49 CFR 229.307 - Safety analysis.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 4 2013-10-01 2013-10-01 false Safety analysis. 229.307 Section 229.307 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD LOCOMOTIVE SAFETY STANDARDS Locomotive Electronics § 229.307 Safety...

49 CFR 229.307 - Safety analysis.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 4 2012-10-01 2012-10-01 false Safety analysis. 229.307 Section 229.307 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD LOCOMOTIVE SAFETY STANDARDS Locomotive Electronics § 229.307 Safety...

10 CFR 830.206 - Preliminary documented safety analysis.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Preliminary documented safety analysis. 830.206 Section 830.206 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.206 Preliminary documented safety analysis. If construction begins after December 11, 2000, the contractor...

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

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

Curtis Smith; Diego Mandelli; Cristian Rabiti

2013-11-01

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

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

Microbial food safety in Ghana: a meta-analysis.

PubMed

Saba, Courage K S; Gonzalez-Zorn, Bruno

2012-12-16

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

Relationships between psychological safety climate facets and safety behavior in the rail industry: a dominance analysis.

PubMed

Morrow, Stephanie L; McGonagle, Alyssa K; Dove-Steinkamp, Megan L; Walker, Curtis T; Marmet, Matthew; Barnes-Farrell, Janet L

2010-09-01

The goals of this study were twofold: (1) to confirm a relationship between employee perceptions of psychological safety climate and safety behavior for a sample of workers in the rail industry and (2) to explore the relative strengths of relationships between specific facets of safety climate and safety behavior. Non-management rail maintenance workers employed by a large North American railroad completed a survey (n=421) regarding workplace safety perceptions and behaviors. Three facets of safety climate (management safety, coworker safety, and work-safety tension) were assessed as relating to individual workers' reported safety behavior. All three facets were significantly associated with safety behavior. Dominance analysis was used to assess the relative importance of each facet as related to the outcome, and work-safety tension evidenced the strongest relationship with safety behavior. Published by Elsevier Ltd.

System safety engineering analysis handbook

NASA Technical Reports Server (NTRS)

Ijams, T. E.

1972-01-01

The basic requirements and guidelines for the preparation of System Safety Engineering Analysis are presented. The philosophy of System Safety and the various analytic methods available to the engineering profession are discussed. A text-book description of each of the methods is included.

SRB Safety Analysis

NASA Image and Video Library

2003-09-11

Jeff Thon, an SRB mechanic with United Space Alliance, is lowered into a mockup of a segment of a solid rocket booster. He is testing a technique for vertical SRB propellant grain inspection. The inspection of segments is required as part of safety analysis.

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.

Infusing Reliability Techniques into Software Safety Analysis

NASA Technical Reports Server (NTRS)

Shi, Ying

2015-01-01

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

Limited-scope probabilistic safety analysis for the Los Alamos Meson Physics Facility (LAMPF)

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

Sharirli, M.; Rand, J.L.; Sasser, M.K.

1992-01-01

The reliability of instrumentation and safety systems is a major issue in the operation of accelerator facilities. A probabilistic safety analysis was performed or the key safety and instrumentation systems at the Los Alamos Meson Physics Facility (LAMPF). in Phase I of this unique study, the Personnel Safety System (PSS) and the Current Limiters (XLs) were analyzed through the use of the fault tree analyses, failure modes and effects analysis, and criticality analysis. Phase II of the program was done to update and reevaluate the safety systems after the Phase I recommendations were implemented. This paper provides a brief reviewmore » of the studies involved in Phases I and II of the program.« less

Limited-scope probabilistic safety analysis for the Los Alamos Meson Physics Facility (LAMPF)

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

Sharirli, M.; Rand, J.L.; Sasser, M.K.

1992-12-01

The reliability of instrumentation and safety systems is a major issue in the operation of accelerator facilities. A probabilistic safety analysis was performed or the key safety and instrumentation systems at the Los Alamos Meson Physics Facility (LAMPF). in Phase I of this unique study, the Personnel Safety System (PSS) and the Current Limiters (XLs) were analyzed through the use of the fault tree analyses, failure modes and effects analysis, and criticality analysis. Phase II of the program was done to update and reevaluate the safety systems after the Phase I recommendations were implemented. This paper provides a brief reviewmore » of the studies involved in Phases I and II of the program.« less

Applying importance-performance analysis to patient safety culture.

PubMed

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

2015-01-01

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

Safety and effectiveness of olanzapine in monotherapy: a multivariate analysis of a naturalistic study.

PubMed

Ciudad, Antonio; Gutiérrez, Miguel; Cañas, Fernando; Gibert, Juan; Gascón, Josep; Carrasco, José-Luis; Bobes, Julio; Gómez, Juan-Carlos; Alvarez, Enrique

2005-07-01

This study investigated safety and effectiveness of olanzapine in monotherapy compared with conventional antipsychotics in treatment of acute inpatients with schizophrenia. This was a prospective, comparative, nonrandomized, open-label, multisite, observational study of Spanish inpatients with an acute episode of schizophrenia. Data included safety assessments with an extrapyramidal symptoms (EPS) questionnaire and the report of spontaneous adverse events, plus clinical assessments with the Brief Psychiatric Rating Scale (BPRS) and the Clinical Global Impressions-Severity of Illness (CGI-S). A multivariate methodology was used to more adequately determine which factors can influence safety and effectiveness of olanzapine in monotherapy. 339 patients treated with olanzapine in monotherapy (OGm) and 385 patients treated with conventional antipsychotics (CG) were included in the analysis. Treatment-emergent EPS were significantly higher in the CG (p<0.0001). Response rate was significantly higher in the OGm (p=0.005). Logistic regression analyses revealed that the only variable significantly correlated with treatment-emergent EPS and clinical response was treatment strategy, with patients in OGm having 1.5 times the probability of obtaining a clinical response and patients in CG having 5 times the risk of developing EPS. In this naturalistic study olanzapine in monotherapy was better-tolerated and at least as effective as conventional antipsychotics.

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).

Interchange Safety Analysis Tool (ISAT) : user manual

DOT National Transportation Integrated Search

2007-06-01

This User Manual describes the usage and operation of the spreadsheet-based Interchange Safety Analysis Tool (ISAT). ISAT provides design and safety engineers with an automated tool for assessing the safety effects of geometric design and traffic con...

14 CFR 417.405 - Ground safety analysis.

Code of Federal Regulations, 2013 CFR

2013-01-01

... qualified to perform the ground safety analysis through training, education, and experience. (c) A launch... unfenced boundary of an entire industrial complex or multi-user launch site. A launch location hazard may.... (j) A launch operator must verify all information in a ground safety analysis, including design...

14 CFR 417.405 - Ground safety analysis.

Code of Federal Regulations, 2014 CFR

2014-01-01

... qualified to perform the ground safety analysis through training, education, and experience. (c) A launch... unfenced boundary of an entire industrial complex or multi-user launch site. A launch location hazard may.... (j) A launch operator must verify all information in a ground safety analysis, including design...

14 CFR 417.405 - Ground safety analysis.

Code of Federal Regulations, 2012 CFR

2012-01-01

... qualified to perform the ground safety analysis through training, education, and experience. (c) A launch... unfenced boundary of an entire industrial complex or multi-user launch site. A launch location hazard may.... (j) A launch operator must verify all information in a ground safety analysis, including design...

Management system of health and safety work (SMK3) with job safety analysis (JSA) in PT. Nira Murni construction

NASA Astrophysics Data System (ADS)

Melliana, Armen, Yusrizal, Akmal, Syarifah

2017-11-01

PT Nira Murni construction is a contractor of PT Chevron Pacific Indonesia which engaged in contractor, fabrication, maintenance construction suppliers, and labor services. The high of accident rate in this company is caused the lack of awareness of workplace safety. Therefore, it requires an effort to reduce the accident rate on the company so that the financial losses can be minimized. In this study, Safe T-Score method is used to analyze the accident rate by measuring the level of frequency. Analysis is continued using risk management methods which identify hazards, risk measurement and risk management. The last analysis uses Job safety analysis (JSA) which will identify the effect of accidents. From the result of this study can be concluded that Job Safety Analysis (JSA) methods has not been implemented properly. Therefore, JSA method needs to follow-up in the next study, so that can be well applied as prevention of occupational accidents.

Safety Hazards During Intrahospital Transport: A Prospective Observational Study.

PubMed

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

2017-10-01

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

[Study of post marketing safety reevaluation of shenqi fuzheng injection].

PubMed

Ai, Qing-Hua; Li, Yuan-Yuan; Xie, Yan-Ming

2014-09-01

In order to promote the Shenqifuzheng injection (SQFZ) clinical medication safety, this study reevaluate on SQFZ post marketing safety study systematically. Including multi center large sample registration type safety monitoring research, the analysis based on national spontaneous reporting system data, the analysis based on the 20 national hospital information system data and literature research. Above the analysis, it suggests that SQFZ has good security. The more adverse drug reaction (ADR) as allergic reactions, mainly involved in the damage of skin, appendages and its systemic damage, serious person can appear allergic shock. ADR/E is more common in the elderly, may be related to medication (tumor) populations. Early warning analysis based on SRS data and literature research are of the view that "phlebitis" has a strong association with SQFZ used.

Safety and tolerability profile of daclizumab in patients with relapsing-remitting multiple sclerosis: An integrated analysis of clinical studies.

PubMed

Giovannoni, Gavin; Kappos, Ludwig; Gold, Ralf; Khatri, Bhupendra O; Selmaj, Krzysztof; Umans, Kimberly; Greenberg, Steven J; Sweetser, Marianne; Elkins, Jacob; McCroskery, Peter

2016-09-01

Daclizumab has been evaluated in multicentre, randomised, double-blind studies for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS). Safety and tolerability are key considerations in MS treatment selection, as they influence adherence to medication. Evaluate the safety of daclizumab in patients with RRMS from an integrated analysis of six clinical studies. Patients treated with at least one dose of subcutaneous daclizumab 150mg or 300mg monthly in three completed and three ongoing clinical studies were included in this integrated analysis. Cumulative incidence of treatment-emergent adverse events (AEs) was the primary endpoint. This analysis included 2236 patients with 5214 patient-years of exposure to daclizumab. The cumulative incidence of any AE was 84% and of any serious AE excluding MS relapse was 16%. The incidences of AEs when evaluated by 6-month intervals remained stable over the 6.5 years of maximum follow-up. Most AEs were mild or moderate in severity. An important safety concern associated with daclizumab therapy involved hepatic AEs (16%) and serum transaminase elevations at least three times the upper limit of normal (10%), most of which were asymptomatic, self-limiting, and non-recurring. Cumulative incidences of cutaneous, infectious, and gastrointestinal AEs were 33%, 59%, and 25%, respectively; most events either resolved spontaneously or were treated successfully with standard medical interventions and did not result in discontinuation of treatment. This integrated analysis demonstrates that treatment of RRMS with daclizumab for periods of up to 6.5 years is associated with an acceptable safety profile with no evidence of cumulative toxicity over time. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

Information Services at the Nuclear Safety Analysis Center.

ERIC Educational Resources Information Center

Simard, Ronald

This paper describes the operations of the Nuclear Safety Analysis Center. Established soon after an accident at the Three Mile Island nuclear power plant near Harrisburg, Pennsylvania, its efforts were initially directed towards a detailed analysis of the accident. Continuing functions include: (1) the analysis of generic nuclear safety issues,…

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

PubMed

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

2018-03-01

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

Overview of Energy Systems' safety analysis report programs

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

Not Available

1992-03-01

The primary purpose of an Safety Analysis Report (SAR) is to provide a basis for judging the adequacy of a facility's safety. The SAR documents the safety analyses that systematically identify the hazards posed by the facility, analyze the consequences and risk of potential accidents, and describe hazard control measures that protect the health and safety of the public and employees. In addition, some SARs document, as Technical Safety Requirements (TSRs, which include Technical Specifications and Operational Safety Requirements), technical and administrative requirements that ensure the facility is operated within prescribed safety limits. SARs also provide conveniently summarized information thatmore » may be used to support procedure development, training, inspections, and other activities necessary to facility operation. This Overview of Energy Systems Safety Analysis Report Programs'' Provides an introduction to the programs and processes used in the development and maintenance of the SARs. It also summarizes some of the uses of the SARs within Energy Systems and DOE.« less

Safety analysis and review system (SARS) assessment report

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

Browne, E.T.

1981-03-01

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

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

PubMed Central

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

2017-01-01

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

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

PubMed

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

2017-03-28

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

Safety of inhaled glycopyrronium in patients with COPD: a comprehensive analysis of clinical studies and post-marketing data.

PubMed

D'Urzo, Anthony D; Kerwin, Edward M; Chapman, Kenneth R; Decramer, Marc; DiGiovanni, Robert; D'Andrea, Peter; Hu, Huilin; Goyal, Pankaj; Altman, Pablo

2015-01-01

Chronic use of inhaled anticholinergics by patients with chronic obstructive pulmonary disease (COPD) has raised long-term safety concerns, particularly cardiovascular. Glycopyrronium is a once-daily anticholinergic with greater receptor selectivity than previously available agents. We assessed the safety of inhaled glycopyrronium using data pooled from two analysis sets, involving six clinical studies and over 4,000 patients with COPD who received one of the following treatments: glycopyrronium 50 μg, placebo (both delivered via the Breezhaler device), or tiotropium 18 μg (delivered via the HandiHaler device). Data were pooled from studies that varied in their duration and severity of COPD of the patients (ie, ≤12 weeks duration with patients having moderate or severe COPD; and >1 year duration with patients having severe and very severe COPD). Safety comparisons were made for glycopyrronium vs tiotropium or placebo. Poisson regression was used to assess the relative risk for either active drug or placebo (and between drugs where placebo was not available) for assessing the incidence of safety events. During post-marketing surveillance (PMS), safety was assessed by obtaining reports from various sources, and disproportionality scores were computed using EMPIRICA. In particular, the cardiac safety of glycopyrronium during the post-marketing phase was evaluated. The overall incidence of adverse events and deaths was similar across groups, while the incidence of serious adverse events was numerically higher in placebo. Furthermore, glycopyrronium did not result in an increased risk of cerebro-cardiovascular events vs placebo. There were no new safety reports during the PMS phase that suggested an increased risk compared to results from the clinical studies. Moreover, the cardiac safety of glycopyrronium during the PMS phase was also consistent with the clinical data. The overall safety profile of glycopyrronium was similar to its comparators indicating no

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

PubMed

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

2018-05-19

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

Safety culture assessment in petrochemical industry: a comparative study of two algerian plants.

PubMed

Boughaba, Assia; Hassane, Chabane; Roukia, Ouddai

2014-06-01

To elucidate the relationship between safety culture maturity and safety performance of a particular company. To identify the factors that contribute to a safety culture, a survey questionnaire was created based mainly on the studies of Fernández-Muñiz et al. The survey was randomly distributed to 1000 employees of two oil companies and realized a rate of valid answer of 51%. Minitab 16 software was used and diverse tests, including the descriptive statistical analysis, factor analysis, reliability analysis, mean analysis, and correlation, were used for the analysis of data. Ten factors were extracted using the analysis of factor to represent safety culture and safety performance. The results of this study showed that the managers' commitment, training, incentives, communication, and employee involvement are the priority domains on which it is necessary to stress the effort of improvement, where they had all the descriptive average values lower than 3.0 at the level of Company B. Furthermore, the results also showed that the safety culture influences the safety performance of the company. Therefore, Company A with a good safety culture (the descriptive average values more than 4.0), is more successful than Company B in terms of accident rates. The comparison between the two petrochemical plants of the group Sonatrach confirms these results in which Company A, the managers of which are English and Norwegian, distinguishes itself by the maturity of their safety culture has significantly higher evaluations than the company B, who is constituted of Algerian staff, in terms of safety management practices and safety performance.

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

PubMed

Kvalheim, Sverre A; Dahl, Øyvind

2016-12-01

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

Demonstration of a Safety Analysis on a Complex System

NASA Technical Reports Server (NTRS)

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

Motorcoach and school bus fire safety analysis.

DOT National Transportation Integrated Search

2016-11-01

This report documents a motorcoach and school bus fire safety analysis performed by the John A. Volpe National Transportation Systems Center (Volpe) for the Federal Motor Carrier Safety Administration. This report aims to: 1) identify the causes, fre...

10 CFR 72.248 - Safety analysis report updating.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Safety analysis report updating. 72.248 Section 72.248 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF... Approval of Spent Fuel Storage Casks § 72.248 Safety analysis report updating. (a) Each certificate holder...

Comprehensive Safety Analysis 2010 Safety Measurement System (SMS) Methodology, Version 2.1 Revised December 2010

DOT National Transportation Integrated Search

2010-12-01

This report documents the Safety Measurement System (SMS) methodology developed to support the Comprehensive Safety Analysis 2010 (CSA 2010) Initiative for the Federal Motor Carrier Safety Administration (FMCSA). The SMS is one of the major tools for...

Sources of Safety Data and Statistical Strategies for Design and Analysis: Clinical Trials.

PubMed

Zink, Richard C; Marchenko, Olga; Sanchez-Kam, Matilde; Ma, Haijun; Jiang, Qi

2018-03-01

There has been an increased emphasis on the proactive and comprehensive evaluation of safety endpoints to ensure patient well-being throughout the medical product life cycle. In fact, depending on the severity of the underlying disease, it is important to plan for a comprehensive safety evaluation at the start of any development program. Statisticians should be intimately involved in this process and contribute their expertise to study design, safety data collection, analysis, reporting (including data visualization), and interpretation. In this manuscript, we review the challenges associated with the analysis of safety endpoints and describe the safety data that are available to influence the design and analysis of premarket clinical trials. We share our recommendations for the statistical and graphical methodologies necessary to appropriately analyze, report, and interpret safety outcomes, and we discuss the advantages and disadvantages of safety data obtained from clinical trials compared to other sources. Clinical trials are an important source of safety data that contribute to the totality of safety information available to generate evidence for regulators, sponsors, payers, physicians, and patients. This work is a result of the efforts of the American Statistical Association Biopharmaceutical Section Safety Working Group.

Analysis of dynamical response of air blast loaded safety device

NASA Astrophysics Data System (ADS)

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

2018-03-01

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

Safety Culture Assessment in Petrochemical Industry: A Comparative Study of Two Algerian Plants

PubMed Central

Boughaba, Assia; Hassane, Chabane; Roukia, Ouddai

2014-01-01

Background To elucidate the relationship between safety culture maturity and safety performance of a particular company. Methods To identify the factors that contribute to a safety culture, a survey questionnaire was created based mainly on the studies of Fernández-Muñiz et al. The survey was randomly distributed to 1000 employees of two oil companies and realized a rate of valid answer of 51%. Minitab 16 software was used and diverse tests, including the descriptive statistical analysis, factor analysis, reliability analysis, mean analysis, and correlation, were used for the analysis of data. Ten factors were extracted using the analysis of factor to represent safety culture and safety performance. Results The results of this study showed that the managers' commitment, training, incentives, communication, and employee involvement are the priority domains on which it is necessary to stress the effort of improvement, where they had all the descriptive average values lower than 3.0 at the level of Company B. Furthermore, the results also showed that the safety culture influences the safety performance of the company. Therefore, Company A with a good safety culture (the descriptive average values more than 4.0), is more successful than Company B in terms of accident rates. Conclusion The comparison between the two petrochemical plants of the group Sonatrach confirms these results in which Company A, the managers of which are English and Norwegian, distinguishes itself by the maturity of their safety culture has significantly higher evaluations than the company B, who is constituted of Algerian staff, in terms of safety management practices and safety performance. PMID:25180135

Integrated Safety Analysis Tiers

NASA Technical Reports Server (NTRS)

Shackelford, Carla; McNairy, Lisa; Wetherholt, Jon

2009-01-01

Commercial partnerships and organizational constraints, combined with complex systems, may lead to division of hazard analysis across organizations. This division could cause important hazards to be overlooked, causes to be missed, controls for a hazard to be incomplete, or verifications to be inefficient. Each organization s team must understand at least one level beyond the interface sufficiently enough to comprehend integrated hazards. This paper will discuss various ways to properly divide analysis among organizations. The Ares I launch vehicle integrated safety analyses effort will be utilized to illustrate an approach that addresses the key issues and concerns arising from multiple analysis responsibilities.

Linguistic analysis of large-scale medical incident reports for patient safety.

PubMed

Fujita, Katsuhide; Akiyama, Masanori; Park, Keunsik; Yamaguchi, Etsuko Nakagami; Furukawa, Hiroyuki

2012-01-01

The analysis of medical incident reports is indispensable for patient safety. The cycles between analysis of incident reports and proposals to medical staffs are a key point for improving the patient safety in the hospital. Most incident reports are composed from freely written descriptions, but an analysis of such free descriptions is not sufficient in the medical field. In this study, we aim to accumulate and reinterpret findings using structured incident information, to clarify improvements that should be made to solve the root cause of the accident, and to ensure safe medical treatment through such improvements. We employ natural language processing (NLP) and network analysis to identify effective categories of medical incident reports. Network analysis can find various relationships that are not only direct but also indirect. In addition, we compare bottom-up results obtained by NLP with existing categories based on experts' judgment. By the bottom-up analysis, the class of patient managements regarding patients' fallings and medicines in top-down analysis is created clearly. Finally, we present new perspectives on ways of improving patient safety.

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

NASA Technical Reports Server (NTRS)

Reveley, Mary S.

2003-01-01

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

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

PubMed

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

2008-10-01

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

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

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

PubMed

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

2005-07-01

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

Development of guidance for states transitioning to new safety analysis tools

NASA Astrophysics Data System (ADS)

Alluri, Priyanka

and exposure for a subset of roadway network. These SPFs, specific to a region and the analysis period are often unavailable. Calibration of already existing default national SPFs to the state's data could be a feasible solution, but, how well the state's data is represented is a legitimate question. With this background, SPFs were generated for various classifications of segments in Georgia and compared against the national default SPFs used in SafetyAnalyst calibrated to Georgia data. Dwelling deeper into the development of SPFs, the influence of actual and estimated traffic data on the fit of the equations is also studied questioning the accuracy and reliability of traffic estimations. In addition to SafetyAnalyst, HSM aims at performing quantitative safety analysis. Applying HSM methodology to two-way two-lane rural roads, the effect of using multiple CMFs (Crash Modification Factors) is studied. Lastly, data requirements, methodology, constraints, and results are compared between SafetyAnalyst and HSM.

Safety and business benefit analysis of NASA's aviation safety program

DOT National Transportation Integrated Search

2004-09-20

NASA Aviation Safety Program elements encompass a wide range of products that require both public and private investment. Therefore, two methods of analysis, one relating to the public and the other to the private industry, must be combined to unders...

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.

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

NASA Technical Reports Server (NTRS)

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

1978-01-01

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

The geography of patient safety: a topical analysis of sterility.

PubMed

Mesman, Jessica

2009-12-01

Many studies on patient safety are geared towards prevention of adverse events by eliminating causes of error. In this article, I argue that patient safety research needs to widen its analytical scope and include causes of strength as well. This change of focus enables me to ask other questions, like why don't things go wrong more often? Or, what is the significance of time and space for patient safety? The focal point of this article is on the spatial dimension of patient safety. To gain insight into the 'geography' of patient safety and perform a topical analysis, I will focus on one specific kind of space (sterile space), one specific medical procedure (insertion of an intravenous line) and one specific medical ward (neonatology). Based on ethnographic data from research in the Netherlands, I demonstrate how spatial arrangements produce sterility and how sterility work produces spatial orders at the same time. Detailed analysis shows how a sterile line insertion involves the convergence of spatially distributed resources, relocations of the field of activity, an assemblage of an infrastructure of attention, a specific compositional order of materials, and the scaling down of one's degree of mobility. Sterility, I will argue, turns out to be a product of spatial orderings. Simultaneously, sterility work generates particular spatial orders, like open and restricted areas, by producing buffers and boundaries. However, the spatial order of sterility intersects with the spatial order of other lines of activity. Insight into the normative structure of these co-existing spatial orders turns out to be crucial for patient safety. By analyzing processes of spatial fine-tuning in everyday practice, it becomes possible to identify spatial competences and circumstances that enable staff members to provide safe health care. As such, a topical analysis offers an alternative perspective of patient safety, one that takes into account its spatial dimension.

Recent Progresses in Nanobiosensing for Food Safety Analysis

PubMed Central

Yang, Tao; Huang, Huifen; Zhu, Fang; Lin, Qinlu; Zhang, Lin; Liu, Junwen

2016-01-01

With increasing adulteration, food safety analysis has become an important research field. Nanomaterials-based biosensing holds great potential in designing highly sensitive and selective detection strategies necessary for food safety analysis. This review summarizes various function types of nanomaterials, the methods of functionalization of nanomaterials, and recent (2014–present) progress in the design and development of nanobiosensing for the detection of food contaminants including pathogens, toxins, pesticides, antibiotics, metal contaminants, and other analytes, which are sub-classified according to various recognition methods of each analyte. The existing shortcomings and future perspectives of the rapidly growing field of nanobiosensing addressing food safety issues are also discussed briefly. PMID:27447636

Recent Progresses in Nanobiosensing for Food Safety Analysis.

PubMed

Yang, Tao; Huang, Huifen; Zhu, Fang; Lin, Qinlu; Zhang, Lin; Liu, Junwen

2016-07-19

With increasing adulteration, food safety analysis has become an important research field. Nanomaterials-based biosensing holds great potential in designing highly sensitive and selective detection strategies necessary for food safety analysis. This review summarizes various function types of nanomaterials, the methods of functionalization of nanomaterials, and recent (2014-present) progress in the design and development of nanobiosensing for the detection of food contaminants including pathogens, toxins, pesticides, antibiotics, metal contaminants, and other analytes, which are sub-classified according to various recognition methods of each analyte. The existing shortcomings and future perspectives of the rapidly growing field of nanobiosensing addressing food safety issues are also discussed briefly.

Requirements Analysis for the Army Safety Management Information System (ASMIS)

DTIC Science & Technology

1989-03-01

8217_>’ Telephone Number « .. PNL-6819 Limited Distribution Requirements Analysis for the Army Safety Management Information System (ASMIS) Final...PNL-6819 REQUIREMENTS ANALYSIS FOR THE ARMY SAFETY MANAGEMENT INFORMATION SYSTEM (ASMIS) FINAL REPORT J. S. Littlefield A. L. Corrigan March...accidents. This accident data is available under the Army Safety Management Information System (ASMIS) which is an umbrella for many databases

Analysis on Dangerous Source of Large Safety Accident in Storage Tank Area

NASA Astrophysics Data System (ADS)

Wang, Tong; Li, Ying; Xie, Tiansheng; Liu, Yu; Zhu, Xueyuan

2018-01-01

The difference between a large safety accident and a general accident is that the consequences of a large safety accident are particularly serious. To study the tank area which factors directly or indirectly lead to the occurrence of large-sized safety accidents. According to the three kinds of hazard source theory and the consequence cause analysis of the super safety accident, this paper analyzes the dangerous source of the super safety accident in the tank area from four aspects, such as energy source, large-sized safety accident reason, management missing, environmental impact Based on the analysis of three kinds of hazard sources and environmental analysis to derive the main risk factors and the AHP evaluation model is established, and after rigorous and scientific calculation, the weights of the related factors in four kinds of risk factors and each type of risk factors are obtained. The result of analytic hierarchy process shows that management reasons is the most important one, and then the environmental factors and the direct cause and Energy source. It should be noted that although the direct cause is relatively low overall importance, the direct cause of Failure of emergency measures and Failure of prevention and control facilities in greater weight.

Posttest analysis of the FFTF inherent safety tests

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

Padilla, A. Jr.; Claybrook, S.W.

Inherent safety tests were performed during 1986 in the 400-MW (thermal) Fast Flux Test Facility (FFTF) reactor to demonstrate the effectiveness of an inherent shutdown device called the gas expansion module (GEM). The GEM device provided a strong negative reactivity feedback during loss-of-flow conditions by increasing the neutron leakage as a result of an expanding gas bubble. The best-estimate pretest calculations for these tests were performed using the IANUS plant analysis code (Westinghouse Electric Corporation proprietary code) and the MELT/SIEX3 core analysis code. These two codes were also used to perform the required operational safety analyses for the FFTF reactormore » and plant. Although it was intended to also use the SASSYS systems (core and plant) analysis code, the calibration of the SASSYS code for FFTF core and plant analysis was not completed in time to perform pretest analyses. The purpose of this paper is to present the results of the posttest analysis of the 1986 FFTF inherent safety tests using the SASSYS code.« less

Crime, perceived safety, and physical activity: A meta-analysis.

