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

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.

The Unexpected Education: What We Can Learn from Disaster News Stories.

ERIC Educational Resources Information Center

Garner, Ana C.

A study explored the safety education provided by six newspapers, using the 1988 crash of Delta Flight 1141 as a case study. A total of 351 "Delta 1141" news stories were analyzed for five key areas: overall story category, passenger safety theme, flight personnel safety theme, plane safety theme, and rescue safety. Of the stories…

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.

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…

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.

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.

Berkeley Lab - Materials Sciences Division

Science.gov Websites

? Click Here! Resources for MSD Safety MSD Safety MSD's Integrated Safety Management Plan [PDF] Safety culture and policies at MSD MSD0010: Integrated Safety Management: Principles and Case Studies Calendar for MSD classes on Integrated Safety Management MSD0015 Handout - Waste Briefing Document [PDF] Waste

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.

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.

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 the same as the attributes of segments with multiple crashes. The results support the hypothesis that the "typical" case-control design may underestimate the safety effects of a given factor compared to methods that account for sites with multiple crashes. Compared to the first alternative case definition (where multiple crash segments represent multiple cases) the results from the "typical" case-control design are less pronounced (i.e., closer to unity). The second alternative (where case definitions are constructed for various crash categories and analyzed separately) provides further evidence that sites with single and multiple crashes should not be grouped together in a case-control analysis. This paper indicates a clear need to differentiate sites with single and multiple crashes in a case-control analysis. While the results suggest that sites with multiple crashes can be accounted for using a case-control design, further research is needed to determine the optimal method for addressing this issue. This paper provides a starting point for that research. Copyright © 2012 Elsevier Ltd. All rights reserved.

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

PubMed

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

2016-08-02

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

Prevalence of Post-tonsillectomy Bleeding as Day-case Surgery with Combination Method; Cold Dissection Tonsillectomy and Bipolar Diathermy Hemostasis

PubMed Central

Faramarzi, Abolahassan; Heydari, Seyed Taghi

2010-01-01

Objective Post-tonsillectomy hemorrhage remains an important factor in determining the safety of performing tonsillectomy as a day case procedure. The aim of this study was to determine the safety of day case tonsillectomy by using combination method, cold dissection tonsillectomy and bipolar diathermy hemostasis. Methods A prospective randomized clinical study conducted on the patients who had undergone day case tonsillectomy (DCT). There were two groups (DCT and control group) each group consisting of 150 cases. Tonsillectomy was performed by using combination method; cold dissection and hemostasis was achieved by ligation of vessels with bipolar electerocautery. Findings We found 3 cases of post-tonsillectomy bleeding in DCT group and 4 cases in the control group. There was no statistically significant difference in the rate of post-operative hemorrhage between the two groups. Conclusion The findings suggest the safety of the combination of cold dissection tonsillectomy and bipolar diathermy hemostasis as day case tonsillectomy. PMID:23056702

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...

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.

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.

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.

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.

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.

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;…

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.

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)

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

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.

[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.

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

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.

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.

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 operations. Such understanding will enable training of construction foremen and crews in these practices to systematically develop high reliability crews.

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.

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

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.

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.

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 records, and home safety assessments about use of safety gates; not leaving children, changing diapers, or putting children in car/bouncing seats on raised surfaces; allowing children to play or climb on furniture; and teaching children safety rules about climbing on objects.

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.

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,…

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,…

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

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.

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…

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

NASA Astrophysics Data System (ADS)

Tripathy, Debi Prasad; Ala, Charan Kumar

2018-04-01

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

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.

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 the extremely low possible exposures and the high NOAELs for these non-toxic proteins. This generalized approach to the safety assessment of highly purified food ingredients like sugar illustrates that sugar processed from Brazilian GM varieties are safe for consumption in representative markets globally.

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 potential and demonstrate the utilities of CBSAF and are not intended for thorough studies of collision avoidance and runway incursions safety, which are extremely challenging problems. Further development and thorough validations are required to allow CBSAF to reach implementation phases, e.g. addressing the issues of limited scalability and subjectivity.

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 recommended.

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 characteristics.

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…

[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.

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.

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.

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;…

National Transportation Safety Board Safety Study: Safety At Passive Grade Crossings. Volume 2: Case Summaries

DOT National Transportation Integrated Search

1998-07-07

More than 4,000 accidents have occurred at the nation's active and passive grade crossings each year from 1991 through 1996. Many of the accidents at active crossings have involved highway vehicle drivers who did not comply with train-activated warni...

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

PubMed

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

2016-08-03

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

Safety 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).

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.

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…

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 the usefulness of social media for safety surveillance.

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.

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.

A Review of Research on Procedures for Teaching Safety Skills to Persons with Developmental Disabilities

ERIC Educational Resources Information Center

Dixon, Dennis R.; Bergstrom, Ryan; Smith, Marlena N.; Tarbox, Jonathan

2010-01-01

Safety skills are an important but often neglected area of training for persons with developmental disabilities (DD). The present study reviewed the literature on teaching safety skills to persons with DD. Safety skills involve a variety of behaviors such as knowing how to cross the street or what to do in case of a house fire. A number of studies…

[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.

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.

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…

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.

[Results of a post-marketing surveillance of meropenem for febrile neutropenia].

PubMed

Wakisaka, Koji; Tani, Shunsuke; Ishibashi, Kazuo; Nukui, Kazuhiko; Nagao, Munehiko

2015-08-01

The post-marketing surveillance of meropenem (Meropen) for febrile neutropenia (FN) was conducted between July 2010 and June 2012 to evaluate safety and efficacy under actual clinical use. There were 1191 and 1124 evaluable cases for safety and efficacy respectively, of 1207 case cards collected from 180 institutions. In safety analysis, the incidence of adverse drug reactions (ADRs) associated with use of meropenem (including abnormal laboratory findings) was 15.7% (187/1191 cases), and the main ADRs were alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, hepatic function abnormal, and liver disorder, which were similar to these observed in the clinical study for FN or post marketing surveillances of meropenem conducted before. In efficacy analysis, the overall efficacy was 81.8% (919/1124 cases). Also, it was 79.2% (708/894 cases) for hematological malignancy and 91.8% (213/232 cases) for solid cancer. These results confirmed meropenem (Meropen) is one of the well-tolerated and potent antimicrobial agents for febrile neutropenia.

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.

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…

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 unsafe behaviors and significant increases in safe behaviors. The results of this case study showed that an approach based on goal setting, feedback, and an effective measure of safety behavior if properly applied by committed management, can improve safety performance significantly in construction site environments. The results proved that the BBS management technique can be applied to any country's culture, showing that it would be a good approach for improving the safety of front-line workers and that it has industry wide application for ongoing construction projects. Copyright © 2014 Elsevier Ltd. All rights reserved.

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.

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.

On the relationship between human papilloma virus vaccine and autoimmune diseases.

PubMed

Pellegrino, Paolo; Carnovale, Carla; Pozzi, Marco; Antoniazzi, Stefania; Perrone, Valentina; Salvati, Dionigi; Gentili, Marta; Brusadelli, Tatiana; Clementi, Emilio; Radice, Sonia

2014-07-01

The human papilloma virus (HPV) vaccines were introduced to reduce the incidence of cervical cancer. The bivalent vaccine is effective against HPV-16, -18, -31, -33 and -45 while the quadrivalent vaccine is effective against HPV-16, 18, 31, 6 and 11 types. The immunisation, recommended for adolescent females, has led to high vaccine coverage in many countries. Along with the introduction of the HPV vaccines, several cases of onset or exacerbations of autoimmune diseases following the vaccine shot have been reported in the literature and pharmacovigilance databases, triggering concerns about its safety. This vaccination programme, however, has been introduced in a population that is at high risk for the onset of autoimmune diseases, making it difficult to assess the role of HPV vaccine in these cases and no conclusive studies have been reported thus far. We have thus analysed and reviewed comprehensively all case reports and studies dealing with either the onset of an autoimmune disease in vaccinated subject or the safety in patients with autoimmune diseases to define the role of the HPV vaccines in these diseases and hence its safety. A solid evidence of causal relationship was provided in few cases in the examined studies, and the risk vs. benefit of vaccination is still to be solved. The on-going vigilance for the safety of this vaccine remains thus of paramount importance. Copyright © 2014 Elsevier B.V. All rights reserved.

Safety leadership and systems thinking: application and evaluation of a Risk Management Framework in the mining industry.

PubMed

Donovan, Sarah-Louise; Salmon, Paul M; Lenné, Michael G; Horberry, Tim

2017-10-01

Safety leadership is an important factor in supporting safety in high-risk industries. This article contends that applying systems-thinking methods to examine safety leadership can support improved learning from incidents. A case study analysis was undertaken of a large-scale mining landslide incident in which no injuries or fatalities were incurred. A multi-method approach was adopted, in which the Critical Decision Method, Rasmussen's Risk Management Framework and Accimap method were applied to examine the safety leadership decisions and actions which enabled the safe outcome. The approach enabled Rasmussen's predictions regarding safety and performance to be examined in the safety leadership context, with findings demonstrating the distribution of safety leadership across leader and system levels, and the presence of vertical integration as key to supporting the successful safety outcome. In doing so, the findings also demonstrate the usefulness of applying systems-thinking methods to examine and learn from incidents in terms of what 'went right'. The implications, including future research directions, are discussed. Practitioner Summary: This paper presents a case study analysis, in which systems-thinking methods are applied to the examination of safety leadership decisions and actions during a large-scale mining landslide incident. The findings establish safety leadership as a systems phenomenon, and furthermore, demonstrate the usefulness of applying systems-thinking methods to learn from incidents in terms of what 'went right'. Implications, including future research directions, are discussed.

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.

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).

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...

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...

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.

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.

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.

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…

Professional and Personal Qualities of the Teacher in the Context of the Psychological Safety of Educational Environment

ERIC Educational Resources Information Center

Kulikova, Tatyana I.; Maliy, Dmitriy V.

2017-01-01

The article deals with the phenomenon of psychological safety of the educational environment (PSEE) in the modern school. Indicators of the educational process participants' psychological safety are revealed. The notion of the teacher's preparedness for the designing activity is defined. The authors have conducted a case study revealing integrated…

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…

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...

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.

Effectiveness of safety belt usage laws

DOT National Transportation Integrated Search

1980-05-01

The study involved the collection of data from a target group of 21 countries around the world. These countries were contacted or visited to collect the necessary data. A case study was written for each country visited. These case studies, which are ...

Certifying Domain-Specific Policies

NASA Technical Reports Server (NTRS)

Lowry, Michael; Pressburger, Thomas; Rosu, Grigore; Koga, Dennis (Technical Monitor)

2001-01-01

Proof-checking code for compliance to safety policies potentially enables a product-oriented approach to certain aspects of software certification. To date, previous research has focused on generic, low-level programming-language properties such as memory type safety. In this paper we consider proof-checking higher-level domain -specific properties for compliance to safety policies. The paper first describes a framework related to abstract interpretation in which compliance to a class of certification policies can be efficiently calculated Membership equational logic is shown to provide a rich logic for carrying out such calculations, including partiality, for certification. The architecture for a domain-specific certifier is described, followed by an implemented case study. The case study considers consistency of abstract variable attributes in code that performs geometric calculations in Aerospace systems.

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.

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.

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.

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.

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.

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.

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.

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.

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)

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.

[Post-marketing surveillance on Guizhi Fuling Jiaonang based on literature review].

PubMed

Wang, Gui-Qian; Gao, Yang; Liu, Fu-Mei; Wei, Rui-Li; Xie, Yan-Ming

2018-02-01

To systemically evaluate the post-marketing safety of Guizhi Fuling Jiaonang. Computer retrieval was conducted in Medline, EMbase, the Web of Science, Clinical Trials. Gov, the Cochrane Library, CNKI, VIP, WanFang Data and CBM to collect relevant information. The papers were then screened according to inclusion and exclusion criteria. A total of 234 papers were included in this study, including 164 randomized controlled trials, 7 quasi-randomized controlled trials, 8 non-randomized controls, 56 case series, and 1 cohort study. The patients were only treated with Guizhi Fuling Jiaonang in 56 studies, and Guizhi Fuling Jiaonang was combined with other drugs in 178 studies. The total ADRs/AEs incidence was 1.99% in single use of Guizhi Fuling Jiaonang, and 8.21% in combined use, but showing no severe adverse reactions. Gastrointestinal system damage was most common in mild ADRs. In this study, it was found that the overall safety of Guizhi Fuling Jiaonang was acceptable. The direct evidences of the drug's safety case reports were systematically analyzed in this study, but the mechanism study on the safety of the drug after marketing or the prospective long-term clinical observation study was not sufficient, so the further studies on the safety of drug use should be conducted in order to provide better guidance for clinical medication. Copyright© by the Chinese Pharmaceutical Association.

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).

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 reserved. No commercial use is permitted unless otherwise expressly granted.

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

Using the electronic health record to build a culture of practice safety: evaluating the implementation of trigger tools in one general practice.

PubMed

Margham, Tom; Symes, Natalie; Hull, Sally A

2018-04-01

Identifying patients at risk of harm in general practice is challenging for busy clinicians. In UK primary care, trigger tools and case note reviews are mainly used to identify rates of harm in sample populations. This study explores how adaptions to existing trigger tool methodology can identify patient safety events and engage clinicians in ongoing reflective work around safety. Mixed-method quantitative and narrative evaluation using thematic analysis in a single East London training practice. The project team developed and tested five trigger searches, supported by Excel worksheets to guide the case review process. Project evaluation included summary statistics of completed worksheets and a qualitative review focused on ease of use, barriers to implementation, and perception of value to clinicians. Trigger searches identified 204 patients for GP review. Overall, 117 (57%) of cases were reviewed and 62 (53%) of these cases had patient safety events identified. These were usually incidents of omission, including failure to monitor or review. Key themes from interviews with practice members included the fact that GPs' work is generally reactive and GPs welcomed an approach that identified patients who were 'under the radar' of safety. All GPs expressed concern that the tool might identify too many patients at risk of harm, placing further demands on their time. Electronic trigger tools can identify patients for review in domains of clinical risk for primary care. The high yield of safety events engaged clinicians and provided validation of the need for routine safety checks. © British Journal of General Practice 2018.

The Impact of Patient Safety Training on Oral and Maxillofacial Surgery Residents' Attitudes and Knowledge: A Mixed Method Case Study

ERIC Educational Resources Information Center

Buhrow, Suzanne

2013-01-01

It is estimated that in the United States, more than 40,000 patients are injured each day because of preventable medical errors. Patient safety experts and graduate medical education accreditation leaders recognize that medical education reform must include the integration of safety training focused on error causation, system engineering, and…

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.

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...

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.

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.

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.

[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.

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.

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...

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.

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.

Financial Considerations for Health and Safety in the Australian Dairy Industry.

PubMed

Lower, Tony; Pollock, Kirrily

2017-01-01

This study aimed to quantify the burden of fatal and workers' compensation-related injuries on the dairy sector in Australia and to assess current financial inputs for work health and safety actions. The first and second phases entailed a review of the financial costs associated with fatal (2001-2013) and workers' compensation cases (2008-2009 to 2012-2013). The third element was a case-study approach focusing on actual production and cost data from a small sample of dairy farms (n = 6) to ascertain an estimate for current financial inputs to work health and safety. The estimated financial impact was approximately AUD$12.4 million each year, comprising AUD$6.8 million for fatalities and AUD$5.6 million for compensable injuries. All sample businesses were investing in health and safety initiatives; however, this was modest and on average represented 0.4% of total expenditure (AUD$4,472) or

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.

A systematic review of dermal fillers for age-related lines and wrinkles.

PubMed

Sturm, Lana P; Cooter, Rodney D; Mutimer, Keith L; Graham, John C; Maddern, Guy J

2011-01-01

Dermal fillers are gaining popularity for rapid aesthetic improvement. Long-term efficacy and safety have not been well documented. The aim of this systematic review was to assess the safety and efficacy of injectable dermal fillers compared with other facial augmentation techniques for the management of age-related lines and wrinkles. Studies including patients receiving injectable semi-permanent or permanent dermal fillers for age-related lines and wrinkles were included in this review. Efficacy outcomes (including changes in skin thickness and patient satisfaction) and safety outcomes (including mortality, lumps and infections) were examined. Three randomized control trials and six case series were included. Permanent and semi-permanent dermal fillers improved subjective ratings of appearance and resulted in higher patient satisfaction than temporary fillers. Long-term efficacy appeared good in the few studies that reported it. Short-term safety appeared favourable. Lumps were reported in all but one study but received little follow-up. Long-term safety data were limited. The treatment of age-related lines and wrinkles with permanent and semi-permanent dermal fillers is more efficacious compared with temporary fillers in those studies that compared them. Case series evidence suggests that these fillers achieve their objective, which is to decrease the visible effects of age-related changes. These fillers appear at least as safe as temporary fillers in the short term in those studies that compared them. Long-term safety could not be determined. © 2010 The Authors. ANZ Journal of Surgery © 2010 Royal Australasian College of Surgeons.

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.

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

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.

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.

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.

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.

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.

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.

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.

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...

Metropolitan transportation management center : a case study : Michigan intelligent transportation system : improving safety and air quality while reducing stress for motorists

DOT National Transportation Integrated Search

1999-10-01

The following case study provides a snapshot of Michigan's Intelligent Transportation Systems transportation management center (MITSC). It follows the outline provided in the companion document, Metropolitan Transportation Management Center Concepts ...

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...

Analysis of Industry Responses to Federal Regulations in Safety Requirements for New Automobiles

DOT National Transportation Integrated Search

1978-03-01

This report presents findings of an initial study of how the automobile industry has responded to the promulgation of motor vehicle standards by the U.S. goverment. The report examines three safety standards as evaluative cases: MVS 203--Steering col...

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…

An analysis of dental patient safety incidents in a patient complaint and healthcare supervisory database in Finland.

PubMed

Hiivala, Nora; Mussalo-Rauhamaa, Helena; Tefke, Hanna-Leena; Murtomaa, Heikki

2016-01-01

Few studies of patient harm and harm-prevention methods in dentistry exist. This study aimed to identify and characterize dental patient safety incidents (PSIs) in a national sample of closed dental cases reported to the Regional State Administrative Agencies (AVIs) and the National Supervisory Authority for Welfare and Health (Valvira) in Finland. The sample included all available fully resolved dental cases (n = 948) during 2000-2012 (initiated by the end of 2011). Cases included both patient and next of kin complaints and notifications from other authorities, employers, pharmacies, etc. The cases analyzed concerned both public and private dentistry and included incident reports lodged against dentists and other dental-care professionals. Data also include the most severe cases since these are reported to Valvira. PSIs were categorized according to common incident types and preventability and severity assessments were based on expert opinions in the decisions from closed cases. Most alleged PSIs were proven valid and evaluated as potentially preventable. PSIs were most often related to different dental treatment procedures or diagnostics. More than half of all PSIs were assessed as severe, posing severe risk or as causing permanent or long-lasting harm to patients. The risk for PSI was highest among male general dental practitioners with recurring complaints and notifications. Despite some limitations, this register-based study identifies new perspectives on improving safety in dental care. Many PSIs could be prevented through the proper and more systematic use of already available error-prevention methods.

Coagulopathy induced by saw palmetto: a case report.

PubMed

Villanueva, Salvador; González, Jenniffer

2009-01-01

Saw palmetto is the most popular herbal supplement used to treat symptoms of benign prostatic hyperplasia (BPH). The safety and efficacy of saw palmetto has been established in the literature. While the majority of studies document the efficacy and safety of saw palmetto, some studies document the adverse side effects, including increased risk of bleeding. There are no reports in the literature about increased prothombin time (PT), partial thromboplastin time (PTT) or international normalized ratio (INR) while using saw palmetto. We present a case of hematuria and coagulopathy in a patient who was using saw palmetto.

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.

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

NASA Astrophysics Data System (ADS)

Du, Xiaorong

2017-04-01

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

Verification and Validation in a Rapid Software Development Process

NASA Technical Reports Server (NTRS)

Callahan, John R.; Easterbrook, Steve M.

1997-01-01

The high cost of software production is driving development organizations to adopt more automated design and analysis methods such as rapid prototyping, computer-aided software engineering (CASE) tools, and high-level code generators. Even developers of safety-critical software system have adopted many of these new methods while striving to achieve high levels Of quality and reliability. While these new methods may enhance productivity and quality in many cases, we examine some of the risks involved in the use of new methods in safety-critical contexts. We examine a case study involving the use of a CASE tool that automatically generates code from high-level system designs. We show that while high-level testing on the system structure is highly desirable, significant risks exist in the automatically generated code and in re-validating releases of the generated code after subsequent design changes. We identify these risks and suggest process improvements that retain the advantages of rapid, automated development methods within the quality and reliability contexts of safety-critical projects.

Trivalent inactivated influenza vaccine is not associated with sickle cell crises in children.

PubMed

Hambidge, Simon J; Ross, Colleen; Glanz, Jason; McClure, David; Daley, Matthew F; Xu, Stan; Shoup, Jo Ann; Narwaney, Komal; Baggs, James; Weintraub, Eric

2012-01-01

Children with sickle cell disease are considered at high risk for complications from influenza infection and are recommended to receive annual influenza vaccination. However, data on the safety of influenza vaccination in children with sickle cell anemia are sparse. Using a retrospective cohort of children aged 6 months to 17 years in 8 managed care organizations that comprise the Vaccine Safety Datalink and who had a diagnosis of sickle cell anemia from 1999 to 2006, we conducted matched case-control and self-controlled case series studies to examine the association of trivalent inactivated influenza vaccination with hospitalization for sickle cell crisis in the 2 weeks after vaccination. From an original pool of 1085 pediatric subjects with a diagnosis of sickle cell anemia, we identified 179 children with at least 1 sickle cell crisis during any influenza season (October 1-March 31). In the matched case-control study (matching on age category, gender, Vaccine Safety Datalink site, and season), the odds ratio of hospitalization for a crisis in vaccinated compared with unvaccinated children was not significant: 1.3 (95% confidence interval 0.8-2.2). In the self-controlled case series study of hospitalized cases, the incident rate ratio for hospitalization with sickle cell crisis in the 2 weeks after trivalent inactivated influenza vaccination was also not significant: 1.2 (95% confidence interval 0.75-1.95). This large cohort study did not find an association of influenza vaccination and hospitalization for sickle cell crises in children with sickle cell anemia.

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.

Office-Based Anesthesia: Safety and Outcomes in Pediatric Dental Patients

PubMed Central

Spera, Allison L.; Saxen, Mark A.; Yepes, Juan F.; Jones, James E.; Sanders, Brian J.

2017-01-01

The number of children with caries requiring general anesthesia to achieve comprehensive dental care and the demand for dentist anesthesiologists to provide ambulatory anesthesia for these patients is increasing. No current published studies examine the safety and outcomes of ambulatory anesthesia performed by dentist anesthesiologists for dental procedures in pediatric patients, and there is no national requirement for reporting outcomes of these procedures. In 2010, the Society for Ambulatory Anesthesia Clinical Outcomes Registry was developed. This Web-based database allows providers of ambulatory anesthesia to track patient demographics and various outcomes of procedures. Our study is a secondary analysis of data collected in the registry over a 4-year period, 2010–2014. Of the 7041 cases reviewed, no cases resulted in serious complications, including death, anaphylaxis, aspiration, cardiovascular adverse events, or neurologic adverse events. Of the 7041 cases reviewed, 196 (3.0%) resulted in a predischarge or postdischarge adverse event. The predischarge adverse event occurring with the highest frequency was laryngospasm, occurring in 35 cases (0.50%). The postdischarge adverse event occurring with the highest frequency was nausea, reported by 99 patients (5.0%). This study provides strong clinical outcomes data to support the safety of office-based anesthesia as performed by dentist anesthesiologists in the treatment of pediatric dental patients. PMID:28858554

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.

Office-Based Anesthesia: Safety and Outcomes in Pediatric Dental Patients.

PubMed

Spera, Allison L; Saxen, Mark A; Yepes, Juan F; Jones, James E; Sanders, Brian J

The number of children with caries requiring general anesthesia to achieve comprehensive dental care and the demand for dentist anesthesiologists to provide ambulatory anesthesia for these patients is increasing. No current published studies examine the safety and outcomes of ambulatory anesthesia performed by dentist anesthesiologists for dental procedures in pediatric patients, and there is no national requirement for reporting outcomes of these procedures. In 2010, the Society for Ambulatory Anesthesia Clinical Outcomes Registry was developed. This Web-based database allows providers of ambulatory anesthesia to track patient demographics and various outcomes of procedures. Our study is a secondary analysis of data collected in the registry over a 4-year period, 2010-2014. Of the 7041 cases reviewed, no cases resulted in serious complications, including death, anaphylaxis, aspiration, cardiovascular adverse events, or neurologic adverse events. Of the 7041 cases reviewed, 196 (3.0%) resulted in a predischarge or postdischarge adverse event. The predischarge adverse event occurring with the highest frequency was laryngospasm, occurring in 35 cases (0.50%). The postdischarge adverse event occurring with the highest frequency was nausea, reported by 99 patients (5.0%). This study provides strong clinical outcomes data to support the safety of office-based anesthesia as performed by dentist anesthesiologists in the treatment of pediatric dental patients.

Alcohol abuse and traffic safety : a study of fatalities, DWI offenders, alcoholics, and court-related treatment approaches

DOT National Transportation Integrated Search

1970-06-26

Author's abstract: Methodology and conclusions on the role of the abusive use of alcohol in traffic safety were developed through three related projects. Project I is a case-history investigation of 616 traffic fatalities from metropolitan Wayne Coun...

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.

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.

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

PubMed Central

Cunningham, Thomas R.; Sinclair, Raymond

2015-01-01

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

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

PubMed

Cunningham, Thomas R; Sinclair, Raymond

2015-01-01

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

Discovering Innovation at the Intersection of Undergraduate Medical Education, Human Factors, and Collaboration: The Development of a Nasogastric Tube Safety Pack.

PubMed

Taylor, Natalie; Bamford, Thomas; Haindl, Cornelia; Cracknell, Alison

2016-04-01

Significant deficiencies exist in the knowledge and skills of medical students and residents around health care quality and safety. The theory and practice of quality and safety should be embedded into undergraduate medical practice so that health care professionals are capable of developing interventions and innovations to effectively anticipate and mitigate errors. Since 2011, Leeds Medical School in the United Kingdom has used case study examples of nasogastric (NG) tube patient safety incidents within the undergraduate patient safety curriculum. In 2012, a medical undergraduate student approached a clinician with an innovative idea after undertaking an NG tubes root cause analysis case study. Simultaneously, a separate local project demonstrated low compliance (11.6%) with the United Kingdom's National Patient Safety Agency NG tubes guideline for use of the correct method to check tube position. These separate endeavors led to interdisciplinary collaboration between a medical student, health care professionals, researchers, and industry to develop the Initial Placement Nasogastric Tube Safety Pack. Human factors engineering was used to inform pack design to allow guideline recommendations to be accessible and easy to follow. A timeline of product development, mapped against key human factors and medical device design principles used throughout the process, is presented. The safety pack has since been launched in five UK National Health Service (NHS) hospitals, and the pack has been introduced into health care professional staff training for NG tubes. A mixed-methods evaluation is currently under way in five NHS organizations.

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.

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.

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.

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.

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…

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…

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.

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/

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

Managing pedestrian safety II : A case-control study of collision locations on state routes in King County and Seattle, Washington

DOT National Transportation Integrated Search

2008-01-01

The safety of non-motorized transportation systems is essential to the public acceptance and overall success of Washington State's and local jurisdictions' efforts to reduce congestion. The State's and the jurisdictions' goals to increase non-SOV (si...

Improving Safety of the Surface Transportation System by Addressing the Issues of Vulnerable Road Users : Case of the Motorcyclists

DOT National Transportation Integrated Search

2012-07-01

Over the past few years, motorcycle fatalities have increased at an alarming rate in the United States. Motorcycle safety issues in Kansas : are no different from the national scenario. Accordingly, this study examines motorcycle crashes in Kansas in...

What To Do When OSHA Comes Calling.

ERIC Educational Resources Information Center

Barber, Charles K.

This booklet explains the actions that college or university administrators should take if their institution is subject to an inspection by the Occupational Safety and Health Administration (OSHA) for possible health or safety violations. After providing a fictional case study and an explanation of the OSHA inspection process, the booklet reviews…

Perception of School Safety of a Local School

ERIC Educational Resources Information Center

Massey-Jones, Darla

2013-01-01

This qualitative case study investigated the perception of school safety, what current policies and procedures were effective, and what policies and procedures should be implemented. Data were collected in two steps, by survey and focus group interview. Analysis determined codes that revealed several themes relevant to the perception of school…

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…

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

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 important role of cycle tracks and the factors that increase or decrease cyclist safety. Results need however to be confirmed using longer periods of video data. Copyright © 2015 Elsevier Ltd. All rights reserved.

MANAGING UNCERTAINTIES ASSOCIATED WITH RADIOACTIVE WASTE DISPOSAL: TASK GROUP 4 OF THE IAEA PRISM PROJECT

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

Seitz, R.

2011-03-02

It is widely recognized that the results of safety assessment calculations provide an important contribution to the safety arguments for a disposal facility, but cannot in themselves adequately demonstrate the safety of the disposal system. The safety assessment and a broader range of arguments and activities need to be considered holistically to justify radioactive waste disposal at any particular site. Many programs are therefore moving towards the production of what has become known as a Safety Case, which includes all of the different activities that are conducted to demonstrate the safety of a disposal concept. Recognizing the growing interest inmore » the concept of a Safety Case, the International Atomic Energy Agency (IAEA) is undertaking an intercomparison and harmonization project called PRISM (Practical Illustration and use of the Safety Case Concept in the Management of Near-surface Disposal). The PRISM project is organized into four Task Groups that address key aspects of the Safety Case concept: Task Group 1 - Understanding the Safety Case; Task Group 2 - Disposal facility design; Task Group 3 - Managing waste acceptance; and Task Group 4 - Managing uncertainty. This paper addresses the work of Task Group 4, which is investigating approaches for managing the uncertainties associated with near-surface disposal of radioactive waste and their consideration in the context of the Safety Case. Emphasis is placed on identifying a wide variety of approaches that can and have been used to manage different types of uncertainties, especially non-quantitative approaches that have not received as much attention in previous IAEA projects. This paper includes discussions of the current results of work on the task on managing uncertainty, including: the different circumstances being considered, the sources/types of uncertainties being addressed and some initial proposals for approaches that can be used to manage different types of uncertainties.« less

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.

An investigation into drug products withdrawn from the EU market between 2002 and 2011 for safety reasons and the evidence used to support the decision-making.

PubMed

McNaughton, Rhian; Huet, Gwenaël; Shakir, Saad

2014-01-15

The objective of this study was to determine the nature of evidence used to support the withdrawal of marketing authorisations of drug products for safety reasons throughout the European Union (EU) between 2002 and 2011. Products withdrawn, either by a medicines agency or a marketing authorisation holder, during the period 2002-2011 were identified by conducting detailed searches of the WHO, the European Medicines Agency (EMA) and national medicines agency websites throughout the EU plus Norway, Iceland and Liechtenstein. The scientific evidence used to support the decision was identified from a search within PubMed, the EMA and national medicines agencies websites. Information about spontaneous case reports entered into EudraVigilance and unavailable on the EMA website was received by email from the EMA. 19 drugs were withdrawn from the market, throughout the EU, for safety reasons from 2002 to 2011. Case reports were cited in 95% of withdrawals (18/19) and case-control studies (4/19), cohort studies (4/19), randomised controlled trials (RCTs) (12/19) or meta-analysis (5/19) were cited in 63% of withdrawals (12/19). Cardiovascular events or disorders were the main reason for withdrawal (9/19), followed by hepatic disorders (4/19) and neurological or psychiatric disorders (4/19). This study has shown that the level of evidence used to support drug withdrawal has improved during the past 10 years, with an increased use of case-control studies, cohort studies, RCTs and meta-analyses. This research has demonstrated that such studies have contributed to decision-making in almost two-thirds of cases.

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.

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.

Best practices for health and safety technology transfer in construction.

PubMed

Welch, Laura S; Russell, Dustin; Weinstock, Deborah; Betit, Eileen

2015-08-01

Construction continues to be a dangerous industry, yet solutions that would prevent injury and illness do exist. Prevention of injury and illness among construction workers requires dissemination, adoption, and implementation of these effective interventions, or "research to practice" (r2p). CPWR recruited participants with experience and insight into effective methods for diffusion of health and safety technologies in this industry for a symposium with 3 group sessions and 3 breakout groups. The organizers reviewed session notes and identified 141 recommendations, which were then assigned to 13 over-arching themes. Recommendations included a guide for researchers on patenting and licensing, a business case model, and in-depth case studies including development, testing, manufacturing, marketing, and diffusion. A more comprehensive understanding of the health and safety technology transfer landscape, the various actors, and their motivators and goals will help to foster the successful commercialization and diffusion of health and safety innovations. © 2015 Wiley Periodicals, Inc.

Attributing Responsibility for Child Maltreatment when Domestic Violence Is Present

ERIC Educational Resources Information Center

Landsman, Miriam J.; Hartley, Carolyn Copps

2007-01-01

Objective: The purpose of this study was to examine factors that influence how child welfare workers attribute responsibility for child maltreatment and child safety in cases involving domestic violence. Methods: The study used a factorial survey approach, combining elements of survey research with an experimental design. Case vignettes were…

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.

Patient safety in nursing education: contexts, tensions and feeling safe to learn.

PubMed

Steven, Alison; Magnusson, Carin; Smith, Pam; Pearson, Pauline H

2014-02-01

Education is crucial to how nurses practice, talk and write about keeping patients safe. The aim of this multisite study was to explore the formal and informal ways the pre-registration medical, nursing, pharmacy and physiotherapy students learn about patient safety. This paper focuses on findings from nursing. A multi-method design underpinned by the concept of knowledge contexts and illuminative evaluation was employed. Scoping of nursing curricula from four UK university programmes was followed by in-depth case studies of two programmes. Scoping involved analysing curriculum documents and interviews with 8 programme leaders. Case-study data collection included focus groups (24 students, 12 qualified nurses, 6 service users); practice placement observation (4 episodes=19 hrs) and interviews (4 Health Service managers). Within academic contexts patient safety was not visible as a curricular theme: programme leaders struggled to define it and some felt labelling to be problematic. Litigation and the risk of losing authorisation to practise were drivers to update safety in the programmes. Students reported being taught idealised skills in university with an emphasis on 'what not to do'. In organisational contexts patient safety was conceptualised as a complicated problem, addressed via strategies, systems and procedures. A tension emerged between creating a 'no blame' culture and performance management. Few formal mechanisms appeared to exist for students to learn about organisational systems and procedures. In practice, students learnt by observing staff who acted as variable role models; challenging practice was problematic, since they needed to 'fit in' and mentors were viewed as deciding whether they passed or failed their placements. The study highlights tensions both between and across contexts, which link to formal and informal patient safety education and impact negatively on students' feelings of emotional safety in their learning. Copyright © 2014 Elsevier Ltd. All rights reserved.

