIV safety profiles included low and expected AEFI rates (fever: 4.3% for TIV compared with 3.2% for QIV (p = .015); injection site reaction: 1.9% for TIV compared with 3.0% for QIV (p < .001)). There was no difference in safety profile between brands. Active participant-reported data provided timely vaccine brand-specific safety information. Our surveillance system has particular utility in monitoring the safety of influenza vaccines, given that they may vary in composition annually. Copyright © 2017 Elsevier Ltd. All rights reserved.

  18. Measurement equivalence of patient safety climate in Chinese hospitals: can we compare across physicians and nurses?

    PubMed

    Zhu, Junya

    2018-06-11

    Self-report instruments have been widely used to better understand variations in patient safety climate between physicians and nurses. Research is needed to determine whether differences in patient safety climate reflect true differences in the underlying concepts. This is known as measurement equivalence, which is a prerequisite for meaningful group comparisons. This study aims to examine the degree of measurement equivalence of the responses to a patient safety climate survey of Chinese hospitals and to demonstrate how the measurement equivalence method can be applied to self-report climate surveys for patient safety research. Using data from the Chinese Hospital Survey of Patient Safety Climate from six Chinese hospitals in 2011, we constructed two groups: physicians and nurses (346 per group). We used multiple-group confirmatory factor analyses to examine progressively more stringent restrictions for measurement equivalence. We identified weak factorial equivalence across the two groups. Strong factorial equivalence was found for Organizational Learning, Unit Management Support for Safety, Adequacy of Safety Arrangements, Institutional Commitment to Safety, Error Reporting and Teamwork. Strong factorial equivalence, however, was not found for Safety System, Communication and Peer Support and Staffing. Nevertheless, further analyses suggested that nonequivalence did not meaningfully affect the conclusions regarding physician-nurse differences in patient safety climate. Our results provide evidence of at least partial equivalence of the survey responses between nurses and physicians, supporting mean comparisons of its constructs between the two groups. The measurement equivalence approach is essential to ensure that conclusions about group differences are valid.

  19. Improving Elementary School Quality Through the Use of a Social-Emotional and Character Development Program: A Matched-Pair, Cluster-Randomized, Controlled Trial in Hawai’i

    PubMed Central

    Snyder, Frank J.; Vuchinich, Samuel; Acock, Alan; Washburn, Isaac J.; Flay, Brian R.

    2012-01-01

    BACKGROUND School safety and quality affect student learning and success. This study examined the effects of a comprehensive elementary school-wide social-emotional and character education program, Positive Action, on teacher, parent, and student perceptions of school safety and quality utilizing a matched-pair, cluster-randomized, controlled design. The Positive Action Hawai’i trial included 20 racially/ethnically diverse schools and was conducted from 2002–2003 through 2005–2006. METHODS School-level archival data, collected by the Hawai’i Department of Education, were used to examine program effects at 1-year post-trial. Teacher, parent, and student data were analyzed to examine indicators of school quality such as student safety and well-being, involvement, and satisfaction, as well as overall school quality. Matched-paired t-tests were used for the primary analysis, and sensitivity analyses included permutation tests and random-intercept growth curve models. RESULTS Analyses comparing change from baseline to 1-year post-trial revealed that intervention schools demonstrated significantly improved school quality compared to control schools, with 21%, 13%, and 16% better overall school quality scores as reported by teachers, parents, and students, respectively. Teacher, parent, and student reports on individual school-quality indicators showed improvement in student safety and well-being, involvement, satisfaction, quality student support, focused and sustained action, standards-based learning, professionalism and system capacity, and coordinated team work. Teacher reports also showed an improvement in the responsiveness of the system. CONCLUSIONS School quality was substantially improved, providing evidence that a school-wide social-emotional and character education program can enhance school quality and facilitate whole-school change. PMID:22142170

  20. Improving elementary school quality through the use of a social-emotional and character development program: a matched-pair, cluster-randomized, controlled trial in Hawai'i.

    PubMed

    Snyder, Frank J; Vuchinich, Samuel; Acock, Alan; Washburn, Isaac J; Flay, Brian R

    2012-01-01

    School safety and quality affect student learning and success. This study examined the effects of a comprehensive elementary school-wide social-emotional and character education program, Positive Action, on teacher, parent, and student perceptions of school safety and quality utilizing a matched-pair, cluster-randomized, controlled design. The Positive Action Hawai'i trial included 20 racially/ethnically diverse schools and was conducted from 2002-2003 through 2005-2006. School-level archival data, collected by the Hawai'i Department of Education, were used to examine program effects at 1-year post-trial. Teacher, parent, and student data were analyzed to examine indicators of school quality such as student safety and well-being, involvement, and satisfaction, as well as overall school quality. Matched-paired t-tests were used for the primary analysis, and sensitivity analyses included permutation tests and random-intercept growth curve models. Analyses comparing change from baseline to 1-year post-trial revealed that intervention schools demonstrated significantly improved school quality compared to control schools, with 21%, 13%, and 16% better overall school quality scores as reported by teachers, parents, and students, respectively. Teacher, parent, and student reports on individual school-quality indicators showed improvement in student safety and well-being, involvement, satisfaction, quality student support, focused and sustained action, standards-based learning, professionalism and system capacity, and coordinated team work. Teacher reports also showed an improvement in the responsiveness of the system. School quality was substantially improved, providing evidence that a school-wide social-emotional and character education program can enhance school quality and facilitate whole-school change. © 2011, American School Health Association.

  1. Child pedestrian safety knowledge, behaviour and road injury in Cape Town, South Africa.

    PubMed

    Koekemoer, Karin; Van Gesselleen, Megan; Van Niekerk, Ashley; Govender, Rajen; Van As, Arjan Bastiaan

    2017-02-01

    Pedestrian injuries are a leading cause of death among South African children, and young children residing in low-income communities are more at risk, due to various factors such as inadequate road infrastructure, exposure to traffic due to reliance on walking as a means of transport, and lack of supervision. This study used a cross-sectional, non-randomized self-report survey to assess pedestrian safety knowledge, road-crossing behaviour and pedestrian injuries of primary school children in selected low-income settings in Cape Town. The survey focused on three primary schools that had joined the Safe Kids Worldwide Model School Zone Project and was administered to 536 children aged 6-15 years, in their home language of isiXhosa. Descriptive and bivariate analyses as well as multivariate regression analyses were conducted to investigate potential predictor variables for pedestrian collision severity and unsafe road-crossing behaviour. Walking was the sole form of travel for 81% of the children, with a large proportion regularly walking unsupervised. Children who walk to or from school alone were younger and reported riskier road-crossing behaviour, although children who walk accompanied tended to have higher pedestrian collision severity. "Negligent Behaviour" related to road-crossing was significantly associated with higher pedestrian collision severity, with predictors of "Negligent Behaviour" including the lack of pedestrian safety knowledge and greater exposure to traffic in terms of time spent walking. More than half of the reported pedestrian collisions involved a bicycle, and older boys (10-15 years) were most at risk of experiencing a severe pedestrian injury. The findings substantiate emerging evidence that children in low-income settings are at greater risk for child pedestrian injury, and emphasise the need for evidence-based safety promotion and injury prevention interventions in these settings. Copyright © 2016. Published by Elsevier Ltd.

  2. Long-term safety and effectiveness of lopinavir/ritonavir in antiretroviral-experienced HIV-1-infected children.

    PubMed

    Rudin, Christoph; Wolbers, Marcel; Nadal, David; Rickenbach, Martin; Bucher, Heiner C

    2010-06-01

    To evaluate the long-term safety and effectiveness of lopinavir/ritonavir (LPV/r) in a population-based cohort of HIV-1-infected children. All children enrolled in the Swiss Mother and Child HIV Cohort Study, treated with LPV/r-based combination antiretroviral treatment (cART) between November 2000 and October 2008, were included. 88 children (25 (28%) protease inhibitor (PI)-naive, 16 (18%) ART-naive) were analysed (251 patient-years on LPV/r). After 48 weeks on LPV/r, 70 children had a median (interquartile range (IQR)) decrease in HIV-1 viral load of 4.25 log (5.45-3.17; PI-naive, n=17) and 2.53 (3.68-1.38; PI-experienced, n=53). Median (IQR) increase in CD4 count was 429 (203-593; PI-naive) and 177 (21-331; PI-experienced) cells/microl. These effects remained stable throughout 192 weeks for 25 children. Treatment was stopped for viral rebound in seven and suspected toxicity in 12 children. Long-term treatment with LPV/r-based cART is safe and effective in HIV-1-infected children.

  3. A procedure for seismic risk reduction in Campania Region

    NASA Astrophysics Data System (ADS)

    Zuccaro, G.; Palmieri, M.; Maggiò, F.; Cicalese, S.; Grassi, V.; Rauci, M.

    2008-07-01

    The Campania Region has set and performed a peculiar procedure in the field of seismic risk reduction. Great attention has been paid to public strategic buildings such as town halls, civil protection buildings and schools. The Ordinance 3274 promulgate in the 2004 by the Italian central authority obliged the owners of strategic buildings to perform seismic analyses within 2008 in order to check the safety of the structures and the adequacy to the use. In the procedure the Campania region, instead of the local authorities, ensure the complete drafting of seismic checks through financial resources of the Italian Government. A regional scientific technical committee has been constituted, composed of scientific experts, academics in seismic engineering. The committee has drawn up guidelines for the processing of seismic analyses. At the same time, the Region has issued a public competition to select technical seismic engineering experts to appoint seismic analysis in accordance with guidelines. The scientific committee has the option of requiring additional documents and studies in order to approve the safety checks elaborated. The Committee is supported by a technical and administrative secretariat composed of a group of expert in seismic engineering. At the moment several seismic safety checks have been completed. The results will be presented in this paper. Moreover, the policy to mitigate the seismic risk, set by Campania region, was to spend the most of the financial resources available on structural strengthening of public strategic buildings rather than in safety checks. A first set of buildings of which the response under seismic action was already known by data and studies of vulnerability previously realised, were selected for immediate retrofitting designs. Secondly, an other set of buildings were identified for structural strengthening. These were selected by using the criteria specified in the Guide Line prepared by the Scientific Committee and based on data obtained by the first set of safety checks. The strengthening philosophy adopt in the projects will be described in the paper.

  4. Pirfenidone safety and adverse event management in idiopathic pulmonary fibrosis.

    PubMed

    Lancaster, Lisa H; de Andrade, Joao A; Zibrak, Joseph D; Padilla, Maria L; Albera, Carlo; Nathan, Steven D; Wijsenbeek, Marlies S; Stauffer, John L; Kirchgaessler, Klaus-Uwe; Costabel, Ulrich

    2017-12-31

    Pirfenidone is one of two approved therapies for the treatment of idiopathic pulmonary fibrosis (IPF). Randomised controlled clinical trials and subsequent post hoc analyses have demonstrated that pirfenidone reduces lung function decline, decreases mortality and improves progression-free survival. Long-term extension trials, registries and real-world studies have also shown similar treatment effects with pirfenidone. However, for patients with IPF to obtain the maximum benefits of pirfenidone treatment, the potential adverse events (AEs) associated with pirfenidone need to be managed. This review highlights the well-known and established safety profile of pirfenidone based on randomised controlled clinical trials and real-world data. Key strategies for preventing and managing the most common pirfenidone-related AEs are described, with the goal of maximising adherence to pirfenidone with minimal AEs. Copyright ©ERS 2017.

  5. Assessing causality in drug policy analyses: How useful are the Bradford Hill criteria in analysing take-home naloxone programs?

    PubMed

    Olsen, Anna; McDonald, David; Lenton, Simon; Dietze, Paul M

    2018-05-01

    The Bradford Hill criteria for assessing causality are useful in assembling evidence, including within complex policy analyses. In this paper, we argue that the implementation of take-home naloxone (THN) programs in Australia and elsewhere reflects sensible, evidence-based public health policy, despite the absence of randomised controlled trials. However, we also acknowledge that the debate around expanding access to THN would benefit from a careful consideration of causal inference and health policy impact of THN program implementation. Given the continued debate around expanding access to THN, and the relatively recent access to new data from implementation studies, two research groups independently conducted Bradford Hill analyses in order to carefully consider causal inference and health policy impact. Hill's criteria offer a useful analytical tool for interpreting current evidence on THN programs and making decisions about the (un)certainty of THN program safety and effectiveness. © 2017 Australasian Professional Society on Alcohol and other Drugs.

  6. Infusing Reliability Techniques into Software Safety Analysis

    NASA Technical Reports Server (NTRS)

    Shi, Ying

    2015-01-01

    Software safety analysis for a large software intensive system is always a challenge. Software safety practitioners need to ensure that software related hazards are completely identified, controlled, and tracked. This paper discusses in detail how to incorporate the traditional reliability techniques into the entire software safety analysis process. In addition, this paper addresses how information can be effectively shared between the various practitioners involved in the software safety analyses. The author has successfully applied the approach to several aerospace applications. Examples are provided to illustrate the key steps of the proposed approach.

  7. Proceedings of the Nuclear Criticality Technology Safety Workshop

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

    Rene G. Sanchez

    1998-04-01

    This document contains summaries of most of the papers presented at the 1995 Nuclear Criticality Technology Safety Project (NCTSP) meeting, which was held May 16 and 17 at San Diego, Ca. The meeting was broken up into seven sessions, which covered the following topics: (1) Criticality Safety of Project Sapphire; (2) Relevant Experiments For Criticality Safety; (3) Interactions with the Former Soviet Union; (4) Misapplications and Limitations of Monte Carlo Methods Directed Toward Criticality Safety Analyses; (5) Monte Carlo Vulnerabilities of Execution and Interpretation; (6) Monte Carlo Vulnerabilities of Representation; and (7) Benchmark Comparisons.

  8. Safety assessment of historical masonry churches based on pre-assigned kinematic limit analysis, FE limit and pushover analyses

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

    Milani, Gabriele, E-mail: milani@stru.polimi.it; Valente, Marco, E-mail: milani@stru.polimi.it

    2014-10-06

    This study presents some results of a comprehensive numerical analysis on three masonry churches damaged by the recent Emilia-Romagna (Italy) seismic events occurred in May 2012. The numerical study comprises: (a) pushover analyses conducted with a commercial code, standard nonlinear material models and two different horizontal load distributions; (b) FE kinematic limit analyses performed using a non-commercial software based on a preliminary homogenization of the masonry materials and a subsequent limit analysis with triangular elements and interfaces; (c) kinematic limit analyses conducted in agreement with the Italian code and based on the a-priori assumption of preassigned failure mechanisms, where themore » masonry material is considered unable to withstand tensile stresses. All models are capable of giving information on the active failure mechanism and the base shear at failure, which, if properly made non-dimensional with the weight of the structure, gives also an indication of the horizontal peak ground acceleration causing the collapse of the church. The results obtained from all three models indicate that the collapse is usually due to the activation of partial mechanisms (apse, façade, lateral walls, etc.). Moreover the horizontal peak ground acceleration associated to the collapse is largely lower than that required in that seismic zone by the Italian code for ordinary buildings. These outcomes highlight that structural upgrading interventions would be extremely beneficial for the considerable reduction of the seismic vulnerability of such kind of historical structures.« less

  9. Automatic recognition of falls in gait-slip training: Harness load cell based criteria.

    PubMed

    Yang, Feng; Pai, Yi-Chung

    2011-08-11

    Over-head-harness systems, equipped with load cell sensors, are essential to the participants' safety and to the outcome assessment in perturbation training. The purpose of this study was to first develop an automatic outcome recognition criterion among young adults for gait-slip training and then verify such criterion among older adults. Each of 39 young and 71 older subjects, all protected by safety harness, experienced 8 unannounced, repeated slips, while walking on a 7m walkway. Each trial was monitored with a motion capture system, bilateral ground reaction force (GRF), harness force, and video recording. The fall trials were first unambiguously indentified with careful visual inspection of all video records. The recoveries without balance loss (in which subjects' trailing foot landed anteriorly to the slipping foot) were also first fully recognized from motion and GRF analyses. These analyses then set the gold standard for the outcome recognition with load cell measurements. Logistic regression analyses based on young subjects' data revealed that the peak load cell force was the best predictor of falls (with 100% accuracy) at the threshold of 30% body weight. On the other hand, the peak moving average force of load cell across 1s period, was the best predictor (with 100% accuracy) separating recoveries with backward balance loss (in which the recovery step landed posterior to slipping foot) from harness assistance at the threshold of 4.5% body weight. These threshold values were fully verified using the data from older adults (100% accuracy in recognizing falls). Because of the increasing popularity in the perturbation training coupling with the protective over-head-harness system, this new criterion could have far reaching implications in automatic outcome recognition during the movement therapy. Copyright © 2011 Elsevier Ltd. All rights reserved.

  10. AUTOMATIC RECOGNITION OF FALLS IN GAIT-SLIP: A HARNESS LOAD CELL BASED CRITERION

    PubMed Central

    Yang, Feng; Pai, Yi-Chung

    2012-01-01

    Over-head-harness systems, equipped with load cell sensors, are essential to the participants’ safety and to the outcome assessment in perturbation training. The purpose of this study was to first develop an automatic outcome recognition criterion among young adults for gait-slip training and then verify such criterion among older adults. Each of 39 young and 71 older subjects, all protected by safety harness, experienced 8 unannounced, repeated slips, while walking on a 7-m walkway. Each trial was monitored with a motion capture system, bilateral ground reaction force (GRF), harness force and video recording. The fall trials were first unambiguously indentified with careful visual inspection of all video records. The recoveries without balance loss (in which subjects’ trailing foot landed anteriorly to the slipping foot) were also first fully recognized from motion and GRF analyses. These analyses then set the gold standard for the outcome recognition with load cell measurements. Logistic regression analyses based on young subjects’ data revealed that peak load cell force was the best predictor of falls (with 100% accuracy) at the threshold of 30% body weight. On the other hand, the peak moving average force of load cell across 1-s period, was the best predictor (with 100% accuracy) separating recoveries with backward balance loss (in which the recovery step landed posterior to slipping foot) from harness assistance at the threshold of 4.5% body weight. These threshold values were fully verified using the data from older adults (100% accuracy in recognizing falls). Because of the increasing popularity in the perturbation training coupling with the protective over-head-harness system, this new criterion could have far reaching implications in automatic outcome recognition during the movement therapy. PMID:21696744

  11. 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

  12. Efficacy and safety of fixed dose combination of arterolane maleate and piperaquine phosphate dispersible tablets in paediatric patients with acute uncomplicated Plasmodium falciparum malaria: a phase II, multicentric, open-label study.

    PubMed

    Toure, Offianan Andre; Rulisa, Stephen; Anvikar, Anupkumar R; Rao, Ballamudi S; Mishra, Pitabas; Jalali, Rajinder K; Arora, Sudershan; Roy, Arjun; Saha, Nilanjan; Iyer, Sunil S; Sharma, Pradeep; Valecha, Neena

    2015-11-25

    The World Health Organization (WHO) recommends artemisinin combination therapy (ACT) for the treatment of uncomplicated Plasmodium falciparum malaria. The present study investigated the efficacy and safety of fixed dose combination (FDC) of arterolane maleate 37.5 mg and piperaquine phosphate (PQP) 187.5 mg dispersible tablets in paediatric patients aged 6 months to 12 years. Male and female patients aged 6 months to 12 years who were confirmed cases of P. falciparum mono-infection with fever or documented history of fever in the previous 24 h were included. The patients were administered FDC of arterolane maleate and PQP as single daily doses for three consecutive days based on their age. The primary efficacy outcome was proportion of patients with polymerase chain reaction (PCR)-corrected adequate clinical and parasitological response (ACPR) on day 28. Safety was analysed based on adverse events (AE), laboratory abnormalities and abnormalities on electrocardiograph. A total of 141 eligible paediatric patients received FDC of arterolane maleate and PQP in a 42-day follow-up study. All the enrolled patients (141) were included in intention to treat (ITT) and safety analyses, and 126 patients were considered in per protocol (PP) population. The PCR-corrected ACPR on day 28 was achieved in all patients (100 %; 95 % CI 97.11-100) included in PP population. The median parasite clearance time (PCT) and fever clearance time (FCT) were 24 h (95 % CI 18.0-24.0) and 10 h (95 % CI 4.0-18.0), respectively. The most frequently reported clinical AE was vomiting. Majority of the AEs were mild to moderate in severity and resolved without sequelae. No patient was discontinued for any QTc (corrected QT interval) prolongation. No deaths or serious AEs were reported during the study. The findings from this study showed that FDC of arterolane maleate and PQP effectively cures P. falciparum malaria and attains acceptable level of cure by day 28 in paediatric patients. The efficacy and safety results observed in children warrants further studies on FDC of arterolane maleate and PQP dispersible tablets. Clinical Trial Registry India: CTRI/2009/091/000531.

  13. 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.

  14. Nuclear safety, Volume 38, Number 1, January--March 1997

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

    None

    1997-03-01

    This journal contains nine articles which fall under the following categories: (1) general safety considerations; (2) control and instrumentation; (3) design features (4) environmental effects; (5) US Nuclear Regulatory Commission information and analyses; and (6) recent developments.

  15. Sensorimotor and postural control factors associated with driving safety in a community-dwelling older driver population.

    PubMed

    Lacherez, Philippe; Wood, Joanne M; Anstey, Kaarin J; Lord, Stephen R

    2014-02-01

    To establish whether sensorimotor function and balance are associated with on-road driving performance in older adults. The performance of 270 community-living adults aged 70-88 years recruited via the electoral roll was measured on a battery of peripheral sensation, strength, flexibility, reaction time, and balance tests and on a standardized measure of on-road driving performance. Forty-seven participants (17.4%) were classified as unsafe based on their driving assessment. Unsafe driving was associated with reduced peripheral sensation, lower limb weakness, reduced neck range of motion, slow reaction time, and poor balance in univariate analyses. Multivariate logistic regression analysis identified poor vibration sensitivity, reduced quadriceps strength, and increased sway on a foam surface with eyes closed as significant and independent risk factors for unsafe driving. These variables classified participants into safe and unsafe drivers with a sensitivity of 74% and specificity of 70%. A number of sensorimotor and balance measures were associated with driver safety and the multivariate model comprising measures of sensation, strength, and balance was highly predictive of unsafe driving in this sample. These findings highlight important determinants of driver safety and may assist in developing efficacious driver safety strategies for older drivers.

