Sample records for safety case study

  1. Improving safety culture through the health and safety organization: a case study.

    PubMed

    Nielsen, Kent J

    2014-02-01

    International research indicates that internal health and safety organizations (HSO) and health and safety committees (HSC) do not have the intended impact on companies' safety performance. The aim of this case study at an industrial plant was to test whether the HSO can improve company safety culture by creating more and better safety-related interactions both within the HSO and between HSO members and the shop-floor. A quasi-experimental single case study design based on action research with both quantitative and qualitative measures was used. Based on baseline mapping of safety culture and the efficiency of the HSO three developmental processes were started aimed at the HSC, the whole HSO, and the safety representatives, respectively. Results at follow-up indicated a marked improvement in HSO performance, interaction patterns concerning safety, safety culture indicators, and a changed trend in injury rates. These improvements are interpreted as cultural change because an organizational double-loop learning process leading to modification of the basic assumptions could be identified. The study provides evidence that the HSO can improve company safety culture by focusing on safety-related interactions. © 2013. Published by Elsevier Ltd and National Safety Council.

  2. Querying Safety Cases

    NASA Technical Reports Server (NTRS)

    Denney, Ewen W.; Naylor, Dwight; Pai, Ganesh

    2014-01-01

    Querying a safety case to show how the various stakeholders' concerns about system safety are addressed has been put forth as one of the benefits of argument-based assurance (in a recent study by the Health Foundation, UK, which reviewed the use of safety cases in safety-critical industries). However, neither the literature nor current practice offer much guidance on querying mechanisms appropriate for, or available within, a safety case paradigm. This paper presents a preliminary approach that uses a formal basis for querying safety cases, specifically Goal Structuring Notation (GSN) argument structures. Our approach semantically enriches GSN arguments with domain-specific metadata that the query language leverages, along with its inherent structure, to produce views. We have implemented the approach in our toolset AdvoCATE, and illustrate it by application to a fragment of the safety argument for an Unmanned Aircraft System (UAS) being developed at NASA Ames. We also discuss the potential practical utility of our query mechanism within the context of the existing framework for UAS safety assurance.

  3. Lessons learned from measuring safety culture: an Australian case study.

    PubMed

    Allen, Suellen; Chiarella, Mary; Homer, Caroline S E

    2010-10-01

    adverse events in maternity care are relatively common but often avoidable. International patient safety strategies advocate measuring safety culture as a strategy to improve patient safety. Evidence suggests it is necessary to fully understand the safety culture of an organisation to make improvements to patient safety. this paper reports a case study examining the safety culture in one maternity service in Australia and considers the benefits of using surveys and interviews to understand safety culture as an approach to identify possible strategies to improve patient safety in this setting. the study took place in one maternity service in two public hospitals in NSW, Australia. Concurrently, both hospitals were undergoing an organisational restructure which was part of a major health reform agenda. The priorities of the reform included improving the quality of care and patient safety; and, creating a more efficient health system by reducing administration inefficiencies and duplication. a descriptive case study using three approaches: the safety culture was identified to warrant improvement across all six safety culture domains. There was reduced infrastructure and capacity to support incident management activities required to improve safety, which was influenced by instability from the organisational restructure. There was a perceived lack of leadership at all levels to drive safety and quality and improving the safety culture was neither a key priority nor was it valued by the organisation. the safety culture was complex as was undertaking this study. We were unable to achieve a desired 60% response rate highlighting the limitations of using safety culture surveys in isolation as a strategy to improve safety culture. Qualitative interviews provided greater insight into the factors influencing the safety culture. The findings of this study provide evidence of the benefits of including qualitative methods with quantitative surveys when examining safety culture

  4. Triangulating case-finding tools for patient safety surveillance: a cross-sectional case study of puncture/laceration.

    PubMed

    Taylor, Jennifer A; Gerwin, Daniel; Morlock, Laura; Miller, Marlene R

    2011-12-01

    To evaluate the need for triangulating case-finding tools in patient safety surveillance. This study applied four case-finding tools to error-associated patient safety events to identify and characterise the spectrum of events captured by these tools, using puncture or laceration as an example for in-depth analysis. Retrospective hospital discharge data were collected for calendar year 2005 (n=48,418) from a large, urban medical centre in the USA. The study design was cross-sectional and used data linkage to identify the cases captured by each of four case-finding tools. Three case-finding tools (International Classification of Diseases external (E) and nature (N) of injury codes, Patient Safety Indicators (PSI)) were applied to the administrative discharge data to identify potential patient safety events. The fourth tool was Patient Safety Net, a web-based voluntary patient safety event reporting system. The degree of mutual exclusion among detection methods was substantial. For example, when linking puncture or laceration on unique identifiers, out of 447 potential events, 118 were identical between PSI and E-codes, 152 were identical between N-codes and E-codes and 188 were identical between PSI and N-codes. Only 100 events that were identified by PSI, E-codes and N-codes were identical. Triangulation of multiple tools through data linkage captures potential patient safety events most comprehensively. Existing detection tools target patient safety domains differently, and consequently capture different occurrences, necessitating the integration of data from a combination of tools to fully estimate the total burden.

  5. Case study: the Argentina Road Safety Project: lessons learned for the decade of action for road safety, 2011-2020.

    PubMed

    Raffo, Veronica; Bliss, Tony; Shotten, Marc; Sleet, David; Blanchard, Claire

    2013-12-01

    This case study of the Argentina Road Safety Project demonstrates how the application of World Bank road safety project guidelines focused on institution building can accelerate knowledge transfer, scale up investment and improve the focus on results. The case study highlights road safety as a development priority and outlines World Bank initiatives addressing the implementation of the World Report on Road Traffic Injury's recommendations and the subsequent launch of the Decade of Action for Road Safety, from 2011-2020. The case study emphasizes the vital role played by the lead agency in ensuring sustainable road safety improvements and promoting the shift to a 'Safe System' approach, which necessitated the strengthening of all elements of the road safety management system. It summarizes road safety performance and institutional initiatives in Argentina leading up to the preparation and implementation of the project. We describe the project's development objectives, financing arrangements, specific components and investment staging. Finally, we discuss its innovative features and lessons learned, and present a set of supplementary guidelines, both to assist multilateral development banks and their clients with future road safety initiatives, and to encourage better linkages between the health and transportation sectors supporting them.

  6. Understanding safety culture in long-term care: a case study.

    PubMed

    Halligan, Michelle H; Zecevic, Aleksandra; Kothari, Anita R; Salmoni, Alan W; Orchard, Treena

    2014-12-01

    This case study aimed to understand safety culture in a high-risk secured unit for cognitively impaired residents in a long-term care (LTC) facility. Specific objectives included the following: diagnosing the present level of safety culture maturity using the Patient Safety Culture Improvement Tool (PSCIT), examining the barriers to a positive safety culture, and identifying actions for improvement. A mixed methods design was used within a secured unit for cognitively impaired residents in a Canadian nonprofit LTC facility. Semistructured interviews, a focus group, and the Modified Stanford Patient Safety Culture Survey Instrument were used to explore this topic. Data were synthesized to situate safety maturity of the unit within the PSCIT adapted for LTC. Results indicated a reactive culture, where safety systems were piecemeal and developed only in response to adverse events and/or regulatory requirements. A punitive regulatory environment, inadequate resources, heavy workloads, poor interdisciplinary collaboration, and resident safety training capacity were major barriers to improving safety. This study highlights the importance of understanding a unit's safety culture and identifies the PSCIT as a useful framework for planning future improvements to safety culture maturity. Incorporating mixed methods in the study of health care safety culture provided a good model that can be recommended for future use in research and LTC practice.

  7. Behavior-based safety on construction sites: a case study.

    PubMed

    Choudhry, Rafiq M

    2014-09-01

    This work presents the results of a case study and describes an important area within the field of construction safety management, namely behavior-based safety (BBS). This paper adopts and develops a management approach for safety improvements in construction site environments. A rigorous behavioral safety system and its intervention program was implemented and deployed on target construction sites. After taking a few weeks of safety behavior measurements, the project management team implemented the designed intervention and measurements were taken. Goal-setting sessions were arranged on-site with workers' participation to set realistic and attainable targets of performance. Safety performance measurements continued and the levels of performance and the targets were presented on feedback charts. Supervisors were asked to give workers recognition and praise when they acted safely or improved critical behaviors. Observers were requested to have discussions with workers, visit the site, distribute training materials to workers, and provide feedback to crews and display charts. They were required to talk to operatives in the presence of line managers. It was necessary to develop awareness and understanding of what was being measured. In the process, operatives learned how to act safely when conducting site tasks using the designed checklists. Current weekly scores were discussed in the weekly safety meetings and other operational site meetings with emphasis on how to achieve set targets. The reliability of the safety performance measures taken by the company's observers was monitored. A clear increase in safety performance level was achieved across all categories: personal protective equipment; housekeeping; access to heights; plant and equipment, and scaffolding. The research reveals that scores of safety performance at one project improved from 86% (at the end of 3rd week) to 92.9% during the 9th week. The results of intervention demonstrated large decreases in

  8. Key aspects in managing safety when working with multiple contractors: A case study.

    PubMed

    Drupsteen, Linda; Rasmussen, Hanna B; Ustailieva, Erika; van Kampen, Jakko

    2015-01-01

    Working with multiple contractors in a shared workplace can introduce and increase safety risks due to complexity. The aim of this study was to explore how safety issues are recognized in a specific case and to identify whether clients and contractors perceive problems similarly. The safety issues are explored through a brief survey and a workshop in the maintenance department of a logistics company. The results indicate that culture and behavior are recognized differently by clients and by contractors. The contractors and client had different perceptions of involvement of contractors by the client. The contractors complained on lack of involvement, which was not fully recognized by the client. The case study used a practical approach to show differences in perception of safety within a project. The study illustrates the need for more applied studies and interventions on contractor safety.

  9. Offshore safety case approach and formal safety assessment of ships.

    PubMed

    Wang, J

    2002-01-01

    Tragic marine and offshore accidents have caused serious consequences including loss of lives, loss of property, and damage of the environment. A proactive, risk-based "goal setting" regime is introduced to the marine and offshore industries to increase the level of safety. To maximize marine and offshore safety, risks need to be modeled and safety-based decisions need to be made in a logical and confident way. Risk modeling and decision-making tools need to be developed and applied in a practical environment. This paper describes both the offshore safety case approach and formal safety assessment of ships in detail with particular reference to the design aspects. The current practices and the latest development in safety assessment in both the marine and offshore industries are described. The relationship between the offshore safety case approach and formal ship safety assessment is described and discussed. Three examples are used to demonstrate both the offshore safety case approach and formal ship safety assessment. The study of risk criteria in marine and offshore safety assessment is carried out. The recommendations on further work required are given. This paper gives safety engineers in the marine and offshore industries an overview of the offshore safety case approach and formal ship safety assessment. The significance of moving toward a risk-based "goal setting" regime is given.

  10. Hierarchical Safety Cases

    NASA Technical Reports Server (NTRS)

    Denney, Ewen W.; Whiteside, Iain J.

    2012-01-01

    We introduce hierarchical safety cases (or hicases) as a technique to overcome some of the difficulties that arise creating and maintaining industrial-size safety cases. Our approach extends the existing Goal Structuring Notation with abstraction structures, which allow the safety case to be viewed at different levels of detail. We motivate hicases and give a mathematical account of them as well as an intuition, relating them to other related concepts. We give a second definition which corresponds closely to our implementation of hicases in the AdvoCATE Assurance Case Editor and prove the correspondence between the two. Finally, we suggest areas of future enhancement, both theoretically and practically.

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

    NASA Technical Reports Server (NTRS)

    Knight, John C.

    1993-01-01

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

  12. Collaboration and patient safety at an emergency department - a qualitative case study.

    PubMed

    Pedersen, Anna Helene Meldgaard; Rasmussen, Kurt; Grytnes, Regine; Nielsen, Kent Jacob

    2018-03-19

    Purpose The purpose of this paper is to examine how conflicts about collaboration between staff at different departments arose during the establishment of a new emergency department and how these conflicts affected the daily work and ultimately patient safety at the emergency department. Design/methodology/approach This qualitative single case study draws on qualitative semi-structured interviews and participant observation. The theoretical concepts "availability" and "receptiveness" as antecedents for collaboration will be applied in the analysis. Findings Close collaboration between departments was an essential precondition for the functioning of the new emergency department. The study shows how a lack of antecedents for collaboration affected the working relation and communication between employees and departments, which spurred negative feelings and reproduced conflicts. This situation was seen as a potential threat for the safety of the emergency patients. Research limitations/implications This study presents a single case study, at a specific point in time, and should be used as an illustrative example of how contextual and situational factors affect the working environment and through that patient safety. Originality/value Few studies provide an in-depth investigation of what actually takes place when collaboration between professional groups goes wrong and escalates, and how problems in collaboration may affect patient safety.

  13. Evaluating Social Media Networks in Medicines Safety Surveillance: Two Case Studies.

    PubMed

    Coloma, Preciosa M; Becker, Benedikt; Sturkenboom, Miriam C J M; van Mulligen, Erik M; Kors, Jan A

    2015-10-01

    There is growing interest in whether social media can capture patient-generated information relevant for medicines safety surveillance that cannot be found in traditional sources. The aim of this study was to evaluate the potential contribution of mining social media networks for medicines safety surveillance using the following associations as case studies: (1) rosiglitazone and cardiovascular events (i.e. stroke and myocardial infarction); and (2) human papilloma virus (HPV) vaccine and infertility. We collected publicly accessible, English-language posts on Facebook, Google+, and Twitter until September 2014. Data were queried for co-occurrence of keywords related to the drug/vaccine and event of interest within a post. Messages were analysed with respect to geographical distribution, context, linking to other web content, and author's assertion regarding the supposed association. A total of 2537 posts related to rosiglitazone/cardiovascular events and 2236 posts related to HPV vaccine/infertility were retrieved, with the majority of posts representing data from Twitter (98 and 85%, respectively) and originating from users in the US. Approximately 21% of rosiglitazone-related posts and 84% of HPV vaccine-related posts referenced other web pages, mostly news items, law firms' websites, or blogs. Assertion analysis predominantly showed affirmation of the association of rosiglitazone/cardiovascular events (72%; n = 1821) and of HPV vaccine/infertility (79%; n = 1758). Only ten posts described personal accounts of rosiglitazone/cardiovascular adverse event experiences, and nine posts described HPV vaccine problems related to infertility. Publicly available data from the considered social media networks were sparse and largely untrackable for the purpose of providing early clues of safety concerns regarding the prespecified case studies. Further research investigating other case studies and exploring other social media platforms are necessary to further characterise

  14. Patient safety challenges in a case study hospital--of relevance for transfusion processes?

    PubMed

    Aase, Karina; Høyland, Sindre; Olsen, Espen; Wiig, Siri; Nilsen, Stein Tore

    2008-10-01

    The paper reports results from a research project with the objective of studying patient safety, and relates the finding to safety issues within transfusion medicine. The background is an increased focus on undesired events related to diagnosis, medication, and patient treatment in general in the healthcare sector. The study is designed as a case study within a regional Norwegian hospital conducting specialised health care services. The study includes multiple methods such as interviews, document analysis, analysis of error reports, and a questionnaire survey. Results show that the challenges for improved patient safety, based on employees' perceptions, are hospital management support, reporting of accidents/incidents, and collaboration across hospital units. Several of these generic safety challenges are also found to be of relevance for a hospital's transfusion service. Positive patient safety factors are identified as teamwork within hospital units, a non-punitive response to errors, and unit manager's actions promoting safety.

  15. System Safety in Early Manned Space Program: A Case Study of NASA and Project Mercury

    NASA Technical Reports Server (NTRS)

    Hansen, Frederick D.; Pitts, Donald

    2005-01-01

    This case study provides a review of National Aeronautics and Space Administration s (NASA's) involvement in system safety during research and evolution from air breathing to exo-atmospheric capable flight systems culminating in the successful Project Mercury. Although NASA has been philosophically committed to the principals of system safety, this case study points out that budget and manpower constraints-as well as a variety of internal and external pressures can jeopardize even a well-designed system safety program. This study begins with a review of the evolution and early years of NASA's rise as a project lead agency and ends with the lessons learned from Project Mercury.

  16. Formal Foundations for Hierarchical Safety Cases

    NASA Technical Reports Server (NTRS)

    Denney, Ewen; Pai, Ganesh; Whiteside, Iain

    2015-01-01

    Safety cases are increasingly being required in many safety-critical domains to assure, using structured argumentation and evidence, that a system is acceptably safe. However, comprehensive system-wide safety arguments present appreciable challenges to develop, understand, evaluate, and manage, partly due to the volume of information that they aggregate, such as the results of hazard analysis, requirements analysis, testing, formal verification, and other engineering activities. Previously, we have proposed hierarchical safety cases, hicases, to aid the comprehension of safety case argument structures. In this paper, we build on a formal notion of safety case to formalise the use of hierarchy as a structuring technique, and show that hicases satisfy several desirable properties. Our aim is to provide a formal, theoretical foundation for safety cases. In particular, we believe that tools for high assurance systems should be granted similar assurance to the systems to which they are applied. To this end, we formally specify and prove the correctness of key operations for constructing and managing hicases, which gives the specification for implementing hicases in AdvoCATE, our toolset for safety case automation. We motivate and explain the theory with the help of a simple running example, extracted from a real safety case and developed using AdvoCATE.

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

    PubMed

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

    2017-09-01

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

  18. Dynamic Safety Cases for Through-Life Safety Assurance

    NASA Technical Reports Server (NTRS)

    Denney, Ewen; Pai, Ganesh; Habli, Ibrahim

    2015-01-01

    We describe dynamic safety cases, a novel operationalization of the concept of through-life safety assurance, whose goal is to enable proactive safety management. Using an example from the aviation systems domain, we motivate our approach, its underlying principles, and a lifecycle. We then identify the key elements required to move towards a formalization of the associated framework.

  19. A hybrid simulation approach for integrating safety behavior into construction planning: An earthmoving case study.

    PubMed

    Goh, Yang Miang; Askar Ali, Mohamed Jawad

    2016-08-01

    One of the key challenges in improving construction safety and health is the management of safety behavior. From a system point of view, workers work unsafely due to system level issues such as poor safety culture, excessive production pressure, inadequate allocation of resources and time and lack of training. These systemic issues should be eradicated or minimized during planning. However, there is a lack of detailed planning tools to help managers assess the impact of their upstream decisions on worker safety behavior. Even though simulation had been used in construction planning, the review conducted in this study showed that construction safety management research had not been exploiting the potential of simulation techniques. Thus, a hybrid simulation framework is proposed to facilitate integration of safety management considerations into construction activity simulation. The hybrid framework consists of discrete event simulation (DES) as the core, but heterogeneous, interactive and intelligent (able to make decisions) agents replace traditional entities and resources. In addition, some of the cognitive processes and physiological aspects of agents are captured using system dynamics (SD) approach. The combination of DES, agent-based simulation (ABS) and SD allows a more "natural" representation of the complex dynamics in construction activities. The proposed hybrid framework was demonstrated using a hypothetical case study. In addition, due to the lack of application of factorial experiment approach in safety management simulation, the case study demonstrated sensitivity analysis and factorial experiment to guide future research. Copyright © 2015 Elsevier Ltd. All rights reserved.

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

    ERIC Educational Resources Information Center

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

    2015-01-01

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

  1. Safety assessment in plant layout design using indexing approach: implementing inherent safety perspective. Part 2-Domino Hazard Index and case study.

    PubMed

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

    2008-12-15

    The design of layout plans requires adequate assessment tools for the quantification of safety performance. The general focus of the present work is to introduce an inherent safety perspective at different points of the layout design process. In particular, index approaches for safety assessment and decision-making in the early stages of layout design are developed and discussed in this two-part contribution. Part 1 (accompanying paper) of the current work presents an integrated index approach for safety assessment of early plant layout. In the present paper (Part 2), an index for evaluation of the hazard related to the potential of domino effects is developed. The index considers the actual consequences of possible escalation scenarios and scores or ranks the subsequent accident propagation potential. The effects of inherent and passive protection measures are also assessed. The result is a rapid quantification of domino hazard potential that can provide substantial support for choices in the early stages of layout design. Additionally, a case study concerning selection among various layout options is presented and analyzed. The case study demonstrates the use and applicability of the indices developed in both parts of the current work and highlights the value of introducing inherent safety features early in layout design.

  2. Automating the Generation of Heterogeneous Aviation Safety Cases

    NASA Technical Reports Server (NTRS)

    Denney, Ewen W.; Pai, Ganesh J.; Pohl, Josef M.

    2012-01-01

    A safety case is a structured argument, supported by a body of evidence, which provides a convincing and valid justification that a system is acceptably safe for a given application in a given operating environment. This report describes the development of a fragment of a preliminary safety case for the Swift Unmanned Aircraft System. The construction of the safety case fragment consists of two parts: a manually constructed system-level case, and an automatically constructed lower-level case, generated from formal proof of safety-relevant correctness properties. We provide a detailed discussion of the safety considerations for the target system, emphasizing the heterogeneity of sources of safety-relevant information, and use a hazard analysis to derive safety requirements, including formal requirements. We evaluate the safety case using three classes of metrics for measuring degrees of coverage, automation, and understandability. We then present our preliminary conclusions and make suggestions for future work.

  3. Safety Case Development as an Information Modelling Problem

    NASA Astrophysics Data System (ADS)

    Lewis, Robert

    This paper considers the benefits from applying information modelling as the basis for creating an electronically-based safety case. It highlights the current difficulties of developing and managing large document-based safety cases for complex systems such as those found in Air Traffic Control systems. After a review of current tools and related literature on this subject, the paper proceeds to examine the many relationships between entities that can exist within a large safety case. The paper considers the benefits to both safety case writers and readers from the future development of an ideal safety case tool that is able to exploit these information models. The paper also introduces the idea that the safety case has formal relationships between entities that directly support the safety case argument using a methodology such as GSN, and informal relationships that provide links to direct and backing evidence and to supporting information.

  4. Changing patient safety culture in China: a case study of an experimental Chinese hospital from a comparative perspective.

    PubMed

    Xu, Xiao Ping; Deng, Dong Ning; Gu, Yong Hong; Ng, Chui Shan; Cai, Xiao; Xu, Jun; Zhang, Xin Shi; Ke, Dong Ge; Yu, Qian Hui; Chan, Chi Kuen

    2018-01-01

    The World Health Organization highlights that patient safety interventions are not lacking but that the local context affects their successful implementation. Increasing attention is being paid to patient safety in Mainland China, yet few studies focus on patient safety in organizations with mixed cultures. This paper evaluates the current patient safety culture in an experimental Chinese hospital with a Hong Kong hospital management culture, and it aims to explore the application of Hong Kong's patient safety strategies in the context of Mainland China. A quantitative survey of 307 hospital staff members was conducted using the Hospital Survey on Patient Safety Culture questionnaire. The findings were compared with a similar study on general Chinese hospitals and were appraised with reference to the Manchester Patient Safety Framework. Lower scores were observed among participants with the following characteristics: males, doctors, those with more work experience, those with higher education, and those from the general practice and otolaryngology departments. However, the case study hospital achieved better scores in management expectations, actions and support for patient safety, incident reporting and communication, and teamwork within units. Its weaknesses were related to non-punitive responses to errors, teamwork across units, and staffing. The case study hospital contributes to a changing patient safety culture in Mainland China, yet its patient safety culture remains mostly bureaucratic. Further efforts could be made to deepen the staff's patient safety culture mind-set, to realize a "bottom-up" approach to cultural change, to build up a comprehensive and integrated incident management system, and to improve team building and staffing for patient safety.

  5. A medication safety model: a case study in Thai hospital.

    PubMed

    Rattanarojsakul, Phichai; Thawesaengskulthai, Natcha

    2013-06-12

    Reaching zero defects is vital in medication service. Medication error can be reduced if the causes are recognized. The purpose of this study is to search for a conceptual framework of the causes of medication error in Thailand and to examine relationship between these factors and its importance. The study was carried out upon an in-depth case study and survey of hospital personals who were involved in the drug use process. The structured survey was based on Emergency Care Research Institute (ECRI) (2008) questionnaires focusing on the important factors that affect the medication safety. Additional questionnaires included content to the context of Thailand's private hospital, validated by five-hospital qualified experts. By correlation Pearson analysis, the result revealed 14 important factors showing a linear relationship with drug administration error except the medication reconciliation. By independent sample t-test, the administration error in the hospital was significantly related to external impact. The multiple regression analysis of the detail of medication administration also indicated the patient identification before administration of medication, detection of the risk of medication adverse effects and assurance of medication administration at the right time, dosage and route were statistically significant at 0.05 level. The major implication of the study is to propose a medication safety model in a Thai private hospital.

  6. Changing patient safety culture in China: a case study of an experimental Chinese hospital from a comparative perspective

    PubMed Central

    Gu, Yong Hong; Ng, Chui Shan; Cai, Xiao; Xu, Jun; Zhang, Xin Shi; Ke, Dong Ge; Yu, Qian Hui; Chan, Chi Kuen

    2018-01-01

    Background The World Health Organization highlights that patient safety interventions are not lacking but that the local context affects their successful implementation. Increasing attention is being paid to patient safety in Mainland China, yet few studies focus on patient safety in organizations with mixed cultures. This paper evaluates the current patient safety culture in an experimental Chinese hospital with a Hong Kong hospital management culture, and it aims to explore the application of Hong Kong’s patient safety strategies in the context of Mainland China. Methods A quantitative survey of 307 hospital staff members was conducted using the Hospital Survey on Patient Safety Culture questionnaire. The findings were compared with a similar study on general Chinese hospitals and were appraised with reference to the Manchester Patient Safety Framework. Results Lower scores were observed among participants with the following characteristics: males, doctors, those with more work experience, those with higher education, and those from the general practice and otolaryngology departments. However, the case study hospital achieved better scores in management expectations, actions and support for patient safety, incident reporting and communication, and teamwork within units. Its weaknesses were related to non-punitive responses to errors, teamwork across units, and staffing. Conclusions The case study hospital contributes to a changing patient safety culture in Mainland China, yet its patient safety culture remains mostly bureaucratic. Further efforts could be made to deepen the staff’s patient safety culture mind-set, to realize a “bottom-up” approach to cultural change, to build up a comprehensive and integrated incident management system, and to improve team building and staffing for patient safety. PMID:29750061

  7. A Medication Safety Model: A Case Study in Thai Hospital

    PubMed Central

    Rattanarojsakul, Phichai; Thawesaengskulthai, Natcha

    2013-01-01

    Reaching zero defects is vital in medication service. Medication error can be reduced if the causes are recognized. The purpose of this study is to search for a conceptual framework of the causes of medication error in Thailand and to examine relationship between these factors and its importance. The study was carried out upon an in-depth case study and survey of hospital personals who were involved in the drug use process. The structured survey was based on Emergency Care Research Institute (ECRI) (2008) questionnaires focusing on the important factors that affect the medication safety. Additional questionnaires included content to the context of Thailand's private hospital, validated by five-hospital qualified experts. By correlation Pearson analysis, the result revealed 14 important factors showing a linear relationship with drug administration error except the medication reconciliation. By independent sample t-test, the administration error in the hospital was significantly related to external impact. The multiple regression analysis of the detail of medication administration also indicated the patient identification before administration of medication, detection of the risk of medication adverse effects and assurance of medication administration at the right time, dosage and route were statistically significant at 0.05 level. The major implication of the study is to propose a medication safety model in a Thai private hospital. PMID:23985110

  8. Deriving Safety Cases from Machine-Generated Proofs

    NASA Technical Reports Server (NTRS)

    Basir, Nurlida; Fischer, Bernd; Denney, Ewen

    2009-01-01

    Proofs provide detailed justification for the validity of claims and are widely used in formal software development methods. However, they are often complex and difficult to understand, because they use machine-oriented formalisms; they may also be based on assumptions that are not justified. This causes concerns about the trustworthiness of using formal proofs as arguments in safety-critical applications. Here, we present an approach to develop safety cases that correspond to formal proofs found by automated theorem provers and reveal the underlying argumentation structure and top-level assumptions. We concentrate on natural deduction proofs and show how to construct the safety cases by covering the proof tree with corresponding safety case fragments.

  9. Deriving Safety Cases from Automatically Constructed Proofs

    NASA Technical Reports Server (NTRS)

    Basir, Nurlida; Denney, Ewen; Fischer, Bernd

    2009-01-01

    Formal proofs provide detailed justification for the validity of claims and are widely used in formal software development methods. However, they are often complex and difficult to understand, because the formalism in which they are constructed and encoded is usually machine-oriented, and they may also be based on assumptions that are not justified. This causes concerns about the trustworthiness of using formal proofs as arguments in safety-critical applications. Here, we present an approach to develop safety cases that correspond to formal proofs found by automated theorem provers and reveal the underlying argumentation structure and top-level assumptions. We concentrate on natural deduction style proofs, which are closer to human reasoning than resolution proofs, and show how to construct the safety cases by covering the natural deduction proof tree with corresponding safety case fragments. We also abstract away logical book-keeping steps, which reduces the size of the constructed safety cases. We show how the approach can be applied to the proofs found by the Muscadet prover.

  10. Case study: reconciling the quality and safety gap through strategic planning.

    PubMed

    Jeffs, Lianne; Merkley, Jane; Jeffrey, Jana; Ferris, Ella; Dusek, Janice; Hunter, Catherine

    2006-05-01

    An essential outcome of professional practice environments is the provision of high-quality, safe nursing care. To mitigate the quality and safety chasm, nursing leadership at St. Michael's Hospital undertook a strategic plan to enhance the nursing professional practice environment. This case study outlines the development of the strategic planning process: the driving forces (platform); key stakeholders (process and players); vision, guiding principles, strategic directions, framework for action and accountability (plan); lessons learned (pearls); and next steps to moving forward the vision, strategic directions and accountability mechanisms (passion and perseverance).

  11. Towards Measurement of Confidence in Safety Cases

    NASA Technical Reports Server (NTRS)

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

    2011-01-01

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

  12. A Case Study of Measuring Process Risk for Early Insights into Software Safety

    NASA Technical Reports Server (NTRS)

    Layman, Lucas; Basili, Victor; Zelkowitz, Marvin V.; Fisher, Karen L.

    2011-01-01

    In this case study, we examine software safety risk in three flight hardware systems in NASA's Constellation spaceflight program. We applied our Technical and Process Risk Measurement (TPRM) methodology to the Constellation hazard analysis process to quantify the technical and process risks involving software safety in the early design phase of these projects. We analyzed 154 hazard reports and collected metrics to measure the prevalence of software in hazards and the specificity of descriptions of software causes of hazardous conditions. We found that 49-70% of 154 hazardous conditions could be caused by software or software was involved in the prevention of the hazardous condition. We also found that 12-17% of the 2013 hazard causes involved software, and that 23-29% of all causes had a software control. The application of the TPRM methodology identified process risks in the application of the hazard analysis process itself that may lead to software safety risk.

  13. The role of production and teamwork practices in construction safety: a cognitive model and an empirical case study.

    PubMed

    Mitropoulos, Panagiotis Takis; Cupido, Gerardo

    2009-01-01

    In construction, the challenge for researchers and practitioners is to develop work systems (production processes and teams) that can achieve high productivity and high safety at the same time. However, construction accident causation models ignore the role of work practices and teamwork. This study investigates the mechanisms by which production and teamwork practices affect the likelihood of accidents. The paper synthesizes a new model for construction safety based on the cognitive perspective (Fuller's Task-Demand-Capability Interface model, 2005) and then presents an exploratory case study. The case study investigates and compares the work practices of two residential framing crews: a 'High Reliability Crew' (HRC)--that is, a crew with exceptional productivity and safety over several years, and an average performing crew from the same company. The model explains how the production and teamwork practices generate the work situations that workers face (the task demands) and affect the workers ability to cope (capabilities). The case study indicates that the work practices of the HRC directly influence the task demands and match them with the applied capabilities. These practices were guided by the 'principle' of avoiding errors and rework and included work planning and preparation, work distribution, managing the production pressures, and quality and behavior monitoring. The Task Demand-Capability model links construction research to a cognitive model of accident causation and provides a new way to conceptualize safety as an emergent property of the production practices and teamwork processes. The empirical evidence indicates that the crews' work practices and team processes strongly affect the task demands, the applied capabilities, and the match between demands and capabilities. The proposed model and the exploratory case study will guide further discovery of work practices and teamwork processes that can increase both productivity and safety in construction

  14. Using systems thinking in patient safety: a case study on medicines management.

    PubMed

    Brimble, Mandy; Jones, Aled

    2017-06-29

    Systems thinking is used as a way of understanding behaviours and actions in complex healthcare organisations. An important premise of the concept is that every action in a system causes a reaction elsewhere in that system. These reactions can lead to unintended consequences, sometimes long after the original action, and so are not always attributed to them. This article applies systems thinking to a medicines management case study, to highlight how quality-improvement practitioners can use the approach to underpin planning and implementation of patient-safety initiatives. The case study is specific to transcribing in children's hospices, but the strategies can be applied to other areas. The article explains that, while root cause analysis tools are useful for identifying the cause of, and possible solutions to, problems, they need to be considered carefully in terms of unintended consequences, and how the system into which the solution is implemented can be affected by the change. Analysis of problems using a systems-thinking approach can help practitioners to develop robust and well informed business cases to present to decision makers.

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

    PubMed

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

    2016-08-03

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

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

    PubMed

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

    2012-09-01

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

  17. A scan statistic for identifying optimal risk windows in vaccine safety studies using self-controlled case series design.

    PubMed

    Xu, Stanley; Hambidge, Simon J; McClure, David L; Daley, Matthew F; Glanz, Jason M

    2013-08-30

    In the examination of the association between vaccines and rare adverse events after vaccination in postlicensure observational studies, it is challenging to define appropriate risk windows because prelicensure RCTs provide little insight on the timing of specific adverse events. Past vaccine safety studies have often used prespecified risk windows based on prior publications, biological understanding of the vaccine, and expert opinion. Recently, a data-driven approach was developed to identify appropriate risk windows for vaccine safety studies that use the self-controlled case series design. This approach employs both the maximum incidence rate ratio and the linear relation between the estimated incidence rate ratio and the inverse of average person time at risk, given a specified risk window. In this paper, we present a scan statistic that can identify appropriate risk windows in vaccine safety studies using the self-controlled case series design while taking into account the dependence of time intervals within an individual and while adjusting for time-varying covariates such as age and seasonality. This approach uses the maximum likelihood ratio test based on fixed-effects models, which has been used for analyzing data from self-controlled case series design in addition to conditional Poisson models. Copyright © 2013 John Wiley & Sons, Ltd.

  18. Raised crosswalks on entrance to the roundabout-a case study on effectiveness of treatment on pedestrian safety and convenience.

    PubMed

    Candappa, Nimmi; Stephan, Karen; Fotheringham, Nicola; Lenné, Michael G; Corben, Bruce

    2014-01-01

    A common concern in the use of a roundabout is providing adequately for the pedestrian. This unique roundabout layout, which introduces raised crosswalks directly at the roundabout entrance, as opposed to at a car length back, aims at improving safety and convenience for pedestrians at roundabouts. A preliminary evaluation of the layout was undertaken to establish its effectiveness in meeting study objectives. A quasi-experimental before-and-after study design was used to compare speeds on approach and immediately prior to the crossing to ascertain potential impact speed and implications for pedestrian safety. Compliance to crossing and crossing time were also compared in relation to safety and convenience outcomes. A questionnaire assessed pedestrian perception of the safety and convenience at the roundabout before and after treatment. Results from this case study indicate that mean approach speeds (free speeds 30 m from crossing) reduced from 32.7 to 30.7 km/h and immediately prior to crossing, mean speeds reduced from 19.1 to 16.3 km/h. There was also a marked reduction in proportions of vehicles traveling at speeds that could elevate risk to pedestrians. Total crossing time after treatment reduced by around 4 s, and crossing compliance increased from approximately half to approximately 90 percent. Survey of pedestrians indicated positive response to the perceived safety and convenience posttreatment. Preliminary results of the case study suggest positive safety and convenience outcomes. Implications for pedestrian safety include less exposure to traffic and lower risk of serious injury, particularly for elderly pedestrians; convenience outcomes include shorter waiting times to cross and greater compliance to the crossing. A larger study is required to substantiate the findings.

  19. Case-control analysis in highway safety: Accounting for sites with multiple crashes.

    PubMed

    Gross, Frank

    2013-12-01

    There is an increased interest in the use of epidemiological methods in highway safety analysis. The case-control and cohort methods are commonly used in the epidemiological field to identify risk factors and quantify the risk or odds of disease given certain characteristics and factors related to an individual. This same concept can be applied to highway safety where the entity of interest is a roadway segment or intersection (rather than a person) and the risk factors of interest are the operational and geometric characteristics of a given roadway. One criticism of the use of these methods in highway safety is that they have not accounted for the difference between sites with single and multiple crashes. In the medical field, a disease either occurs or it does not; multiple occurrences are generally not an issue. In the highway safety field, it is necessary to evaluate the safety of a given site while accounting for multiple crashes. Otherwise, the analysis may underestimate the safety effects of a given factor. This paper explores the use of the case-control method in highway safety and two variations to account for sites with multiple crashes. Specifically, the paper presents two alternative methods for defining cases in a case-control study and compares the results in a case study. The first alternative defines a separate case for each crash in a given study period, thereby increasing the weight of the associated roadway characteristics in the analysis. The second alternative defines entire crash categories as cases (sites with one crash, sites with two crashes, etc.) and analyzes each group separately in comparison to sites with no crashes. The results are also compared to a "typical" case-control application, where the cases are simply defined as any entity that experiences at least one crash and controls are those entities without a crash in a given period. In a "typical" case-control design, the attributes associated with single-crash segments are weighted

  20. Safety distance assessment of industrial toxic releases based on frequency and consequence: a case study in Shanghai, China.

    PubMed

    Yu, Q; Zhang, Y; Wang, X; Ma, W C; Chen, L M

    2009-09-15

    A case study on the safety distance assessment of a chemical industry park in Shanghai, China, is presented in this paper. Toxic releases were taken into consideration. A safety criterion based on frequency and consequence of major hazard accidents was set up for consequence analysis. The exposure limits for the accidents with the frequency of more than 10(-4), 10(-5)-10(-4) and 10(-6)-10(-5) per year were mortalities of 1% (or SLOT), 50% (SLOD) and 75% (twice of SLOD) respectively. Accidents with the frequency of less than 10(-6) per year were considered incredible and ignored in the consequence analysis. Taking the safety distance of all the hazard installations in a chemical plant into consideration, the results based on the new criterion were almost smaller than those based on LC50 or SLOD. The combination of the consequence and risk based results indicated that the hazard installations in two of the chemical plants may be dangerous to the protection targets and measurements had to be taken to reduce the risk. The case study showed that taking account of the frequency of occurrence in the consequence analysis would give more feasible safety distances for major hazard accidents and the results were more comparable to those calculated by risk assessment.

  1. Model Transformation for a System of Systems Dependability Safety Case

    NASA Technical Reports Server (NTRS)

    Murphy, Judy; Driskell, Stephen B.

    2010-01-01

    Software plays an increasingly larger role in all aspects of NASA's science missions. This has been extended to the identification, management and control of faults which affect safety-critical functions and by default, the overall success of the mission. Traditionally, the analysis of fault identification, management and control are hardware based. Due to the increasing complexity of system, there has been a corresponding increase in the complexity in fault management software. The NASA Independent Validation & Verification (IV&V) program is creating processes and procedures to identify, and incorporate safety-critical software requirements along with corresponding software faults so that potential hazards may be mitigated. This Specific to Generic ... A Case for Reuse paper describes the phases of a dependability and safety study which identifies a new, process to create a foundation for reusable assets. These assets support the identification and management of specific software faults and, their transformation from specific to generic software faults. This approach also has applications to other systems outside of the NASA environment. This paper addresses how a mission specific dependability and safety case is being transformed to a generic dependability and safety case which can be reused for any type of space mission with an emphasis on software fault conditions.

  2. A Formal Basis for Safety Case Patterns

    NASA Technical Reports Server (NTRS)

    Denney, Ewen; Pai, Ganesh

    2013-01-01

    By capturing common structures of successful arguments, safety case patterns provide an approach for reusing strategies for reasoning about safety. In the current state of the practice, patterns exist as descriptive specifications with informal semantics, which not only offer little opportunity for more sophisticated usage such as automated instantiation, composition and manipulation, but also impede standardization efforts and tool interoperability. To address these concerns, this paper gives (i) a formal definition for safety case patterns, clarifying both restrictions on the usage of multiplicity and well-founded recursion in structural abstraction, (ii) formal semantics to patterns, and (iii) a generic data model and algorithm for pattern instantiation. We illustrate our contributions by application to a new pattern, the requirements breakdown pattern, which builds upon our previous work

  3. [Case-non case studies: Principles, methods, bias and interpretation].

    PubMed

    Faillie, Jean-Luc

    2017-10-31

    Case-non case studies belongs to the methods assessing drug safety by analyzing the disproportionality of notifications of adverse drug reactions in pharmacovigilance databases. Used for the first time in the 1980s, the last few decades have seen a significant increase in the use of this design. The principle of the case-non case study is to compare drug exposure in cases of a studied adverse reaction with that of cases of other reported adverse reactions and called "non cases". Results are presented in the form of a reporting odds ratio (ROR), the interpretation of which makes it possible to identify drug safety signals. This article describes the principle of the case-non case study, the method of calculating the ROR and its confidence interval, the different modalities of analysis and how to interpret its results with regard to the advantages and limitations of this design. Copyright © 2017 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

  4. Towards a Formal Basis for Modular Safety Cases

    NASA Technical Reports Server (NTRS)

    Denney, Ewen; Pai, Ganesh

    2015-01-01

    Safety assurance using argument-based safety cases is an accepted best-practice in many safety-critical sectors. Goal Structuring Notation (GSN), which is widely used for presenting safety arguments graphically, provides a notion of modular arguments to support the goal of incremental certification. Despite the efforts at standardization, GSN remains an informal notation whereas the GSN standard contains appreciable ambiguity especially concerning modular extensions. This, in turn, presents challenges when developing tools and methods to intelligently manipulate modular GSN arguments. This paper develops the elements of a theory of modular safety cases, leveraging our previous work on formalizing GSN arguments. Using example argument structures we highlight some ambiguities arising through the existing guidance, present the intuition underlying the theory, clarify syntax, and address modular arguments, contracts, well-formedness and well-scopedness of modules. Based on this theory, we have a preliminary implementation of modular arguments in our toolset, AdvoCATE.

  5. Fire safety: A case study of technology transfer

    NASA Technical Reports Server (NTRS)

    Heins, C. F.

    1975-01-01

    Two basic ways in which NASA-generated technology is being used by the fire safety community are described. First, improved products and systems that embody NASA technical advances are entering the marketplace. Second, NASA test data and technical information related to fire safety are being used by persons concerned with reducing the hazards of fire through improved design information and standards. The development of commercial fire safety products and systems typically requires adaptation and integration of aerospace technologies that may not have been originated for NASA fire safety applications.

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

    NASA Astrophysics Data System (ADS)

    Du, Xiaorong

    2017-04-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2017-10-01

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

  8. Recent Cases: Administrative Law--Occupational Safety and Health Act

    ERIC Educational Resources Information Center

    Harvard Law Review, 1976

    1976-01-01

    Implications of the Occupational Safety and Health Act of 1970 are described in two cases: Brennan v. Occupational Safety and Health Review Commission (Underhill Construction Corp.), and Anning-Johnson Co. v. United States Occupational Safety and Health Review Commission. (LBH)

  9. The business case for patient safety.

    PubMed

    Hwang, Raymond W; Herndon, James H

    2007-04-01

    Recent trends have focused attention on improving patient safety in the United States healthcare system. Lapses in patient safety create undue, often preventable, morbidity. These include adverse drug events, adverse surgical events and nosocomial infections. From an organizational perspective, these events are both inefficient and expensive. Many safe practices and quality enhancing improvements, such as computer provider order entry, proper infection surveillance, telemedicine intensive care, and registered nurse staffing are in fact cost-effective. However, in order to fully achieve higher quality, better adverse event reporting and a culture of safety must first be developed. Increased provider recognition, models of success, public awareness and consumer demand are propelling improvements. As we will outline in this review of the current literature, the business case for patient safety is a compelling one, offering substantial economic incentives for achieving the necessary goal of improved patient outcomes.

  10. Sun Safety at Work Canada: a multiple case-study protocol to develop sun safety and heat protection programs and policies for outdoor workers.

    PubMed

    Kramer, Desre M; Tenkate, Thomas; Strahlendorf, Peter; Kushner, Rivka; Gardner, Audrey; Holness, D Linn

    2015-07-10

    CAREX Canada has identified solar ultraviolet radiation (UV) as the second most prominent carcinogenic exposure in Canada, and over 75 % of Canadian outdoor workers fall within the highest exposure category. Heat stress also presents an important public health issue, particularly for outdoor workers. The most serious form of heat stress is heat stroke, which can cause irreversible damage to the heart, lungs, kidneys, and liver. Although the need for sun and heat protection has been identified, there is no Canada-wide heat and sun safety program for outdoor workers. Further, no prevention programs have addressed both skin cancer prevention and heat stress in an integrated approach. The aim of this partnered study is to evaluate whether a multi-implementation, multi-evaluation approach can help develop sustainable workplace-specific programs, policies, and procedures to increase the use of UV safety and heat protection. This 2-year study is a theory-driven, multi-site, non-randomized study design with a cross-case analysis of 13 workplaces across four provinces in Canada. The first phase of the study includes the development of workplace-specific programs with the support of the intensive engagement of knowledge brokers. There will be a three-points-in-time evaluation with process and impact components involving the occupational health and safety (OHS) director, management, and workers with the goal of measuring changes in workplace policies, procedures, and practices. It will use mixed methods involving semi-structured key informant interviews, focus groups, surveys, site observations, and UV dosimetry assessment. Using the findings from phase I, in phase 2, a web-based, interactive, intervention planning tool for workplaces will be developed, as will the intensive engagement of intermediaries such as industry decision-makers to link to policymakers about the importance of heat and sun safety for outdoor workers. Solar UV and heat are both health and safety hazards

  11. Evolution of a holistic systems approach to planning and managing road safety: the Victorian case study, 1970-2015.

    PubMed

    Muir, Carlyn; Johnston, Ian R; Howard, Eric

    2018-06-01

    The Victorian Safe System approach to road safety slowly evolved from a combination of the Swedish Vision Zero philosophy and the Sustainable Safety model developed by the Dutch. The Safe System approach reframes the way in which road safety is viewed and managed. This paper presents a case study of the institutional change required to underpin the transformation to a holistic approach to planning and managing road safety in Victoria, Australia. The adoption and implementation of a Safe System approach require strong institutional leadership and close cooperation among all the key agencies involved, and Victoria was fortunate in that it had a long history of strong interagency mechanisms in place. However, the challenges in the implementation of the Safe System strategy in Victoria are generally neither technical nor scientific; they are predominantly social and political. While many governments purport to develop strategies based on Safe System thinking, on-the-ground action still very much depends on what politicians perceive to be publicly acceptable, and Victoria is no exception. This is a case study of the complexity of institutional change and is presented in the hope that the lessons may prove useful for others seeking to adopt more holistic planning and management of road safety. There is still much work to be done in Victoria, but the institutional cultural shift has taken root. Ongoing efforts must be continued to achieve alert and compliant road users; however, major underpinning benefits will be achieved through focusing on road network safety improvements (achieving forgiving infrastructure, such as wire rope barriers) in conjunction with reviews of posted speed limits (to be set in response to the level of protection offered by the road infrastructure) and by the progressive introduction into the fleet of modern vehicle safety features. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights

  12. 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

  13. Assuring consumer safety without animal testing: a feasibility case study for skin sensitisation.

    PubMed

    Maxwell, Gavin; Aleksic, Maja; Aptula, Aynur; Carmichael, Paul; Fentem, Julia; Gilmour, Nicola; Mackay, Cameron; Pease, Camilla; Pendlington, Ruth; Reynolds, Fiona; Scott, Daniel; Warner, Guy; Westmoreland, Carl

    2008-11-01

    Allergic Contact Dermatitis (ACD; chemical-induced skin sensitisation) represents a key consumer safety endpoint for the cosmetics industry. At present, animal tests (predominantly the mouse Local Lymph Node Assay) are used to generate skin sensitisation hazard data for use in consumer safety risk assessments. An animal testing ban on chemicals to be used in cosmetics will come into effect in the European Union (EU) from March 2009. This animal testing ban is also linked to an EU marketing ban on products containing any ingredients that have been subsequently tested in animals, from March 2009 or March 2013, depending on the toxicological endpoint of concern. Consequently, the testing of cosmetic ingredients in animals for their potential to induce skin sensitisation will be subject to an EU marketing ban, from March 2013 onwards. Our conceptual framework and strategy to deliver a non-animal approach to consumer safety risk assessment can be summarised as an evaluation of new technologies (e.g. 'omics', informatics), leading to the development of new non-animal (in silico and in vitro) predictive models for the generation and interpretation of new forms of hazard characterisation data, followed by the development of new risk assessment approaches to integrate these new forms of data and information in the context of human exposure. Following the principles of the conceptual framework, we have been investigating existing and developing new technologies, models and approaches, in order to explore the feasibility of delivering consumer safety risk assessment decisions in the absence of new animal data. We present here our progress in implementing this conceptual framework, with the skin sensitisation endpoint used as a case study. 2008 FRAME.

  14. Federal and tribal lands road safety audits : case studies

    DOT National Transportation Integrated Search

    2009-12-01

    A road safety audit (RSA) is a formal safety performance examination by an independent, multidisciplinary team. RSAs are an effective tool for proactively improving the safety performance of a road project during the planning and design stages, and f...

  15. Safety testing of monoclonal antibodies in non-human primates: Case studies highlighting their impact on human risk assessment.

    PubMed

    Brennan, Frank R; Cavagnaro, Joy; McKeever, Kathleen; Ryan, Patricia C; Schutten, Melissa M; Vahle, John; Weinbauer, Gerhard F; Marrer-Berger, Estelle; Black, Lauren E

    2018-01-01

    Monoclonal antibodies (mAbs) are improving the quality of life for patients suffering from serious diseases due to their high specificity for their target and low potential for off-target toxicity. The toxicity of mAbs is primarily driven by their pharmacological activity, and therefore safety testing of these drugs prior to clinical testing is performed in species in which the mAb binds and engages the target to a similar extent to that anticipated in humans. For highly human-specific mAbs, this testing often requires the use of non-human primates (NHPs) as relevant species. It has been argued that the value of these NHP studies is limited because most of the adverse events can be predicted from the knowledge of the target, data from transgenic rodents or target-deficient humans, and other sources. However, many of the mAbs currently in development target novel pathways and may comprise novel scaffolds with multi-functional domains; hence, the pharmacological effects and potential safety risks are less predictable. Here, we present a total of 18 case studies, including some of these novel mAbs, with the aim of interrogating the value of NHP safety studies in human risk assessment. These studies have identified mAb candidate molecules and pharmacological pathways with severe safety risks, leading to candidate or target program termination, as well as highlighting that some pathways with theoretical safety concerns are amenable to safe modulation by mAbs. NHP studies have also informed the rational design of safer drug candidates suitable for human testing and informed human clinical trial design (route, dose and regimen, patient inclusion and exclusion criteria and safety monitoring), further protecting the safety of clinical trial participants.

  16. Stories from the Sharp End: Case Studies in Safety Improvement

    PubMed Central

    McCarthy, Douglas; Blumenthal, David

    2006-01-01

    Motivated by pressure and a wish to improve, health care organizations are implementing programs to improve patient safety. This article describes six natural experiments in health care safety that show where the safety field is heading and opportunities for and barriers to improvement. All these programs identified organizational culture change as critical to making patients safer, differing chiefly in their methods of creating a patient safety culture. Their goal is a safety culture that promotes continuing innovation and improvement, transcending whatever particular safety methodology is used. Policymakers could help stimulate a culture of safety by linking regulatory goals to safety culture expectations, sponsoring voluntary learning collaborations, rewarding safety improvements, better using publicly reported data, encouraging consumer involvement, and supporting research and education. PMID:16529572

  17. The role of electronic checklists - case study on MRI-safety.

    PubMed

    Landmark, Andreas; Selnes, May-Britt; Larsen, Elisabeth; Svensli, Astrid; Solum, Linda; Brattheim, Berit

    2012-01-01

    Checklists can be used to improve and standardize safety critical processes and their communication. The introduction of potentially harmful medical technology and equipment has created additional requirements for the safe delivery of health care. We have studied the implementation of an electronic checklist to ensure the safety of patients scheduled for Magnetic Resonance Imaging examinations. Through a combination of observations and semi-structured interviews we investigated how health care workers in a Norwegian University hospital dealt with variations in checklist compliance, missing and lack of information. The checklist provided different functionality for the different users, ranging from a memory/attention support to a standardized form of communication on safety matters. However, the rigidity afforded by the electronic implementation, showed some serious drawbacks over the prior, simpler, paper-based versions.

  18. Development of a Reality-Based Multimedia Case Study Teaching Method and Its Effect on Students' Planned Food Safety Behaviors

    ERIC Educational Resources Information Center

    Alberts, Caitlin M.; Stevenson, Clinton D.

    2017-01-01

    There is opportunity to decrease the frequency of foodborne illnesses by improving food safety competencies and planned behaviors of college students before they begin careers in the food industry. The objectives of this study were to (1) develop a multimedia case study teaching method that provides real world context for food science education;…

  19. Patient safety incidents in hospice care: observations from interdisciplinary case conferences.

    PubMed

    Oliver, Debra Parker; Demiris, George; Wittenberg-Lyles, Elaine; Gage, Ashley; Dewsnap-Dreisinger, Mariah L; Luetkemeyer, Jamie

    2013-12-01

    In the home hospice environment, issues arise every day presenting challenges to the safety, care, and quality of the dying experience. The literature pertaining to the safety challenges in this environment is limited. The study explored two research questions; 1) What types of patient safety incidents occur in the home hospice setting? 2) How many of these incidents are recognized by the hospice staff and/or the patient or caregiver as a patient safety incident? Video-recordings of hospice interdisciplinary team case conferences were reviewed and coded for patient safety incidents. Patient safety incidents were defined as any event or circumstance that could have resulted or did result in unnecessary harm to the patient or caregiver, or that could have resulted or did result in a negative impact on the quality of the dying experience for the patient. Codes for categories of patient safety incidents were based on the International Classification for Patient Safety. The setting for the study included two rural hospice programs in one Midwestern state in the United States. One hospice team had two separately functioning teams, the second hospice had three teams. 54 video-recordings were reviewed and coded. Patient safety incidents were identified that involved issues in clinical process, medications, falls, family or caregiving, procedural problems, documentation, psychosocial issues, administrative challenges and accidents. This study distinguishes categories of patient safety events that occur in home hospice care. Although the scope and definition of potential patient safety incidents in hospice is unique, the events observed in this study are similar to those observed with in other settings. This study identifies an operating definition and a potential classification for further research on patient safety incidents in hospice. Further research and consensus building of the definition of patient safety incidents and patient safety incidents in this setting is

  20. Assessing the home fire safety of urban older adults: a case study.

    PubMed

    Twyman, Stephanie; Fahey, Erin; Lehna, Carlee

    2014-01-01

    Older adults are at a higher risk for fatal house fire injury due to decreased mobility, chronic illness, and lack of smoke alarms. The purpose of this illustrative case study is to describe the home fire safety (HFS) status of an urban older adult who participated in a large study funded by the Federal Emergency Management Agency (FEMA). During a home visit with the participant, HFS data were collected from documents, observation, physical artifacts, reflective logs, and interviews. Numerous HFS hazards were identified including non-working smoke alarms, inadequate number and inappropriate placement of smoke alarms, lack of carbon monoxide (CO) alarms, inability to identify a home fire escape plan, hot water heater temperature set too high, and cooking hazards. Identification of HFS risk factors will assist in the development of educational materials that can be tailored to the older adult population to decrease their risk of fire-related injuries and death.

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

    PubMed

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

    2014-05-01

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

  2. A Software Safety Risk Taxonomy for Use in Retrospective Safety Cases

    NASA Technical Reports Server (NTRS)

    Hill, Janice L.

    2007-01-01

    Safety standards contain technical and process-oriented safely requirements. The best time to include these requirements is early in the development lifecycle of the system. When software safety requirements are levied on a legacy system after the fact, a retrospective safety case will need to be constructed for the software in the system. This can be a difficult task because there may be few to no art facts available to show compliance to the software safely requirements. The risks associated with not meeting safely requirements in a legacy safely-critical computer system must be addressed to give confidence for reuse. This paper introduces a proposal for a software safely risk taxonomy for legacy safely-critical computer systems, by specializing the Software Engineering Institute's 'Software Development Risk Taxonomy' with safely elements and attributes.

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

    PubMed

    Martinelli, Lucia; Karbarz, Małgorzata; Siipi, Helena

    2013-02-01

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

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

    PubMed

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

    2006-10-11

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

  5. Nutritional and safety assessment of foods and feeds nutritionally improved through biotechnology--case studies by the International Food Biotechnology Committee of ILSI.

    PubMed

    Glenn, Kevin C

    2008-01-01

    During the last two decades, the public and private sectors have made substantial research progress internationally toward improving the nutritional value of a wide range of food and feed crops. Nevertheless, significant numbers of people still suffer from the effects of undernutrition. As newly developed crops with nutritionally improved traits come closer to being available to producers and consumers, scientifically sound and efficient processes are needed to assess the safety and nutritional quality of these crops. In 2004, a Task Force of international scientific experts, convened by the International Food Biotechnology Committee (IFBiC) of ILSI, published recommendations for the safety and nutritional assessment of foods and feeds nutritionally improved through modern biotechnology (J. Food Science, 2004, 69:CRH62-CRH68). The comparative safety assessment process is a basic principle in this publication and is the starting point, not the conclusion, of the analysis. Significant differences in composition are expected to be observed in the case of nutritionally enhanced crops and must be assessed on a case-by-case basis. The Golden Rice 2 case study will be presented as an example of a food crop nutritionally enhanced through the application of modern biotechnology (i.e., recombinant DNA techniques) to illustrate how the 2004 recommendations provide a robust paradigm for the safety assessment of "real world" examples of improved nutrition crops.

  6. Reducing medication errors and increasing patient safety: case studies in clinical pharmacology.

    PubMed

    Benjamin, David M

    2003-07-01

    Today, reducing medication errors and improving patient safety have become common topics of discussion for the president of the United States, federal and state legislators, the insurance industry, pharmaceutical companies, health care professionals, and patients. But this is not news to clinical pharmacologists. Improving the judicious use of medications and minimizing adverse drug reactions have always been key areas of research and study for those working in clinical pharmacology. However, added to the older terms of adverse drug reactions and rational therapeutics, the now politically correct expression of medication error has emerged. Focusing on the word error has drawn attention to "prevention" and what can be done to minimize mistakes and improve patient safety. Webster's New Collegiate Dictionary has several definitions of error, but the one that seems to be most appropriate in the context of medication errors is "an act that through ingnorance, deficiency, or accident departs from or fails to achieve what should be done." What should be done is generally known as "the five rights": the right drug, right dose, right route, right time, and right patient. One can make an error of omission (failure to act correctly) or an error of commission (acted incorrectly). This article now summarizes what is currently known about medication errors and translates the information into case studies illustrating common scenarios leading to medication errors. Each case is analyzed to provide insight into how the medication error could have been prevented. "System errors" are described, and the application of failure mode effect analysis (FMEA) is presented to determine the part of the "safety net" that failed. Examples of reengineering the system to make it more "error proof" are presented. An error can be prevented. However, the practice of medicine, pharmacy, and nursing in the hospital setting is very complicated, and so many steps occur from "pen to patient" that there

  7. Safety Training--A Special Case?

    ERIC Educational Resources Information Center

    Cooper, Mark; Cotton, David

    2000-01-01

    Review of research on industrial training and occupational safety and health did not find materials on training safely or risk assessment for training. A study of 34 safety inspectors indicated that risk decision making and assessment are serious concerns that should be addressed in safety training. (Contains 56 references.) (SK)

  8. A Case Study of Dynamic Response Analysis and Safety Assessment for a Suspended Monorail System

    PubMed Central

    Bao, Yulong; Li, Yongle; Ding, Jiajie

    2016-01-01

    A suspended monorail transit system is a category of urban rail transit, which is effective in alleviating traffic pressure and injury prevention. Meanwhile, with the advantages of low cost and short construction time, suspended monorail transit systems show vast potential for future development. However, the suspended monorail has not been systematically studied in China, and there is a lack of relevant knowledge and analytical methods. To ensure the health and reliability of a suspended monorail transit system, the driving safety of vehicles and structure dynamic behaviors when vehicles are running on the bridge should be analyzed and evaluated. Based on the method of vehicle-bridge coupling vibration theory, the finite element method (FEM) software ANSYS and multi-body dynamics software SIMPACK are adopted respectively to establish the finite element model for bridge and the multi-body vehicle. A co-simulation method is employed to investigate the vehicle-bridge coupling vibration for the transit system. The traffic operation factors, including train formation, track irregularity and tire stiffness, are incorporated into the models separately to analyze the bridge and vehicle responses. The results show that the coupling of dynamic effects of the suspended monorail system between vehicle and bridge are significant in the case studied, and it is strongly suggested to take necessary measures for vibration suppression. The simulation of track irregularity is a critical factor for its vibration safety, and the track irregularity of A-level road roughness negatively influences the system vibration safety. PMID:27834923

  9. A Case Study of Dynamic Response Analysis and Safety Assessment for a Suspended Monorail System.

    PubMed

    Bao, Yulong; Li, Yongle; Ding, Jiajie

    2016-11-10

    A suspended monorail transit system is a category of urban rail transit, which is effective in alleviating traffic pressure and injury prevention. Meanwhile, with the advantages of low cost and short construction time, suspended monorail transit systems show vast potential for future development. However, the suspended monorail has not been systematically studied in China, and there is a lack of relevant knowledge and analytical methods. To ensure the health and reliability of a suspended monorail transit system, the driving safety of vehicles and structure dynamic behaviors when vehicles are running on the bridge should be analyzed and evaluated. Based on the method of vehicle-bridge coupling vibration theory, the finite element method (FEM) software ANSYS and multi-body dynamics software SIMPACK are adopted respectively to establish the finite element model for bridge and the multi-body vehicle. A co-simulation method is employed to investigate the vehicle-bridge coupling vibration for the transit system. The traffic operation factors, including train formation, track irregularity and tire stiffness, are incorporated into the models separately to analyze the bridge and vehicle responses. The results show that the coupling of dynamic effects of the suspended monorail system between vehicle and bridge are significant in the case studied, and it is strongly suggested to take necessary measures for vibration suppression. The simulation of track irregularity is a critical factor for its vibration safety, and the track irregularity of A-level road roughness negatively influences the system vibration safety.

  10. Are signalized intersections with cycle tracks safer? A case-control study based on automated surrogate safety analysis using video data.

    PubMed

    Zangenehpour, Sohail; Strauss, Jillian; Miranda-Moreno, Luis F; Saunier, Nicolas

    2016-01-01

    Cities in North America have been building bicycle infrastructure, in particular cycle tracks, with the intention of promoting urban cycling and improving cyclist safety. These facilities have been built and expanded but very little research has been done to investigate the safety impacts of cycle tracks, in particular at intersections, where cyclists interact with turning motor-vehicles. Some safety research has looked at injury data and most have reached the conclusion that cycle tracks have positive effects of cyclist safety. The objective of this work is to investigate the safety effects of cycle tracks at signalized intersections using a case-control study. For this purpose, a video-based method is proposed for analyzing the post-encroachment time as a surrogate measure of the severity of the interactions between cyclists and turning vehicles travelling in the same direction. Using the city of Montreal as the case study, a sample of intersections with and without cycle tracks on the right and left sides of the road were carefully selected accounting for intersection geometry and traffic volumes. More than 90h of video were collected from 23 intersections and processed to obtain cyclist and motor-vehicle trajectories and interactions. After cyclist and motor-vehicle interactions were defined, ordered logit models with random effects were developed to evaluate the safety effects of cycle tracks at intersections. Based on the extracted data from the recorded videos, it was found that intersection approaches with cycle tracks on the right are safer than intersection approaches with no cycle track. However, intersections with cycle tracks on the left compared to no cycle tracks seem to be significantly safer. Results also identify that the likelihood of a cyclist being involved in a dangerous interaction increases with increasing turning vehicle flow and decreases as the size of the cyclist group arriving at the intersection increases. The results highlight the

  11. Safety cases for medical devices and health information technology: involving health-care organisations in the assurance of safety.