Beyond the cold hit: measuring the impact of the national DNA data bank on public safety at the city and county level.

PubMed

Gabriel, Matthew; Boland, Cherisse; Holt, Cydne

2010-01-01

Over the past decade, the Combined DNA Index System (CODIS) has increased solvability of violent crimes by linking evidence DNA profiles to known offenders. At present, an in-depth analysis of the United States National DNA Data Bank effort has not assessed the success of this national public safety endeavor. Critics of this effort often focus on laboratory and police investigators unable to provide timely investigative support as a root cause(s) of CODIS' failure to increase public safety. By studying a group of nearly 200 DNA cold hits obtained in SFPD criminal investigations from 2001-2006, three key performance metrics (Significance of Cold Hits, Case Progression & Judicial Resolution, and Potential Reduction of Future Criminal Activity) provide a proper context in which to define the impact of CODIS at the City and County level. Further, the analysis of a recidivist group of cold hit offenders and their past interaction with law enforcement established five noteworthy criminal case resolution trends; these trends signify challenges to CODIS in achieving meaningful case resolutions. CODIS' effectiveness and critical activities to support case resolutions are the responsibility of all criminal justice partners in order to achieve long-lasting public safety within the United States.

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/.

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

Bisphosphonates and Nonhealing Femoral Fractures: Analysis of the FDA Adverse Event Reporting System (FAERS) and International Safety Efforts

PubMed Central

Edwards, Beatrice J.; Bunta, Andrew D.; Lane, Joseph; Odvina, Clarita; Rao, D. Sudhaker; Raisch, Dennis W.; McKoy, June M.; Omar, Imran; Belknap, Steven M.; Garg, Vishvas; Hahr, Allison J.; Samaras, Athena T.; Fisher, Matthew J.; West, Dennis P.; Langman, Craig B.; Stern, Paula H.

2013-01-01

Background: In the United States, hip fracture rates have declined by 30% coincident with bisphosphonate use. However, bisphosphonates are associated with sporadic cases of atypical femoral fracture. Atypical femoral fractures are usually atraumatic, may be bilateral, are occasionally preceded by prodromal thigh pain, and may have delayed fracture-healing. This study assessed the occurrence of bisphosphonate-associated nonhealing femoral fractures through a review of data from the U.S. FDA (Food and Drug Administration) Adverse Event Reporting System (FAERS) (1996 to 2011), published case reports, and international safety efforts. Methods: We analyzed the FAERS database with use of the proportional reporting ratio (PRR) and empiric Bayesian geometric mean (EBGM) techniques to assess whether a safety signal existed. Additionally, we conducted a systematic literature review (1990 to February 2012). Results: The analysis of the FAERS database indicated a PRR of 4.51 (95% confidence interval [CI], 3.44 to 5.92) for bisphosphonate use and nonhealing femoral fractures. Most cases (n = 317) were attributed to use of alendronate (PRR = 3.32; 95% CI, 2.71 to 4.17). In 2008, international safety agencies issued warnings and required label changes. In 2010, the FDA issued a safety notification, and the American Society for Bone and Mineral Research (ASBMR) issued recommendations about bisphosphonate-associated atypical femoral fractures. Conclusions: Nonhealing femoral fractures are unusual adverse drug reactions associated with bisphosphonate use, as up to 26% of published cases of atypical femoral fractures exhibited delayed healing or nonhealing. PMID:23426763

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

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.

Safety Profile of Biologic Drugs in the Therapy of Ulcerative Colitis: A Systematic Review and Network Meta-Analysis.

PubMed

Moćko, Paweł; Kawalec, Paweł; Pilc, Andrzej

2016-08-01

We compared the safety profile of biologic drugs in patients with moderately to severely active ulcerative colitis (UC). A systematic literature search was performed using Medline (PubMed), Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) databases through February 9, 2016. We included randomized controlled trials (RCTs) that compared the safety of biologic drugs (infliximab, adalimumab, golimumab, and vedolizumab) with one another or with placebo in patients with UC. Two reviewers independently conducted the search and selection of studies and rated the risk of bias in each trial. The network meta-analysis (NMA) was conducted for an induction phase (6-8 weeks) and maintenance phase (52-54 weeks) with a Bayesian hierarchical random effects model in Aggregate Data Drug Information System (ADDIS) software. The PROSPERO registration number was CRD42016032607. Seven RCTs were included in the systematic review with NMA. In the case of the induction phase, the NMA could be conducted for the assessment of the relative safety profile of adalimumab, golimumab, and vedolizumab, and in the case of the maintenance phase of infliximab, adalimumab, golimumab, and vedolizumab. The methodological quality of the included RCTs was evaluated as low risk of bias, but high risk of bias in the case of attrition bias (incomplete outcome data) according to the Cochrane criteria. No significant differences were found in the rate of adverse events in patients treated with the reviewed biologics. Vedolizumab was most likely to have the most favorable safety profile in the induction phase as was infliximab for the maintenance phase. The assessment of the relative safety profile revealed no significant differences between the biologic drugs. Further studies are needed to confirm our findings including head-to-head comparisons between the analyzed biologics. © 2016 Pharmacotherapy Publications, Inc.

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...

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

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.

Improving Performance of the System Safety Function at Marshall Space Flight Center

NASA Technical Reports Server (NTRS)

Kiessling, Ed; Tippett, Donald D.; Shivers, Herb

2004-01-01

The Columbia Accident Investigation Board (CAIB) determined that organizational and management issues were significant contributors to the loss of Space Shuttle Columbia. In addition, the CAIB observed similarities between the organizational and management climate that preceded the Challenger accident and the climate that preceded the Columbia accident. To prevent recurrence of adverse organizational and management climates, effective implementation of the system safety function is suggested. Attributes of an effective system safety program are presented. The Marshall Space Flight Center (MSFC) system safety program is analyzed using the attributes. Conclusions and recommendations for improving the MSFC system safety program are offered in this case study.

Post-marketing safety monitoring of shenqifuzheng injection: a solution made of dangshen (Radix Codonopsis) and huangqi (Radix Astragali Mongolici).

PubMed

Ai, Qinghua; Zhang, Wen; Xie, Yanming; Huang, Wenhua; Liang, Hong; Cao, Hui

2014-08-01

To identify the potential risk factors associated with Shenqifuzheng injection (SFI), a solution made of Dangshen (Radix Codonopsis) and Huangqi (Radix Astragali Mongolici), for the timely provision of information to regulatory authorities. A comprehensive analysis of the production process, quality standards, pharmacology, post-marketing clinical studies, and safety evaluation using the primary literature of adverse reactions (ADR), case analyses, and systematic reviews, intensive hospital safety monitoring of post-marketing drugs, and data provided by the hospital information system (HIS). Sub-acute toxicity tests suggesting that a dose of 15 mL/kg (concentrated solution) had specific biological effects, whereas a smaller dose engendered no observable effects. Long-term toxicity testing in domestic rabbits showed that after SFI was administered for 90 days, the animals in each dosing group showed no chronic toxic reactions. Among 20 100 cases observed, the incidence of an ADR was 1.85 per thousand. From March to November 2013, of the leading institutions and 22 sub-centers involved in the post-marketing clinical safety intensive hospital monitoring, 21 units completed 8484 cases of monitoring, and reported 23 cases of adverse reactions. No damage to renal function was found using SFI at a dosage and a treatment course larger and longer than that recommended for the adjuvant treatment of tumors. This could reduce the mortality rate of admitted patients based on the analysis of the data provided by the HIS. A total of 16 clinical case reports of adverse reactions related to SFI in 1999-2012 were obtained through literature retrieval. These reports contained information concerning 17 cases, with adverse reaction symptoms including thrombocytopenia, rash, chills, feeling cold, palpitation, dyspnea, edema of a lower extremity, palpebral edema, and superficial vein inflammation, among others. This study introduces "get full access" to the flow of information on medicines regarding their ADR incidence rate and characteristics and factors. It supports the safety of SFI for clinical, research,and production uses based on objective, reliable, and scientific information to provide safe medication.

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

Relating safety, productivity and company type for motor-manual logging operations in the Italian Alps.

PubMed

Montorselli, Niccolò Brachetti; Lombardini, Carolina; Magagnotti, Natascia; Marchi, Enrico; Neri, Francesco; Picchi, Gianni; Spinelli, Raffaele

2010-11-01

The study compared the performance of four different logging crews with respect to productivity, organization and safety. To this purpose, the authors developed a data collection method capable of providing a quantitative analysis of risk-taking behavior. Four crews were tested under the same working conditions, representative of close-to-nature alpine forestry. Motor-manual working methods were applied, since these methods are still prevalent in the specific study area, despite the growing popularity of mechanical processors. Crews from public companies showed a significantly lower frequency of risk-taking behavior. The best safety performance was offered by the only (public) crew that had been administered formal safety training. The study seems to deny the common prejudice that safety practice is inversely proportional to productivity. Instead, productivity is increased by introducing more efficient working methods and equipment. The quantitative analysis of risk-taking behavior developed in this study can be applied to a number of industrial fields besides forestry. Characterizing risk-taking behavior for a given case may eventually lead to the development of custom-made training programmes, which may address problem areas while avoiding that the message is weakened by the inclusion of redundant information. In the specific case of logging crews in the central Alps, the study suggests that current training courses may be weak on ergonomics, and advocates a staged training programme, focusing first on accident reduction and then expanding to the prevention of chronic illness. 2010 Elsevier Ltd. All rights reserved.

Impact of energy sector growth on perceived transportation safety in the seventeen-county oil region of western North Dakota : a three-year case study, [project brief].

DOT National Transportation Integrated Search

2015-10-01

Traffic safety in western North Dakotas oil-producing counties has changed significantly since the : latest oil boom beginning in 2004. A survey measured local residents perceptions and crash data : validated these perceptions of dangerous driv...

Safety and Security in Schools in KwaZulu-Natal

ERIC Educational Resources Information Center

White, C. J.; Gina, J. M.; Coetzee, I. E. M.

2015-01-01

This article is based on research conducted on the topic: "Safety and security in schools: The case of KwaZulu-Natal." For the research project a purposive sample consisting of secondary school learners, teachers, school governing body chairpersons and principals were selected from the rural and township schools used in this study to…

Clinical governance breakdown: Australian cases of wilful blindness and whistleblowing.

PubMed

Cleary, Sonja; Duke, Maxine

2017-01-01

After their attempts to have patient safety concerns addressed internally were ignored by wilfully blind managers, nurses from Bundaberg Base Hospital and Macarthur Health Service felt compelled to 'blow the whistle'. Wilful blindness is the human desire to prefer ignorance to knowledge; the responsibility to be informed is shirked. To provide an account of instances of wilful blindness identified in two high-profile cases of nurse whistleblowing in Australia. Critical case study methodology using Fay's Critical Social Theory to examine, analyse and interpret existing data generated by the Commissions of Inquiry held into Bundaberg Base Hospital and Macarthur Health Service patient safety breaches. All data was publicly available and assessed according to the requirements of unobtrusive research methods and secondary data analysis. Ethical considerations: Data collection for the case studies relied entirely on publicly available documentary sources recounting and detailing past events. Data from both cases reveal managers demonstrating wilful blindness towards patient safety concerns. Concerns were unaddressed; nurses, instead, experienced retaliatory responses leading to a 'social crisis' in the organisation and to whistleblowing. Managers tasked with clinical governance must be aware of mechanisms with the potential to blind them. The human tendency to favour positive news and avoid conflict is powerful. Understanding wilful blindness can assist managers' awareness of the competing emotions occurring in response to ethical challenges, such as whistleblowing.

Safety in out-of-hours operating in trauma and orthopaedics at a district general hospital.

PubMed

Gulamhussein, M A; Chaudhry, S; Noor, S; Chaudhry, T; Guha, A; Knebel, R

2017-05-01

INTRODUCTION According to the National Confidential Enquiry into Perioperative Deaths (NCEPOD), out-of-hours operating in trauma and orthopaedics should be reserved for life or limb threatening cases only. The aim of our study was to determine the nature of non-emergency work carried out in our trust at night in 2015. The overall efficacy and clinical safety of the services provided was evaluated. METHODS Surgical activity undertaken after 9pm was reviewed along with patient ASA (American Society of Anesthesiologists) grade, grade of operating surgeon and any complications that occurred following the procedure. Furthermore, the clinical urgency and safety of cases was assessed based on whether there was any record of life or limb threatening indications at the time of admission. RESULTS Overall, 131 procedures were performed after 9pm, with 102 performed between 9pm and midnight, and 29 after midnight. Consultants performed 16 cases and the remaining 115 cases were operated on by middle grades or specialty trainees. A fifth (20%) of the cases were genuinely life or limb threatening. A total of 123 procedures were classed as having good outcomes. The complication rate was 8%. CONCLUSIONS In our study, 80% of the procedures performed after 9pm could not be categorised as life or limb threatening. Appropriate NCEPOD classification would ensure that only life or limb threatening cases were listed for theatre after 9pm. Alternative methods of operating within working hours should be considered.

Safety in out-of-hours operating in trauma and orthopaedics at a district general hospital

PubMed Central

Chaudhry, S; Noor, S; Chaudhry, T; Guha, A; Knebel, R

2017-01-01

INTRODUCTION According to the National Confidential Enquiry into Perioperative Deaths (NCEPOD), out-of-hours operating in trauma and orthopaedics should be reserved for life or limb threatening cases only. The aim of our study was to determine the nature of non-emergency work carried out in our trust at night in 2015. The overall efficacy and clinical safety of the services provided was evaluated. METHODS Surgical activity undertaken after 9pm was reviewed along with patient ASA (American Society of Anesthesiologists) grade, grade of operating surgeon and any complications that occurred following the procedure. Furthermore, the clinical urgency and safety of cases was assessed based on whether there was any record of life or limb threatening indications at the time of admission. RESULTS Overall, 131 procedures were performed after 9pm, with 102 performed between 9pm and midnight, and 29 after midnight. Consultants performed 16 cases and the remaining 115 cases were operated on by middle grades or specialty trainees. A fifth (20%) of the cases were genuinely life or limb threatening. A total of 123 procedures were classed as having good outcomes. The complication rate was 8%. CONCLUSIONS In our study, 80% of the procedures performed after 9pm could not be categorised as life or limb threatening. Appropriate CEPOD classification would ensure that only life or limb threatening cases were listed for theatre after 9pm. Alternative methods of operating within working hours should be considered. PMID:27917666

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.

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.

Facilitators and barriers for the adoption, implementation and monitoring of child safety interventions: a multinational qualitative analysis.

PubMed

Scholtes, Beatrice; Schröder-Bäck, Peter; MacKay, J Morag; Vincenten, Joanne; Förster, Katharina; Brand, Helmut

2017-06-01

The efficiency and effectiveness of child safety interventions are determined by the quality of the implementation process. This multinational European study aimed to identify facilitators and barriers for the three phases of implementation: adoption, implementation and monitoring (AIM process). Twenty-seven participants from across the WHO European Region were invited to provide case studies of child safety interventions from their country. Cases were selected by the authors to ensure broad coverage of injury issues, age groups and governance level of implementation (eg, national, regional or local). Each participant presented their case and provided a written account according to a standardised template. Presentations and question and answer sessions were recorded. The presentation slides, written accounts and the notes taken during the workshops were analysed using thematic content analysis to elicit facilitators and barriers. Twenty-six cases (from 26 different countries) were presented and analysed. Facilitators and barriers were identified within eight general themes, applicable across the AIM process: management and collaboration; resources; leadership; nature of the intervention; political, social and cultural environment; visibility; nature of the injury problem and analysis and interpretation. The importance of the quality of the implementation process for intervention effectiveness, coupled with limited resources for child safety makes it more difficult to achieve successful actions. The findings of this study, divided by phase of the AIM process, provide practitioners with practical suggestions, where proactive planning might help increase the likelihood of effective implementation. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Safety and licensing of a small modular gas-cooled reactor system

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

Brown, N.W.; Kelley, A.P. Jr.

A modular side-by-side high-temperature gas-cooled reactor (SBS-HTGR) is being developed by Interatom/Kraftwerk Union (KWU). The General Electric Company and Interatom/KWU entered into a proprietary working agreement to continue develop jointly of the SBS-HTGR. A study on adapting the SBS-HTGR for application in the US has been completed. The study investigated the safety characteristics and the use of this type of design in an innovative approach to licensing. The safety objective guiding the design of the modular SBS-HTGR is to control radionuclide release by the retention of fission products within the fuel particles with minimal reliance on active design features. Themore » philosophy on which this objective is predicated is that by providing a simple safety case, the safety criteria can be demonstrated as being met with high confidence through conduct of a full-scale module safety test.« less

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.

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.

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.

Brilliant Blue G double staining enhances successful internal limiting membrane peeling with minimal adverse effect by low cellular permeability into live cells.

PubMed

Hisatomi, Toshio; Notomi, Shoji; Tachibana, Takashi; Oishi, Seiichiro; Asato, Ryo; Yamashita, Takehiro; Murakami, Yusuke; Ikeda, Yasuhiro; Enaida, Hiroshi; Sakamoto, Taiji; Ishibashi, Tatsuro

2015-02-01

Brilliant Blue G is used as a surgical adjuvant for retinal surgery. Although BBG double or multiple staining was reported, the effectiveness and safety of repeated staining is still elusive. To further examine the effectiveness and safety, we examined BBG in clinical cases in vivo, primary cell culture in vitro, and surgically resected specimen ex vivo. A retrospective interventional case series with in vitro and ex vivo studies were performed. Vitrectomy was performed in 28 cases of epiretinal membrane with BBG single to multiple staining. The surgically resected membranes were stained by BBG with or without cellular fixation. Primary cell cultures were examined with BBG and live/death cell markers, such as Calcein AM and TUNEL. Single staining provided satisfactory staining in seven cases. Double or multiple staining substantially visualized internal limiting membrane (21 cases), especially the edges of remaining internal limiting membrane (11 cases). Adverse retinal staining was not noted and the final visual acuity showed no difference with multiple staining. The live cells barely stained with BBG, while some dead cells were stained. Brilliant Blue G multiple staining substantially enhanced the visualization of internal limiting membrane. The absence of abnormal staining supports the safety of repeated BBG staining.

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…

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…

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,…

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.

Injection safety practices in a main referral hospital in Northeastern Nigeria.

PubMed

Gadzama, G B; Bawa, S B; Ajinoma, Z; Saidu, M M; Umar, A S

2014-01-01

No adherence of safe injection policies remains a major challenge, and, worldwide, annually, it leads to 21 million new hepatitis B cases and 260,000 HIV infection cases. This descriptive observational survey was conducted to determine the level of adherence to universal precaution for safe injection practices in the hospital. The study units were selected using a simple random sampling of injection services provider/phlebotomist in 27 units/wards of the hospital. The study instruments were observation checklist and interviewer administered questionnaires. EPI info (version 3.5.2) software was used for data entry and generation of descriptive statistics was done with units of analysis (units/wards) on injection safety practices of health workers, availability of logistics and supplies, and disposal methods. Only 33.3% of the units (95% CI, 16-54) had non-sharps infectious healthcare waste of any type inside containers specific for non-sharps infectious waste and 17 (77.3%) of the observed therapeutic injections were prepared on a clean, dedicated table or tray, where contamination of the equipment with blood, body fluids, or dirty swabs was unlikely. Absence of recapping of needles was observed in 11 (50.0%) units giving therapeutic injections. Only 7.4% of units surveyed had separate waste containers for infectious non-sharps. This study depicts poor knowledge and a practice of injection safety, inadequate injection safety supplies, and non-compliance to injection safety policy and guidelines.

Systematic review of the safety and effectiveness of peripheral neurostimulation of the sphenopalatine ganglion for the treatment of refractory chronic cluster headache.

PubMed

Sánchez-Gómez, L M; Polo-deSantos, M; Pinel-González, A; Oreja-Guevara, C; Luengo-Matos, S

2018-01-12

This study aimed to assess the safety and effectiveness of peripheral neurostimulation of the sphenopalatine ganglion (SPG) in the treatment of refractory chronic cluster headache. Various medical databases were used to perform a systematic review of the scientific literature. The search for articles continued until 31 October 2016, and included clinical trials, systematic reviews and/or meta-analyses, health technology assessment reports, and clinical practice guidelines that included measurements of efficiency/effectiveness or adverse effects associated with the treatment. The review excluded cohort studies, case-control studies, case series, literature reviews, letters to the editor, opinion pieces, editorials, and studies that had been duplicated or outdated by later publications from the same institution. Regarding effectiveness, we found that SPG stimulation had positive results for pain relief, attack frequency, medication use, and patients' quality of life. In the results regarding safety, we found a significant number of adverse events in the first 30 days following the intervention. Removal of the device was necessary in some patients. Little follow-up data, and no long-term data, is available. These results are promising, despite the limited evidence available. We consider it essential for research to continue into the safety and efficacy of SPG stimulation for patients with refractory chronic cluster headache. In cases where this intervention may be indicated, treatment should be closely monitored. Copyright © 2017 Sociedad Española de Neurología. Publicado por Elsevier España, S.L.U. All rights reserved.

Managing risks of noncancer health effects at hazardous waste sites: A case study using the Reference Concentration (RfC) of trichloroethylene (TCE).

PubMed

Dourson, Michael L; Gadagbui, Bernard K; Thompson, Rod B; Pfau, Edward J; Lowe, John

2016-10-01

A method for determining a safety range for non-cancer risks is proposed, similar in concept to the range used for cancer in the management of waste sites. This safety range brings transparency to the chemical specific Reference Dose or Concentration by replacing their "order of magnitude" definitions with a scientifically-based range. EPA's multiple RfCs for trichloroethylene (TCE) were evaluated as a case study. For TCE, a multi-endpoint safety range was judged to be 3 μg/m(3) to 30 μg/m,(3) based on a review of kidney effects found in NTP (1988), thymus effects found in Keil et al. (2009) and cardiac effects found in the Johnson et al. (2003) study. This multi-endpoint safety range is derived from studies for which the appropriate averaging time corresponds to different exposure durations, and, therefore, can be applied to both long- and short-term exposures with appropriate consideration of exposure averaging times. For shorter-term exposures, averaging time should be based on the time of cardiac development in humans during fetal growth, an average of approximately 20-25 days. Copyright © 2016 The Author(s). Published by Elsevier Inc. All rights reserved.

The evolving role and care management approaches of safety-net Medicaid managed care plans.

PubMed

Gusmano, Michael K; Sparer, Michael S; Brown, Lawrence D; Rowe, Catherine; Gray, Bradford

2002-12-01

This article provides new empirical data about the viability and the care management activities of Medicaid managed-care plans sponsored by provider organizations that serve Medicaid and other low-income populations. Using survey and case study methods, we studied these "safety-net" health plans in 1998 and 2000. Although the number of safety-net plans declined over this period, the surviving plans were larger and enjoying greater financial success than the plans we surveyed in 1998. We also found that, based on a partnership with providers, safety-net plans are moving toward more sophisticated efforts to manage the care of their enrollees. Our study suggests that, with supportive state policies, safety-net plans are capable of remaining viable. Contracting with safety-net plans may not be an efficient mechanism for enabling Medicaid recipients to "enter the mainstream of American health care," but it may provide states with an effective way to manage and coordinate the care of Medicaid recipients, while helping to maintain the health care safety-net for the uninsured.

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.

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.

The exploration of effects of Chinese cultural values on the attitudes and behaviors of Chinese restaurateurs toward food safety training.

PubMed

Liu, Pei; Kwon, Junehee

2013-06-01

Foodborne illness is a challenge in the production and service of ethnic foods. The purpose of the study described in this article was to explore variables influencing the behaviors of U.S. Chinese restaurant owners/operators regarding the provision of food safety training in their restaurants. Seventeen major Chinese cultural values were identified through individual interviews with 20 Chinese restaurant owners/operators. Most participants felt satisfied with their previous health inspections. Several expressed having difficulty, however, following the health inspectors' instructions and in understanding the health inspection report. A few participants provided food safety training to their employees due to state law. Lack of money, time, labor/energy, and a perceived need for food safety training were recognized as major challenges to providing food safety training in Chinese restaurants. Videos, case studies, and food safety training handbooks were the most preferred food safety training methods of Chinese restaurant owners/operators, and Chinese was the preferred language in which to conduct the training.

[Analysis of patient complaints in Primary Care: An opportunity to improve clinical safety].

PubMed

Añel-Rodríguez, R M; Cambero-Serrano, M I; Irurzun-Zuazabal, E

2015-01-01

To determine the prevalence and type of the clinical safety problems contained in the complaints made by patients and users in Primary Care. An observational, descriptive, cross-sectional study was conducted by analysing both the complaint forms and the responses given to them in the period of one year. At least 4.6% of all claims analysed in this study contained clinical safety problems. The family physician is the professional who received the majority of the complaints (53.6%), and the main reason was the problems related to diagnosis (43%), mainly the delay in diagnosis. Other variables analysed were the severity of adverse events experienced by patients (in 68% of cases the patient suffered some harm), the subsequent impact on patient care, which was affected in 39% of cases (7% of cases even requiring hospital admission), and the level of preventability of adverse events (96% avoidable) described in the claims. Finally the type of response issued to each complaint was analysed, being purely bureaucratic in 64% of all cases. Complaints are a valuable source of information about the deficiencies identified by patients and healthcare users. There is considerable scope for improvement in the analysis and management of claims in general, and those containing clinical safety issues in particular. To date, in our area, there is a lack of appropriate procedures for processing these claims. Likewise, we believe that other pathways or channels should be opened to enable communication by patients and healthcare users. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.

A perspective on emerging law, consumer trust and social responsibility in China's food sector: the "bleaching" case study.

PubMed

Roberts, Michael T

2011-01-01

Trust underpins the Chinese social system, and yet it is lacking from a Chinese food system that is riddled with safety disasters and disgruntled consumers. Government and industry play a major role in rehabilitating consumer trust in China. To this end, food safety and quality laws have been constructed to foster this process; however, safety scandals continue even in the face of stricter regulations and increased enforcement. A potential toll to abate food-safety problems and to build trust is the implementation of Corporate Social Responsibility ("CSR"). Mandates by the government promote CSR in enterprise activity, including Article 3 of the 2009 China Food Safety Law. Officials have also recently touted the need for "moral education" of operators in the food industry. Regardless of government activity or whether CSR is employed by food enterprises, it is imperative that the food industry recognizes how critical it is to establish trust with Chinese consumers, who increasingly expect safe, quality food. The case study with pistachios highlights this evolving consumer expectation and the principles of social responsibility in the framework of the relationship between government and industry and consumers, while demonstrating the benefits of doing the right thing for food companies doing business in China.

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.

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

PubMed

Xie, Yanming; Wei, Xu

2011-10-01

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

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.

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…

19 CFR 122.187 - Revocation or suspension of access.

Code of Federal Regulations, 2010 CFR

2010-04-01

... that continued access might pose an unacceptable risk to public health, interest or safety, national security, aviation safety, the revenue, or the security of the area. In this case the port director will... health, safety, or security is involved and, in such a case, a final notice of revocation or suspension...

76 FR 14641 - Defense Federal Acquisition Regulation Supplement; Identification of Critical Safety Items (DFARS...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-17

... Federal Acquisition Regulation Supplement; Identification of Critical Safety Items (DFARS Case 2010-D022... contract clause that clearly identifies any items being purchased that are critical safety items so that.... SUPPLEMENTARY INFORMATION: I. Background This DFARS case was initiated at the request of the Defense Contract...

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.

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.

Mine Safety and Health Administration's Part 50 program does not fully capture chronic disease and injury in the Illinois mining industry.

PubMed

Almberg, Kirsten S; Friedman, Lee S; Swedler, David; Cohen, Robert A

2018-05-01

The Mine Safety and Health Administration (MSHA) requires reporting of injuries and illnesses to their Part 50 program. A 2011 study indicated that the Part 50 program did not capture many cases of injury in Kentucky, causing concern about underreporting in other states. MSHA Part 50 reports from Illinois for 2001-2013 were linked to Illinois Workers' Compensation Commission (IWCC) data. IWCC cases not found in the Part 50 data were considered unreported. Overall, the Part 50 Program did not capture 66% of IWCC cases from 2001 to 2013. Chronic injuries or illnesses were more likely to be unreported to MSHA. The majority of occupational injuries and illnesses found in the IWCC from this time period, were not captured by Part 50. Inaccurate reporting of injuries and illnesses to the Part 50 program hinders MSHA's ability to enforce safety and health standards in the mining industry. © 2018 Wiley Periodicals, Inc.

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…

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

PubMed Central

Fan, Qixiang; Qiang, Maoshan

2014-01-01

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

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

PubMed

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

2014-01-01

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

Safety and health practice among laboratory staff in Malaysian education sector

NASA Astrophysics Data System (ADS)

Husna Che Hassan, Nurul; Rasdan Ismail, Ahmad; Kamilah Makhtar, Nor; Azwadi Sulaiman, Muhammad; Syuhadah Subki, Noor; Adilah Hamzah, Noor

2017-10-01

Safety is the most important issue in industrial sector such as construction and manufacturing. Recently, the increasing number of accident cases reported involving school environment shows the important of safety issues in education sector. Safety awareness among staff in this sector is crucial in order to find out the method to prevent the accident occurred in future. This study was conducted to analyze the knowledge of laboratory staff in term of safety and health practice in laboratory. Survey questionnaires were distributing among 255 of staff laboratory from ten District Education Offices in Kelantan. Descriptive analysis shows that the understanding of safety and health practice are low while doing some job activities in laboratory. Furthermore, some of the staff also did not implemented safety practice that may contribute to unplanned event occur in laboratory. Suggestion that the staff at laboratory need to undergo on Occupational Safety and Health training to maintain and create safe environment in workplaces.

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.

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.

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 may contribute to under-reporting; because of under-reporting, worker surveys and symptom reports may provide more valuable and timely information on risks than recordable injury logs. Safety incentive programmes should be carefully designed to ensure that they provide a stimulus for safety-related changes, and to discourage under-reporting. A case-control study of similar establishments, or data before and after instituting safety incentives, would be required to more clearly establish the role of these programmes in under-reporting.

Impact of the time-out process on safety attitude in a tertiary neurosurgical department.

PubMed

McLaughlin, Nancy; Winograd, Deborah; Chung, Hallie R; Van de Wiele, Barbara; Martin, Neil A

2014-11-01

In July 2011, the UCLA Health System released its current time-out process protocol used across the Health System. Numerous interventions were performed to improve checklist completion and time-out process observance. This study assessed the impact of the current protocol for the time-out on healthcare providers' safety attitude and operating room safety climate. All members involved in neurosurgical procedures in the main operating room of the Ronald Reagan UCLA Medical Center were asked to anonymously complete an online survey on their overall perception of the time-out process. The survey was completed by 93 of 128 members of the surgical team. Overall, 98.9% felt that performing a pre-incision time-out improves patient safety. The majority of respondents (97.8%) felt that the team member introductions helped to promote a team spirit during the case. In addition, 93.5% felt that performing a time-out helped to ensure all team members were comfortable to voice safety concerns throughout the case. All respondents felt that the attending surgeon should be present during the time-out and 76.3% felt that he/she should lead the time-out. Unanimously, it was felt that the review of anticipated critical elements by the attending surgeon was helpful to respondents' role during the case. Responses revealed that although the time-out brings the team together physically, it does not necessarily reinforce teamwork. The time-out process favorably impacted team members' safety attitudes and perception as well as overall safety climate in neurosurgical ORs. Survey responses identified leadership training and teamwork training as two avenues for future improvement. Copyright © 2014 Elsevier Inc. All rights reserved.

Approaches to the safety assessment of engineered nanomaterials (ENM) in food.

PubMed

Cockburn, Andrew; Bradford, Roberta; Buck, Neil; Constable, Anne; Edwards, Gareth; Haber, Bernd; Hepburn, Paul; Howlett, John; Kampers, Frans; Klein, Christoph; Radomski, Marek; Stamm, Hermann; Wijnhoven, Susan; Wildemann, Tanja

2012-06-01

A systematic, tiered approach to assess the safety of engineered nanomaterials (ENMs) in foods is presented. The ENM is first compared to its non-nano form counterpart to determine if ENM-specific assessment is required. Of highest concern from a toxicological perspective are ENMs which have potential for systemic translocation, are insoluble or only partially soluble over time or are particulate and bio-persistent. Where ENM-specific assessment is triggered, Tier 1 screening considers the potential for translocation across biological barriers, cytotoxicity, generation of reactive oxygen species, inflammatory response, genotoxicity and general toxicity. In silico and in vitro studies, together with a sub-acute repeat-dose rodent study, could be considered for this phase. Tier 2 hazard characterisation is based on a sentinel 90-day rodent study with an extended range of endpoints, additional parameters being investigated case-by-case. Physicochemical characterisation should be performed in a range of food and biological matrices. A default assumption of 100% bioavailability of the ENM provides a 'worst case' exposure scenario, which could be refined as additional data become available. The safety testing strategy is considered applicable to variations in ENM size within the nanoscale and to new generations of ENM. Copyright © 2012 Elsevier Ltd. All rights reserved.

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…

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.

A multi-jurisdictional outbreak of hepatitis A related to a youth camp--implications for catering operations and mass gatherings.

PubMed

Munnoch, Sally A; Ashbolt, Rosie H; Coleman, David J; Walton, Nerissa; Beers-Deeble, Mary Y; Taylor, Roscoe

2004-01-01

In June 2003, Australian state and territory health departments were notified of an outbreak of Hepatitis A in people who had attended a five-day youth camp. Approximately 350 people attended the event in Central Australia between 24 and 28 April 2003. The public health investigation comprised of case identification, food handler interviews, an environmental health investigation of the campground and associated food premises, laboratory analysis of blood specimens and food/water samples, and an epidemiological study. Twenty-one cases fitted the case definition for the outbreak. A retrospective cohort study involving four states was conducted, with 213 people interviewed. Coleslaw and cordial were significantly associated with illness, however when the two exposures were adjusted for each other to account for confounding, only coleslaw remained significantly associated with illness (adjusted RR 2.5, 95% CI 1.09 - 5.77). The investigation highlighted a number of food hygiene and safety issues relating to the catering of mass gatherings. Implementation of food safety programs in these settings are likely to reduce the occurrence of such outbreaks. The recent proposal by Food Standards Australia New Zealand to mandate food safety programs for catering operations is supported.