PubMed

Rees-Punia, Erika; Hathaway, Elizabeth D; Gay, Jennifer L

2018-06-01

Perceived safety from crime and objectively-measured crime rates may be associated with physical inactivity. The purpose of this meta-analysis is to estimate the odds of accumulating high levels of physical activity (PA) when the perception of safety from crime is high and when objectively-measured crime is high. Peer-reviewed studies were identified through PubMed, Web of Science, ProQuest Criminal Justice, and ScienceDirect from earliest record through 2016. Included studies measured total PA, leisure-time PA, or walking in addition to perceived safety from crime or objective measures of crime. Mean odds ratios were aggregated with random effects models, and meta-regression was used to examine effects of potential moderators: country, age, and crime/PA measure. Sixteen cross-sectional studies yielded sixteen effects for perceived safety from crime and four effects for objective crime. Those reporting feeling safe from crime had a 27% greater odds of achieving higher levels of physical activity (OR=1.27 [1.08, 1.49]), and those living in areas with higher objectively-measured crime had a 28% reduced odds of achieving higher levels of physical activity (OR=0.72 [0.61, 0.83]). Effects of perceived safety were highly heterogeneous (I 2 =94.09%), but explored moderators were not statistically significant, likely because of the small sample size. Despite the limited number of effects suitable for aggregation, the mean association between perceived safety and PA was significant. As it seems likely that perceived lack of safety from crime constrains PA behaviors, future research exploring moderators of this association may help guide public health recommendations and interventions. Copyright © 2017 Elsevier Inc. All rights reserved.

Roadway safety analysis methodology for Utah : final report.

DOT National Transportation Integrated Search

2016-12-01

This research focuses on the creation of a three-part Roadway Safety Analysis methodology that applies and automates the cumulative work of recently-completed roadway safety research. The first part is to prepare the roadway and crash data for analys...

The surgical safety checklist and patient outcomes after surgery: a prospective observational cohort study, systematic review and meta-analysis.

PubMed

Abbott, T E F; Ahmad, T; Phull, M K; Fowler, A J; Hewson, R; Biccard, B M; Chew, M S; Gillies, M; Pearse, R M

2018-01-01

The surgical safety checklist is widely used to improve the quality of perioperative care. However, clinicians continue to debate the clinical effectiveness of this tool. Prospective analysis of data from the International Surgical Outcomes Study (ISOS), an international observational study of elective in-patient surgery, accompanied by a systematic review and meta-analysis of published literature. The exposure was surgical safety checklist use. The primary outcome was in-hospital mortality and the secondary outcome was postoperative complications. In the ISOS cohort, a multivariable multi-level generalized linear model was used to test associations. To further contextualise these findings, we included the results from the ISOS cohort in a meta-analysis. Results are reported as odds ratios (OR) with 95% confidence intervals. We included 44 814 patients from 497 hospitals in 27 countries in the ISOS analysis. There were 40 245 (89.8%) patients exposed to the checklist, whilst 7508 (16.8%) sustained ≥1 postoperative complications and 207 (0.5%) died before hospital discharge. Checklist exposure was associated with reduced mortality [odds ratio (OR) 0.49 (0.32-0.77); P<0.01], but no difference in complication rates [OR 1.02 (0.88-1.19); P=0.75]. In a systematic review, we screened 3732 records and identified 11 eligible studies of 453 292 patients including the ISOS cohort. Checklist exposure was associated with both reduced postoperative mortality [OR 0.75 (0.62-0.92); P<0.01; I 2 =87%] and reduced complication rates [OR 0.73 (0.61-0.88); P<0.01; I 2 =89%). Patients exposed to a surgical safety checklist experience better postoperative outcomes, but this could simply reflect wider quality of care in hospitals where checklist use is routine. Copyright © 2017 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.

Efficacy and safety profile of xanthines in COPD: a network meta-analysis.

PubMed

Cazzola, Mario; Calzetta, Luigino; Barnes, Peter J; Criner, Gerard J; Martinez, Fernando J; Papi, Alberto; Gabriella Matera, Maria

2018-06-30

Theophylline can still have a role in the management of stable chronic obstructive pulmonary disease (COPD), but its use remains controversial, mainly due to its narrow therapeutic window. Doxofylline, another xanthine, is an effective bronchodilator and displays a better safety profile than theophylline. Therefore, we performed a quantitative synthesis to compare the efficacy and safety profile of different xanthines in COPD.The primary end-point of this meta-analysis was the impact of xanthines on lung function. In addition, we assessed the risk of adverse events by normalising data on safety as a function of person-weeks. Data obtained from 998 COPD patients were selected from 14 studies and meta-analysed using a network approach.The combined surface under the cumulative ranking curve (SUCRA) analysis of efficacy (change from baseline in forced expiratory volume in 1 s) and safety (risk of adverse events) showed that doxofylline was superior to aminophylline (comparable efficacy and significantly better safety), bamiphylline (significantly better efficacy and comparable safety), and theophylline (comparable efficacy and significantly better safety).Considering the overall efficacy/safety profile of the investigated agents, the results of this quantitative synthesis suggest that doxofylline seems to be the best xanthine for the treatment of COPD. Copyright ©ERS 2018.

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.

Manned space flight nuclear system safety. Volume 3: Reactor system preliminary nuclear safety analysis. Part 3: Nuclear Safety Analysis Document (NSAD)

NASA Technical Reports Server (NTRS)

1972-01-01

Nuclear safety analysis as applied to a space base mission is presented. The nuclear safety analysis document summarizes the mission and the credible accidents/events which may lead to nuclear hazards to the general public. The radiological effects and associated consequences of the hazards are discussed in detail. The probability of occurrence is combined with the potential number of individuals exposed to or above guideline values to provide a measure of accident and total mission risk. The overall mission risk has been determined to be low with the potential exposure to or above 25 rem limited to less than 4 individuals per every 1000 missions performed. No radiological risk to the general public occurs during the prelaunch phase at KSC. The most significant risks occur from prolonged exposure to reactor debris following land impact generally associated with the disposal phase of the mission where fission product inventories can be high.

Safety analysis, risk assessment, and risk acceptance criteria

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

Jamali, K.; Stack, D.W.; Sullivan, L.H.

1997-08-01

This paper discusses a number of topics that relate safety analysis as documented in the Department of Energy (DOE) safety analysis reports (SARs), probabilistic risk assessments (PRA) as characterized primarily in the context of the techniques that have assumed some level of formality in commercial nuclear power plant applications, and risk acceptance criteria as an outgrowth of PRA applications. DOE SARs of interest are those that are prepared for DOE facilities under DOE Order 5480.23 and the implementing guidance in DOE STD-3009-94. It must be noted that the primary area of application for DOE STD-3009 is existing DOE facilities andmore » that certain modifications of the STD-3009 approach are necessary in SARs for new facilities. Moreover, it is the hazard analysis (HA) and accident analysis (AA) portions of these SARs that are relevant to the present discussions. Although PRAs can be qualitative in nature, PRA as used in this paper refers more generally to all quantitative risk assessments and their underlying methods. HA as used in this paper refers more generally to all qualitative risk assessments and their underlying methods that have been in use in hazardous facilities other than nuclear power plants. This discussion includes both quantitative and qualitative risk assessment methods. PRA has been used, improved, developed, and refined since the Reactor Safety Study (WASH-1400) was published in 1975 by the Nuclear Regulatory Commission (NRC). Much debate has ensued since WASH-1400 on exactly what the role of PRA should be in plant design, reactor licensing, `ensuring` plant and process safety, and a large number of other decisions that must be made for potentially hazardous activities. Of particular interest in this area is whether the risks quantified using PRA should be compared with numerical risk acceptance criteria (RACs) to determine whether a facility is `safe.` Use of RACs requires quantitative estimates of consequence frequency and magnitude.« less

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

PubMed

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

2015-07-01

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

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

PubMed

Nielsen, Kent J

2014-02-01

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

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

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.

A root cause analysis project in a medication safety course.

PubMed

Schafer, Jason J

2012-08-10

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

TA-55 Final Safety Analysis Report Comparison Document and DOE Safety Evaluation Report Requirements

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

Alan Bond

2001-04-01

This document provides an overview of changes to the currently approved TA-55 Final Safety Analysis Report (FSAR) that are included in the upgraded FSAR. The DOE Safety Evaluation Report (SER) requirements that are incorporated into the upgraded FSAR are briefly discussed to provide the starting point in the FSAR with respect to the SER requirements.

Investigation of safety analysis methods using computer vision techniques

NASA Astrophysics Data System (ADS)

Shirazi, Mohammad Shokrolah; Morris, Brendan Tran

2017-09-01

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

Development and Psychometric Analysis of a Nurses' Attitudes and Skills Safety Scale: Initial Results.

PubMed

Armstrong, Gail E; Dietrich, Mary; Norman, Linda; Barnsteiner, Jane; Mion, Lorraine

Health care organizations have incorporated updated safety principles in the analysis of errors and in norms and standards. Yet no research exists that assesses bedside nurses' perceived skills or attitudes toward updated safety concepts. The aims of this study were to develop a scale assessing nurses' perceived skills and attitudes toward updated safety concepts, determine content validity, and examine internal consistency of the scale and subscales. Understanding nurses' perceived skills and attitudes about safety concepts can be used in targeting strategies to enhance their safety practices.

14 CFR Appendix J to Part 417 - Ground Safety Analysis Report

Code of Federal Regulations, 2014 CFR

2014-01-01

... information required by this appendix. J417.3Ground safety analysis report chapters (a) Introduction. A ground... analysis report must include a chapter that provides detailed safety information about each launch vehicle... data. A hazard analysis form must contain or reference all information necessary to understand the...

14 CFR Appendix J to Part 417 - Ground Safety Analysis Report

Code of Federal Regulations, 2013 CFR

2013-01-01

... information required by this appendix. J417.3Ground safety analysis report chapters (a) Introduction. A ground... analysis report must include a chapter that provides detailed safety information about each launch vehicle... data. A hazard analysis form must contain or reference all information necessary to understand the...

14 CFR Appendix J to Part 417 - Ground Safety Analysis Report

Code of Federal Regulations, 2010 CFR

2010-01-01

... information required by this appendix. J417.3Ground safety analysis report chapters (a) Introduction. A ground... analysis report must include a chapter that provides detailed safety information about each launch vehicle... data. A hazard analysis form must contain or reference all information necessary to understand the...

14 CFR Appendix J to Part 417 - Ground Safety Analysis Report

Code of Federal Regulations, 2011 CFR

2011-01-01

... information required by this appendix. J417.3Ground safety analysis report chapters (a) Introduction. A ground... analysis report must include a chapter that provides detailed safety information about each launch vehicle... data. A hazard analysis form must contain or reference all information necessary to understand the...

14 CFR Appendix J to Part 417 - Ground Safety Analysis Report

Code of Federal Regulations, 2012 CFR

2012-01-01

... information required by this appendix. J417.3Ground safety analysis report chapters (a) Introduction. A ground... analysis report must include a chapter that provides detailed safety information about each launch vehicle... data. A hazard analysis form must contain or reference all information necessary to understand the...

Study design and analysis of automobile bumper for pedestrian safety

NASA Astrophysics Data System (ADS)

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

2017-11-01

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

14 CFR 33.75 - Safety analysis.

Code of Federal Regulations, 2011 CFR

2011-01-01

... Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT AIRWORTHINESS STANDARDS: AIRCRAFT ENGINES Design and Construction; Turbine Aircraft Engines § 33.75 Safety analysis. (a) (1) The applicant must analyze the engine, including the control system, to assess the likely...

Multimorbidity and Patient Safety Incidents in Primary Care: A Systematic Review and Meta-Analysis

PubMed Central

Panagioti, Maria; Stokes, Jonathan; Esmail, Aneez; Coventry, Peter; Cheraghi-Sohi, Sudeh; Alam, Rahul; Bower, Peter

2015-01-01

Background Multimorbidity is increasingly prevalent and represents a major challenge in primary care. Patients with multimorbidity are potentially more likely to experience safety incidents due to the complexity of their needs and frequency of their interactions with health services. However, rigorous syntheses of the link between patient safety incidents and multimorbidity are not available. This review examined the relationship between multimorbidity and patient safety incidents in primary care. Methods We followed our published protocol (PROSPERO registration number: CRD42014007434). Medline, Embase and CINAHL were searched up to May 2015. Study design and quality were assessed. Odds ratios (OR) and 95% confidence intervals (95% CIs) were calculated for the associations between multimorbidity and two categories of patient safety outcomes: ‘active patient safety incidents’ (such as adverse drug events and medical complications) and ‘precursors of safety incidents’ (such as prescription errors, medication non-adherence, poor quality of care and diagnostic errors). Meta-analyses using random effects models were undertaken. Results Eighty six relevant comparisons from 75 studies were included in the analysis. Meta-analysis demonstrated that physical-mental multimorbidity was associated with an increased risk for ‘active patient safety incidents’ (OR = 2.39, 95% CI = 1.40 to 3.38) and ‘precursors of safety incidents’ (OR = 1.69, 95% CI = 1.36 to 2.03). Physical multimorbidity was associated with an increased risk for active safety incidents (OR = 1.63, 95% CI = 1.45 to 1.80) but was not associated with precursors of safety incidents (OR = 1.02, 95% CI = 0.90 to 1.13). Statistical heterogeneity was high and the methodological quality of the studies was generally low. Conclusions The association between multimorbidity and patient safety is complex, and varies by type of multimorbidity and type of safety incident. Our analyses suggest that multimorbidity

Development and Psychometric Analysis of a Nurses’ Attitudes and Skills Safety Scale: Initial Results

PubMed Central

Armstrong, Gail E.; Dietrich, Mary; Norman, Linda; Barnsteiner, Jane; Mion, Lorraine

2016-01-01

Health care organizations have incorporated updated safety principles in the analysis of errors and in norms and standards. Yet no research exists that assesses bedside nurses’ perceived skills or attitudes toward updated safety concepts. The aims of this study were to develop a scale assessing nurses’ perceived skills and attitudes toward updated safety concepts, determine content validity, and examine internal consistency of the scale and subscales. Understanding nurses’ perceived skills and attitudes about safety concepts can be used in targeting strategies to enhance their safety practices. PMID:27479518

Efficacy and safety of biologic therapies for systemic lupus erythematosus treatment: systematic review and meta-analysis.

PubMed

Borba, Helena Hiemisch Lobo; Wiens, Astrid; de Souza, Thais Teles; Correr, Cassyano Januário; Pontarolo, Roberto

2014-04-01

The objectives of this study were to evaluate the efficacy, safety, and tolerability of biologic drugs compared with placebo for systemic lupus erythematosus (SLE) treatment. A systematic review evaluating the efficacy and safety of biologic therapies compared with placebo in adult SLE patients treatment was performed. Data from studies performed before September 2013 were collected from several databases (MEDLINE, Cochrane Library, SCIELO, Scopus, and International Pharmaceutical Abstracts). Study eligibility criteria included randomized, double-blind, placebo-controlled trials; regarding treatment with biologic agents in SLE adult patients; and published in English, German, Portuguese, and Spanish. Extracted data were statistically analyzed in a meta-analysis using the Review Manager (RevMan) 5.1 software. Efficacy outcomes included the SELENA-SLEDAI (Safety of Estrogens in Lupus Erythematosus National Assessment version of the SLE Disease Activity Index) score, the SRI (Systemic Lupus Erythematosus Responder Index), normalization of low C3 (<90 mg/dL), anti-double-stranded DNA positive to negative, and no new BILAG (British Isles Lupus Assessment Group index) 1A or 2B flares. Data on safety profile included adverse events, serious and severe adverse events, death, malignancy, infections, and infusion reactions. We also evaluated withdrawals from treatment due to lack of efficacy or adverse events. Thirteen randomized placebo-controlled trials met the criteria for data extraction for systematic review. A meta-analysis regarding the efficacy and safety of belimumab compared with placebo involving four of these trials was undertaken and the remainder contributed to a meta-analysis of the safety of biologic agents. In addition, two trials allowed the performance of a meta-analysis regarding the efficacy and safety of rituximab compared with placebo. Belimumab was more effective than placebo in most evaluated outcomes. No significant differences in the safety and

Random safety auditing, root cause analysis, failure mode and effects analysis.

PubMed

Ursprung, Robert; Gray, James

2010-03-01

Improving quality and safety in health care is a major concern for health care providers, the general public, and policy makers. Errors and quality issues are leading causes of morbidity and mortality across the health care industry. There is evidence that patients in the neonatal intensive care unit (NICU) are at high risk for serious medical errors. To facilitate compliance with safe practices, many institutions have established quality-assurance monitoring procedures. Three techniques that have been found useful in the health care setting are failure mode and effects analysis, root cause analysis, and random safety auditing. When used together, these techniques are effective tools for system analysis and redesign focused on providing safe delivery of care in the complex NICU system. Copyright 2010 Elsevier Inc. All rights reserved.

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

PubMed

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

2012-04-01

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

School Safety Study: Phase I.

ERIC Educational Resources Information Center

Arora, Alka

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

Work zone safety analysis and modeling: a state-of-the-art review.

PubMed

Yang, Hong; Ozbay, Kaan; Ozturk, Ozgur; Xie, Kun

2015-01-01

Work zone safety is one of the top priorities for transportation agencies. In recent years, a considerable volume of research has sought to determine work zone crash characteristics and causal factors. Unlike other non-work zone-related safety studies (on both crash frequency and severity), there has not yet been a comprehensive review and assessment of methodological approaches for work zone safety. To address this deficit, this article aims to provide a comprehensive review of the existing extensive research efforts focused on work zone crash-related analysis and modeling, in the hopes of providing researchers and practitioners with a complete overview. Relevant literature published in the last 5 decades was retrieved from the National Work Zone Crash Information Clearinghouse and the Transport Research International Documentation database and other public digital libraries and search engines. Both peer-reviewed publications and research reports were obtained. Each study was carefully reviewed, and those that focused on either work zone crash data analysis or work zone safety modeling were identified. The most relevant studies are specifically examined and discussed in the article. The identified studies were carefully synthesized to understand the state of knowledge on work zone safety. Agreement and inconsistency regarding the characteristics of the work zone crashes discussed in the descriptive studies were summarized. Progress and issues about the current practices on work zone crash frequency and severity modeling are also explored and discussed. The challenges facing work zone safety research are then presented. The synthesis of the literature suggests that the presence of a work zone is likely to increase the crash rate. Crashes are not uniformly distributed within work zones and rear-end crashes are the most prevalent type of crashes in work zones. There was no across-the-board agreement among numerous papers reviewed on the relationship between work zone

Reliability Modeling Methodology for Independent Approaches on Parallel Runways Safety Analysis

NASA Technical Reports Server (NTRS)

Babcock, P.; Schor, A.; Rosch, G.

1998-01-01

This document is an adjunct to the final report An Integrated Safety Analysis Methodology for Emerging Air Transport Technologies. That report presents the results of our analysis of the problem of simultaneous but independent, approaches of two aircraft on parallel runways (independent approaches on parallel runways, or IAPR). This introductory chapter presents a brief overview and perspective of approaches and methodologies for performing safety analyses for complex systems. Ensuing chapter provide the technical details that underlie the approach that we have taken in performing the safety analysis for the IAPR concept.

Galileo and Ulysses missions safety analysis and launch readiness status

NASA Technical Reports Server (NTRS)

Cork, M. Joseph; Turi, James A.

1989-01-01

The Galileo spacecraft, which will release probes to explore the Jupiter system, was launched in October, 1989 as the payload on STS-34, and the Ulysses spacecraft, which will fly by Jupiter en route to a polar orbit of the sun, is presently entering system-test activity in preparation for an October, 1990 launch. This paper reviews the Galileo and Ulysses mission objectives and design approaches and presents details of the missions' safety analysis. The processes used to develop the safety analysis are described and the results of safety tests are presented.

Persuasive appeals in road safety communication campaigns: Theoretical frameworks and practical implications from the analysis of a decade of road safety campaign materials.

PubMed

Guttman, Nurit

2015-11-01

Communication campaigns are employed as an important tool to promote road safety practices. Researchers maintain road safety communication campaigns are more effective when their persuasive appeals, which are central to their communicative strategy, are based on explicit theoretical frameworks. This study's main objectives were to develop a detailed categorization of persuasive appeals used in road safety communication campaigns that differentiate between appeals that appear to be similar but differ conceptually, and to indicate the advantages, limitations and ethical issues associated with each type, drawing on behavior change theories. Materials from over 300 campaigns were obtained from 41 countries, mainly using road safety organizations' websites. Drawing on the literature, five types of main approaches were identified, and the analysis yielded a more detailed categorizations of appeals within these general categories. The analysis points to advantages, limitations, ethical issues and challenges in using different types of appeals. The discussion summarizes challenges in designing persuasive-appeals for road safety communication campaigns. Copyright © 2015 Elsevier Ltd. All rights reserved.

Neonatal Safety Information Reported to the FDA During Drug Development Studies

PubMed Central

Avant, Debbie; Baer, Gerri; Moore, Jason; Zheng, Panli; Sorbello, Alfred; Ariagno, Ron; Yao, Lynne; Burckart, Gilbert J.; Wang, Jian

2017-01-01

Background Relatively few neonatal drug development studies have been conducted, but an increase is expected with the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA). Understanding the safety of drugs studied in neonates is complicated by the unique nature of the population and the level of illness. The objective of this study was to examine neonatal safety data submitted to the FDA in studies pursuant to the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) between 1998 and 2015. Methods FDA databases were searched for BPCA and/or PREA studies that enrolled neonates. Studies that enrolled a minimum of 3 neonates were analyzed for the presence and content of neonatal safety data. Results The analysis identified 40 drugs that were studied in 3 or more neonates. Of the 40 drugs, 36 drugs received a pediatric labeling change as a result of studies between 1998 and 2015, that included information from studies including neonates. Fourteen drugs were approved for use in neonates. Clinical trials for 20 of the drugs reported serious adverse events (SAEs) in neonates. The SAEs primarily involved cardiovascular events such as bradycardia and/or hypotension or laboratory abnormalities such as anemia, neutropenia, and electrolyte disturbances. Deaths were reported during studies of 9 drugs. Conclusions Our analysis revealed that SAEs were reported in studies involving 20 of the 40 drugs evaluated in neonates, with deaths identified in 9 of those studies. Patients enrolled in studies were often critically ill, which complicated determination of whether an adverse event was drug-related. We conclude that the traditional means for collecting safety information in drug development trials needs to be adjusted for neonates and will require the collaboration of regulators, industry, and the clinical and research communities to establish appropriate definitions and reporting strategies for the neonatal

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

NASA Astrophysics Data System (ADS)

Mikula, J. F. Kip

2005-12-01

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

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

DOT National Transportation Integrated Search

1986-02-01

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

Ares I-X Malfunction Turn Range Safety Analysis

NASA Technical Reports Server (NTRS)

Beaty, J. R.

2011-01-01

Ares I-X was the designation given to the flight test version of the Ares I rocket which was developed by NASA (also known as the Crew Launch Vehicle (CLV) component of the Constellation Program). The Ares I-X flight test vehicle achieved a successful flight test on October 28, 2009, from Pad LC-39B at Kennedy Space Center, Florida (KSC). As part of the flight plan approval for the test vehicle, a range safety malfunction turn analysis was performed to support the risk assessment and vehicle destruct criteria development processes. Several vehicle failure scenarios were identified which could have caused the vehicle trajectory to deviate from its normal flight path. The effects of these failures were evaluated with an Ares I-X 6 degrees-of-freedom (6-DOF) digital simulation, using the Program to Optimize Simulated Trajectories Version II (POST2) simulation tool. The Ares I-X simulation analysis provided output files containing vehicle trajectory state information. These were used by other risk assessment and vehicle debris trajectory simulation tools to determine the risk to personnel and facilities in the vicinity of the launch area at KSC, and to develop the vehicle destruct criteria used by the flight test range safety officer in the event of a flight test anomaly of the vehicle. The simulation analysis approach used for this study is described, including descriptions of the failure modes which were considered and the underlying assumptions and ground rules of the study.

Probabilistic safety analysis of earth retaining structures during earthquakes

NASA Astrophysics Data System (ADS)

Grivas, D. A.; Souflis, C.

1982-07-01

A procedure is presented for determining the probability of failure of Earth retaining structures under static or seismic conditions. Four possible modes of failure (overturning, base sliding, bearing capacity, and overall sliding) are examined and their combined effect is evaluated with the aid of combinatorial analysis. The probability of failure is shown to be a more adequate measure of safety than the customary factor of safety. As Earth retaining structures may fail in four distinct modes, a system analysis can provide a single estimate for the possibility of failure. A Bayesian formulation of the safety retaining walls is found to provide an improved measure for the predicted probability of failure under seismic loading. The presented Bayesian analysis can account for the damage incurred to a retaining wall during an earthquake to provide an improved estimate for its probability of failure during future seismic events.

An integrated safety analysis of intravenous ibuprofen (Caldolor®) in adults

PubMed Central

Southworth, Stephen R; Woodward, Emily J; Peng, Alex; Rock, Amy D

2015-01-01

Intravenous (IV) nonsteroidal anti-inflammatory drugs such as IV ibuprofen are increasingly used as a component of multimodal pain management in the inpatient and outpatient settings. The safety of IV ibuprofen as assessed in ten sponsored clinical studies is presented in this analysis. Overall, 1,752 adult patients have been included in safety and efficacy trials over 11 years; 1,220 of these patients have received IV ibuprofen and 532 received either placebo or comparator medication. The incidence of adverse events (AEs), serious AEs, and changes in vital signs and clinically significant laboratory parameters have been summarized and compared to patients receiving placebo or active comparator drug. Overall, IV ibuprofen has been well tolerated by hospitalized and outpatient patients when administered both prior to surgery and postoperatively as well as for nonsurgical pain or fever. The overall incidence of AEs is lower in patients receiving IV ibuprofen as compared to those receiving placebo in this integrated analysis. Specific analysis of hematological and renal effects showed no increased risk for patients receiving IV ibuprofen. A subset analysis of elderly patients suggests that no dose adjustment is needed in this higher risk population. This integrated safety analysis demonstrates that IV ibuprofen can be safely administered prior to surgery and continued in the postoperative period as a component of multimodal pain management. PMID:26604816

14 CFR 33.75 - Safety analysis.

Code of Federal Regulations, 2013 CFR

2013-01-01

... judgment and previous experience combined with sound design and test philosophies. (4) The applicant must... STANDARDS: AIRCRAFT ENGINES Design and Construction; Turbine Aircraft Engines § 33.75 Safety analysis. (a... the effects of failures and likely combination of failures be verified by test. (c) The primary...

14 CFR 33.75 - Safety analysis.

Code of Federal Regulations, 2010 CFR

2010-01-01

... judgment and previous experience combined with sound design and test philosophies. (4) The applicant must... STANDARDS: AIRCRAFT ENGINES Design and Construction; Turbine Aircraft Engines § 33.75 Safety analysis. (a... the effects of failures and likely combination of failures be verified by test. (c) The primary...

14 CFR 33.75 - Safety analysis.

Code of Federal Regulations, 2012 CFR

2012-01-01

... judgment and previous experience combined with sound design and test philosophies. (4) The applicant must... STANDARDS: AIRCRAFT ENGINES Design and Construction; Turbine Aircraft Engines § 33.75 Safety analysis. (a... the effects of failures and likely combination of failures be verified by test. (c) The primary...

14 CFR 33.75 - Safety analysis.

Code of Federal Regulations, 2014 CFR

2014-01-01

... judgment and previous experience combined with sound design and test philosophies. (4) The applicant must... STANDARDS: AIRCRAFT ENGINES Design and Construction; Turbine Aircraft Engines § 33.75 Safety analysis. (a... the effects of failures and likely combination of failures be verified by test. (c) The primary...

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

PubMed Central

West, Jonathan; Ogston, Simon; Foerster, John

2016-01-01

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

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

14 CFR 35.15 - Safety analysis.

Code of Federal Regulations, 2014 CFR

2014-01-01

... combined with sound design and test philosophies. (b) If significant doubt exists as to the effects of... STANDARDS: PROPELLERS Design and Construction § 35.15 Safety analysis. (a)(1) The applicant must analyze the... to be verified by test. (c) The primary failures of certain single propeller elements (for example...

14 CFR 35.15 - Safety analysis.

Code of Federal Regulations, 2013 CFR

2013-01-01

... combined with sound design and test philosophies. (b) If significant doubt exists as to the effects of... STANDARDS: PROPELLERS Design and Construction § 35.15 Safety analysis. (a)(1) The applicant must analyze the... to be verified by test. (c) The primary failures of certain single elements (for example, blades...

14 CFR 35.15 - Safety analysis.

Code of Federal Regulations, 2012 CFR

2012-01-01

... combined with sound design and test philosophies. (b) If significant doubt exists as to the effects of... STANDARDS: PROPELLERS Design and Construction § 35.15 Safety analysis. (a)(1) The applicant must analyze the... to be verified by test. (c) The primary failures of certain single elements (for example, blades...