    PubMed

    Sujan, Mark A; Koornneef, Floor; Chozos, Nick; Pozzi, Simone; Kelly, Tim

    2013-09-01

    In the United Kingdom, there are more than 9000 reports of adverse events involving medical devices annually. The regulatory processes in Europe and in the United States have been challenged as to their ability to protect patients effectively from unreasonable risk and harm. Two of the major shortcomings of current practice include the lack of transparency in the safety certification process and the lack of involvement of service providers. We reviewed recent international standardisation activities in this area, and we reviewed regulatory practices in other safety-critical industries. The review showed that the use of safety cases is an accepted practice in UK safety-critical industries, but at present, there is little awareness of this concept in health care. Safety cases have the potential to provide greater transparency and confidence in safety certification and to act as a communication tool between manufacturers, service providers, regulators and patients.

  12. Statin-Associated Polymyalgia Rheumatica. An Analysis Using WHO Global Individual Case Safety Database: A Case/Non-Case Approach

    PubMed Central

    de Jong, Hilda J. I.; Saldi, Siti R. F.; Klungel, Olaf H.; Vandebriel, Rob J.; Souverein, Patrick C.; Meyboom, Ronald H. B.; Passier, J. L. M. (Anneke); van Loveren, Henk; Tervaert, Jan Willem Cohen

    2012-01-01

    Objective To assess whether there is an association between statin use and the occurrence of polymyalgia rheumatic (PMR) in the spontaneous reporting database of the World Health Organisation (WHO). Methods We conducted a case/non-case study based on individual case safety reports (ICSR) in the WHO global ICSR database (VigiBase). Case reports containing the adverse event term polymyalgia rheumatica (WHOART or MedDRA Preferred Term) were defined as cases. Non-cases were all case reports containing other adverse event terms. Each case was matched to five non-cases by age, gender, and time of reporting. Case reports regarding a statin as suspected or concomitant drug were identified using the Anatomical Therapeutic Chemical (ATC) classification. Multivariate logistic regression was used to calculate reporting odds ratios (RORs) with 95% confidence intervals (CI). Results We identified 327 reports of PMR as cases and 1635 reports of other ADRs as non-cases. Among cases, statins were more frequently reported as suspected agent (29.4%) compared to non-cases (2.9%). After adjustment for several covariates, statins were significantly associated with reports of PMR (ROR 14.21; 95% CI 9.89–20.85). Conclusion The results of this study lends support to previous anecdotal case reports in the literature suggesting that the use of a statin may be associated with the occurrence of PMR. Further studies are needed to study the strength of the association in more detail and to elucidate the underlying mechanism. PMID:22844450

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

    PubMed Central

    Cunningham, Thomas R.; Sinclair, Raymond

    2015-01-01

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

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

    PubMed

    Cunningham, Thomas R; Sinclair, Raymond

    2015-01-01

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

  15. Preparing Safety Cases for Operating Outside Prescriptive Fatigue Risk Management Regulations.

    PubMed

    Gander, Philippa; Mangie, Jim; Wu, Lora; van den Berg, Margo; Signal, Leigh; Phillips, Adrienne

    2017-07-01

    Transport operators seeking to operate outside prescriptive fatigue management regulations are typically required to present a safety case justifying how they will manage the associated risk. This paper details a method for constructing a successful safety case. The method includes four elements: 1) scope (prescriptive rules and operations affected); 2) risk assessment; 3) risk mitigation strategies; and 4) monitoring ongoing risk. A successful safety case illustrates this method. It enables landing pilots in 3-pilot crews to choose the second or third in-flight rest break, rather than the regulatory requirement to take the third break. Scope was defined using a month of scheduled flights that would be covered (N = 4151). These were analyzed in the risk assessment using existing literature on factors affecting fatigue to estimate the maximum time awake at top of descent and sleep opportunities in each break. Additionally, limited data collected before the new regulations showed that pilots flying at landing chose the third break on only 6% of flights. A prospective survey comparing subjective reports (N = 280) of sleep in the second vs. third break and fatigue and sleepiness ratings at top of descent confirmed that the third break is not consistently superior. The safety case also summarized established systems for fatigue monitoring, risk assessment and hazard identification, and multiple fatigue mitigation strategies that are in place. Other successful safety cases have used this method. The evidence required depends on the expected level of risk and should evolve as experience with fatigue risk management systems builds.Gander P, Mangie J, Wu L, van den Berg M, Signal L, Phillips A. Preparing safety cases for operating outside prescriptive fatigue risk management regulations. Aerosp Med Hum Perform. 2017; 88(7):688-696.

  16. Food safety issues in China: a case study of the dairy sector.

    PubMed

    Dong, Xiaoxia; Li, Zhemin

    2016-01-15

    Over the past 10 years, food safety incidents have occurred frequently in China. Food safety issues in the dairy sector have increasingly gained the attention of the Chinese government and the public. The objective of this research is to explore consumption changes of dairy products of different income groups after these dairy safety incidents. The research indicates that consumers' response to dairy safety risk is very intense. Dairy consumption has experienced a declining trend in recent years, and the impact of dairy safety incidents has lasted for at least 5 years. Until 2012, dairy consumption had not yet fully recovered from this influence. Using the random effects model, this study examined the relationship between food safety incident and consumption. Overall, the results show that consumers in the low-income group are more sensitive to safety risk than those in the high-income group. It can be seen from this paper that the decrease of urban residents' dairy consumption was mainly driven by changes in fresh milk consumption, while the decline of milk powder consumption, which was affected by the melamine incident, was relatively moderate, and milk powder consumption for the high-income group even increased. © 2015 Society of Chemical Industry.

  17. Indicators of Faculty and Staff Perceptions of Campus Safety: A Case Study

    ERIC Educational Resources Information Center

    Woolfolk, Willie A.

    2013-01-01

    The study addressed the problem of a critical increase in campus crime between 1999 and 2009, a period during which overall crime in the United States declined. Further the research explored the perceptions of campus safety among faculty and staff at an institution where campus safety initiatives are nationally ranked as exemplary and incidents of…

  18. Integrated Safety Risk Reduction Approach to Enhancing Human-Rated Spaceflight Safety

    NASA Astrophysics Data System (ADS)

    Mikula, J. F. Kip

    2005-12-01

    This paper explores and defines the current accepted concept and philosophy of safety improvement based on a Reliability enhancement (called here Reliability Enhancement Based Safety Theory [REBST]). In this theory a Reliability calculation is used as a measure of the safety achieved on the program. This calculation may be based on a math model or a Fault Tree Analysis (FTA) of the system, or on an Event Tree Analysis (ETA) of the system's operational mission sequence. In each case, the numbers used in this calculation are hardware failure rates gleaned from past similar programs. As part of this paper, a fictional but representative case study is provided that helps to illustrate the problems and inaccuracies of this approach to safety determination. Then a safety determination and enhancement approach based on hazard, worst case analysis, and safety risk determination (called here Worst Case Based Safety Theory [WCBST]) is included. This approach is defined and detailed using the same example case study as shown in the REBST case study. In the end it is concluded that an approach combining the two theories works best to reduce Safety Risk.

  19. Mining hidden knowledge for drug safety assessment: topic modeling of LiverTox as a case study

    PubMed Central

    2014-01-01

    Background Given the significant impact on public health and drug development, drug safety has been a focal point and research emphasis across multiple disciplines in addition to scientific investigation, including consumer advocates, drug developers and regulators. Such a concern and effort has led numerous databases with drug safety information available in the public domain and the majority of them contain substantial textual data. Text mining offers an opportunity to leverage the hidden knowledge within these textual data for the enhanced understanding of drug safety and thus improving public health. Methods In this proof-of-concept study, topic modeling, an unsupervised text mining approach, was performed on the LiverTox database developed by National Institutes of Health (NIH). The LiverTox structured one document per drug that contains multiple sections summarizing clinical information on drug-induced liver injury (DILI). We hypothesized that these documents might contain specific textual patterns that could be used to address key DILI issues. We placed the study on drug-induced acute liver failure (ALF) which was a severe form of DILI with limited treatment options. Results After topic modeling of the "Hepatotoxicity" sections of the LiverTox across 478 drug documents, we identified a hidden topic relevant to Hy's law that was a widely-accepted rule incriminating drugs with high risk of causing ALF in humans. Using this topic, a total of 127 drugs were further implicated, 77 of which had clear ALF relevant terms in the "Outcome and management" sections of the LiverTox. For the rest of 50 drugs, evidence supporting risk of ALF was found for 42 drugs from other public databases. Conclusion In this case study, the knowledge buried in the textual data was extracted for identification of drugs with potential of causing ALF by applying topic modeling to the LiverTox database. The knowledge further guided identification of drugs with the similar potential and most

  20. Mining hidden knowledge for drug safety assessment: topic modeling of LiverTox as a case study.

    PubMed

    Yu, Ke; Zhang, Jie; Chen, Minjun; Xu, Xiaowei; Suzuki, Ayako; Ilic, Katarina; Tong, Weida

    2014-01-01

    Given the significant impact on public health and drug development, drug safety has been a focal point and research emphasis across multiple disciplines in addition to scientific investigation, including consumer advocates, drug developers and regulators. Such a concern and effort has led numerous databases with drug safety information available in the public domain and the majority of them contain substantial textual data. Text mining offers an opportunity to leverage the hidden knowledge within these textual data for the enhanced understanding of drug safety and thus improving public health. In this proof-of-concept study, topic modeling, an unsupervised text mining approach, was performed on the LiverTox database developed by National Institutes of Health (NIH). The LiverTox structured one document per drug that contains multiple sections summarizing clinical information on drug-induced liver injury (DILI). We hypothesized that these documents might contain specific textual patterns that could be used to address key DILI issues. We placed the study on drug-induced acute liver failure (ALF) which was a severe form of DILI with limited treatment options. After topic modeling of the "Hepatotoxicity" sections of the LiverTox across 478 drug documents, we identified a hidden topic relevant to Hy's law that was a widely-accepted rule incriminating drugs with high risk of causing ALF in humans. Using this topic, a total of 127 drugs were further implicated, 77 of which had clear ALF relevant terms in the "Outcome and management" sections of the LiverTox. For the rest of 50 drugs, evidence supporting risk of ALF was found for 42 drugs from other public databases. In this case study, the knowledge buried in the textual data was extracted for identification of drugs with potential of causing ALF by applying topic modeling to the LiverTox database. The knowledge further guided identification of drugs with the similar potential and most of them could be verified and

  1. A General Safety Assessment for Purified Food Ingredients Derived From Biotechnology Crops: Case Study of Brazilian Sugar and Beverages Produced From Insect-Protected Sugarcane.

    PubMed

    Kennedy, Reese D; Cheavegatti-Gianotto, Adriana; de Oliveira, Wladecir S; Lirette, Ronald P; Hjelle, Jerry J

    2018-01-01

    Insect-protected sugarcane that expresses Cry1Ab has been developed in Brazil. Analysis of trade information has shown that effectively all the sugarcane-derived Brazilian exports are raw or refined sugar and ethanol. The fact that raw and refined sugar are highly purified food ingredients, with no detectable transgenic protein, provides an interesting case study of a generalized safety assessment approach. In this study, both the theoretical protein intakes and safety assessments of Cry1Ab, Cry1Ac, NPTII, and Bar proteins used in insect-protected biotechnology crops were examined. The potential consumption of these proteins was examined using local market research data of average added sugar intakes in eight diverse and representative Brazilian raw and refined sugar export markets (Brazil, Canada, China, Indonesia, India, Japan, Russia, and the USA). The average sugar intakes, which ranged from 5.1 g of added sugar/person/day (India) to 126 g sugar/p/day (USA) were used to calculated possible human exposure. The theoretical protein intake estimates were carried out in the "Worst-case" scenario, assumed that 1 μg of newly-expressed protein is detected/g of raw or refined sugar; and the "Reasonable-case" scenario assumed 1 ng protein/g sugar. The "Worst-case" scenario was based on results of detailed studies of sugarcane processing in Brazil that showed that refined sugar contains less than 1 μg of total plant protein /g refined sugar. The "Reasonable-case" scenario was based on assumption that the expression levels in stalk of newly-expressed proteins were less than 0.1% of total stalk protein. Using these calculated protein intake values from the consumption of sugar, along with the accepted NOAEL levels of the four representative proteins we concluded that safety margins for the "Worst-case" scenario ranged from 6.9 × 10 5 to 5.9 × 10 7 and for the "Reasonable-case" scenario ranged from 6.9 × 10 8 to 5.9 × 10 10 . These safety margins are very high due to

  2. How 3 rural safety net clinics integrate care for patients: a qualitative case study.

    PubMed

    Derrett, Sarah; Gunter, Kathryn E; Nocon, Robert S; Quinn, Michael T; Coleman, Katie; Daniel, Donna M; Wagner, Edward H; Chin, Marshall H

    2014-11-01

    Integrated care focuses on care coordination and patient centeredness. Integrated care supports continuity of care over time, with care that is coordinated within and between settings and is responsive to patients' needs. Currently, little is known about care integration for rural patients. To examine challenges to care integration in rural safety net clinics and strategies to address these challenges. Qualitative case study. Thirty-six providers and staff from 3 rural clinics in the Safety Net Medical Home Initiative. Interviews were analyzed using the framework method with themes organized within 3 constructs: Team Coordination and Empanelment, External Coordination and Partnerships, and Patient-centered and Community-centered Care. Participants described challenges common to safety net clinics, including limited access to specialists for Medicaid and uninsured patients, difficulty communicating with external providers, and payment models with limited support for care integration activities. Rurality compounded these challenges. Respondents reported benefits of empanelment and team-based care, and leveraged local resources to support care for patients. Rural clinics diversified roles within teams, shared responsibility for patient care, and colocated providers, as strategies to support care integration. Care integration was supported by 2 fundamental changes to organize and deliver care to patients-(1) empanelment with a designated group of patients being cared for by a provider; and (2) a multidisciplinary team able to address rural issues. New funding and organizational initiatives of the Affordable Care Act may help to further improve care integration, although additional solutions may be necessary to address particular needs of rural communities.

  3. A Safety Case Approach for Deep Geologic Disposal of DOE HLW and DOE SNF in Bedded Salt - 13350

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

    Sevougian, S. David; MacKinnon, Robert J.; Leigh, Christi D.

    2013-07-01

    The primary objective of this study is to investigate the feasibility and utility of developing a defensible safety case for disposal of United States Department of Energy (U.S. DOE) high-level waste (HLW) and DOE spent nuclear fuel (SNF) in a conceptual deep geologic repository that is assumed to be located in a bedded salt formation of the Delaware Basin [1]. A safety case is a formal compilation of evidence, analyses, and arguments that substantiate and demonstrate the safety of a proposed or conceptual repository. We conclude that a strong initial safety case for potential licensing can be readily compiled bymore » capitalizing on the extensive technical basis that exists from prior work on the Waste Isolation Pilot Plant (WIPP), other U.S. repository development programs, and the work published through international efforts in salt repository programs such as in Germany. The potential benefits of developing a safety case include leveraging previous investments in WIPP to reduce future new repository costs, enhancing the ability to effectively plan for a repository and its licensing, and possibly expediting a schedule for a repository. A safety case will provide the necessary structure for organizing and synthesizing existing salt repository science and identifying any issues and gaps pertaining to safe disposal of DOE HLW and DOE SNF in bedded salt. The safety case synthesis will help DOE to plan its future R and D activities for investigating salt disposal using a risk-informed approach that prioritizes test activities that include laboratory, field, and underground investigations. It should be emphasized that the DOE has not made any decisions regarding the disposition of DOE HLW and DOE SNF. Furthermore, the safety case discussed herein is not intended to either site a repository in the Delaware Basin or preclude siting in other media at other locations. Rather, this study simply presents an approach for accelerated development of a safety case for a

  4. Correlated Topics in a Scalable Multidimensional Text Cube: Algorithms and Aviation Safety Case Study

    NASA Technical Reports Server (NTRS)

    Zhao, Bo; Lin, Cindy X.; Srivastava, Ashok N.; Oza, Nikunj C.; Han, Jiawei

    2010-01-01

    As world-wide air traffic continues to grow even at a modest pace, the overall complexity of the system will increase significantly. This increased complexity can lead to a larger number of fatalities per year even if the extremely low fatality rate that we currently enjoy is maintained. One important source of information about the safety of the aviation system is in Aviation Safety Text Reports which are written by members of the flight crew, air traffic controllers, and other parties involved with the aviation system. These anonymized narrative reports contain fixed-field contextual information about the flight but also contain free-form narratives that describe, in the author s own words, the nature of the safety incident and, in many cases, the contributing factors that led to the safety incident. Several thousand such reports are filed each month, each of which is read and analyzed by highly trained experts. However, it is possible that there are emerging safety issues due to the fact that they may be reported very infrequently and in different contexts with different descriptions. The goal of this research paper is to develop correlated topic models which uncover correlations in the subspaces defined by the intersection of numerous fixed fields and discovered correlated topics. This task requires the discovery of latent topics in the text reports and the creation of a topic cube. Furthermore, because the number of potential cells in the topic cube is very large, we discuss novel methods of pruning the search space in the topic cells, thereby making the analysis feasible. We demonstrate the new algorithms on an analysis of pilot fatigue and its contributing factors, as well as the safety incidents that are correlated with this phenomenon.

  5. Lessons learnt from Dental Patient Safety Case Reports

    PubMed Central

    Obadan, Enihomo M.; Ramoni, Rachel B.; Kalenderian, Elsbeth

    2015-01-01

    Background Errors are commonplace in dentistry, it is therefore our imperative as dental professionals to intercept them before they lead to an adverse event, and/or mitigate their effects when an adverse event occurs. This requires a systematic approach at both the profession-level, encapsulated in the Agency for Healthcare Research and Quality’s Patient Safety Initiative structure, as well as at the practice-level, where Crew Resource Management is a tested paradigm. Supporting patient safety at both the dental practice and profession levels relies on understanding the types and causes of errors, an area in which little is known. Methods A retrospective review of dental adverse events reported in the literature was performed. Electronic bibliographic databases were searched and data were extracted on background characteristics, incident description, case characteristics, clinic setting where adverse event originated, phase of patient care that adverse event was detected, proximal cause, type of patient harm, degree of harm and recovery actions. Results 182 publications (containing 270 cases) were identified through our search. Delayed and unnecessary treatment/disease progression after misdiagnosis was the largest type of harm reported. 24.4% of reviewed cases were reported to have experienced permanent harm. One of every ten case reports reviewed (11.1%) reported that the adverse event resulted in the death of the affected patient. Conclusions Published case reports provide a window into understanding the nature and extent of dental adverse events, but for as much as the findings revealed about adverse events, they also identified the need for more broad-based contributions to our collective body of knowledge about adverse events in the dental office and their causes. Practical Implications Siloed and incomplete contributions to our understanding of adverse events in the dental office are threats to dental patients’ safety. PMID:25925524

  6. [Case-control study on accuracy and safety of patient-specific drill-guide templates used in scoliosis cases].

    PubMed

    Zhang, Yu-peng; Shi, Ya-min; Wang, Hua-dong; Hou, Shu-xun

    2015-10-01

    To evaluate the accuracy and safety of pedicle screw insertion with the aid of novel patient-specific drill-guide templates in scoliosis cases. Ten patients with scoliosis were selected to participate in the research (the observation group) from December 2013 to December 2014. The data was obtained from CT scanning, and put into the computer to perform reconstruction of spine, simulation of pedicle screw insertion, and design of patient-specific drill-guide templates with software. The templates were made with rapid prototyping technique. After sterilization, the templates were used to aid the pedicle screw insertion intraoperatively. The blood loss, operation duration, change of creatinine level pre- and post-operation, and complications related to pedicle screw insertion were recorded. The location of pedicle screws were graded so as to evaluate the accuracy. A comparative study was then performed with the data of ten scoliosis cases operated with free-hand method during the same period (control group). There were 5 cases of idiopathic scoliosis and 5 cases of congenital scoliosis in the observation group, including 3 males and 7 females. Their average age was 11.9 years old (ranged, 4 to 18 years old), and the average Cobb angle of main curve was 54.9° (ranged, 42.1° to 78.4°). There were also 5 cases of idiopathic scoliosis and 5 cases of congenital scoliosis in the control group,including 2 males and 8 females. Their average age was 12.6 years old (ranged, 6 to 17 years old), and the average Cobb angle of main curve was 56.6° (ranged, 38.2° to 93.4°). A total of 167 pedicle screws were inserted intraoperatively, with 138 screws (82.6%) in grade I, 26 screws (15.0%) in grade II, 4 screws in grade III (2.4%), but no screws in grade IV according to the CT image. There were 29 (17.4%) screws perforated, and 163 (97.6%) screws could be accepted. In the control group, a total of 165 pedicle screws were inserted intraoperatively, with 98 screws (59.4%) in grade

  7. Receptionist input to quality and safety in repeat prescribing in UK general practice: ethnographic case study.

    PubMed

    Swinglehurst, Deborah; Greenhalgh, Trisha; Russell, Jill; Myall, Michelle

    2011-11-03

    To describe, explore, and compare organisational routines for repeat prescribing in general practice to identify contributors and barriers to safety and quality. Ethnographic case study. Four urban UK general practices with diverse organisational characteristics using electronic patient records that supported semi-automation of repeat prescribing. 395 hours of ethnographic observation of staff (25 doctors, 16 nurses, 4 healthcare assistants, 6 managers, and 56 reception or administrative staff), and 28 documents and other artefacts relating to repeat prescribing locally and nationally. Potential threats to patient safety and characteristics of good practice. Observation of how doctors, receptionists, and other administrative staff contributed to, and collaborated on, the repeat prescribing routine. Analysis included mapping prescribing routines, building a rich description of organisational practices, and drawing these together through narrative synthesis. This was informed by a sociological model of how organisational routines shape and are shaped by information and communications technologies. Results Repeat prescribing was a complex, technology-supported social practice requiring collaboration between clinical and administrative staff, with important implications for patient safety. More than half of requests for repeat prescriptions were classed as "exceptions" by receptionists (most commonly because the drug, dose, or timing differed from what was on the electronic repeat list). They managed these exceptions by making situated judgments that enabled them (sometimes but not always) to bridge the gap between the idealised assumptions about tasks, roles, and interactions that were built into the electronic patient record and formal protocols, and the actual repeat prescribing routine as it played out in practice. This work was creative and demanded both explicit and tacit knowledge. Clinicians were often unaware of this input and it did not feature in policy

  8. Evaluating performance of a Lead Road Safety Agency (LRSA) in a low-income country: a case study from Pakistan.

    PubMed

    Bhatti, Junaid A; Ahmed, Aizaz

    2014-01-01

    The World Health Organization recommends identifying a Lead Road Safety Agency (LRSA) within the government to coordinate preventive interventions. As LRSAs in developing countries have rarely been evaluated, this case study describes the performance of the LRSA of Pakistan with respect to the World Bank criteria. The designated LRSA, the National Road Safety Secretariat, was put into operation in 2006 and worked for about two years with World Bank funding. The agency had a stand-alone structure headed by an experienced road safety specialist during the first year only and faced difficulty in recruiting other required experts. The LRSA drafted the first National Road Safety Plan, including strategic review of road safety and existing legislation, articulated multisectorial collaboration nationally and provincially, and collected traffic injury data in some districts. Its progress was halted by its dissolution because of funding problems. Currently, two agencies specialising in traffic enforcement and transport research respectively are fulfilling LRSA functions on an ad-hoc basis. Results suggest that sustainability and consistency of LRSAs in developing countries like Pakistan may only be ensured if they are legally protected, inter-ministerial, have permanent funding and are provided with the required expertise through international cooperation, so they can perform their required functions effectively.

  9. Efficacy and safety of oral CDP-choline. Drug surveillance study in 2817 cases.

    PubMed

    Lozano Fernández, R

    1983-01-01

    A drug surveillance study has been carried out with oral cytidine diphosphate choline (CDP-choline, citicoline, Somazina) in 2817 patients of all ages, predominating those between 60 and 80 years old. They were suffering from several neurological processes, mainly the vasculocerebral insufficiency and senile involution. Treatment was carried out for between 15 days and 2 months, the mean dose being 6 ml/d. The efficacy of the treatment was determined on the basis of the disappearance, improvement or worsening of clinical manifestations, most frequently shown by patients. The most benefited clinical manifestations by the treatment were: dizziness disappearing in 48.4% of the cases, and improving in 25.2%, cephalea disappearing in 46.5% and improving in 26.7%, insomnia with 38.6% and 24.9%, respectively; depression with 36.9% and 24.1% and memory shortage with 21.2% and 44.7% respectively. The best results were obtained in chronic cerebrovascular insufficiency, the improvements obtained in dizziness, cephalea, insomnia, fatigue and speech troubles being the most important. The safety of the drug was excellent since side effects were observed only in 5.01% of the patients. Among these effects, the most frequently seen were digestive troubles, observed in 3.6% of the cases.

  10. Implications of case managers' perceptions and attitude on safety of home-delivered care.

    PubMed

    Jones, Sarahjane

    2015-12-01

    Perceptions on safety in community care have been relatively unexplored. A project that sought to understand the multiple perspectives on safety in the NHS case-management programme was carried out in relation to the structure, process, and outcome of care. This article presents a component of the nursing perspective that highlights an important element in the structure of nursing care that could potentially impede the nurses' ability to be fully effective and safe. A single case study of the case-management programme was undertaken. Three primary care organisations from three strategic health authorities participated, and three focus groups were conducted (one within each organisation). In total, 17 case management nurses participated. Data were audiotaped and transcribed verbatim and subjected to framework analysis. Nursing staff attitudes were identified as a structure of care that influence safety outcomes, particularly their perceptions of the care setting and the implications it has on their role and patient behaviour. Greater understanding of the expected role of the community nurse is necessary, and relevant training is required for nurses to be successful in empowering patients to perform more safely. In addition, efforts need to be made to improve patients' trust in the health-care system to prevent harm and promote more effective utilisation of resources.

  11. Violence and School Safety. Case Citations, 2002.

    ERIC Educational Resources Information Center

    Russo, Charles J., Ed.; Mawdsley, Ralph D., Ed.

    This publication highlights and explains some 400 court cases from 2002 involving issues of school violence and safety. It is divided into four sections, or topics: (1) "The Fourth Amendment: Search and Seizure" (R. Mawdsley); (2) "Negligence" (W. Evans, Jr.); (3) "Assault on School Personnel" (M. Yates); and (4) "Drugs and Weapons in Schools" (M.…

  12. Influence of professional drivers' personality traits on road traffic safety: case study.

    PubMed

    Živković, Snežana; Nikolić, Vesna; Markič, Mirko

    2015-01-01

    The purpose of this paper is to present basic elements of the research directed at identifying and determining the personality traits of professional drivers that affect safe, secure and enjoyable ride on public roads. A quantitative method has been used here, whereas data were acquired from a questionnaire based on a sample of 59 professional drivers. Determining personality traits of professional drivers that are in correlation with a safe and pleasant ride on the roads has been enabled by applying the five-factor model of personality ('Big Five') and the Personality Inventory NEO-PI. From these results it was concluded that safe operation of the vehicle in traffic involves the successful 'conduct' of oneself, which recognises the importance of certain personality traits of professional drivers for traffic safety and the need for appropriate professional selection in the case of employment of professional drivers. Research results implicate development of educational programmes aimed at achieving harmony of psychological, physical and sensory health, that is, programmes for permanent informing, educating and training professional drivers for defensive driving. The research opens the way for new research tasks that should help in creating a specific structure of curricula that can be used in a variety of transportation companies and enterprises to improve general and public safety.

  13. Safety Risk Knowledge Elicitation in Support of Aeronautical R and D Portfolio Management: A Case Study

    NASA Technical Reports Server (NTRS)

    Shih, Ann T.; Ancel, Ersin; Jones, Sharon Monica; Reveley, Mary S.; Luxhoj, James T.

    2012-01-01

    Aviation is a problem domain characterized by a high level of system complexity and uncertainty. Safety risk analysis in such a domain is especially challenging given the multitude of operations and diverse stakeholders. The Federal Aviation Administration (FAA) projects that by 2025 air traffic will increase by more than 50 percent with 1.1 billion passengers a year and more than 85,000 flights every 24 hours contributing to further delays and congestion in the sky (Circelli, 2011). This increased system complexity necessitates the application of structured safety risk analysis methods to understand and eliminate where possible, reduce, and/or mitigate risk factors. The use of expert judgments for probabilistic safety analysis in such a complex domain is necessary especially when evaluating the projected impact of future technologies, capabilities, and procedures for which current operational data may be scarce. Management of an R&D product portfolio in such a dynamic domain needs a systematic process to elicit these expert judgments, process modeling results, perform sensitivity analyses, and efficiently communicate the modeling results to decision makers. In this paper a case study focusing on the application of an R&D portfolio of aeronautical products intended to mitigate aircraft Loss of Control (LOC) accidents is presented. In particular, the knowledge elicitation process with three subject matter experts who contributed to the safety risk model is emphasized. The application and refinement of a verbal-numerical scale for conditional probability elicitation in a Bayesian Belief Network (BBN) is discussed. The preliminary findings from this initial step of a three-part elicitation are important to project management practitioners as they illustrate the vital contribution of systematic knowledge elicitation in complex domains.

  14. Comparative Case Studies Of Corridor Safety Improvement Efforts

    DOT National Transportation Integrated Search

    1999-12-01

    In 1988, following a series of fatal crashes on U.S. Route 322, Pennsylvania's governor directed Pennsylvania's secretary of transportation to develop immediate, short-term measures to improve safety on the roadway. In response, the Pennsylvania Depa...

  15. Alternative perspectives of safety in home delivered health care: a sequential exploratory mixed method study.

    PubMed

    Jones, Sarahjane

    2016-10-01

    The aim of this study was to discover and describe how patients, carers and case management nurses define safety and compare it to the traditional risk reduction and harm avoidance definition of safety. Care services are increasingly being delivered in the home for patients with complex long-term conditions. However, the concept of safety remains largely unexplored. A sequential, exploratory mixed method design. A qualitative case study of the UK National Health Service case management programme in the English UK National Health Service was deployed during 2012. Thirteen interviews were conducted with patients (n = 9) and carers (n = 6) and three focus groups with nurses (n = 17) from three community care providers. The qualitative element explored the definition of safety. Data were subjected to framework analysis and themes were identified by participant group. Sequentially, a cross-sectional survey was conducted during 2013 in a fourth community care provider (patient n = 35, carer n = 19, nurse n = 26) as a form of triangulation. Patients and carers describe safety differently to case management nurses, choosing to focus on meeting needs. They use more positive language and recognize the role they have in safety in home-delivered health care. In comparison, case management nurses described safety similarly to the definitions found in the literature. However, when offered the patient and carer definition of safety, they preferentially selected this definition to their own or the literature definition. Patients and carers offer an alternative perspective on patient safety in home-delivered health care that identifies their role in ensuring safety and is more closely aligned with the empowerment philosophy of case management. © 2016 John Wiley & Sons Ltd.

  16. Receptionist input to quality and safety in repeat prescribing in UK general practice: ethnographic case study

    PubMed Central

    Greenhalgh, Trisha; Russell, Jill; Myall, Michelle

    2011-01-01

    Objective To describe, explore, and compare organisational routines for repeat prescribing in general practice to identify contributors and barriers to safety and quality. Design Ethnographic case study. Setting Four urban UK general practices with diverse organisational characteristics using electronic patient records that supported semi-automation of repeat prescribing. Participants 395 hours of ethnographic observation of staff (25 doctors, 16 nurses, 4 healthcare assistants, 6 managers, and 56 reception or administrative staff), and 28 documents and other artefacts relating to repeat prescribing locally and nationally. Main outcome measures Potential threats to patient safety and characteristics of good practice. Methods Observation of how doctors, receptionists, and other administrative staff contributed to, and collaborated on, the repeat prescribing routine. Analysis included mapping prescribing routines, building a rich description of organisational practices, and drawing these together through narrative synthesis. This was informed by a sociological model of how organisational routines shape and are shaped by information and communications technologies. Results Repeat prescribing was a complex, technology-supported social practice requiring collaboration between clinical and administrative staff, with important implications for patient safety. More than half of requests for repeat prescriptions were classed as “exceptions” by receptionists (most commonly because the drug, dose, or timing differed from what was on the electronic repeat list). They managed these exceptions by making situated judgments that enabled them (sometimes but not always) to bridge the gap between the idealised assumptions about tasks, roles, and interactions that were built into the electronic patient record and formal protocols, and the actual repeat prescribing routine as it played out in practice. This work was creative and demanded both explicit and tacit knowledge

  17. Making a Case for Organizational Change in Patient Safety Initiatives

    DTIC Science & Technology

    2005-05-01

    or medical staff could be required to directly observe patient care processes. Such firsthand encounters with process flaws are particularly...can actually make patient safety worse. Take, for example, the previously described situation where nurses stopped reporting when the medication ...455 Making a Case for Organizational Change in Patient Safety Initiatives Rangaraj Ramanujam, Donna J. Keyser, Carl A. Sirio Abstract

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

    PubMed

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

    2008-04-01

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

  19. Exploiting heterogeneous publicly available data sources for drug safety surveillance: computational framework and case studies.

    PubMed

    Koutkias, Vassilis G; Lillo-Le Louët, Agnès; Jaulent, Marie-Christine

    2017-02-01

    Driven by the need of pharmacovigilance centres and companies to routinely collect and review all available data about adverse drug reactions (ADRs) and adverse events of interest, we introduce and validate a computational framework exploiting dominant as well as emerging publicly available data sources for drug safety surveillance. Our approach relies on appropriate query formulation for data acquisition and subsequent filtering, transformation and joint visualization of the obtained data. We acquired data from the FDA Adverse Event Reporting System (FAERS), PubMed and Twitter. In order to assess the validity and the robustness of the approach, we elaborated on two important case studies, namely, clozapine-induced cardiomyopathy/myocarditis versus haloperidol-induced cardiomyopathy/myocarditis, and apixaban-induced cerebral hemorrhage. The analysis of the obtained data provided interesting insights (identification of potential patient and health-care professional experiences regarding ADRs in Twitter, information/arguments against an ADR existence across all sources), while illustrating the benefits (complementing data from multiple sources to strengthen/confirm evidence) and the underlying challenges (selecting search terms, data presentation) of exploiting heterogeneous information sources, thereby advocating the need for the proposed framework. This work contributes in establishing a continuous learning system for drug safety surveillance by exploiting heterogeneous publicly available data sources via appropriate support tools.

  20. Safety sign designs for children by considering effect of the colors preferences: A case study

    NASA Astrophysics Data System (ADS)

    Iftadi, Irwan; Nugraha, Dian Cahya; Jauhari, Wakhid Ahmad

    2018-02-01

    Color has become a major consideration in ergonomics. Color conveys a message and it is an important element in safety signs. The importance of colors usage in safety sign designs makes the colors research into one of the things that must be done before designing them. So far, research in the related field only focused on the adult's perspective without involving children's perspective in designing the safety signs. This paper aims to find out how children's perception towards colors affects the safety sign designs. This study consist of eight sections which are literature study, direct observation, determining referents and other parameters, determining research respondents, making the booklet, assessing the colors preferences, determining the design's parameter value and creating the safety sign designs. Limitation of the research are the objects are the students with the age of 10 - 11 years old in Grade IV and then the research is conducted in the school day and hours that apply to the school. Chi square test and odds ratio are employed to assess the colors preferences. Twelve safety sign designs are proposed by considering the children's colors perception. The designs are grouped into three types of sign which are Mandatory Action Sign, Warning Sign and Prohibition Sign. Six colors are used to draw the safety signs i.e. red, orange, yellow, green, blue and black. On the basis of the study, it is concluded that the colors that often appears in safety signs is green with the percentage of 75% and that rarely appears is red with the percentage of 8.33%.

  1. A systematic review of occupational safety and health business cases.

    PubMed

    Verbeek, Jos; Pulliainen, Marjo; Kankaanpää, Eila

    2009-12-01

    Business cases are commonly developed as means to rationalize investment. We systematically reviewed 26 reported cases on occupational safety and health (OSH) interventions to assess if health and productivity arguments make a good business case. To be included in the review, studies had to analyze the costs and benefits, including productivity, of an OSH intervention at the enterprise level. We searched Medline and Embase for studies and used Google search in addition. Two reviewers independently selected studies and extracted data. The intervention profitability was calculated in euros (euro in 2008) as the first year's benefits minus the total intervention costs per worker. The payback period was calculated as the intervention costs divided by the first year's benefits. We found three ex-ante and 23 ex-post cases. In 20 cases, the study design was a before-after comparison without a control group. Generally a 100% reduction of injuries or sickness absence was assumed. In two cases, productivity and quality increases were very large. The main benefit was avoided sick leave. Depreciation or discounting was applied only in a minority of cases. The intervention profitability was negative in seven studies, up to euro 500 per employee in 12 studies and more than euro 500 per employee in seven studies. The payback period was less than half a year for 19 studies. Only a few studies included sensitivity analyses. Few ex-ante business cases for management decisions on OSH are reported. Guidelines for reporting and evaluation are needed. Business cases need more sound assumptions on the effectiveness of interventions and should incorporate greater uncertainty into their design. Ex-post evaluation should be based preferably on study designs that control for trends at a time different from that of the intervention.

  2. Safety Case Notations: Alternatives for the Non-Graphically Inclined?

    NASA Technical Reports Server (NTRS)

    Holloway, C. M.

    2008-01-01

    This working paper presents preliminary ideas of five possible text-based notations for representing safety cases, which may be easier for non-graphically inclined people to use and understand than the currently popular graphics-based representations.

  3. Safety of Silicone Oil Removal in Cases of Gunshot Perforating Eye Injuries.

    PubMed

    Ghoraba, Hammouda Hamdy; Elgouhary, Sameh Mohamed; Mansour, Hosam Osman; Abdel-Fattah, Hitham Mamoun; Heikal, Mohamed Amin; Elgemaey, Emad Mohamed

    2017-03-01

    To evaluate the feasibility and safety of silicone oil (SO) removal in cases of gunshot perforating eye injuries (PEI). A retrospective, consecutive, interventional study from medical records regarding cases of gunshot PEI during the periods of Egyptian political instability (January 2011 until December 2013). The main outcomes were to evaluate the feasibility of SO removal in cases of gunshot PEI and management of retinal detachment (RD) after SO removal in such cases. One hundred ninety-six eyes of 193 patients were reviewed. SO was removed in 72 eyes of 70 patients (36.7%). After SO removal, five eyes (6.9%) developed RD. One case refused any other intervention. RD in the remaining four cases was treated with revision surgery and SO reinjection. The retina remained stable throughout follow-up. None of the eyes developed phthisis bulbi after SO removal. Mean follow-up after SO removal was 10.86 months (range: 3 months to 30 months). Mean follow-up after management of RD after SO removal was 17.7 months (range: 13 months to 21 months). Patients aged younger than 20 years were associated with extensive fibrous proliferation, which might affect the safety profile of SO removal in cases of gunshot PEI. Rate of RD after SO removal in cases of apparent retinal stability and localized fibrous proliferation was 6.9%. Retinal detachment after SO removal in such cases can be treated with revision surgery and SO reinjection. [Ophthalmic Surg Lasers Imaging Retina. 2017;48:242-250.]. Copyright 2017, SLACK Incorporated.

  4. Safety Case Patterns: Theory and Applications

    NASA Technical Reports Server (NTRS)

    Denney, Ewen W.; Pai, Ganesh J.

    2015-01-01

    We develop the foundations for a theory of patterns of safety case argument structures, clarifying the concepts involved in pattern specification, including choices, labeling, and well-founded recursion. We specify six new patterns in addition to those existing in the literature. We give a generic way to specify the data required to instantiate patterns and a generic algorithm for their instantiation. This generalizes earlier work on generating argument fragments from requirements tables. We describe an implementation of these concepts in AdvoCATE, the Assurance Case Automation Toolset, showing how patterns are defined and can be instantiated. In particular, we describe how our extended notion of patterns can be specified, how they can be instantiated in an interactive manner, and, finally, how they can be automatically instantiated using our algorithm.

  5. Commuter Train Passenger Safety Model Using Positive Behavior Approach: The Case Study in Suburban Area

    NASA Astrophysics Data System (ADS)

    Suryanto, D. A.; Adisasmita, S. A.; Hamid, S.; Hustim, M.

    2018-04-01

    Currently, Train passanger safety measures are more predominantly measurable using negative dimensions in user mode behavior, such as accident rate, accident intensity and accident impact. This condition suggests that safety improvements aim only to reduce accidents. Therefore, this study aims to measure the safety level of light train transit modes (KRL) through the dimensions of traveling safety on commuters based on positive safety indicators with severel condition departure times and returns for work purposes and long trip rates above KRL. The primary survey were used in data collection methods. Structural Equation Modeling (SEM) were used in data analysis. The results show that there are different models of the safety level of departure and return journey. The highest difference is in the security dimension which is the internal variable of KRL users.

  6. Crude versus case-mix-adjusted control charts for safety monitoring in thyroid surgery.

    PubMed

    Duclos, Antoine; Voirin, Nicolas; Touzet, Sandrine; Soardo, Pietro; Schott, Anne-Marie; Colin, Cyrille; Peix, Jean-Louis; Lifante, Jean-Christophe

    2010-12-01

    Patient-safety monitoring based on health-outcome indicators can lead to misinterpretation of changes in case mix. This study aimed to compare the detection of indicator variations between crude and case-mix-adjusted control charts using data from thyroid surgeries. The study population included each patient who underwent thyroid surgery in a teaching hospital from January 2006 to May 2008. Patient safety was monitored according to two indicators, which are immediately recognisable postoperative complications: recurrent laryngeal nerve palsy and hypocalcaemia. Each indicator was plotted monthly on a p-control chart using exact limits. The weighted κ statistic was calculated to measure the agreement between crude and case-mix-adjusted control charts. We evaluated the outcomes of 1405 thyroidectomies. The overall proportions of immediate recurrent laryngeal nerve palsy and hypocalcaemia were 7.4% and 20.5%, respectively. The proportion of agreement in the detection of indicator variations between the crude and case-mix-adjusted p-charts was 95% (95% CI 85% to 99%). The strength of the agreement was κ = 0.76 (95% CI 0.54 to 0.98). The single special cause of variation that occurred was only detected by the case-mix-adjusted p-chart. There was good agreement in the detection of indicator variations between crude and case-mix-adjusted p-charts. The joint use of crude and adjusted charts seems to be a reasonable approach to increase the accuracy of interpretation of variations in outcome indicators.

  7. [Effectiveness and safety of oxcarbazepine in chronic neuropathic pain: a study of 40 cases].

    PubMed

    Fenollosa-Vázquez, P; Canós-Verdecho, M A; Núñez-Cornejo, C; Pallarés-Delgado, J

    Neuropathic pain (NP) often fails to respond to the commonly established analgesic treatment. This fact, together with the existence of side effects, has led to the need to evaluate the analgesic effectiveness of antiepileptic drugs, which, as in the case of oxcarbazepine (OXC), are a valid alternative. The aim of this study was to evaluate the effectiveness and safety of OXC in patients suffering from chronic NP. We conducted a prospective, open study involving a series of 40 patients diagnosed with a long history of NP, which was previously resistant to different kinds of treatment with anticonvulsants, non-steroidal anti-inflammatory (NSAI) drugs, opiates and adjuncts. Patients were treated with OXC and they were evaluated in both the basal (prior to treatment) and final visits (after treatment) by means of the visual analogue scale (VAS), SF-McGill questionnaire and the Lattinen test. The patient's general impression of the result was also obtained. The statistical analysis was performed by calculating the "effect size", by computing Cohen's d. Treatment with OXC diminishes different symptomatic variations of this pain, but especially so in the case of lancinating discharges (d = 0.87, important effect) and burning pain (d = 0.60, moderate-important effect), although the allodynia (d = 0.48, moderate effect) also improved with treatment. In the opinion of the patients themselves, response to treatment was good or very good in 50% of cases. The chief side effects observed were dizziness, drowsiness and abdominal upsets. OXC can be seen as a therapeutic alternative to be taken very much into account in patients with NP having different aetiologies; it has a good benefit-risk ratio and is a form of treatment that is well accepted by patients.

  8. Bias correction of risk estimates in vaccine safety studies with rare adverse events using a self-controlled case series design.

    PubMed

    Zeng, Chan; Newcomer, Sophia R; Glanz, Jason M; Shoup, Jo Ann; Daley, Matthew F; Hambidge, Simon J; Xu, Stanley

    2013-12-15

    The self-controlled case series (SCCS) method is often used to examine the temporal association between vaccination and adverse events using only data from patients who experienced such events. Conditional Poisson regression models are used to estimate incidence rate ratios, and these models perform well with large or medium-sized case samples. However, in some vaccine safety studies, the adverse events studied are rare and the maximum likelihood estimates may be biased. Several bias correction methods have been examined in case-control studies using conditional logistic regression, but none of these methods have been evaluated in studies using the SCCS design. In this study, we used simulations to evaluate 2 bias correction approaches-the Firth penalized maximum likelihood method and Cordeiro and McCullagh's bias reduction after maximum likelihood estimation-with small sample sizes in studies using the SCCS design. The simulations showed that the bias under the SCCS design with a small number of cases can be large and is also sensitive to a short risk period. The Firth correction method provides finite and less biased estimates than the maximum likelihood method and Cordeiro and McCullagh's method. However, limitations still exist when the risk period in the SCCS design is short relative to the entire observation period.

  9. Using practical ergonomic evaluations in the restaurant industry to enhance safety and comfort: a case study.

    PubMed

    Gentzler, Marc D; Smither, Janan A

    2012-01-01

    Restaurant employees must deal with loud noise, busy environments, difficult customers, heavy, awkward, sharp, and hot objects, repetitive motions, and stress on various joints, all of which can lead to fatigue, sudden accidents, and longterm musculoskeletal injury. The goal of this case study was to assess the risk of injuries and accidents from conducting various tasks in the restaurant, specifically carrying/lifting, table management, and polishing silverware. The nine participants were servers at a local country club restaurant. Physical workload was measured by a scale of physical exertion. Cognitive workload was assessed, as well as cumulative trauma disorder risk. Overall results show that there is sufficient risk in some of the tasks to warrant concern. Specific results are discussed, as well as recommendations for improved safety.

  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. 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.

  12. The effect of safety initiatives on safety performance: a longitudinal study.

    PubMed

    Hoonakker, Peter; Loushine, Todd; Carayon, Pascale; Kallman, James; Kapp, Andrew; Smith, Michael J

    2005-07-01

    Construction industry is one of the most dangerous industries, not only in the USA, but worldwide. In this longitudinal study we examined the effects of safety initiatives on the safety performance of construction companies. One of the measures commonly used in the USA to track a company's safety performance is the experience modification rate (EMR). The EMR is based on the company's safety records (injury claims) from the past three full years and is used to calculate the workers' compensation insurance premiums. In a longitudinal study, we studied the effects of safety efforts and initiatives on the EMR. The results show that safety initiatives and money spent on safety do improve safety performance, but only over time.

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

    PubMed

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

    2016-05-03

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

  14. How to reduce your inventory: a real world case study.

    PubMed

    Mack, J A; Jordan, H H

    1994-08-01

    This case study describes the use of a performance analysis system at the Safety Products Division of Mine Safety Appliances Company, which contributed to the reduction of excess inventories by more than $8,000,000 during the first two years of implementation.

  15. Impact of individual resilience and safety climate on safety performance and psychological stress of construction workers: A case study of the Ontario construction industry.

    PubMed

    Chen, Yuting; McCabe, Brenda; Hyatt, Douglas

    2017-06-01

    The construction industry has hit a plateau in terms of safety performance. Safety climate is regarded as a leading indicator of safety performance; however, relatively little safety climate research has been done in the Canadian construction industry. Safety climate may be geographically sensitive, thus it is necessary to examine how the construct of safety climate is defined and used to improve safety performance in different regions. On the other hand, more and more attention has been paid to job related stress in the construction industry. Previous research proposed that individual resilience may be associated with a better safety performance and may help employees manage stress. Unfortunately, few empirical research studies have examined this hypothesis. This paper aims to examine the role of safety climate and individual resilience in safety performance and job stress in the Canadian construction industry. The research was based on 837 surveys collected in Ontario between June 2015 and June 2016. Structural equation modeling (SEM) techniques were used to explore the impact of individual resilience and safety climate on physical safety outcomes and on psychological stress among construction workers. The results show that safety climate not only affected construction workers' safety performance but also indirectly affected their psychological stress. In addition, it was found that individual resilience had a direct negative impact on psychological stress but had no impact on physical safety outcomes. These findings highlight the roles of both organizational and individual factors in individual safety performance and in psychological well-being. Construction organizations need to not only monitor employees' safety performance, but also to assess their employees' psychological well-being. Promoting a positive safety climate together with developing training programs focusing on improving employees' psychological health - especially post-trauma psychological

  16. Safety Challenges and Improvement Strategies of Ethnic Minority Construction Workers: A Case Study in Hong Kong.

    PubMed

    Wu, Chunlin; Luo, Xiaowei; Wang, Tao; Wang, Yue; Sapkota, Bibek

    2018-04-18

    Due to cultural differences, ethnic minority construction workers are more difficult to manage and more vulnerable to accidents. This study aims to identify the major barriers faced by ethnic minority workers from their own perspectives and determine potential strategies to enhance safety climate of construction projects, thus ultimately improve their safety performance. A survey with modified Nordic safety climate questionnaire was conducted in a certain sub-contractor in Hong Kong. In-depth interviews, status quo description, major challenge investigation and safety knowledge tests were carried as well. The top three most important safety challenges identified are improper stereotypes from the whole industry, lack of opportunities for job assignment, and language barriers. To improve the safety performance, employers should allocate sufficient personal protective equipment and governments should organize unannounced site visits more frequently. Besides, the higher-level management should avoid giving contradictory instructions to foremen against to the standards of supervisors.

  17. Medication safety research by observational study design.

    PubMed

    Lao, Kim S J; Chui, Celine S L; Man, Kenneth K C; Lau, Wallis C Y; Chan, Esther W; Wong, Ian C K

    2016-06-01

    Observational studies have been recognised to be essential for investigating the safety profile of medications. Numerous observational studies have been conducted on the platform of large population databases, which provide adequate sample size and follow-up length to detect infrequent and/or delayed clinical outcomes. Cohort and case-control are well-accepted traditional methodologies for hypothesis testing, while within-individual study designs are developing and evolving, addressing previous known methodological limitations to reduce confounding and bias. Respective examples of observational studies of different study designs using medical databases are shown. Methodology characteristics, study assumptions, strengths and weaknesses of each method are discussed in this review.

  18. The reduction of a ""safety catastrophic'' potential hazard: A case history

    NASA Technical Reports Server (NTRS)

    Jones, J. P.

    1971-01-01

    A worst case analysis is reported on the safety of time watch movements for triggering explosive packages on the lunar surface in an experiment to investigate physical lunar structural characteristics through induced seismic energy waves. Considered are the combined effects of low pressure, low temperature, lunar gravity, gear train error, and position. Control measures constitute a seal control cavity and design requirements to prevent overbanking in the mainspring torque curve. Thus, the potential hazard is reduced to safety negligible.

  19. 75 FR 15485 - Pipeline Safety: Workshop on Guidelines for Integrity Assessment of Cased Pipe

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-29

    ... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket ID...: Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT. ACTION: Notice of workshop. SUMMARY... ``Guidelines for Integrity Assessment of Cased Pipe in Gas Transmission Pipelines'' and related Frequently...

  20. Local food protection and safety infrastructure and capacity: a Maryland case study.

    PubMed

    Kufel, Joanna Zablotsky; Resnick, Beth A; Fox, Mary; Frattaroli, Shannon; Gielen, Andrea; Burke, Thomas A

    2011-01-01

    In Maryland, county Food Protection Programs (FPP), housed within Environmental Public Health (EPH) Divisions, maintain responsibility for regular inspection of all food service facilities (FSF). With growing concerns about how our food supply is protected, it is important to determine the state and effectiveness of our food safety systems. This research elucidates the roles, responsibilities, strengths, and weaknesses of Food Safety and Protection Programs in Maryland. A 16-question survey tool, which addressed facets of the local food protection infrastructure, including FSF inspections, staffing, budget, and foodborne illness surveillance, was distributed to all 24 county FPP. The number of FSF in Maryland increased 97% from 2001 to 2006 and counties had an average inspection completion rate of 73%, with a 4% increase over the time period. Statewide, there were 4.1 EPH full-time employees (FTE) per 10 000 population and 1.6 FPP FTE per 10 000 population. EPH Division budgets increased 63% statewide, from $19.5 million in 2000 to $31.9 million in 2007. FPP budgets also increased 59% over the period, from $6.2 million in 2000 to $9.8 million in 2007. This study offers new quantitative measures of the demands, capacities, and performance of Food Protection and Safety Programs in Maryland. This assessment of local EPH and FPP capacity also offers insight into the strengths and weaknesses of the local food protection and safety infrastructure. Importantly, it reveals an infrastructure and dedicated food protection workforce that inspects the food supply and responds to foodborne illness outbreaks. Yet, resources vary substantially from county to county, impacting which services can be provided and how well they can be performed. This can, in turn, impact the potential risk of foodborne illness and the public's overall health.

  1. Postmarketing Safety Surveillance and Reevaluation of Danhong Injection: Clinical Study of 30888 Cases

    PubMed Central

    Li, Xue-Lin; Tang, Jin-Fa; Li, Wei-Xia; Li, Chun-Xiao; Zhao, Tao; Zhao, Bu-Chang; Wang, Yong; Zhang, Hui; Chen, Xiao-Fei; Xu, Tao; Zhu, Ming-Jun

    2015-01-01

    Traditional Chinese medicine injections (TCMIs) have played an irreplaceable role for treating some clinical emergency, severe illness, and infectious diseases in China. In recent years, the incidence rates of adverse drug reactions (ADRs) of TCMIs have increased year by year. Danhong injection (DHI) is one representative TCMI comprised of Danshen and Honghua for treating cardiovascular and cerebrovascular diseases in clinic. In present study, the postmarketing safety surveillance and reevaluation of DHI were reported. Total 30888 patients in 37 hospitals from 6 provinces participated in the study. The results showed that the ADR incidence rate of DHI was 3.50‰. Seventeen kinds of new adverse reactions of DHI were found. The main type of ADRs of DHI was type A (including sweating, dizziness, headache, flushing, vasodilation, eye hemorrhage, faintness, chest pain, palpitations, breathlessness, anxious, nausea, flatulence, vomiting, hypotension, hypertension, local numbness, dyspnea, joint disease, and tinnitus) accounting for 57.75%. The severities of most ADRs of DHI were mild and moderate reactions accounting for 25.93% and 66.67%, respectively. The main disposition of ADRs of DHI was drug withdrawal and without any treatments. The results can provide basis for amendment and improvement of the instructions of DHI, as well as demonstration and reference for the postmarketing safety surveillance and reevaluation of other TCMIs. And the rationality, scientificity, and safety of clinical applications of TCMIs could be improved. PMID:26508981

  2. Safety Education and Science.

    ERIC Educational Resources Information Center

    Ralph, Richard

    1980-01-01

    Safety education in the science classroom is discussed, including the beginning of safe management, attitudes toward safety education, laboratory assistants, chemical and health regulation, safety aids, and a case study of a high school science laboratory. Suggestions for safety codes for science teachers, student behavior, and laboratory…

  3. The Drug Safety and Risk Management Advisory Committee: a case study of meeting frequency, content, and outcomes before and after FDAAA.

    PubMed

    Morrato, Elaine H; Ling, Sarah B

    2012-11-01

    The Food and Drug Administration Amendments Act (FDAAA) of 2007 granted FDA-expanded drug safety authority. We hypothesized that meetings involving the FDA Drug Safety and Risk Management (DSaRM) Advisory Committee might serve as a barometer for the impact of FDAAA on drug safety regulatory decision making. We conducted a case study analysis of 42 DSaRM advisory committee meetings held between 2002 and 2011. Publicly available sources (FDA meeting minutes and materials, safety alerts, and drug manufacturer Web sites) were reviewed to describe and compare DSaRM meeting frequency, content and outcomes between the pre-FDAAA (2002-2007) and post-FDAAA (2008-2011) periods. DSaRM meeting frequency increased after FDAAA (from 2.7 to 6.5 meetings per year). DSaRM meetings were more likely to be held jointly with other drug advisory committees after FDAAA (from 68% to 92% of meetings). DSaRM members were invited participants in 35 additional meetings of other drug advisory committees (2007-2011). DSaRM meetings were more likely to review issues of approvability (eg, new drugs, new indications, and new product formulations) after FDAAA. FDA questions to the committee were more likely to request an explicit drug safety assessment after FDAAA (from 31% to 76% of meetings). Content analysis of meeting outcomes and subsequent FDA regulatory decisions did not suggest a more or less risk aversive climate after FDAAA. Increased DSaRM advisory committee activity indicates its advice was being sought more broadly for drug regulatory decision making and at earlier stages of drug development after FDAAA was enacted.

  4. Participants' safety versus confidentiality: A case study of HIV research.

    PubMed

    Leyva-Moral, Juan Manuel; Feijoo-Cid, Maria

    2017-05-01

    Background When conducting qualitative research, participants usually share lots of personal and private information with the researcher. As researchers, we must preserve participants' identity and confidentiality of the data. Objective To critically analyze an ethical conflict encountered regarding confidentiality when doing qualitative research. Research design Case study. Findings and discussion one of the participants in a study aiming to explain the meaning of living with HIV verbalized his imminent intention to commit suicide because of stigma of other social problems arising from living with HIV. Given the life-threatening situation, the commitment related to not disclosing the participant's identity and/or the content of the interview had to be broken. To avoid or prevent suicide, the therapist in charge of the case was properly informed about the participant's intentions. One important question arises from this case: was it ethically appropriate to break the confidentiality commitment? Conclusion confidentiality could be broken if a life-threatening event is identified during data collection and participants must know that. This has to be clearly stated in the informed consent form.

  5. Software Safety Risk in Legacy Safety-Critical Computer Systems

    NASA Technical Reports Server (NTRS)

    Hill, Janice L.; Baggs, Rhoda

    2007-01-01

    Safety Standards contain technical and process-oriented safety requirements. Technical requirements are those such as "must work" and "must not work" functions in the system. Process-Oriented requirements are software engineering and safety management process requirements. Address the system perspective and some cover just software in the system > NASA-STD-8719.13B Software Safety Standard is the current standard of interest. NASA programs/projects will have their own set of safety requirements derived from the standard. Safety Cases: a) Documented demonstration that a system complies with the specified safety requirements. b) Evidence is gathered on the integrity of the system and put forward as an argued case. [Gardener (ed.)] c) Problems occur when trying to meet safety standards, and thus make retrospective safety cases, in legacy safety-critical computer systems.

  6. Semiquantitative analysis of gaps in microbiological performance of fish processing sector implementing current food safety management systems: a case study.

    PubMed

    Onjong, Hillary Adawo; Wangoh, John; Njage, Patrick Murigu Kamau

    2014-08-01

    Fish processing plants still face microbial food safety-related product rejections and the associated economic losses, although they implement legislation, with well-established quality assurance guidelines and standards. We assessed the microbial performance of core control and assurance activities of fish exporting processors to offer suggestions for improvement using a case study. A microbiological assessment scheme was used to systematically analyze microbial counts in six selected critical sampling locations (CSLs). Nine small-, medium- and large-sized companies implementing current food safety management systems (FSMS) were studied. Samples were collected three times on each occasion (n = 324). Microbial indicators representing food safety, plant and personnel hygiene, and overall microbiological performance were analyzed. Microbiological distribution and safety profile levels for the CSLs were calculated. Performance of core control and assurance activities of the FSMS was also diagnosed using an FSMS diagnostic instrument. Final fish products from 67% of the companies were within the legally accepted microbiological limits. Salmonella was absent in all CSLs. Hands or gloves of workers from the majority of companies were highly contaminated with Staphylococcus aureus at levels above the recommended limits. Large-sized companies performed better in Enterobacteriaceae, Escherichia coli, and S. aureus than medium- and small-sized ones in a majority of the CSLs, including receipt of raw fish material, heading and gutting, and the condition of the fish processing tables and facilities before cleaning and sanitation. Fish products of 33% (3 of 9) of the companies and handling surfaces of 22% (2 of 9) of the companies showed high variability in Enterobacteriaceae counts. High variability in total viable counts and Enterobacteriaceae was noted on fish products and handling surfaces. Specific recommendations were made in core control and assurance activities

  7. Indian reservation safety improvement program : a methodology and case study.

    DOT National Transportation Integrated Search

    2015-11-01

    Improving roadway safety on Indian reservations requires a comprehensive approach. Limited : resources, lack of crash data, and few cross-jurisdictions coordination has made it difficult for : Native American communities to address their roadway safe...

  8. Beyond the classroom: a case study of immigrant safety liaisons in residential construction.

    PubMed

    Ochsner, Michele; Marshall, Elizabeth G; Martino, Carmen; Pabelón, Marién Casillas; Kimmel, Louis; Rostran, Damaris

    2012-01-01

    Latino day laborers often work at dangerous construction sites with little power to change conditions. We describe the development, implementation, and early-stage results of a program to train immigrant day laborers as safety liaisons. These are construction workers prepared to recognize and respond to health and safety hazards. Based in Newark, NJ, the project involves collaboration between New Labor, a membership-based worker center, and university researchers and labor educators. Safety liaisons undergo training and receive ongoing support for their roles. Both qualitative and quantitative data are collected to monitor progress. Although lacking in formal authority, safety liaisons have prompted improvements at specific sites, filed OSHA complaints, and developed a local worker council. Participatory training methods, opportunities for leadership outside the classroom, and participation in project planning have strengthened liaisons' effectiveness, leadership skills, and commitment. The safety liaison approach could be adapted by worker centers and their partner organizations.

  9. A Comprehensive Approach to Managing School Safety: Case Studies in Catalonia, Spain

    ERIC Educational Resources Information Center

    Díaz-Vicario, Anna; Gairín Sallán, Joaquín

    2017-01-01

    Background: Schools should be safe spaces for students, teaching staff and non-teaching staff. For the concept of "safety" to be meaningful, it must be interpreted broadly to encompass well-being in its widest sense. A common challenge for schools and educational authorities is, therefore, to manage school safety appropriately not only…

  10. Health, safety and environmental unit performance assessment model under uncertainty (case study: steel industry).

    PubMed

    Shamaii, Azin; Omidvari, Manouchehr; Lotfi, Farhad Hosseinzadeh

    2017-01-01

    Performance assessment is a critical objective of management systems. As a result of the non-deterministic and qualitative nature of performance indicators, assessments are likely to be influenced by evaluators' personal judgments. Furthermore, in developing countries, performance assessments by the Health, Safety and Environment (HSE) department are based solely on the number of accidents. A questionnaire is used to conduct the study in one of the largest steel production companies in Iran. With respect to health, safety, and environment, the results revealed that control of disease, fire hazards, and air pollution are of paramount importance, with coefficients of 0.057, 0.062, and 0.054, respectively. Furthermore, health and environment indicators were found to be the most common causes of poor performance. Finally, it was shown that HSE management systems can affect the majority of performance safety indicators in the short run, whereas health and environment indicators require longer periods of time. The objective of this study is to present an HSE-MS unit performance assessment model in steel industries. Moreover, we seek to answer the following question: what are the factors that affect HSE unit system in the steel industry? Also, for each factor, the extent of impact on the performance of the HSE management system in the organization is determined.

  11. ELECTRO CONVULSIVE THERAPY IN PRE-PUBERTAL CATATONIA: A CASE STUDY

    PubMed Central

    Thakur, Anupam; Dutta, S.; Jagadheesan, K.; Sinha, Vinod Kumar

    2001-01-01

    Depression in prepubertal age group is a relatively rare condition. The presence of life threatening catatonic features call for aggressive treatment. Electro convulsive therapy (ECT) has been described to be effective in these circumstances; however, doubts have been raised about its safety profile. This present case study illustrates the efficacy and safety of ECT in prepubertal catatonia. PMID:21407888

  12. Nutritional and safety assessments of foods and feeds nutritionally improved through biotechnology: lysine maize as a case study.