Using an Animated Case Scenario Based on Constructivist 5E Model to Enhance Pre-Service Teachers' Awareness of Electrical Safety

ERIC Educational Resources Information Center

Hirca, Necati

2013-01-01

The objective of this study is to get pre-service teachers to develop an awareness of first aid knowledge and skills related to electrical shocking and safety within a scenario based animation based on a Constructivist 5E model. The sample of the study was composed of 78 (46 girls and 32 boys) pre-service classroom teachers from two faculties of…

Categorizing accident sequences in the external radiotherapy for risk analysis

PubMed Central

2013-01-01

Purpose This study identifies accident sequences from the past accidents in order to help the risk analysis application to the external radiotherapy. Materials and Methods This study reviews 59 accidental cases in two retrospective safety analyses that have collected the incidents in the external radiotherapy extensively. Two accident analysis reports that accumulated past incidents are investigated to identify accident sequences including initiating events, failure of safety measures, and consequences. This study classifies the accidents by the treatments stages and sources of errors for initiating events, types of failures in the safety measures, and types of undesirable consequences and the number of affected patients. Then, the accident sequences are grouped into several categories on the basis of similarity of progression. As a result, these cases can be categorized into 14 groups of accident sequence. Results The result indicates that risk analysis needs to pay attention to not only the planning stage, but also the calibration stage that is committed prior to the main treatment process. It also shows that human error is the largest contributor to initiating events as well as to the failure of safety measures. This study also illustrates an event tree analysis for an accident sequence initiated in the calibration. Conclusion This study is expected to provide sights into the accident sequences for the prospective risk analysis through the review of experiences. PMID:23865005

Restructuring within an academic health center to support quality and safety: the development of the Center for Quality and Safety at the Massachusetts General Hospital.

PubMed

Bohmer, Richard M J; Bloom, Jonathan D; Mort, Elizabeth A; Demehin, Akinluwa A; Meyer, Gregg S

2009-12-01

Recent focus on the need to improve the quality and safety of health care has created new challenges for academic health centers (AHCs). Whereas previously quality was largely assumed, today it is increasingly quantifiable and requires organized systems for improvement. Traditional structures and cultures within AHCs, although well suited to the tripartite missions of teaching, research, and clinical care, are not easily adaptable to the tasks of measuring, reporting, and improving quality. Here, the authors use a case study of Massachusetts General Hospital's efforts to restructure quality and safety to illustrate the value of beginning with a focus on organizational culture, using a systematic process of engaging clinical leadership, developing an organizational framework dependent on proven business principles, leveraging focus events, and maintaining executive dedication to execution of the initiative. The case provides a generalizable example for AHCs of how applying explicit management design can foster robust organizational change with relatively modest incremental financial resources.

Neurovascular safety and clinical outcome of outside-in repair of tears of the posterior horn of the medial meniscus.

PubMed

Sobhy, Mohamed Hassan; AbouElsoud, Maged M Samy; Kamel, Ezzat Mohamed; Desouki, Ahmed Mohamed

2010-12-01

The purpose of this study was to evaluate the safety and clinical outcome of a new posterior approach for the known outside-in technique for repair of tears of the posterior horn of the medial meniscus (PHMM). First, a cadaveric study was performed on 6 cadaveric knees to assess the safety of a point just lateral to the semitendinosus tendon as an entry point for outside-in repair. Dissection was done to measure the clearance of this point to the nearby popliteal bundle and saphenous nerve. A prospective case series study was then performed to assess the clinical outcome of such an approach. We treated 41 consecutive cases with PHMM tears by the outside-in technique using a shuttle relay method through the same point. Clinical assessments, magnetic resonance imaging findings, Lysholm scores, and International Knee Documentation Committee subjective scores were recorded for all patients. After a minimum postoperative period of 2 years, all cases were re-evaluated and re-scored. The cadaveric study showed a mean clearance distance of 2.4 cm for the popliteal bundle and 4.6 cm for the saphenous nerve. The case series study was done on 41 meniscal repairs; 15 of 41 cases (37%) were performed in conjunction with anterior cruciate ligament reconstruction. There were 22 right knees (54%) and 19 left knees (36%). After a mean follow-up period of 27 months, patients showed a clinical success rate of 88% in terms of disappearance of pain, locking, and swelling, together with improved Lysholm scores (from 34 to 88) and International Knee Documentation Committee scores (from 25 to 88). These improvements were statistically significant (P < .05). An outside-in repair technique with a posterior entry central to the semitendinosus tendon was used safely with 88% satisfactory clinical results for treatment of PHMM tears. Level IV, therapeutic case series. Copyright © 2010 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Tolerability and safety of the intravenous immunoglobulin octagam® 10% in patients with immune thrombocytopenia: a post-authorisation safety analysis of two non-interventional phase IV trials.

PubMed

Wietek, Stefan; Svorc, Daniel; Debes, Anette; Svae, Tor-Einar

2018-05-01

To provide detailed data on the tolerability and safety of octagam ® 10%, a ready-to-use intravenous immunoglobulin, in a subgroup of patients with immune thrombocytopenia (ITP) involved in an integrated analysis of post-authorisation safety surveillance (PASS) studies. A subgroup analysis was conducted using data collected from two non-interventional studies that included patients with ITP treated with octagam ® 10%. Patients were observed and monitored for possible adverse drug reactions (ADRs) during or after administration of octagam ® 10%, with a particular focus on thromboembolic events (TEEs). ADRs were analysed at the case and event level. In this analysis of 112 patients receiving octagam ® 10% (mean dose 0.4 g/kg/infusion), there were five cases with at least one adverse drug reaction (ADR) associated with 626 infusions of octagam ® 10% (case incidence of 0.8% per infusion). ADRs were of mild or moderate severity. There were a total of 10 events, most commonly back pain (n = 3) and headache (n = 2). Nausea, dizziness and a sensation of heaviness were also reported. The remaining two events involved drug exposure during pregnancy. There were no TEEs or other serious ADRs. In this subgroup analysis of patients who received octagam ® 10% (manufactured using an amended process) in two PASS studies, the overall ADR rate was low, with ADRs occurring in only 0.8% of all infusions. No TEEs or other serious ADRs were reported. Routine clinical use of octagam ® 10% was safe and well tolerated, with no unexpected safety issues, in patients with ITP. The two studies from which data were taken are registered with the International Standard Randomised Controlled Trial Number Registry, numbers ISRCTN58800347 and ISRCTN02245668.

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. Using an occupational health and safety risk assessment and control framework, Sun Safety at Work Canada will support workplaces to assess their exposure risks, implement control strategies that build on their existing programs, and embed the controls into their existing occupational health and safety system.

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.

[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.

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.

Aspartame, low-calorie sweeteners and disease: regulatory safety and epidemiological issues.

PubMed

Marinovich, Marina; Galli, Corrado L; Bosetti, Cristina; Gallus, Silvano; La Vecchia, Carlo

2013-10-01

Aspartame is a synthetic sweetener that has been used safely in food for more than 30 years. Its safety has been evaluated by various regulatory agencies in accordance with procedures internationally recognized, and decisions have been revised and updated regularly. The present review summarizes the most relevant conclusions of epidemiological studies concerning the use of low-calorie sweeteners (mainly aspartame), published between January 1990 and November 2012. In the Nurses' Health study and the Health Professionals Followup study some excess risk of Hodgkin lymphoma and multiple myeloma was found in men but not in women; no association was found with leukemia. In the NIH-AARP Diet and Health Study, there was no association between aspartame and haematopoietic neoplasms. US case-control studies of brain and haematopoietic neoplasms also showed no association. The NIH-AARP Diet and Health Study and case-control studies from California showed no association with pancreatic cancer, and a case-control study from Denmark found no relation with breast cancer risk. Italian case-control studies conducted in 1991-2008 reported no consistent association for cancers of the upper aerodigestive tract, digestive tract, breast, endometrium, ovary, prostate, and kidney. Low calorie sweeteners were not consistently related to vascular events and preterm deliveries. Copyright © 2013 Elsevier Ltd. All rights reserved.

The Lawrence D. Dorr Surgical Techniques & Technologies Award: "Running Two Rooms" Does Not Compromise Outcomes or Patient Safety in Joint Arthroplasty.

PubMed

Hamilton, William G; Ho, Henry; Parks, Nancy L; Strait, Alexander V; Hopper, Robert H; McDonald, James F; Goyal, Nitin; Fricka, Kevin B; Engh, C Anderson

2018-07-01

Scrutiny from the federal government and the media regarding the safety of 1 surgeon doing cases in 2 operating rooms (ORs) on the same day, prompted us to examine our own institutional data. Over the past 11 years, surgeons at our facility have operated consecutively in 1 OR on a given day or used 2 alternating ORs. This study compares these cases with a focus on revisions and complications in both groups. Six surgeons performed a total of 16,916 primary hip and knee arthroplasties from 2006-2016. 7002 cases (41%) were consecutive cases (CCs) and 9914 cases (59%) were overlapping cases (OCs). Intraoperative complications, component revisions, and postoperative complications within 90 days of surgery were compared between the CC and OC groups. There was no difference in intraoperative complication rates between the two groups (CC 1.6% vs. OC 1.7%, relative risk 1.082, 95% confidence interval 0.852 to 1.375, P = .52). There was no difference in 90-day component revision rates among the CC and OC groups (0.66% vs. 0.85% respectively, relative risk = 1.290, 95% confidence interval 0.901 to 1.845, P = .19). There was also no difference in 90-day complication rates among the CC and OC groups (1.33% vs. 1.45% respectively, relative risk = 1.094, 95% confidence interval 0.844 to 1.417, P = .54). This large study of a single institution with multiple surgeons over an 11-year period shows no compromise in patient safety or outcomes when comparing cases done in either consecutive or overlapping rooms. Copyright © 2018 Elsevier Inc. All rights reserved.

A Case Report of Severe Corneal Toxicity following 0.5% Topical Moxifloxacin Use.

PubMed

Vignesh, A P; Srinivasan, Renuka; Karanth, Swathi

2015-01-01

Moxifloxacin is a widely used topical antibiotic in various bacterial infections of the eye. Its safety and efficacy have been proved by many studies. We report a case of a rare adverse effect following its use. A 10-year-old female who had presented with acute bacterial conjunctivitis in both eyes with no corneal involvement was started on preservative-free 0.5% topical moxifloxacin four times a day. The child developed a severe form of corneal toxicity in both eyes with circumcorneal congestion and corneal edema following its use. The child's visual acuity had dropped from 20/20 to 20/400 in both the eyes. Topical moxifloxacin was discontinued, following which the cornea cleared dramatically and the visual acuity became normal. This case indicates that though rare, topical moxifloxacin can cause severe keratitis and that more studies need to be conducted to evaluate its safety.

Noni juice is not hepatotoxic

PubMed Central

West, Brett J; Jensen, C Jarakae; Westendorf, Johannes

2006-01-01

Noni juice (Morinda citrifolia) has been approved for use as a safe food within the European Union, following a review of safety. Since approval, three cases of acute hepatitis in Austrian noni juice consumers have been published, where a causal link is suggested between the liver dysfunction and ingestion of anthraquinones from the plant. Measurements of liver function in a human clinical safety study of TAHITIAN NONI® Juice, as well as subacute and subchronic animal toxicity tests revealed no evidence of adverse liver effects at doses many times higher than those reported in the case studies. Additionally, M. citrifolia anthraquinones occur in the fruit in quantities too small to be of any toxicological significance. Further, these do not have chemical structures capable of being reduced to reactive anthrone radicals, which were implicated in previous cases of herbal hepototoxicity. The available data reveals no evidence of liver toxicity. PMID:16773722

[Assessment of SUSARs. Clinical evaluation of single cases in terms of regulatory requirements].

PubMed

Wroblewski, H; Schmickler, M

2005-04-01

In the course of implementing the European directives on pharmaceutical law, focus is set on suspected unexpected serious adverse reactions (SUSARs). SUSARs are essential for expedited reporting to authorities and ethics committees. During on-line monitoring of the study, the investigator documents all adverse events. Serious adverse events are forwarded to the sponsor in due time. The sponsor identifies SUSARs for expedited reporting. Clinical causality assessment between the investigational product and the adverse event is substantial in this process. This requires a balanced clinical assessment of all case relevant aspects and information available reflecting the complexity of the specific case, which cannot be covered by algorithms in general. In the setting of on-line monitoring, SUSARs ensure the safety of the patient and the study. In addition, SUSARs are relevant for generation of the safety profile of the substance.

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.

Adverse outcomes in maternity care for women with a low risk profile in The Netherlands: a case series analysis

PubMed Central

2013-01-01

Background This study aimed to perform a structural analysis of determinants of risk of critical incidents in care for women with a low risk profile at the start of pregnancy with a view on improving patient safety. Methods We included 71 critical incidents in primary midwifery care and subsequent hospital care in case of referral after 36 weeks of pregnancy that were related to substandard care and for that reason were reported to the Health Care Inspectorate in The Netherlands in 36 months (n = 357). We performed a case-by-case analysis, using a previously validated instrument which covered five broad domains: healthcare organization, communication between healthcare providers, patient risk factors, clinical management, and clinical outcomes. Results Determinants that were associated with risk concerned healthcare organization (n = 20 incidents), communication about treatment procedures (n = 39), referral processes (n = 19), risk assessment by telephone triage (n = 10), and clinical management in an out of hours setting (n = 19). The 71 critical incidents included three cases of maternal death, eight cases of severe maternal morbidity, 42 perinatal deaths and 12 critical incidents with severe morbidity for the child. Suboptimal prenatal risk assessment, a delay in availability of health care providers in urgent situations, miscommunication about treatment between care providers, and miscommunication with patients in situations with a language barrier were associated with safety risks. Conclusions Systematic analysis of critical incidents improves insight in determinants of safety risk. The wide variety of determinants of risk of critical incidents implies that there is no single intervention to improve patient safety in the care for pregnant women with initially a low risk profile. PMID:24286376

Saccharomyces boulardii probiotic-associated fungemia: questioning the safety of this preventive probiotic's use.

PubMed

Martin, Isabella W; Tonner, Rita; Trivedi, Julie; Miller, Heather; Lee, Richard; Liang, Xinglun; Rotello, Leo; Isenbergh, Elena; Anderson, Jennifer; Perl, Trish; Zhang, Sean X

2017-03-01

We report a case of fungemia in an immunocompetent patient after administration of probiotic containing Saccharomyces boulardii. We demonstrated the strain relatedness of the yeast from the probiotic capsule and the yeast causing fungal infection using genomic and proteomic typing methods. Our study questions the safety of this preventative biotherapy. Copyright © 2016 Elsevier Inc. All rights reserved.

The Tennis Ball Bomb Incident or the Safety Plan as "Shelf Document"

ERIC Educational Resources Information Center

Fast, Jonathan; Fanelli, Rossella

2003-01-01

This article presents a case study of a single incident involving a high school student who brought a "tennis ball" bomb to school. Although the district had recently created a safety plan, with a specific protocol for the discovery of a bomb in the building, the principal and the crises team ignored it. The principal did not refer to…

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.

Jane's School Safety Handbook.

ERIC Educational Resources Information Center

Wong, Marleen; Kelly, James; Stephens, Ronald D.

This book advises schools in a concise, detailed format about crisis management. Its chapters address: (1) crisis planning; (2) early warning signs; (3) crisis response; (4) crisis recovery; (5) case studies of schools that have encountered crisis situations; and (6) sample letters to be distributed in case of crisis. (Appendices discuss…

Defining the methodological challenges and opportunities for an effective science of sociotechnical systems and safety.

PubMed

Waterson, Patrick; Robertson, Michelle M; Cooke, Nancy J; Militello, Laura; Roth, Emilie; Stanton, Neville A

2015-01-01

An important part of the application of sociotechnical systems theory (STS) is the development of methods, tools and techniques to assess human factors and ergonomics workplace requirements. We focus in this paper on describing and evaluating current STS methods for workplace safety, as well as outlining a set of six case studies covering the application of these methods to a range of safety contexts. We also describe an evaluation of the methods in terms of ratings of their ability to address a set of theoretical and practical questions (e.g. the degree to which methods capture static/dynamic aspects of tasks and interactions between system levels). The outcomes from the evaluation highlight a set of gaps relating to the coverage and applicability of current methods for STS and safety (e.g. coverage of external influences on system functioning; method usability). The final sections of the paper describe a set of future challenges, as well as some practical suggestions for tackling these. We provide an up-to-date review of STS methods, a set of case studies illustrating their use and an evaluation of their strengths and weaknesses. The paper concludes with a 'roadmap' for future work.

[Aripiprazole in pregnancy: a review of literature].

PubMed

Bellantuono, Cesario; Di Massimo, Giorgia; Mauro, Antonella; Martellini, Mariasole; Nardi, Bernardo

2015-01-01

Data on tolerability and safety of aripiprazolo during pregnancy and in childbirth are so far limited. Aim of the present study is to provide a review of the literature on the safety profile of aripiprazole during pregnancy and on maternal and neonatal outcomes, including two cases coming from our database (www.degradatabase.it). Medline database was searched for English language articles by using the following keywords: "aripiprazole", "atypical antipsychotic", "major malformations", "perinatal complications", "pregnancy". We reported 2 cases of women treated with aripiprazole during their pregnancy at the Clinic of Affective Disorders in Pregnancy and Postpartum of the United Hospital of Ancona (DEGRA Center - www.depressionegravidanza.it). The data available in the literature did not provide clear evidence about the safety and potential risks related to this drug during pregnancy. Data coming from our database did not detected any malformations and perinatal complications after exposure to aripiprazole in 2 newborns beyond the first trimester of pregnancy. From the evidence available, aripiprazole seems to be an antipsychotic effective and well tolerated in the treatment of women with psychotic disorders in pregnancy. However, further studies are needed to better establish the safety of aripiprazole during pregnancy, particularly as the risk of major malformtions and perinatal complications is concerned.

Safety and efficacy of endoscopic submucosal dissection using IT knife nano with clip traction method for early esophageal squamous cell carcinoma.

PubMed

Kitagawa, Yoshiyasu; Suzuki, Takuto; Hara, Taro; Yamaguchi, Taketo

2018-01-01

Although endoscopic submucosal dissection (ESD) is an accepted and established treatment for early esophageal squamous cell carcinoma (EESCC), it is technically difficult, time consuming, and less safe than endoscopic mucosal resection. To perform ESD safely and more efficiently, we proposed a new technique of esophageal ESD using an IT knife nano with the clip traction method. This study aimed to evaluate the efficacy and safety of ESD using this new technique. We retrospectively reviewed all consecutive cases of esophageal ESD performed using an IT knife nano with the clip traction method at our hospital between March 2013 and January 2017. Therapeutic efficacy and safety were also assessed. A total of 103 patients underwent esophageal ESD using the IT knife nano with the clip traction method. In all cases, we performed en bloc resection. Complete resection was achieved in 100 cases (97.1%). The median operating time was 40 (range 13-230) min. No cases of perforation or delayed bleeding occurred. Although two cases (2.0%) of mediastinal emphysema occurred without visible perforation at endoscopy, all were successfully managed conservatively. The new technique of esophageal ESD using the IT knife nano with the clip traction method appears to be feasible, effective, and safe for EESCC treatment.

Efficacy and Safety of Gabapentin in the Treatment of Chronic Cough: A Systematic Review.

PubMed

Shi, Guanglin; Shen, Qin; Zhang, Caixin; Ma, Jun; Mohammed, Anaz; Zhao, Huan

2018-06-19

Despite recent clinical guidelines, the optimal therapeutic strategy for the management of refractory chronic cough is still a challenge. The present systematic review was designed to assess the evidence for efficacy and safety of gabapentin in the treatment of chronic cough. A systematic search of PubMed, Embase, Cochrane Library databases, and publications cited in bibliographies was performed. Articles were searched by two reviewers with a priori criteria for study selection. Seven relevant articles were identified, including two randomized controlled trials, one prospective case-series designed with consecutive patients, one retrospective case series of consecutive patients, one retrospective case series with unknown consecutive status, and two case reports comprising six and two patients, respectively. Improvements were detected in cough-specific quality of life (Leicester Cough Questionnaire score) and cough severity (visual analogue scale score) following gabapentin treatment in randomized controlled trials. The results of prospective case-series showed that the rate of overall improvement of cough and sensory neuropathy with gabapentin was 68%. Gabapentin treatment of patients with chronic cough showed superior efficacy and a good safety record compared with placebo or standard medications. Additional randomized and controlled trials are needed. Copyright©2018. The Korean Academy of Tuberculosis and Respiratory Diseases.

Weight of the Evidence or Wait for the Evidence? Protecting Underground Miners From Diesel Particulate Matter

PubMed Central

Monforton, Celeste

2006-01-01

A coalition of mine operators has used a variety of tactics to obstruct scientific inquiry and impede public health action designed to protect underground miners from diesel particulate matter. These workers are exposed to the highest level of diesel particulate matter compared with any other occupational group. This case study profiles a decade-long saga of the Methane Awareness Resource Group Diesel Coalition to impede epidemiological studies on diesel exhaust undertaken by the National Institute for Occupational Safety and Health and the National Cancer Institute, and to derail a health standard promulgated by the Mine Safety and Health Administration. The case study highlights the coalition’s mastery of legislative, judicial, and executive branch operations and the reaction of policymakers. PMID:16380560

A Multiple Case Study Exploring Members' Perceptions of Threat Assessment Teams' Training and Resources at Two-Year Colleges

ERIC Educational Resources Information Center

Pendleton, Kristi A.

2017-01-01

Incorporating a qualitative approach, the purpose of this multiple case study dissertation was: 1) to explore the perceptions of threat assessment teams on campus safety; 2) to study the challenges and barriers two-year colleges experience in relation to the threat assessment team process; and 3) to describe how the teams' perceptions of risk may…

US and Dutch nurse experiences with fall prevention technology within nursing home environment and workflow: A qualitative study.

PubMed

Vandenberg, Ann E; van Beijnum, Bert-Jan; Overdevest, Vera G P; Capezuti, Elizabeth; Johnson, Theodore M

Falls remain a major geriatric problem, and the search for new solutions continues. We investigated how existing fall prevention technology was experienced within nursing home nurses' environment and workflow. Our NIH-funded study in an American nursing home was followed by a cultural learning exchange with a Dutch nursing home. We constructed two case reports from interview and observational data and compared the magnitude of falls, safety cultures, and technology characteristics and effectiveness. Falls were a high-magnitude problem at the US site, with a collectively vigilant safety culture attending to non-directional audible alarms; falls were a low-magnitude problem at the NL site which employed customizable, infrared sensors that directed text alerts to assigned staff members' mobile devices in patient-centered care culture. Across cases, 1) a coordinated communication system was essential in facilitating effective fall prevention alert response, and 2) nursing home safety culture is tightly associated with the chosen technological system. Copyright © 2016 Elsevier Inc. All rights reserved.

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

Model-Driven Safety Analysis of Closed-Loop Medical Systems

PubMed Central

Pajic, Miroslav; Mangharam, Rahul; Sokolsky, Oleg; Arney, David; Goldman, Julian; Lee, Insup

2013-01-01

In modern hospitals, patients are treated using a wide array of medical devices that are increasingly interacting with each other over the network, thus offering a perfect example of a cyber-physical system. We study the safety of a medical device system for the physiologic closed-loop control of drug infusion. The main contribution of the paper is the verification approach for the safety properties of closed-loop medical device systems. We demonstrate, using a case study, that the approach can be applied to a system of clinical importance. Our method combines simulation-based analysis of a detailed model of the system that contains continuous patient dynamics with model checking of a more abstract timed automata model. We show that the relationship between the two models preserves the crucial aspect of the timing behavior that ensures the conservativeness of the safety analysis. We also describe system design that can provide open-loop safety under network failure. PMID:24177176

Model-Driven Safety Analysis of Closed-Loop Medical Systems.

PubMed

Pajic, Miroslav; Mangharam, Rahul; Sokolsky, Oleg; Arney, David; Goldman, Julian; Lee, Insup

2012-10-26

In modern hospitals, patients are treated using a wide array of medical devices that are increasingly interacting with each other over the network, thus offering a perfect example of a cyber-physical system. We study the safety of a medical device system for the physiologic closed-loop control of drug infusion. The main contribution of the paper is the verification approach for the safety properties of closed-loop medical device systems. We demonstrate, using a case study, that the approach can be applied to a system of clinical importance. Our method combines simulation-based analysis of a detailed model of the system that contains continuous patient dynamics with model checking of a more abstract timed automata model. We show that the relationship between the two models preserves the crucial aspect of the timing behavior that ensures the conservativeness of the safety analysis. We also describe system design that can provide open-loop safety under network failure.

Attributing Illness to Food

PubMed Central

Doyle, Michael P.; Morris, J. Glenn; Painter, John; Singh, Ruby; Tauxe, Robert V.; Taylor, Michael R.; Wong, Danilo M.A. Lo Fo

2005-01-01

Identification and prioritization of effective food safety interventions require an understanding of the relationship between food and pathogen from farm to consumption. Critical to this cause is food attribution, the capacity to attribute cases of foodborne disease to the food vehicle or other source responsible for illness. A wide variety of food attribution approaches and data are used around the world, including the analysis of outbreak data, case-control studies, microbial subtyping and source tracking methods, and expert judgment, among others. The Food Safety Research Consortium sponsored the Food Attribution Data Workshop in October 2003 to discuss the virtues and limitations of these approaches and to identify future options for collecting food attribution data in the United States. We summarize workshop discussions and identify challenges that affect progress in this critical component of a risk-based approach to improving food safety. PMID:16022770

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 exposures. Health education and safety training are important in preventing eye injuries. Maintenance and repair of machines and equipment may effectively reduce or eliminate the sources of exposures.

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

The SEURAT-1 approach towards animal free human safety assessment.

PubMed

Gocht, Tilman; Berggren, Elisabet; Ahr, Hans Jürgen; Cotgreave, Ian; Cronin, Mark T D; Daston, George; Hardy, Barry; Heinzle, Elmar; Hescheler, Jürgen; Knight, Derek J; Mahony, Catherine; Peschanski, Marc; Schwarz, Michael; Thomas, Russell S; Verfaillie, Catherine; White, Andrew; Whelan, Maurice

2015-01-01

SEURAT-1 is a European public-private research consortium that is working towards animal-free testing of chemical compounds and the highest level of consumer protection. A research strategy was formulated based on the guiding principle to adopt a toxicological mode-of-action framework to describe how any substance may adversely affect human health.The proof of the initiative will be in demonstrating the applicability of the concepts on which SEURAT-1 is built on three levels:(i) Theoretical prototypes for adverse outcome pathways are formulated based on knowledge already available in the scientific literature on investigating the toxicological mode-of-actions leading to adverse outcomes (addressing mainly liver toxicity);(ii)adverse outcome pathway descriptions are used as a guide for the formulation of case studies to further elucidate the theoretical model and to develop integrated testing strategies for the prediction of certain toxicological effects (i.e., those related to the adverse outcome pathway descriptions);(iii) further case studies target the application of knowledge gained within SEURAT-1 in the context of safety assessment. The ultimate goal would be to perform ab initio predictions based on a complete understanding of toxicological mechanisms. In the near-term, it is more realistic that data from innovative testing methods will support read-across arguments. Both scenarios are addressed with case studies for improved safety assessment. A conceptual framework for a rational integrated assessment strategy emerged from designing the case studies and is discussed in the context of international developments focusing on alternative approaches for evaluating chemicals using the new 21st century tools for toxicity testing.

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

PubMed

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

2017-02-01

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

Results of implementing programmes for modifying unsafe behaviour in Polish companies.

PubMed

Pęciłło, Małgorzata

2012-01-01

This article presents the results of 3 Polish companies implementing programmes for modifying unsafe behaviour. Those programmes involved training workers and supervisors, and observing, registering and analysing the workers' behaviour. They focused on the quality of life and safety culture as factors key to the level of unsafe behaviour and, thus, to the level of safety in an organisation. To assess the effectiveness of the programmes, the quality of life and safety culture were studied before, during and after the intervention. The implementation of the programmes resulted in a higher level of safety culture and workers' well-being and fewer cases of unsafe behaviour. The improved level of safety culture and well-being was different in each company.

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

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 neurotoxic adverse reactions. In several cases, some types of toxicities, associated with zidovudine, efavirenz, and nevirapine, had a high level of severity, necessitating hospitalization and drug regimen or single-agent substitution. Severe cases of hematological, hepatobiliary, and psychiatric toxicities were associated with pre-existing risk factors. CEM is an effective tool for safety and effectiveness monitoring and could be successfully implemented for intensive study of important safety issues and for overcoming knowledge gaps regarding safety. In order to achieve a favorable benefit-risk ratio for HAART in the specific sections of the population with pre-existing risk factors for development of ART toxicities, more vigilant consideration and careful assessment before therapy is commenced and further regular monitoring of key laboratory parameters is required.

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.

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.

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.

Safety and efficacy of physical restraints for the elderly. Review of the evidence.

PubMed Central

Frank, C.; Hodgetts, G.; Puxty, J.

1996-01-01

OBJECTIVE: To critically review evidence on the safety and efficacy of physical restraints for the elderly and to provide family physicians with guidelines for rational use of restraints. DATA SOURCES: Articles cited on MEDLINE (from 1989 to November 1994) and Cinahl (from 1982 to 1994) under the MeSH heading "physical restraints." STUDY SELECTION: Articles that specifically dealt with the safety and efficacy of restraints and current patterns of use, including prevalence, risk factors, and indications, were selected. Eight original research articles were identified and critically appraised. DATA EXTRACTION: Data extracted concerned the negative sequelae of restraints and the association between restraint use and fall and injury rates. General data about current patterns of restraint use were related to safety and efficacy findings. DATA SYNTHESIS: No randomized, controlled trials of physical restraint use were found in the literature. A variety of study design, including retrospective chart review, prospective cohort studies, and case reports, found little evidence that restraints prevent injury. Some evidence suggested that restraints might increase risk of falls and injury. Restraint-reduction programs have not been shown to increase fall or injury rates. Numerous case reports document injuries or deaths resulting from restraint use or misuse. CONCLUSIONS: Although current evidence does not support the belief that restraints prevent falls and injuries and questions their safety, further prospective and controlled studies are needed to clarify these issues. Information from review and research articles was synthesized in this paper to produce guidelines for the safe and rational use of restraints. PMID:8969858

Heavy Metal Veggies: A Decision Case for Environmental and Nutrition Education.

ERIC Educational Resources Information Center

Schramm, J.; And Others

1994-01-01

One alternative to continued landfilling or incineration is the development of municipal solid waste (MSW) composting facilities. This case study permits students to examine issues associated with environmental contamination by MSW and to make decisions based on agricultural, environmental, economic, food safety, and ethical considerations. The…

Safety analysis of Ziagen® (abacavir sulfate) in postmarketing surveillance in Japan.

PubMed

Kurita, Tomoko; Kitaichi, Tomomi; Nagao, Takako; Miura, Toshiyuki; Kitazono, Yoshifumi

2014-04-01

Abacavir is a nucleoside reverse transcriptase inhibitor indicated for human immunodeficiency virus (HIV) infection. In Japan, Ziagen® (300-mg abacavir sulfate) has been marketed since 1999. To obtain safety data on Ziagen, a mandatory postmarketing surveillance was conducted between September 1999 and September 2009. A joint survey [HIV-related Drug Surveys (HRD)] has been conducted involving manufacturers of drugs for HIV treatment in Japan. Safety data from total 643 cases (1345.7 person-years) registered to the HRD surveys and received Ziagen were obtained. Adverse drug reaction (ADR) was defined as adverse event of which association with abacavir could not be "ruled out." It was found that the overall frequency of ADR was 47.6% (306/643); the common ADRs were "hyperlipidemia," "nausea," "increased γ-glutamyltransferase level," "increased blood triglycerides," "abnormal hepatic function," and so on. Serious adverse events were reported in 65 subjects; however, none of the three fatal cases were clearly associated with Ziagen use. The survey-defined hypersensitivity has been infrequently reported in 15 subjects (2.3%). Although some studies had indicated of the association between abacavir and myocardial infarction, no ischemic heart diseases were reported in the present survey. Two of the three pregnant cases delivered normal neonates (one induced abortion). During the mandatory postmarketing survey of Ziagen, there were no cases of ischemic heart diseases, and the incidence of hypersensitivity was considerably low. These indicated that abacavir can be safely used in Japanese HIV+ population. However, the safety profile of Ziagen should be continued to be monitored through pharmacovigilance. © 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd.

A comparative study of bike lane injuries.

PubMed

Wee, Jung Hee; Park, Jeong Ho; Park, Kyu Nam; Choi, Seung Pill

2012-02-01

Because of the increased number of bicycle riders and governmental promotions, a recent increase in the construction of bicycle lanes has occurred. We aimed to characterize injuries specific to bicycle lane accidents by comparing them with injuries that occurred on regular roadways. On the basis of our findings, we provide suggestions on proper preventive strategies. We performed a retrospective study on 408 cases obtained between January 1, 2009, and December 31, 2010. Of these cases, 387 met the criterion that the location of the injury could be confirmed by telephone or via review of the patient's chart. Data regarding age, gender, Injury Severity Score, time of the accident, location of the accident, and other characteristics were collected. Data were analyzed using SPSS 12.0K. Of the 387 cases, 204 (52.7%) patients were injured in bicycle lanes and 183 (47.3%) were injured on regular roadways. Comparing cases of bicycle lane injuries and non-bicycle lane injuries, there were no differences in age, day of the week, season, or the time at which the accident occurred. Bicycle helmets were used more frequently in bicycle lane injuries (33.2% vs. 13.7%; p < 0.001). In addition, the most common causes of injury for bicycle lane incidences were falls (59.3%) and collisions with other bicycles (23.5%), whereas in non-bicycle lane cases, falls (42.6%) and collisions with other vehicles (39.3%) were the most common causes of injury. Although the severity of injuries was slightly lower in bicycle lane cases, it was not significantly lower than non-bicycle lane cases. Although people are increasingly using bicycle lanes for safety, this study shows that they are not definitively safer. Therefore, improvements in the policies related to implementing bicycle lane safety are needed, for example, by enforcing the use of protective gear or preventing the use of bicycle lanes by pedestrians. More safety education programs are also needed. III.

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

Protest and survive, the U.K. Construction Safety Campaign: a case study of workers' and victims' family action and legal and regulatory inaction on construction health and safety.

PubMed

Holder, Mick; O'Brien, Tony

2007-01-01

The U.K. Construction Safety Campaign, based on grass-roots rank-and-file trade union activity, has both a domestic agenda and a wider sphere with regard to international developments. Using organized protests and media exposure to achieve its ends, the Campaign has contributed substantially to reducing injuries and fatalities in the U.K. construction industry, as well as achieving some justice for victims of the industry's neglect of safe management practices.

Assessing safety of extractables from materials and leachables in pharmaceuticals and biologics - Current challenges and approaches.