  16. Cognitive-Behavioral Family Treatment for Suicide Attempt Prevention: A Randomized Controlled Trial.

    PubMed

    Asarnow, Joan Rosenbaum; Hughes, Jennifer L; Babeva, Kalina N; Sugar, Catherine A

    2017-06-01

    Suicide is a leading cause of death. New data indicate alarming increases in suicide death rates, yet no treatments with replicated efficacy or effectiveness exist for youths with self-harm presentations, a high-risk group for both fatal and nonfatal suicide attempts. We addressed this gap by evaluating Safe Alternatives for Teens and Youths (SAFETY), a cognitive-behavioral, dialectical behavior therapy-informed family treatment designed to promote safety. Randomized controlled trial for adolescents (12-18 years of age) with recent (past 3 months) suicide attempts or other self-harm. Youth were randomized either to SAFETY or to treatment as usual enhanced by parent education and support accessing community treatment (E-TAU). Outcomes were evaluated at baseline, 3 months, or end of treatment period, and were followed up through 6 to 12 months. The primary outcome was youth-reported incident suicide attempts through the 3-month follow-up. Survival analyses indicated a significantly higher probability of survival without a suicide attempt by the 3-month follow-up point among SAFETY youths (cumulative estimated probability of survival without suicide attempt = 1.00, standard error = 0), compared to E-TAU youths (cumulative estimated probability of survival without suicide attempt = 0.67, standard error = 0.14; z = 2.45, p = .02, number needed to treat = 3) and for the overall survival curves (Wilcoxon χ 2 1  = 5.81, p = .02). Sensitivity analyses using parent report when youth report was unavailable and conservative assumptions regarding missing data yielded similar results for 3-month outcomes. Results support the efficacy of SAFETY for preventing suicide attempts in adolescents presenting with recent self-harm. This is the second randomized trial to demonstrate that treatment including cognitive-behavioral and family components can provide some protection from suicide attempt risk in these high-risk youths. Clinical trial registration information-Effectiveness of a Family-Based Intervention for Adolescent Suicide Attempters (The SAFETY Study); http://clinicaltrials.gov/; NCT00692302. Copyright © 2017 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

  17. Modeling and Simulations for the High Flux Isotope Reactor Cycle 400

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

    Ilas, Germina; Chandler, David; Ade, Brian J

    2015-03-01

    A concerted effort over the past few years has been focused on enhancing the core model for the High Flux Isotope Reactor (HFIR), as part of a comprehensive study for HFIR conversion from high-enriched uranium (HEU) to low-enriched uranium (LEU) fuel. At this time, the core model used to perform analyses in support of HFIR operation is an MCNP model for the beginning of Cycle 400, which was documented in detail in a 2005 technical report. A HFIR core depletion model that is based on current state-of-the-art methods and nuclear data was needed to serve as reference for the designmore » of an LEU fuel for HFIR. The recent enhancements in modeling and simulations for HFIR that are discussed in the present report include: (1) revision of the 2005 MCNP model for the beginning of Cycle 400 to improve the modeling data and assumptions as necessary based on appropriate primary reference sources HFIR drawings and reports; (2) improvement of the fuel region model, including an explicit representation for the involute fuel plate geometry that is characteristic to HFIR fuel; and (3) revision of the Monte Carlo-based depletion model for HFIR in use since 2009 but never documented in detail, with the development of a new depletion model for the HFIR explicit fuel plate representation. The new HFIR models for Cycle 400 are used to determine various metrics of relevance to reactor performance and safety assessments. The calculated metrics are compared, where possible, with measurement data from preconstruction critical experiments at HFIR, data included in the current HFIR safety analysis report, and/or data from previous calculations performed with different methods or codes. The results of the analyses show that the models presented in this report provide a robust and reliable basis for HFIR analyses.« less

  18. Jerky driving--An indicator of accident proneness?

    PubMed

    Bagdadi, Omar; Várhelyi, András

    2011-07-01

    This study uses continuously logged driving data from 166 private cars to derive the level of jerks caused by the drivers during everyday driving. The number of critical jerks found in the data is analysed and compared with the self-reported accident involvement of the drivers. The results show that the expected number of accidents for a driver increases with the number of critical jerks caused by the driver. Jerk analyses make it possible to identify safety critical driving behaviour or "accident prone" drivers. They also facilitate the development of safety measures such as active safety systems or advanced driver assistance systems, ADAS, which could be adapted for specific groups of drivers or specific risky driving behaviour. Copyright © 2011 Elsevier Ltd. All rights reserved.

  19. 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.

  20. The impact of web-based and face-to-face simulation on patient deterioration and patient safety: protocol for a multi-site multi-method design.

    PubMed

    Cooper, Simon J; Kinsman, Leigh; Chung, Catherine; Cant, Robyn; Boyle, Jayne; Bull, Loretta; Cameron, Amanda; Connell, Cliff; Kim, Jeong-Ah; McInnes, Denise; McKay, Angela; Nankervis, Katrina; Penz, Erika; Rotter, Thomas

    2016-09-07

    There are international concerns in relation to the management of patient deterioration which has led to a body of evidence known as the 'failure to rescue' literature. Nursing staff are known to miss cues of deterioration and often fail to call for assistance. Medical Emergency Teams (Rapid Response Teams) do improve the management of acutely deteriorating patients, but first responders need the requisite skills to impact on patient safety. In this study we aim to address these issues in a mixed methods interventional trial with the objective of measuring and comparing the cost and clinical impact of face-to-face and web-based simulation programs on the management of patient deterioration and related patient outcomes. The education programs, known as 'FIRST(2)ACT', have been found to have an impact on education and will be tested in four hospitals in the State of Victoria, Australia. Nursing staff will be trained in primary (the first 8 min) responses to emergencies in two medical wards using a face-to-face approach and in two medical wards using a web-based version FIRST(2)ACTWeb. The impact of these interventions will be determined through quantitative and qualitative approaches, cost analyses and patient notes review (time series analyses) to measure quality of care and patient outcomes. In this 18 month study it is hypothesised that both simulation programs will improve the detection and management of deteriorating patients but that the web-based program will have lower total costs. The study will also add to our overall understanding of the utility of simulation approaches in the preparation of nurses working in hospital wards. (ACTRN12616000468426, retrospectively registered 8.4.2016).

  1. Intelligent power wheelchair use in long-term care: potential users' experiences and perceptions.

    PubMed

    Rushton, Paula W; Mortenson, Ben W; Viswanathan, Pooja; Wang, Rosalie H; Miller, William C; Hurd Clarke, Laura

    2017-10-01

    Long-term care (LTC) residents with cognitive impairments frequently experience limited mobility and participation in preferred activities. Although a power wheelchair could mitigate some of these mobility and participation challenges, this technology is often not prescribed for this population due to safety concerns. An intelligent power wheelchair (IPW) system represents a potential intervention that could help to overcome these concerns. The purpose of this study was to explore a) how residents experienced an IPW that used three different modes of control and b) what perceived effect the IPW would have on their daily lives. We interviewed 10 LTC residents with mild or moderate cognitive impairment twice, once before and once after testing the IPW. Interviews were conducted using a semi-structured interview guide, audio recorded and transcribed verbatim for thematic analyses. Our analyses identified three overarching themes: (1) the difference an IPW would make, (2) the potential impact of the IPW on others and (3) IPW-related concerns. Findings from this study confirm the need for and potential benefits of IPW use in LTC. Future studies will involve testing IPW improvements based on feedback and insights from this study. Implications for rehabilitation Intelligent power wheelchairs may enhance participation and improve safety and feelings of well-being for long-term care residents with cognitive impairments. Intelligent power wheelchairs could potentially have an equally positive impact on facility staff, other residents, and family and friends by decreasing workload and increasing safety.

  2. Fracture Analyses of Cracked Delta Eye Plates in Ship Towing

    NASA Astrophysics Data System (ADS)

    Huang, Xiangbing; Huang, Xingling; Sun, Jizheng

    2018-01-01

    Based on fracture mechanics, a safety analysis approach is proposed for cracked delta eye plates in ship towing. The static analysis model is presented when the delta eye plate is in service, and the fracture criterion is introduced on basis of stress intensity factor, which is estimated with domain integral method. Subsequently, three-dimensional finite element analyses are carried out to obtain the effective stress intensity factors, and a case is studied to demonstrate the reasonability of the approach. The results show that the classical strength theory is not applicable to evaluate the cracked plate while fracture mechanics can solve the problem very well, and the load level, which a delta eye plate can carry on, decreases evidently when it is damaged.

  3. Engineering evaluation of SSME dynamic data from engine tests and SSV flights

    NASA Technical Reports Server (NTRS)

    1986-01-01

    An engineering evaluation of dynamic data from SSME hot firing tests and SSV flights is summarized. The basic objective of the study is to provide analyses of vibration, strain and dynamic pressure measurements in support of MSFC performance and reliability improvement programs. A brief description of the SSME test program is given and a typical test evaluation cycle reviewed. Data banks generated to characterize SSME component dynamic characteristics are described and statistical analyses performed on these data base measurements are discussed. Analytical models applied to define the dynamic behavior of SSME components (such as turbopump bearing elements and the flight accelerometer safety cut-off system) are also summarized. Appendices are included to illustrate some typical tasks performed under this study.

  4. Use of Structure as a Basis for Abstraction in Air Traffic Control

    NASA Technical Reports Server (NTRS)

    Davison, Hayley J.; Hansman, R. John

    2004-01-01

    The safety and efficiency of the air traffic control domain is highly dependent on the capabilities and limitations of its human controllers. Past research has indicated that structure provided by the airspace and procedures could aid in simplifying the controllers cognitive tasks. In this paper, observations, interviews, voice command data analyses, and radar analyses were conducted at the Boston Terminal Route Control (TRACON) facility to determine if there was evidence of controllers using structure to simplify their cognitive processes. The data suggest that controllers do use structure-based abstractions to simplify their cognitive processes, particularly the projection task. How structure simplifies the projection task and the implications of understanding the benefits structure provides to the projection task was discussed.

  5. Intelligent image processing for machine safety

    NASA Astrophysics Data System (ADS)

    Harvey, Dennis N.

    1994-10-01

    This paper describes the use of intelligent image processing as a machine guarding technology. One or more color, linear array cameras are positioned to view the critical region(s) around a machine tool or other piece of manufacturing equipment. The image data is processed to provide indicators of conditions dangerous to the equipment via color content, shape content, and motion content. The data from these analyses is then sent to a threat evaluator. The purpose of the evaluator is to determine if a potentially machine-damaging condition exists based on the analyses of color, shape, and motion, and on `knowledge' of the specific environment of the machine. The threat evaluator employs fuzzy logic as a means of dealing with uncertainty in the vision data.

  6. Meditation for posttraumatic stress: Systematic review and meta-analysis.

    PubMed

    Hilton, Lara; Maher, Alicia Ruelaz; Colaiaco, Benjamin; Apaydin, Eric; Sorbero, Melony E; Booth, Marika; Shanman, Roberta M; Hempel, Susanne

    2017-07-01

    We conducted a systematic review and meta-analysis that synthesized evidence from randomized controlled trials of meditation interventions to provide estimates of their efficacy and safety in treating adults diagnosed with posttraumatic stress disorder (PTSD). This review was based on an established protocol (PROSPERO: CRD42015025782) and is reported according to PRISMA guidelines. Outcomes of interest included PTSD symptoms, depression, anxiety, health-related quality of life, functional status, and adverse events. Meta-analyses were conducted using the Hartung-Knapp-Sidik-Jonkman method for random-effects models. Quality of evidence was assessed using the Grade of Recommendations Assessment, Development, and Evaluation (GRADE) approach. In total, 10 trials on meditation interventions for PTSD with 643 participants met inclusion criteria. Across interventions, adjunctive meditation interventions of mindfulness-based stress reduction, yoga, and the mantram repetition program improve PTSD and depression symptoms compared with control groups, but the findings are based on low and moderate quality of evidence. Effects were positive but not statistically significant for quality of life and anxiety, and no studies addressed functional status. The variety of meditation intervention types, the short follow-up times, and the quality of studies limited analyses. No adverse events were reported in the included studies; only half of the studies reported on safety. Meditation appears to be effective for PTSD and depression symptoms, but in order to increase confidence in findings, more high-quality studies are needed on meditation as adjunctive treatment with PTSD-diagnosed participant samples large enough to detect statistical differences in outcomes. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  7. Dialysis Facility Safety: Processes and Opportunities.

    PubMed

    Garrick, Renee; Morey, Rishikesh

    2015-01-01

    Unintentional human errors are the source of most safety breaches in complex, high-risk environments. The environment of dialysis care is extremely complex. Dialysis patients have unique and changing physiology, and the processes required for their routine care involve numerous open-ended interfaces between providers and an assortment of technologically advanced equipment. Communication errors, both within the dialysis facility and during care transitions, and lapses in compliance with policies and procedures are frequent areas of safety risk. Some events, such as air emboli and needle dislodgments occur infrequently, but are serious risks. Other adverse events include medication errors, patient falls, catheter and access-related infections, access infiltrations and prolonged bleeding. A robust safety system should evaluate how multiple, sequential errors might align to cause harm. Systems of care can be improved by sharing the results of root cause analyses, and "good catches." Failure mode effects and analyses can be used to proactively identify and mitigate areas of highest risk, and methods drawn from cognitive psychology, simulation training, and human factor engineering can be used to advance facility safety. © 2015 Wiley Periodicals, Inc.

  8. Cerebrospinal fluid protein and glucose examinations and tuberculosis:
Will laboratory safety regulations force a change of practice?

    PubMed

    Tormey, William P; O'Hagan, Christopher

    2015-01-01

    Cerebrospinal fluid (CSF) protein and glucose examinations are usually performed in chemical pathology departments on autoanalysers. Tuberculosis (TB) is a group 3 biological agent under Directive 2000/54/EC of the European Parliament but in the biochemistry laboratory, no extra precautions are taken in its analysis in possible TB cases. The issue of laboratory practice and safety in the biochemical analyses of CSF specimens, when tuberculosis infection is in question is addressed in the context of ambiguity in the implementation of current national and international health and safety regulations. Additional protective measures for laboratory staff during the analysis of CSF TB samples should force a change in current laboratory practice and become a regulatory issue under ISO 15189. Annual Mantoux skin test or an interferon-γ release assay for TB should be mandatory for relevant staff. This manuscript addresses the issue of biochemistry laboratory practice and safety in the biochemical analyses of CSF specimens when tuberculosis infection is in question in the context of the ambiguity of statutory health and safety regulations.

  9. Making the Hubble Space Telescope servicing mission safe

    NASA Technical Reports Server (NTRS)

    Bahr, N. J.; Depalo, S. V.

    1992-01-01

    The implementation of the HST system safety program is detailed. Numerous safety analyses are conducted through various phases of design, test, and fabrication, and results are presented to NASA management for discussion during dedicated safety reviews. Attention is given to the system safety assessment and risk analysis methodologies used, i.e., hazard analysis, fault tree analysis, and failure modes and effects analysis, and to how they are coupled with engineering and test analysis for a 'synergistic picture' of the system. Some preliminary safety analysis results, showing the relationship between hazard identification, control or abatement, and finally control verification, are presented as examples of this safety process.

  10. Assessment of potential exposure to friable insulation materials containing asbestos

    NASA Technical Reports Server (NTRS)

    Kim, W. S.; Kuivinen, D. E.

    1980-01-01

    Asbestos and the procedures for assessing potential exposure hazards are discussed. Assessment includes testing a bulk sample of the suspected material for the presence of asbestos, and monitoring the air, if necessary. Based on field inspections and laboratory analyses, the health hazard is evaluated, and abatement measures are taken if a potential hazard exists. Throughout the assessment and abatement program, all applicable regulations are administered as specified by the Environmental Protection Agency and the Occupational Safety and Health Administration.

  11. Medical-Information-Management System

    NASA Technical Reports Server (NTRS)

    Alterescu, Sidney; Friedman, Carl A.; Frankowski, James W.

    1989-01-01

    Medical Information Management System (MIMS) computer program interactive, general-purpose software system for storage and retrieval of information. Offers immediate assistance where manipulation of large data bases required. User quickly and efficiently extracts, displays, and analyzes data. Used in management of medical data and handling all aspects of data related to care of patients. Other applications include management of data on occupational safety in public and private sectors, handling judicial information, systemizing purchasing and procurement systems, and analyses of cost structures of organizations. Written in Microsoft FORTRAN 77.

  12. Space shuttle hypergolic bipropellant RCS engine design study, Bell model 8701

    NASA Technical Reports Server (NTRS)

    1974-01-01

    A research program was conducted to define the level of the current technology base for reaction control system rocket engines suitable for space shuttle applications. The project consisted of engine analyses, design, fabrication, and tests. The specific objectives are: (1) extrapolating current engine design experience to design of an RCS engine with required safety, reliability, performance, and operational capability, (2) demonstration of multiple reuse capability, and (3) identification of current design and technology deficiencies and critical areas for future effort.

  13. Systems-based accident analysis in the led outdoor activity domain: application and evaluation of a risk management framework.

    PubMed

    Salmon, P; Williamson, A; Lenné, M; Mitsopoulos-Rubens, E; Rudin-Brown, C M

    2010-08-01

    Safety-compromising accidents occur regularly in the led outdoor activity domain. Formal accident analysis is an accepted means of understanding such events and improving safety. Despite this, there remains no universally accepted framework for collecting and analysing accident data in the led outdoor activity domain. This article presents an application of Rasmussen's risk management framework to the analysis of the Lyme Bay sea canoeing incident. This involved the development of an Accimap, the outputs of which were used to evaluate seven predictions made by the framework. The Accimap output was also compared to an analysis using an existing model from the led outdoor activity domain. In conclusion, the Accimap output was found to be more comprehensive and supported all seven of the risk management framework's predictions, suggesting that it shows promise as a theoretically underpinned approach for analysing, and learning from, accidents in the led outdoor activity domain. STATEMENT OF RELEVANCE: Accidents represent a significant problem within the led outdoor activity domain. This article presents an evaluation of a risk management framework that can be used to understand such accidents and to inform the development of accident countermeasures and mitigation strategies for the led outdoor activity domain.

  14. Safety climate in Swiss hospital units: Swiss version of the Safety Climate Survey

    PubMed Central

    Gehring, Katrin; Mascherek, Anna C.; Bezzola, Paula

    2015-01-01

    Abstract Rationale, aims and objectives Safety climate measurements are a broadly used element of improvement initiatives. In order to provide a sound and easy‐to‐administer instrument for the use in Swiss hospitals, we translated the Safety Climate Survey into German and French. Methods After translating the Safety Climate Survey into French and German, a cross‐sectional survey study was conducted with health care professionals (HCPs) in operating room (OR) teams and on OR‐related wards in 10 Swiss hospitals. Validity of the instrument was examined by means of Cronbach's alpha and missing rates of the single items. Item‐descriptive statistics group differences and percentage of ‘problematic responses’ (PPR) were calculated. Results 3153 HCPs completed the survey (response rate: 63.4%). 1308 individuals were excluded from the analyses because of a profession other than doctor or nurse or invalid answers (n = 1845; nurses = 1321, doctors = 523). Internal consistency of the translated Safety Climate Survey was good (Cronbach's alpha G erman = 0.86; Cronbach's alpha F rench = 0.84). Missing rates at item level were rather low (0.23–4.3%). We found significant group differences in safety climate values regarding profession, managerial function, work area and time spent in direct patient care. At item level, 14 out of 21 items showed a PPR higher than 10%. Conclusions Results indicate that the French and German translations of the Safety Climate Survey might be a useful measurement instrument for safety climate in Swiss hospital units. Analyses at item level allow for differentiating facets of safety climate into more positive and critical safety climate aspects. PMID:25656302

  15. Safety climate and the theory of planned behavior: towards the prediction of unsafe behavior.

    PubMed

    Fogarty, Gerard J; Shaw, Andrew

    2010-09-01

    The present study is concerned with the human factors that contribute to violations in aviation maintenance. Much of our previous research in this area has been based on safety climate surveys and the analysis of relations among core dimensions of climate. In this study, we tap into mainstream psychological theory to help clarify the mechanisms underlying the links between climate and behavior. Specifically, we demonstrate the usefulness of Ajzen's (1991, 2001) Theory of Planned Behavior (TPB) to understanding violation behaviors in aircraft maintenance. A questionnaire was administered to 307 aircraft maintenance workers. Constructs measured by the survey included perceptions of management attitudes to safety, own attitudes to violations, intention to violate, group norms, workplace pressures, and violations. A model based on the TPB illustrated hypothetical connections among these variables. Path analyses using AMOS suggested some theoretically justifiable modifications to the model. Fit statistics of the revised model were excellent with intentions, group norms, and personal attitudes combining to explain 50% of the variance in self-reported violations. The model highlighted the importance of management attitudes and group norms as direct and indirect predictors of violation behavior. We conclude that the TPB is a useful tool for understanding the psychological background to the procedural violations so often associated with incidents and accidents. 2009 Elsevier Ltd. All rights reserved.

  16. Development of a patient safety climate survey for Chinese hospitals: cross-national adaptation and psychometric evaluation.

    PubMed

    Zhu, Junya; Li, Liping; Zhao, Hailei; Han, Guangshu; Wu, Albert W; Weingart, Saul N

    2014-10-01

    Existing patient safety climate instruments, most of which have been developed in the USA, may not accurately reflect the conditions in the healthcare systems of other countries. To develop and evaluate a patient safety climate instrument for healthcare workers in Chinese hospitals. Based on a review of existing instruments, expert panel review, focus groups and cognitive interviews, we developed items relevant to patient safety climate in Chinese hospitals. The draft instrument was distributed to 1700 hospital workers from 54 units in six hospitals in five Chinese cities between July and October 2011, and 1464 completed surveys were received. We performed exploratory and confirmatory factor analyses and estimated internal consistency reliability, within-unit agreement, between-unit variation, unit-mean reliability, correlation between multi-item composites, and association between the composites and two single items of perceived safety. The final instrument included 34 items organised into nine composites: institutional commitment to safety, unit management support for safety, organisational learning, safety system, adequacy of safety arrangements, error reporting, communication and peer support, teamwork and staffing. All composites had acceptable unit-mean reliabilities (≥0.74) and within-unit agreement (Rwg ≥0.71), and exhibited significant between-unit variation with intraclass correlation coefficients ranging from 9% to 21%. Internal consistency reliabilities ranged from 0.59 to 0.88 and were ≥0.70 for eight of the nine composites. Correlations between composites ranged from 0.27 to 0.73. All composites were positively and significantly associated with the two perceived safety items. The Chinese Hospital Survey on Patient Safety Climate demonstrates adequate dimensionality, reliability and validity. The integration of qualitative and quantitative methods is essential to produce an instrument that is culturally appropriate for Chinese hospitals. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  17. The interplay between teamwork, clinicians' emotional exhaustion, and clinician-rated patient safety: a longitudinal study.

    PubMed

    Welp, Annalena; Meier, Laurenz L; Manser, Tanja

    2016-04-19

    Effectively managing patient safety and clinicians' emotional exhaustion are important goals of healthcare organizations. Previous cross-sectional studies showed that teamwork is associated with both. However, causal relationships between all three constructs have not yet been investigated. Moreover, the role of different dimensions of teamwork in relation to emotional exhaustion and patient safety is unclear. The current study focused on the long-term development of teamwork, emotional exhaustion, and patient safety in interprofessional intensive care teams by exploring causal relationships between these constructs. A secondary objective was to disentangle the effects of interpersonal and cognitive-behavioral teamwork. We employed a longitudinal study design. Participants were 2100 nurses and physicians working in 55 intensive care units. They answered an online questionnaire on interpersonal and cognitive-behavioral aspects of teamwork, emotional exhaustion, and patient safety at three time points with a 3-month lag. Data were analyzed with cross-lagged structural equation modeling. We controlled for professional role. Analyses showed that emotional exhaustion had a lagged effect on interpersonal teamwork. Furthermore, interpersonal and cognitive-behavioral teamwork mutually influenced each other. Finally, cognitive-behavioral teamwork predicted clinician-rated patient safety. The current study shows that the interrelations between teamwork, clinician burnout, and clinician-rated patient safety unfold over time. Interpersonal and cognitive-behavioral teamwork play specific roles in a process leading from clinician emotional exhaustion to decreased clinician-rated patient safety. Emotionally exhausted clinicians are less able to engage in positive interpersonal teamwork, which might set in motion a vicious cycle: negative interpersonal team interactions negatively affect cognitive-behavioral teamwork and vice versa. Ultimately, ineffective cognitive-behavioral teamwork negatively impacts clinician-rated patient safety. Thus, reducing clinician emotional exhaustion is an important prerequisite of managing teamwork and patient safety. From a practical point of view, team-based interventions targeting patient safety are less likely to be effective when clinicians are emotionally exhausted.