    PubMed

    Glenn, Kevin C

    2007-01-01

    During the last decade, the area of biotech crops modified for agronomic input traits (e.g., herbicide tolerance and insect protection) has increased to 90 million halyear, grown by over 8 million farmers in a total of 17 countries. As adoption of these improved agronomic trait biotech crops has grown, so has interest in biotech crops that have improved nutritional characteristics for use as feed and food. A previous publication by the International Life Sciences Institute (ILSI) reported on the principles and concepts proposed for the nutritional and safety assessments of foods and feeds nutritionally improved through biotechnology. In this paper, the guidelines and principles recommended in the earlier publication are discussed relative to a specific case study, Lysine maize. Lysine maize is a feed ingredient with enhanced nutritional characteristics for poultry and swine and provides an alternative to the need for addition of supplemental lysine to some diets for these animals. The 2004 Task Force of the ILSI has also applied the concepts from that report to 4 other case studies: sweet potato enriched in provitamin A (2 examples, one using biotechnology and one using conventional breeding); Golden Rice 2; double-embryo maize; and ASP-1 enhanced protein sweet potato.

  13. The role of paediatric nurses in medication safety prior to the implementation of electronic prescribing: a qualitative case study.

    PubMed

    Farre, Albert; Heath, Gemma; Shaw, Karen; Jordan, Teresa; Cummins, Carole

    2017-04-01

    Objectives To explore paediatric nurses' experiences and perspectives of their role in the medication process and how this role is enacted in everyday practice. Methods A qualitative case study on a general surgical ward of a paediatric hospital in England, one year prior to the planned implementation of ePrescribing. Three focus groups and six individual semi-structured interviews were conducted, involving 24 nurses. Focus groups and interviews were audio-recorded, transcribed, anonymized and subjected to thematic analysis. Results Two overarching analytical themes were identified: the centrality of risk management in nurses' role in the medication process and the distributed nature of nurses' medication risk management practices. Nurses' contribution to medication safety was seen as an intrinsic feature of a role that extended beyond just preparing and administering medications as prescribed and placed nurses at the heart of a dynamic set of interactions, practices and situations through which medication risks were managed. These findings also illustrate the collective nature of patient safety. Conclusions Both the recognized and the unrecognized contributions of nurses to the management of medications needs to be considered in the design and implementation of ePrescribing systems.

  14. Effect of static electronic advertising signs on road safety: an experimental case study.

    PubMed

    Izadpanah, Pedram; Omrani, Reza; Koo, Sheldon; Hadayeghi, Ali

    2014-01-01

    As technology continues to advance, the outdoor advertising industry is taking advantage of electronic signs, some of which are static electronic signs (SES), with the ability to automatically change the message shown on the sign at regular intervals. Studies indicate that SES has a negative impact on the drivers' visual attention and on vehicle control. However, the actual effects of the SES on the number of collisions have been difficult to prove conclusively. The objective of this article is to generate a clear understanding of the safety impacts of SES on the number collisions by conducting a before-and-after analysis with comparison groups. The analysis was based on a total of 10 SES along the Highway 27 and the Gardiner Expressway of the city of Toronto. The results of the before-and-after study revealed that there was not enough evidence to suggest that these signs have any impact on road safety along the adjacent roadway sections at a 95% confidence interval. The same results were obtained by comparing collisions that occurred during daylight and artificial light.

  15. School Safety Study: Phase I.

    ERIC Educational Resources Information Center

    Arora, Alka

    This report summarizes findings from a study concerned with Arizona school safety. The survey component highlights safety-related policy information across 300 schools; the interview component highlights school-safety perceptions of 64 staff across 16 schools. Various policies and programs that respond to internal and external threats to school…

  16. Screening for Chemical Contributions to Breast Cancer Risk: A Case Study for Chemical Safety Evaluation

    PubMed Central

    Ackerman, Janet M.; Dairkee, Shanaz H.; Fenton, Suzanne E.; Johnson, Dale; Navarro, Kathleen M.; Osborne, Gwendolyn; Rudel, Ruthann A.; Solomon, Gina M.; Zeise, Lauren; Janssen, Sarah

    2015-01-01

    . Screening for chemical contributions to breast cancer risk: a case study for chemical safety evaluation. Environ Health Perspect 123:1255–1264; http://dx.doi.org/10.1289/ehp.1408337 PMID:26032647

  17. Safety management by walking around (SMBWA): a safety intervention program based on both peer and manager participation.

    PubMed

    Luria, Gil; Morag, Ido

    2012-03-01

    "Management by walking around" (MBWA) is a practice that has aroused much interest in management science and practice. The purpose of this study is to demonstrate adaptation of this practice to safety management. We describe a three-year long case study that collected empirical data in which a modified MBWA was practiced in order to improve safety in a semiconductor fabrication facility. The main modification involved integrating an information system with the MBWA in order to create a practice that would generate safety leadership development and an organizational safety learning mechanism, while promoting employee safety participation. The results of the case study demonstrate that the SMBWA practice facilitated thousands of tours in which safety leadership behaviors were practiced by managers and by employees (employees performed five times as many tours as managers). The information system collected information about safety behaviors and safety conditions that could not otherwise be obtained. Thus, this study presents a new organizational safety practice SMBWA, and demonstrates the ways in which SMBWA may improve safety in organizations. Copyright © 2011 Elsevier Ltd. All rights reserved.

  18. [Regional Study of Patient Safety Incidents (ERIDA) in the Emergency Services].

    PubMed

    Alcaraz-Martínez, J; Aranaz-Andrés, J M; Martínez-Ros, C; Moreno-Reina, S; Escobar-Álvaro, L; Ortega-Liarte, J V

    2016-01-01

    Evaluate the patient safety incidents that occur in the emergency departments of our region. Observational study conducted in all the hospital emergency departments in the Regional Health Service of Murcia. After systematic random sampling, data were collected during care and a week later by telephone survey. Health professionals of each service were trained and collected the information, following the methodology of the National Study of Adverse Events Related to Hospitalization -ENEAS- and the Adverse Events Related to Spanish Hospital Emergency Department Care -EVADUR-. A total of 393 samples were collected, proportional to the cases treated in each hospital. In 10 cases (3.1%) the complaint was a previous safety incident. At least one incident was detected in 47 patients (11.95%; 8.7 to 15.1%). In 3 cases there were 2 incidents, bringing the number of incidents to 50. Regarding the impact, the 51% of incidents caused harm to the patients. The effects more frequent in patients were the need for repeat visits (9 cases), and mismanagement of pain (8 cases). In 24 cases (51.1%) health care was not affected, although 3 cases required an additional test, 11 cases required further consultation, and led to hospitalisation in 2 cases. The most frequent causal factors of these incidents were medication (14) and care (12). The incidents were considered preventable in 60% of cases. A rate of incidents in the emergency departments, representative of the region, has been obtained. The implications of the results for the population means that 12 out of every 100 patients treated in emergency departments have an adverse event, and 7 of these are avoidable. Copyright © 2016 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

  19. Measuring the impact of pharmacoepidemiologic research using altmetrics: A case study of a CNODES drug-safety article.

    PubMed

    Gamble, J M; Traynor, Robyn L; Gruzd, Anatoliy; Mai, Philip; Dormuth, Colin R; Sketris, Ingrid S

    2018-03-24

    To provide an overview of altmetrics, including their potential benefits and limitations, how they may be obtained, and their role in assessing pharmacoepidemiologic research impact. Our review was informed by compiling relevant literature identified through searching multiple health research databases (PubMed, Embase, and CIHNAHL) and grey literature sources (websites, blogs, and reports). We demonstrate how pharmacoepidemiologists, in particular, may use altmetrics to understand scholarly impact and knowledge translation by providing a case study of a drug-safety study conducted by the Canadian Network of Observational Drug Effect Studies. A common approach to measuring research impact is the use of citation-based metrics, such as an article's citation count or a journal's impact factor. "Alternative" metrics, or altmetrics, are increasingly supported as a complementary measure of research uptake in the age of social media. Altmetrics are nontraditional indicators that capture a diverse set of traceable, online research-related artifacts including peer-reviewed publications and other research outputs (software, datasets, blogs, videos, posters, policy documents, presentations, social media posts, wiki entries, etc). Compared with traditional citation-based metrics, altmetrics take a more holistic view of research impact, attempting to capture the activity and engagement of both scholarly and nonscholarly communities. Despite the limited theoretical underpinnings, possible commercial influence, potential for gaming and manipulation, and numerous data quality-related issues, altmetrics are promising as a supplement to more traditional citation-based metrics because they can ingest and process a larger set of data points related to the flow and reach of scholarly communication from an expanded pool of stakeholders. Unlike citation-based metrics, altmetrics are not inherently rooted in the research publication process, which includes peer review; it is unclear to

  20. Ready to Respond: Case Studies in Campus Safety and Security

    ERIC Educational Resources Information Center

    Hyatt, James A.

    2010-01-01

    Is your campus primed for the next big emergency? The National Campus Safety and Security Project (NCSSP), led by NACUBO, sought to help colleges and universities develop comprehensive emergency management plans that address the four phases of emergency management: prevention/mitigation, preparedness, response, and recovery. A major component of…

  1. Improving Patient Safety with X-Ray and Anesthesia Machine Ventilator Synchronization: A Medical Device Interoperability Case Study

    NASA Astrophysics Data System (ADS)

    Arney, David; Goldman, Julian M.; Whitehead, Susan F.; Lee, Insup

    When a x-ray image is needed during surgery, clinicians may stop the anesthesia machine ventilator while the exposure is made. If the ventilator is not restarted promptly, the patient may experience severe complications. This paper explores the interconnection of a ventilator and simulated x-ray into a prototype plug-and-play medical device system. This work assists ongoing interoperability framework development standards efforts to develop functional and non-functional requirements and illustrates the potential patient safety benefits of interoperable medical device systems by implementing a solution to a clinical use case requiring interoperability.

  2. Public Participation Guide: Skorpion Zinc Project Case Study - Namibia

    EPA Pesticide Factsheets

    This case study describes the efforts of an independent professional team working with South African and Namibian specialists to identify and address environmental and public health and safety concerns related to a zinc mine and refinery.

  3. Bovine thrombin safety reporting: an example of study design and publication bias.

    PubMed

    Crean, Sheila; Michels, Shannon L; Moschella, Kevin; Reynolds, Matthew W

    2010-01-01

    Bovine thrombin, a popular hemostat and sealant since 1945, has recently been subjected to clinical trial testing due to reformulations in 1998. We sought to compare adverse event rates of early observational studies with those of later interventional trials. A MEDLINE-based literature search in publications that report safety in bovine thrombin exposed surgical patients was extracted and reviewed. In 38 studies, about half were case reports and 31.5% were interventional trials. In case reports, 41% of authors reported severe coagulopathic adverse events. In contrast, whereas blood complications were common in large trials, no association of harm was established for bovine thrombin product exposure and/or immunization. In this review, later clinical trials failed to reproduce the common and severe coagulopathy predicted by earlier observational studies in bovine exposed patients. This example illustrates that perceptions of safety can change as a function of study design, even for a widely adopted, well established biologic such as thrombin. Caution must be exercised in interpreting evidence from observational studies alone.

  4. Strengths, weaknesses, opportunities, and threats analysis of integrating the World Health Organization patient safety curriculum into undergraduate medical education in Pakistan: a qualitative case study

    PubMed Central

    2017-01-01

    Purpose The purpose of this study was to conduct a strengths, weaknesses, opportunities, and threats (SWOT) analysis of integrating the World Health Organization (WHO) patient safety curriculum into undergraduate medical education in Pakistan. Methods A qualitative interpretive case study was conducted at Riphah International University, Islamabad, from October 2016 to June 2017. The study included 9 faculty members and 1 expert on patient safety. The interviews were audiotaped, and a thematic analysis of the transcripts was performed using NVivo software. Results Four themes were derived based on the need analysis model. The sub-themes derived from the collected data were arranged under the themes of strengths, weaknesses, opportunities, and threats, in accordance with the principles of SWOT analysis. The strengths identified were the need for a formal patient safety curriculum and its early integration into the undergraduate program. The weaknesses were faculty awareness and participation in development programs. The opportunities were an ongoing effort to develop an appropriate curriculum, to improve the current culture of healthcare, and to use the WHO curricular resource guide. The threats were attitudes towards patient safety in Pakistani culture, resistance to implementation from different levels, and the role of regulatory authorities. Conclusion The theme of patient safety needs to be incorporated early into the formal medical education curriculum, with the main goals of striving to do no harm and seeing mistakes as opportunities to learn. Faculty development activities need to be organized, and faculty members should to be encouraged to participate in them. The lack of a patient safety culture was identified as the primary reason for resistance to this initiative at many levels. The WHO curriculum, amended according to local institutional culture, can be implemented appropriately with support from the corresponding regulatory bodies. PMID:29284217

  5. Strengths, weaknesses, opportunities, and threats analysis of integrating the World Health Organization patient safety curriculum into undergraduate medical education in Pakistan: a qualitative case study.

    PubMed

    Misbah, Samreen; Mahboob, Usman

    2017-01-01

    The purpose of this study was to conduct a strengths, weaknesses, opportunities, and threats (SWOT) analysis of integrating the World Health Organization (WHO) patient safety curriculum into undergraduate medical education in Pakistan. A qualitative interpretive case study was conducted at Riphah International University, Islamabad, from October 2016 to June 2017. The study included 9 faculty members and 1 expert on patient safety. The interviews were audiotaped, and a thematic analysis of the transcripts was performed using NVivo software. Four themes were derived based on the need analysis model. The sub-themes derived from the collected data were arranged under the themes of strengths, weaknesses, opportunities, and threats, in accordance with the principles of SWOT analysis. The strengths identified were the need for a formal patient safety curriculum and its early integration into the undergraduate program. The weaknesses were faculty awareness and participation in development programs. The opportunities were an ongoing effort to develop an appropriate curriculum, to improve the current culture of healthcare, and to use the WHO curricular resource guide. The threats were attitudes towards patient safety in Pakistani culture, resistance to implementation from different levels, and the role of regulatory authorities. The theme of patient safety needs to be incorporated early into the formal medical education curriculum, with the main goals of striving to do no harm and seeing mistakes as opportunities to learn. Faculty development activities need to be organized, and faculty members should to be encouraged to participate in them. The lack of a patient safety culture was identified as the primary reason for resistance to this initiative at many levels. The WHO curriculum, amended according to local institutional culture, can be implemented appropriately with support from the corresponding regulatory bodies.

  6. Implementing Stakeholders' Access to Expertise: Experimenting on Nuclear Installations' Safety Cases - 12160

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

    Gilli, Ludivine; Charron, Sylvie

    2012-07-01

    In 2009 and 2010, the Institute for Nuclear Safety and Radiation Protection (IRSN) led two pilot actions dealing with nuclear installations' safety cases. One concerned the periodical review of the French 900 MWe nuclear reactors, the other concerned the decommissioning of a workshop located on the site of Areva's La Hague fuel-reprocessing plant site in Northwestern France. The purpose of both these programs was to test ways for IRSN and a small number of stakeholders (Non-Governmental Organizations (NGOs) members, local elected officials, etc.) to engage in technical discussions. The discussions were intended to enable the stakeholders to review future applicationsmore » and provide valuable input. The test cases confirmed there is a definite challenge in successfully opening a meaningful dialogue to discuss technical issues, in particular the fact that most expertise reports were not public and the conflict that exists between the contrary demands of transparency and confidentiality of information. The test case also confirmed there are ways to further improvement of stakeholders' involvement. (authors)« less

  7. How Past Loss of Control Accidents May Inform Safety Cases for Advanced Control Systems on Commercial Aircraft

    NASA Technical Reports Server (NTRS)

    Holloway, C. M.; Johnson, C. W.

    2008-01-01

    This paper describes five loss of control accidents involving commercial aircraft, and derives from those accidents three principles to consider when developing a potential safety case for an advanced flight control system for commercial aircraft. One, among the foundational evidence needed to support a safety case is the availability to the control system of accurate and timely information about the status and health of relevant systems and components. Two, an essential argument to be sustained in the safety case is that pilots are provided with adequate information about the control system to enable them to understand the capabilities that it provides. Three, another essential argument is that the advanced control system will not perform less safely than a good pilot.

  8. Generalized implementation of software safety policies

    NASA Technical Reports Server (NTRS)

    Knight, John C.; Wika, Kevin G.

    1994-01-01

    As part of a research program in the engineering of software for safety-critical systems, we are performing two case studies. The first case study, which is well underway, is a safety-critical medical application. The second, which is just starting, is a digital control system for a nuclear research reactor. Our goal is to use these case studies to permit us to obtain a better understanding of the issues facing developers of safety-critical systems, and to provide a vehicle for the assessment of research ideas. The case studies are not based on the analysis of existing software development by others. Instead, we are attempting to create software for new and novel systems in a process that ultimately will involve all phases of the software lifecycle. In this abstract, we summarize our results to date in a small part of this project, namely the determination and classification of policies related to software safety that must be enforced to ensure safe operation. We hypothesize that this classification will permit a general approach to the implementation of a policy enforcement mechanism.

  9. Ethics in occupational health and safety: case studies from Gujarat.

    PubMed

    Patel, Jagdish; David, Siddarth

    2016-01-01

    Rapid industrialisation in India is giving employment to millions of people in the formal sector, and many more in the unorganised sector. However, the absence of clear policies, poorly enforced regulations, lack of systematic reporting of occupational diseases, lamentable socioeconomic conditions of the workers and their limited access to healthcare make occupational health and safety (OHS) a critical area.

  10. Age, overtime, and employee health, safety and productivity outcomes: a case study.

    PubMed

    Allen, Harris; Woock, Christopher; Barrington, Linda; Bunn, William

    2008-08-01

    To expand a study of the impact of overtime on employee health, safety, and productivity outcomes, previously reported in this journal, with tests comparing older versus younger workers on these relationships. Secondary analyses of a longitudinal panel (n = 2746) representing workers at US sites for a heavy manufacturer during 2001 to 2002. Structural equation techniques were used to assess two hypotheses in the context of multiple group models positing the prediction of a broad set of employee outcomes using a three-step causal sequence. One set of models compared overtime impact for three age groups (<45, 45 to 49, 50+) at the aggregate level. Two others compared overtime impact for the three age groups by compensation type (hourly vs salaried). Advancing age was linked to greater rates of adverse consequences as a function of overtime (hypothesis #1), but these increases were largely confined to hourly employees working extended overtime (averaging 60+ hours per week) and occurred on only four of the nine study outcomes. With respect to moderate overtime (48.01 to 59.99 hours) and to variables reflecting the possible impact of past overtime (eg, prior disability episodes), increases in age among hourly employees did not lead to stronger associations between overtime and adverse outcomes on most tests and in fact in many cases were linked to decrements in these associations (hypothesis #2). Salaried employees recorded no greater linkages between overtime and adverse outcomes with advancing age across all tests involving hypothesized overtime effects or "possibly a function of overtime" effects. The results support the proposition that, when employees work overtime, adverse outcomes--and indirect costs--do not increase with advancing age in any kind of wholesale fashion. Where rates of adverse outcomes do increase, they are confined to certain subgroups of employees doing certain types of work and occur on certain dimensions at certain levels of longer work hours

  11. Station Blackout: A case study in the interaction of mechanistic and probabilistic safety analysis

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

    Curtis Smith; Diego Mandelli; Cristian Rabiti

    2013-11-01

    The ability to better characterize and quantify safety margins is important to improved decision making about nuclear power plant design, operation, and plant life extension. As research and development (R&D) in the light-water reactor (LWR) Sustainability (LWRS) Program and other collaborative efforts yield new data, sensors, and improved scientific understanding of physical processes that govern the aging and degradation of plant SSCs needs and opportunities to better optimize plant safety and performance will become known. The purpose of the Risk Informed Safety Margin Characterization (RISMC) Pathway R&D is to support plant decisions for risk-informed margin management with the aim tomore » improve economics, reliability, and sustain safety of current NPPs. In this paper, we describe the RISMC analysis process illustrating how mechanistic and probabilistic approaches are combined in order to estimate a safety margin. We use the scenario of a “station blackout” wherein offsite power and onsite power is lost, thereby causing a challenge to plant safety systems. We describe the RISMC approach, illustrate the station blackout modeling, and contrast this with traditional risk analysis modeling for this type of accident scenario.« less

  12. Case-control study on the prevention of occupational eye injuries.

    PubMed

    Ho, Chi-Kung; Yen, Ya-Lin; Chang, Cheng-Hsien; Chiang, Hung-Che; Shen, Ying-Ying; Chang, Po-Ya

    2008-01-01

    The risk factors for occupational eye injuries have never been published in Taiwan. We conducted a case-control study to analyze the differences among workers on their knowledge, attitude to and practice (KAP) of occupational accident prevention. In the study, a statistical model was also set up for predicting the occupational problem. Subjects, including 31 cases of work-related eye injuries and 62 controls, completed a structured questionnaire on KAP, which revealed that 80.6% and 62.7% of workers in the case and control groups, respectively, did not wear eye protection during work. Furthermore, we found that temporary employment (OR, 10.7; 95% CI, 3.03-36.16) and fewer than 10 years of education (OR, 4.44; 95% CI, 1.73-11.44) were the major risk factors for occupational eye injuries. In addition, we developed a logistic regression model with four predictors (temporary employment, education years less than 10, poor management of industrial health and safety in the workplace, and poor attitude towards accident prevention) for the occurrence of occupational eye injuries. In conclusion, in Taiwan, compulsory regulation of wearing eye protection during work, good education, management of work safety and hygiene and employee (especially temporary worker) commitment to safety and health are strongly recommended prevention strategies.

  13. Abused women's experiences of a primary care identification and referral intervention: a case study analysis.

    PubMed

    Bradbury-Jones, Caroline; Clark, Maria; Taylor, Julie

    2017-12-01

    The aim of this study was to report the findings of a qualitative case study that investigated abused women's experiences of an identification and referral intervention and to discuss the implications for nurses, specifically those working in primary and community care. Domestic violence and abuse is a significant public health issue globally but it is a hidden problem that is under-reported. In the UK, Identification and Referral to Improve Safety is a primary care-based intervention that has been found to increase referral rates of abused women to support and safety services. This paper reports on the findings of an evaluation study of two sites in England. Qualitative study with a case study design. In line with case study design, the entire evaluation study employed multiple data collection methods. We report on the qualitative interviews with women referred through the programme. The aim was to elicit their experiences of the three aspects of the intervention: identification; referral; safety. Data collection took place March 2016. Ten women took part. Eight had exited the abusive relationship but two remained with the partner who had perpetrated the abuse. Women were overwhelmingly positive about the programme and irrespective of whether they had remained or exited the relationship all reported perceptions of increased safety and improved health. Nurses have an important role to play in identifying domestic violence and abuse and in referral and safety planning. As part of a portfolio of domestic violence and abuse interventions, those that empower women to take control of their safety (such as Identification and Referral to Improve Safety) are important. © 2017 John Wiley & Sons Ltd.

  14. Safety of escitalopram in pregnancy: a case series.

    PubMed

    Bellantuono, Cesario; Bozzi, Francesca; Orsolini, Laura

    2013-01-01

    The aim of this paper is to report maternal and neonatal outcomes in pregnant women treated with escitalopram during pregnancy and breastfeeding. Women enrolled in the DEGRA Database at the Clinic of Affective Disorders in Pregnancy and Postpartum in Italy, treated during pregnancy with escitalopram and followed up throughout pregnancy, were included in this study. All patients provided written informed consent and the study was approved by the local ethics committee. Psychiatric diagnoses were assessed using the Structured Clinical Interview for DSM-IV (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition) Axis I Disorders and symptoms were assessed using the Hamilton Rating Scale for Depression (17 items) and Hamilton Rating Scale for Anxiety (14 items). Clinical and sociodemographic characteristics as well as maternal and neonatal outcomes were recorded. The case histories of seven pregnant women treated for depression and/or anxiety disorders with escitalopram were reported. Four women were also treated with benzodiazepines. All pregnancies were full-term and all newborns had normal Apgar scores. There were no major malformations or miscarriages following exposure to escitalopram. Mild withdrawal syndrome was reported only in a newborn who was also exposed to a benzodiazepine. Two infants exposed to escitalopram during breastfeeding did not show any health problems. Our experience with use of escitalopram in pregnant women did not reveal any maternal or neonatal concerns. However, considering the few cases analyzed and the paucity of published literature, no conclusions can be drawn on its safety profile in pregnancy and breastfeeding.

  15. Safety of escitalopram in pregnancy: a case series

    PubMed Central

    Bellantuono, Cesario; Bozzi, Francesca; Orsolini, Laura

    2013-01-01

    Background The aim of this paper is to report maternal and neonatal outcomes in pregnant women treated with escitalopram during pregnancy and breastfeeding. Methods Women enrolled in the DEGRA Database at the Clinic of Affective Disorders in Pregnancy and Postpartum in Italy, treated during pregnancy with escitalopram and followed up throughout pregnancy, were included in this study. All patients provided written informed consent and the study was approved by the local ethics committee. Psychiatric diagnoses were assessed using the Structured Clinical Interview for DSM-IV (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition) Axis I Disorders and symptoms were assessed using the Hamilton Rating Scale for Depression (17 items) and Hamilton Rating Scale for Anxiety (14 items). Clinical and sociodemographic characteristics as well as maternal and neonatal outcomes were recorded. Results The case histories of seven pregnant women treated for depression and/or anxiety disorders with escitalopram were reported. Four women were also treated with benzodiazepines. All pregnancies were full-term and all newborns had normal Apgar scores. There were no major malformations or miscarriages following exposure to escitalopram. Mild withdrawal syndrome was reported only in a newborn who was also exposed to a benzodiazepine. Two infants exposed to escitalopram during breastfeeding did not show any health problems. Conclusion Our experience with use of escitalopram in pregnant women did not reveal any maternal or neonatal concerns. However, considering the few cases analyzed and the paucity of published literature, no conclusions can be drawn on its safety profile in pregnancy and breastfeeding. PMID:24043940

  16. Safety pharmacology investigations in toxicology studies: an industry survey.

    PubMed

    Authier, Simon; Vargas, Hugo M; Curtis, Michael J; Holbrook, Mark; Pugsley, Michael K

    2013-01-01

    The Safety Pharmacology (SP) Society (SPS) conducted an industry survey in 2012 in an attempt to define current industry practices as they relate to inclusion of safety pharmacology (SP) endpoints into Toxicology studies. A total of 361 participants from Asia (9.1%), Europe (19.4%) and North America (71.4%) responded to the survey. The preponderance of respondents were toxicologists (53.2%) followed by safety pharmacologists (27.2%) and scientists involved in the conduct of both disciplines (19.6%). Most participants (58.6%) were from pharmaceutical companies employing more than 500 employees. A majority (68.2%) reported having experience in designing, performing or interpreting the SP component of a study when performed as part of a toxicology study. Some participants (42.0%) had submitted data to a regulatory agency where ICHS7 studies were performed as part of a toxicology study rather than as a standalone study. When comparing species that were used in studies in which SP was added to toxicology studies, canines were the most frequently reported animals used for new chemical entities (NCE) whereas non-human (NH) primates were the most frequent for the assessment of biological agents. The most frequent primary motivator for adding ICHS7 SP endpoints to regulatory toxicology studies was to generate additional data to allow for determination of an integrated risk assessment thereby testing Confidence in Safety (CIS) to better manage and/or mitigate risk. The current ability to add safety pharmacology endpoints into regulatory toxicology studies was used to address a specific concern (by 42.1% of respondents) to allow management of risk more effectively (36.8%) or to generate data that contributes to cessation of the progression of a compound (21.1%). For an NCE, SP measurements in toxicology studies were conducted in addition to standalone SP studies (by 40.6% of respondents) or in addition/instead of standalone safety pharmacology studies (by 39.8% of respondents

  17. Food safety evaluation for R-proteins introduced by biotechnology: A case study of VNT1 in late blight protected potatoes.

    PubMed

    Habig, Jeffrey W; Rowland, Aaron; Pence, Matthew G; Zhong, Cathy X

    2018-06-01

    Resistance genes (R-genes) from wild potato species confer protection against disease and can be introduced into cultivated potato varieties using breeding or biotechnology. The R-gene, Rpi-vnt1, which encodes the VNT1 protein, protects against late blight, caused by Phytophthora infestans. Heterologous expression and purification of active VNT1 in quantities sufficient for regulatory biosafety studies was problematic, making it impractical to generate hazard characterization data. As a case study for R-proteins, a weight-of-evidence, tiered approach was used to evaluate the safety of VNT1. The hazard potential of VNT1 was identified from relevant safety information including history of safe use, bioinformatics, mode of action, expression levels, and dietary intake. From the assessment it was concluded that Tier II hazard characterization was not needed. R-proteins homologous to VNT1 and identified in edible crops, have a history of safe consumption. VNT1 does not share sequence identity with known allergens. Expression levels of R-proteins are generally low, and VNT1 was not detected in potato varieties expressing the Rpi-vnt1 gene. With minimal hazard and negligible exposure, the risks associated with consumption of R-proteins in late blight protected potatoes are exceedingly low. R-proteins introduced into potatoes to confer late blight protection are safe for consumption. Copyright © 2018 Elsevier Inc. All rights reserved.

  18. 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

  19. Use of a risk characterisation approach to contextualise the safety profile of new rheumatoid arthritis treatments: a case study using tofacitinib.

    PubMed

    Curtis, Jeffrey R; Zhang, Richard; Krishnaswami, Sriram; Anisfeld, Andrew; Chen, Yan; Strengholt, Sander; Chen, Connie; Geier, Jamie

    2017-03-01

    Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). To characterise the relative safety profile of tofacitinib to biologic disease-modifying antirheumatic drugs (bDMARDs), the accrued patient-years (pt-yrs) of exposure needed in an RA clinical trial programme to detect a potential increase in risk of specific adverse events (AEs) was determined. This case study/framework was constructed on the pt-yrs' accrual within pooled phase (P)1, P2 and P3, as well as long-term extension, studies of tofacitinib in RA (March 2015 data-cut) and published AE incidence rates for bDMARDs. Sample size calculations were based on a Poisson distribution to estimate pt-yrs' exposure required for 90 % probability that the lower bound of the 95 % confidence interval for tofacitinib/bDMARD would be >1, assuming that tofacitinib rates were 1.2×/1.5×/2.0× greater than comparator rates. AE rates for bDMARDs were derived from sources intended to optimise similarity with the tofacitinib database in terms of baseline characteristics, study duration and follow-up. Based on the tofacitinib exposure accrued (19,406 pt-yrs), data were sufficient (90 % probability) to detect potential differences over external bDMARD comparator rates in serious infections (≥1.2×), malignancies (excluding non-melanoma skin cancer [NMSC]), NMSC, major adverse cardiovascular events (MACE) and lymphoma (each ≥1.5×), as well as opportunistic infections and gastrointestinal perforations (≥2×), should they exist. This risk characterisation approach can support the comparative safety of new RA medications. To date, tofacitinib safety appears similar to approved published data from bDMARDs with respect to serious infections, malignancies (excluding NMSC), NMSC, MACE, lymphoma, opportunistic infections and gastrointestinal perforations.

  20. Key Performance Criteria Affecting the Most the Safety of a Nuclear Waste Long Term Storage : A Case Study Commissioned by CEA

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

    Marvy, A.; Lioure, A; Heriard-Dubreuil, G.

    2003-02-24

    As part of the work scope set in the French law on high level long lived waste R&D passed in 1991, CEA is conducting a research program to establish the scientific basis and assess the feasibility of long term storage as an option for the safe management of nuclear waste for periods as long as centuries. This goal is a significant departure from the current industrial practice where storage facilities are usually built to last only a few decades. From a technical viewpoint such an extension in time seems feasible provided care and maintenance is exercised. Considering such long periodsmore » of time, the risk for Society of loosing oversight and control of such a facility is real, which triggers the question of whether and how long term storage safety can be actually achieved. Therefore CEA commissioned a study (1) in which MUTADIS Consultants (2) and CEPN (3) were both involved. The case study looks into several past and actual human enterprises conducted over significant periods o f time, one of them dating back to the end of the 18th century, and all identified out of the nuclear field. Then-prevailing societal behavior and organizational structures are screened out to show how they were or are still able to cope with similar oversight and control goals. As a result, the study group formulated a set of performance criteria relating to issues like responsibility, securing funds, legal and legislative implications, economic sustainable development, all being areas which are not traditionally considered as far as technical studies are concerned. These criteria can be most useful from the design stage onward, first in an attempt to define the facility construction and operating guiding principles, and thereafter to substantiate the safety case for long term storage and get geared to the public dialogue on that undertaking should it become a reality.« less

  1. Pedestrian safety impacts of curb extensions : a case study : final report.

    DOT National Transportation Integrated Search

    2005-07-01

    This report documents a case study evaluating motorist yielding behavior at a crosswalk in Albany, Oregon. In 2003 the City of Albany installed curb extensions, continental markings and advance stop bars at several uncontrolled intersections along th...

  2. Understanding procedural violations using Safety-I and Safety-II: The case of community pharmacies.

    PubMed

    Jones, Christian E L; Phipps, Denham L; Ashcroft, Darren M

    2018-06-01

    Procedural violations are known to occur in a range of work settings, and are an important topic of interest with regard to safety management. A Safety-I perspective sees violations as undesirable digressions from standardised procedures, while a Safety-II perspective sees violations as adaptations to a complex work system. This study aimed to apply both perspectives to the examination of violations in community pharmacies. Twenty-four participants (13 pharmacists and 11 pharmacy support staff) were purposively sampled to participate in semi-structured interviews using the critical incident technique. Participants described violations they made during the course of their work. Interviews were digitally recorded, transcribed verbatim and analysed using template analysis. Community pharmacies located in England and Wales. 31 procedural violations were described during the interviews revealing multiple reasons for violations in this setting. Our findings suggest that from a Safety-II perspective, staff violated to adapt to situations and to manage safety. However, participants also violated procedures in order to maintain productivity which was found to increase risk in some, but not all situations. Procedural violations often relied on the context in which staff were working, resulting in the violation being deemed rational to the individual making the violation, yet the behaviour may be difficult to justify from an outside perspective. Combining Safety-I and Safety-II perspectives provided a detailed understanding of the underlying reasons for procedural violations. Our findings identify aspects of practice that could benefit from targeted interventions to help support staff in providing safe patient care.

  3. Railway safety climate: a study on organizational development.

    PubMed

    Cheng, Yung-Hsiang

    2017-09-07

    The safety climate of an organization is considered a leading indicator of potential risk for railway organizations. This study adopts the perceptual measurement-individual attribute approach to investigate the safety climate of a railway organization. The railway safety climate attributes are evaluated from the perspective of railway system staff. We identify four safety climate dimensions from exploratory factor analysis, namely safety communication, safety training, safety management and subjectively evaluated safety performance. Analytical results indicate that the safety climate differs at vertical and horizontal organizational levels. This study contributes to the literature by providing empirical evidence of the multilevel safety climate in a railway organization, presents possible causes of the differences under various cultural contexts and differentiates between safety climate scales for diverse workgroups within the railway organization. This information can be used to improve the safety sustainability of railway organizations and to conduct safety supervisions for the government.

  4. Safety of gentamicin bladder irrigations in complex urological cases.

    PubMed

    Defoor, William; Ferguson, Denise; Mashni, Susan; Creelman, Lisa; Reeves, Deborah; Minevich, Eugene; Reddy, Pramod; Sheldon, Curtis

    2006-05-01

    Recurrent urinary tract infections are common in complex pediatric urological cases, particularly those requiring clean intermittent catheterization. At our institution gentamicin bladder irrigations have been used for antimicrobial prophylaxis and to treat symptomatic bacteriuria, particularly when the infection does not involve the upper urinary tract. The purpose of this study was to assess the safety of this therapy. A retrospective study was performed of all children treated with gentamicin bladder irrigations from 1999 to 2004. The dose was 14 mg gentamicin in 30 ml saline instilled via catheter once or twice daily. Serum creatinine and random gentamicin levels were obtained according to a protocol based on risk of gentamicin toxicity. Patient demographics, laboratory results and outcomes were abstracted from the medical records. A total of 80 patients (38 males and 42 females) were identified. Median patient age was 10 years and median duration of treatment was 90 days. No patient had detectable serum gentamicin levels greater than 0.4 mg/dl. Small increases in serum creatinine were seen in 3 patients, all of whom had chronic renal insufficiency. A total of 21 patients (26%) had breakthrough UTIs, of which 5 (24%) were gentamicin resistant. No adverse events were documented. Gentamicin bladder irrigations are a helpful adjunct in the management of complex pediatric urological cases involving recurrent symptomatic bacteriuria. We no longer require intensive laboratory monitoring of low risk patients at our institution.

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

    PubMed

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

    2010-06-01

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

  6. HSE's safety assessment principles for criticality safety.

    PubMed

    Simister, D N; Finnerty, M D; Warburton, S J; Thomas, E A; Macphail, M R

    2008-06-01

    The Health and Safety Executive (HSE) published its revised Safety Assessment Principles for Nuclear Facilities (SAPs) in December 2006. The SAPs are primarily intended for use by HSE's inspectors when judging the adequacy of safety cases for nuclear facilities. The revised SAPs relate to all aspects of safety in nuclear facilities including the technical discipline of criticality safety. The purpose of this paper is to set out for the benefit of a wider audience some of the thinking behind the final published words and to provide an insight into the development of UK regulatory guidance. The paper notes that it is HSE's intention that the Safety Assessment Principles should be viewed as a reflection of good practice in the context of interpreting primary legislation such as the requirements under site licence conditions for arrangements for producing an adequate safety case and for producing a suitable and sufficient risk assessment under the Ionising Radiations Regulations 1999 (SI1999/3232 www.opsi.gov.uk/si/si1999/uksi_19993232_en.pdf).

  7. Evaluating the implementation of health and safety innovations under a regulatory context: a collective case study of Ontario's safer needle regulation.

    PubMed

    Chambers, Andrea; Mustard, Cameron A; Breslin, Curtis; Holness, Linn; Nichol, Kathryn

    2013-01-22

    Implementation effectiveness models have identified important factors that can promote the successful implementation of an innovation; however, these models have been examined within contexts where innovations are adopted voluntarily and often ignore the socio-political and environmental context. In the field of occupational health and safety, there are circumstances where organizations must adopt innovations to comply with a regulatory standard. Examining how the external environment can facilitate or challenge an organization's change process may add to our understanding of implementation effectiveness. The objective of this study is to describe implementation facilitators and barriers in the context of a regulation designed to promote the uptake of safer engineered medical devices in healthcare. The proposed study will focus on Ontario's safer needle regulation (2007) which requires healthcare organizations to transition to the use of safer engineered medical devices for the prevention of needlestick injuries. A collective case study design will be used to learn from the experiences of three acute care hospitals in the province of Ontario, Canada. Interviews with management and front-line healthcare workers and analysis of supporting documents will be used to describe the implementation experience and examine issues associated with the integration of these devices. The data collection and analysis process will be influenced by a conceptual framework that draws from implementation science and the occupational health and safety literature. The focus of this study in addition to the methodology creates a unique opportunity to contribute to the field of implementation science. First, the study will explore implementation experiences under circumstances where regulatory pressures are influencing the organization's change process. Second, the timing of this study provides an opportunity to focus on issues that arise during later stages of implementation, a phase

  8. Continuous Improvement and the Safety Case for the Waste Isolation Pilot Plant Geologic Repository - 13467

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

    Van Luik, Abraham; Patterson, Russell; Nelson, Roger

    2013-07-01

    The Waste Isolation Pilot Plant (WIPP) is a geologic repository 2150 feet (650 m) below the surface of the Chihuahuan desert near Carlsbad, New Mexico. WIPP permanently disposes of transuranic waste from national defense programs. Every five years, the U.S. Department of Energy (DOE) submits an application to the U.S. Environmental Protection Agency (EPA) to request regulatory-compliance re-certification of the facility for another five years. Every ten years, DOE submits an application to the New Mexico Environment Department (NMED) for the renewal of its hazardous waste disposal permit. The content of the applications made by DOE to the EPA formore » re-certification, and to the NMED for permit-renewal, reflect any optimization changes made to the facility, with regulatory concurrence if warranted by the nature of the change. DOE points to such changes as evidence for its having taken seriously its 'continuous improvement' operations and management philosophy. Another opportunity for continuous improvement is to look at any delta that may exist between the re-certification and re-permitting cases for system safety and the consensus advice on the nature and content of a safety case as being developed and published by the Nuclear Energy Agency's Integration Group for the Safety Case (IGSC) expert group. DOE at WIPP, with the aid of its Science Advisor and teammate, Sandia National Laboratories, is in the process of discerning what can be done, in a reasonably paced and cost-conscious manner, to continually improve the case for repository safety that is being made to the two primary regulators on a recurring basis. This paper will discuss some aspects of that delta and potential paths forward to addressing them. (authors)« less

  9. Fire prevention in Delaware: a case study of fire and life safety initiatives.

    PubMed

    Frattaroli, Shannon; Gielen, Andrea C; Piver-Renna, Jennifer; Pollack, Keshia M; Ta, Van M

    2011-01-01

    Injuries resulting from residential house fires are a significant public health issue. The fire service is engaged in fire prevention activities aimed at preventing fire-related morbidity and mortality. The fire service in Delaware is regarded by some leaders in the field as a model for fire and life safety education (FLSE). We identified 3 questions to guide this research. What is the culture and context of fire prevention in Delaware? What prevention programs and policies constitute Delaware's fire prevention efforts? What can be learned from select model programs regarding their impact, sustainability, strengths, limitations, and general applicability? A discussion of the lessons learned from Delaware's experience with FLSE initiatives concludes the article. We used a single case study design and collected and analyzed data from in-depth interviews, documents, and participant observation notes to address the research questions. Data were collected in Delaware. Interviewees included a purposeful sample of members of the Delaware fire service. Descriptions of the context in which fire prevention occurs, the initiatives underway, and the factors associated with successfully supporting fire prevention in the state. Data from 16 key informant interviews, relevant documents, and direct observations of FLSE events revealed a fire service rooted in tradition, dedication, and community. A compilation of state and local FLSE initiatives illustrates the diversity of FLSE in Delaware. Thematic analysis of the data emphasize the importance of a strategic, comprehensive, and coordinated approach to realizing success in Delaware's approach to FLSE. The fire service is an important part of the public health infrastructure. While their role as first responders is evident, their contributions to prevention are also significant. This research suggests ways to support fire service prevention efforts and more fully integrate their FLSE work into the public health infrastructure.

  10. Application of an engineering problem-solving methodology to address persistent problems in patient safety: a case study on retained surgical sponges after surgery.

    PubMed

    Anderson, Devon E; Watts, Bradley V

    2013-09-01

    Despite innumerable attempts to eliminate the postoperative retention of surgical sponges, the medical error persists in operating rooms worldwide and places significant burden on patient safety, quality of care, financial resources, and hospital/physician reputation. The failure of countless solutions, from new sponge counting methods to radio labeled sponges, to truly eliminate the event in the operating room requires that the emerging field of health-care delivery science find innovative ways to approach the problem. Accordingly, the VA National Center for Patient Safety formed a unique collaboration with a team at the Thayer School of Engineering at Dartmouth College to evaluate the retention of surgical sponges after surgery and find a solution. The team used an engineering problem solving methodology to develop the best solution. To make the operating room a safe environment for patients, the team identified a need to make the sponge itself safe for use as opposed to resolving the relatively innocuous counting methods. In evaluation of this case study, the need for systematic engineering evaluation to resolve problems in health-care delivery becomes clear.

  11. Occupational health and safety-ergonomics improvement as a corporate responsibility of a Bali handicraft company: a case study.

    PubMed

    Purnawati, Susy

    2007-12-01

    The issue of corporate social responsibility is nowadays becoming popular around industrial communities. The support for the issue has initially spread since the adoption in 1998 of the ILO Declaration concerning fundamental principles and rights at work and then followed up by industries in developed countries. A case study was done from February to August 2006 at a handicraft company in Bali in order to find out the core application of the issue at the enterprise level. The study was conducted by observation in the field of the factory and suppliers, taking photos and interviewing management and employees of the company. The results of the study show that the company has already executed the activities that reflect the application of the core principles. The activities included programs which concerned not only the business corporate community but also wider communities. With regard to the business corporate community, the company had improved the conditions related to ergonomics and occupational health and safety. The improvement was done by referring to the external audit. At the national community level, the company had participated in the recovery measures of national disasters by helping small industries revive. It is hoped that this core program is soon copied by other companies considering that it is very beneficial to the communities and companies.

  12. Risk and protective factors for falls from furniture in young children: multicenter case-control study.

    PubMed

    Kendrick, Denise; Maula, Asiya; Reading, Richard; Hindmarch, Paul; Coupland, Carol; Watson, Michael; Hayes, Mike; Deave, Toity

    2015-02-01

    Falls from furniture are common in young children but there is little evidence on protective factors for these falls. To estimate associations for risk and protective factors for falls from furniture in children aged 0 to 4 years. Multicenter case-control study at hospitals, minor injury units, and general practices in and around 4 UK study centers. Recruitment commenced June 14, 2010, and ended April 27, 2012. Participants included 672 children with falls from furniture and 2648 control participants matched on age, sex, calendar time, and study center. Thirty-five percent of cases and 33% of control individuals agreed to participate. The mean age was 1.74 years for cases and 1.91 years for control participants. Fifty-four percent of cases and 56% of control participants were male. Exposures included safety practices, safety equipment use, and home hazards. Falls from furniture occurring at the child's home resulting in attendance at an emergency department, minor injury unit, or hospital admission. Compared with parents of control participants, parents of cases were significantly more likely not to use safety gates in the home (adjusted odds ratio [AOR], 1.65; 95% CI, 1.29-2.12) and not to have taught their children rules about climbing on kitchen objects (AOR, 1.58; 95% CI, 1.16-2.15). Cases aged 0 to 12 months were significantly more likely to have been left on raised surfaces (AOR, 5.62; 95% CI, 3.62-8.72), had their diapers changed on raised surfaces (AOR, 1.89; 95% CI, 1.24-2.88), and been put in car/bouncing seats on raised surfaces (AOR, 2.05; 95% CI, 1.29-3.27). Cases 3 years and older were significantly more likely to have played or climbed on furniture (AOR, 9.25; 95% CI, 1.22-70.07). Cases were significantly less likely to have played or climbed on garden furniture (AOR, 0.74; 95% CI, 0.56-0.97). If estimated associations are causal, some falls from furniture may be prevented by incorporating advice into child health contacts, personal child health

  13. Obtaining Valid Safety Data for Software Safety Measurement and Process Improvement

    NASA Technical Reports Server (NTRS)

    Basili, Victor r.; Zelkowitz, Marvin V.; Layman, Lucas; Dangle, Kathleen; Diep, Madeline

    2010-01-01

    We report on a preliminary case study to examine software safety risk in the early design phase of the NASA Constellation spaceflight program. Our goal is to provide NASA quality assurance managers with information regarding the ongoing state of software safety across the program. We examined 154 hazard reports created during the preliminary design phase of three major flight hardware systems within the Constellation program. Our purpose was two-fold: 1) to quantify the relative importance of software with respect to system safety; and 2) to identify potential risks due to incorrect application of the safety process, deficiencies in the safety process, or the lack of a defined process. One early outcome of this work was to show that there are structural deficiencies in collecting valid safety data that make software safety different from hardware safety. In our conclusions we present some of these deficiencies.

  14. Safety compliance and safety climate: A repeated cross-sectional study in the oil and gas industry.

    PubMed

    Kvalheim, Sverre A; Dahl, Øyvind

    2016-12-01

    Violations of safety rules and procedures are commonly identified as a causal factor in accidents in the oil and gas industry. Extensive knowledge on effective management practices related to improved compliance with safety procedures is therefore needed. Previous studies of the causal relationship between safety climate and safety compliance demonstrate that the propensity to act in accordance with prevailing rules and procedures is influenced to a large degree by workers' safety climate. Commonly, the climate measures employed differ from one study to another and identical measures of safety climate are seldom tested repeatedly over extended periods of time. This research gap is addressed in the present study. The study is based on a survey conducted four times among sharp-end workers of the Norwegian oil and gas industry (N=31,350). This is done by performing multiple tests (regression analysis) over a period of 7years of the causal relationship between safety climate and safety compliance. The safety climate measure employed is identical across the 7-year period. Taking all periods together, the employed safety climate model explained roughly 27% of the variance in safety compliance. The causal relationship was found to be stable across the period, thereby increasing the reliability and the predictive validity of the factor structure. The safety climate factor that had the most powerful effect on safety compliance was work pressure. The factor structure employed shows high predictive validity and should therefore be relevant to organizations seeking to improve safety in the petroleum sector. The findings should also be relevant to other high-hazard industries where safety rules and procedures constitute a central part of the approach to managing safety. Copyright © 2016 Elsevier Ltd and National Safety Council. All rights reserved.

  15. Performance analysis of Virginia's safety service patrol programs : a case study approach.

    DOT National Transportation Integrated Search

    2006-01-01

    Many state departments of transportation (DOTs) operate safety service patrols (SSPs) as part of their incident management programs. The primary objectives of SSPs are to minimize the duration of freeway incidents, restore full capacity of the freewa...

  16. Impact of intraoperative distractions on patient safety: a prospective descriptive study using validated instruments.

    PubMed

    Sevdalis, Nick; Undre, Shabnam; McDermott, James; Giddie, Jasdeep; Diner, Lila; Smith, Gillian

    2014-04-01

    There is emerging evidence indicating that distractions in the operating room (OR) are prevalent. Studies have shown a negative impact of distractions, but they have been conducted mostly with residents in simulated environments. We tested the hypothesis that intraoperative distractions are associated with deterioration in patient safety checks in the OR. We assessed 24 elective urologic procedures. Blinded trained assessors (two surgeons, one psychologist) used validated instruments to prospectively assess in vivo frequency and severity of distractions (related to communication, phones/pagers, equipment/provisions, OR environment, other hospital departments, or a member of the OR team) and completion of safety-related tasks (related to the patient, equipment, and communication). Descriptive and correlational analyses were conducted. Mean case duration was 70 min (mean intraoperative time 31 min). A mean of 4.0 communication distractions (range 0-9) and 2.48 other distractions (range 0-5) were recorded per case (distraction rate of one per 10 min). Distractions from external visitors (addressed to the entire team or the surgeon) and distractions due to lack of coordination between hospital departments were most disruptive. Regarding safety checks, patient tasks were completed most often (85-100 %) followed by equipment tasks (75-100 %) and communication tasks (55-90 %). Correlational analyses showed that more frequent/severe communication distractions were linked to lower completion of patient checks intraoperatively (median rho -0.56, p < 0.05). Distractions are prevalent in ORs and in this study were linked to deterioration in intraoperative patient safety checks. Surgeons should be mindful of their tolerance to distractions. Surgical leadership can help control distractions and reduce their potential impact on patient safety and performance.

  17. Case Study: Testing with Case Studies

    ERIC Educational Resources Information Center

    Herreid, Clyde Freeman

    2015-01-01

    This column provides original articles on innovations in case study teaching, assessment of the method, as well as case studies with teaching notes. This month's issue discusses using case studies to test for knowledge or lessons learned.

  18. Using network screening methods to determine locations with specific safety issues: A design consistency case study.

    PubMed

    Butsick, Andrew J; Wood, Jonathan S; Jovanis, Paul P

    2017-09-01

    The Highway Safety Manual provides multiple methods that can be used to identify sites with promise (SWiPs) for safety improvement. However, most of these methods cannot be used to identify sites with specific problems. Furthermore, given that infrastructure funding is often specified for use related to specific problems/programs, a method for identifying SWiPs related to those programs would be very useful. This research establishes a method for Identifying SWiPs with specific issues. This is accomplished using two safety performance functions (SPFs). This method is applied to identifying SWiPs with geometric design consistency issues. Mixed effects negative binomial regression was used to develop two SPFs using 5 years of crash data and over 8754km of two-lane rural roadway. The first SPF contained typical roadway elements while the second contained additional geometric design consistency parameters. After empirical Bayes adjustments, sites with promise (SWiPs) were identified. The disparity between SWiPs identified by the two SPFs was evident; 40 unique sites were identified by each model out of the top 220 segments. By comparing sites across the two models, candidate road segments can be identified where a lack design consistency may be contributing to an increase in expected crashes. Practitioners can use this method to more effectively identify roadway segments suffering from reduced safety performance due to geometric design inconsistency, with detailed engineering studies of identified sites required to confirm the initial assessment. Copyright © 2017 Elsevier Ltd. All rights reserved.

  19. 77 FR 75633 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-21

    ... Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH) In... Public Law 92-463. Purpose: The Safety and Occupational Health Study Section will review, discuss, and... cycles pertaining to research issues in occupational safety and health, and allied areas. It is the...

  20. 75 FR 26266 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-11

    ... Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH) In...) Public Law 92-463. Purpose: The Safety and Occupational Health Study Section will review, discuss, and... cycles pertaining to research issues in occupational safety and health, and allied areas. It is the...

  1. Facility safety study

    NASA Technical Reports Server (NTRS)

    1979-01-01

    The safety of NASA's in house microelectronics facility is addressed. Industrial health standards, facility emission control requirements, operation and safety checklists, and the disposal of epitaxial vent gas are considered.

  2. A Comparison of Two Approaches to Safety Analysis Based on Use Cases

    NASA Astrophysics Data System (ADS)

    Stålhane, Tor; Sindre, Guttorm

    Engineering has a long tradition in analyzing the safety of mechanical, electrical and electronic systems. Important methods like HazOp and FMEA have also been adopted by the software engineering community. The misuse case method, on the other hand, has been developed by the software community as an alternative to FMEA and preliminary HazOp for software development. To compare the two methods misuse case and FMEA we have run a small experiment involving 42 third year software engineering students. In the experiment, the students should identify and analyze failure modes from one of the use cases for a commercial electronic patient journals system. The results of the experiment show that on the average, the group that used misuse cases identified and analyzed more user related failure modes than the persons using FMEA. In addition, the persons who used the misuse cases scored better on perceived ease of use and intention to use.

  3. A study of patient safety management in the framework of clinical governance according to the nurses working in the ICU of the hospitals in the East of Tehran.

    PubMed

    Sahebalzamani, Mohammad; Mohammady, Mohsen

    2014-05-01

    The improvement of patient safety conditions in the framework of clinical service governance is one of the most important concerns worldwide. The importance of this issue and its effects on the health of patients encouraged the researcher to conduct this study to evaluate patient safety management in the framework of clinical governance according to the nurses working in the intensive care units (ICUs) of the hospitals of the east of Tehran, Iran in 2012. This descriptive study, which was based on census method, was conducted on 250 nurses sampled from the hospitals located in the east of Tehran. For the collection of data, a researcher-made questionnaire in five categories, including culture, leadership, training, environment, and technology, as well as on safety items was used. To test the validity of the questionnaire, content validity test was conducted, and the reliability of the questionnaire was assessed by retest method, in which the value of alpha was equal to 91%. The results showed that safety culture was at a high level in 55% of cases, safety leadership was at a high level in 40% cases and at a low level in 2.04% cases, safety training was at a high level in 64.8% cases and at a low level in 4% cases, safety of environment and technology was at a high level in 56.8% cases and at a low level in 1.6% cases, and safety items of the patients in their reports were at a high level in approximately 44% cases and at a low level in 6.5% cases. The results of Student's t-test (P < 0.001) showed that the average score of all safety categories of the patients was significantly higher than the average points. Diligence of the management and personnel of the hospital is necessary for the improvement of safety management. For this purpose, the management of hospitals can show interest in safety, develop an events reporting system, enhance teamwork, and implement clinical governance plans.

  4. To what extent can theory account for the findings of road safety evaluation studies?

    PubMed

    Elvik, Rune

    2004-09-01

    This paper proposes a conceptual framework that can be used to assess to what extent the findings of road safety evaluation research make sense from a theoretical point of view. The effects of road safety measures are modelled as passing through two causal chains. One of these, termed the engineering effect, refers to the intended effects of a road safety measure on a set of risk factors related to accident occurrence or injury severity. The engineering effect of road safety measures is modelled in terms of nine basic risk factors, one or more of which any road safety measure needs to influence in order to have the intended effect on accidents or injuries. The other causal chain producing the effects of road safety measures is termed the behavioural effect, and refers to road user behavioural adaptations to road safety measures. The behavioural effect is related to the engineering effect, in the sense that certain properties of the engineering effect of a road safety measure influence the likelihood that behavioural adaptation will occur. The behavioural effect of a road safety measure is modelled in terms of six factors that influence the likelihood that behavioural adaptation will occur. The nine basic risk factors representing the engineering effect of a road safety measure, and the six factors influencing the likelihood of behavioural adaptation can be used as checklists in assessing whether or not the findings of road safety evaluation studies make sense from a theoretical point of view. At the current state of knowledge, a more stringent evaluation of the extent to which theory can explain the findings of road safety evaluation studies is, in most cases, not possible. Copyright 2003 Elsevier Ltd.

  5. Wisconsin large truck safety and enforcement study.

    DOT National Transportation Integrated Search

    2011-07-01

    The Wisconsin Large Truck Safety and Enforcement Study (LTS&E) focused on a system-wide evaluation of large truck safety in the : state of Wisconsin. This study analyzes crash data related to large trucks that are close to the following criteria: gre...

  6. Reporting of methodological features in observational studies of pre-harvest food safety.

    PubMed

    Sargeant, Jan M; O'Connor, Annette M; Renter, David G; Kelton, David F; Snedeker, Kate; Wisener, Lee V; Leonard, Erin K; Guthrie, Alessia D; Faires, Meredith

    2011-02-01

    Observational studies in pre-harvest food safety may be useful for identifying risk factors and for evaluating potential mitigation strategies to reduce foodborne pathogens. However, there are no structured reporting guidelines for these types of study designs in livestock species. Our objective was to evaluate the reporting of observational studies in the pre-harvest food safety literature using guidelines modified from the human healthcare literature. We identified 100 pre-harvest food safety studies published between 1999 and 2009. Each study was evaluated independently by two reviewers using a structured checklist. Of the 38 studies that explicitly stated the observational study design, 27 were described as cross-sectional studies, eight as case-control studies, and three as cohort studies. Study features reported in over 75% of the selected studies included: description of the geographic location of the studies, definitions and sources of data for outcomes, organizational level and source of data for independent variables, description of statistical methods and results, number of herds enrolled in the study and included in the analysis, and sources of study funding. However, other features were not consistently reported, including details related to eligibility criteria for groups (such as barn, room, or pen) and individuals, numbers of groups and individuals included in various stages of the study, identification of primary outcomes, the distinction between putative risk factors and confounding variables, the identification of a primary exposure variable, the referent level for evaluation of categorical variable associations, methods of controlling confounding variables and missing variables, model fit, details of subset analysis, demographic information at the sampling unit level, and generalizability of the study results. Improvement in reporting of observational studies of pre-harvest food safety will aid research readers and reviewers in interpreting and

  7. Postmarketing Safety Study Tool: A Web Based, Dynamic, and Interoperable System for Postmarketing Drug Surveillance Studies

    PubMed Central

    Sinaci, A. Anil; Laleci Erturkmen, Gokce B.; Gonul, Suat; Yuksel, Mustafa; Invernizzi, Paolo; Thakrar, Bharat; Pacaci, Anil; Cinar, H. Alper; Cicekli, Nihan Kesim

    2015-01-01

    Postmarketing drug surveillance is a crucial aspect of the clinical research activities in pharmacovigilance and pharmacoepidemiology. Successful utilization of available Electronic Health Record (EHR) data can complement and strengthen postmarketing safety studies. In terms of the secondary use of EHRs, access and analysis of patient data across different domains are a critical factor; we address this data interoperability problem between EHR systems and clinical research systems in this paper. We demonstrate that this problem can be solved in an upper level with the use of common data elements in a standardized fashion so that clinical researchers can work with different EHR systems independently of the underlying information model. Postmarketing Safety Study Tool lets the clinical researchers extract data from different EHR systems by designing data collection set schemas through common data elements. The tool interacts with a semantic metadata registry through IHE data element exchange profile. Postmarketing Safety Study Tool and its supporting components have been implemented and deployed on the central data warehouse of the Lombardy region, Italy, which contains anonymized records of about 16 million patients with over 10-year longitudinal data on average. Clinical researchers in Roche validate the tool with real life use cases. PMID:26543873

  8. Discussion on the Criterion for the Safety Certification Basis Compilation - Brazilian Space Program Case

    NASA Astrophysics Data System (ADS)

    Niwa, M.; Alves, N. C.; Caetano, A. O.; Andrade, N. S. O.

    2012-01-01

    The recent advent of the commercial launch and re- entry activities, for promoting the expansion of human access to space for tourism and hypersonic travel, in the already complex ambience of the global space activities, brought additional difficulties over the development of a harmonized framework of international safety rules. In the present work, with the purpose of providing some complementary elements for global safety rule development, the certification-related activities conducted in the Brazilian space program are depicted and discussed, focusing mainly on the criterion for certification basis compilation. The results suggest that the composition of a certification basis with the preferential use of internationally-recognized standards, as is the case of ISO standards, can be a first step toward the development of an international safety regulation for commercial space activities.

  9. Safety Early Warning Research for Highway Construction Based on Case-Based Reasoning and Variable Fuzzy Sets

    PubMed Central

    Liu, Yan; Xu, Zhen-Jun

    2013-01-01

    As a high-risk subindustry involved in construction projects, highway construction safety has experienced major developments in the past 20 years, mainly due to the lack of safe early warnings in Chinese construction projects. By combining the current state of early warning technology with the requirements of the State Administration of Work Safety and using case-based reasoning (CBR), this paper expounds on the concept and flow of highway construction safety early warnings based on CBR. The present study provides solutions to three key issues, index selection, accident cause association analysis, and warning degree forecasting implementation, through the use of association rule mining, support vector machine classifiers, and variable fuzzy qualitative and quantitative change criterion modes, which fully cover the needs of safe early warning systems. Using a detailed description of the principles and advantages of each method and by proving the methods' effectiveness and ability to act together in safe early warning applications, effective means and intelligent technology for a safe highway construction early warning system are established. PMID:24191134

  10. Safety early warning research for highway construction based on case-based reasoning and variable fuzzy sets.

    PubMed

    Liu, Yan; Yi, Ting-Hua; Xu, Zhen-Jun

    2013-01-01

    As a high-risk subindustry involved in construction projects, highway construction safety has experienced major developments in the past 20 years, mainly due to the lack of safe early warnings in Chinese construction projects. By combining the current state of early warning technology with the requirements of the State Administration of Work Safety and using case-based reasoning (CBR), this paper expounds on the concept and flow of highway construction safety early warnings based on CBR. The present study provides solutions to three key issues, index selection, accident cause association analysis, and warning degree forecasting implementation, through the use of association rule mining, support vector machine classifiers, and variable fuzzy qualitative and quantitative change criterion modes, which fully cover the needs of safe early warning systems. Using a detailed description of the principles and advantages of each method and by proving the methods' effectiveness and ability to act together in safe early warning applications, effective means and intelligent technology for a safe highway construction early warning system are established.

  11. [Cardiac safety of electroconvulsive therapy in an elderly patient--a case report].

    PubMed

    Karakuła-Juchnowicz, Hanna; Próchnicki, Michał; Kiciński, Paweł; Olajossy, Marcin; Pelczarska-Jamroga, Agnieszka; Dzikowski, Michał; Jaroszyński, Andrzej

    2015-10-01

    Since electroconvulsive therapy (ECT) was introduced as treatment for psychiatric disorders in 1938, it has remained one of the most effective therapeutic methods. ECT is often used as a "treatment of last resort" when other methods fail, and a life-saving procedure in acute clinical states when a rapid therapeutic effect is needed. Mortality associated with ECT is lower, compared to the treatment with tricyclic antidepressants, and comparable to that observed in so-called minor surgery. In the literature, cases of effective and safe electroconvulsive therapy have been described in patients of advanced age, with a burden of many somatic disorders. However, cases of acute cardiac episodes have also been reported during ECT. The qualification of patients for ECT and the selection of a group of patients at the highest risk of cardiovascular complications remains a serious clinical problem. An assessment of the predictive value of parameters of standard electrocardiogram (ECG), which is a simple, cheap and easily available procedure, deserves special attention. This paper reports a case of a 74-year-old male patient treated with ECT for a severe depressive episode, in the context of cardiologic safety. Both every single ECT session and the full course were assessed to examine their impact on levels of troponin T, which is a basic marker of cardiac damage, and selected ECG parameters (QTc, QRS). In the presented case ECT demonstrated its high general and cardiac safety with no negative effect on cardiac troponin (TnT) levels, corrected QT interval (QTc) duration, or other measured ECG parameters despite initially increased troponin levels, the patient's advanced age, the burden of a severe somatic disease and its treatment (anticancer therapy). © 2015 MEDPRESS.