14 CFR 35.15 - Safety analysis.

Code of Federal Regulations, 2010 CFR

2010-01-01

... combined with sound design and test philosophies. (b) If significant doubt exists as to the effects of... STANDARDS: PROPELLERS Design and Construction § 35.15 Safety analysis. (a)(1) The applicant must analyze the... to be verified by test. (c) The primary failures of certain single elements (for example, blades...

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

PubMed Central

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

2015-01-01

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

Comparative efficacy and safety of six antidepressants and anticonvulsants in painful diabetic neuropathy: a network meta-analysis.

PubMed

Rudroju, Neelima; Bansal, Dipika; Talakokkula, Shiva Teja; Gudala, Kapil; Hota, Debasish; Bhansali, Anil; Ghai, Babita

2013-01-01

Anticonvulsants and antidepressants are mostly used in management of painful diabetic neuropathy (PDN). However there are few direct comparisons between drugs of these classes, making evidence-based decision-making in the treatment of painful diabetic neuropathy difficult. This study aimed to perform a network meta-analysis and benefit-risk analysis to evaluate the comparative efficacy and safety of these drugs in PDN treatment. Comparative effectiveness study. Medical Education and Research facility in India. A comprehensive data search was done in PubMed, Cochrane, and Embase up to August 2012. We then systematically reviewed the studies which compared any of 6 drugs for the management of PDN: amitriptyline, duloxetine, gabapentin, pregabalin, valproate, and venlafaxine or any of their combinations. We performed a random-effects network meta-analysis to rank treatments in terms of efficacy and safety. We chose the number of patients experiencing = 50% reduction in pain and number of patient withdrawals due to adverse events (AE) as primary outcomes for efficacy and safety, respectively. We also performed benefit-risk analysis, taking efficacy outcome as benefit and safety outcome as risk. Analysis was intention-to-treat. We included 21 published trials in the analysis. Duloxetine, gabapentin, pregabalin, and venlafaxine were shown to be significantly efficacious compared to placebo with odds ratios (OR) of 2.12, 3.98, 2.78, and 4.43, respectively. Amitriptyline (OR: 7.03, 95% confidence interval [CI]: 1.87, 29.05) and duloxetine (OR: 3.26, 95% CI: 1.04, 9.97) caused more withdrawals than gabapentin. The ranking order of efficacy was gabapentin, venlafaxine, pregabalin, duloxetine/gabapentin, duloxetine, amitriptyline, and placebo and the ranking order of safety was placebo, gabapentin, pregabalin, venlafaxine, duloxetine/gabapentin combination, duloxetine, and amitriptyline. Benefit-risk balance favored the order: gabapentin, venlafaxine, pregabalin, duloxetine

Safety analysis report for packaging (onsite) steel drum

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

McCormick, W.A.

This Safety Analysis Report for Packaging (SARP) provides the analyses and evaluations necessary to demonstrate that the steel drum packaging system meets the transportation safety requirements of HNF-PRO-154, Responsibilities and Procedures for all Hazardous Material Shipments, for an onsite packaging containing Type B quantities of solid and liquid radioactive materials. The basic component of the steel drum packaging system is the 208 L (55-gal) steel drum.

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

Safety analysis of urban arterials at the meso level.

PubMed

Li, Jia; Wang, Xuesong

2017-11-01

Urban arterials form the main structure of street networks. They typically have multiple lanes, high traffic volume, and high crash frequency. Classical crash prediction models investigate the relationship between arterial characteristics and traffic safety by treating road segments and intersections as isolated units. This micro-level analysis does not work when examining urban arterial crashes because signal spacing is typically short for urban arterials, and there are interactions between intersections and road segments that classical models do not accommodate. Signal spacing also has safety effects on both intersections and road segments that classical models cannot fully account for because they allocate crashes separately to intersections and road segments. In addition, classical models do not consider the impact on arterial safety of the immediately surrounding street network pattern. This study proposes a new modeling methodology that will offer an integrated treatment of intersections and road segments by combining signalized intersections and their adjacent road segments into a single unit based on road geometric design characteristics and operational conditions. These are called meso-level units because they offer an analytical approach between micro and macro. The safety effects of signal spacing and street network pattern were estimated for this study based on 118 meso-level units obtained from 21 urban arterials in Shanghai, and were examined using CAR (conditional auto regressive) models that corrected for spatial correlation among the units within individual arterials. Results showed shorter arterial signal spacing was associated with higher total and PDO (property damage only) crashes, while arterials with a greater number of parallel roads were associated with lower total, PDO, and injury crashes. The findings from this study can be used in the traffic safety planning, design, and management of urban arterials. Copyright © 2017 Elsevier Ltd. All

Macro-level safety analysis of pedestrian crashes in Shanghai, China.

PubMed

Wang, Xuesong; Yang, Junguang; Lee, Chris; Ji, Zhuoran; You, Shikai

2016-11-01

Pedestrian safety has become one of the most important issues in the field of traffic safety. This study aims at investigating the association between pedestrian crash frequency and various predictor variables including roadway, socio-economic, and land-use features. The relationships were modeled using the data from 263 Traffic Analysis Zones (TAZs) within the urban area of Shanghai - the largest city in China. Since spatial correlation exists among the zonal-level data, Bayesian Conditional Autoregressive (CAR) models with seven different spatial weight features (i.e. (a) 0-1 first order, adjacency-based, (b) common boundary-length-based, (c) geometric centroid-distance-based, (d) crash-weighted centroid-distance-based, (e) land use type, adjacency-based, (f) land use intensity, adjacency-based, and (g) geometric centroid-distance-order) were developed to characterize the spatial correlations among TAZs. Model results indicated that the geometric centroid-distance-order spatial weight feature, which was introduced in macro-level safety analysis for the first time, outperformed all the other spatial weight features. Population was used as the surrogate for pedestrian exposure, and had a positive effect on pedestrian crashes. Other significant factors included length of major arterials, length of minor arterials, road density, average intersection spacing, percentage of 3-legged intersections, and area of TAZ. Pedestrian crashes were higher in TAZs with medium land use intensity than in TAZs with low and high land use intensity. Thus, higher priority should be given to TAZs with medium land use intensity to improve pedestrian safety. Overall, these findings can help transportation planners and managers understand the characteristics of pedestrian crashes and improve pedestrian safety. Copyright © 2016 Elsevier Ltd. All rights reserved.

Ares-I-X Vehicle Preliminary Range Safety Malfunction Turn Analysis

NASA Technical Reports Server (NTRS)

Beaty, James R.; Starr, Brett R.; Gowan, John W., Jr.

2008-01-01

Ares-I-X is the designation given to the flight test version of the Ares-I rocket (also known as the Crew Launch Vehicle - CLV) being developed by NASA. As part of the preliminary flight plan approval process for the test vehicle, a range safety malfunction turn analysis was performed to support the launch area risk assessment and vehicle destruct criteria development processes. Several vehicle failure scenarios were identified which could cause the vehicle trajectory to deviate from its normal flight path, and the effects of these failures were evaluated with an Ares-I-X 6 degrees-of-freedom (6-DOF) digital simulation, using the Program to Optimize Simulated Trajectories Version 2 (POST2) simulation framework. The Ares-I-X simulation analysis provides output files containing vehicle state information, which are used by other risk assessment and vehicle debris trajectory simulation tools to determine the risk to personnel and facilities in the vicinity of the launch area at Kennedy Space Center (KSC), and to develop the vehicle destruct criteria used by the flight test range safety officer. The simulation analysis approach used for this study is described, including descriptions of the failure modes which were considered and the underlying assumptions and ground rules of the study, and preliminary results are presented, determined by analysis of the trajectory deviation of the failure cases, compared with the expected vehicle trajectory.

Associations between safety culture and employee engagement over time: a retrospective analysis.

PubMed

Daugherty Biddison, Elizabeth Lee; Paine, Lori; Murakami, Peter; Herzke, Carrie; Weaver, Sallie J

2016-01-01

With the growth of the patient safety movement and development of methods to measure workforce health and success have come multiple modes of assessing healthcare worker opinions and attitudes about work and the workplace. Safety culture, a group-level measure of patient safety-related norms and behaviours, has been proposed to influence a variety of patient safety outcomes. Employee engagement, conceptualised as a positive, work-related mindset including feelings of vigour, dedication and absorption in one's work, has also demonstrated an association with a number of important worker outcomes in healthcare. To date, the relationship between responses to these two commonly used measures has been poorly characterised. Our study used secondary data analysis to assess the relationship between safety culture and employee engagement over time in a sample of >50 inpatient hospital units in a large US academic health system. With >2000 respondents in each of three time periods assessed, we found moderate to strong positive correlations (r=0.43-0.69) between employee engagement and four Safety Attitudes Questionnaire domains. Independent collection of these two assessments may have limited our analysis in that minimally different inclusion criteria resulted in some differences in the total respondents to the two instruments. Our findings, nevertheless, suggest a key area in which healthcare quality improvement efforts might be streamlined. 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/

Reprint of "Persuasive appeals in road safety communication campaigns: Theoretical frameworks and practical implications from the analysis of a decade of road safety campaign materials".

PubMed

Guttman, Nurit

2016-12-01

Communication campaigns are employed as an important tool to promote road safety practices. Researchers maintain road safety communication campaigns are more effective when their persuasive appeals, which are central to their communicative strategy, are based on explicit theoretical frameworks. This study's main objectives were to develop a detailed categorization of persuasive appeals used in road safety communication campaigns that differentiate between appeals that appear to be similar but differ conceptually, and to indicate the advantages, limitations and ethical issues associated with each type, drawing on behavior change theories. Materials from over 300 campaigns were obtained from 41 countries, mainly using road safety organizations' websites. Drawing on the literature, five types of main approaches were identified, and the analysis yielded a more detailed categorizations of appeals within these general categories. The analysis points to advantages, limitations, ethical issues and challenges in using different types of appeals. The discussion summarizes challenges in designing persuasive-appeals for road safety communication campaigns. Copyright © 2015 Elsevier Ltd. All rights reserved.

The effect of challenge and hindrance stressors on safety behavior and safety outcomes: a meta-analysis.

PubMed

Clarke, Sharon

2012-10-01

The significance of occupational stressors as a risk factor in accidents has long been recognized; however, the behavioral mechanisms underlying this relationship are currently not well-understood. Meta-analysis was utilized to test the relationships between occupational stressors (challenge and hindrance), safety behaviors (compliance and participation), and safety outcomes (occupational injuries and near-misses). It was hypothesized that hindrance stressors would have negative effects on both safety compliance and safety participation, and subsequently, safety outcomes, whereas challenge stressors would have positive effects. The hypotheses relating to hindrance stressors were supported, suggesting that hindrance stressors lead to a significant reduction in both compliance with safety rules and participation in safety-related activities. Hindrance stressors were also associated with higher levels of occupational injuries and near-misses. The relationship between hindrance stressors and occupational injuries was fully mediated by safety behaviors. However, the hypotheses related to challenge stressors were not supported. Challenge stressors had a nonsignificant, near-zero association with compliance and occupational injuries, a small negative association with participation, and a small positive association with near-misses. The theoretical and practical implications of the meta-analytic findings are discussed, as well as avenues for further research.

System analysis of vehicle active safety problem

NASA Astrophysics Data System (ADS)

Buznikov, S. E.

2018-02-01

The problem of the road transport safety affects the vital interests of the most of the population and is characterized by a global level of significance. The system analysis of problem of creation of competitive active vehicle safety systems is presented as an interrelated complex of tasks of multi-criterion optimization and dynamic stabilization of the state variables of a controlled object. Solving them requires generation of all possible variants of technical solutions within the software and hardware domains and synthesis of the control, which is close to optimum. For implementing the task of the system analysis the Zwicky “morphological box” method is used. Creation of comprehensive active safety systems involves solution of the problem of preventing typical collisions. For solving it, a structured set of collisions is introduced with its elements being generated also using the Zwicky “morphological box” method. The obstacle speed, the longitudinal acceleration of the controlled object and the unpredictable changes in its movement direction due to certain faults, the road surface condition and the control errors are taken as structure variables that characterize the conditions of collisions. The conditions for preventing typical collisions are presented as inequalities for physical variables that define the state vector of the object and its dynamic limits.

Ares I-X Range Safety Flight Envelope Analysis

NASA Technical Reports Server (NTRS)

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

2011-01-01

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

Safety culture in a pharmacy setting using a pharmacy survey on patient safety culture: a cross-sectional study in China.

PubMed

Jia, P L; Zhang, L H; Zhang, M M; Zhang, L L; Zhang, C; Qin, S F; Li, X L; Liu, K X

2014-06-30

To explore the attitudes and perceptions of patient safety culture for pharmacy workers in China by using a Pharmacy Survey on Patient Safety Culture (PSOPSC), and to assess the psychometric properties of the translated Chinese language version of the PSOPSC. Cross-sectional study. Data were obtained from 20 hospital pharmacies in the southwest part of China. We performed χ(2) test to explore the differences on pharmacy staff in different hospital and qualification levels and countries towards patient safety culture. We also computed descriptive statistics, internal consistency coefficients and intersubscale correlation analysis, and then conducted an exploratory factor analysis. A test-retest was performed to assess reproducibility of the items. A total of 630 questionnaires were distributed of which 527 were responded to validly (response rate 84%). The positive response rate for each item ranged from 37% to 90%. The positive response rate on three dimensions ('Teamwork', 'Staff Training and Skills' and 'Staffing, Work Pressure and Pace') was higher than that of Agency for Healthcare Research and Quality (AHRQ) data (p<0.05). There was a statistical difference in the perception of patient safety culture at different hospital and qualification levels. The internal consistency of the total survey was comparatively satisfied (Cronbach's α=0.89). The results demonstrated that among the pharmacy staffs surveyed in China, there was a positive attitude towards patient safety culture in their organisations. Identifying perspectives of patient safety culture from pharmacists in different hospital and qualification levels are important, since this can help support decisions about action to improve safety culture in pharmacy settings. The Chinese translation of the PSOPSC questionnaire (V.2012) applied in our study is acceptable. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Enhancing Safety of Artificially Ventilated Patients Using Ambient Process Analysis.

PubMed

Lins, Christian; Gerka, Alexander; Lüpkes, Christian; Röhrig, Rainer; Hein, Andreas

2018-01-01

In this paper, we present an approach for enhancing the safety of artificially ventilated patients using ambient process analysis. We propose to use an analysis system consisting of low-cost ambient sensors such as power sensor, RGB-D sensor, passage detector, and matrix infrared temperature sensor to reduce risks for artificially ventilated patients in both home and clinical environments. We describe the system concept and our implementation and show how the system can contribute to patient safety.

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

PubMed

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

2008-12-01

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

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

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

HEY, B.E.

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

An analysis of electronic health record-related patient safety concerns

PubMed Central

Meeks, Derek W; Smith, Michael W; Taylor, Lesley; Sittig, Dean F; Scott, Jean M; Singh, Hardeep

2014-01-01

Objective A recent Institute of Medicine report called for attention to safety issues related to electronic health records (EHRs). We analyzed EHR-related safety concerns reported within a large, integrated healthcare system. Methods The Informatics Patient Safety Office of the Veterans Health Administration (VA) maintains a non-punitive, voluntary reporting system to collect and investigate EHR-related safety concerns (ie, adverse events, potential events, and near misses). We analyzed completed investigations using an eight-dimension sociotechnical conceptual model that accounted for both technical and non-technical dimensions of safety. Using the framework analysis approach to qualitative data, we identified emergent and recurring safety concerns common to multiple reports. Results We extracted 100 consecutive, unique, closed investigations between August 2009 and May 2013 from 344 reported incidents. Seventy-four involved unsafe technology and 25 involved unsafe use of technology. A majority (70%) involved two or more model dimensions. Most often, non-technical dimensions such as workflow, policies, and personnel interacted in a complex fashion with technical dimensions such as software/hardware, content, and user interface to produce safety concerns. Most (94%) safety concerns related to either unmet data-display needs in the EHR (ie, displayed information available to the end user failed to reduce uncertainty or led to increased potential for patient harm), software upgrades or modifications, data transmission between components of the EHR, or ‘hidden dependencies’ within the EHR. Discussion EHR-related safety concerns involving both unsafe technology and unsafe use of technology persist long after ‘go-live’ and despite the sophisticated EHR infrastructure represented in our data source. Currently, few healthcare institutions have reporting and analysis capabilities similar to the VA. Conclusions Because EHR-related safety concerns have complex

14 CFR 417.405 - Ground safety analysis.

Code of Federal Regulations, 2011 CFR

2011-01-01

... hazard from affecting the public. A launch operator must incorporate the launch site operator's systems... personnel who are knowledgeable of launch vehicle systems, launch processing, ground systems, operations...) Begin a ground safety analysis by identifying the systems and operations to be analyzed; (2) Define the...

14 CFR 417.405 - Ground safety analysis.

Code of Federal Regulations, 2010 CFR

2010-01-01

... hazard from affecting the public. A launch operator must incorporate the launch site operator's systems... personnel who are knowledgeable of launch vehicle systems, launch processing, ground systems, operations...) Begin a ground safety analysis by identifying the systems and operations to be analyzed; (2) Define the...

Analysis of Aviation Safety Reporting System Incident Data Associated with the Technical Challenges of the Atmospheric Environment Safety Technology Project

NASA Technical Reports Server (NTRS)

Withrow, Colleen A.; Reveley, Mary S.

2014-01-01

This study analyzed aircraft incidents in the NASA Aviation Safety Reporting System (ASRS) that apply to two of the three technical challenges (TCs) in NASA's Aviation Safety Program's Atmospheric Environment Safety Technology Project. The aircraft incidents are related to airframe icing and atmospheric hazards TCs. The study reviewed incidents that listed their primary problem as weather or environment-nonweather between 1994 and 2011 for aircraft defined by Federal Aviation Regulations (FAR) Parts 121, 135, and 91. The study investigated the phases of flight, a variety of anomalies, flight conditions, and incidents by FAR part, along with other categories. The first part of the analysis focused on airframe-icing-related incidents and found 275 incidents out of 3526 weather-related incidents over the 18-yr period. The second portion of the study focused on atmospheric hazards and found 4647 incidents over the same time period. Atmospheric hazards-related incidents included a range of conditions from clear air turbulence and wake vortex, to controlled flight toward terrain, ground encounters, and incursions.

Safety analysis

NASA Technical Reports Server (NTRS)

Knight, John C.

1995-01-01

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

Deaths following prehospital safety incidents: an analysis of a national database.

PubMed

Yardley, Iain E; Donaldson, Liam J

2016-10-01

Ensuring patient safety in the prehospital environment is difficult due to the unpredictable nature of the workload and the uncontrolled situations that care is provided in. Studying previous safety incidents can help understand risks and take action to mitigate them. We present an analysis of safety incidents related to patient deaths in ambulance services in England. All incidents related to a patient death reported to the National Reporting and Learning System from an ambulance service between 1 June 2010 and 31 October 2012 were subjected to thematic analysis to identify the failings that led to the incident. Sixty-nine incidents were analysed, equating to one safety incident-related death per 168 000 calls received. Just three event categories were identified: delayed response (59%, 41/69), shortfalls in clinical care (35%, 24/69) and injury during transit (6%, 4/69). Primary failures differed for the categories: problems with dispatch caused the majority of delays in response, with equipment problems and bad weather accounting for the remainder. Failure to provide necessary care was predominantly caused by clinical misjudgements by ambulance staff and equipment issues underlay incidents that led to a patient injury. Improvements intended to address safety related mortality in the ambulance service should include ensuring adequate equipping and resourcing of ambulance services, improving coordination and decision-making during dispatch and supporting individual staff members in the difficult decisions they are faced with. 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/

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

Efficacy and safety of accelerated partial breast irradiation: a meta-analysis of published randomized studies

PubMed Central

Huang, Baqun; Liu, Yuelong; Tang, Yan; Li, Qing; Zhu, Yihui

2017-01-01

Background and purpose Accelerated partial breast irradiation (APBI) technology has theoretical advantages in comparison with traditional adjuvant radiation therapy (whole-breast irradiation; WBI) after breast-conserving surgery. However, published randomized controlled trials have shown inconsistent outcomes. Therefore, a comprehensive assessment of the effectiveness and safety of APBI technology is needed. Results A total of 7 studies of 7452 patients were included in this analysis. All 7 studies reported local recurrence as an outcome. Meta-analysis of 5 trials that included 6486 patients showed significantly different 5-year local recurrence rates for APBI and WBI groups (hazard ratio = 4.54, 95% confidence interval: 1.78–11.61, p = 0.002). Further analysis showed that this difference may be related to the choice of treatment methods. Benefit was conferred to the APBI group for the outcome of non-breast cancer deaths. There was no significant difference between the two groups in terms of nodal recurrence, systemic recurrence, overall survival, or mortality rates. Toxicity side effects and cosmetic effects were similar in both groups, but intraoperative radiotherapy seemed to have a greater acute response. Material and methods Searches for relevant randomized controlled trials of APBI versus WBI were performed using the following sources: PubMed, EMBASE, Cochrane Library, Web of Science. Two independent observers evaluated the identified studies. The meta-analysis was conducted using RevMan 5.2 software. Conclusions Although the analysis showed that patients receiving APBI had a higher local recurrence rate, subgroup analyses suggested that this might be related to treatment options. Patients who receive accurate radiotherapy may have greater benefits. APBI is a promising treatment technology and more phase III clinical trials are expected based on new treatments. PMID:28938661

Hazard Identification and Risk Assessment of Health and Safety Approach JSA (Job Safety Analysis) in Plantation Company

NASA Astrophysics Data System (ADS)

Sugarindra, Muchamad; Ragil Suryoputro, Muhammad; Tiya Novitasari, Adi

2017-06-01

Plantation company needed to identify hazard and perform risk assessment as an Identification of Hazard and Risk Assessment Crime and Safety which was approached by using JSA (Job Safety Analysis). The identification was aimed to identify the potential hazards that might be the risk of workplace accidents so that preventive action could be taken to minimize the accidents. The data was collected by direct observation to the workers concerned and the results were recorded on a Job Safety Analysis form. The data were as forklift operator, macerator worker, worker’s creeper, shredder worker, workers’ workshop, mechanical line worker, trolley cleaning workers and workers’ crepe decline. The result showed that shredder worker value was 30 and had the working level with extreme risk with the risk value range was above 20. So to minimize the accidents could provide Personal Protective Equipment (PPE) which were appropriate, information about health and safety, the company should have watched the activities of workers, and rewards for the workers who obey the rules that applied in the plantation.

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

PubMed

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

2008-10-01

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

Comparison of a Traditional Probabilistic Risk Assessment Approach with Advanced Safety Analysis

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

Smith, Curtis L; Mandelli, Diego; Zhegang Ma

2014-11-01

As part of the Light Water Sustainability Program (LWRS) [1], the purpose of the Risk Informed Safety Margin Characterization (RISMC) [2] Pathway research and development (R&D) is to support plant decisions for risk-informed margin management with the aim to improve economics, reliability, and sustain safety of current NPPs. In this paper, we describe the RISMC analysis process illustrating how mechanistic and probabilistic approaches are combined in order to estimate a safety margin. We use the scenario of a “station blackout” (SBO) wherein offsite power and onsite power is lost, thereby causing a challenge to plant safety systems. We describe themore » RISMC approach, illustrate the station blackout modeling, and contrast this with traditional risk analysis modeling for this type of accident scenario. We also describe our approach we are using to represent advanced flooding analysis.« less

Integrated Safety Analysis Teams

NASA Technical Reports Server (NTRS)

Wetherholt, Jonathan C.

2008-01-01

Today's complex systems require understanding beyond one person s capability to comprehend. Each system requires a team to divide the system into understandable subsystems which can then be analyzed with an Integrated Hazard Analysis. The team must have both specific experiences and diversity of experience. Safety experience and system understanding are not always manifested in one individual. Group dynamics make the difference between success and failure as well as the difference between a difficult task and a rewarding experience. There are examples in the news which demonstrate the need to connect the pieces of a system into a complete picture. The Columbia disaster is now a standard example of a low consequence hazard in one part of the system; the External Tank is a catastrophic hazard cause for a companion subsystem, the Space Shuttle Orbiter. The interaction between the hardware, the manufacturing process, the handling, and the operations contributed to the problem. Each of these had analysis performed, but who constituted the team which integrated this analysis together? This paper will explore some of the methods used for dividing up a complex system; and how one integration team has analyzed the parts. How this analysis has been documented in one particular launch space vehicle case will also be discussed.

41 CFR 102-80.130 - Who must perform the equivalent level of safety analysis?

Code of Federal Regulations, 2010 CFR

2010-07-01

...-SAFETY AND ENVIRONMENTAL MANAGEMENT Accident and Fire Prevention Equivalent Level of Safety Analysis... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Who must perform the equivalent level of safety analysis? 102-80.130 Section 102-80.130 Public Contracts and Property Management...

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.

Safety climate and mindful safety practices in the oil and gas industry.

PubMed

Dahl, Øyvind; Kongsvik, Trond

2018-02-01

The existence of a positive association between safety climate and the safety behavior of sharp-end workers in high-risk organizations is supported by a considerable body of research. Previous research has primarily analyzed two components of safety behavior, namely safety compliance and safety participation. The present study extends previous research by looking into the relationship between safety climate and another component of safety behavior, namely mindful safety practices. Mindful safety practices are defined as the ability to be aware of critical factors in the environment and to act appropriately when dangers arise. Regression analysis was used to examine whether mindful safety practices are, like compliance and participation, promoted by a positive safety climate, in a questionnaire-based study of 5712 sharp-end workers in the oil and gas industry. The analysis revealed that a positive safety climate promotes mindful safety practices. The regression model accounted for roughly 31% of the variance in mindful safety practices. The most important safety climate factor was safety leadership. The findings clearly demonstrate that mindful safety practices are highly context-dependent, hence, manageable and susceptible to change. In order to improve safety climate in a direction which is favorable for mindful safety practices, the results demonstrate that it is important to give the fundamental features of safety climate high priority and in particular that of safety leadership. Copyright © 2017 National Safety Council and Elsevier Ltd. All rights reserved.

Analysis of microgravity space experiments Space Shuttle programmatic safety requirements

NASA Technical Reports Server (NTRS)

Terlep, Judith A.

1996-01-01

This report documents the results of an analysis of microgravity space experiments space shuttle programmatic safety requirements and recommends the creation of a Safety Compliance Data Package (SCDP) Template for both flight and ground processes. These templates detail the programmatic requirements necessary to produce a complete SCDP. The templates were developed from various NASA centers' requirement documents, previously written guidelines on safety data packages, and from personal experiences. The templates are included in the back as part of this report.

Safety analysis report for the Waste Storage Facility. Revision 2

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

Bengston, S.J.

1994-05-01

This safety analysis report outlines the safety concerns associated with the Waste Storage Facility located in the Radioactive Waste Management Complex at the Idaho National Engineering Laboratory. The three main objectives of the report are: define and document a safety basis for the Waste Storage Facility activities; demonstrate how the activities will be carried out to adequately protect the workers, public, and environment; and provide a basis for review and acceptance of the identified risk that the managers, operators, and owners will assume.

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

PubMed

Yoshikawa, Etsuko

2013-01-01

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

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

PubMed

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

2011-02-01

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

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

PubMed

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

2016-01-01

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

Predicting safety culture: the roles of employer, operations manager and safety professional.

PubMed

Wu, Tsung-Chih; Lin, Chia-Hung; Shiau, Sen-Yu

2010-10-01

This study explores predictive factors in safety culture. In 2008, a sample 939 employees was drawn from 22 departments of a telecoms firm in five regions in central Taiwan. The sample completed a questionnaire containing four scales: the employer safety leadership scale, the operations manager safety leadership scale, the safety professional safety leadership scale, and the safety culture scale. The sample was then randomly split into two subsamples. One subsample was used for measures development, one for the empirical study. A stepwise regression analysis found four factors with a significant impact on safety culture (R²=0.337): safety informing by operations managers; safety caring by employers; and safety coordination and safety regulation by safety professionals. Safety informing by operations managers (ß=0.213) was by far the most significant predictive factor. The findings of this study provide a framework for promoting a positive safety culture at the group level. Crown Copyright © 2010. Published by Elsevier Ltd. All rights reserved.

Manned space flight nuclear system safety. Volume 3: Reactor system preliminary nuclear safety analysis. Part 1: Reference Design Document (RDD)

NASA Technical Reports Server (NTRS)

1972-01-01

The Reference Design Document, of the Preliminary Safety Analysis Report (PSAR) - Reactor System provides the basic design and operations data used in the nuclear safety analysis of the Rector Power Module as applied to a Space Base program. A description of the power module systems, facilities, launch vehicle and mission operations, as defined in NASA Phase A Space Base studies is included. Each of two Zirconium Hydride Reactor Brayton power modules provides 50 kWe for the nominal 50 man Space Base. The INT-21 is the prime launch vehicle. Resupply to the 500 km orbit over the ten year mission is provided by the Space Shuttle. At the end of the power module lifetime (nominally five years), a reactor disposal system is deployed for boost into a 990 km high altitude (long decay time) earth orbit.