  18. Reflections on system safety and the law

    NASA Technical Reports Server (NTRS)

    Hayes, D. F., Sr.

    1971-01-01

    The application of law to the determination of what constitutes safeness is discussed. The numerous factors are analyzed which enter into the decisions of courts in deciding what is safe and what is unsafe. It is pointed out that as technology changes, legal interpretations of safety also change. Arguements are given for the use of system safety techniques and better engineering analyses as instruments of defense against liability.

  19. Pharmacoeconomic evaluations of pharmacogenetic and genomic screening programmes: a systematic review on content and adherence to guidelines.

    PubMed

    Vegter, Stefan; Boersma, Cornelis; Rozenbaum, Mark; Wilffert, Bob; Navis, Gerjan; Postma, Maarten J

    2008-01-01

    The fields of pharmacogenetics and pharmacogenomics have become important practical tools to progress goals in medical and pharmaceutical research and development. As more screening tests are being developed, with some already used in clinical practice, consideration of cost-effectiveness implications is important. A systematic review was performed on the content of and adherence to pharmacoeconomic guidelines of recent pharmacoeconomic analyses performed in the field of pharmacogenetics and pharmacogenomics. Economic analyses of screening strategies for genetic variations, which were evidence-based and assumed to be associated with drug efficacy or safety, were included in the review. The 20 papers included cover a variety of healthcare issues, including screening tests on several cytochrome P450 (CYP) enzyme genes, thiopurine S-methyltransferase (TMPT) and angiotensin-converting enzyme (ACE) insertion deletion (ACE I/D) polymorphisms. Most economic analyses reported that genetic screening was cost effective and often even clearly dominated existing non-screening strategies. However, we found a lack of standardization regarding aspects such as the perspective of the analysis, factors included in the sensitivity analysis and the applied discount rates. In particular, an important limitation of several studies related to the failure to provide a sufficient evidence-based rationale for an association between genotype and phenotype. Future economic analyses should be conducted utilizing correct methods, with adherence to guidelines and including extensive sensitivity analyses. Most importantly, genetic screening strategies should be based on good evidence-based rationales. For these goals, we provide a list of recommendations for good pharmacoeconomic practice deemed useful in the fields of pharmacogenetics and pharmacogenomics, regardless of country and origin of the economic analysis.

  20. Expert Consensus Statement on achieving self-sufficiency in safe blood and blood products, based on voluntary non-remunerated blood donation (VNRBD).

    PubMed

    2012-11-01

    All countries face challenges in making sufficient supplies of blood and blood products available and sustainable, while also ensuring the quality and safety of these products in the face of known and emerging threats to public health. Since 1975, the World Health Assembly (WHA) has highlighted the global need for blood safety and availability. WHA resolutions 63·12, 58·13 and 28·72, The Melbourne Declaration on 100% Voluntary Non-Remunerated Donation of Blood and Blood Components and WHO Global Blood Safety Network recommendations have reaffirmed the achievement of 'Self-sufficiency in blood and blood products based on voluntary non-remunerated blood donation (VNRBD)' as the important national policy direction for ensuring a safe, secure and sufficient supply of blood and blood products, including labile blood components and plasma-derived medicinal products. Despite some successes, self-sufficiency is not yet a reality in many countries. A consultation of experts, convened by the World Health Organization (WHO) in September 2011 in Geneva, Switzerland, addressed the urgent need to establish strategies and mechanisms for achieving self-sufficiency. Information on the current situation, and country perspectives and experiences were shared. Factors influencing the global implementation of self-sufficiency, including safety, ethics, security and sustainability of supply, trade and its potential impact on public health, availability and access for patients, were analysed to define strategies and mechanisms and provide practical guidance on achieving self-sufficiency. Experts developed a consensus statement outlining the rationale and definition of self-sufficiency in safe blood and blood products based on VNRBD and made recommendations to national health authorities and WHO. © 2012 World Health Organization. Vox Sanguinis © 2012 International Society of Blood Transfusion.

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

    PubMed Central

    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

    Introduction 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. Material and methods 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. Results 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. Conclusions 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. PMID:26525595

  2. Acceptability of text messages for safety netting patients with low-risk cancer symptoms: a qualitative study.

    PubMed

    Hirst, Yasemin; Lim, Anita Wey Wey

    2018-05-01

    Safety netting is an important diagnostic strategy for patients presenting to primary care with potential (low-risk) cancer symptoms. Typically, this involves asking patients to return if symptoms persist. However, this relies on patients re-appraising their symptoms and making follow-up appointments, which could contribute to delays in diagnosis. Text messaging is increasingly used in primary care to communicate with patients, and could be used to improve safety netting. To explore the acceptability and feasibility of using text messages to safety net patients presenting with low-risk cancer symptoms in GP primary care (txt-netting). Qualitative focus group and interview study with London-based GPs. Participants were identified using convenience sampling methods. Five focus groups and two interviews were conducted with 22 GPs between August and December 2016. Sessions were audiorecorded, transcribed verbatim, and analysed using thematic analysis. GPs were amenable to the concept of using text messages in cancer safety netting, identifying it as an additional tool that could help manage patients and promote symptom awareness. There was wide variation in GP preferences for text message content, and a number of important potential barriers to txt-netting were identified. Concerns were raised about the difficulties of conveying complex safety netting advice within the constraints of a text message, and about confidentiality, widening inequalities, and workload implications. Text messages were perceived to be an acceptable potential strategy for safety netting patients with low-risk cancer symptoms. Further work is needed to ensure it is cost-effective, user friendly, confidential, and acceptable to patients. © British Journal of General Practice 2018.

  3. An application of the theory of planned behavior--a randomized controlled food safety pilot intervention for young adults.

    PubMed

    Milton, Alyssa C; Mullan, Barbara A

    2012-03-01

    Approximately 48 million Americans are affected by foodborne illness each year. Evidence suggests that the application of health psychology theory to food safety interventions can increase behaviors that reduce the incidence of illness such as adequately keeping hands, surfaces and equipment clean. This aim of this pilot study was to be the first to explore the effectiveness of a food safety intervention based on the Theory of Planned Behavior (TPB). Young adult participants (N = 45) were randomly allocated to intervention, general control or mere measurement control conditions. Food safety observations and TPB measures were taken at baseline and at 4-week follow-up. Within and between group differences on target variables were considered and regression analyses were conducted to determine the relationship between condition, behavior and the TPB intention constructs; attitude, subjective norm, perceived behavioral control (PBC). TPB variables at baseline predicted observed food safety behaviors. At follow-up, the intervention led to significant increases in PBC (p = .024) and observed behaviors (p = .001) compared to both control conditions. Furthermore, correlations were found between observed and self-reported behaviors (p = .008). The pilot intervention supports the utility of the TPB as a method of improving food safety behavior. Changes in TPB cognitions appear to be best translated to behavior via behavioral intentions and PBC. Further research should be conducted to increase effectiveness of translating TPB variables to food safety behaviors. The additional finding of a correlation between self-reported and observed behavior also has implications for future research as it provides evidence toward the construct validity of self-reported behavioral measures.

  4. The European space suit, a design for productivity and crew safety.

    PubMed

    Skoog, A I; Berthier, S; Ollivier, Y

    1991-01-01

    In order to fulfill the two major mission objectives, i.e. support planned and unplanned external servicing of the COLUMBUS FFL and support the HERMES vehicle for safety critical operations and emergencies, the European Space Suit System baseline configuration incorporates a number of design features, which shall enhance the productivity and the crew safety of EVA astronauts. The work in EVA is today--and will be for several years--a manual work. Consequently, to improve productivity, the first challenge is to design a suit enclosure which minimizes movement restrictions and crew fatigue. It is covered by the "ergonomic" aspect of the suit design. Furthermore, it is also necessary to help the EVA crewmember in his work, by giving him the right information at the right time. Many solutions exist in this field of Man-Machine Interface, from a very simple system, based on cuff check lists, up to advanced systems, including Head-Up Displays. The design concept for improved productivity encompasses following features: easy donning/doffing thru rear entry, suit ergonomy optimisation, display of operational information in alpha-numerical and graphical form, and voice processing for operations and safety critical information. Concerning crew safety the major design features are: a lower R-factor for emergency EVA operations thru increased suit pressure, zero prebreath conditions for normal operations, visual and voice processing of all safety critical functions, and an autonomous life support system to permit unrestricted operations around HERMES and the CFFL. The paper analyses crew safety and productivity criteria and describes how these features are being built into the design of the European Space Suit System.

  5. Relationship between organizational justice and organizational safety climate: do fairness perceptions influence employee safety behaviour?

    PubMed

    Gyekye, Seth Ayim; Haybatollahi, Mohammad

    2014-01-01

    This study investigated the relationships between organizational justice, organizational safety climate, job satisfaction, safety compliance and accident frequency. Ghanaian industrial workers participated in the study (N = 320). Safety climate and justice perceptions were assessed with Hayes, Parender, Smecko, et al.'s (1998) and Blader and Tyler's (2003) scales respectively. A median split was performed to dichotomize participants into 2 categories: workers with positive and workers with negative justice perceptions. Confirmatory factors analysis confirmed the 5-factor structure of the safety scale. Regression analyses and t tests indicated that workers with positive fairness perceptions had constructive perspectives regarding workplace safety, expressed greater job satisfaction, were more compliant with safety policies and registered lower accident rates. These findings provide evidence that the perceived level of fairness in an organization is closely associated with workplace safety perception and other organizational factors which are important for safety. The implications for safety research are discussed.

  6. Factors influencing patient safety in Sweden: perceptions of patient safety officers in the county councils

    PubMed Central

    2013-01-01

    Background National, regional and local activities to improve patient safety in Sweden have increased over the last decade. There are high ambitions for improved patient safety in Sweden. This study surveyed health care professionals who held key positions in their county council’s patient safety work to investigate their perceptions of the conditions for this work, factors they believe have been most important in reaching the current level of patient safety and factors they believe would be most important for achieving improved patient safety in the future. Methods The study population consisted of 218 health care professionals holding strategic positions in patient safety work in Swedish county councils. Using a questionnaire, the following topics were analysed in this study: profession/occupation; number of years involved in a designated task on patient safety issues; knowledge/overview of the county council’s patient safety work; ability to influence this work; conditions for this work; and the importance of various factors for current and future levels of patient safety. Results The response rate to the questionnaire was 79%. The conditions that had the highest number of responses in complete agreement were “patients’ involvement is important for patient safety” and “patient safety work has good support from the county council’s management”. Factors that were considered most important for achieving the current level of patient safety were root cause and risk analyses, incident reporting and the Swedish Patient Safety Law. An organizational culture that encourages reporting and avoids blame was considered most important for improved patient safety in the future, closely followed by improved communication between health care practitioners and patients. Conclusion Health care professionals with important positions in the Swedish county councils’ patient safety work believe that conditions for this work are somewhat constrained. They attribute the current levels of patient safety to a broad range of factors and believe that many different solutions can contribute to enhanced patient safety in the future, suggesting that this work must be multifactorial. PMID:23391301

  7. Does patient reporting lead to earlier detection of drug safety signals? A retrospective comparison of time to reporting between patients and healthcare professionals in a global database.

    PubMed

    Rolfes, Leàn; van Hunsel, Florence; Caster, Ola; Taavola, Henric; Taxis, Katja; van Puijenbroek, Eugène

    2018-03-09

    To explore if there is a difference between patients and healthcare professionals (HCPs) in time to reporting drug-adverse drug reaction (ADR) associations that led to drug safety signals. This was a retrospective comparison of time to reporting selected drug-ADR associations which led to drug safety signals between patients and HCPs. ADR reports were selected from the World Health Organization Global database of individual case safety reports, VigiBase. Reports were selected based on drug-ADR associations of actual drug safety signals. Primary outcome was the difference in time to reporting between patients and HCPs. The date of the first report for each individual signal was used as time zero. The difference in time between the date of the reports and time zero was calculated. Statistical differences in timing were analysed on the corresponding survival curves using a Mann-Whitney U test. In total, 2822 reports were included, of which 52.7% were patient reports, with a median of 25% for all included signals. For all signals, median time to signal detection was 10.4 years. Overall, HCPs reported earlier than patients: median 7.0 vs. 8.3 years (P < 0.001). Patients contributed a large proportion of reports on drug-ADR pairs that eventually became signals. HCPs reported 1.3 year earlier than patients. These findings strengthen the evidence on the value of patient reporting in signal detection and highlight an opportunity to encourage patients to report suspected ADRs even earlier in the future. © 2018 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.

  8. Cross-comparison of three surrogate safety methods to diagnose cyclist safety problems at intersections in Norway.

    PubMed

    Laureshyn, Aliaksei; Goede, Maartje de; Saunier, Nicolas; Fyhri, Aslak

    2017-08-01

    Relying on accident records as the main data source for studying cyclists' safety has many drawbacks, such as high degree of under-reporting, the lack of accident details and particularly of information about the interaction processes that led to the accident. It is also an ethical problem as one has to wait for accidents to happen in order to make a statement about cyclists' (un-)safety. In this perspective, the use of surrogate safety measures based on actual observations in traffic is very promising. In this study we used video data from three intersections in Norway that were all independently analysed using three methods: the Swedish traffic conflict technique (Swedish TCT), the Dutch conflict technique (DOCTOR) and the probabilistic surrogate measures of safety (PSMS) technique developed in Canada. The first two methods are based on manual detection and counting of critical events in traffic (traffic conflicts), while the third considers probabilities of multiple trajectories for each interaction and delivers a density map of potential collision points per site. Due to extensive use of microscopic data, PSMS technique relies heavily on automated tracking of the road users in video. Across the three sites, the methods show similarities or are at least "compatible" with the accident records. The two conflict techniques agree quite well for the number, type and location of conflicts, but some differences with no obvious explanation are also found. PSMS reports many more safety-relevant interactions including less severe events. The location of the potential collision points is compatible with what the conflict techniques suggest, but the possibly significant share of false alarms due to inaccurate trajectories extracted from video complicates the comparison. The tested techniques still require enhancement, with respect to better adjustment to analysis of the situations involving cyclists (and vulnerable road users in general) and further validation. However, we believe this to be a future direction for the road safety analysis as the number of accidents is constantly decreasing and the quality of accident data does not seem to improve. Copyright © 2016 Elsevier Ltd. All rights reserved.

  9. Intervention effects on safety compliance and citizenship behaviors: Evidence from the Work, Family, and Health Study.

    PubMed

    Hammer, Leslie B; Johnson, Ryan C; Crain, Tori L; Bodner, Todd; Kossek, Ellen Ernst; Davis, Kelly D; Kelly, Erin L; Buxton, Orfeu M; Karuntzos, Georgia; Chosewood, L Casey; Berkman, Lisa

    2016-02-01

    We tested the effects of a work-family intervention on employee reports of safety compliance and organizational citizenship behaviors in 30 health care facilities using a group-randomized trial. Based on conservation of resources theory and the work-home resources model, we hypothesized that implementing a work-family intervention aimed at increasing contextual resources via supervisor support for work and family, and employee control over work time, would lead to improved personal resources and increased employee performance on the job in the form of self-reported safety compliance and organizational citizenship behaviors. Multilevel analyses used survey data from 1,524 employees at baseline and at 6-month and 12-month postintervention follow-ups. Significant intervention effects were observed for safety compliance at the 6-month, and organizational citizenship behaviors at the 12-month, follow-ups. More specifically, results demonstrate that the intervention protected against declines in employee self-reported safety compliance and organizational citizenship behaviors compared with employees in the control facilities. The hypothesized mediators of perceptions of family-supportive supervisor behaviors, control over work time, and work-family conflict (work-to-family conflict, family-to-work conflict) were not significantly improved by the intervention. However, baseline perceptions of family-supportive supervisor behaviors, control over work time, and work-family climate were significant moderators of the intervention effect on the self-reported safety compliance and organizational citizenship behavior outcomes. (c) 2016 APA, all rights reserved).

  10. Safety Study of Double-Decker Motorcoaches with Rear Luggage Compartment : Technology Brief

    DOT National Transportation Integrated Search

    2017-12-01

    The study was conducted through a combination of analyses and tests with a double-decker motorcoach. State transportation safety and law enforcement officials were consulted, and the study plan was revised according to their comments. An exemplar mot...

  11. Health And Safety In Maintenance Activities

    NASA Astrophysics Data System (ADS)

    Ungureanu, Nicolae Stelian; Daraba, Dinu; Moraru, Roland Iosif

    2015-07-01

    The paper examines some aspects of health and safety at work in maintenance activities. It was analysed the occurrence of accidents, statistically, in maintenance work. There have been identified a number of causes of accidents and there have been proposed some measures to reduce them.

  12. Columbus safety and reliability

    NASA Astrophysics Data System (ADS)

    Longhurst, F.; Wessels, H.

    1988-10-01

    Analyses carried out to ensure Columbus reliability, availability, and maintainability, and operational and design safety are summarized. Failure modes/effects/criticality is the main qualitative tool used. The main aspects studied are fault tolerance, hazard consequence control, risk minimization, human error effects, restorability, and safe-life design.

  13. 10 CFR 851.21 - Hazard identification and assessment.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    .... Procedures must include methods to: (1) Assess worker exposure to chemical, physical, biological, or safety workplace hazards through appropriate workplace monitoring; (2) Document assessment for chemical, physical... hazards; (6) Perform routine job activity-level hazard analyses; (7) Review site safety and health...

  14. 10 CFR 851.21 - Hazard identification and assessment.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    .... Procedures must include methods to: (1) Assess worker exposure to chemical, physical, biological, or safety workplace hazards through appropriate workplace monitoring; (2) Document assessment for chemical, physical... hazards; (6) Perform routine job activity-level hazard analyses; (7) Review site safety and health...

  15. Hazard Analysis Guidelines for Transit Projects

    DOT National Transportation Integrated Search

    2000-01-01

    These hazard analysis guidelines discuss safety critical systems and subsystems, types of hazard analyses, when hazard analyses should be performed, and the hazard analysis philosophy. These guidelines are published by FTA to assist the transit indus...

  16. Accident Analyses in Support of the Sludge Water System Safety Analysis

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

    FINFROCK, S.H.

    This document quantifies the potential health effects of the unmitigated hazards identified Hey (2002) for retrieval of sludge from the KE basin. It also identifies potential controls and any supporting mitigative analyses.

  17. Demonstration of a Safety Analysis on a Complex System

    NASA Technical Reports Server (NTRS)

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

    1997-01-01

    For the past 17 years, Professor Leveson and her graduate students have been developing a theoretical foundation for safety in complex systems and building a methodology upon that foundation. The methodology includes special management structures and procedures, system hazard analyses, software hazard analysis, requirements modeling and analysis for completeness and safety, special software design techniques including the design of human-machine interaction, verification, operational feedback, and change analysis. The Safeware methodology is based on system safety techniques that are extended to deal with software and human error. Automation is used to enhance our ability to cope with complex systems. Identification, classification, and evaluation of hazards is done using modeling and analysis. To be effective, the models and analysis tools must consider the hardware, software, and human components in these systems. They also need to include a variety of analysis techniques and orthogonal approaches: There exists no single safety analysis or evaluation technique that can handle all aspects of complex systems. Applying only one or two may make us feel satisfied, but will produce limited results. We report here on a demonstration, performed as part of a contract with NASA Langley Research Center, of the Safeware methodology on the Center-TRACON Automation System (CTAS) portion of the air traffic control (ATC) system and procedures currently employed at the Dallas/Fort Worth (DFW) TRACON (Terminal Radar Approach CONtrol). CTAS is an automated system to assist controllers in handling arrival traffic in the DFW area. Safety is a system property, not a component property, so our safety analysis considers the entire system and not simply the automated components. Because safety analysis of a complex system is an interdisciplinary effort, our team included system engineers, software engineers, human factors experts, and cognitive psychologists.

  18. Improvements and applications of COBRA-TF for stand-alone and coupled LWR safety analyses

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

    Avramova, M.; Cuervo, D.; Ivanov, K.

    2006-07-01

    The advanced thermal-hydraulic subchannel code COBRA-TF has been recently improved and applied for stand-alone and coupled LWR core calculations at the Pennsylvania State Univ. in cooperation with AREVA NP GmbH (Germany)) and the Technical Univ. of Madrid. To enable COBRA-TF for academic and industrial applications including safety margins evaluations and LWR core design analyses, the code programming, numerics, and basic models were revised and substantially improved. The code has undergone through an extensive validation, verification, and qualification program. (authors)

  19. Waste Sampling & Characterization Facility (WSCF) Complex Safety Analysis

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

    MELOY, R.T.

    2002-04-01

    This document was prepared to analyze the Waste Sampling and Characterization Facility for safety consequences by: Determining radionuclide and highly hazardous chemical inventories; Comparing these inventories to the appropriate regulatory limits; Documenting the compliance status with respect to these limits; and Identifying the administrative controls necessary to maintain this status. The primary purpose of the Waste Sampling and Characterization Facility (WSCF) is to perform low-level radiological and chemical analyses on various types of samples taken from the Hanford Site. These analyses will support the fulfillment of federal, Washington State, and Department of Energy requirements.

  20. SU-D-201-05: On the Automatic Recognition of Patient Safety Hazards in a Radiotherapy Setup Using a Novel 3D Camera System and a Deep Learning Framework

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

    Santhanam, A; Min, Y; Beron, P

    Purpose: Patient safety hazards such as a wrong patient/site getting treated can lead to catastrophic results. The purpose of this project is to automatically detect potential patient safety hazards during the radiotherapy setup and alert the therapist before the treatment is initiated. Methods: We employed a set of co-located and co-registered 3D cameras placed inside the treatment room. Each camera provided a point-cloud of fraxels (fragment pixels with 3D depth information). Each of the cameras were calibrated using a custom-built calibration target to provide 3D information with less than 2 mm error in the 500 mm neighborhood around the isocenter.more » To identify potential patient safety hazards, the treatment room components and the patient’s body needed to be identified and tracked in real-time. For feature recognition purposes, we used a graph-cut based feature recognition with principal component analysis (PCA) based feature-to-object correlation to segment the objects in real-time. Changes in the object’s position were tracked using the CamShift algorithm. The 3D object information was then stored for each classified object (e.g. gantry, couch). A deep learning framework was then used to analyze all the classified objects in both 2D and 3D and was then used to fine-tune a convolutional network for object recognition. The number of network layers were optimized to identify the tracked objects with >95% accuracy. Results: Our systematic analyses showed that, the system was effectively able to recognize wrong patient setups and wrong patient accessories. The combined usage of 2D camera information (color + depth) enabled a topology-preserving approach to verify patient safety hazards in an automatic manner and even in scenarios where the depth information is partially available. Conclusion: By utilizing the 3D cameras inside the treatment room and a deep learning based image classification, potential patient safety hazards can be effectively avoided.« less

  1. 75 FR 13 - Alternate Fracture Toughness Requirements for Protection Against Pressurized Thermal Shock Events

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-04

    ...The Nuclear Regulatory Commission (NRC) is amending its regulations to provide alternate fracture toughness requirements for protection against pressurized thermal shock (PTS) events for pressurized water reactor (PWR) pressure vessels. This final rule provides alternate PTS requirements based on updated analysis methods. This action is desirable because the existing requirements are based on unnecessarily conservative probabilistic fracture mechanics analyses. This action reduces regulatory burden for those PWR licensees who expect to exceed the existing requirements before the expiration of their licenses, while maintaining adequate safety, and may choose to comply with the final rule as an alternative to complying with the existing requirements.