  12. Development of a Comprehensive Database System for Safety Analyst

    PubMed Central

    Paz, Alexander; Veeramisti, Naveen; Khanal, Indira; Baker, Justin

    2015-01-01

    This study addressed barriers associated with the use of Safety Analyst, a state-of-the-art tool that has been developed to assist during the entire Traffic Safety Management process but that is not widely used due to a number of challenges as described in this paper. As part of this study, a comprehensive database system and tools to provide data to multiple traffic safety applications, with a focus on Safety Analyst, were developed. A number of data management tools were developed to extract, collect, transform, integrate, and load the data. The system includes consistency-checking capabilities to ensure the adequate insertion and update of data into the database. This system focused on data from roadways, ramps, intersections, and traffic characteristics for Safety Analyst. To test the proposed system and tools, data from Clark County, which is the largest county in Nevada and includes the cities of Las Vegas, Henderson, Boulder City, and North Las Vegas, was used. The database and Safety Analyst together help identify the sites with the potential for safety improvements. Specifically, this study examined the results from two case studies. The first case study, which identified sites having a potential for safety improvements with respect to fatal and all injury crashes, included all roadway elements and used default and calibrated Safety Performance Functions (SPFs). The second case study identified sites having a potential for safety improvements with respect to fatal and all injury crashes, specifically regarding intersections; it used default and calibrated SPFs as well. Conclusions were developed for the calibration of safety performance functions and the classification of site subtypes. Guidelines were provided about the selection of a particular network screening type or performance measure for network screening. PMID:26167531

  13. Relationship between preventable hospital deaths and other measures of safety: an exploratory study.

    PubMed

    Hogan, Helen; Healey, Frances; Neale, Graham; Thomson, Richard; Vincent, Charles; Black, Nick

    2014-06-01

    To explore associations between the proportion of hospital deaths that are preventable and other measures of safety. Retrospective case record review to provide estimates of preventable death proportions. Simple monotonic correlations using Spearman's rank correlation coefficient to establish the relationship with eight other measures of patient safety. Ten English acute hospital trusts. One thousand patients who died during 2009. The proportion of preventable deaths varied between hospitals (3-8%) but was not statistically significant (P = 0.94). Only one of the eight measures of safety (Methicillin-resistant Staphylococcus aureus bacteraemia rate) was clinically and statistically significantly associated with preventable death proportion (r = 0.73; P < 0.02). There were no significant associations with the other measures including hospital standardized mortality ratios (r = -0.01). There was a suggestion that preventable deaths may be more strongly associated with some other measures of outcome than with process or with structure measures. The exploratory nature of this study inevitably limited its power to provide definitive results. The observed relationships between safety measures suggest that a larger more powerful study is needed to establish the inter-relationship of different measures of safety (structure, process and outcome), in particular the widely used standardized mortality ratios. © The Author 2014. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

  14. Public perception of drinking water safety in South Africa 2002-2009: a repeated cross-sectional study.

    PubMed

    Wright, Jim A; Yang, Hong; Rivett, Ulrike; Gundry, Stephen W

    2012-07-27

    In low and middle income countries, public perceptions of drinking water safety are relevant to promotion of household water treatment and to household choices over drinking water sources. However, most studies of this topic have been cross-sectional and not considered temporal variation in drinking water safety perceptions. The objective of this study is to explore trends in perceived drinking water safety in South Africa and its association with disease outbreaks, water supply and household characteristics. This repeated cross-sectional study draws on General Household Surveys from 2002-2009, a series of annual nationally representative surveys of South African households, which include a question about perceived drinking water safety. Trends in responses to this question were examined from 2002-2009 in relation to reported cholera cases. The relationship between perceived drinking water safety and organoleptic qualities of drinking water, supply characteristics, and socio-economic and demographic household characteristics was explored in 2002 and 2008 using hierarchical stepwise logistic regression. The results suggest that perceived drinking water safety has remained relatively stable over time in South Africa, once the expansion of improved supplies is controlled for. A large cholera outbreak in 2000-02 had no apparent effect on public perception of drinking water safety in 2002. Perceived drinking water safety is primarily related to water taste, odour, and clarity rather than socio-economic or demographic characteristics. This suggests that household perceptions of drinking water safety in South Africa follow similar patterns to those observed in studies in developed countries. The stability over time in public perception of drinking water safety is particularly surprising, given the large cholera outbreak that took place at the start of this period.

  15. Cause and Prevention of Playground Injuries and Litigation; Case Studies.

    ERIC Educational Resources Information Center

    Frost, Joe L.; Sweeney, Theodora B.

    This study examined 187 playground injuries and 13 fatalities that resulted in lawsuits between 1981 and 1995, taken from the files of two expert witnesses on playground safety who testified in the cases. The data are presented by geographic location, nature of injuries, cause of injuries/fatalities, playground equipment implicated, location of…

  16. Another Approach to Enhance Airline Safety: Using Management Safety Tools

    NASA Technical Reports Server (NTRS)

    Lu, Chien-tsug; Wetmore, Michael; Przetak, Robert

    2006-01-01

    The ultimate goal of conducting an accident investigation is to prevent similar accidents from happening again and to make operations safer system-wide. Based on the findings extracted from the investigation, the "lesson learned" becomes a genuine part of the safety database making risk management available to safety analysts. The airline industry is no exception. In the US, the FAA has advocated the usage of the System Safety concept in enhancing safety since 2000. Yet, in today s usage of System Safety, the airline industry mainly focuses on risk management, which is a reactive process of the System Safety discipline. In order to extend the merit of System Safety and to prevent accidents beforehand, a specific System Safety tool needs to be applied; so a model of hazard prediction can be formed. To do so, the authors initiated this study by reviewing 189 final accident reports from the National Transportation Safety Board (NTSB) covering FAR Part 121 scheduled operations. The discovered accident causes (direct hazards) were categorized into 10 groups Flight Operations, Ground Crew, Turbulence, Maintenance, Foreign Object Damage (FOD), Flight Attendant, Air Traffic Control, Manufacturer, Passenger, and Federal Aviation Administration. These direct hazards were associated with 36 root factors prepared for an error-elimination model using Fault Tree Analysis (FTA), a leading tool for System Safety experts. An FTA block-diagram model was created, followed by a probability simulation of accidents. Five case studies and reports were provided in order to fully demonstrate the usefulness of System Safety tools in promoting airline safety.

  17. A longitudinal, multi-level comparative study of quality and safety in European hospitals: the QUASER study protocol.

    PubMed

    Robert, Glenn B; Anderson, Janet E; Burnett, Susan J; Aase, Karina; Andersson-Gare, Boel; Bal, Roland; Calltorp, Johan; Nunes, Francisco; Weggelaar, Anne-Marie; Vincent, Charles A; Fulop, Naomi J

    2011-10-26

    although there is a wealth of information available about quality improvement tools and techniques in healthcare there is little understanding about overcoming the challenges of day-to-day implementation in complex organisations like hospitals. The 'Quality and Safety in Europe by Research' (QUASER) study will investigate how hospitals implement, spread and sustain quality improvement, including the difficulties they face and how they overcome them. The overall aim of the study is to explore relationships between the organisational and cultural characteristics of hospitals and how these impact on the quality of health care; the findings will be designed to help policy makers, payers and hospital managers understand the factors and processes that enable hospitals in Europe to achieve-and sustain-high quality services for their patients. in-depth multi-level (macro, meso and micro-system) analysis of healthcare quality policies and practices in 5 European countries, including longitudinal case studies in a purposive sample of 10 hospitals. The project design has three major features: • a working definition of quality comprising three components: clinical effectiveness, patient safety and patient experience • a conceptualisation of quality as a human, social, technical and organisational accomplishment • an emphasis on translational research that is evidence-based and seeks to provide strategic and practical guidance for hospital practitioners and health care policy makers in the European Union. Throughout the study we will adopt a mixed methods approach, including qualitative (in-depth, narrative-based, ethnographic case studies using interviews, and direct non-participant observation of organisational processes) and quantitative research (secondary analysis of safety and quality data, for example: adverse incident reporting; patient complaints and claims). the protocol is based on the premise that future research, policy and practice need to address the

  18. Motorcycle safety among motorcycle taxi drivers and nonoccupational motorcyclists in developing countries: A case study of Maoming, South China.

    PubMed

    Wu, Connor Y H; Loo, Becky P Y

    2016-01-01

    An increasing number of motorcycle taxis have been involved in traffic crashes in many developing countries. This study examines the characteristics of both motorcycle taxi drivers and nonoccupational motorcyclists, investigates the risks they pose to road safety, and provides recommendations to minimize their risks. Based on the data collected from a questionnaire survey of 867 motorcycle taxi drivers and 2,029 nonoccupational motorcyclists in Maoming, South China, comparisons were made to analyze differences of personal attributes, attitudes toward road safety, and self-reported behavior of the 2 groups. Results of the chi-square tests show that not only motorcycle taxi drivers but also nonoccupational motorcyclists in Maoming held poor attitudes toward road safety and both groups reported unsafe driving behavior. There is much room for improving local road safety education among all motorcyclists in Maoming. Yet, motorcycle taxi drivers were more likely to pose road safety risks than nonoccupational motorcyclists under some circumstances, such as speeding late at night or early in the morning, not requiring passengers to wear helmets, and running a red light. The results of the binary logistic regression model show that possessing a vehicle license for a motorcycle or not was the common significant predictor for unsafe driving behavior of motorcycle taxi drivers and nonoccupational motorcyclists. Therefore, enforcement against all motorcyclists not showing vehicle licenses for their motorcycles should be stepped up. Motorcycle safety is largely poor in Maoming. Therefore, efforts to improve motorcycle safety should be strengthened by targeting not only motorcycle taxi drivers but also nonoccupational motorcyclists.

  19. A Team, Case-based Examination and Its Impact on Student Performance in a Patient Safety and Informatics Course

    PubMed Central

    Etheridge, Kierstan; DeLellis, Teresa

    2017-01-01

    Objective. To describe the redesigned assessment plan for a patient safety and informatics course and assess student pharmacist performance and perceptions. Methods. The final examination of a patient safety course was redesigned from traditional multiple choice and short answer to team-based, open-ended, and case-based. Faculty for each class session developed higher level activities, focused on developing key skills or attitudes deemed essential for practice, for a progressive patient case consisting of nine activities. Student performance and perceptions were analyzed with pre- and post-surveys using 5-point scales. Results. Mean performance on the examination was 93.6%; median scores for each assessed course outcome ranged from 90% to 100%. Eighty-five percent of students completed both surveys. Confidence performing skills and demonstrating attitudes improved for each item on post-survey compared with pre-survey. Eighty-one percent of students indicated the experience of taking the examination was beneficial for their professional development. Conclusion. A team, case-based examination was associated with high student performance and improved self-confidence in performing medication safety-related skills. PMID:28970618

  20. Safety improvements through Intelligent Transport Systems: a South African case study based on microscopic simulation modelling.

    PubMed

    Vanderschuren, Marianne

    2008-03-01

    Intelligent Transport Systems (ITS) can facilitate the delivery of a wide range of policy objectives. There are six main objectives/benefits identified in the international literature: Safety (reduction of (potential) crashes), mobility (reduction of delays and travel times), efficiency (optimise the use of existing infrastructure), productivity (cost saving), energy/environment and customer satisfaction [Mitretek Systems, 2001. Intelligent Transport System Benefits: 2001 update, Under Contract to the Federal Highway Administration, US Department of Transportation, Washington, DC, US]. In the South African context, there is an interest for measures that can reduce (potential) crashes. In South Africa the number of year on year traffic related fatalities is still increasing. In 2005 the number of fatalities was 15393 (from 14135 in 2004) while the estimated costs for the same period increased from R8.89-billion to R9.99-billion [RTMC, 2007. Interim Road Traffic and Fatal Crash Report 2006, Road Traffic Management Corporation, Pretoria, SA]. Given the extent of the road safety problem and the potential benefits of ITS, the need for further research is apparent. A study with regards to the potential of different types of models (macroscopic, mesoscopic and miscroscopic simulation models) led to the use of Paramics. Two corridors and three types of ITS measures were investigated and safety benefits were estimated.

  1. Efficacy and safety of oral citicoline in acute ischemic stroke: drug surveillance study in 4,191 cases.

    PubMed

    Cho, H-J; Kim, Y J

    2009-04-01

    Citicoline is an essential precursor in the synthesis of phosphatidylcholine, a key cell membrane phospholipid, and is known to have neuroprotective effects in acute ischemic stroke. The aim of this study was to determine the efficacy and safety of oral citicoline in Korean patients with acute ischemic stroke. A drug surveillance study was carried out in 4,191 patients with a diagnosis of acute ischemic stroke. Oral citicoline (500-4000 mg/day) was administered within less than 24 h after acute ischemic stroke in 3,736 patients (early group) and later than 24 h after acute ischemic stroke in 455 patients (late group) for at least 6 weeks. For efficacy assessment, primary outcomes were patients' scores obtained with a short form of the National Institutes of Health Stroke Scale (s-NIHSS), a short form of the Barthel Index of activities of daily living (s-BI) and a modified Rankin Scale (mRS) at enrollment, after 6 weeks and at the end of therapy for those patients with extended treatment. All adverse reactions were monitored during the study period for safety assessment. All measured outcomes, including s-NIHSS, s-BI and mRS, were improved after 6 weeks of therapy (P < 0.05). Further improvement was observed in 125 patients who continued citicoline therapy for more than 12 weeks when compared with those who ended therapy at week 6. Improvements were more significant in the higher dose group (> or = 2000 mg/day) (P < 0.001). s-BI scores showed no differences between the early and late groups at the end of therapy. Citicoline safety was excellent; 37 side effects were observed in 31 patients (0.73%). The most frequent findings were nervous system-related symptoms (8 of 37, 21.62%), followed by gastrointestinal symptoms (5 of 37, 13.5%). Oral citicoline improved neurological, functional and global outcomes in patients with acute ischemic stroke without significant safety concerns. Copyright 2009 Prous Science, S.A.U. or its licensors. All rights reserved.

  2. Case studies with new excipients: development, implementation and regulatory approval.

    PubMed

    Koo, Otilia M Y; Varia, Sailesh A

    2011-07-01

    The purpose of this article is to describe the process whereby new excipients become accepted and to describe three case studies to illustrate the process. New excipients are defined according to the 2005 FDA Guidance on Nonclinical Safety Evaluation of New Excipients. The requirements for safety data submission for new excipients used in different classes of products for different durations are outlined in the guidance. Currently, the development of new excipients is linked to the development and approval of new drug products that contain them. New excipients that are used in US-approved drug products become listed in the FDA Inactive Ingredients Guide (IIG) database. Thereafter, US Pharmacopeia monographs for the new excipients are proposed. New excipients are reviewed and become accepted in the same way in Europe and Japan, except that there is no equivalent IIG database. Therefore, the focus of this article will be on the FDA review process. Three case studies, polyoxyl 15 hydroxystearate, sulfobutyl ether cyclodextrin and silicified microcrystalline cellulose, are used to illustrate how new excipients are accepted and implemented.

  3. Methods and Case Studies for Teaching and Learning about Failure and Safety.

    ERIC Educational Resources Information Center

    Bignell, Victor

    1999-01-01

    Discusses methods for analyzing case studies of failures of technological systems. Describes two distance learning courses that compare standard models of failure and success with the actuality of given scenarios. Provides teaching and learning materials and information sources for application to aspects of design, manufacture, inspection, use,…

  4. Safety of plant-made pharmaceuticals: product development and regulatory considerations based on case studies of two autologous human cancer vaccines.

    PubMed

    Tusé, Daniel

    2011-03-01

    Guidelines issued by regulatory agencies for the development of plant-made pharmaceutical (PMP) products provide criteria for product manufacturing and characterization, safety determination, containment and mitigation of environmental risks. Features of plant-made products do not always enable an easy fit within the criteria subscribed to by regulators. The unconventional nature of plant-based manufacturing processes and peculiarities of plant biology relative to that of traditional biological production systems have led to special considerations in the regulatory scrutiny of PMP. Presented in this review are case studies of two plant-made autologous (patient-specific) cancer vaccines, the nature of which introduced challenges to conventional and standardized development and preclinical evaluation routes. The rationale presented to FDA by the sponsors of each vaccine to build consensus and obtain variances to existing guidelines is discussed. While development of many plant-made biologics can be accomplished within the existing regulatory framework, the development of specialized products can be defended with rational arguments based on strong science.

  5. Multiple Kernel Learning for Heterogeneous Anomaly Detection: Algorithm and Aviation Safety Case Study

    NASA Technical Reports Server (NTRS)

    Das, Santanu; Srivastava, Ashok N.; Matthews, Bryan L.; Oza, Nikunj C.

    2010-01-01

    The world-wide aviation system is one of the most complex dynamical systems ever developed and is generating data at an extremely rapid rate. Most modern commercial aircraft record several hundred flight parameters including information from the guidance, navigation, and control systems, the avionics and propulsion systems, and the pilot inputs into the aircraft. These parameters may be continuous measurements or binary or categorical measurements recorded in one second intervals for the duration of the flight. Currently, most approaches to aviation safety are reactive, meaning that they are designed to react to an aviation safety incident or accident. In this paper, we discuss a novel approach based on the theory of multiple kernel learning to detect potential safety anomalies in very large data bases of discrete and continuous data from world-wide operations of commercial fleets. We pose a general anomaly detection problem which includes both discrete and continuous data streams, where we assume that the discrete streams have a causal influence on the continuous streams. We also assume that atypical sequence of events in the discrete streams can lead to off-nominal system performance. We discuss the application domain, novel algorithms, and also discuss results on real-world data sets. Our algorithm uncovers operationally significant events in high dimensional data streams in the aviation industry which are not detectable using state of the art methods

  6. U. K. pressing campaign to improve offshore safety

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

    Knott, D.

    1994-02-14

    The U.K. government is making progress in its campaign to improve the safety of personnel working offshore. The government's Health and Safety Executive (HSE) plans to assess and pass judgment on at lease one safety plan, called a safety case, from each U.K. North Sea operator as soon as possible. HSE has agreed with the industry on a list of 61 priority safety cases, known as exemplars. Feedback from exemplar assessment will help operators review safety management and assist in preparation or revision of future safety cases. It also will give HSE practice in assessing a range of case types.more » The requirement for a safety program is part of new U.K. offshore legislation designed to prevent another accident similar to the Piper Alpha platform fire and explosion of 1988. After the transition period it will be against the law to operate an oil and gas installation in British waters without an accepted safety case. Besides existing installations, safety cases are also required for new installations reaching design stage by May 31, 1993, the date safety case regulations went into force. The paper describes the Cullen report, companies' experiences with the new law, and the safety assessment progress so far.« less

  7. Comprehensive Lifecycle for Assuring System Safety

    NASA Technical Reports Server (NTRS)

    Knight, John C.; Rowanhill, Jonathan C.

    2017-01-01

    CLASS is a novel approach to the enhancement of system safety in which the system safety case becomes the focus of safety engineering throughout the system lifecycle. CLASS also expands the role of the safety case across all phases of the system's lifetime, from concept formation to decommissioning. As CLASS has been developed, the concept has been generalized to a more comprehensive notion of assurance becoming the driving goal, where safety is an important special case. This report summarizes major aspects of CLASS and contains a bibliography of papers that provide additional details.

  8. Case Study: Writing a Journal Case Study

    ERIC Educational Resources Information Center

    Prud'homme-Genereux, Annie

    2016-01-01

    This column provides original articles on innovations in case study teaching, assessment of the method, as well as case studies with teaching notes. This month's issue describes incorporating a journal article into the classroom by first converting it into a case study.

  9. Renal studies in safety pharmacology and toxicology: A survey conducted in the top 15 pharmaceutical companies.

    PubMed

    Benjamin, Amanda; Gallacher, David J; Greiter-Wilke, Andrea; Guillon, Jean-Michel; Kasai, Cheiko; Ledieu, David; Levesque, Paul; Prelle, Katja; Ratcliffe, Sian; Sannajust, Frederick; Valentin, Jean-Pierre

    2015-01-01

    With the recent development of more sensitive biomarkers to assess kidney injury preclinically, a survey was designed i) to investigate what strategies are used to investigate renal toxicity in both ICH S7A compliant Safety Pharmacology (SP) studies after a single dose of a compound and within repeat-dose toxicity studies by large pharmaceutical companies today; ii) to understand whether renal SP studies have impact or utility in drug development and/or if it may be more appropriate to assess renal effects after multiple doses of compounds; iii) to ascertain how much mechanistic work is performed by the top 15 largest pharmaceutical companies (as determined by R&D revenue size); iv) to gain an insight into the impact of the validation of DIKI biomarkers and their introduction in the safety evaluation paradigm; and v) to understand the impact of renal/urinary safety study data on progression of projects. Two short anonymous surveys were submitted to SP leaders of the top 15 pharmaceutical companies, as defined by 2012 R&D portfolio size. Fourteen multiple choice questions were designed to explore the strategies used to investigate renal effects in both ICH S7A compliant SP studies and within toxicology studies. A 67% and 60% response rate was obtained in the first and second surveys, respectively. Nine out of ten respondent companies conduct renal excretory measurements (eg. urine analysis) in toxicology studies whereas only five out of ten conduct specific renal SP studies; and all of those 5 also conduct the renal excretory measurements in toxicology studies. These companies measure and/or calculate a variety of parameters as part of these studies, and also on a case by case basis include regulatory qualified and non-qualified DIKI biomarkers. Finally, only one company has used renal/urinary functional data alone to stop a project, whereas the majority of respondents combine renal data with other target organ assessments to form an integrated decision-making set

  10. Numerical and Experimental Case Study of Blasting Works Effect

    NASA Astrophysics Data System (ADS)

    Papán, Daniel; Valašková, Veronika; Drusa, Marian

    2016-10-01

    This article introduces the theoretical and experimental case study of dynamic monitoring of the geological environment above constructed highway tunnel. The monitored structure is in this case a very important water supply pipeline, which crosses the tunnel and was made from steel tubes with a diameter of 800 mm. The basic dynamic parameters had been monitored during blasting works, and were compared with the FEM (Finite Element Method) calculations and checked by the Slovak standard limits. A calibrated FEM model based on the experimental measurement data results was created and used in order to receive more realistic results in further predictions, time and space extrapolations. This case study was required and demanded by the general contractor company and also by the owner of water pipeline, and it was an answer of public safety evaluation of risks during tunnel construction.

  11. A distributed research network model for post-marketing safety studies: the Meningococcal Vaccine Study.

    PubMed

    Velentgas, Priscilla; Bohn, Rhonda L; Brown, Jeffrey S; Chan, K Arnold; Gladowski, Patricia; Holick, Crystal N; Kramer, Judith M; Nakasato, Cynthia; Spettell, Claire M; Walker, Alexander M; Zhang, Fang; Platt, Richard

    2008-12-01

    We describe a multi-center post-marketing safety study that uses distributed data methods to minimize the need for covered entities to share protected health information (PHI). Implementation has addressed several issues relevant to creation of a large scale post-marketing drug safety surveillance system envisioned by the FDA's Sentinel Initiative. This retrospective cohort study of Guillain-Barré syndrome (GBS) following meningococcal conjugate vaccination incorporates the data and analytic expertise of five research organizations closely affiliated with US health insurers. The study uses administrative claims data, plus review of full text medical records to adjudicate the status of individuals with a diagnosis code for GBS (ICD9 357.0). A distributed network approach is used to create the analysis files and to perform most aspects of the analysis, allowing nearly all of the data to remain behind institutional firewalls. Pooled analysis files transferred to a central site will contain one record per person for approximately 0.2% of the study population, and contain PHI limited to the month and year of GBS onset for cases or the index date for matched controls. The first planned data extraction identified over 9 million eligible adolescents in the target age range of 11-21 years. They contributed an average of 14 months of eligible time on study over 27 months of calendar time. MCV4 vaccination coverage levels exceeded 20% among 17-18-year olds and 16% among 11-13 and 14-16-year-old age groups by the second quarter of 2007. This study demonstrates the feasibility of using a distributed data network approach to perform large scale post-marketing safety analyses and is scalable to include additional organizations and data sources. We believe these results can inform the development of a large national surveillance system. Copyright (c) 2008 John Wiley & Sons, Ltd.

  12. The role of the Data and Safety Monitoring Board in a clinical trial: the CRISIS study.

    PubMed

    Holubkov, Richard; Casper, T Charles; Dean, J Michael; Anand, K J S; Zimmerman, Jerry; Meert, Kathleen L; Newth, Christopher J L; Berger, John; Harrison, Rick; Willson, Douglas F; Nicholson, Carol

    2013-05-01

    Randomized clinical trials are commonly overseen by a Data and Safety Monitoring Board comprised of experts in medicine, ethics, and biostatistics. Data and Safety Monitoring Board responsibilities include protocol approval, interim review of study enrollment, protocol compliance, safety, and efficacy data. Data and Safety Monitoring Board decisions can affect study design and conduct, as well as reported findings. Researchers must incorporate Data and Safety Monitoring Board oversight into the design, monitoring, and reporting of randomized trials. Case study, narrative review. The Data and Safety Monitoring Board's role during the comparative pediatric Critical Illness Stress-Induced Immune Suppression (CRISIS) Prevention Trial is described. The National Institutes of Health-appointed CRISIS Data and Safety Monitoring Board was charged with monitoring sample size adequacy and feasibility, safety with respect to adverse events and 28-day mortality, and efficacy with respect to the primary nosocomial infection/sepsis outcome. The Federal Drug Administration also requested Data and Safety Monitoring Board interim review before opening CRISIS to children below 1 yr of age. The first interim analysis found higher 28-day mortality in one treatment arm. The Data and Safety Monitoring Board maintained trial closure to younger children and requested a second interim data review 6 months later. At this second meeting, mortality was no longer of concern, whereas a weak efficacy trend of lower infection/sepsis rates in one study arm emerged. As over 40% of total patients had been enrolled, the Data and Safety Monitoring Board elected to examine conditional power and unmask treatment arm identities. On finding somewhat greater efficacy in the placebo arm, the Data and Safety Monitoring Board recommended stopping CRISIS due to futility. The design and operating procedures of a multicenter randomized trial must consider a pivotal Data and Safety Monitoring Board role. Maximum

  13. White Paper on studying the safety of the childhood immunization schedule in the Vaccine Safety Datalink.

    PubMed

    Glanz, Jason M; Newcomer, Sophia R; Jackson, Michael L; Omer, Saad B; Bednarczyk, Robert A; Shoup, Jo Ann; DeStefano, Frank; Daley, Matthew F

    2016-02-15

    While the large majority of parents in the U.S. vaccinate their children according to the recommended immunization schedule, some parents have refused or delayed vaccinating, often citing safety concerns. In response to public concern, the U.S. Institute of Medicine (IOM) evaluated existing research regarding the safety of the recommended immunization schedule. The IOM concluded that although available evidence strongly supported the safety of the currently recommended schedule as a whole, additional observational research was warranted to compare health outcomes between fully vaccinated children and those on a delayed or alternative schedule. In addition, the IOM identified the Vaccine Safety Datalink (VSD) as an important resource for conducting this research. Guided by the IOM findings, the Centers for Disease Control and Prevention (CDC) commissioned a White Paper to assess how the VSD could be used to study the safety of the childhood immunization schedule. Guided by subject matter expert engagement, the resulting White Paper outlines a 4 stage approach for identifying exposure groups of undervaccinated children, presents a list of health outcomes of highest priority to examine in this context, and describes various study designs and statistical methods that could be used to analyze the safety of the schedule. While it appears feasible to study the safety of the recommended immunization schedule in settings such as the VSD, these studies will be inherently complex, and as with all observational studies, will need to carefully address issues of confounding and bias. In light of these considerations, decisions about conducting studies of the safety of the schedule will also need to assess epidemiological evidence of potential adverse events that could be related to the schedule, the biological plausibility of an association between an adverse event and the schedule, and public concern about the safety of the schedule. Copyright © 2015 Elsevier Ltd. All rights

  14. 78 FR 56235 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-12

    ... delivery of occupational safety and health services, and the prevention of work-related injury and illness... Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH or... occupational safety and health, and allied areas. It is the intent of NIOSH to support broad-based research...

  15. 78 FR 24751 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-26

    ... improvements in the delivery of occupational safety and health services, and the prevention of work-related... Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH or... issues in occupational safety and health, and allied areas. It is the intent of NIOSH to support broad...

  16. Hospital safety climate surveys: measurement issues.

    PubMed

    Jackson, Jeanette; Sarac, Cakil; Flin, Rhona

    2010-12-01

    Organizational safety culture relates to behavioural norms in the workplace and is usually assessed by safety climate surveys. These can be a diagnostic indicator on the state of safety in a hospital. This review examines recent studies using staff surveys of hospital safety climate, focussing on measurement issues. Four questionnaires (hospital survey on patient safety culture, safety attitudes questionnaire, patient safety climate in healthcare organizations, hospital safety climate scale), with acceptable psychometric properties, are now applied across countries and clinical settings. Comparisons for benchmarking must be made with caution in case of questionnaire modifications. Increasing attention is being paid to the unit and hospital level wherein distinct cultures may be located, as well as to associated measurement and study design issues. Predictive validity of safety climate is tested against safety behaviours/outcomes, with some relationships reported, although effects may be specific to professional groups/units. Few studies test the role of intervening variables that could influence the effect of climate on outcomes. Hospital climate studies are becoming a key component of healthcare safety management systems. Large datasets have established more reliable instruments that allow a more focussed investigation of the role of culture in the improvement and maintenance of staff's safety perceptions within units, as well as within hospitals.

  17. Electrical Safety: Safety and Health for Electrical Trades. Student Manual.

    ERIC Educational Resources Information Center

    Fowler, Thaddeus W.; Miles, Karen K.

    This document is designed to teach learners in secondary and postsecondary electrical trades courses to recognize, evaluate, and control hazards associated with electrical work, The manual's eight sections each include some or all of the following components: instructional text; definitions; case studies illustrating key safety considerations;…

  18. New safety rules challenge U. K. operators, regulators

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

    Hudson, J.

    1994-08-15

    Offshore safety regulations based on lessons learned from the Piper Alpha blast of 1988 have been in operation in the U.K. for a year. The Offshore Installations (Safety Case) Regulations 1992 make operators of fixed and mobile installations (the duty holders'') responsible for producing a formal safety assessment, or safety case, for each installation. After the end of November 1995 it will be an offense to operate an installation without a safety case which has been approved by the government's Health and Safety Executive (HSE). Producing safety cases for installations is a major task for duty holder, while assessing themmore » is a huge under taking for HSE's Offshore Safety Division (OSD). This paper reviews how HSE has established management arrangements to handle safety cases, considers progress in assessment, highlights some of the important lessons learned, and look to the future.« less

  19. Implementation of Water Safety Plans (WSPs): A Case Study in the Coastal Area in Semarang City, Indonesia

    NASA Astrophysics Data System (ADS)

    Budiyono; Ginandjar, P.; Saraswati, L. D.; Pangestuti, D. R.; Martini; Jati, S. P.

    2018-02-01

    An area of 508.28 hectares in North Semarang is flooded by tidal inundation, including Bandarharjo village, which could affect water quality in the area. People in Bandarharjo use safe water from deep groundwater, without disinfection process. More than 90% of water samples in the Bandaharjo village had poor bacteriological quality. The aimed of the research was to describe the implementation of Water Safety Plans (WSPs) program in Bandarharjo village. This was a descriptive study with steps for implementations adopted the guidelines and tools of the World Health Organization. The steps consist of introducing WSPs program, team building, training the team, examination of water safety before risk assessment, risk assessment, minor repair I, examination of water safety risk, minor repair II (after monitoring). Data were analyzed using descriptive methods. WSPs program has been introduced and formed WSPs team, and the training of the team has been conducted. The team was able to conduct risks assessment, planned the activities, examined water quality, conduct minor repair and monitoring at the source, distribution, and households connection. The WSPs program could be implemented in the coastal area in Semarang, however regularly supervision and some adjustment are needed.

  20. Improving Quality and Safety of Care Using “Technovigilance”: An Ethnographic Case Study of Secondary Use of Data from an Electronic Prescribing and Decision Support System

    PubMed Central

    Dixon-Woods, Mary; Redwood, Sabi; Leslie, Myles; Minion, Joel; Martin, Graham P; Coleman, Jamie J

    2013-01-01

    Context “Meaningful use” of electronic health records to improve quality of care has remained understudied. We evaluated an approach to improving patients’ safety and quality of care involving the secondary use of data from a hospital electronic prescribing and decision support system (ePDSS). Methods We conducted a case study of a large English acute care hospital with a well-established ePDSS. Our study was based on ethnographic observations of clinical settings (162 hours) and meetings (28 hours), informal conversations with clinical staff, semistructured interviews with ten senior executives, and the collection of relevant documents. Our data analysis was based on the constant comparative method. Findings This hospital's approach to quality and safety could be characterized as “technovigilance.” It involved treating the ePDSS as a warehouse of data on clinical activity and performance. The hospital converted the secondary data into intelligence about the performance of individuals, teams, and clinical services and used this as the basis of action for improvement. Through a combination of rapid audit, feedback to clinical teams, detailed and critical review of apparent omissions in executive-led meetings, a focus on personal professional responsibility for patients’ safety and quality care, and the correction of organizational or systems defects, technovigilance was—based on the hospital's own evidence—highly effective in improving specific indicators. Measures such as the rate of omitted doses of medication showed marked improvement. As do most interventions, however, technovigilance also had unintended consequences. These included the risk of focusing attention on aspects of patient safety made visible by the system at the expense of other, less measurable but nonetheless important, concerns. Conclusions The secondary use of electronic data can be effective for improving specific indicators of care if accompanied by a range of interventions to

  1. Safety of Cryo-Transbronchial Biopsy in Diffuse Lung Diseases: Analysis of Three Hundred Cases.

    PubMed

    Gershman, Evgeni; Fruchter, Oren; Benjamin, Fox; Nader, Abed Rahman; Rosengarten, Dror; Rusanov, Victoria; Fridel, Ludmila; Kramer, Mordechai R

    2015-01-01

    Transbronchial biopsy (TBB) which is performed with metal forceps (forceps TBB) has been accepted as a useful technique in establishing diagnoses of diffuse lung diseases (DLDs). The use of cryoprobes to obtain alveolar tissue (cryo-TBB) is a new method which is currently used by our institute as well as others with excellent results. To assess the safety of cryo-TBB compared with conventional forceps TBB. We performed a retrospective data evaluation of 300 consecutive patients who underwent cryo-TBB between January 2012 and April 2014 and compared them with historical cases treated with forceps TBB between 2010 and 2012. The results of both diagnostic modalities were compared based on pathological reports. The major complications (significant bleeding and pneumothorax) were compared, along with postprocedural hospitalization. Pneumothorax was observed in 15 cases (4.95%) treated with cryo-TBB versus 9 cases (3.15%) treated with forceps TBB, with no significant difference (p = 0.303). The insertion of a chest tube was necessary in 6 (2%) and 4 (1.3%) of the cases having undergone cryo-TBB or forceps TBB, respectively (p = 0.8). In the cryo-TBB group, bleeding was encountered in 16 cases (5.2%), and it occurred in 13 cases (4.5%) of the forceps TBB group, with no significant difference in rates (p = 0.706). Also, there was no significant difference in hospital admission rates between the groups [cryo-TBB: 10 (3.3%); forceps TBB: 4 (1.44%); p = 0.181]. The safety profile of cryo- and forceps TBB remained the same even when stratified according to indications for TBB, i.e. immunocompromised hosts, patients after lung transplantation and those with DLDs. In patients with DLDs, cryo-TBB is as safe as forceps TBB.

  2. Effective Safety Management in Construction Project

    NASA Astrophysics Data System (ADS)

    Othman, I.; Shafiq, Nasir; Nuruddin, M. F.

    2017-12-01

    Effective safety management is one of the serious problems in the construction industry worldwide, especially in large-scale construction projects. There have been significant reductions in the number and the rate of injury over the last 20 years. Nevertheless, construction remains as one of the high risk industry. The purpose of this study is to examine safety management in the Malaysian construction industry, as well as to highlight the importance of construction safety management. The industry has contributed significantly to the economic growth of the country. However, when construction safety management is not implemented systematically, accidents will happen and this can affect the economic growth of the country. This study put the safety management in construction project as one of the important elements to project performance and success. The study emphasize on awareness and the factors that lead to the safety cases in construction project.

  3. 'Geo'chemical research: a key building block for nuclear waste disposal safety cases.

    PubMed

    Altmann, Scott

    2008-12-12

    Disposal of high level radioactive waste in deep underground repositories has been chosen as solution by several countries. Because of the special status this type waste has in the public mind, national implementation programs typically mobilize massive R&D efforts, last decades and are subject to extremely detailed and critical social-political scrutiny. The culminating argument of each program is a 'Safety Case' for a specific disposal concept containing, among other elements, the results of performance assessment simulations whose object is to model the release of radionuclides to the biosphere. Public and political confidence in performance assessment results (which generally show that radionuclide release will always be at acceptable levels) is based on their confidence in the quality of the scientific understanding in the processes included in the performance assessment model, in particular those governing radionuclide speciation and mass transport in the geological host formation. Geochemistry constitutes a core area of research in this regard. Clay-mineral rich formations are the subjects of advanced radwaste programs in several countries (France, Belgium, Switzerland...), principally because of their very low permeabilities and demonstrated capacities to retard by sorption most radionuclides. Among the key processes which must be represented in performance assessment models are (i) radioelement speciation (redox state, speciation, reactions determining radionuclide solid-solution partitioning) and (ii) diffusion-driven transport. The safety case must therefore demonstrate a detailed understanding of the physical-chemical phenomena governing the effects of these two aspects, for each radionuclide, within the geological barrier system. A wide range of coordinated (and internationally collaborated) research has been, and is being, carried out in order to gain the detailed scientific understanding needed for constructing those parts of the Safety Case

  4. Strengthening leadership as a catalyst for enhanced patient safety culture: a repeated cross-sectional experimental study.

    PubMed

    Kristensen, Solvejg; Christensen, Karl Bang; Jaquet, Annette; Møller Beck, Carsten; Sabroe, Svend; Bartels, Paul; Mainz, Jan

    2016-05-13

    Current literature emphasises that clinical leaders are in a position to enable a culture of safety, and that the safety culture is a performance mediator with the potential to influence patient outcomes. This paper aims to investigate staff's perceptions of patient safety culture in a Danish psychiatric department before and after a leadership intervention. A repeated cross-sectional experimental study by design was applied. In 2 surveys, healthcare staff were asked about their perceptions of the patient safety culture using the 7 patient safety culture dimensions in the Safety Attitudes Questionnaire. To broaden knowledge and strengthen leadership skills, a multicomponent programme consisting of academic input, exercises, reflections and discussions, networking, and action learning was implemented among the clinical area level leaders. In total, 358 and 325 staff members participated before and after the intervention, respectively. 19 of the staff members were clinical area level leaders. In both surveys, the response rate was >75%. The proportion of frontline staff with positive attitudes improved by ≥5% for 5 of the 7 patient safety culture dimensions over time. 6 patient safety culture dimensions became more positive (increase in mean) (p<0.05). Frontline staff became more positive on all dimensions except stress recognition (p<0.05). For the leaders, the opposite was the case (p<0.05). Staff leaving the department after the first measurement had rated job satisfaction lower than the staff staying on (p<0.05). The improvements documented in the patient safety culture are remarkable, and imply that strengthening the leadership can act as a significant catalyst for patient safety culture improvement. Further studies using a longitudinal study design are recommended to investigate the mechanism behind leadership's influence on patient safety culture, sustainability of improvements over time, and the association of change in the patient safety culture measures

  5. Increased risk for an atypical autism diagnosis following Thimerosal-containing vaccine exposure in the United States: A prospective longitudinal case-control study in the Vaccine Safety Datalink.

    PubMed

    Geier, David A; Kern, Janet K; Geier, Mark R

    2017-07-01

    Thimerosal is an organic-mercury (Hg)-containing compound (49.55% Hg by weight) historically added to many multi-dose vials of vaccine as a preservative and still added to some vaccines today. Concerns about the toxic effects from Thimerosal-containing childhood vaccines and the risk of an atypical autism diagnosis were evaluated in this study. A hypothesis-testing, prospective longitudinal, case-control study assessed exposure to Hg from Thimerosal-containing hepatitis B vaccines (TM-HepB) among cases diagnosed with atypical autism (n=164) and controls (n=15,216). Automated medical records for subjects born from 1991 to 2000 and continuously enrolled in the Vaccine Safety Datalink (VSD) database were examined. Cases diagnosed with atypical autism were statistically significantly more likely to have received greater overall and dose-dependent exposures to Hg from TM-HepB vaccines administered within the first month of life, first two months of life, and first six months of life than the controls. Similar phenomena were observed when cases and controls were separated by gender. Routine childhood vaccination is an important public health tool to reduce infectious diseases. The present study provides important epidemiological evidence significantly associating increasing Hg exposure from Thimerosal-containing childhood vaccines and the subsequent risk of atypical autism diagnosis, and suggests that Thimerosal should be eliminated from vaccines. Copyright © 2017 Elsevier GmbH. All rights reserved.

  6. Clinical Laboratory Automation: A Case Study

    PubMed Central

    Archetti, Claudia; Montanelli, Alessandro; Finazzi, Dario; Caimi, Luigi; Garrafa, Emirena

    2017-01-01

    Background This paper presents a case study of an automated clinical laboratory in a large urban academic teaching hospital in the North of Italy, the Spedali Civili in Brescia, where four laboratories were merged in a unique laboratory through the introduction of laboratory automation. Materials and Methods The analysis compares the preautomation situation and the new setting from a cost perspective, by considering direct and indirect costs. It also presents an analysis of the turnaround time (TAT). The study considers equipment, staff and indirect costs. Results The introduction of automation led to a slight increase in equipment costs which is highly compensated by a remarkable decrease in staff costs. Consequently, total costs decreased by 12.55%. The analysis of the TAT shows an improvement of nonemergency exams while emergency exams are still validated within the maximum time imposed by the hospital. Conclusions The strategy adopted by the management, which was based on re-using the available equipment and staff when merging the pre-existing laboratories, has reached its goal: introducing automation while minimizing the costs. Significance for public health Automation is an emerging trend in modern clinical laboratories with a positive impact on service level to patients and on staff safety as shown by different studies. In fact, it allows process standardization which, in turn, decreases the frequency of outliers and errors. In addition, it induces faster processing times, thus improving the service level. On the other side, automation decreases the staff exposition to accidents strongly improving staff safety. In this study, we analyse a further potential benefit of automation, that is economic convenience. We study the case of the automated laboratory of one of the biggest hospital in Italy and compare the cost related to the pre and post automation situation. Introducing automation lead to a cost decrease without affecting the service level to patients

  7. Socio-technical issues and challenges in implementing safe patient handovers: insights from ethnographic case studies.

    PubMed

    Balka, Ellen; Tolar, Marianne; Coates, Shannon; Whitehouse, Sandra

    2013-12-01

    Ineffective handovers in patient care, including those where information loss occurs between care providers, have been identified as a risk to patient safety. Computerization of health information is often offered as a solution to improve the quality of care handovers and decrease adverse events related to patient safety. The purpose of this paper is to broaden our understanding of clinical handover as a patient safety issue, and to identify socio-technical issues which may come to bear on the success of computer based handover tools. Three in depth ethnographic case studies were undertaken. Field notes were transcribed and analyzed with the aid of qualitative data analysis software. Within case analysis was performed on each case, and subsequently, cross case analyses were performed. We identified five types of socio-technical issues which must be addressed if electronic handover tools are to succeed. The inter-dependencies of these issues are addressed in relation to arenas in which health care work takes place. We suggest that the contextual nature of information, ethical and medico-legal issues arising in relation to information handover, and issues related to data standards and system interoperability must be addressed if computerized health information systems are to achieve improvements in patient safety related to handovers in care. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  8. Designing Effective Safety Signs, Based on a Study of Recall for Safety Signs.

    ERIC Educational Resources Information Center

    Berry, Dennis W.

    Aside from direct supervision at a recreational facility, safety signs, if designed properly, are the most effective approach to facility safety. This study was conducted to investigate the effectiveness of various sign designs: (l) multiple concepts with text; (2) single concept with text; and (3) single concept with graphics. A discussion of…

  9. Occupational Safety and Health Programs in Career Education.

    ERIC Educational Resources Information Center

    DiCarlo, Robert D.; And Others

    This resource guide was developed in response to the Occupational Safety and Health Act of 1970 and is intended to assist teachers in implementing courses in occupational safety and health as part of a career education program. The material is a synthesis of films, programed instruction, slides and narration, case studies, safety pamphlets,…

  10. Scientific evaluation of the safety factor for the acceptable daily intake (ADI). Case study: butylated hydroxyanisole (BHA).

    PubMed

    Würtzen, G

    1993-01-01

    The principles of 'data-derived safety factors' are applied to toxicological and biochemical information on butylated hydroxyanisole (BHA). The calculated safety factor for an ADI is, by this method, comparable to the existing internationally recognized safety evaluations. Relevance for humans of forestomach tumours in rodents is discussed. The method provides a basis for organizing data in a way that permits an explicit assessment of its relevance.

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

    PubMed

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

    2007-01-01

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

  12. Public perception of drinking water safety in South Africa 2002–2009: a repeated cross-sectional study

    PubMed Central

    2012-01-01

    Background In low and middle income countries, public perceptions of drinking water safety are relevant to promotion of household water treatment and to household choices over drinking water sources. However, most studies of this topic have been cross-sectional and not considered temporal variation in drinking water safety perceptions. The objective of this study is to explore trends in perceived drinking water safety in South Africa and its association with disease outbreaks, water supply and household characteristics. Methods This repeated cross-sectional study draws on General Household Surveys from 2002–2009, a series of annual nationally representative surveys of South African households, which include a question about perceived drinking water safety. Trends in responses to this question were examined from 2002–2009 in relation to reported cholera cases. The relationship between perceived drinking water safety and organoleptic qualities of drinking water, supply characteristics, and socio-economic and demographic household characteristics was explored in 2002 and 2008 using hierarchical stepwise logistic regression. Results The results suggest that perceived drinking water safety has remained relatively stable over time in South Africa, once the expansion of improved supplies is controlled for. A large cholera outbreak in 2000–02 had no apparent effect on public perception of drinking water safety in 2002. Perceived drinking water safety is primarily related to water taste, odour, and clarity rather than socio-economic or demographic characteristics. Conclusion This suggests that household perceptions of drinking water safety in South Africa follow similar patterns to those observed in studies in developed countries. The stability over time in public perception of drinking water safety is particularly surprising, given the large cholera outbreak that took place at the start of this period. PMID:22834485

  13. Moving research to practice through partnership: a case study in Asphalt Paving.

    PubMed

    Chang, Charlotte; Nixon, Laura; Baker, Robin

    2015-08-01

    Multi-stakeholder partnerships play a critical role in dissemination and implementation in health and safety. To better document and understand construction partnerships that have successfully scaled up effective interventions to protect workers, this case study focused on the collaborative processes of the Asphalt Paving Partnership. In the 1990s, this partnership developed, evaluated, disseminated, and achieved near universal, voluntary adoption of paver engineering controls to reduce exposure to asphalt fumes. We used in-depth interviews (n = 15) and document review in the case study. We describe contextual factors that both facilitated and challenged the formation of the collaboration, central themes and group processes, and research to practice (r2p) outcomes. The Asphalt Paving Partnership offers insight into how multi-stakeholder partnerships in construction can draw upon the strengths of diverse members to improve the dissemination and adoption of health and safety innovations and build a collaborative infrastructure to sustain momentum over time. © 2015 Wiley Periodicals, Inc.

  14. Safe use of cellular telephones in hospitals: fundamental principles and case studies.

    PubMed

    Cohen, Ted; Ellis, Willard S; Morrissey, Joseph J; Bakuzonis, Craig; David, Yadin; Paperman, W David

    2005-01-01

    Many industries and individuals have embraced cellular telephones. They provide mobile, synchronous communication, which could hypothetically increase the efficiency and safety of inpatient healthcare. However, reports of early analog cellular telephones interfering with critical life-support machines had led many hospitals to strictly prohibit cellular telephones. A literature search revealed that individual hospitals now are allowing cellular telephone use with various policies to prevent electromagnetic interference with medical devices. The fundamental principles underlying electromagnetic interference are immunity, frequency, modulation technology, distance, and power Electromagnetic interference risk mitigation methods based on these principles have been successfully implemented. In one case study, a minimum distance between cellular telephones and medical devices is maintained, with restrictions in critical areas. In another case study, cellular telephone coverage is augmented to automatically control the power of the cellular telephone. While no uniform safety standard yet exists, cellular telephones can be safely used in hospitals when their use is managed carefully.

  15. Integrate genome-based assessment of safety for probiotic strains: Bacillus coagulans GBI-30, 6086 as a case study.

    PubMed

    Salvetti, Elisa; Orrù, Luigi; Capozzi, Vittorio; Martina, Alessia; Lamontanara, Antonella; Keller, David; Cash, Howard; Felis, Giovanna E; Cattivelli, Luigi; Torriani, Sandra; Spano, Giuseppe

    2016-05-01

    Probiotics are microorganisms that confer beneficial effects on the host; nevertheless, before being allowed for human consumption, their safety must be verified with accurate protocols. In the genomic era, such procedures should take into account the genomic-based approaches. This study aims at assessing the safety traits of Bacillus coagulans GBI-30, 6086 integrating the most updated genomics-based procedures and conventional phenotypic assays. Special attention was paid to putative virulence factors (VF), antibiotic resistance (AR) genes and genes encoding enzymes responsible for harmful metabolites (i.e. biogenic amines, BAs). This probiotic strain was phenotypically resistant to streptomycin and kanamycin, although the genome analysis suggested that the AR-related genes were not easily transferrable to other bacteria, and no other genes with potential safety risks, such as those related to VF or BA production, were retrieved. Furthermore, no unstable elements that could potentially lead to genomic rearrangements were detected. Moreover, a workflow is proposed to allow the proper taxonomic identification of a microbial strain and the accurate evaluation of risk-related gene traits, combining whole genome sequencing analysis with updated bioinformatics tools and standard phenotypic assays. The workflow presented can be generalized as a guideline for the safety investigation of novel probiotic strains to help stakeholders (from scientists to manufacturers and consumers) to meet regulatory requirements and avoid misleading information.

  16. Maintenance and Safety Practices of Escalator in Commercial Buildings

    NASA Astrophysics Data System (ADS)

    Afida Isnaini Janipha, Nurul; Nur Aina Syed Alwee, Sharifah; Ariff, Raihan Mohd; Ismail, Faridah

    2018-02-01

    The escalator is very crucial to transport a person from one place to another. Nevertheless, there are many cases recorded the accidents in relation to escalator. These may occur due to lack of maintenance which leads to systems breakdown, poor safety practices, wear and tear, users’ negligence and others. Thus, proper maintenance systems need to be improvised to prevent and reduce escalator accident in future. This research was aimed to determine the escalator maintenance activities and safety practices in a commercial building. Three case studies were selected within Selangor area. Semi-structured interviews were conducted for collecting data from these three case studies. To achieve the aim of this research, the study was carried out on the maintenance activities, safety practices and cost related to escalator maintenance. As one of the important means of access in building, it is very crucial to increase effectiveness of escalator particularly in commercial building. It is expected that readers will get clear information on the maintenance activities and safety practices of escalator in commercial building.

  17. 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.

  18. Use of Visuals for Food Safety Education of Spanish-Speaking Foodservice Workers: A Case Study in Iowa

    ERIC Educational Resources Information Center

    Rajagopal, Lakshman

    2012-01-01

    Providing food safety training to an audience whose native language is not English is always a challenge. In the study reported here, minimal-text visuals in Spanish were used to train Hispanic foodservice workers about proper handwashing technique and glove use based on the 2005 Food Code requirements. Overall, results indicated that visuals…

  19. Specific issues, exact locations: case study of a community mapping project to improve safety in a disadvantaged community.

    PubMed

    Qummouh, Rana; Rose, Vanessa; Hall, Pat

    2012-12-01

    Safety is a health issue and a significant concern in disadvantaged communities. This paper describes an example of community-initiated action to address perceptions of fear and safety in a suburb in south-west Sydney which led to the development of a local, community-driven research project. As a first step in developing community capacity to take action on issues of safety, a joint resident-agency group implemented a community safety mapping project to identify the extent of safety issues in the community and their exact geographical location. Two aerial maps of the suburb, measuring one metre by two metres, were placed on display at different locations for four months. Residents used coloured stickers to identify specific issues and exact locations where crime and safety were a concern. Residents identified 294 specific safety issues in the suburb, 41.9% (n=123) associated with public infrastructure, such as poor lighting and pathways, and 31.9% (n=94) associated with drug-related issues such as drug activity and discarded syringes. Good health promotion practice reflects community need. In a very practical sense, this project responded to community calls for action by mapping resident knowledge on specific safety issues and exact locations and presenting these maps to local decision makers for further action.

  20. Safety of oral alpha-lipoic acid treatment in pregnant women: a retrospective observational study.

    PubMed

    Parente, E; Colannino, G; Picconi, O; Monastra, G

    2017-09-01

    Alpha-lipoic acid is a natural molecule, which directly or by means of its reduced form, dihydrolipoic acid, exerts antioxidant, anti-inflammatory and immunomodulatory activities, very helpful also in preventing miscarriage and preterm delivery. Used as dietary supplement alpha-lipoic acid was demonstrated to be safe for living organisms even when administered at high doses. However, no study was made so far to verify the safety of its continuous administration on a substantial number of pregnant women. The present investigation was performed to answer this issue. An observational retrospective study was carried out analyzing 610 expectant mothers. They had been treated daily by oral route with 600 mg alpha-lipoic acid, for at least 7 weeks during gestation. The primary outcome was to verify alpha-lipoic acid safety in the mother and infant. Maternal safety was assessed by monitoring for adverse reactions, physical and clinical examination, including a morbidity assessment. Laboratory and clinical examinations were performed monthly. Neonatal safety was assessed by the evaluation of birth weight, gestational age, Apgar scores, neonatal death with the related cause of death. Data collected from the Birth Registry of Campania Region were used as control. This study provided a very clear and reassuring picture about the safety of alpha-lipoic acid oral treatment during pregnancy. No adverse effect was noticed in mothers or newborns. The two sets of monitored data, from treated and controls, were completely superimposable or, in some cases, better in alpha-lipoic acid group. Our results open a reassuring scenario regarding the administration of alpha-lipoic acid during pregnancy.

  1. 40 CFR 720.90 - Data from health and safety studies.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 31 2011-07-01 2011-07-01 false Data from health and safety studies... Data from health and safety studies. (a) Information other than specific chemical identity. Except as... information included in a health and safety study, unless the information would disclose confidential business...

  2. 40 CFR 720.90 - Data from health and safety studies.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Data from health and safety studies... Data from health and safety studies. (a) Information other than specific chemical identity. Except as... information included in a health and safety study, unless the information would disclose confidential business...

  3. 40 CFR 720.90 - Data from health and safety studies.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 32 2012-07-01 2012-07-01 false Data from health and safety studies... Data from health and safety studies. (a) Information other than specific chemical identity. Except as... information included in a health and safety study, unless the information would disclose confidential business...

  4. 40 CFR 720.90 - Data from health and safety studies.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 31 2014-07-01 2014-07-01 false Data from health and safety studies... Data from health and safety studies. (a) Information other than specific chemical identity. Except as... information included in a health and safety study, unless the information would disclose confidential business...

  5. The case for improving road safety in Pacific Islands: a population-based study from Fiji (TRIP 6).

    PubMed

    Herman, Josephine; Ameratunga, Shanthi; Wainiqolo, Iris; Kafoa, Berlin; McCaig, Eddie; Jackson, Rod

    2012-10-01

    To estimate the incidence and demographic characteristics associated with road traffic injuries (RTIs) resulting in deaths or hospital admission for 12 hours or more in Viti Levu, Fiji. Analysis of the prospective population-based Fiji Injury Surveillance in Hospitals database (October 2005 - September 2006). Of the 374 RTI cases identified (17% of all injuries), 72% were males and one third were aged 15-29 years. RTI fatalities (10.3 per 100,000 per year) were higher among Indians compared to Fijians. Two-thirds of deaths (largely ascribed to head, chest and abdominal trauma) occurred before hospital admission. While the RTI fatality rate was comparable to the global average for high-income countries, the level of motorisation in Fiji is considerably lower. To avert rising RTI rates with increasing motorisation, Fiji requires a robust road safety strategy alongside effective trauma-care services and a reliable population-based RTI surveillance system. © 2012 The Authors. ANZJPH © 2012 Public Health Association of Australia.

  6. An examination of some safety issues among commercial motorcyclists in Nigeria: a case study.

    PubMed

    Arosanyin, Godwin Tunde; Olowosulu, Adekunle Taiwo; Oyeyemi, Gafar Matanmi

    2013-01-01

    The reduction of road crashes and injuries among motorcyclists in Nigeria requires a system inquiry into some safety issues at pre-crash, crash and post-crash stages to guide action plans. This paper examines safety issues such as age restriction, motorcycle engine capacity, highway code awareness, licence holding, helmet usage, crash involvement, rescue and payment for treatment among commercial motorcyclists. The primary data derived from a structured questionnaire administered to 334 commercial motorcyclists in Samaru, Zaria were analysed using descriptive statistics and logistic regression technique. There was total compliance with age restriction and motorcycle engine capacity. About 41.8% of the operators were not aware of the existence of the highway code. The odds of licence holding increased with highway code awareness, education with above senior secondary as the reference category and earnings. The odds of crash involvement decreased with highway code awareness, earnings and mode of operation. About 84% of the motorcyclists did not use crash helmet, in spite of being aware of the benefit, and 65.4% of motorcycle crashes was found to be with other road users. The promotion of safety among motorcyclists therefore requires strict traffic law enforcement and modification of road design to segregate traffic and protect pedestrians.

  7. Schools Located Near Highways: Problems and Prospects. Final Report [and] Case Studies.

    ERIC Educational Resources Information Center

    Wells, Leslie J.; Shapiro, Richard; Felsburg, Robert W.

    In this 1977 publication, findings and recommendations are presented from 22 case studies involving the impact on schools adjacent to highway systems in the states of California, New Mexico, Colorado, Texas, Missouri, Maryland, and Virginia. The impacts described include: noise; vehicular and pedestrian safety; air pollution; access; circulation…

  8. Machinery safety of lathe machine using SHARP-systemic human action reliability procedure: a pilot case study in academic laboratory

    NASA Astrophysics Data System (ADS)

    Suryoputro, M. R.; Sari, A. D.; Sugarindra, M.; Arifin, R.

    2017-12-01

    This research aimed to understand the human reliability analysis, to find the SHARP method with its functionality on case study and also emphasize the practice in Lathe machine, continued with identifying improvement that could be made to the existing safety system. SHARP comprises of 7 stages including definition, screening, breakdown, representation, impact assessment, quantification and documentation. These steps were combined and analysed using HIRA, FTA and FMEA. HIRA analysed the lathe at academic laboratory showed the level of the highest risk with a score of 9 for the activities of power transmission parts and a score of 6 for activities which shall mean the moving parts required to take action to reduce the level of risk. Hence, the highest RPN values obtained in the power transmission activities with a value of 18 in the power transmission and then the activities of moving parts is 12 and the activities of the operating point of 8. Thus, this activity has the highest risk of workplace accidents in the operation. On the academic laboratory the improvement made on the engineering control initially with a machine guarding and completed with necessary administrative controls (SOP, work permit, training and routine cleaning) and dedicated PPEs.

  9. A Taxonomy of Fallacies in System Safety Arguments

    NASA Technical Reports Server (NTRS)

    Greenwell, William S.; Knight, John C.; Holloway, C. Michael; Pease, Jacob J.

    2006-01-01

    Safety cases are gaining acceptance as assurance vehicles for safety-related systems. A safety case documents the evidence and argument that a system is safe to operate; however, logical fallacies in the underlying argument may undermine a system s safety claims. Removing these fallacies is essential to reduce the risk of safety-related system failure. We present a taxonomy of common fallacies in safety arguments that is intended to assist safety professionals in avoiding and detecting fallacious reasoning in the arguments they develop and review. The taxonomy derives from a survey of general argument fallacies and a separate survey of fallacies in real-world safety arguments. Our taxonomy is specific to safety argumentation, and it is targeted at professionals who work with safety arguments but may lack formal training in logic or argumentation. We discuss the rationale for the selection and categorization of fallacies in the taxonomy. In addition to its applications to the development and review of safety cases, our taxonomy could also support the analysis of system failures and promote the development of more robust safety case patterns.

  10. Day-Case Treatment of Peripheral Arterial Disease: Results from a Multi-Center European Study

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

    Spiliopoulos, Stavros, E-mail: stavspiliop@med.uoa.gr, E-mail: stavspiliop@upatras.gr; Karnabatidis, Dimitrios, E-mail: karnaby@med.upatras.gr; Katsanos, Konstantinos, E-mail: katsanos@med.upatras.gr

    PurposeThe purpose of the study was to investigate safety and feasibility of day-case endovascular procedures for the management of peripheral arterial disease.Materials and MethodsThis was a multi-center, retrospective study including all patients treated over a 30-month period with endovascular angioplasty or stenting for intermittent claudication (IC) or critical limb ischemia (CLI) on a day-case basis, in Interventional Radiology (IR) departments of three European tertiary hospitals. Exclusion criteria were not related to the type of lesion and included unavailability of an adult able to take care of patient overnight; high bleeding risk and ASA score ≥4. Primary efficacy outcome was themore » rate of procedures performed on an outpatient basis requiring no further hospitalization and primary safety outcome was freedom from 30-day major complications’ rate.ResultsThe study included 652 patients (male 75 %; mean age 68 ± 10 years; range: 27–93), 24.6 % treated for CLI. In 53.3 % of the cases a 6Fr sheath was used. Technical success was 97.1 %. Haemostasis was obtained by manual compression in 52.4 % of the accesses. The primary efficacy outcome occurred in 95.4 % (622/652 patients) and primary safety outcome in 98.6 % (643/652 patients). Major complications included five (0.7 %) retroperitoneal hematomas requiring transfusion; one (0.1 %) common femoral artery pseudoaneurysm successfully treated with US-guided thrombin injection, two cases of intra-procedural distal embolization treated with catheter-directed local thrombolysis and one on-table cardiac arrest necessitating >24 h recovery. No major complication was noted after same-day discharge.ConclusionsDay-case endovascular procedures for the treatment of IC or CLI can be safely and efficiently performed in experienced IR departments of large tertiary hospitals.« less

  11. 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

  12. Safety Study--Crashworthiness of Large Poststandard Schoolbuses.

    ERIC Educational Resources Information Center

    National Transportation Safety Board (DOT), Washington, DC.

    This study reports on the crash performance of large poststandard school buses (school buses manufactured after April 1, 1977, and weighing more than 10,000 pounds unloaded) in 43 accidents investigated by the National Transportation Safety Board. The report discusses the Safety Board's findings as to how well the standards are working to protect…

  13. Allopurinol use in pregnancy in three women with inflammatory bowel disease: safety and outcomes: a case series

    PubMed Central

    2013-01-01

    Background Allopurinol is a frequently prescribed drug. In inflammatory bowel disease patients who shunt thiopurine metabolism towards more toxic and less desirable pathways, allopurinol is proving to be an effective add on therapy with good resultant disease control and less treatment side effects. As many such patients are young, the potential for pregnant women to be exposed to allopurinol is increasing. The safety of allopurinol in pregnancy is not known however. Case presentation We report three cases of safe use of allopurinol in pregnancy for women with inflammatory bowel disease. This included 2 patients with ulcerative colitis and 1 patient with fistulising Crohn’s disease. Allopurinol was used throughout pregnancy in all patients. All 3 pregnancies resulted in normal healthy babies born at term by Caesarean section. Conclusion It is important to evaluate and document the safety of allopurinol during pregnancy, as it is finding new roles in young patients. These three cases add significantly to the very limited data on allopurinol use in pregnancy. We encourage reporting of all cases of allopurinol use in pregnant patients and suggest an allopurinol pregnancy registry to document drug exposures and outcomes. PMID:24345189

  14. Catastrophic sinkhole formation in Kansas: A case study

    USGS Publications Warehouse

    Lambrecht, J.L.; Miller, R.D.