Transit safety & security statistics & analysis 2003 annual report (formerly SAMIS)

DOT National Transportation Integrated Search

2005-12-01

The Transit Safety & Security Statistics & Analysis 2003 Annual Report (formerly SAMIS) is a compilation and analysis of mass transit accident, casualty, and crime statistics reported under the Federal Transit Administrations (FTAs) National Tr...

Transit safety & security statistics & analysis 2002 annual report (formerly SAMIS)

DOT National Transportation Integrated Search

2004-12-01

The Transit Safety & Security Statistics & Analysis 2002 Annual Report (formerly SAMIS) is a compilation and analysis of mass transit accident, casualty, and crime statistics reported under the Federal Transit Administrations (FTAs) National Tr...

Effectiveness of Occupational Health and Safety Training: A Systematic Review with Meta-Analysis

ERIC Educational Resources Information Center

Ricci, Federico; Chiesi, Andrea; Bisio, Carlo; Panari, Chiara; Pelosi, Annalisa

2016-01-01

Purpose: This meta-analysis aims to verify the efficacy of occupational health and safety (OHS) training in terms of knowledge, attitude and beliefs, behavior and health. Design/methodology/approach: The authors included studies published in English (2007-2014) selected from ten databases. Eligibility criteria were studies concerned with the…

Nursing practice environment, job outcomes and safety climate: a structural equation modelling analysis.

PubMed

Dos Santos Alves, Daniela Fernanda; da Silva, Dirceu; de Brito Guirardello, Edinêis

2017-01-01

To assess correlations between the characteristics of the nursing practice environment, job outcomes and safety climate. The nursing practice environment is critical to the well-being of professionals and to patient safety, as highlighted by national and international studies; however, there is a lack of evidence regarding this theme in paediatric units. A cross-sectional study, in two paediatric hospitals in Brazil, was conducted from December 2013 to February 2014. For data collection, we used the Nursing Work Index - Revised, Safety Attitudes Questionnaire - Short Form 2006 and the Maslach Burnout Inventory, and for analysis Spearman's correlation coefficient and structural equation modelling were used. Two hundred and sixty-seven professional nurses participated in the study. Autonomy, control over the work environment and the relationship between nursing and medical staff are factors associated with job outcomes and safety climate and can be considered their predictors. Professional nurses with greater autonomy, good working relationships and control over their work environment have lower levels of emotional exhaustion, higher job satisfaction, less intention of leaving the job and the safety climate is positive. Initiatives to improve the professional practice environment can improve the safety of paediatric patients and the well-being of professional nurses. © 2016 John Wiley & Sons Ltd.

Bayesian road safety analysis: incorporation of past evidence and effect of hyper-prior choice.

PubMed

Miranda-Moreno, Luis F; Heydari, Shahram; Lord, Dominique; Fu, Liping

2013-09-01

This paper aims to address two related issues when applying hierarchical Bayesian models for road safety analysis, namely: (a) how to incorporate available information from previous studies or past experiences in the (hyper) prior distributions for model parameters and (b) what are the potential benefits of incorporating past evidence on the results of a road safety analysis when working with scarce accident data (i.e., when calibrating models with crash datasets characterized by a very low average number of accidents and a small number of sites). A simulation framework was developed to evaluate the performance of alternative hyper-priors including informative and non-informative Gamma, Pareto, as well as Uniform distributions. Based on this simulation framework, different data scenarios (i.e., number of observations and years of data) were defined and tested using crash data collected at 3-legged rural intersections in California and crash data collected for rural 4-lane highway segments in Texas. This study shows how the accuracy of model parameter estimates (inverse dispersion parameter) is considerably improved when incorporating past evidence, in particular when working with the small number of observations and crash data with low mean. The results also illustrates that when the sample size (more than 100 sites) and the number of years of crash data is relatively large, neither the incorporation of past experience nor the choice of the hyper-prior distribution may affect the final results of a traffic safety analysis. As a potential solution to the problem of low sample mean and small sample size, this paper suggests some practical guidance on how to incorporate past evidence into informative hyper-priors. By combining evidence from past studies and data available, the model parameter estimates can significantly be improved. The effect of prior choice seems to be less important on the hotspot identification. The results show the benefits of incorporating prior

Too much information? A document analysis of sport safety resources from key organisations

PubMed Central

Finch, Caroline F

2016-01-01

Objectives The field of sport injury prevention has seen a marked increase in published research in recent years, with concomitant proliferation of lay sport safety resources, such as policies, fact sheets and posters. The aim of this study was to catalogue and categorise the number, type and topic focus of sport safety resources from a representative set of key organisations. Design Cataloguing and qualitative document analysis of resources available from the websites of six stakeholder organisations in Australia. Setting This study was part of a larger investigation, the National Guidance for Australian Football Partnerships and Safety (NoGAPS) project. Participants The NoGAPS study provided the context for a purposive sampling of six organisations involved in the promotion of safety in Australian football. These partners are recognised as being highly representative of organisations at national and state level that reflect similarly in their goals around sport safety promotion in Australia. Results The catalogue comprised 284 resources. More of the practical and less prescriptive types of resources, such as fact sheets, than formal policies were found. Resources for the prevention of physical injuries were the predominant sport safety issue addressed, with risk management, environmental issues and social behaviours comprising other categories. Duplication of resources for specific safety issues, within and across organisations, was found. Conclusions People working within sport settings have access to a proliferation of resources, which creates a potential rivalry for sourcing of injury prevention information. Important issues that are likely to influence the uptake of safety advice by the general sporting public include the sheer number of resources available, and the overlap and duplication of resources addressing the same issues. The existence of a large number of resources from reputable organisations does not mean that they are necessarily evidence based

Assessing the general safety and tolerability of vildagliptin: value of pooled analyses from a large safety database versus evaluation of individual studies

PubMed Central

Schweizer, Anja; Dejager, Sylvie; Foley, James E; Kothny, Wolfgang

2011-01-01

Aim: Analyzing safety aspects of a drug from individual studies can lead to difficult-to-interpret results. The aim of this paper is therefore to assess the general safety and tolerability, including incidences of the most common adverse events (AEs), of vildagliptin based on a large pooled database of Phase II and III clinical trials. Methods: Safety data were pooled from 38 studies of ≥12 to ≥104 weeks’ duration. AE profiles of vildagliptin (50 mg bid; N = 6116) were evaluated relative to a pool of comparators (placebo and active comparators; N = 6210). Absolute incidence rates were calculated for all AEs, serious AEs (SAEs), discontinuations due to AEs, and deaths. Results: Overall AEs, SAEs, discontinuations due to AEs, and deaths were all reported with a similar frequency in patients receiving vildagliptin (69.1%, 8.9%, 5.7%, and 0.4%, respectively) and patients receiving comparators (69.0%, 9.0%, 6.4%, and 0.4%, respectively), whereas drug-related AEs were seen with a lower frequency in vildagliptin-treated patients (15.7% vs 21.7% with comparators). The incidences of the most commonly reported specific AEs were also similar between vildagliptin and comparators, except for increased incidences of hypoglycemia, tremor, and hyperhidrosis in the comparator group related to the use of sulfonylureas. Conclusions: The present pooled analysis shows that vildagliptin was overall well tolerated in clinical trials of up to >2 years in duration. The data further emphasize the value of a pooled analysis from a large safety database versus assessing safety and tolerability from individual studies. PMID:21415917

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

Code of Federal Regulations, 2013 CFR

2013-01-01

...; technical information in final safety analysis report. The application must contain a final safety analysis...) Information sufficient to demonstrate compliance with the applicable requirements regarding testing, analysis... 10 Energy 2 2013-01-01 2013-01-01 false Contents of applications; technical information in final...

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

Code of Federal Regulations, 2012 CFR

2012-01-01

...; technical information in final safety analysis report. The application must contain a final safety analysis...) Information sufficient to demonstrate compliance with the applicable requirements regarding testing, analysis... 10 Energy 2 2012-01-01 2012-01-01 false Contents of applications; technical information in final...

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

Code of Federal Regulations, 2014 CFR

2014-01-01

...; technical information in final safety analysis report. The application must contain a final safety analysis...) Information sufficient to demonstrate compliance with the applicable requirements regarding testing, analysis... 10 Energy 2 2014-01-01 2014-01-01 false Contents of applications; technical information in final...

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

Code of Federal Regulations, 2011 CFR

2011-01-01

...; technical information in final safety analysis report. The application must contain a final safety analysis...) Information sufficient to demonstrate compliance with the applicable requirements regarding testing, analysis... 10 Energy 2 2011-01-01 2011-01-01 false Contents of applications; technical information in final...

Analysis of governmental Web sites on food safety issues: a global perspective.

PubMed

Namkung, Young; Almanza, Barbara A

2006-10-01

Despite a growing concern over food safety issues, as well as a growing dependence on the Internet as a source of information, little research has been done to examine the presence and relevance of food safety-related information on Web sites. The study reported here conducted Web site analysis in order to examine the current operational status of governmental Web sites on food safety issues. The study also evaluated Web site usability, especially information dimensionalities such as utility, currency, and relevance of content, from the perspective of the English-speaking consumer. Results showed that out of 192 World Health Organization members, 111 countries operated governmental Web sites that provide information about food safety issues. Among 171 searchable Web sites from the 111 countries, 123 Web sites (71.9 percent) were accessible, and 81 of those 123 (65.9 percent) were available in English. The majority of Web sites offered search engine tools and related links for more information, but their availability and utility was limited. In terms of content, 69.9 percent of Web sites offered information on foodborne-disease outbreaks, compared with 31.5 percent that had travel- and health-related information.

Safety-critical event risk associated with cell phone tasks as measured in naturalistic driving studies: A systematic review and meta-analysis.

PubMed

Simmons, Sarah M; Hicks, Anne; Caird, Jeff K

2016-02-01

A systematic review and meta-analysis of naturalistic driving studies involving estimates of safety-critical event risk associated with handheld device use while driving is described. Fifty-seven studies identified from targeted databases, journals and websites were reviewed in depth, and six were ultimately included. These six studies, published between 2006 and 2014, encompass seven sets of naturalistic driver data and describe original research that utilized naturalistic methods to assess the effects of distracting behaviors. Four studies involved non-commercial drivers of light vehicles and two studies involved commercial drivers of trucks and buses. Odds ratios quantifying safety-critical event (SCE) risk associated with talking, dialing, locating or answering, and texting or browsing were extracted. Stratified meta-analysis of pooled odds ratios was used to estimate SCE risk by distraction type; meta-regression was used to test for sources of heterogeneity. The results indicate that tasks that require drivers to take their eyes off the road, such as dialing, locating a phone and texting, increase SCE risk to a greater extent than tasks that do not require eyes off the road such as talking. Although talking on a handheld device did not increase SCE risk, further research is required to determine whether it indirectly influences SCE risk (e.g., by encouraging other cell phone activities). In addition, a number of study biases and quality issues of naturalistic driving studies are discussed. Copyright © 2015 Elsevier Ltd. All rights reserved.

Transportation safety data and analysis : Volume 1, Analyzing the effectiveness of safety measures using Bayesian methods.

DOT National Transportation Integrated Search

2010-12-01

Recent research suggests that traditional safety evaluation methods may be inadequate in accurately determining the effectiveness of roadway safety measures. In recent years, advanced statistical methods are being utilized in traffic safety studies t...

Safety analysis of interchanges

DOT National Transportation Integrated Search

2007-06-01

The objectives of this research are to synthesize the current state of knowledge concerning the safety assessment of new or modified interchanges; develop a spreadsheet-based computational tool for performing safety assessments of interchanges; and i...

Safety and efficacy of low molecular weight heparins in children: a systematic review of the literature and meta-analysis of single-arm studies.

PubMed

Bidlingmaier, Christoph; Kenet, Gili; Kurnik, Karin; Mathew, Prasad; Manner, Daniela; Mitchell, Lesley; Krümpel, Anne; Nowak-Göttl, Ulrike

2011-10-01

Within the last two decades low molecular weight heparins (LMWH) have gained increasing widespread use as anticoagulants in children. The use of LMWH has been implemented into clinical care even though there is a lack of firm evidence on the efficacy and safety of LMWH in this population due to the absence of sufficiently powered randomized controlled trials. In the absence of clinical trials, we performed a meta-analysis of available single-arm studies using LMWH in children. A systematic search of electronic databases (Medline, EMBASE, OVID, Web of Science, The Cochrane Library) for studies published from 1980 to 2010 was conducted using keywords in combination both as MeSH terms and text words. Two authors independently screened citations and those meeting a priori defined inclusion criteria were retained. Data on year of publication, study design, country of origin, number of patients, ethnicity, venous thromboembolic events type, and frequency of recurrence and major bleedings were abstracted. Pooled incidence rates (IR) including 95% confidence intervals (95% CIs) on efficacy and safety data of LMWH administration on primary prophylaxis, as well as on secondary prophylaxis in children following symptomatic thromboembolism (TE) were shown. We included 2251 pediatric patients derived from 35 single-arm studies from 12 study countries who were eligible for analysis in the present systematic review. Pooled incidence rates (95% CI) to develop first TE on primary prophylaxis, further TE event on LMWH secondary prophylaxis, or a major bleeding event on LMWH were 0.047 (0.023 to 0.091), 0.052 (0.037 to 0.073) for efficacy, and 0.054 (0.039 to 0.074) for safety (treatment data only), respectively. Efficacy and safety data are comparable with adult data. The present systematic review suggests that use of LMWH in children as primary prophylaxis and in treatment of symptomatic thrombosis is effective and safe. However, properly designed randomized controlled trials are

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-21

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-11

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

Facility safety study

NASA Technical Reports Server (NTRS)

1979-01-01

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

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

PubMed

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

2018-04-01

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

Safety analysis report for packaging (onsite) multicanister overpack cask

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

Edwards, W.S.

1997-07-14

This safety analysis report for packaging (SARP) documents the safety of shipments of irradiated fuel elements in the MUlticanister Overpack (MCO) and MCO Cask for a highway route controlled quantity, Type B fissile package. This SARP evaluates the package during transfers of (1) water-filled MCOs from the K Basins to the Cold Vacuum Drying Facility (CVDF) and (2) sealed and cold vacuum dried MCOs from the CVDF in the 100 K Area to the Canister Storage Building in the 200 East Area.

14 CFR 417.213 - Flight safety limits analysis.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 4 2011-01-01 2011-01-01 false Flight safety limits analysis. 417.213 Section 417.213 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION... launch vehicle's flight to prevent the hazardous effects of the resulting debris impacts from reaching...

14 CFR 417.213 - Flight safety limits analysis.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 4 2014-01-01 2014-01-01 false Flight safety limits analysis. 417.213 Section 417.213 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION... launch vehicle's flight to prevent the hazardous effects of the resulting debris impacts from reaching...

14 CFR 417.213 - Flight safety limits analysis.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Flight safety limits analysis. 417.213 Section 417.213 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION... launch vehicle's flight to prevent the hazardous effects of the resulting debris impacts from reaching...

14 CFR 417.213 - Flight safety limits analysis.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 4 2013-01-01 2013-01-01 false Flight safety limits analysis. 417.213 Section 417.213 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION... launch vehicle's flight to prevent the hazardous effects of the resulting debris impacts from reaching...

14 CFR 417.213 - Flight safety limits analysis.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 4 2012-01-01 2012-01-01 false Flight safety limits analysis. 417.213 Section 417.213 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION... launch vehicle's flight to prevent the hazardous effects of the resulting debris impacts from reaching...

Analysis and comparison of safety models using average daily, average hourly, and microscopic traffic.

PubMed

Wang, Ling; Abdel-Aty, Mohamed; Wang, Xuesong; Yu, Rongjie

2018-02-01

There have been plenty of traffic safety studies based on average daily traffic (ADT), average hourly traffic (AHT), or microscopic traffic at 5 min intervals. Nevertheless, not enough research has compared the performance of these three types of safety studies, and seldom of previous studies have intended to find whether the results of one type of study is transferable to the other two studies. First, this study built three models: a Bayesian Poisson-lognormal model to estimate the daily crash frequency using ADT, a Bayesian Poisson-lognormal model to estimate the hourly crash frequency using AHT, and a Bayesian logistic regression model for the real-time safety analysis using microscopic traffic. The model results showed that the crash contributing factors found by different models were comparable but not the same. Four variables, i.e., the logarithm of volume, the standard deviation of speed, the logarithm of segment length, and the existence of diverge segment, were positively significant in the three models. Additionally, weaving segments experienced higher daily and hourly crash frequencies than merge and basic segments. Then, each of the ADT-based, AHT-based, and real-time models was used to estimate safety conditions at different levels: daily and hourly, meanwhile, the real-time model was also used in 5 min intervals. The results uncovered that the ADT- and AHT-based safety models performed similar in predicting daily and hourly crash frequencies, and the real-time safety model was able to provide hourly crash frequency. Copyright © 2017 Elsevier Ltd. All rights reserved.

Use of cultural consensus analysis to evaluate expert feedback of median safety.

PubMed

Kim, Tae-Gyu; Donnell, Eric T; Lee, Dongmin

2008-07-01

Cultural consensus analysis is a statistical method that can be used to assess participant responses to survey questions. The technique concurrently estimates the knowledge of each survey participant and estimates the culturally correct answer to each question asked, based on the existence of consensus among survey participants. The main objectives of this paper are to present the cultural consensus methodology and apply it to a set of median design and safety survey data that were collected using the Delphi method. A total of 21 Delphi survey participants were asked to answer research questions related to cross-median crashes. It was found that the Delphi panel had agreeable opinions with respect to the association of average daily traffic (ADT) and heavy vehicle percentage combination on the risk of cross-median crashes; relative importance of additional factors, other than ADT, median width, and crash history that may contribute to cross-median crashes; and, the relative importance of geometric factors that may be associated with the likelihood of cross-median crashes. Therefore, the findings from the cultural consensus analysis indicate that the expert panel selected to participate in the Delphi survey shared a common knowledge pool relative to the association between median design and safety. There were, however, diverse opinions regarding median barrier type and its preferred placement location. The panel showed a higher level of knowledge on the relative importance regarding the association of geometric factors on cross-median crashes likelihood than on other issues considered. The results of the cultural consensus analysis of the present median design and safety survey data could be used to design a focused field study of median safety.

Final safety analysis report for the Ground Test Accelerator (GTA), Phase 2

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

NONE

1994-10-01

This document is the second volume of a 3 volume safety analysis report on the Ground Test Accelerator (GTA). The GTA program at the Los Alamos National Laboratory (LANL) is the major element of the national Neutral Particle Beam (NPB) program, which is supported by the Strategic Defense Initiative Office (SDIO). A principal goal of the national NPB program is to assess the feasibility of using hydrogen and deuterium neutral particle beams outside the Earth`s atmosphere. The main effort of the NPB program at Los Alamos concentrates on developing the GTA. The GTA is classified as a low-hazard facility, exceptmore » for the cryogenic-cooling system, which is classified as a moderate-hazard facility. This volume consists of failure modes and effects analysis; accident analysis; operational safety requirements; quality assurance program; ES&H management program; environmental, safety, and health systems critical to safety; summary of waste-management program; environmental monitoring program; facility expansion, decontamination, and decommissioning; summary of emergency response plan; summary plan for employee training; summary plan for operating procedures; glossary; and appendices A and B.« less

Total Diet Studies as a Tool for Ensuring Food Safety

PubMed Central

Lee, Joon-Goo; Kim, Sheen-Hee; Kim, Hae-Jung

2015-01-01

With the diversification and internationalization of the food industry and the increased focus on health from a majority of consumers, food safety policies are being implemented based on scientific evidence. Risk analysis represents the most useful scientific approach for making food safety decisions. Total diet study (TDS) is often used as a risk assessment tool to evaluate exposure to hazardous elements. Many countries perform TDSs to screen for chemicals in foods and analyze exposure trends to hazardous elements. TDSs differ from traditional food monitoring in two major aspects: chemicals are analyzed in food in the form in which it will be consumed and it is cost-effective in analyzing composite samples after processing multiple ingredients together. In Korea, TDSs have been conducted to estimate dietary intakes of heavy metals, pesticides, mycotoxins, persistent organic pollutants, and processing contaminants. TDSs need to be carried out periodically to ensure food safety. PMID:26483881

Evolution of Safety Analysis to Support New Exploration Missions

NASA Technical Reports Server (NTRS)

Thrasher, Chard W.

2008-01-01

NASA is currently developing the Ares I launch vehicle as a key component of the Constellation program which will provide safe and reliable transportation to the International Space Station, back to the moon, and later to Mars. The risks and costs of the Ares I must be significantly lowered, as compared to other manned launch vehicles, to enable the continuation of space exploration. It is essential that safety be significantly improved, and cost-effectively incorporated into the design process. This paper justifies early and effective safety analysis of complex space systems. Interactions and dependences between design, logistics, modeling, reliability, and safety engineers will be discussed to illustrate methods to lower cost, reduce design cycles and lessen the likelihood of catastrophic events.

Wisconsin large truck safety and enforcement study.

DOT National Transportation Integrated Search

2011-07-01

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

Adapting Cognitive Task Analysis to Investigate Clinical Decision Making and Medication Safety Incidents.

PubMed

Russ, Alissa L; Militello, Laura G; Glassman, Peter A; Arthur, Karen J; Zillich, Alan J; Weiner, Michael

2017-05-03

Cognitive task analysis (CTA) can yield valuable insights into healthcare professionals' cognition and inform system design to promote safe, quality care. Our objective was to adapt CTA-the critical decision method, specifically-to investigate patient safety incidents, overcome barriers to implementing this method, and facilitate more widespread use of cognitive task analysis in healthcare. We adapted CTA to facilitate recruitment of healthcare professionals and developed a data collection tool to capture incidents as they occurred. We also leveraged the electronic health record (EHR) to expand data capture and used EHR-stimulated recall to aid reconstruction of safety incidents. We investigated 3 categories of medication-related incidents: adverse drug reactions, drug-drug interactions, and drug-disease interactions. Healthcare professionals submitted incidents, and a subset of incidents was selected for CTA. We analyzed several outcomes to characterize incident capture and completed CTA interviews. We captured 101 incidents. Eighty incidents (79%) met eligibility criteria. We completed 60 CTA interviews, 20 for each incident category. Capturing incidents before interviews allowed us to shorten the interview duration and reduced reliance on healthcare professionals' recall. Incorporating the EHR into CTA enriched data collection. The adapted CTA technique was successful in capturing specific categories of safety incidents. Our approach may be especially useful for investigating safety incidents that healthcare professionals "fix and forget." Our innovations to CTA are expected to expand the application of this method in healthcare and inform a wide range of studies on clinical decision making and patient safety.

Automation for System Safety Analysis

NASA Technical Reports Server (NTRS)

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

2009-01-01

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

The use of experimental data in an MTR-type nuclear reactor safety analysis

NASA Astrophysics Data System (ADS)

Day, Simon E.

Reactivity initiated accidents (RIAs) are a category of events required for research reactor safety analysis. A subset of this is unprotected RIAs in which mechanical systems or human intervention are not credited in the response of the system. Light-water cooled and moderated MTR-type ( i.e., aluminum-clad uranium plate fuel) reactors are self-limiting up to some reactivity insertion limit beyond which fuel damage occurs. This characteristic was studied in the Borax and Spert reactor tests of the 1950s and 1960s in the USA. This thesis considers the use of this experimental data in generic MTR-type reactor safety analysis. The approach presented herein is based on fundamental phenomenological understanding and uses correlations in the reactor test data with suitable account taken for differences in important system parameters. Specifically, a semi-empirical approach is used to quantify the relationship between the power, energy and temperature rise response of the system as well as parametric dependencies on void coefficient and the degree of subcooling. Secondary effects including the dependence on coolant flow are also examined. A rigorous curve fitting approach and error assessment is used to quantify the trends in the experimental data. In addition to the initial power burst stage of an unprotected transient, the longer term stability of the system is considered with a stylized treatment of characteristic power/temperature oscillations (chugging). A bridge from the HEU-based experimental data to the LEU fuel cycle is assessed and outlined based on existing simulation results presented in the literature. A cell-model based parametric study is included. The results are used to construct a practical safety analysis methodology for determining reactivity insertion safety limits for a light-water moderated and cooled MTR-type core.

Understanding of safety monitoring in clinical trials by individuals with CF or their parents: A qualitative analysis.

PubMed

Kern-Goldberger, Andrew S; Hessels, Amanda J; Saiman, Lisa; Quittell, Lynne M

2018-03-14

Recruiting both pediatric and adult participants for clinical trials in CF is currently of paramount importance as numerous new therapies are being developed. However, recruitment is challenging as parents of children with CF and adults with CF cite safety concerns as a principal barrier to enrollment. In conjunction with the CF Foundation (CFF) Data Safety Monitoring Board (DSMB), a pilot brochure was developed to inform patients and parents of the multiple levels of safety monitoring; the CFF simultaneously created an infographic representing the safety monitoring process. This study explores the attitudes and beliefs of CF patients and families regarding safety monitoring and clinical trial participation, and elicits feedback regarding the educational materials. Semi-structured interviews were conducted using a pre-tested interview guide and audio-recorded during routine CF clinic visits. Participants included 5 parents of children with CF <16years old; 5 adolescents and young adults with CF 16-21years old; and 5 adults with CF ≥22years old from pediatric and adult CF centers. The study team performed systematic text condensation analysis of the recorded interviews using an iterative process. Four major thematic categories with subthemes emerged as supported by exemplar quotations: attitudes toward clinical trials, safety values, conceptualizing the safety monitoring process, and priorities for delivery of patient education. Participant feedback was used to revise the pilot brochure; text was shortened, unfamiliar words clarified (e.g., "pipeline"), abbreviations eliminated, and redundancy avoided. Qualitative analysis of CF patient and family interviews provided insights into barriers to participation in clinical trials, safety concerns, perspectives on safety monitoring and educational priorities. We plan a multicenter study to determine if the revised brochure reduces knowledge, attitude and practice barriers regarding participation in CF clinical trials

10 CFR 72.70 - Safety analysis report updating.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Safety analysis report updating. 72.70 Section 72.70 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE Records...

10 CFR 70.62 - Safety program and integrated safety analysis.

Code of Federal Regulations, 2013 CFR

2013-01-01

...; (iv) Potential accident sequences caused by process deviations or other events internal to the... of occurrence of each potential accident sequence identified pursuant to paragraph (c)(1)(iv) of this... have experience in nuclear criticality safety, radiation safety, fire safety, and chemical process...

10 CFR 70.62 - Safety program and integrated safety analysis.

Code of Federal Regulations, 2014 CFR

2014-01-01

...; (iv) Potential accident sequences caused by process deviations or other events internal to the... of occurrence of each potential accident sequence identified pursuant to paragraph (c)(1)(iv) of this... have experience in nuclear criticality safety, radiation safety, fire safety, and chemical process...

10 CFR 70.62 - Safety program and integrated safety analysis.

Code of Federal Regulations, 2012 CFR

2012-01-01

...; (iv) Potential accident sequences caused by process deviations or other events internal to the... of occurrence of each potential accident sequence identified pursuant to paragraph (c)(1)(iv) of this... have experience in nuclear criticality safety, radiation safety, fire safety, and chemical process...

Study on occupational safety and health strategy for Taiwan.

PubMed

Chuang, Kuen-Yuan; Su, Teh-Sheng; Kuo, Chao-Yin; Lin, Chien-Liang; Lin, Han-Yu; Yu, Yi-Chun

2009-12-01

The aim of this study was to establish a set of occupational safety and health (OSH) issues and development policies suitable for adoption in Taiwan. A survey was conducted on a sample of 102 experts and 235 industrial work safety personnel in Taiwan for statistical analysis of the general consensus, with the results showing such consensus in 104 individual policy indicators. Our results reveal that the most appropriate targets were considered to be annual 10% reductions in the 'occupational accident disability rate', 'occupational accident injury rate' and 'occupational diseases before 2010'. Responding to the specific question of the appropriate method of achieving a reduction in the number of accidents in Taiwan, the primary consideration for 13.4% of the experts and 10.6% of the industry personnel was 'promoting OSH awareness and enhancing the overall safety culture'. As regards the current OSH policy focus, 11.2% of the experts considered 'improving OSH legislation, standards and systems' to be the most important, whilst 8.9% of the industry personnel felt that 'recognizing work stress, overwork and emerging OSH issues' were the most important.

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.

Safety studies on vacuum insulated liquid helium cryostats

NASA Astrophysics Data System (ADS)

Weber, C.; Henriques, A.; Zoller, C.; Grohmann, S.