PubMed

Broschard, Thomas H; Glowienke, Susanne; Bruen, Uma S; Nagao, Lee M; Teasdale, Andrew; Stults, Cheryl L M; Li, Kim L; Iciek, Laurie A; Erexson, Greg; Martin, Elizabeth A; Ball, Douglas J

2016-11-01

Leachables from pharmaceutical container closure systems can present potential safety risks to patients. Extractables studies may be performed as a risk mitigation activity to identify potential leachables for dosage forms with a high degree of concern associated with the route of administration. To address safety concerns, approaches to toxicological safety evaluation of extractables and leachables have been developed and applied by pharmaceutical and biologics manufacturers. Details of these approaches may differ depending on the nature of the final drug product. These may include application, the formulation, route of administration and length of use. Current regulatory guidelines and industry standards provide general guidance on compound specific safety assessments but do not provide a comprehensive approach to safety evaluations of leachables and/or extractables. This paper provides a perspective on approaches to safety evaluations by reviewing and applying general concepts and integrating key steps in the toxicological evaluation of individual extractables or leachables. These include application of structure activity relationship studies, development of permitted daily exposure (PDE) values, and use of safety threshold concepts. Case studies are provided. The concepts presented seek to encourage discussion in the scientific community, and are not intended to represent a final opinion or "guidelines." Copyright © 2016 Elsevier Inc. All rights reserved.

Protecting Contract Workers: Case Study of the US Department of Energy’s Nuclear and Chemical Waste Management

PubMed Central

Gochfeld, Michael; Mohr, Sandra

2007-01-01

Increased reliance on subcontractors in all economic sectors is a serious occupational health and safety challenge. Short-term cost savings are offset by long-term liability. Hiring subcontractors brings specialized knowledge but also young, inexperienced, inadequately trained workers onto industrial and hazardous waste sites, which leads to increased rates of accidents and injuries. Reliable data on subcontractor occupational health and safety programs and performance are sparse. The US Department of Energy has an excellent safety culture on paper, but procurement practices and contract language deliver a mixed message—including some safety disincentives. Its biphasic safety outcome data are consistent with underreporting by some subcontractors and underachievement by others. These observations are relevant to the private and public sectors. Occupational health and safety should be viewed as an asset, not merely a cost. PMID:17666686

Protecting contract workers: case study of the US Department of Energy's nuclear and chemical waste management.

PubMed

Gochfeld, Michael; Mohr, Sandra

2007-09-01

Increased reliance on subcontractors in all economic sectors is a serious occupational health and safety challenge. Short-term cost savings are offset by long-term liability. Hiring subcontractors brings specialized knowledge but also young, inexperienced, inadequately trained workers onto industrial and hazardous waste sites, which leads to increased rates of accidents and injuries. Reliable data on subcontractor occupational health and safety programs and performance are sparse. The US Department of Energy has an excellent safety culture on paper, but procurement practices and contract language deliver a mixed message--including some safety disincentives. Its biphasic safety outcome data are consistent with underreporting by some subcontractors and underachievement by others. These observations are relevant to the private and public sectors. Occupational health and safety should be viewed as an asset, not merely a cost.

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.

Improving patient safety incident reporting systems by focusing upon feedback - lessons from English and Welsh trusts.

PubMed

Wallace, Louise M; Spurgeon, Peter; Benn, Jonathan; Koutantji, Maria; Vincent, Charles

2009-08-01

This paper describes practical implications and learning from a multi-method study of feedback from patient safety incident reporting systems. The study was performed using the Safety Action and Information Feedback from Incident Reporting model, a model of the requirements of the feedback element of a patient safety incident reporting and learning system, derived from a scoping review of research and expert advice from world leaders in safety in high-risk industries. We present the key findings of the studies conducted in the National Health Services (NHS) trusts in England and Wales in 2006. These were a survey completed by risk managers for 351 trusts in England and Wales, three case studies including interviews with staff concerning an example of good practice feedback and an audit of 90 trusts clinical risk staff newsletters. We draw on an Expert Workshop that included 71 experts from the NHS, from regulatory bodies in health care, Royal Colleges, Health and Safety Executive and safety agencies in health care and high-risk industries (commercial aviation, rail and maritime industries). We draw recommendations of enduring relevance to the UK NHS that can be used by trust staff to improve their systems. The recommendations will be of relevance in general terms to health services worldwide.

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.

Risk-based requirements management framework with applications to assurance cases

NASA Astrophysics Data System (ADS)

Feng, D.; Eyster, C.

The current regulatory approach for assuring device safety primarily focuses on compliance with prescriptive safety regulations and relevant safety standards. This approach, however, does not always lead to a safe system design even though safety regulations and standards have been met. In the medical device industry, several high profile recalls involving infusion pumps have prompted the regulatory agency to reconsider how device safety should be managed, reviewed and approved. An assurance case has been cited as a promising tool to address this growing concern. Assurance cases have been used in safety-critical systems for some time. Most assurance cases, if not all, in literature today are developed in an ad hoc fashion, independent from risk management and requirement development. An assurance case is a resource-intensive endeavor that requires additional effort and documentation from equipment manufacturers. Without a well-organized requirements infrastructure in place, such “ additional effort” can be substantial, to the point where the cost of adoption outweighs the benefit of adoption. In this paper, the authors present a Risk-Based Requirements and Assurance Management (RBRAM) methodology. The RBRAM is an elaborate framework that combines Risk-Based Requirements Management (RBRM) with assurance case methods. Such an integrated framework can help manufacturers leverage an existing risk management to present a comprehensive assurance case with minimal additional effort while providing a supplementary means to reexamine the integrity of the system design in terms of the mission objective. Although the example used is from the medical industry, the authors believe that the RBRAM methodology underlines the fundamental principle of risk management, and offers a simple, yet effective framework applicable to aerospace industry, perhaps, to any industry.

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.

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.

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

A day in the life of a pharmacovigilance case processor.

PubMed

Bhangale, Ritesh; Vaity, Sayali; Kulkarni, Niranjan

2017-01-01

Pharmacovigilance (PV) has grown significantly in India in the last couple of decades. The etymological roots for the word "pharmacovigilance" are "Pharmakon" (Greek for drug) and "Vigilare" (Latin for to keep watch). It relies on information gathered from the collection of individual case safety reports and other pharmacoepidemiological data. The PV data processing cycle starts with data collection in computerized systems followed by complete data entry which includes adverse event coding, drug coding, causality and expectedness assessment, narrative writing, quality control, and report submissions followed by data storage and maintenance. A case processor plays an important role in conducting these various tasks. The case processor should also manage drug safety information, possess updated knowledge about global drug safety regulations, summarize clinical safety data, participate in meetings, write narratives with medical input from a physician, report serious adverse events to the regulatory authorities, participate in the training of operational staff on drug safety issues, quality control work of other staff in the department, and take on any other task as assigned by the manager or medical director within the capabilities of the drug safety associate. There can be challenges while handling all these tasks at a time, hence the associate will have to maintain a balance to overcome them and keep on updating their knowledge on drug safety regulations, which in turn, would help in increasing their learning curve.

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

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.

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.

Drug safety in pregnancy--monitoring congenital anomalies.

PubMed

Morgan, Margery; De Jong-van den Berg, Lolkje T W; Jordan, Sue

2011-04-01

This paper outlines research into the causes of congenital anomalies, and introduces a pan-European study. The potential roles of nurses and midwives in this area are illustrated by a case report. Since the thalidomide disaster, use of drugs in pregnancy has been carefully monitored to prevent anything similar happening again. However, monitoring is incomplete and questions remain unanswered. Many medicines are essential for the health of pregnant women. However, drug use in pregnancy requires surveillance. Methods include spontaneous reporting of adverse events, cohort studies and case control studies. It is hoped that a Europe-wide study, combining data from several congenital anomaly registers, will provide a sufficiently large population to assess the impact of selected drugs on congenital anomalies. However, this work depends on the consistency of reporting by nurses and midwives. Drug safety in pregnancy remains undetermined. Collaboration across Europe has the potential to provide a framework for safety evaluation. Prescribers should consider the possibility of pregnancy in women of child-bearing age. Careful review of maternal drug use in early pregnancy is essential. Midwives and nurses should be aware of adverse event drug reporting systems, including congenital anomaly registers. © 2011 The Authors. Journal compilation © 2011 Blackwell Publishing Ltd.

Electrocution-related mortality: a survey of 295 deaths in Tehran, Iran between 2002 and 2006.

PubMed

Sheikhazadi, Ardeshir; Kiani, Mehrzad; Ghadyani, Mohammad H

2010-03-01

Electrical burns are associated with significant morbidity and mortality, which are usually preventable with simple safety measures. We conducted a retrospective study of non-lightening electrocution deaths in Tehran, Iran, between 2002 and 2006. Of 295 deaths, 285 investigated were accidental. The remnants were suicidal. The age range was 11 months to 75 years with a mean age of 28.99 + or - 12.58 years. Two hundred seventy-nine victims (96.6%) were males. The upper extremity was the most frequently involved contact site in 185 deaths (66.3%). No electrical burn marks were present in 16 (5.4%) cases. Workrelated accidents were responsible for 188 cases deaths (63.9%) and home accident for 85 cases deaths (28.8%). Deaths were caused most frequently by touching an electrical cable (95 cases, 32.2%). There was an increase in electrocution deaths in the summer (119 cases, 40.3%). One hundred seventy-nine cases (60.7%) were dead on the scene of death and 94 cases (31.9%) were dead on arrival at hospital. The unique findings of our study include 10 cases (3.4%) of suicidal electrocution and a high rate of workrelated accidental electrocution among Afghan workers. Death rates from electrocution among all medico-legal deaths were found to be lower in our study than in previous reports, most of them were work-related and preventable. Workers and their employers should be educated to avoid such accidents with safety measures.

A new patient safety smartphone application for prevention of "forgotten" ureteral stents: results from a clinical pilot study in 194 patients.

PubMed

Molina, Wilson R; Pessoa, Rodrigo; Donalisio da Silva, Rodrigo; Kenny, McCabe C; Gustafson, Diedra; Nogueira, Leticia; Leo, Mark E; Yu, Michael K; Kim, Fernando J

2017-01-01

Approximately 12% of all ureteral stents placed are retained or "forgotten." Forgotten stents are associated with significant safety concerns as well as increased costs and legal issues. Retained ureteral stents (RUS) often occur due to lack of clinical follow-up, communication or language barriers, and economic concerns. We describe a multiplatform application that facilitates data collection to prevent RUS. The "Stent Tracker" application can be installed on mobile devices and computers. The encrypted and password-protected information is accessible from any device and provides information about each procedure, stent placement and removal dates, as well as product description. This multicenter retrospective study included 194 patients who underwent stent placement between July and October 2015. Nominal data was tallied and ordinal data was divided into quartiles of 25, 50, and 75%. A total of 194 patients from three institutions underwent ureteral stent placement. Reasons for stent placement include 122 cases post ureteroscopy (63%), 8 cases post percutaneous nephrolithotomy (PCNL) (4%), 14 cases post extracorporeal shock wave lithotripsy (SWL) (7%), 18 cases of cancer-related ureteral obstruction (9%), 21 cases of hydronephrosis (11%), and 11 for other reasons (6%). Of these patients, only one patient was lost to follow-up (0.5%). On average, ureteral stents were removed within 14 days of placement (IQR: 8-26 days). The "Stent Tracker" is a patient safety application that provides a secure and simplified interface, which can significantly reduce the incidence of RUS. Further developments could include automated notifications to patients and staff, color-coding, and integrated information with electronic patient charts.

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.

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

NASA Astrophysics Data System (ADS)

Buscarnera, G.; Lizarraga-Barrera, J.

2014-12-01

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

A Case Study of Environmental, Health and Safety Issues Involving the Burlington, Massachusetts Public School System. "Tips, Suggestions, and Resources for Investigating and Resolving EHS Issues in Schools."

ERIC Educational Resources Information Center

Dresser, Todd H.

An investigation was initiated concerning the environmental health within the Burlington, Massachusetts public school system to determine what specific environmental hazards were present and determine ways of eliminating them. This report presents 20 case studies that detail the environmental health issues involved, the approaches taken in…

Liability and Safety in Physical Education and Sport: A Practitioner's Guide to the Legal Aspects of Teaching and Coaching in Elementary and Secondary Schools.

ERIC Educational Resources Information Center

Hart, James E.; Ritson, Robert J.

This second edition contains updated information and new case studies, offering guidance for safer programs and management of risk while reinforcing sound educational practices. The book features overviews of legal concepts and presents examples of situations from the trenches. Case studies illustrate a variety of teacher, coach, and administrator…

Safety of catheter-directed thrombolysis for the treatment of acute lower extremity deep vein thrombosis: A systematic review and meta-analysis.

PubMed

Wang, Li; Zhang, Chuanlin; Mu, Shaoyu; Yeh, Chao Hsing; Chen, Liqun; Zhang, Zeju; Wang, Xueqin

2017-09-01

Despite established guidelines, catheter-directed thrombolysis (CDT) for the management of acute lower extremity deep vein thrombosis (DVT) should not be overstated because the risks of CDT are uncertain. We performed a meta-analysis to comprehensively and quantitatively evaluate the safety of CDT for patients with acute lower extremity DVT. Relevant databases, including PubMed, Embase, Cochrane, Ovid MEDLINE, and Scopus, were searched up to January 2017. The inclusion criteria were applied to select patients with acute lower extremity DVT treated by CDT or compared CDT with anticoagulation. In case series studies, the pooled estimates of safety outcomes for complications, pulmonary embolism (PE), and mortality were calculated across studies. In studies comparing CDT with anticoagulation, summary odds ratios (ORs) were calculated. Of the 1696 citations identified, 24 studies (6 comparing CDT with anticoagulation and 18 case series) including 9157 patients met the eligibility criteria. In the case series studies, the pooled risks of major, minor, and total complications were 0.03 (95% confidence interval [CI]: 0.02-0.04), 0.07 (95% CI: 0.05-0.08), and 0.09 (95% CI: 0.08-0.11), respectively; other pooled risk results were 0.00 for PE (95% CI: 0.00-0.01) and 0.07 for mortality (95% CI: 0.03-0.11). Our meta-analysis of 6 studies comparing the risk of complications and PE related to CDT with those related to anticoagulation showed that CDT was associated with an increased risk of complications (OR = 4.36; 95% CI: 2.94-6.47) and PE (OR = 1.57; 95% CI: 1.37-1.79). Acute lower extremity DVT patients receiving CDT are associated with a low risk of complications. However, compared with anticoagulation, CDT is associated with a higher risk of complications and PE. Rare mortality related to thrombolytic therapy was reported. More evidence should be accumulated to prove the safety of CDT.

Safety and Efficacy of PD-1 Inhibitors Among HIV-Positive Patients With Non-Small Cell Lung Cancer.

PubMed

Ostios-Garcia, Lorena; Faig, Jennifer; Leonardi, Giulia C; Adeni, Anika E; Subegdjo, Safiya J; Lydon, Christine A; Rangachari, Deepa; Huberman, Mark S; Sehgal, Kartik; Shea, Meghan; VanderLaan, Paul A; Cheng, Matthew P; Marty, Francisco M; Hammond, Sarah P; Costa, Daniel B; Awad, Mark M

2018-04-06

Despite widespread administration of programmed death receptor 1 (PD-1) pathway inhibitors among individuals with NSCLC, little is known about the safety and activity of these agents among human immunodeficiency virus (HIV) - infected patients since this population has largely been excluded from immunotherapy clinical trials. Here, we describe seven patients with metastatic NSCLC and HIV infection who were treated with PD-1 inhibitors nivolumab (two cases) or pembrolizumab (five cases with three in the first-line setting). Partial responses to immune checkpoint inhibitors were observed in three of seven cases. Among four patients with a programmed death ligand-1 tumor proportion score ≥50%, three partial responses were observed. All patients received antiretroviral therapy while on anti-PD-1 treatment. None of the patients experienced grade 3 or 4 immune-related adverse events or immune reconstitution inflammatory syndrome, and none required PD-1 inhibitor dose interruption or discontinuation due to toxicity. Nivolumab and pembrolizumab can be safe and effective among patients with NSCLC and HIV. Larger studies will be needed to determine the overall safety and efficacy of immune checkpoint inhibitors among cancer patients with HIV. Copyright © 2018 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.

A World Health Organization field trial assessing a proposed ICD-11 framework for classifying patient safety events.

PubMed

Forster, Alan J; Bernard, Burnand; Drösler, Saskia E; Gurevich, Yana; Harrison, James; Januel, Jean-Marie; Romano, Patrick S; Southern, Danielle A; Sundararajan, Vijaya; Quan, Hude; Vanderloo, Saskia E; Pincus, Harold A; Ghali, William A

2017-08-01

To assess the utility of the proposed World Health Organization (WHO)'s International Classification of Disease (ICD) framework for classifying patient safety events. Independent classification of 45 clinical vignettes using a web-based platform. The WHO's multi-disciplinary Quality and Safety Topic Advisory Group. The framework consists of three concepts: harm, cause and mode. We defined a concept as 'classifiable' if more than half of the raters could assign an ICD-11 code for the case. We evaluated reasons why cases were nonclassifiable using a qualitative approach. Harm was classifiable in 31 of 45 cases (69%). Of these, only 20 could be classified according to cause and mode. Classifiable cases were those in which a clear cause and effect relationship existed (e.g. medication administration error). Nonclassifiable cases were those without clear causal attribution (e.g. pressure ulcer). Of the 14 cases in which harm was not evident (31%), only 5 could be classified according to cause and mode and represented potential adverse events. Overall, nine cases (20%) were nonclassifiable using the three-part patient safety framework and contained significant ambiguity in the relationship between healthcare outcome and putative cause. The proposed framework enabled classification of the majority of patient safety events. Cases in which potentially harmful events did not cause harm were not classifiable; additional code categories within the ICD-11 are one proposal to address this concern. Cases with ambiguity in cause and effect relationship between healthcare processes and outcomes remain difficult to classify. © The Author 2017. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

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).

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

PubMed

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

2013-07-29

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

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

PubMed Central

2013-01-01

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

The Child Welfare Response to Serious Nonaccidental Head Trauma

ERIC Educational Resources Information Center

Jaudes, Paula Kienberger; Bilaver, Lucy A.

2004-01-01

Serious nonaccidental head trauma (NHT) can leave permanent neurological damage in children who survive abuse. This study reports on child welfare's handling of NHT cases compared with cases of physical abuse and head trauma due to neglect with regard to placement in foster care, reunification with family, and safety issues. The results show that…

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

EPA Science Inventory

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

Attention-Deficit/Hyperactivity Disorder and Fatal Accidents in Aviation Medicine.

PubMed

Laukkala, Tanja; Bor, Robert; Budowle, Bruce; Sajantila, Antti; Navathe, Pooshan; Sainio, Markku; Vuorio, Alpo

2017-09-01

Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder with symptoms of inattention and/or hyperactivity-impulsivity that interfere with functioning and/or development. ADHD occurs in about 2.5% of adults. ADHD can be an excluding medical condition among pilots due to the risk of attentional degradation and therefore impact on flight safety. Diagnosis of ADHD is complex, which complicates aeromedical assessment. This study highlights fatal accident cases among pilots with ADHD and discusses protocols to detect its presence to help to assess its importance to flight safety. To identify fatal accidents in aviation (including airplanes, helicopters, balloons, and gliders) in the United States between the years 2000 to 2015, the National Transportation Safety Board (NTSB) database was searched with the terms ADHD, attention deficit hyperactivity disorder, and attention deficit disorder (ADD). The NTSB database search for fatal aviation accidents possibly associated with ADHD yielded four accident cases of interest in the United States [4/4894 (0.08%)]. Two of the pilots had ADHD diagnosed by a doctor, one was reported by a family member, and one by a flight instructor. An additional five cases were identified searching for ADD [5/4894 (0.1%)]. Altogether, combined ADHD and ADD cases yielded nine accident cases of interest (0.18%). It is generally accepted by aviation regulatory authorities that ADHD is a disqualifying neurological condition. Yet FAA and CASA provide specific protocols for tailor-made pilot assessment. Accurate evaluation of ADHD is essential because of its potential negative impact on aviation safety.Laukkala T, Bor R, Budowle B, Sajantila A, Navathe P, Sainio M, Vuorio A. Attention-deficit/hyperactivity disorder and fatal accidents in aviation medicine. Aerosp Med Hum Perform. 2017; 88(9):871-875.

Assuring Ground-Based Detect and Avoid for UAS Operations

NASA Technical Reports Server (NTRS)

Denney, Ewen W.; Pai, Ganeshmadhav Jagadeesh; Berthold, Randall; Fladeland, Matthew; Storms, Bruce; Sumich, Mark

2014-01-01

One of the goals of the Marginal Ice Zones Observations and Processes Experiment (MIZOPEX) NASA Earth science mission was to show the operational capabilities of Unmanned Aircraft Systems (UAS) when deployed on challenging missions, in difficult environments. Given the extreme conditions of the Arctic environment where MIZOPEX measurements were required, the mission opted to use a radar to provide a ground-based detect-and-avoid (GBDAA) capability as an alternate means of compliance (AMOC) with the see-and-avoid federal aviation regulation. This paper describes how GBDAA safety assurance was provided by interpreting and applying the guidelines in the national policy for UAS operational approval. In particular, we describe how we formulated the appropriate safety goals, defined the processes and procedures for system safety, identified and assembled the relevant safety verification evidence, and created an operational safety case in compliance with Federal Aviation Administration (FAA) requirements. To the best of our knowledge, the safety case, which was ultimately approved by the FAA, is the first successful example of non-military UAS operations using GBDAA in the U.S. National Airspace System (NAS), and, therefore, the first nonmilitary application of the safety case concept in this context.

[Occupational injuries among construction workers in Hong Kong].

PubMed

Huang, Zihui; Chen, Weiqing

2002-02-01

To explore the nature and severity of occupational injuries among construction workers and its risk factors in Hong Kong. One hundred and twenty-two injured construction workers in a public hospital and an equal number of workmate controls were studied. Contents included socio -demographic characteristics, the availability and use of safety equipment, smoking and alcohol consumption, etc. Abbreviated injury scale (AIS) and injury severity score (ISS) were employed for describing the nature, pattern and severity of injuries. Single injuries were seen in 80% of cases. Of 149 injuries classified by body region, 49% were external, 26% involved either the upper or lower extremities, and 11% were spinal injuries. Working at height was associated with the injury severity score. Safety hazards were identified in the work environment in 68% of the cases. Significant odds ratios for accidents were obtained for 'no formal education', 'non safety training' and 'current smokers'. The results implicated that construction was a hazardous occupation in Hong Kong. Improving the work environment and promoting safety education among construction workers would be helpful for minimizing or eliminating occupational injuries in construction occupation in Hong Kong.

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

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.

Nature of Blame in Patient Safety Incident Reports: Mixed Methods Analysis of a National Database.

PubMed

Cooper, Jennifer; Edwards, Adrian; Williams, Huw; Sheikh, Aziz; Parry, Gareth; Hibbert, Peter; Butlin, Amy; Donaldson, Liam; Carson-Stevens, Andrew

2017-09-01

A culture of blame and fear of retribution are recognized barriers to reporting patient safety incidents. The extent of blame attribution in safety incident reports, which may reflect the underlying safety culture of health care systems, is unknown. This study set out to explore the nature of blame in family practice safety incident reports. We characterized a random sample of family practice patient safety incident reports from the England and Wales National Reporting and Learning System. Reports were analyzed according to prespecified classification systems to describe the incident type, contributory factors, outcomes, and severity of harm. We developed a taxonomy of blame attribution, and we then used descriptive statistical analyses to identify the proportions of blame types and to explore associations between incident characteristics and one type of blame. Health care professionals making family practice incident reports attributed blame to a person in 45% of cases (n = 975 of 2,148; 95% CI, 43%-47%). In 36% of cases, those who reported the incidents attributed fault to another person, whereas 2% of those reporting acknowledged personal responsibility. Blame was commonly associated with incidents where a complaint was anticipated. The high frequency of blame in these safety, incident reports may reflect a health care culture that leads to blame and retribution, rather than to identifying areas for learning and improvement, and a failure to appreciate the contribution of system factors in others' behavior. Successful improvement in patient safety through the analysis of incident reports is unlikely without achieving a blame-free culture. © 2017 Annals of Family Medicine, Inc.

Nature of Blame in Patient Safety Incident Reports: Mixed Methods Analysis of a National Database

PubMed Central

Cooper, Jennifer; Edwards, Adrian; Williams, Huw; Sheikh, Aziz; Parry, Gareth; Hibbert, Peter; Butlin, Amy; Donaldson, Liam; Carson-Stevens, Andrew

2017-01-01

PURPOSE A culture of blame and fear of retribution are recognized barriers to reporting patient safety incidents. The extent of blame attribution in safety incident reports, which may reflect the underlying safety culture of health care systems, is unknown. This study set out to explore the nature of blame in family practice safety incident reports. METHODS We characterized a random sample of family practice patient safety incident reports from the England and Wales National Reporting and Learning System. Reports were analyzed according to prespecified classification systems to describe the incident type, contributory factors, outcomes, and severity of harm. We developed a taxonomy of blame attribution, and we then used descriptive statistical analyses to identify the proportions of blame types and to explore associations between incident characteristics and one type of blame. RESULTS Health care professionals making family practice incident reports attributed blame to a person in 45% of cases (n = 975 of 2,148; 95% CI, 43%–47%). In 36% of cases, those who reported the incidents attributed fault to another person, whereas 2% of those reporting acknowledged personal responsibility. Blame was commonly associated with incidents where a complaint was anticipated. CONCLUSIONS The high frequency of blame in these safety, incident reports may reflect a health care culture that leads to blame and retribution, rather than to identifying areas for learning and improvement, and a failure to appreciate the contribution of system factors in others’ behavior. Successful improvement in patient safety through the analysis of incident reports is unlikely without achieving a blame-free culture. PMID:28893816

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.

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/.

A Case History Introducing the Oregon Ag Seminar Series-Keys to Program and Research-to-Practice Success.

PubMed

Harrington, Marcy J; Lloyd, Kirk

2017-01-01

This case history of Oregon state's Ag Seminar Series is consistent with the Socio-Ecological Model, demonstrating how policy at a state level can influence an organizational approach with impacts that ultimately influence safety practices on the farm. From modest beginnings, the Ag Seminar Series, offered through a workers compensation insurance company, now serves over 2,300 Oregon farmers annually in English and Spanish. This case offers unique but also replicable methods for educators, insurers, and researchers in safety education, safety motivators, and research-to-practice (r2p).

Impact of a Food Safety Campaign on Streptococcus suis Infection in Humans in Thailand.

PubMed

Takeuchi, Dan; Kerdsin, Anusak; Akeda, Yukihiro; Chiranairadul, Piphat; Loetthong, Phacharaphan; Tanburawong, Nutchada; Areeratana, Prasanee; Puangmali, Panarat; Khamisara, Kasean; Pinyo, Wirasinee; Anukul, Rapeepun; Samerchea, Sutit; Lekhalula, Punpong; Nakayama, Tatsuya; Yamamoto, Kouji; Hirose, Masayo; Hamada, Shigeyuki; Dejsirilert, Surang; Oishi, Kazunori

2017-06-01

Abstract Streptococcus suis is an important zoonotic pathogen in swine and humans that causes sepsis and meningitis. Our previous study in Thailand showed that the prevalence of S. suis infection in humans, especially in northern areas of Thailand, and the transmission of the pathogen occurred mainly through the consumption of traditional raw pork products. Considering the high incidence proportion and mortality rate of the disease as an important public health problem, we implemented a food safety campaign in the Phayao Province in northern Thailand in 2011. We evaluated the effects of a food safety campaign by comparing the sociodemographic, clinical, and bacteriological characteristics of cases before and after the campaign. The follow-up study showed a marked decrease of the incidence proportion in the first 2 years, indicating the effectiveness of the campaign. In the third year, however, the incidence proportion slightly increased again, indicating the existence of deep-rooted cultural behaviors and the necessity of continuous public health intervention. Furthermore, epidemiological analysis of the cases made it possible to estimate the infectivity of the pathogen via the oral route of infection. In the present study, we showed the effectiveness of the food safety campaign for controlling the S. suis infection, and we present a role model public health intervention for prevalent areas affected by S. suis infection in humans.

Impact of a Food Safety Campaign on Streptococcus suis Infection in Humans in Thailand

PubMed Central

Takeuchi, Dan; Kerdsin, Anusak; Akeda, Yukihiro; Chiranairadul, Piphat; Loetthong, Phacharaphan; Tanburawong, Nutchada; Areeratana, Prasanee; Puangmali, Panarat; Khamisara, Kasean; Pinyo, Wirasinee; Anukul, Rapeepun; Samerchea, Sutit; Lekhalula, Punpong; Nakayama, Tatsuya; Yamamoto, Kouji; Hirose, Masayo; Hamada, Shigeyuki; Dejsirilert, Surang; Oishi, Kazunori

2017-01-01

Streptococcus suis is an important zoonotic pathogen in swine and humans that causes sepsis and meningitis. Our previous study in Thailand showed that the prevalence of S. suis infection in humans, especially in northern areas of Thailand, and the transmission of the pathogen occurred mainly through the consumption of traditional raw pork products. Considering the high incidence proportion and mortality rate of the disease as an important public health problem, we implemented a food safety campaign in the Phayao Province in northern Thailand in 2011. We evaluated the effects of a food safety campaign by comparing the sociodemographic, clinical, and bacteriological characteristics of cases before and after the campaign. The follow-up study showed a marked decrease of the incidence proportion in the first 2 years, indicating the effectiveness of the campaign. In the third year, however, the incidence proportion slightly increased again, indicating the existence of deep-rooted cultural behaviors and the necessity of continuous public health intervention. Furthermore, epidemiological analysis of the cases made it possible to estimate the infectivity of the pathogen via the oral route of infection. In the present study, we showed the effectiveness of the food safety campaign for controlling the S. suis infection, and we present a role model public health intervention for prevalent areas affected by S. suis infection in humans. PMID:28719258

Labouring Together: collaborative alliances in maternity care in Victoria, Australia—protocol of a mixed-methods study

PubMed Central

Nagle, Cate; Kent, Bridie; Hutchinson, Alison M

2017-01-01

Introduction For over a decade, enquiries into adverse perinatal outcomes have led to reports that poor collaboration has been detrimental to the safety and experience of maternity care. Despite efforts to improve collaboration, investigations into maternity care at Morecambe Bay (UK) and Djerriwarrh Health Services (Australia) have revealed that poor collaboration and decision-making remain a threat to perinatal safety. The Labouring Together study will investigate how elements hypothesised to influence the effectiveness of collaboration are reflected in perceptions and experiences of clinicians and childbearing women in Victoria, Australia. The study will explore conditions that assist clinicians and women to work collaboratively to support positive maternity outcomes. Results of the study will provide a platform for consumers, clinician groups, organisations and policymakers to work together to improve the quality, safety and experience of maternity care. Methods and analysis 4 case study sites have been selected to represent a range of models of maternity care in metropolitan and regional Victoria, Australia. A mixed-methods approach including cross-sectional surveys and interviews will be used in each case study site, involving both clinicians and consumers. Quantitative data analysis will include descriptive statistics, 2-way multivariate analysis of variance for the dependent and independent variables, and χ2 analysis to identify the degree of congruence between consumer preferences and experiences. Interview data will be analysed for emerging themes and concepts. Data will then be analysed for convergent lines of enquiry supported by triangulation of data to draw conclusions. Ethics and dissemination Organisational ethics approval has been received from the case study sites and Deakin University Human Research Ethics Committee (2014–238). Dissemination of the results of the Labouring Together study will be via peer-reviewed publications and conference presentations, and in written reports for each case study site to support organisational change. PMID:28270390

Labouring Together: collaborative alliances in maternity care in Victoria, Australia-protocol of a mixed-methods study.

PubMed

Watkins, Vanessa; Nagle, Cate; Kent, Bridie; Hutchinson, Alison M

2017-03-07

For over a decade, enquiries into adverse perinatal outcomes have led to reports that poor collaboration has been detrimental to the safety and experience of maternity care. Despite efforts to improve collaboration, investigations into maternity care at Morecambe Bay (UK) and Djerriwarrh Health Services (Australia) have revealed that poor collaboration and decision-making remain a threat to perinatal safety. The Labouring Together study will investigate how elements hypothesised to influence the effectiveness of collaboration are reflected in perceptions and experiences of clinicians and childbearing women in Victoria, Australia. The study will explore conditions that assist clinicians and women to work collaboratively to support positive maternity outcomes. Results of the study will provide a platform for consumers, clinician groups, organisations and policymakers to work together to improve the quality, safety and experience of maternity care. 4 case study sites have been selected to represent a range of models of maternity care in metropolitan and regional Victoria, Australia. A mixed-methods approach including cross-sectional surveys and interviews will be used in each case study site, involving both clinicians and consumers. Quantitative data analysis will include descriptive statistics, 2-way multivariate analysis of variance for the dependent and independent variables, and χ 2 analysis to identify the degree of congruence between consumer preferences and experiences. Interview data will be analysed for emerging themes and concepts. Data will then be analysed for convergent lines of enquiry supported by triangulation of data to draw conclusions. Organisational ethics approval has been received from the case study sites and Deakin University Human Research Ethics Committee (2014-238). Dissemination of the results of the Labouring Together study will be via peer-reviewed publications and conference presentations, and in written reports for each case study site to support organisational change. 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/.

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.

Monitoring the safety of quadrivalent human papillomavirus vaccine: findings from the Vaccine Safety Datalink.

PubMed

Gee, Julianne; Naleway, Allison; Shui, Irene; Baggs, James; Yin, Ruihua; Li, Rong; Kulldorff, Martin; Lewis, Edwin; Fireman, Bruce; Daley, Matthew F; Klein, Nicola P; Weintraub, Eric S

2011-10-26

In 7 large managed care organizations (MCOs), we performed a post-licensure safety assessment of quadrivalent human papillomavirus vaccine (HPV4) among 9-26 year-old female vaccine recipients between August 2006 and October 2009. Sequential analyses were conducted weekly to detect associations between HPV4 exposure and pre-specified outcomes. The pre-specified outcomes identified by ICD-9 codes using computerized data at the participating MCOs included: Guillan-Barré Syndrome (GBS), stroke, venous thromboembolism (VTE), appendicitis, seizures, syncope, allergic reactions, and anaphylaxis. For rare outcomes, historical background rates were used as the comparison group. For more common outcomes, a concurrent unexposed comparison group was utilized. A standardized review of medical records was conducted for all cases of GBS, VTE, and anaphylaxis. A total of 600,558 HPV4 doses were administered during the study period. We found no statistically significant increased risk for the outcomes studied. However, a non-statistically significant relative risk (RR) for VTE ICD-9 codes following HPV4 vaccination of 1.98 was detected among females age 9-17 years. Medical record review of all 8 vaccinated potential VTE cases in this age group revealed that 5 met the standard case definition for VTE. All 5 confirmed cases had known risk factors for VTE (oral contraceptive use, coagulation disorders, smoking, obesity or prolonged hospitalization). In a study of over 600,000 HPV4 vaccine doses administered, no statistically significant increased risk for any of the pre-specified adverse events after vaccination was detected. Further study of a possible association with VTE following HPV4 vaccination is warranted. Published by Elsevier Ltd.