    2006-01-01

    Sinkholes represent a hazard to property and human safety in a wide variety of geologic settings across the globe. In most cases, the subsidence rate of a sinkhole represents the most significant potential impact and risk to public safety. Since 1979, the Kansas Geological Survey has studied numerous sinkholes using high-resolution seismic reflection in an attempt to better understand the mechanisms that control their formation. Most sinkholes in central Kansas form as a result of dissolution of the Permian Hutchinson salt (Figure 1). The fluid source and associated pathway responsible for leaching these bedded evaporites have been natural, anthropogenic, and a combination of both. Sinkholes have been a part of the landscape in the North American midcontinent long before modern oil, gas, and mineral exploration, but clearly the activities of man have played a significant role in both increasing the number of sinkholes and affecting their subsidence rates.

  15. The safety climate in primary care (SAP-C) study: study protocol for a randomised controlled feasibility study.

    PubMed

    Lydon, Sinéad; Cupples, Margaret E; Hart, Nigel; Murphy, Andrew W; Faherty, Aileen; O'Connor, Paul

    2016-01-01

    Research on patient safety has focused largely on secondary care settings, and there is a dearth of knowledge relating to safety culture or climate, and safety climate improvement strategies, in the context of primary care. This is problematic given the high rates of usage of primary care services and the myriad of opportunities for clinical errors daily. The current research programme aimed to assess the effectiveness of an intervention derived from the Scottish Patient Safety Programme in Primary Care. The intervention consists of safety climate measurement and feedback and patient chart audit using the trigger review method. The purpose of this paper is to describe the background to this research and to present the methodology of this feasibility study in preparation for a future definitive RCT. The SAP-C study is a feasibility study employing a randomised controlled pretest-posttest design that will be conducted in 10 general practices in the Republic of Ireland and Northern Ireland. Five practices will receive the safety climate intervention over a 9-month period. The five practices in the control group will continue care as usual but will complete the GP-SafeQuest safety climate questionnaire at baseline (month 1) and at the terminus of the intervention (month 9). The outcomes of the study include process evaluation metrics (i.e. rates of participant recruitment and retention, rates of completion of safety climate measures, qualitative data regarding participants' perceptions of the intervention's potential efficacy, acceptability, and sustainability), patient safety culture in intervention and control group practices at posttest, and instances of undetected patient harm identified through patient chart audit using the trigger review method. The planned study investigates an intervention to improve safety climate in Irish primary care settings. The resulting data may inform our knowledge of the frequency of undetected patient safety incidents in primary care

  16. Macroergonomic analysis and design for improved safety and quality performance.

    PubMed

    Kleiner, B M

    1999-01-01

    Macroergonomics, which emerged historically after sociotechnical systems theory, quality management, and ergonomics, is presented as the basis for a needed integrative methodology. A macroergonomics methodology was presented in some detail to demonstrate how aspects of microergonomics, total quality management (TQM), and sociotechnical systems (STS) can be triangulated in a common approach. In the context of this methodology, quality and safety were presented as 2 of several important performance criteria. To demonstrate aspects of the methodology, 2 case studies were summarized with safety and quality performance results where available. The first case manipulated both personnel and technical factors to achieve a "safety culture" at a nuclear site. The concept of safety culture is defined in INSAG-4 (International Atomic Energy Agency, 1991). as "that assembly of characteristics and attitudes in organizations and individuals which establishes that, as an overriding priority, nuclear plant safety issues receive the attention warranted by their significance." The second case described a tire manufacturing intervention to improve quality (as defined by Sink and Tuttle, 1989) through joint consideration of technical and social factors. It was suggested that macroergonomics can yield greater performance than can be achieved through ergonomic intervention alone. Whereas case studies help to make the case, more rigorous formative and summative research is needed to refine and validate the proposed methodology respectively.

  17. The Development and Implementation of Ground Safety Requirements for Project Orion Abort Flight Testing - A Case Study

    NASA Technical Reports Server (NTRS)

    Kirkpatrick, Paul D.; Williams, Jeffrey G.; Condzella, Bill R.

    2008-01-01

    A rigorous set of detailed ground safety requirements is required to make sure that ground support equipment (GSE) and associated planned ground operations are conducted safely. Detailed ground safety requirements supplement the GSE requirements already called out in NASA-STD-5005. This paper will describe the initial genesis of these ground safety requirements, the establishment and approval process and finally the implementation process for Project Orion. The future of the requirements will also be described. Problems and issues encountered and overcame will be discussed.

  18. Software Safety Risk in Legacy Safety-Critical Computer Systems

    NASA Technical Reports Server (NTRS)

    Hill, Janice; Baggs, Rhoda

    2007-01-01

    Safety-critical computer systems must be engineered to meet system and software safety requirements. For legacy safety-critical computer systems, software safety requirements may not have been formally specified during development. When process-oriented software safety requirements are levied on a legacy system after the fact, where software development artifacts don't exist or are incomplete, the question becomes 'how can this be done?' The risks associated with only meeting certain software safety requirements in a legacy safety-critical computer system must be addressed should such systems be selected as candidates for reuse. This paper proposes a method for ascertaining formally, a software safety risk assessment, that provides measurements for software safety for legacy systems which may or may not have a suite of software engineering documentation that is now normally required. It relies upon the NASA Software Safety Standard, risk assessment methods based upon the Taxonomy-Based Questionnaire, and the application of reverse engineering CASE tools to produce original design documents for legacy systems.

  19. Lessons Learned from JTA Tester Safety Studies

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

    R. L. Bierbaum

    2001-05-01

    EP401575, Issue C, calls out a requirement to perform safety studies for testers that are used to accept Joint Test Assembly (JTA) product at Pantex (Reference 1). The underlying motivation is to ensure that personnel hazards due to inadvertent initiation of electro-explosive devices (EEDs) during JTA testing are understood and minimized. Studies have been performed on the B61-7/11 JTA, B61-3/4/10 JTA, B83 JTA, and W76 Type 2F testers at Pantex (References 2-5). Each of these studies includes an examination of the relevant Pantex tester as well as the instrumentation and War Reserve (WR) hardware. In performing these analyses, several themesmore » have emerged that could be useful for the Phase 6.3 design efforts for the weapons, the associated instrumentation, and the JTA testers. This report summarizes the lessons learned from these studies. Note that in some cases, the recommendations provided below to enhance safety during JTA testing operations (e.g., adding isolation resistors in the monitoring lines) may result in a reliability degradation or other surety impact. Thus it is important to consider these lessons learned in the context of the overall design and to make tradeoffs in light of the integrated surety objectives. The lessons learned are listed in five different categories, summarized as: (1) Instrumentation considerations; (2) WR design considerations; (3) Tester considerations; (4) Administrative procedures during JTA assembly; and (5) Administrative procedures prior to and during JTA testing. The first three focus on minimizing the probability of inadvertent application of power to EED initiation lines due to component, connector, and assembly failures. The last two describe procedural steps that can be taken at Pantex to either minimize the risk (e.g., by ensuring that tester power supplies cannot supply excessive power to the unit under test) or to mitigate the consequences of unexpected EED initiation (e.g., by instructing test operators to

  20. The Safety Argumentation Schools of Thought

    NASA Technical Reports Server (NTRS)

    Graydon, Patrick John

    2017-01-01

    Safety cases have been produced and researched for decades. Definitions of `safety case' agree on both the need to generate suitable evidence and the central role of argument. But the relevant literature seems to exhibit multiple schools of thought that are largely unrecognized and somewhat at odds with each other. This paper presents preliminary results from research to identify and characterize the safety case schools of thought so as to reduce confusion and discord in research and practice.

  1. Learning in Collaboration: A Case Study of a Community Based Partnership Program

    ERIC Educational Resources Information Center

    Syam, Devarati S.

    2010-01-01

    This ethnographic case study investigated a multi-agency partnership project in a Midwestern city, the goal of which was to holistically address the health, safety and wellness issues of teen girls in an alternative school. The researcher was one of the eleven partners representing five different organizations that came together to create a…

  2. Safety Awareness & Communications Internship

    NASA Technical Reports Server (NTRS)

    Jefferson, Zanani

    2015-01-01

    The projects that I have worked on during my internships were updating the JSC Safety & Health Action Team JSAT Employee Guidebook, conducting a JSC mishap case study, preparing for JSC Today Close Call success stories, and assisting with event planning and awareness.

  3. Factors Influencing Knowledge, Food Safety Practices and Food Preferences During Warm Weather of Salmonella and Campylobacter Cases in South Australia.

    PubMed

    Milazzo, Adriana; Giles, Lynne C; Zhang, Ying; Koehler, Ann P; Hiller, Janet E; Bi, Peng

    2017-03-01

    To assess food safety practices, food shopping preferences, and eating behaviors of people diagnosed with Salmonella or Campylobacter infection in the warm seasons, and to identify socioeconomic factors associated with behavior and practices. A cross-sectional survey was conducted among Salmonella and Campylobacter cases with onset of illness from January 1 to March 31, 2013. Multivariable logistic regression analyses examined relationships between socioeconomic position and food safety knowledge and practices, shopping and food preferences, and preferences, perceptions, and knowledge about food safety information on warm days. Respondents in our study engaged in unsafe personal and food hygiene practices. They also carried out unsafe food preparation practices, and had poor knowledge of foods associated with an increased risk of foodborne illness. Socioeconomic position did not influence food safety practices. We found that people's reported eating behaviors and food preferences were influenced by warm weather. Our study has explored preferences and practices related to food safety in the warm season months. This is important given that warmer ambient temperatures are projected to rise, both globally and in Australia, and will have a substantial effect on the burden of infectious gastroenteritis including foodborne disease. Our results provide information about modifiable behaviors for the prevention of foodborne illness in the household in the warm weather and the need for information to be disseminated across the general population. An understanding of the knowledge and factors associated with human behavior during warmer weather is critical for public health interventions on foodborne prevention.

  4. 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.

  5. Safety Hazards During Intrahospital Transport: A Prospective Observational Study.

    PubMed

    Bergman, Lina M; Pettersson, Monica E; Chaboyer, Wendy P; Carlström, Eric D; Ringdal, Mona L

    2017-10-01

    To identify, classify, and describe safety hazards during the process of intrahospital transport of critically ill patients. A prospective observational study. Data from participant observations of the intrahospital transport process were collected over a period of 3 months. The study was undertaken at two ICUs in one university hospital. Critically ill patients transported within the hospital by critical care nurses, unlicensed nurses, and physicians. None. Content analysis was performed using deductive and inductive approaches. We detected a total of 365 safety hazards (median, 7; interquartile range, 4-10) during 51 intrahospital transports of critically ill patients, 80% of whom were mechanically ventilated. The majority of detected safety hazards were assessed as increasing the risk of harm, compromising patient safety (n = 204). Using the System Engineering Initiative for Patient Safety, we identified safety hazards related to the work system, as follows: team (n = 61), tasks (n = 83), tools and technologies (n = 124), environment (n = 48), and organization (n = 49). Inductive analysis provided an in-depth description of those safety hazards, contributing factors, and process-related outcomes. Findings suggest that intrahospital transport is a hazardous process for critically ill patients. We have identified several factors that may contribute to transport-related adverse events, which will provide the opportunity for the redesign of systems to enhance patient safety.

  6. Lean manufacturing comes to China: a case study of its impact on workplace health and safety.

    PubMed

    Brown, Garrett D; O'Rourke, Dara

    2007-01-01

    Lean manufacturing, which establishes small production "cells," or teams of workers, who complete an entire product from raw material processing through final assembly and shipment, increases health and safety hazards by mixing previously separated exposures to various chemicals (with possible additive and cumulative effects) and noise. The intensification of work leads to greater ergonomic and stress-related adverse health effects, as well as increased safety hazards. The standard industrial hygiene approach of anticipation, recognition, evaluation, and hazard control is applicable to lean operations. A focus on worker participation in identifying and solving problems is critical for reducing negative impacts. A key to worker safety in lean production operations is the development of informed, empowered, and active workers with the knowledge, skills, and opportunity to act in the workplace to eliminate or reduce hazards.

  7. Monitoring product safety in the postmarketing environment.

    PubMed

    Sharrar, Robert G; Dieck, Gretchen S

    2013-10-01

    The safety profile of a medicinal product may change in the postmarketing environment. Safety issues not identified in clinical development may be seen and need to be evaluated. Methods of evaluating spontaneous adverse experience reports and identifying new safety risks include a review of individual reports, a review of a frequency distribution of a list of the adverse experiences, the development and analysis of a case series, and various ways of examining the database for signals of disproportionality, which may suggest a possible association. Regulatory agencies monitor product safety through a variety of mechanisms including signal detection of the adverse experience safety reports in databases and by requiring and monitoring risk management plans, periodic safety update reports and postauthorization safety studies. The United States Food and Drug Administration is working with public, academic and private entities to develop methods for using large electronic databases to actively monitor product safety. Important identified risks will have to be evaluated through observational studies and registries.

  8. Effects of a case-based interactive e-learning course on knowledge and attitudes about patient safety: a quasi-experimental study with third-year medical students.

    PubMed

    Gaupp, Rainer; Körner, Mirjam; Fabry, Götz

    2016-07-11

    Patient safety (PS) is influenced by a set of factors on various levels of the healthcare system. Therefore, a systems-level approach and systems thinking is required to understand and improve PS. The use of e-learning may help to develop a systems thinking approach in medical students, as case studies featuring audiovisual media can be used to visualize systemic relationships in organizations. The goal of this quasi-experimental study was to determine if an e-learning can be utilized to improve systems thinking, knowledge, and attitudes towards PS. A quasi-experimental, longitudinal within- subjects design was employed. Participants were 321 third-year medical students who received online surveys before and after they participated in an e-learning course on PS. Primary outcome measures where levels of systems thinking and attitudes towards PS. Secondary outcome measures were the improvement of PS specific knowledge through the e-learning course. Levels of systems thinking showed significant improvement (58.72 vs. 61.27; p < .001) after the e-learning. Student's attitudes towards patient safety improved in several dimensions: After the course, students rated the influence of fatigue on safety higher (6.23 vs. 6.42, p < .01), considered patient empowerment more important (5.16 vs. 5.93, p < .001) and realized more often that human error is inevitable (5.75 vs. 5.97, p < .05). Knowledge on PS improved from 36.27 % correct answers before to 76.45 % after the e-learning (p < .001). Our results suggest that e-learning can be used to teach PS. Attitudes towards PS improved on several dimensions. Furthermore, we were able to demonstrate that a specifically designed e-learning program can foster the development of conceptual frameworks such as systems thinking, which facilitates the understanding of complex socio-technical systems within healthcare organisations.

  9. CASE STUDY CRITIQUE; UPPER CLINCH CASE STUDY

    EPA Science Inventory

    Case study critique: Upper Clinch case study (from Research on Methods for Integrating Ecological Economics and Ecological Risk Assessment: A Trade-off Weighted Index Approach to Integrating Economics and Ecological Risk Assessment). This critique answers the questions: 1) does ...

  10. Applied Use of Safety Event Occurrence Control Charts of Harm and Non-Harm Events: A Case Study.

    PubMed

    Robinson, Susan N; Neyens, David M; Diller, Thomas

    Most hospitals use occurrence reporting systems that facilitate identifying serious events that lead to root cause investigations. Thus, the events catalyze improvement efforts to mitigate patient harm. A serious limitation is that only a few of the occurrences are investigated. A challenge is leveraging the data to generate knowledge. The goal is to present a methodology to supplement these incident assessment efforts. The framework affords an enhanced understanding of patient safety through the use of control charts to monitor non-harm and harm incidents simultaneously. This approach can identify harm and non-harm reporting rates and also can facilitate monitoring occurrence trends. This method also can expedite identifying changes in workflow, processes, or safety culture. Although unable to identify root causes, this approach can identify changes in near real time. This approach also supports evaluating safety or policy interventions that may not be observable in annual safety climate surveys.

  11. Interprofessional learning for medication safety.

    PubMed

    Hardisty, Jessica; Scott, Lesley; Chandler, Sarah; Pearson, Pauline; Powell, Suzanne

    2014-07-01

    Patient safety is a worldwide priority. Recommendations have been made that doctors, nurses and pharmacists could interact more effectively to improve patient outcomes, and that interprofessional education should be encouraged. In 2009, the North East Strategic Health Authority awarded Workforce Development Initiative funding to Northumbria Healthcare National Health Service (NHS) Foundation Trust to develop an undergraduate interprofessional training activity in medication safety for medicine, pharmacy and nursing students. Interprofessional seminars for medication safety and therapeutics were developed that were delivered across the North East of England. The initial seminars took place between January and April 2011 at 10 teaching hospitals, and were attended by over 400 students (from medicine, pharmacy and nursing). The majority of the workshops were facilitated by an interprofessional team comprised of pharmacists, doctors and nurses, with all students working in small groups with participants from each of the professional groups, where possible. All seminars had standardised materials, but it was up to individual facilitators to choose which of the five case studies were used within the seminar. The seminars lasted between 2 and 3 hours, and depending on which case studies were used, two or three cases could be discussed. Student feedback showed that the seminar was particularly successful in highlighting and improving the students' understanding of each other's roles and responsibilities in relation to medication safety. There are considerable organisational challenges in arranging interprofessional groups. Scenarios need to provide tasks that engage and challenge all of the professions involved. Facilitation is an important element. Interprofessional education should be encouraged. © 2014 John Wiley & Sons Ltd.

  12. Safety analysis in test facility design

    NASA Astrophysics Data System (ADS)

    Valk, A.; Jonker, R. J.

    1990-09-01

    The application of safety analysis techniques as developed in, for example nuclear and petrochemical industry, can be very beneficial in coping with the increasing complexity of modern test facility installations and their operations. To illustrate the various techniques available and their phasing in a project, an overview of the most commonly used techniques is presented. Two case studies are described: the hazard and operability study techniques and safety zoning in relation to the possible presence of asphyxiating atmospheres.

  13. Learning Road Safety Skills in the Classroom

    ERIC Educational Resources Information Center

    Brown, Freddy Jackson; Gillard, Duncan

    2009-01-01

    This case study demonstrates the effectiveness of a classroom based learning programme in the acquisition of road safety skills. The participant, a child with severe learning disabilities, was taught road safety behaviours in the classroom with the aid of photograph cards. When he had mastered these skills in the classroom, he returned to the…

  14. Application of Gap Analysis to Education: A Case Study of the Food Safety and Quality Assurance Program at the University of Guelph

    ERIC Educational Resources Information Center

    Fuchs, C.; Wilcock, A.; Aung, M.

    2004-01-01

    This study was designed to identify the skills and knowledge deemed important for food safety professionals and the degree to which the Food Safety and Quality Assurance (FSQA) program at the Univ. of Guelph helps students to develop these skills. The research included 2 phases: interviews were conducted to identify these skill and knowledge…

  15. Nanotechnology Safety Self-Study

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

    Grogin, Phillip W.

    2016-03-29

    Nanoparticles are near-atomic scale structures between 1 and 100 nanometers (one billionth of a meter). Engineered nanoparticles are intentionally created and are used in research and development at Sandia National Laboratories (SNL) and Los Alamos National Laboratory (LANL). This course, Nanotechnology Safety Self-Study, presents an overview of the hazards, controls, and uncertainties associated with the use of unbound engineered nanoscale particles (UNP) in a laboratory environment.

  16. 77 FR 4048 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-26

    ... occupational safety and health services, and the prevention of work-related injury and illness. It is... the magnitude of the aggregate health burden associated with occupational injuries and illnesses, as... Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health, (NIOSH) In...

  17. 76 FR 52330 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-22

    ... occupational safety and health services, and the prevention of work-related injury and illness. It is... the magnitude of the aggregate health burden associated with occupational injuries and illnesses, as... Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH) In...

  18. 78 FR 64504 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-29

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH or..., Number 177, Pages 56235-56236. Contact Person for More Information: Price Connor, Ph.D., NIOSH Health...

  19. 77 FR 51810 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-27

    ... occupational safety and health services, and the prevention of work-related injury and illness. It is... the magnitude of the aggregate health burden associated with occupational injuries and illnesses, as... Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH) In...

  20. Hard and Soft Safety Verifications

    NASA Technical Reports Server (NTRS)

    Wetherholt, Jon; Anderson, Brenda

    2012-01-01

    The purpose of this paper is to examine the differences between and the effects of hard and soft safety verifications. Initially, the terminology should be defined and clarified. A hard safety verification is datum which demonstrates how a safety control is enacted. An example of this is relief valve testing. A soft safety verification is something which is usually described as nice to have but it is not necessary to prove safe operation. An example of a soft verification is the loss of the Solid Rocket Booster (SRB) casings from Shuttle flight, STS-4. When the main parachutes failed, the casings impacted the water and sank. In the nose cap of the SRBs, video cameras recorded the release of the parachutes to determine safe operation and to provide information for potential anomaly resolution. Generally, examination of the casings and nozzles contributed to understanding of the newly developed boosters and their operation. Safety verification of SRB operation was demonstrated by examination for erosion or wear of the casings and nozzle. Loss of the SRBs and associated data did not delay the launch of the next Shuttle flight.

  1. Ensuring food safety in food donations: Case study of the Belgian donation/acceptation chain.

    PubMed

    De Boeck, E; Jacxsens, L; Goubert, H; Uyttendaele, M

    2017-10-01

    The food donation process in Belgium is mapped and analyzed to identify bottlenecks in compliance with the legal framework and implementation of food safety management, based on literature search and interviews with stakeholders (donors, acceptors, regulators and facilitators) in Belgium and at EU level. The study revealed that the food donation/acceptation chain is far less structured and organized than the conventional food supply chain. The fragmented landscape of many small food banks and charity organizations (acceptors), often directed by and working with volunteers without training in food safety and lack of knowledge of legal food hygiene requirements is a bottleneck to generate trust among food donors and restricts the provision of perishable products in food donations. Lack of refrigerated transport and insufficient cold/freezing capacity in food banks and charity organizations was identified as a barrier to distribute perishable products. Furthermore, in two cities in Flanders (Belgium), at some food donation centers, donated perishable food samples (n=72) were taken and subjected to microbiological analysis to determine their overall food quality, hygiene and food safety status. Twenty-two of 72 analyzed samples showed marginal microbiological quality based on numbers of yeast, lactic acid bacteria or total viable count. In three samples Listeria monocytogenes was detected per 25g among which one ready-to-eat cooked meat product which showed increased numbers of L. monocytogenes (3.5logCFU/g) and Enterobacteriaceae (6.7logCFU/g). Overall, in Belgium, most of the donated foods considers nonperishable foods, with more or less half of the food collected by the food banks being purchased with funds from FEAD (Fund for European Aid to the Most Deprived) and thus not derived from food losses. Efforts are being made by facilitators to provide a platform for better coordination of donors and acceptors to make more efficient use of food losses. Regulators at the

  2. Groundwater-Surface Water Interaction: A Case Study of Embankment Dam Safety Assessment in Sweden.

    NASA Astrophysics Data System (ADS)

    Ferdos, F.; Dargahi, B.

    2015-12-01

    Seepage, when excessive and unimpeded, can cause embankment dam failure. Such failures are often initiated by internal erosion and piping. Modelling these phenomena in embankment dams, accounting for the groundwater-surface water interactions, is crucial when performing dam safety assessments. The aim of this study was to evaluate the applicability of modelling seepage flows in multi-region dams using a finite element based multi-physics model. The model was applied to the Trängslet dam, the largest dam in Sweden. The objectives were to analyze the characteristics of both the flow and the surface-ground water interactions occurring in the dam, including: i) the saturated and unsaturated laminar flow regimes within the dam body, ii) the non-linear through-flow in the dam shoulders' coarse material, iii) the influence of the surface waves in the reservoir on the seepage flow by coupling the physics to a hydrodynamic interface, and iv) the influence of a conceptual "erosion tunnel" on the seepage flow and its interaction with the surface water flow by coupling the physics to a CFD interface. The focus of the study was on the influence of the transient water head boundary condition, surface waves and the internal erosion tunnel on the location of the phreatic line and the seepage flow rate. The simulated seepage flow of the dam in its original condition tallied with the monitoring measurements (40-70 l/s). The main feature found was the relatively high position of the phreatic line, which could compromise the stability of the dam. The combination of the seepage model with the reservoir hydrodynamics indicated a negligible influence of the surface waves on seepage flow. Results from the combination of the seepage model with fluid dynamics indicated that a conceptual "erosion tunnel" placed within the dam, even as high as in the unsaturated zone, significantly affects the phreatic line's position. This also causes the seepage flow to increase by several orders of

  3. Flammable Gas Safety Self-Study 52827

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

    Glass, George

    2016-03-17

    This course, Flammable Gas Safety Self-Study (COURSE 52827), presents an overview of the hazards and controls associated with commonly used, compressed flammable gases at Los Alamos National Laboratory (LANL).

  4. Managing Safety and Operations: The Effect of Joint Management System Practices on Safety and Operational Outcomes.

    PubMed

    Tompa, Emile; Robson, Lynda; Sarnocinska-Hart, Anna; Klassen, Robert; Shevchenko, Anton; Sharma, Sharvani; Hogg-Johnson, Sheilah; Amick, Benjamin C; Johnston, David A; Veltri, Anthony; Pagell, Mark

    2016-03-01

    The aim of this study was to determine whether management system practices directed at both occupational health and safety (OHS) and operations (joint management system [JMS] practices) result in better outcomes in both areas than in alternative practices. Separate regressions were estimated for OHS and operational outcomes using data from a survey along with administrative records on injuries and illnesses. Organizations with JMS practices had better operational and safety outcomes than organizations without these practices. They had similar OHS outcomes as those with operations-weak practices, and in some cases, better outcomes than organizations with safety-weak practices. They had similar operational outcomes as those with safety-weak practices, and better outcomes than those with operations-weak practices. Safety and operations appear complementary in organizations with JMS practices in that there is no penalty for either safety or operational outcomes.

  5. Modeling the Relationship between Safety Climate and Safety Performance in a Developing Construction Industry: A Cross-Cultural Validation Study

    PubMed Central

    Zahoor, Hafiz; Chan, Albert P. C.; Utama, Wahyudi P.; Gao, Ran; Zafar, Irfan

    2017-01-01

    This study attempts to validate a safety performance (SP) measurement model in the cross-cultural setting of a developing country. In addition, it highlights the variations in investigating the relationship between safety climate (SC) factors and SP indicators. The data were collected from forty under-construction multi-storey building projects in Pakistan. Based on the results of exploratory factor analysis, a SP measurement model was hypothesized. It was tested and validated by conducting confirmatory factor analysis on calibration and validation sub-samples respectively. The study confirmed the significant positive impact of SC on safety compliance and safety participation, and negative impact on number of self-reported accidents/injuries. However, number of near-misses could not be retained in the final SP model because it attained a lower standardized path coefficient value. Moreover, instead of safety participation, safety compliance established a stronger impact on SP. The study uncovered safety enforcement and promotion as a novel SC factor, whereas safety rules and work practices was identified as the most neglected factor. The study contributed to the body of knowledge by unveiling the deviations in existing dimensions of SC and SP. The refined model is expected to concisely measure the SP in the Pakistani construction industry, however, caution must be exercised while generalizing the study results to other developing countries. PMID:28350366

  6. Modeling the Relationship between Safety Climate and Safety Performance in a Developing Construction Industry: A Cross-Cultural Validation Study.

    PubMed

    Zahoor, Hafiz; Chan, Albert P C; Utama, Wahyudi P; Gao, Ran; Zafar, Irfan

    2017-03-28

    This study attempts to validate a safety performance (SP) measurement model in the cross-cultural setting of a developing country. In addition, it highlights the variations in investigating the relationship between safety climate (SC) factors and SP indicators. The data were collected from forty under-construction multi-storey building projects in Pakistan. Based on the results of exploratory factor analysis, a SP measurement model was hypothesized. It was tested and validated by conducting confirmatory factor analysis on calibration and validation sub-samples respectively. The study confirmed the significant positive impact of SC on safety compliance and safety participation , and negative impact on number of self-reported accidents/injuries . However, number of near-misses could not be retained in the final SP model because it attained a lower standardized path coefficient value. Moreover, instead of safety participation , safety compliance established a stronger impact on SP. The study uncovered safety enforcement and promotion as a novel SC factor, whereas safety rules and work practices was identified as the most neglected factor. The study contributed to the body of knowledge by unveiling the deviations in existing dimensions of SC and SP. The refined model is expected to concisely measure the SP in the Pakistani construction industry, however, caution must be exercised while generalizing the study results to other developing countries.

  7. 77 FR 27776 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-11

    ... safety and health services, and the prevention of work-related injury and illness. It is anticipated that... magnitude of the aggregate health burden associated with occupational injuries and illnesses, as well as to... Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH) In...

  8. 76 FR 18220 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-01

    ... safety and health services, and the prevention of work-related injury and illness. It is anticipated that... magnitude of the aggregate health burden associated with occupational injuries and illnesses, as well as to... Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH) In...

  9. Casing pipe damage detection with optical fiber sensors: a case study in oil well constructions

    NASA Astrophysics Data System (ADS)

    Zhou, Zhi; He, Jianping; Huang, Minghua; He, Jun; Ou, Jinping; Chen, Genda

    2010-04-01

    Casing pipes in oil well constructions may suddenly buckle inward as their inside and outside hydrostatic pressure difference increases. For the safety of construction workers and the steady development of oil industries, it is critically important to measure the stress state of a casing pipe. This study develops a rugged, real-time monitoring, and warning system that combines the distributed Brillouin Scattering Time Domain Reflectometry (BOTDR) and the discrete fiber Bragg grating (FBG) measurement. The BOTDR optical fiber sensors were embedded with no optical fiber splice joints in a fiber reinforced polymer (FRP) rebar and the FBG sensors were wrapped in epoxy resins and glass clothes, both installed during the segmental construction of casing pipes. In-situ tests indicate that the proposed sensing system and installation technique can survive the downhole driving process of casing pipes, withstand a harsh service environment, and remain in tact with the casing pipes for compatible strain measurements. The relative error of the measured strains between the distributed and discrete sensors is less than 12%. The FBG sensors successfully measured the maximum horizontal principal stress with a relative error of 6.7% in comparison with a cross multi-pole array acoustic instrument.

  10. A case for safety leadership team training of hospital managers.

    PubMed

    Singer, Sara J; Hayes, Jennifer; Cooper, Jeffrey B; Vogt, Jay W; Sales, Michael; Aristidou, Angela; Gray, Garry C; Kiang, Mathew V; Meyer, Gregg S

    2011-01-01

    Delivering safe patient care remains an elusive goal. Resolving problems in complex organizations like hospitals requires managers to work together. Safety leadership training that encourages managers to exercise learning-oriented, team-based leadership behaviors could promote systemic problem solving and enhance patient safety. Despite the need for such training, few programs teach multidisciplinary groups of managers about specific behaviors that can enhance their role as leadership teams in the realm of patient safety. The aims of this study were to describe a learning-oriented, team-based, safety leadership training program composed of reinforcing exercises and to provide evidence confirming the need for such training and demonstrating behavior change among management groups after training. Twelve groups of managers from an academic medical center based in the Northeast United States were randomly selected to participate in the program and exposed to its customized, experience-based, integrated, multimodal curriculum. We extracted data from transcripts of four training sessions over 15 months with groups of managers about the need for the training in these groups and change in participants' awareness, professional behaviors, and group activity. Training transcripts confirmed the need for safety leadership team training and provided evidence of the potential for training to increase targeted behaviors. The training increased awareness and use of leadership behaviors among many managers and led to new routines and coordinated effort among most management groups. Enhanced learning-oriented leadership often helped promote a learning orientation in managers' work areas. Team-based training that promotes specific learning-oriented leader behaviors can promote behavioral change among multidisciplinary groups of hospital managers.

  11. Safety management for polluted confined space with IT system: a running case.

    PubMed

    Hwang, Jing-Jang; Wu, Chien-Hsing; Zhuang, Zheng-Yun; Hsu, Yi-Chang

    2015-01-01

    This study traced a deployed real IT system to enhance occupational safety for a polluted confined space. By incorporating wireless technology, it automatically monitors the status of workers on the site and upon detected anomalous events, managers are notified effectively. The system, with a redefined standard operations process, is running well at one of Formosa Petrochemical Corporation's refineries. Evidence shows that after deployment, the system does enhance the safety level by real-time monitoring the workers and by managing well and controlling the anomalies. Therefore, such technical architecture can be applied to similar scenarios for safety enhancement purposes.

  12. Faculty Roles, Responsibilities, and Involvement in Campus Safety Initiatives as Perceived by Faculty and Administrators: A Case Study at a Large State University

    ERIC Educational Resources Information Center

    Rollings, Meda Janeen

    2010-01-01

    The study addressed the problem of campus safety and the extent to which faculty and administrators are aware of institutional security policies. Further, the research compared perceptions of administrators and faculty regarding faculty awareness of and involvement in campus safety policy initiatives. The research sought to determine if the…

  13. Risk and protective factors for falls on one level in young children: multicentre case-control study.

    PubMed

    Benford, P; Young, B; Coupland, C; Watson, M; Hindmarch, P; Hayes, M; Goodenough, T; Majsak-Newman, G; Kendrick, D

    2015-12-01

    Childhood falls are an important global public health problem, but there is lack of evidence about their prevention. Falls on one level result in considerable morbidity and they are costly to health services. To estimate ORs for falls on one level in children aged 0-4 years for a range of safety behaviours, safety equipment use and home hazards. Multicentre case-control study at hospitals, minor injury units and general practices in and around four UK study centres. Participants included 582 children less than 5 years of age with a medically attended fall injury occurring at home and 2460 controls matched on age, sex, calendar time and study centre. Fall on one level. Cases' most common injuries were bangs on the head (52%), cuts or grazes not needing stitches (29%) or cuts or grazes needing stitches (17%). Comparing cases to community controls in the adjusted analyses, significant findings were observed for only two exposures. Injured children were significantly less likely to live in a household without furniture corner covers (adjusted OR (AOR) 0.72, 95% CI 0.55 to 0.95), or without rugs and carpets firmly fixed to the floor (AOR 0.76, 95% CI 0.59 to 0.98). We did not find any safety practices, use of safety equipment or home hazards associated with a reduced risk of fall on one level. Our findings do not provide evidence to support changes to current injury prevention practice. 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/

  14. A Framework for School Safety and Risk Management: Results from a Study of 18 Targeted School Shooters

    ERIC Educational Resources Information Center

    Lenhardt, Ann Marie C.; Graham, Lemuel W.; Farrell, Melissa L.

    2018-01-01

    Targeted violence continues to pose a threat to school safety. Reported here are the results of a study of 18 cases of school shooters from 1996 to 2012. Variables examined are individual factors and behaviors, family dynamics, and triggering events. Results indicate the need for expanded school-based mental health services, threat assessment, and…

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

    PubMed

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

    2018-03-01

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

  16. Allopurinol use in pregnancy in three women with inflammatory bowel disease: safety and outcomes: a case series.

    PubMed

    Fazal, Muhammad W; Doogue, Matt P; Leong, Rupert W; Bampton, Peter A; Andrews, Jane M

    2013-12-17

    Allopurinol is a frequently prescribed drug. In inflammatory bowel disease patients who shunt thiopurine metabolism towards more toxic and less desirable pathways, allopurinol is proving to be an effective add on therapy with good resultant disease control and less treatment side effects. As many such patients are young, the potential for pregnant women to be exposed to allopurinol is increasing. The safety of allopurinol in pregnancy is not known however. We report three cases of safe use of allopurinol in pregnancy for women with inflammatory bowel disease. This included 2 patients with ulcerative colitis and 1 patient with fistulising Crohn's disease. Allopurinol was used throughout pregnancy in all patients. All 3 pregnancies resulted in normal healthy babies born at term by Caesarean section. It is important to evaluate and document the safety of allopurinol during pregnancy, as it is finding new roles in young patients. These three cases add significantly to the very limited data on allopurinol use in pregnancy. We encourage reporting of all cases of allopurinol use in pregnant patients and suggest an allopurinol pregnancy registry to document drug exposures and outcomes.

  17. MO-F-16A-04: Case Study: Estimation of Peak Skin Dose Following a Physician Reported “High Dose” Case and Sentinel Event Considerations

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

    Supanich, M; Chu, J; Wehmeyer, A

    2014-06-15

    Purpose: This work offers as a teaching example a reported high dose fluoroscopy case and the workflow the institution followed to self-report a radiation overdose sentinel event to the Joint Commission. Methods: Following the completion of a clinical case in a hybrid OR room with a reported air kerma of >18 Gy at the Interventional Reference Point (IRP) the physicians involved in the case referred study to the institution's Radiation Safety Committee (RSC) for review. The RSC assigned a Diagnostic Medical Physicist (DMP) to estimate the patient's Peak Skin Dose (PSD) and analyze the case. Following the DMP's analysis andmore » estimate of a PSD of >15 Gy the institution's adverse event committee was convened to discuss the case and to self-report the case as a radiation overdose sentinel event to the Joint Commission. The committee assigned a subgroup to perform the root cause analysis and develop institutional responses to the event. Results: The self-reporting of the sentinel event and the associated root cause analysis resulted in several institutional action items that are designed to improve process and safety. A formal reporting and analysis mechanism was adopted to review fluoroscopy cases with air kerma greater than 6 Gy at the IRP. An improved and formalized radiation safety training program for physicians using fluoroscopy equipment was implemented. Additionally efforts already under way to monitor radiation exposure in the Radiology department were expanded to include all fluoroscopy equipment capable of automated dose reporting. Conclusion: The adverse event review process and the root cause analysis following the self-reporting of the sentinel event resulted in policies and procedures that are expected to improve the quality and safe usage of fluoroscopy throughout the institution.« less

  18. A Multi-Perspective Study on Safety Performance at the Colorado DOT

    DOT National Transportation Integrated Search

    2018-01-01

    This effort focuses on the safety culture within CDOT and the effectiveness of the CDOT safety programs on improving safety culture. The study used a survey approach based on interviews with senior safety officials to determine the scope of the surve...

  19. A case-control study of eye injuries in the workplace in Hong Kong.

    PubMed

    Yu, Tak Sun Ignatius; Liu, Hongjie; Hui, Karen

    2004-01-01

    Eye injury in the workplace is common worldwide. This study proposed to explore both risk and preventive factors re eye injuries in Hong Kong. Case-control study. A total of 239 work-related eye injury patients, and 253 subjects without a history of any eye injury as controls. Patients with all incident cases of work-related eye injuries attending the ophthalmology clinics of 3 major public hospitals in Hong Kong during the first 3 months of 2000 were invited to participate. Controls were selected from the general population and were frequency matched to patients based on gender. Patients were interviewed face-to-face by trained interviewers in the ophthalmology clinics, using a structured questionnaire. Telephone interviews were used for controls. Risk and protective factors associated with eye injuries. Among eye injury cases, 158 patients (66.1%) reported having incurred 1 episode of eye injury during employment, 49 (20.5%) having suffered 2 episodes, and 32 (13.4%) having experienced >/==" BORDER="0">3 eye injuries at work. Most of the patients (85.4%) did not wear any protective devices at the time of injury. Subjects who wore safety glasses regularly were less likely to have eye injuries (odds ratio [OR] = 0.29, 95% confidence interval [CI] = 0.14-0.62). Having a safety requirement for wearing safety glasses was negatively associated with eye injuries (OR = 0.31, 95% CI = 0.15-0.62). Multivariate analysis indicated that exposures to certain work hazards and working in the construction industry were positively associated with eye injuries. Subjects who worked longer in their current job, who reported having received job safety training before employment, or whose machines or equipment were maintained or repaired regularly by employers were at lower risk of experiencing eye injuries. Construction workers and those exposed to multiple hazards may get eye injuries at work. They should be provided with protective devices that are effective in preventing such

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

    PubMed

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

    2016-05-05

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

  1. Systemic study on the safety of immuno-deficient nude mice treated by atmospheric plasma-activated water

    NASA Astrophysics Data System (ADS)

    Dehui, XU; Qingjie, CUI; Yujing, XU; Bingchuan, WANG; Miao, TIAN; Qiaosong, LI; Zhijie, LIU; Dingxin, LIU; Hailan, CHEN; Michael, G. KONG

    2018-04-01

    Cold atmospheric-pressure plasma is a new technology, widely used in many fields of biomedicine, especially in cancer treatment. Cold plasma can selectively kill a variety of tumor cells, and its biological safety in clinical trials is also very important. In many cases, the patient’s immune level is relatively low, so we first studied the safety assessment of plasma treatment in an immuno-compromised animal model. In this study, we examined the safety of immuno-deficient nude mice by oral lavage treatment of plasma-activated water, and studied the growth status, main organs and blood biochemical indexes. Acute toxicity test results showed that the maximum dose of plasma treatment for 15 min had no lethal effect and other acute toxicity. There were no significant changes in body weight and survival status of mice after 2 min and 4 min of plasma-activated water (PAW) treatment for 2 weeks. After treatment, the major organs, including heart, liver, spleen, lung and kidney, were not significantly changed in organ coefficient and tissue structure. Blood biochemical markers showed that blood neutrophils and mononuclear cells were slightly increased, and the others remained unchanged. Liver function, renal function, electrolytes, glucose metabolism and lipid metabolism were not affected by different doses of PAW treatment. The above results indicate that PAW treatment can be used to treat immuno-deficient nude mice without significant safety problems.

  2. Safety and IVHM

    NASA Technical Reports Server (NTRS)

    Goebel, Kai

    2012-01-01

    When we address safety in a book on the business case for IVHM, the question arises whether safety isn t inherently in conflict with the need of operators to run their systems as efficiently (and as cost effectively) as possible. The answer may be that the system needs to be just as safe as needed, but not significantly more. That begs the next question: How safe is safe enough? Several regulatory bodies provide guidelines for operational safety, but irrespective of that, operators do not want their systems to be known as lacking safety. We illuminate the role of safety within the context of IVHM.

  3. Safety culture and the 5 steps to safer surgery: an intervention study.

    PubMed

    Hill, M R; Roberts, M J; Alderson, M L; Gale, T C E

    2015-06-01

    Improvements in safety culture have been postulated as one of the mechanisms underlying the association between the introduction of the World Health Organisation (WHO) Surgical Safety Checklist with perioperative briefings and debriefings, and enhanced patient outcomes. The 5 Steps to Safer Surgery (5SSS) incorporates pre-list briefings, the three steps of the WHO Surgical Safety Checklist (SSC) and post-list debriefings in one framework. We aimed to identify any changes in safety culture associated with the introduction of the 5SSS in orthopaedic operating theatres. We assessed the safety culture in the elective orthopaedic theatres of a large UK teaching hospital before and after introduction of the 5SSS using a modified version of the Safety Attitude Questionnaire - Operating Room (SAQ-OR). Primary outcome measures were pre-post intervention changes in the six safety culture domains of the SAQ-OR. We also analysed changes in responses to two items regarding perioperative briefings. The SAQ-OR survey response rate was 80% (60/75) at baseline and 74% (53/72) one yr later. There were significant improvements in both the reported frequency (P<0.001) and perceived importance (P=0.018) of briefings, and in five of the six safety culture domain scores (Working Conditions, Perceptions of Management, Job Satisfaction, Safety Climate and Teamwork Climate) of the SAQ-OR (P<0.001 in all cases). Scores in the sixth domain (Stress Recognition) decreased significantly (P=0.028). Implementation of the 5SSS was associated with a significant improvement in the safety culture of elective orthopaedic operating theatres. © The Author 2015. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  4. Efficacy and safety of bariatric surgery for craniopharyngioma-related hypothalamic obesity: a matched case-control study with 2 years of follow-up.

    PubMed

    Wijnen, M; Olsson, D S; van den Heuvel-Eibrink, M M; Wallenius, V; Janssen, J A M J L; Delhanty, P J D; van der Lely, A J; Johannsson, G; Neggers, S J C M M

    2017-02-01

    Hypothalamic obesity is a devastating consequence of craniopharyngioma. Bariatric surgery could be a promising therapeutic option. However, its efficacy and safety in patients with craniopharyngioma-related hypothalamic obesity remain largely unknown. We investigated the efficacy of bariatric surgery for inducing weight loss in patients with craniopharyngioma-related hypothalamic obesity. In addition, we studied the safety of bariatric surgery regarding its effects on hormone replacement therapy for pituitary insufficiency. In this retrospective matched case-control study, we compared weight loss after bariatric surgery (that is, Roux-en-Y gastric bypass and sleeve gastrectomy) between eight patients with craniopharyngioma-related hypothalamic obesity and 75 controls with 'common' obesity during 2 years of follow-up. We validated our results at 1 year of follow-up in a meta-analysis. In addition, we studied alterations in hormone replacement therapy after bariatric surgery in patients with craniopharyngioma. Mean weight loss after bariatric surgery was 19% vs 25% (difference -6%, 95% confidence of interval (CI) -14.1 to 4.6; P=0.091) at 2 years of follow-up in patients with craniopharyngioma-related hypothalamic obesity compared with control subjects with 'common' obesity. Mean weight loss was 25% vs 29% (difference -4%, 95% CI -11.6 to 8.1; P=0.419) after Roux-en-Y gastric bypass and 10% vs 20% (difference -10%, 95% CI -14.1 to -6.2; P=0.003) after sleeve gastrectomy at 2 years of follow-up in patients with craniopharyngioma-related hypothalamic obesity vs control subjects with 'common' obesity. Our meta-analysis demonstrated significant weight loss 1 year after Roux-en-Y gastric bypass, but not after sleeve gastrectomy. Seven patients with craniopharyngioma suffered from pituitary insufficiency; three of them required minor adjustments in hormone replacement therapy after bariatric surgery. Weight loss after Roux-en-Y gastric bypass, but not sleeve gastrectomy

  5. Development of the safety control framework for shield tunneling in close proximity to the operational subway tunnels: case studies in mainland China.

    PubMed

    Li, Xinggao; Yuan, Dajun

    2016-01-01

    China's largest cities like Beijing and Shanghai have seen a sharp increase in subway network development as a result of the rapid urbanization in the last decade. The cities are still expanding their subway networks now, and many shield tunnels are being or will be constructed in close proximity to the existing operational subway tunnels. The execution plans for the new nearby shield tunnel construction calls for the development of a safety control framework-a set of control standards and best practices to help organizations manage the risks involved. Typical case studies and relevant key technical parameters are presented with a view to presenting the resulting safety control framework. The framework, created through collaboration among the relevant parties, addresses and manages the risks in a systematic way based on actual conditions of each tunnel crossing construction. The framework consists of six parts: (1) inspecting the operational subway tunnels; (2) deciding allowed movements of the existing tunnels and tracks; (3) simulating effects of the shield tunneling on the existing tunnels; (4) doing preparation work; (5) monitoring design and information management; and (6) measures and activation mechanism of the countermeasures. The six components are explained and demonstrated in detail. In the end, discussions made involve construction and post-construction settlement of the operational tunnel, application of the remedial grouting to rectify excessive settlements of the operational tunnel, and use of the innovative tool of the optical fiber measurement for tunnel movement monitoring. It is concluded that the construction movement of the tunnel can be controlled within 15 mm when the shield machine is <7 m in excavation diameter. The post-construction settlement of the tunnel buried in the very soft ground is much greater than its construction settlement, and last several years until reaching a final stable state. Two cases are outlined to demonstrate the

  6. COLD-SAT feasibility study safety analysis

    NASA Technical Reports Server (NTRS)

    Mchenry, Steven T.; Yost, James M.

    1991-01-01

    The Cryogenic On-orbit Liquid Depot-Storage, Acquisition, and Transfer (COLD-SAT) satellite presents some unique safety issues. The feasibility study conducted at NASA-Lewis desired a systems safety program that would be involved from the initial design in order to eliminate and/or control the inherent hazards. Because of this, a hazards analysis method was needed that: (1) identified issues that needed to be addressed for a feasibility assessment; and (2) identified all potential hazards that would need to be controlled and/or eliminated during the detailed design phases. The developed analysis method is presented as well as the results generated for the COLD-SAT system.

  7. Generic health/safety/environment cases

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

    Kelland, A.N.; Primrose, M.; Pickles, J.C.

    1996-12-31

    A desire to implement HSE Management Systems including HSE Cases in all Shell companies operations prompted the development of a relational data base software package (THESIS) to provide a structured way of preparing an HSE Case. The software includes features which facilitate the management of {open_quotes}Keeping the Case Alive{close_quotes}, enabling the dissemination of tasks and hazard information to the workplace. During the software development it was recognized that a significant reduction could be made in the resources which would be required to prepare an HSE Case for each and every operation by the building of {open_quotes}Generic HSE Cases{close_quotes} addressing specificmore » activities which were repeated across the Company`s operations. This was recognized to be particularly valid for the smaller Single String Venture type of operations. The activities selected for the initial Generic HSE Case development include Land Drilling Operations, Land Seismic Acquisition, and Land Transport. To establish the Generic HSE Case, the THESIS data base is populated with data for a generic operation, identifying all the hazards and activities associated with that operation including all the associated controls, with established formats for the textual sections. In effect, the Generic Case defines the standards required for that type of operation. To generate an operation specific HSE Case, the Generic Case thereafter requires to be modified/adapted so that it represents the actual situation in the operation which it defines. This process includes itemization of all the operation specific details, and may involve the inclusion/deletion of any additional/existing activities or hazards together with their associated controls.« less

  8. Safety of lornoxicam in the treatment of postoperative pain: a post-marketing study of analgesic regimens containing lornoxicam compared with standard analgesic treatment in 3752 day-case surgery patients.

    PubMed

    Rawal, Narinder; Krøner, Karsten; Simin-Geertsen, Marija; Hejl, Charlotte; Likar, Rudolf

    2010-01-01

    Post-marketing surveillance studies can provide supplemental data on the safety of medications in the general population. This study aimed to evaluate the safety of analgesic regimens including the NSAID lornoxicam in the short-term treatment of postoperative pain in a clinically relevant population. Randomized, open-label, multicentre, multinational, observational cohort study of 4 days' duration. In-hospital postoperative setting, with discharge to home treatment within 24 hours of surgery. Adults aged > or =18 years expected to be in need of analgesic treatment after day-case surgery. Analgesic regimens containing lornoxicam were compared with a standard analgesic treatment, which was defined as the treatment that the patient would normally receive at the centre. Following day-case surgery, patients were provided with appropriate analgesic medication, and adverse events (AEs; defined as all recorded events with symptoms) were recorded by the investigator during the in-hospital stay and by the patient for the next 3 days using entries recorded morning and evening in a patient diary. Statistical analyses tested for between-treatment differences in AEs, adverse drug reactions (ADRs; defined as events probably, possibly or unlikely to be related to treatment) and gastrointestinal AEs (GI-AEs). A total of 4152 patients were randomized to treatment. Since 400 patients did not take any analgesic, the safety population consisted of 1838 patients for lornoxicam and 1914 patients for standard analgesic treatment. Demographic and disease characteristics were similar between the two treatment groups, as were the type of surgery and the anaesthesia used in surgery. In the safety population, 16.9% of patients received no analgesic in hospital, and when analgesics were provided they were often administered in combination. Similarly, approximately 17% of patients did not take any analgesics at home. AEs were reported in 27.1% and 29.4% of patients in the lornoxicam and standard

  9. Safety Alerts: An Observational Study in Portugal.

    PubMed

    Soares, Sara; Roque, Fátima; Teixeira Rodrigues, António; Figueiras, Adolfo; Herdeiro, Maria Teresa

    2015-09-01

    The information that is available when marketing authorizations are approved is limited. Pharmacovigilance has an important role during the postauthorization period, and alerts published by national authorities allow health care professionals to be informed about new data on safety profiles. This study therefore sought to analyze all safety alerts published by the Portuguese National Authority of Medicines and Health Products I.P. (INFARMED). We conducted an observational study of all alerts published on the INFARMED website from January 2002 through December 2014. From the data included in the alerts, the following information was abstracted: active substance name (and trade name), event that led to the alert, and the resulting safety measures. Active substances were classified according to the Anatomical Therapeutic Chemical (ATC) code. A total of 562 alerts were published, and 304 were eligible for inclusion. The musculoskeletal system was the ATC code with more alerts (n = 53), followed by the nervous system (n = 42). Communication of the information and recommendations to the health care professionals and the public in general was the most frequent safety measure (n = 128), followed by changes in the Summary of the Product Characteristics and package information leaflet (n = 66). During the study period, 26 marketing authorizations were temporarily suspended and 10 were revoked. The knowledge of the alerts published during the postmarketing period is very useful to the health care professionals for improving prescription and use of medicines and to the scientific community for the development of new researches. Copyright © 2015 Elsevier HS Journals, Inc. All rights reserved.

  10. A case series: evaluation of the metabolic safety of aripiprazole.

    PubMed

    De Hert, Marc; Hanssens, Linda; van Winkel, Ruud; Wampers, Martien; Van Eyck, Dominique; Scheen, Andre; Peuskens, Joseph

    2007-05-01

    Metabolic abnormalities occur frequently in patients treated with antipsychotics and are of growing concern to clinicians. This study sought to determine whether antipsychotic-associated metabolic abnormalities identified through intensive monitoring can be reversed by switching to aripiprazole. Recent evidence suggests that aripiprazole may exhibit a favorable metabolic safety profile. The study population is a subset of a large (n > 500) ongoing prospective cohort. Thirty-one consecutive patients with schizophrenia who were started on aripiprazole were included in the study. All patients underwent an extensive metabolic evaluation, including an oral glucose tolerance test, at baseline, at 6 weeks, and at 3 months post switch. Metabolic abnormalities were defined as any of the following: new onset diabetes, impaired fasting glucose, impaired glucose tolerance, metabolic syndrome (MetS) according to various definitions, and dyslipidemia. After 3 months of treatment with aripiprazole (mean daily dose 16.3 mg), there was a significant decrease in body weight, body mass index, and waist circumference. There was a significant reduction in fasting glucose, fasting insulin, insulin resistance index, and serum lipids levels (cholesterol, triglycerides, low-density lipoprotein (LDL), LDL/HDL, Chol/HDL, and non-HDL cholesterol). There was also a significant reduction in prolactin levels. All 7 cases of recent onset diabetes were reversed at 3 months follow-up. The MetS was reversed in 50% of patients at 3 months follow-up. Our results support the reversibility of recent onset diabetes on antipsychotic medication when detected early and followed by a switch to aripiprazole.

  11. Time Safety Margin: Theory and Practice

    DTIC Science & Technology

    2016-09-01

    Basic Dive Recovery Terminology The Simplest Definition of TSM: Time Safety Margin is the time to directly travel from the worst-case vector to an...Safety Margin (TSM). TSM is defined as the time in seconds to directly travel from the worst case vector (i.e. worst case combination of parameters...invoked by this AFI, base recovery planning and risk management upon the calculated TSM. TSM is the time in seconds to di- rectly travel from the worst case

  12. Software development for safety-critical medical applications

    NASA Technical Reports Server (NTRS)

    Knight, John C.

    1992-01-01

    There are many computer-based medical applications in which safety and not reliability is the overriding concern. Reduced, altered, or no functionality of such systems is acceptable as long as no harm is done. A precise, formal definition of what software safety means is essential, however, before any attempt can be made to achieve it. Without this definition, it is not possible to determine whether a specific software entity is safe. A set of definitions pertaining to software safety will be presented and a case study involving an experimental medical device will be described. Some new techniques aimed at improving software safety will also be discussed.

  13. Study of a safety margin system for powered-lift STOL aircraft

    NASA Technical Reports Server (NTRS)

    Heffley, R. K.; Jewell, W. F.

    1978-01-01

    A study was conducted to explore the feasibility of a safety margin system for powered-lift aircraft which require a backside piloting technique. The objective of the safety margin system was to present multiple safety margin criteria as a single variable which could be tracked manually or automatically and which could be monitored for the purpose of deriving safety margin status. The study involved a pilot-in-the-loop analysis of several safety margin system concepts and a simulation experiment to evaluate those concepts which showed promise of providing a good solution. A system was ultimately configured which offered reasonable compromises in controllability, status information content, and the ability to regulate the safety margin at some expense of the allowable low speed flight path envelope.

  14. Transferring results of occupational safety and health cost-effectiveness studies from one country to another - a case study.

    PubMed

    Verbeek, Jos; Pulliainen, Marjo; Kankaanpää, Eila; Taimela, Simo

    2010-06-01

    There are a limited number of studies about the cost-effectiveness of occupational health and safety (OSH) interventions. Applying the results of a cost-effectiveness study from one country to another is hampered by differences in the organization of healthcare and social security. In order to find out how these problems can be overcome, we transferred the results of a Dutch occupational cost-effectiveness study to the Finnish situation and vice-versa. We recalculated incremental cost-effectiveness ratios (ICER) for the target country based on resource use in the original study and the associated costs in the target country. We also allocated the costs to the employer, the employee, and tax-payers. We found that the ICER did not differ very much from those in the original studies. However, the different healthcare funding structure led to a more unfavorable ICER for employers in the Netherlands. Both interventions represented a cost saving for tax-payers and employees. Employers had to invest euro10-54 to avert one day of sick leave. We conclude that results of cost-effectiveness studies can be transferred from one country to another, but many adjustments are needed. An extensive description of the intervention, a detailed list of resource use, allocation of costs to various parties, and detailed knowledge of the healthcare systems in the original studies are necessary to enable calculations.

  15. Long-term (5 years), high daily dosage of dietary agmatine--evidence of safety: a case report.

    PubMed

    Gilad, Gad M; Gilad, Varda H

    2014-11-01

    There is presently a great interest in the therapeutic potential of agmatine, decarboxylated arginine, for various diseases. Recent clinical studies have already shown that oral agmatine sulfate given for up to 3 weeks provides a safe and, as compared with current therapeutics, more effective treatment for neuropathic pain. These studies have ushered in the use of dietary agmatine as a nutraceutical. However, in view of information paucity, assessment of long-term safety of oral agmatine treatment is now clearly required. The authors of this report undertook to assess their own health status during ongoing consumption of a high daily dosage of oral agmatine over a period of 4-5 years. A daily dose of 2.67 g agmatine sulfate was encapsulated in gelatin capsules; the regimen consists of six capsules daily, each containing 445 mg, three in the morning and three in the evening after meals. Clinical follow-up consists of periodic physical examinations and laboratory blood and urine analyses. All measurements thus far remain within normal values and good general health status is sustained throughout the study period, up to 5 years. This case study shows for the first time that the recommended high dosage of agmatine may be consumed for at least 5 years without evidence of any adverse effects. These initial findings are highly important as they provide significant evidence for the extended long-term safety of a high daily dosage of dietary agmatine--a cardinal advantage for its utility as a nutraceutical.

  16. An Automated System Combining Safety Signal Detection and Prioritization from Healthcare Databases: A Pilot Study.

    PubMed

    Arnaud, Mickael; Bégaud, Bernard; Thiessard, Frantz; Jarrion, Quentin; Bezin, Julien; Pariente, Antoine; Salvo, Francesco

    2018-04-01

    Signal detection from healthcare databases is possible, but is not yet used for routine surveillance of drug safety. One challenge is to develop methods for selecting signals that should be assessed with priority. The aim of this study was to develop an automated system combining safety signal detection and prioritization from healthcare databases and applicable to drugs used in chronic diseases. Patients present in the French EGB healthcare database for at least 1 year between 2005 and 2015 were considered. Noninsulin glucose-lowering drugs (NIGLDs) were selected as a case study, and hospitalization data were used to select important medical events (IME). Signal detection was performed quarterly from 2008 to 2015 using sequence symmetry analysis. NIGLD/IME associations were screened if one or more exposed case was identified in the quarter, and three or more exposed cases were identified in the population at the date of screening. Detected signals were prioritized using the Longitudinal-SNIP (L-SNIP) algorithm based on strength (S), novelty (N), and potential impact of signal (I), and pattern of drug use (P). Signals scored in the top 10% were identified as of high priority. A reference set was built based on NIGLD summaries of product characteristics (SPCs) to compute the performance of the developed system. A total of 815 associations were screened and 241 (29.6%) were detected as signals; among these, 58 (24.1%) were prioritized. The performance for signal detection was sensitivity = 47%; specificity = 80%; positive predictive value (PPV) 33%; negative predictive value = 82%. The use of the L-SNIP algorithm increased the early identification of positive controls, restricted to those mentioned in the SPCs after 2008: PPV = 100% versus PPV = 14% with its non-use. The system revealed a strong new signal with dipeptidylpeptidase-4 inhibitors and venous thromboembolism. The developed system seems promising for the routine use of healthcare data for safety

  17. Safe clinical practice for patients hospitalised in a suicidal crisis: a study protocol for a qualitative case study

    PubMed Central

    Berg, Siv Hilde; Rørtveit, Kristine; Walby, Fredrik A; Aase, Karina

    2017-01-01

    Introduction Suicide prevention in psychiatric care is arguably complex and incompletely understood as a patient safety issue. A resilient healthcare approach provides perspectives through which to understand this complexity by understanding everyday clinical practice. By including suicidal patients and healthcare professionals as sources of knowledge, a deeper understanding of what constitutes safe clinical practice can be achieved. Methods This planned study aims to adopt the perspective of resilient healthcare to provide a deeper understanding of safe clinical practice for suicidal patients in psychiatric inpatient care. It will describe the experienced components and conditions of safe clinical practice and the experienced practice of patient safety. The study will apply a descriptive case study approach consisting of qualitative semistructured interviews and focus groups. The data sources are hospitalised patients in a suicidal crisis and healthcare professionals in clinical practice. Ethics and dissemination This study was approved by the Regional Ethics Committee (2016/34). The results will be disseminated through scientific articles, a PhD dissertation, and national and international conferences. These findings can generate knowledge to be integrated into the practice of safety for suicidal inpatients in Norway and to improve the feasibility of patient safety measures. Theoretical generalisations can be drawn regarding safe clinical practice by taking into account the experiences of patients and healthcare professionals. Thus, this study can inform the conceptual development of safe clinical practice for suicidal patients. PMID:28132001

  18. Patterns of spontaneous reports on narcolepsy following administration of pandemic influenza vaccine; a case series of individual case safety reports in Eudravigilance.

    PubMed

    Gadroen, Kartini; Straus, Sabine M J M; Pacurariu, Alexandra; Weibel, Daniel; Kurz, Xavier; Sturkenboom, Miriam C J M

    2016-09-22

    This study aims to describe the frequency and quality of spontaneous narcolepsy case reports following administration of pandemic influenza vaccine as captured in the Eudravigilance database. We conducted a retrospective descriptive study of spontaneous Individual Case Safety Reports (ICSRs), reporting narcolepsy following administration of pandemic influenza vaccine as received by Eudravigilance until July 2014. De-duplication was carried out by Eudravigilance. Frequency of reporting is described as number of ICSRs received per month over time. The quality of the ICSRs was evaluated by completeness of information and diagnostic certainty using the Automated Brighton Collaboration case definition tool (ABC-tool) for narcolepsy. After de-duplication, a total of 1333 ICSRs of narcolepsy and/or cataplexy following pandemic influenza vaccine were identified, originating from 18 countries worldwide. Most of the ICSRs (61.9%) originated from the signaling countries, Sweden and Finland. Although de-duplication of case reports was carried out, it is suspected that many duplicates exist, in particular from Sweden. The majority of the ICSRs (95.3%), reported exposure to Pandemrix®. Only few reports were received for Arepanrix® (1.6%) or Focetria® (0.5%), and Celvapan® (0.1%). Of those ICSRs reporting age, 73.1% concerned persons below age of 20years. When using the ABC-tool, all ICSRs were classified as having insufficient information to meet the Brighton Collaboration case definition of narcolepsy. An increase in reporting of narcolepsy appeared in Eudravigilance only after awareness was raised by the national authorities. Most narcolepsy reports were received from countries where the signal initially occurred, and were related to Pandemrix® in children/adolescents. Basic information about the patient and the exposure was present in most of the ICSRs. The ICSRs captured by Eudravigilance however, do not collect enough information to assess the diagnostic certainty

  19. Outcomes studies of the gastrointestinal safety of cyclooxygenase-2 inhibitors.

    PubMed

    Scheiman, James M

    2002-01-01

    Short-term endoscopic studies of the highly selective cyclooxygenase-2 (COX-2) inhibitors (coxibs) rofecoxib and celecoxib have shown that these agents are well tolerated and have efficacy equivalent to nonselective nonsteroidal anti-inflammatory drugs (NSAIDs) with fewer adverse effects on the upper gastrointestinal (GI) tract. These studies are limited, however, as the detection of endoscopic lesions is not well correlated with symptomatic ulcers and ulcer complications. Outcomes studies of the GI safety are, therefore, essential to understanding how coxibs are likely to perform in a clinical practice setting. Four large outcomes studies (Vioxx Gastrointestinal Outcomes Research, VIGOR; Assessment of Difference Between Vioxx and Naproxen to Ascertain Gastrointestinal Tolerability and Effectiveness trial, ADVANTAGE; Celecoxib Long-term Arthritis Safety Study, CLASS; and the Successive Celecoxib Efficacy and Safety Studies, SUCCESS) examined the GI safety of rofecoxib and celecoxib in over 39,000 patients with osteoarthritis or rheumatoid arthritis. Results of these studies showed that patients taking a supratherapeutic dose of rofecoxib or celecoxib had significantly lower rates of GI-related adverse events than those taking a nonselective NSAID (naproxen, ibuprofen, or diclofenac). Reduced risk of upper GI events was seen in patients with multiple risk factors and in patients using low-dose aspirin and corticosteroids concomitantly with a coxib. Results of large outcomes studies provide support for the COX-2 hypothesis and demonstrate the long-term safety and tolerability of coxibs.