  2. Organizational factors affecting safety implementation in food companies in Thailand.

    PubMed

    Chinda, Thanwadee

    2014-01-01

    Thai food industry employs a massive number of skilled and unskilled workers. This may result in an industry with high incidences and accident rates. To improve safety and reduce the accident figures, this paper investigates factors influencing safety implementation in small, medium, and large food companies in Thailand. Five factors, i.e., management commitment, stakeholders' role, safety information and communication, supportive environment, and risk, are found important in helping to improve safety implementation. The statistical analyses also reveal that small, medium, and large food companies hold similar opinions on the risk factor, but bear different perceptions on the other 4 factors. It is also found that to improve safety implementation, the perceptions of safety goals, communication, feedback, safety resources, and supervision should be aligned in small, medium, and large companies.

  3. The development and validation of a psychological contract of safety scale.

    PubMed

    Walker, Arlene

    2010-08-01

    This paper builds on previous research by the author and describes the development and validation of a new measure of the psychological contract of safety. The psychological contract of safety is defined as the beliefs of individuals about reciprocal safety obligations inferred from implicit and explicit promises. A psychological contract is established when an individual believes that perceived employer and employee safety obligations are contingent on each other. A pilot test of the measure is first undertaken with participants from three different occupations: nurses, construction workers, and meat processing workers (N=99). Item analysis is used to refine the measure and provide initial validation of the scale. A larger validation study is then conducted with a participant sample of health care workers (N=424) to further refine the measure and to determine the psychometric properties of the scale. Item and correlational analyses produced the final employer and employee obligations scales, consisting of 21 and 17 items, respectively. Factor analyses identified two underlying dimensions in each scale comparable to that previously established in the organizational literature. These transactional and relational-type obligations provided construct validity of the scale. Internal consistency ratings using Cronbach's alpha found the components of the psychological contract of safety measure to be reliable. The refined and validated psychological contract of safety measure will allow investigation of the positive and negative outcomes associated with fulfilment and breach of the psychological contract of safety in future research. 2010 Elsevier Ltd. All rights reserved.

  4. Multimorbidity and Patient Safety Incidents in Primary Care: A Systematic Review and Meta-Analysis

    PubMed Central

    Panagioti, Maria; Stokes, Jonathan; Esmail, Aneez; Coventry, Peter; Cheraghi-Sohi, Sudeh; Alam, Rahul; Bower, Peter

    2015-01-01

    Background Multimorbidity is increasingly prevalent and represents a major challenge in primary care. Patients with multimorbidity are potentially more likely to experience safety incidents due to the complexity of their needs and frequency of their interactions with health services. However, rigorous syntheses of the link between patient safety incidents and multimorbidity are not available. This review examined the relationship between multimorbidity and patient safety incidents in primary care. Methods We followed our published protocol (PROSPERO registration number: CRD42014007434). Medline, Embase and CINAHL were searched up to May 2015. Study design and quality were assessed. Odds ratios (OR) and 95% confidence intervals (95% CIs) were calculated for the associations between multimorbidity and two categories of patient safety outcomes: ‘active patient safety incidents’ (such as adverse drug events and medical complications) and ‘precursors of safety incidents’ (such as prescription errors, medication non-adherence, poor quality of care and diagnostic errors). Meta-analyses using random effects models were undertaken. Results Eighty six relevant comparisons from 75 studies were included in the analysis. Meta-analysis demonstrated that physical-mental multimorbidity was associated with an increased risk for ‘active patient safety incidents’ (OR = 2.39, 95% CI = 1.40 to 3.38) and ‘precursors of safety incidents’ (OR = 1.69, 95% CI = 1.36 to 2.03). Physical multimorbidity was associated with an increased risk for active safety incidents (OR = 1.63, 95% CI = 1.45 to 1.80) but was not associated with precursors of safety incidents (OR = 1.02, 95% CI = 0.90 to 1.13). Statistical heterogeneity was high and the methodological quality of the studies was generally low. Conclusions The association between multimorbidity and patient safety is complex, and varies by type of multimorbidity and type of safety incident. Our analyses suggest that multimorbidity involving mental health may be a key driver of safety incidents, which has important implication for the design and targeting of interventions to improve safety. High quality studies examining the mechanisms of patient safety incidents in patients with multimorbidity are needed, with the goal of promoting effective service delivery and ameliorating threats to safety in this group of patients. PMID:26317435

  5. Guidance, Navigation, and Control System Design in a Mass Reduction Exercise

    NASA Technical Reports Server (NTRS)

    Crain, Timothy; Begly, Michael; Jackson, Mark; Broome, Joel

    2008-01-01

    Early Orion GN&C system designs optimized for robustness, simplicity, and utilization of commercially available components. During the System Definition Review (SDR), all subsystems on Orion were asked to re-optimize with component mass and steady state power as primary design metrics. The objective was to create a mass reserve in the Orion point of departure vehicle design prior to beginning the PDR analysis cycle. The Orion GN&C subsystem team transitioned from a philosophy of absolute 2 fault tolerance for crew safety and 1 fault tolerance for mission success to an approach of 1 fault tolerance for crew safety and risk based redundancy to meet probability allocations of loss of mission and loss of crew. This paper will discuss the analyses, rationale, and end results of this activity regarding Orion navigation sensor hardware, control effectors, and trajectory design.

  6. Key factors contributing to accident severity rate in construction industry in Iran: a regression modelling approach.

    PubMed

    Soltanzadeh, Ahmad; Mohammadfam, Iraj; Moghimbeigi, Abbas; Ghiasvand, Reza

    2016-03-01

    Construction industry involves the highest risk of occupational accidents and bodily injuries, which range from mild to very severe. The aim of this cross-sectional study was to identify the factors associated with accident severity rate (ASR) in the largest Iranian construction companies based on data about 500 occupational accidents recorded from 2009 to 2013. We also gathered data on safety and health risk management and training systems. Data were analysed using Pearson's chi-squared coefficient and multiple regression analysis. Median ASR (and the interquartile range) was 107.50 (57.24- 381.25). Fourteen of the 24 studied factors stood out as most affecting construction accident severity (p<0.05). These findings can be applied in the design and implementation of a comprehensive safety and health risk management system to reduce ASR.

  7. Sun safety in construction: a U.K. intervention study.

    PubMed

    Houdmont, J; Madgwick, P; Randall, R

    2016-01-01

    Interventions to promote sun safety in the U.K. construction sector are warranted given the high incidence of skin cancer attributable to sun exposure relative to other occupational groups. To evaluate change in sun safety knowledge and practices among construction workers in response to an educational intervention. A baseline questionnaire was administered, followed by a bespoke sector-specific DVD-based intervention. At 12-month follow-up, participants completed a further questionnaire. Analyses were conducted on a sample of 120 workers (intervention group, n = 70; comparison group, n = 50). At follow-up, the proportion of intervention group participants that reported correct sun safety knowledge was not significantly greater than at baseline. However, the intervention group demonstrated significant positive change on 9 out of 10 behavioural measures, the greatest change being use of a shade/cover when working in the sun followed by regularly checking skin for moles or unusual changes. Exposure to this intervention was linked to some specific positive changes in construction workers' self-reported sun safety practices. These findings highlight the potential for educational interventions to contribute to tackling skin cancer in the UK construction sector. The findings support the development of bespoke educational interventions for other high-risk outdoor worker groups. © 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.

  8. The role of eye protection in work-related eye injuries.

    PubMed

    Fong, L P; Taouk, Y

    1995-05-01

    A recent survey of general hospitals by the Victorian Injury Surveillance System found that ocular trauma represented 15% of work-related injuries. As circumstances surrounding occupational eye injuries have been poorly documented previously, their associations to occupation, industry and work-safety practices, including safety eyewear use, need to be identified to develop appropriate preventive strategies for high-risk groups. From a prospective cross-sectional survey of all eye injuries treated at the Royal Victorian Eye and Ear Hospital, work-related cases were analysed for demographic, occupational and safety eye-wear information. Hospital-based data were supplemented by information from WorkCover Authorities and Labour Force statistics to derive incidence and cost estimates. There were 9390 eye injuries during the 18-month survey period; 42% (n=3923) of total and 29% (n=52) of penetrating ocular injuries occurred at work. The most frequently injured were metal, automotive and building trades workers grinding and drilling (41% of outpatients) and hammering (53% of penetrating eye injuries). Automotive workers had the highest frequency for penetrating injuries, and most were exposed to hammering and were also the least likely to wear safety eye-wear. Eye injuries are frequent (10% of work-related injuries) and highly preventable by the correct use of safety eye-wear, a cost-effective intervention that may result in cost savings of $59 million for work-type activities in the occupational and domestic settings in Australia each year.

  9. An Innovative Hybrid Loop-Pool SFR Design and Safety Analysis Methods: Today and Tomorrow

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

    Hongbin Zhang; Haihua Zhao; Vincent Mousseau

    2008-04-01

    Investment in commercial sodium cooled fast reactor (SFR) power plants will become possible only if SFRs achieve economic competitiveness as compared to light water reactors and other Generation IV reactors. Toward that end, we have launched efforts to improve the economics and safety of SFRs from the thermal design and safety analyses perspectives at Idaho National Laboratory. From the thermal design perspective, an innovative hybrid loop-pool SFR design has been proposed. This design takes advantage of the inherent safety of a pool design and the compactness of a loop design to further improve economics and safety. From the safety analysesmore » perspective, we have initiated an effort to develop a high fidelity reactor system safety code.« less

  10. Patient safety culture in China: a case study in an outpatient setting in Beijing

    PubMed Central

    Liu, Chaojie; Liu, Weiwei; Wang, Yuanyuan; Zhang, Zhihong; Wang, Peng

    2014-01-01

    Objectives To investigate the patient safety culture in an outpatient setting in Beijing and explore the meaning and implications of the safety culture from the perspective of health workers and patients. Methods A mixed methods approach involving a questionnaire survey and in-depth interviews was adopted. Among the 410 invited staff members, 318 completed the Hospital Survey of Patient Safety Culture (HSOPC). Patient safety culture was described using 12 subscale scores. Inter-subscale correlation analysis, ANOVA and stepwise multivariate regression analyses were performed to identify the determinants of the patient safety culture scores. Interviewees included 22 patients selected through opportunity sampling and 27 staff members selected through purposive sampling. The interview data were analysed thematically. Results The survey respondents perceived high levels of unsafe care but had personally reported few events. Lack of ‘communication openness’ was identified as a major safety culture problem, and a perception of ‘penalty’ was the greatest barrier to the encouragement of error reporting. Cohesive ‘teamwork within units’, while found to be an area of strength, conversely served as a protective and defensive mechanism for medical practice. Low levels of trust between providers and consumers and lack of management support constituted an obstacle to building a positive patient safety culture. Conclusions This study in China demonstrates that a punitive approach to error is still widespread despite increasing awareness of unsafe care, and managers have been slow in acknowledging the importance of building a positive patient safety culture. Strong ‘teamwork within units’, a common area of strength, could fuel the concealment of errors. PMID:24351971

  11. The culture of patient safety in an Iranian intensive care unit.

    PubMed

    Abdi, Zhaleh; Delgoshaei, Bahram; Ravaghi, Hamid; Abbasi, Mohsen; Heyrani, Ali

    2015-04-01

    To explore nurses' and physicians' attitudes and perceptions relevant to safety culture and to elicit strategies to promote safety culture in an intensive care unit. A strong safety culture is essential to ensure patient safety in the intensive care unit. This case study adopted a mixed method design. The Safety Attitude Questionnaire (SAQ-ICU version), assessing the safety climate through six domains, was completed by nurses and physicians (n = 42) in an academic intensive care unit. Twenty semi-structured interviews and document analyses were conducted as well. Interviews were analysed using a framework analysis method. Mean scores across the six domains ranged from 52.3 to 72.4 on a 100-point scale. Further analysis indicated that there were statistically significant differences between physicians' and nurses' attitudes toward teamwork (mean scores: 64.5/100 vs. 52.6/100, d = 1.15, t = 3.69, P < 0.001) and job satisfaction (mean scores: 78.2/100 vs. 57.7/100, d = 1.5, t = 4.8, P < 0.001). Interviews revealed several safety challenges including underreporting, failure to learn from errors, lack of speaking up, low job satisfaction among nurses and ineffective nurse-physician communication. The results indicate that all the domains need improvements. However, further attention should be devoted to error reporting and analysis, communication and teamwork among professional groups, and nurses' job satisfaction. Nurse managers can contribute to promoting a safety culture by encouraging staff to report errors, fostering learning from errors and addressing inter-professional communication problems. © 2013 John Wiley & Sons Ltd.

  12. Use of a safety climate questionnaire in UK health care: factor structure, reliability and usability.

    PubMed

    Hutchinson, A; Cooper, K L; Dean, J E; McIntosh, A; Patterson, M; Stride, C B; Laurence, B E; Smith, C M

    2006-10-01

    To explore the factor structure, reliability, and potential usefulness of a patient safety climate questionnaire in UK health care. Four acute hospital trusts and nine primary care trusts in England. The questionnaire used was the 27 item Teamwork and Safety Climate Survey. Thirty three healthcare staff commented on the wording and relevance. The questionnaire was then sent to 3650 staff within the 13 NHS trusts, seeking to achieve at least 600 responses as the basis for the factor analysis. 1307 questionnaires were returned (36% response). Factor analyses and reliability analyses were carried out on 897 responses from staff involved in direct patient care, to explore how consistently the questions measured the underlying constructs of safety climate and teamwork. Some questionnaire items related to multiple factors or did not relate strongly to any factor. Five items were discarded. Two teamwork factors were derived from the remaining 11 teamwork items and three safety climate factors were derived from the remaining 11 safety items. Internal consistency reliabilities were satisfactory to good (Cronbach's alpha > or =0.69 for all five factors). This is one of the few studies to undertake a detailed evaluation of a patient safety climate questionnaire in UK health care and possibly the first to do so in primary as well as secondary care. The results indicate that a 22 item version of this safety climate questionnaire is useable as a research instrument in both settings, but also demonstrates a more general need for thorough validation of safety climate questionnaires before widespread usage.

  13. Posttest analysis of the FFTF inherent safety tests

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

    Padilla, A. Jr.; Claybrook, S.W.

    Inherent safety tests were performed during 1986 in the 400-MW (thermal) Fast Flux Test Facility (FFTF) reactor to demonstrate the effectiveness of an inherent shutdown device called the gas expansion module (GEM). The GEM device provided a strong negative reactivity feedback during loss-of-flow conditions by increasing the neutron leakage as a result of an expanding gas bubble. The best-estimate pretest calculations for these tests were performed using the IANUS plant analysis code (Westinghouse Electric Corporation proprietary code) and the MELT/SIEX3 core analysis code. These two codes were also used to perform the required operational safety analyses for the FFTF reactormore » and plant. Although it was intended to also use the SASSYS systems (core and plant) analysis code, the calibration of the SASSYS code for FFTF core and plant analysis was not completed in time to perform pretest analyses. The purpose of this paper is to present the results of the posttest analysis of the 1986 FFTF inherent safety tests using the SASSYS code.« less

  14. A multilevel examination of affective job insecurity climate on safety outcomes.

    PubMed

    Jiang, Lixin; Probst, Tahira M

    2016-07-01

    Previous research has established a causal link between individual perceptions of job insecurity and safety outcomes. However, whether job insecurity climate is associated with safety outcomes has not been studied. The purpose of the current study was to explore the main and cross-level interaction effects of affective job insecurity climate on safety outcomes, including behavioral safety compliance, reporting attitudes, workplace injuries, experienced safety events, unreported safety events, and accident underreporting, beyond individual affective job insecurity. With 171 employees nested in 40 workgroups, multilevel analyses revealed that the negative impacts of individual affective job insecurity on safety outcomes are exacerbated when they occur in a climate of high affective job insecurity. These results are interpreted in light of safety management efforts and suggest that efforts to create a secure climate within one's workgroup may reap safety-related benefits. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

  15. 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.

  16. Estimation of integrated public risks for nonseismic external events affecting the Savannah River Site

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

    Durant, W.S.; robinette, R.J.; Kirchner, J.R.

    1994-03-01

    In essence, this study was envisioned as the ``combination`` of existing accident dose and risk calculations from safety analyses of individual facilities. However, because of the extended time period over which the safety analyses were prepared, calculational assumptions and methodologies differed between the analyses. The scope of this study therefore included the standardization of assumptions and calculations as necessary to insure that the analytical logic was consistent for all the facilities. Each of the nonseismic external events considered in the analyses are addressed in individual sections in this report. In Section 2, extreme straight-line winds are examined. Section 3 addressesmore » tornadoes, and Section 4 addresses other external events [floods, other extreme weather events (lightning, hail, and extremes in temperature or precipitation), vehicle impact, accidents involving adjacent facilities, aircraft impact, and meteorite impact]. Section 5 provides a summary of the general conclusions of the report.« less

  17. Safety analysis report for packaging (onsite) steel drum

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

    McCormick, W.A.

    This Safety Analysis Report for Packaging (SARP) provides the analyses and evaluations necessary to demonstrate that the steel drum packaging system meets the transportation safety requirements of HNF-PRO-154, Responsibilities and Procedures for all Hazardous Material Shipments, for an onsite packaging containing Type B quantities of solid and liquid radioactive materials. The basic component of the steel drum packaging system is the 208 L (55-gal) steel drum.

  18. Use of safety management practices for improving project performance.

    PubMed

    Cheng, Eddie W L; Kelly, Stephen; Ryan, Neal

    2015-01-01

    Although site safety has long been a key research topic in the construction field, there is a lack of literature studying safety management practices (SMPs). The current research, therefore, aims to test the effect of SMPs on project performance. An empirical study was conducted in Hong Kong and the data collected were analysed with multiple regression analysis. Results suggest that 3 of the 15 SMPs, which were 'safety committee at project/site level', 'written safety policy', and 'safety training scheme' explained the variance in project performance significantly. Discussion about the impact of these three SMPs on construction was provided. Assuring safe construction should be an integral part of a construction project plan.

  19. Granite disposal of U.S. high-level radioactive waste.

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

    Freeze, Geoffrey A.; Mariner, Paul E.; Lee, Joon H.

    This report evaluates the feasibility of disposing U.S. high-level radioactive waste in granite several hundred meters below the surface of the earth. The U.S. has many granite formations with positive attributes for permanent disposal. Similar crystalline formations have been extensively studied by international programs, two of which, in Sweden and Finland, are the host rocks of submitted or imminent repository license applications. This report is enabled by the advanced work of the international community to establish functional and operational requirements for disposal of a range of waste forms in granite media. In this report we develop scoping performance analyses, basedmore » on the applicable features, events, and processes (FEPs) identified by international investigators, to support generic conclusions regarding post-closure safety. Unlike the safety analyses for disposal in salt, shale/clay, or deep boreholes, the safety analysis for a mined granite repository depends largely on waste package preservation. In crystalline rock, waste packages are preserved by the high mechanical stability of the excavations, the diffusive barrier of the buffer, and favorable chemical conditions. The buffer is preserved by low groundwater fluxes, favorable chemical conditions, backfill, and the rigid confines of the host rock. An added advantage of a mined granite repository is that waste packages would be fairly easy to retrieve, should retrievability be an important objective. The results of the safety analyses performed in this study are consistent with the results of comprehensive safety assessments performed for sites in Sweden, Finland, and Canada. They indicate that a granite repository would satisfy established safety criteria and suggest that a small number of FEPs would largely control the release and transport of radionuclides. In the event the U.S. decides to pursue a potential repository in granite, a detailed evaluation of these FEPs would be needed to inform site selection and safety assessment.« less

  20. Safety and efficacy of first-line bevacizumab combination therapy in Chinese population with advanced non-squamous NSCLC: data of subgroup analyses from MO19390 (SAiL) study.

    PubMed

    Zhou, C C; Bai, C X; Guan, Z Z; Jiang, G L; Shi, Y K; Wang, M Z; Wu, Y L; Zhang, Y P; Zhu, Y Z

    2014-05-01

    Bevacizumab is a monoclonal antibody with high antitumor activity against malignant diseases. Previous studies have demonstrated the efficacy of first-line bevacizumab combination therapy in advanced, non-squamous non-small cell lung cancer (NS-NSCLC). SAiL (MO19390), an open-label, multicenter, single-arm study, evaluated the safety and efficacy of first-line bevacizumab-based treatment in clinical practice. This report presents the results of a subgroup analysis of Chinese patients enrolled in SAiL. Chemo-naive Chinese patients with locally advanced, metastatic or recurrent NSCLC were randomized to receive Bev 15 mg/kg every 3 weeks plus carboplatin + paclitaxel for maximum of six cycles, followed by single-agent bevacizumab until disease progression. The primary endpoint was safety. Secondary endpoints included time to progression and overall survival. The Chinese intent-to-treat (ITT) population consists of 198 Chinese patients, among whom 107 (54 %) were non-smokers and 90 (45.5 %) were female. The median cycle of bevacizumab administration was 10 and median duration of bevacizumab treatment was 29.5 weeks. Only eight cases of severe adverse events were observed in the study, which were deemed to be related to bevacizumab. The incidence of AEs over grade 3 in Chinese ITT patients was generally low (<9 %). No new safety signals were reported. Objective response rate in 195 evaluable Chinese patients was 68.8 %, including four complete responses (2.1 %). Time to disease progression (TTP) and overall survival were 8.8 and 18.5 months, respectively. The safety and efficacy of first-line bevacizumab-based treatment in Chinese population with advanced NS-NSCLC are consistent with those in previous studies as well as in Asian subgroup population from SAiL study. No new safety signals were reported.