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.

Teaching the science of safety in US colleges and schools of pharmacy.

PubMed

Holdford, David A; Warholak, Terri L; West-Strum, Donna; Bentley, John P; Malone, Daniel C; Murphy, John E

2011-05-10

This paper provides baseline information on integrating the science of safety into the professional degree curriculum at colleges and schools of pharmacy. A multi-method examination was conducted that included a literature review, key informant interviews of 30 individuals, and in-depth case studies of 5 colleges and schools of pharmacy. Educators believe that they are devoting adequate time to science of safety topics and doing a good job teaching students to identify, understand, report, manage, and communicate medication risk. Areas perceived to be in need of improvement include educating pharmacy students about the Food and Drug Administration's (FDA's) role in product safety, how to work with the FDA in post-marketing surveillance and other FDA safety initiatives, teaching students methods to improve safety, and educating students to practice in interprofessional teams. The report makes 10 recommendations to help pharmacy school graduates be more effective in protecting patients from preventable drug-related problems.

A simulation model for determining the optimal size of emergency teams on call in the operating room at night.

PubMed

van Oostrum, Jeroen M; Van Houdenhoven, Mark; Vrielink, Manon M J; Klein, Jan; Hans, Erwin W; Klimek, Markus; Wullink, Gerhard; Steyerberg, Ewout W; Kazemier, Geert

2008-11-01

Hospitals that perform emergency surgery during the night (e.g., from 11:00 pm to 7:30 am) face decisions on optimal operating room (OR) staffing. Emergency patients need to be operated on within a predefined safety window to decrease morbidity and improve their chances of full recovery. We developed a process to determine the optimal OR team composition during the night, such that staffing costs are minimized, while providing adequate resources to start surgery within the safety interval. A discrete event simulation in combination with modeling of safety intervals was applied. Emergency surgery was allowed to be postponed safely. The model was tested using data from the main OR of Erasmus University Medical Center (Erasmus MC). Two outcome measures were calculated: violation of safety intervals and frequency with which OR and anesthesia nurses were called in from home. We used the following input data from Erasmus MC to estimate distributions of all relevant parameters in our model: arrival times of emergency patients, durations of surgical cases, length of stay in the postanesthesia care unit, and transportation times. In addition, surgeons and OR staff of Erasmus MC specified safety intervals. Reducing in-house team members from 9 to 5 increased the fraction of patients treated too late by 2.5% as compared to the baseline scenario. Substantially more OR and anesthesia nurses were called in from home when needed. The use of safety intervals benefits OR management during nights. Modeling of safety intervals substantially influences the number of emergency patients treated on time. Our case study showed that by modeling safety intervals and applying computer simulation, an OR can reduce its staff on call without jeopardizing patient safety.

Defining the methodological challenges and opportunities for an effective science of sociotechnical systems and safety

PubMed Central

Waterson, Patrick; Robertson, Michelle M.; Cooke, Nancy J.; Militello, Laura; Roth, Emilie; Stanton, Neville A.

2015-01-01

An important part of the application of sociotechnical systems theory (STS) is the development of methods, tools and techniques to assess human factors and ergonomics workplace requirements. We focus in this paper on describing and evaluating current STS methods for workplace safety, as well as outlining a set of six case studies covering the application of these methods to a range of safety contexts. We also describe an evaluation of the methods in terms of ratings of their ability to address a set of theoretical and practical questions (e.g. the degree to which methods capture static/dynamic aspects of tasks and interactions between system levels). The outcomes from the evaluation highlight a set of gaps relating to the coverage and applicability of current methods for STS and safety (e.g. coverage of external influences on system functioning; method usability). The final sections of the paper describe a set of future challenges, as well as some practical suggestions for tackling these. Practitioner Summary: We provide an up-to-date review of STS methods, a set of case studies illustrating their use and an evaluation of their strengths and weaknesses. The paper concludes with a ‘roadmap’ for future work. PMID:25832121

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

PubMed

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

2013-12-01

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

Safety of pandemic H1N1 vaccines in children and adolescents.

PubMed

Wijnans, Leonoor; de Bie, Sandra; Dieleman, Jeanne; Bonhoeffer, Jan; Sturkenboom, Miriam

2011-10-06

During the 2009 influenza A (H1N1) pandemic several pandemic H1N1 vaccines were licensed using fast track procedures, with relatively limited data on the safety in children and adolescents. Different extensive safety monitoring efforts were put in place to ensure timely detection of adverse events following immunization. These combined efforts have generated large amounts of data on the safety of the different pandemic H1N1 vaccines, also in children and adolescents. In this overview we shortly summarize the safety experience with seasonal influenza vaccines as a background and focus on the clinical and post marketing safety data of the pandemic H1N1 vaccines in children. We identified 25 different clinical studies including 10,505 children and adolescents, both healthy and with underlying medical conditions, between the ages of 6 months and 23 years. In addition, large monitoring efforts have resulted in large amounts of data, with almost 13,000 individual case reports in children and adolescents to the WHO. However, the diversity in methods and data presentation in clinical study publications and publications of spontaneous reports hampered the analysis of safety of the different vaccines. As a result, relatively little has been learned on the comparative safety of these pandemic H1N1 vaccines - particularly in children. It should be a collective effort to give added value to the enormous work going into the individual studies by adhering to available guidelines for the collection, analysis, and presentation of vaccine safety data in clinical studies and to guidance for the clinical investigation of medicinal products in the pediatric population. Importantly the pandemic has brought us the beginning of an infrastructure for collaborative vaccine safety studies in the EU, USA and globally. Copyright © 2011 Elsevier Ltd. All rights reserved.

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.

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 study design flexibility must be allowed, and investigators must be prepared for protocol modifications due to interim findings. The Data and Safety Monitoring Board must have sufficient clinical and statistical expertise to assess potential importance of interim treatment differences in the setting of multiple looks at accumulating data with numerous outcomes and subgroups.

Space Station Furnace Facility. Volume 2: Requirements Definition and Conceptual Design Study. Appendix 3: Environment Analysis. Volume 2; Appendix 3

NASA Technical Reports Server (NTRS)

1992-01-01

A Preliminary Safety Analysis (PSA) is being accomplished as part of the Space Station Furnace Facility (SSFF) contract. This analysis is intended to support SSFF activities by analyzing concepts and designs as they mature to develop essential safety requirements for inclusion in the appropriate specifications, and designs, as early as possible. In addition, the analysis identifies significant safety concerns that may warrant specific trade studies or design definition, etc. The analysis activity to date concentrated on hazard and hazard cause identification and requirements development with the goal of developing a baseline set of detailed requirements to support trade study, specifications development, and preliminary design activities. The analysis activity will continue as the design and concepts mature. Section 2 defines what was analyzed, but it is likely that the SSFF definitions will undergo further changes. The safety analysis activity will reflect these changes as they occur. The analysis provides the foundation for later safety activities. The hazards identified will in most cases have Preliminary Design Review (PDR) applicability. The requirements and recommendations developed for each hazard will be tracked to ensure proper and early resolution of safety concerns.

77 FR 21782 - International Conference on Harmonisation; Draft Guidance for Industry on E2C(R2) Periodic...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-11

... electronic submission of individual case safety reports to regulatory authorities, automated data mining... Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (E2C guidance) and ``Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (addendum...

Use of asenapine as add-on therapy in the treatment of bipolar disorder: a comprehensive review and case series.

PubMed

Dell'Osso, Bernardo; Cremaschi, Laura; Palazzo, Maria Carlotta; Spagnolin, Gregorio; Cattaneo, Alma; Grancini, Benedetta; Maggi, Matteo; Altamura, Alfredo Carlo

2014-09-01

Several randomized controlled trials (RCTs), conducted in schizophrenic and bipolar patients, have documented the efficacy and tolerability of asenapine as monotherapy both for short- and long-term treatment. However, evidence on its augmentative use is more limited and related to the manic/mixed phase of bipolar disorder (BD). The present article reviews augmentative asenapine efficacy and safety/tolerability in the treatment of BD. It also includes some original cases of bipolar patients treated with add-on asenapine in the short- and long-term. To date, only a single RCT with manic/mixed patients with partial response to mood-stabilizer monotherapy supports the efficacy and safety/tolerability of augmentative asenapine to lithium/valproate, both in acute and long-term treatment. Additionally, two case reports confirm the overall effectiveness of augmentative asenapine to clozapine and valproate. Our case series, consisting of 4 bipolar patients treated with adjunctive asenapine to mood stabilizers and atypical antipsychotics - with treatment duration ranging from 1 to 14 months - provided clinical results that are consistent with literature data. Taken as a whole, available evidence seems to support the efficacy and safety of adjunctive asenapine in bipolar patients, though additional studies with active comparators are requested to confirm the current body of evidence.

Reducing air pollutant emissions at airports by controlling aircraft ground operations

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

Gelinas, C.G.; Fan, H.S.L.

1979-02-01

Potential reductions in air pollutant emissions were determined for four stategies to control aircraft ground operations at two case study airports, Los Angeles and San Francisco International Airports. Safety, cost, and fuel savings associated with strategy implementation were examined. Two strategies, aircraft towing and shutdown of one engine during taxi operations, provided significant emission reductions. However, there are a number of safety problems associated with aircraft towing. The shutdown of one engine while taxiing was found to be the most viable strategy because of substantial emission reductions, cost benefits resulting from fuel savings, and no apparent safety problems.

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.

First series of total robotic hysterectomy (TRH) using new integrated table motion for the da Vinci Xi: feasibility, safety and efficacy.

PubMed

Giannini, Andrea; Russo, Eleonora; Mannella, Paolo; Palla, Giulia; Pisaneschi, Silvia; Cecchi, Elena; Maremmani, Michele; Morelli, Luca; Perutelli, Alessandra; Cela, Vito; Melfi, Franca; Simoncini, Tommaso

2017-08-01

To present the first case series of total robotic hysterectomy (TRH), using integrated table motion (ITM), which is a new feature comprising a unique operating table by Trumpf Medical that communicates wirelessly with the da Vinci Xi surgical system. ITM has been specifically developed to improve multiquadrant robotic surgery such as that conducted in colorectal surgery. Between May and October 2015, a prospective post-market study was conducted on ITM in the EU in 40 cases from different specialties. The gynecological study group comprised 12 patients. Primary endpoints were ITM feasibility, safety and efficacy. Ten patients underwent TRH. Mean number of ITM moves was three during TRH; there were 31 instances of table moves in the ten procedures. Twenty-eight of 31 ITM moves were made to gain internal exposure. The endoscope remained inserted during 29 of the 31 table movements (94%), while the instruments remained inserted during 27 of the 31 moves (87%). No external instrument collisions or other problems related to the operating table were noted. There were no ITM safety-related observations and no adverse events. This preliminary study demonstrated the feasibility, safety and efficacy of ITM for the da Vinci Xi surgical system in TRH. ITM was safe, with no adverse events related to its use. Further studies will be useful to define the real role and potential benefit of ITM in gynecological surgery.

A 6-Month Trial of the Efficacy and Safety of Triptorelin Pamoate (11.25 mg) Every 3 Months in Children with Precocious Puberty: A Retrospective Comparison with Triptorelin Acetate.

PubMed

Zenaty, Delphine; Blumberg, Joelle; Liyanage, Nilani; Jacqz-Aigrain, Evelyne; Lahlou, Najiba; Carel, Jean-Claude

2016-01-01

To evaluate the efficacy and safety of a triptorelin pamoate (11.25 mg) 3-month formulation in the management of central precocious puberty (CPP) (TP Study) and to retrospectively compare it with a triptorelin acetate (11.25 mg) 3-month formulation (TA Study). We conducted two phase III, multicentre, single-stage, non-comparative, open-label studies. In the TP Study, patients with CPP received an intramuscular injection of triptorelin pamoate 11.25 mg at baseline and 3 months after baseline. Hormonal changes as well as safety and efficacy endpoints were measured at baseline, 3 months, and 6 months. The baseline characteristics of the 37 patients in the TP Study were similar to those of the TA Study population. A suppressed luteinising hormone (LH) response (LH peak ≤3 IU/l) to the gonadotrophin-releasing hormone test at 3 months (primary endpoint) occurred in 83.8 and 82.8% of the cases in the TP and the TA Study, respectively. At 6 months, a suppressed LH response occurred in 86.5 and 96.8% of the cases in the TP and the TA Study, respectively. Pubertal development was slowed in both studies. Adverse events were mild to moderate and resolved without sequelae in the TP Study. Triptorelin pamoate 11.25 mg administered at 3-month intervals is an effective and well-tolerated treatment in patients with CPP. The efficacy and safety profiles appear similar to those reported in the literature for triptorelin acetate 11.25 mg. © 2016 S. Karger AG, Basel.

Impact of software and hardware technologies on occupational health and safety policies in Saudi Arabian oil refineries.

PubMed

Idreis, Hany M; Siqueira, Carlos E; Levenstein, Charles C

2006-01-01

This article seeks to examine the impact of technology importation on occupational health and safety in both Saudi Arabian and U.S. oil refining industries. Technologies imported to the Saudi oil industry take two forms: hardware (sophisticated equipment to run oil facilities) and software (policies and regulations pertaining to workers' health and safety, and employment rights installed by Aramco's founding multinational companies). This study utilizes qualitative, historically oriented, cross-national case studies to compare and assess workers' health, safety, and rights in Saudi Aramco with its U.S. counterpart, Motiva Enterprises. Two facilities were chosen to conduct field research: the Saudi Aramco oil refinery at Jeddah and Motiva's refinery at Port Arthur, Texas. The Jeddah refinery is fully owned by Saudi Aramco, thus, representing Aramco's health and safety policies and regulations. The Port Arthur refinery serves as a reference case study for U.S. oil refining facilities. The aspects of occupational health and safety in Saudi Aramco--ExxonMobil's joint ventures SAMREF and LUBREF--also are discussed to examine workers' health policies in both companies. The American oil industry made a significant contribution in establishing the Saudi oil industry, with the cooperation of the Saudi government. Despite having outstanding employment benefits schemes in Saudi Aramco, the presence of an organized work force better serves employee participation in Motiva than in Aramco. Safety systems such as Process Safety Management (PSM)--applied in Motiva--partially exist in Aramco to operate hardware technologies safely. Motiva training systems are better through PACE's Triangle of Prevention (TOP). Both companies follow the same pattern of handling occupational injuries and diseases; however, Saudi government agencies (GOSI) are responsible for compensating and treating injured workers. Saudi workers expressed conditional support for the worker committee program proposed by the Ministry of Labor. American and Saudi workers are concerned about the quality and sufficiency of health and safety training, employment promotion, work pressure, and job uncertainty due to continuous downsizing. This article recommends that Saudi social actors increase safety and health awareness in the work environment by providing intensive occupational safety training to the employees (as demanded by Saudi and American workers), improve labor-management relations through establishing strong cooperative contacts with regional and international trade unions, and establish uniform and standard occupational health and safety regulations for Saudi Aramco and its subsidiaries in order to provide an equal level of protection for Saudi workers.

Safety monitoring of ophthalmic biologics: a systematic review of pre- and postmarketing safety data.

PubMed

Penedones, Ana; Mendes, Diogo; Alves, Carlos; Batel Marques, Francisco

2014-11-01

The present study evaluates the safety of the biologics approved for the treatment of ocular diseases. The European medicines agency Website was searched to identify biologics with approved ophthalmologic therapeutic indications. A systematic search was performed using MEDLINE, the Cochrane Central Register of Controlled Trials (CENTRAL) and the International Clinical Trials Registry Platform up to December 2013. Pre-marketing, phase III randomized controlled trials (RCT), postmarketing clinical trials, observational longitudinal studies, and case reports involving adverse events (AE) were included. Methodological quality was assessed by Downs & Black checklist. All European spontaneous reports of AE included in the Eudravigilance up to December 2013 were also considered. AE were classified as ocular (related and non-related with the injection procedure) and non-ocular (related or non-related with vascular endothelial growth factor inhibition). Incidences of all reported AEs were estimated. Pegaptanib, ranibizumab, and aflibercept were identified as ophthalmic biologics. Fourteen premarketing RCT, 7 postmarketing clinical trials, 31 observational studies, along with 31 case reports and 7,720 spontaneous reports were identified and included in this study. Both in pre- and postmarketing settings, ocular AEs were more frequent than non-ocular AEs. Premarketing safety data inform the most common AEs. Postmarketing studies suggest an increased number of events such as retinal pigmented epithelium tears (0.6%-24%), thromboembolic events (0.8%-5%), and mortality (2.8%-4%). This study highlights the need to properly evaluate the risk for rare, serious, and long-term AEs, such as thromboembolic events, since they can lead to imbalances in the benefit-risk ratio of biologics in ophthalmology.

Mine safety assessment using gray relational analysis and bow tie model

PubMed Central

2018-01-01

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

Multi-Center Pilot Study to Evaluate the Safety Pro le of High Energy Fractionated Radiofrequency With Insulated Microneedles to Multiple Levels of the Dermis.

PubMed

Cohen, Joel L; Weiner, Steven F; Pozner, Jason N; Ibrahimi, Omar A; Vasily, David B; Ross, E Victor; Gabriel, Zena

2016-11-01

In this multi-center pilot study, the safety pro le of high intensity focused radiofrequency (RF) delivered to the dermis was evaluated for safety in the treatment of the aging neck and face. A newly designed insulated microneedle system delivers a signi cant coagulative thermal injury into the dermis while sparing the epidermis from RF injury. Thirty- ve healthy subjects from seven aesthetic practices were evaluated, and data from each were incorporated in this case report. The subjects received a single treatment using settings that delivered the highest RF energies suggested from the new recommended protocols. The depth of thermal delivery was adjusted before each pass and all subjects received a minimum of two to three passes to the treated areas. Before and after photographs along with adverse effects were recorded. This case report demonstrates the ability to deliver significant RF thermal injury to several layers of the dermis with insulated microneedles safely with little injury to the epidermis and minimum downtime. J Drugs Dermatol. 2016;15(11):1308-1312..

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.

Application of an aviation model of incident reporting and investigation to the neurosurgical scenario: method and preliminary data.

PubMed

Ferroli, Paolo; Caldiroli, Dario; Acerbi, Francesco; Scholtze, Maurizio; Piro, Alfonso; Schiariti, Marco; Orena, Eleonora F; Castiglione, Melina; Broggi, Morgan; Perin, Alessandro; DiMeco, Francesco

2012-11-01

Incident reporting systems are universally recognized as important tools for quality improvement in all complex adaptive systems, including the operating room. Nevertheless, introducing a safety culture among neurosurgeons is a slow process, and few studies are available in the literature regarding the implementation of an incident reporting system within a neurosurgical department. The authors describe the institution of an aviation model of incident reporting and investigation in neurosurgery, focusing on the method they have used and presenting some preliminary results. In 2010, the Inpatient Safety On-Board project was developed through cooperation between a team of human factor and safety specialists with aviation backgrounds (DgSky team) and the general manager of the Fondazione Istituto Neurologico Carlo Besta. In 2011, after specific training in safety culture, the authors implemented an aviation-derived prototype of incident reporting within the Department of Neurosurgery. They then developed an experimental protocol to track, analyze, and categorize any near misses that happened in the operating room. This project officially started in January 2012, when a dedicated team of assessors was established. All members of the neurosurgical department were asked to report near misses on a voluntary, confidential, and protected form (Patient Incident Reporting System form, Besta Safety Management Programme). Reports were entered into an online database and analyzed by a dedicated team of assessors with the help of a facilitator, and an aviation-derived root cause analysis was performed. Since January 2012, 14 near misses were analyzed and classified. The near-miss contributing factors were mainly related to human factors (9 of 14 cases), technology (1 of 14 cases), organizational factors (3 of 14 cases), or procedural factors (1 of 14 cases). Implementing an incident reporting system is quite demanding; the process should involve all of the people who work within the environment under study. Persistence and strong commitment are required to enact the culture change essential in shifting from a paradigm of infallible operators to the philosophy of errare humanum est. For this paradigm shift to be successful, contributions from aviation and human factor experts are critical.

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

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.

How do chiropractors manage clinical risk? A questionnaire study.

PubMed

Wangler, Martin; Peterson, Cynthia; Zaugg, Beatrice; Thiel, Haymo; Finch, Rob

2013-06-08

The literature on chiropractic safety tends to focus on adverse events and little is known about how chiropractors ensure safety and manage risk in the course of their daily practice. The purpose of this study was to investigate how chiropractors manage potentially risky clinical scenarios. We also sought to establish how chiropractors perceive the safety climate in their workplace and thus whether there is an observable culture of safety within the profession. An online questionnaire was designed to determine which of nine management options would be chosen by the respondent in response to four defined clinical case scenarios. Safety climate within the respondent's practice setting was measured by seeking the level of agreement with 23 statements relating to six different safety dimensions. 260 licensed chiropractors in Switzerland and 1258 UK members of The Royal College of Chiropractors were invited to complete the questionnaire. Questionnaire responses were analysed quantitatively in respect of the four clinical scenarios and the nine management options to determine the likelihood of each option being undertaken, with results recorded in terms of % likelihood. Gender differences in response to the management options for each scenario were evaluated using the Mann-Whitney U (MWU) test. Positive agreement with elements comprising each of the six safety dimensions contributed to a composite '% positive agreement' score calculated for each dimension. Questionnaire responses were received from 76% (200/260) of Swiss participants and 31% (393/1258) of UK members of The Royal College of Chiropractors. There was a general trend for Swiss and UK chiropractors to manage clinical scenarios where treatment appears not to be successful, not indicated, possibly harmful or where a patient is apparently getting worse, by re-evaluating their care. Stopping treatment and/or incident reporting to a safety incident reporting and learning system were generally found to be unlikely courses of action. Gender differences were observed with female chiropractors appearing to be more risk averse. Swiss and UK chiropractors tend to manage potentially risky clinical scenarios by re-evaluating the case. The unlikeliness of safety incident reporting is probably due to a range of recognised barriers, although Swiss and UK chiropractors are positive about local communication and openness which are important tenets for safety incident reporting. The observed positivity towards key aspects of clinic safety indicates a developing safety culture within the Swiss and UK chiropractic professions.

Emotions at work: what is the link to patient and staff safety? Implications for nurse managers in the NHS.

PubMed

Smith, Pam; Pearson, Pauline H; Ross, Fiona

2009-03-01

This paper sets the discussion of emotions at work within the modern NHS and the current prioritisation of creating a safety culture within the service. The paper focuses on the work of students, frontline nurses and their managers drawing on recent studies of patient safety in the curriculum, and governance and incentives in the care of patients with complex long term conditions. The primary research featured in the paper combined a case study design with focus groups, interviews and observation. In the patient safety research the importance of physical and emotional safety emerged as a key finding both for users and professionals. In the governance and incentives research, risk emerged as a key concern for managers, frontline workers and users. The recognition of emotions and the importance of emotional labour at an individual and organizational level managed by emotionally intelligent leaders played an important role in promoting worker and patient safety and reducing workplace risk. Nurse managers need to be aware of the emotional complexities of their organizations in order to set up systems to support the emotional wellbeing of professionals and users which in turn ensures safety and reduces risk.

International Approaches for Nuclear Waste Disposal in Geological Formations: Report on Fifth Worldwide Review

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

Faybishenko, Boris; Birkholzer, Jens; Persoff, Peter

2016-09-01

The goal of the Fifth Worldwide Review is to document evolution in the state-of-the-art of approaches for nuclear waste disposal in geological formations since the Fourth Worldwide Review that was released in 2006. The last ten years since the previous Worldwide Review has seen major developments in a number of nations throughout the world pursuing geological disposal programs, both in preparing and reviewing safety cases for the operational and long-term safety of proposed and operating repositories. The countries that are approaching implementation of geological disposal will increasingly focus on the feasibility of safely constructing and operating their repositories in short-more » and long terms on the basis existing regulations. The WWR-5 will also address a number of specific technical issues in safety case development along with the interplay among stakeholder concerns, technical feasibility, engineering design issues, and operational and post-closure safety. Preparation and publication of the Fifth Worldwide Review on nuclear waste disposal facilitates assessing the lessons learned and developing future cooperation between the countries. The Report provides scientific and technical experiences on preparing for and developing scientific and technical bases for nuclear waste disposal in deep geologic repositories in terms of requirements, societal expectations and the adequacy of cases for long-term repository safety. The Chapters include potential issues that may arise as repository programs mature, and identify techniques that demonstrate the safety cases and aid in promoting and gaining societal confidence. The report will also be used to exchange experience with other fields of industry and technology, in which concepts similar to the design and safety cases are applied, as well to facilitate the public perception and understanding of the safety of the disposal approaches relative to risks that may increase over long times frames in the absence of a successful implementation of final dispositioning.« less

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.

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

PubMed

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

2012-09-01

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

Mines Systems Safety Improvement Using an Integrated Event Tree and Fault Tree Analysis

NASA Astrophysics Data System (ADS)

Kumar, Ranjan; Ghosh, Achyuta Krishna

2017-04-01

Mines systems such as ventilation system, strata support system, flame proof safety equipment, are exposed to dynamic operational conditions such as stress, humidity, dust, temperature, etc., and safety improvement of such systems can be done preferably during planning and design stage. However, the existing safety analysis methods do not handle the accident initiation and progression of mine systems explicitly. To bridge this gap, this paper presents an integrated Event Tree (ET) and Fault Tree (FT) approach for safety analysis and improvement of mine systems design. This approach includes ET and FT modeling coupled with redundancy allocation technique. In this method, a concept of top hazard probability is introduced for identifying system failure probability and redundancy is allocated to the system either at component or system level. A case study on mine methane explosion safety with two initiating events is performed. The results demonstrate that the presented method can reveal the accident scenarios and improve the safety of complex mine systems simultaneously.

Case study report.

DOT National Transportation Integrated Search

2012-04-19

The Michigan Department of Transportation (MDOT) desired to explore the impact that recently completed roadway projects had on automobile, pedestrian, and bicycle safety. Additionally, MDOT wanted to determine to what extent these improvements also i...

[Effects, safety and cost-benefit analysis of Down syndrome screening in first trimester].

PubMed

Shengmou, Lin; Min, Chen; Chenhong, Wang; Shengli, Li; Jiansheng, Xie; Hui, Yuan; Dinghao, Lin; Xiaoxia, Wu; Wei, Wang; Hongyun, Zhang; Haiyan, Tang

2014-05-01

To investigate the effects, safety and cost-benefit analysis of Down syndrome screening in first trimester. From January 2009 to December 2012, 43 729 pregnant women undergoing 3 methods of Down syndrome traditional screening strategies in Shenzhen Maternity and Child Healthcare Hospital were studied retrospectively, including in 17 502 cases in pregnancy associated plasma protein A (PAPP-A) and free β-hCG measured biochemistry screening, 14 080 cases in nuchal translucency (NT) screening and 12 147 cases in combined screening, meanwhile, 7 389 cases on non-invasive fetal trisomy test (NIFTY) were performed in Huada Gene Research Institute(BGI). The effects and safety of four screening strategies were assessed throughout a decision tree. The economical characters of each screening strategy were compared by cost-effectiveness analysis as well as cost-benefit analysis. (1) The effects of four strategies are: NIFTY > combined screening > NT screening > biochemistry screening. (2) The safety of four strategies are: NIFTY > combined screening > NT screening > biochemistry screening. (3) Cost-effectiveness analysis and cost-benefit analysis:the biochemistry screening has lowest cost-effectiveness ratio (CER) and highest cost-benefit ratio (CBR), which performed a better economical efficiency. The incremental CER of three traditional screening strategies are all less than the economical burden of Down syndrome.NIFTY has highest CER and negative net present value (NPV), NPV would be positive and CBR would be more than 1 if the price of NIFTY reduce to 1 434 Yuan. Combined screening possess best screening efficiency, while biochemistry screening was demonstrated more economical in traditional screening.NIFTY is the future of Down syndrome screening.

Strategic Accident Reduction in an Energy Company and Its Resulting Financial Benefits.

PubMed

Reiman, Arto; Räisänen, Tuomo; Väyrynen, Seppo; Autio, Tommi

2018-04-10

This study provides a case example of an energy company that prioritised occupational safety and health and accident reduction as long-term, strategic development targets. Furthermore, this study describes the monetary benefits of this strategic decision. Company-specific accident indicators and monetary costs and benefits are evaluated. During the observation period (2010-2016), strategic investments in occupational safety and health cost the company EUR 0.8 million. However, EUR 1.8 million were saved in the same period, resulting in a 2.20 cost-benefit ratio. The trend in cost savings is strongly positive. Annual accident costs were EUR 0.4 million lower in 2016 compared to costs in 2010. This study demonstrates that long-term, strategic commitment to occupational safety and health provides monetary value.

A performance improvement case study in aircraft maintenance and its implications for hazard identification.

PubMed

Ward, Marie; McDonald, Nick; Morrison, Rabea; Gaynor, Des; Nugent, Tony

2010-02-01

Aircraft maintenance is a highly regulated, safety critical, complex and competitive industry. There is a need to develop innovative solutions to address process efficiency without compromising safety and quality. This paper presents the case that in order to improve a highly complex system such as aircraft maintenance, it is necessary to develop a comprehensive and ecologically valid model of the operational system, which represents not just what is meant to happen, but what normally happens. This model then provides the backdrop against which to change or improve the system. A performance report, the Blocker Report, specific to aircraft maintenance and related to the model was developed gathering data on anything that 'blocks' task or check performance. A Blocker Resolution Process was designed to resolve blockers and improve the current check system. Significant results were obtained for the company in the first trial and implications for safety management systems and hazard identification are discussed. Statement of Relevance: Aircraft maintenance is a safety critical, complex, competitive industry with a need to develop innovative solutions to address process and safety efficiency. This research addresses this through the development of a comprehensive and ecologically valid model of the system linked with a performance reporting and resolution system.

Comprehensive safety management and assessment at rugby football competitions.

PubMed

Tajima, T; Chosa, E; Kawahara, K; Nakamura, Y; Yoshikawa, D; Yamaguchi, N; Kashiwagi, T

2014-11-01

The present study aims to improve medical systems by designing objective safety assessment criteria for rugby competitions. We evaluated 195 competitions between 2002 and 2011 using an original safety scale comprising the following sections: 1) competence of staff such as referees, medical attendants and match day doctor; 2) environment such as weather, wet bulb globe temperature and field conditions; and 3) emergency medical care systems at the competitions. Each section was subdivided into groups A, B and C according to good, normal or fair degrees of safety determined by combinations of the results.Overall safety was assessed as A, B and C for 110, 78 and 7 competitions, respectively. The assessments of individual major factors were mostly favorable for staff, but the environment and medical care systems were assessed as C in 25 and 70, respectively, of the 195 competitions. Medical management involves not having a match day doctor, but also comprehensive management including preventive factors and responses from the staff, environment and medical-care systems. 6 cases of severe injuries and accidents occurred between 2002 and 2011, which were observed in Grade A competition. These cases revealed better prognosis without obvious impairment, thus confirming the value of the present assessment scale. © Georg Thieme Verlag KG Stuttgart · New York.

TeamSTEPPS Improves Operating Room Efficiency and Patient Safety.

PubMed

Weld, Lancaster R; Stringer, Matthew T; Ebertowski, James S; Baumgartner, Timothy S; Kasprenski, Matthew C; Kelley, Jeremy C; Cho, Doug S; Tieva, Erwin A; Novak, Thomas E

2016-09-01

The objective was to evaluate the effect of TeamSTEPPS on operating room efficiency and patient safety. TeamSTEPPS consisted of briefings attended by all health care personnel assigned to the specific operating room to discuss issues unique to each case scheduled for that day. The operative times, on-time start rates, and turnover times of all cases performed by the urology service during the initial year with TeamSTEPPS were compared to the prior year. Patient safety issues identified during postoperative briefings were analyzed. The mean case time was 12.7 minutes less with TeamSTEPPS (P < .001). The on-time first-start rate improved by 21% with TeamSTEPPS (P < .001). The mean room turnover time did not change. Patient safety issues declined from an initial rate of 16% to 6% at midyear and remained stable (P < 0.001). TeamSTEPPS was associated with improved operating room efficiency and diminished patient safety issues in the operating room. © The Author(s) 2015.

Effectiveness and safety of bedaquiline-containing regimens in the treatment of MDR- and XDR-TB: a multicentre study.

PubMed

Borisov, Sergey E; Dheda, Keertan; Enwerem, Martin; Romero Leyet, Rodolfo; D'Ambrosio, Lia; Centis, Rosella; Sotgiu, Giovanni; Tiberi, Simon; Alffenaar, Jan-Willem; Maryandyshev, Andrey; Belilovski, Evgeny; Ganatra, Shashank; Skrahina, Alena; Akkerman, Onno; Aleksa, Alena; Amale, Rohit; Artsukevich, Janina; Bruchfeld, Judith; Caminero, Jose A; Carpena Martinez, Isabel; Codecasa, Luigi; Dalcolmo, Margareth; Denholm, Justin; Douglas, Paul; Duarte, Raquel; Esmail, Aliasgar; Fadul, Mohammed; Filippov, Alexey; Davies Forsman, Lina; Gaga, Mina; Garcia-Fuertes, Julia-Amaranta; García-García, José-María; Gualano, Gina; Jonsson, Jerker; Kunst, Heinke; Lau, Jillian S; Lazaro Mastrapa, Barbara; Teran Troya, Jorge Lazaro; Manga, Selene; Manika, Katerina; González Montaner, Pablo; Mullerpattan, Jai; Oelofse, Suzette; Ortelli, Martina; Palmero, Domingo Juan; Palmieri, Fabrizio; Papalia, Antonella; Papavasileiou, Apostolos; Payen, Marie-Christine; Pontali, Emanuele; Robalo Cordeiro, Carlos; Saderi, Laura; Sadutshang, Tsetan Dorji; Sanukevich, Tatsiana; Solodovnikova, Varvara; Spanevello, Antonio; Topgyal, Sonam; Toscanini, Federica; Tramontana, Adrian R; Udwadia, Zarir Farokh; Viggiani, Pietro; White, Veronica; Zumla, Alimuddin; Migliori, Giovanni Battista

2017-05-01

Large studies on bedaquiline used to treat multidrug-resistant (MDR-) and extensively drug-resistant tuberculosis (XDR-TB) are lacking. This study aimed to evaluate the safety and effectiveness of bedaquiline-containing regimens in a large, retrospective, observational study conducted in 25 centres and 15 countries in five continents.428 culture-confirmed MDR-TB cases were analysed (61.5% male; 22.1% HIV-positive, 45.6% XDR-TB). MDR-TB cases were admitted to hospital for a median (interquartile range (IQR)) 179 (92-280) days and exposed to bedaquiline for 168 (86-180) days. Treatment regimens included, among others, linezolid, moxifloxacin, clofazimine and carbapenems (82.0%, 58.4%, 52.6% and 15.3% of cases, respectively).Sputum smear and culture conversion rates in MDR-TB cases were 63.6% and 30.1%, respectively at 30 days, 81.1% and 56.7%, respectively at 60 days; 85.5% and 80.5%, respectively at 90 days and 88.7% and 91.2%, respectively at the end of treatment. The median (IQR) time to smear and culture conversion was 34 (30-60) days and 60 (33-90) days. Out of 247 culture-confirmed MDR-TB cases completing treatment, 71.3% achieved success (62.4% cured; 8.9% completed treatment), 13.4% died, 7.3% defaulted and 7.7% failed. Bedaquiline was interrupted due to adverse events in 5.8% of cases. A single case died, having electrocardiographic abnormalities that were probably non-bedaquiline related.Bedaquiline-containing regimens achieved high conversion and success rates under different nonexperimental conditions. Copyright ©ERS 2017.