  20. Safety analysis

    NASA Technical Reports Server (NTRS)

    Knight, John C.

    1995-01-01

    We are engaged in a research program in safety-critical computing that is based on two case studies. We use these case studies to provide application-specific details of the various research issues, and as targets for evaluation of research ideas. The first case study is the Magnetic Stereotaxis System (MSS), an investigational device for performing human neurosurgery being developed in a joint effort between the Department of Physics at the University of Virginia and the Department of Neurosurgery at the University of Iowa. The system operates by manipulating a small permanent magnet (known as a 'seed') within the brain using an externally applied magnetic field. By varying the magnitude and gradient of the external magnetic field, the seed can be moved along a non-linear path and positioned at a site requiring therapy, e.g., a tumor. The magnetic field required for movement through brain tissue is extremely high, and is generated by a set of six superconducting magnets located in a housing surrounding the patient's head. The system uses two X-ray cameras positioned at right angles to detect in real time the locations of the seed and of X-ray opaque markers affixed to the patient's skull. the X-ray images are used to locate the objects of interest in a canonical frame of reference. the second case study is the University of Virginia Research Nuclear Reactor (UVAR). It is a 2 MW thermal, concrete-walled pool reactor. The system operates using 20 to 25 plate-type fuel assemblies placed on a rectangular grid plate. There are three scramable safety rods, and one non-scramable regulating rod that can be put in automatic mode. It was originally constructed in 1959 as a 1 MW system, and it was upgraded to 2 MW in 1973. Though only a research reactor rather than a power reactor, the issues raised are significant and can be related to the problems faced by full-scale reactor systems.

  1. Safety of intravenous thrombolysis in stroke mimics: prospective 5-year study and comprehensive meta-analysis.

    PubMed

    Tsivgoulis, Georgios; Zand, Ramin; Katsanos, Aristeidis H; Goyal, Nitin; Uchino, Ken; Chang, Jason; Dardiotis, Efthimios; Putaala, Jukka; Alexandrov, Anne W; Malkoff, Marc D; Alexandrov, Andrei V

    2015-05-01

    Shortening door-to-needle time may lead to inadvertent intravenous thrombolysis (IVT) administration in stroke mimics (SMs). We sought to determine the safety of IVT in SMs using prospective, single-center data and by conducting a comprehensive meta-analysis of reported case-series. We prospectively analyzed consecutive IVT-treated patients during a 5-year period at a tertiary care stroke center. A systematic review and meta-analysis of case-series reporting safety of IVT in SMs and confirmed acute ischemic stroke were conducted. Symptomatic intracerebral hemorrhage was defined as imaging evidence of ICH with an National Institutes of Health Stroke scale increase of ≥4 points. Favorable functional outcome at hospital discharge was defined as a modified Rankin Scale score of 0 to 1. Of 516 consecutive IVT patients at our tertiary care center (50% men; mean age, 60±14 years; median National Institutes of Health Stroke scale, 11; range, 3-22), SMs comprised 75 cases. Symptomatic intracerebral hemorrhage occurred in 1 patient, whereas we documented no cases of orolingual edema or major extracranial hemorrhagic complications. In meta-analysis of 9 studies (8942 IVT-treated patients), the pooled rates of symptomatic intracerebral hemorrhage and orolingual edema among 392 patients with SM treated with IVT were 0.5% (95% confidence interval, 0%-2%) and 0.3% (95% confidence interval, 0%-2%), respectively. Patients with SM were found to have a significantly lower risk for symptomatic intracerebral hemorrhage compared with patients with acute ischemic stroke (risk ratio=0.33; 95% confidence interval, 0.14-0.77; P=0.010), with no evidence of heterogeneity or publication bias. Favorable functional outcome was almost 3-fold higher in patients with SM in comparison with patients with acute ischemic stroke (risk ratio=2.78; 95% confidence interval, 2.07-3.73; P<0.00001). Our prospective, single-center experience coupled with the findings of the comprehensive meta

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

    PubMed

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

    2016-08-17

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

  3. Cost of Hospitalization for Foodborne Diarrhea: A Case Study from Vietnam.

    PubMed

    Hoang, Van Minh; Tran, Tuan Anh; Ha, Anh Duc; Nguyen, Viet Hung

    2015-11-01

    Vietnam is undergoing a rapid social and economic developments resulting in speedy urbanization, changes in methods for animal production, food marketing systems, and food consumption habits. These changes will have major impacts on human exposures to food poisoning. The present case study aimed to estimate hospitalization costs of foodborne diarrhea cases in selected health facilities in Vietnam. This is a facility-based cost-of-illness study conducted in seven health facilities in Northern Vietnam. All suspect cases of foodborne diarrhea, as diagnosed by doctors, who admitted to the studied health facilities during June-August, 2013 were selected. Costs associated with hospitalization for foodborne diseases were estimated from societal perspective using retrospective approach. We included direct and indirect costs of hospitalization of foodborne diarrhea cases. During the study period, 87 foodborne diarrhea cases were included. On average, the costs per treatment episode and per hospitalization day for foodborne diarrhea case were US$ 106.9 and US$ 33.6 respectively. Indirect cost (costs of times to patient, their relatives due to the patient's illness) made up the largest share (51.3%). Direct medical costs accounted for 33.8%; direct non-medical costs (patient and their relatives) represented 14.9%. Cost levels and compositions varied by level of health facilities. More attentions should be paid on prevention, control of foodborne diarrhea cases in Vietnam. Ensuring safety of food depends on efforts of everyone involved in food chain continuum, from production, processing, and transport to consumption.

  4. Parental vaccine refusal in Wisconsin: a case-control study.

    PubMed

    Salmon, Daniel A; Sotir, Mark J; Pan, William K; Berg, Jeffrey L; Omer, Saad B; Stokley, Shannon; Hopfensperger, Daniel J; Davis, Jeffrey P; Halsey, Neal A

    2009-02-01

    Successful immunization programs have diminished parental fear of diseases and increased fear of vaccines. Children with nonmedical exemptions to school immunization requirements are at increased risk of acquiring and transmitting disease. We explored differences in vaccine attitudes, beliefs, and information sources among parents of exempt and vaccinated children. Self-administered surveys were mailed to 780 parents of children with nonmedical exemptions (cases) and 1491 parents of fully-vaccinated children (controls). Vaccines most often refused by exempt children were varicella (49%) and hepatitis B (30%). The most common reason for claiming exemptions was vaccine might cause harm (57%). Parents of vaccinated children were less likely than parents of exempt children to report concern about vaccine safety, question the need for immunization, and oppose immunization requirements. Nearly 25% of parents of vaccinated children reported that children get more immunizations than are good for them and 34% expressed concern that children's immune systems could be weakened by too many immunizations. Both groups received information from health care professionals; parents of exempt children were more likely to also consult other sources. Our findings support the need for improved methods to communicate vaccine safety information. Further studies to explore vaccine safety concerns among parents are needed.

  5. A Study in Iowa. Teaching Food Safety in Secondary FCS Classes

    ERIC Educational Resources Information Center

    Ellis, Jason D.; Henroid, Daniel H., Jr.

    2005-01-01

    Food safety is a significant issue in the United States and yet minimal research has been done on the inclusion of food safety in secondary school curricula. This study examined the feasibility of including food safety in Iowa FCS middle and secondary classes. Teachers reported food safety was important; only a few believed students were…

  6. Influence of visual clutter on the effect of navigated safety inspection: a case study on elevator installation.

    PubMed

    Liao, Pin-Chao; Sun, Xinlu; Liu, Mei; Shih, Yu-Nien

    2018-01-11

    Navigated safety inspection based on task-specific checklists can increase the hazard detection rate, theoretically with interference from scene complexity. Visual clutter, a proxy of scene complexity, can theoretically impair visual search performance, but its impact on the effect of safety inspection performance remains to be explored for the optimization of navigated inspection. This research aims to explore whether the relationship between working memory and hazard detection rate is moderated by visual clutter. Based on a perceptive model of hazard detection, we: (a) developed a mathematical influence model for construction hazard detection; (b) designed an experiment to observe the performance of hazard detection rate with adjusted working memory under different levels of visual clutter, while using an eye-tracking device to observe participants' visual search processes; (c) utilized logistic regression to analyze the developed model under various visual clutter. The effect of a strengthened working memory on the detection rate through increased search efficiency is more apparent in high visual clutter. This study confirms the role of visual clutter in construction-navigated inspections, thus serving as a foundation for the optimization of inspection planning.

  7. Epidemiological designs for vaccine safety assessment: methods and pitfalls.

    PubMed

    Andrews, Nick

    2012-09-01

    Three commonly used designs for vaccine safety assessment post licensure are cohort, case-control and self-controlled case series. These methods are often used with routine health databases and immunisation registries. This paper considers the issues that may arise when designing an epidemiological study, such as understanding the vaccine safety question, case definition and finding, limitations of data sources, uncontrolled confounding, and pitfalls that apply to the individual designs. The example of MMR and autism, where all three designs have been used, is presented to help consider these issues. Copyright © 2011 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

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

    PubMed

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

    2017-12-01

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

  9. Studies on Labour Safety in Construction Sites

    PubMed Central

    Kanchana, S.; Sivaprakash, P.; Joseph, Sebastian

    2015-01-01

    Construction industry has accomplished extensive growth worldwide particularly in past few decades. For a construction project to be successful, safety of the structures as well as that of the personnel is of utmost importance. The safety issues are to be considered right from the design stage till the completion and handing over of the structure. Construction industry employs skilled and unskilled labourers subject to construction site accidents and health risks. A proper coordination between contractors, clients, and workforce is needed for safe work conditions which are very much lacking in Indian construction companies. Though labour safety laws are available, the numerous accidents taking place at construction sites are continuing. Management commitment towards health and safety of the workers is also lagging. A detailed literature study was carried out to understand the causes of accidents, preventive measures, and development of safe work environment. This paper presents the results of a questionnaire survey, which was distributed among various categories of construction workers in Kerala region. The paper examines and discusses in detail the total working hours, work shifts, nativity of the workers, number of accidents, and type of injuries taking place in small and large construction sites. PMID:26839916

  10. Studies on Labour Safety in Construction Sites.

    PubMed

    Kanchana, S; Sivaprakash, P; Joseph, Sebastian

    2015-01-01

    Construction industry has accomplished extensive growth worldwide particularly in past few decades. For a construction project to be successful, safety of the structures as well as that of the personnel is of utmost importance. The safety issues are to be considered right from the design stage till the completion and handing over of the structure. Construction industry employs skilled and unskilled labourers subject to construction site accidents and health risks. A proper coordination between contractors, clients, and workforce is needed for safe work conditions which are very much lacking in Indian construction companies. Though labour safety laws are available, the numerous accidents taking place at construction sites are continuing. Management commitment towards health and safety of the workers is also lagging. A detailed literature study was carried out to understand the causes of accidents, preventive measures, and development of safe work environment. This paper presents the results of a questionnaire survey, which was distributed among various categories of construction workers in Kerala region. The paper examines and discusses in detail the total working hours, work shifts, nativity of the workers, number of accidents, and type of injuries taking place in small and large construction sites.

  11. Focus on patient safety all day, every day.

    PubMed

    2015-06-01

    Case managers may think their job doesn't involve patient safety, but they promote safety by ensuring a safe discharge and are in a position to see safety breaches and mistakes all over the hospital. CMS includes discharge planning in its worksheets for surveyors to use to assess a hospital's compliance with Medicare Conditions of Participation. Because they work with patients from admission to discharge, case managers know which clinicians are competent, those who are not, and may observe safety breaches like failure to wash hands and leaving the catheter in too long. Case managers should spend enough time with their patients to know their situations at home and their support systems and use the information to create workable and safe discharge plans. Hospitals should create an environment and a culture where case managers and other clinicians feel comfortable speaking up when they see safety breaches.

  12. Improving patient safety culture in general practice: an interview study

    PubMed Central

    Verbakel, Natasha J; de Bont, Antoinette A; Verheij, Theo JM; Wagner, Cordula; Zwart, Dorien LM

    2015-01-01

    Background When improving patient safety a positive safety culture is key. As little is known about improving patient safety culture in primary care, this study examined whether administering a culture questionnaire with or without a complementary workshop could be used as an intervention for improving safety culture. Aim To gain insight into how two interventions affected patient safety culture in everyday practice. Design and setting After conducting a randomised control trial of two interventions, this was a qualitative study conducted in 30 general practices to aid interpretation of the previous quantitative findings. Method Interviews were conducted at practice locations (n = 27) with 24 GPs and 24 practice nurses. The theory of communities of practice — in particular, its concepts of a domain, a community, and a practice — was used to interpret the findings by examining which elements were or were not present in the participating practices. Results Communal awareness of the problem was only raised after getting together and discussing patient safety. The combination of a questionnaire and workshop enhanced the interaction of team members and nourished team feelings. This shared experience also helped them to understand and develop tools and language for daily practice. Conclusion In order for patient safety culture to improve, the safety culture questionnaire was more successful when accompanied by a practice workshop. Initial discussion and negotiation of shared goals during the workshop fuelled feelings of coherence and belonging to a community wishing to learn about enhancing patient safety. Team meetings and day-to-day interactions enhanced further liaison and sharing, making patient safety a common and conscious goal. PMID:26622035

  13. An investigation of safety climate in OHSAS 18001-certified and non-certified organizations.

    PubMed

    Ghahramani, Abolfazl

    2016-09-01

    Many organizations worldwide have implemented Occupational Health and Safety Assessment Series (OHSAS) 18001 in their premises because of the assumed positive effects of this standard on safety. Few studies have analyzed the effect of the safety climate in OHSAS 18001-certified organizations. This case-control study used a new safety climate questionnaire to evaluate three OHSAS 18001-certified and three non-certified manufacturing companies in Iran. Hierarchical regression indicated that the safety climate was influenced by OHSAS implementation and by safety training. Employees who received safety training had better perceptions of the safety climate and its dimensions than other respondents within the certified companies. This study found that the implementation of OHSAS 18001 does not guarantee improvement of the safety climate. This study also emphasizes the need for high-quality safety training for employees of the certified companies to improve the safety climate.

  14. Safety Communication Tools and Healthcare Professionals' Awareness of Specific Drug Safety Issues in Europe: A Survey Study.

    PubMed

    de Vries, Sieta T; van der Sar, Maartje J M; Coleman, Anna Marie; Escudero, Yvette; Rodríguez Pascual, Alfonso; Maciá Martínez, Miguel-Ángel; Cupelli, Amelia; Baldelli, Ilaria; Šipić, Ivana; Andrić, Adriana; Michan, Line; Denig, Petra; Mol, Peter G M

    2018-07-01

    National competent authorities (NCAs) use Direct Healthcare Professional Communications (DHPCs) to communicate new drug safety issues to healthcare professionals (HCPs). More knowledge is needed about the effectiveness of DHPCs and the extent to which they raise awareness of new safety issues among HCPs. The objective was to assess and compare general practitioners' (GPs'), cardiologists', and pharmacists' familiarity with DHPCs as communication tools, their awareness of specific drug safety issues, and the sources through which they had become aware of the specific issues. GPs, cardiologists, and pharmacists from nine European countries (Croatia, Denmark, Ireland, Italy, the Netherlands, Norway, Spain, Sweden, and the UK) completed a web-based survey. The survey was conducted in the context of the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action. Respondents were asked about their familiarity with DHPCs in general and their awareness of safety issues that had recently been communicated and involved the following drugs: combined hormonal contraceptives, diclofenac, valproate, and ivabradine. Those HCPs who were aware of the specific safety issues were subsequently asked to indicate the source through which they had become aware of them. Differences between professions in familiarity with DHPCs and awareness were tested using a Pearson χ 2  test per country and post hoc Pearson χ 2  tests in the case of statistically significant differences. Of the 3288 included respondents, 54% were GPs, 40% were pharmacists, and 7% were cardiologists. The number of respondents ranged from 67 in Denmark to 916 in Spain. Most respondents (92%) were familiar with DHPCs, with one significant difference between the professions: pharmacists were more familiar than GPs in Italy (99 vs 90%, P = 0.004). GPs' awareness ranged from 96% for the diclofenac issue to 70% for the ivabradine issue. A similar pattern was shown for pharmacists (91

  15. [Case managers experience improved trajectories for cancer patients after implementation of the case manager function].

    PubMed

    Axelsen, Karina Rahbek; Nafei, Hanne; Jakobsen, Stine Finne; Gandrup, Per; Knudsen, Janne Lehmann

    2014-10-13

    Case managers are increasingly used to optimize trajectories for patients. This study is based on a questionnaire among case managers in cancer care, aiming at the clarification of the function and its impact on especially patient safety, when handing over the responsibility. The results show a major variation in how the function is organized, the level of competence and the task to be handled. The responsibility has in general been narrowed to department level. Overall, the case managers believe that the function has optimized pathways for cancer patients and improved safety, but barriers persist.

  16. A global health partnership's use of time-limited support to catalyze health practice change: the case of GAVI's Injection Safety Support.

    PubMed

    Levin, Ann; Fang, Arnold; Hansen, Peter M; Pyle, David; Dia, Ousmane; Schwalbe, Nina

    2010-09-27

    This paper presents the findings of a study to assess the effectiveness and sustainability of a GAVI (Global Alliance of Vaccines and Immunization) sponsored, time-limited Injection Safety (INS) support. The support came in two forms: 1) in-kind, in the form of AD syringes and safety boxes, and 2) in cash, for those countries that already had a secure, multi-year source of AD syringes and safety boxes, but proposed to use INS support to strengthen their injection safety activities. In total, GAVI gave INS support for a three-year period to 58 countries: 46 with commodities and 12 with cash support. To identify variables that might be associated with financial sustainability, frequencies and cross-tabulations were run against various programmatic and socio-economic variables in the 58 countries. All but two of the 46 commodity-recipient countries were able to replace and sustain the use of AD syringes and safety boxes after the end of their GAVI INS support despite the fact that standard disposable syringes are less costly than ADs (10-15 percent differential). In addition, all 12 cash-recipient countries continued to use AD syringes and safety boxes in their immunization programs in the years following GAVI INS assistance. At the same time, countries were often not prepared for the increased waste management requirements associated with the use of the syringes, suggesting the importance of anticipating challenges with the introduction of new technologies. The sustained use of AD syringes in countries receiving injection safety support from GAVI, in a majority of cases through government financing, following the completion of three years of time-limited support, represents an early indication of how GHPs can contribute to improved health outcomes in immunization safety in the world's poorest countries in a sustainable way.

  17. Safety interventions on the labor and delivery unit.

    PubMed

    Kacmar, Rachel M

    2017-06-01

    The present review highlights recent advances in efforts to improve patient safety on labor and delivery units and well tolerated care for pregnant patients in general. Recent studies in obstetric patient safety have a broad focus but repetitive themes for interdisciplinary training include: simulating critical events, having open multidisciplinary communication, frequent reviews of cases of maternal morbidity, and implementing maternal early warning systems. The National Partnership for Maternal Safety is also active in promoting care bundles across many topics on maternal safety. A culture of safety is the goal for all obstetric units. Achieving that ideal requires multidisciplinary collaboration, frequent reassessment for areas of improvement, and a culture of openness to change when improvement opportunities arise.

  18. Exploring approaches to patient safety: the case of spinal manipulation therapy.

    PubMed

    Rozmovits, Linda; Mior, Silvano; Boon, Heather

    2016-06-02

    The purpose of this study was to gain insight into the current safety culture around the use of spinal manipulation therapy (SMT) by regulated health professionals in Canada and to explore perceptions of readiness for implementing formal mechanisms for tracking associated adverse events. Fifty-six semi-structured telephone interviews were conducted with professional leaders and frontline practitioners in chiropractic, physiotherapy, naturopathy and medicine, all professions regulated to perform SMT in the provinces of Alberta and Ontario Canada. Interviews were digitally audio-recorded for verbatim transcription. Transcripts were entered into HyperResearch software for qualitative data analysis and were coded for both anticipated and emergent themes using the constant comparative method. A thematic, descriptive analysis was produced. The safety culture around SMT is characterized by substantial disagreement about its actual rather than putative risks. Competing intra- and inter-professional narratives further cloud the safety picture. Participants felt that safety talk is sometimes conflated with competition for business in the context of fee-for-service healthcare delivery by several professions with overlapping scopes of practice. Both professional leaders and frontline practitioners perceived multiple barriers to the implementation of an incident reporting system for SMT. The established 'measure and manage' approach to patient safety is difficult to apply to care which is geographically dispersed and delivered by practitioners in multiple professions with overlapping scopes of practice, primarily in a fee-for-service model. Collaboration across professions on models that allow practitioners to share information anonymously and help practitioners learn from the reported incidents is needed.

  19. Using a safety net and following the safety instructions could prevent half the paediatric trampoline injuries.

    PubMed

    Rättyä, J; Serlo, W

    2008-08-01

    The number of recreational trampolines in Finnish households has increased. There also appears to be a drastic increase in trampoline-related injuries among paediatric patients. The aim of this study was to quantify and describe trampoline-related injuries in North Finnish paediatric patients. A retrospective analysis of medical data was used in the study, covering children 16 years and younger treated for trampoline-related injuries at Oulu University Hospital over a five-month period of time from May 1 to September 30, 2005. Medical records were reviewed and additional details regarding the injuries were obtained by questionnaire. Altogether 76 patients were treated for trampoline-related injuries, which represented 13.4 % of all paediatric accidental trauma patients. In 57 accidents (86 %), there had been multiple jumpers on the trampoline. Twenty-five of the injuries (38 %) had occurred on the trampoline, in 25 cases (38 %) a child had fallen off, in 8 cases (12 %) there had been a collision with another jumper and the person had jumped onto a trampoline from a high platform in 5 incidents (8 %). Only 3 children (5 %) hurt themselves on the trampoline when jumping alone. Orthopaedic procedures requiring general anaesthesia were necessary in a total of 31 cases (41 %). The study shows that 50 % of traumas (falling off and collisions) could have been avoided by using a safety net and by jumping one at a time. The importance of following safety instructions and the need for a safety net should be emphasised to both the supervising adults and the children.

  20. Stuffed in a Locker: A Case Study Involving Guns on Campus

    ERIC Educational Resources Information Center

    Lampron, Phillip Andrew

    2017-01-01

    Ensuring that children are safe is imperative for any educational institution. This case presents a realistic scenario of the safety concerns of leaders and staff in a middle school concerned with potential gang activity. Inspired by actual events, this case illustrates burdens that many middle school leaders across the nation face on a daily…

  1. Advancing the hydrogen safety knowledge base

    DOE PAGES

    Weiner, S. C.

    2014-08-29

    The International Energy Agency's Hydrogen Implementing Agreement (IEA HIA) was established in 1977 to pursue collaborative hydrogen research and development and information exchange among its member countries. Information and knowledge dissemination is a key aspect of the work within IEA HIA tasks, and case studies, technical reports and presentations/publications often result from the collaborative efforts. The work conducted in hydrogen safety under Task 31 and its predecessor, Task 19, can positively impact the objectives of national programs even in cases for which a specific task report is not published. As a result, the interactions within Task 31 illustrate how technologymore » information and knowledge exchange among participating hydrogen safety experts serve the objectives intended by the IEA HIA.« less

  2. Patient safety in primary care: a survey of general practitioners in The Netherlands.

    PubMed

    Gaal, Sander; Verstappen, Wim; Wensing, Michel

    2010-01-21

    Primary care encompasses many different clinical domains and patient groups, which means that patient safety in primary care may be equally broad. Previous research on safety in primary care has focused on medication safety and incident reporting. In this study, the views of general practitioners (GPs) on patient safety were examined. A web-based survey of a sample of GPs was undertaken. The items were derived from aspects of patient safety issues identified in a prior interview study. The questionnaire used 10 clinical cases and 15 potential risk factors to explore GPs' views on patient safety. A total of 68 GPs responded (51.5% response rate). None of the clinical cases was uniformly judged as particularly safe or unsafe by the GPs. Cases judged to be unsafe by a majority of the GPs concerned either the maintenance of medical records or prescription and monitoring of medication. Cases which only a few GPs judged as unsafe concerned hygiene, the diagnostic process, prevention and communication. The risk factors most frequently judged to constitute a threat to patient safety were a poor doctor-patient relationship, insufficient continuing education on the part of the GP and a patient age over 75 years. Language barriers and polypharmacy also scored high. Deviation from evidence-based guidelines and patient privacy in the reception/waiting room were not perceived as risk factors by most of the GPs. The views of GPs on safety and risk in primary care did not completely match those presented in published papers and policy documents. The GPs in the present study judged a broader range of factors than in previously published research on patient safety in primary care, including a poor doctor-patient relationship, to pose a potential threat to patient safety. Other risk factors such as infection prevention, deviation from guidelines and incident reporting were judged to be less relevant than by policy makers.

  3. SAFETY AT FLUOR HANFORD (A) CASE STUDY - PREPARED BY THUNDERBIRD SCHOOL OF GLOBAL MANAGEMENT

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

    ARNOLD LD

    2009-09-25

    By November of 1997, Fluor Hanford (Fluor) had been the site manager of the Hanford nuclear reservation for a year. The Hanford site had been established as part of the Manhattan Project in the 1940s that gave birth to the atomic bomb. Hanford produced two thirds of U.S. plutonium during the Cold War period. The Hanford site was half the size of Rhode Island and occupied 586 square miles in southeastern Washington State. The production of plutonium for more than 40 years left a huge legacy of chemical and radiological contamination: 80 square miles of contaminated groundwater; 2,300 tons ofmore » spent nuclear fuel stored in underwater basins; 20 tons of plutonium-laced contaminated materials; and 500 contaminated facilities. The cleanup involved a challenging combination of radioactive material handling within an infrastructure constructed in the 1940s and 1950s. The cleanup that began in 1988 was expected to take 30 years or more. Improving safety at Hanford had already proven to be a significant challenge. As the new site manager at Hanford, Fluor Hanford inherited lower- and mid-level managers and thousands of unionized employees, many of whom were second or third generation Hanford employees. These employees had seen many contractors come and go over the years. Some of the managers who had worked with the previous contractor saw Fluor's emphasis on safety as getting in the way of operations. Union-management relations were fractious. Hanford's culture was described as 'production driven-management told everyone what to do, and, if you didn't do it, there were consequences'. Worker involvement in designing and implementing safety programs was negligible. Fluor Hanford also was having trouble satisfying its client, the Department of Energy (DOE). The DOE did not see a clear path forward for performance improvements at Hanford. Clearly, major change was necessary, but how and where should it be implemented?« less

  4. Light-Driven Contact Hearing Aid for Broad-Spectrum Amplification: Safety and Effectiveness Pivotal Study.

    PubMed

    Gantz, Bruce J; Perkins, Rodney; Murray, Michael; Levy, Suzanne Carr; Puria, Sunil

    2017-03-01

    Demonstrate safety and effectiveness of the light-driven contact hearing aid to support FDA clearance. A single-arm, open-label investigational-device clinical trial. Two private-practice and one hospital-based ENT clinics. Forty-three subjects (86 ears) with mild-to-severe bilateral sensorineural hearing impairment. Bilateral amplification delivered via a light-driven contact hearing aid comprising a Tympanic Lens (Lens) with a customized platform to directly drive the umbo and a behind-the-ear sound processor (Processor) that encodes sound into light pulses to wirelessly deliver signal and power to the Lens. The primary safety endpoint was a determination of "no change" (PTA4 < 10 dB) in residual unaided hearing at the 120-day measurement interval. The primary efficacy endpoint was improvement in word recognition using NU-6 at the 30-day measurement interval over the baseline unaided case. Secondary efficacy endpoints included functional gain from 2 to 10 kHz and speech-in-noise improvement over the baseline unaided case using both omnidirectional and directional microphones. The results for the 86 ears in the study determined a mean change of -0.40 dB in PTA4, indicating no change in residual hearing (p < 0.0001). There were no serious device- or procedure-related adverse events, or unanticipated adverse events. Word recognition aided with the Earlens improved significantly (p < 0.0001) over the unaided performance, by 35% rationalized arcsine units on average. Mean functional gain was 31 dB across 2 to 10 kHz. The average speech-recognition threshold improvement over the unaided case for the Hearing in Noise Test was 0.75 dB (p = 0.028) and 3.14 dB (p < 0.0001) for the omnidirectional and directional microphone modes, respectively. The safety and effectiveness data supported a de novo 510(k) submission that received clearance from the FDA.

  5. 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.

  6. Safe clinical practice for patients hospitalised in a suicidal crisis: a study protocol for a qualitative case study.

    PubMed

    Berg, Siv Hilde; Rørtveit, Kristine; Walby, Fredrik A; Aase, Karina

    2017-01-27

    Suicide prevention in psychiatric care is arguably complex and incompletely understood as a patient safety issue. A resilient healthcare approach provides perspectives through which to understand this complexity by understanding everyday clinical practice. By including suicidal patients and healthcare professionals as sources of knowledge, a deeper understanding of what constitutes safe clinical practice can be achieved. This planned study aims to adopt the perspective of resilient healthcare to provide a deeper understanding of safe clinical practice for suicidal patients in psychiatric inpatient care. It will describe the experienced components and conditions of safe clinical practice and the experienced practice of patient safety. The study will apply a descriptive case study approach consisting of qualitative semistructured interviews and focus groups. The data sources are hospitalised patients in a suicidal crisis and healthcare professionals in clinical practice. This study was approved by the Regional Ethics Committee (2016/34). The results will be disseminated through scientific articles, a PhD dissertation, and national and international conferences. These findings can generate knowledge to be integrated into the practice of safety for suicidal inpatients in Norway and to improve the feasibility of patient safety measures. Theoretical generalisations can be drawn regarding safe clinical practice by taking into account the experiences of patients and healthcare professionals. Thus, this study can inform the conceptual development of safe clinical practice for suicidal patients. 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/.

  7. DFN Modeling for the Safety Case of the Final Disposal of Spent Nuclear Fuel in Olkiluoto, Finland

    NASA Astrophysics Data System (ADS)

    Vanhanarkaus, O.

    2017-12-01

    Olkiluoto Island is a site in SW Finland chosen to host a deep geological repository for high-level nuclear waste generated by nuclear power plants of power companies TVO and Fortum. Posiva, a nuclear waste management organization, submitted a construction license application for the Olkiluoto repository to the Finnish government in 2012. A key component of the license application was an integrated geological, hydrological and biological description of the Olkiluoto site. After the safety case was reviewed in 2015 by the Radiation and Nuclear Safety Authority in Finland, Posiva was granted a construction license. Posiva is now preparing an updated safety case for the operating license application to be submitted in 2022, and an update of the discrete fracture network (DFN) model used for site characterization is part of that. The first step describing and modelling the network of fractures in the Olkiluoto bedrock was DFN model version 1 (2009), which presented an initial understanding of the relationships between rock fracturing and geology at the site and identified the important primary controls on fracturing. DFN model version 2 (2012) utilized new subsurface data from additional drillholes, tunnels and excavated underground facilities in ONKALO to better understand spatial variability of the geological controls on geological and hydrogeological fracture properties. DFN version 2 connected fracture geometric and hydraulic properties to distinct tectonic domains and to larger-scale hydraulically conductive fault zones. In the version 2 DFN model, geological and hydrogeological models were developed along separate parallel tracks. The version 3 (2017) DFN model for the Olkiluoto site integrates geological and hydrogeological elements into a single consistent model used for geological, rock mechanical, hydrogeological and hydrogeochemical studies. New elements in the version 3 DFN model include a stochastic description of fractures within Brittle Fault Zones (BFZ

  8. Safety of ceftriaxone in paediatrics: a systematic review protocol.

    PubMed

    Zeng, Linan; Choonara, Imti; Zhang, Lingli; Xue, Song; Chen, Zhe; He, Miaomiao

    2017-08-21

    Ceftriaxone is widely used in children in the treatment of sepsis. However, concerns have been raised about the safety of ceftriaxone, especially in young children. The aim of this review is to systematically evaluate the safety of ceftriaxone in children of all age groups. MEDLINE, PubMed, Cochrane Central Register of Controlled Trials, EMBASE, CINAHL, International Pharmaceutical Abstracts and adverse drug reaction (ADR) monitoring systems will be systematically searched for randomised controlled trials (RCTs), cohort studies, case-control studies, cross-sectional studies, case series and case reports evaluating the safety of ceftriaxone in children. The Cochrane risk of bias tool, Newcastle-Ottawa and quality assessment tools developed by the National Institutes of Health will be used for quality assessment. Meta-analysis of the incidence of ADRs from RCTs and prospective studies will be done. Subgroup analyses will be performed for age and dosage regimen. Formal ethical approval is not required as no primary data are collected. This systematic review will be disseminated through a peer-reviewed publication and at conference meetings. CRD42017055428. © 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.

  9. Canadian Consumer Food Safety Practices and Knowledge: Foodbook Study.

    PubMed

    Murray, Regan; Glass-Kaastra, Shiona; Gardhouse, Christine; Marshall, Barbara; Ciampa, Nadia; Franklin, Kristyn; Hurst, Matt; Thomas, M Kate; Nesbitt, Andrea

    2017-10-01

    Understanding consumers' food safety practices and knowledge supports food safety education for the prevention of foodborne illness. The objective of this study was to describe Canadian consumer food safety practices and knowledge. This study identifies demographic groups for targeted food safety education messaging and establishes a baseline measurement to assess the effectiveness of food safety interventions over time. Questions regarding consumer food safety practices and knowledge were included in a population-based telephone survey, Foodbook, conducted from November 2014 to March 2015. The results were analyzed nationally by age group and by gender. The results showed that approximately 90% of Canadians reported taking the recommended cleaning and separating precautions when handling raw meat to prevent foodborne illness. Only 29% of respondents reported using a food thermometer when cooking any meat, and even fewer (12%) reported using a food thermometer for small cuts of meat such as chicken pieces. The majority (>80%) of Canadians were aware of the foodborne illness risks related to chicken and hamburger, but fewer (<40%) were aware of the risks related to frozen chicken nuggets, alfalfa sprouts, soft unpasteurized cheese, and unpasteurized juices. Generally, men were less likely to follow cooking instructions on packaging and took fewer steps to prevent cross-contamination than women. The youngest (18 to 29 years) age group was less likely to take steps to avoid cross-contamination and was less aware of the risks associated with eating an undercooked hamburger. The oldest (60+ years) respondents were less likely to be aware of the risks associated with raw eggs, alfalfa sprouts, and unpasteurized juice than the middle (30 to 59 years) age group. As a priority, food safety education in Canada should focus on increasing people's awareness of high-risk foods, specifically foods for which the awareness of risk found in this study was low; targeting messaging

  10. Lift truck safety review

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

    Cadwallader, L.C.

    1997-03-01

    This report presents safety information about powered industrial trucks. The basic lift truck, the counterbalanced sit down rider truck, is the primary focus of the report. Lift truck engineering is briefly described, then a hazard analysis is performed on the lift truck. Case histories and accident statistics are also given. Rules and regulations about lift trucks, such as the US Occupational Safety an Health Administration laws and the Underwriter`s Laboratories standards, are discussed. Safety issues with lift trucks are reviewed, and lift truck safety and reliability are discussed. Some quantitative reliability values are given.

  11. A review of national policies and strategies to improve quality of health care and patient safety: a case study from Lebanon and Jordan.

    PubMed

    El-Jardali, Fadi; Fadlallah, Racha

    2017-08-16

    Improving quality of care and patient safety practices can strengthen health care delivery systems, improve health sector performance, and accelerate attainment of health-related Sustainability Development Goals. Although quality improvement is now prominent on the health policy agendas of governments in low- and middle-income countries (LMICs), including countries of the Eastern Mediterranean Region (EMR), progress to date has not been optimal. The objective of this study is to comprehensively review existing quality improvement and patient safety policies and strategies in two selected countries of the EMR (Lebanon and Jordan) to determine the extent to which these have been institutionalized within existing health systems. We used a mixed methods approach that combined documentation review, stakeholder surveys and key informant interviews. Existing quality improvement and patient safety initiatives were assessed across five components of an analytical framework for assessing health care quality and patient safety: health systems context; national policies and legislation; organizations and institutions; methods, techniques and tools; and health care infrastructure and resources. Both Lebanon and Jordan have made important progress in terms of increased attention to quality and accreditation in national health plans and strategies, licensing requirements for health care professionals and organizations (albeit to varying extents), and investments in health information systems. A key deficiency in both countries is the absence of an explicit national policy for quality improvement and patient safety across the health system. Instead, there is a spread of several (disjointed) pieces of legal measures and national plans leading to fragmentation and lack of clear articulation of responsibilities across the entire continuum of care. Moreover, both countries lack national sets of standardized and applicable quality indicators for performance measurement and benchmarking

  12. Initiation of farm safety programs in the Arkansas Delta: a case study of participatory methods.

    PubMed

    Richter, Jan S; Hall, Becky G; Deere, G David

    2007-01-01

    Outreach to high-risk communities is one of the goals of Area Health Education Centers. One such population is the farm community, which is known to suffer high rates of traumatic events. To describe a participatory methods initiative by the Arkansas Delta Area Health Education Center and other agencies to address farm-related health hazards in a 7-county region. Regional injury and fatality data were gathered from sources including Arkansas Farm Bureau Federation insurance claims, the Arkansas Statistical Service Phone Survey, the National Agricultural Statistics Service, and the Cooperative Extension Service Division of Agriculture at the University of Arkansas. Focus groups were held to assess farmer perceptions and recommendations. Accidents involving tractors accounted for 42% of deaths, and accidents with crop-spraying aircraft accounted for 36%. Focus group participants agreed that planting and harvesting seasons were particularly dangerous. Recommendations included educating motorists to be more cautious on agricultural area roads, using local farmers to provide farm safety training, and making safety equipment more available.

  13. A Pilot Study of Seeking Safety Therapy with OEF/OIF Veterans

    PubMed Central

    Norman, Sonya B.; Wilkins, Kendall C.; Tapert, Susan F.; Lang, Ariel J.; Najavits, Lisa M.

    2010-01-01

    PTSD and substance use disorder (SUD) are highly prevalent among Veterans returning from Iraq and Afghanistan (Operation Enduring Freedom/Operation Iraqi Freedom; OEF/OIF). Seeking Safety (SS) is a cognitive-behavioral psychotherapy for co-occurring PTSD/SUD. This pilot study with fourteen male OEF/OIF Veterans suggests that SS may help to reduce alcohol use, PTSD, and depression in some participants at clinically significant levels, even when providing less than half of the full model. We emphasize several SS features as especially helpful: the case management component to help engage clients in further mental health and SUD care; offering PTSD as an entry point, and emphasis on community resources. Issues particular to Veterans include reintegration to civilian life and supporting Veterans’ connection with other Veterans. PMID:20464809

  14. 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.

  15. How case characteristics differ across four types of elder maltreatment: implications for tailoring interventions to increase victim safety.

    PubMed

    Jackson, Shelly L; Hafemeister, Thomas L

    2014-12-01

    The purpose of this study was to determine whether case characteristics are differentially associated with four forms of elder maltreatment. Triangulated interviews were conducted with 71 APS caseworkers, 55 victims of substantiated abuse whose cases they managed, and 35 third party persons. Pure financial exploitation (PFE) was characterized by victim unawareness of financial exploitation and living alone. Physical abuse (PA) was characterized by victim's desire to protect the abusive individual. Neglect was characterized by isolation and victim's residing with the abusive individual. Hybrid financial exploitation (HFE) was characterized by mutual dependency. These differences indicate the need for tailoring interventions to increase victim safety. PFE requires victims to maintain financial security and independence. PA requires services to meet the needs of abusive individuals. Neglect requires greater monitoring when elderly persons reside with another person. HFE requires the provision of services to both members of the dyad. © The Author(s) 2012.

  16. Study Abroad Programs: Making Safety a Priority

    ERIC Educational Resources Information Center

    Buddan, Michael Craig; Budden, Connie B.; Juban, Rusty; Baraya, Aristides

    2014-01-01

    Increasingly, students are participating in study abroad programs. Such programs provide participants a variety of learning experiences. Developing cross-cultural appreciation, communication skills, maturity and a less ethno-centric mindset are among the impacts study abroad programs offer. However, care must be taken to assure student safety and…

  17. Case Study Teaching

    ERIC Educational Resources Information Center

    Herreid, Clyde Freeman

    2011-01-01

    This chapter describes the history of case study teaching, types of cases, and experimental data supporting their effectiveness. It also describes a model for comparing the efficacy of the various case study methods. (Contains 1 figure.)

  18. Safe laser application requires more than laser safety

    NASA Astrophysics Data System (ADS)

    Frevel, A.; Steffensen, B.; Vassie, L.

    1995-02-01

    An overview is presented concerning aspects of laser safety in European industrial laser use. Surveys indicate that there is a large variation in the safety strategies amongst industrial laser users. Some key problem areas are highlighted. Emission of hazardous substances is a major problem for users of laser material processing systems where the majority of the particulate is of a sub-micrometre size, presenting a respiratory hazard. Studies show that in many cases emissions are not frequently monitored in factories and uncertainty exists over the hazards. Operators of laser machines do not receive adequate job training or safety training. The problem is compounded by a plethora of regulations and standards which are difficult to interpret and implement, and inspectors who are not conversant with the technology or the issues. A case is demonstrated for a more integrated approach to laser safety, taking into account the development of laser applications, organizational and personnel development, in addition to environmental and occupational health and safety aspects. It is necessary to achieve a harmonization between these elements in any organization involved in laser technology. This might be achieved through establishing technology transfer centres in laser technology.

  19. Remote video auditing with real-time feedback in an academic surgical suite improves safety and efficiency metrics: a cluster randomised study.

    PubMed

    Overdyk, Frank J; Dowling, Oonagh; Newman, Sheldon; Glatt, David; Chester, Michelle; Armellino, Donna; Cole, Brandon; Landis, Gregg S; Schoenfeld, David; DiCapua, John F

    2016-12-01

    Compliance with the surgical safety checklist during operative procedures has been shown to reduce inhospital mortality and complications but proper execution by the surgical team remains elusive. We evaluated the impact of remote video auditing with real-time provider feedback on checklist compliance during sign-in, time-out and sign-out and case turnover times. Prospective, cluster randomised study in a 23-operating room (OR) suite. Surgeons, anaesthesia providers, nurses and support staff. ORs were randomised to receive, or not receive, real-time feedback on safety checklist compliance and efficiency metrics via display boards and text messages, followed by a period during which all ORs received feedback. Checklist compliance (Pass/Fail) during sign-in, time-out and sign-out demonstrated by (1) use of checklist, (2) team attentiveness, (3) required duration, (4) proper sequence and duration of case turnover times. Sign-in, time-out and sign-out PASS rates increased from 25%, 16% and 32% during baseline phase (n=1886) to 64%, 84% and 68% for feedback ORs versus 40%, 77% and 51% for no-feedback ORs (p<0.004) during the intervention phase (n=2693). Pass rates were 91%, 95% and 84% during the all-feedback phase (n=2001). For scheduled cases (n=1406, 71%), feedback reduced mean turnover times by 14% (41.4 min vs 48.1 min, p<0.004), and the improvement was sustained during the all-feedback period. Feedback had no effect on turnover time for unscheduled cases (n=587, 29%). Our data indicate that remote video auditing with feedback improves surgical safety checklist compliance for all cases, and turnover time for scheduled cases, but not for unscheduled cases. 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/.

  20. Remote video auditing with real-time feedback in an academic surgical suite improves safety and efficiency metrics: a cluster randomised study

    PubMed Central

    Overdyk, Frank J; Dowling, Oonagh; Newman, Sheldon; Glatt, David; Chester, Michelle; Armellino, Donna; Cole, Brandon; Landis, Gregg S; Schoenfeld, David; DiCapua, John F

    2016-01-01

    Importance Compliance with the surgical safety checklist during operative procedures has been shown to reduce inhospital mortality and complications but proper execution by the surgical team remains elusive. Objective We evaluated the impact of remote video auditing with real-time provider feedback on checklist compliance during sign-in, time-out and sign-out and case turnover times. Design, setting Prospective, cluster randomised study in a 23-operating room (OR) suite. Participants Surgeons, anaesthesia providers, nurses and support staff. Exposure ORs were randomised to receive, or not receive, real-time feedback on safety checklist compliance and efficiency metrics via display boards and text messages, followed by a period during which all ORs received feedback. Main outcome(s) and measure(s) Checklist compliance (Pass/Fail) during sign-in, time-out and sign-out demonstrated by (1) use of checklist, (2) team attentiveness, (3) required duration, (4) proper sequence and duration of case turnover times. Results Sign-in, time-out and sign-out PASS rates increased from 25%, 16% and 32% during baseline phase (n=1886) to 64%, 84% and 68% for feedback ORs versus 40%, 77% and 51% for no-feedback ORs (p<0.004) during the intervention phase (n=2693). Pass rates were 91%, 95% and 84% during the all-feedback phase (n=2001). For scheduled cases (n=1406, 71%), feedback reduced mean turnover times by 14% (41.4 min vs 48.1 min, p<0.004), and the improvement was sustained during the all-feedback period. Feedback had no effect on turnover time for unscheduled cases (n=587, 29%). Conclusions and relevance Our data indicate that remote video auditing with feedback improves surgical safety checklist compliance for all cases, and turnover time for scheduled cases, but not for unscheduled cases. PMID:26658775

  1. Value of shared preclinical safety studies - The eTOX database.

    PubMed

    Briggs, Katharine; Barber, Chris; Cases, Montserrat; Marc, Philippe; Steger-Hartmann, Thomas

    2015-01-01

    A first analysis of a database of shared preclinical safety data for 1214 small molecule drugs and drug candidates extracted from 3970 reports donated by thirteen pharmaceutical companies for the eTOX project (www.etoxproject.eu) is presented. Species, duration of exposure and administration route data were analysed to assess if large enough subsets of homogenous data are available for building in silico predictive models. Prevalence of treatment related effects for the different types of findings recorded were analysed. The eTOX ontology was used to determine the most common treatment-related clinical chemistry and histopathology findings reported in the database. The data were then mined to evaluate sensitivity of established in vivo biomarkers for liver toxicity risk assessment. The value of the database to inform other drug development projects during early drug development is illustrated by a case study.

  2. Prevalence and test characteristics of national health safety network ventilator-associated events.

    PubMed

    Lilly, Craig M; Landry, Karen E; Sood, Rahul N; Dunnington, Cheryl H; Ellison, Richard T; Bagley, Peter H; Baker, Stephen P; Cody, Shawn; Irwin, Richard S

    2014-09-01

    The primary aim of the study was to measure the test characteristics of the National Health Safety Network ventilator-associated event/ventilator-associated condition constructs for detecting ventilator-associated pneumonia. Its secondary aims were to report the clinical features of patients with National Health Safety Network ventilator-associated event/ventilator-associated condition, measure costs of surveillance, and its susceptibility to manipulation. Prospective cohort study. Two inpatient campuses of an academic medical center. Eight thousand four hundred eight mechanically ventilated adults discharged from an ICU. None. The National Health Safety Network ventilator-associated event/ventilator-associated condition constructs detected less than a third of ventilator-associated pneumonia cases with a sensitivity of 0.325 and a positive predictive value of 0.07. Most National Health Safety Network ventilator-associated event/ventilator-associated condition cases (93%) did not have ventilator-associated pneumonia or other hospital-acquired complications; 71% met the definition for acute respiratory distress syndrome. Similarly, most patients with National Health Safety Network probable ventilator-associated pneumonia did not have ventilator-associated pneumonia because radiographic criteria were not met. National Health Safety Network ventilator-associated event/ventilator-associated condition rates were reduced 93% by an unsophisticated manipulation of ventilator management protocols. The National Health Safety Network ventilator-associated event/ventilator-associated condition constructs failed to detect many patients who had ventilator-associated pneumonia, detected many cases that did not have a hospital complication, and were susceptible to manipulation. National Health Safety Network ventilator-associated event/ventilator-associated condition surveillance did not perform as well as ventilator-associated pneumonia surveillance and had several undesirable

  3. Evaluation of protein safety in the context of agricultural biotechnology.

    PubMed

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

    2008-05-01

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

  4. 40 CFR 725.92 - Data from health and safety studies of microorganisms.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 32 2012-07-01 2012-07-01 false Data from health and safety studies of... Public Access to Information § 725.92 Data from health and safety studies of microorganisms. (a..., EPA will deny any claim of confidentiality with respect to information included in a health and safety...

  5. 40 CFR 725.92 - Data from health and safety studies of microorganisms.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 31 2011-07-01 2011-07-01 false Data from health and safety studies of... Public Access to Information § 725.92 Data from health and safety studies of microorganisms. (a..., EPA will deny any claim of confidentiality with respect to information included in a health and safety...

  6. 40 CFR 725.92 - Data from health and safety studies of microorganisms.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Data from health and safety studies of... Public Access to Information § 725.92 Data from health and safety studies of microorganisms. (a..., EPA will deny any claim of confidentiality with respect to information included in a health and safety...

  7. 40 CFR 725.92 - Data from health and safety studies of microorganisms.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 32 2013-07-01 2013-07-01 false Data from health and safety studies of... Public Access to Information § 725.92 Data from health and safety studies of microorganisms. (a..., EPA will deny any claim of confidentiality with respect to information included in a health and safety...

  8. 40 CFR 725.92 - Data from health and safety studies of microorganisms.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 31 2014-07-01 2014-07-01 false Data from health and safety studies of... Public Access to Information § 725.92 Data from health and safety studies of microorganisms. (a..., EPA will deny any claim of confidentiality with respect to information included in a health and safety...

  9. Safety Awareness and Preparedness in Secondary Schools in Kenya: A Case of Turkana District

    ERIC Educational Resources Information Center

    Kipngeno, Ronoh Richard; Benjamin, Kyalo Wambua

    2009-01-01

    Safety for students and staff from hazards that can be created by unsafe conditions, behaviour, disasters or emergencies in schools cannot be guaranteed. This is because of inadequate preparedness and awareness programs for safety needs. This study investigated the adequacy of procedures, precautions and infrastructure to respond to fire outbreaks…

  10. A feasibility study for Arizona's roadway safety management process using the Highway Safety Manual and SafetyAnalyst : final report.

    DOT National Transportation Integrated Search

    2016-07-01

    To enable implementation of the American Association of State Highway Transportation (AASHTO) Highway Safety Manual using : SaftetyAnalyst (an AASHTOWare software product), the Arizona Department of Transportation (ADOT) studied the data assessment :...

  11. The Attitude of Civil Engineering Students towards Health and Safety Risk Management: A Case Study

    ERIC Educational Resources Information Center

    Petersen, A. K.; Reynolds, J. H.; Ng, L. W. T.

    2008-01-01

    The highest rate of accidents and injuries in British industries has been reported by the construction industry during the past decade. Since then stakeholders have recognised that a possible solution would be to inculcate a good attitude towards health and safety risk management in undergraduate civil engineering students and construction…

  12. Projecting the health and economic impact of road safety initiatives: a case study of a multi-country project.

    PubMed

    Esperato, Alexo; Bishai, David; Hyder, Adnan A

    2012-01-01

    The Road Safety in 10 Countries (RS-10) project will implement 12 different road safety interventions at specific sites within 10 low- and middle-income countries (LMICs). This evaluation reports the number of lives that RS-10 is projected to save in those locations, the economic value of the risk reduction, and the maximum level of investment that a public health intervention of this magnitude would be able to incur before its costs outweigh its health benefits. We assumed a 5-year time implementation horizon corresponding to the duration of RS-10. Based on a preliminary literature review, we estimated the effectiveness for each of the RS-10 interventions. Applying these effectiveness estimates to the size of the population at risk at RS-10 sites, we calculated the number of lives and life years saved (LYS) by RS-10. We projected the value of a statistical life (VSL) in each RS-10 country based on gross national income (GNI) and estimated the value of the lives saved using each country's VSL. Sensitivity analysis addressed robustness to assumptions about elasticity, discount rates, and intervention effectiveness. From the evidence base reviewed, only 13 studies met our selection criteria. Such a limited base presents uncertainties about the potential impact of the modeled interventions. We tried to account for these uncertainties by allowing effectiveness to vary ± 20 percent for each intervention. Despite this variability, RS-10 remains likely to be worth the investment. RS-10 is expected to save 10,310 lives over 5 years (discounted at 3%). VSL and $/LYS methods provide concordant results. Based on our estimates of each country's VSL, the respective countries would be willing to pay $2.45 billion to lower these fatality risks (varying intervention effectiveness by ± 20 percent, the corresponding range is $2.0-$2.9 billion). Analysis based on $/LYS shows that the RS-10 project will be cost-effective as long as its costs do not exceed $5.14 billion (under ± 20

  13. [Case managers experience improved trajectories for cancer patients after implementation of the case manager function].

    PubMed

    Axelsen, Karina Rahbek; Nafei, Hanne; Jakobsen, Stine Finne; Gandrup, Per; Knudsen, Janne Lehmann

    2015-06-08

    Case managers are increasingly used to optimize trajectories for patients. This study is based on a questionnaire among case managers in cancer care, aiming at the clarification of the func­tion and its impact on especially patient safety, when handing over the responsibility. The results show a major variation in how the function is organized, the level of competence and the task to be handled. The responsibility has in general been nar­rowed to department level. Overall, the case managers believe that the function has optimized pathways for cancer patients and improved safety, but barriers persist.

  14. Space Station crew safety alternatives study. Volume 5: Space Station safety plan

    NASA Technical Reports Server (NTRS)

    Mead, G. H.; Peercy, R. L., Jr.; Raasch, R. F.

    1985-01-01

    The Space Station Safety Plan has been prepared as an adjunct to the subject contract final report, suggesting the tasks and implementation procedures to ensure that threats are addressed and resolution strategy options identified and incorporated into the space station program. The safety program's approach is to realize minimum risk exposure without levying undue design and operational constraints. Safety objectives and risk acceptances are discussed.

  15. The Shirts on Our Backs: Teleological Perspectives on Factory Safety in Bangladesh

    ERIC Educational Resources Information Center

    Dhooge, Lucien J.

    2016-01-01

    This case study addresses the issue of factory safety in the garment industry through an examination of two recent catastrophic failures in Bangladesh. The case study was designed for students in Business Ethics in the MBA curriculum at the Scheller College of Business at the Georgia Institute of Technology. The case study has also been adapted…

  16. Alaska Humans Factors Safety Study: The Southern Coastal Area

    NASA Technical Reports Server (NTRS)

    Chappell, Sheryl L.; Reynard, William (Technical Monitor)

    1995-01-01

    At the request of the Alaska Air Carriers Association, researchers from the NASA Aviation Safety Reporting System, at NASA Ames Research Center, conducted a study on aspects of safety in Alaskan Part 135 air taxi operations. An interview form on human factors safety issues was created by a representative team from the FAA-Alaska, NTSB-Alaska, NASA-ASRS, and representatives of the Alaska Air Carriers Association which was subsequently used in the interviews of pilots and managers. Because of the climate and operational differences, the study was broken into two geographical areas, the southern coastal areas and the northern portion of the state. This presentation addresses the southern coastal areas, specifically: Anchorage, Dillingham, King Salmon, Kodiak, Cold Bay, Juneau, and Ketchikan. The interview questions dealt with many of the potential pressures on pilots and managers associated with the daily air taxi operations in Alaska. The impact of the environmental factors such as the lack of available communication, navigation and weather information systems was evaluated. The results of this study will be used by government and industry working in Alaska. These findings will contribute important information on specific Alaska safety issues for eventual incorporation into training materials and policies that will help to assure the safe conduct of air taxi flights in Alaska.

  17. The conception of fashion products for children: reflections on safety parameters.

    PubMed

    Prete, Lígia Gomes Pereira; Emidio, Lucimar de Fátima Bilmaia; Martins, Suzana Barreto

    2012-01-01

    The purpose of this study is to reflect on safety requirements for children's clothing, based on the standardization proposed by the ABNT (Technical Standardization Brazilian Association). Bibliographic research and case studies were considered on writing this work. We also discuss the importance of adding other safety requirements to the current standardization, as well as the increasing of the actual age range specified by the ABNT, following the children's clothing safety standardizations in Portugal and the United States, also stated here.

  18. 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

    .' 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.

  19. [The case-case-time-control study design].

    PubMed

    Wang, Jing; Zhuo, Lin; Zhan, Siyan

    2014-12-01

    Although the 'self-matched case-only studies' (such as the case-cross-over or self-controlled case-series method) can control the time-invariant confounders (measured or unmeasured) through design of the study, however, they can not control those confounders that vary with time. A bidirectional case-crossover design can be used to adjust the exposure-time trends. In the areas of pharmaco-epidemiology, illness often influence the future use of medications, making a bidirectional study design problematic. Suissa's case-time-control design combines the case-crossover and the case-control design which could adjust for exposure-trend bias, but the control group may reintroduce selection bias, if the matching does not go well. We propose a "case-case-time-control" design which is an extension of the case-time-control design. However, rather than using a sample of external controls, we choose those future cases as controls for current cases to counter the bias that arising from temporal trends caused by exposure to the target of interest. In the end of this article we will discuss the strength and limitations of this design based on an applied example.

  20. Neonatal case studies using active leptospermum honey.

    PubMed

    Mohr, Lynn D; Reyna, Roxana; Amaya, Rene

    2014-01-01

    Treatment of the neonatal patient with clinically complex wounds creates a challenge due to the safety and efficacy issues associated with the use of many advanced wound care products. The purpose of this case series was to present outcomes of 3 neonates with wounds of differing etiologies managed by Active Leptospermum Honey (ALH). Clinical case series. Clinical experiences with 3 neonates, 1 male and 2 females, are described. These premature infants received care at Rush University Medical Center, Houston, Texas, or Driscoll Children's Hospital, Corpus Christi, Texas. Each neonate presented with dissimilar wounds and differing treatment goals. For a premature infant with left foot ischemia, ALH dressings allowed for removal of nonviable tissue and facilitated the granulation of the open wounds. This removal of nonviable tissue coupled with the facilitation of granulation tissue enabled the premature infant's toe tips to be salvaged without requiring aggressive surgical intervention. For the 2 preterm infants with extravasation of intravenous solutions, ALH dressings allowed healing and increased tissue granulation without any noted toxicity to the wound bed. Further, the method of action of ALH includes an osmotic pull effect that reduced periwound erythema and edema. Although the use of ALH has been well documented in adult care, these case studies demonstrate its potential use in different wound etiologies in 3 neonatal patients.

  1. Car Safety Seat Usage and Selection Among Families Attending University Hospital Limerick.

    PubMed

    Scully, P; Finner, N; Letshwiti, J B; O'Gorman, C

    2016-05-10

    The safest way for children to travel within a car is by provision of a weight-appropriate safety-seat. To investigate this, we conducted a cross-sectional study of adult parents who had children under 12 years, and collected information related to: car use, safety-seat legislation, and type of safety-seat employed. Data were reviewed on 120 children from 60 respondents. Ninety-eight (81.7%) children were transported daily by car. Forty-eight (81.4%) respondents were aware that current safety-seat legislation is based on the weight of the child. One hundred and seven (89.9%) children were restrained during travel using a car safety-seat. One hundred and two (96.2%) safety seats were newly purchased, installed in 82.3% (88) cases by family members with installation instructions fully read in 58 (55.2%) cases. Ninety-nine (83.2%) children were restrained using an appropriate safety-seat for their weight. The results show that four out of five families are employing the most appropriate safety-seat for their child, so providing an effective mechanism to reduce car-related injury. However, the majority of safety-seats are installed by family members, which may have child safety consequences.

  2. Understanding the relationship between safety culture dimensions and safety performance of construction projects through partial least square method

    NASA Astrophysics Data System (ADS)

    Latief, Yusuf; Machfudiyanto, Rossy A.; Arifuddin, Rosmariani; Yogiswara, Yoko

    2017-03-01

    Based on the data, 32% of accidental cases in Indonesia occurs on constructional sectors. It is supported by the data from Public Work and Housing Department that 27.43% of the implementation level of Safety Management System policy at construction companies in Indonesia remains unsafe categories. Moreover, there are dimensions of occupational safety culture formed including leadership, behavior, strategy, policy, process, people, safety cost, value and contract system. The aim of this study is to determine the model of an effective safety culture and know the relationship between dimensions in construction industry. The method used in this research was questionnaire survey which was distributed to the sample of construction companies either in a national private one in Indonesia. The result of this research is supposed to be able to illustrate the development of the relationship among occupational safety culture dimensions which have influences to the performances of constructional companies in Indonesia.

  3. Outdoor workers and sun protection strategies: two case study examples in Queensland, Australia.

    PubMed

    Sendall, Marguerite C; Stoneham, Melissa; Crane, Phil; Fleming, MaryLou; Janda, Monika; Tenkate, Thomas; Youl, Philippa; Kimlin, Michael

    2016-01-01

    Outdoor workers are at risk of developing skin cancer because they are exposed to high levels of harmful ultraviolet radiation. The Outdoor Workers Sun Protection Project investigated sun protection strategies for high risk outdoor workers in rural and regional Australia. Fourteen workplaces (recruitment rate 37%) across four industries in rural and regional Queensland, Australia were recruited to the OWSPP. In 2011-2012, data were collected using pre- and post-intervention interviews and discussion groups. This article presents two workplaces as case study examples. The flat organisational structure of workplace 1 supported the implementation of the Sun Safety Action Plan (SSAP), whilst the hierarchical organisational nature of workplace 2 delayed implementation of the SSAP. Neither workplace had an existing sun protection policy but both workplaces adopted one. An effect related to the researchers' presence was seen in workplace 1 and to a lesser degree in workplace 2. Overt reciprocity was seen between management and workers in workplace 1 but this was not so evident in workplace 2. In both workplaces, the role of the workplace champion was pivotal to SSAP progression. These two case studies highlight a number of contextually bound workplace characteristics related to sun safety. These issues are (1) the structure of workplace, (2) policy, (3) an effect related to the researchers' presence, (4) the workplace champion and (5) reciprocity. There are several recommendations from this article. Workplace health promotion strategies for sun safety need to be contextualised to individual workplaces to take advantage of the strengths of the workplace and to build capacity.