  1. Exploring the relationship between development and road traffic injuries: a case study from India.

    PubMed

    Garg, Nitin; Hyder, Adnan A

    2006-10-01

    Road traffic injuries (RTI) are a major cause of mortality and disability in the world. Only after significant losses have communities in developed nations taken necessary steps to prevent crashes and their consequences. Increase in road safety is related to increasing socio-economic development. We aim to study the trends in injury and death rates in a developing country, India, define sub-national variations, and analyse these trends in relation to economic and population growth. Public sector data from India were used to develop a standardized database on traffic injuries and indicator of economic development. The data were analysed using linear regression models to test the a priori hypothesis of a positive relationship between net domestic product (NDP), and injury and death rates from road crashes across states. The absolute burden of RTI in India has been consistently rising over the past three decades. The reported rates are lower than those estimated by global health agencies and may reflect under-reporting. Population-based rates provide a better assessment of the public health burden of RTI than vehicle-based rates. There is an inverted U-shaped relationship between NDP and injury and death rates. Even with the limited data, Kuznets phenomenon is evident for within-country level comparisons. India and other developing countries could learn from the experience of highly motorized nations to avoid the expected rise in RTI and deaths with economic development, by currently investing in road safety and prevention measures.

  2. Hemodynamic Parameters during Laryngoscopic Procedures in the Office and in the Operating Room.

    PubMed

    Tierney, William S; Chota, Rebecca L; Benninger, Michael S; Nowacki, Amy S; Bryson, Paul C

    2016-09-01

    Previous research has shown that office-based laryngoscopic procedures can induce hemodynamic changes, including tachycardia and severe hypertension, calling into question the safety of these procedures. However, comparison between office and operating room (OR) procedures has not been carried out. Therefore, we prospectively measured hemodynamic variables in both settings to compare hemodynamic changes between office and OR procedures. Prospective cohort study. Single academic center. Subjects undergoing office and OR laryngoscopic procedures were prospectively identified, and 92 OR and 70 office subjects were included. Heart rate and blood pressure were measured at established time points before, during, and after the procedures. Descriptive and comparative statistical analyses were conducted. Severe hemodynamic events, either tachycardia or severe hypertension (blood pressure >180 mm Hg systolic or >110 mm Hg diastolic), occurred significantly more frequently in OR than office procedures (41% vs 20%; P = .006). OR severe hemodynamic events occurred more commonly than previously reported rates in the office (41% vs 28%; P = .012). Regression analyses showed that the odds of having a severe hemodynamic event were 3.66 times higher in OR versus office procedures. Severe hemodynamic events are more likely to occur in the OR than in the office during laryngologic procedures. While larger studies will be required to establish rates of dangerous cardiovascular events in laryngoscopic procedures, hemodynamic parameters indicate that office-based procedures have a safety benefit for procedures that can be conducted in either setting. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2016.

  3. Patient safety in dentistry - state of play as revealed by a national database of errors.

    PubMed

    Thusu, S; Panesar, S; Bedi, R

    2012-08-01

    Modern dentistry has become increasingly invasive and sophisticated. Consequently the risk to the patient has increased. The aim of this study is to investigate the types of patient safety incidents (PSIs) that occur in dentistry and the accuracy of the National Patient Safety Agency (NPSA) database in identifying those attributed to dentistry. The database was analysed for all incidents of iatrogenic harm in the speciality of dentistry. A snapshot view using the timeframe January to December 2009 was used. The free text elements from the database were analysed thematically and reclassified according to the nature of the PSI. Descriptive statistics were provided. Two thousand and twelve incident reports were analysed and organised into ten categories. The commonest was due to clerical errors - 36%. Five areas of PSI were further analysed: injury (10%), medical emergency (6%), inhalation/ingestion (4%), adverse reaction (4%) and wrong site extraction (2%). There is generally low reporting of PSIs within the dental specialities. This may be attributed to the voluntary nature of reporting and the reluctance of dental practitioners to disclose incidences for fear of loss of earnings. A significant amount of iatrogenic harm occurs not during treatment but through controllable pre- and post-procedural checks. Incidences of iatrogenic harm to dental patients do occur but their reporting is not widely used. The use of a dental specific reporting system would aid in minimising iatrogenic harm and adhere to the Care Quality Commission (CQC) compliance monitoring system on essential standards of quality and safety in dental practices.

  4. [Analysis of patient complaints in Primary Care: An opportunity to improve clinical safety].

    PubMed

    Añel-Rodríguez, R M; Cambero-Serrano, M I; Irurzun-Zuazabal, E

    2015-01-01

    To determine the prevalence and type of the clinical safety problems contained in the complaints made by patients and users in Primary Care. An observational, descriptive, cross-sectional study was conducted by analysing both the complaint forms and the responses given to them in the period of one year. At least 4.6% of all claims analysed in this study contained clinical safety problems. The family physician is the professional who received the majority of the complaints (53.6%), and the main reason was the problems related to diagnosis (43%), mainly the delay in diagnosis. Other variables analysed were the severity of adverse events experienced by patients (in 68% of cases the patient suffered some harm), the subsequent impact on patient care, which was affected in 39% of cases (7% of cases even requiring hospital admission), and the level of preventability of adverse events (96% avoidable) described in the claims. Finally the type of response issued to each complaint was analysed, being purely bureaucratic in 64% of all cases. Complaints are a valuable source of information about the deficiencies identified by patients and healthcare users. There is considerable scope for improvement in the analysis and management of claims in general, and those containing clinical safety issues in particular. To date, in our area, there is a lack of appropriate procedures for processing these claims. Likewise, we believe that other pathways or channels should be opened to enable communication by patients and healthcare users. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.

  5. Evaluation of the personal dental services (wave 1) for Lambeth, Southwark and Lewisham primary care trusts--Part 2: Retrospective analyses of treatment and other dental record data.

    PubMed

    Best, Helen; Newton, Tim

    2005-06-01

    The purpose of the study was to undertake analyses of treatment data for the Personal Dental Services (PDS) of Lambeth, Southwark and Lewisham Primary Care Trusts and relate the analyses to the PDS goals of supporting practitioners deliver appropriate quality dental care and ensuring that appropriate quality safety net services are available for all residents. Analyses of treatment data provided by the Dental Practice Board were undertaken for the post-PDS period (February 1999-March 2003, based on data availability). Analyses of the clinic notes for 1500 patients were also undertaken for the 1 year pre-PDS period (October 1997-September 1998) and post-introduction of the PDS (October 1998-June 2003). Two sets of analyses were undertaken to evaluate trends in treatment claims for the Dental Practice Board data, absolute numbers of each type of treatment claimed each month and change in numbers of types of treatments claimed over time. The clinic notes were used to undertake post-PDS, pre-PDS comparisons of the number of treatment items and grouped treatment item categories undertaken and the number of courses and percentages of private treatment items provided. The following sociodemographic characteristics of the patients were also analysed, age, gender, exemption status and attendance status. Overall it was identified that the percentage reduction in the number of treatment items undertaken was 13% (95% CI -19%, -7%), post- as compared to the pre-PDS introduction period. On an annual basis it was identified that the percentage reduction in the number of treatment items undertaken per year per patient post-PDS was 4% (95% CI -6%, -2%). There were significant variations in the impact of the PDS on the number of treatment items undertaken for different types of patients. A limited number of treatment types changed significantly post- as compared to pre-PDS. The proportion of exempt patients treated did not increase post-PDS. It is possible that a less invasive style of dental treatment was provided during the course of the PDS, however, there was only limited evidence to indicate that dentists practice style changed based on types of treatment categories provided. The PDS provided a limited safety net service for local residents. In setting program goals the nature of quality dental practice requires definition and evaluation should be undertaken on a prospective basis.

  6. The safety of women health workers at the frontlines.

    PubMed

    Dasgupta, Jashodhara; Velankar, Jayashree; Borah, Pritisha; Nath, Gangotri Hazarika

    2017-01-01

    This article, based on the report of the fact-finding team on the gang rape and death of an accredited social health activist (ASHA) in Muzaffarnagar in January 2016, attempts to analyse the issues of the safety and mobility of front-line women health workers. It argues that although the National Health Mission is often alluded to as a flagship programme of the government, it has failed in its basic responsibility as an ethical employer, since there is no support and back-up system that can be easily accessed by ASHAs in terms of dealing with the fallout of their social role as "change agents" in rural areas, and community reactions to their mobility and public exposure. The report stresses the need to consider the deeply patriarchal system within which ASHAs function in states such as Uttar Pradesh. It also discusses the fact that the workforce is increasingly shifting from the formal to the informal sector, which has given rise to an assumption that the employer is no longer accountable for women workers' safety at the workplace.

  7. The Role of Geographical Indication in Supporting Food Safety: A not Taken for Granted Nexus

    PubMed Central

    2014-01-01

    The paper focuses on the role of geographical indication in supporting strategies of food safety. Starting from the distinction between generic and specific quality, the article analyses the main factors influencing food safety in cases of geographical indication products, by stressing the importance of traceability systems and biodiversity in securing generic and specific quality. In the second part, the paper investigates the coordination problems behind a designation of origin and conditions to foster an effective collective action, a prerequisite to grant food safety through geographical indications. PMID:27800417

  8. Reliability Modeling Methodology for Independent Approaches on Parallel Runways Safety Analysis

    NASA Technical Reports Server (NTRS)

    Babcock, P.; Schor, A.; Rosch, G.

    1998-01-01

    This document is an adjunct to the final report An Integrated Safety Analysis Methodology for Emerging Air Transport Technologies. That report presents the results of our analysis of the problem of simultaneous but independent, approaches of two aircraft on parallel runways (independent approaches on parallel runways, or IAPR). This introductory chapter presents a brief overview and perspective of approaches and methodologies for performing safety analyses for complex systems. Ensuing chapter provide the technical details that underlie the approach that we have taken in performing the safety analysis for the IAPR concept.

  9. 75 FR 68781 - Workforce Guidelines for Home Energy Upgrades

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-09

    ... Work Specifications (SWSs), Job Task Analyses (JTAs) and essential Knowledge, Skills and Abilities..., organized labor, healthy homes and worker safety experts, and other professionals in the building trades and... reviews, a healthy homes review coordinated by the EPA, and a worker health and safety review coordinated...

  10. Cognitive process modelling of controllers in en route air traffic control.

    PubMed

    Inoue, Satoru; Furuta, Kazuo; Nakata, Keiichi; Kanno, Taro; Aoyama, Hisae; Brown, Mark

    2012-01-01

    In recent years, various efforts have been made in air traffic control (ATC) to maintain traffic safety and efficiency in the face of increasing air traffic demands. ATC is a complex process that depends to a large degree on human capabilities, and so understanding how controllers carry out their tasks is an important issue in the design and development of ATC systems. In particular, the human factor is considered to be a serious problem in ATC safety and has been identified as a causal factor in both major and minor incidents. There is, therefore, a need to analyse the mechanisms by which errors occur due to complex factors and to develop systems that can deal with these errors. From the cognitive process perspective, it is essential that system developers have an understanding of the more complex working processes that involve the cooperative work of multiple controllers. Distributed cognition is a methodological framework for analysing cognitive processes that span multiple actors mediated by technology. In this research, we attempt to analyse and model interactions that take place in en route ATC systems based on distributed cognition. We examine the functional problems in an ATC system from a human factors perspective, and conclude by identifying certain measures by which to address these problems. This research focuses on the analysis of air traffic controllers' tasks for en route ATC and modelling controllers' cognitive processes. This research focuses on an experimental study to gain a better understanding of controllers' cognitive processes in air traffic control. We conducted ethnographic observations and then analysed the data to develop a model of controllers' cognitive process. This analysis revealed that strategic routines are applicable to decision making.

  11. Pediatric patient safety events during hospitalization: approaches to accounting for institution-level effects.

    PubMed

    Slonim, Anthony D; Marcin, James P; Turenne, Wendy; Hall, Matt; Joseph, Jill G

    2007-12-01

    To determine the rates, patient, and institutional characteristics associated with the occurrence of patient safety indicators (PSIs) in hospitalized children and the degree of statistical difference derived from using three approaches of controlling for institution level effects. Pediatric Health Information System Dataset consisting of all pediatric discharges (<21 years of age) from 34 academic, freestanding children's hospitals for calendar year 2003. The rates of PSIs were computed for all discharges. The patient and institutional characteristics associated with these PSIs were calculated. The analyses sequentially applied three increasingly conservative methods to control for the institution-level effects robust standard error estimation, a fixed effects model, and a random effects model. The degree of difference from a "base state," which excluded institution-level variables, and between the models was calculated. The effects of these analyses on the interpretation of the PSIs are presented. PSIs are relatively infrequent events in hospitalized children ranging from 0 per 10,000 (postoperative hip fracture) to 87 per 10,000 (postoperative respiratory failure). Significant variables associated PSIs included age (neonates), race (Caucasians), payor status (public insurance), severity of illness (extreme), and hospital size (>300 beds), which all had higher rates of PSIs than their reference groups in the bivariable logistic regression results. The three different approaches of adjusting for institution-level effects demonstrated that there were similarities in both the clinical and statistical significance across each of the models. Institution-level effects can be appropriately controlled for by using a variety of methods in the analyses of administrative data. Whenever possible, resource-conservative methods should be used in the analyses especially if clinical implications are minimal.

  12. Measuring patient safety in a UK dental hospital: development of a dental clinical effectiveness dashboard.

    PubMed

    Pemberton, M N; Ashley, M P; Shaw, A; Dickson, S; Saksena, A

    2014-10-01

    Patient safety is an important marker of quality for any healthcare organisation. In 2008, the British Government white paper entitled High quality care for all, resulting from a review led by Lord Darzi, identified patient safety as a key component of quality and discussed how it might be measured, analysed and acted upon. National and local clinically curated metrics were suggested, which could be displayed via a 'clinical dashboard'. This paper explains the development of a clinical effectiveness dashboard focused on patient safety in an English dental hospital and how it has helped us identify relevant patient safety issues in secondary dental care.

  13. Ares I Static Tests Design

    NASA Technical Reports Server (NTRS)

    Carson, William; Lindemuth, Kathleen; Mich, John; White, K. Preston; Parker, Peter A.

    2009-01-01

    Probabilistic engineering design enhances safety and reduces costs by incorporating risk assessment directly into the design process. In this paper, we assess the format of the quantitative metrics for the vehicle which will replace the Space Shuttle, the Ares I rocket. Specifically, we address the metrics for in-flight measurement error in the vector position of the motor nozzle, dictated by limits on guidance, navigation, and control systems. Analyses include the propagation of error from measured to derived parameters, the time-series of dwell points for the duty cycle during static tests, and commanded versus achieved yaw angle during tests. Based on these analyses, we recommend a probabilistic template for specifying the maximum error in angular displacement and radial offset for the nozzle-position vector. Criteria for evaluating individual tests and risky decisions also are developed.

  14. The Earth Science Afternoon Constellation Contingency Procedures

    NASA Technical Reports Server (NTRS)

    Case, Warren F.; Richon, Karen

    2005-01-01

    The Earth Science Afternoon Constellation comprises NASA missions Aqua, Aura, CloudSat and the Orbiting Carbon Observatory (OCO), the joint NASA/CNES mission CALIPSO and the CNES mission PARASOL. Both NASA and CNES offices are responsible for ensuring that contingency plans or other arrangements exist to cope with contingencies within their respective jurisdictions until the conclusion of all Afternoon Constellation operations. The Mission Operations Working Group, comprised of members from each of the missions, has developed the high-level procedures for maintaining the safety of this constellation. Each contingency situation requires detailed analyses before any decisions are made. This paper describes these procedures, and includes defining what constitutes a contingency situation, the pertinent parameters involved in the contingency analysis and guidelines for the actions required, based on the results of the contingency analyses.

  15. Patient-specific fracture risk assessment of vertebrae: A multiscale approach coupling X-ray physics and continuum micromechanics.

    PubMed

    Blanchard, Romane; Morin, Claire; Malandrino, Andrea; Vella, Alain; Sant, Zdenka; Hellmich, Christian

    2016-09-01

    While in clinical settings, bone mineral density measured by computed tomography (CT) remains the key indicator for bone fracture risk, there is an ongoing quest for more engineering mechanics-based approaches for safety analyses of the skeleton. This calls for determination of suitable material properties from respective CT data, where the traditional approach consists of regression analyses between attenuation-related grey values and mechanical properties. We here present a physics-oriented approach, considering that elasticity and strength of bone tissue originate from the material microstructure and the mechanical properties of its elementary components. Firstly, we reconstruct the linear relation between the clinically accessible grey values making up a CT, and the X-ray attenuation coefficients quantifying the intensity losses from which the image is actually reconstructed. Therefore, we combine X-ray attenuation averaging at different length scales and over different tissues, with recently identified 'universal' composition characteristics of the latter. This gives access to both the normally non-disclosed X-ray energy employed in the CT-device and to in vivo patient-specific and location-specific bone composition variables, such as voxel-specific mass density, as well as collagen and mineral contents. The latter feed an experimentally validated multiscale elastoplastic model based on the hierarchical organization of bone. Corresponding elasticity maps across the organ enter a finite element simulation of a typical load case, and the resulting stress states are increased in a proportional fashion, so as to check the safety against ultimate material failure. In the young patient investigated, even normal physiological loading is probable to already imply plastic events associated with the hydrated mineral crystals in the bone ultrastructure, while the safety factor against failure is still as high as five. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  16. Adverse events following school-based vaccination of girls with quadrivalent human papillomavirus vaccine in Slovenia, 2009 to 2013.

    PubMed

    Šubelj, Maja; Učakar, Veronika; Kraigher, Alenka; Klavs, Irena

    2016-01-01

    Adverse events following immunisation (AEFIs) with qHPV reported to the Slovenian AEFI Registry for the first four school years of the vaccination programme were analysed. We calculated annual reporting rates for 11-14 year-old vaccinees with AEFIs, using the number of qHPV doses distributed within the school-based vaccination programme as the denominator. Between September 2009 and August 2013, 211 AEFIs that occurred in 89 vaccinees were reported, a rate of 149.5 vaccinees with AEFI per 100,000 qHPV doses distributed. For five vaccinees, serious AEFIs (8.4 per 100,000 doses distributed) were reported. The highest reporting rates were for fatigue, headache, and fever (≥ 38.0⁰) (53.8, 40.3, and 35.3 per 100,000 qHPV doses distributed, respectively). As no AEFI resulted in permanent sequelae and they all were categorised as serious only due to the criterion of a minimum of one day of hospitalisation, this provides reassurance for the safety of our school-based HPV vaccination programme. Further AEFI surveillance is warranted to provide data for HPV vaccination programme monitoring and evaluation of its safety.

  17. [Organisational responsibility versus individual responsibility: safety culture? About the relationship between patient safety and medical malpractice law].

    PubMed

    Hart, Dieter

    2009-01-01

    The contribution is concerned with the correlations between risk information, patient safety, responsibility and liability, in particular in terms of liability law. These correlations have an impact on safety culture in healthcare, which can be evaluated positively if--in addition to good quality of medical care--as many sources of error as possible can be identified, analysed, and minimised or eliminated by corresponding measures (safety or risk management). Liability influences the conduct of individuals and enterprises; safety is (probably) also a function of liability; this should also apply to safety culture. The standard of safety culture does not only depend on individual liability for damages, but first of all on strict enterprise liability (system responsibility) and its preventive effects. Patient safety through quality and risk management is therefore also an organisational programme of considerable relevance in terms of liability law.

  18. 78 FR 63479 - Meta-Analyses of Randomized Controlled Clinical Trials (RCTs) for the Evaluation of Risk To...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-24

    ... methodological issues that arise in the use of meta-analyses to evaluate safety risks, followed by a discussion... design, conduct and use of meta-analysis. Although many external stakeholders conduct meta-analyses, FDA... meeting. FDA expects that this meeting will build upon prior stakeholder feedback on the design, conduct...

  19. Nuclear and chemical safety analysis: Purex Plant 1970 thorium campaign

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

    Boldt, A.L.; Oberg, G.C.

    The purpose of this document is to discuss the flowsheet and the related processing equipment with respect to nuclear and chemical safety. The analyses presented are based on equipment utilization and revised piping as outlined in the design criteria. Processing of thorium and uranium-233 in the Purex Plant can be accomplished within currently accepted levels of risk with respect to chemical and nuclear safety if minor instrumentation changes are made. Uranium-233 processing is limited to a rate of about 670 grams per hour by equipment capacities and criticality safety considerations. The major criticality prevention problems result from the potential accumulationmore » of uranium-233 in a solvent phase in E-H4 (ICU concentrator), TK-J1 (IUC receiver), and TK-J21 (2AF pump tank). The same potential problems exist in TK-J5 (3AF pump tank) and TK-N1 (3BU receiver), but the probabilities of reaching a critical condition are not as great. In order to prevent the excessive accumulation of uranium-233 in any of these vessels by an extraction mechanism, it is necessary to maintain the uranium-233 and salting agent concentrations below the point at which a critical concentration of uranium-233 could be reached in a solvent phase.« less

  20. 10 CFR Appendix A to Subpart B of... - General Statement of Safety Basis Policy

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Analysis Reports for Nuclear Power Plants, or successor document. (2) A DOE nonreactor nuclear facility... with DOE Policy 450.2A, “Identifying, Implementing and Complying with Environment, Safety and Health..., the public and the environment from adverse consequences. These analyses and hazard controls...

  1. A comparative study of quality and safety of Atlantic cod (Gadus morhua) fillets during cold storage, as affected by different thawing methods of pre‐rigor frozen headed and gutted fish

    PubMed Central

    Jónsson, Ásbjörn; Backi, Christoph Josef; Lunestad, Bjørn Tore; Karlsdóttir, Magnea G

    2017-01-01

    Abstract BACKGROUND The catch of marine whitefish is typically seasonal, whereas the land‐based processing industry has a need for all‐year stable supply of raw materials. This challenge can be met by applying fish frozen at sea. When using frozen fish, the methods employed for thawing may influence the safety and quality of the final product. This study aimed to investigate the applicability of novel thawing strategies in order to provide an all‐year supply of high‐quality and safe cod products. RESULTS Comparative investigations of quality and safety factors after thawing in water, with and without air circulation, and contact thawing were performed. The parameters included water‐holding capacity, thawing loss, drip loss, cooking yield, sensory evaluation and microbiological analyses (including total volatile bases nitrogen). Water thawing with air circulation provided faster thawing than water thawing without air circulation and contact thawing. For all three methods, the quality of the thawed fish was acceptable and the shelf life of the fillets during chilled storage was between 10 and 14 days post‐filleting. CONCLUSION The results show that controlled freezing of cod, followed by appropriate thawing, may provide the processing industry with an all‐year delivery of raw materials, without compromising quality and safety of the final product. © 2017 The Authors. Journal of The Science of Food and Agriculture published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry. PMID:28862323

  2. Perceptions of housing conditions among migrant farmworkers and their families: implications for health, safety and social policy.

    PubMed

    Keim-Malpass, Jessica; Spears Johnson, Chaya R; Quandt, Sara A; Arcury, Thomas A

    2015-01-01

    In the USA, migrant farmworkers are a vulnerable group due to their low socioeconomic status, risk of occupational exposures and injury, lack of social mobility, lack of adequate access to health services and dependency on employer for provided housing. Previous reports have documented migrant farmworker housing conditions to be variable, but poor overall. This paper explores the perceptions of housing conditions among migrant farmworkers in rural North Carolina, and develops an understanding of potential impacts of their housing on health and safety. This study used qualitative descriptive data and directed content analysis to analyse semi-structured interviews and photographs that were data elements of a larger community-based participatory research study designed to document housing quality and health among North Carolina farmworkers. Many of the study participants described poor housing conditions that were reflected in the photographic analysis of the houses and camps. Specific problems described by the participants include exposure to pesticides, safety issues, pests, water supply and air quality, temperature and moisture. This study describes migrant farmworkers' perceptions of housing quality and numerous potential impacts on health and safety. Research, social policy and practice-based implications derived from this research could serve to improve the health status of these individuals and their families. This study suggests there is much room for sustained advocacy and action, given that many of the farmworkers' descriptions and photographs depicted housing conditions below accepted standards of living. Access to adequate and safe employer-provided housing for migrant farmworkers should be considered a basic human right.