2017-12-01

The loss of insulating vacuum is often considered as a reasonable foreseeable accident for the dimensioning of cryogenic safety relief devices (SRD). The cryogenic safety test facility PICARD was designed at KIT to investigate such events. In the course of first experiments, discharge instabilities of the spring loaded safety relief valve (SRV) occurred, the so-called chattering and pumping effects. These instabilities reduce the relief flow capacity, which leads to impermissible over-pressures in the system. The analysis of the process dynamics showed first indications for a smaller heat flux than the commonly assumed 4W/cm2. This results in an oversized discharge area for the reduced relief flow rate, which corresponds to the lower heat flux. This paper presents further experimental investigations on the venting of the insulating vacuum with atmospheric air under variation of the set pressure (p set) of the SRV. Based on dynamic process analysis, the results are discussed with focus on effective heat fluxes and operating characteristics of the spring-loaded SRV.

Too much information? A document analysis of sport safety resources from key organisations.

PubMed

Bekker, Sheree; Finch, Caroline F

2016-05-06

The field of sport injury prevention has seen a marked increase in published research in recent years, with concomitant proliferation of lay sport safety resources, such as policies, fact sheets and posters. The aim of this study was to catalogue and categorise the number, type and topic focus of sport safety resources from a representative set of key organisations. Cataloguing and qualitative document analysis of resources available from the websites of six stakeholder organisations in Australia. This study was part of a larger investigation, the National Guidance for Australian Football Partnerships and Safety (NoGAPS) project. The NoGAPS study provided the context for a purposive sampling of six organisations involved in the promotion of safety in Australian football. These partners are recognised as being highly representative of organisations at national and state level that reflect similarly in their goals around sport safety promotion in Australia. The catalogue comprised 284 resources. More of the practical and less prescriptive types of resources, such as fact sheets, than formal policies were found. Resources for the prevention of physical injuries were the predominant sport safety issue addressed, with risk management, environmental issues and social behaviours comprising other categories. Duplication of resources for specific safety issues, within and across organisations, was found. People working within sport settings have access to a proliferation of resources, which creates a potential rivalry for sourcing of injury prevention information. Important issues that are likely to influence the uptake of safety advice by the general sporting public include the sheer number of resources available, and the overlap and duplication of resources addressing the same issues. The existence of a large number of resources from reputable organisations does not mean that they are necessarily evidence based, fully up to date or even effective in supporting sport

Analysis of factors influencing safety management for metro construction in China.

PubMed

Yu, Q Z; Ding, L Y; Zhou, C; Luo, H B

2014-07-01

With the rapid development of urbanization in China, the number and size of metro construction projects are increasing quickly. At the same time, and increasing number of accidents in metro construction make it a disturbing focus of social attention. In order to improve safety management in metro construction, an investigation of the participants' perspectives on safety factors in China metro construction has been conducted to identify the key safety factors, and their ranking consistency among the main participants, including clients, consultants, designers, contractors and supervisors. The result of factor analysis indicates that there are five key factors which influence the safety of metro construction including safety attitude, construction site safety, government supervision, market restrictions and task unpredictability. In addition, ANOVA and Spearman rank correlation coefficients were performed to test the consistency of the means rating and the ranking of safety factors. The results indicated that the main participants have significant disagreement about the importance of safety factors on more than half of the items. Suggestions and recommendations on practical countermeasures to improve metro construction safety management in China are proposed. Copyright © 2013 Elsevier Ltd. All rights reserved.

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.

Initial empirical analysis of nuclear power plant organization and its effect on safety performance

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

Olson, J.; McLaughlin, S.D.; Osborn, R.N.

This report contains an analysis of the relationship between selected aspects of organizational structure and the safety-related performance of nuclear power plants. The report starts by identifying and operationalizing certain key dimensions of organizational structure that may be expected to be related to plant safety performance. Next, indicators of plant safety performance are created by combining existing performance measures into more reliable indicators. Finally, the indicators of plant safety performance using correlational and discriminant analysis. The overall results show that plants with better developed coordination mechanisms, shorter vertical hierarchies, and a greater number of departments tend to perform more safely.

Analysis of safety impacts of access management alternatives using the surrogate safety assessment model : final report.

DOT National Transportation Integrated Search

2017-06-01

The purpose of this study was to evaluate if the Surrogate Safety Assessment Model (SSAM) could be used to assess the safety of a highway segment or an intersection in terms of the number and type of conflicts and to compare the safety effects of mul...

Data collection and analysis for local roadway safety assessment.

DOT National Transportation Integrated Search

2014-11-01

The project Data Analysis for Local Roadway : Assessment conducted systematic road-safety : assessment and identified major risks that can be el : iminated or reduced by pr : actical road-improvement : measures. Specifically, the primary task o...

A framework for a cost benefit analysis of the Fairfax County, Virginia Alcohol Safety Action Project.

DOT National Transportation Integrated Search

1973-01-01

Cost-benefit analysis is sometimes a useful tool for evaluating the advantages and disadvantages of alternative courses of action. The first half of this study was an attempt to further the use of such analysis in the evaluation of a highway safety p...

Safety and Convergence Analysis of Intersecting Aircraft Flows Under Decentralized Collision Avoidance

NASA Astrophysics Data System (ADS)

Dallal, Ahmed H.

Safety is an essential requirement for air traffic management and control systems. Aircraft are not allowed to get closer to each other than a specified safety distance, to avoid any conflicts and collisions between aircraft. Forecast analysis predicts a tremendous increase in the number of flights. Subsequently, automated tools are needed to help air traffic controllers resolve air born conflicts. In this dissertation, we consider the problem of conflict resolution of aircraft flows with the assumption that aircraft are flowing through a fixed specified control volume at a constant speed. In this regard, several centralized and decentralized resolution rules have been proposed for path planning and conflict avoidance. For the case of two intersecting flows, we introduce the concept of conflict touches, and a collaborative decentralized conflict resolution rule is then proposed and analyzed for two intersecting flows. The proposed rule is also able to resolved airborne conflicts that resulted from resolving another conflict via the domino effect. We study the safety conditions under the proposed conflict resolution and collision avoidance rule. Then, we use Lyapunov analysis to analytically prove the convergence of conflict resolution dynamics under the proposed rule. The analysis show that, under the proposed conflict resolution rule, the system of intersecting aircraft flows is guaranteed to converge to safe, conflict free, trajectories within a bounded time. Simulations are provided to verify the analytically derived conclusions and study the convergence of the conflict resolution dynamics at different encounter angles. Simulation results show that lateral deviations taken by aircraft in each flow, to resolve conflicts, are bounded, and aircraft converged to safe and conflict free trajectories, within a finite time.

Efficacy and Safety of Oral Beclomethasone Dipropionate in Ulcerative Colitis: A Systematic Review and Meta-Analysis.

PubMed

Manguso, Francesco; Bennato, Raffaele; Lombardi, Giovanni; Riccio, Elisabetta; Costantino, Giuseppe; Fries, Walter

2016-01-01

We performed a systematic review and meta-analysis of all the available evidence comparing efficacy and safety of oral prolonged released beclomethasone dipropionate (BDP) to active oral controls in patients with mild-to-moderate ulcerative colitis (UC). A subgroup-analysis compared the effectiveness of BDP and 5-ASA. Literature research was performed in different databases, as well as manual search to identify abstracts from international meetings with data not included in extensive publications. Experts in the field and companies involved in BDP development and manufacture were contacted to identify unpublished studies used for registration purposes. Dichotomous data were pooled to obtain odds ratio meta-analysis. Five randomized controlled trials that compared oral BDP 5mg/day vs. all oral active controls in treating UC were identified as eligible. Efficacy and safety have been addressed after 4-week treatment period. One study evaluated efficacy and safety of BDP vs. prednisone and 4 of BDP vs. 5-ASA. Treatment with oral BDP 5 mg/day induces a significant better clinical response compared to oral 5-ASA (OR 1.86, 95% CI = 1.23-2.82, P = 0.003). The effect is detectable even when the comparison to prednisone is added (OR 1.41, 95% CI = 1.03-1.93, P = 0.03). Data on remission indicate that the potential clinical efficacy of BDP may be better than 5-ASA (OR 1.55, 95% CI = 1.00-2.40, P = 0.05). This difference is lost when the comparison with prednisone is added (OR 1.30, 95% CI = 0.76-2.23, P = 0.34). The safety analysis showed no differences between BDP and 5-ASA (OR 0.55, 95% CI = 0.24-1.27, P = 0.16). The lack of difference is maintained even when the study with prednisone is added (OR 0.67, 95% CI = 0.44-1.01, P = 0.06). However, the trend of difference is clear and indicates a more favourable safety profile of BDP compared to 5-ASA and PD. Oral prolonged release BDP showed a superior efficacy vs. oral 5-ASA in inducing clinical improvement of mild

Efficacy and Safety of Oral Beclomethasone Dipropionate in Ulcerative Colitis: A Systematic Review and Meta-Analysis

PubMed Central

Bennato, Raffaele; Lombardi, Giovanni; Riccio, Elisabetta; Costantino, Giuseppe; Fries, Walter

2016-01-01

Background and Aim We performed a systematic review and meta-analysis of all the available evidence comparing efficacy and safety of oral prolonged released beclomethasone dipropionate (BDP) to active oral controls in patients with mild-to-moderate ulcerative colitis (UC). A subgroup-analysis compared the effectiveness of BDP and 5-ASA. Methods Literature research was performed in different databases, as well as manual search to identify abstracts from international meetings with data not included in extensive publications. Experts in the field and companies involved in BDP development and manufacture were contacted to identify unpublished studies used for registration purposes. Dichotomous data were pooled to obtain odds ratio meta-analysis. Results Five randomized controlled trials that compared oral BDP 5mg/day vs. all oral active controls in treating UC were identified as eligible. Efficacy and safety have been addressed after 4-week treatment period. One study evaluated efficacy and safety of BDP vs. prednisone and 4 of BDP vs. 5-ASA. Treatment with oral BDP 5 mg/day induces a significant better clinical response compared to oral 5-ASA (OR 1.86, 95% CI = 1.23–2.82, P = 0.003). The effect is detectable even when the comparison to prednisone is added (OR 1.41, 95% CI = 1.03–1.93, P = 0.03). Data on remission indicate that the potential clinical efficacy of BDP may be better than 5-ASA (OR 1.55, 95% CI = 1.00–2.40, P = 0.05). This difference is lost when the comparison with prednisone is added (OR 1.30, 95% CI = 0.76–2.23, P = 0.34). The safety analysis showed no differences between BDP and 5-ASA (OR 0.55, 95% CI = 0.24–1.27, P = 0.16). The lack of difference is maintained even when the study with prednisone is added (OR 0.67, 95% CI = 0.44–1.01, P = 0.06). However, the trend of difference is clear and indicates a more favourable safety profile of BDP compared to 5-ASA and PD. Conclusions Oral prolonged release BDP showed a superior efficacy vs. oral

System safety education focused on flight safety

NASA Technical Reports Server (NTRS)

Holt, E.

1971-01-01

The measures necessary for achieving higher levels of system safety are analyzed with an eye toward maintaining the combat capability of the Air Force. Several education courses were provided for personnel involved in safety management. Data include: (1) Flight Safety Officer Course, (2) Advanced Safety Program Management, (3) Fundamentals of System Safety, and (4) Quantitative Methods of Safety Analysis.

[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.

An integrated analysis of liver safety data from orlistat clinical trials.

PubMed

Morris, Marc; Lane, Peter; Lee, Kwan; Parks, Daniel

2012-01-01

Orlistat is an oral gastrointestinal lipase inhibitor and is indicated for treatment of obesity in combination with a hypocaloric diet. Post-marketing reports of adverse reactions revealed hints for possible drug-induced liver injury which has prompted changes to the product information. Orlistat's development program, involving over 30,000 patients, did not indicate a hepatic safety issue. We analyzed liver function test data from randomized clinical trials of orlistat, using i) meta-analysis of published study safety data, ii) time-to-event analysis for individual patients, and iii) a novel and more sensitive method derived from the U.S. Food and Drug Administration's (FDA) evaluation of drug-induced serious hepatotoxicity (eDISH) technique. Over 10,000 subjects were included. The combined odds ratio from a simple summary-level fixed-effects meta-analysis of treatment-emergent abnormalities in serum alanine aminotransferase (ALT) (defined as greater than the upper level of normal for 2 successive measurements) was 1.09 (95% CI 0.93-1.28), and in total bilirubin 1.24 (95% CI 1.03-1.49). Part of the small apparent effect was due to longer exposure to orlistat than to placebo, on average. A patient-level display, adjusting for regression towards the mean, and Kaplan-Meier analysis of changes in ALT and bilirubin, taking account of different exposure, showed no significant difference between orlistat and placebo. This shows that there is no signal for hepatic damage in clinical studies of orlistat. While idiosyncratic liver injury following exposure to orlistat cannot be excluded, it is likely to be extremely rare.

[Social network analysis: a method to improve safety in healthcare organizations].

PubMed

Marqués Sánchez, Pilar; González Pérez, Marta Eva; Agra Varela, Yolanda; Vega Núñez, Jorge; Pinto Carral, Arrate; Quiroga Sánchez, Enedina

2013-01-01

Patient safety depends on the culture of the healthcare organization involving relationships between professionals. This article proposes that the study of these relations should be conducted from a network perspective and using a methodology called Social Network Analysis (SNA). This methodology includes a set of mathematical constructs grounded in Graph Theory. With the SNA we can know aspects of the individual's position in the network (centrality) or cohesion among team members. Thus, the SNA allows to know aspects related to security such as the kind of links that can increase commitment among professionals, how to build those links, which nodes have more prestige in the team in generating confidence or collaborative network, which professionals serve as intermediaries between the subgroups of a team to transmit information or smooth conflicts, etc. Useful aspects in stablishing a safety culture. The SNA would analyze the relations among professionals, their level of communication to communicate errors and spontaneously seek help and coordination between departments to participate in projects that enhance safety. Thus, they related through a network, using the same language, a fact that helps to build a culture. In summary, we propose an approach to safety culture from a SNA perspective that would complement other commonly used methods.

Analysis respons to the implementation of nuclear installations safety culture using AHP-TOPSIS

NASA Astrophysics Data System (ADS)

Situmorang, J.; Kuntoro, I.; Santoso, S.; Subekti, M.; Sunaryo, G. R.

2018-02-01

An analysis of responses to the implementation of nuclear installations safety culture has been done using AHP (Analitic Hierarchy Process) - TOPSIS (Technique for Order of Preference by Similarity to Ideal Solution). Safety culture is considered as collective commitments of the decision-making level, management level, and individual level. Thus each level will provide a subjective perspective as an alternative approach to implementation. Furthermore safety culture is considered by the statement of five characteristics which in more detail form consist of 37 attributes, and therefore can be expressed as multi-attribute state. Those characteristics and or attributes will be a criterion and its value is difficult to determine. Those criteria of course, will determine and strongly influence the implementation of the corresponding safety culture. To determine the pattern and magnitude of the influence is done by using a TOPSIS that is based on decision matrix approach and is composed of alternatives and criteria. The weight of each criterion is determined by AHP technique. The data used are data collected through questionnaires at the workshop on safety and health in 2015. .Reliability test of data gives Cronbah Alpha value of 95.5% which according to the criteria is stated reliable. Validity test using bivariate correlation analysis technique between each attribute give Pearson correlation for all attribute is significant at level 0,01. Using confirmatory factor analysis gives Kaise-Meyer-Olkin of sampling Adequacy (KMO) is 0.719 and it is greater than the acceptance criterion 0.5 as well as the 0.000 significance level much smaller than 0.05 and stated that further analysis could be performed. As a result of the analysis it is found that responses from the level of decision maker (second echelon) dominate the best order preference rank to be the best solution in strengthening the nuclear installation safety culture, except for the first characteristics, safety is a

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

PubMed

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

2010-10-01

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

Patient Safety Culture Survey in Pediatric Complex Care Settings: A Factor Analysis.

PubMed

Hessels, Amanda J; Murray, Meghan; Cohen, Bevin; Larson, Elaine L

2017-04-19

Children with complex medical needs are increasing in number and demanding the services of pediatric long-term care facilities (pLTC), which require a focus on patient safety culture (PSC). However, no tool to measure PSC has been tested in this unique hybrid acute care-residential setting. The objective of this study was to evaluate the psychometric properties of the Nursing Home Survey on Patient Safety Culture tool slightly modified for use in the pLTC setting. Factor analyses were performed on data collected from 239 staff at 3 pLTC in 2012. Items were screened by principal axis factoring, and the original structure was tested using confirmatory factor analysis. Exploratory factor analysis was conducted to identify the best model fit for the pLTC data, and factor reliability was assessed by Cronbach alpha. The extracted, rotated factor solution suggested items in 4 (staffing, nonpunitive response to mistakes, communication openness, and organizational learning) of the original 12 dimensions may not be a good fit for this population. Nevertheless, in the pLTC setting, both the original and the modified factor solutions demonstrated similar reliabilities to the published consistencies of the survey when tested in adult nursing homes and the items factored nearly identically as theorized. This study demonstrates that the Nursing Home Survey on Patient Safety Culture with minimal modification may be an appropriate instrument to measure PSC in pLTC settings. Additional psychometric testing is recommended to further validate the use of this instrument in this setting, including examining the relationship to safety outcomes. Increased use will yield data for benchmarking purposes across these specialized settings to inform frontline workers and organizational leaders of areas of strength and opportunity for improvement.

Shielding calculation and criticality safety analysis of spent fuel transportation cask in research reactors.

PubMed

Mohammadi, A; Hassanzadeh, M; Gharib, M

2016-02-01

In this study, shielding calculation and criticality safety analysis were carried out for general material testing reactor (MTR) research reactors interim storage and relevant transportation cask. During these processes, three major terms were considered: source term, shielding, and criticality calculations. The Monte Carlo transport code MCNP5 was used for shielding calculation and criticality safety analysis and ORIGEN2.1 code for source term calculation. According to the results obtained, a cylindrical cask with body, top, and bottom thicknesses of 18, 13, and 13 cm, respectively, was accepted as the dual-purpose cask. Furthermore, it is shown that the total dose rates are below the normal transport criteria that meet the standards specified. Copyright © 2015 Elsevier Ltd. All rights reserved.

Integration of Active and Passive Safety Technologies--A Method to Study and Estimate Field Capability.

PubMed

Hu, Jingwen; Flannagan, Carol A; Bao, Shan; McCoy, Robert W; Siasoco, Kevin M; Barbat, Saeed

2015-11-01

The objective of this study is to develop a method that uses a combination of field data analysis, naturalistic driving data analysis, and computational simulations to explore the potential injury reduction capabilities of integrating passive and active safety systems in frontal impact conditions. For the purposes of this study, the active safety system is actually a driver assist (DA) feature that has the potential to reduce delta-V prior to a crash, in frontal or other crash scenarios. A field data analysis was first conducted to estimate the delta-V distribution change based on an assumption of 20% crash avoidance resulting from a pre-crash braking DA feature. Analysis of changes in driver head location during 470 hard braking events in a naturalistic driving study found that drivers' head positions were mostly in the center position before the braking onset, while the percentage of time drivers leaning forward or backward increased significantly after the braking onset. Parametric studies with a total of 4800 MADYMO simulations showed that both delta-V and occupant pre-crash posture had pronounced effects on occupant injury risks and on the optimal restraint designs. By combining the results for the delta-V and head position distribution changes, a weighted average of injury risk reduction of 17% and 48% was predicted by the 50th percentile Anthropomorphic Test Device (ATD) model and human body model, respectively, with the assumption that the restraint system can adapt to the specific delta-V and pre-crash posture. This study demonstrated the potential for further reducing occupant injury risk in frontal crashes by the integration of a passive safety system with a DA feature. Future analyses considering more vehicle models, various crash conditions, and variations of occupant characteristics, such as age, gender, weight, and height, are necessary to further investigate the potential capability of integrating passive and DA or active safety systems.

Multilevel model of safety climate for furniture industries.

PubMed

Rodrigues, Matilde A; Arezes, Pedro M; Leão, Celina P

2015-01-01

Furniture companies can analyze their safety status using quantitative measures. However, the data needed are not always available and the number of accidents is under-reported. Safety climate scales may be an alternative. However, there are no validated Portuguese scales that account for the specific attributes of the furniture sector. The current study aims to develop and validate an instrument that uses a multilevel structure to measure the safety climate of the Portuguese furniture industry. The Safety Climate in Wood Industries (SCWI) model was developed and applied to the safety climate analysis using three different scales: organizational, group and individual. A multilevel exploratory factor analysis was performed to analyze the factorial structure. The studied companies' safety conditions were also analyzed. Different factorial structures were found between and within levels. In general, the results show the presence of a group-level safety climate. The scores of safety climates are directly and positively related to companies' safety conditions; the organizational scale is the one that best reflects the actual safety conditions. The SCWI instrument allows for the identification of different safety climates in groups that comprise the same furniture company and it seems to reflect those groups' safety conditions. The study also demonstrates the need for a multilevel analysis of the studied instrument.

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.

Meta-analysis of pemetrexed plus carboplatin doublet safety profile in first-line non-squamous non-small cell lung cancer studies.

PubMed

Okamoto, Isamu; Schuette, Wolfgang H W; Stinchcombe, Thomas E; Rodrigues-Pereira, José; San Antonio, Belén; Chen, Jian; Liu, Jingyi; John, William J; Zinner, Ralph G

2017-05-01

This meta-analysis compared safety profiles (selected drug-related treatment-emergent adverse events [TEAEs]) of first-line pemetrexed plus carboplatin (PCb) area under the concentration-time curve 5 mg/min•mL (PCb5) or 6 mg/min•mL (PCb6), two widely used regimens in clinical practice for advanced non-squamous non-small cell lung cancer. All patients received pemetrexed 500 mg/m 2 every 21 days with either of two carboplatin doses for up to 4-6 cycles. Safety profiles of PCb doses were compared using three statistical analysis methods: frequency table analysis (FTA), generalized linear mixed effect model (GLMM), and the propensity score method. Efficacy outcomes of PCb5 and PCb6 regimens were summarized. A total of 486 patients mainly from the US, Europe, and East Asia were included in the analysis; 22% (n = 105) received PCb5 in one trial and 78% (n = 381) received PCb6 in four trials. The FTA comparison demonstrated that PCb5 vs PCb6 was associated with a statistically significantly lower incidence of TEAEs, including all-grade thrombocytopenia, anemia, fatigue, and vomiting, and grade 3/4 thrombocytopenia. In the GLMM analysis, PCb5 patients were numerically less likely to experience all-grade and grade 3/4 neutropenia, anemia, and thrombocytopenia. The propensity score regression analysis showed PCb5 group patients were significantly less likely than PCb6 group patients to experience all-grade hematologic TEAEs and grade 3/4 thrombocytopenia and anemia. After applying propensity score 1:1 matching, FTA analysis showed that the PCb5 group had significantly less all-grade and grade 3/4 hematologic toxicities. Overall efficacy outcomes, including overall survival, progression-free survival, and response rate, were similar between the two carboplatin doses. Acknowledging the limitations of this meta-analysis of five trials, heterogeneous in patient's characteristics and trial designs, the results show that the PCb5 regimen was generally associated

Safety analysis, 200 Area, Savannah River Plant: Separations area operations

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

Perkins, W.C.; Lee, R.; Allen, P.M.

1991-07-01

The nev HB-Line, located on the fifth and sixth levels of Building 221-H, is designed to replace the aging existing HB-Line production facility. The nev HB-Line consists of three separate facilities: the Scrap Recovery Facility, the Neptunium Oxide Facility, and the Plutonium Oxide Facility. There are three separate safety analyses for the nev HB-Line, one for each of the three facilities. These are issued as supplements to the 200-Area Safety Analysis (DPSTSA-200-10). These supplements are numbered as Sup 2A, Scrap Recovery Facility, Sup 2B, Neptunium Oxide Facility, Sup 2C, Plutonium Oxide Facility. The subject of this safety analysis, the, Plutoniummore » Oxide Facility, will convert nitrate solutions of {sup 238}Pu to plutonium oxide (PuO{sub 2}) powder. All these new facilities incorporate improvements in: (1) engineered barriers to contain contamination, (2) barriers to minimize personnel exposure to airborne contamination, (3) shielding and remote operations to decrease radiation exposure, and (4) equipment and ventilation design to provide flexibility and improved process performance.« less

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.

Development of the FHR advanced natural circulation analysis code and application to FHR safety analysis

DOE PAGES

Guo, Z.; Zweibaum, N.; Shao, M.; ...

2016-04-19

The University of California, Berkeley (UCB) is performing thermal hydraulics safety analysis to develop the technical basis for design and licensing of fluoride-salt-cooled, high-temperature reactors (FHRs). FHR designs investigated by UCB use natural circulation for emergency, passive decay heat removal when normal decay heat removal systems fail. The FHR advanced natural circulation analysis (FANCY) code has been developed for assessment of passive decay heat removal capability and safety analysis of these innovative system designs. The FANCY code uses a one-dimensional, semi-implicit scheme to solve for pressure-linked mass, momentum and energy conservation equations. Graph theory is used to automatically generate amore » staggered mesh for complicated pipe network systems. Heat structure models have been implemented for three types of boundary conditions (Dirichlet, Neumann and Robin boundary conditions). Heat structures can be composed of several layers of different materials, and are used for simulation of heat structure temperature distribution and heat transfer rate. Control models are used to simulate sequences of events or trips of safety systems. A proportional-integral controller is also used to automatically make thermal hydraulic systems reach desired steady state conditions. A point kinetics model is used to model reactor kinetics behavior with temperature reactivity feedback. The underlying large sparse linear systems in these models are efficiently solved by using direct and iterative solvers provided by the SuperLU code on high performance machines. Input interfaces are designed to increase the flexibility of simulation for complicated thermal hydraulic systems. In conclusion, this paper mainly focuses on the methodology used to develop the FANCY code, and safety analysis of the Mark 1 pebble-bed FHR under development at UCB is performed.« less

Multi-sectoral action for child safety-a European study exploring implicated sectors.

PubMed

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

2017-06-01

Injury to children in Europe, resulting in both death and disability, constitutes a significant burden on individuals, families and society. Inequalities between high and low-income countries are growing. The World Health Organisation Health 2020 strategy calls for inter-sectoral collaboration to address injury in Europe and advocates the whole of government and whole of society approaches to wicked problems. In this study we explore which sectors (e.g. health, transport, education) are relevant for four domains of child safety (intentional injury, water, road and home safety). We used the organigraph methodology, originally developed to demonstrate how organizations work, to describe the governance of child safety interventions. Members of the European Child Safety Alliance, working in the field of child safety in 24 European countries, drew organigraphs of evidence-based interventions. They included the different actors involved and the processes between them. We analyzed the organigraphs by counting the actors presented and categorizing them into sectors using a pre-defined analysis framework. We received 44 organigraphs from participants in 24 countries. Twenty-seven sectors were identified across the four domains. Nine of the 27 identified sectors were classified as 'core sectors' (education, health, home affairs, justice, media, recreation, research, social/welfare services and consumers). This study reveals the multi-sectoral nature of child safety in practice. It provides information for stakeholders working in child safety to help them implement inter-sectoral child safety interventions taking a whole-of-government and whole-of-society approach to health governance. © The Author 2017. Published by Oxford University Press on behalf of the European Public Health Association. All rights reserved.

Safety analysts training

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

Bolton, P.

The purpose of this task was to support ESH-3 in providing Airborne Release Fraction and Respirable Fraction training to safety analysts at LANL who perform accident analysis, hazard analysis, safety analysis, and/or risk assessments at nuclear facilities. The task included preparation of materials for and the conduct of two 3-day training courses covering the following topics: safety analysis process; calculation model; aerosol physic concepts for safety analysis; and overview of empirically derived airborne release fractions and respirable fractions.

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

PubMed

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

2018-03-01

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

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.

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

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

PubMed

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

2016-02-15

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

Advanced missions safety. Volume 2: Technical discussion, Part 2: Experiment safety, guidelines

NASA Technical Reports Server (NTRS)

Hinton, M. G., Jr.

1972-01-01

A technical analysis of a portion of the advanced missions safety study is presented. The potential hazards introduced when experimental equipment is carried aboard the Earth Orbit Shuttle are identified. Safety guidelines and requirements for eliminating or reducing these hazards are recommended.

In-space propellant systems safety. Volume 3: System safety analysis

NASA Technical Reports Server (NTRS)

1972-01-01

The primary objective was to examine from a system safety viewpoint in-space propellant logistic elements and operations to define the potential hazards and to recommend means to reduce, eliminate or control them. A secondary objective was to conduct trade studies of specific systems or operations to determine the safest of alternate approaches.

The roles and functions of safety professionals in Taiwan: Comparing the perceptions of safety professionals and safety educators.