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.

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.

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%.

Self-Report of Guardians Ad Litem: Provision of Information to Judges in Child Abuse and Neglect Cases.

ERIC Educational Resources Information Center

Goldman, Jacquelin; And Others

1993-01-01

This study of the reporting practices of 91 Guardians Ad Litem to Florida judges in child abuse and neglect cases found that information reported most often concerned the child's physical safety, interaction between parent and child, and parents' personality characteristics. Less frequently reported was information regarding conflict in the home…

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. These short surveys highlighted areas of similarity: a) urinary measurements are most commonly taken on repeat-dose toxicity studies, and b) renal SP studies are less often utilised. The two major differences are a) lack of consistent use of DIKI biomarkers in urinary safety studies and b) the way large pharmaceutical companies assess renal function. Finally, suggestions were made to improve the safety assessment methods for determining the safety of compounds with potential renal liability. Copyright © 2015 Elsevier Inc. All rights reserved.

FHWA study tour for road safety audits. Part 2 : case studies and checklists

DOT National Transportation Integrated Search

1998-01-01

This is the fifth plenary symposium on public policy issues in global freight logistics conducted by the Organization for Economic Cooperation and Development (OECD). OECD's Trilateral Logistics Project, Trilog Project, is aimed at clarifying the pub...

"Genetic Engineering" Gains Momentum (Science/Society Case Study).

ERIC Educational Resources Information Center

Moore, John W.; Moore, Elizabeth A., Eds.

1980-01-01

Reviews the benefits and hazards of genetic engineering, or "recombinant-DNA" research. Recent federal safety rules issued by NIH which ease the strict prohibitions on recombinant-DNA research are explained. (CS)

Acute And Long-Term Bioeffects And Lamp Safety

NASA Astrophysics Data System (ADS)

Andersen, F. Alan

1980-10-01

Knowledge of both acute and chronic biological effects is currently used to evaluate lamp safety. In some cases, a quantitative basis for avoiding exposures greater than a certain value can be stated. In other cases, however, only a qualitative estimate of the hazard is available. In a discussion that uses mercury vapor lamps, tanning booths, and sodium vapor lamps as examples, the interplay between the two types of data leading to an evaluation of lamp safety is described.

National Consultation on Safety and Force: An Opportunity for Police-Minority Community Cooperation (Silver Spring, Maryland, December 11-13, 1979). Summary Report.

ERIC Educational Resources Information Center

Department of Justice, Washington, DC. Community Relations Service.

This report presents the proceedings of a conference held to examine the relationship between the police and minority groups with a focus on the problem of police use of excessive force. Successful community-police efforts to increase safety and reduce the use of force are described in case studies from four cities. Also presented are the texts of…

Six sigma tools for a patient safety-oriented, quality-checklist driven radiation medicine department.

PubMed

Kapur, Ajay; Potters, Louis

2012-01-01

The purpose of this work was to develop and implement six sigma practices toward the enhancement of patient safety in an electronic, quality checklist-driven, multicenter, paperless radiation medicine department. A quality checklist process map (QPM), stratified into consultation through treatment-completion stages was incorporated into an oncology information systems platform. A cross-functional quality management team conducted quality-function-deployment and define-measure-analyze-improve-control (DMAIC) six sigma exercises with a focus on patient safety. QPM procedures were Pareto-sorted in order of decreasing patient safety risk with failure mode and effects analysis (FMEA). Quantitative metrics for a grouped set of highest risk procedures were established. These included procedural delays, associated standard deviations and six sigma Z scores. Baseline performance of the QPM was established over the previous year of usage. Data-driven analysis led to simplification, standardization, and refinement of the QPM with standard deviation, slip-day reduction, and Z-score enhancement goals. A no-fly policy (NFP) for patient safety was introduced at the improve-control DMAIC phase, with a process map interlock imposed on treatment initiation in the event of FMEA-identified high-risk tasks being delayed or not completed. The NFP was introduced in a pilot phase with specific stopping rules and the same metrics used for performance assessments. A custom root-cause analysis database was deployed to monitor patient safety events. Relative to the baseline period, average slip days and standard deviations for the risk-enhanced QPM procedures improved by over threefold factors in the NFP period. The Z scores improved by approximately 20%. A trend for proactive delays instead of reactive hard stops was observed with no adverse effects of the NFP. The number of computed potential no-fly delays per month dropped from 60 to 20 over a total of 520 cases. The fraction of computed potential no-fly cases that were delayed in NFP compliance rose from 28% to 45%. Proactive delays rose to 80% of all delayed cases. For potential no-fly cases, event reporting rose from 18% to 50%, while for actually delayed cases, event reporting rose from 65% to 100%. With complex technologies, resource-compromised staff, and pressures to hasten treatment initiation, the use of the six sigma driven process interlocks may mitigate potential patient safety risks as demonstrated in this study. Copyright © 2012 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.

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.

[A case-control study on the risk factors of work-related acute pesticide poisoning among farmers from Jiangsu province].

PubMed

Tu, Zhi-bin; Cui, Meng-jing; Yao, Hong-yan; Hu, Guo-qing; Xiang, Hui-yun; Stallones, Lorann; Zhang, Xu-jun

2012-04-01

To explore the risk factors on cases regarding work-related acute pesticide poisoning among farmers of Jiangsu province. A population-based, 1:2 matched case-control study was carried out, with 121 patients as case-group paired by 242 persons with same gender, district and age less then difference of 3 years, as controls. Cases were the ones who had suffered from work-related acute pesticide poisoning. A unified questionnaire was used. Data base was established by EpiData 3.1, and SPSS 16.0 was used for both data single factor and multi-conditional logistics regression analysis. Results from the single factor logistic regression analysis showed that the related risk factors were: lack of safety guidance, lack of readable labels before praying pesticides, no regression during application, using hand to wipe sweat, using leaking knapsack, body contaminated during application and continuing to work when feeling ill after the contact of pesticides. Results from multi-conditional logistic regression analysis indicated that the lack of safety guidance (OR=2.25, 95%CI: 1.35-3.74), no readable labels before praying pesticides (OR=1.95, 95%CI: 1.19-3.18), wiping the sweat by hand during application (OR=1.97, 95%CI: 1.20-3.24) and using leaking knapsack during application (OR=1.82, 95%CI:1.10-3.01) were risk factors for the occurrence of work-related acute pesticide poisoning. The lack of safety guidance, no readable labels before praying pesticides, wiping the sweat by hand or using leaking knapsack during application were correlated to the occurrence of work-related acute pesticide poisoning.

Impact of operator experience and training strategy on procedural outcomes with leadless pacing: Insights from the Micra Transcatheter Pacing Study.

PubMed

El-Chami, Mikhael; Kowal, Robert C; Soejima, Kyoko; Ritter, Philippe; Duray, Gabor Z; Neuzil, Petr; Mont, Lluis; Kypta, Alexander; Sagi, Venkata; Hudnall, John Harrison; Stromberg, Kurt; Reynolds, Dwight

2017-07-01

Leadless pacemaker systems have been designed to avoid the need for a pocket and transvenous lead. However, delivery of this therapy requires a new catheter-based procedure. This study evaluates the role of operator experience and different training strategies on procedural outcomes. A total of 726 patients underwent implant attempt with the Micra transcatheter pacing system (TPS; Medtronic, Minneapolis, MN, USA) by 94 operators trained in a teaching laboratory using a simulator, cadaver, and large animal models (lab training) or locally at the hospital with simulator/demo model and proctorship (hospital training). Procedure success, procedure duration, fluoroscopy time, and safety outcomes were compared between training methods and experience (implant case number). The Micra TPS procedure was successful in 99.2% of attempts and did not differ between the 55 operators trained in the lab setting and the 39 operators trained locally at the hospital (P = 0.189). Implant case number was also not a determinant of procedural success (P = 0.456). Each operator performed between one and 55 procedures. Procedure time and fluoroscopy duration decreased by 2.0% (P = 0.002) and 3.2% (P < 0.001) compared to the previous case. Major complication rate and pericardial effusion rate were not associated with case number (P = 0.755 and P = 0.620, respectively). There were no differences in the safety outcomes by training method. Among a large group of operators, implantation success was high regardless of experience. While procedure duration and fluoroscopy times decreased with implant number, complications were low and not associated with case number. Procedure and safety outcomes were similar between distinct training methodologies. © 2017 Wiley Periodicals, Inc.

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

PubMed

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

2015-03-01

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

Assessment of the living and workplace health and safety conditions of site-resident construction workers in Tehran, Iran.

PubMed

Mohseni, Peyman Hossein; Farshad, Ali Asghar; Mirkazemi, Roksana; Orak, Rouhangiz Jamshidi

2015-01-01

The purpose of this study was to assess living and workplace safety conditions of construction workers in Tehran, Iran. This cross-sectional study was conducted among 410 construction sites in a municipal area of Tehran whose municipal building permits were issued in 2011. Data on ventilation, workplace safety and hygiene were collected by direct observation and interviews with site foremen. Noise levels were estimated from 10 sound-level-meter stations in the municipality area. Lack of ventilation in the workers' rooms was abundant. Bathrooms were unhygienic and minimum requirements such as lighting and ventilation did not exist in 80% of the cases. In nearly 50% of large construction sites, sewage and garbage disposal were inappropriate. Elevator safety was poor at all sites and no measures for fall prevention were present in over 88% of active construction sites. This study showed that the mean 24-h equivalent continuous sound level Leq was over 70 dB in 80% of the sites during weekdays. The results of this study revealed poor health and safety living and working conditions of construction workers in Tehran.

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 expected. Few cases of serious infections occurred, while no case of malignancy did. Overall, the safety profile of biotech drugs used in our population was similar to those observed in pivotal trials. Notwithstanding the positive results of our study, some safety concerns still remain unresolved. In order to collect more effectiveness and safety data on biotech drugs, the collection and analysis of real world data should be endorsed as well as the management of post-authorization studies. PMID:28932193

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 health - can improve the safety performance of an organization. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

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.

Safety in the Chemical Laboratory: Hazards in a Photography Lab.

ERIC Educational Resources Information Center

Houk, Cliff; Hart, Charles

1987-01-01

Described are case studies illustrating chemical hazards in a photography lab due to compounds containing cyanide. Suggestions for preventing problems including proper procedures, housekeeping, facilities, and ventilation are considered. (RH)

Post-marketing surveillance of live-attenuated Japanese encephalitis vaccine safety in China.

PubMed

Wang, Yali; Dong, Duo; Cheng, Gang; Zuo, Shuyan; Liu, Dawei; Du, Xiaoxi

2014-10-07

Japanese encephalitis (JE) is the most severe form of viral encephalitis in Asia and no specific treatment is available. Vaccination provides an effective intervention to prevent JE. In this paper, surveillance data for adverse events following immunization (AEFI) related to SA-14-14-2 live-attenuated Japanese encephalitis vaccine (Chengdu Institute of Biological Products) was presented. This information has been routinely generated by the Chinese national surveillance system for the period 2009-2012. There were 6024 AEFI cases (estimated reported rate 96.55 per million doses). Most common symptoms of adverse events were fever, redness, induration and skin rash. There were 70 serious AEFI cases (1.12 per million doses), including 9 cases of meningoencephalitis and 4 cases of death. The post-marketing surveillance data add the evidence that the Chengdu institute live attenutated vaccine has a reasonable safety profile. The relationship between encephalitis and SA-14-14-2 vaccination should be further studied. Copyright © 2014 Elsevier Ltd. All rights reserved.

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.

Kombucha: a systematic review of the clinical evidence.

PubMed

Ernst, E

2003-04-01

Kombucha has become a popular complementary remedy. The aim of this systematic review was to critically evaluate the evidence related to its efficacy and safety. Computerised literature searches were carried out to locate all human medical investigations of kombucha regardless of study design. Data were extracted and validated by the present author and are reported in narrative form. No clinical studies were found relating to the efficacy of this remedy. Several case reports and case series raise doubts about the safety of kombucha. They include suspected liver damage, metabolic acidosis and cutaneous anthrax infections. One fatality is on record. On the basis of these data it was concluded that the largely undetermined benefits do not outweigh the documented risks of kombucha. It can therefore not be recommended for therapeutic use. Copyright 2003 S. Karger GmbH, Freiburg

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.

Final report of the safety assessment of cosmetic ingredients derived from Zea mays (corn).

PubMed

Andersen, F Alan; Bergfeld, Wilma F; Belsito, Donald V; Klaassen, Curtis D; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W

2011-05-01

Many cosmetic ingredients are derived from Zea mays (corn). While safety test data were not available for most ingredients, similarities in preparation and the resulting similar composition allowed extrapolation of safety data to all listed ingredients. Animal studies included acute toxicity, ocular and dermal irritation studies, and dermal sensitization studies. Clinical studies included dermal irritation and sensitization. Case reports were available for the starch as used as a donning agent in medical gloves. Studies of many other endpoints, including reproductive and developmental toxicity, use corn oil as a vehicle control with no reported adverse effects at levels used in cosmetics. While industry should continue limiting ingredient impurities such as pesticide residues before blending into a cosmetic formulation, the CIR Expert Panel determined that corn-derived ingredients are safe for use in cosmetics in the practices of use and concentration described in the assessment.

A comprehensive obstetric patient safety program reduces liability claims and payments.

PubMed

Pettker, Christian M; Thung, Stephen F; Lipkind, Heather S; Illuzzi, Jessica L; Buhimschi, Catalin S; Raab, Cheryl A; Copel, Joshua A; Lockwood, Charles J; Funai, Edmund F

2014-10-01

Begun in 2003, the Yale-New Haven Hospital comprehensive obstetric safety program consisted of measures to standardize care, improve teamwork and communication, and optimize oversight and quality review. Prior publications have demonstrated improvements in adverse outcomes and safety culture associated with this program. In this analysis, we aimed to assess the impact of this program on liability claims and payments at a single institution. We reviewed liability claims at a single, tertiary-care, teaching hospital for two 5-year periods (1998-2002 and 2003-2007), before and after implementing the safety program. Connecticut statute of limitations for professional malpractice is 36 months from injury. Claims/events were classified by event-year and payments were adjusted for inflation. We analyzed data for trends as well as differences between periods before and after implementation. Forty-four claims were filed during the 10-year study period. Annual cases per 1000 deliveries decreased significantly over the study period (P < .01). Claims (30 vs 14) and payments ($50.7 million vs $2.9 million) decreased in the 5-years after program inception. Compared with before program inception, median annual claims dropped from 1.31 to 0.64 (P = .02), and median annual payments per 1000 deliveries decreased from $1,141,638 to $63,470 (P < .01). Even estimating the monetary awards for the 2 remaining open cases using the median payments for the surrounding 5 years, a reduction in the median monetary amount per case resulting in payment to the claimant was also statistically significant ($632,262 vs $216,815, P = .046). In contrast, the Connecticut insurance market experienced a stable number of claims and markedly increased cost per claim during the same period. We conclude that an obstetric safety initiative can improve liability claims exposure and reduce liability payments. Copyright © 2014 Elsevier Inc. All rights reserved.

Pure retroperitoneal natural orifice translumenal endoscopic surgery (NOTES) transvaginal nephrectomy using standard laparoscopic instruments: a safety and feasibility study in a porcine model.

PubMed

Wei, Dechao; Han, Yili; Li, Mingchuan; Wang, Yongxing; Chen, Yatong; Luo, Yong; Jiang, Yongguang

2016-06-11

Among the different organs used for NOTES (natural orifice translumenal endoscopic surgery) technique, the transvaginal approach may be the optimal choice because of a simple and secure closure of colpotomy site. Pure and hybrid NOTES transvaginal operations were routinely performed via transperitoneal access. In this study, we investigate the safety and feasibility of pure retroperitoneal natural orifice translumenal endoscopic surgery (NOTES) transvaginal nephrectomy using conventional laparoscopic techniques in a porcine model. Six female pigs, weighing an average of 30 kg, were used in this study. Under general anesthesia, pure retroperitoneal NOTES transvaginal nephrectomy was conducted using standard laparoscopic instruments. Posterolateral colpotomy was performed, and the incision was enlarged laterally using blunt dissection and pneumatic dilation. A single-port device was inserted to construct the operative channel. The retroperitoneal space was created using sharp and blunt dissection under endoscopic guidance up to the level of the kidney. Dissection and removal of the kidney were performed according to standard surgical procedure, and the colpotomy site was closed using interrupted sutures. The survival and complications were observed 1 week postoperatively. Our results showed that two cases failed because of peritoneal rupture. One case was successful, but required the assistance of an extra 5 mm laparoscopic trocar inserted in the flank. Three cases of pure retroperitoneal NOTES transvaginal nephrectomy were completed, and survived 1 week after the operation. In these three cases, no intra- or postoperative complications were observed. All findings confirmed the safety and feasibility of the retroperitoneal pure retroperitoneal NOTES transvaginal nephrectomy using standard laparoscopic instruments, which suggested the possibility of clinical application in human beings in the future.

77 FR 75443 - Draft Safety Culture Policy Statement: Request for Public Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-20

... personal and organizational characteristics are present in a positive safety culture. A characteristic, in this case, is a pattern of thinking, feeling, and behaving that emphasizes safety, particularly in goal...

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…

49 CFR 1106.4 - The Safety Integration Plan process.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 8 2011-10-01 2011-10-01 false The Safety Integration Plan process. 1106.4... CONSIDERATION OF SAFETY INTEGRATION PLANS IN CASES INVOLVING RAILROAD CONSOLIDATIONS, MERGERS, AND ACQUISITIONS OF CONTROL § 1106.4 The Safety Integration Plan process. (a) Each applicant in a transaction subject...

49 CFR 1106.4 - The Safety Integration Plan process.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 8 2013-10-01 2013-10-01 false The Safety Integration Plan process. 1106.4... CONSIDERATION OF SAFETY INTEGRATION PLANS IN CASES INVOLVING RAILROAD CONSOLIDATIONS, MERGERS, AND ACQUISITIONS OF CONTROL § 1106.4 The Safety Integration Plan process. (a) Each applicant in a transaction subject...

49 CFR 1106.4 - The Safety Integration Plan process.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 8 2014-10-01 2014-10-01 false The Safety Integration Plan process. 1106.4... CONSIDERATION OF SAFETY INTEGRATION PLANS IN CASES INVOLVING RAILROAD CONSOLIDATIONS, MERGERS, AND ACQUISITIONS OF CONTROL § 1106.4 The Safety Integration Plan process. (a) Each applicant in a transaction subject...

49 CFR 1106.4 - The Safety Integration Plan process.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 8 2012-10-01 2012-10-01 false The Safety Integration Plan process. 1106.4... CONSIDERATION OF SAFETY INTEGRATION PLANS IN CASES INVOLVING RAILROAD CONSOLIDATIONS, MERGERS, AND ACQUISITIONS OF CONTROL § 1106.4 The Safety Integration Plan process. (a) Each applicant in a transaction subject...

49 CFR 1106.3 - Actions for which Safety Integration Plan is required.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 8 2010-10-01 2010-10-01 false Actions for which Safety Integration Plan is... TRANSPORTATION BOARD CONSIDERATION OF SAFETY INTEGRATION PLANS IN CASES INVOLVING RAILROAD CONSOLIDATIONS, MERGERS, AND ACQUISITIONS OF CONTROL § 1106.3 Actions for which Safety Integration Plan is required. A SIP...

49 CFR 1106.4 - The Safety Integration Plan process.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 8 2010-10-01 2010-10-01 false The Safety Integration Plan process. 1106.4... CONSIDERATION OF SAFETY INTEGRATION PLANS IN CASES INVOLVING RAILROAD CONSOLIDATIONS, MERGERS, AND ACQUISITIONS OF CONTROL § 1106.4 The Safety Integration Plan process. (a) Each applicant in a transaction subject...

Assessing the Biological Safety Profession's Evaluation and Control of Risks Associated with the Field Collection of Potentially Infectious Specimens.

PubMed

Patlovich, Scott J; Emery, Robert J; Whitehead, Lawrence W; Brown, Eric L; Flores, Rene

2015-03-01

Because the origins of the biological safety profession are rooted in the control and prevention of laboratory-associated infections, the vocation focuses primarily on the safe handling of specimens within the laboratory. But in many cases, the specimens and samples handled in the lab are originally collected in the field where a broader set of possible exposure considerations may be present, each with varying degrees of controllability. The failure to adequately control the risks associated with collecting biological specimens in the field may result in illness or injury, and could have a direct impact on laboratory safety, if infectious specimens were packaged or transported inappropriately, for example. This study developed a web-based survey distributed to practicing biological safety professionals to determine the prevalence of and extent to which biological safety programs consider and evaluate field collection activities. In cases where such issues were considered, the data collected characterize the types of controls and methods of oversight at the institutional level that are employed. Sixty-one percent (61%) of the survey respondents indicated that research involving the field collection of biological specimens is conducted at their institutions. A majority (79%) of these field collection activities occur at academic institutions. Twenty-seven percent (27%) of respondents indicated that their safety committees do not consider issues related to biological specimens collected in the field, and only 25% with an oversight committee charged to review field collection protocols have generated a field research-specific risk assessment form to facilitate the assembly of pertinent information for a project risk assessment review. The results also indicated that most biosafety professionals (73% overall; 71% from institutions conducting field collection activities) have not been formally trained on the topic, but many (64% overall; 87% from institutions conducting field collection activities) indicated that training on field research safety issues would be helpful, and even more (71% overall; 93% from institutions conducting field collection activities) would consider participation in such a training course. Results obtained from this study can be used to develop a field research safety toolkit and associated training curricula specifically targeted to biological safety professionals.

IN CASE YOU MISSED IT: EPA Releases New Chemical Safety Guidelines Aimed at Curbing Animal Testing, Tracking Mercury Imports, and Facilitating the Sharing of Confidential Business Information

EPA Pesticide Factsheets

EPA News Release: IN CASE YOU MISSED IT: EPA Releases New Chemical Safety Guidelines Aimed at Curbing Animal Testing, Tracking Mercury Imports, and Facilitating the Sharing of Confidential Business Information

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-analysis underscores the safety of IVT in SM. © 2015 American Heart Association, Inc.

[The safety profile of escitalopram in pregnancy and breastfeeding].

PubMed

Bellantuono, Cesario; Orsolini, Laura; Bozzi, Francesca

2013-01-01

Escitalopram (ESC) is considered one of the most effective selective serotonin reuptake inhibitors (SSRI) for the treatment of major depression disorder. However, little is known on its potential risk of inducing major malformations (MM) and/or perinatal complications (PC). Aim of the present study is to provide a review of the available literature on the safety profile of ESC during pregnancy and breastfeeding and to compare data with the maternal and neonatal outcomes of 8 cases of the DEGRA Center. MEDLINE and PubMed databases were searched for English language articles by using the following keywords: "escitalopram", "selective serotonin reuptake inhibitors", "major malformations", "perinatal complications", "pregnancy", "breastfeeding". We also reported 8 cases of women treated with ESC during their pregnancy and breastfeeding at the Clinic of Affective Disorders in Pregnancy and Postpartum of the United Hospital of Ancona (DEGRA Center). Although some cases of MM have been reported in the literature after maternal exposure to ESC during early pregnancy, the rate of MM is substantially in the range of those reported in unexposed women. ESC exposure seems to be significantly associated with some PC such as lower rates of live births and higher rates of newborns with low birth weight. On the contrary, no short-term adverse effects in newborns were reported in the 5 studies evaluating the safety of ESC during breastfeeding. Data coming from DEGRA Center are consistent with the literature: all pregnancy were full term, all newborns were healthy and obtained normal APGAR score; no MM or miscarriage were reported. Only one case of mild withdrawal syndrome was reported in a newborn who was also exposed to benzodiazepines and paroxetine late in pregnancy. Two infants exposed to ESC also during the lactation did not reported any adverse effects at short-term. Data coming from published studies and from our cases seem to support the notion that ESC might be considered safe during pregnancy and breastfeeding, particularly as far as MM is concerned. As well as other SSRI it could be associated with an increased risk of PC. Nevertheless, given the few cases here analysed and the paucity of the studies so far published, no definitive conclusions should be drawn.

What is Taught on Firearm Safety in Undergraduate, Graduate, and Continuing Medical Education? A Review of Educational Programs.

PubMed

Puttagunta, R; Coverdale, T R; Coverdale, J

2016-10-01

Because there have been no published formal reviews on teaching of firearm safety, we set out to systematically locate and review the literature on curricula that educated physicians and other health care providers, residents across specialties, and medical students on how to counsel on firearm safety. We searched for all papers with outcomes that described firearm safety training programs for healthcare providers and trainees. Studies were identified through PubMed, Scopus, Google Scholar, PsychInfo, EMBASE, and MedEdPortal databases and electronically searched using combinations of words from general topic areas of firearms, learners, and education. We found four programs that met inclusion criteria. These targeted a narrow range of learners including medical students, pediatric residents, practicing pediatricians, and nurse practitioners. Teaching methods included lectures, case-based learning, group discussions, and audiotape training. There were two randomized controlled trials, one cohort design, and one posttest design. One of the randomized controlled trials was an office-based high quality multisite national study, although the focus of teaching was not on firearm safety alone. All studies used different outcomes, and only one study validated the outcome measures. There were no studies targeting psychiatrists or psychiatry residents. These results underscore a priority for developing firearm safety education programs in undergraduate, graduate, and continuing medical education settings.

The economic burden of patient safety targets in acute care: a systematic review

PubMed Central

Mittmann, Nicole; Koo, Marika; Daneman, Nick; McDonald, Andrew; Baker, Michael; Matlow, Anne; Krahn, Murray; Shojania, Kaveh G; Etchells, Edward

2012-01-01

Background Our objective was to determine the quality of literature in costing of the economic burden of patient safety. Methods We selected 15 types of patient safety targets for our systematic review. We searched the literature published between 2000 and 2010 using the following terms: “costs and cost analysis,” “cost-effectiveness,” “cost,” and “financial management, hospital.” We appraised the methodologic quality of potentially relevant studies using standard economic methods. We recorded results in the original currency, adjusted for inflation, and then converted to 2010 US dollars for comparative purposes (2010 US$1.00 = 2010 €0.76). The quality of each costing study per patient safety target was also evaluated. Results We screened 1948 abstracts, and identified 158 potentially eligible studies, of which only 61 (39%) reported any costing methodology. In these 61 studies, we found wide estimates of the attributable costs of patient safety events ranging from $2830 to $10,074. In general hospital populations, the cost per case of hospital-acquired infection ranged from $2132 to $15,018. Nosocomial bloodstream infection was associated with costs ranging from $2604 to $22,414. Conclusion There are wide variations in the estimates of economic burden due to differences in study methods and methodologic quality. Greater attention to methodologic standards for economic evaluations in patient safety is needed. PMID:23097615

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 associated with sampling locations showing poor performance.

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.

Electronic cigarette devices and oro-facial trauma (Literature review)

NASA Astrophysics Data System (ADS)

Ghazali, A. F.; Ismail, A. F.; Daud, A.

2017-08-01

Detrimental effects of cigarette smoking have been well described and recognized globally. With recent advancement of technology, electronic cigarette has been introduced and gained its popularity and became a global trend, especially among young adults. However, the safety of the electronic devices remains debatable. This paper aimed to compile and review the reported cases of oro-facial trauma related to the usage of electronic cigarette devices. A literature search was conducted using PubMed/Medline in December 2016. The search terms used were a combination of “oral trauma”, “dental trauma”, “oral injury” and “electronic cigarette”. The search included all abstract published from the inception of the database until December 2016. Abstract that was written in English, case report, letter to editors, clinical and human studies were included for analysis. All selected abstract were searched for full articles. A total of 8 articles were included for review. All of the articles were published in 2016 with mostly case reports. The sample size of the studies ranged from 1 to 15 patients. Seven of the included articles are from United States of America and one from Mexico. Our review concluded that the use of electronic cigarette devices posed not only a safety concern but also that the devices were mostly unregulated. There should be a recognized authority body to regulate the safety and standard of the electronic devices.

Electric bicycle-related injuries presenting to a provincial hospital in China: A retrospective study.

PubMed

Zhou, Sheng Ang; Ho, Andrew Fu Wah; Ong, Marcus Eng Hock; Liu, Nan; Pek, Pin Pin; Wang, Yi Qing; Jin, Tao; Yan, Guang Zhao; Han, Nan Nan; Li, Gang; Xu, Li Ming; Cai, Wen Wei

2017-06-01

The use of electric bicycles (EBs) in China is growing. In the present study, we aimed to characterize the pattern and outcomes of EB-related injuries presenting to a major general hospital in China.This was a retrospective review of EB-related injuries presenting to Zhejiang Provincial People's Hospital from 2008 to 2011. Cases were identified from medical records according to diagnosis codes. Data captured included demographics, injury characteristics, and outcomes.A total of 3156 cases were reviewed in the present study. There were 1460 cases of traffic accidents, of which 482 cases were EB-related (32.7%). In addition, most of EB-related cases (44.6%) belonged to the 41- to 60-year-old age group. Median injury severity score was 10. Moreover, 34.9% underwent surgery and 24.7% were admitted to intensive care unit. The median hospitalization cost was 14,269 USD. Fracture (56.5%) was the most frequently diagnosed injury type, and head was the most commonly injured body region (31.1%).EB-related injuries have become a major health concern, making up a sizeable proportion of injuries presenting to the emergency department. Therefore, it is necessary to establish injury prevention and strategies for EB road safety. Implementation of policy such as compulsory helmet use, as well as popularization of EB road safety education should be considered to improve the current situation of EB-related injuries in China.

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.

Study concerning the loads over driver's chests in car crashes with cars of the same or different generation

NASA Astrophysics Data System (ADS)

Ispas, N.; Năstăsoiu, M.

2016-08-01

Reducing occupant injuries for cars involves in traffic accidents is a main target of today cars designers. Known as active or passive safety, many technological solutions were developing over the time for an actual better car's occupant safety. In the real world, in traffic accidents are often involved cars from different generations with various safety historical solutions. The main aim of these papers are to quantify the influences over the car driver chest loads in cases of same or different generation of cars involved in side car crashes. Both same and different cars generations were used for the study. Other goal of the paper was the study of in time loads conformity for diver's chests from both cars involved in crash. The paper's experimental results were obtained by support of DSD, Dr. Steffan Datentechnik GmbH - Linz, Austria. The described tests were performed in full test facility of DSD Linz, in “Easter 2015 PC-Crash Seminar”. In all crashes we obtaining results from both dummy placed in impacted and hits car. The novelty of the paper are the comparisons of data set from each of driver (dummy) of two cars involved in each of six experimental crashes. Another novelty of this paper consists in possibilities to analyse the influences of structural historical cars solutions over deformation and loads in cases of traffic accidents involved. Paper's conclusions can be future used for car passive safety improvement.

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.

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

Utilization of the Seniors Falls Investigation Methodology to identify system-wide causes of falls in community-dwelling seniors.

PubMed

Zecevic, Aleksandra A; Salmoni, Alan W; Lewko, John H; Vandervoort, Anthoney A; Speechley, Mark

2009-10-01

As a highly heterogeneous group, seniors live in complex environments influenced by multiple physical and social structures that affect their safety. Until now, the major approach to falls research has been person centered. However, in industrial settings, the individuals involved in an accident are seen as the inheritors of system defects. The objective of the present study was to investigate safety deficiencies that contributed to falls in community-dwelling seniors using a systems approach. The investigations were conducted using the Seniors Falls Investigation Methodology (SFIM), an adapted version of a method used to examine transportation accidents, such as airplane crashes. Fifteen seniors, who experienced a fall or near fall, participated in multiple case studies. A cross-case synthesis was used to summarize findings and identify common patterns of causes and safety deficiencies. Falls and near falls are a result of latent unsafe conditions, and unsafe acts and decisions combined in a diverse set of circumstances. If not identified and removed, these unsafe conditions can cause falls for other seniors. This study provided compelling evidence that causes of falling are systemic and develop over time. It demonstrated that the systems approach is needed to expand the focus from the individual to multilayered organizational and supervisory causes. The SFIM demonstrated capability to identify causes of falls that will allow better prevention and management programs, hence advancing seniors' safety. SFIM shows great potential for implementation in organized settings, such as hospitals and long-term care homes.

Sleepiness/fatigue and distraction/inattention as factors for fatal versus nonfatal commercial motor vehicle driver injuries.

PubMed

Bunn, T L; Slavova, S; Struttmann, T W; Browning, S R

2005-09-01

A retrospective population-based case-control study was conducted to determine whether driver sleepiness/fatigue and inattention/distraction increase the likelihood that a commercial motor vehicle collision (CVC) will be fatal. Cases were identified as CVC drivers who died (fatal) and controls were drivers who survived (nonfatal) an injury collision using the Kentucky Collision Report Analysis for Safer Highways (CRASH) electronic database from 1998-2002. Cases and controls were matched on unit type and roadway type. Conditional logistic regression was performed. Driver sleepiness/fatigue, distraction/inattention, age of 51 years of age and older, and nonuse of safety belts increase the odds that a CVC will be fatal. Primary safety belt law enactment and enforcement for all states, commercial vehicle driver education addressing fatigue and distraction and other approaches including decreased hours-of-service, rest breaks and policy changes, etc. may decrease the probability that a CVC will be fatal.

Physician training protocol within the WEB Intrasaccular Therapy (WEB-IT) study.