  4. Quantitative safety assessment of air traffic control systems through system control capacity

    NASA Astrophysics Data System (ADS)

    Guo, Jingjing

    Quantitative Safety Assessments (QSA) are essential to safety benefit verification and regulations of developmental changes in safety critical systems like the Air Traffic Control (ATC) systems. Effectiveness of the assessments is particularly desirable today in the safe implementations of revolutionary ATC overhauls like NextGen and SESAR. QSA of ATC systems are however challenged by system complexity and lack of accident data. Extending from the idea "safety is a control problem" in the literature, this research proposes to assess system safety from the control perspective, through quantifying a system's "control capacity". A system's safety performance correlates to this "control capacity" in the control of "safety critical processes". To examine this idea in QSA of the ATC systems, a Control-capacity Based Safety Assessment Framework (CBSAF) is developed which includes two control capacity metrics and a procedural method. The two metrics are Probabilistic System Control-capacity (PSC) and Temporal System Control-capacity (TSC); each addresses an aspect of a system's control capacity. And the procedural method consists three general stages: I) identification of safety critical processes, II) development of system control models and III) evaluation of system control capacity. The CBSAF was tested in two case studies. The first one assesses an en-route collision avoidance scenario and compares three hypothetical configurations. The CBSAF was able to capture the uncoordinated behavior between two means of control, as was observed in a historic midair collision accident. The second case study compares CBSAF with an existing risk based QSA method in assessing the safety benefits of introducing a runway incursion alert system. Similar conclusions are reached between the two methods, while the CBSAF has the advantage of simplicity and provides a new control-based perspective and interpretation to the assessments. The case studies are intended to investigate the

  5. Comparison of case note review methods for evaluating quality and safety in health care.

    PubMed

    Hutchinson, A; Coster, J E; Cooper, K L; McIntosh, A; Walters, S J; Bath, P A; Pearson, M; Young, T A; Rantell, K; Campbell, M J; Ratcliffe, J

    2010-02-01

    To determine which of two methods of case note review--holistic (implicit) and criterion-based (explicit)--provides the most useful and reliable information for quality and safety of care, and the level of agreement within and between groups of health-care professionals when they use the two methods to review the same record. To explore the process-outcome relationship between holistic and criterion-based quality-of-care measures and hospital-level outcome indicators. Case notes of patients at randomly selected hospitals in England. In the first part of the study, retrospective multiple reviews of 684 case notes were undertaken at nine acute hospitals using both holistic and criterion-based review methods. Quality-of-care measures included evidence-based review criteria and a quality-of-care rating scale. Textual commentary on the quality of care was provided as a component of holistic review. Review teams comprised combinations of: doctors (n = 16), specialist nurses (n = 10) and clinically trained audit staff (n = 3) and non-clinical audit staff (n = 9). In the second part of the study, process (quality and safety) of care data were collected from the case notes of 1565 people with either chronic obstructive pulmonary disease (COPD) or heart failure in 20 hospitals. Doctors collected criterion-based data from case notes and used implicit review methods to derive textual comments on the quality of care provided and score the care overall. Data were analysed for intrarater consistency, inter-rater reliability between pairs of staff using intraclass correlation coefficients (ICCs) and completeness of criterion data capture, and comparisons were made within and between staff groups and between review methods. To explore the process-outcome relationship, a range of publicly available health-care indicator data were used as proxy outcomes in a multilevel analysis. Overall, 1473 holistic and 1389 criterion-based reviews were undertaken in the first part of the study

  6. Why is patient safety so hard? A selective review of ethnographic studies.

    PubMed

    Dixon-Woods, Mary

    2010-01-01

    Ethnographic studies are valuable in studying patient safety. This is a narrative review of four reports of ethnographic studies of patient safety in UK hospitals conducted as part of the Patient Safety Research Programme. Three of these studies were undertaken in operating theatres and one in an A&E Department. The studies found that hospitals were rarely geared towards ensuring perfect performances. The coordination and mobilization of the large number of inter-dependent processes and resources needed to support the achievement of tasks was rarely optimal. This produced significant strain that staff learned to tolerate by developing various compensatory strategies. Teamwork and inter-professional communication did not always function sufficiently well to ensure that basic procedural information was shared or that the required sequence of events was planned. Staff did not always do the right things, for a wide range of different reasons, including contestations about what counted as the right thing. Structures of authority and accountability were not always clear or well-functioning. Patient safety incidents were usually not reported, though there were many different reasons for this. It can be concluded that securing patient safety is hard. There are multiple interacting influences on safety, and solutions need to be based on a sound understanding of the nature of the problems and which approaches are likely to be best suited to resolving them. Some solutions that appear attractive and straightforward are likely to founder. Addressing safety problems requires acknowledgement that patient safety is not simply a technical issue, but a site of organizational and professional politics.

  7. Influences on Young Children's Knowledge: The Case of Road Safety Education.

    ERIC Educational Resources Information Center

    Cullen, Joy

    1998-01-01

    Argues that effective road safety education for young children needs to incorporate constructivist and socio-cultural perspectives on learning. Excerpts interviews with young children highlighting the variety of influences affecting children's road safety knowledge and examination of a road safety curriculum to illustrate the value of a dual…

  8. Efficacy and safety of aflibercept in metastatic colorectal cancer pretreated with bevacizumab: A report of five cases.

    PubMed

    Alcaide, Julia; Delgado, Mayte; Legerén, Marta; Jurado, José Miguel; Blancas, Isabel; Pereda, Teresa; López, Jorge; Garrido, Margarita; Sánchez, María J; García, José L; Rueda, Antonio

    2016-11-01

    Aflibercept is a recombinant fusion protein that acts by inhibiting tumoural angiogenesis. Efficacy data obtained in the VELOUR randomised study has contributed to the approval of aflibercept as a second-line metastatic colorectal cancer (mCRC) treatment following an oxaliplatin-based regimen. The present study reports a case series of five patients with mCRC, who were treated in two centres since 2011 in the Compassionate Use Program for aflibercept. All patients had a KRAS mutation and previously received palliative fluoropyrimidine-oxaliplatin-based chemotherapy with bevacizumab. A doublet with irinotecan combined with aflibercept was administered until progression of disease. The majority of patients received a greater number of aflibercept cycles than the median reported in the VELOUR study (12 vs. 7 cycles), with manageable and reversible toxicity. The most frequent adverse events observed were diarrhoea, neutropenia, fatigue, proteinuria and hypertension. Most cases obtained a progression-free survival greater than the median reported in the VELOUR study (11 vs. 6.9 months) and, in a subgroup of patients previously treated with bevacizumab, and a median survival time of ~47 months was reached from the initial treatment of the disease. The present study contrasts the efficacy and safety results obtained from the pivotal VELOUR trial, and confirms that aflibercept, used in routine clinical practice outside of the clinical trial environment, is active and well-tolerated following bevacizumab treatment.

  9. Assessment of the accuracy and consistency in the application of standardized surveillance definitions: A summary of the American Journal of Infection Control and National Healthcare Safety Network case studies, 2010-2016.

    PubMed

    Wright, Marc-Oliver; Allen-Bridson, Katherine; Hebden, Joan N

    2017-06-01

    The Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) surveillance definitions are the most widely used criteria for health care-associated infection (HAI) surveillance. NHSN participants agree to conduct surveillance in accordance with the NHSN protocol and criteria. To assess the application of these standardized surveillance specifications and offer infection preventionists (IPs) opportunities for ongoing education, a series of case studies, with questions related to NHSN definitions and criteria were published. Beginning in 2010, case studies with multiple-choice questions based on standard surveillance criteria and protocols were written and published in the American Journal of Infection Control with a link to an online survey. Participants anonymously submitted their responses before receiving the correct answers. The 22 case studies had 7,950 respondents who provided 27,790 responses to 75 questions during the first 6 years. Correct responses were selected 62.5% of the time (17,376 out of 27,290), but ranged widely (16%-87%). In a subset analysis, 93% of participants self-identified as IPs (3,387 out of 3,640), 4.5% were public health professionals (163 out of 3,640), and 2.5% were physicians (90 out of 3,640). IPs responded correctly (62%) more often than physicians (55%) (P = .006). Among a cohort of voluntary participants, accurate application of surveillance criteria to case studies was suboptimal, highlighting the need for continuing education, competency development, and auditing. Copyright © 2017 Association for Professionals in Infection Control and Epidemiology, Inc. All rights reserved.

  10. Clinical studies of the effectiveness and safety of antivenoms.

    PubMed

    Williams, David J; Habib, Abdulrazaq G; Warrell, David A

    2018-05-07

    practical, logistical and funding challenges. Basic requirements for clinical trials include identification of the biting species of snake in every case; the use of objective, clinically-relevant endpoints, such as restoration of blood coagulability; definition of inclusion, exclusion and withdrawal criteria; assurance of antivenom safety; ethical considerations; inclusion of one or more control (comparator) groups; and analysis based on intention to treat. The highest quality evidence comes from Phase II and larger Phase III studies that have been designed as statistically powerful, randomized, controlled trials (RCTs), ideally with blinding of patients and investigators to avoid bias. Because of the challenges to carrying out clinical trials of antivenoms, Phase IV trials (post-marketing surveillance) are potentially more important and useful than for most other drugs. Copyright © 2018 Elsevier Ltd. All rights reserved.

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

    PubMed

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

    2014-07-01

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

  12. Small town health care safety nets: report on a pilot study.

    PubMed

    Taylor, Pat; Blewett, Lynn; Brasure, Michelle; Call, Kathleen Thiede; Larson, Eric; Gale, John; Hagopian, Amy; Hart, L Gary; Hartley, David; House, Peter; James, Mary Katherine; Ricketts, Thomas

    2003-01-01

    Very little is known about the health care safety net in small towns, especially in towns where there is no publicly subsidized safety-net health care. This pilot study of the primary care safety net in 7 such communities was conducted to start building knowledge about the rural safety net. Interviews were conducted and secondary data collected to assess the community need for safety-net care, the health care safety-net role of public officials, and the availability of safety-net care at private primary care practices and its financial impact on these practices. An estimated 20% to 40% of the people in these communities were inadequately insured and needed access to affordable health care, and private primary care practices in most towns played an important role in making primary care available to them. Most of the physician practices were owned or subsidized by a hospital or regional network, though not explicitly to provide charity care. It is likely this ownership or support enabled the practices to sustain a higher level of charity care than would have been possible otherwise. In the majority of communities studied, the leading public officials played no role in ensuring access to safety-net care. State and national government policy makers should consider subsidy programs for private primary care practices that attempt to meet the needs of the inadequately insured in the many rural communities where no publicly subsidized primary safety-net care is available. Subsidies should be directed to physicians in primary care shortage areas who provide safety-net care; this will improve safety-net access and, at the same time, improve physician retention by bolstering physician incomes. Options include enhanced Medicare physician bonuses and grants or tax credits to support income-related sliding fee scales.

  13. An organizational process for promoting home fire safety in two community settings.

    PubMed

    Lehna, Carlee; Twyman, Stephanie; Fahey, Erin; Coty, Mary-Beth; Williams, Joe; Scrivener, Drane; Wishnia, Gracie; Myers, John

    2017-02-01

    The purpose of this study was to describe the home fire safety quality improvement model designed to aid organizations in achieving institutional program goals. The home fire safety model was developed from community-based participatory research (CBPR) applying training-the-trainer methods and is illustrated by an institutional case study. The model is applicable to other types of organizations to improve home fire safety in vulnerable populations. Utilizing the education model leaves trained employees with guided experience to build upon, adapt, and modify the home fire safety intervention to more effectively serve their clientele, promote safety, and meet organizational objectives. Copyright © 2016 Elsevier Ltd and ISBI. All rights reserved.

  14. TOOKUIL: A case study in user interface development for safety code application

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

    Gray, D.L.; Harkins, C.K.; Hoole, J.G.

    1997-07-01

    Traditionally, there has been a very high learning curve associated with using nuclear power plant (NPP) analysis codes. Even for seasoned plant analysts and engineers, the process of building or modifying an input model for present day NPP analysis codes is tedious, error prone, and time consuming. Current cost constraints and performance demands place an additional burden on today`s safety analysis community. Advances in graphical user interface (GUI) technology have been applied to obtain significant productivity and quality assurance improvements for the Transient Reactor Analysis Code (TRAC) input model development. KAPL Inc. has developed an X Windows-based graphical user interfacemore » named TOOKUIL which supports the design and analysis process, acting as a preprocessor, runtime editor, help system, and post processor for TRAC. This paper summarizes the objectives of the project, the GUI development process and experiences, and the resulting end product, TOOKUIL.« less

  15. Using Dust Assessment Technology to Leverage Mine Site Manager-Worker Communication and Health Behavior: A Longitudinal Case Study

    PubMed Central

    Haas, Emily J.; Cecala, Andrew B.; Hoebbel, Cassandra L.

    2016-01-01

    Research continues to investigate barriers to managing occupational health and safety behaviors among the workforce. Recent literature argues that (1) there is a lack of consistent, multilevel communication and application of health and safety practices, and (2) social scientific methods are absent when determining how to manage injury prevention in the workplace. In response, the current study developed and tested a multilevel intervention case study at two industrial mineral mines to help managers and workers communicate about and reduce respirable silica dust exposures at their mine sites. A dust assessment technology, the Helmet-CAM, was used to identify and encourage communication about potential problem areas and tasks on site that contributed to elevated exposures. The intervention involved pre- and post-assessment field visits, four weeks apart that included multiple forms of data collection from workers and managers. Results revealed that mine management can utilize dust assessment technology as a risk communication tool to prompt and communicate about healthier behaviors with their workforce. Additionally, when workers were debriefed with the Helmet-CAM data through the device software, the dust exposure data can help improve the knowledge and awareness of workers, empowering them to change subtle behaviors that could reduce future elevated exposures to respirable silica dust. This case study demonstrates that incorporating social scientific methods into the application of health and safety management strategies, such as behavioral modification and technology integration, can leverage managers’ communication practices with workers, subsequently improving health and safety behaviors. PMID:26807445

  16. Safety climate in dialysis centers in Saudi Arabia: a multicenter study.

    PubMed

    Taher, Saadi; Hejaili, Fayez; Karkar, Ayman; Shaheen, Faissal; Barahmien, Majdah; Al Saran, Khalid; Jondeby, Mohamed; Suleiman, Mohamed; Al Sayyari, Abdulla Ahmed

    2014-06-01

    The aim of this study was to assess the safety climate as perceived by nurses and physicians in the dialysis units in Saudi Arabia. This is a cross-sectional survey-based multicenter study using the Safety Climate Scale, which assesses the perception by staff of the prevailing climate of safety. We used 17 items in this survey. These could be further divided into 3 summative categories: (a) handling of errors and safety concerns (9 items), (b) leadership emphasis of safety (7 items), and (c) overall safety recommendation (1 item). The survey uses 5 Likert scale options (1, disagree strongly; 2, disagree slightly; 3, neutral; 4, agree slightly; and 5, agree strongly). There were 509 respondents--a response rate of 76.6% and 53.3% among nurses and physicians, respectively. The internal consistency using Cronbach α was 0.899. The overall mean (SD) of satisfaction with safety climate was higher among the nurses than the physicians (4.13 [1.1] and 4.05 [1.7], respectively; P = 0.029). The overall agreement rate was 73.8%, with more nurses than physicians agreeing that safety climate prevails the dialysis center (75.4% versus 72.1%, respectively; P = 0.047).The respondents perceived a stronger commitment to safety from their clinical area leaders than from senior leaders in the organization (76.2% and 72.4%, respectively). In addition, the physicians gave lower scores to more questions than the nurses particularly in 3 areas, namely, "leadership is driving us to be a safety-centered institution" (71.5% versus 76.5%; P = 0.037), "I am encouraged by my colleagues to report any patient safety concerns I may have" (67.4% versus 84.7%; P = 0.03), and "I know proper channels to ask questions about safety" (69.6% versus 87.2%; P = 0.002).The scores by the physicians in all the 3 summative categories were again less than the scores by the nurses, but this did not reach a statistical significance. The nurses had higher perceptions of a prevailing safety climate than the

  17. The challenge of compiling data profiles to stimulate local preventive health action: a European case study from child safety.

    PubMed

    Alexander, Denise; Rigby, Michael; Gissler, Mika; Köhler, Lennart; MacKay, Morag

    2015-05-01

    Positive recent experience of presenting comparative child safety data at national level has instigated policy action in Europe. It was hoped a Child Safety Index could quantify how safe a community, region or locality is for its children in comparison with similar areas within Europe, as a focus for local targeted action. Validated indicators proposed by previous European projects identified from areas of child injury prevention, such as road safety, burns or poisoning, were selected to give a balanced profile, and populated from available published data. An index using a sub-score for each specific injury topic was proposed. The indicators' presentation, sensitivity and appropriateness were considered, as well as data availability. Satisfactory indicators were not identified for all areas and very few local area data were available. This forced the researchers to conclude that at present, constructing a reliable Child Safety Index for use at the local level is not feasible. There is a worrying lack of data available at the sub-national level to support injury prevention, evaluate interventions, and enable informed local decision making.

  18. [Case and studies].

    PubMed

    Schubert, András

    2015-11-15

    Case studies and case reports form an important and ever growing part of scientific and scholarly literature. The paper deals with the share and citation rate of these publication types on different fields of research. In general, evidence seems to support the opinion that an excessive number of such publications may negatively influence the impact factor of the journal. In the literature of scientometrics, case studies (at least the presence of the term "case study" in the titles of the papers) have a moderate share, but their citation rate is practically equal to that of other publication types.

  19. Model-Driven Development of Safety Architectures

    NASA Technical Reports Server (NTRS)

    Denney, Ewen; Pai, Ganesh; Whiteside, Iain

    2017-01-01

    We describe the use of model-driven development for safety assurance of a pioneering NASA flight operation involving a fleet of small unmanned aircraft systems (sUAS) flying beyond visual line of sight. The central idea is to develop a safety architecture that provides the basis for risk assessment and visualization within a safety case, the formal justification of acceptable safety required by the aviation regulatory authority. A safety architecture is composed from a collection of bow tie diagrams (BTDs), a practical approach to manage safety risk by linking the identified hazards to the appropriate mitigation measures. The safety justification for a given unmanned aircraft system (UAS) operation can have many related BTDs. In practice, however, each BTD is independently developed, which poses challenges with respect to incremental development, maintaining consistency across different safety artifacts when changes occur, and in extracting and presenting stakeholder specific information relevant for decision making. We show how a safety architecture reconciles the various BTDs of a system, and, collectively, provide an overarching picture of system safety, by considering them as views of a unified model. We also show how it enables model-driven development of BTDs, replete with validations, transformations, and a range of views. Our approach, which we have implemented in our toolset, AdvoCATE, is illustrated with a running example drawn from a real UAS safety case. The models and some of the innovations described here were instrumental in successfully obtaining regulatory flight approval.

  20. Bus safety study : a report to Congress.

    DOT National Transportation Integrated Search

    2013-11-01

    Section 20021(b) of the Moving Ahead for Progress for the 21st Century (MAP-21) legislation requires the Secretary of Transportation : to submit a report of the results of a Bus Safety Study to the Committee on Banking, Housing, and Urban Affai...

  1. Subsonic Aircraft Safety Icing Study

    NASA Technical Reports Server (NTRS)

    Jones, Sharon Monica; Reveley, Mary S.; Evans, Joni K.; Barrientos, Francesca A.

    2008-01-01

    NASA's Integrated Resilient Aircraft Control (IRAC) Project is one of four projects within the agency s Aviation Safety Program (AvSafe) in the Aeronautics Research Mission Directorate (ARMD). The IRAC Project, which was redesigned in the first half of 2007, conducts research to advance the state of the art in aircraft control design tools and techniques. A "Key Decision Point" was established for fiscal year 2007 with the following expected outcomes: document the most currently available statistical/prognostic data associated with icing for subsonic transport, summarize reports by subject matter experts in icing research on current knowledge of icing effects on control parameters and establish future requirements for icing research for subsonic transports including the appropriate alignment. This study contains: (1) statistical analyses of accident and incident data conducted by NASA researchers for this "Key Decision Point", (2) an examination of icing in other recent statistically based studies, (3) a summary of aviation safety priority lists that have been developed by various subject-matter experts, including the significance of aircraft icing research in these lists and (4) suggested future requirements for NASA icing research. The review of several studies by subject-matter experts was summarized into four high-priority icing research areas. Based on the Integrated Resilient Aircraft Control (IRAC) Project goals and objectives, the IRAC project was encouraged to conduct work in all of the high-priority icing research areas that were identified, with the exception of the developing of methods to sense and document actual icing conditions.

  2. Pilot Study: A Pediatric Pedestrian Safety Curriculum for Preschool Children.

    PubMed

    Bovis, Stephanie E; Harden, Taijha; Hotz, Gillian

    2016-01-01

    To evaluate and implement the WalkSafe Pre-Kindergarten Pedestrian Safety Curriculum. A quasi-experimental pretest-posttest design without a control group was used to measure children's pedestrian safety knowledge. Knowledge assessments consisting of multiple-choice and short-answer questions were administered pre- and post-curriculum implementation by classroom teachers. Knowledge assessments gauged prekindergarten students' knowledge of pedestrian safety activities prior to safety curriculum implementation and, again, after the students received the curriculum. A total of 605 children (aged 3- to 5-year) from 38 prekindergarten classrooms in 16 randomly selected elementary schools participated in the pedestrian safety education pilot program. Subjects were of multiethnic and diverse backgrounds from the Miami-Dade County Public School District. Of the 605 educated subjects, 454 children completed both pre- and posttests. A statistically significant difference was found between pretest knowledge (M = 5.49, SD = 1.54) and posttest knowledge (M = 6.64, SD = 1.35) assessment scores across all 454 subjects, t(452) = -16.22, p < .001, 95% CI [-1.29, -1.01]. Previous studies have shown that classroom-based training of children as young as 4 years old can yield significant improvements in traffic safety knowledge. The statistical findings of the WalkSafe Pre-Kindergarten Pedestrian Safety Curriculum revealed statistically significant improvements in pedestrian safety knowledge of these young children. Future research efforts will focus on longitudinal behavioral changes in these students and an increase in pedestrian safety behaviors (e.g., utilization of crosswalks or sidewalks).

  3. Interrelation Between Safety Factors and Reliability

    NASA Technical Reports Server (NTRS)

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

    2001-01-01

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

  4. Institutional Ethical Review and Ethnographic Research Involving Injection Drug Users: A Case Study

    PubMed Central

    Small, Will; Maher, Lisa; Kerr, Thomas

    2014-01-01

    Ethnographic research among people who inject drugs (PWID) involves complex ethical issues. While ethical review frameworks have been critiqued by social scientists, there is a lack of social science research examining institutional ethical review processes, particularly in relation to ethnographic work. This case study describes the institutional ethical review of an ethnographic research project using observational fieldwork and in-depth interviews to examine injection drug use. The review process and the salient concerns of the review committee are recounted, and the investigators’ responses to the committee’s concerns and requests are described to illustrate how key issues were resolved. The review committee expressed concerns regarding researcher safety when conducting fieldwork and the investigators were asked to liaise with the police regarding the proposed research. An ongoing dialogue with the institutional review committee regarding researcher safety and autonomy from police involvement, as well as formal consultation with a local drug user group and solicitation of opinions from external experts, helped to resolve these issues. This case study suggests that ethical review processes can be particularly challenging for ethnographic projects focused on illegal behaviours, and that while some challenges could be mediated by modifying existing ethical review procedures, there is a need for legislation that provides legal protection of research data and participant confidentiality. PMID:24581074

  5. 75 FR 29754 - Claims of Confidentiality of Certain Chemical Identities Contained in Health and Safety Studies...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-27

    ... Certain Chemical Identities Contained in Health and Safety Studies and Data from Health and Safety Studies... identities in health and safety studies, and in data from health and safety studies, submitted under the.... Section 14(b) of TSCA does not extend confidential treatment to health and safety studies, or data from...

  6. A longitudinal study of clinical peer review's impact on quality and safety in U.S. hospitals.

    PubMed

    Edwards, Marc T

    2013-01-01

    Clinical peer review is the dominant method of event analysis in U.S. hospitals. It is pivotal to medical staff efforts to improve quality and safety, yet the quality assurance process model that has prevailed for the past 30 years evokes fear and is fundamentally antithetical to a culture of safety. Two prior national studies characterized a quality improvement model that corrects this dysfunction but failed to demonstrate progress toward its adoption despite a high rate of program change between 2007 and 2009. This study's online survey of 470 organizations participating in either of the prior studies further assessed relationships between clinical peer review program factors, including the degree of conformance to the quality improvement model (the QI model score), and subjectively measured program impact variables. Among the 300 hospitals (64%) that responded, the median QI model score was only 60 on a 100-point scale. Scores increased somewhat for the 2007 cohort (mean pair-wise difference of 5.9 [2-10]), but not for the 2009 cohort. The QI model is expanded as the result of the finding that self-reporting of adverse events, near misses, and hazardous conditions--an essential practice in high-reliability organizations--is no longer rare in hospitals. Self-reporting and the quality of case review are additional multivariate predictors of the perceived ongoing impact of clinical peer review on quality and safety, medical staff perceptions of the program, and medical staff engagement in quality and safety initiatives. Hospital leaders and trustees who seek to improve patient outcomes should facilitate the adoption of this best practice model for clinical peer review.

  7. Regenerative braking strategies, vehicle safety and stability control systems: critical use-case proposals

    NASA Astrophysics Data System (ADS)

    Oleksowicz, Selim A.; Burnham, Keith J.; Southgate, Adam; McCoy, Chris; Waite, Gary; Hardwick, Graham; Harrington, Cian; McMurran, Ross

    2013-05-01

    The sustainable development of vehicle propulsion systems that have mainly focused on reduction of fuel consumption (i.e. CO2 emission) has led, not only to the development of systems connected with combustion processes but also to legislation and testing procedures. In recent years, the low carbon policy has made hybrid vehicles and fully electric vehicles (H/EVs) popular. The main virtue of these propulsion systems is their ability to restore some of the expended energy from kinetic movement, e.g. the braking process. Consequently new research and testing methods for H/EVs are currently being developed. This especially concerns the critical 'use-cases' for functionality tests within dynamic events for both virtual simulations, as well as real-time road tests. The use-case for conventional vehicles for numerical simulations and road tests are well established. However, the wide variety of tests and their great number (close to a thousand) creates a need for selection, in the first place, and the creation of critical use-cases suitable for testing H/EVs in both virtual and real-world environments. It is known that a marginal improvement in the regenerative braking ratio can significantly improve the vehicle range and, therefore, the economic cost of its operation. In modern vehicles, vehicle dynamics control systems play the principal role in safety, comfort and economic operation. Unfortunately, however, the existing standard road test scenarios are insufficient for H/EVs. Sector knowledge suggests that there are currently no agreed tests scenarios to fully investigate the effects of brake blending between conventional and regenerative braking as well as the regenerative braking interaction with active driving safety systems (ADSS). The paper presents seven manoeuvres, which are considered to be suitable and highly informative for the development and examination of H/EVs with regenerative braking capability. The critical manoeuvres presented are considered to be

  8. A case-control study of forklift and other powered industrial vehicle incidents.

    PubMed

    Collins, J W; Smith, G S; Baker, S P; Landsittel, D P; Warner, M

    1999-11-01

    This study examined risk factors associated with forklift and other powered industrial vehicle (PIV) collision injuries with an emphasis on the design of factory traffic systems, the loading and safety features of PIVs, and the characteristics of the drivers. A case-control study examined risk factors for circumstances of injury-producing PIV incidents at eight automotive manufacturing plants between July 1992 and March 1995. A computerized safety and health surveillance system identified 171 incidents where a PIV (forklift 70%, personnel carriers 15%, other 15%) was involved in a collision incident. Site visits were conducted to collect data regarding the factory environment at the collision site, the PIVs involved in the incidents, and driver characteristics. These data were compared with information collected from a random sample of comparison worksites, PIVs, and PIV drivers who had not been involved in a PIV-related incident in the prior 3 years. In half of the cases (86 of 171), an employee (pedestrian) was struck by a PIV or an object being carried by the PIV. The presence of an obstruction that restricted the aisle width increased the odds of a collision incident 1.89 times (95% CI=1.22, 2.86). The presence of overhead mirrors at intersections and blind corners with limited visibility reduced the odds of a PIV collision incident by a third (OR=0.33, 95% CI=0.16, 0.68). When carrying a load, the odds of a PIV being involved in a collision was 1.58 (95% CI=1.03, 2.41) times greater than an unloaded one. Changes in the factory environment, vehicle safety features, and driver and pedestrian training are suggested to reduce the risk of PIV incidents. Am. J. Ind. Med. 36:522-531, 1999. Published 1999 Wiley-Liss, Inc.

  9. The Effects of Safety Discrimination Training and Frequent Safety Observations on Safety-Related Behavior

    ERIC Educational Resources Information Center

    Taylor, Matthew A.; Alvero, Alicia M.

    2012-01-01

    The intent of the present study was to assess the effects of discrimination training only and in combination with frequent safety observations on five participants' safety-related behavior in a simulated office setting. The study used a multiple-baseline design across safety-related behaviors. Across all participants and behavior, safety improved…

  10. Impact of the World Health Organization's Surgical Safety Checklist on safety culture in the operating theatre: a controlled intervention study

    PubMed Central

    Haugen, A. S.; Søfteland, E.; Eide, G. E.; Sevdalis, N.; Vincent, C. A.; Nortvedt, M. W.; Harthug, S.

    2013-01-01

    Background Positive changes in safety culture have been hypothesized to be one of the mechanisms behind the reduction in mortality and morbidity after the introduction of the World Health Organization's Surgical Safety Checklist (SSC). We aimed to study the checklist effects on safety culture perceptions in operating theatre personnel using a prospective controlled intervention design at a single Norwegian university hospital. Methods We conducted a study with pre- and post-intervention surveys using the intervention and control groups. The primary outcome was the effects of the Norwegian version of the SSC on safety culture perceptions. Safety culture was measured using the validated Norwegian version of the Hospital Survey on Patient Safety Culture. Descriptive characteristics of operating theatre personnel and checklist compliance data were also recorded. A mixed linear regression model was used to assess changes in safety culture. Results The response rate was 61% (349/575) at baseline and 51% (292/569) post-intervention. Checklist compliance ranged from 77% to 85%. We found significant positive changes in the checklist intervention group for the culture factors ‘frequency of events reported’ and ‘adequate staffing’ with regression coefficients at −0.25 [95% confidence interval (CI), −0.47 to −0.07] and 0.21 (95% CI, 0.07–0.35), respectively. Overall, the intervention group reported significantly more positive culture scores—including at baseline. Conclusions Implementation of the SSC had rather limited impact on the safety culture within this hospital. PMID:23404986

  11. Do whole-food animal feeding studies have any value in the safety assessment of GM crops?

    PubMed

    Herman, Rod A; Ekmay, Ricardo

    2014-02-01

    The use of whole-food (grain meal contained in feed) animal-feeding studies to support the safety assessment of genetically modified crops has been contentious. This may be, in part, a consequence of poorly agreed upon study objectives. Whole-food animal-feeding studies have been postulated to be useful in detecting both expected and unexpected effects on the composition of genetically modified crops. While the justification of animal feeding studies to detect unexpected effects may be inadequately supported, there may be better justification to conduct such studies in specific cases to investigate the consequences of expected compositional effects including expression of transgenic proteins. Such studies may be justified when (1) safety cannot reasonably be predicted from other evidence, (2) reasonable hypothesis for adverse effects are postulated, (3) the compositional component in question cannot be isolated or enriched in an active form for inclusion in animal feeding studies, and (4) reasonable multiples of exposure can be accomplished relative to human diets. The study design for whole-food animal-feeding studies should be hypotheses-driven, and the types of data collected should be consistent with adverse effects that are known to occur from dietary components of biological origin. Copyright © 2013 The Authors. Published by Elsevier Inc. All rights reserved.

  12. Technology and Tool Development to Support Safety and Mission Assurance

    NASA Technical Reports Server (NTRS)

    Denney, Ewen; Pai, Ganesh

    2017-01-01

    The Assurance Case approach is being adopted in a number of safety-mission-critical application domains in the U.S., e.g., medical devices, defense aviation, automotive systems, and, lately, civil aviation. This paradigm refocuses traditional, process-based approaches to assurance on demonstrating explicitly stated assurance goals, emphasizing the use of structured rationale, and concrete product-based evidence as the means for providing justified confidence that systems and software are fit for purpose in safely achieving mission objectives. NASA has also been embracing assurance cases through the concepts of Risk Informed Safety Cases (RISCs), as documented in the NASA System Safety Handbook, and Objective Hierarchies (OHs) as put forth by the Agency's Office of Safety and Mission Assurance (OSMA). This talk will give an overview of the work being performed by the SGT team located at NASA Ames Research Center, in developing technologies and tools to engineer and apply assurance cases in customer projects pertaining to aviation safety. We elaborate how our Assurance Case Automation Toolset (AdvoCATE) has not only extended the state-of-the-art in assurance case research, but also demonstrated its practical utility. We have successfully developed safety assurance cases for a number of Unmanned Aircraft Systems (UAS) operations, which underwent, and passed, scrutiny both by the aviation regulator, i.e., the FAA, as well as the applicable NASA boards for airworthiness and flight safety, flight readiness, and mission readiness. We discuss our efforts in expanding AdvoCATE capabilities to support RISCs and OHs under a project recently funded by OSMA under its Software Assurance Research Program. Finally, we speculate on the applicability of our innovations beyond aviation safety to such endeavors as robotic, and human spaceflight.

  13. Lung Function Measurements in Rodents in Safety Pharmacology Studies

    PubMed Central

    Hoymann, Heinz Gerd

    2012-01-01

    The ICH guideline S7A requires safety pharmacology tests including measurements of pulmonary function. In the first step – as part of the “core battery” – lung function tests in conscious animals are requested. If potential adverse effects raise concern for human safety, these should be explored in a second step as a “follow-up study”. For these two stages of safety pharmacology testing, both non-invasive and invasive techniques are needed which should be as precise and reliable as possible. A short overview of typical in vivo measurement techniques is given, their advantages and disadvantages are discussed and out of these the non-invasive head-out body plethysmography and the invasive but repeatable body plethysmography in orotracheally intubated rodents are presented in detail. For validation purposes the changes in the respective parameters such as tidal midexpiratory flow (EF50) or lung resistance have been recorded in the same animals in typical bronchoconstriction models and compared. In addition, the technique of head-out body plethysmography has been shown to be useful to measure lung function in juvenile rats starting from day two of age. This allows safety pharmacology testing and toxicological studies in juvenile animals as a model for the young developing organism as requested by the regulatory authorities (e.g., EMEA Guideline 1/2008). It is concluded that both invasive and non-invasive pulmonary function tests are capable of detecting effects and alterations on the respiratory system with different selectivity and area of operation. The use of both techniques in a large number of studies in mice and rats in the last years have demonstrated that they provide useful and reliable information on pulmonary mechanics in safety pharmacology and toxicology testing, in investigations of respiratory disorders, and in pharmacological efficacy studies. PMID:22973226

  14. Tritium safety study using Caisson Assembly (CATS) at TPL/JAEA

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

    Hayashi, T.; Kobayashi, K.; Iwai, Y.

    Tritium confinement is required as the most important safety Junction for a fusion reactor. In order to demonstrate the confinement performance experimentally, an unique equipment, called CATS: Caisson Assembly for Tritium Safety study, was installed in Tritium Process Laboratory of Japan Atomic Energy Agency and operated for about 10 years. Tritium confinement and migration data in CATS have been accumulated and dynamic simulation code was accumulated using these data. Contamination and decontamination behavior on various materials and new safety equipment functions have been investigated under collaborations with a lot of laboratories and universities. (authors)

  15. Human factors and ergonomics assessment of food pantry work: A case study.

    PubMed

    Higgins, Nicholas A; Talone, Andrew B; Fraulini, Nicholas W; Smither, Janan A

    2017-01-01

    Research assessing work processes in food pantries has been limited to the client's experience and aspects of food donations [3-5]. Research on food pantries has yet to focus on understanding and evaluating worker-environment interaction. The present case study examined the interaction between workers and their work environment while performing common tasks in a food pantry. Data were collected through naturalistic observations and structured interviews. A task analysis was performed on the data. Several potential issues in the pantry were identified including with the workspace layout, environmental conditions, and signage. Human factors and ergonomics principles were then utilized to provide insights and recommendations (e.g., use of numbered rather than color-coded signage). Recommendations were provided to the case study food pantry for enhancing safety and productivity. Further research is needed to assess the generalizability of our findings to other food pantries.

  16. Model Transformation for a System of Systems Dependability Safety Case

    NASA Technical Reports Server (NTRS)

    Murphy, Judy; Driskell, Steve

    2011-01-01

    The presentation reviews the dependability and safety effort of NASA's Independent Verification and Validation Facility. Topics include: safety engineering process, applications to non-space environment, Phase I overview, process creation, sample SRM artifact, Phase I end result, Phase II model transformation, fault management, and applying Phase II to individual projects.

  17. Age and Workers' Perceptions of Workplace Safety: A Comparative Study

    ERIC Educational Resources Information Center

    Gyekye, Seth Ayim; Salminen, Simo

    2009-01-01

    The study examined the relationship between age and I) safety perception; ii) job satisfaction; iii) compliance with safety management policies; and (iv) accident frequency. Participants were Ghanaian industrial workers (N = 320) categorized into 4 age groups: 19-29 years; 30-39 years; 40-50 years; and 51 years and above. Workplace safety…

  18. Indian social safety net programs as platforms for introducing wheat flour fortification: a case study of Gujarat, India.

    PubMed

    Fiedler, John L; Babu, Sunil; Smitz, Marc-Francois; Lividini, Keith; Bermudez, Odilia

    2012-03-01

    Micronutrient deficiencies exact an enormous health burden on India. The release of the National Family Health Survey results--showing the relatively wealthy state of Gujarat having deficiency levels exceeding national averages--prompted Gujarat officials to introduce fortified wheat flour in their social safety net programs (SSNPs). To provide a case study of the introduction of fortified wheat flour in Gujarat's Public Distribution System (PDS), Integrated Child Development Scheme (ICDS), and Mid-Day Meal (MDM) Programme to assess the coverage, costs, impact, and cost-effectiveness of the initiative. India's 2004/05 National Sample Survey data were used to identify beneficiaries of each of Gujarat's three SSNPs and to estimate usual intake levels of vitamin A, iron, and zinc. Comparing age- and sex-specific usual intakes to Estimated Average Requirements, the proportion of the population with inadequate intakes was estimated. Postfortification intake levels and reductions in inadequate intake were estimated. The incremental cost of fortifying wheat flour and the cost-effectiveness of each program were estimated. When each program was assessed independently, the proportion of the population with inadequate vitamin A intakes was reduced by 34% and 74% among MDM and ICDS beneficiaries, respectively. Both programs effectively eliminated inadequate intakes of both iron and zinc. Among PDS beneficiaries, the proportion with inadequate iron intakes was reduced by 94%. CONCLUSIONS. Gujarat's substitution of fortified wheat flour for wheat grain is dramatically increasing the intake of micronutrients among its SSNP beneficiaries. The incremental cost of introducing fortification in each of the programs is low, and, according to World Health Organization criteria, each program is "highly cost-effective." The introduction of similar reforms throughout India would largely eliminate the inadequate iron intake among persons participating in any of the three SSNPs and would

  19. Campania Region (Italy) spontaneous reporting system and preventability assessment through a case-by-case approach: a pilot study on psychotropic drugs.

    PubMed

    Sessa, Maurizio; Rafaniello, Concetta; Sportiello, Liberata; Mascolo, Annamaria; Scavone, Cristina; Maccariello, Alessandra; Iannaccone, Teresa; Fabrazzo, Michele; Berrino, Liberato; Rossi, Francesco; Capuano, Annalisa

    2016-12-01

    We conducted the first pilot Italian study to assess the preventability of adverse drug reactions involving psychotropic drugs reported through spontaneous reporting system from 01/07/2012 to 31/12/2014 in Campania Region. Preventability was assessed, case-by-case, using an adapted version of the P-method. The evaluation was performed only for those reports that had, as suspected drug, antipsychotics, mood stabilizers, antidepressants, anxiolytic and/or sedative-hypnotic. Eighty-one cases (19.2%) out of 421 reported during the study period were preventable. In seventy-seven (95.1%) out of 81 preventable cases, the underlying mechanism of the adverse drug reactions was dose-related, in four (4.9%) preventable cases the underlying mechanism of the adverse drug reactions was respectively susceptibility- (1; 1.2%), unknown- (1; 1.2%) and time-related (2; 2.5%). In the 81 preventable cases, 97 critical criteria were detected of which 29/97 (29.9%) related to healthcare professionals' practices, 0/97 (0.0%) to drug quality and 68/97 (70.1%) to patient behaviour. We proved that it was possible to apply and adapt the P-Method to assess the preventability of the adverse drug reactions involving psychotropic drugs, analysing individual case safety report sent through Campania Region spontaneous reporting system. Information acquired will be used to organize educational activities for both physicians and patients to promote a more appropriate drug use.

  20. Study on lockage safety of LNG-fueled ships based on FSA

    PubMed Central

    Lv, Pengfei; Zhuang, Yuan; Deng, Jian; Su, Wei

    2017-01-01

    In the present study, formal safety assessment (FSA) is introduced to investigate lockage safety of LNG-fueled ships. Risk sources during lockage of LNG-fueled ships in four typical scenarios, namely, navigation between two dams, lockage, anchorage, and fueling, are identified, and studied in combination with fundamental leakage probabilities of various components of LNG storage tanks, and simulation results of accident consequences. Some suggestions for lockage safety management of LNG-fueled ships are then proposed. The present research results have certain practical significance for promoting applications of LNG-fueled ships along Chuanjiang River and in Three Gorges Reservoir Region. PMID:28437482

  1. Study on lockage safety of LNG-fueled ships based on FSA.

    PubMed

    Lv, Pengfei; Zhuang, Yuan; Deng, Jian; Su, Wei

    2017-01-01

    In the present study, formal safety assessment (FSA) is introduced to investigate lockage safety of LNG-fueled ships. Risk sources during lockage of LNG-fueled ships in four typical scenarios, namely, navigation between two dams, lockage, anchorage, and fueling, are identified, and studied in combination with fundamental leakage probabilities of various components of LNG storage tanks, and simulation results of accident consequences. Some suggestions for lockage safety management of LNG-fueled ships are then proposed. The present research results have certain practical significance for promoting applications of LNG-fueled ships along Chuanjiang River and in Three Gorges Reservoir Region.

  2. Pharmaceuticals Safety Practices-A Comparative Pilot Study

    PubMed Central

    Tawfik, Kamilia A.; Jabeen, Arshia

    2013-01-01

    Introduction The safety of medicine is essential for the safety of patients. Inappropriate drug storage, expiration dates, sharing prescription drugs, self medication habits and misuse of some drugs are contributing factors affecting medication safety. One or more of these factors may lead to serious health complications and even death. Objectives The purpose of this study was to highlight the common errors and pharmaceutical malpractices that people usually engage in on a daily basis and to correlate these to culture, gender and educational levels. This may spread awareness in an easy and understandable manner and provide certain guidelines to drug consumers ensuring that pharmaceutical preparations are used correctly and safely. Methods Two hundred questionnaires were randomly distributed in two countries; Saudi Arabia and India. The collected data were statistically analyzed. Outcomes and conclusion Results showed that alarming percentages of various participants were using pharmaceuticals inappropriately due to carelessness, unawareness or intentional mistakes. Therefore, active participation by health care professionals is essential for the prevention of drug misuse. Increasing population awareness about self medication, products expiration, pharmaceuticals labels and optimum storage conditions would minimize the adverse effects and may even be life saving. PMID:24533025

  3. Neonatal Safety Information Reported to the FDA During Drug Development Studies

    PubMed Central

    Avant, Debbie; Baer, Gerri; Moore, Jason; Zheng, Panli; Sorbello, Alfred; Ariagno, Ron; Yao, Lynne; Burckart, Gilbert J.; Wang, Jian

    2017-01-01

    Background Relatively few neonatal drug development studies have been conducted, but an increase is expected with the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA). Understanding the safety of drugs studied in neonates is complicated by the unique nature of the population and the level of illness. The objective of this study was to examine neonatal safety data submitted to the FDA in studies pursuant to the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) between 1998 and 2015. Methods FDA databases were searched for BPCA and/or PREA studies that enrolled neonates. Studies that enrolled a minimum of 3 neonates were analyzed for the presence and content of neonatal safety data. Results The analysis identified 40 drugs that were studied in 3 or more neonates. Of the 40 drugs, 36 drugs received a pediatric labeling change as a result of studies between 1998 and 2015, that included information from studies including neonates. Fourteen drugs were approved for use in neonates. Clinical trials for 20 of the drugs reported serious adverse events (SAEs) in neonates. The SAEs primarily involved cardiovascular events such as bradycardia and/or hypotension or laboratory abnormalities such as anemia, neutropenia, and electrolyte disturbances. Deaths were reported during studies of 9 drugs. Conclusions Our analysis revealed that SAEs were reported in studies involving 20 of the 40 drugs evaluated in neonates, with deaths identified in 9 of those studies. Patients enrolled in studies were often critically ill, which complicated determination of whether an adverse event was drug-related. We conclude that the traditional means for collecting safety information in drug development trials needs to be adjusted for neonates and will require the collaboration of regulators, industry, and the clinical and research communities to establish appropriate definitions and reporting strategies for the neonatal

  4. Exploring the Effects of Cultural Variables in the Implementation of Behavior-Based Safety in Two Organizations

    ERIC Educational Resources Information Center

    Bumstead, Alaina; Boyce, Thomas E.

    2005-01-01

    The present case study examines how culture can influence behavior-based safety in different organizational settings and how behavior-based safety can impact different organizational cultures. Behavior-based safety processes implemented in two culturally diverse work settings are described. Specifically, despite identical implementation plans,…

  5. Under-reporting of work-related disorders in the workplace: a case study and review of the literature.

    PubMed

    Pransky, G; Snyder, T; Dembe, A; Himmelstein, J

    1999-01-01

    Accurate reporting of work-related conditions is necessary to monitor workplace health and safety, and to identify the interventions that are most needed. Reporting systems may be designed primarily for external agencies (OSHA or workers' compensation) or for the employer's own use. Under-reporting of workplace injuries and illnesses is common due to a variety of causes and influences. Based on previous reports, the authors were especially interested in the role of safety incentive programmes on under-reporting. Safety incentive programmes typically reward supervisors and employees for reducing workplace injury rates, and thus may unintentionally inhibit proper reporting. The authors describe a case study of several industrial facilities in order to illustrate the extent of under-reporting and the reasons for its occurrence. A questionnaire and interview survey was administered to 110 workers performing similar tasks and several managers, health, and safety personnel at each of three industrial facilities. Although less than 5% of workers had officially reported a work-related injury or illness during the past year, over 85% experienced work-related symptoms, 50% had persistent work-related problems, and 30% reported either lost time from work or work restrictions because of their ailment. Workers described several reasons for not reporting their injuries, including fear of reprisal, a belief that pain was an ordinary consequence of work activity or ageing, lack of management responsiveness after prior reports, and a desire not to lose their usual job. Interviews with management representatives revealed administrative and other barriers to reporting, stemming from their desire to attain a goal of no reported injuries, and misconceptions about requirements for recordability. The corporate and facility safety incentives appeared to have an indirect, but significant negative influence on the proper reporting of workplace injuries by workers. A variety of influences

  6. A patient safety objective structured clinical examination.

    PubMed

    Singh, Ranjit; Singh, Ashok; Fish, Reva; McLean, Don; Anderson, Diana R; Singh, Gurdev

    2009-06-01

    There are international calls for improving education for health care workers around certain core competencies, of which patient safety and quality are integral and transcendent parts. Although relevant teaching programs have been developed, little is known about how best to assess their effectiveness. The objective of this work was to develop and implement an objective structured clinical examination (OSCE) to evaluate the impact of a patient safety curriculum. The curriculum was implemented in a family medicine residency program with 47 trainees. Two years after commencing the curriculum, a patient safety OSCE was developed and administered at this program and, for comparison purposes, to incoming residents at the same program and to residents at a neighboring residency program. All 47 residents exposed to the training, all 16 incoming residents, and 10 of 12 residents at the neighboring program participated in the OSCE. In a standardized patient case, error detection and error disclosure skills were better among trained residents. In a chart-based case, trained residents showed better performance in identifying deficiencies in care and described more appropriate means of addressing them. Third year residents exposed to a "Systems Approach" course performed better at system analysis and identifying system-based solutions after the course than before. Results suggest increased systems thinking and inculcation of a culture of safety among residents exposed to a patient safety curriculum. The main weaknesses of the study are its small size and suboptimal design. Much further investigation is needed into the effectiveness of patient safety curricula.

  7. Real life juvenile toxicity case studies: the good, the bad and the ugly.

    PubMed

    De Schaepdrijver, Luc; Rouan, Marie-Claude; Raoof, Araz; Bailey, Graham P; De Zwart, Loeckie; Monbaliu, Johan; Coogan, Timothy P; Lammens, Lieve; Coussement, Werner

    2008-09-01

    With the growing experience in the conduct of juvenile toxicity studies for multiple classes of compound, the 'case-by-case' approach has become under much more pressure. Instead, a general screen or 'standard design' is now commonly expected by regulatory authorities with more routine inclusion of neurological and reproductive assessments. Minor modifications or additions can be made to the design to address specific questions according to the class of drug or intended clinical use. This drift from a 'case-by-case' approach to a 'standard design' approach is present within certain reviewing divisions of the FDA, often requesting by default a rodent and non-rodent juvenile animal study. However, juvenile animal studies should be designed thoughtfully to fulfil a purpose based on scientific rationale, with each endpoint carefully considered in terms of practicality and interpretability of data generated. Only when using the appropriate strategy and design may juvenile studies add value by (1) identifying potential safety or pharmacokinetic issues for drugs intended for paediatric use, (2) suggesting additional clinical endpoints and (3) adding new information to the product label. As the knowledge from juvenile animal studies in various species grows, a better understanding of the significance/relevance of findings will be achieved.

  8. Electroacupuncture for children with autism spectrum disorder: pilot study of 2 cases.

    PubMed

    Chen, Wen-Xiong; Wu-Li, Liu; Wong, Virginia C N

    2008-10-01

    The objective of this study was to observe for efficacy, safety, and compliance of electroacupuncture for autism spectrum disorder (ASD). Two (2) children with ASD received electroacupuncture for 24 sessions over 8 weeks and were assessed pre- and postacupuncture. We defined a positive or negative change as an improvement or deterioration of 25%, respectively, in total score or any subscales of Aberrant Behavioral Checklist (ABC), Ritvo-Freeman Real Life Scale (RFRLS), WeeFIM, and as a rating of much improved or much worse on the Clinical Global Impression-Improvement (CGI-I) scale. For ABC, positive changes in "Irritability" and "Stereotypy" was noted in case 1 but no changes occurred for case 2. For RFRLS, positive changes were found for both cases in "Sensory motor," "Sensory response," and "Total score," although negative change was noted for case 2 in "Affectual response." For WeeFIM, there were no positive or negative changes in both cases. For CGI-I, positive change in case 1 with much improved in "Social relatedness, Communication, and Stereotypy behavior" was reported. A short intensive course of electroacupuncture might improve some core features of children with ASD.

  9. An early (3-6 weeks) active surveillance study to assess the safety of pandemic influenza vaccine Focetria in a province of Emilia-Romagna region, Italy - part one.

    PubMed

    Candela, Silvia; Pergolizzi, Sara; Ragni, Pietro; Cavuto, Silvio; Nobilio, Lucia; Di Mario, Simona; Dragosevic, Valentina; Groth, Nicola; Magrini, Nicola

    2013-02-27

    An observational, non-comparative, prospective, surveillance study of individuals vaccinated with the MF59-adjuvanted A/H1N1 influenza vaccine, Focetria, (Novartis Vaccines & Diagnostics, Siena, Italy), was performed in Italy during the 2009 A/H1N1 influenza pandemic. This study assessed the short-term (six-week) safety profile of the investigational vaccine in real time. After vaccination (N=7943), adverse events (AE) were assessed using both active (telephone) and passive (healthcare database) follow-up in enrolled vaccinated subjects, including infants (6-23 months), pregnant women, and the immunosuppressed. The treating physicians of all subjects experiencing AEs post-vaccination were consulted for clinical information on the conditions reported. All AEs were coded according to ICD-10. A total of 1583 AEs occurred during the study, 67 (4.2%) of which were serious adverse events (SAEs). One SAE was considered to be possibly related to vaccination (transitory and ill-defined neurologic disorder experienced by a 16-year-old asthmatic male). Three adverse events of special interest (AESI) were identified (convulsions experienced by two epileptic subjects), none of which were considered to be vaccine-related. Six individuals died during the study period, in each case the cause of death was not related to vaccination (four cases of severe underlying co-morbidity, one case of psychoactive drug misuse, and one case of acute myocardial infarction). No cases of clinically relevant AEs, SAEs, or AESI were observed within a six-week period of vaccine administration. In accordance with existing clinical and post-marketing safety data, the results of this active surveillance study demonstrate a good safety profile for the MF59-adjuvanted A/H1N1 vaccine, Focetria, within the general population. Copyright © 2012 Elsevier Ltd. All rights reserved.

  10. Current food safety management systems in fish-exporting companies require further improvements to adequately cope with contextual pressure: case study.

    PubMed

    Onjong, Hillary Adawo; Wangoh, John; Njage, Patrick Murigu Kamau

    2014-10-01

    Fish-processing plants still face food safety (FS) challenges worldwide despite the existence of several quality assurance standards and food safety management systems/s (FSMSs). This study assessed performance of FSMS in fish exporting sector considering pressure from the context in which they operate. A FSMS diagnostic tool with checklist was used to assess the context, FSMS, and FS output in 9 Kenyan fish exporting companies. Majority (67%) companies operated at moderate- to high-risk context but with an average performance in control and assurance activities. This situation could be insufficient to deal with ambiguity, uncertainty, and vulnerability issues in the context characteristics. Contextual risk posed by product characteristics (nature of raw materials) and chain environment characteristics was high. Risk posed by the chain environment characteristics, low power in supplier relationships, and low degree of authority in customer relationships was high. Lack of authority in relationship with suppliers would lead to high raw material risk situation. Even though cooling facilities, a key control activity, was at an advanced level, there was inadequate packaging intervention equipment which coupled with inadequate physical intervention equipment could lead to further weakened FSMS performance. For the fish companies to improve their FSMS to higher level and enhance predictability, they should base their FSMS on scientific information sources, historical results, and own experimental trials in their preventive, intervention, and monitoring systems. Specific suggestions are derived for improvements toward higher FSMS activity levels or lower risk levels in context characteristics. Weak areas in performance of control and assurance activities in export fish-processing sector already implementing current quality assurance guidelines and standards were studied taking into consideration contextual pressure wherein the companies operate. Important mitigation

  11. Evaluating efficiency and statistical power of self-controlled case series and self-controlled risk interval designs in vaccine safety.

    PubMed

    Li, Rongxia; Stewart, Brock; Weintraub, Eric

    2016-01-01

    The self-controlled case series (SCCS) and self-controlled risk interval (SCRI) designs have recently become widely used in the field of post-licensure vaccine safety monitoring to detect potential elevated risks of adverse events following vaccinations. The SCRI design can be viewed as a subset of the SCCS method in that a reduced comparison time window is used for the analysis. Compared to the SCCS method, the SCRI design has less statistical power due to fewer events occurring in the shorter control interval. In this study, we derived the asymptotic relative efficiency (ARE) between these two methods to quantify this loss in power in the SCRI design. The equation is formulated as [Formula: see text] (a: control window-length ratio between SCRI and SCCS designs; b: ratio of risk window length and control window length in the SCCS design; and [Formula: see text]: relative risk of exposed window to control window). According to this equation, the relative efficiency declines as the ratio of control-period length between SCRI and SCCS methods decreases, or with an increase in the relative risk [Formula: see text]. We provide an example utilizing data from the Vaccine Safety Datalink (VSD) to study the potential elevated risk of febrile seizure following seasonal influenza vaccine in the 2010-2011 season.

  12. Are your employees sick of hearing about safety? Ways to improve how safety is communicated at your company

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

    Pollari, Roger A.

    2008-06-02

    Companies that care about their employees care about their employees’ safety and will go to great lengths to communicate the importance of working safely. Monthly safety meetings, creative safety contests, safety websites, sharing lessons learned—safety communicators tend to use a variety of methods to distribute procedures and critical safety information to help employees plan and perform work. However, the safety message falls on deaf ears in some cases, especially when employees feel they’re being overloaded with safety information to the point where they are sick of hearing about it. This poses a conundrum for safety communicators: Should they keep pouringmore » on the safety, or should they lighten up? How much is the right amount?« less

  13. Ending on a positive: Examining the role of safety leadership decisions, behaviours and actions in a safety critical situation.

    PubMed

    Donovan, Sarah-Louise; Salmon, Paul M; Horberry, Timothy; Lenné, Michael G

    2018-01-01

    Safety leadership is an important factor in supporting safe performance in the workplace. The present case study examined the role of safety leadership during the Bingham Canyon Mine high-wall failure, a significant mining incident in which no fatalities or injuries were incurred. The Critical Decision Method (CDM) was used in conjunction with a self-reporting approach to examine safety leadership in terms of decisions, behaviours and actions that contributed to the incidents' safe outcome. Mapping the analysis onto Rasmussen's Risk Management Framework (Rasmussen, 1997), the findings demonstrate clear links between safety leadership decisions, and emergent behaviours and actions across the work system. Communication and engagement based decisions featured most prominently, and were linked to different leadership practices across the work system. Further, a core sub-set of CDM decision elements were linked to the open flow and exchange of information across the work system, which was critical to supporting the safe outcome. The findings provide practical implications for the development of safety leadership capability to support safety within the mining industry. Copyright © 2017 Elsevier Ltd. All rights reserved.

  14. Fire safety of ground-based space facilities on the spaceport ;Vostochny;

    NASA Astrophysics Data System (ADS)

    Artamonov, Vladimir S.; Gordienko, Denis M.; Melikhov, Anatoly S.

    2017-06-01

    The facilities of the spaceport ;Vostochny; and the innovative technologies for fire safety to be implemented are considered. The planned approaches and prospects for fire safety ensuring at the facilities of the spaceport ;Vostochny; are presented herein, based on the study of emergency situations having resulted in fire accidents and explosion cases at the facilities supporting space vehicles operation.

  15. Matching safety to access: global actors and pharmacogovernance in Kenya- a case study.

    PubMed

    Moscou, Kathy; Kohler, Jillian C

    2017-03-23

    The Kenyan government has sought to address inadequacies in its National Pharmaceutical Policy and the Pharmacy and Poisons Board's (PPB) medicines governance by engaging with global actors (e.g. the World Health Organization). Policy actors have influenced the way pharmacovigilance is defined, how challenges are understood and which norms are requisite to address drug safety issues. In this paper, we investigate the relationship between specific modes of engagement among global (exogenous) and domestic actors at the national and sub-national level to identify the positive or negative effect on pharmacovigilance and pharmacogovernance in Kenya. Pharmacogovernance is defined as the manner in which governing structures; policy instruments; institutional authority (e.g., ability to act, implement and enforce norms, policies and processes) and resources are managed to promote societal interests for patient safety and protection from adverse drug reactions (ADRs). Qualitative research methods that included key informant interviews and document analysis, were employed to investigate the relationship between global actors' patterns of engagement with national actors and pharmacogovernance in Kenya. Global actors' influence on pharmacogovernance and pharmacovigilance priorities in Kenya (e.g., legislation and adverse drug reaction surveillance) was positively perceived by key informants. We found that global actors' engagement with state actors produced positive and negative outcomes. Engagement with the PPB and Ministry of Health (MOH) that was characterized as dependent (advocacy, empowerment, delegated) or interdependent (collaborative, cooperative, consultative) was mostly associated with positive outcomes e.g., capacity building; strengthening legislation and stakeholder coordination. Fragmentation (independent engagement) hindered risk communication between public, private, and NGO health programs. A framework for assessing pharmacogovernance would support policy

  16. Product Engineering Class in the Software Safety Risk Taxonomy for Building Safety-Critical Systems

    NASA Technical Reports Server (NTRS)

    Hill, Janice; Victor, Daniel

    2008-01-01

    When software safety requirements are imposed on legacy safety-critical systems, retrospective safety cases need to be formulated as part of recertifying the systems for further use and risks must be documented and managed to give confidence for reusing the systems. The SEJ Software Development Risk Taxonomy [4] focuses on general software development issues. It does not, however, cover all the safety risks. The Software Safety Risk Taxonomy [8] was developed which provides a construct for eliciting and categorizing software safety risks in a straightforward manner. In this paper, we present extended work on the taxonomy for safety that incorporates the additional issues inherent in the development and maintenance of safety-critical systems with software. An instrument called a Software Safety Risk Taxonomy Based Questionnaire (TBQ) is generated containing questions addressing each safety attribute in the Software Safety Risk Taxonomy. Software safety risks are surfaced using the new TBQ and then analyzed. In this paper we give the definitions for the specialized Product Engineering Class within the Software Safety Risk Taxonomy. At the end of the paper, we present the tool known as the 'Legacy Systems Risk Database Tool' that is used to collect and analyze the data required to show traceability to a particular safety standard

  17. [Study of post marketing safety reevaluation of shenqi fuzheng injection].

    PubMed

    Ai, Qing-Hua; Li, Yuan-Yuan; Xie, Yan-Ming

    2014-09-01

    In order to promote the Shenqifuzheng injection (SQFZ) clinical medication safety, this study reevaluate on SQFZ post marketing safety study systematically. Including multi center large sample registration type safety monitoring research, the analysis based on national spontaneous reporting system data, the analysis based on the 20 national hospital information system data and literature research. Above the analysis, it suggests that SQFZ has good security. The more adverse drug reaction (ADR) as allergic reactions, mainly involved in the damage of skin, appendages and its systemic damage, serious person can appear allergic shock. ADR/E is more common in the elderly, may be related to medication (tumor) populations. Early warning analysis based on SRS data and literature research are of the view that "phlebitis" has a strong association with SQFZ used.

  18. Refugee settlement workers' perspectives on home safety issues for people from refugee backgrounds.

    PubMed

    Campbell, Emma Jean; Turpin, Merrill June

    2010-12-01

    Refugees experience higher levels of emotional, psychological and physical distress than the general migrant population during settlement in a new country. Safety in the home can be a major concern and is an issue of which occupational therapists should be aware. Occupational therapists working with refugees in many contexts feel unprepared and overwhelmed. As refugee settlement workers attend to home safety of refugees during the settlement process, this study aimed to develop an in-depth understanding of their perceptions of this issue. Such information can contribute to occupational therapists' knowledge and practice when working with refugees. An exploratory qualitative case study approach used 16 semi-structured interviews and observation of a settlement worker assisting newly arrived refugees. Participants were settlement service staff (an occupational therapist, case coordinators and cultural support workers). Three themes are reported: considerations for safety in the homes of refugees; factors influencing home safety for refugees; and sensitivity to culture. Participants described tailoring home safety-related services to each individual based on factors that influence home safety and sensitivity to culture. Awareness of home safety issues can increase cultural competence and inform practice and policy. © 2010 The Authors. Australian Occupational Therapy Journal © 2010 Australian Association of Occupational Therapists.

  19. Safety and Effectiveness of Highly Active Antiretroviral Therapy in Treatment-Naïve HIV Patients: Preliminary Findings of a Cohort Event Monitoring Study in Belarus.

    PubMed

    Setkina, Svetlana; Dotsenko, Marina; Bondar, Sviatlana; Charnysh, Iryna; Kuchko, Alla; Kaznacheeva, Alena; Kozorez, Elena; Dodaleva, Alena; Rossa, Natalia

    2015-04-01

    Antiretroviral drugs have well-documented evidence-based favorable benefit-risk ratios. Although various studies have investigated and characterized the safety profile of antiretroviral medicines, there are a limited number of studies evaluating the safety of first-line antiretroviral therapy (ART) in patients with a specific co-morbidity. A cohort event monitoring (CEM) study of the safety and effectiveness of antiretroviral medicines in a target population that has a significant level of co-morbidities (chronic infectious diseases, peripheral blood cytopenias) was implemented. The aim was to evaluate the safety profile of the highly active ART (HAART) in the target population and subpopulations with risk factors, to optimize the monitoring and decision-making procedure for subgroups of patients with specific types of co-morbidity, and to implement a more vigilant approach to therapy management in risk groups of patients. Prospective observational CEM was implemented among HAART-naïve HIV-positive patients at four clinical sites from December 2012. Eligible patients were those starting first-line HAART. Close medical supervision of all enrolled patients, with regular clinical and laboratory monitoring, was provided by healthcare professionals within 1 year after commencement of therapy. Standardized forms were used for data collection on initial and subsequent visits. All objective or subjective deviations in condition (events) were assessed for a causal relationship with ART, and for severity, seriousness, reversibility, preventability, and pre-existing risk factors in the case of adverse drug reactions (ADRs). A total of 518 HAART-naïve HIV-positive patients were enrolled in the CEM study. Of these patients, 65% (337) experienced one or several ADRs related to one or more components of HAART. Most of the ADRs reported were non-serious, expected, common (very common), transient (correctable), or reversible. The most common were hematotoxic, hepatotoxic, and

  20. Safety of live vaccinations on immunosuppressive therapy in patients with immune-mediated inflammatory diseases, solid organ transplantation or after bone-marrow transplantation - A systematic review of randomized trials, observational studies and case reports.