PubMed

Wu, Tsung-Chih

2011-10-01

The perspectives of both internal and external members have to be considered when developing safety curricula. This study discusses perceptional differences between safety educators (SEs) and safety professionals (SPs) regarding the function of SPs. The findings will serve as a reference framework for the establishment of core safety competencies and the development of safety curricula for SPs. 248 respondents, including both SEs and SPs, completed self-administered questionnaires, which included the 45-item safety function scale (SFS). Nine factors were extracted from the scale using exploratory factor analysis (EFA), namely inspection and research, regulatory tasks, emergency procedures and settlement of damage, management and financial affairs, culture change, problem identification and analysis, developing and implementing solutions, knowledge management, and training and communications. Descriptive statistical results indicated that SPs and SEs hold differing views on the rank of the frequency of safety functions. MANOVA results indicated that SPs' perceptions of developing and implementing solutions, training and communications, inspection and research, and management and financial affairs were significantly higher than that of SEs. On the other hand, SE's perceptions regarding participation in regulatory tasks were significantly higher than those of SPs. Based on these results, the author suggests that a clear communication channel should be established between universities and industry to reduce the gap between the perceptions of SEs and SPs. The results of the study are statistically and practically significant. In addition to serving as a reference for the development of safety curricula, the results are also conducive to the establishment of SP roles and functions. Ultimately the development of more suitable safety curricula would open up employment competition for students who graduate from safety-related programs. SPs, on the other hand, can correctly

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.

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.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-12

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-26

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

Analysis of Aviation Safety Reporting System Incident Data Associated With the Technical Challenges of the Vehicle Systems Safety Technology Project

NASA Technical Reports Server (NTRS)

Withrow, Colleen A.; Reveley, Mary S.

2014-01-01

This analysis was conducted to support the Vehicle Systems Safety Technology (VSST) Project of the Aviation Safety Program (AVsP) milestone VSST4.2.1.01, "Identification of VSST-Related Trends." In particular, this is a review of incident data from the NASA Aviation Safety Reporting System (ASRS). The following three VSST-related technical challenges (TCs) were the focus of the incidents searched in the ASRS database: (1) Vechicle health assurance, (2) Effective crew-system interactions and decisions in all conditions; and (3) Aircraft loss of control prevention, mitigation, and recovery.

76 FR 31507 - Domestic Licensing of Source Material-Amendments/Integrated Safety Analysis

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-01

... Licensing of Source Material--Amendments/Integrated Safety Analysis AGENCY: Nuclear Regulatory Commission... rule announced the availability of a draft regulatory analysis for public comment. This document... in Section XI, ``Regulatory Analysis.'' The correct ADAMS accession number is ML102380243. DATES: The...

Safety climate and attitude as evaluation measures of organizational safety.

PubMed

Isla Díaz, R; Díaz Cabrera, D

1997-09-01

The main aim of this research is to develop a set of evaluation measures for safety attitudes and safety climate. Specifically it is intended: (a) to test the instruments; (b) to identify the essential dimensions of the safety climate in the airport ground handling companies; (c) to assess the quality of the differences in the safety climate for each company and its relation to the accident rate; (d) to analyse the relationship between attitudes and safety climate; and (e) to evaluate the influences of situational and personal factors on both safety climate and attitude. The study sample consisted of 166 subjects from three airport companies. Specifically, this research was centered on ground handling departments. The factor analysis of the safety climate instrument resulted in six factors which explained 69.8% of the total variance. We found significant differences in safety attitudes and climate in relation to type of enterprise.

Worker safety and injury severity analysis of earthmoving equipment accidents.

PubMed

Kazan, Emrah; Usmen, Mumtaz A

2018-06-01

Research on construction worker safety associated with construction equipment has mostly focused on accident type rather than injury severity and the embedded factor relationships. Significant variables and their effects on the degree of injury are examined for earthmoving equipment using data from OSHA. Four types of equipment, backhoe, bulldozer, excavator, and scraper are included in the study. Accidents involving on-foot workers and equipment operators are investigated collectively, as well as separately. Cross tabulation analysis was conducted to establish the associations between selected categorical variables, using degree of injury as a dichotomous dependent variable (fatal vs. nonfatal) and a number of independent variables having different values. Odds ratios were calculated to determine how much a certain variable/factor increases the odds of fatality in an accident, and the odds ratios were ranked to determine the relative impact of a given factor. It was found that twelve variables were significantly associated with injury severity. Rankings based on odds ratios showed that inadequate safety training (2.54), missing equipment protective system (2.38), being a non-union worker (2.26), being an equipment operator (1.93), and being on or around inadequately maintained equipment (1.58) produced higher odds for fatality. A majority of the earthmoving equipment accidents resulted in fatality. Backhoes were the most common equipment involved in accidents and fatalities. Struck-by accidents were the most prevalent and most fatal. Non-OSHA compliant safety training, missing seatbelt, operator not using seatbelt, malfunctioning back-up alarms, and poorly maintained equipment were factors contributing to accidents and fatalities. On-foot workers experienced a higher number of accidents than operators, while fatality odds were higher for the operators. Practical applications: Safety professionals should benefit from our findings in planning and delivering training

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

PubMed

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

2017-12-01

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

Reactor Safety Gap Evaluation of Accident Tolerant Components and Severe Accident Analysis

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

Farmer, Mitchell T.; Bunt, R.; Corradini, M.

The overall objective of this study was to conduct a technology gap evaluation on accident tolerant components and severe accident analysis methodologies with the goal of identifying any data and/or knowledge gaps that may exist, given the current state of light water reactor (LWR) severe accident research, and additionally augmented by insights obtained from the Fukushima accident. The ultimate benefit of this activity is that the results can be used to refine the Department of Energy’s (DOE) Reactor Safety Technology (RST) research and development (R&D) program plan to address key knowledge gaps in severe accident phenomena and analyses that affectmore » reactor safety and that are not currently being addressed by the industry or the Nuclear Regulatory Commission (NRC).« less

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

PubMed

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

2017-03-04

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

75 FR 74022 - Safety Analysis Requirements for Defining Adequate Protection for the Public and the Workers

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-30

... DEFENSE NUCLEAR FACILITIES SAFETY BOARD [Recommendation 2010-1] Safety Analysis Requirements for Defining Adequate Protection for the Public and the Workers AGENCY: Defense Nuclear Facilities Safety Board... Nuclear Facilities Safety Board has made a recommendation to the Secretary of Energy requesting an...

Putting the ‘patient’ in patient safety: a qualitative study of consumer experiences

PubMed Central

Rathert, Cheryl; Brandt, Julie; Williams, Eric S.

2011-01-01

Abstract Background  Although patient safety has been studied extensively, little research has directly examined patient and family (consumer) perceptions. Evidence suggests that clinicians define safety differently from consumers, e.g. clinicians focus more on outcomes, whereas consumers may focus more on processes. Consumer perceptions of patient safety are important for several reasons. First, health‐care policy leaders have been encouraging patients and families to take a proactive role in ensuring patient safety; therefore, an understanding of how patients define safety is needed. Second, consumer perceptions of safety could influence outcomes such as trust and satisfaction or compliance with treatment protocols. Finally, consumer perspectives could be an additional lens for viewing complex systems and processes for quality improvement efforts. Objectives  To qualitatively explore acute care consumer perceptions of patient safety. Design and methods  Thirty‐nine individuals with a recent overnight hospital visit participated in one of four group interviews. Analysis followed an interpretive analytical approach. Results  Three basic themes were identified: Communication, staffing issues and medication administration. Consumers associated care process problems, such as delays or lack of information, with safety rather than as service quality problems. Participants agreed that patients need family caregivers as advocates. Conclusions  Consumers seem acutely aware of care processes they believe pose risks to safety. Perceptual measures of patient safety and quality may help to identify areas where there are higher risks of preventable adverse events. PMID:21624026

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.

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

ERIC Educational Resources Information Center

Berry, Dennis W.

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

Analysis of event data recorder data for vehicle safety improvement

DOT National Transportation Integrated Search

2008-04-01

The Volpe Center performed a comprehensive engineering analysis of Event Data Recorder (EDR) data supplied by the National Highway Traffic Safety Administration (NHTSA) to assess its accuracy and usefulness in crash reconstruction and improvement of ...

75 FR 69648 - Safety Analysis Requirements for Defining Adequate Protection for the Public and the Workers

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-15

... DEFENSE NUCLEAR FACILITIES SAFETY BOARD [Recommendation 2010-1] Safety Analysis Requirements for Defining Adequate Protection for the Public and the Workers AGENCY: Defense Nuclear Facilities Safety Board... Facilities Safety Board has made a recommendation to the Secretary of Energy requesting an amendment to the...

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

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

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

2006-05-18

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

Safety analysis report for the SR-101 inert reservoir package

DOT National Transportation Integrated Search

1998-11-01

Department of Energy (DOE) AL Weapons Surety Division (WSD) requires the SR-101 Inert Reservoir Package to : meet applicable hazardous material transportation requirements. This Safety Analysis Report (SAR) is based on : requirements in place at the ...

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

PubMed

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

2015-01-01

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

Analysis of School Food Safety Programs Based on HACCP Principles

ERIC Educational Resources Information Center

Roberts, Kevin R.; Sauer, Kevin; Sneed, Jeannie; Kwon, Junehee; Olds, David; Cole, Kerri; Shanklin, Carol

2014-01-01

Purpose/Objectives: The purpose of this study was to determine how school districts have implemented food safety programs based on HACCP principles. Specific objectives included: (1) Evaluate how schools are implementing components of food safety programs; and (2) Determine foodservice employees food-handling practices related to food safety.…

Efficacy and safety of the adjustable gastric band - pooled interim analysis of the APEX and HERO studies at 48 weeks.

PubMed

Ponce, Jaime; Taheri, Shahrad; Lusco, Vincent; Cornell, Christopher; Ng-Mak, Daisy S; Shi, Rui; Okerson, Ted

2014-05-01

This 48 week combined analysis reports safety and clinical effectiveness of the LAP-BAND AP * laparoscopic adjustable gastric band (LAGB) in severely obese patients enrolled in the 5 year, prospective, observational, open-label APEX (NCT00501085) and HERO (NCT00953173) studies. The studies enrolled 1620 patients (APEX: N = 514; HERO: N = 1106), 1140 patients in the US (including all APEX patients), and 480 patients in the European Union (EU), Canada or Australia. APEX and HERO are non-randomized, non-comparator, open-label studies with differences in study management practices and follow-up. Notably, laboratory data were not collected during the APEX study. After 48 weeks, mean (SD) percentage weight loss (%WL) was for APEX: 18.7% (7.9); HERO-US: 17.9% (8.5); HERO-EU: 16.5% (10.3); HERO-Canada: 13.4% (8.9); and HERO-Australia: 12.3% (6.9). After 48 weeks, there were no significant differences in %WL for APEX vs. HERO-US. After 48 weeks in the combined analysis (APEX + HERO): (1) patients without vs. with type 2 diabetes at baseline had greater %WL (18% [8.7] vs. 16% [8.5], p = 0.002); (2) female patients had greater %WL vs. male patients (17.9% [8.5] vs. 15.9% [9.3], p = 0.003); (3) younger patients had greater %WL vs. older patients (<50 years: 17.8% [8.7] vs. ≥50 years: 16.7% [8.6], p = 0.035); (4) baseline BMI did not affect %WL (≤35 to ≤45 kg/m(2): 17.7% [8.4] vs. >45 kg/m(2): 17.1% [9.1], p = 0.272). Device-related serious adverse events and adverse events were reported in 1.9% and 17.7% of patients, respectively. Revision and explantation surgeries were carried out on 3.4% and 2.3% of patients, respectively during the 48 weeks of follow-up. This analysis demonstrates the effective weight loss and safety profile of the current LAGB system, with US patients achieving better weight loss than patients from outside the US.

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

PubMed

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

2017-06-01

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

49 CFR 209.501 - Review of rail transportation safety and security route analysis.

Code of Federal Regulations, 2010 CFR

2010-10-01

... establish that the route chosen by the carrier poses the least overall safety and security risk, the... analysis, including a clear description of the risks on the selected route that have not been... commercially practicable alternative route poses fewer overall safety and security risks than the route...

41 CFR 102-80.105 - What information must be included in an equivalent level of safety analysis?

Code of Federal Regulations, 2011 CFR

2011-01-01

... of Safety Analysis § 102-80.105 What information must be included in an equivalent level of safety... 41 Public Contracts and Property Management 3 2011-01-01 2011-01-01 false What information must be included in an equivalent level of safety analysis? 102-80.105 Section 102-80.105 Public Contracts and...

41 CFR 102-80.105 - What information must be included in an equivalent level of safety analysis?

Code of Federal Regulations, 2014 CFR

2014-01-01

... of Safety Analysis § 102-80.105 What information must be included in an equivalent level of safety... 41 Public Contracts and Property Management 3 2014-01-01 2014-01-01 false What information must be included in an equivalent level of safety analysis? 102-80.105 Section 102-80.105 Public Contracts and...

41 CFR 102-80.105 - What information must be included in an equivalent level of safety analysis?

Code of Federal Regulations, 2013 CFR

2013-07-01

... of Safety Analysis § 102-80.105 What information must be included in an equivalent level of safety... 41 Public Contracts and Property Management 3 2013-07-01 2013-07-01 false What information must be included in an equivalent level of safety analysis? 102-80.105 Section 102-80.105 Public Contracts and...

41 CFR 102-80.105 - What information must be included in an equivalent level of safety analysis?

Code of Federal Regulations, 2012 CFR

2012-01-01

... of Safety Analysis § 102-80.105 What information must be included in an equivalent level of safety... 41 Public Contracts and Property Management 3 2012-01-01 2012-01-01 false What information must be included in an equivalent level of safety analysis? 102-80.105 Section 102-80.105 Public Contracts and...

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

PubMed

Mascherek, Anna C; Schwappach, David L B

2017-01-01

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

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

PubMed Central

Mascherek, Anna C.

2017-01-01

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

40 CFR 720.90 - Data from health and safety studies.

Code of Federal Regulations, 2011 CFR

2011-07-01

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

40 CFR 720.90 - Data from health and safety studies.

Code of Federal Regulations, 2010 CFR

2010-07-01

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

40 CFR 720.90 - Data from health and safety studies.

Code of Federal Regulations, 2012 CFR

2012-07-01

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

40 CFR 720.90 - Data from health and safety studies.

Code of Federal Regulations, 2014 CFR

2014-07-01

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

Implementation of the Generic Safety Analysis Report - Lessons Learned

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

Blanchard, A.

1999-06-02

The Savannah River Site has completed the development, review and approval process for the Generic Safety Analysis Report (GSAR) and implemented this information in facility SARs and BIOs. This includes the yearly revision of the GSAR and the facility-specific SARs. The process has provided us with several lessons learned.

A Quantitative Analysis of Nursing Students' Perceptions of Patient Safety Competencies

ERIC Educational Resources Information Center

Steighner, Tammy Rose

2017-01-01

The purpose of the study was to determine nursing students' perceptions of patient safety competencies as it related to Quality and Safety Education for Nurses (QSEN) competencies and the Safety Competencies Framework developed by The Canadian Patient Safety Institute. The study determined if nursing students knew how to provide safe patient care…

Analysis of Aviation Safety Reporting System Incident Data Associated with the Technical Challenges of the System-Wide Safety and Assurance Technologies Project

NASA Technical Reports Server (NTRS)

Withrow, Colleen A.; Reveley, Mary S.

2015-01-01

The Aviation Safety Program (AvSP) System-Wide Safety and Assurance Technologies (SSAT) Project asked the AvSP Systems and Portfolio Analysis Team to identify SSAT-related trends. SSAT had four technical challenges: advance safety assurance to enable deployment of NextGen systems; automated discovery of precursors to aviation safety incidents; increasing safety of human-automation interaction by incorporating human performance, and prognostic algorithm design for safety assurance. This report reviews incident data from the NASA Aviation Safety Reporting System (ASRS) for system-component-failure- or-malfunction- (SCFM-) related and human-factor-related incidents for commercial or cargo air carriers (Part 121), commuter airlines (Part 135), and general aviation (Part 91). The data was analyzed by Federal Aviation Regulations (FAR) part, phase of flight, SCFM category, human factor category, and a variety of anomalies and results. There were 38 894 SCFM-related incidents and 83 478 human-factorrelated incidents analyzed between January 1993 and April 2011.

AADL Fault Modeling and Analysis Within an ARP4761 Safety Assessment

DTIC Science & Technology

2014-10-01

Analysis Generator 27 3.2.3 Mapping to OpenFTA Format File 27 3.2.4 Mapping to Generic XML Format 28 3.2.5 AADL and FTA Mapping Rules 28 3.2.6 Issues...PSSA), System Safety Assessment (SSA), Common Cause Analysis (CCA), Fault Tree Analysis ( FTA ), Failure Modes and Effects Analysis (FMEA), Failure...Modes and Effects Summary, Mar - kov Analysis (MA), and Dependence Diagrams (DDs), also referred to as Reliability Block Dia- grams (RBDs). The

Vortex Advisory System Safety Analysis : Volume III, Summary of Laser Data Collection and Analysis

DOT National Transportation Integrated Search

1979-08-01

A Laser-Doppler velocimeter (LDV) was used to monitor the wake vortices shed by 5300 landing aircraft at a point 10,000 feet from the runway threshold. The data were collected to verify the analysis in Volume I of the safety of decreasing interarriva...

[Economic analysis versus the principle of guaranteed safety in blood transfusion].

PubMed

Moatti, J P; Loubière, S; Rotily, M

2000-06-01

This article shows that policies aimed at reducing risks of infectious agents transmissible through blood unfortunately follow a law of 'diminishing returns': increasing marginal costs have to be devoted for limited reductions in the risks of contamination through blood donations. Therefore, the economic cost-effectiveness analysis is appropriate to identify screening strategies which may minimize costs to reach a certain level of safety. Moreover, economic analysis can contribute to public debates about the level of residual risk that society is willing to accept. Empirical results from French studies about screening for hepatitis C virus (HCV) in individuals who have received blood transfusions and in blood donations are presented to illustrate these points.

Analysis of occupational accidents: prevention through the use of additional technical safety measures for machinery.

PubMed

Dźwiarek, Marek; Latała, Agata

2016-01-01

This article presents an analysis of results of 1035 serious and 341 minor accidents recorded by Poland's National Labour Inspectorate (PIP) in 2005-2011, in view of their prevention by means of additional safety measures applied by machinery users. Since the analysis aimed at formulating principles for the application of technical safety measures, the analysed accidents should bear additional attributes: the type of machine operation, technical safety measures and the type of events causing injuries. The analysis proved that the executed tasks and injury-causing events were closely connected and there was a relation between casualty events and technical safety measures. In the case of tasks consisting of manual feeding and collecting materials, the injuries usually occur because of the rotating motion of tools or crushing due to a closing motion. Numerous accidents also happened in the course of supporting actions, like removing pollutants, correcting material position, cleaning, etc.

Safety Study--Crashworthiness of Large Poststandard Schoolbuses.

ERIC Educational Resources Information Center

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

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

A meta-analysis of personality and workplace safety: addressing unanswered questions.

PubMed

Beus, Jeremy M; Dhanani, Lindsay Y; McCord, Mallory A

2015-03-01

[Correction Notice: An Erratum for this article was reported in Vol 100(2) of Journal of Applied Psychology (see record 2015-08139-001). Table 3 contained formatting errors. Minus signs used to indicate negative statistical estimates within the table were inadvertently changed to m-dashes. All versions of this article have been corrected.] The purpose of this meta-analysis was to address unanswered questions regarding the associations between personality and workplace safety by (a) clarifying the magnitude and meaning of these associations with both broad and facet-level personality traits, (b) delineating how personality is associated with workplace safety, and (c) testing the relative importance of personality in comparison to perceptions of the social context of safety (i.e., safety climate) in predicting safety-related behavior. Our results revealed that whereas agreeableness and conscientiousness were negatively associated with unsafe behaviors, extraversion and neuroticism were positively associated with them. Of these traits, agreeableness accounted for the largest proportion of explained variance in safety-related behavior and openness to experience was unrelated. At the facet level, sensation seeking, altruism, anger, and impulsiveness were all meaningfully associated with safety-related behavior, though sensation seeking was the only facet that demonstrated a stronger relationship than its parent trait (i.e., extraversion). In addition, meta-analytic path modeling supported the theoretical expectation that personality's associations with accidents are mediated by safety-related behavior. Finally, although safety climate perceptions accounted for the majority of explained variance in safety-related behavior, personality traits (i.e., agreeableness, conscientiousness, neuroticism) still accounted for a unique and substantive proportion of the explained variance. Taken together, these results substantiate the value of considering personality traits as key

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

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.

ESSAA: Embedded system safety analysis assistant

NASA Technical Reports Server (NTRS)

Wallace, Peter; Holzer, Joseph; Guarro, Sergio; Hyatt, Larry

1987-01-01

The Embedded System Safety Analysis Assistant (ESSAA) is a knowledge-based tool that can assist in identifying disaster scenarios. Imbedded software issues hazardous control commands to the surrounding hardware. ESSAA is intended to work from outputs to inputs, as a complement to simulation and verification methods. Rather than treating the software in isolation, it examines the context in which the software is to be deployed. Given a specified disasterous outcome, ESSAA works from a qualitative, abstract model of the complete system to infer sets of environmental conditions and/or failures that could cause a disasterous outcome. The scenarios can then be examined in depth for plausibility using existing techniques.

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

PubMed

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

2016-01-01

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

Scenario Analysis for the Safety Assessment of Nuclear Waste Repositories: A Critical Review.

PubMed

Tosoni, Edoardo; Salo, Ahti; Zio, Enrico

2018-04-01

A major challenge in scenario analysis for the safety assessment of nuclear waste repositories pertains to the comprehensiveness of the set of scenarios selected for assessing the safety of the repository. Motivated by this challenge, we discuss the aspects of scenario analysis relevant to comprehensiveness. Specifically, we note that (1) it is necessary to make it clear why scenarios usually focus on a restricted set of features, events, and processes; (2) there is not yet consensus on the interpretation of comprehensiveness for guiding the generation of scenarios; and (3) there is a need for sound approaches to the treatment of epistemic uncertainties. © 2017 Society for Risk Analysis.

Safety huddles to proactively identify and address electronic health record safety

PubMed Central

Menon, Shailaja; Singh, Hardeep; Giardina, Traber D; Rayburn, William L; Davis, Brenda P; Russo, Elise M

2017-01-01

Objective: Methods to identify and study safety risks of electronic health records (EHRs) are underdeveloped and largely depend on limited end-user reports. “Safety huddles” have been found useful in creating a sense of collective situational awareness that increases an organization’s capacity to respond to safety concerns. We explored the use of safety huddles for identifying and learning about EHR-related safety concerns. Design: Data were obtained from daily safety huddle briefing notes recorded at a single midsized tertiary-care hospital in the United States over 1 year. Huddles were attended by key administrative, clinical, and information technology staff. We conducted a content analysis of huddle notes to identify what EHR-related safety concerns were discussed. We expanded a previously developed EHR-related error taxonomy to categorize types of EHR-related safety concerns recorded in the notes. Results: On review of daily huddle notes spanning 249 days, we identified 245 EHR-related safety concerns. For our analysis, we defined EHR technology to include a specific EHR functionality, an entire clinical software application, or the hardware system. Most concerns (41.6%) involved “EHR technology working incorrectly,” followed by 25.7% involving “EHR technology not working at all.” Concerns related to “EHR technology missing or absent” accounted for 16.7%, whereas 15.9% were linked to “user errors.” Conclusions: Safety huddles promoted discussion of several technology-related issues at the organization level and can serve as a promising technique to identify and address EHR-related safety concerns. Based on our findings, we recommend that health care organizations consider huddles as a strategy to promote understanding and improvement of EHR safety. PMID:28031286

An Independent Evaluation of the FMEA/CIL Hazard Analysis Alternative Study

NASA Technical Reports Server (NTRS)

Ray, Paul S.

1996-01-01

The present instruments of safety and reliability risk control for a majority of the National Aeronautics and Space Administration (NASA) programs/projects consist of Failure Mode and Effects Analysis (FMEA), Hazard Analysis (HA), Critical Items List (CIL), and Hazard Report (HR). This extensive analytical approach was introduced in the early 1970's and was implemented for the Space Shuttle Program by NHB 5300.4 (1D-2. Since the Challenger accident in 1986, the process has been expanded considerably and resulted in introduction of similar and/or duplicated activities in the safety/reliability risk analysis. A study initiated in 1995, to search for an alternative to the current FMEA/CIL Hazard Analysis methodology generated a proposed method on April 30, 1996. The objective of this Summer Faculty Study was to participate in and conduct an independent evaluation of the proposed alternative to simplify the present safety and reliability risk control procedure.

Prescription safety eyewear: impact studies of lens and frame failure.

PubMed

Vinger, P F; Woods, T A

2000-02-01

To determine if a plano lens could be the test lens for all prescription (Rx) lenses and to investigate why Rx lenses pop out of safety eyewear. Plano and Rx polycarbonate lenses (n = 641) with varying thickness and edge geometry, mounted on steel lens holders, and Rx safety eyewear (n = 128) placed on headforms were impacted with test objects of varying diameter and hardness. Impacts were studied with 500 to 2,000 frames-per-second motion analysis. Plano lenses were at least, or more, prone to failure (dislodgment, perforation, shatter, or crack) than -3.00 or +3.00 lenses of the same minimum thickness. More than 40% of safety frames with removable lenses broke or had lenses pop out when impacted with energies expected in industry and sports. Plano lenses can be used as the test lenses for all Rx lenses made of the same material with the same minimal thickness. The ANSI Z87.1-1989 industrial standard for Rx eyewear is inadequate for sports or other activities with high-impact potential. The best lens-retention system has, as a component, a frame with a bevel perpendicular to a frontal impact force.

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

PubMed

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

2012-09-01

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

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

PubMed Central

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

2015-01-01

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

Integrated deterministic and probabilistic safety analysis for safety assessment of nuclear power plants

DOE PAGES

Di Maio, Francesco; Zio, Enrico; Smith, Curtis; ...

2015-07-06

The present special issue contains an overview of the research in the field of Integrated Deterministic and Probabilistic Safety Assessment (IDPSA) of Nuclear Power Plants (NPPs). Traditionally, safety regulation for NPPs design and operation has been based on Deterministic Safety Assessment (DSA) methods to verify criteria that assure plant safety in a number of postulated Design Basis Accident (DBA) scenarios. Referring to such criteria, it is also possible to identify those plant Structures, Systems, and Components (SSCs) and activities that are most important for safety within those postulated scenarios. Then, the design, operation, and maintenance of these “safety-related” SSCs andmore » activities are controlled through regulatory requirements and supported by Probabilistic Safety Assessment (PSA).« less

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.

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

PubMed

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

2013-11-01

At time of approval, knowledge of the full benefit risk of any drug is limited, in particular with regards to safety. Post-approval surveillance of potential drug safety concerns is recognized as an important task of regulatory agencies. For innovative, often first-in-class drugs, safety knowledge at time of approval is often even less extensive and these may require tighter scrutiny post approval. We evaluated whether more post-approval serious safety issues were identified for drugs with a higher level of innovation. A cohort study was performed that included all new active substances approved under the European Centralized Procedure and for which serious safety issues were identified post-approval from 1 January 1999 to 1 January 2012. Serious safety issues were defined as issues requiring a Direct Healthcare Professional Communication to alert individual healthcare professionals of a new serious safety issue, or a safety-related drug withdrawal. Data were retrieved from publicly available websites of the Dutch Medicines Evaluation Board and the European Medicines Agency. The level of innovation was scored using a validated algorithm, grading drugs as important (A), moderate (B) or modest (C) innovations or as pharmacological or technological (pharm/tech) innovations. The data were analyzed using appropriate descriptive statistics and Kaplan-Meier analysis, with a Mantel-Cox log-rank test, and Cox-regression models correcting for follow-up duration, to identify a possible trend in serious safety issues with an increasing level of innovation. In Europe, 279 new drugs were approved between 1999 and 2011. Fifty-nine (21 %) were graded as important, 63 (23 %) moderate, or 34 (12 %) modest innovations and 123 (44 %) as non-innovative (pharm/tech), while 15 (25 %), 13 (21 %), 8 (24 %) and 17 (14 %) had post-approval safety issues, respectively (p = 0.06, linear-by-linear test). Five drugs were withdrawn from the market. The Kaplan-Meier-derived probability for having

Efficacy and Safety of Lubiprostone in Patients with Opioid-Induced Constipation: Phase 3 Study Results and Pooled Analysis of the Effect of Concomitant Methadone Use on Clinical Outcomes.