PubMed

Arthur, Adam; Hoit, Daniel; Coon, Alexander; Delgado Almandoz, Josser E; Elijovich, Lucas; Cekirge, Saruhan; Fiorella, David

2018-05-01

The WEB Intra-saccular Therapy (WEB-IT) trial is an investigational device exemption study to demonstrate the safety and effectiveness of the WEB device for the treatment of wide-neck bifurcation aneurysms. The neurovascular replicator (Vascular Simulations, Stony Brook, New York, USA) creates a physical environment that replicates patient-specific neurovascular anatomy and hemodynamic physiology, and allows devices to be implanted under fluoroscopic guidance. To report the results of a unique neurovascular replicator-based training program, which was incorporated into the WEB-IT study to optimize technical performance and patient safety. US investigators participated in a new training program that incorporated full surgical rehearsals on a neurovascular replicator. No roll-in cases were permitted within the trial. Custom replicas of patient-specific neurovascular anatomy were created for the initial cases treated at each center, as well as for cases expected to be challenging. On-site surgical rehearsals were performed before these procedures. A total of 48 participating investigators at 25 US centers trained using the replicator. Sessions included centralized introductory training, on-site training, and patient-specific full surgical rehearsal. Fluoroscopy and procedure times in the WEB-IT study were not significantly different from those seen in two European trials where participating physicians had significant WEB procedure experience before study initiation. A new program of neurovascular-replicator-based physician training was employed within the WEB-IT study. This represents a new methodology for education and training that may be an effective means to optimize technical success and patient safety during the introduction of a new technology. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Dose-dependent acute liver injury with hypersensitivity features in humans due to a novel microsomal prostaglandin E synthase 1 inhibitor.

PubMed

Jin, Yan; Regev, Arie; Kam, Jeanelle; Phipps, Krista; Smith, Claire; Henck, Judith; Campanale, Kristina; Hu, Leijun; Hall, D Greg; Yang, Xiao Yan; Nakano, Masako; McNearney, Terry Ann; Uetrecht, Jack; Landschulz, William

2018-01-01

LY3031207, a novel microsomal prostaglandin E synthase 1 inhibitor, was evaluated in a multiple ascending dose study after nonclinical toxicology studies and a single ascending dose study demonstrated an acceptable toxicity, safety and tolerability profile. Healthy subjects were randomized to receive LY3031207 (25, 75 and 275 mg), placebo or celecoxib (400 mg) once daily for 28 days. The safety, tolerability and pharmacokinetic and pharmacodynamic profiles of LY3031207 were evaluated. The study was terminated when two subjects experienced drug-induced liver injury (DILI) after they had received 225 mg LY3031207 for 19 days. Liver biopsy from these subjects revealed acute liver injury with eosinophilic infiltration. Four additional DILI cases were identified after LY3031207 dosing had been stopped. All six DILI cases shared unique presentations of hepatocellular injury with hypersensitivity features and demonstrated a steep dose-dependent trend. Prompt discontinuation of the study drug and supportive medical care resulted in full recovery. Metabolites from metabolic activation of the imidazole ring were observed in plasma and urine samples from all subjects randomized to LY3031207 dosing. This study emphasized the importance of careful safety monitoring and serious adverse events management in phase I trials. Metabolic activation of the imidazole ring may be involved in the development of hepatotoxicity of LY3031207. © 2017 The British Pharmacological Society.

Investment appraisal using quantitative risk analysis.

PubMed

Johansson, Henrik

2002-07-01

Investment appraisal concerned with investments in fire safety systems is discussed. Particular attention is directed at evaluating, in terms of the Bayesian decision theory, the risk reduction that investment in a fire safety system involves. It is shown how the monetary value of the change from a building design without any specific fire protection system to one including such a system can be estimated by use of quantitative risk analysis, the results of which are expressed in terms of a Risk-adjusted net present value. This represents the intrinsic monetary value of investing in the fire safety system. The method suggested is exemplified by a case study performed in an Avesta Sheffield factory.

The shutdown reactor: Optimizing spent fuel storage cost

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

Pennington, C.W.

1995-12-31

Several studies have indicated that the most prudent way to store fuel at a shutdown reactor site safely and economically is through the use of a dry storage facility licensed under 10CFR72. While such storage is certainly safe, is it true that the dry ISFSI represents the safest and most economical approach for the utility? While no one is really able to answer that question definitely, as yet, Holtec has studied this issue for some time and believes that both an economic and safety case can be made for an optimization strategy that calls for the use of both wetmore » and dry ISFSI storage of spent fuel at some plants. For the sake of brevity, this paper summarizes some of Holtec`s findings with respect to the economics of maintaining some fuel in wet storage at a shutdown reactor. The safety issue, or more importantly the perception of safety of spent fuel in wet storage, still varies too much with the eye of the beholder, and until a more rigorous presentation of safety analyses can be made in a regulatory setting, it is not practically useful to argue about how many angels can sit on the head of a safety-related pin. Holtec is prepared to present such analyses, but this does not appear to be the proper venue. Thus, this paper simply looks at certain economic elements of a wet ISFSI at a shutdown reactor to make a prima facie case that wet storage has some attractiveness at a shutdown reactor and should not be rejected out of hand. Indeed, an optimization study at certain plants may well show the economic vitality of keeping some fuel in the pool and converting the NRC licensing coverage from 10CFR50 to 10CFR72. If the economics look attractive, then the safety issue may be confronted with a compelling interest.« less

Prospective drug safety monitoring using the UK primary-care General Practice Research Database: theoretical framework, feasibility analysis and extrapolation to future scenarios.

PubMed

Johansson, Saga; Wallander, Mari-Ann; de Abajo, Francisco J; García Rodríguez, Luis Alberto

2010-03-01

Post-launch drug safety monitoring is essential for the detection of adverse drug signals that may be missed during preclinical trials. Traditional methods of postmarketing surveillance such as spontaneous reporting have intrinsic limitations, many of which can be overcome by the additional application of structured pharmacoepidemiological approaches. However, further improvement in drug safety monitoring requires a shift towards more proactive pharmacoepidemiological methods that can detect adverse drug signals as they occur in the population. To assess the feasibility of using proactive monitoring of an electronic medical record system, in combination with an independent endpoint adjudication committee, to detect adverse events among users of selected drugs. UK General Practice Research Database (GPRD) information was used to detect acute liver disorder associated with the use of amoxicillin/clavulanic acid (hepatotoxic) or low-dose aspirin (acetylsalicylic acid [non-hepatotoxic]). Individuals newly prescribed these drugs between 1 October 2005 and 31 March 2006 were identified. Acute liver disorder cases were assessed using GPRD computer records in combination with case validation by an independent endpoint adjudication committee. Signal generation thresholds were based on the background rate of acute liver disorder in the general population. Over a 6-month period, 8148 patients newly prescribed amoxicillin/clavulanic acid and 5577 patients newly prescribed low-dose aspirin were identified. Within this cohort, searches identified 11 potential liver disorder cases from computerized records: six for amoxicillin/clavulanic acid and five for low-dose aspirin. The independent endpoint adjudication committee refined this to four potential acute liver disorder cases for whom paper-based information was requested for final case assessment. Final case assessments confirmed no cases of acute liver disorder. The time taken for this study was 18 months (6 months for recruitment and 12 months for data management and case validation). To reach the estimated target exposure necessary to raise or rule out a signal of concern to public health, we determined that a recruitment period 2-3 times longer than that used in this study would be required. Based on the real market uptake of six commonly used medicinal products launched between 2001 and 2006 in the UK (budesonide/eformoterol [fixed-dose combination], duloxetine, ezetimibe, metformin/rosiglitazone [fixed-dose combination], tiotropium bromide and tadalafil) the target exposure would not have been reached until the fifth year of marketing using a single database. It is feasible to set up a system that actively monitors drug safety using a healthcare database and an independent endpoint adjudication committee. However, future successful implementation will require multiple databases to be queried so that larger study populations are included. This requires further development and harmonization of international healthcare databases.

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.

Safety, Risk, and Recovery: Women and Men as Parents in Contemporary American Fiction. Working Paper No. 179.

ERIC Educational Resources Information Center

Gullette, Margaret Morganroth

In contemporary American fiction, children are still dying. On the scale of innocence and guilt, there is a complete range, in 13 contemporary novels studied, from cases where the parents are clearly "innocent," to cases where they are clearly guilty. The novels are not about the children but instead are about the fictional midlife…

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.

SLUDGE TREATMENT PROJECT KOP DISPOSITION - THERMAL AND GAS ANALYSIS FOR THE COLD VACUUM DRYING FACILITY

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

SWENSON JA; CROWE RD; APTHORPE R

2010-03-09

The purpose of this document is to present conceptual design phase thermal process calculations that support the process design and process safety basis for the cold vacuum drying of K Basin KOP material. This document is intended to demonstrate that the conceptual approach: (1) Represents a workable process design that is suitable for development in preliminary design; and (2) Will support formal safety documentation to be prepared during the definitive design phase to establish an acceptable safety basis. The Sludge Treatment Project (STP) is responsible for the disposition of Knock Out Pot (KOP) sludge within the 105-K West (KW) Basin.more » KOP sludge consists of size segregated material (primarily canister particulate) from the fuel and scrap cleaning process used in the Spent Nuclear Fuel process at K Basin. The KOP sludge will be pre-treated to remove fines and some of the constituents containing chemically bound water, after which it is referred to as KOP material. The KOP material will then be loaded into a Multi-Canister Overpack (MCO), dried at the Cold Vacuum Drying Facility (CVDF) and stored in the Canister Storage Building (CSB). This process is patterned after the successful drying of 2100 metric tons of spent fuel, and uses the same facilities and much of the same equipment that was used for drying fuel and scrap. Table ES-l present similarities and differences between KOP material and fuel and between MCOs loaded with these materials. The potential content of bound water bearing constituents limits the mass ofKOP material in an MCO load to a fraction of that in an MCO containing fuel and scrap; however, the small particle size of the KOP material causes the surface area to be significantly higher. This relatively large reactive surface area represents an input to the KOP thermal calculations that is significantly different from the calculations for fuel MCOs. The conceptual design provides for a copper insert block that limits the volume available to receive KOP material, enhances heat conduction, and functions as a heat source and sink during drying operations. This use of the copper insert represents a significant change to the thermal model compared to that used for the fuel calculations. A number of cases were run representing a spectrum of normal and upset conditions for the drying process. Dozens of cases have been run on cold vacuum drying of fuel MCOs. Analysis of these previous calculations identified four cases that provide a solid basis for judgments on the behavior of MCO in drying operations. These four cases are: (1) Normal Process; (2) Degraded vacuum pumping; (3) Open MCO with loss of annulus water; and (4) Cool down after vacuum drying. The four cases were run for two sets of input parameters for KOP MCOs: (1) a set of parameters drawn from safety basis values from the technical data book and (2) a sensitivity set using parameters selected to evaluate the impact of lower void volume and smaller particle size on MCO behavior. Results of the calculations for the drying phase cases are shown in Table ES-2. Cases using data book safety basis values showed dry out in 9.7 hours and heat rejection sufficient to hold temperature rise to less than 25 C. Sensitivity cases which included unrealistically small particle sizes and corresponding high reactive surface area showed higher temperature increases that were limited by water consumption. In this document and in the attachment (Apthorpe, R. and M.G. Plys, 2010) cases using Technical Databook safety basis values are referred to as nominal cases. In future calculations such cases will be called safety basis cases. Also in these documents cases using parameters that are less favorable to acceptable performance than databook safety values are referred to as safety cases. In future calculations such cases will be called sensitivity cases or sensitivity evaluations Calculations to be performed in support of the detailed design and formal safety basis documentation will expand the calculations presented in this document to include: additional features of the drying cycle, more realistic treatment of uranium metal consumption during oxidation, larger water inventory, longer time scales, and graphing of results of hydrogen gas concentration.« less

Perspectives of rural and remote primary healthcare services on the meaning and goals of clinical governance.

PubMed

Kwedza, Ruyamuro K; Larkins, Sarah; Johnson, Julie K; Zwar, Nicholas

2017-10-01

Definitions of clinical governance are varied and there is no one agreed model. This paper explored the perspectives of rural and remote primary healthcare services, located in North Queensland, Australia, on the meaning and goals of clinical governance. The study followed an embedded multiple case study design with semi-structured interviews, document analysis and non-participant observation. Participants included clinicians, non-clinical support staff, managers and executives. Similarities and differences in the understanding of clinical governance between health centre and committee case studies were evident. Almost one-third of participants were unfamiliar with the term or were unsure of its meaning; alongside limited documentation of a definition. Although most cases linked the concept of clinical governance to key terms, many lacked a comprehensive understanding. Similarities between cases included viewing clinical governance as a management and administrative function. Differences included committee members' alignment of clinical governance with corporate governance and frontline staff associating clinical governance with staff safety. Document analysis offered further insight into these perspectives. Clinical governance is well-documented as an expected organisational requirement, including in rural and remote areas where geographic, workforce and demographic factors pose additional challenges to quality and safety. However, in reality, it is not clearly, similarly or comprehensively understood by all participants.

Special Feature: Epistemological Paradigms in Evaluation: Implications for Practice. Section 1: "Paradigm Contrast" Case Studies.

ERIC Educational Resources Information Center

Rose, Tom; And Others

1991-01-01

This section presents two pragmatic studies focusing on a real-life situation and specific applications in managerial decision making. One study deals with improving occupational safety in a bedding manufacturing plant, whereas the other concentrates on managing a state mental health program. (SLD)

Measuring mining safety with injury statistics: lost workdays as indicators of risk.

PubMed

Coleman, Patrick J; Kerkering, John C

2007-01-01

Mining in the United States remains one of the most hazardous industries, despite significant reductions in fatal injury rates over the last century. Coal mine fatality rates, for example, have dropped almost a thousand-fold since their peak in 1908. While incidence rates are very important indicators, lost worktime measures offer an alternative metric for evaluating job safety and health performance. The first objective of this study examined the distributions and summary statistics of all injuries reported to the Mine Safety and Health Administration from 1983 through 2004. Over the period studied (1983-2004), there were 31,515,368 lost workdays associated with mining injuries, for an equivalent of 5,700 person-years lost annually. The second objective addressed the problem of comparing safety program performance in mines for situations where denominator data were lacking. By examining the consequences of injuries, comparisons can be made between disparate operations without the need for denominators. Total risk in the form of lost workday sums can help to distinguish between lower- and higher-risk operations or time periods. Our method was to use a beta distribution to model the losses and to compare underground coal mining to underground metal/nonmetal mining from 2000 to 2004. Our results showed the probability of an injury having 10 or more lost workdays was 0.52 for coal mine cases versus 0.35 for metal/nonmetal mine cases. In addition, a comparison of injuries involving continuous mining machines over 2001-2002 versus 2003-2004 showed that the ratio of average losses in the later period to those in the earlier period was approximately 1.08, suggesting increasing risks for such operations. This denominator-free safety measure will help the mining industry more effectively identify higher-risk operations and more realistically evaluate their safety improvement programs. Attention to a variety of metrics concerning the performance of a job safety and health program will enhance industry's ability to manage these programs and reduce risk.

The Integration of Information and Communications Technology in Full Spectrum Operations: A Case Study of CJTF-101 in Afghanistan

DTIC Science & Technology

2010-06-11

Albert Maslow , “Maslow’s Hierarchy of Needs .” Maslow describes basic needs as “physiological, safety, love, esteem, and self-actualization” and...Maslow’s Hierarchy of Needs Essential Service (Consolidated) DoD Definitions DoS Definitions Dept. of Army Definitions Physiological...the physiological and safety needs identified by Maslow . However, it 52 is also evident there are several services that do not directly correlate

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.

SCAP: a new methodology for safety management based on feedback from credible accident-probabilistic fault tree analysis system.

PubMed

Khan, F I; Iqbal, A; Ramesh, N; Abbasi, S A

2001-10-12

As it is conventionally done, strategies for incorporating accident--prevention measures in any hazardous chemical process industry are developed on the basis of input from risk assessment. However, the two steps-- risk assessment and hazard reduction (or safety) measures--are not linked interactively in the existing methodologies. This prevents a quantitative assessment of the impacts of safety measures on risk control. We have made an attempt to develop a methodology in which risk assessment steps are interactively linked with implementation of safety measures. The resultant system tells us the extent of reduction of risk by each successive safety measure. It also tells based on sophisticated maximum credible accident analysis (MCAA) and probabilistic fault tree analysis (PFTA) whether a given unit can ever be made 'safe'. The application of the methodology has been illustrated with a case study.

A Collaborative Learning Network Approach to Improvement: The CUSP Learning Network.

PubMed

Weaver, Sallie J; Lofthus, Jennifer; Sawyer, Melinda; Greer, Lee; Opett, Kristin; Reynolds, Catherine; Wyskiel, Rhonda; Peditto, Stephanie; Pronovost, Peter J

2015-04-01

Collaborative improvement networks draw on the science of collaborative organizational learning and communities of practice to facilitate peer-to-peer learning, coaching, and local adaption. Although significant improvements in patient safety and quality have been achieved through collaborative methods, insight regarding how collaborative networks are used by members is needed. Improvement Strategy: The Comprehensive Unit-based Safety Program (CUSP) Learning Network is a multi-institutional collaborative network that is designed to facilitate peer-to-peer learning and coaching specifically related to CUSP. Member organizations implement all or part of the CUSP methodology to improve organizational safety culture, patient safety, and care quality. Qualitative case studies developed by participating members examine the impact of network participation across three levels of analysis (unit, hospital, health system). In addition, results of a satisfaction survey designed to evaluate member experiences were collected to inform network development. Common themes across case studies suggest that members found value in collaborative learning and sharing strategies across organizational boundaries related to a specific improvement strategy. The CUSP Learning Network is an example of network-based collaborative learning in action. Although this learning network focuses on a particular improvement methodology-CUSP-there is clear potential for member-driven learning networks to grow around other methods or topic areas. Such collaborative learning networks may offer a way to develop an infrastructure for longer-term support of improvement efforts and to more quickly diffuse creative sustainment strategies.

Ergonomics and safety in secondary wood processing

Treesearch

Rado Gazo; James D. McGlothlin; Yuehwern, Wiedenbeck, Jan Yih; Yuehwern Yih

2002-01-01

The main goal of the project was to initiate a pilot program in ergonomics for the secondary wood products industry. Case studies were conducted at three Midwest secondary wood product companies in 2000 and 2001.

Revised Standard Rules Tender Governing Motor Carrier Transportation

DOT National Transportation Integrated Search

2002-05-10

The following case study provides an in-depth view of the deployment of the safety information exchange components of the Commercial Vehicle Information Systems and Networks (CVISN) technology program in Connecticut. It describes successful practices...

A capping case study : integrating freight rail into a community setting.

DOT National Transportation Integrated Search

2011-11-01

"This investigation seeks to explore specific design solutions that could potentially enhance the capabilities of heavy rail facilities while increasing : their safety and reducing their environmental and community impacts. : Using Portland's Brookly...

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.

Systemic thrombolysis in acute ischemic stroke patients with unruptured intracranial aneurysms

PubMed Central

Goyal, Nitin; Tsivgoulis, Georgios; Zand, Ramin; Sharma, Vijay K.; Barlinn, Kristian; Male, Shailesh; Katsanos, Aristeidis H.; Bodechtel, Ulf; Iftikhar, Sulaiman; Arthur, Adam; Elijovich, Lucas; Alexandrov, Anne W.

2015-01-01

Objective: We sought to determine the safety of IV thrombolysis (IVT) in acute ischemic stroke (AIS) patients harboring unruptured intracranial aneurysm (UIA) in a multicenter study and a comprehensive meta-analysis of available case series. Methods: We analyzed prospectively collected data from consecutive AIS patients treated with IVT during a 4-year period at 4 tertiary-care stroke centers. All patients routinely underwent CT or magnetic resonance angiography during hospitalization. The presence of UIA was documented on the basis of neuroradiology reports. Symptomatic intracranial hemorrhage (sICH) was defined as imaging evidence of ICH combined with an increase in NIH Stroke Scale score of ≥4 points. A systematic meta-analysis of case series reporting safety of IVT in AIS with concomitant UIA was conducted according to PRISMA recommendations. Results: Among 1,398 AIS patients treated with IVT, we identified 42 cases (3.0%) harboring a total of 48 UIAs. The rates of symptomatic and asymptomatic ICH were 2.4% (95% confidence interval [CI] by adjusted Wald method: 0%–12.6%) and 7.1% (95% CI: 1.8%–19.7%), respectively. A total of 5 case series met our inclusion criteria for meta-analysis, and the pooled rate of sICH among 120 IVT-treated AIS patients harboring UIA was 6.7% (95% CI: 3.1%–13.7%). In the overall analysis of 5 case-series studies, the risk ratio of sICH did not differ between AIS patients with and without UIA (risk ratio = 1.60; 95% CI: 0.54–4.77; p = 0.40) with no evidence of heterogeneity across included studies (I2 = 22% and p = 0.27 for Cochran Q test). Conclusions: Our prospectively collected multicenter data, coupled with the findings of the meta-analysis, indicate the potential safety of IVT in AIS patients with UIA. PMID:26408492

Systemic thrombolysis in acute ischemic stroke patients with unruptured intracranial aneurysms.

PubMed

Goyal, Nitin; Tsivgoulis, Georgios; Zand, Ramin; Sharma, Vijay K; Barlinn, Kristian; Male, Shailesh; Katsanos, Aristeidis H; Bodechtel, Ulf; Iftikhar, Sulaiman; Arthur, Adam; Elijovich, Lucas; Alexandrov, Anne W; Alexandrov, Andrei V

2015-10-27

We sought to determine the safety of IV thrombolysis (IVT) in acute ischemic stroke (AIS) patients harboring unruptured intracranial aneurysm (UIA) in a multicenter study and a comprehensive meta-analysis of available case series. We analyzed prospectively collected data from consecutive AIS patients treated with IVT during a 4-year period at 4 tertiary-care stroke centers. All patients routinely underwent CT or magnetic resonance angiography during hospitalization. The presence of UIA was documented on the basis of neuroradiology reports. Symptomatic intracranial hemorrhage (sICH) was defined as imaging evidence of ICH combined with an increase in NIH Stroke Scale score of ≥4 points. A systematic meta-analysis of case series reporting safety of IVT in AIS with concomitant UIA was conducted according to PRISMA recommendations. Among 1,398 AIS patients treated with IVT, we identified 42 cases (3.0%) harboring a total of 48 UIAs. The rates of symptomatic and asymptomatic ICH were 2.4% (95% confidence interval [CI] by adjusted Wald method: 0%-12.6%) and 7.1% (95% CI: 1.8%-19.7%), respectively. A total of 5 case series met our inclusion criteria for meta-analysis, and the pooled rate of sICH among 120 IVT-treated AIS patients harboring UIA was 6.7% (95% CI: 3.1%-13.7%). In the overall analysis of 5 case-series studies, the risk ratio of sICH did not differ between AIS patients with and without UIA (risk ratio = 1.60; 95% CI: 0.54-4.77; p = 0.40) with no evidence of heterogeneity across included studies (I(2) = 22% and p = 0.27 for Cochran Q test). Our prospectively collected multicenter data, coupled with the findings of the meta-analysis, indicate the potential safety of IVT in AIS patients with UIA. © 2015 American Academy of Neurology.

Akkermansia muciniphila: a novel functional microbe with probiotic properties.

PubMed

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

2016-09-01

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

Safety 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.

Vancomycin Ophthalmic Ointment 1% for methicillin-resistant Staphylococcus aureus or methicillin-resistant Staphylococcus epidermidis infections: a case series

PubMed Central

Sotozono, Chie; Fukuda, Masahiko; Ohishi, Masao; Yano, Keiko; Origasa, Hideki; Saiki, Yoshinori; Shimomura, Yoshikazu; Kinoshita, Shigeru

2013-01-01

Objectives To investigate the efficacy and safety of Vancomycin Ophthalmic Ointment 1% (Toa Pharmaceutical Co., Ltd, Toyama, Japan) in patients with external ocular infections caused by methicillin-resistant Staphylococcus aureus (MRSA) or methicillin-resistant Staphylococcus epidermidis (MRSE). Design A case series. Setting This study was a multicentre, open-label, uncontrolled study in Japan approved as orphan drug status. Participants Patients with MRSA or MRSE external ocular infections unresponsive to the treatment of fluoroquinolone eye drops. Interventions Vancomycin Ophthalmic Ointment 1% was administered four times daily. Primary and secondary outcome measures The subjective and objective clinical scores and bacterial cultures were collected at days 0 (baseline), 3, 7 and 14. The primary outcome was clinical response evaluation (efficacy rate) determined as complete response, partial response, no response and worsening. Secondary outcome was the eradication of the bacteria. Safety was assessed by adverse events including cases in which neither MRSA nor MRSE was detected. Results Twenty-five cases with MRSA (20) or MRSE (5) infections were enrolled. Of these 25 cases, 4 discontinued the treatment due to the negative results for bacterial culture during screening or at baseline. Of the 21 cases with conjunctivitis (14), blepharitis (3), meibomitis (1), dacryocystitis (2) or keratitis (1), 14 (66.7%) cases were evaluated as being excellently (complete response, 2 cases) or well (partial response, 12 cases) treated. The eradication rates were 68.4% in MRSA (13 of 19 cases) and 100% in MRSE (2 of 2 cases). Ten adverse events occurred in 7 (28.0%) of 25 cases at the local administration site. Conclusions Vancomycin Ophthalmic Ointment 1% was considered to be useful for the treatment of intractable ocular MRSA/MRSE infections. PMID:23364319

Analysis of Safety-Related Regulatory Actions for New Drugs in Japan by Nature of Identified Risks.

PubMed

Fujikawa, Makoto; Ono, Shunsuke

2017-01-01

Mechanisms underlying safety events may be heterogeneous and depend on conditions of development and marketing, including the populations studied in clinical trials and the amount of data required for approval, especially under pathways for accelerated access. This study was conducted to investigate possible factors affecting the first post-marketing safety-related regulatory actions (SRRAs) after launch of new drugs in Japan. We studied 338 new molecular entities (NMEs) approved in Japan between 2004 and 2014. We focused on three different types of SRRAs: (1) all-SRRAs (i.e. SRRAs from domestic cases and other countries), (2) domestic-SRRAs (i.e. SRRAs from domestic cases) and (3) domestic unknown-SRRAs (i.e. SRRAs of unknown risks from domestic cases). Occurrences of the three types of SRRAs were analyzed using Kaplan-Meier analysis and Cox-regression. SRRAs tended to occur sooner for NMEs launched in recent years versus those launched towards the beginning of the study period. Risk of SRRA was high for antineoplastics. Drugs for cardiovascular diseases, central nervous system, and diabetes had positive associations with all-SRRAs, but the associations were weaker with domestic-SRRAs. Domestic-SRRAs were more likely for drugs with relatively novel modes of action (MOAs). Longer lag to Japanese launch after first global launch significantly lowered SRRA risks. While most of the variables showed similar associations across the three types of SRRAs, adoption of bridging strategies showed higher risks only for domestic-SRRAs, not for all-SRRAs. FDA safety labeling changes and non-orphan priority review drugs presented higher domestic-SRRA risks. The number of adverse drug reactions (ADRs) from spontaneous reports had positive correlations with the three types of SRRAs, whereas the number from company-led surveillance showed no association. Our results indicated that global clinical development pathways and marketing status should be considered more seriously in implementing locally optimized pharmacovigilance activities. Caution may be needed not only for drugs with novel MOAs, but also for drugs for which local dose-finding studies have been skipped, expedited review status has been given, timing of launch is close to those in the USA and the EU, and spontaneous reports rather than company-lead surveillance suggest possible safety risks.

Meeting report: Spontaneous lesions and diseases in wild, captive-bred, and zoo-housed nonhuman primates and in nonhuman primate species used in drug safety studies.

PubMed

Sasseville, V G; Mansfield, K G; Mankowski, J L; Tremblay, C; Terio, K A; Mätz-Rensing, K; Gruber-Dujardin, E; Delaney, M A; Schmidt, L D; Liu, D; Markovits, J E; Owston, M; Harbison, C; Shanmukhappa, S; Miller, A D; Kaliyaperumal, S; Assaf, B T; Kattenhorn, L; Macri, S Cummings; Simmons, H A; Baldessari, A; Sharma, P; Courtney, C; Bradley, A; Cline, J M; Reindel, J F; Hutto, D L; Montali, R J; Lowenstine, L J

2012-11-01

The combination of loss of habitat, human population encroachment, and increased demand of select nonhuman primates for biomedical research has significantly affected populations. There remains a need for knowledge and expertise in understanding background findings as related to the age, source, strain, and disease status of nonhuman primates. In particular, for safety/biomedical studies, a broader understanding and documentation of lesions would help clarify background from drug-related findings. A workshop and a minisymposium on spontaneous lesions and diseases in nonhuman primates were sponsored by the concurrent Annual Meetings of the American College of Veterinary Pathologists and the American Society for Veterinary Clinical Pathology held December 3-4, 2011, in Nashville, Tennessee. The first session had presentations from Drs Lowenstine and Montali, pathologists with extensive experience in wild and zoo populations of nonhuman primates, which was followed by presentations of 20 unique case reports of rare or newly observed spontaneous lesions in nonhuman primates (see online files for access to digital whole-slide images corresponding to each case report at http://www.scanscope.com/ACVP%20Slide%20Seminars/2011/Primate%20Pathology/view.apml). The minisymposium was composed of 5 nonhuman-primate researchers (Drs Bradley, Cline, Sasseville, Miller, Hutto) who concentrated on background and spontaneous lesions in nonhuman primates used in drug safety studies. Cynomolgus and rhesus macaques were emphasized, with some material presented on common marmosets. Congenital, acquired, inflammatory, and neoplastic changes were highlighed with a focus on clinical, macroscopic, and histopathologic findings that could confound the interpretation of drug safety studies.

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.

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.

Changing Operating Room Culture: Implementation of a Postoperative Debrief and Improved Safety Culture.

PubMed

Magill, Stephen T; Wang, Doris D; Rutledge, W Caleb; Lau, Darryl; Berger, Mitchel S; Sankaran, Sujatha; Lau, Catherine Y; Imershein, Sarah G

2017-11-01

Patient safety is foundational to neurosurgical care. Postprocedural "debrief" checklists have been proposed to improve patient safety, but data about their use in neurosurgery are limited. Here, we implemented an initiative to routinely perform postoperative debriefs and evaluated the impact of debriefing on operating room (OR) safety culture. A 10-question safety attitude questionnaire (SAQ) was sent to neurosurgical OR staff at a major academic medical center before and 18 months after the implementation of a postoperative debriefing initiative. Rates of debrief compliance and changes in attitudes before and after the survey were evaluated. The survey used a Likert scale and analyzed with standard statistical methods. After the debrief initiative, the rate of debriefing increased from 51% to 86% of cases for the neurosurgery service. Baseline SAQ responses found that neurosurgeons had a more favorable perception of OR safety than did anesthesiologists and nurses. After implementation of the postoperative debriefing process, perceptions of OR safety significantly improved for neurosurgeons, anesthesiologists, and nurses. Furthermore, the disparity between nurses and surgeons was no longer significant. After debrief implementation, neurosurgical OR staff had improved perceptions of patient safety compared with surgical services that did not commonly perform debriefing. Debriefing identified OR efficiency concerns in 26.9% of cases, and prevention of potential adverse events/near misses was reported in 8% of cases. Postoperative debriefing can be effectively introduced into the OR and improves the safety culture after implementation. Debriefing is an effective tool to identify OR inefficiencies and potential adverse events. Copyright © 2017 Elsevier Inc. All rights reserved.

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 of them could be verified and confirmed. This study highlights the utility of topic modeling to leverage information within textual drug safety databases, which provides new opportunities in the big data era to assess drug safety. PMID:25559675

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 confirmed. This study highlights the utility of topic modeling to leverage information within textual drug safety databases, which provides new opportunities in the big data era to assess drug safety.

Berkeley Lab - Materials Sciences Division

Science.gov Websites

Investigators Division Staff Facilities and Centers Staff Jobs Safety Personnel Resources Committees In Case of complete EHS0470, General Employee Radiation Safety (on-line course). Escort is required for visitors who Safety (on-line course) ii. EHS0348 Chemical Hygiene and Safety (on-line course) iii. EHS0470 General

Public risk perception of food additives and food scares. The case in Suzhou, China.

PubMed

Wu, Linhai; Zhong, Yingqi; Shan, Lijie; Qin, Wei

2013-11-01

This study examined the factors affecting public risk perception of food additive safety and possible resulting food scares using a survey conducted in Suzhou, Jiangsu Province, China. The model was proposed based on literature relating to the role of risk perception and information perception of public purchase intention under food scares. Structural equation modeling (SEM) was used for data analysis. The results showed that attitude towards behavior, subjective norm and information perception exerted moderate to high effect on food scares, and the effects were also mediated by risk perceptions of additive safety. Significant covariance was observed between attitudes toward behavior, subjective norm and information perception. Establishing an effective mechanism of food safety risk communication, releasing information of government supervision on food safety in a timely manner, curbing misleading media reports on public food safety risk, and enhancing public knowledge of the food additives are key to the development and implementation of food safety risk management policies by the Chinese government. Copyright © 2013 Elsevier Ltd. All rights reserved.

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

PubMed

Yang, Wei; Xie, Yanming; Zhuang, Yan

2011-10-01

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

Situations of car-to-pedestrian contact.

PubMed

Matsui, Yasuhiro; Hitosugi, Masahito; Takahashi, Kunio; Doi, Tsutomu

2013-01-01

To reduce the severity of injuries and the number of pedestrian deaths in traffic accidents, active safety devices providing pedestrian detection are considered effective countermeasures. The features of car-to-pedestrian collisions need to be known in detail to develop such safety devices. Because information on real-world accidents is limited, this study investigated near-miss situations captured by drive recorders installed in passenger cars. We showed similarities of the contact situation between near-miss incidents and real-world fatal pedestrian accidents in Japan. We analyzed the near-miss incident data via video capturing pedestrians crossing the road in front of forward-moving cars. Using a video frame captured by a drive recorder, the time to collision (TTC) was calculated from the car velocity and the distance between the car and pedestrian at the moment that the pedestrian initially appeared. The average TTC in the cases where pedestrians were not using a pedestrian crossing was shorter than that in the cases where pedestrians were using a pedestrian crossing. The average TTC in the cases where pedestrians emerged from behind obstructions was shorter than that in the cases where drivers had unobstructed views of the pedestrians. We propose that the specifications of the safety device for pedestrian detection and automatic braking should reflect the severe approach situation for a pedestrian and car including the TTC observed for near-miss incidents.

Effective apatinib treatment of pleomorphic liposarcoma: A case report.

PubMed

Yan, Peng; Sun, Mei-Li; Sun, Yu-Ping; Liu, Chuan-Yong

2017-08-01

Pleomorphic liposarcoma (PLS) is a rare and aggressive malignant tumor, and both radiation and conventional cytotoxic chemotherapy remain controversial for metastatic or unresectable disease. We presented an 81-year-old Chinese woman with advanced PLS who received apatinib after failure chemotherapy. The patient was diagnosed as having PLS by biopsy. After a failed chemotherapy, apatinib started to be taken orally 425 mg per day. This patient achieved 3-month progression-free survival (PFS) and a higher quality of life. Meanwhile, this patient suffered grade 2 hypertension and grade 3 hand-foot syndrome (HFS). In this case, apatinib presented good efficacy and safety to treat PLS. Randomized clinical studies are required to confirm the efficacy and safety of apatinib in the treatment of PLS.