  3. Mass media health information: quantitative and qualitative analysis of daily press coverage and its relation with public perceptions.

    PubMed

    Carducci, Annalaura; Alfani, Simona; Sassi, Manuela; Cinini, Alessandra; Calamusa, Andrea

    2011-03-01

    This paper describes the methods followed by the Pisa University OCS for collecting, storing and analyzing all health-related articles and database contents. Moreover, an example population survey on the topic of food safety based on such analysis is shown. Articles published each day since 1999 in Italy's three most popular newspapers are collected and stored in a Data Base Text; on these articles quantitative and qualitative analyses were conducted. On the basis of these results as well as of epidemiological data, a questionnaire survey was carried out about sources of information, knowledge and risk perception of citizens regarding food safety. On a total of 24,434 articles on all health topics, 18% regarded food related hazards: their evolution over time showed peaks on BSE, avian flu and dioxin. A large proportion of the people surveyed declared having changed their food habits, at least temporarily, as a consequence of media information. Most get their information on food safety mainly from television. Most respondents remembered having previously heard news on BSE, avian flu and dioxin, but did not recall having heard of listeriosis, brucellosis or typhoid fever. Newspapers articles facing food related hazards tend to be alarming thus affecting the citizens risk perception. On the other hand people often ignore how to manage their own food safety in a practical way. Analysis of media messages can help to evaluate and correct the negative effects that may result in wrong information. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  4. Biological therapies in Crohn's disease: are they cost-effective? A critical appraisal of model-based analyses.

    PubMed

    Marchetti, Monia; Liberato, Nicola Lucio

    2014-12-01

    In refractory Crohn's disease, anti-TNF and anti-α 4 integrin agents are used for ameliorating disease activity but impose high costs to health-care systems. The authors systematically reviewed cost-effectiveness analyses based on decision models: most of the studies were judged to have a good quality, but a large portion assessed health and costs in a short time horizon, usually disregarding fistulizing disease and not considering safety. Infliximab induction followed by on-demand retreatment consistently proved to have a good cost per quality-adjusted life year, while maintenance treatment never satisfied commonly accepted cost-utility thresholds. Challenges in cost-effectiveness analysis include the lack of a standard model structure, a large variability in the costs of surgery and poor data on indirect costs. As clinical practice is moving to mucosal healing as a robust response marker, personalized schedules of anti-TNF therapies might prove cost-effective even in the perspective of the health-care system in the near future.

  5. Dimensions of adolescent rebellion: Risks for academic failure among high- and low-income youth

    PubMed Central

    Luthar, Suniya S.; Ansary, Nadia S.

    2015-01-01

    The central question addressed in this study was whether upper class, suburban teenagers can engage in various problem behaviors and still maintain adequate academic grades, because of environmental safety nets, unlike their low-income, inner-city counterparts. Three problem behavior dimensions were assessed among tenth graders, that is, substance use, delinquency, and low school engagement. Academic achievement was assessed in terms of grades across four major subjects. Variable-based analyses indicated unique links with grades for self-reported delinquency and school disengagement in high- and low-income samples, but for substance use only among the former. Person-based analyses showed that in both schools, grades were clearly compromised among youth with disturbances in all three problem domains. In addition, in the suburban school only, grades were low in the cluster characterized chiefly by high substance use. Results are discussed in terms of stereotypes regarding risks (or lack thereof) stemming from families' socioeconomic status; implications for theory and interventions are also considered. PMID:15971768

  6. A General Accelerated Degradation Model Based on the Wiener Process.

    PubMed

    Liu, Le; Li, Xiaoyang; Sun, Fuqiang; Wang, Ning

    2016-12-06

    Accelerated degradation testing (ADT) is an efficient tool to conduct material service reliability and safety evaluations by analyzing performance degradation data. Traditional stochastic process models are mainly for linear or linearization degradation paths. However, those methods are not applicable for the situations where the degradation processes cannot be linearized. Hence, in this paper, a general ADT model based on the Wiener process is proposed to solve the problem for accelerated degradation data analysis. The general model can consider the unit-to-unit variation and temporal variation of the degradation process, and is suitable for both linear and nonlinear ADT analyses with single or multiple acceleration variables. The statistical inference is given to estimate the unknown parameters in both constant stress and step stress ADT. The simulation example and two real applications demonstrate that the proposed method can yield reliable lifetime evaluation results compared with the existing linear and time-scale transformation Wiener processes in both linear and nonlinear ADT analyses.

  7. A General Accelerated Degradation Model Based on the Wiener Process

    PubMed Central

    Liu, Le; Li, Xiaoyang; Sun, Fuqiang; Wang, Ning

    2016-01-01

    Accelerated degradation testing (ADT) is an efficient tool to conduct material service reliability and safety evaluations by analyzing performance degradation data. Traditional stochastic process models are mainly for linear or linearization degradation paths. However, those methods are not applicable for the situations where the degradation processes cannot be linearized. Hence, in this paper, a general ADT model based on the Wiener process is proposed to solve the problem for accelerated degradation data analysis. The general model can consider the unit-to-unit variation and temporal variation of the degradation process, and is suitable for both linear and nonlinear ADT analyses with single or multiple acceleration variables. The statistical inference is given to estimate the unknown parameters in both constant stress and step stress ADT. The simulation example and two real applications demonstrate that the proposed method can yield reliable lifetime evaluation results compared with the existing linear and time-scale transformation Wiener processes in both linear and nonlinear ADT analyses. PMID:28774107

  8. The Worry Behaviors Inventory: Assessing the behavioral avoidance associated with generalized anxiety disorder.

    PubMed

    Mahoney, Alison E J; Hobbs, Megan J; Newby, Jill M; Williams, Alishia D; Sunderland, Matthew; Andrews, Gavin

    2016-10-01

    Understanding behavioral avoidance associated with generalized anxiety disorder (GAD) has implications for the classification, theoretical conceptualization, and clinical management of the disorder. This study describes the development and preliminary psychometric evaluation of a self-report measure of avoidant behaviors associated with GAD: the Worry Behaviors Inventory (WBI). The WBI was administered to treatment-seeking patients (N=1201). Convergent validity was assessed by correlating the WBI with measures of GAD symptom severity. Divergent validity was assessed by correlating the WBI with measures of general disability and measures of depression, social anxiety and panic disorder symptom severity. Exploratory and confirmatory factor analyses supported a two-factor structure (Safety Behaviors and Avoidance). Internal reliability was acceptable for the 10-item WBI scale (α=.86), Safety Behaviors (α=.85) and Avoidance subscales (α=.75). Evidence of convergent, divergent, and discriminant validity is reported. WBI subscales demonstrated differential associations with measures of symptom severity. The Safety Behaviors subscale was more strongly associated with GAD symptoms than symptoms of other disorders, whereas the Avoidance subscale was as strongly correlated with GAD severity as it was with depression, social anxiety and panic disorder severity. Structured diagnostic interviews were not conducted therefor validity analyses are limited to probable diagnoses based on self-report. The cross-sectional design precluded examination of the WBI's temporal stability and treatment sensitivity. Preliminary evidence supports the use of the WBI in research and clinical settings and may assist clinicians to identify behaviors that are theorized to maintain GAD and that can be targeted during psychological treatment. Copyright © 2016 Elsevier B.V. All rights reserved.

  9. RELEASE OF DRIED RADIOACTIVE WASTE MATERIALS TECHNICAL BASIS DOCUMENT

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

    KOZLOWSKI, S.D.

    2007-05-30

    This technical basis document was developed to support RPP-23429, Preliminary Documented Safety Analysis for the Demonstration Bulk Vitrification System (PDSA) and RPP-23479, Preliminary Documented Safety Analysis for the Contact-Handled Transuranic Mixed (CH-TRUM) Waste Facility. The main document describes the risk binning process and the technical basis for assigning risk bins to the representative accidents involving the release of dried radioactive waste materials from the Demonstration Bulk Vitrification System (DBVS) and to the associated represented hazardous conditions. Appendices D through F provide the technical basis for assigning risk bins to the representative dried waste release accident and associated represented hazardous conditionsmore » for the Contact-Handled Transuranic Mixed (CH-TRUM) Waste Packaging Unit (WPU). The risk binning process uses an evaluation of the frequency and consequence of a given representative accident or represented hazardous condition to determine the need for safety structures, systems, and components (SSC) and technical safety requirement (TSR)-level controls. A representative accident or a represented hazardous condition is assigned to a risk bin based on the potential radiological and toxicological consequences to the public and the collocated worker. Note that the risk binning process is not applied to facility workers because credible hazardous conditions with the potential for significant facility worker consequences are considered for safety-significant SSCs and/or TSR-level controls regardless of their estimated frequency. The controls for protection of the facility workers are described in RPP-23429 and RPP-23479. Determination of the need for safety-class SSCs was performed in accordance with DOE-STD-3009-94, Preparation Guide for US. Department of Energy Nonreactor Nuclear Facility Documented Safety Analyses, as described below.« less

  10. Measurement and monitoring of safety: impact and challenges of putting a conceptual framework into practice.

    PubMed

    Chatburn, Eleanor; Macrae, Carl; Carthey, Jane; Vincent, Charles

    2018-03-06

    The Measurement and Monitoring of Safety Framework provides a conceptual model to guide organisations in assessing safety. The Health Foundation funded a large-scale programme to assess the value and impact of applying the Framework in regional and frontline care settings. We explored the experiences and reflections of key participants in the programme. The study was conducted in the nine healthcare organisations in England and Scotland testing the Framework (three regional improvement bodies, six frontline settings). Post hoc interviews with clinical and managerial staff were analysed using template analysis. Participants reported that the Framework promoted a substantial shift in their thinking about how safety is actively managed in their environment. It provided a common language, facilitated a more inquisitive approach and encouraged a more holistic view of the components of safety. These changes in conceptual understanding, however, did not always translate into broader changes in practice, with many sites only addressing some aspects of the Framework. One of the three regions did embrace the Framework in its entirety and achieved wider impact with a range of interventions. This region had committed leaders who took time to fully understand the concepts, who maintained a flexible approach to exploring the utility of the Framework and who worked with frontline staff to translate the concepts for local settings. The Measuring and Monitoring of Safety Framework has the potential to support a broader and richer approach to organisational safety. Such a conceptually based initiative requires both committed leaders who themselves understand the concepts and more time to establish understanding and aims than might be needed in a standard improvement programme. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  11. Safety in home care: A research protocol for studying medication management

    PubMed Central

    2010-01-01

    Background Patient safety is an ongoing global priority, with medication safety considered a prevalent, high-risk area of concern. Yet, we have little understanding of the supports and barriers to safe medication management in the Canadian home care environment. There is a clear need to engage the providers and recipients of care in studying and improving medication safety with collaborative approaches to exploring the nature and safety of medication management in home care. Methods A socio-ecological perspective on health and health systems drives our iterative qualitative study on medication safety with elderly home care clients, family members and other informal caregivers, and home care providers. As we purposively sample across four Canadian provinces: Alberta (AB), Ontario (ON), Quebec (QC) and Nova Scotia (NS), we will collect textual and visual data through home-based interviews, participant-led photo walkabouts of the home, and photo elicitation sessions at clients' kitchen tables. Using successive rounds of interpretive description and human factors engineering analyses, we will generate robust descriptions of managing medication at home within each provincial sample and across the four-province group. We will validate our initial interpretations through photo elicitation focus groups with home care providers in each province to develop a refined description of the phenomenon that can inform future decision-making, quality improvement efforts, and research. Discussion The application of interpretive and human factors lenses to the visual and textual data is expected to yield findings that advance our understanding of the issues, challenges, and risk-mitigating strategies related to medication safety in home care. The images are powerful knowledge translation tools for sharing what we learn with participants, decision makers, other healthcare audiences, and the public. In addition, participants engage in knowledge exchange throughout the study with the use of participatory data collection methods. PMID:20525363

  12. Assessing the general safety and tolerability of vildagliptin: value of pooled analyses from a large safety database versus evaluation of individual studies

    PubMed Central

    Schweizer, Anja; Dejager, Sylvie; Foley, James E; Kothny, Wolfgang

    2011-01-01

    Aim: Analyzing safety aspects of a drug from individual studies can lead to difficult-to-interpret results. The aim of this paper is therefore to assess the general safety and tolerability, including incidences of the most common adverse events (AEs), of vildagliptin based on a large pooled database of Phase II and III clinical trials. Methods: Safety data were pooled from 38 studies of ≥12 to ≥104 weeks’ duration. AE profiles of vildagliptin (50 mg bid; N = 6116) were evaluated relative to a pool of comparators (placebo and active comparators; N = 6210). Absolute incidence rates were calculated for all AEs, serious AEs (SAEs), discontinuations due to AEs, and deaths. Results: Overall AEs, SAEs, discontinuations due to AEs, and deaths were all reported with a similar frequency in patients receiving vildagliptin (69.1%, 8.9%, 5.7%, and 0.4%, respectively) and patients receiving comparators (69.0%, 9.0%, 6.4%, and 0.4%, respectively), whereas drug-related AEs were seen with a lower frequency in vildagliptin-treated patients (15.7% vs 21.7% with comparators). The incidences of the most commonly reported specific AEs were also similar between vildagliptin and comparators, except for increased incidences of hypoglycemia, tremor, and hyperhidrosis in the comparator group related to the use of sulfonylureas. Conclusions: The present pooled analysis shows that vildagliptin was overall well tolerated in clinical trials of up to >2 years in duration. The data further emphasize the value of a pooled analysis from a large safety database versus assessing safety and tolerability from individual studies. PMID:21415917

  13. The European space suit, a design for productivity and crew safety

    NASA Astrophysics Data System (ADS)

    Skoog, A. Ingemar; Berthier, S.; Ollivier, Y.

    In order to fulfil the two major mission objectives, i.e. support planned and unplanned external servicing of the COLUMBUS FFL and support the HERMES vehicle for safety critical operations and emergencies, the European Space Suit System baseline configuration incorporates a number of design features, which shall enhance the productivity and the crew safety of EVA astronauts. The work in EVA is today - and will be for several years - a manual work. Consequently, to improve productivity, the first challenge is to design a suit enclosure which minimizes movement restrictions and crew fatigue. It is covered by the "ergonomic" aspect of the suit design. Furthermore, it is also necessary to help the EVA crewmember in his work, by giving him the right information at the right time. Many solutions exist in this field of Man-Machine Interface, from a very simple system, based on cuff check lists, up to advanced systems, including Head-Up Displays. The design concept for improved productivity encompasses following features: • easy donning/doffing thru rear entry, • suit ergonomy optimisation, • display of operational information in alpha-numerical and graphical from, and • voice processing for operations and safety critical information. Concerning crew safety the major design features are: • a lower R-factor for emergency EVA operations thru incressed suit pressure, • zero prebreath conditions for normal operations, • visual and voice processing of all safety critical functions, and • an autonomous life support system to permit unrestricted operations around HERMES and the CFFL. The paper analyses crew safety and productivity criteria and describes how these features are being built into the design of the European Space Suit System.

  14. Embedding 'speaking up' into systems for safe healthcare product development and marketing surveillance.

    PubMed

    Edwards, Brian; Hugman, Bruce; Tobin, Mary; Whalen, Matthew

    2012-04-01

    Robust, active cooperation, and effective, open communication between all stakeholders is essential for ensuring regulatory compliance and healthcare product safety; avoiding the necessity for whistle-blowing; and, most essentially, meeting the transparency requirements of public trust.The focus here is on what can be done within a healthcare product organization (HPO) to achieve actionable, sustainable policies and practices such as leadership, management, and supervision role-modelling of best practice; ongoing process review and improvements in every department; protection of those who report concerns through robust policies endorsed at Board level throughout an organization to eliminate the fear of retaliation; training in open, non-defensive team-working principles; and mediation structure and process for resolution of differences of opinion or interpretation of contradictory and volatile data.Based on analyses of other safety systems, workplace silence and interpersonal breakdowns are warning signs of defective systems underlying poor compliance and compromising safety. Remedying the situation requires attention to the root causes underlying such symptoms of dysfunction, especially the human factor, i.e. those factors that influence human performance. It is essential that leadership and management listen to employees' concerns about systems and processes, assess them impartially and reward contributions that improve safety.Fundamentally, the safety, transparency, and trustworthiness of HPOs, both commercial and regulatory, can be judged by the extent of the freedom of their staff to 'speak up' when the time is right. This, in turn, consolidates the trust of external stakeholders in the safety of a system and its products. The promotion of 'speaking up' in an organization provides an important safeguard against the risk of poor compliance and the undermining of societal confidence in the safety of healthcare products.

  15. Patient safety culture in China: a case study in an outpatient setting in Beijing.

    PubMed

    Liu, Chaojie; Liu, Weiwei; Wang, Yuanyuan; Zhang, Zhihong; Wang, Peng

    2014-07-01

    To investigate the patient safety culture in an outpatient setting in Beijing and explore the meaning and implications of the safety culture from the perspective of health workers and patients. A mixed methods approach involving a questionnaire survey and in-depth interviews was adopted. Among the 410 invited staff members, 318 completed the Hospital Survey of Patient Safety Culture (HSOPC). Patient safety culture was described using 12 subscale scores. Inter-subscale correlation analysis, ANOVA and stepwise multivariate regression analyses were performed to identify the determinants of the patient safety culture scores. Interviewees included 22 patients selected through opportunity sampling and 27 staff members selected through purposive sampling. The interview data were analysed thematically. The survey respondents perceived high levels of unsafe care but had personally reported few events. Lack of 'communication openness' was identified as a major safety culture problem, and a perception of 'penalty' was the greatest barrier to the encouragement of error reporting. Cohesive 'teamwork within units', while found to be an area of strength, conversely served as a protective and defensive mechanism for medical practice. Low levels of trust between providers and consumers and lack of management support constituted an obstacle to building a positive patient safety culture. This study in China demonstrates that a punitive approach to error is still widespread despite increasing awareness of unsafe care, and managers have been slow in acknowledging the importance of building a positive patient safety culture. Strong 'teamwork within units', a common area of strength, could fuel the concealment of errors. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  16. Limited-scope probabilistic safety analysis for the Los Alamos Meson Physics Facility (LAMPF)

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

    Sharirli, M.; Rand, J.L.; Sasser, M.K.

    1992-01-01

    The reliability of instrumentation and safety systems is a major issue in the operation of accelerator facilities. A probabilistic safety analysis was performed or the key safety and instrumentation systems at the Los Alamos Meson Physics Facility (LAMPF). in Phase I of this unique study, the Personnel Safety System (PSS) and the Current Limiters (XLs) were analyzed through the use of the fault tree analyses, failure modes and effects analysis, and criticality analysis. Phase II of the program was done to update and reevaluate the safety systems after the Phase I recommendations were implemented. This paper provides a brief reviewmore » of the studies involved in Phases I and II of the program.« less

  17. Limited-scope probabilistic safety analysis for the Los Alamos Meson Physics Facility (LAMPF)

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

    Sharirli, M.; Rand, J.L.; Sasser, M.K.

    1992-12-01

    The reliability of instrumentation and safety systems is a major issue in the operation of accelerator facilities. A probabilistic safety analysis was performed or the key safety and instrumentation systems at the Los Alamos Meson Physics Facility (LAMPF). in Phase I of this unique study, the Personnel Safety System (PSS) and the Current Limiters (XLs) were analyzed through the use of the fault tree analyses, failure modes and effects analysis, and criticality analysis. Phase II of the program was done to update and reevaluate the safety systems after the Phase I recommendations were implemented. This paper provides a brief reviewmore » of the studies involved in Phases I and II of the program.« less

  18. Proposed system safety design and test requirements for the microlaser ordnance system

    NASA Technical Reports Server (NTRS)

    Stoltz, Barb A.; Waldo, Dale F.

    1993-01-01

    Safety for pyrotechnic ignition systems is becoming a major concern for the military. In the past twenty years, stray electromagnetic fields have steadily increased during peacetime training missions and have dramatically increased during battlefield missions. Almost all of the ordnance systems in use today depend on an electrical bridgewire for ignition. Unfortunately, the bridgewire is the cause of the majority of failure modes. The common failure modes include the following: broken bridgewires; transient RF power, which induces bridgewire heating; and cold temperatures, which contracts the explosive mix away from the bridgewire. Finding solutions for these failure modes is driving the costs of pyrotechnic systems up. For example, analyses are performed to verify that the system in the environment will not see more energy than 20 dB below the 'No-fire' level. Range surveys are performed to determine the operational, storage, and transportation RF environments. Cryogenic tests are performed to verify the bridgewire to mix interface. System requirements call for 'last minute installation,' 'continuity checks after installation,' and rotating safety devices to 'interrupt the explosive train.' As an alternative, MDESC has developed a new approach based upon our enabling laser diode technology. We believe that Microlaser initiated ordnance offers a unique solution to the bridgewire safety concerns. For this presentation, we will address, from a system safety viewpoint, the safety design and the test requirements for a Microlaser ordnance system. We will also review how this system could be compliant to MIL-STD-1576 and DOD-83578A and the additional necessary requirements.

  19. Optimism about safety and group-serving interpretations of safety among pedestrians and cyclists in relation to road use in general and under low light conditions.

    PubMed

    King, M J; Wood, J M; Lacherez, P F; Marszalek, R P

    2012-01-01

    Drivers are known to be optimistic about their risk of crash involvement, believing that they are less likely to be involved in a crash than other drivers. However, little comparative research has been conducted among other road users. In addition, optimism about crash risk is conceptualised as applying only to an individual's assessment of his or her personal risk of crash involvement. The possibility that the self-serving nature of optimism about safety might be generalised to the group-level as a cyclist or a pedestrian, i.e., becoming group-serving rather than self-serving, has been overlooked in relation to road safety. This study analysed a subset of data collected as part of a larger research project on the visibility of pedestrians, cyclists and road workers, focusing on a set of questionnaire items administered to 406 pedestrians, 838 cyclists and 622 drivers. The items related to safety in various scenarios involving drivers, pedestrians and cyclists, allowing predictions to be derived about group differences in agreement with items based on the assumption that the results would exhibit group-serving bias. Analysis of the responses indicated that specific hypotheses about group-serving interpretations of safety and responsibility were supported in 22 of the 26 comparisons. When the nine comparisons relevant to low lighting conditions were considered separately, seven were found to be supported. The findings of the research have implications for public education and for the likely acceptance of messages which are inconsistent with current assumptions and expectations of pedestrians and cyclists. They also suggest that research into group-serving interpretations of safety, even for temporary roles rather than enduring groups, could be fruitful. Further, there is an implication that gains in safety can be made by better educating road users about the limitations of their visibility and the ramifications of this for their own road safety, particularly in low light. 2010 Elsevier Ltd. All rights reserved.