PubMed

Spierings, Egilius L H; Drossman, Douglas A; Cryer, Byron; Mazen Jamal, M; Losch-Beridon, Taryn; Mareya, Shadreck M; Wang, Martin

2018-06-01

The efficacy and safety of oral lubiprostone for relieving symptoms of opioid-induced constipation (OIC) in patients with chronic noncancer pain were evaluated in a randomized, double-blind, placebo-controlled study. These data were also pooled with those from two similar phase 3 studies to explore the effects of methadone on treatment response. In the primary study, adults with OIC (fewer than three spontaneous bowel movements [SBMs] per week) were randomized to receive lubiprostone 24 mcg or placebo twice daily for 12 weeks. The primary end point was a change from baseline in the frequency of SBMs at week 8 in patients without a prior dose reduction. For the pooled analysis, the efficacy of lubiprostone was compared with placebo in patients receiving methadone or nonmethadone opioids. Responders were defined as patients with nine or more weeks of nonmissing SBM data who had one or more additional SBMs per week from baseline for each week that data were available and three or more SBMs per week for nine or more weeks. In the primary study, the change from baseline at week 8 in SBM frequency was similar in the lubiprostone and placebo groups (P = 0.842). In the pooled analysis, the response rate was significantly higher with lubiprostone treatment vs placebo for patients receiving nonmethadone opioids (P = 0.002) but was similar between lubiprostone treatment and placebo in patients receiving methadone (P = 0.692). The safety profile of lubiprostone was unaffected by methadone use. The phase 3 study did not meet its primary efficacy end point. However, analysis of pooled data from all phase 3 studies in the OIC clinical development program, stratified by methadone opioid usage, confirmed that lubiprostone is effective for treatment of OIC in patients taking nonmethadone opioids; no safety concerns were identified based on the type of opioid used.

Analysis of occupational accidents: prevention through the use of additional technical safety measures for machinery

PubMed Central

Dźwiarek, Marek; Latała, Agata

2016-01-01

This article presents an analysis of results of 1035 serious and 341 minor accidents recorded by Poland's National Labour Inspectorate (PIP) in 2005–2011, in view of their prevention by means of additional safety measures applied by machinery users. Since the analysis aimed at formulating principles for the application of technical safety measures, the analysed accidents should bear additional attributes: the type of machine operation, technical safety measures and the type of events causing injuries. The analysis proved that the executed tasks and injury-causing events were closely connected and there was a relation between casualty events and technical safety measures. In the case of tasks consisting of manual feeding and collecting materials, the injuries usually occur because of the rotating motion of tools or crushing due to a closing motion. Numerous accidents also happened in the course of supporting actions, like removing pollutants, correcting material position, cleaning, etc. PMID:26652689

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.

Relationship between organizational justice and organizational safety climate: do fairness perceptions influence employee safety behaviour?

PubMed

Gyekye, Seth Ayim; Haybatollahi, Mohammad

2014-01-01

This study investigated the relationships between organizational justice, organizational safety climate, job satisfaction, safety compliance and accident frequency. Ghanaian industrial workers participated in the study (N = 320). Safety climate and justice perceptions were assessed with Hayes, Parender, Smecko, et al.'s (1998) and Blader and Tyler's (2003) scales respectively. A median split was performed to dichotomize participants into 2 categories: workers with positive and workers with negative justice perceptions. Confirmatory factors analysis confirmed the 5-factor structure of the safety scale. Regression analyses and t tests indicated that workers with positive fairness perceptions had constructive perspectives regarding workplace safety, expressed greater job satisfaction, were more compliant with safety policies and registered lower accident rates. These findings provide evidence that the perceived level of fairness in an organization is closely associated with workplace safety perception and other organizational factors which are important for safety. The implications for safety research are discussed.

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.

Simulation for Prediction of Entry Article Demise (SPEAD): An Analysis Tool for Spacecraft Safety Analysis and Ascent/Reentry Risk Assessment

NASA Technical Reports Server (NTRS)

Ling, Lisa

2014-01-01

For the purpose of performing safety analysis and risk assessment for a potential off-nominal atmospheric reentry resulting in vehicle breakup, a synthesis of trajectory propagation coupled with thermal analysis and the evaluation of node failure is required to predict the sequence of events, the timeline, and the progressive demise of spacecraft components. To provide this capability, the Simulation for Prediction of Entry Article Demise (SPEAD) analysis tool was developed. The software and methodology have been validated against actual flights, telemetry data, and validated software, and safety/risk analyses were performed for various programs using SPEAD. This report discusses the capabilities, modeling, validation, and application of the SPEAD analysis tool.

Open-label, multicentre safety study of vemurafenib in 3219 patients with BRAFV600 mutation-positive metastatic melanoma: 2-year follow-up data and long-term responders' analysis.

PubMed

Blank, Christian U; Larkin, James; Arance, Ana M; Hauschild, Axel; Queirolo, Paola; Del Vecchio, Michele; Ascierto, Paolo A; Krajsova, Ivana; Schachter, Jacob; Neyns, Bart; Garbe, Claus; Chiarion Sileni, Vanna; Mandalà, Mario; Gogas, Helen; Espinosa, Enrique; Hospers, Geke A P; Miller, Wilson H; Robson, Susan; Makrutzki, Martina; Antic, Vladan; Brown, Michael P

2017-07-01

The orally available BRAF kinase inhibitor vemurafenib is an effective and tolerable treatment option for patients with metastatic melanoma harbouring BRAF V600 mutations. We assessed the safety of vemurafenib in a large population of patients with few alternative treatment options; we report updated 2-year safety. This was an open-label, multicentre study of vemurafenib (960 mg bid) in patients with previously treated or untreated BRAF mutation-positive metastatic melanoma (cobas ® 4800 BRAF V600 Mutation Test). The primary end-point was safety; efficacy end-points were secondary. An exploratory analysis was performed to assess safety outcomes in patients with long duration of response (DOR) (≥12 or ≥24 months). After a median follow-up of 32.2 months (95% CI, 31.1-33.2 months), 3079/3219 patients (96%) had discontinued treatment. Adverse events (AEs) were largely consistent with previous reports; the most common all-grade treatment-related AEs were arthralgia (37%), alopecia (25%) and hyperkeratosis (23%); the most common grade 3/4 treatment-related AEs were squamous cell carcinoma of the skin (8%) and keratoacanthoma (8%). In the exploratory analysis, patients with DOR ≥12 months (n = 287) or ≥24 months (n = 133) were more likely to experience grade 3/4 AEs than the overall population. No new specific safety signals were observed with longer vemurafenib exposure. After 2 years' follow-up, safety was maintained in this large group of patients with BRAF V600 mutation-positive metastatic melanoma who are more representative of routine clinical practice than typical clinical trial populations. These data suggest that long-term vemurafenib treatment is effective and tolerable without the development of new safety signals. Copyright © 2017 Elsevier Ltd. All rights reserved.

Safety assessment of widely used fermented virgin coconut oil (Cocos nucifera) in Malaysia: Chronic toxicity studies and SAR analysis of the active components.

PubMed

Ibrahim, Ahmad H; Khan, Md Shamsuddin Sultan; Al-Rawi, Sawsan S; Ahamed, Mohamed B Khadeer; Majid, Aman Shah Bin Abdul; Al-Suede, Fouad Saleih R; Ji, Dan; Majid, Amin Malik Shah Abdul

2016-11-01

Fermented Virgin Coconut Oil (FVCO) is widely used in the Southeast Asia as food and traditional medicine. The objective of the present study is the evaluation of chronic safety of the commercialized FVCO of Malaysia and other Southeast Asian countries. A single dose of 5000 mg/kg of FVCO was administered orally in rats (each group, n = 5) for the acute toxicity study and 175, 550 and 2000 mg/kg for sub-chronic and chronic studies (each group, n = 10), respectively. The behavior, mortality, and body weight of the rats were assessed to determine the toxic effects of FVCO. The haematology, biochemistry and histopathology of the treated rats were evaluated. The treated rats were safe with the dose of 5000 mg/kg in acute, sub-chronic and chronic indication. Abnormal clinical signs and morphology (gross necroscopy), changes of organ weight, anomalous haematology and biochemistry indexes were not found in comparison with the control (p > 0.05). In general, food and water intake were higher in the treated rats related to control. It was concluded that the presence of the antioxidant active compounds of FVCO might be the reason of safety. The structure activity relationship (SAR) provides a comprehensive mechanism to determine the safety that is the presence of the electron donating phenolic groups, carbonyl groups, and carboxylic acid in the ortho and meta position of the aromatic rings. The SAR showed the antioxidant properties of myristic acid and lauric acid determined by GC-MS analysis. This result suggests the safety of FVCO for chronic use, nutritional activity that FVCO formulation complies the requirements of regulatory agencies. Copyright © 2016 Elsevier Inc. All rights reserved.

Improving food safety within the dairy chain: an application of conjoint analysis.

PubMed

Valeeva, N I; Meuwissen, M P M; Lansink, A G J M Oude; Huirne, R B M

2005-04-01

This study determined the relative importance of attributes of food safety improvement in the production chain of fluid pasteurized milk. The chain was divided into 4 blocks: "feed" (compound feed production and its transport), "farm" (dairy farm), "dairy processing" (transport and processing of raw milk, delivery of pasteurized milk), and "consumer" (retailer/catering establishment and pasteurized milk consumption). The concept of food safety improvement focused on 2 main groups of hazards: chemical (antibiotics and dioxin) and microbiological (Salmonella, Escherichia coli, Mycobacterium paratuberculosis, and Staphylococcus aureus). Adaptive conjoint analysis was used to investigate food safety experts' perceptions of the attributes' importance. Preference data from individual experts (n = 24) on 101 attributes along the chain were collected in a computer-interactive mode. Experts perceived the attributes from the "feed" and "farm" blocks as being more vital for controlling the chemical hazards; whereas the attributes from the "farm" and "dairy processing" were considered more vital for controlling the microbiological hazards. For the chemical hazards, "identification of treated cows" and "quality assurance system of compound feed manufacturers" were considered the most important attributes. For the microbiological hazards, these were "manure supply source" and "action in salmonellosis and M. paratuberculosis cases". The rather high importance of attributes relating to quality assurance and traceability systems of the chain participants indicates that participants look for food safety assurance from the preceding participants. This information has substantial decision-making implications for private businesses along the chain and for the government regarding the food safety improvement of fluid pasteurized milk.

FY2017 Updates to the SAS4A/SASSYS-1 Safety Analysis Code

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

Fanning, T. H.

The SAS4A/SASSYS-1 safety analysis software is used to perform deterministic analysis of anticipated events as well as design-basis and beyond-design-basis accidents for advanced fast reactors. It plays a central role in the analysis of U.S. DOE conceptual designs, proposed test and demonstration reactors, and in domestic and international collaborations. This report summarizes the code development activities that have taken place during FY2017. Extensions to the void and cladding reactivity feedback models have been implemented, and Control System capabilities have been improved through a new virtual data acquisition system for plant state variables and an additional Block Signal for a variablemore » lag compensator to represent reactivity feedback for novel shutdown devices. Current code development and maintenance needs are also summarized in three key areas: software quality assurance, modeling improvements, and maintenance of related tools. With ongoing support, SAS4A/SASSYS-1 can continue to fulfill its growing role in fast reactor safety analysis and help solidify DOE’s leadership role in fast reactor safety both domestically and in international collaborations.« less

Bayesian Statistics and Uncertainty Quantification for Safety Boundary Analysis in Complex Systems

NASA Technical Reports Server (NTRS)

He, Yuning; Davies, Misty Dawn

2014-01-01

The analysis of a safety-critical system often requires detailed knowledge of safe regions and their highdimensional non-linear boundaries. We present a statistical approach to iteratively detect and characterize the boundaries, which are provided as parameterized shape candidates. Using methods from uncertainty quantification and active learning, we incrementally construct a statistical model from only few simulation runs and obtain statistically sound estimates of the shape parameters for safety boundaries.

Annotation analysis for testing drug safety signals using unstructured clinical notes

PubMed Central

2012-01-01

Background The electronic surveillance for adverse drug events is largely based upon the analysis of coded data from reporting systems. Yet, the vast majority of electronic health data lies embedded within the free text of clinical notes and is not gathered into centralized repositories. With the increasing access to large volumes of electronic medical data—in particular the clinical notes—it may be possible to computationally encode and to test drug safety signals in an active manner. Results We describe the application of simple annotation tools on clinical text and the mining of the resulting annotations to compute the risk of getting a myocardial infarction for patients with rheumatoid arthritis that take Vioxx. Our analysis clearly reveals elevated risks for myocardial infarction in rheumatoid arthritis patients taking Vioxx (odds ratio 2.06) before 2005. Conclusions Our results show that it is possible to apply annotation analysis methods for testing hypotheses about drug safety using electronic medical records. PMID:22541596

Safety analysis of urban signalized intersections under mixed traffic.

PubMed

S, Anjana; M V L R, Anjaneyulu

2015-02-01

This study examined the crash causative factors of signalized intersections under mixed traffic using advanced statistical models. Hierarchical Poisson regression and logistic regression models were developed to predict the crash frequency and severity of signalized intersection approaches. The prediction models helped to develop general safety countermeasures for signalized intersections. The study shows that exclusive left turn lanes and countdown timers are beneficial for improving the safety of signalized intersections. Safety is also influenced by the presence of a surveillance camera, green time, median width, traffic volume, and proportion of two wheelers in the traffic stream. The factors that influence the severity of crashes were also identified in this study. As a practical application, the safe values of deviation of green time provided from design green time, with varying traffic volume, is presented in this study. This is a useful tool for setting the appropriate green time for a signalized intersection approach with variations in the traffic volume. Copyright © 2014 Elsevier Ltd. All rights reserved.

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

[The safety data sheets of the paint and coatings sector: analysis of the items of most interest to health and safety in the workplace].

PubMed

Boniardi, Luca; Canti, Zulejka; Cantoni, Susanna; Fustinoni, Silvia

2014-07-15

The interlinked REACH-CLP regulations promote the sharing of knowledge regarding the risks and hazards of chemicals throughout the supply chain. The safety data sheet (SDS) is the main instrument to achieve this goal. to study 100 SDS of paints and coatings sector in order to highlight major criticisms related to health and safety of workers. Using the criteria prescribed by Regulation 453/2010/EC and preparing a suitable check list, some items of the sections 1 "Identification of the substance/mixture and of the company", 2 "Hazards identification", 3 "Composition/information on ingredients", the first part of section 7 "Precautions for safe handling", sections 8 "Exposure controls/personal protection" and 16 "Other information", were therefore evaluated for their appropriateness. Seven SDS were written in a foreign language and were excluded from further analysis. Of the remaining 93 SDS, only 23% had a proportion of adequate items greater than 80%, 49 % had adequate items between 60 and 80%, and 28% had less than 60% adequate items. The most critical sections were those relating to workers' safe handling and exposure controls and protection. In conclusion, from the analysis of SDS we found high percentages of inadequacy, especially in sections 7 and 8, the most relevant for the protection of the health and safety of workers.

Professional Preparation for Careers in Safety.

ERIC Educational Resources Information Center

Della-Giustina, Daniel

There has been a long existing need for individuals with extensive training and concentration in safety studies. The foundation areas upon which a curriculum for training safety practitioners is based should include: (1) trends in accident prevention and control; (2) safety analysis of human and machine tasks; (3) hazard identification and control…

Nanotechnology Safety Self-Study

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

Grogin, Phillip W.

2016-03-29

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

Crash Simulation and Animation: 'A New Approach for Traffic Safety Analysis'

DOT National Transportation Integrated Search

2001-02-01

This researchs objective is to present a methodology to supplement the conventional traffic safety analysis techniques. This methodology aims at using computer simulation to animate and visualize crash occurrence at high-risk locations. This methodol...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-26

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-22

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-29

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-27

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

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.

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

Pharmacodynamic analysis of eribulin safety in breast cancer patients using real-world post-marketing surveillance data.

PubMed

Kawamura, Takahisa; Kasai, Hidefumi; Fermanelli, Valentina; Takahashi, Toshiaki; Sakata, Yukinori; Matsuoka, Toshiyuki; Ishii, Mika; Tanigawara, Yusuke

2018-06-22

Post-marketing surveillance is useful to collect safety data in real-world clinical settings. In this study, we firstly applied the post-marketing real-world data on a mechanistic model analysis for neutropenic profiles of eribulin in patients with recurrent or metastatic breast cancer (RBC/MBC). Demographic and safety data were collected using an active surveillance method from eribulin-treated RBC/MBC patients. Changes in neutrophil counts over time were analyzed using a mechanistic pharmacodynamic model. Pathophysiological factors that may affect the severity of neutropenia were investigated and neutropenic patterns were simulated for different treatment schedules. Clinical and laboratory data were collected from 401 patients (5199 neutrophil count measurements) who had not received granulocyte colony stimulating factor and were eligible for pharmacodynamic analysis. The estimated mean parameters were: mean transit time = 104.5 h, neutrophil proliferation rate constant = 0.0377 h -1 , neutrophil elimination rate constant = 0.0295 h -1 , and linear coefficient of drug effect = 0.0413 mL/ng. Low serum albumin levels and low baseline neutrophil counts were associated with severe neutropenia. The probability of grade ≥3 neutropenia was predicted to be 69%, 27%, and 27% for patients on standard, biweekly, and triweekly treatment scenarios, respectively, based on virtual simulations using the developed pharmacodynamic model. In conclusion, this is the first application of post-marketing surveillance data to a model-based safety analysis. This analysis of safety data reflecting authentic clinical settings will provide useful information on the safe use and potential risk factors of eribulin. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

FEM Analysis of Glass/Epoxy Composite Based Industrial Safety Helmet

NASA Astrophysics Data System (ADS)

Ram, Khushi; Bajpai, Pramendra Kumar

2017-08-01

Recently, the use of fiber reinforced polymer in every field of engineering (automobile, industry and aerospace) and medical has increased due to its distinctive mechanical properties. The fiber based polymer composites are more popular because these have high strength, light in weight, low cost and easily available. In the present work, the finite element analysis (FEA) of glass/epoxy composite based industrial safety helmet has been performed using solid-works simulation software. The modeling results show that glass fiber reinforced epoxy composite can be used as a material for fabrication of industrial safety helmet which has good mechanical properties than the existing helmet material.

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

Knowledge and perceived implementation of food safety risk analysis framework in Latin America and the Caribbean region.

PubMed

Cherry, C; Mohr, A Hofelich; Lindsay, T; Diez-Gonzalez, F; Hueston, W; Sampedro, F

2014-12-01

Risk analysis is increasingly promoted as a tool to support science-based decisions regarding food safety. An online survey comprising 45 questions was used to gather information on the implementation of food safety risk analysis within the Latin American and Caribbean regions. Professionals working in food safety in academia, government, and private sectors in Latin American and Caribbean countries were contacted by email and surveyed to assess their individual knowledge of risk analysis and perceptions of its implementation in the region. From a total of 279 participants, 97% reported a familiarity with risk analysis concepts; however, fewer than 25% were able to correctly identify its key principles. The reported implementation of risk analysis among the different professional sectors was relatively low (46%). Participants from industries in countries with a long history of trade with the United States and the European Union, such as Mexico, Brazil, and Chile, reported perceptions of a higher degree of risk analysis implementation (56, 50, and 20%, respectively) than those from the rest of the countries, suggesting that commerce may be a driver for achieving higher food safety standards. Disagreement among respondents on the extent of the use of risk analysis in national food safety regulations was common, illustrating a systematic lack of understanding of the current regulatory status of the country. The results of this survey can be used to target further risk analysis training on selected sectors and countries.

Flammable Gas Safety Self-Study 52827

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

Glass, George

2016-03-17

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

Optimization of coupled multiphysics methodology for safety analysis of pebble bed modular reactor

NASA Astrophysics Data System (ADS)

Mkhabela, Peter Tshepo

The research conducted within the framework of this PhD thesis is devoted to the high-fidelity multi-physics (based on neutronics/thermal-hydraulics coupling) analysis of Pebble Bed Modular Reactor (PBMR), which is a High Temperature Reactor (HTR). The Next Generation Nuclear Plant (NGNP) will be a HTR design. The core design and safety analysis methods are considerably less developed and mature for HTR analysis than those currently used for Light Water Reactors (LWRs). Compared to LWRs, the HTR transient analysis is more demanding since it requires proper treatment of both slower and much longer transients (of time scale in hours and days) and fast and short transients (of time scale in minutes and seconds). There is limited operation and experimental data available for HTRs for validation of coupled multi-physics methodologies. This PhD work developed and verified reliable high fidelity coupled multi-physics models subsequently implemented in robust, efficient, and accurate computational tools to analyse the neutronics and thermal-hydraulic behaviour for design optimization and safety evaluation of PBMR concept The study provided a contribution to a greater accuracy of neutronics calculations by including the feedback from thermal hydraulics driven temperature calculation and various multi-physics effects that can influence it. Consideration of the feedback due to the influence of leakage was taken into account by development and implementation of improved buckling feedback models. Modifications were made in the calculation procedure to ensure that the xenon depletion models were accurate for proper interpolation from cross section tables. To achieve this, the NEM/THERMIX coupled code system was developed to create the system that is efficient and stable over the duration of transient calculations that last over several tens of hours. Another achievement of the PhD thesis was development and demonstration of full-physics, three-dimensional safety analysis

The effect of nurses' empowerment perceptions on job safety behaviours: a research study in Turkey.

PubMed

Yıldız, Ahmet; Kaya, Sıdıka; Teleş, Mesut; Korku, Cahit

2018-05-03

This study aimed to investigate the effect of nurses' empowerment perceptions on job safety behaviours. A survey of 377 nurses working in five hospitals in Turkey was conducted using the conditions of work effectiveness questionnaire, psychological empowerment instrument, universal precautions compliance scale and occupational health and safety obligations compliance scale. Relations between variables were tested using Pearson's correlation and path analysis. There was a moderate and statistically significant relationship between psychological and structural empowerment and complying with universal safety measures and meeting occupational health and safety obligations. Also, an increase of 1 unit on the level of psychological empowerment was found to correspond to an increase of 0.37 units on the level of universal precautions compliance and to an increase of 0.46 units on the level of occupational health and safety obligations compliance. As such, an increase of 1 unit in structural empowerment corresponds to an increase of 0.53 units on the level of universal precautions compliance and to an increase of 0.36 units (total effect) on the level of occupational health and safety obligations compliance. The findings reveal that empowerment is a valuable tool for nurses' positive job safety behaviours.

Flight deck party line issues : an Aviation Safety Reporting System analysis

DOT National Transportation Integrated Search

1995-06-01

This document describes an analysis of the Aviation Safety Reporting System : (ASRS) database with regards to human factors aspects concerning the : implementation of Data Link into the flightdeck. The ASRS database contains : thousands of reports co...

A comparative analysis of occupational health and safety risk prevention practices in Sweden and Spain.

PubMed

Morillas, Rosa María; Rubio-Romero, Juan Carlos; Fuertes, Alba

2013-12-01

Scandinavian countries such as Sweden implemented the occupational health and safety (OHS) measures in the European Directive 89/391/EEC earlier than other European counties, including Spain. In fact, statistics on workplace accident rates reveal that between 2004 and 2009, there were considerably fewer accidents in Sweden than in Spain. The objective of the research described in this paper was to reduce workplace accidents and to improve OHS management in Spain by exploring the OHS practices in Sweden. For this purpose, an exploratory comparative study was conducted, which focused on the effectiveness of the EU directive in both countries. The study included a cross-sectional analysis of workplace accident rates and other contextual indicators in both national contexts. A case study of 14 Swedish and Spanish companies identified 14 differences in the preventive practices implemented. These differences were then assessed with a Delphi study to evaluate their contribution to the reduction of workplace accidents and their potential for improving health and safety management in Spain. The results showed that there was agreement concerning 12 of the 14 practices. Finally, we discuss opportunities of improvement in Spanish companies so that they can make their risk management practices more effective. The findings of this comparative study on the implementation of the European Directive 89/391/EEC in both Sweden and Spain have revealed health and safety managerial practices which, if properly implemented, could contribute to improved work conditions and accident statistics of Spanish companies. In particular, the results suggest that Spanish employers, safety managers, external prevention services, safety deputies and Labour Inspectorates should consider implementing streamlined internal preventive management, promoting the integration of prevention responsibilities to the chain of command, and preventing health and safety management from becoming a mere exchange of

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Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-11

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-01

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

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

PubMed

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

2011-10-26

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

Gender differences in the adverse events’ profile registered in seven observational studies of a wide gender-medicine (MetaGeM) project: the MetaGeM safety analysis

PubMed Central

Colombo, Delia; Zagni, Emanuela; Nica, Mihaela; Rizzoli, Sara; Ori, Alessandra; Bellia, Gilberto

2016-01-01

Background MetaGeM is a wide gender-medicine project comprising post hoc and meta-analyses by gender of clinical outcomes, therapeutic approaches, and safety data from previously conducted observational studies to explore possible gender differences in real-life clinical settings. We report the results of the safety meta-analysis of seven MetaGeM studies, evaluating gender differences in adverse event (AE) incidence and severity. Methods Data were collected between February 2002 and July 2013. Male and female patients were compared for the main safety variables, using Student’s t-test, χ2 test, or Fisher’s exact test as appropriate. As supportive analysis, a logistic regression model was estimated to evaluate associations between gender and outcome. Results In total, 4,870 patients (46% females, 54% males) were included in the analysis; age was higher for females (mean ± standard deviation 61.2±18.3 years) than males (56.3±16.6 years). Overall, 264 AEs were reported (59.1% in males). There were no significant gender differences in the percentage of patients with at least one AE: 3.0% for females versus 3.9% for males, χ2 test P>0.05. According to the logistic regression model results, no association between gender and AEs occurrence seems to exist. A statistically significant gender difference in the percentage of drug-related AEs emerged (37.6% in females vs 20.8% in males, χ2 P=0.0039). Slightly significantly more AEs in females were addressed with treatment compared with males (78.1% vs 66.7%, χ2 P=0.0485). Total serious AEs (SAEs) were 47 (72% in males). The frequency of patients with ≥1 SAE was 0.6% in females versus 1.2% in males (χ2 test P=0.0246). Conclusion This safety analysis on a large sample of almost 5,000 patients with different diseases and treated with a wide range of different drugs provides a useful overview on possible gender differences in drug tolerability, which may be helpful in more accurately designing future clinical trials

Using Qualitative Hazard Analysis to Guide Quantitative Safety Analysis

NASA Technical Reports Server (NTRS)

Shortle, J. F.; Allocco, M.

2005-01-01

Quantitative methods can be beneficial in many types of safety investigations. However, there are many difficulties in using quantitative m ethods. Far example, there may be little relevant data available. This paper proposes a framework for using quantitative hazard analysis to prioritize hazard scenarios most suitable for quantitative mziysis. The framework first categorizes hazard scenarios by severity and likelihood. We then propose another metric "modeling difficulty" that desc ribes the complexity in modeling a given hazard scenario quantitatively. The combined metrics of severity, likelihood, and modeling difficu lty help to prioritize hazard scenarios for which quantitative analys is should be applied. We have applied this methodology to proposed concepts of operations for reduced wake separation for airplane operatio ns at closely spaced parallel runways.

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

PubMed

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

2014-01-01

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

Analysis of existing work-zone devices with MASH safety performance criteria.

DOT National Transportation Integrated Search

2009-02-01

Crashworthy, work-zone, portable sign support systems accepted under NCHRP Report No. 350 were analyzed to : predict their safety peformance according to the TL-3 MASH evaluation criteria. An analysis was conducted to determine : which hardware param...

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.

Combustion Safety Simplified Test Protocol Field Study

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

Brand, L; Cautley, D.; Bohac, D.

2015-11-05

"9Combustions safety is an important step in the process of upgrading homes for energy efficiency. There are several approaches used by field practitioners, but researchers have indicated that the test procedures in use are complex to implement and provide too many false positives. Field failures often mean that the house is not upgraded until after remediation or not at all, if not include in the program. In this report the PARR and NorthernSTAR DOE Building America Teams provide a simplified test procedure that is easier to implement and should produce fewer false positives. A survey of state weatherization agencies onmore » combustion safety issues, details of a field data collection instrumentation package, summary of data collected over seven months, data analysis and results are included. The project provides several key results. State weatherization agencies do not generally track combustion safety failures, the data from those that do suggest that there is little actual evidence that combustion safety failures due to spillage from non-dryer exhaust are common and that only a very small number of homes are subject to the failures. The project team collected field data on 11 houses in 2015. Of these homes, two houses that demonstrated prolonged and excessive spillage were also the only two with venting systems out of compliance with the National Fuel Gas Code. The remaining homes experienced spillage that only occasionally extended beyond the first minute of operation. Combustion zone depressurization, outdoor temperature, and operation of individual fans all provide statistically significant predictors of spillage.« less

Identifying knowledge activism in worker health and safety representation: A cluster analysis.