    PubMed

    Croce, Evelina; Hatz, Christoph; Jonker, Emile F; Visser, L G; Jaeger, Veronika K; Bühler, Silja

    2017-03-01

    Live vaccines are generally contraindicated on immunosuppressive therapy due to safety concerns. However, data are limited to corroborate this practice. To estimate the safety of live vaccinations in patients with immune-mediated inflammatory diseases (IMID) or solid organ transplantation (SOT) on immunosuppressive treatment and in patients after bone-marrow transplantation (BMT). A search was conducted in electronic databases (Cochrane, Pubmed, Embase) and additional literature was identified by targeted searches. Randomized trials, observational studies and case reports. Patients with IMID or SOT on immunosuppressive treatment and BMT patients <2years after transplantation. Live vaccinations: mumps, measles, rubella (MMR), yellow fever (YF), varicella vaccine (VV), herpes zoster (HZ), oral typhoid, oral polio, rotavirus, Bacillus Calmette-Guérin (BCG), smallpox. One author performed the data extraction using predefined data fields. It was cross-checked by two other authors. 7305 articles were identified and 64 articles were included: 40 on IMID, 16 on SOT and 8 on BMT patients. In most studies, the administration of live vaccines was safe. However, some serious vaccine-related adverse events occurred. 32 participants developed an infection with the vaccine strain; in most cases the infection was mild. However, in two patients fatal infections were reported: a patient with RA/SLE overlap who started MTX/dexamethasone treatment four days after the YFV developed a yellow fever vaccine-associated viscerotropic disease (YEL-AVD) and died. The particular vaccine lot was found to be associated with a more than 20 times risk of YEL-AVD. One infant whose mother was under infliximab treatment during pregnancy received the BCG vaccine at the age of three months and developed disseminated BCG infection and died. An immunogenicity assessment was performed in 43 studies. In most cases the patients developed satisfactory seroprotection rates. In the IMID group, YFV and VV

  1. Development of requirements on safety cases of machine industry products for power engineering

    NASA Astrophysics Data System (ADS)

    Aronson, K. E.; Brezgin, V. I.; Brodov, Yu. M.; Gorodnova, N. V.; Kultyshev, A. Yu.; Tolmachev, V. V.; Shablova, E. G.

    2016-12-01

    This article considers security assurance for power engineering machinery in the design and production phases. The Federal Law "On Technical Regulation" and the Customs Union Technical Regulations "On Safety of Machinery and Equipment" are analyzed in the legal, technical, and economic aspect with regard to power engineering machine industry products. From the legal standpoint, it is noted that the practical enforcement of most norms of the Law "On Technical Regulation" makes it necessary to adopt subordinate statutory instruments currently unavailable; moreover, the current level of adoption of technical regulations leaves much to be desired. The intensive integration processes observed in the Eurasian Region in recent years have made it a more pressing task to harmonize the laws of the region's countries, including their technical regulation framework. The technical aspect of analyzing the technical regulation of the Customs Union has been appraised by the IDEF0 functional modeling method. The object of research is a steam turbine plant produced at the turbine works. When developing the described model, we considered the elaboration of safety case (SC) requirements from the standpoint of the chief designer of the turbine works as the person generally responsible for the elaboration of the SC document. The economic context relies on risk analysis and appraisal methods. In their respect, these are determined by the purposes and objectives of analysis, complexity of considered objects, availability of required data, and expertise of specialists hired to conduct the analysis. The article proposes the description of all sources of hazard and scenarios of their actualization in all production phases of machinery life cycle for safety assurance purposes. The detection of risks and hazards allows forming the list of unwanted events. It describes the sources of hazard, various risk factors, conditions for their rise and development, tentative risk appraisals, and

  2. Quantifying the utilization of medical devices necessary to detect postmarket safety differences: A case study of implantable cardioverter defibrillators.

    PubMed

    Bates, Jonathan; Parzynski, Craig S; Dhruva, Sanket S; Coppi, Andreas; Kuntz, Richard; Li, Shu-Xia; Marinac-Dabic, Danica; Masoudi, Frederick A; Shaw, Richard E; Warner, Frederick; Krumholz, Harlan M; Ross, Joseph S

    2018-06-12

    To estimate medical device utilization needed to detect safety differences among implantable cardioverter defibrillators (ICDs) generator models and compare these estimates to utilization in practice. We conducted repeated sample size estimates to calculate the medical device utilization needed, systematically varying device-specific safety event rate ratios and significance levels while maintaining 80% power, testing 3 average adverse event rates (3.9, 6.1, and 12.6 events per 100 person-years) estimated from the American College of Cardiology's 2006 to 2010 National Cardiovascular Data Registry of ICDs. We then compared with actual medical device utilization. At significance level 0.05 and 80% power, 34% or fewer ICD models accrued sufficient utilization in practice to detect safety differences for rate ratios <1.15 and an average event rate of 12.6 events per 100 person-years. For average event rates of 3.9 and 12.6 events per 100 person-years, 30% and 50% of ICD models, respectively, accrued sufficient utilization for a rate ratio of 1.25, whereas 52% and 67% for a rate ratio of 1.50. Because actual ICD utilization was not uniformly distributed across ICD models, the proportion of individuals receiving any ICD that accrued sufficient utilization in practice was 0% to 21%, 32% to 70%, and 67% to 84% for rate ratios of 1.05, 1.15, and 1.25, respectively, for the range of 3 average adverse event rates. Small safety differences among ICD generator models are unlikely to be detected through routine surveillance given current ICD utilization in practice, but large safety differences can be detected for most patients at anticipated average adverse event rates. Copyright © 2018 John Wiley & Sons, Ltd.

  3. Additional nuclear criticality safety calculations for small-diameter containers

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

    Hone, M.J.

    This report documents additional criticality safety analysis calculations for small diameter containers, which were originally documented in Reference 1. The results in Reference 1 indicated that some of the small diameter containers did not meet the criteria established for criticality safety at the Portsmouth facility (K{sub eff} +2{sigma}<.95) when modeled under various contingency assumptions of reflection and moderation. The calculations performed in this report reexamine those cases which did not meet the criticality safety criteria. In some cases, unnecessary conservatism is removed, and in other cases mass or assay limits are established for use with the respective containers.

  4. [Agricultural biotechnology safety assessment].

    PubMed

    McClain, Scott; Jones, Wendelyn; He, Xiaoyun; Ladics, Gregory; Bartholomaeus, Andrew; Raybould, Alan; Lutter, Petra; Xu, Haibin; Wang, Xue

    2015-01-01

    Genetically modified (GM) crops were first introduced to farmers in 1995 with the intent to provide better crop yield and meet the increasing demand for food and feed. GM crops have evolved to include a thorough safety evaluation for their use in human food and animal feed. Safety considerations begin at the level of DNA whereby the inserted GM DNA is evaluated for its content, position and stability once placed into the crop genome. The safety of the proteins coded by the inserted DNA and potential effects on the crop are considered, and the purpose is to ensure that the transgenic novel proteins are safe from a toxicity, allergy, and environmental perspective. In addition, the grain that provides the processed food or animal feed is also tested to evaluate its nutritional content and identify unintended effects to the plant composition when warranted. To provide a platform for the safety assessment, the GM crop is compared to non-GM comparators in what is typically referred to as composition equivalence testing. New technologies, such as mass spectrometry and well-designed antibody-based methods, allow better analytical measurements of crop composition, including endogenous allergens. Many of the analytical methods and their intended uses are based on regulatory guidance documents, some of which are outlined in globally recognized documents such as Codex Alimentarius. In certain cases, animal models are recommended by some regulatory agencies in specific countries, but there is typically no hypothesis or justification of their use in testing the safety of GM crops. The quality and standardization of testing methods can be supported, in some cases, by employing good laboratory practices (GLP) and is recognized in China as important to ensure quality data. Although the number of recommended, in some cases, required methods for safety testing are increasing in some regulatory agencies, it should be noted that GM crops registered to date have been shown to be

  5. A Safety and Efficacy Study of Tolvaptan Following Open Heart Surgery in 109 Cases.

    PubMed

    Kono, Takanori; Tayama, Eiki; Hori, Hidetsugu; Ueda, Tomohiro; Yamaki, Yuta; Tanaka, Hiroyuki

    2016-07-27

    This study was conducted to evaluate the safety and efficacy of tolvaptan following open heart surgery.We retrospectively reviewed 109 patients who were administered tolvaptan following open heart surgery between August 2011 and July 2014. We divided the patients according to their urine output index (amount of urine output/body surface area) into tertiles as follows: T1 (low responders; n = 36), T2 (intermediate responders; n = 36), and T3 (high responders; n = 37). No fatal adverse events were observed following tolvaptan administration. The factors that showed a significant difference among the 3 groups were body surface area (BSA) and preoperative body weight. Body weight rapidly decreased and a greater increase in the serum sodium level was observed on day 1 in the T3 group than in the other 2 groups. No decrease in blood pressure and no significant differences in the occurrence of atrial fibrillation were observed among the 3 groups during tolvaptan administration.Tolvaptan can be safely and effectively administered to increase the urine output without adversely affecting the cardiovascular system or renal function following open heart surgery. However, careful attention is required regarding the possibility of a rapid increase in the serum sodium level so it is important to monitor changes in serum Na levels.

  6. [Post-marketing safety surveillance of Diemailing Kudiezi injection: real world study in 30 233 cases].

    PubMed

    Liao, Xing; Yu, Dan-Dan; Xie, Yan-Ming; Zhang, Yun-Ling; He, Yan; Zhang, Yin; Liu, Yan; Yi, Dan-Hui; Wang, Yong-Yan

    2017-08-01

    This study was aimed to obtain the incidence of adverse drug reaction (ADR) of Diemailing Kudiezi injection, explore its characteristics, related risk factors and application in real world. A prospective single cohort study was conducted from 25 hospitals (including Chinese medicine hospitals and Western medicine hospitals) for 4 years. 30 233 consecutive inpatients using Diemailing Kudiezi injection were observed. Their general information was analyzed by using statistic frequency description. Association rules were used to analyze the correlation between comorbidities or drug combinations; the influential factors for ADRs were initially screened by using cross contingency method and Chi-square test, and then Group LASSAO method was used for further analysis. 54 patients with adverse drug events and 30 patients with ADRs were reported among 30 233 patients, with a total ADR incidence of 0.099%[95%CI (0.06%, 0.13%)]. There were 27 patients identified as the "general" ADR, one patients with "severe" ADR (anaphylactic shock) and two patients with new ADRs. ADR occurred most in 30 min after using Diemailing Kudiezi injection, in a total of 16 patients. The most ADRs were palpitation, vomiting, chills, pruritus and rash, 6 times for each symptom. Diemailing Kudiezi injection was well tolerated in the general population. The overall incidence of adverse reactions was rare, with high safety. However, the real incidence of ADRs may be underestimated in this study, and the blood samples were not obtained for the patients, so further mechanism studies shall be conducted. Copyright© by the Chinese Pharmaceutical Association.

  7. NASA System Safety Handbook. Volume 2: System Safety Concepts, Guidelines, and Implementation Examples

    NASA Technical Reports Server (NTRS)

    Dezfuli, Homayoon; Benjamin, Allan; Everett, Christopher; Feather, Martin; Rutledge, Peter; Sen, Dev; Youngblood, Robert

    2015-01-01

    This is the second of two volumes that collectively comprise the NASA System Safety Handbook. Volume 1 (NASASP-210-580) was prepared for the purpose of presenting the overall framework for System Safety and for providing the general concepts needed to implement the framework. Volume 2 provides guidance for implementing these concepts as an integral part of systems engineering and risk management. This guidance addresses the following functional areas: 1.The development of objectives that collectively define adequate safety for a system, and the safety requirements derived from these objectives that are levied on the system. 2.The conduct of system safety activities, performed to meet the safety requirements, with specific emphasis on the conduct of integrated safety analysis (ISA) as a fundamental means by which systems engineering and risk management decisions are risk-informed. 3.The development of a risk-informed safety case (RISC) at major milestone reviews to argue that the systems safety objectives are satisfied (and therefore that the system is adequately safe). 4.The evaluation of the RISC (including supporting evidence) using a defined set of evaluation criteria, to assess the veracity of the claims made therein in order to support risk acceptance decisions.

  8. Study Gives Good Odds on Nuclear Reactor Safety

    ERIC Educational Resources Information Center

    Russell, Cristine

    1974-01-01

    Summarized is data from a recent study on nuclear reactor safety completed by Norman C. Rasmussen and others. Non-nuclear events are about 10,000 times more likely to produce large accidents than nuclear plants. (RH)

  9. Identification of Behavior Based Safety by Using Traffic Light Analysis to Reduce Accidents

    NASA Astrophysics Data System (ADS)

    Mansur, A.; Nasution, M. I.

    2016-01-01

    This work present the safety assessment of a case study and describes an important area within the field production in oil and gas industry, namely behavior based safety (BBS). The company set a rigorous BBS and its intervention program that implemented and deployed continually. In this case, observers requested to have discussion and spread a number of determined questions related with work behavior to the workers during observation. Appraisal of Traffic Light Analysis (TLA) as one tools of risk assessment used to determine the estimated score of BBS questionnaire. Standardization of TLA appraisal in this study are based on Regulation of Minister of Labor and Occupational Safety and Health No:PER.05/MEN/1996. The result shown that there are some points under 84%, which categorized in yellow category and should corrected immediately by company to prevent existing bad behavior of workers. The application of BBS expected to increase the safety performance at work time-by-time and effective in reducing accidents.

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

    PubMed

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

    2012-01-01

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

  11. High-Definition transcranial direct current stimulation in early onset epileptic encephalopathy: a case study.

    PubMed

    Meiron, Oded; Gale, Rena; Namestnic, Julia; Bennet-Back, Odeya; David, Jonathan; Gebodh, Nigel; Adair, Devin; Esmaeilpour, Zeinab; Bikson, Marom

    2018-01-01

    Early onset epileptic encephalopathy is characterized by high daily seizure-frequency, multifocal epileptic discharges, severe psychomotor retardation, and death at infancy. Currently, there are no effective treatments to alleviate seizure frequency and high-voltage epileptic discharges in these catastrophic epilepsy cases. The current study examined the safety and feasibility of High-Definition transcranial direct current stimulation (HD-tDCS) in reducing epileptiform activity in a 30-month-old child suffering from early onset epileptic encephalopathy. HD-tDCS was administered over 10 intervention days spanning two weeks including pre- and post-intervention video-EEG monitoring. There were no serious adverse events or side effects related to the HD-tDCS intervention. Frequency of clinical seizures was not significantly reduced. However, interictal sharp wave amplitudes were significantly lower during the post-intervention period versus baseline. Vital signs and blood biochemistry remained stable throughout the entire study. These exploratory findings support the safety and feasibility of 4 × 1 HD-tDCS in early onset epileptic encephalopathy and provide the first evidence of HD-tDCS effects on paroxysmal EEG features in electroclinical cases under the age of 36 months. Extending HD-tDCS treatment may enhance electrographic findings and clinical effects.

  12. Space Station crew safety alternatives study. Volume 4: Appendices

    NASA Technical Reports Server (NTRS)

    Peercy, R. L., Jr.; Raasch, R. F.; Rockoff, L. A.

    1985-01-01

    The scope of this study considered the first 15 years of accumulated space station concepts for Initial Operational Capability (10C) during the early 1990's. Twenty-five threats to the space station are identified and selected threats addressed as impacting safety criteria, escape and rescue, and human factors safety concerns. Of the 25 threats identified, eight are discussed including strategy options for threat control: fire, biological or toxic contamination, injury/illness, explosion, loss of pressurization, radiation, meteoroid penetration and debris.

  13. Aging road user studies of intersection safety : lab and simulator-based studies of crosswalk markings and flashing yellow arrow comprehension -- phase 2 : [summary].

    DOT National Transportation Integrated Search

    2014-10-01

    Nearly half of all traffic-related fatalities occur : at intersections, so engineering intersections : for greater safety remains a priority for the : Florida Department of Transportation (FDOT). : Engineering in this case must take into accoun...

  14. A Study on Drug Safety Monitoring Program in India

    PubMed Central

    Ahmad, A.; Patel, Isha; Sanyal, Sudeepa; Balkrishnan, R.; Mohanta, G. P.

    2014-01-01

    Pharmacovigilance is useful in assuring the safety of medicines and protecting the consumers from their harmful effects. A number of single drugs as well as fixed dose combinations have been banned from manufacturing, marketing and distribution in India. An important issue about the availability of banned drugs over the counter in India is that sufficient adverse drug reactions data about these drugs have not been reported. The most common categories of drugs withdrawn in the last decade were nonsteroidal antiinflammatory drugs (28%), antidiabetics (14.28%), antiobesity (14.28%), antihistamines (14.28%), gastroprokinetic drugs (7.14%), breast cancer and infertility drugs (7.14%), irritable bowel syndrome and constipation drugs (7.14%) and antibiotics (7.14%). Drug withdrawals from market were made mainly due to safety issues involving cardiovascular events (57.14%) and liver damage (14.28%). Majority of drugs have been banned since 3-5 years in other countries but are still available for sale in India. The present study compares the drug safety monitoring systems in the developed countries such as the USA and UK and provides implications for developing a system that can ensure the safety and efficacy of drugs in India. Absence of a gold standard for a drug safety surveillance system, variations in culture and clinical practice across countries makes it difficult for India to completely adopt another country's practices. There should be a multidisciplinary approach towards drug safety that should be implemented throughout the entire duration spanning from drug discovery to usage by consumers. PMID:25425751

  15. A study on drug safety monitoring program in India.

    PubMed

    Ahmad, A; Patel, Isha; Sanyal, Sudeepa; Balkrishnan, R; Mohanta, G P

    2014-09-01

    Pharmacovigilance is useful in assuring the safety of medicines and protecting the consumers from their harmful effects. A number of single drugs as well as fixed dose combinations have been banned from manufacturing, marketing and distribution in India. An important issue about the availability of banned drugs over the counter in India is that sufficient adverse drug reactions data about these drugs have not been reported. The most common categories of drugs withdrawn in the last decade were nonsteroidal antiinflammatory drugs (28%), antidiabetics (14.28%), antiobesity (14.28%), antihistamines (14.28%), gastroprokinetic drugs (7.14%), breast cancer and infertility drugs (7.14%), irritable bowel syndrome and constipation drugs (7.14%) and antibiotics (7.14%). Drug withdrawals from market were made mainly due to safety issues involving cardiovascular events (57.14%) and liver damage (14.28%). Majority of drugs have been banned since 3-5 years in other countries but are still available for sale in India. The present study compares the drug safety monitoring systems in the developed countries such as the USA and UK and provides implications for developing a system that can ensure the safety and efficacy of drugs in India. Absence of a gold standard for a drug safety surveillance system, variations in culture and clinical practice across countries makes it difficult for India to completely adopt another country's practices. There should be a multidisciplinary approach towards drug safety that should be implemented throughout the entire duration spanning from drug discovery to usage by consumers.

  16. Institutional ethical review and ethnographic research involving injection drug users: a case study.

    PubMed

    Small, Will; Maher, Lisa; Kerr, Thomas

    2014-03-01

    Ethnographic research among people who inject drugs (PWID) involves complex ethical issues. While ethical review frameworks have been critiqued by social scientists, there is a lack of social science research examining institutional ethical review processes, particularly in relation to ethnographic work. This case study describes the institutional ethical review of an ethnographic research project using observational fieldwork and in-depth interviews to examine injection drug use. The review process and the salient concerns of the review committee are recounted, and the investigators' responses to the committee's concerns and requests are described to illustrate how key issues were resolved. The review committee expressed concerns regarding researcher safety when conducting fieldwork, and the investigators were asked to liaise with the police regarding the proposed research. An ongoing dialogue with the institutional review committee regarding researcher safety and autonomy from police involvement, as well as formal consultation with a local drug user group and solicitation of opinions from external experts, helped to resolve these issues. This case study suggests that ethical review processes can be particularly challenging for ethnographic projects focused on illegal behaviours, and that while some challenges could be mediated by modifying existing ethical review procedures, there is a need for legislation that provides legal protection of research data and participant confidentiality. Copyright © 2013 Elsevier Ltd. All rights reserved.

  17. Safety of Gadobutrol

    PubMed Central

    Endrikat, Jan; Vogtlaender, Kai; Dohanish, Susan; Balzer, Thomas; Breuer, Josy

    2016-01-01

    Objective The aim of this study was to provide a systematic safety analysis of gadobutrol after more than 29 million applications in clinical routine. Materials and Methods Forty-two clinical development phase II to IV studies on gadobutrol or comparator and the postmarketing safety surveillance database for gadobutrol (1998–2015) were analyzed. Adverse events (AEs) and drug-related AEs were evaluated in the clinical development database and spontaneous adverse drug reactions (ADRs) in the postmarketing database. Subgroup analyses were run on patients with special medical history and on patients of different age groups. Results In the clinical development studies, 6809 and 2184 patients received gadobutrol or comparators, respectively. The incidence of drug-related AEs was 3.5% for both groups. With the exception of nausea (0.7% related cases in both groups), all other drug-related AEs were 0.3% or less in both groups. Hypersensitivity reactions were sporadic (<0.1%). Patients with history of allergies to contrast agents experienced slightly more drug-related AEs. No differences were seen between age groups. The overall reporting rate of ADRs from postmarketing surveillance was 0.05%. The most frequent ADRs were anaphylactoid/hypersensitivity reactions, nausea, vomiting, and dyspnea. For 3 single-agent reports of nephrogenic systemic fibrosis, using a conservative approach, association with gadobutrol could not be excluded. Conclusions Gadobutrol is well tolerated and has a favorable safety profile for patients of all age groups. PMID:26964075

  18. Middle School Students' Perceptions of Safety: A Mixed-Methods Study.

    PubMed

    Sweeney, Shannon M; Von Hagen, Leigh Ann

    2015-10-01

    Active travel to school has been on the decline, despite its beneficial influence on children's current and future well-being. Adults' safety perceptions have been shown to influence children's active travel. Children's perceptions, particularly of safety, may be an important link not only to their present health and travel behaviors, but also their future health and behaviors. This study examined middle school students' perceptions of the built environment and safety. Overall, 776 students from 3 schools in Hudson County, New Jersey participated in a visual survey and structured, interactive classroom discussions. Emergent themes from the discussions were tested using multivariate statistical models. Findings suggest that older students, boys, and students who self-identified as black, rated built environment scenes as safer. Students also perceived being near adults, traveling in a group, and using crosswalks as significantly safer and want additional recognition of these to further improve safety. Students perceived that being near a school, in daylight, and aesthetics as factors contributing to safety. Schools and municipalities may increase programs for students to travel in groups, prioritize maintenance in school zones, and increase the number of crossing guards, particularly outside the immediate school proximity to further improve safety. © 2015, American School Health Association.

  19. Aircraft fire safety research

    NASA Technical Reports Server (NTRS)

    Botteri, Benito P.

    1987-01-01

    During the past 15 years, very significant progress has been made toward enhancing aircraft fire safety in both normal and hostile (combat) operational environments. Most of the major aspects of the aircraft fire safety problem are touched upon here. The technology of aircraft fire protection, although not directly applicable in all cases to spacecraft fire scenarios, nevertheless does provide a solid foundation to build upon. This is particularly true of the extensive research and testing pertaining to aircraft interior fire safety and to onboard inert gas generation systems, both of which are still active areas of investigation.

  20. Interventional cardiology live case presentations: regulatory considerations.

    PubMed

    Farb, Andrew; Brown, Sheila A; Wolf, Deborah A; Zuckerman, Bram

    2010-10-01

    Live case presentations are increasingly common at interventional cardiology conferences. Taking advantage of significant advances in communication technology, broadcasts of procedures can be viewed as an extension of traditional medical education targeted to large groups of practitioners. However, there are important ethical, commercial, and patient safety issues associated with live cases that deserve attention. Use of investigational devices in live case demonstrations is subject to review and approval by FDA's Center for Devices and Radiological Health (CDRH), and the outcomes of patients participating in live cases are considered in the overall clinical study results. This article discusses CDRH's regulatory view of live case presentations with a focus on patient safety, clinical trial integrity, and concerns regarding improper medical device promotion. © 2010 Wiley-Liss, Inc.

  1. Interventional cardiology live case presentations regulatory considerations.

    PubMed

    Farb, Andrew; Brown, Sheila A; Wolf, Deborah A; Zuckerman, Bram

    2010-10-01

    Live case presentations are increasingly common at interventional cardiology conferences. Taking advantage of significant advances in communication technology, broadcasts of procedures can be viewed as an extension of traditional medical education targeted to large groups of practitioners. However, there are important ethical, commercial, and patient safety issues associated with live cases that deserve attention. Use of investigational devices in live case demonstrations is subject to review and approval by FDA's Center for Devices and Radiological Health (CDRH), and the outcomes of patients participating in live cases are considered in the overall clinical study results. This article discusses CDRH's regulatory view of live case presentations with a focus on patient safety, clinical trial integrity, and concerns regarding improper medical device promotion. Copyright © 2010. Published by Elsevier Inc.

  2. The use of relative incidence ratios in self-controlled case series studies: an overview.

    PubMed

    Hawken, Steven; Potter, Beth K; Little, Julian; Benchimol, Eric I; Mahmud, Salah; Ducharme, Robin; Wilson, Kumanan

    2016-09-23

    The self-controlled case series (SCCS) is a useful design for investigating associations between outcomes and transient exposures. The SCCS design controls for all fixed covariates, but effect modification can still occur. This can be evaluated by including interaction terms in the model which, when exponentiated, can be interpreted as a relative incidence ratio (RIR): the change in relative incidence (RI) for a unit change in an effect modifier. We conducted a scoping review to investigate the use of RIRs in published primary SCCS studies, and conducted a case-study in one of our own primary SCCS studies to illustrate the use of RIRs within an SCCS analysis to investigate subgroup effects in the context of comparing whole cell (wcp) and acellular (acp) pertussis vaccines. Using this case study, we also illustrated the potential utility of RIRs in addressing the healthy vaccinee effect (HVE) in vaccine safety surveillance studies. Our scoping review identified 122 primary studies reporting an SCCS analysis. Of these, 24 described the use of interaction terms to test for effect modification. 21 of 24 studies reported stratum specific RIs, 22 of 24 reported the p-value for interaction, and less than half (10 of 24) reported the estimate of the interaction term/RIR, the stratum specific RIs and interaction p-values. Our case-study demonstrated that there was a nearly two-fold greater RI of ER visits and admissions following wcp vaccination relative to acp vaccination (RIR = 1.82, 95 % CI 1.64-2.01), where RI estimates in each subgroup were clearly impacted by a strong healthy vaccinee effect. We demonstrated in our scoping review that calculating RIRs is not a widely utilized strategy. We showed that calculating RIRs across time periods is useful for the detection of relative changes in adverse event rates that might otherwise be missed due to the HVE. Many published studies of vaccine-associated adverse events could have missed/underestimated important safety

  3. Making the invisible visible: a qualitative study of the values, attitudes and norms of radiologists relating to radiation safety.

    PubMed

    Fridell, Kent; Ekberg, Jessica

    2016-06-01

    Some shortcomings regarding safety have emerged in inspections by the Swedish Radiation Safety Authority of Swedish radiology departments which perform 5.4 million radiological examinations and 100 000 nuclear scans annually. To ensure safety in the healthcare system and to build a strong environment of radiation protection for patients (and for employees) there must be a strong culture of safety. To understand an organization's behaviour, decisions and actions it is important to study its cultural values. The aims of this study were to discuss how values, attitudes and norms affect radiologists' decisions as well as how they influence the implementation of various radiation protection measures. To investigate this, focus group interviews and in-depth individual interviews were performed in a sample from a number of radiology departments at hospitals in Sweden. The results show that the core value was derived from the patients' perspective with the focus on the knowledge that he or she has come to the healthcare system for a particular reason: to discover disease or, in the best case, to be declared healthy. The majority attitudes were based on experiences associated with aspects that the radiologist could not influence. This often concerns increased pressure on radiology investigations from clinics in the various operational units. Under the concept of norms, the radiologists in the study requested that the development of regulations and guidelines should be connected to issues of justification for various radiological queries.

  4. The Evolution of System Safety at NASA

    NASA Technical Reports Server (NTRS)

    Dezfuli, Homayoon; Everett, Chris; Groen, Frank

    2014-01-01

    The NASA system safety framework is in the process of change, motivated by the desire to promote an objectives-driven approach to system safety that explicitly focuses system safety efforts on system-level safety performance, and serves to unify, in a purposeful manner, safety-related activities that otherwise might be done in a way that results in gaps, redundancies, or unnecessary work. An objectives-driven approach to system safety affords more flexibility to determine, on a system-specific basis, the means by which adequate safety is achieved and verified. Such flexibility and efficiency is becoming increasingly important in the face of evolving engineering modalities and acquisition models, where, for example, NASA will increasingly rely on commercial providers for transportation services to low-earth orbit. A key element of this objectives-driven approach is the use of the risk-informed safety case (RISC): a structured argument, supported by a body of evidence, that provides a compelling, comprehensible and valid case that a system is or will be adequately safe for a given application in a given environment. The RISC addresses each of the objectives defined for the system, providing a rational basis for making informed risk acceptance decisions at relevant decision points in the system life cycle.

  5. Building Safer Secondary Schools in Uganda through Collective Commitment to Health and Safety Compliance

    ERIC Educational Resources Information Center

    Sekiwu, Denis; Kabanda, Milly

    2014-01-01

    The area of safety and accident prevention is of great concern to managers, because of the increasing number of deaths and accidents at work places. Using a case of Wakiso district, the study sought to investigate the relationship between collective commitment and management of health and safety in Ugandan secondary schools. The study employed a…

  6. Statistical issues in the design, conduct and analysis of two large safety studies.

    PubMed

    Gaffney, Michael

    2016-10-01

    The emergence, post approval, of serious medical events, which may be associated with the use of a particular drug or class of drugs, is an important public health and regulatory issue. The best method to address this issue is through a large, rigorously designed safety study. Therefore, it is important to elucidate the statistical issues involved in these large safety studies. Two such studies are PRECISION and EAGLES. PRECISION is the primary focus of this article. PRECISION is a non-inferiority design with a clinically relevant non-inferiority margin. Statistical issues in the design, conduct and analysis of PRECISION are discussed. Quantitative and clinical aspects of the selection of the composite primary endpoint, the determination and role of the non-inferiority margin in a large safety study and the intent-to-treat and modified intent-to-treat analyses in a non-inferiority safety study are shown. Protocol changes that were necessary during the conduct of PRECISION are discussed from a statistical perspective. Issues regarding the complex analysis and interpretation of the results of PRECISION are outlined. EAGLES is presented as a large, rigorously designed safety study when a non-inferiority margin was not able to be determined by a strong clinical/scientific method. In general, when a non-inferiority margin is not able to be determined, the width of the 95% confidence interval is a way to size the study and to assess the cost-benefit of relative trial size. A non-inferiority margin, when able to be determined by a strong scientific method, should be included in a large safety study. Although these studies could not be called "pragmatic," they are examples of best real-world designs to address safety and regulatory concerns. © The Author(s) 2016.

  7. Safety and tolerability of cladribine tablets in multiple sclerosis: the CLARITY (CLAdRIbine Tablets treating multiple sclerosis orallY) study.

    PubMed

    Cook, S; Vermersch, P; Comi, G; Giovannoni, G; Rammohan, K; Rieckmann, P; Sørensen, P Soelberg; Hamlett, A; Miret, M; Weiner, J; Viglietta, V; Musch, B; Greenberg, S J

    2011-05-01

    Cladribine is a synthetic deoxyadenosine analogue in development as an oral multiple sclerosis (MS) therapy. To report in detail the safety findings from the 96-week, phase III, double-blind CLARITY study, which evaluated treatment with cladribine tablets in relapsing-remitting MS. A total of 1,326 patients were randomized 1:1:1 to two short-course regimens of cladribine tablets (3.5 or 5.25 mg/kg cumulative dose over 96 weeks) or placebo. Safety assessments included monitoring for adverse events (AEs), routine physical and neurologic examinations and frequent laboratory parameter assessments. Of the randomized patients, 88.6% completed treatment with cladribine tablets versus 86.3% with placebo. Lymphopenia was the most commonly reported AE in patients treated with cladribine tablets and was anticipated based on the mechanism of action. The incidence of infections was 48.3% with cladribine tablets and 42.5% with placebo, with 99.1% and 99.0% rated mild-to-moderate by investigators. Herpes zoster infections developed in 20 (2.3%) cladribine-treated patients; all cases were dermatomal. There were no herpes zoster infections in the placebo group. Nine (1.0%) patients experienced events related to uterine leiomyomas in the cladribine tablets groups versus one (0.2%) with placebo. Three isolated cases of malignancy were reported in cladribine-treated patients during the study; a fourth was reported during post-study surveillance. A pre-malignant cervical carcinoma in situ was also reported. The incidence of malignancies during the study did not exceed the expected rate in a population standardized for country, gender and age. The safety and tolerability profile observed in the CLARITY study together with the reported efficacy support the potential for cladribine tablets as an MS therapy.

  8. Metropolitan transportation management center : a case study : Milwaukee MONITOR : addressing congestion while improving safety and air quality

    DOT National Transportation Integrated Search

    1999-10-01

    The following case study provides a snapshot of Milwaukee's MONITOR transportation management center. It follows the outline provided in the companion document, Metropolitan Transportation Management Center Concepts of Operation - A Cross Cutting Stu...

  9. AMDIS Case Conference: Intrusive Medication Safety Alerts.

    PubMed

    Graham, J; Levick, D; Schreiber, R

    2010-01-01

    Clinical decision support that provides enhanced patient safety at the point of care frequently encounters significant pushback from clinicians who find the process intrusive or time-consuming. We present a hypothetical medical center's dilemma about its allergy alerting system and discuss similar problems faced by real hospitals. We then share some lessons learned and best practices for institutions who wish to implement these tools themselves.

  10. Analyzing self-controlled case series data when case confirmation rates are estimated from an internal validation sample.

    PubMed

    Xu, Stanley; Clarke, Christina L; Newcomer, Sophia R; Daley, Matthew F; Glanz, Jason M

    2018-05-16

    Vaccine safety studies are often electronic health record (EHR)-based observational studies. These studies often face significant methodological challenges, including confounding and misclassification of adverse event. Vaccine safety researchers use self-controlled case series (SCCS) study design to handle confounding effect and employ medical chart review to ascertain cases that are identified using EHR data. However, for common adverse events, limited resources often make it impossible to adjudicate all adverse events observed in electronic data. In this paper, we considered four approaches for analyzing SCCS data with confirmation rates estimated from an internal validation sample: (1) observed cases, (2) confirmed cases only, (3) known confirmation rate, and (4) multiple imputation (MI). We conducted a simulation study to evaluate these four approaches using type I error rates, percent bias, and empirical power. Our simulation results suggest that when misclassification of adverse events is present, approaches such as observed cases, confirmed case only, and known confirmation rate may inflate the type I error, yield biased point estimates, and affect statistical power. The multiple imputation approach considers the uncertainty of estimated confirmation rates from an internal validation sample, yields a proper type I error rate, largely unbiased point estimate, proper variance estimate, and statistical power. © 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  11. Safety of topical minoxidil solution: a one-year, prospective, observational study.

    PubMed

    Shapiro, Jerry

    2003-01-01

    Topical minoxidil solution (TMS) is widely used for androgenetic alopecia (AGA), and this is the first report of a large safety trial. The aim of the study was to evaluate the safety profile of TMS by comparing hospitalization and death rates among subjects using TMS with controls. Cardiovascular safety and pregnancy outcomes were evaluated, and usage patterns were described. All subjects were followed at baseline, 3, 6, 9, and 12 months. Usage patterns, pregnancy status, overnight hospital stays, and cardiovascular risk factors were evaluated. Subjects rated effectiveness of TMS in the treatment of AGA. Statistical analyses were conducted to determine if TMS was associated with an increased risk of death or hospitalization. TMS is a safe and effective treatment for AGA. There were no increases in cardiovascular events and no apparent increased risk for adverse pregnancy outcomes. This large, prospective study demonstrated the overall safety of TMS in the treatment of AGA.

  12. Improvements in medical quality and patient safety through implementation of a case bundle management strategy in a large outpatient blood collection center.

    PubMed

    Zhao, Shuzhen; He, Lujia; Feng, Chenchen; He, Xiaoli

    2018-06-01

    Laboratory errors in blood collection center (BCC) are most common in the preanalytical phase. It is, therefore, of vital importance for administrators to take measures to improve healthcare quality and patient safety.In 2015, a case bundle management strategy was applied in a large outpatient BCC to improve its medical quality and patient safety.Unqualified blood sampling, complications, patient waiting time, largest number of patients waiting during peak hours, patient complaints, and patient satisfaction were compared over the period from 2014 to 2016.The strategy reduced unqualified blood sampling, complications, patient waiting time, largest number of patients waiting during peak hours, and patient complaints, while improving patient satisfaction.This strategy was effective in improving BCC healthcare quality and patient safety.

  13. Metropolitan Transportation Management Center : a case study : Houston TranStar maximizing safety and mobility for the public

    DOT National Transportation Integrated Search

    1999-10-01

    The following case study provides a snapshot of Houston's TranStar transportation management center. It follows the outline provided in the companion document, Metropolitan Transportation Management Center Concepts of Operation - A Cross Cutting Stud...

  14. Implementation Procedure for STS Payloads, System Safety Requirements

    NASA Technical Reports Server (NTRS)

    1979-01-01

    Guidelines and instructions for the implementation of the SP&R system safety requirements applicable to STS payloads are provided. The initial contact meeting with the payload organization and the subsequent safety reviews necessary to comply with the system safety requirements of the SP&R document are described. Waiver instructions are included for the cases in which a safety requirement cannot be met.

  15. Safety Profile of Anticancer and Immune-Modulating Biotech Drugs Used in a Real World Setting in Campania Region (Italy): BIO-Cam Observational Study

    PubMed Central

    Scavone, Cristina; Sportiello, Liberata; Sullo, Maria G.; Ferrajolo, Carmen; Ruggiero, Rosanna; Sessa, Maurizio; Berrino, Pasquale M.; di Mauro, Gabriella; Berrino, Liberato; Rossi, Francesco; Rafaniello, Concetta; Capuano, Annalisa; Valentini, G.

    2017-01-01

    Objectives: To investigate the occurrence of adverse events (AEs) in naïve patients receiving biotech drugs. Design: A prospective observational study. Setting: Onco-hematology, Hepato-gastroenterology, Rheumatology, Dermatology, and Neurology Units in Campania Region (Italy). Participants: 775 patients (53.81% female) with mean age 56.0 (SD 15.2). The mean follow-up/patient was 3.48 (95% confidence interval 3.13–3.84). Main outcome measures: We collected all AEs associated to biotech drugs, including serious infections and malignancies. Serious AEs were defined according to the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, clinical safety data management: definitions and standards for expedited reporting E2A guideline. Results: The majority of the study population was enrolled in Onco-hematology and Rheumatology Units and the most common diagnosis were hematological malignancies, followed by rheumatoid arthritis, colorectal cancer, breast cancer, and psoriatic arthritis. The most commonly prescribed biotech drugs were rituximab, bevacizumab, infliximab, trastuzumab, adalimumab, and cetuximab. Out of 775 patients, 320 experienced at least one AE. Most of patients experienced AEs to cetuximab therapy, rituximab and trastuzumab. Comparing female and male population, our findings highlighted a statistically significant difference in terms of AEs for adalimumab (35.90% vs. 7.41%, p < 0.001) and etanercept (27.59% vs. 10.00%, p = 0.023). Considering all biotech drugs, we observed a peak for all AEs occurrence at follow-up 91–180 days category. Bevacizumab, brentuximab, rituximab, trastuzumab and cetuximab were more commonly associated to serious adverse events; most of these were possibly related to biotech drugs, according to causality assessment. Three cases of serious infections occurred. Conclusions: The results of our study demonstrated that the majority of AEs were not serious and

  16. Promoting Health and Safety. Skills for Independent Living.

    ERIC Educational Resources Information Center

    Agran, Martin, Ed.; And Others

    This guidebook provides behavioral-instructional strategies for teaching essential personal safety skills and promoting overall well-being to persons with developmental disabilities. Case studies demonstrate these strategies in practice, and detailed curriculum goals are included to guide intervention efforts. To ensure that learners both…

  17. 76 FR 81761 - Mine Safety Disclosure

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-28

    ... inspections pursuant to miners' complaints.\\18\\ If violations of safety or health standards are found, MSHA... appropriateness of proposed penalties. Other types of cases include miners' complaints of safety- or health-related discrimination and miners' applications for compensation after a mine has been idled by a closure...

  18. Space station crew safety alternatives study. Volume 3: Safety impact of human factors

    NASA Technical Reports Server (NTRS)

    Rockoff, L. A.; Raasch, R. F.; Peercy, R. L., Jr.

    1985-01-01

    The first 15 years of accumulated space station concepts for Initial Operational Capability (IOC) during the early 1990's was considered. Twenty-five threats to the space station are identified and selected threats addressed as impacting safety criteria, escape and rescue, and human factors safety concerns. Of the 25 threats identified, eight are discussed including strategy options for threat control: fire, biological or toxic contamination, injury/illness, explosion, loss of pressurization, radiation, meteoroid penetration and debris. Of particular interest here is volume three (of five volumes) pertaining to the safety impact of human factors.

  19. Screening Electronic Health Record-Related Patient Safety Reports Using Machine Learning.

    PubMed

    Marella, William M; Sparnon, Erin; Finley, Edward

    2017-03-01

    The objective of this study was to develop a semiautomated approach to screening cases that describe hazards associated with the electronic health record (EHR) from a mandatory, population-based patient safety reporting system. Potentially relevant cases were identified through a query of the Pennsylvania Patient Safety Reporting System. A random sample of cases were manually screened for relevance and divided into training, testing, and validation data sets to develop a machine learning model. This model was used to automate screening of remaining potentially relevant cases. Of the 4 algorithms tested, a naive Bayes kernel performed best, with an area under the receiver operating characteristic curve of 0.927 ± 0.023, accuracy of 0.855 ± 0.033, and F score of 0.877 ± 0.027. The machine learning model and text mining approach described here are useful tools for identifying and analyzing adverse event and near-miss reports. Although reporting systems are beginning to incorporate structured fields on health information technology and the EHR, these methods can identify related events that reporters classify in other ways. These methods can facilitate analysis of legacy safety reports by retrieving health information technology-related and EHR-related events from databases without fields and controlled values focused on this subject and distinguishing them from reports in which the EHR is mentioned only in passing. Machine learning and text mining are useful additions to the patient safety toolkit and can be used to semiautomate screening and analysis of unstructured text in safety reports from frontline staff.

  20. Violence against Women and Gastroschisis: A Case-Control Study

    PubMed Central

    Ortega-García, Juan Antonio; Soldin, Offie P.; Sánchez-Sauco, Miguel Felipe; Cánovas-Conesa, Alicia; Gomaríz-Peñalver, Virtudes; Jaimes-Vega, Diana Carolina; Perales, Joseph E.; Cárceles-Alvarez, Alberto; Martínez-Ros, Maria Teresa; Ruiz, Daniel

    2013-01-01

    Background: Gastroschisis, a birth defect characterized by herniated fetal abdominal wall, occurs more commonly in infants born to teenage and young mothers. Ischemia of the vascular vitelline vessels is the likely mechanism of pathogenesis. Given that chronic stress and violence against women are risk factors for cardiovascular disease we explored whether these may represent risk factors for gastroschisis, when they occur during pregnancy. A case-control study was conducted, with 15 incident cases of children born with gastroschisis in the Region of Murcia, Spain, from December 2007 to June 2013. Forty concurrent controls were recruited at gestation weeks 20–24 or post-partum. All mothers of cases and controls completed a comprehensive, in-person, ‘green sheet’ questionnaire on environmental exposures. Results: Mothers of children with gastroschisis were younger, smoked more cigarettes per week relative to controls, were exposed to higher amounts of illegal drugs, and suffered from domestic violence more frequently than the controls. Multivariable logistic regression analysis highlights periconceptional ‘gender-related violence’ (OR: 16.6, 95% CI 2.7 to 101.7) and younger maternal age (OR 1.1, 95% CI 1.0–1.3). Conclusions: Violence against pregnant women is associated with birth defects, and should be studied in more depth as a cause-effect teratogenic. Psychosocial risk factors, including gender-based violence, are important for insuring the health and safety of the pregnant mother and the fetus. PMID:24142184

  1. Pressure Safety: Advanced Self-Study 30120

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

    Glass, George

    2016-02-29

    Pressure Safety Advance Self-Study (Course 30120) consists of an introduction, five modules, and a quiz. To receive credit in UTrain for completing this course, you must score 80% or better on the 15-question quiz (check UTrain). Directions for initiating the quiz are appended to the end of this training manual. This course contains several links to LANL websites. UTrain might not support active links, so please copy links into the address line in your browser.

  2. Governance and implementation of sports safety practices by municipal offices in Swedish communities.

    PubMed

    Backe, S; Janson, S; Timpka, T

    2012-01-01

    The objective of this study was to explore whether all-purpose health or safety promotion programmes and sports safety policies affect sports safety practices in local communities. Case study research methods were used to compare sports safety activities among offices in 73 Swedish municipalities; 28 with ongoing health or safety promotion programmes and 45 controls. The offices in municipalities with the WHO Healthy Cities (HC) or Safe Communities programmes were more likely to perform frequent inspections of sports facilities, and offices in the WHO HC programme were more likely to involve sports clubs in inspections. More than every second, property management office and environmental protection office conducted sports safety inspections compared with less than one in four planning offices and social welfare offices. It is concluded that all-purpose health and safety promotion programmes can reach out to have an effect on sports safety practices in local communities. These safety practices also reflect administrative work routines and managerial traditions.

  3. Monitoring drug safety in Astrakhan, Russia.

    PubMed

    Kirilochev, O O; Dorfman, I P; Umerova, A R

    2015-01-01

    The problem of drug safety will never disappear as new drugs are delivered in increasing numbers. They have high biological activity and adverse drug reactions (ADR) [1]. Currently, adverse drug reactions are the fourth leading cause of death for patients.There are databases of ADRs (Vigibase, Eudravigilance), but we know that ADR manifestations may vary in different countries and regions, due to the demographic, genetic characteristics of the population and the quality of manufactured drugs [2]. In this regard, the study of the ADR at the regional level is very relevant. We aimed to optimize the work on monitoring drug safety in Astrakhan region through pharmacoepidemiological research and development of computer database for analysis of information coming to the center for drug safety monitoring (CDSM). 1. To study the rates of ADR reporting and the structure in the Astrakhan region at the regional center for drug safety monitoring.2. To analyze the outcomes of registered adverse drug reactions.3. To determine the causality of adverse drug reactions.4. To identify reports on the ineffectiveness of drugs.5. To analyze the rates and structure of ADR reporting for drugs prescribed off-label. We studied spontaneous adverse event reporting. The adverse event reports received by the regional CDSM for the period of 2010 to 2014 was analyzed. The groups of drugs were categorized according by Anatomical Therapeutic Chemical classification system. The data were analyzed using Microsoft Office Excel. The likelihood of whether an ADR was actually due to the drugs was assessed with the Naranjo algorithm. The analysis of the results showed that the establishment of the CDSM in September 2010, contributed to improvement of drug safety monitoring in health facilities of the region. Noteworthy was the increasing the number of adverse event reports in 2011 and 2012, compared with the beginning of the year 2010, when the CDSM was not yet functioning.The decrease of adverse event

  4. Travtek Evaluation Safety Study

    DOT National Transportation Integrated Search

    1996-02-01

    One of the major evaluation goals of the TravTek operational test was to assess the safety impact of the TravTek system as implemented in Orlando, Florida during the 1 -year deployment phase. Also, the results of the TravTek operational test, with re...

  5. Safety culture assessment in petrochemical industry: a comparative study of two algerian plants.

    PubMed

    Boughaba, Assia; Hassane, Chabane; Roukia, Ouddai

    2014-06-01

    To elucidate the relationship between safety culture maturity and safety performance of a particular company. To identify the factors that contribute to a safety culture, a survey questionnaire was created based mainly on the studies of Fernández-Muñiz et al. The survey was randomly distributed to 1000 employees of two oil companies and realized a rate of valid answer of 51%. Minitab 16 software was used and diverse tests, including the descriptive statistical analysis, factor analysis, reliability analysis, mean analysis, and correlation, were used for the analysis of data. Ten factors were extracted using the analysis of factor to represent safety culture and safety performance. The results of this study showed that the managers' commitment, training, incentives, communication, and employee involvement are the priority domains on which it is necessary to stress the effort of improvement, where they had all the descriptive average values lower than 3.0 at the level of Company B. Furthermore, the results also showed that the safety culture influences the safety performance of the company. Therefore, Company A with a good safety culture (the descriptive average values more than 4.0), is more successful than Company B in terms of accident rates. The comparison between the two petrochemical plants of the group Sonatrach confirms these results in which Company A, the managers of which are English and Norwegian, distinguishes itself by the maturity of their safety culture has significantly higher evaluations than the company B, who is constituted of Algerian staff, in terms of safety management practices and safety performance.

  6. Lamotrigine rechallenge after a skin rash. A combined study of open cases and a meta-analysis.

    PubMed

    Serrani Azcurra, Daniel J L

    2013-01-01

    To determine the safety of lamotrigine rechallenge after a first episode of skin rash in bipolar patients. An open cases prospective study was conducted with patients who, developed a skin rash when first treated with lamotrigine, were refractory to other treatments, and were offered lamotrigine rechallenge using a different dose titration. Additionally a review was performed on previous skin rash management strategies and lamotrigine rechallenge reports. Every 3 out of 10 lamotrigine rechallenge patients required drug interruption due to persistent rash. One of them was potentially serious and resolved by stopping the lamotrigine. The review of available literature identified several lamotrigine rechallenge studies with rates of positive results varying between 70% and 87% depending on the study. No patient developed Stevens-Johnson syndrome or toxic epidermal necrolysis after rechallenge. The rate of rash was higher when rechallenge began between 4 weeks from initial rash (19% vs. 7%, P=.001) and decreased when first rash showed no potentially serious signs (0% vs.19%, P=.01). Rechallenge is a viable option after a benign lamotrigine-induced rash, and can even be rechallenged after rash with greater precautions when there exists one or two potentially serious signs. In cases of more serious rash there are no reliable data available on rechallenge safety and it may pose a significant risk. In those cases rechallenge should better be avoided between 4 weeks from first rash. Copyright © 2011 SEP y SEPB. Published by Elsevier Espana. All rights reserved.

  7. Safety Assessment of Probiotics

    NASA Astrophysics Data System (ADS)

    Lahtinen, Sampo J.; Boyle, Robert J.; Margolles, Abelardo; Frias, Rafael; Gueimonde, Miguel

    Viable microbes have been a natural part of human diet throughout the history of mankind. Today, different fermented foods and other foods containing live microbes are consumed around the world, including industrialized countries, where the diet has become increasingly sterile during the last decades. By definition, probiotics are viable microbes with documented beneficial effects on host health. Probiotics have an excellent safety record, both in humans and in animals. Despite the wide and continuously increasing consumption of probiotics, adverse events related to probiotic use are extremely rare. Many popular probiotic strains such as lactobacilli and bifidobacteria can be considered as components of normal healthy intestinal microbiota, and thus are not thought to pose a risk for the host health - in contrast, beneficial effects on health are commonly reported. Nevertheless, the safety of probiotics is an important issue, in particular in the case of new potential probiotics which do not have a long history of safe use, and of probiotics belonging to species for which general assumption of safety cannot be made. Furthermore, safety of probiotics in high-risk populations such as critically ill patients and immunocompromized subjects deserves particular attention, as virtually all reported cases of bacteremia and fungemia associated with probiotic use, involve subjects with underlying diseases, compromised immune system or compromised intestinal integrity.

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

    PubMed

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

    2015-08-01

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

  9. Making safety an integral part of 5S in healthcare.

    PubMed

    Ikuma, Laura H; Nahmens, Isabelina

    2014-01-01

    Healthcare faces major challenges with provider safety and rising costs, and many organizations are using Lean to instigate change. One Lean tool, 5S, is becoming popular for improving efficiency of physical work environments, and it can also improve safety. This paper demonstrates that safety is an integral part of 5S by examining five specific 5S events in acute care facilities. We provide two arguments for how safety is linked to 5S:1. Safety is affected by 5S events, regardless of whether safety is a specific goal and 2. Safety can and should permeate all five S's as part of a comprehensive plan for system improvement. Reports of 5S events from five departments in one health system were used to evaluate how changes made at each step of the 5S impacted safety. Safety was affected positively in each step of the 5S through initial safety goals and side effects of other changes. The case studies show that 5S can be a mechanism for improving safety. Practitioners may reap additional safety benefits by incorporating safety into 5S events through a safety analysis before the 5S, safety goals and considerations during the 5S, and follow-up safety analysis.

  10. Stringency of workplace air contaminant exposure limits: a case study of OSHA risk management.

    PubMed

    Hakes, J K

    1999-12-01

    Political context may play a large role in influencing the efficiency of environmental and health regulations. This case study uses data from a 1989 update of the Occupational Safety and Health Administration (OSHA) Permissible Exposure Limits (PELs) program to determine the relative effects of legislative mandates, costly acquisition of information by the agency, and pressure applied by special interest groups upon exposure standards. The empirical analysis suggests that federal agencies successfully thwart legislative attempts to limit agency discretion, and that agencies exercise bounded rationality by placing greater emphasis on more easily obtained information. The 1989 PELs were less significantly related to more costly information, contained "safety factors" for chemicals presenting relatively more ambiguous risks, and the proposed standard stringencies showed evidence of being influenced by vying industry and labor interests.

  11. [Medical fault or professional negligence? Case studies in two recovery nutrition centers in Niger].

    PubMed

    Halidou Doudou, M; Manzo, M L; Guero, D

    2014-12-01

    In developing countries such as Niger, the risk of medical malpractice is ubiquitous in health, jeopardizing patient safety. The aim of this work was to contribute to patients' safety and respect of code of ethics and conduct in the exercise of the medical profession. The reported cases involved two children under 5 years who were admitted to nutrition rehabilitation centers, died as a result of medical malpractice. In Niger, there are no statistics on this phenomenon and a few cases found have always been considered "accident" or "fate." The establishment of an observatory collections of such information should improve their frequency, consequences and propose a prevention plan. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  12. Safety practices in Jordanian manufacturing enterprises within industrial estates.

    PubMed

    Khrais, Samir; Al-Araidah, Omar; Aweisi, Assaf Mohammad; Elias, Fadia; Al-Ayyoub, Enas

    2013-01-01

    This paper investigates occupational health and safety practices in manufacturing enterprises within Jordanian industrial estates. Response rates were 21.9%, 58.6% and 70.8% for small, medium and large sized enterprises, respectively. Survey results show that most companies comply with state regulations, provide necessary facilities to enhance safety and provide several measures to limit and control hazards. On the negative side, little attention is given to safety training that might be due to the lack of related regulations and follow-up, financial limitations or lack of awareness on the importance of safety training. In addition, results show that ergonomic hazards, noise and hazardous chemicals are largely present. Accident statistics show that medium enterprises have the highest accident cases per enterprise, and chemical industries reported highest total number of accidents per enterprise. The outcomes of this study establish a base for appropriate safety recommendations to enhance the awareness and commitment of companies to appropriate safety rules.

  13. The occupational safety and health scorecard--a business case example for strategic management.

    PubMed

    Köper, Birgit; Möller, Klaus; Zwetsloot, Gerard

    2009-12-01

    Human resources and health issues are crucial in terms of corporate competitiveness. However, systematic, continuous and strategically aligned occupational safety and health (OSH) management is scarcely applied in companies. One major reason for this could be the lack of generally accepted and standardised OSH control methods. Our objective was thus to conceptualize a method by which qualitative factors such as human resources and OSH aspects contribute to the performance or value-added layer of an organization. We developed a business case based on the well-known and accepted Balanced Scorecard approach, which we adapted and applied to the management of OSH issues. The concept was implemented in the course of a comprehensive case study at a German automobile manufacturer. We gathered health as well as finance data in order to test which health-related indicators had an impact on financial performance. The demonstration of, and reporting on, how the promotion of workplace health contributes strategically to the organization is crucial for both health and human resource managers. Based on multivariate regression analyses, our main finding was that the Balanced Scorecard approach is an adequate means to control OSH issues in terms of strategic health management. Our analyses demonstrated that health-related interventions contribute significantly to performance aspects such as quality, productivity, absenteeism, and cost reduction. Therefore, the financial impact of health-related aspects / interventions could be demonstrated by means of the OSH scorecard. The availability and quality of health data within the context of overall corporate performance data needs to be improved in order to bridge OSH-related and performance issues of an organization.

  14. Donor Safety in Living Donor Liver Transplantation: A Single-Center Analysis of 300 Cases

    PubMed Central

    Lei, Jianyong; Yan, Lunan; Wang, Wentao

    2013-01-01

    Aim To evaluate the safety to donors of living-donor liver transplantation. Methods This study included 300 consecutive living liver tissue donors who underwent operations at our center from July 2002 to December 2012. We evaluated the safety of donors with regard to three aspects complications were recorded prospectively and stratified by grade according to Clavien’s classification, and the data were compared in two stages (the first 5 years’ experience (pre-January 2008) and the latter 5 years’ experience (post-January 2008); laboratory tests such as liver function and blood biochemistry were performed; and the health-related quality of life was evaluated. Results There was no donor mortality at our center, and the overall morbidity rate was 25.3%. Most of the complications of living donors were either grade I or II. There were significantly fewer complications in the latter period of our study than in the initial period (19.9% vs 32.6%, P<0.001), and biliary complications were the most common complications, with an incidence of 9%. All of the liver dysfunction was temporary; however, the post-operative suppression of platelet count lasted for years. Although within the normal range, eight years after operation, 22 donors showed lower platelet levels (189×109/L) compared with the pre-operative levels (267×109/L) (P<0.05). A total of 98.4% of donors had returned to their previous levels of social activity and work, and 99.2% of donors would donate again if it was required and feasible. With the exception of two donors who experienced grade III complications (whose recipients died) and a few cases of abdominal discomfort, fatigue, chronic pain and scar itching, none of the living donors were affected by physical problems. Conclusion With careful donor selection and specialized patient care, low morbidity rates and satisfactory long-term recovery can be achieved after hepatectomy for living-donor liver transplantation. PMID:23637904

  15. Donor safety in living donor liver transplantation: a single-center analysis of 300 cases.

    PubMed

    Lei, Jianyong; Yan, Lunan; Wang, Wentao

    2013-01-01

    To evaluate the safety to donors of living-donor liver transplantation. This study included 300 consecutive living liver tissue donors who underwent operations at our center from July 2002 to December 2012. We evaluated the safety of donors with regard to three aspects complications were recorded prospectively and stratified by grade according to Clavien's classification, and the data were compared in two stages (the first 5 years' experience (pre-January 2008) and the latter 5 years' experience (post-January 2008); laboratory tests such as liver function and blood biochemistry were performed; and the health-related quality of life was evaluated. There was no donor mortality at our center, and the overall morbidity rate was 25.3%. Most of the complications of living donors were either grade I or II. There were significantly fewer complications in the latter period of our study than in the initial period (19.9% vs 32.6%, P<0.001), and biliary complications were the most common complications, with an incidence of 9%. All of the liver dysfunction was temporary; however, the post-operative suppression of platelet count lasted for years. Although within the normal range, eight years after operation, 22 donors showed lower platelet levels (189 × 10(9)/L) compared with the pre-operative levels (267 × 10(9)/L) (P<0.05). A total of 98.4% of donors had returned to their previous levels of social activity and work, and 99.2% of donors would donate again if it was required and feasible. With the exception of two donors who experienced grade III complications (whose recipients died) and a few cases of abdominal discomfort, fatigue, chronic pain and scar itching, none of the living donors were affected by physical problems. With careful donor selection and specialized patient care, low morbidity rates and satisfactory long-term recovery can be achieved after hepatectomy for living-donor liver transplantation.

  16. 75 FR 42455 - Safety and Occupational Health Study Section: Notice of Charter Renewal

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-21

    ... Occupational Health Study Section: Notice of Charter Renewal This gives notice under the Federal Advisory Committee Act (Pub. L. 92-463) of October 6, 1972, that the Safety and Occupational Health Study Section... Secretary, Safety and Occupational Health Study Section, Department of Health and Human Services, 1600...

  17. 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.

  18. A prospective clinical study to evaluate the safety and performance of wireless localization of nonpalpable breast lesions using radiofrequency identification technology.

    PubMed

    Dauphine, Christine; Reicher, Joshua J; Reicher, Murray A; Gondusky, Christina; Khalkhali, Iraj; Kim, Michelle

    2015-06-01

    The purpose of this study was to evaluate the safety and performance of localizing nonpalpable breast lesions using radiofrequency identification technology. Twenty consecutive women requiring preoperative localization of a breast lesion were recruited. Subjects underwent placement of both a hook wire and a radiofrequency identification tag immediately before surgery. The radiofrequency identification tag was the primary method used by the operating surgeon to localize each lesion during excision, with the hook wire serving as backup in case of tag migration or failed localization. Successful localization with removal of the intended lesion was the primary outcome measured. Tag migration and postoperative infection were also noted to assess safety. Twenty patients underwent placement of a radiofrequency identification tag, 12 under ultrasound guidance and eight with stereotactic guidance. In all cases, the radiofrequency identification tag was successfully localized by the reader at the level of the skin before incision, and the intended lesion was removed along with the radiofrequency identification tag. There were no localization failures and no postoperative infections. Tag migration did not occur before incision, but in three cases, occurred as the lesion was being retracted with fingers to make the final cut along the deep surface of the specimen. In this initial clinical study, radiofrequency tags were safe and able to successfully localize nonpalpable breast lesions. Radiofrequency identification technology may represent an alternative method to hook wire localization.

  19. [Case Study] CityCenter and Cosmopolitan Construction Projects, Las Vegas, Nevada: lessons learned from the use of multiple sources and mixed methods in a safety needs assessment.

    PubMed

    Gittleman, Janie L; Gardner, Paige C; Haile, Elizabeth; Sampson, Julie M; Cigularov, Konstantin P; Ermann, Erica D; Stafford, Pete; Chen, Peter Y

    2010-06-01

    The present study describes a response to eight tragic deaths over an eighteen month times span on a fast track construction project on the largest commercial development project in U.S. history. Four versions of a survey were distributed to workers, foremen, superintendents, and senior management. In addition to standard Likert-scale safety climate scale items, an open-ended item was included at the end of the survey. Safety climate perceptions differed by job level. Specifically, management perceived a more positive safety climate as compared to workers. Content analysis of the open-ended item was used to identify important safety and health concerns which might have been overlooked with the qualitative portion of the survey. The surveys were conducted to understand workforce issues of concern with the aim of improving site safety conditions. Such efforts can require minimal investment of resources and time and result in critical feedback for developing interventions affecting organizational structure, management processes, and communication. The most important lesson learned was that gauging differences in perception about site safety can provide critical feedback at all levels of a construction organization. Implementation of multi-level organizational perception surveys can identify major safety issues of concern. Feedback, if acted upon, can potentially result in fewer injuries and fatal events. (c) 2010 Elsevier Ltd. All rights reserved.

  20. Consumer food handling in the home: a review of food safety studies.

    PubMed

    Redmond, Elizabeth C; Griffith, Christopher J

    2003-01-01

    Epidemiological data from Europe, North America, Australia, and New Zealand indicate that a substantial proportion of foodborne disease is attributable to improper food preparation practices in consumers' homes. International concern about consumer food safety has prompted considerable research to evaluate domestic food-handling practices. The majority of consumer food safety studies in the last decade have been conducted in the United Kingdom and Northern Ireland (48%) and in the United States (42%). Surveys (questionnaires and interviews), the most frequent means of data collection, were used in 75% of the reviewed studies. Focus groups and observational studies have also been used. One consumer food safety study examined the relationship between pathogenic microbial contamination from raw chicken and observed food-handling behaviors, and the results of this study indicated extensive Campylobacter cross-contamination during food preparation sessions. Limited information about consumers' attitudes and intentions with regard to safe food-handling behaviors has been obtained, although a substantial amount of information about consumer knowledge and self-reported practices is available. Observation studies suggest that substantial numbers of consumers frequently implement unsafe food-handling practices. Knowledge, attitudes, intentions, and self-reported practices did not correspond to observed behaviors, suggesting that observational studies provide a more realistic indication of the food hygiene actions actually used in domestic food preparation. An improvement in consumer food-handling behavior is likely to reduce the risk and incidence of foodborne disease. The need for the development and implementation of food safety education strategies to improve specific food safety behaviors is reviewed in this paper.