  20. Dimensions of the local health care environment and use of care by uninsured children in rural and urban areas.

    PubMed

    Gresenz, Carole Roan; Rogowski, Jeannette; Escarce, José J

    2006-03-01

    Despite concerted policy efforts, a sizeable percentage of children lack health insurance coverage. This article examines the impact of the health care safety net and health care market structure on the use of health care by uninsured children. We used the Medical Expenditure Panel Survey linked with data from multiple sources to analyze health care utilization among uninsured children. We ran analyses separately for children who lived in rural and urban areas and assessed the effects on utilization of the availability of safety net providers, safety net funding, supply of primary care physicians, health maintenance organization penetration, and the percentage of people who are uninsured, controlling for other factors that influence use. Fewer than half of uninsured children had office-based visits to health care providers during the year, 8% of rural and 10% of urban children visited the emergency department at least once, and just over half of children had medical expenditures or charges during the year. Among uninsured children in rural areas, living closer to a safety net provider and living in an area with a higher supply of primary care physicians were positively associated with higher use and medical expenditures. In urban areas, the supply of primary care physicians and the level of safety net funding were positively associated with uninsured children's medical expenditures, whereas the percentage of the population that was uninsured was negatively associated with use of the emergency department. Uninsured children had low levels of utilization over a range of different health care provider types and settings. The availability of safety net providers in the local area and the safety net's capacity to serve the uninsured influence access to care among children. Possible measures for ensuring access to health care among uninsured children include increasing the density of safety net providers in rural areas, enhancing funding for the safety net, and policies to increase primary care physician supply.

  1. Los Alamos Climatology 2016 Update

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

    Bruggeman, David Alan

    The Los Alamos National Laboratory (LANL or the Laboratory) operates a meteorology monitoring network to support LANL emergency response, engineering designs, environmental compliance, environmental assessments, safety evaluations, weather forecasting, environmental monitoring, research programs, and environmental restoration. Weather data has been collected in Los Alamos since 1910. Bowen (1990) provided climate statistics (temperature and precipitation) for the 1961– 1990 averaging period, and included other analyses (e.g., wind and relative humidity) based on the available station locations and time periods. This report provides an update to the 1990 publication Los Alamos Climatology (Bowen 1990).

  2. 'No suicide contracts' in community crisis situations: a conceptual analysis.

    PubMed

    Farrow, T L

    2003-04-01

    'No suicide contracts' are commonly used in community crisis situations with suicidal people in New Zealand. These take the form of a 'guarantee of safety', along with a 'promise' to call specified persons if the suicidal ideation becomes unmanageable. This article describes the use of 'no suicide contracts' in community crisis situations, analyses the use of the tool within this context, and, in particular, argues that the theoretical base (transactional analysis) of the 'no suicide contract' is likely to be deleterious in the community crisis situation.

  3. Environmental and economic comparisons of the satellite power system and six alternative energy technologies

    NASA Astrophysics Data System (ADS)

    Whitfield, R. G.; Habegger, L. J.; Levine, E. P.; Tanzman, E.

    1981-04-01

    The satellite power system (SPS) was compared with alternative systems on life cycle cost and environmental impacts. Environmental and economic effects are evaluated and subdivided into the following issue areas: human health and safety, environmental welfare, resources (land, materials, energy, water, labor), macroeconomics, socioeconomics, and institutional. These evaluations are based on technology characterization data and alternative futures scenarios, developed as part of CDEP. The technologies and the scenarios are described. The cost and performance of the SPS and the alternative technologies provide the basis of the macroeconomic analyses.

  4. Effect of the Road Environment on Road Safety in Poland

    NASA Astrophysics Data System (ADS)

    Budzynski, Marcin; Jamroz, Kazimierz; Antoniuk, Marcin

    2017-10-01

    Run-off-road accidents tend to be very severe because when a vehicle leaves the road, it will often crash into a solid obstacle (tree, pole, supports, front wall of a culvert, barrier). A statistical analysis of the data shows that Poland’s main roadside hazard is trees and the severity of vehicles striking a tree in a run-off-road crash. The risks are particularly high in north-west Poland with many of the roads lined up with trees. Because of the existing rural road cross-sections, i.e. having trees directly on road edge followed immediately by drainage ditches, vulnerable road users are prevented from using shoulders and made to use the roadway. With no legal definition of the road safety zone in Polish regulations, attempts to remove roadside trees lead to major conflicts with environmental stakeholders. This is why a compromise should be sought between the safety of road users and protection of the natural environment and the aesthetics of the road experience. Rather than just cut the trees, other road safety measures should be used where possible to treat the hazardous spots by securing trees and obstacles and through speed management. Accidents that are directly related to the road environment fall into the following categories: hitting a tree, hitting a barrier, hitting a utility pole or sign, vehicle rollover on the shoulder, vehicle rollover on slopes or in ditch. The main consequence of a roadside hazard is not the likelihood of an accident itself but of its severity. Poland’s roadside accident severity is primarily the result of poor design or operation of road infrastructure. This comes as a consequence of a lack of regulations or poorly defined regulations and failure to comply with road safety standards. The new analytical model was designed as a combination of the different factors and one that will serve as a comprehensive model. It was assumed that it will describe the effect of the roadside on the number of accidents and their consequences. The design of the model was based on recommendations from analysing other models. The assumptions were the following: the model will be used to calculate risk factors and accident severity, the indicators will depend on number of vehicle kilometres travelled or traffic volumes, analyses will be based on accident data: striking a tree, hitting a barrier, hitting a utility pole or sign. Additional data will include roadside information and casualty density measures will be used - killed and injured.

  5. Maintenance: organizational modes, activities and health and safety. Use of a French national survey and in-situ analyses.

    PubMed

    Grusenmeyer, Corinne

    2014-12-01

    Maintenance activities are identified as critical both to operator safety and to systems safety and reliability. However, it is still difficult to identify maintenance workers in French occupational accident and disease statistics. Moreover, few analyses of these activities and of organizational changes in this field have been conducted. This paper presents two different approaches to this same issue. Analyses were aimed firstly at identifying the occupational exposures of these operators and at comparing them with occupational exposures of production staff and, secondly at developing understanding of normal real maintenance activities, i.e. maintenance activities that are normally actually carried out, while taking into account the socio-technical system and maintenance organization within which they lie. The use of the French SUMER 2003 survey shows that occupational exposures of maintenance staff to various constraints are more frequent than occupational exposures of their production colleagues. However, maintenance staff appear to have greater independence. Analyses were also conducted in a subcontracting urban public transport company, who outsources some maintenance work. Those analyses highlight a complex network of companies involved in maintenance activities, a substantial number of work interruptions and a significant fragmentation of the internal technicians' activities that can be cognitively costly, reduce anticipation possibilities and lead to incidents or accidents. Above all they underline internal technicians' contributions to the completion of outsourced interventions and interdependent relationships between the activities of the internal and the external technicians. Outsourcing maintenance interventions thus raises the question of risks associated with the interdependence of actual work activities undertaken by the different types of staff, since they contribute to the same maintenance intervention. This study therefore pinpoints the need to integrate inter-organizational interactions in order to understand the variability of maintenance activities and its relationships with reliability and safety. In this respect, some suggestions are provided with a prevention aim. Copyright © 2014 Elsevier Ltd. All rights reserved.

  6. Microscale Heat Conduction Models and Doppler Feedback

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

    Hawari, Ayman I.; Ougouag, Abderrafi

    2015-01-22

    The objective of this project is to establish an approach for providing the fundamental input that is needed to estimate the magnitude and time-dependence of the Doppler feedback mechanism in Very High Temperature reactors. This mechanism is the foremost contributor to the passive safety of gas-cooled, graphite-moderated high temperature reactors that use fuel based on Tristructural-Isotropic (TRISO) coated particles. Therefore, its correct prediction is essential to the conduct of safety analyses for these reactors. Since the effect is directly dependent on the actual temperature reached by the fuel during transients, the underlying phenomena of heat deposition, heat transfer and temperaturemore » rise must be correctly predicted. To achieve the above objective, this project will explore an approach that accounts for lattice effects as well as local temperature variations and the correct definition of temperature and related local effects.« less

  7. Impact of Pathogen Population Heterogeneity and Stress-Resistant Variants on Food Safety.

    PubMed

    Abee, T; Koomen, J; Metselaar, K I; Zwietering, M H; den Besten, H M W

    2016-01-01

    This review elucidates the state-of-the-art knowledge about pathogen population heterogeneity and describes the genotypic and phenotypic analyses of persister subpopulations and stress-resistant variants. The molecular mechanisms underlying the generation of persister phenotypes and genetic variants are identified. Zooming in on Listeria monocytogenes, a comparative whole-genome sequence analysis of wild types and variants that enabled the identification of mutations in variants obtained after a single exposure to lethal food-relevant stresses is described. Genotypic and phenotypic features are compared to those for persistent strains isolated from food processing environments. Inactivation kinetics, models used for fitting, and the concept of kinetic modeling-based schemes for detection of variants are presented. Furthermore, robustness and fitness parameters of L. monocytogenes wild type and variants are used to model their performance in food chains. Finally, the impact of stress-resistant variants and persistence in food processing environments on food safety is discussed.

  8. Systemic Analysis Approaches for Air Transportation

    NASA Technical Reports Server (NTRS)

    Conway, Sheila

    2005-01-01

    Air transportation system designers have had only limited success using traditional operations research and parametric modeling approaches in their analyses of innovations. They need a systemic methodology for modeling of safety-critical infrastructure that is comprehensive, objective, and sufficiently concrete, yet simple enough to be used with reasonable investment. The methodology must also be amenable to quantitative analysis so issues of system safety and stability can be rigorously addressed. However, air transportation has proven itself an extensive, complex system whose behavior is difficult to describe, no less predict. There is a wide range of system analysis techniques available, but some are more appropriate for certain applications than others. Specifically in the area of complex system analysis, the literature suggests that both agent-based models and network analysis techniques may be useful. This paper discusses the theoretical basis for each approach in these applications, and explores their historic and potential further use for air transportation analysis.

  9. Structural health monitoring using wireless sensor networks

    NASA Astrophysics Data System (ADS)

    Sreevallabhan, K.; Nikhil Chand, B.; Ramasamy, Sudha

    2017-11-01

    Monitoring and analysing health of large structures like bridges, dams, buildings and heavy machinery is important for safety, economical, operational, making prior protective measures, and repair and maintenance point of view. In recent years there is growing demand for such larger structures which in turn make people focus more on safety. By using Microelectromechanical Systems (MEMS) Accelerometer we can perform Structural Health Monitoring by studying the dynamic response through measure of ambient vibrations and strong motion of such structures. By using Wireless Sensor Networks (WSN) we can embed these sensors in wireless networks which helps us to transmit data wirelessly thus we can measure the data wirelessly at any remote location. This in turn reduces heavy wiring which is a cost effective as well as time consuming process to lay those wires. In this paper we developed WSN based MEMS-accelerometer for Structural to test the results in the railway bridge near VIT University, Vellore campus.

  10. Clinical governance breakdown: Australian cases of wilful blindness and whistleblowing.

    PubMed

    Cleary, Sonja; Duke, Maxine

    2017-01-01

    After their attempts to have patient safety concerns addressed internally were ignored by wilfully blind managers, nurses from Bundaberg Base Hospital and Macarthur Health Service felt compelled to 'blow the whistle'. Wilful blindness is the human desire to prefer ignorance to knowledge; the responsibility to be informed is shirked. To provide an account of instances of wilful blindness identified in two high-profile cases of nurse whistleblowing in Australia. Critical case study methodology using Fay's Critical Social Theory to examine, analyse and interpret existing data generated by the Commissions of Inquiry held into Bundaberg Base Hospital and Macarthur Health Service patient safety breaches. All data was publicly available and assessed according to the requirements of unobtrusive research methods and secondary data analysis. Ethical considerations: Data collection for the case studies relied entirely on publicly available documentary sources recounting and detailing past events. Data from both cases reveal managers demonstrating wilful blindness towards patient safety concerns. Concerns were unaddressed; nurses, instead, experienced retaliatory responses leading to a 'social crisis' in the organisation and to whistleblowing. Managers tasked with clinical governance must be aware of mechanisms with the potential to blind them. The human tendency to favour positive news and avoid conflict is powerful. Understanding wilful blindness can assist managers' awareness of the competing emotions occurring in response to ethical challenges, such as whistleblowing.

  11. Rough surface reconstruction for ultrasonic NDE simulation

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

    Choi, Wonjae; Shi, Fan; Lowe, Michael J. S.

    2014-02-18

    The reflection of ultrasound from rough surfaces is an important topic for the NDE of safety-critical components, such as pressure-containing components in power stations. The specular reflection from a rough surface of a defect is normally lower than it would be from a flat surface, so it is typical to apply a safety factor in order that justification cases for inspection planning are conservative. The study of the statistics of the rough surfaces that might be expected in candidate defects according to materials and loading, and the reflections from them, can be useful to develop arguments for realistic safety factors.more » This paper presents a study of real rough crack surfaces that are representative of the potential defects in pressure-containing power plant. Two-dimensional (area) values of the height of the roughness have been measured and their statistics analysed. Then a means to reconstruct model cases with similar statistics, so as to enable the creation of multiple realistic realizations of the surfaces, has been investigated, using random field theory. Rough surfaces are reconstructed, based on a real surface, and results for these two-dimensional descriptions of the original surface have been compared with those from the conventional model based on a one-dimensional correlation coefficient function. In addition, ultrasonic reflections from them are simulated using a finite element method.« less

  12. Infant gastro-oesophageal reflux disease (GORD): Australian GP attitudes and practices.

    PubMed

    Kirby, Catherine N; Segal, Ahuva Y; Hinds, Rupert; Jones, Kay M; Piterman, Leon

    2016-01-01

    The aim of this study was to evaluate the attitudes and practices of Australian general practitioners (GPs) regarding infant gastro-oesophageal reflux disease (GORD) diagnosis and management. A national cross-sectional survey, involving a random sample of currently practising Australian GPs (n = 2319) was undertaken between July and September 2011. GPs attitudes and management of infant GORD were surveyed via an online and paper-based 41-item questionnaire. In total, 400 responses were analysed (17.24% response rate). The majority of GPs employed empirical trials of acid-suppression medication and/or lifestyle modifications to diagnose infant GORD. GPs frequently recommended dietary modification despite the belief that they were only moderately effective at best. In addition, GPs frequently prescribed acid-suppression medication, despite concerns regarding their safety in the infant population. Other GP concerns included the lack of clinical guidelines and education for GPs about infant GORD, as well as the level of evidence available for the safety and efficacy of diagnostic tests and treatments. Despite the important role Australian GPs play in the diagnosis and management of infant GORD, high-level evidence-based guidelines for GPs are lacking. Consequently, GPs engage in diagnostic and management practices despite their concerns regarding the safety and effectiveness. © 2015 The Authors. Journal of Paediatrics and Child Health © 2015 Paediatrics and Child Health Division (Royal Australasian College of Physicians).

  13. Algorithm-based arterial blood sampling recognition increasing safety in point-of-care diagnostics.

    PubMed

    Peter, Jörg; Klingert, Wilfried; Klingert, Kathrin; Thiel, Karolin; Wulff, Daniel; Königsrainer, Alfred; Rosenstiel, Wolfgang; Schenk, Martin

    2017-08-04

    To detect blood withdrawal for patients with arterial blood pressure monitoring to increase patient safety and provide better sample dating. Blood pressure information obtained from a patient monitor was fed as a real-time data stream to an experimental medical framework. This framework was connected to an analytical application which observes changes in systolic, diastolic and mean pressure to determine anomalies in the continuous data stream. Detection was based on an increased mean blood pressure caused by the closing of the withdrawal three-way tap and an absence of systolic and diastolic measurements during this manipulation. For evaluation of the proposed algorithm, measured data from animal studies in healthy pigs were used. Using this novel approach for processing real-time measurement data of arterial pressure monitoring, the exact time of blood withdrawal could be successfully detected retrospectively and in real-time. The algorithm was able to detect 422 of 434 (97%) blood withdrawals for blood gas analysis in the retrospective analysis of 7 study trials. Additionally, 64 sampling events for other procedures like laboratory and activated clotting time analyses were detected. The proposed algorithm achieved a sensitivity of 0.97, a precision of 0.96 and an F1 score of 0.97. Arterial blood pressure monitoring data can be used to perform an accurate identification of individual blood samplings in order to reduce sample mix-ups and thereby increase patient safety.

  14. [Safety Culture in Orthopaedic Surgery and Trauma Surgery - Where Are We Today?

    PubMed

    Münzberg, Matthias; Rüsseler, Miriam; Egerth, Martin; Doepfer, Anna Katharina; Mutschler, Manuel; Stange, Richard; Bouillon, Bertil; Kladny, Bernd; Hoffmann, Reinhard

    2018-06-05

    The development of a new safety culture in orthopaedics and trauma surgery needs to be based on the knowledge of the status quo. The objective of this research was therefore to perform a survey of orthopaedic and trauma surgeons to achieve a subjective assessment of the frequency and causes of "insecurities" or errors in daily practice. Based on current literature, an online questionnaire was created by a team of experts (26 questions total) and was sent via e-mail to all active members of a medical society (DGOU) in April 2015. This was followed by two reminder e-mails. The survey was completed in May 2015. The results were transmitted electronically, anonymously and voluntarily into a database and evaluated by univariate analyses. 799 active members took part in the survey. 65% of the interviewed people stated that they noticed mistakes in their own clinical work environment at least once a week. The main reasons for these mistakes were "time pressure", "lack of communication", "lack of staff" and "stress". Technical mistakes or lack of knowledge were not of primary importance. The survey indicated that errors in orthopaedics and trauma surgery are observed regularly. "Human factors" were regarded as a major cause. In order to develop a new safety culture in orthopaedics and trauma surgery, new approaches must focus on the human factor. Georg Thieme Verlag KG Stuttgart · New York.

  15. [What Surgeons Should Know about Risk Management].

    PubMed

    Strametz, R; Tannheimer, M; Rall, M

    2017-02-01

    Background: The fact that medical treatment is associated with errors has long been recognized. Based on the principle of "first do no harm", numerous efforts have since been made to prevent such errors or limit their impact. However, recent statistics show that these measures do not sufficiently prevent grave mistakes with serious consequences. Preventable mistakes such as wrong patient or wrong site surgery still frequently occur in error statistics. Methods: Based on insight from research on human error, in due consideration of recent legislative regulations in Germany, the authors give an overview of the clinical risk management tools needed to identify risks in surgery, analyse their causes, and determine adequate measures to manage those risks depending on their relevance. The use and limitations of critical incident reporting systems (CIRS), safety checklists and crisis resource management (CRM) are highlighted. Also the rationale for IT systems to support the risk management process is addressed. Results/Conclusion: No single tool of risk management can be effective as a standalone instrument, but unfolds its effect only when embedded in a superordinate risk management system, which integrates tailor-made elements to increase patient safety into the workflows of each organisation. Competence in choosing adequate tools, effective IT systems to support the risk management process as well as leadership and commitment to constructive handling of human error are crucial components to establish a safety culture in surgery. Georg Thieme Verlag KG Stuttgart · New York.

  16. Fluoxetine: a review on evidence based medicine

    PubMed Central

    Rossi, Andrea; Barraco, Alessandra; Donda, Pietro

    2004-01-01

    Background Fluoxetine was the first molecule of a new generation of antidepressants, the Selective Serotonin Re-uptake Inhibitors (SSRIs). It is recurrently the paradigm for the development of any new therapy in the treatment of depression. Many controlled studies and meta-analyses were performed on Fluoxetine, to improve the understanding of its real impact in the psychiatric area. The main objective of this review is to assess the quality and the results reported in the meta-analyses published on Fluoxetine. Methods Published articles on Medline, Embase and Cochrane databases reporting meta-analyses were used as data sources for this review. Articles found in the searches were reviewed by 2 independent authors, to assess if these were original meta-analyses. Only data belonging to the most recent and comprehensive meta-analytic studies were included in this review. Results Data, based on a group of 9087 patients, who were included in 87 different randomized clinical trials, confirms that fluoxetine is safe and effective in the treatment of depression from the first week of therapy. Fluoxetine's main advantage over previously available antidepressants (TCAs) was its favorable safety profile, that reduced the incidence of early drop-outs and improved patient's compliance, associated with a comparable efficacy on depressive symptoms. In these patients, Fluoxetine has proven to be more effective than placebo from the first week of therapy. Fluoxetine has shown to be safe and effective in the elderly population, as well as during pregnancy. Furthermore, it was not associated with an increased risk of suicide in the overall evaluation of controlled clinical trials. The meta-analysis available on the use of Fluoxetine in the treatment of bulimia nervosa shows that the drug is as effective as other agents with fewer patients dropping out of treatment. Fluoxetine has demonstrated to be as effective as chlomipramine in the treatment of Obsessive-Compulsive-Disorder (OCD). Conclusion Fluoxetine can be considered a drug successfully used in several diseases for its favorable safety/efficacy ratio. As the response rate of mentally ill patients is strictly related to each patient's personal characteristics, any new drug in this area, will have to be developed under these considerations. PMID:14962351

  17. Design and Analysis of Tooth Impact Test Rig for Spur Gear

    NASA Astrophysics Data System (ADS)

    Ghazali, Wafiuddin Bin Md; Aziz, Ismail Ali Bin Abdul; Daing Idris, Daing Mohamad Nafiz Bin; Ismail, Nurazima Binti; Sofian, Azizul Helmi Bin

    2016-02-01

    This paper is about the design and analysis of a prototype of tooth impact test rig for spur gear. The test rig was fabricated and analysis was conducted to study its’ limitation and capabilities. The design of the rig is analysed to ensure that there will be no problem occurring during the test and reliable data can be obtained. From the result of the analysis, the maximum amount of load that can be applied, the factor of safety of the machine, the stresses on the test rig parts were determined. This is important in the design consideration of the test rig. The materials used for the fabrication of the test rig were also discussed and analysed. MSC Nastran Patran software was used to analyse the model, which was designed by using SolidWorks 2014 software. Based from the results, there were limitations found from the initial design and the test rig design needs to be improved in order for the test rig to operate properly.

  18. Parametric Criticality Safety Calculations for Arrays of TRU Waste Containers

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

    Gough, Sean T.

    The Nuclear Criticality Safety Division (NCSD) has performed criticality safety calculations for finite and infinite arrays of transuranic (TRU) waste containers. The results of these analyses may be applied in any technical area onsite (e.g., TA-54, TA-55, etc.), as long as the assumptions herein are met. These calculations are designed to update the existing reference calculations for waste arrays documented in Reference 1, in order to meet current guidance on calculational methodology.

  19. Subsurface safety valves: safety asset or safety liability

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

    Busch, J.M.; Llewelyn, D.C.G.; Policky, B.J.