PubMed

Hall, Alan; Oudyk, John; King, Andrew; Naqvi, Syed; Lewchuk, Wayne

2016-01-01

Although worker representation in OHS has been widely recognized as contributing to health and safety improvements at work, few studies have examined the role that worker representatives play in this process. Using a large quantitative sample, this paper seeks to confirm findings from an earlier exploratory qualitative study that worker representatives can be differentiated by the knowledge intensive tactics and strategies that they use to achieve changes in their workplace. Just under 900 worker health and safety representatives in Ontario completed surveys which asked them to report on the amount of time they devoted to different types of representation activities (i.e., technical activities such as inspections and report writing vs. political activities such as mobilizing workers to build support), the kinds of conditions or hazards they tried to address through their representation (e.g., housekeeping vs. modifications in ventilation systems), and their reported success in making positive improvements. A cluster analysis was used to determine whether the worker representatives could be distinguished in terms of the relative time devoted to different activities and the clusters were then compared with reference to types of intervention efforts and outcomes. The cluster analysis identified three distinct groupings of representatives with significant differences in reported types of interventions and in their level of reported impact. Two of the clusters were consistent with the findings in the exploratory study, identified as knowledge activism for greater emphasis on knowledge based political activity and technical-legal representation for greater emphasis on formalized technical oriented procedures and legal regulations. Knowledge activists were more likely to take on challenging interventions and they reported more impact across the full range of interventions. This paper provides further support for the concepts of knowledge activism and technical

75 FR 8239 - School Food Safety Program Based on Hazard Analysis and Critical Control Point Principles (HACCP...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-24

... 0584-AD65 School Food Safety Program Based on Hazard Analysis and Critical Control Point Principles... Safety Program Based on Hazard Analysis and Critical Control Point Principles (HACCP) was published on... of Management and Budget (OMB) cleared the associated information collection requirements (ICR) on...

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

PubMed

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

2013-12-01

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

Safety Analysis of Soybean Processing for Advanced Life Support

NASA Technical Reports Server (NTRS)

Hentges, Dawn L.

1999-01-01

Soybeans (cv. Hoyt) is one of the crops planned for food production within the Advanced Life Support System Integration Testbed (ALSSIT), a proposed habitat simulation for long duration lunar/Mars missions. Soybeans may be processed into a variety of food products, including soymilk, tofu, and tempeh. Due to the closed environmental system and importance of crew health maintenance, food safety is a primary concern on long duration space missions. Identification of the food safety hazards and critical control points associated with the closed ALSSIT system is essential for the development of safe food processing techniques and equipment. A Hazard Analysis Critical Control Point (HACCP) model was developed to reflect proposed production and processing protocols for ALSSIT soybeans. Soybean processing was placed in the type III risk category. During the processing of ALSSIT-grown soybeans, critical control points were identified to control microbiological hazards, particularly mycotoxins, and chemical hazards from antinutrients. Critical limits were suggested at each CCP. Food safety recommendations regarding the hazards and risks associated with growing, harvesting, and processing soybeans; biomass management; and use of multifunctional equipment were made in consideration of the limitations and restraints of the closed ALSSIT.

Final safety analysis report for the Galileo Mission: Volume 1, Reference design document

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

Not Available

The Galileo mission uses nuclear power sources called Radioisotope Thermoelectric Generators (RTGs) to provide the spacecraft's primary electrical power. Because these generators contain nuclear material, a Safety Analysis Report (SAR) is required. A preliminary SAR and an updated SAR were previously issued that provided an evolving status report on the safety analysis. As a result of the Challenger accident, the launch dates for both Galileo and Ulysses missions were later rescheduled for November 1989 and October 1990, respectively. The decision was made by agreement between the DOE and the NASA to have a revised safety evaluation and report (FSAR) preparedmore » on the basis of these revised vehicle accidents and environments. The results of this latest revised safety evaluation are presented in this document (Galileo FSAR). Volume I, this document, provides the background design information required to understand the analyses presented in Volumes II and III. It contains descriptions of the RTGs, the Galileo spacecraft, the Space Shuttle, the Inertial Upper Stage (IUS), the trajectory and flight characteristics including flight contingency modes, and the launch site. There are two appendices in Volume I which provide detailed material properties for the RTG.« less

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...

Learning health 'safety' within non-technical skills interprofessional simulation education: a qualitative study.

PubMed

Gordon, Morris; Fell, Christopher W R; Box, Helen; Farrell, Michael; Stewart, Alison

2017-01-01

Healthcare increasingly recognises and focusses on the phenomena of 'safe practice' and 'patient safety.' Success with non-technical skills (NTS) training in other industries has led to widespread transposition to healthcare education, with communication and teamwork skills central to NTS frameworks. This study set out to identify how the context of interprofessional simulation learning influences NTS acquisition and development of 'safety' amongst learners. Participants receiving a non-technical skills (NTS) safety focussed training package were invited to take part in a focus group interview which set out to explore communication, teamwork, and the phenomenon of safety in the context of the learning experiences they had within the training programme. The analysis was aligned with a constructivist paradigm and took an interactive methodological approach. The analysis proceeded through three stages, consisting of open, axial, and selective coding, with constant comparisons taking place throughout each phase. Each stage provided categories that could be used to explore the themes of the data. Additionally, to ensure thematic saturation, transcripts of observed simulated learning encounters were then analysed. Six themes were established at the axial coding level, i.e., analytical skills, personal behaviours, communication, teamwork, context, and pedagogy. Underlying these themes, two principal concepts emerged, namely: intergroup contact anxiety - as both a result of and determinant of communication - and teamwork, both of which must be considered in relation to context. These concepts have subsequently been used to propose a framework for NTS learning. This study highlights the role of intergroup contact anxiety and teamwork as factors in NTS behaviour and its dissipation through interprofessional simulation learning. Therefore, this should be a key consideration in NTS education. Future research is needed to consider the role of the affective non

Patient safety in the clinical laboratory: a longitudinal analysis of specimen identification errors.

PubMed

Wagar, Elizabeth A; Tamashiro, Lorraine; Yasin, Bushra; Hilborne, Lee; Bruckner, David A

2006-11-01

Patient safety is an increasingly visible and important mission for clinical laboratories. Attention to improving processes related to patient identification and specimen labeling is being paid by accreditation and regulatory organizations because errors in these areas that jeopardize patient safety are common and avoidable through improvement in the total testing process. To assess patient identification and specimen labeling improvement after multiple implementation projects using longitudinal statistical tools. Specimen errors were categorized by a multidisciplinary health care team. Patient identification errors were grouped into 3 categories: (1) specimen/requisition mismatch, (2) unlabeled specimens, and (3) mislabeled specimens. Specimens with these types of identification errors were compared preimplementation and postimplementation for 3 patient safety projects: (1) reorganization of phlebotomy (4 months); (2) introduction of an electronic event reporting system (10 months); and (3) activation of an automated processing system (14 months) for a 24-month period, using trend analysis and Student t test statistics. Of 16,632 total specimen errors, mislabeled specimens, requisition mismatches, and unlabeled specimens represented 1.0%, 6.3%, and 4.6% of errors, respectively. Student t test showed a significant decrease in the most serious error, mislabeled specimens (P < .001) when compared to before implementation of the 3 patient safety projects. Trend analysis demonstrated decreases in all 3 error types for 26 months. Applying performance-improvement strategies that focus longitudinally on specimen labeling errors can significantly reduce errors, therefore improving patient safety. This is an important area in which laboratory professionals, working in interdisciplinary teams, can improve safety and outcomes of care.

Safe Kids Week: Analysis of gender bias in a national child safety campaign, 1997-2016.

PubMed

Bauer, Michelle E E; Brussoni, Mariana; Giles, Audrey R; Fuselli, Pamela

2017-09-29

Background and Purpose Child safety campaigns play an important role in disseminating injury prevention information to families. A critical discourse analysis of gender bias in child safety campaign marketing materials can offer important insights into how families are represented and the potential influence that gender bias may have on uptake of injury prevention information. Methods Our approach was informed by poststructural feminist theory, and we used critical discourse analysis to identify discourses within the poster materials. We examined the national Safe Kids Canada Safe Kids Week campaign poster material spanning twenty years (1997-2016). Specifically, we analyzed the posters' typeface, colour, images, and language to identify gender bias in relation to discourses surrounding parenting, safety, and societal perceptions of gender. Results The findings show that there is gender bias present in the Safe Kids Week poster material. The posters represent gender as binary, mothers as primary caregivers, and showcase stereotypically masculine sporting equipment among boys and stereotypically feminine equipment among girls. Interestingly, we found that the colour and typeface of the text both challenge and perpetuate the feminization of safety. Discussion It is recommended that future child safety campaigns represent changing family dynamics, include representations of children with non-traditionally gendered sporting equipment, and avoid the representation of gender as binary. This analysis contributes to the discussion of the feminization of safety in injury prevention research and challenges the ways in which gender is represented in child safety campaigns. © 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.

Assessment of documentation requirements under DOE 5481. 1, Safety Analysis and Review System (SARS)

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

Browne, E.T.

1981-03-01

This report assesses the requirements of DOE Order 5481.1, Safety Analysis and Review System for DOE Operations (SARS) in regard to maintaining SARS documentation. Under SARS, all pertinent details of the entire safety analysis and review process for each DOE operation are to be traceable from the initial identification of a hazard. This report is intended to provide assistance in identifying the points in the SARS cycle at which documentation is required, what type of documentation is most appropriate, and where it ultimately should be maintained.

Efficacy and safety of prophylactic levetiracetam in supratentorial brain tumour surgery: a systematic review and meta‐analysis

PubMed Central

Tsaousi, Georgia; Apostolidou, Eirini; Karakoulas, Konstantinos; Kouvelas, Dimitrios; Amaniti, Ekaterini

2016-01-01

Aims The aim of this study was to perform an up‐to‐date systematic review and meta‐analysis on the efficacy and safety of prophylactic administration of levetiracetam in brain tumour patients. Method A systematic review of studies published until April 2015 was conducted using Scopus/Elsevier, EMBASE and MEDLINE. The search was limited to articles reporting results from adult patients, suffering from brain tumour, undergoing supratentorial craniotomy for tumour resection or biopsy and administered levetiracetam in the perioperative period for seizure prophylaxis. Outcomes included the efficacy and safety of levetiracetam, as well as the tolerability of the specific regimen, defined by the discontinuation of the treatment due to side effects. Results The systematic review included 1148 patients from 12 studies comparing levetiracetam with no treatment, phenytoin and valproate, while only 243 patients from three studies, comparing levetiracetam vs phenytoin efficacy and safety, were included in the meta‐analysis. The combined results from the meta‐analysis showed that levetiracetam administration was followed by significantly fewer seizures than treatment with phenytoin (OR = 0.12 [0.03–0.42]: χ2 = 1.76: I2 = 0%). Analysis also showed significantly fewer side effects in patients receiving levetiracetam, compared to other groups (P < 0.05). The combined results showed fewer side effects in the levetiracetam group compared to the phenytoin group (OR = 0.65 [0.14–2.99]: χ2 = 8.79: I2 = 77%). Conclusions The efficacy of prophylaxis with levetiracetam seems to be superior to that with phenytoin and valproate administration. Moreover, levetiracetam use demonstrates fewer side effects in brain tumour patients. Nevertheless, high risk of bias and moderate methodological quality must be taken into account when considering these results. PMID:26945547

14 CFR 415.115 - Flight safety.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 4 2012-01-01 2012-01-01 false Flight safety. 415.115 Section 415.115... From a Non-Federal Launch Site § 415.115 Flight safety. (a) Flight safety analysis. An applicant's safety review document must describe each analysis method employed to meet the flight safety analysis...

14 CFR 415.115 - Flight safety.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Flight safety. 415.115 Section 415.115... From a Non-Federal Launch Site § 415.115 Flight safety. (a) Flight safety analysis. An applicant's safety review document must describe each analysis method employed to meet the flight safety analysis...

14 CFR 415.115 - Flight safety.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 4 2013-01-01 2013-01-01 false Flight safety. 415.115 Section 415.115... From a Non-Federal Launch Site § 415.115 Flight safety. (a) Flight safety analysis. An applicant's safety review document must describe each analysis method employed to meet the flight safety analysis...

14 CFR 415.115 - Flight safety.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 4 2011-01-01 2011-01-01 false Flight safety. 415.115 Section 415.115... From a Non-Federal Launch Site § 415.115 Flight safety. (a) Flight safety analysis. An applicant's safety review document must describe each analysis method employed to meet the flight safety analysis...

14 CFR 415.115 - Flight safety.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 4 2014-01-01 2014-01-01 false Flight safety. 415.115 Section 415.115... From a Non-Federal Launch Site § 415.115 Flight safety. (a) Flight safety analysis. An applicant's safety review document must describe each analysis method employed to meet the flight safety analysis...

Reliability/safety analysis of a fly-by-wire system

NASA Technical Reports Server (NTRS)

Brock, L. D.; Goddman, H. A.

1980-01-01

An analysis technique has been developed to estimate the reliability of a very complex, safety-critical system by constructing a diagram of the reliability equations for the total system. This diagram has many of the characteristics of a fault-tree or success-path diagram, but is much easier to construct for complex redundant systems. The diagram provides insight into system failure characteristics and identifies the most likely failure modes. A computer program aids in the construction of the diagram and the computation of reliability. Analysis of the NASA F-8 Digital Fly-by-Wire Flight Control System is used to illustrate the technique.

Patient safety culture in Norwegian primary care: a study in out-of-hours casualty clinics and GP practices.

PubMed

Bondevik, Gunnar Tschudi; Hofoss, Dag; Hansen, Elisabeth Holm; Deilkås, Ellen Catharina Tveter

2014-09-01

This study aimed to investigate patient safety attitudes amongst health care providers in Norwegian primary care by using the Safety Attitudes Questionnaire, in both out-of-hours (OOH) casualty clinics and GP practices. The questionnaire identifies five major patient safety factors: Teamwork climate, Safety climate, Job satisfaction, Perceptions of management, and Working conditions. Cross-sectional study. Statistical analysis included multiple linear regression and independent samples t-tests. Seven OOH casualty clinics and 17 GP practices in Norway. In October and November 2012, 510 primary health care providers working in OOH casualty clinics and GP practices (316 doctors and 194 nurses) were invited to participate anonymously. To study whether patterns in patient safety attitudes were related to professional background, gender, age, and clinical setting. The overall response rate was 52%; 72% of the nurses and 39% of the doctors answered the questionnaire. In the OOH clinics, nurses scored significantly higher than doctors on Safety climate and Job satisfaction. Older health care providers scored significantly higher than younger on Safety climate and Working conditions. In GP practices, male health professionals scored significantly higher than female on Teamwork climate, Safety climate, Perceptions of management and Working conditions. Health care providers in GP practices had significant higher mean scores on the factors Safety climate and Working conditions, compared with those working in the OOH clinics. Our study showed that nurses scored higher than doctors, older health professionals scored higher than younger, male GPs scored higher than female GPs, and health professionals in GP practices scored higher than those in OOH clinics - on several patient safety factors.

Ultrasound-Guided Regional Anesthesia and Patient Safety: Update of an Evidence-Based Analysis.

PubMed

Neal, Joseph M

2016-01-01

In 2010, the American Society of Regional Anesthesia and Pain Medicine's evidence-based medicine assessment of ultrasound (US)-guided regional anesthesia (UGRA) analyzed the effect of this nerve localization technology on patient safety. That analysis focused on 4 important regional anesthesia complications: peripheral nerve injury, local anesthetic systemic toxicity (LAST), hemidiaphragmatic paresis (HDP), and pneumothorax. In the intervening 5 years, further research has allowed us to refine our original conclusions. This update reviews previous findings and critically evaluates new literature published since late 2009 that compares the patient safety attributes of UGRA with those of traditional nerve localization methods. As with the previous version of this exercise, analysis focused on randomized controlled trials that compared UGRA with an alternative neural localization method and case series of more than 500 patients. The Jadad score was used to grade individual study quality, and conclusions were graded as to strength of evidence. Of those randomized controlled trials identified by our search techniques, 28 compared the incidence of postoperative nerve symptoms, 27 assessed LAST parameters, 7 studied HDP, and 9 reported the incidence of pneumothorax. The current analysis strengthens our original conclusions that US guidance has no significant effect on the incidence of postoperative neurologic symptoms and that UGRA reduces the incidence and intensity of HDP but does so in an unpredictable manner. Conversely, emerging evidence supports the effectiveness of US guidance for reducing LAST across its clinical presentation continuum. The predicted frequency of pneumothorax has grown smaller in tandem with increased experience with US-guided supraclavicular block. This evidence-based review summarizes both the power and the limitations of UGRA as a tool for improving patient safety. Since the original 2010 publication of this analysis, evidence has continued to

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

PubMed

Jones, Sarahjane

2016-10-01

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

Identifying positive deviants in healthcare quality and safety: a mixed methods study.

PubMed

O'Hara, Jane K; Grasic, Katja; Gutacker, Nils; Street, Andrew; Foy, Robbie; Thompson, Carl; Wright, John; Lawton, Rebecca

2018-01-01

Objective Solutions to quality and safety problems exist within healthcare organisations, but to maximise the learning from these positive deviants, we first need to identify them. This study explores using routinely collected, publicly available data in England to identify positively deviant services in one region of the country. Design A mixed methods study undertaken July 2014 to February 2015, employing expert discussion, consensus and statistical modelling to identify indicators of quality and safety, establish a set of criteria to inform decisions about which indicators were robust and useful measures, and whether these could be used to identify positive deviants. Setting Yorkshire and Humber, England. Participants None - analysis based on routinely collected, administrative English hospital data. Main outcome measures We identified 49 indicators of quality and safety from acute care settings across eight data sources. Twenty-six indicators did not allow comparison of quality at the sub-hospital level. Of the 23 remaining indicators, 12 met all criteria and were possible candidates for identifying positive deviants. Results Four indicators (readmission and patient reported outcomes for hip and knee surgery) offered indicators of the same service. These were selected by an expert group as the basis for statistical modelling, which supported identification of one service in Yorkshire and Humber showing a 50% positive deviation from the national average. Conclusion Relatively few indicators of quality and safety relate to a service level, making meaningful comparisons and local improvement based on the measures difficult. It was possible, however, to identify a set of indicators that provided robust measurement of the quality and safety of services providing hip and knee surgery.

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

DOT National Transportation Integrated Search

2018-01-01

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

Safety culture: analysis of the causal relationships between its key dimensions.

PubMed

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

2007-01-01

Several fields are showing increasing interest in safety culture as a means of reducing accidents in the workplace. The literature shows that safety culture is a multidimensional concept. However, considerable confusion surrounds this concept, about which little consensus has been reached. This study proposes a model for a positive safety culture and tests this on a sample of 455 Spanish companies, using the structural equation modeling statistical technique. Results show the important role of managers in the promotion of employees' safe behavior, both directly, through their attitudes and behaviors, and indirectly, by developing a safety management system. This paper identifies the key dimensions of safety culture. In addition, a measurement scale for the safety management system is validated. This will assist organizations in defining areas where they need to progress if they wish to improve their safety. Also, we stress that managers need to be wholly committed to and personally involved in safety activities, thereby conveying the importance the firm attaches to these issues.

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

PubMed

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

2018-01-01

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

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

PubMed Central

Zeng, Pei-Shan; Huang, Chih-Hsuan

2018-01-01

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

Safety and efficacy of ezetimibe: A meta-analysis.

PubMed

Savarese, Gianluigi; De Ferrari, Gaetano M; Rosano, Giuseppe M C; Perrone-Filardi, Pasquale

2015-12-15

The addition of ezetimibe to statin therapy has been widely demonstrated to significantly reduce low-density lipoprotein cholesterol levels. However, the efficacy of ezetimibe in reducing CV events and its safety has been less investigated. The aim of the current meta-analysis was to report efficacy and safety of ezetimibe from randomized clinical trials. Randomized clinical trials with a follow-up of at least 24 weeks, enrolling more than 200 patients, comparing ezetimibe versus placebo or ezetimibe plus another hypolipidemic agent versus the same hypolipidemic drug alone and reporting at least one event among all-cause and CV mortality, myocardial infarction (MI), stroke and new onset of cancer were included in the analysis. 7 trials enrolling 31,048 patients (median follow-up 34.1 ± 26.3 months; 70% women; mean age 61 ± 8 years) were included in the analysis. Compared to control therapy, ezetimibe significantly reduced the risk of MI by 13.5% (RR: 0.865, 95% CI: 0.801 to 0.934, p<0.001) and the risk of any stroke by 16.0% (RR: 0.840, 95% CI: 0.744 to 0.949, p=0.005), without any effect on all-cause and CV mortality (RR: 1.003, 95% CI: 0.954 to 1.055, p=0.908; RR: 0.958, 95% CI: 0.879 to 1.044, p=0.330; respectively) and risk of new cancer (RR: 1.040, 95% CI: 0.965 to 1.120, p=0.303). Ezetimibe significantly reduces the risk of MI and stroke without any effect on all-cause and CV mortality and risk of cancer. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Seepage-Based Factor of Safety Analysis Using 3D Groundwater Simulation Results

DTIC Science & Technology

2014-08-01

Edris, and D . Richards. 2006. A first-principle, physics- based watershed model: WASH123D. In Watershed models, ed. V. P. Singh and D . K . Frevert...should be cited as follows: Cheng, H.-P., K . D . Winters, S. M. England, and R. E. Pickett. 2014. Factor of safety analysis using 3D groundwater...Journal of Dam Safety 11(3): 33–42. Pickett, R. E., K . D . Winters, H.-P. Cheng, and S. M. England. 2013. Herbert Hoover Dike (HHD) flow model. Project

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

PubMed

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

2012-03-01

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

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.

Understanding parental motivators and barriers to uptake of child poison safety strategies: a qualitative study.

PubMed

Gibbs, L; Waters, E; Sherrard, J; Ozanne-Smith, J; Robinson, J; Young, S; Hutchinson, A

2005-12-01

To develop an understanding of factors acting as barriers and motivators to parental uptake of child poison safety strategies. A qualitative study involving semistructured interviews and focus groups. A grounded theory approach was used for the collection and analysis of data. Sixty five parents of children under 5 years of age, some of whom had experienced an unintentional child poisoning incident. A range of knowledge based, environmental, and behavioral barriers to comprehensive parental uptake of poison safety practices were identified. As a result there tended to be only partial implementation of safety initiatives in the home. Selection of safety practices was often guided by the interests and behaviors of the child. This made the child vulnerable to changes in the home environment, inadequate supervision, and/or shifts in their own behavior and developmental ability. Personal or vicarious exposure of a parent to a child poisoning incident was a significant motivator for parental review of safety practices. Environmental measures targeting child resistant containers, warning labels, and lockable poisons cupboards will support parents' efforts to maintain poison safety. Additional education campaigns using stories of actual poisoning incidents may help to increase awareness of risk and encourage increased uptake.

Safety and pharmacokinetic profile of rufinamide in pediatric patients aged less than 4 years with Lennox-Gastaut syndrome: An interim analysis from a multicenter, randomized, active-controlled, open-label study.

PubMed

Arzimanoglou, Alexis; Ferreira, Jose A; Satlin, Andrew; Mendes, Shannon; Williams, Betsy; Critchley, David; Schuck, Edgar; Hussein, Ziad; Kumar, Dinesh; Dhadda, Shobha; Bibbiani, Francesco

2016-05-01

A good knowledge of safety and age group-specific pharmacokinetics (PK) of antiepileptic drugs (AEDs) in young pediatric patients is of great importance in clinical practice. This paper presents 6-month interim safety and PK from an ongoing 2-year open-label study (Study 303) of adjunctive rufinamide treatment in pediatric subjects ≥ 1 to < 4 years with inadequately controlled epilepsies of the Lennox-Gastaut syndrome (LGS) spectrum. Subjects (N = 37) were randomized to either rufinamide or any other approved AED chosen by the investigator as adjunctive therapy to the subject's existing regimen of 1-3 AEDs. Interim safety results showed that treatment-emergent adverse events (TEAEs) were similar between the rufinamide (22 [88.0%]) and any-other-AED group (9 [81.8%]), with most events considered mild or moderate. A population PK analysis was conducted including plasma rufinamide concentrations from Study 303 and two other study populations of LGS subjects ≥ 4 years. The rufinamide PK profile was dose independent. The apparent clearance (CL/F) estimated from the PK model was 2.19 L/h; it was found to increase significantly as a function of body weight. Coadministration of valproic acid significantly decreased rufinamide CL/F. CL/F was not significantly affected by other concomitant AEDs, age, gender, race, hepatic function, or renal function. No adjustments to body weight-based rufinamide dosing in subjects ≥ 1 to < 4 years are necessary. Rufinamide was safe and well tolerated in these pediatric subjects. Results from the interim analysis demonstrate that rufinamide's safety and PK profile is comparable in subjects ≥ 1 to < 4 and ≥ 4 years with LGS. Study 303 (clinicaltrials.gov: NCT01405053). Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Software Safety Progress in NASA

NASA Technical Reports Server (NTRS)

Radley, Charles F.

1995-01-01

NASA has developed guidelines for development and analysis of safety-critical software. These guidelines have been documented in a Guidebook for Safety Critical Software Development and Analysis. The guidelines represent a practical 'how to' approach, to assist software developers and safety analysts in cost effective methods for software safety. They provide guidance in the implementation of the recent NASA Software Safety Standard NSS-1740.13 which was released as 'Interim' version in June 1994, scheduled for formal adoption late 1995. This paper is a survey of the methods in general use, resulting in the NASA guidelines for safety critical software development and analysis.

Automated Mixed Traffic Vehicle (AMTV) technology and safety study

NASA Technical Reports Server (NTRS)

Johnston, A. R.; Peng, T. K. C.; Vivian, H. C.; Wang, P. K.

1978-01-01

Technology and safety related to the implementation of an Automated Mixed Traffic Vehicle (AMTV) system are discussed. System concepts and technology status were reviewed and areas where further development is needed are identified. Failure and hazard modes were also analyzed and methods for prevention were suggested. The results presented are intended as a guide for further efforts in AMTV system design and technology development for both near term and long term applications. The AMTV systems discussed include a low speed system, and a hybrid system consisting of low speed sections and high speed sections operating in a semi-guideway. The safety analysis identified hazards that may arise in a properly functioning AMTV system, as well as hardware failure modes. Safety related failure modes were emphasized. A risk assessment was performed in order to create a priority order and significant hazards and failure modes were summarized. Corrective measures were proposed for each hazard.

78 FR 4477 - Review of Safety Analysis Reports for Nuclear Power Plants, Introduction

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-22

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0268] Review of Safety Analysis Reports for Nuclear Power... Analysis Reports for Nuclear Power Plants: LWR Edition.'' The new subsection is the Standard Review Plan... Nuclear Power Plants: Integral Pressurized Water Reactor (iPWR) Edition.'' DATES: Comments must be filed...

Safety Alerts: An Observational Study in Portugal.

PubMed

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

2015-09-01

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

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 probabilistic safety analysis of incidents in nuclear research reactors.

PubMed

Lopes, Valdir Maciel; Agostinho Angelo Sordi, Gian Maria; Moralles, Mauricio; Filho, Tufic Madi

2012-06-01

This work aims to evaluate the potential risks of incidents in nuclear research reactors. For its development, two databases of the International Atomic Energy Agency (IAEA) were used: the Research Reactor Data Base (RRDB) and the Incident Report System for Research Reactor (IRSRR). For this study, the probabilistic safety analysis (PSA) was used. To obtain the result of the probability calculations for PSA, the theory and equations in the paper IAEA TECDOC-636 were used. A specific program to analyse the probabilities was developed within the main program, Scilab 5.1.1. for two distributions, Fischer and chi-square, both with the confidence level of 90 %. Using Sordi equations, the maximum admissible doses to compare with the risk limits established by the International Commission on Radiological Protection (ICRP) were obtained. All results achieved with this probability analysis led to the conclusion that the incidents which occurred had radiation doses within the stochastic effects reference interval established by the ICRP-64.

Measuring safety climate in elderly homes.

PubMed

Yeung, Koon-Chuen; Chan, Charles C

2012-02-01

Provision of a valid and reliable safety climate dimension brings enormous benefits to the elderly home sector. The aim of the present study was to make use of the safety climate instrument developed by OSHC to measure the safety perceptions of employees in elderly homes such that the factor structure of the safety climate dimensions of elderly homes could be explored. In 2010, surveys by mustering on site method were administered in 27 elderly homes that had participated in the "Hong Kong Safe and Healthy Residential Care Home Accreditation Scheme" organized by the Occupational Safety and Health Council. Six hundred and fifty-one surveys were returned with a response rate of 54.3%. To examine the factor structure of safety climate dimensions in our study, an exploratory factor analysis (EFA) using principal components analysis method was conducted to identify the underlying factors. The results of the modified seven-factor's safety climate structure extracted from 35 items better reflected the safety climate dimensions of elderly homes. The Cronbach alpha range for this study (0.655 to 0.851) indicated good internal consistency among the seven-factor structure. Responses from managerial level, supervisory and professional level, and front-line staff were analyzed to come up with the suggestion on effective ways of improving the safety culture of elderly homes. The overall results showed that managers generally gave positive responses in the factors evaluated, such as "management commitment and concern to safety," "perception of work risks and some contributory influences," "safety communication and awareness," and "safe working attitude and participation." Supervisors / professionals, and frontline level staff on the other hand, have less positive responses. The result of the lowest score in the factors - "perception of safety rules and procedures" underlined the importance of the relevance and practicability of safety rules and procedures. The modified OSHC

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