30 CFR 56.4530 - Exits.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE SAFETY AND HEALTH SAFETY AND HEALTH STANDARDS-SURFACE METAL AND NONMETAL MINES Fire Prevention and Control... a sufficient number of exits to permit prompt escape in case of fire. ...

Using Machine Learning to Predict MCNP Bias

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

Grechanuk, Pavel Aleksandrovi

For many real-world applications in radiation transport where simulations are compared to experimental measurements, like in nuclear criticality safety, the bias (simulated - experimental k eff) in the calculation is an extremely important quantity used for code validation. The objective of this project is to accurately predict the bias of MCNP6 [1] criticality calculations using machine learning (ML) algorithms, with the intention of creating a tool that can complement the current nuclear criticality safety methods. In the latest release of MCNP6, the Whisper tool is available for criticality safety analysts and includes a large catalogue of experimental benchmarks, sensitivity profiles,more » and nuclear data covariance matrices. This data, coming from 1100+ benchmark cases, is used in this study of ML algorithms for criticality safety bias predictions.« less

A toolbox for safety instrumented system evaluation based on improved continuous-time Markov chain

NASA Astrophysics Data System (ADS)

Wardana, Awang N. I.; Kurniady, Rahman; Pambudi, Galih; Purnama, Jaka; Suryopratomo, Kutut

2017-08-01

Safety instrumented system (SIS) is designed to restore a plant into a safe condition when pre-hazardous event is occur. It has a vital role especially in process industries. A SIS shall be meet with safety requirement specifications. To confirm it, SIS shall be evaluated. Typically, the evaluation is calculated by hand. This paper presents a toolbox for SIS evaluation. It is developed based on improved continuous-time Markov chain. The toolbox supports to detailed approach of evaluation. This paper also illustrates an industrial application of the toolbox to evaluate arch burner safety system of primary reformer. The results of the case study demonstrates that the toolbox can be used to evaluate industrial SIS in detail and to plan the maintenance strategy.

Safety Profile of Eslicarbazepine Acetate as Add-On Therapy in Adults with Refractory Focal-Onset Seizures: From Clinical Studies to 6 Years of Post-Marketing Experience.

PubMed

Gama, Helena; Vieira, Mariana; Costa, Raquel; Graça, Joana; Magalhães, Luís M; Soares-da-Silva, Patrício

2017-12-01

Eslicarbazepine acetate was first approved in the European Union in 2009 as adjunctive therapy in adults with partial-onset seizures with or without secondary generalization. The objective of this study was to review the safety profile of eslicarbazepine acetate analyzing the data from several clinical studies to 6 years of post-marketing surveillance. We used a post-hoc pooled safety analysis of four phase III, double-blind, randomized, placebo-controlled studies (BIA-2093-301, -302, -303, -304) of eslicarbazepine acetate as add-on therapy in adults. Safety data of eslicarbazepine acetate in special populations of patients aged ≥65 years with partial-onset seizures (BIA-2093-401) and subjects with moderate hepatic impairment (BIA-2093-111) and renal impairment (BIA-2093-112) are also considered. The incidences of treatment-emergent adverse events, treatment-emergent adverse events leading to discontinuation, and serious adverse events were analyzed. The global safety database of eslicarbazepine acetate was analyzed for all cases from post-marketing surveillance from 1 October, 2009 to 21 October, 2015. From a pooled analysis of four phase III studies, it was concluded that the incidence of treatment-emergent adverse events, treatment-emergent adverse events leading to discontinuation, and adverse drug reactions were dose dependent. Dizziness, somnolence, headache, and nausea were the most common treatment-emergent adverse events (≥10% of patients) and the majority were of mild-to-moderate intensity. No dose-dependent trend was observed for serious adverse events and individual serious adverse events were reported in less than 1% of patients. Hyponatremia was classified as a possibly related treatment-emergent adverse event in phase III studies (1.2%); however, after 6 years of post-marketing surveillance it represents the most frequently (10.2%) reported adverse drug reaction, with more than half of these cases occurring with eslicarbazepine acetate at daily doses of 1200 mg. Other adverse drug reactions reported in post-marketing surveillance are seizure (5.8%), dizziness (4.1%), rash (2.6%), and fatigue (2.1%). The safety profile of eslicarbazepine acetate in renal and hepatic impairment subjects (phase I studies) and in elderly patients (phase III study) did not raise any specific concern. After 6 years of post-marketing surveillance, eslicarbazepine acetate maintains a similar safety profile to that observed in pivotal clinical studies.

36 CFR 292.65 - Plan of operations-suspension.

Code of Federal Regulations, 2014 CFR

2014-07-01

... those cases that do not present a threat of imminent harm to public health, safety, or the environment.... (1) In those cases that present a threat of imminent harm to public health, safety, or the environment, or where such harm is already occurring, the authorized officer may take immediate action to stop...

36 CFR 292.65 - Plan of operations-suspension.

Code of Federal Regulations, 2012 CFR

2012-07-01

... those cases that do not present a threat of imminent harm to public health, safety, or the environment.... (1) In those cases that present a threat of imminent harm to public health, safety, or the environment, or where such harm is already occurring, the authorized officer may take immediate action to stop...

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.…

Safety analysis of Ziagen® (abacavir sulfate) in postmarketing surveillance in Japan†

PubMed Central

Kurita, Tomoko; Kitaichi, Tomomi; Nagao, Takako; Miura, Toshiyuki; Kitazono, Yoshifumi

2014-01-01

Purpose Abacavir is a nucleoside reverse transcriptase inhibitor indicated for human immunodeficiency virus (HIV) infection. In Japan, Ziagen® (300-mg abacavir sulfate) has been marketed since 1999. To obtain safety data on Ziagen, a mandatory postmarketing surveillance was conducted between September 1999 and September 2009. Methods A joint survey [HIV-related Drug Surveys (HRD)] has been conducted involving manufacturers of drugs for HIV treatment in Japan. Safety data from total 643 cases (1345.7 person-years) registered to the HRD surveys and received Ziagen were obtained. Adverse drug reaction (ADR) was defined as adverse event of which association with abacavir could not be “ruled out.” Results It was found that the overall frequency of ADR was 47.6% (306/643); the common ADRs were “hyperlipidemia,” “nausea,” “increased γ-glutamyltransferase level,” “increased blood triglycerides,” “abnormal hepatic function,” and so on. Serious adverse events were reported in 65 subjects; however, none of the three fatal cases were clearly associated with Ziagen use. The survey-defined hypersensitivity has been infrequently reported in 15 subjects (2.3%). Although some studies had indicated of the association between abacavir and myocardial infarction, no ischemic heart diseases were reported in the present survey. Two of the three pregnant cases delivered normal neonates (one induced abortion). Conclusions During the mandatory postmarketing survey of Ziagen, there were no cases of ischemic heart diseases, and the incidence of hypersensitivity was considerably low. These indicated that abacavir can be safely used in Japanese HIV+ population. However, the safety profile of Ziagen should be continued to be monitored through pharmacovigilance. PMID:24585486

Role of champions in the implementation of patient safety practice change.

PubMed

Soo, Stephanie; Berta, Whitney; Baker, G Ross

2009-01-01

Practitioners of patient safety practice change agree that champions are central to the success of implementation. The clinical champion role is a concept that has been widely promoted yet empirically underdeveloped in health services literature. Questions remain as to who these champions are, what roles they play in patient safety practice change and what contexts serve to facilitate their efforts. This investigation used a multiple-case study design to critically examine the role of champions in the implementation of rapid response teams (RRTs), an innovative complex patient safety intervention, in two large urban acute care facilities. An analysis of interviews with key individuals involved in the RRT implementation process revealed a typology of the patient safety practice champion that extended beyond clinical personnel to include managerial and executive staff. Champions engaged to a varying extent in a number of core activities, including education, advocacy, relationship building and boundary spanning. Individuals became champions both through informal emergence and a combination of formal appointment and informal emergence. By identifying and elaborating upon specific features of the champion role, this study aims to expand the dialogue about champions for patient safety practice change.

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

NASA Astrophysics Data System (ADS)

Rolita, Lisa; Surarso, Bayu; Gernowo, Rahmat

2018-02-01

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

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

Evidence Arguments for Using Formal Methods in Software Certification

NASA Technical Reports Server (NTRS)

Denney, Ewen W.; Pai, Ganesh

2013-01-01

We describe a generic approach for automatically integrating the output generated from a formal method/tool into a software safety assurance case, as an evidence argument, by (a) encoding the underlying reasoning as a safety case pattern, and (b) instantiating it using the data produced from the method/tool. We believe this approach not only improves the trustworthiness of the evidence generated from a formal method/tool, by explicitly presenting the reasoning and mechanisms underlying its genesis, but also provides a way to gauge the suitability of the evidence in the context of the wider assurance case. We illustrate our work by application to a real example-an unmanned aircraft system- where we invoke a formal code analysis tool from its autopilot software safety case, automatically transform the verification output into an evidence argument, and then integrate it into the former.

Food Safety at Farmers' Markets: A Knowledge Synthesis of Published Research.

PubMed

Young, Ian; Thaivalappil, Abhinand; Reimer, Danielle; Greig, Judy

2017-12-01

Farmers' markets are increasingly popular venues in North America for the sale of fresh produce and other foods. However, the nature of their operation can present possible food safety issues, challenges, and risks to consumers. A knowledge synthesis was conducted to identify, characterize, and summarize published research on the microbial food safety issues and implications associated with farmers' markets. A scoping review was conducted using the following steps: comprehensive search strategy, relevance screening of abstracts, and characterization of relevant articles. Two subsets of data were prioritized for more detailed systematic review (data extraction and risk-of-bias assessment) and meta-analysis: (i) studies comparing the microbial safety of foods from farmers' markets versus other sources and (ii) studies evaluating the use of food safety practices at farmers' markets. Overall, 83 relevant studies were identified. The majority of studies were published as journal articles (64%), used a cross-sectional design (81%), and were conducted in the United States (78%). Most studies (39%; n = 32) investigated stakeholder, mostly consumer (n = 22), attitudes toward food safety at farmers' markets. Limited but heterogeneous evidence indicated a higher prevalence of Campylobacter and Salmonella in chicken meat from farmers' markets versus other retail sources, but there was no difference in the microbial contamination of fresh produce. Studies evaluating the use of food safety practices at farmers' markets identified some gaps; for example, the average prevalence of vendor hand washing was 4% (95% confidence interval: 0 to 11%; I 2 = 27%; n = 5 studies). Twelve foodborne outbreaks and case reports were identified, resulting in a total of 411 illnesses, 38 hospitalizations, and two deaths from 1994 to 2016. Only five intervention studies were identified. Key knowledge gaps and areas warranting future research, training, and education are highlighted and discussed.

Severe anaemia associated with Plasmodium falciparum infection in children: consequences for additional blood sampling for research.

PubMed

Kuijpers, Laura Maria Francisca; Maltha, Jessica; Guiraud, Issa; Kaboré, Bérenger; Lompo, Palpouguini; Devlieger, Hugo; Van Geet, Chris; Tinto, Halidou; Jacobs, Jan

2016-06-02

Plasmodium falciparum infection may cause severe anaemia, particularly in children. When planning a diagnostic study on children suspected of severe malaria in sub-Saharan Africa, it was questioned how much blood could be safely sampled; intended blood volumes (blood cultures and EDTA blood) were 6 mL (children aged <6 years) and 10 mL (6-12 years). A previous review [Bull World Health Organ. 89: 46-53. 2011] recommended not to exceed 3.8 % of total blood volume (TBV). In a simulation exercise using data of children previously enrolled in a study about severe malaria and bacteraemia in Burkina Faso, the impact of this 3.8 % safety guideline was evaluated. For a total of 666 children aged >2 months to <12 years, data of age, weight and haemoglobin value (Hb) were available. For each child, the estimated TBV (TBVe) (mL) was calculated by multiplying the body weight (kg) by the factor 80 (ml/kg). Next, TBVe was corrected for the degree of anaemia to obtain the functional TBV (TBVf). The correction factor consisted of the rate 'Hb of the child divided by the reference Hb'; both the lowest ('best case') and highest ('worst case') reference Hb values were used. Next, the exact volume that a 3.8 % proportion of this TBVf would present was calculated and this volume was compared to the blood volumes that were intended to be sampled. When applied to the Burkina Faso cohort, the simulation exercise pointed out that in 5.3 % (best case) and 11.4 % (worst case) of children the blood volume intended to be sampled would exceed the volume as defined by the 3.8 % safety guideline. Highest proportions would be in the age groups 2-6 months (19.0 %; worst scenario) and 6 months-2 years (15.7 %; worst case scenario). A positive rapid diagnostic test for P. falciparum was associated with an increased risk of violating the safety guideline in the worst case scenario (p = 0.016). Blood sampling in children for research in P. falciparum endemic settings may easily violate the proposed safety guideline when applied to TBVf. Ethical committees and researchers should be wary of this and take appropriate precautions.

Safety, tolerability, efficacy and pharmacodynamics of the selective JAK1 inhibitor GSK2586184 in patients with systemic lupus erythematosus.

PubMed

Kahl, L; Patel, J; Layton, M; Binks, M; Hicks, K; Leon, G; Hachulla, E; Machado, D; Staumont-Sallé, D; Dickson, M; Condreay, L; Schifano, L; Zamuner, S; van Vollenhoven, R F

2016-11-01

We aimed to evaluate the pharmacodynamics, efficacy, safety and tolerability of the JAK1 inhibitor GSK2586184 in adults with systemic lupus erythematosus (SLE). In this adaptive, randomized, double-blind, placebo-controlled study, patients received oral GSK2586184 50-400 mg, or placebo twice daily for 12 weeks. Primary endpoints included interferon-mediated messenger RNA transcription over time, changes in Safety of Estrogen in Lupus National Assessment-SLE Disease Activity Index score, and number/severity of adverse events. A pre-specified interim analysis was performed when ≥ 5 patients per group completed 2 weeks of treatment. In total, 84-92% of patients were high baseline expressors of the interferon transcriptional biomarkers evaluated. At interim analysis, GSK2586184 showed no significant effect on mean interferon transcriptional biomarker expression (all panels). The study was declared futile and recruitment was halted at 50 patients. Shortly thereafter, significant safety data were identified, including elevated liver enzymes in six patients (one confirmed and one suspected case of Drug Reaction with Eosinophilia and Systemic Symptoms), leading to immediate dosing cessation. Safety of Estrogen in Lupus National Assessment-SLE Disease Activity Index scores were not analysed due to the small number of patients completing the study. The study futility and safety data described for GSK2586184 do not support further evaluation in patients with SLE. Study identifiers: GSK Study JAK115919; ClinicalTrials.gov identifier: NCT01777256.

Do safety checklists improve teamwork and communication in the operating room? A systematic review.

PubMed

Russ, Stephanie; Rout, Shantanu; Sevdalis, Nick; Moorthy, Krishna; Darzi, Ara; Vincent, Charles

2013-12-01

The aim of this systematic review was to assess the impact of surgical safety checklists on the quality of teamwork and communication in the operating room (OR). Safety checklists have been shown to impact positively on patient morbidity and mortality following surgery, but it is unclear whether this clinical improvement is related to an improvement in OR teamwork and communication. A systematic search strategy of MEDLINE, EMBASE, PsycINFO, Google Scholar, and the Cochrane Database for Systematic Reviews was undertaken to obtain relevant articles. After de-duplication and the addition of limits, 315 articles were screened for inclusion by 2 researchers and all articles meeting a set of prespecified inclusion criteria were retained. Information regarding the type of checklist, study design, assessment tools used, outcomes, and study limitations was extracted. Twenty articles formed the basis of this systematic review. All articles described an empirical study relating to a case-specific safety checklist for surgery as the primary intervention, with some measure of change/improvement in teamwork and/or communication relating to its use. The methods for assessing teamwork and communication varied greatly, including surveys, observations, interviews, and 360° assessments. The evidence suggests that safety checklists improve the perceived quality of OR teamwork and communication and reduce observable errors relating to poor team skills. This is likely to function through establishing an open platform for communication at the start of a procedure: encouraging the sharing of critical case-related information, promoting team coordination and decision making, flagging knowledge gaps, and enhancing team cohesion. However, the evidence would also suggest that when used suboptimally or when individuals have not bought in to the process, checklists may conversely have a negative impact on the function of the team. Safety checklists are beneficial for OR teamwork and communication and this may be one mechanism through which patient outcomes are improved. Future research should aim to further elucidate the relationship between how safety checklists are used and team skills in the OR using more consistent methodological approaches and utilizing validated measures of teamwork such that best practice guidelines can be established.

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.

The Relationship Between Professional Burnout and Quality and Safety in Healthcare: A Meta-Analysis.

PubMed

Salyers, Michelle P; Bonfils, Kelsey A; Luther, Lauren; Firmin, Ruth L; White, Dominique A; Adams, Erin L; Rollins, Angela L

2017-04-01

Healthcare provider burnout is considered a factor in quality of care, yet little is known about the consistency and magnitude of this relationship. This meta-analysis examined relationships between provider burnout (emotional exhaustion, depersonalization, and reduced personal accomplishment) and the quality (perceived quality, patient satisfaction) and safety of healthcare. Publications were identified through targeted literature searches in Ovid MEDLINE, PsycINFO, Web of Science, CINAHL, and ProQuest Dissertations & Theses through March of 2015. Two coders extracted data to calculate effect sizes and potential moderators. We calculated Pearson's r for all independent relationships between burnout and quality measures, using a random effects model. Data were assessed for potential impact of study rigor, outliers, and publication bias. Eighty-two studies including 210,669 healthcare providers were included. Statistically significant negative relationships emerged between burnout and quality (r = -0.26, 95 % CI [-0.29, -0.23]) and safety (r = -0.23, 95 % CI [-0.28, -0.17]). In both cases, the negative relationship implied that greater burnout among healthcare providers was associated with poorer-quality healthcare and reduced safety for patients. Moderators for the quality relationship included dimension of burnout, unit of analysis, and quality data source. Moderators for the relationship between burnout and safety were safety indicator type, population, and country. Rigor of the study was not a significant moderator. This is the first study to systematically, quantitatively analyze the links between healthcare provider burnout and healthcare quality and safety across disciplines. Provider burnout shows consistent negative relationships with perceived quality (including patient satisfaction), quality indicators, and perceptions of safety. Though the effects are small to medium, the findings highlight the importance of effective burnout interventions for healthcare providers. Moderator analyses suggest contextual factors to consider for future study.

Long-Term Safety and Immunogenicity of a Tetravalent Live-Attenuated Dengue Vaccine and Evaluation of a Booster Dose Administered to Healthy Thai Children

PubMed Central

Watanaveeradej, Veerachai; Simasathien, Sriluck; Mammen, Mammen P.; Nisalak, Ananda; Tournay, Elodie; Kerdpanich, Phirangkul; Samakoses, Rudiwilai; Putnak, Robert J.; Gibbons, Robert V.; Yoon, In-Kyu; Jarman, Richard G.; De La Barrera, Rafael; Moris, Philippe; Eckels, Kenneth H.; Thomas, Stephen J.; Innis, Bruce L.

2016-01-01

We evaluated the safety and immunogenicity of two doses of a live-attenuated, tetravalent dengue virus vaccine (F17/Pre formulation) and a booster dose in a dengue endemic setting in two studies. Seven children (7- to 8-year-olds) were followed for 1 year after dose 2 and then given a booster dose (F17/Pre formulation), and followed for four more years (Child study). In the Infant study, 49 2-year-olds, vaccinated as infants, were followed for approximately 3.5 years after dose 2 and then given a booster dose (F17) and followed for one additional year. Two clinically notable events were observed, both in dengue vaccine recipients in the Infant study: 1 case of dengue approximately 2.7 years after dose 2 and 1 case of suspected dengue after booster vaccinations. The booster vaccinations had a favorable safety profile in terms of reactogenicity and adverse events reported during the 1-month follow-up periods. No vaccine-related serious adverse events were reported during the studies. Neutralizing antibodies against dengue viruses 1–4 waned during the 1–3 years before boosting, which elicited a short-lived booster response but did not provide a long-lived, multivalent antibody response in most subjects. Overall, this candidate vaccine did not elicit a durable humoral immune response. PMID:27022153

Regulatory considerations on new adjuvants and delivery systems.

PubMed

Sesardic, D

2006-04-12

New and improved vaccines and delivery systems are increasingly being developed for prevention, treatment and diagnosis of human diseases. Prior to their use in humans, all new biological products must undergo pre-clinical evaluation. These pre-clinical studies are important not only to establish the biological properties of the material and to evaluate its possible risk to the public, but also to plan protocols for subsequent clinical trials from which safety and efficacy can be evaluated. For vaccines, evaluation in pre-clinical studies is particularly important as information gained may also contribute to identifying the optimum composition and formulation process and provide an opportunity to develop suitable indicator tests for quality control. Data from pre-clinical and laboratory evaluation studies, which continue during clinical studies, is used to support an application for marketing authorisation. Addition of a new adjuvant and exploration of new delivery systems for vaccines presents challenges to both manufacturers and regulatory authorities. Because no adjuvant is licensed as a medicinal product in its own right, but only as a component of a particular vaccine, pre-clinical and appropriate toxicology studies need to be designed on a case-by-case basis to evaluate the safety profile of the adjuvant and adjuvant/vaccine combination. Current regulatory requirements for the pharmaceutical and pre-clinical safety assessment of vaccines are insufficient and initiatives are in place to develop more specific guidelines for evaluation of adjuvants in vaccines.

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

PubMed

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

1998-06-01

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

Fibrin Sealants in Dura Sealing: A Systematic Literature Review

PubMed Central

2016-01-01

Background Fibrin sealants are widely used in neurosurgery to seal the suture line, provide watertight closure, and prevent cerebrospinal fluid leaks. The aim of this systematic review is to summarize the current efficacy and safety literature of fibrin sealants in dura sealing and the prevention/treatment of cerebrospinal fluid leaks. Methods A comprehensive electronic literature search was run in the following databases: Cochrane Database of Systematic Reviews, Cochrane Central Resister of Controlled Trials, clinicaltrials.gov, MEDLINE/PubMed, and EMBASE. Titles and abstracts of potential articles of interest were reviewed independently by 3 of the authors. Results A total of 1006 database records and additional records were identified. After screening for duplicates and relevance, a total of 78 articles were assessed by the investigators for eligibility. Thirty-eight were excluded and the full-text of 40 articles were included in the qualitative synthesis. Seven of these included only safety data and were included in the safety assessment. The remaining 33 articles included findings from 32 studies that enrolled a total of 2935 patients who were exposed to fibrin sealant. Among these 33 studies there were only 3 randomized controlled trials, with the remaining being prospective cohort analysis, case controlled studies, prospective or retrospective case series. One randomized controlled trial, with 89 patients exposed to fibrin sealant, found a greater rate of intraoperative watertight dura closure in the fibrin sealant group than the control group (92.1% versus 38.0%, p<0.001); however, post-operative cerebrospinal fluid leakage occurred in more fibrin sealant than control patients (6.7% versus 2.0%, p>0.05). Other clinical trials evaluated the effect of fibrin sealant in the postoperative prevention of cerebrospinal fluid leaks. These were generally lower level evidence studies (ie, not prospective, randomized, controlled trials) that were not designed or powered to demonstrate a significant advantage to fibrin sealant use. Two small case series studies evaluated the effect of fibrin sealants in persistent cerebrospinal fluid leak treatment, but did not establish firm efficacy conclusions. Specific adverse reports where fibrin sealants were used for dura sealing were limited, with only 8 cases reported in neurosurgical procedures since 1987 and most reporting only a speculative relationship/association with fibrin sealant exposure. Conclusions A major finding of this systematic literature review is that there is a paucity of randomized studies that have evaluated the effectiveness and safety of fibrin sealants in providing intraoperative watertight dura closure and post-operative cerebrospinal fluid leakage. Among the limited studies available, evidence from a single randomized, controlled trial indicates that fibrin sealants provide a higher rate of intraoperative watertight closure of the dura suture line than control, albeit with a higher rate of postoperative cerebrospinal fluid leakage. Evidence from non-randomized, controlled trials suggests that fibrin sealants may be effective in preventing cerebrospinal fluid leaks with an acceptable safety profile. There is a substantial need for randomized, controlled clinical trials or well-designed prospective observational trials where the conduct of a randomized trial is not feasible to fully assess the impact of fibrin sealant utilization on the rates of intraoperative dura closure, postoperative cerebrospinal leakage, and safety. PMID:27119993

Fibrin Sealants in Dura Sealing: A Systematic Literature Review.

PubMed

Esposito, Felice; Angileri, Filippo Flavio; Kruse, Peter; Cavallo, Luigi Maria; Solari, Domenico; Esposito, Vincenzo; Tomasello, Francesco; Cappabianca, Paolo

2016-01-01

Fibrin sealants are widely used in neurosurgery to seal the suture line, provide watertight closure, and prevent cerebrospinal fluid leaks. The aim of this systematic review is to summarize the current efficacy and safety literature of fibrin sealants in dura sealing and the prevention/treatment of cerebrospinal fluid leaks. A comprehensive electronic literature search was run in the following databases: Cochrane Database of Systematic Reviews, Cochrane Central Resister of Controlled Trials, clinicaltrials.gov, MEDLINE/PubMed, and EMBASE. Titles and abstracts of potential articles of interest were reviewed independently by 3 of the authors. A total of 1006 database records and additional records were identified. After screening for duplicates and relevance, a total of 78 articles were assessed by the investigators for eligibility. Thirty-eight were excluded and the full-text of 40 articles were included in the qualitative synthesis. Seven of these included only safety data and were included in the safety assessment. The remaining 33 articles included findings from 32 studies that enrolled a total of 2935 patients who were exposed to fibrin sealant. Among these 33 studies there were only 3 randomized controlled trials, with the remaining being prospective cohort analysis, case controlled studies, prospective or retrospective case series. One randomized controlled trial, with 89 patients exposed to fibrin sealant, found a greater rate of intraoperative watertight dura closure in the fibrin sealant group than the control group (92.1% versus 38.0%, p<0.001); however, post-operative cerebrospinal fluid leakage occurred in more fibrin sealant than control patients (6.7% versus 2.0%, p>0.05). Other clinical trials evaluated the effect of fibrin sealant in the postoperative prevention of cerebrospinal fluid leaks. These were generally lower level evidence studies (ie, not prospective, randomized, controlled trials) that were not designed or powered to demonstrate a significant advantage to fibrin sealant use. Two small case series studies evaluated the effect of fibrin sealants in persistent cerebrospinal fluid leak treatment, but did not establish firm efficacy conclusions. Specific adverse reports where fibrin sealants were used for dura sealing were limited, with only 8 cases reported in neurosurgical procedures since 1987 and most reporting only a speculative relationship/association with fibrin sealant exposure. A major finding of this systematic literature review is that there is a paucity of randomized studies that have evaluated the effectiveness and safety of fibrin sealants in providing intraoperative watertight dura closure and post-operative cerebrospinal fluid leakage. Among the limited studies available, evidence from a single randomized, controlled trial indicates that fibrin sealants provide a higher rate of intraoperative watertight closure of the dura suture line than control, albeit with a higher rate of postoperative cerebrospinal fluid leakage. Evidence from non-randomized, controlled trials suggests that fibrin sealants may be effective in preventing cerebrospinal fluid leaks with an acceptable safety profile. There is a substantial need for randomized, controlled clinical trials or well-designed prospective observational trials where the conduct of a randomized trial is not feasible to fully assess the impact of fibrin sealant utilization on the rates of intraoperative dura closure, postoperative cerebrospinal leakage, and safety.

Effect of Neutron Absorbers Mixed in or Coating the Fuel of a 1-MWt Lithium-Cooled Space Reactor

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

Amiri, Benjamin W.; Los Alamos National Laboratory, Los Alamos, NM 87545; Poston, David I.

2005-02-06

The goal of this study was to determine the effect of various neutron poisons (boron, dysprosium, erbium, and gadolinium) on a 1-MWt, lithium-cooled liquid-metal reactor. The isotopes were considered to be in-fuel poisons, as well as poisons coating the fuel. One way to quantify the effectiveness of a poison in meeting accident-condition requirements is by defining the safety margin as the difference between keff at the beginning of life and keff during the accident scenarios. The isotope that showed the most potential in increasing the safety margin for the wet-sand/water case was 157Gd. The safety margin was 10%-20% greater usingmore » 157Gd as an in-fuel poison as opposed to a coating, depending on the poison quantity. However, the most limiting condition (i.e., the accident scenario with the highest keff, thus the lowest safety margin) is when the reactor is submerged in wet sand. None of the isotopes considered significantly affected the safety margin for the dry-sand case. However, the poison isotopes considered may have applicability for meeting the wet-sand/water keff requirements or as burnable poisons in a moderated system. The views expressed in this document are those of the author and do not necessarily reflect agreement by the government.« less

The safety and regulation of natural products used as foods and food ingredients.

PubMed

Abdel-Rahman, Ali; Anyangwe, Njwen; Carlacci, Louis; Casper, Steve; Danam, Rebecca P; Enongene, Evaristus; Erives, Gladys; Fabricant, Daniel; Gudi, Ramadevi; Hilmas, Corey J; Hines, Fred; Howard, Paul; Levy, Dan; Lin, Ying; Moore, Robert J; Pfeiler, Erika; Thurmond, T Scott; Turujman, Saleh; Walker, Nigel J

2011-10-01

The use of botanicals and dietary supplements derived from natural substances as an adjunct to an improved quality of life or for their purported medical benefits has become increasingly common in the United States. This review addresses the safety assessment and regulation of food products containing these substances by the U.S. Food and Drug Administration (FDA). The issue of safety is particularly critical given how little information is available on the toxicity of some of these products. The first section uses case studies for stevia and green tea extracts as examples of how FDA evaluates the safety of botanical and herbal products submitted for consideration as Generally Recognized as Safe under the Federal Food, Drug, and Cosmetics Act. The 1994 Dietary Supplement Health Education Act (DSHEA) created a regulatory framework for dietary supplements. The article also discusses the regulation of this class of dietary supplements under DSHEA and addresses the FDA experience in analyzing the safety of natural ingredients described in pre-market safety submissions. Lastly, we discuss an ongoing interagency collaboration to conduct safety testing of nominated dietary supplements.

Translating Health Services Research into Practice in the Safety Net.

PubMed

Moore, Susan L; Fischer, Ilana; Havranek, Edward P

2016-02-01

To summarize research relating to health services research translation in the safety net through analysis of the literature and case study of a safety net system. Literature review and key informant interviews at an integrated safety net hospital. This paper describes the results of a comprehensive literature review of translational science literature as applied to health care paired with qualitative analysis of five key informant interviews conducted with senior-level management at Denver Health and Hospital Authority. Results from the literature suggest that implementing innovation may be more difficult in the safety net due to multiple factors, including financial and organizational constraints. Results from key informant interviews confirmed the reality of financial barriers to innovation implementation but also implied that factors, including institutional respect for data, organizational attitudes, and leadership support, could compensate for disadvantages. Translating research into practice is of critical importance to safety net providers, which are under increased pressure to improve patient care and satisfaction. Results suggest that translational research done in the safety net can better illuminate the special challenges of this setting; more such research is needed. © Health Research and Educational Trust.

[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.

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 with change in psychiatric patient safety outcomes. 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/

Use of car crashes resulting in fatal and serious injuries to analyze a safe road transport system model and to identify system weaknesses.

PubMed

Stigson, Helena; Hill, Julian

2009-10-01

The objective of this study was to evaluate a model for a safe road transport system, based on some safety performance indicators regarding the road user, the vehicle, and the road, by using crashes with fatally and seriously injured car occupants. The study also aimed to evaluate whether the model could be used to identify system weaknesses and components (road user, vehicles, and road) where improvements would yield the highest potential for further reductions in serious injuries. Real-life car crashes with serious injury outcomes (Maximum Abbreviated Injury Scale 2+) were classified according to the vehicle's safety rating by Euro NCAP (European New Car Assessment Programme) and whether the vehicle was fitted with ESC (Electronic Stability Control). For each crash, the road was also classified according to EuroRAP (European Road Assessment Programme) criteria, and human behavior in terms of speeding, seat belt use, and driving under the influence of alcohol/drugs. Each crash was compared and classified according to the model criteria. Crashes where the safety criteria were not met in more than one of the 3 components were reclassified to identify whether all the components were correlated to the injury outcome. In-depth crash injury data collected by the UK On The Spot (OTS) accident investigation project was used in this study. All crashes in the OTS database occurring between 2000 and 2005 with a car occupant with injury rated MAIS2+ were included, for a total of 101 crashes with 120 occupants. It was possible to classify 90 percent of the crashes according to the model. Eighty-six percent of the occupants were injured when more than one of the 3 components were noncompliant with the safety criteria. These cases were reclassified to identify whether all of the components were correlated to the injury outcome. In 39 of the total 108 cases, at least two components were still seen to interact. The remaining cases were only related to one of the safety criteria, namely, the road user (26), the vehicle (19), and the road (24). The criteria for the road and the vehicle did not address multiple event crashes, rear-end crashes, hitting stationary/parked vehicles, or trailers. The model for a safe road transport system was found useful to classify fatal and serious road vehicle crashes. It was possible to classify 90 percent of the crashes according to the safety road transport model. For all these cases it was possible to identify weaknesses and parts of the road transport system with the highest potential to prevent fatal and serious injuries. Injury outcomes were mostly related to an interaction between the 3 components: the road, the vehicle, and the road user.

The influence of flexible management practices on the sharing of experiential knowledge in the workplace: a case study of food service helpers.

PubMed

Ledoux, Elise; Cloutier, Esther; Fournier, Pierre-Sébastien

2012-01-01

Previous studies have shown that the job knowledge and prudent knowledge of experienced workers constitute a wealth that needs to be shared in workplaces to promote worker integration, job retention and occupational health and safety. It appears, however, that certain management practices undermine this knowledge sharing process. This case study of food service helpers in institutional food service departments is part of a research project aimed at comparing the impact of different work organization methods on knowledge sharing in the workplace on the basis of case studies carried out in several organizations. The results of this case study reveal that by destabilizing and weakening the work teams, flexible management practices create an environment that is not conducive to experiential knowledge sharing.

Total Quality Management and the System Safety Secretary

NASA Technical Reports Server (NTRS)

Elliott, Suzan E.

1993-01-01

The system safety secretary is a valuable member of the system safety team. As downsizing occurs to meet economic constraints, the Total Quality Management (TQM) approach is frequently adopted as a formula for success and, in some cases, for survival.

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

DOT National Transportation Integrated Search

2014-08-01

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

Preliminary plan for case-control crash risk study

DOT National Transportation Integrated Search

2002-01-31

The goal of the Federal Motor Carrier Safety Administration (FMCSA) is to reduce commercial vehicle-related fatalities and injuries. This is achieved through a thorough understanding of crash characteristics, precursors, and risk factors. This will h...

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.