    1983-10-01

    This paper summarizes the methods used to compare the risk of a blowout for a well completed with a subsurface safety valve (SSSV) vs. a completion without an SSSV. These methods, which could be applied to any field, include a combination of SSSV reliability and conventional risk analyses. The Kuparuk River Unit Working Interest Owners recently formed a group to examine the risks associated with installing and maintaining SSSV's in the Kuparuk field. The group was charged with answering the question: ''Assuming Kuparuk field operating conditions, are SSSV's a safety asset, or do numerous operating and maintenance procedures make themmore » a safety liability.'' The results indicate that for the Kuparuk River Unit, an SSSV becomes a safety liability when the mean time between SSSV failures is less than one year. Since current SSSV mean time to failure (MTTF) at Kuparuk is approximately 1000 days, they are considered a safety asset.« less

  20. Overview of Energy Systems` safety analysis report programs. Safety Analysis Report Update Program

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

    Not Available

    1992-03-01

    The primary purpose of an Safety Analysis Report (SAR) is to provide a basis for judging the adequacy of a facility`s safety. The SAR documents the safety analyses that systematically identify the hazards posed by the facility, analyze the consequences and risk of potential accidents, and describe hazard control measures that protect the health and safety of the public and employees. In addition, some SARs document, as Technical Safety Requirements (TSRs, which include Technical Specifications and Operational Safety Requirements), technical and administrative requirements that ensure the facility is operated within prescribed safety limits. SARs also provide conveniently summarized information thatmore » may be used to support procedure development, training, inspections, and other activities necessary to facility operation. This ``Overview of Energy Systems Safety Analysis Report Programs`` Provides an introduction to the programs and processes used in the development and maintenance of the SARs. It also summarizes some of the uses of the SARs within Energy Systems and DOE.« less

  1. Back schools for the treatment of chronic low back pain: possibility of benefit but no convincing evidence after 47 years of research—systematic review and meta-analysis

    PubMed Central

    Straube, Sebastian; Harden, Markus; Schröder, Heiko; Arendacka, Barbora; Fan, Xiangning; Moore, R. Andrew; Friede, Tim

    2016-01-01

    Abstract Back schools are interventions that comprise exercise and education components. We aimed to systematically review the randomized controlled trial evidence on back schools for the treatment of chronic low back pain. By searching MEDLINE, Embase, and Cochrane Central as well as bibliographies, we identified 31 studies for inclusion in our systematic review and 5 of these for inclusion in meta-analyses. Meta-analyses for pain scores and functional outcomes revealed statistical superiority of back schools vs no intervention for some comparisons but not others. No meta-analysis was feasible for the comparison of back schools vs other active treatments. Adverse events were poorly reported so that no reliable conclusions regarding the safety of back schools can be drawn, although some limited reassurance in this regard may be derived from the fact that few adverse events and no serious adverse events were reported in the back school groups in the studies that did report on safety. Overall, the evidence base for the use of back schools to treat chronic low back pain is weak; in nearly a half-century since back schools were first trialled, no unequivocal evidence of benefit has emerged. PMID:27257858

  2. Back schools for the treatment of chronic low back pain: possibility of benefit but no convincing evidence after 47 years of research-systematic review and meta-analysis.

    PubMed

    Straube, Sebastian; Harden, Markus; Schröder, Heiko; Arendacka, Barbora; Fan, Xiangning; Moore, R Andrew; Friede, Tim

    2016-10-01

    Back schools are interventions that comprise exercise and education components. We aimed to systematically review the randomized controlled trial evidence on back schools for the treatment of chronic low back pain. By searching MEDLINE, Embase, and Cochrane Central as well as bibliographies, we identified 31 studies for inclusion in our systematic review and 5 of these for inclusion in meta-analyses. Meta-analyses for pain scores and functional outcomes revealed statistical superiority of back schools vs no intervention for some comparisons but not others. No meta-analysis was feasible for the comparison of back schools vs other active treatments. Adverse events were poorly reported so that no reliable conclusions regarding the safety of back schools can be drawn, although some limited reassurance in this regard may be derived from the fact that few adverse events and no serious adverse events were reported in the back school groups in the studies that did report on safety. Overall, the evidence base for the use of back schools to treat chronic low back pain is weak; in nearly a half-century since back schools were first trialled, no unequivocal evidence of benefit has emerged.

  3. On the effect of grain burnback on STS-SRM fragment velocity

    NASA Astrophysics Data System (ADS)

    Eck, Marshall B.; Mukunda, Meera

    Concerns raised during the Ulysses Final Safety Analysis Review (FSAR) process called the solid rocket motor (SRM) fragment velocity prediction model into question. The specific area of concern was that there was a section of the SRM casing which was exposed to SRM chamber pressure as the grain (fuel) was consumed. These questions centered on the velocity of fragments which originated from the field joint region given that failure occurred between 37 and 72 seconds mission elapsed time (MET). Two dimensional coupled Eulerian-Lagrangian calculations were performed to assess the hot gas flow field which resulted from SRM casing fragmentation. The fragment to gas interface-pressure time-history obtained from these analyses was reduced to a boundary condition algorithm which was applied to an explicit-time-integration, finite element, three dimensional shell model of the SRM casing and unburned fuel. The results of these calculations showed that the velocity of fragments originating in the field joint was adequately described by the range of velocities given in the Shuttle Data Book (1988). Based on these results, no further analyses were required, and approval was obtained from the Launch Abort Subpanel of the Interagency Nuclear Safety Review Panel to use the SRM fragment velocity environments presented in the Ulysses FSAR (1990).

  4. On the effect of grain burnback on STS-SRM fragment velocity

    NASA Astrophysics Data System (ADS)

    Eck, Marshall B.; Mukunda, Meera

    1991-01-01

    Concerns raised during the Ulysses Final Safety Analysis Review (FSAR) process called the solid rocket motor (SRM) fragment velocity prediction model into question. The specific area of concern was that there was a section of the SRM casing which was exposed to SRM chamber pressure as the grain (fuel) was consumed. These questions centered on the velocity of fragments which originated from the field joint region given that failure occurred between 37 and 72 seconds mission elapsed time (MET). Two dimensional coupled Eulerian-Lagrangian calculations were performed to assess the hot gas flow field which resulted from SRM casing fragmentation. The fragment to gas interface-pressure time-history obtained from these analyses was reduced to a boundary condition algorithm which was applied to an explicit-time-integration, finite element, three dimensional shell model of the SRM casing and unburned fuel. The results of these calculations showed that the velocity of fragments originating in the field joint was adequately described by the range of velocities given in the Shuttle Data Book (1988). Based on these results, no further analyses were required, and approval was obtained from the Launch Abort Subpanel of the Interagency Nuclear Safety Review Panel to use the SRM fragment velocity environments presented in the Ulysses FSAR (1990).

  5. Structural safety analysis based on seismic service conditions for butterfly valves in a nuclear power plant.

    PubMed

    Han, Sang-Uk; Ahn, Dae-Gyun; Lee, Myeong-Gon; Lee, Kwon-Hee; Han, Seung-Ho

    2014-01-01

    The structural integrity of valves that are used to control cooling waters in the primary coolant loop that prevents boiling within the reactor in a nuclear power plant must be capable of withstanding earthquakes or other dangerous situations. In this study, numerical analyses using a finite element method, that is, static and dynamic analyses according to the rigid or flexible characteristics of the dynamic properties of a 200A butterfly valve, were performed according to the KEPIC MFA. An experimental vibration test was also carried out in order to verify the results from the modal analysis, in which a validated finite element model was obtained via a model-updating method that considers changes in the in situ experimental data. By using a validated finite element model, the equivalent static load under SSE conditions stipulated by the KEPIC MFA gave a stress of 135 MPa that occurred at the connections of the stem and body. A larger stress of 183 MPa was induced when we used a CQC method with a design response spectrum that uses 2% damping ratio. These values were lower than the allowable strength of the materials used for manufacturing the butterfly valve, and, therefore, its structural safety met the KEPIC MFA requirements.

  6. Sources of stress in impoverished neighbourhoods: insights into links between neighbourhood environments and health.

    PubMed

    Warr, Deborah; Feldman, Peter; Tacticos, Theonie; Kelaher, Margaret

    2009-02-01

    This paper explores associations between residents' perceptions of social incivilities and physical disorders in local environments and self-reported health status. Surveys were conducted with 4,029 residents from 13 Neighbourhood Renewal sites and 1,857 residents of corresponding Local Government Areas in Victoria. An open-ended question asked respondents to nominate the worst things about living in their neighbourhood and this qualitative data was analysed for the range of perceptions of incivilities. Quantitative data analysis considered associations between incivilities in neighbourhood environments and self-reported health status. Issues conceptualised as social incivilities (drug and alcohol use, dangerous driving, the behaviour of other people, feeling unsafe, noise, racism) accounted for 58% of issues nominated. Quantitative analyses suggested that increased exposure to issues related to aspects of neighbourhood safety were associated with living in a disadvantaged neighbourhood. Perceptions of lower levels of neighbourhood safety were, in turn, associated with poorer health. Cumulative and compounding aspects of local environments that heighten feelings of insecurity and anxiety may be mechanisms through which places affect health. While the characteristics of populations are important determinants of health outcomes, the findings endorse the value of incorporating complementary place-based approaches for addressing mechanisms that contribute to health inequalities in local environments.

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

    Gougar, Hans

    This document outlines the development of a high fidelity, best estimate nuclear power plant severe transient simulation capability that will complement or enhance the integral system codes historically used for licensing and analysis of severe accidents. As with other tools in the Risk Informed Safety Margin Characterization (RISMC) Toolkit, the ultimate user of Enhanced Severe Transient Analysis and Prevention (ESTAP) capability is the plant decision-maker; the deliverable to that customer is a modern, simulation-based safety analysis capability, applicable to a much broader class of safety issues than is traditional Light Water Reactor (LWR) licensing analysis. Currently, the RISMC pathway’s majormore » emphasis is placed on developing RELAP-7, a next-generation safety analysis code, and on showing how to use RELAP-7 to analyze margin from a modern point of view: that is, by characterizing margin in terms of the probabilistic spectra of the “loads” applied to systems, structures, and components (SSCs), and the “capacity” of those SSCs to resist those loads without failing. The first objective of the ESTAP task, and the focus of one task of this effort, is to augment RELAP-7 analyses with user-selected multi-dimensional, multi-phase models of specific plant components to simulate complex phenomena that may lead to, or exacerbate, severe transients and core damage. Such phenomena include: coolant crossflow between PWR assemblies during a severe reactivity transient, stratified single or two-phase coolant flow in primary coolant piping, inhomogeneous mixing of emergency coolant water or boric acid with hot primary coolant, and water hammer. These are well-documented phenomena associated with plant transients but that are generally not captured in system codes. They are, however, generally limited to specific components, structures, and operating conditions. The second ESTAP task is to similarly augment a severe (post-core damage) accident integral analyses code with high fidelity simulations that would allow investigation of multi-dimensional, multi-phase containment phenomena that are only treated approximately in established codes.« less

  8. Fault tree applications within the safety program of Idaho Nuclear Corporation

    NASA Technical Reports Server (NTRS)

    Vesely, W. E.

    1971-01-01

    Computerized fault tree analyses are used to obtain both qualitative and quantitative information about the safety and reliability of an electrical control system that shuts the reactor down when certain safety criteria are exceeded, in the design of a nuclear plant protection system, and in an investigation of a backup emergency system for reactor shutdown. The fault tree yields the modes by which the system failure or accident will occur, the most critical failure or accident causing areas, detailed failure probabilities, and the response of safety or reliability to design modifications and maintenance schemes.

  9. Defining the pharmaceutical system to support proactive drug safety.

    PubMed

    Lewis, Vicki R; Hernandez, Angelica; Meadors, Margaret

    2013-02-01

    The military, aviation, nuclear, and transportation industries have transformed their safety records by using a systems approach to safety and risk mitigation. This article creates a preliminary model of the U.S. pharmaceutical system using available literature including academic publications, policies, and guidelines established by regulatory bodies and drug industry trade publications. Drawing from the current literature, the goals, roles, and individualized processes of pharmaceutical subsystems will be defined. Defining the pharmaceutical system provides a vehicle to assess and address known problems within the system, and provides a means to conduct proactive risk analyses, which would create significant pharmaceutical safety advancement.

  10. STS safety approval process for small self-contained payloads

    NASA Technical Reports Server (NTRS)

    Gum, Mary A.

    1988-01-01

    The safety approval process established by the National Aeronautics and Space Administration for Get Away Special (GAS) payloads is described. Although the designing organization is ultimately responsible for the safe operation of its payload, the Get Away Special team at the Goddard Space Flight Center will act as advisors while iterative safety analyses are performed and the Safety Data Package inputs are submitted. This four phase communications process will ultimately give NASA confidence that the GAS payload is safe, and successful completion of the Phase 3 package and review will clear the way for flight aboard the Space Transportation System orbiter.

  11. Isolation, Characterization, and Bioinformatic Analyses of Lytic Salmonella Enteritidis Phages and Tests of Their Antibacterial Activity in Food.

    PubMed

    Han, Han; Wei, Xiaoting; Wei, Yi; Zhang, Xiufeng; Li, Xuemin; Jiang, Jinzhong; Wang, Ran

    2017-02-01

    Salmonella Enteritidis remains a major threat for food safety. To take efforts to develop phage-based biocontrol for S. Enteritidis contamination in food, in this study, the phages against S. Enteritidis were isolated from sewage samples, characterized by host range assays, DNA restriction enzyme pattern analyses, and transmission electron microscope observations, and tested for antibacterial activity in food; some potent phages were further characterized by bioinformatic analyses. Results showed that based on the plaque quality and host range, seven lytic phages targeting S. Enteritidis were selected, considered as seven distinct phages through DNA physical maps, and classified as Myoviridae or Siphoviridae family by morphologic observations; the combined use of such seven strain phages as a "food additive" could succeed in controlling the artificial S. Enteritidis contamination in the different physical forms of food at a range of temperatures; by bioinformatic analyses, both selected phage BPS 11 Q 3 and BPS 15 Q 2 seemed to be newfound obligate lytic phage strains with no indications for any potentially harmful genes in their genomes. In conclusion, our results showed a potential of isolated phages as food additives for controlling S. Enteritidis contamination in some salmonellosis outbreak-associated food vehicles, and there could be minimized potential risk associated with using BPS 11 Q 3 and BPS 15 Q 2 in food.

  12. Functional Safety of Hybrid Laser Safety Systems - How can a Combination between Passive and Active Components Prevent Accidents?

    NASA Astrophysics Data System (ADS)

    Lugauer, F. P.; Stiehl, T. H.; Zaeh, M. F.

    Modern laser systems are widely used in industry due to their excellent flexibility and high beam intensities. This leads to an increased hazard potential, because conventional laser safety barriers only offer a short protection time when illuminated with high laser powers. For that reason active systems are used more and more to prevent accidents with laser machines. These systems must fulfil the requirements of functional safety, e.g. according to IEC 61508, which causes high costs. The safety provided by common passive barriers is usually unconsidered in this context. In the presented approach, active and passive systems are evaluated from a holistic perspective. To assess the functional safety of hybrid safety systems, the failure probability of passive barriers is analysed and added to the failure probability of the active system.

  13. The Role of Leadership in Safety Performance and Results

    NASA Astrophysics Data System (ADS)

    Caravello, Halina E.

    Employee injury rates in U.S. land-based operations in the energy industry are 2 to 3 times higher relative to other regions in the world. Although a rich literature exists on drivers of safety performance, no previous studies investigated factors influencing this elevated rate. Leadership has been identified as a key contributor to safety outcomes and this grounded theory study drew upon the full range leadership model, situational leadership, and leader-member exchange theories for the conceptual framework. Leadership aspects influencing safety performance were investigated through guided interviews of 27 study participants; data analyses included open and axial coding, and constant comparisons identified higher-level categories. Selective coding integrated categories into the theoretical framework that developed the idealized, transformational leader traits motivating safe behaviors of leading by example, expressing care and concern for employees' well-being, celebrating successes, and communicating the importance of safety (other elements included visibility and commitment). Employee and supervisor participants reported similar views on the idealized leader traits, but low levels of these qualities may be driving elevated injury rates. Identifying these key elements provides the foundation to creating strategies and action plans enabling energy sector companies to prevent employee injuries and fatalities in an industry where tens of thousands of employees are subjected to significant hazards and elevated risks. Creating safer workplaces for U.S. employees by enhancing leaders' skills, building knowledge, and improving behaviors will improve the employees' and their families' lives by reducing the pain and suffering resulting from injuries and fatalities.

  14. Towards an International Classification for Patient Safety: a Delphi survey.

    PubMed

    Thomson, Richard; Lewalle, Pierre; Sherman, Heather; Hibbert, Peter; Runciman, William; Castro, Gerard

    2009-02-01

    Interpretation and comparison of patient safety information have been compromised by the lack of a common understanding of the concepts involved. The World Alliance set out to develop an International Classification for Patient Safety (ICPS) to address this, and to test the relevance and acceptability of the draft ICPS and progressively refine it prior to field testing. Two-stage Delphi survey. Quantitative and qualitative analyses informed the review of the ICPS. International web-based survey of expert opinion. Experts in the fields of patient safety, health policy, reporting systems, safety and quality control, classification theory and development, health informatics, consumer advocacy, law and medicine; 253 responded to the first round survey, 30% of whom responded to the second round. In the first round, 14% felt that the conceptual framework was missing at least one class, although it was apparent that most respondents were actually referring to concepts they felt should be included within the classes rather than the classes themselves. There was a need for clarification of several components of the classification, particularly its purpose, structure and depth. After revision and feedback, round 2 results were more positive, but further significant changes were made to the conceptual framework and to the major classes in response to concerns about terminology and relationships between classes. The Delphi approach proved invaluable, as both a consensus-building exercise and consultation process, in engaging stakeholders to support completion of the final draft version of the ICPS. Further refinement will occur.

  15. [Experience feedback committee: a method for patient safety improvement].

    PubMed

    François, P; Sellier, E; Imburchia, F; Mallaret, M-R

    2013-04-01

    An experience feedback committee (CREX, Comité de Retour d'EXpérience) is a method which contributes to the management of safety of care in a medical unit. Originally used for security systems of civil aviation, the method has been adapted to health care facilities and successfully implemented in radiotherapy units and in other specialties. We performed a brief review of the literature for studies reporting data on CREX established in hospitals. The review was performed using the main bibliographic databases and Google search results. The CREX is designed to analyse incidents reported by professionals. The method includes monthly meetings of a multi-professional committee that reviews the reported incidents, chooses a priority incident and designates a "pilot" responsible for investigating the incident. The investigation of the incident involves a systemic analysis method and a written synthesis presented at the next meeting of the committee. The committee agrees on actions for improvement that are suggested by the analysis and follows their implementation. Systems for the management of health care, including reporting systems, are organized into three levels: the medical unit, the hospital and the country as a triple loop learning process. The CREX is located in the base level, short loop of risk management and allows direct involvement of care professionals in patient safety. Safety of care has become a priority of health systems. In this context, the CREX can be a useful vehicle for the implementation of a safety culture in medical units. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

  16. Towards an International Classification for Patient Safety: a Delphi survey

    PubMed Central

    Thomson, Richard; Lewalle, Pierre; Sherman, Heather; Hibbert, Peter; Runciman, William; Castro, Gerard

    2009-01-01

    Objective Interpretation and comparison of patient safety information have been compromised by the lack of a common understanding of the concepts involved. The World Alliance set out to develop an International Classification for Patient Safety (ICPS) to address this, and to test the relevance and acceptability of the draft ICPS and progressively refine it prior to field testing. Design Two-stage Delphi survey. Quantitative and qualitative analyses informed the review of the ICPS. Setting International web-based survey of expert opinion. Participants Experts in the fields of patient safety, health policy, reporting systems, safety and quality control, classification theory and development, health informatics, consumer advocacy, law and medicine; 253 responded to the first round survey, 30% of whom responded to the second round. Results In the first round, 14% felt that the conceptual framework was missing at least one class, although it was apparent that most respondents were actually referring to concepts they felt should be included within the classes rather than the classes themselves. There was a need for clarification of several components of the classification, particularly its purpose, structure and depth. After revision and feedback, round 2 results were more positive, but further significant changes were made to the conceptual framework and to the major classes in response to concerns about terminology and relationships between classes. Conclusions The Delphi approach proved invaluable, as both a consensus-building exercise and consultation process, in engaging stakeholders to support completion of the final draft version of the ICPS. Further refinement will occur. PMID:19147596

  17. Near Real-Time Surveillance for Influenza Vaccine Safety: Proof-of-Concept in the Vaccine Safety Datalink Project

    PubMed Central

    Greene, Sharon K.; Kulldorff, Martin; Lewis, Edwin M.; Li, Rong; Yin, Ruihua; Weintraub, Eric S.; Fireman, Bruce H.; Lieu, Tracy A.; Nordin, James D.; Glanz, Jason M.; Baxter, Roger; Jacobsen, Steven J.; Broder, Karen R.; Lee, Grace M.

    2010-01-01

    The emergence of pandemic H1N1 influenza in 2009 has prompted public health responses, including production and licensure of new influenza A (H1N1) 2009 monovalent vaccines. Safety monitoring is a critical component of vaccination programs. As proof-of-concept, the authors mimicked near real-time prospective surveillance for prespecified neurologic and allergic adverse events among enrollees in 8 medical care organizations (the Vaccine Safety Datalink Project) who received seasonal trivalent inactivated influenza vaccine during the 2005/06–2007/08 influenza seasons. In self-controlled case series analysis, the risk of adverse events in a prespecified exposure period following vaccination was compared with the risk in 1 control period for the same individual either before or after vaccination. In difference-in-difference analysis, the relative risk in exposed versus control periods each season was compared with the relative risk in previous seasons since 2000/01. The authors used Poisson-based analysis to compare the risk of Guillian-Barré syndrome following vaccination in each season with that in previous seasons. Maximized sequential probability ratio tests were used to adjust for repeated analyses on weekly data. With administration of 1,195,552 doses to children under age 18 years and 4,773,956 doses to adults, no elevated risk of adverse events was identified. Near real-time surveillance for selected adverse events can be implemented prospectively to rapidly assess seasonal and pandemic influenza vaccine safety. PMID:19965887

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

    Jo, J.

    This document is a report of the analytical results for samples collected from the radioactive wastes in Tank 241-U-202 at the Hanford Reservation. Core samples were collected from the solid wastes in the tank and underwent safety screening analyses including differential scanning calorimetry, thermogravimetric analysis, and total alpha analysis. Results indicate that no safety screening notification limits were exceeded.

  19. Patient safety: honoring advanced directives.

    PubMed

    Tice, Martha A

    2007-02-01

    Healthcare providers typically think of patient safety in the context of preventing iatrogenic injury. Prevention of falls and medication or treatment errors is the typical focus of adverse event analyses. If healthcare providers are committed to honoring the wishes of patients, then perhaps failures to honor advanced directives should be viewed as reportable medical errors.

  20. How Organisations Learn from Safety Incidents: A Multifaceted Problem

    ERIC Educational Resources Information Center

    Lukic, Dane; Margaryan, Anoush; Littlejohn, Allison

    2010-01-01

    Purpose: This paper seeks to review current approaches to learning from health and safety incidents in the workplace. The aim of the paper is to identify the diversity of approaches and analyse them in terms of learning aspects. Design/methodology/approach: A literature review was conducted searching for terms incident/accident/near…

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